0001104659-12-054145.txt : 20120803 0001104659-12-054145.hdr.sgml : 20120803 20120803160107 ACCESSION NUMBER: 0001104659-12-054145 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20120630 FILED AS OF DATE: 20120803 DATE AS OF CHANGE: 20120803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OPTIMER PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001142576 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330830300 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-33291 FILM NUMBER: 121006854 BUSINESS ADDRESS: STREET 1: 10110 SORRENTO VALLEY ROAD STREET 2: SUITE C CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8589090736 MAIL ADDRESS: STREET 1: 10110 SORRENTO VALLEY ROAD STREET 2: SUITE C CITY: SAN DIEGO STATE: CA ZIP: 92121 10-Q 1 a12-13878_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

x      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2012

 

or

 

o         TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from               to              

 

Commission File Number 001-33291

 


 

OPTIMER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware
(State or other jurisdiction of
incorporation or organization)

 

33-0830300
(I.R.S. Employer
Identification No.)

 

10110 Sorrento Valley Road, Suite C
San Diego, CA 92121

(Address of principal executive offices, including zip code)

 

(858) 909-0736
(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days:  Yes x  No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files):  Yes x  No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act:

 

Large Accelerated Filer o

 

Accelerated Filer x

 

 

 

Non-accelerated Filer o

 

Smaller Reporting Company o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):  Yes o  No x

 

The number of shares of the registrant’s common stock, par value $0.001 per share, outstanding as of July 27, 2012 was 47,556,034 shares.

 

 

 



Table of Contents

 

OPTIMER PHARMACEUTICALS, INC.
FORM 10-Q
For the Quarterly Period Ended June 30, 2012

 

TABLE OF CONTENTS

 

 

Page

PART I — FINANCIAL INFORMATION

 

 

 

Item 1. Financial Statements (unaudited)

 

 

 

Consolidated Balance Sheets — June 30, 2012 and December 31, 2011

3

 

 

Consolidated Statements of Operations and Comprehensive Income (Loss) — Three months and six months ended June 30, 2012 and 2011

4

 

 

Consolidated Statements of Cash Flows — Six months ended June 30, 2012 and 2011

5

 

 

Notes to Consolidated Financial Statements

6

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

 

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

28

 

 

Item 4. Controls and Procedures

29

 

 

PART II — OTHER INFORMATION

 

 

 

Item 1A. Risk Factors

29

 

 

Item 6. Exhibits

49

 

 

SIGNATURE

50

 

2



Table of Contents

 

PART I — FINANCIAL INFORMATION

 

Item 1.  Financial Statements

 

Optimer Pharmaceuticals, Inc.

Consolidated Balance Sheets

 

 

 

June 30,

 

December 31,

 

 

 

2012

 

2011

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

99,703,307

 

$

31,787,512

 

Short-term investments

 

30,934,774

 

78,791,066

 

Trade accounts receivable, net

 

5,312,432

 

6,563,645

 

Accounts receivable, other

 

3,181,320

 

52,289,290

 

Inventory, net

 

7,962,112

 

3,947,380

 

Prepaid expenses and other current assets

 

2,326,122

 

3,781,830

 

Total current assets

 

149,420,067

 

177,160,723

 

Equity investment in OBI

 

29,013,792

 

 

Property, equipment and other, net

 

3,693,670

 

2,590,715

 

Long-term investments

 

882,000

 

882,000

 

Other assets

 

1,411,026

 

1,389,734

 

Total assets

 

$

184,420,555

 

$

182,023,172

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

6,697,835

 

$

9,860,462

 

Accrued expenses

 

30,243,749

 

21,447,544

 

Deferred revenue

 

245,319

 

 

Total current liabilities

 

37,186,903

 

31,308,006

 

Deferred rent

 

177,874

 

151,141

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, par value $0.001, 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively

 

 

 

Common stock, $0.001 par value, 75,000,000 shares authorized, 47,531,412 shares and 46,689,951 shares issued and outstanding at June 30, 2012 and December 31, 2011 respectively

 

47,531

 

46,690

 

Additional paid-in capital

 

372,132,440

 

358,895,471

 

Accumulated other comprehensive income (loss)

 

1,085,248

 

(46,725

)

Accumulated deficit

 

(226,209,441

)

(214,992,783

)

Total Optimer Pharmaceuticals, Inc. stockholders’ equity

 

147,055,778

 

143,902,653

 

Non-controlling interest

 

 

6,661,372

 

Total stockholders’ equity

 

147,055,778

 

150,564,025

 

Total liabilities and stockholders’ equity

 

$

184,420,555

 

$

182,023,172

 

 

See accompanying notes.

 

3



Table of Contents

 

Optimer Pharmaceuticals, Inc.

Consolidated Statements of Operations and Comprehensive Income (Loss)

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

15,232,087

 

$

 

$

29,612,628

 

$

 

Contract revenue

 

34,525,485

 

 

34,525,485

 

69,165,000

 

Other

 

 

33,294

 

2,106

 

144,933

 

Total revenues

 

49,757,572

 

33,294

 

64,140,219

 

69,309,933

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

2,269,331

 

 

4,553,591

 

 

Cost of contract revenue

 

1,744,182

 

 

1,744,182

 

4,273,532

 

Research and development

 

11,557,217

 

10,290,760

 

22,625,184

 

18,668,769

 

Selling, general and administrative

 

28,856,929

 

14,760,723

 

54,379,211

 

26,566,998

 

Co-promotion expenses with Cubist

 

5,001,583

 

 

15,083,166

 

 

Total operating expenses

 

49,429,242

 

25,051,483

 

98,385,334

 

49,509,299

 

Income (loss) from operations

 

328,330

 

(25,018,189

)

(34,245,115

)

19,800,634

 

Gain on de-consolidation of OBI

 

 

 

23,782,229

 

 

Equity in net loss of OBI

 

(668,852

)

 

(1,154,821

)

 

Interest income and other, net

 

44,318

 

95,860

 

120,705

 

119,102

 

Consolidated net income (loss)

 

(296,204

)

(24,922,329

)

(11,497,002

)

19,919,736

 

Net loss attributable to non-controlling interest

 

 

683,483

 

280,344

 

974,288

 

Net income (loss) attributable to Optimer Pharmaceuticals, Inc.

 

$

(296,204

)

$

(24,238,846

)

$

(11,216,658

)

$

20,894,024

 

Net income (loss) per share - basic

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.47

 

Net income (loss) per share - diluted

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.46

 

Weighted average number of shares used to compute net income (loss) per share - basic

 

47,234,371

 

46,479,395

 

46,978,497

 

44,581,010

 

Weighted average number of shares used to compute net income (loss) per share - diluted

 

47,234,371

 

46,479,395

 

46,978,497

 

45,447,261

 

 

 

 

 

 

 

 

 

 

 

Comprehensive income (loss)

 

$

(177,625

)

$

(23,954,597

)

$

(10,084,685

)

$

21,417,416

 

 

See accompanying notes.

 

4



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Optimer Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

Operating activities:

 

 

 

 

 

Net income (loss)

 

$

(11,497,002

)

$

19,919,736

 

Adjustments to reconcile net income (loss) to net cash provided (used) in operating activities:

 

 

 

 

 

Depreciation and amortization

 

390,874

 

206,406

 

Stock-based compensation

 

7,058,709

 

4,687,680

 

Issuance of common stock for consulting services and other

 

1,923,763

 

2,793,514

 

Deferred rent

 

26,733

 

42,377

 

Gain on de-consolidation of OBI

 

(23,782,229

)

 

Equity in net loss of OBI

 

1,154,821

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

Trade accounts receivable, net

 

1,251,213

 

 

Accounts receivable, other

 

48,889,506

 

(5,380,204

)

Inventory

 

(4,014,732

)

(25,405

)

Prepaid expenses and other current assets

 

(1,131,761

)

(1,369,482

)

Other assets

 

(88,424

)

(734,333

)

Accounts payable and accrued expenses

 

8,336,602

 

7,126,305

 

Deferred revenues

 

245,319

 

 

Net cash provided by operating activities

 

28,763,392

 

27,266,594

 

 

 

 

 

 

 

Investing activities:

 

 

 

 

 

Purchases of short-term investments

 

 

(91,899,393

)

Sales or maturities of short-term investments

 

38,744,220

 

25,165,000

 

Purchases of property and equipment

 

(1,721,109

)

(1,681,166

)

Reduction of cash due to de-consolidation of OBI

 

(4,010,680

)

 

Purchase of OBI common stock

 

(468,748

)

 

Proceeds from sale of OBI common stock

 

2,027,109

 

 

Net cash provided (used) by investing activities

 

34,570,792

 

(68,415,559

)

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

Proceeds from sale of common stock

 

4,255,338

 

82,270,022

 

Net cash provided by financing activities

 

4,255,338

 

82,270,022

 

Effect of exchange rate changes on cash and cash equivalents

 

326,273

 

419,548

 

Net increase in cash and cash equivalents

 

67,915,795

 

41,540,605

 

Cash and cash equivalents at beginning of period

 

31,787,512

 

19,861,924

 

Cash and cash equivalents at end of period

 

$

99,703,307

 

$

61,402,529

 

 

See accompanying notes.

 

5



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Optimer Pharmaceuticals, Inc.

Notes to Consolidated Financial Statements

(unaudited)

 

1.              Interim Financial Information

 

Organization and Business Activities

 

Optimer Pharmaceuticals, Inc. (“Optimer” or the “Company”) is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products.  The Company currently markets one product in the United States and Canada, DIFICID® (fidaxomicin).  DIFICID is a macrolide antibacterial drug that is approved in the United States for the treatment of Clostridium difficile-associated diarrhea (“CDAD”) in adults.  CDAD is the most common symptom of Clostridium difficile infection (“CDI”).  DIFICID is approved in Canada for the treatment of CDI. Fidaxomicin also is approved in Europe for the treatment of CDI, where it is marketed by a licensee as DIFICLIR™. Optimer is pursuing regulatory approval in other territories through collaboration partners.  The Company also is moving forward with life-cycle management initiatives for fidaxomicin.

 

Optimer was incorporated in Delaware on November 18, 1998. Optimer has two wholly-owned subsidiaries with active operations, Optimer Pharmaceuticals Canada, Inc. (“Optimer Canada”), which is incorporated and located in Canada, and Optimer Luxembourg 2 S.à r.l. (“Optimer Europe”), which is incorporated in Luxembourg. During the first quarter of 2012, the Company established, as part of its international structure strategy, additional wholly-owned subsidiaries, including Optimer Pharmaceuticals U.S. Holdings LLC, Optimer Bermuda LP and Optimer Luxembourg 1 S.à r.l.  As of June 30, 2012, none of these additional wholly-owned subsidiaries was conducting operational activities.

 

Basis of Presentation

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals, considered necessary for a fair presentation of the results of these interim periods have been included. The results of operations for the three months and six months ended June 30, 2012 are not necessarily indicative of the results that may be expected for the full year. These unaudited consolidated financial statements should be read in conjunction with the audited financial statements and related notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011, which was filed with the Securities and Exchange Commission (“SEC”) on March 8, 2012.

 

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

 

2.     Summary of Significant Accounting Policies

 

Principles of Consolidation

 

The consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. Prior to February 7, 2012, Optimer Biotechnology Inc. (“OBI”) was consolidated for financial reporting purposes.  All intercompany balances and transactions have been eliminated in consolidation.

 

Cash, Cash Equivalents and Investments

 

Investments with original maturities of less than 90 days at the date of purchase are considered to be cash equivalents.  Except for one auction rate preferred security (“ARPS”), all other investments are classified as short-term investments which are deemed by management to be available-for-sale and are reported at fair value with net unrealized gains or losses reported within comprehensive income (loss).  Realized gains and losses, and declines in value judged to be other than temporary, are included in investment income or interest expense.  The cost of securities sold is computed using the specific identification method. As of June 30, 2012, cash, cash equivalents and short-term investments totaled approximately $130.6 million.

 

Accounts Receivable

 

Trade accounts receivable are recorded net of reserves for estimated chargeback obligations, prompt-payment discounts, service fee arrangements and any allowance for doubtful accounts. Reserves for other sales-related allowances such as rebates, distribution and

 

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other fees, and product returns are included in accrued expenses in the Company’s consolidated balance sheet. The allowance for prompt-pay discounts and service fee arrangements was $1.4 million and $1.6 million at June 30, 2012 and December 31, 2011, respectively.

 

Inventory

 

Inventory is stated at the lower of cost or market.  Cost is determined in a manner which approximates the first-in, first-out (“FIFO”) method. The Company capitalized inventory produced in preparation for product launches upon FDA approval, as costs are expected to be recoverable through the commercialization of the product.  The Company reserves for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales.  Net inventory consisted of the following as of the dates indicated:

 

 

 

June 30,

 

December 31,

 

 

 

2012

 

2011

 

Raw materials

 

$

6,633,880

 

$

1,815,696

 

Work in process

 

553,186

 

1,321,763

 

Finished goods

 

1,316,863

 

809,921

 

 

 

8,503,929

 

3,947,380

 

Reserves

 

(541,817

)

 

 

 

$

7,962,112

 

$

3,947,380

 

 

Investment in OBI

 

Beginning as of February 7, 2012, the Company accounted for its investment in OBI under the equity method of accounting as the Company ceased to have voting control or other elements of control that would require consolidation. Prior to February 7, 2012, OBI was consolidated for financial reporting purposes. The investment is subsequently adjusted for the Company’s share in equity in net income (loss) and cash contributions and distributions. In addition, the Company records adjustments to reflect the amortization of basis differences attributable to the fair values in excess of net book values of identified tangible and intangible assets which were generated at the date of deconsolidation.  Any difference between the carrying amount of the investment on the Company’s balance sheet and the underlying equity in net assets is evaluated for impairment at each reporting period. As of June 30, 2012, the Company’s investment in OBI was $29.0 million.

 

Foreign Currency Translation

 

The functional currency for the Company’s foreign subsidiaries is the local currency. Assets and liabilities denominated in foreign currencies are translated using the exchange rates on the balance sheet dates. Net revenues and expenses are translated using the average exchange rates prevailing during the period. Any translation adjustments resulting from this process are shown separately as a component of accumulated other comprehensive income (loss) within stockholders’ equity in the consolidated balance sheets. Foreign currency transaction gains and losses are reported in operating expenses, net in the consolidated statements of operations.

 

Fair Value of Financial Instruments

 

The carrying amount of cash and cash equivalents, short-term investments, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of these instruments.  The fair value of available-for-sale securities is based upon quoted market prices for these securities.

 

Reclassifications

 

The Company has reclassified certain prior-period amounts to conform to the current period presentation.  Specifically, it has consolidated its sales and marketing expense and its general and administrative expenses into a single selling, general and administrative expense category.  This reclassification has no impact on the net loss from operations or stockholders’ equity as previously reported.

 

7



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Net Product Sales

 

DIFICID is available in the United States and Canada through national and regional wholesalers that provide DIFICID to hospital and retail pharmacies and to long-term care facilities. The Company recognizes revenue from product sales when there is persuasive evidence of an arrangement, delivery has occurred, title has passed to the customer, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, the amount of returns can be reasonably estimated and collectability is reasonably assured. The Company recognizes revenue from product sales of DIFICID upon delivery of product to the wholesalers.

 

The Company’s net product sales represent total product sales less allowances for customer credits, including estimated rebates, chargebacks, discounts and returns. These allowances are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Allowances for rebates, chargebacks, discounts and returns are established based on the contractual terms with customers, communications with customers as well as expectations about the market for the product and anticipated introduction of competitive products.  Product shipping and handling costs are included in cost of product sales.

 

Product Sales Allowances.  The Company establishes reserves for prompt-payment discounts, fee-for-service arrangements, government rebates, product returns and other applicable allowances.

 

Allowances relate to prompt-payment discounts and fee-for-service arrangements with the Company’s contracted wholesalers and are recorded at the time of sale, resulting in a reduction in product sales revenue.  Accruals related to government rebates, product returns and other applicable allowances are recognized at the time of sale, resulting in a reduction in product sales revenue and an increase in accrued expenses.

 

Prompt-payment Discounts.  The Company offers a prompt-payment discount to its contracted wholesalers.  Since the Company expects its customers will take advantage of this discount, the Company accrues 100% of the prompt payment discount that is based on the gross amount of each invoice, at the time of sale.  The accrual is adjusted quarterly to reflect actual earned discounts.

 

Government Rebates and Chargebacks.  The Company estimates government-mandated rebates and discounts relating to federal and state programs such as Medicaid, Veterans’ Administration (“VA”) and Department of Defense programs, the Medicare Part D Coverage Discount Program and certain other qualifying federal and state government programs.  The Company estimates the amount of these reductions based on DIFICID patient data, actual sales data and market research data related to payor mix.  These allowances are adjusted each period based on actual experience.

 

Medicaid rebate reserves relate to the Company’s estimated obligations to states under statutory “best price” obligations which also may include supplemental rebate agreements with certain states.  Rebate accruals are recorded during the same period in which the related product sales are recognized.  Actual rebate amounts are determined at the time of claim by the state, and the Company will generally make cash payments for such amounts after receiving billings from the state.

 

VA rebates or chargeback reserves represent the Company’s estimated obligations resulting from contractual commitments to sell DIFICID to qualified healthcare providers at a price lower than the list price charged to the Company’s distributors.  The distributor will charge the Company for the difference between what the distributor pays for the product and the ultimate selling price to the qualified healthcare provider.  Rebate accruals are established during the same period in which the revenue from the related product sales is recognized. Actual chargeback amounts for Public Health Service are determined at the time of resale to the qualified healthcare provider from the distributor, and the Company will generally issue credits for such amounts after receiving notification from the distributor.

 

Although allowances and accruals are recorded at the time of product sale, certain rebates generally will be paid, on average, up to six months or longer after the sale.  Reserve estimates are evaluated quarterly and, if necessary, adjusted to reflect actual results.  Any such adjustments will be reflected in the Company’s operating results in the period of the adjustment.

 

Product Returns.  The Company’s policy is to accept returns of DIFICID for six months prior to, and twelve months after, the product expiration date.  The Company also permits returns if the product is damaged or defective when received by its customers. The Company will provide a credit for such returns to customers with whom the Company has a direct relationship. Once product is dispensed, it cannot be returned, but the Company allows partial returns in states where such returns are mandated. The Company does not exchange product from inventory for the returned product.

 

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Allowances for product returns are recorded during the period in which the related product sales are recognized, resulting in a reduction to product revenue.  The Company estimates product returns based upon historical trends in the pharmaceutical industry and trends for similar products sold by others.

 

Contract Revenue

 

In order to determine the revenue recognition for contingent milestones, the Company evaluates the contingent milestones at the inception of a collaboration agreement.

 

Accounting Standard Codification (“ASC”) Topic 605-28, Revenue Recognition — Milestone Method (“ASC 605-28”), established the milestone method as an acceptable method of revenue recognition for certain contingent, event-based payments under research and development arrangements.  Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved.  A milestone is an event (i) that can be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company.  The determination that a milestone is substantive is judgmental and is made at the inception of the arrangement.  Milestones are considered substantive when the consideration earned from the achievement of the milestone is (i) commensurate with either the Company’s performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from the Company’s performance to achieve the milestone, (ii) relates solely to past performance and (iii) is reasonable relative to all deliverables and payment terms in the arrangement.

 

Other contingent, event-based payments received for which payment is either contingent solely upon the passage of time or the results of a collaborative partner’s performance are not considered milestones under ASC 605-28.  In accordance with ASC Topic 605-25, Revenue Recognition — Multiple-Element Arrangements, such payments will be recognized as revenue when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured.

 

Revenues recognized for royalty payments, if any, are recognized as earned in accordance with the terms of various research and collaboration agreements.

 

For collaboration agreements with multiple deliverables, the Company recognizes collaboration revenues and expenses by analyzing each element of the agreement to determine if it is to be accounted for as a separate element or single unit of accounting. If an element is to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue is to be recognized. If an element is not to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue is to be recognized.

 

Cash received in advance of services being performed is recorded as deferred revenue and recognized as revenue as services are performed over the applicable term of the agreement. In connection with certain research and collaboration agreements, revenues are recognized from non-refundable up-front fees, that the Company does not believe are specifically tied to a separate earnings process, ratably over the term of the agreement.  Research fees are recognized as revenue as the related research activities are performed.

 

With respect to revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with grants, where the Company acts as a principal, with discretion to choose suppliers, bears credit risk and performs part of the services required in the transaction, the Company records revenue for the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in the consolidated statements of operations.

 

None of the payments that the Company has received from collaborators to date, whether recognized as revenue or deferred, is refundable even if the related program is not successful.

 

Research and Development Expense

 

The Company expenses costs related to research and development until technological feasibility has been established for the product.  Once technological feasibility is established, all product costs are generally capitalized until the product is available for general release to customers.  The Company has determined that technological feasibility for its product candidates will be reached when the requisite regulatory approvals are obtained to make the product available for sale which, in the United States, generally occurs upon the approval of the New Drug Application (“NDA”) for such product.

 

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The Company’s research and development expenses consist primarily of license fees, salaries and related employee benefits, costs associated with clinical trials managed by contract research organizations and costs associated with non-clinical activities and regulatory approvals.  The Company uses external service providers and vendors to conduct clinical trials, to manufacture supplies of product candidates to be used in clinical trials and to provide various other research and development-related products and services.

 

When non-refundable payments for goods or services to be received in the future for use in research and development activities are made, the Company defers and capitalizes these types of payments. The capitalized amounts are expensed when the related goods are delivered or the services are performed.

 

Net Income (Loss) per Share Attributable to Common Stockholders

 

Basic net income (loss) per common share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted-average number of common shares and dilutive common stock equivalents then outstanding. Common stock equivalents consist of common shares issuable upon the exercise of stock options and warrants and upon the vesting of restricted stock units.

 

Income Taxes

 

Income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income in the period that includes the enactment date.  The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized.

 

Segment Reporting

 

Our management has determined that we operate in one business segment which is the development and commercialization of pharmaceutical products.

 

3.     Fair Value of Financial Instruments

 

The following table summarizes the Company’s financial assets measured at fair value as of June 30, 2012:

 

 

 

Quoted Prices in
Active Markets

(Level 1)

 

Other
Observable
Inputs

(Level 2)

 

Unobservable
Inputs

(Level 3)

 

Total

 

Cash equivalents

 

$

98,131,193

 

$

 

$

 

$

98,131,193

 

Marketable securities

 

 

29,758,727

 

 

29,758,727

 

Auction rate preferred securities

 

 

 

882,000

 

882,000

 

Investment in Cempra

 

1,176,047

 

 

 

1,176,047

 

 

 

$

99,307,240

 

$

29,758,727

 

$

882,000

 

$

129,947,967

 

 

Level 1:           Quoted prices in active markets for identical assets and liabilities; or

 

Level 2:           Quoted prices for identical or similar assets and liabilities in markets that are not active, or observable inputs other than quoted prices in active markets for identical assets and liabilities; or

 

Level 3:  Unobservable inputs.

 

Marketable Securities.  With the exception of auction rate preferred securities, the Company obtains pricing information from quoted market prices, pricing vendors or quotes from brokers/dealers. The Company conducts reviews of its primary pricing vendors to determine whether the inputs used in the vendors’ pricing processes are deemed to be observable. As of June 30, 2012, the marketable securities included government agencies and corporate bonds.

 

The fair value of government-related securities and corporate bonds generally are determined using standard observable inputs, including reported trades, quoted market prices and broker/dealer quotes and thus these securities are in Level 2.

 

The fair value of auction rate preferred securities is estimated by the Company using a discounted cash flow model that incorporates transaction details such as contractual terms, maturity and timing and amount of cash flows and the expected holding period of the ARPS. The Company’s ARPS is classified as a long-term investment on the consolidated balance sheets, as the Company does not believe it could liquidate the security in the near term. The ARPS does not have observable inputs and thus the ARPS is included in Level 3.

 

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Table of Contents

 

Investment in Cempra.  Equity securities that have readily determinable fair values not classified as trading securities or as held-to-maturity securities are classified as available-for-sale securities.  Any unrealized gains and losses are reported in other comprehensive income until realized. In February 2012, Cempra became a publicly-traded company and, as such, the Company assigned a value to the shares it received in March 2006 (see Note 8) and recorded the entire amount as an unrealized gain. The Company considers the equity it owns in Cempra as available-for-sale.  For the quarter ended June 30, 2012, the Company recorded an unrealized gain of $227,420 and has included the fair value of $1,176,047 in short-term investments. Cempra’s stock is publicly traded and thus is in Level 1.

 

A reconciliation of the beginning and ending balances of assets measured at fair value on a recurring basis using Level 3 inputs is as follows:

 

 

 

Auction Rate
Preferred
Securities

 

Beginning balance at January 1, 2012

 

$

882,000

 

Total gains and losses:

 

 

 

Realized net income

 

 

Unrealized in accumulated other comprehensive income

 

 

Purchases, sales, issuances and settlements

 

 

Transfers in (out) of Level 3

 

 

Ending balance at June 30, 2012

 

$

882,000

 

Change in unrealized gains (losses) included in net income related to assets still held

 

$

 

 

As of June 30, 2012, the Company held one ARPS valued at $882,000 with a perpetual maturity date that resets every 28 days. Although as of June 30, 2012 this ARPS continued to pay interest according to its stated terms, the market in these securities continues to be illiquid. Based on a discounted cash flow model used to determine the estimated fair value of its investment in the ARPS, the Company has previously recognized in the consolidated statement of operations an unrealized loss of approximately $118,000 in investment income since the Company had determined that the decline in value was other than temporary. The assumptions used for the discontinued cash flow model include estimates for interest rates, timing and amount of cash flows and the expected holding period of the ARPS.  The Company’s ARPS is classified as a long-term investment on the consolidated balance sheets, as the Company does not believe it could liquidate this security in the near term.

 

4.     Short-term Investments

 

The following is a summary of the Company’s consolidated investment securities, all of which are classified as available-for-sale. Determination of estimated fair value is based upon quoted market prices, pricing vendors or quotes from brokers/dealers as of the dates presented.

 

 

 

June 30, 2012

 

 

 

Gross
Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Market Value

 

Government agencies

 

$

25,727,803

 

$

14,497

 

$

(15

)

$

25,742,285

 

Corporate bonds

 

4,015,237

 

1,205

 

 

4,016,442

 

Investment in Cempra

 

 

1,176,047

 

 

1,176,047

 

 

 

$

29,743,040

 

$

1,191,749

 

$

(15

)

$

30,934,774

 

 

 

 

December 31, 2011

 

 

 

Gross
Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Market Value

 

Government agencies

 

$

69,241,792

 

$

106,347

 

$

 

$

69,348,139

 

Corporate bonds

 

9,429,485

 

13,442

 

 

9,442,927

 

 

 

$

78,671,277

 

$

119,789

 

$

 

78,791,066

 

 

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As of June 30, 2012, we had one investment with an immaterial net unrealized loss position.

 

In February 2012, Cempra completed its initial public offering and the Company has determined that its equity in Cempra had readily determinable value at that time and recorded its fair value in the Company’s books. Prior to February 2012, the Company assigned no value to its equity in Cempra.

 

The amortized cost and estimated fair value of securities available-for-sale at June 30, 2012, by contractual maturity, are as follows:

 

 

 

Amortized Cost

 

Estimated Fair Value

 

Due in one year or less

 

$

29,743,040

 

$

29,758,727

 

 

The weighted-average maturity of the Company’s short-term investments as of June 30, 2012 and December 31, 2011 was approximately three months and seven months, respectively.

 

5.              Investment in OBI

 

In February 2012, OBI issued 36 million newly-issued shares of its common stock resulting in gross proceeds of approximately 540 million New Taiwan dollars (approximately $18.3 million based on then-current exchange rates).  The Company did not participate in the February 2012 financing.  In March 2012, the Company sold 1.5 million shares of its equity interest in OBI.  These transactions reduced the Company’s ownership interest in OBI from a majority interest to a 42.9% interest and triggered consideration regarding whether or not to continue consolidating OBI, as well as an evaluation to consider whether OBI was a variable interest entity (‘VIE”).  As a result of its evaluation, the Company determined that OBI was not a VIE and that Optimer no longer had voting control or other forms of control over the operations and decision making of OBI. As a result of this evaluation, the Company de-consolidated OBI as of February 7, 2012 and de-recognized the OBI assets, liabilities and non-controlling interest from its financial statements. Management applied de-consolidation accounting guidance, which included analyzing Optimer’s investment in OBI at February 7, 2012 to determine the fair value on the date of de-consolidation and the related gain or loss upon de-consolidation. Based on a preliminary valuation, management determined that the fair value of Optimer’s investment in OBI at February 7, 2012 was $29.7 million.  This fair value was based primarily on OBI’s financing transaction in February 2012 in which shares of common stock were sold at approximately $0.51 per share (based on then-current exchange rates).  As a significant portion of the additional investment in OBI was made by outside investors in an arms-length transaction, management determined that this price per share approximated fair market value as of February 7, 2012. In the financing transaction, OBI sold common shares which have the same rights and preferences as the shares held by Optimer.

 

For the six months ended June 30, 2012, the gain attributed to the de-consolidation of OBI was $23.8 million. During the period ended June 30, 2012, Optimer provided consulting, purchasing and other services to OBI. At this time there is no written contract or agreement for services between OBI and Optimer.

 

As of the date of de-consolidation, the Company accounts for its investment in OBI under the equity method. The investment is subsequently adjusted for Optimer’s share in the equity in net income (loss) and cash contributions and distributions. In addition, the Company records adjustments to reflect the amortization of basis differences attributable to the fair values in excess of net book values of identified tangible and intangible assets.  Based on a preliminary valuation, the fair value in excess of book value can be attributed to in-process research and development related to a License and Collaboration Agreement for fidaxomicin and an Intellectual Property Assignment and License Agreement related to OBI’s OPT-822/821 program (see Note 8). For the period post de-consolidation, the Company’s equity method investment in OBI has been reduced by $1.2 million to reflect its share in OBI losses during that period. Any difference between the carrying amount of the investment on the Company’s balance sheet and the underlying equity in net assets is evaluated for impairment at each reporting period.

 

On May 2, 2012, the Company purchased, at cost, 924,000 shares in OBI from the Company’s President and Chief Executive Officer for approximately $0.5 million, resulting in an increase in the fair value of the Company’s investment in OBI. As of June 30, 2012, the Company had a 43.6% ownership interest in OBI that was valued at $29.0 million.

 

6.              Net Income (Loss) per Share Attributable to Common Stockholders

 

The following table sets forth the computation of basic and diluted net income (loss) per share for the periods indicated:

 

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Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss) — basic and diluted

 

$

(296,204

)

$

(24,238,846

)

$

(11,216,658

)

$

20,894,024

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average number of shares of common stock outstanding - basic

 

47,234,371

 

46,479,395

 

46,978,497

 

44,581,010

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Restricted stock units

 

 

 

 

43,560

 

Employee stock purchase plan

 

 

 

 

39,381

 

Stock award common share equivalents

 

 

 

 

783,310

 

Weighted average number of shares of common stock outstanding - diluted

 

47,234,371

 

46,479,395

 

46,978,497

 

45,447,261

 

Net income (loss) per share - basic

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.47

 

Net income (loss) per share - diluted

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.46

 

 

For the three months ended June 30, 2012 and 2011, 4.8 million and 5.8 million, respectively, of potentially dilutive shares of common stock were not included in the diluted net income per share calculations because they would have been antidilutive.

 

For the six months ended June 30, 2012 and 2011, 5.0 million and 4.1 million, respectively, of potentially dilutive shares of common stock were not included in the diluted net income per share calculations because they would have been antidilutive.

 

7.              Stock Based Compensation

 

Stock Options

 

In November 1998, the Company adopted the 1998 Stock Plan (the “1998 Plan”).  The Company terminated and ceased granting options under the 1998 Plan upon the closing of the Company’s initial public offering in February 2007.

 

In December 2006, the Company’s board of directors approved the 2006 Equity Incentive Plan (“2006 Plan”) which became effective upon the closing of the Company’s initial public offering.  The 2006 Plan was succeeded by the 2012 Equity Plan (“2012 Plan”) which became effective upon approval by the Company’s stockholders on May 9, 2012. After May 9, 2012, no additional stock awards will be awarded under the 2006 Plan.  However, all outstanding stock awards granted under the 2006 Plan remain subject to the terms of the 2006 Plan.

 

The 2012 Plan is a continuation of the 2006 Plan.  The aggregate number of shares of the Company’s common stock that may be issued under the 2012 Plan will not exceed 11,289,455, which consists of (a) 3,400,000 new shares and (b) the number of unallocated shares remaining available for grant of new awards under the 2006 Plan as of May 9, 2012 and the shares subject to outstanding stock awards granted under the 2006 Plan that (i) expire or terminate for any reason prior to exercise or settlement; (ii) are forfeited because of the failure to meet a contingency or condition required to vest such shares or repurchased at the original issuance price; or (iii) are re-acquired or withheld (or not issued) to satisfy a tax withholding obligation in connection with an award other than a stock option or stock appreciation right.

 

Options granted under the 1998 Plan, the 2006 Plan and the 2012 Plan generally expire 10 years from the date of grant (five years for a 10% or greater stockholder) and vest over a period of four years.  The exercise price of options granted must at least be equal to the fair market value of the Company’s common stock on the date of grant.

 

Restricted Stock Units

 

From time to time the Company grants restricted stock units (“RSUs”) to its executives, board members and employees. RSUs are valued based on the fair market value of the Company’s stock on the date of grant.

 

Performance-based Stock Options and Performance-based Restricted Stock Units

 

In February 2012, the Compensation Committee granted to certain executives performance-based RSUs covering up to an aggregate of 250,000 shares of common stock, which vest over time beginning on the date the Company determines that a specified product revenue goal has been achieved.

 

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In May 2010, the Company’s Board of Directors appointed Pedro Lichtinger as its President and CEO and as a member of the Board.  Pursuant to Mr. Lichtinger’s offer letter, he received performance-based stock options to purchase up to an aggregate of 480,000 shares of common stock and performance-based restricted stock units covering up to an aggregate of 120,000 shares of common stock, which vest over time beginning on the dates the Company achieves specified development and commercialization goals.  In February 2011, one of the performance criteria was met and, in May 2011, another of the performance criteria was met. As a result, 1/4th of the performance-based stock options and performance-based restricted stock units related to each goal vested in February 2012 and the remaining shares will vest in 36 equal monthly installments thereafter.

 

Simultaneously with Mr. Lichtinger’s appointment, Michael Chang resigned as the Company’s President and CEO.  The Company entered into a consulting agreement with Dr. Chang to provide consulting services. Pursuant to his consulting agreement and as part of his compensation, Dr. Chang received performance-based stock options to purchase up to an aggregate of 400,000 shares of common stock which vested over time beginning on the dates certain regulatory filings were accepted and approved. Dr. Chang’s consulting agreement was terminated in April 2012 and, as a result, the unvested portion of the performance-based options was cancelled.  Prior to the termination of his consulting agreement, 248,437 options vested.  However, due to Dr. Chang’s continuing role as a director, his other equity awards remain outstanding and continue to vest as per the vesting term of the awards.

 

Employee Stock Purchase Plan

 

Optimer issues stock awards under its employee stock purchase plan (“ESPP”). Under the terms of the ESPP, eligible employees may purchase shares of Optimer’s common stock at the lesser of 85% of the fair market value of Optimer’s common stock on the offering date or the purchase date.

 

Valuations

 

Stock options are valued using the Black-Scholes option pricing model on the date of grant. This option pricing model involves a number of estimates, including the expected lives of stock options, the Company’s anticipated stock volatility and applicable interest rates.  The Company recognizes compensation expense for performance-based stock awards granted to employees under the accelerated attribution method.  The following table shows the assumptions used to compute stock-based compensation expense for the stock options, restricted stock units and ESPP purchase rights during the three months and six months ended June 30, 2012 and 2011, using the Black-Scholes option pricing model:

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

Stock Options

 

2012

 

2011

 

2012

 

2011

 

Risk-free interest rate

 

1.22

%

2.10-3.46

%

1.22-2.17

%

2.10-3.46

%

Dividend yield

 

0.00

%

0.00

%

0.00

%

0.00

%

Expected life of options (years)

 

6.08-8.08

 

6.08-9.08

 

6.08-8.33

 

5.27-9.49

 

Volatility

 

70.72-72.54

%

69.13-72.20

%

69.71-72.54

%

69.13-73.63

%

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

ESPP

 

2012

 

2011

 

2012

 

2011

 

Risk-free interest rate

 

0.10-0.13

%

0.14-0.16

%

0.09-0.13

%

0.14-0.18

%

Dividend yield

 

0.00

%

0.00

%

0.00

%

0.00

%

Expected life of options (years)

 

0.5

 

0.5

 

0.5

 

0.5

 

Volatility

 

37.16-42.75

%

41.05-44.29

%

37.16-42.75

%

40.01-44.29

%

 

The risk-free interest rate assumption was based on the United States Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.  The assumed dividend yield was based on the Company’s expectation of not paying dividends for the foreseeable future.  The weighted-average expected life of options was calculated using the simplified method.  Due to the Company’s limited historical data as a commercial entity, the Company used the historical volatility of comparable companies whose share prices are publicly available to estimate the Company’s options volatility rate.

 

Total stock-based compensation expense related to all of the Company’s stock options, RSUs and other stock awards issued to employees and consultants, and employee stock purchases, recognized for the three months and six months ended June 30, 2012 and 2011, was as follows:

 

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Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Research and development

 

$

1,249,360

 

$

637,374

 

$

2,214,142

 

$

1,312,897

 

Selling, general and administrative

 

2,704,006

 

1,819,622

 

4,826,921

 

3,275,332

 

Stock-based compensation expense

 

$

3,953,366

 

$

2,456,996

 

$

7,041,063

 

$

4,588,229

 

 

At June 30, 2012, the total unrecognized compensation expense related to unvested stock options and restricted stock units issued to employees was approximately $28.7 million and the related weighted-average period over which such expense is expected to be recognized is approximately 3.1 years.

 

Optimer Biotechnology, Inc.

 

Stock Options

 

Until February 7, 2012, we consolidated OBI into our results of operations and recorded stock based compensation related to options granted by OBI. The following table summarizes the stock-based compensation expense for OBI included in each operating expense line item in Optimer’s consolidated statements of operations for the six months ended June 30, 2012 and 2011:

 

 

 

Six months ended
June 30,

 

 

 

2012

 

2011

 

Research and development

 

$

8,465

 

$

27,727

 

Selling, general and administrative

 

9,181

 

71,724

 

Stock-based compensation expense

 

$

17,646

 

$

99,451

 

 

8.     Other Collaborative Agreements

 

Specialised Therapeutics Australia Pty. Ltd. (“STA”)

 

In June 2012, the Company entered into a distribution and license agreement with STA to register and commercialize fidaxomicin tablets in Australia and New Zealand for the treatment of Clostridium difficile infection.  Under the agreement, STA is responsible for all costs associated with the registration and commercialization of fidaxomicin tablets in Australia and New Zealand. Pursuant to the agreement, STA made a one-time payment of $500,866. Additionally, the Company is entitled to receive contingent payments, which may exceed $1.5 million, upon the achievement of cumulative net sales targets and also will receive payments for the supply of fidaxomicin tablets to STA.

 

The Company has assessed that the achievement of the performance conditions associated with the payments is solely based on the performance of STA and has determined that the payments do not meet the criteria for a milestone under the revised authoritative guidance for contingent milestones. We will recognize the revenue for the contingent payment when the contingency is relieved.

 

Astelllas Pharma Inc. (“Astellas Japan”)

 

In March 2012, the Company entered into a collaboration and license agreement with Astellas Japan pursuant to which the Company granted to Astellas Japan an exclusive, royalty-bearing license under certain of its know-how and intellectual property to develop and commercialize fidaxomicin in Japan.  Under the terms of the license agreement, and at its expense, Astellas Japan agreed to use commercially reasonable efforts to develop and commercialize fidaxomicin in Japan and achieve certain additional regulatory and commercial diligence milestones with respect to fidaxomicin in Japan.  In addition, under the terms of the license agreement, Astellas Japan granted to the Company an exclusive, royalty-free license under know-how and intellectual property generated by Astellas Japan and its sublicensees in the course of developing fidaxomicin and controlled by Astellas Japan or its affiliates for use by the Company and any of its sublicensees in the development and commercialization of fidaxomicin outside Japan and, following termination of the license agreement and subject to payment by the Company of a single-digit royalties, in Japan.  In addition, under the terms of a supply agreement entered into by Astellas Japan and Optimer Europe, on the same date, Optimer Europe will be the exclusive supplier of fidaxomicin to Astellas Japan for Astellas Japan’s development and commercialization activities in Japan during the term of the supply agreement.

 

Under the terms of the license agreement, Astellas Japan paid the Company an up-front fee equal to $20.0 million in April 2012. The Company also is eligible to receive additional cash payments totaling up to $70.0 million upon the achievement by Astellas Japan of specified regulatory and commercial milestones.  In addition, the Company will be entitled to receive high-single-digit royalties on net sales of fidaxomicin products in Japan above an agreed threshold, which royalties are subject to reduction in certain limited circumstances.  Such royalties will be payable by Astellas Japan on a product-by-product basis until a generic product accounts for a specified market share of the applicable fidaxomicin product in Japan. Under the supply agreement, in exchange for commercial supply of fidaxomicin, Astellas Japan is obligated to pay Optimer Europe a price equal to net sales of fidaxomicin products in Japan minus a discount that is based on a high-double-digit percentage of such net sales and a mark-up to cost of goods.  This price will be payable by Astellas Japan on a product-by-product basis for commercial supply until a generic product accounts for a specified market share of the applicable fidaxomicin product in Japan.

 

The license agreement will continue in effect on a product-by-product basis until expiration of Astellas Japan’s obligation to pay royalties with respect to each fidaxomicin product in Japan, unless terminated early by either party.  Following expiration of the license agreement, Astellas Japan’s license to develop and commercialize the applicable fidaxomicin product will become non-exclusive.  Each of the Company and Astellas Japan may terminate the license agreement prior to expiration upon the material breach of such agreement by the other party or upon the bankruptcy or insolvency of the other party.  In addition, the Company may terminate the license agreement prior to expiration in the event Astellas Japan or any of its affiliates or sublicensees commences an interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any patent licensed to it under the license agreement. Astellas Japan may terminate the license agreement prior to expiration for any reason upon 180 days’ prior written notice to the Company.  Upon any

 

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such termination, the license granted to Astellas Japan (in total or with respect to the terminated product, as applicable) will terminate and revert to the Company.  The supply agreement will continue in effect until terminated by either party.  Each of Optimer Europe and Astellas Japan may terminate the supply agreement (i) upon the material breach of such agreement by the other party, (ii) upon the bankruptcy or insolvency of the other party or (iii) on a product-by-product basis following expiration of Astellas Japan’s obligation to pay the price described above with respect to the applicable fidaxomicin product, or in its entirety following expiration of Astellas Japan’s obligation to pay the price described above with respect to all fidaxomicin products.

 

The Company assessed the deliverables under the authoritative guidance for multiple element arrangements. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset or another performance obligation.  Once the Company identified the deliverables under the arrangement, the Company determined whether or not the deliverables can be accounted for as separate units of accounting, and the appropriate method of revenue recognition for each element. During the quarter ended June 30, 2012, the Company recognized $19.9 million of the $20.0 million up-front payment, as the Company determined that revenue was earned upon the delivery of license rights and related know-how.

 

Cubist Pharmaceuticals, Inc. (“Cubist”)

 

In April 2011, the Company entered into a co-promotion agreement with Cubist pursuant to which the Company engaged Cubist as its exclusive partner for the promotion of DIFICID in the United States.  Under the terms of the agreement, the Company and Cubist have agreed to co-promote DIFICID to physicians, hospitals, long-term care facilities and other healthcare institutions as well as jointly provide medical affairs support for DIFICID. In conducting their respective co-promotion activities, each party is obligated under the agreement to commit minimum levels of personnel, and Cubist is obligated to tie a portion of the incentive compensation paid to its sales representatives to the promotion of DIFICID in the United States.  Under the terms of the agreement, the Company is responsible for the distribution of DIFICID in the United States and for recording revenue from sales of DIFICID, and agreed to use commercially reasonable efforts to maintain adequate inventory and third-party logistics support for the supply of DIFICID in the United States.  In addition, Cubist agreed to not promote competing products in the United States during the term of the agreement and, subject to certain exceptions, for a specified period of time thereafter. The initial term of the agreement is two years ending July 31, 2013, subject to renewal or early termination as described below.

 

In exchange for Cubist’s co-promotion activities and personnel commitments, the Company is obligated to pay a quarterly fee of approximately $3.8 million to Cubist beginning upon the commencement of the sales program of DIFICID in the United States.  Except for the first quarterly payment which the Company paid in advance, all subsequent payments are paid in arrears. Cubist also is eligible to receive an additional $5.0 million in the first year after first commercial sale and $12.5 million in the second year after first commercial sale if mutually agreed upon annual sales targets are achieved, as well as a portion of the Company’s gross profits derived from net sales above the specified annual targets, if any.  In the quarter ended June 30, 2012, the Company achieved the first-year sales target and, as of June 30, 2012, accrued $10.4 million representing service fees, the $5.0 million bonus as well as a pro-rated portion of estimated gross profit on sales above the sales target which will be payable to Cubist in August 2012.

 

The agreement may be renewed by mutual agreement of the parties for additional, consecutive one-year terms.  The Company and Cubist each may terminate the agreement prior to expiration upon the uncured material breach of the agreement by the other party, upon the bankruptcy or insolvency of the other party.  In addition, the Company may terminate the agreement, subject to certain limitations, if (i) the Company withdraws DIFICID from the market in the United States, (ii) Cubist fails to comply with applicable laws in performing its obligations, (iii) Cubist undergoes a change of control, (iv) certain market events occur related to Cubist’s product CUBICIN® (daptomycin for injection) in the United States or (v) Cubist undertakes certain restructuring activities with respect to its sales force.  In addition, Cubist may terminate the agreement, subject to certain limitations, if (i) the Company experiences certain supply failures in relation to the demand for DIFICID in the United States, (ii) the Company is acquired by certain types of entities, including competitors of Cubist, (iii) certain market events occur related to CUBICIN in the United States or (iv) the Company fails to comply with applicable laws in performing its obligations.

 

The following is a summary of accrued expenses related to the Company’s co-promotion agreement with Cubist:

 

Expenses

 

Six Months
Ended
June 30, 2012

 

Target bonus and portion of gross profit payments

 

$

7,880,000

 

Service fees

 

2,523,000

 

Total

 

$

10,403,000

 

 

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Astellas Pharma Europe Ltd. (“APEL”)

 

In February 2011, the Company entered into a collaboration and license agreement with APEL pursuant to which the Company granted to APEL an exclusive, royalty-bearing license under certain of the Company’s know-how and intellectual property to develop and commercialize fidaxomicin in Europe, and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (“CIS”). In March 2011, the parties amended the agreements to include certain additional countries in the CIS and all additional territories in Africa (all such countries and territories are referred to as the APEL territories). Under the terms of the agreement, APEL has agreed to use commercially reasonable efforts to develop and commercialize fidaxomicin in the APEL territories at its expense, and to achieve certain additional regulatory and commercial diligence milestones with respect to fidaxomicin in the APEL territories.  The Company and APEL also may agree to collaborate in, and share data resulting from, global development activities with respect to fidaxomicin, in which case the Company and APEL will be obligated to co-fund such activities.  In addition, under the terms of the agreement, APEL granted the Company an exclusive, royalty-free license under know-how and intellectual property generated by APEL and its sublicensees in the course of developing fidaxomicin and controlled by APEL or its affiliates for use by the Company and any of its sublicensees in the development and commercialization of fidaxomicin outside the APEL territories and, following termination of the agreement and subject to payment by the Company of single-digit royalties, in the APEL territories.  In addition, under the terms of a supply agreement entered into between the Company and APEL on the same date, the Company will be the exclusive supplier of fidaxomicin to APEL for APEL’s development and commercialization activities in the APEL territories during the term of the supply agreement, and APEL is obligated to pay the Company an amount equal to cost plus an agreed mark-up for such supply.

 

Under the terms of the license agreement, APEL paid the Company an up-front fee of $69.2 million in March 2011 and the Company recognized a milestone payment of 40 million Euros in December 2011 as the result of APEL attaining EMA approval of DIFICLIR.  APEL paid the Company 50.0 million Euros in June 2012, which consisted of the 40 million Euro approval milestone payment and a 10 million Euro milestone payment for the first commercial launch of DIFICLIR in the APEL territories. The Company is eligible to receive additional cash payments totaling up to 65.0 million Euros upon the achievement by APEL of additional specified commercial milestones.

 

In addition, the Company will be entitled to receive escalating double-digit royalties ranging from the high teens to low twenties on net sales of DIFICLIR products in the APEL territories, which royalties are subject to reduction in certain, limited circumstances.  Such royalties will be payable by APEL on a product-by-product and country-by-country basis until a generic product accounts for a specified market share of the applicable DIFICLIR product in the applicable country.

 

When determining whether or not to account for the additional cash payments under the milestone method, the Company makes a determination of whether or not each milestone is considered substantive. During this assessment the Company considers if the milestone is achieved based in whole or in part on its performance or on the occurrence of a separate outcome resulting from its performance, if there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and if achievement will result in additional payments being due.  Based on the Company’s assessment process it was determined that additional payments due related to regulatory approval and product launch will be accounted for under the milestone method as technological hurdles create uncertainty as to whether or not the milestones will be met and the achievement of the milestones is based in part on the occurrence of a separate outcome resulting from its performance.

 

The Company assessed the deliverables under the authoritative guidance for multiple element arrangements. Based on the results of the Company’s analysis, it determined that the up-front payment was earned upon the delivery of the license and related know-how, which occurred by March 31, 2011.

 

The agreements with APEL will continue in effect on a product-by-product and country-by-country basis until expiration of APEL’s obligation to pay royalties with respect to each fidaxomicin product in each country in the APEL territory, unless terminated early by either party as more fully described below.  Following expiration, APEL’s license to develop and commercialize the applicable fidaxomicin product in the applicable country will become non-exclusive.  The Company and APEL each may terminate either of the agreements prior to expiration upon the material breach of such agreement by the other party or upon the bankruptcy or insolvency of the other party.  In addition, the Company may terminate the agreements prior to expiration in the event APEL or any of its affiliates or sublicensees commences an interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any patent licensed to it. APEL may terminate the agreements prior to expiration for any reason on a product-by-product and country-by-country basis upon 180 days’ prior written notice to the Company.  Upon any such termination, the license granted to APEL (in total or with respect to the terminated product or terminated country, as applicable) will terminate and revert to the Company.

 

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Par Pharmaceuticals, Inc. (“Par”)

 

In February 2007, the Company repurchased the rights to develop and commercialize DIFICID in North America and Israel from Par under a prospective buy-back agreement.  The Company paid Par a one-time $5.0 million milestone payment in June 2010 for the successful completion by the Company of its second pivotal Phase 3 trial for DIFICID.  The Company is obligated to pay Par a 5% royalty on net sales by the Company its affiliates or its licensees of DIFICID in North America and Israel, and a 1.5% royalty on net sales by the Company or its affiliates, of fidaxomicin in the rest of the world.  In addition, in the event the Company licenses its right to market fidaxomicin in the rest of the world, the Company will be required to pay Par a 6.25% royalty on net revenues received by it related to the licensing of fidaxomicin.  The Company is obligated to pay each of these royalties, on a country-by-country basis, for seven years commencing on the applicable commercial launch in each such country. In March 2011, the Company paid Par $4.3 million in royalties for net revenues received by the Company under the APEL agreement.  During the second quarter, the Company paid Par $1.3 million in royalties in association with the $20.0 million up-front payment from Astellas Japan.  In the third quarter, the Company will pay Par approximately $3.0 million in royalties in connection with the milestone payments from APEL and $0.8 million from net product sales of DIFICID during the second quarter.

 

Biocon Limited (“Biocon”)

 

In May 2010, the Company entered into a long-term supply agreement with Biocon for the commercial manufacture of fidaxomicin active pharmaceutical ingredient (“API”).  Pursuant to the agreement, Biocon agreed to manufacture and supply the Company, up to certain limits, fidaxomicin API and, subject to certain conditions, the Company agreed to purchase from Biocon at least a portion of its requirements for fidaxomicin API in the United States and Canada.  The Company previously paid to Biocon $2.5 million for certain equipment purchases and manufacturing scale-up activities, and it may be entitled to recover up to $1.5 million of this amount under the supply agreement in the form of discounted prices for fidaxomicin API.  Unless both the Company and Biocon agree to extend the term of the supply agreement, it will terminate seven and one-half years from the date the Company obtained marketing authorization for DIFICID in the United States.  In addition, the supply agreement may be earlier terminated (i) by either party by giving two and one-half years notice after the fifth anniversary of the Effective Date or upon a material breach of the supply agreement by the other party, (ii) by the Company upon the occurrence of certain events, including Biocon’s failure to supply requested amounts of fidaxomicin API, or (iii) by Biocon upon the occurrence of certain events, including the Company’s failure to purchase amounts of fidaxomicin API that it indicates in binding forecasts.

 

Patheon Inc. (“Patheon”)

 

In June 2011, the Company entered into a commercial manufacturing services agreement with Patheon to manufacture and supply fidaxomicin drug products, including DIFICID, in North America, Europe and other countries, subject to agreement by the parties to any additional fees for such countries.  The Company agreed to purchase a specified percentage of its fidaxomicin product requirements for North America and Europe from Patheon or its affiliates.

 

The term of the agreement extends through December 31, 2016 and will automatically renew for subsequent two-year terms unless either party provides a timely notice of its intent not to renew or unless the agreement is terminated early pursuant to its terms. The Company and Patheon may terminate the agreement prior to expiration upon the uncured material breach of the agreement by the other party or upon the bankruptcy or insolvency of the other party. In addition, the agreement will terminate with respect to any fidaxomicin product if the Company provides notice to Patheon that it no longer requires manufacturing services for such product because the product has been discontinued. Additionally, the Company may terminate the agreement, subject to certain limitations, (i) with respect to any fidaxomicin product, if any regulatory authority takes any action or raises any objection that prevents the Company from importing, exporting, purchasing or selling such product or if the Company determines to discontinue development or commercialization of such product for safety or efficacy reasons, (ii) if any regulatory authority takes an enforcement action against Patheon’s manufacturing site that relates to fidaxomicin products or that could reasonably be expected to adversely affect Patheon’s ability to supply fidaxomicin products to the Company, (iii) if Patheon is unable to deliver or supply any firm orders for any two calendar quarters during any four consecutive calendar quarters, (iv) if Patheon uses any debarred or suspended person in the performance of its service obligations under the agreement or (v) if Patheon fails to meet certain production yield requirements in relation to fidaxomicin API.

 

Cempra Pharmaceuticals, Inc. (“Cempra”)

 

In March 2006, the Company entered into a collaborative research and development and license agreement with Cempra.  The Company granted to Cempra an exclusive worldwide license, except in the Association of Southeast Asian Nations (“ASEAN”), with the right to sublicense the Company’s patent and know-how related to the Company’s macrolide and ketolide antibacterial program.  As partial consideration for granting Cempra the licenses, the Company obtained equity of Cempra and the Company assigned no value to such equity.  The Company may receive milestone payments as product candidates are developed and/or co-developed by Cempra, in addition to milestone payments

 

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based on certain sublicense revenue.  The aggregate potential amount of such milestone payments is not capped and, based in part on the number of products developed under the agreement, may exceed $24.5 million. The milestone payments will be triggered upon the completion of certain clinical development milestones and in certain instances, regulatory approval of products.  The Company also may receive royalty payments based on a percentage of net sales of licensed products.

 

Pursuant to the agreement, Cempra also granted the Company an exclusive license whereby Cempra may receive milestone payments from the Company in the amount of $1.0 million for each of the first two products the Company develops which receive regulatory approval in ASEAN countries, as well as royalty payments on the net sales of such products.

 

Subject to certain exceptions, on a country-by-country basis, the general terms of this agreement continue until the later of: (i) the expiration of the last to expire patent rights of a covered product in the applicable country or (ii) ten years from the first commercial sale of a covered product in the applicable country.  Either party may terminate the agreement in the event of a material breach by the other party, subject to prior notice and the opportunity to cure.  Either party also may terminate the agreement for any reason upon 30 days’ prior written notice provided that all licenses granted by the terminating party to the non-terminating party will survive upon the express election of the non-terminating party.

 

The Company has assessed milestones under the revised authoritative guidance for research and development milestones and determined that the preclinical milestone payments, as defined in the agreement, meet the definition of a milestone as they are (i) events that can only be achieved in part on the Company’s past performance or upon the occurrence of a specific outcome resulting from the Company’s performance, (ii) there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) they result in additional payments being due to the Company. Clinical development and commercial milestone payments, however, currently do not meet these criteria as their achievement is solely based on the performance of Cempra.

 

In February 2012, Cempra completed an initial public offering at which time the Company’s equity interest in Cempra was converted to 125,646 shares of common stock.  The Company considers its equity interest in Cempra as available-for-sale (see Note 3).

 

In June 2012, Cempra completed its first Phase 2 clinical trial of solithromycin (CEM101) in patients with community-acquired bacterial pneumonia, which triggered a $1.0 million milestone payment in June 2012 to the Company.  The Company recorded the $1.0 million as a receivable in the second quarter of 2012 and expects to receive the payment from Cempra during the subsequent quarter. To date the Company has recognized $1.5 million in payments from this collaboration.

 

Optimer Biotechnology, Inc.

 

In October 2009, the Company entered into certain transactions involving OBI, its then wholly-owned subsidiary, to provide funding for the development of two of its early-stage programs.  The transactions with OBI included an Intellectual Property Assignment and License Agreement, pursuant to which the Company assigned to OBI certain patent rights, information and know-how related to OPT-822/821.  In anticipation of these transactions, the Company also assigned, and OBI assumed, its rights and obligations under a related license agreement with Memorial Sloan-Kettering Cancer Center (“MSKCC”).  Under the agreement, the Company is eligible to receive up to $10.0 million in milestone payments related to the development of OPT-822/821 and also is eligible to receive royalties on net sales of any product which is commercialized under the program.  The term of the Intellectual Property Assignment and License Agreement continues until the last to expire of the certain patents assigned to and licensed by the Company to OBI.

 

In January 2012, the Company and OBI executed a letter of agreement which provided the Company the right of first refusal if OBI or one of its affiliates receives any offer to obtain an exclusive, royalty-bearing license (including the right to sublicense) under the OPT-822/821 patents and the OBI OPT-822/821 technology to develop, make, have made, use, sell, offer for sale, have sold and import OPT-822/821 products in a specified territory.  As consideration for the grant of the right of first refusal, the Company waived certain of OBI’s obligations under the Intellectual Property Assignment and License Agreement. The agreement expires 10 years from the effective date of the agreement.

 

Memorial Sloan-Kettering Cancer Center

 

In July 2002, the Company entered into a license agreement with MSKCC to acquire, together with certain non-exclusive licenses, exclusive, worldwide licensing and sublicensing rights to certain patented and patent-pending carbohydrate-based cancer immunotherapies.  As partial consideration for the licensing rights, the Company paid to MSKCC a one-time fee consisting of both cash and 55,383 shares of its common stock.  In anticipation of the various transactions involving OBI which the Company completed in October 2009, the Company assigned its rights and obligations under this agreement to OBI.

 

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The Scripps Research Institute (“TSRI”)

 

In July 1999, the Company acquired exclusive, worldwide rights to its OPopS technology from TSRI.  This agreement includes the license to the Company of patents, patent applications and copyrights related to OPopS technology.  The Company also acquired, pursuant to three separate license agreements with TSRI, exclusive, worldwide rights to over 20 TSRI patents and patent applications related to other potential drug compounds and technologies, including HIV/FIV protease inhibitors, aminoglycoside antibiotics, polysialytransferase, selectin inhibitors, nucleic acid binders, carbohydrate mimetics and osteoarthritis.  Under the four agreements with TSRI, the Company paid TSRI license fees consisting of an aggregate of 239,996 shares of the Company’s common stock with a deemed aggregate fair market value of $46,400, as determined on the dates of each such payment. In October 2009, the Company assigned to OBI one of the agreements with TSRI related to OPT-88 which, after further evaluation, OBI decided not to pursue. In February 2011, OBI and TSRI agreed to terminate the agreement and OBI returned the patents related to OPT-88. Under each of the three remaining agreements, the Company owes TSRI royalties based on net sales by the Company, the Company’s affiliates and sublicensees of the covered products and royalties based on revenue the Company generates from sublicenses granted pursuant to the agreements.  For the first licensed product under each of the three remaining agreements, the Company also will owe TSRI payments upon achievement of certain milestones.  In two of the three TSRI agreements, the milestones are the successful completion of a Phase 2 trial or its foreign equivalent, the submission of an NDA or its foreign equivalent and government marketing and distribution approval.  In the remaining TSRI agreement, the milestones are the initiation of a Phase 3 trial or its foreign equivalent, the submission of an NDA or its foreign equivalent and government marketing and distribution approval.  The aggregate potential amount of milestone payments the Company may be required to pay TSRI under the three remaining TSRI agreements is approximately $11.1 million.

 

Revenues from Research Grants

 

The Company has one grant from the National Institute of Allergy and Infectious Diseases. This $3.0 million grant was awarded in September 2007 for three years and was subsequently extended to August 2012. The award has been used to conduct supplementary studies to the DIFICID trials to confirm narrow-spectrum activity and potency of DIFICID against hypervirulent epidemic strains and to support additional toxicology studies.  The award is currently being used for microbiological studies to demonstrate the safety and efficacy of DIFICID and its major metabolite in CDAD patients and to support surveillance studies of C. difficile isolates across North America to compare the activity of DIFICID with existing CDAD treatments.  For the three months ended June 30, 2012 and 2011, the Company recognized revenues related to research grants of $0, and $33,294, respectively. For the six months ended June 30, 2012 and 2011, the Company recognized revenues related to research grants of $2,106, and $144,933, respectively.

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis should be read in conjunction with our consolidated financial statements and accompanying notes appearing elsewhere in this report, as well as the audited financial statements and accompanying notes included in our annual report on Form 10-K for the fiscal year ended December 31, 2011, as filed with the Securities and Exchange Commission, or SEC.  This discussion and other parts of this report may contain forward-looking statements based upon current expectations that involve risks and uncertainties.  Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this report.

 

Overview

 

We are a global biopharmaceutical company currently focused on commercializing our antibiotic product DIFICID®(fidaxomicin) in the United States and Canada, and further developing other fidaxomicin products in the United States and worldwide, both by ourselves and with our partners and licensees.  DIFICID is a macrolide antibacterial drug indicated in adults 18 years of age and older for the treatment of Clostridium difficile-associated diarrhea, or CDAD.  CDAD is the most common symptom of Clostridium difficile infection, or CDI. We market DIFICID in the United States through our own sales force and through our co-promotion agreement with Cubist Pharmaceuticals, Inc., or Cubist.

 

In December 2011, the European Medicines Agency, or EMA, approved the Marketing Authorization Application, or MAA, for DIFICLIR (fidaxomicin) tablets for the treatment of adults suffering with CDI in Europe. In June 2012, our collaboration partner, Astellas Pharma Europe Ltd., or APEL, achieved the first sales of DIFICLIR tablets in its European territories. In addition, in June 2012, our subsidiary, Optimer Pharmaceuticals Canada, Inc., began marketing DIFICID in Canada where we recently received marketing approval from Health Canada. We have entered into agreements with Astellas Pharma Inc., or Astellas Japan, and with Specialised Therapeutics Australia Pty. Ltd, or STA, for the development and commercialization of fidaxomicin in Japan and in Australia and New Zealand, respectively. We are pursuing regulatory approval and commercialization of fidaxomicin in other geographies outside the United States through various collaboration partners.

 

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We were incorporated in November 1998. We have incurred significant net losses since our inception.  As of June 30, 2012, we had an accumulated deficit of $226.2 million.  These losses have resulted principally from costs incurred in connection with research and development activities, including the costs of clinical trial activities, license fees and general and administrative expenses, and more recently expenses incurred in connection with our commercial efforts with respect to DIFICID in the United States and Canada.  We expect to incur operating losses for at least the next two years as we commercialize DIFICID, and pursue further development of DIFICID, including conducting post-marketing studies for label expansion and continuing further development, regulatory approval and commercialization of fidaxomicin worldwide.  We may acquire or in-license additional products or product candidates, technologies or businesses that are complementary.

 

Critical Accounting Policies

 

Our Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our consolidated financial statements, which have been prepared in conformity with generally accepted accounting principles in the United States.  The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures.  Actual results could differ from those estimates. While our significant accounting policies are described in more detail in Note 2 of the Notes to Consolidated Financial Statements appearing elsewhere in this report, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our consolidated financial statements.

 

Net Product Sales

 

DIFICID is available in the United States only through the three major wholesalers - AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson Corporation - and regional wholesalers that provide DIFICID to hospital and retail pharmacies, and long-term care facilities. We recognize revenue from product sales when there is persuasive evidence of an arrangement, delivery has occurred, title has passed to the customer, the price is fixed and determinable, the buyer is obligated to pay us, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from us, we have no obligation to bring about the sale of the product, and the amount of returns can be reasonably estimated and collectability is reasonably assured. We recognize revenue from product sales of DIFICID upon delivery of product to the wholesalers.

 

During the six months ended June 30, 2012, the $29.6 million in net product revenue reflected a total of 12,289 DIFICID treatments shipped to wholesalers. Wholesalers shipped 11,675 DIFICID treatments to hospitals, retail pharmacies and long-term care facilities.  As of June 30, 2012, approximately 1,800 hospitals had ordered DIFICID and the number of target hospitals including DIFICID on their formularies was approaching 900.

 

Our net revenues represent total revenues less allowances for customer credits, including estimated rebates, chargebacks, discounts and returns. These allowances are established by management as its best estimate, based on available information and are adjusted to reflect known changes in the factors that impact such allowances. Allowances for rebates, chargebacks, discounts and returns are established based on the contractual terms with customers, communications with customers as well as expectations about the market for the product and anticipated introduction of competitive products.  Product shipping and handling costs are included in cost of sales.

 

Product Sales Allowances.  We establish reserves for prompt-payment discounts, government rebates, product returns and other applicable allowances.

 

Allowances primarily relate to prompt-payment discounts and fee-for-service arrangements with our contracted wholesalers and are recorded at the time of sale, resulting in a reduction in product sales revenue.  Accruals related to government rebates, product returns and other applicable allowances are recognized at the time of sale, resulting in a reduction in product sales revenue and an increase in accrued expenses.

 

Prompt-payment Discounts.  We offer a prompt-payment discount to our contracted wholesalers.  Since we expect our customers will take advantage of this discount, we accrue 100% of the prompt-payment discount that is based on the gross amount of each invoice, at the time of sale. The accrual is adjusted quarterly to reflect actual earned discounts.

 

Government Rebates and Chargebacks.  We estimate government-mandated rebates and discounts relating to federal and state programs such as Medicaid, Veterans’ Administration, or VA, and Department of Defense programs, the Medicare Part D Coverage Discount Program and certain other qualifying federal and state government programs.  We estimate the amount of these reductions based on historical trends for similar competitive products, until such time as DIFICID patient data, actual sales data and market research data related to payor mix has reached an established steady state.  These allowances are adjusted each period based on actual experience.

 

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Medicaid rebate reserves relate to our estimated obligations to states under statutory “best price” obligations which also may include supplemental rebate agreements with certain states.  Rebate accruals are recorded during the same period in which the related product sales are recognized.  Actual rebate amounts are determined at the time of claim by the state, and we will generally make cash payments for such amounts after receiving billings from the state.

 

VA rebates or chargeback reserves represent our estimated obligations resulting from contractual commitments to sell DIFICID to qualified healthcare providers at a price lower than the list price charged to our distributors.  The distributor will charge us for the difference between what the distributor pays for the product and the ultimate selling price to the qualified healthcare provider.  Rebate accruals are established during the same period in which the related product sales are recognized. Actual chargeback amounts for Public Health Service are determined at the time of resale to the qualified healthcare provider from the distributor, and we generally will issue credits for such amounts after receiving notification from the distributor.

 

Although allowances and accruals are recorded at the time of product sale, certain rebates generally will be paid out, on average, up to six months or longer after the sale.  Reserve estimates are evaluated quarterly and, if necessary, adjusted to reflect actual results.  Any such adjustments will be reflected in our operating results in the period of the adjustment.

 

Product Returns.  Our policy is to accept returns of DIFICID for six months prior to, and twelve months after, the product expiration date.  We also permit returns if the product is damaged or defective when received by its customers. We will provide a credit for such returns to customers with whom we have a direct relationship. Once product is dispensed it cannot be returned, but we allow partial returns in states where such returns are mandated. We do not exchange product from inventory for the returned product.

 

Allowances for product returns are recorded during the period in which the related product sales are recognized, resulting in a reduction to product revenue.  We estimate product returns based upon sales of DIFICID, management experience with similar products, historical trends in the pharmaceutical industry and trends for similar products sold by others.

 

Contract Revenue

 

In order to determine the revenue recognition for contingent milestones, we evaluate the contingent milestones using the criteria as provided by the Financial Accounting Standards Board, or FASB, guidance on the milestone method of revenue recognition at the inception of a collaboration agreement.

 

Accounting Standard Codification (“ASC”) Topic 605-28, Revenue Recognition — Milestone Method (“ASC 605-28”), established the milestone method as an acceptable method of revenue recognition for certain contingent event-based payments under research and development arrangements.  Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved.  A milestone is an event (i) that can be achieved based in whole or in part on either our performance or on the occurrence of a specific outcome resulting from our performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to us.  The determination that a milestone is substantive is judgmental and is made at the inception of the arrangement.  Milestones are considered substantive when the consideration earned from the achievement of the milestone is (i) commensurate with either our performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone, (ii) relates solely to past performance and (iii) is reasonable relative to all deliverables and payment terms in the arrangement.

 

Other contingent, event-based payments received for which payment is either contingent solely upon the passage of time or the results of a collaborative partner’s performance are not considered milestones under ASC 605-28.  In accordance with ASC Topic 605-25, Revenue Recognition — Multiple-Element Arrangements (“ASC 605-25”), such payments will be recognized as revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; price is fixed or determinable; and collectability is reasonably assured.

 

Revenues recognized for royalty payments, if any, are recognized as earned in accordance with the terms of various research and collaboration agreements.

 

For collaboration agreements with multiple deliverables, we recognize collaboration revenues and expenses by analyzing each element of the agreement to determine if it is to be accounted for as a separate element or single unit of accounting. If an element is to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue is to be recognized. If an element is not to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue is to be recognized.

 

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Cash received in advance of services being performed is recorded as deferred revenue and recognized as revenue as services are performed over the applicable term of the agreement.  In connection with certain research collaboration agreements, revenues are recognized from non-refundable up-front fees, that we do not believe are specifically tied to a separate earnings process, ratably over the term of the agreement.  Research fees are recognized as revenue as the related research activities are performed.

 

With respect to revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with grants, where we act as a principal, with discretion to choose suppliers, bear credit risk and perform part of the services required in the transaction, we record revenue for the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in the consolidated statements of operations.

 

Inventory

 

Inventory is stated at the lower of cost or market.  Cost is determined in a manner which approximates the first-in, first-out (FIFO) method. We capitalize inventory produced in preparation for product launches upon FDA approval when costs are expected to be recoverable through the commercialization of the product.  We reserve for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales. As of June 30, 2012, inventories consisted of $6.6 million in raw materials, $0.6 million in work in process and $1.3 million in finished goods.  During the second quarter, we reserved $0.5 million of our inventory cost.

 

Research and Development

 

Research and development costs are expensed as incurred and consist primarily of costs associated with clinical trials, medical affairs, compensation, including stock-based compensation, and other expenses related to research and development, including personnel costs, facilities costs and depreciation.

 

When non-refundable payments for goods or services to be received in the future for use in research and development activities are made, we defer and capitalize these types of payments. The capitalized amounts are expensed when the related goods are delivered or the services are performed.

 

Stock-based Compensation

 

The FASB authoritative guidance requires that share-based payment transactions with employees be recognized in the financial statements based on their fair value and recognized as compensation expense over the vesting period.

 

Total consolidated stock-based compensation expense of $4.0 million and $2.5 million was recognized in the three months ended June 30, 2012 and 2011, respectively.  Total consolidated stock-based compensation expense of $7.0 million and $4.7 million was recognized in the six months ended June 30, 2012 and 2011, respectively. The stock-based compensation expense recognized included expense from performance-based stock options and restricted stock units.

 

Stock-based compensation expense is estimated as of the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which generally represents the vesting period. We estimate the fair value of our stock options using the Black-Scholes option-pricing model and the fair value of our stock awards based on the quoted market price of our common stock.

 

Equity instruments issued to non-employees are recorded at their fair value and are periodically revalued as the equity instruments vest and are recognized as expense over the related service period.

 

Investment in OBI

 

We account for our investment in OBI under the equity method of accounting as we do not have the elements of control that would require consolidation. The investment is subsequently adjusted for equity in net income and cash contributions and distributions. In addition, we record adjustments to reflect the amortization of basis differences attributable to the fair values in excess of net book values of identified tangible and intangible assets.  Any difference between the carrying amount of the investment on our balance sheet and the underlying equity in net assets is evaluated for impairment at each reporting period.

 

Income Taxes

 

We estimate income taxes based on the jurisdictions where we conduct business.  Significant judgment is required in determining our worldwide income tax provision.  We estimate our current tax liability and assess temporary differences that result from differing treatments of certain items for tax and accounting purposes.  These differences result in net deferred tax assets and liabilities.  We then

 

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assess the likelihood that deferred tax assets will be realized.  A valuation allowance is recorded when it is more likely than not that some of the deferred tax assets will not be realized.  We review the need for a valuation allowance each interim period to reflect uncertainties about whether we will be able to utilize deferred tax assets before they expire.  The valuation allowance analysis is based on estimates of taxable income for the jurisdictions in which we operate and the periods over which our deferred tax assets may be realized.  Changes in our valuation allowance could result in material increases or decreases in our income tax expense in the period such changes occur, which could have a material impact on our operating results.

 

We estimate that our federal and state taxable income, if any, for the current year will be fully offset by net operating losses and research and development credit carryovers.  As such, no current tax provision has been recorded.  We also have recorded a full valuation allowance for the remaining net deferred tax benefits. We have completed a Section 382/383 analysis regarding the limitation of the net operating losses and credit carryovers and have considered the annual limitation when determining the amount available for utilization in the current year.

 

We recognize and measure benefits for uncertain tax positions using a two-step approach.  The first step is to evaluate the tax position taken and expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that the tax position will be sustained upon audit, including resolution of any related appeals or litigation processes.  For tax positions that are more likely than not to be sustained upon audit, the second step is to measure the tax benefit as the largest amount that has more than a 50% chance of being realized upon settlement.  Significant judgment is required to evaluate uncertain tax positions.  We evaluate uncertain tax positions on a quarterly basis.  The evaluations are based upon a number of factors, including changes in facts or circumstances, changes in tax law, correspondence with tax authorities during the course of audits and effective settlement of audit issues.  Changes in recognition or measurement of uncertain tax positions could result in material increases or decreases in our income tax expense in the period such changes occur, which could have a material impact on our effective tax rate and operating results.

 

 

Results of Operations

 

Comparison of Three Months Ended June 30, 2012 and 2011

 

Revenues

 

Total revenues for the three months ended June 30, 2012 and 2011 were $49.8 million and $33,000, respectively, an increase of $49.8 million.  In April 2012, pursuant to our collaboration and license agreement, we received a $20.0 million up-front payment from Astellas Japan. We assessed the deliverable for stand alone value under the contract and recognized $19.9 million as contract revenue during the second quarter of 2012 upon delivery of the license know-how. A portion of the up-front payment was deferred for undelivered items.  We also recognized revenue on the 10.0 million Euros milestone payment from APEL in association with the first sales of fidaxomicin in an APEL territory.  In addition, we recognized $15.2 million of net product revenue from sales of DIFICID.  We launched DIFICID in the U.S. in July 2011 and in Canada in June 2012.

 

Costs and Expenses

 

Cost of product sales. Cost of product sales for the three months ended June 30, 2012 was $2.3 million and consisted inventory sold and royalties due to Par.

 

Cost of contract revenue. The $1.7 million incurred for the three months ended June 30, 2012 represented a royalty payment we paid to Par based on the revenue from the Astellas Japan up-front payment and the 10.0 million Euros milestone payment from APEL.

 

Research and development expense.  Research and development expense for the three months ended June 30, 2012 and 2011 was $11.6 million and $10.3 million, respectively, an increase of $1.3 million. The increase was due primarily to higher health economics and outcomes research costs.

 

Selling, general and administrative expense. Selling, general and administrative expense for the three months ended June 30, 2012 and 2011 was $28.9 million and $14.8 million, respectively, an increase of $14.1 million. The increase was due primarily to our commercialization efforts on DIFICID. We had higher headcount during the 2012 period and thus incurred higher salary expense. We also incurred higher advertising and promotion expenses as well as higher legal, consulting and other outside services.

 

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Co-promotion expenses with Cubist. The $5.0 million in the quarter ended June 30, 2012 represented certain expenses that may be due Cubist under our April 2011 DIFICID co-promotion agreement. We did not incur similar expenses in the three months ended June 30, 2011.

 

Equity in net loss of OBI. The $0.7 million represented the loss recognized in our investment in OBI using the equity method. We did not have a similar loss for the same period in the prior year.

 

Interest income and other, net. Net interest income and other of $44,000 for the three months ended June 30, 2012 was relatively consistent with the $96,000 for the three months ended June 30, 2011.

 

Net loss attributable to non-controlling interest. We did not incur a net loss attributable to non-controlling interest for the three months ended June 30, 2012 as OBI was not consolidated in our financial statements during the period. During 2011, such amount represented the non-controlling interest’s proportionate share of OBI’s net losses.

 

Comparison of Six Months Ended June 30, 2012 and 2011

 

Revenues

 

Total revenues for the six months ended June 30, 2012 and 2011 were $64.1 million and $69.3 million, respectively. In 2012, our revenues were made up of $29.6 million in DIFICID product sales and $34.5 million in contract revenue. The decrease of $5.2 million was primarily due to the $69.2 million up-front payment we received from APEL in the first quarter of the 2011, partially offset by the receipt in April 2012 of the $20.0 million up-front payment from Astellas Japan and the 10.0 million Euro milestone payment from APEL in association with the first commercial sale of DIFICLIR in an APEL territory.  In addition, we recognized $29.6 million of net product sales of DIFICID in the six months ended June 2012.  We launched DIFICID in the U.S. in July 2011 and in Canada in June 2012.

 

Costs and Expenses

 

Cost of product sales. Cost of product sales for the six months ended June 30, 2012 was $4.6 million and consisted of inventory sold and royalties due to Par on net sales of DIFICID.

 

Cost of contract revenue. Cost of contract revenue for the six months ended June 30, 2012 and 2011 was $1.7 million and $4.3 million, respectively, a decrease of $2.6 million.  The decrease is due to lower collaboration revenue in the current period as compared to the same period in the prior year.

 

Research and development expense.  Research and development expense for the six months ended June 30, 2012 and 2011 was $22.6 million and $18.7 million, respectively, an increase of $3.9 million. The increase was primarily due to higher health economics and outcomes research, medical affairs, medical education, pharmacovigilance and publication expenses.

 

Selling, general and administrative expense. Selling, general and administrative expense for the six months ended June 30, 2012 and 2011 was $54.4 million and $26.6 million, respectively, an increase of $27.8 million. The increase was primarily due to our commercialization efforts on DIFICID. We had higher headcount during the 2012 period and thus incurred higher salary expense. We also incurred higher advertising and promotion expenses as well as higher legal, consulting and other outside services.

 

Co-promotion expenses with Cubist. The $15.1 million represented certain expenses that may be due Cubist under our April 2011 DIFICID co-promotion agreement. Based on the level of sales to date and the estimated continued growth in revenues, Optimer achieved the first year sales target and has accrued $10.4 million, representing the quarterly service fee and a pro-rated portion of the $5.0 million bonus payment as well as pro-rated portion of gross profit. We did not incur similar expenses in the six months ended June 30, 2011.

 

Gain on de-consolidation of OBI. The $23.8 million represented the gain on the de-consolidation of OBI.  We did not have a similar gain in the six months ended June 30, 2011.

 

Equity in net loss of OBI. The $1.2 million represented the loss recognized in our investment in OBI using the equity method. We did not have a similar loss in the six months ended June 30, 2011.

 

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Interest income and other, net. Net interest income and other of $121,000 for the six months ended June 30, 2012 was relatively consistent with the $119,000 for the six months ended June 30, 2011.

 

Net loss attributable to non-controlling interest. Net loss attributable to non-controlling interest for the six months ended June 30, 2012 and 2011 was approximately $0.3 million and $1.0 million, respectively, a decrease of $0.7 million. The $0.3 million represented approximately one month of non-controlling interest prior to deconsolidation of OBI on February 7, 2012.

 

Liquidity and Capital Resources

 

Sources of Liquidity

 

Prior to our launch of DIFICID in July 2011, our operations were financed primarily through the sale of equity securities.  Through June 30, 2012, we received gross proceeds of approximately $333.8 million from the sale of shares of our preferred and common stock in various private and public financing transactions. Since July 2011, we entered into collaboration and license agreements and received a total of approximately $155.3 million from up-front and milestone payments pursuant to the agreements. Through June 30, 2012, we have generated $51.1 million of net products sales.

 

Until required for operations, we invest a substantial portion of our available funds in money market funds, U.S. government instruments and other readily marketable debt instruments, almost all of which are investment-grade quality.  We have established guidelines relating to diversification and maturities of our investments to preserve principal and maintain liquidity.

 

Cash Flows

 

As of June 30, 2012, our consolidated cash, cash equivalents and short-term investments totaled approximately $130.6 million as compared to $110.6 million as of December 31, 2011, an increase of approximately $20.1 million.  The increase in our cash, cash equivalents and short-term investments was primarily due to the receipt of 50.0 million Euros in June 2012 as a result of attaining EMA approval and the commercial launch of DIFICLIR in the APEL territories. We also received a $20.0 million up-front payment from Astellas Japan pursuant to our collaboration and license agreement.  The increase is offset by day-to-day operating expenses as well as the exclusion of OBI’s cash and cash equivalents as a result of the deconsolidation of OBI in February 2012.

 

Although we started selling DIFICID in July 2011, we cannot be certain if, when or to what extent we will receive meaningful cash inflows from our commercialization activities.  We expect our commercialization expenses to be substantial and to increase over the next few years. We also expect to continue to incur development expenses as we pursue life-cycle management opportunities for DIFICID.

 

In March 2012, we entered into a collaboration and license agreement with Astellas Japan pursuant to which we granted to Astellas Japan an exclusive, royalty-bearing license under certain of our know-how and intellectual property to develop and commercialize fidaxomicin in Japan. Under the terms of the license agreement, Astellas Japan paid to us an up-front fee equal to $20.0 million which we received in April 2012. We are also eligible to receive additional cash payments totaling up to $70.0 million upon the achievement by Astellas Japan of specified regulatory and commercial milestones.  In addition, we will be entitled to receive high single-digit royalties on net sales of fidaxomicin products in Japan above an agreed threshold, which royalties are subject to reduction in certain, limited circumstances.  Such royalties will be payable by Astellas Japan on a product-by-product basis until a generic product accounts for a specified market share of the applicable fidaxomicin product in Japan. Under the supply agreement, in exchange for commercial supply of fidaxomicin, Astellas Japan is obligated to pay Optimer Europe a price equal to net sales of fidaxomicin products in Japan minus a discount that is based on a high double-digit percentage of such net sales and a mark-up to cost of goods.  This price will be payable by Astellas Japan on a product-by-product basis for commercial supply until a generic product accounts for a specified market share of the applicable fidaxomicin product in Japan.

 

In April 2011, we entered into a co-promotion agreement with Cubist pursuant to which we engaged Cubist as our exclusive partner for the promotion of DIFICID in the United States.  Under the terms of the agreement, Cubist and we have agreed to co-promote DIFICID to physicians, hospitals, long-term care facilities and other healthcare institutions as well as jointly provide medical affairs support for DIFICID. In exchange for Cubist’s co-promotion activities and personnel commitments, we are obligated to pay a quarterly fee of approximately $3.8 million to Cubist which we began paying upon the commencement of the DIFICID sales program in the United States. Cubist also is eligible to receive an additional $5.0 million in the first year after first commercial sale and $12.5 million in the second year after first commercial sale if mutually agreed upon annual sales targets are achieved, as well as a portion of our gross profits derived from net sales above the specified annual targets, if any.  Based on the level of sales to date, we achieved the first year sales target and as of June 30, 2012, accrued $10.4 million representing service fees, the $5.0 million bonus as well as a portion of estimated gross profit on sales above the sales target which will become due to Cubist in August 2012.

 

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In February 2011, we entered into a collaboration and license agreement with APEL pursuant to which we granted to APEL an exclusive, royalty-bearing license under certain of our know-how and intellectual property to develop and commercialize fidaxomicin in the APEL territories. Under the terms of the license agreement, APEL paid to us an upfront fee of $69.2 million in March 2011 and we recognized a milestone payment of 40.0 million Euros in December 2011 as the result of APEL attaining EMA approval of DIFICLIR. APEL paid to us 50.0 million Euros in June 2012 which consisted of the 40.0 million Euro approval milestone payment and a 10.0 million Euro milestone for the first commercial launch of DIFICLIR in the APEL territories. We are eligible to receive additional cash payments totaling up to 65.0 million Euros upon the achievement by APEL of specified commercial milestones.  In addition, we will be entitled to receive escalating double-digit royalties ranging from the high-teens to low-twenties on net sales of fidaxomicin products in the APEL territories, which royalties are subject to reduction in certain, limited circumstances.  We expect to begin receiving royalties in the third quarter based on the recent commercial launch of DIFICLIR in Europe. Such royalties will be payable by APEL on a product-by-product and country-by-country basis until a generic product accounts for a specified market share of the applicable fidaxomicin product in the applicable country.

 

In June 2011, we entered into a commercial manufacturing services agreement with Patheon Inc., or Patheon, to manufacture and supply fidaxomicin drug products, including DIFICID, in North America, Europe and other countries, subject to agreement by the parties to any additional fees for such countries.  We agreed to purchase a specified percentage of our fidaxomicin product requirements for North America and Europe from Patheon or its affiliates.

 

In May 2010, we entered into a long-term supply agreement with Biocon Limited, or Biocon, for the commercial manufacture of fidaxomicin’s active pharmaceutical ingredient, or API. Pursuant to the agreement, Biocon agreed to manufacture and supply to us, up to certain limits, fidaxomicin API and, subject to certain conditions, we agreed to purchase from Biocon at least a portion of our requirements for fidaxomicin API in the United States and Canada.  We previously paid to Biocon $2.5 million for certain equipment purchases and manufacturing scale-up activities, and we may be entitled to recover up to $1.5 million of this amount under the supply agreement in the form of discounted prices for fidaxomicin API.  We may be obligated to make additional payments to Biocon if we fail to meet minimum purchase requirements after Biocon has dedicated certain manufacturing capacity to the production of fidaxomicin API and if Biocon is unable to manufacture alternative products with the dedicated capacity.

 

In February 2007, we repurchased the rights to develop and commercialize DIFICID in North America and Israel from Par under a prospective buy-back agreement.  We paid Par a one-time $5.0 million milestone payment in June 2010 for the successful completion of the second pivotal Phase 3 trial for DIFICID.  We are obligated to pay Par a 5% royalty on net sales by us, our affiliates, or our licensees of DIFICID in North America and Israel, and a 1.5% royalty on net sales by us or our affiliates, of fidaxomicin in the rest of the world.  In addition, in the event we licenses our right to market fidaxomicin in the rest of the world, we will be required to pay Par a 6.25% royalty on net revenues received related to fidaxomicin.  We are obligated to pay each of these royalties, on a country-by-country basis, for seven years commencing on the applicable commercial launch in each such country. In March 2011, we paid Par $4.3 million in royalties for net revenues received by us under the APEL agreement.  During the second quarter, we paid Par $1.3 million in royalties in association with the $20.0 million up-front payment from Astellas Japan.  In the third quarter, we expect to pay Par approximately $3.0 million in royalties in connection with the milestone payments from APEL and $0.8 million from net product sales of DIFICID in the second quarter of 2012.

 

Funding Requirements

 

Our future capital requirements depend on numerous factors including, but not limited to, the following:

 

·                  our ability to successfully market and sell DIFICID in the United States and Canada and the ability of our collaborators to market other fidaxomicin products in countries outside the United States and Canada;

 

·                  the costs of establishing, maintaining and managing our commercial infrastructure including our sales and distribution capabilities and the timing of such efforts;

 

·                  our decision to conduct future clinical trials, including the design, timing and progress of such clinical trials;

 

·                  our ability to establish and maintain strategic collaborations, including licensing and other arrangements;

 

·                  the amount and timing of payments we may receive or be required to make under strategic collaborations, including licensing, co-promotion and other arrangements;

 

·                  our decision to partner or license fidaxomicin or commercialize fidaxomicin ourselves in countries where we currently do not have a collaboration partner or our own presence;

 

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·                  the costs of preparing and pursuing applications for regulatory approvals and the timing of such approvals;

 

·                  the costs involved in prosecuting, enforcing or defending patent claims or other intellectual property rights; and

 

·                  the extent to which we in-license, acquire or invest in other indications, products, technologies and businesses.

 

We believe that our existing cash and cash equivalents, and cash flows from DIFICID sales will be sufficient to meet our capital requirements for at least the next 12 months.

 

Until we can generate significant cash from our operations, we expect to continue to fund our operations with existing cash resources, revenues from sales of DIFICID in the United States and revenues from collaboration agreements.  In addition, we may finance future cash needs through the sale of additional equity securities, new collaboration agreements or debt financing.  However, we may not be successful in completing future equity financings, in entering into additional collaboration agreements, in receiving milestone or royalty payments under new or existing collaboration agreements, in obtaining new government grants or in obtaining debt financing.  In addition, we cannot be sure that our existing cash and investment resources will be adequate, that financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our stockholders.

 

The capital markets continue to be volatile which has generally made equity and debt financing more difficult to obtain, and may negatively impact our ability to complete financing transactions.  Having insufficient funds may require us to delay, scale-back or eliminate some or all of our planned commercialization activities and development programs, relinquish some or even all of our rights to product candidates at an earlier stage of development or negotiate less favorable terms for rights to our products or product candidates than we would otherwise choose.  Failure to obtain adequate financing also may adversely affect our ability to operate as a going concern.  If we raise funds by issuing equity securities, substantial dilution to existing stockholders would likely result.  If we raise funds by incurring debt, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Cash Equivalents and Marketable Securities Risk

 

Our cash and cash equivalents and short-term investments as of June 30, 2012 consisted primarily of money market funds and U.S. government instruments and other readily marketable debt instruments.  Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates.  The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from our investments without significantly increasing risk.  A hypothetical ten percent change in interest rates during the quarter ended June 30, 2012 would have resulted in an approximately $6,000 change in net income. Accordingly, we would not expect our operating results or cash flows to be affected to any significant degree by a sudden change in market interest rates applicable to our securities portfolio.  In general, money market funds are not subject to market risk because the interest paid on such funds fluctuates with the prevailing interest rate.

 

Fair Value Measurements

 

All of our investment securities are available-for-sale securities and are reported on the consolidated balance sheet at market value except for one auction rate preferred security, or ARPS, with a par value of approximately $1.0 million. As a result of the negative conditions in the global credit markets, our ARPS currently is not liquid.  In the event we need to access the funds that are in an illiquid state, we will not be able to do so without a loss of principal, until the security is redeemed by the issuer or it matures.

 

Foreign Currency Risk

 

While we operate primarily in the United States, we are exposed to foreign currency risk.  Our agreement with APEL includes milestone and royalty payments which are denominated in Euros.  Our fidaxomicin API manufacturer, Biocon, is located in India and our manufacturer of fidaxomicin tablets, Patheon, is located in Canada.  Although we pay Biocon and Patheon in U.S. dollars, changes in the Rupee and the Canadian dollar may result in price adjustments and affect our operating results.

 

We established subsidiaries in Canada, Optimer Pharmaceuticals Canada, Inc., or Optimer Canada, and in Luxembourg, Optimer Luxembourg 2 S.à.r.l., or Optimer Europe, and we expect Optimer Canada’s and Optimer Europe’s transactions to be denominated primarily in Canadian dollars and Euros, respectively.  As a result, our financial results could be affected by factors such as changes in foreign currency exchange rates or weak economic conditions in foreign markets where we conduct business, including the impact of

 

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the existing conditions in the global financial markets in such countries and the impact on both the U.S. dollar the Canadian dollar and the Euro.

 

We do not use derivative financial instruments for speculative purposes. We do not engage in exchange rate hedging or hold or issue foreign exchange contracts for trading purposes. Currently, we do not expect the impact of fluctuations in the relative fair value of the other currencies to be material to our results of operations.

 

Item 4. Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Evaluation of Disclosure Controls and Procedures. As required by Exchange Act Rule 13a-15(b), we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based on the foregoing, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control over Financial Reporting. There was no change in our internal control over financial reporting during the quarter ended June 30, 2012 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.  During the quarter ended June 30, 2012, we experienced some personnel changes including the departure of our prior Chief Financial Officer in April 2012.  The roles and responsibilities of the former Chief Financial Officer related to internal control over financial reporting were performed by our Acting Chief Financial Officer and various consultants while we conducted a search for a new Chief Financial Officer. In June 2012, we replaced our Acting Financial Officer with a new Chief Financial Officer. Such personnel changes during the quarter ended June 30, 2012 did not materially affect, nor are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II — OTHER INFORMATION

 

Item 1a. Risk Factors

 

The risk factors set forth below with an asterisk (*) next to the title are new risk factors or risk factors containing changes, including any material changes, from the risk factors previously disclosed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2011, as filed with the SEC.

 

Risks Related to Our Business

 

Our success largely depends on our ability to successfully commercialize our only product, DIFICID.*

 

Our success depends on our ability to effectively commercialize our only product, DIFICID, which was approved by the FDA in May 2011, for the treatment of CDAD in adults 18 years of age and older.  We launched DIFICID in the United States in July 2011 and launched DIFICID in Canada in June 2012 following our receipt of Canadian marketing approval. Our ability to effectively commercialize and generate revenues from DIFICID will depend on several factors, including:

 

·                  our ability to create market demand for DIFICID through our own marketing and sales activities as well as through our co-promotion agreement with Cubist;

 

·                  the ability of our collaboration partners to successfully commercialize fidaxomicin outside the United States and Canada;

 

·                  our ability to train, deploy and support a qualified sales force;

 

·                  our ability to secure formulary approvals for DIFICID at a substantial number of targeted hospitals and long-term care facilities;

 

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·                  adequate coverage or reimbursement for DIFICID by government healthcare programs and third-party payors, including private health coverage insurers and health maintenance organizations;

 

·                  the performance of our third-party manufacturers and our ability to ensure that our supply chain for DIFICID efficiently and consistently delivers DIFICID to our customers;

 

·                  our ability to implement and maintain agreements with wholesalers and distributors on commercially reasonable terms;

 

·                  our ability to expand the label of DIFICID to cover additional indications; and

 

·                  our ability to maintain and defend our patent protection and regulatory exclusivity for DIFICID.

 

Any disruption in our ability to generate revenues from the sale of DIFICID or lack of success in its commercialization will have a substantial adverse impact on our results of operations.

 

The success of our efforts to commercialize DIFICID in the United States will be partially dependent on our co-promotion agreement with Cubist.*

 

Pursuant to our co-promotion agreement with Cubist, we engaged Cubist as our exclusive partner for the promotion of DIFICID in the United States. We have limited control over the amount and timing of resources that Cubist may devote to the co-promotion of DIFICID. If Cubist fails to adequately promote DIFICID, or if Cubist’s efforts are not effective for any other reason, our business may be negatively affected.  In particular, we are relying on our co-promotion agreement with Cubist to reach a broader segment of the CDAD market than we could otherwise reach on our own.  If Cubist is unsuccessful or the co-promotion agreement is terminated earlier than we expect, we may not be able to address these broader CDAD market segments, and the revenues we may generate from sales of DIFICID in the United States will be limited.

 

We are subject to a number of other risks associated with our dependence on our co-promotion agreement with Cubist, including:

 

·                  Cubist could fail to devote sufficient resources to the promotion of DIFICID, including by failing to maintain or train sufficient sales or medical affairs personnel to promote or provide information regarding DIFICID;

 

·                  Cubist may not provide us with timely and accurate information regarding promotion and sales activities with respect to DIFICID, which could adversely impact our ability to manage our own inventory of DIFICID in the United States, as well as our ability to generate accurate financial forecasts;

 

·                  Cubist and we may not be successful in coordinating our respective sales and promotion activities under the co-promotion agreement, which could lead to inefficiencies, the failure to maximize DIFICID sales in the Unites States, and/or disagreements between Cubist and us;

 

·                  Cubist may not comply with applicable regulatory guidelines with respect to the promotion of DIFICID, which could adversely impact sales of DIFICID in the United States; or

 

·                  business combinations or significant changes in Cubist’s business strategy, including the acquisition or development by Cubist of other products, may adversely affect Cubist’s ability or willingness to perform its obligations under our co-promotion agreement.

 

Our co-promotion agreement with Cubist is subject to early termination, including through Cubist’s right to terminate if we experience certain supply failures in relation to the demand for DIFICID in the United States or if we are acquired by certain types of entities, including competitors of Cubist.  If the agreement is terminated early, we may not be able to find another partner to co-promote DIFICID in the United States on acceptable terms, or at all, and we may be unable to sufficiently promote and commercialize DIFICID in the United States on our own.

 

We are dependent on our collaboration agreements with various third parties to commercialize and further develop fidaxomicin in territories outside the United States and Canada.  The failure to maintain these agreements or the failure of our collaboration partners to perform their obligations under their respective agreements, could negatively impact our business.*

 

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Pursuant to the terms of our collaboration agreements, we granted to third parties, including APEL, Astellas Japan and STA, exclusive rights to develop and commercialize fidaxomicin in various territories outside the United States and Canada, including Europe, Japan and Australia. We also have entered into supply agreements with our collaboration partners pursuant to which we are obligated to supply our partners all of their requirements of fidaxomicin for such development and commercialization activities.  Consequently, our ability to generate any revenues from fidaxomicin in territories outside the United States and Canada depends on our collaboration partners’ ability to obtain regulatory approvals for and successfully commercialize fidaxomicin in their respective territories.  We have limited control over the amount and timing of resources that our collaboration partners will dedicate to these efforts.

 

We are subject to a number of other risks associated with our dependence on our collaboration agreements including:

 

·                  our collaboration partners may not comply with applicable regulatory guidelines with respect to developing or commercializing fidaxomicin, which could adversely impact sales or future development of fidaxomicin in the Astellas territory and/or Japan;

 

·                  our collaboration partners could disagree as to future development plans and our collaboration partners may delay future clinical trials or stop a future clinical trial;

 

·                  there may be disputes between our collaboration partners and us, including disagreements regarding the applicable collaboration agreement, that may result in (1) the delay of or failure to achieve regulatory and commercial objectives that would result in milestone or royalty payments, (2) the delay or termination of any future development or commercialization of fidaxomicin and/or (3) costly litigation or arbitration that diverts our management’s attention and resources;

 

·                  because the milestone and royalty payments in the collaboration agreement with APEL are stated in terms of Euros but paid to us in U.S. Dollars, the amounts of any milestone or royalty payments that may be paid to us under the collaboration agreement could be less than what we expect, depending on the applicable exchange rate at the time of such payments;

 

·                  our collaboration partners may not provide us with timely and accurate information regarding sales and marketing activities and supply forecasts, which could adversely impact our ability to comply with our supply obligations to our collaboration partners and manage our own inventory of fidaxomicin, as well as our ability to generate accurate financial forecasts;

 

·                  business combinations or significant changes in our collaboration partners’ business strategy may adversely affect our collaboration partners’ ability or willingness to perform their respective obligations under our collaboration and supply agreements;

 

·                  our collaboration partners may not properly maintain or defend our intellectual property rights in the their respective territories or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or expose us to potential litigation;

 

·                  the payments we are eligible to receive from our collaboration partners may be reduced or eliminated based upon our collaboration partners’ and our ability to maintain or defend our intellectual property rights and the presence of generic competitors in the applicable territories;

 

·                  limitations under certain of our collaboration agreements on our or an acquiror’s ability to maintain or pursue development or commercialization of products that are competitive with fidaxomicin could deter a potential acquisition of us that our stockholders may otherwise view as beneficial; and

 

·                  if our collaboration partners are unsuccessful in obtaining regulatory approvals for or commercializing fidaxomicin in the their respective territories, we may not receive any payments under the applicable collaboration agreement and our business prospects and financial results may be materially harmed.

 

Our collaboration and supply agreements are subject to early termination, including through our collaboration partners’ right to terminate without cause upon advance notice to us.  If the agreements are terminated early, we may not be able to find another collaborator for the commercialization and further development of fidaxomicin in the applicable territory on acceptable terms, or at all, and we may be unable to pursue continued commercialization or development of fidaxomicin in the applicable territory on our own.

 

We may enter into additional agreements for the commercialization of fidaxomicin or other of our drug candidates, and may be similarly dependent on the performance of third parties with similar risk.

 

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Other than our existing collaboration agreements, we may not be able to enter into acceptable agreements to commercialize fidaxomicin outside of the United States and Canada or if, needed, adequately build our own marketing and sales capabilities.*

 

We intend to pursue the development of and potentially commercialize fidaxomicin outside of the United States and Canada through collaboration arrangements with third parties, such as our collaborations with APEL, Astellas Japan and STA, or independently.  We may be unable to enter into additional collaboration arrangements in international markets.  In addition, there can be no guarantee that our existing collaboration partners or any other parties with which we may enter into collaboration arrangements will be successful or result in more revenues than we could obtain by marketing fidaxomicin on our own. If we are unable to enter into additional collaboration arrangements for our products or develop an effective international sales force, our ability to generate product revenues would be limited, which would adversely affect our business, financial condition, results of operations and prospects. If we are unable to enter into additional collaboration arrangements for development of fidaxomicin in countries outside of the United States and Canada, or if we otherwise decide to market fidaxomicin ourselves in these countries, we will need to develop our own marketing and sales force to market fidaxomicin in these territories to hospital-based and long-term care physicians.  These efforts, may not be successful as we have limited relationships among such hospital-based and long-term care physicians and may not currently have sufficient funds to develop an adequate sales force in each of these regions.  There is no guarantee that we will be able to develop an effective international sales force to successfully commercialize our products in these international markets.  If we cannot commercialize fidaxomicin, either through a collaboration or independently, in any territory that represents a significant market opportunity, our ability to achieve and sustain profitability will be substantially limited.

 

We have incurred significant operating losses since inception and anticipate that we will incur continued losses for the foreseeable future.*

 

We have experienced significant operating losses since our inception in 1998.  As of June 30, 2012, we had an accumulated deficit of approximately $226.2 million.  We have generated limited revenues from product sales and collaborations to date and we expect our expenses to continue to be significant in the near-term as we execute the commercial launch of DIFICID due to, among other things, our employee headcount, on-going payments to Cubist pursuant to our co-promotion agreement and as we pursue additional research and development activities, including potential additional indications and life-cycle management projects for DIFICID. We have funded our operations through June 30, 2012 from the sale of approximately $333.8 million of our equity securities and through payments received under collaborations with partners or government grants and product revenues from sales of DIFICID. Because of the numerous risks and uncertainties associated with commercializing DIFICID and with developing, obtaining regulatory approval for and commercializing any future product candidates, we are unable to predict the extent of any future losses.  Our collaborators or we may never successfully commercialize our product candidates, including fidaxomicin outside of the United States, and thus we may never have any significant future revenues or achieve and sustain profitability.

 

The commercial success of DIFICID and any other products we develop or acquire will depend upon attaining significant market acceptance among physicians, hospitals, patients, healthcare payors and the medical community.*

 

Even after approved by the appropriate regulatory authorities for marketing and sale, physicians may not prescribe any of our products, which would prevent us from generating revenues or becoming profitable.  Market acceptance of our products by physicians, hospitals, patients and healthcare payors generally will depend on a number of factors, many of which are beyond our control, including:

 

·                  timing of market introduction of our products as well as of competitive drugs;

 

·                  the clinical indications for which the product is approved;

 

·                  acceptance by physicians and patients of each product as a safe and effective treatment;

 

·                  perceived advantages over alternative treatments;

 

·                  the cost of treatment in relation to alternative treatments, including numerous generic antibiotics;

 

·                  the extent to which the product is approved for inclusion on formularies of hospitals and managed care organizations;

 

·                  the extent to which bacteria develop resistance to the product, thereby limiting its efficacy in treating or managing infections;

 

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·                  whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular infections;

 

·                  the availability of adequate reimbursement by third parties, such as insurance companies and other healthcare payors;

 

·                  patients’ compliance in filling prescriptions;

 

·                  limitations or warnings contained in a product’s FDA-approved labeling;

 

·                  relative convenience and ease of administration; and

 

·                  prevalence and severity of adverse side effects.

 

With respect to DIFICID specifically, successful commercialization will depend on whether and to what extent physicians, pharmacists, long-term care facilities and hospital pharmacies, over whom we have no control, determine to utilize DIFICID. The sale of DIFICID to each hospital is to a large extent dependent upon the addition of DIFICID to that hospital’s list of approved drugs, or formulary list, by the hospital’s Pharmacy and Therapeutics, or P&T, committee. A hospital’s P&T committee typically governs all matters pertaining to the use of medications within the institution, including review of medication formulary data and recommendations for the appropriate use of drugs within the institution to the medical staff. The frequency of P&T committee meetings at various hospitals varies considerably, and P&T committees often require additional information to aide in their decision-making process, so we may experience substantial delays in obtaining formulary approvals. Additionally, hospital pharmacists may be concerned that the cost of DIFICID will adversely impact their overall pharmacy budgets, which could cause pharmacists to resist adding DIFICID to the formulary, or to implement restrictions on the usage of the drug in order to control costs. We cannot guarantee that we will be successful in getting additional approvals from P&T committees in a timely manner or at all, and the failure to do so will limit our ability to optimize hospital sales of DIFICID.

 

Even if we obtain hospital formulary approval for DIFICID, physicians must still prescribe DIFICID for its commercialization to be successful. Because DIFICID is a new drug with a very limited track record of sales in the U.S., any inability to timely supply DIFICID to our customers, or any unexpected side effects that arise from the use of the drug, particularly early in the product launch, may lead physicians to not accept DIFICID as a viable treatment alternative.

 

Even after receipt of regulatory approval from the FDA, DIFICID is, and any other products we may develop or acquire in the future will be, subject to substantial, ongoing regulatory requirements.*

 

DIFICID is, and any future approved products will be, subject to ongoing FDA requirements with respect to manufacturing, labeling, packaging, storage, distribution, advertising, promotion, record-keeping and submission of safety and other post-market information on the drug. The FDA has the authority to regulate the claims we make in marketing any products, including DIFICID, to ensure that such claims are true, not misleading, supported by scientific evidence and consistent with the approved label for the drug. In addition, the discovery of previously unknown problems with DIFICID or any future approved product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where active pharmaceutical ingredient, or API, or final drug product is manufactured, may result in the imposition of additional restrictions, including requiring us to reformulate the product, conduct additional clinical trials, make changes in the labeling of the product or withdraw the product from the market.

 

The FDA or foreign regulatory authorities also may impose ongoing requirements for potentially costly post-approval studies for any approved product. For example, as a condition of the FDA’s approval of DIFICID, we are required to conduct a microbiological surveillance program to identify the potential for decreased susceptibility of C. difficile to DIFICID, as well as two post-marketing studies in pediatric patients and a randomized trial to evaluate the efficacy of DIFICID in the treatment of patients with multiple CDAD recurrences.  Depending on the outcome of the studies, we may be unable to expand the indications for DIFICID or we may be required to include specific warnings or limitations on dosing this product, which could negatively impact our sales of DIFICID.

 

We have implemented a comprehensive compliance program and related infrastructure, but we cannot provide absolute assurance that we are or will be in compliance with all potentially applicable laws and regulations. If our operations in relation to DIFICID or any future approved product fail to comply with applicable regulatory requirements, the FDA or other regulatory agencies may:

 

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·                  issue warning letters or untitled letters;

 

·                  impose consent decrees, which may include the imposition of various fines, reimbursement for inspection costs, due dates for specific actions and penalties for noncompliance;

 

·                  impose fines or other civil or criminal penalties;

 

·                  suspend regulatory approval;

 

·                  suspend any ongoing clinical trials;

 

·                  refuse to approve pending applications or supplements to approved applications filed by us;

 

·                  impose restrictions on operations, including costly new manufacturing requirements;

 

·                  exclude us from participating in U.S. federal healthcare programs, including Medicaid or Medicare; or

 

·                  seize or detain products or require a product recall.

 

Any of these regulatory actions due to our failure to comply with post-approval requirements could damage our reputation, limit our ability to market our products and adversely affect our operating results.  In addition, the failure of our current or future collaborators to comply with these regulations and similar regulations in foreign jurisdictions would limit our ability to fully commercialize fidaxomicin and any other product we may develop or acquire in the future.

 

We must comply with federal and state “fraud and abuse” laws, and, if we are unable to fully comply with such laws, we could face substantial penalties, which may adversely affect our business, financial condition and results of operations.*

 

In the United States, in addition to FDA restrictions, we are subject to healthcare fraud and abuse regulation and enforcement by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

 

·                  the federal healthcare programs’ Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

 

·                  federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent;

 

·                  the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any health care benefit program or making false statements relating to health care matters;

 

·                  federal “sunshine” laws that require transparency regarding financial arrangements with health care providers, such as the reporting and disclosure requirements imposed by the PPACA on drug manufacturers regarding any “transfer of value” made or distributed to prescribers and other health care providers; and

 

·                  state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

 

Some states, such as California, Massachusetts and Vermont, mandate implementation of comprehensive compliance programs to ensure compliance with these laws.

 

The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by applicable regulatory authorities or the courts, and their provisions are open to a variety of interpretations. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

 

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Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn are used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, also may violate false claims laws.

 

Recent healthcare reform legislation also has strengthened these laws.  For example, the recently enacted PPACA, among other things, amended the intent requirement of the federal anti-kickback and criminal health care fraud statutes such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it.  In addition, PPACA provides that the government may assert that a claim including items or services resulting from a violation of the federal anti-kickback statute constitutes a false or fraudulent claim for purposes of the false claims statutes.  We also expect there will continue to be federal and state laws and/or regulations, proposed and implemented, that could impact our operations and business.  The extent to which future legislation or regulations, if any, relating to healthcare fraud abuse laws and/or enforcement, may be enacted or what effect such legislation or regulation would have on our business remains uncertain.

 

Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs, including Medicare and Medicaid, and the curtailment or restructuring of operations.  We believe that our operations are in material compliance with these laws and we recently increased our compliance resources in connection with the commercial launch of DIFICID.  However, because of the far-reaching nature of these laws, there can be no assurance that we will not be required to alter one or more of our practices to be in compliance with these laws.  In addition, there can be no assurance that the occurrence of one or more violations of these laws or regulations would not result in a material adverse effect on our financial condition and results of operations.

 

Our product sales depend on adequate coverage and reimbursement from third-party payors.*

 

Sales of DIFICID by our collaboration and us are, and sales of any future approved products will be, dependent on the availability and extent of coverage and reimbursement from third-party payors, including government healthcare programs and private insurance plans. Our collaborators and we rely in large part on the reimbursement coverage by federal and state sponsored government programs, such as Medicare and Medicaid in the United States, which are increasingly challenging prices charged and the cost-effectiveness of medical products.  These practices may be further exacerbated by future healthcare reform measures.  In addition, many healthcare providers, such as hospitals, receive a fixed reimbursement amount per procedure or other treatment therapy based on a prospective payment system, and these amounts are not necessarily based on the actual costs incurred.  As a result, these healthcare providers may be inclined to choose the least expensive therapies.  We cannot guarantee that our potential customers will find the reimbursement amounts sufficient to cover the costs of our products, including DIFICID.

 

We have licensed rights to develop and commercialize fidaxomicin in Europe and certain other territories to our collaboration partners.  In the event our collaborators or we, including APEL, seek approvals to market fidaxomicin in other non-U.S. territories, our collaborators or we will need to work with the government-sponsored healthcare entities in Europe and each other foreign country, as applicable, that are the primary payers of healthcare costs in such regions.  Certain government payers may regulate prices, reimbursement levels and/or access to fidaxomicin or any future products to control costs or to affect levels of use of the product.

 

We cannot predict the availability or level of coverage and reimbursement for DIFICID or any future approved product.  If third-party coverage and reimbursement is not available or is available only to limited levels, we may not be able to commercialize DIFICID or any other products successfully or at all, which would materially harm our business and prospects.

 

Regulatory approval for any approved product is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated as listed in the approved labeling.

 

Any regulatory approval is limited to those specific diseases and indications for which a product is deemed to be safe and effective by the FDA. In addition to the FDA approval required for new formulations, any new indication for an approved product also requires FDA approval.

 

While physicians may choose to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical studies and approved by the regulatory authorities, our ability to promote the products is limited to those indications that are specifically approved by the FDA. Regulatory authorities in the U.S. generally do not regulate the behavior of physicians in their choice of treatments, and such off-label uses by healthcare professionals are common. Regulatory authorities do, however, restrict communications by pharmaceutical companies on the subject of off-label use. If we are not able to obtain FDA approval for any desired future indications for DIFICID or any future approved products, our ability to market and sell such products will be limited and our business may be adversely affected.

 

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If our collaborators or we fail to gain and/or maintain marketing approvals from regulatory authorities in international markets for fidaxomicin and any future product candidates for which we have or license rights in international markets, our market opportunities will be limited.*

 

The ability of our collaborators and us to sell our product candidates outside of the United States is subject to foreign regulatory requirements governing clinical trials and marketing approval.  Even if the FDA grants marketing approval for a product candidate, comparable regulatory authorities of foreign countries also must approve the marketing of the product candidate in those countries. Regulatory requirements can vary widely from country to country and could delay the introduction of our products in those countries.  Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval will be obtained in any other country.  In addition, our collaborators’ or our failure to obtain regulatory approval in any country may delay or have negative effects on the process for regulatory approval in others. We could experience significant delays and difficulties and incur significant costs in obtaining foreign regulatory approvals in the territories for which we retain commercialization rights.

 

Other than DIFICLIR’s approval by the EMA in Europe and DIFICID’s approval in Canada, none of our product candidates is approved for sale in any international market. If our collaborators or we fail to comply with regulatory requirements with respect to our product candidates in international markets or to obtain and maintain required approvals, our market opportunities and ability to generate revenues will be diminished, which would significantly harm our business, results of operations and prospects.

 

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.

 

We face an inherent risk of product liability lawsuits related to the testing of our product candidates, and face an even greater risk related to the sale of commercial products, such as DIFICID.  An individual may bring a liability claim against us if one of our products or product candidates causes, or merely appears to have caused, an injury.  If we cannot successfully defend ourselves against a product liability claim, we may incur substantial liabilities.  Regardless of merit or eventual outcome, product liability claims may result in:

 

·                  significant litigation costs;

 

·                  substantial monetary awards, to or costly settlement with, patients;

 

·                  product recalls and/or an inability to continue marketing our products;

 

·                  decreased demand for our product;

 

·                  injury to our reputation;

 

·                  termination of clinical trial sites or entire clinical trial programs;

 

·                  withdrawal of clinical trial participants;

 

·                  loss of revenues; and

 

·                  the inability to commercialize our product candidates.

 

Our ability to market products is dependent upon physician and patient perceptions of us and the safety and quality of our products. We could be adversely affected if we or our products and product candidates are subject to negative publicity.  We also could be adversely affected if any of our products or product candidates or any similar products distributed by other companies prove to be, or are asserted to be, harmful to patients.  Also, because of our dependence upon physician and patient perceptions, any adverse publicity associated with illness or other adverse effects resulting from patients’ use or misuse of our products or any similar products distributed by other companies could have a material adverse impact on our results of operations.

 

We have product liability insurance that covers our commercial product as well as global clinical trial liability insurance.  Our current or future insurance coverage may prove insufficient to cover any liability claims brought against us.  Because of the increasing costs of insurance coverage, we may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise.

 

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If we fail to obtain additional financing, we may be unable to commercialize DIFICID and develop and commercialize other product candidates.*

 

We may require additional capital to fully commercialize DIFICID and any future products for which we obtain regulatory approval or acquire or in-license.  We cannot be certain that additional funding will be available on acceptable terms, or at all.  To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution.  Any debt financing, if available, may require us to pledge our assets as collateral or involve restrictive covenants, such as limitations on our ability to incur additional indebtedness, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could negatively impact our ability to conduct our business.  If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly scale back our commercialization activities for DIFICID in the United States and Canada or significantly delay, scale back or discontinue the development of one or more of our product candidates or research and development initiatives.

 

To the extent we require addition resources to successfully commercialize DIFICID, and we are unable to raise additional capital or are unable to effectively collaborate with additional partners for the commercialization of DIFICID, we will not generate significant revenues from sales of this product and our business will be harmed materially.

 

If we fail to attract and retain senior management and key scientific personnel, we may be unable to successfully develop or commercialize our product candidates.*

 

Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, sales and marketing, clinical and scientific personnel and on our ability to develop and maintain important relationships with leading academic institutions, clinicians and scientists.  We are highly dependent on our chief executive officer, and the other principal members of our executive and scientific teams. The unexpected loss of the service of any of these persons may significantly delay or prevent the achievement of research, development, commercialization and other business objectives.  Replacing key employees may be difficult and costly and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop and commercialize pharmaceutical products successfully.  We do not maintain “key person” insurance policies on the lives of these individuals or the lives of any of our other employees.  With the exception of Mr. Lichtinger, we employ these individuals on an at-will basis and their employment can be terminated by us or them at any time, for any reason and with or without notice.

 

We may not be able to attract or retain qualified management, sales and marketing and scientific personnel on acceptable terms in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses, particularly in the San Diego, California and New Jersey areas.  If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will impede significantly the achievement of our commercialization and research and development objectives, our ability to raise additional capital and our ability to implement our business strategy.  In particular, if we lose any members of our senior management team, we may not be able to find suitable replacements, and our business and prospects may be harmed as a result.

 

As a result of events we are still investigating, it is possible that we and certain of our current and former employees and directors may be named as defendants in future litigation or as subjects of government investigations or future enforcement proceedings that could result in substantial costs and divert management’s attention.*

 

In April 2012 we announced the termination of each of our then - Chief Financial Officer, Mr. Prunty, and our then - Vice President, Clinical Development, Dr. Shue, the removal of Dr. Chang as the Chairman of our Board of Directors and our request that Dr. Chang resign his directorship at Optimer.  Dr. Chang’s removal as Chairman resulted from our Board of Directors’ views as to his actions in his capacity as Optimer’s representative on the Board of Directors of OBI as well as his failure to identify and effectively manage compliance, record keeping and conflict of interest issues in connection with OBI’s grant to Dr. Chang of 1.5 million shares of OBI. The terminations of Mr. Prunty and Dr. Shue were related to the belief of our Board of Directors that both individuals failed to follow proper procedures when they became aware of potential issues related to the issuance of the OBI shares to Dr. Chang.

 

While the full facts are not yet known to us and are the subject of our own investigation, these events could potentially result in lawsuits being filed against us and certain of our employees and directors or we and our employees and directors could be the subject of governmental investigations or enforcement proceedings. In the event any such lawsuit is filed or investigation or proceeding is instigated there is no guarantee that we will be successful in defending it. Also, our insurance coverage may be insufficient, our assets may be insufficient to cover any amounts that exceed our insurance coverage and we may have to pay damage awards or otherwise may enter into settlement arrangements in connection with such claims. A settlement of any such lawsuit could involve the issuance of common stock or other equity, which may result in dilution to existing stockholders. Any payments or settlement arrangements could have material adverse effects on our business, operating results and financial condition. Even if any claims against us are not

 

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successful, any related litigation, investigation or proceeding could result in substantial costs and significantly and adversely impact our reputation and divert management’s attention and resources, which could have a material adverse effect on our business, operating results and financial condition. In addition, any such lawsuit, investigation or proceeding may make it more difficult to finance our operations, obtain certain types of insurance (including directors and officers liability insurance) and attract and retain qualified executive officers, other employees and directors.

 

We recently established a sales and marketing organization and have little experience as a company in marketing drug products.*

 

Our strategy is to build a fully-integrated U.S.-focused biopharmaceutical company to successfully execute the commercial launch of DIFICID in the U.S. market.  Although we have engaged Cubist as our exclusive partner to co-promote DIFICID in the United States, we have very limited experience commercializing pharmaceutical products on our own. In order to commercialize products, in addition to our engagement of Cubist, we have established our own marketing, sales, distribution, pharmacovigilance, managerial and other non-technical capabilities. We established the commercial organization primarily in New Jersey, and our bi-coastal organizational structure could create management challenges. The establishment and development of our own sales force to market DIFICID has been and will continue to be expensive and time consuming, and we cannot be certain that we will be able to successfully maintain this capability or successfully adapt it to commercialize and future products we may develop or acquire. Although we have engaged Cubist to assist in the promotion of DIFICID in the United States, our agreement with Cubist could terminate early, and our commercial presence may not be sufficient to adequately market DIFICID in the United States on our own. We compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel. To the extent we rely on third parties to commercialize our products, if any, we may receive less revenues than if we commercialized these products ourselves. In addition, we may have little or no control over the sales efforts of any third parties involved in commercializing our products, including those of APEL in Europe and Cubist in the United States. In the event we are unable to further develop and maintain our own marketing and sales capabilities or collaborate with a third-party marketing and sales organization, we would not be able to fully commercialize any product, including DIFICID, which would negatively impact our ability to generate product revenues.

 

We substantially increased the size of our organization, and we may experience difficulties in managing growth.*

 

We had 287 employees as of July 27, 2012.  The commercial launch of DIFICID required us to expand our managerial, operational, marketing, sales, financial and other resources.  Our management, personnel, systems and facilities currently in place may not be adequate to support this recent growth, and we may not be able to retain or recruit qualified personnel in the future due to competition for personnel among pharmaceutical businesses, and the failure to do so could have a significant negative impact on our future product revenue and business results.  To effectively manage our operations growth and various projects, we must:

 

·                  ensure that our consultants and other service providers successfully carry out their contractual obligations, provide high quality results and meet expected deadlines;

 

·                  continue to carry out our own contractual obligations to our licensors and other third parties; and

 

·                  continue to improve our operational, financial and management controls, reporting systems and procedures.

 

We may not be able to implement these tasks on a larger scale, and accordingly, may not achieve our development and commercialization goals.  Our failure to accomplish any of these goals could harm our financial results and prospects.

 

We currently depend, and will in the future continue to depend, on third parties to manufacture our products and product candidates, including DIFICID.  If these manufacturers fail to provide our collaborators and us with adequate supplies of commercial product and clinical trial materials or fail to comply with the requirements of regulatory authorities, we may be unable to develop or commercialize our products.*

 

We have outsourced all manufacturing of supplies of our products and product candidates to third parties.  We seek to establish long-term supply arrangements with third-party contract manufacturers. For example, in May 2010, we entered into a long-term supply agreement with Biocon for the commercial manufacturing of the API for fidaxomicin and in June 2011, we entered into a manufacturing services agreement with Patheon to manufacture and supply certain fidaxomicin products, including DIFICID. Biocon is our sole source for the commercial manufacturing of fidaxomicin API and Patheon is our sole source of supply for finished fidaxomicin drug supply. We intend to continue outsourcing the manufacture of our products and product candidates to third parties for any future clinical trials and large-scale commercialization of any product candidates that receive regulatory approval and become commercial drugs, such as DIFICID.

 

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Our ability and that of our collaborators to develop and commercialize fidaxomicin and any other product candidates will depend in part on our ability and that of our collaborators to arrange for third parties to manufacture our products at a competitive cost, in accordance with strictly enforced regulatory requirements and in sufficient quantities for regulatory approval, commercialization and any future clinical trials.  Third-party manufacturers that we select to manufacture our product candidates for clinical testing or on a commercial scale may encounter difficulties with the small- and large-scale formulation and manufacturing processes required for such manufacture.  Further, development of large-scale manufacturing processes will require additional validation studies, which the FDA must review and approve.  Difficulties in establishing these required manufacturing processes could result in delays in clinical trials, regulatory submissions and approvals, or commercialization of our product candidates.

 

While we work closely with Biocon and Patheon to try to ensure continuity of supply while maintaining high quality and reliability, we cannot guarantee that these efforts will be successful, and we do not have secondary sources of supply to replace these third parties.  Even if we are able to establish additional or replacement manufacturers, identifying these sources and entering into definitive supply agreements and obtaining regulatory approvals may involve a substantial amount of time and cost and such supply arrangements may not be available on acceptable economic terms.  A reduction or interruption in our supply of fidaxomicin API or drug product from our current suppliers, and an inability to develop alternative sources for such supply, could adversely affect our ability to obtain fidaxomicin in a timely or cost effective manner to maximize product sales, and could result in a breach of our supply agreement with APEL or Astellas Japan or our co-promotion agreement with Cubist, which could result in either or both of those parties terminating their respective agreements with us.

 

In addition, our collaborators, we and other third-party manufacturers of our products must comply with strictly enforced current good manufacturing practices, or cGMP, requirements enforced by the FDA through its facilities inspection program.  These requirements include quality control, quality assurance and the maintenance of records and documentation.  We currently rely on Biocon to manufacture fidaxomicin API and rely on Patheon to manufacture the drug product supplies.  As such, Biocon and Patheon will be subject to ongoing periodic unannounced inspections by the FDA and other agencies for compliance with current cGMP, and similar foreign standards. The manufacturing facilities of Biocon and Patheon have been inspected and approved by the FDA for other companies’ drug products; however, none of Biocon’s or Patheon’s facilities have been inspected by the FDA for the manufacture of our drug supplies.  We or other third-party manufacturers of our products may be unable to comply with cGMP requirements and with other FDA, state, local and foreign regulatory requirements.  Our collaborators and we have little control over third-party manufacturers’ compliance with these regulations and standards.  A failure to comply with these requirements by our third-party manufacturers, including Biocon and Patheon, could result in the issuance of untitled letters and/or warning letters from authorities, as well as sanctions being imposed on us, including fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or recall or withdrawal of product approval.  In addition, we have no control over these manufacturers’ ability to maintain adequate quality control, quality assurance and qualified personnel.  If the safety of any quantities supplied by third parties is compromised due to their failure to adhere to applicable laws or for other reasons, our collaborators and we may not be able to obtain or maintain regulatory approval for or successfully commercialize one or more of our products, which would significantly harm our business and prospects.

 

If our product candidates are unable to compete effectively with branded and generic antibiotics, our commercial opportunity would be reduced or eliminated.*

 

Our products and product candidates compete or will compete against both branded and generic antibiotic therapies. With respect to DIFICID, we face competition from branded Vancocin Pulvules, generic vancomycin capsules, reconstituted intravenious vancomycin “slurry” for oral administration and metronidazole.  In addition, we anticipate that DIFICID will compete with other antibiotic and anti-infective product candidates currently in development for the treatment of CDAD. For example, Cubist recently announced the initiation of a Phase 3 clinical trial for its compound, CB-183,315, as a potential treatment for CDAD. Many of these products have been or will be developed and marketed by major pharmaceutical companies, who have significantly greater financial resources and expertise than we do in research and development, preclinical testing, conducting clinical trials, obtaining regulatory approvals, manufacturing and marketing approved products.  As a result, these companies may obtain regulatory approval more rapidly than we are able to and may be more effective in selling and marketing their products as well.  Smaller or early-stage companies also may prove to be significant competitors, particularly through collaborative arrangements with large, established pharmaceutical or other companies.

 

DIFICID currently faces, and we anticipate it will continue to face, increasing competition in the form of generic versions of branded products of competitors that will lose their patent exclusivity.  For example, DIFICID currently faces direct competition from an inexpensive generic form of metronidazole in the United States.  In Europe, DIFICLIR immediately will face generic oral vancomycin competition.  In addition, our internal market research suggests that there is continued significant use of oral reconstituted intravenous vancomycin “slurry” in the hospital setting.  Generic antibiotic therapies typically are sold at lower prices than branded antibiotics and are generally preferred by managed care providers of health services.  For example,

 

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because metronidazole and generic vancomycin “slurry” are available at such a low price and because vancomycin capsules may become available at a low price, we believe it may be difficult to sell DIFICID as a first-line therapy for the treatment of CDAD other than in certain limited circumstances, such as in patients at high risk of recurrence.  If our collaborators or we are unable to demonstrate to physicians and patients that, based on experience, clinical data, side-effect profiles and other factors, our products are preferable to these generic antibiotic therapies, we may never generate meaningful product revenues.  In addition, many antibiotics experience bacterial resistance over time because of their continued use.  There can be no guarantee that bacteria would not develop resistance to DIFICID or any of our other product candidates.  Our commercial opportunity would also be reduced or eliminated if our competitors develop and commercialize generic or branded antibiotics that are safer, more effective, have lower recurrence rates, have fewer side effects or are less expensive than our product candidates.

 

Our future growth depends on our ability to identify and acquire or in-license products.  If we do not successfully identify and acquire or in-license related product candidates or integrate them into our operations, we may have limited growth opportunities.*

 

An important part of our business strategy is to continue to develop a pipeline of product candidates by developing new indications for fidaxomicin or by acquiring or in-licensing products, businesses or technologies that we believe are a strategic fit for our business.  Future in-licenses or acquisitions, however, may entail numerous operational and financial risks, including:

 

·                                    exposure to unknown liabilities;

 

·                                    disruption of our business and diversion of our management’s time and attention to develop acquired products or technologies;

 

·                                    incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions or licenses;

 

·                                    higher than expected acquisition and integration costs;

 

·                                    difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;

 

·                                    impairment of relationships with key suppliers, customers or partners of any acquired businesses due to changes in management and ownership; and

 

·                                    inability to retain key employees of any acquired businesses.

 

We have limited resources to identify and execute the acquisition or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure.  In particular, we may compete with larger pharmaceutical companies and other competitors in our efforts to establish new collaborations and in-licensing opportunities.  These competitors likely will have access to greater financial resources than us and may have greater expertise in identifying and evaluating new opportunities. Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts.

 

We rely on OBI for the development of one of our product candidates.*

 

In October 2009, we completed a number of transactions involving our then-wholly owned subsidiary, OBI, including the sale of 40% of our ownership interest in OBI to various third party investors.  In connection with these transactions, we assigned to OBI, and OBI assumed from us, our rights and obligations under our license agreement with MSKCC related to our OPT-822/821 product candidate. We also assigned to OBI certain of our intellectual property and know-how related to this product candidate. In exchange for these assignments, we have the right to receive certain milestone or royalty payments relating to OPT-822/821.

 

We cannot assure you that OBI will successfully advance the development of OPT-822/821.  In addition, if OBI does not comply with its obligations under the agreement with MSKCC, the agreement may be terminated and we may not be able to re-assume our rights under the agreement.  If the agreement with MSKCC were terminated and we were unable to re-assume our rights, we would not be able to pursue further development of OPT-822/821.  Moreover, we no longer maintain a controlling interest in OBI.  As a result, we have to rely on OBI’s contractual obligations, including under our Intellectual Property Assignment and License Agreement, to ensure that OBI continues development of OPT-822/821 and complies with its obligations under the MSKCC agreement.  Finally, OBI will need additional funds to further develop and commercialize OPT-822/821, and OBI may not be able to secure adequate funding or be able to do so on terms you or we believe are favorable.  If OBI is unable to raise additional funds to continue operations, or otherwise fails to advance the development of OPT-822/821, we will not receive milestone or royalty payments with respect to this product

 

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candidate, and the value of our OBI equity position would likely diminish. To the extent we provide funds to OBI through additional equity investments or otherwise, we may need to divert funds away from our operations which could adversely affect the development and/or commercialization of our products and product candidates. Our recent termination of Dr. Shue, OBI’s president and chief executive officer and removal of Dr. Michael Chang as Chairman of our Board of Directors also may have a negative effect on our relationship with OBI and our ability to maximize the value of our ownership position in OBI or any rights we may have in OPT-822/821.

 

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.*

 

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain.  Failure can occur at any time during the clinical trial process. The results of preclinical studies and early clinical trials may not be predictive of the results of later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical testing.  In addition, sub-analysis of clinical trial data may reveal limitations even though top-line results are positive.  The type and amount of clinical data necessary to gain regulatory approval also may change during or after completion of clinical trials or we may inaccurately characterize such requirements. Moreover, we cannot guarantee that the FDA or comparable foreign regulatory authorities will agree with our interpretation of clinical trial data, or find such data sufficient to grant product approval. There are also risks that post-approval clinical trials we agreed to conduct or otherwise plan to conduct with respect to DIFICID will not yield positive results, which would impair our ability to continue marketing DIFICID in the United States.

 

Delays in clinical trials are common and have many causes, and any such delays could result in increased costs to us and jeopardize or delay our ability to achieve regulatory approval and commence product sales as currently contemplated.*

 

We have in the past experienced delays in clinical trials of our product candidates and we may experience delays in future clinical trials.  We do not know whether planned clinical trials will begin on time, will need to be redesigned or will be completed on schedule, if at all.  Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a trial, in reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and clinical trial sites, in obtaining institutional review board approval at each site, in recruiting suitable patients to participate in a trial, in having patients complete a trial or return for post-treatment follow-up, in adding new sites or in obtaining sufficient supplies of clinical trial materials.  Many factors affect patient enrollment, including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials, clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating and whether the clinical trial design involves comparison to placebo.

 

We could encounter delays if prescribing physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing antibiotics that have established safety and efficacy profiles or with administering placebo to patients in our placebo-controlled trials.  Further, a clinical trial may be suspended or terminated by us, our collaborators, the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.  If we experience delays in the completion of, or termination of, any clinical trial, the commercial prospects of our product candidates may be harmed, and our ability to generate product revenues from any of these product candidates will be delayed.  In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenues.  Any of these occurrences may significantly harm our business, financial condition and prospects.

 

We may be required to suspend or discontinue clinical trials due to adverse events, adverse side effects or other safety risks that could preclude approval of our product candidates or negatively affect sales of any marketed product.

 

Our clinical trials may be suspended at any time for a number of reasons.  We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants.  In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to participants.  In our Phase 3 clinical trials of DIFICID, the most common drug-related side effects reported were nausea, vomiting, constipation, anorexia, headache and dizziness.  If adverse, drug-related events are encountered or suspected, our trials would be interrupted, delayed or halted and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications.  Adverse events encountered in any post-approval studies also may harm our

 

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efforts and those of our collaborators to market our product candidates or could result in withdrawal of regulatory approvals.  Even if we believe our product candidates are safe, our data is subject to review by the FDA, which may disagree with our conclusions and delay or deny approval of our product candidates which would significantly harm the commercial prospects of such product candidates.  Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse side effects as a result of participating in our clinical trials.  Any of these occurrences may significantly harm our business and prospects.

 

We have relied and currently rely on third parties to conduct our clinical trials.  If these third parties do not successfully carry out their contractual duties or meet expected deadlines, our collaborators and we may not be able to obtain or maintain regulatory approval for or commercialize our product candidates.*

 

We have entered into agreements with third-party CROs to provide monitors for and to manage data for our clinical programs.

 

We and any CROs conducting clinical trials for us are required to comply with current good clinical practices, or GCPs, regulations and guidelines enforced by the FDA for all of our products in clinical development.  The FDA enforces GCPs through periodic inspections of trial sponsors, principal investigators and trial sites.  If we or the CROs that conduct clinical trials of our product candidates fail to comply with applicable GCPs, the clinical data generated in the clinical trials may be deemed unreliable and the FDA may require additional clinical trials before approving any marketing applications.  We cannot assure you that, upon inspection, the FDA will determine that any clinical trials of our product candidates comply with GCPs.  In addition, our clinical trials must be conducted with product produced under cGMP regulations, and require a large number of test subjects.  Our failure to comply with these regulations may require us to repeat clinical trials, which would be costly and delay the regulatory approval process and commercialization of our product candidates or could prevent us from complying with post-approval study requirements.

 

In addition, these third-party CROs are not our employees, and we cannot control whether or not they devote sufficient time and resources to our clinical programs.  These CROs also may have relationships with other commercial entities, including our competitors, for whom they also may be conducting clinical studies or other drug development activities, which could harm our competitive position.  If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain are compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated or may have to be repeated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates or our ability to comply with post-approval study requirements could be jeopardized. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed.

 

Current healthcare laws and regulations and future legislative or regulatory reforms to the healthcare system may affect our ability to sell DIFICID and any future approved product profitably.*

 

The U.S. and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect our ability to sell our products profitably. Among policy makers and payors in the U.S. and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the U.S., the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

 

In March 2010, PPACA became law in the U.S. PPACA substantially changes the way healthcare is financed by both governmental and private insurers and significantly affects the pharmaceutical industry. Among the provisions of PPACA of greatest importance to the pharmaceutical industry are the following:

 

·                                    an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

 

·                                    an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively;

 

·                                    a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their overage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

 

·                                    extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

 

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·                                    expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals which began in April 2010 and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the Federal Poverty Level beginning in 2014, thereby potentially increasing manufacturers’ Medicaid rebate liability;

 

·                                    expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

 

·                                    new requirements to report certain financial arrangements with physicians, including reporting any “transfer of value” made or distributed to prescribers and other healthcare providers, effective March 30, 2013, and reporting any investment interests held by physicians and their immediate family members during the preceding calendar year;

 

·                                    a new requirement to report annually drug samples that manufacturers and distributors provide to physicians, effective April 1, 2012;

 

·                                    a licensure framework for follow-on biologic products; and

 

·                                    a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.

 

We anticipate that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and an additional downward pressure on the price that we receive for any approved product, and could seriously harm our business. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.

 

We also cannot be certain that DIFICID or any future approved products will successfully be placed on the list of drugs covered by particular health plan formularies, nor can we predict the negotiated price for any future products, which will be determined by market factors. Many states also have created preferred drug lists and include drugs on those lists only when the manufacturers agree to pay a supplemental rebate.  If DIFICID or any future products are not included on these preferred drug lists, physicians may not be inclined to prescribe them to their Medicaid patients, thereby diminishing the potential market for our products.

 

As a result of the PPACA and the trend towards cost-effectiveness criteria and managed healthcare in the United States, third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs.  They also may refuse to provide any coverage of uses of approved products for medical indications other than those for which the FDA has granted market approvals.  As a result, significant uncertainty exists as to whether and how much third-party payors will reimburse for newly-approved drugs, which in turn will put pressure on the pricing of drugs.  Further, we do not have experience in ensuring approval by applicable third-party payors outside of the United States for coverage and reimbursement of our products.  The availability of numerous generic antibiotics at lower prices than branded antibiotics can also be expected to substantially reduce the likelihood of reimbursement for DIFICID.  We also anticipate pricing pressures in connection with the sale of our products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative proposals.

 

Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.*

 

Our third-party manufacturers’ activities and, to a lesser extent, our own activities involve the controlled storage, use and disposal of hazardous materials, including the components of our products and product candidates and other hazardous compounds. Our manufacturers and we are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials.  Although we believe that the safety procedures for handling and disposing of these materials comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination or injury from these materials.  We currently have insurance coverage for damage claims arising from contamination on our property.  These amounts may not be sufficient to adequately protect us from liability for damage claims relating to contamination.  If we are subject to liability exceeding our insurance coverage amounts, our business and prospects would be harmed.  In the event of an accident, state or federal authorities may also curtail our use of these materials and interrupt our business operations.

 

Our business and operations would suffer in the event of computer, telecommunications or other system failure.

 

Despite the implementation of security measures, our internal computer systems are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.  Any system failure, accident or security breach that causes interruptions in our operations could result in a material disruption of our commercialization activities or drug development programs.  To the extent that any disruption or security breach results in a loss or damage to our data or

 

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applications, or inappropriate disclosure of confidential or proprietary information, we may incur liability, the commercialization of our products may be harmed and the further development of our product candidates may be delayed.

 

Risks Related to Our Intellectual Property

 

It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.*

 

Our commercial success will depend, in part, on obtaining and maintaining patent protection and trade secret protection of the use, formulation and structure of our products and product candidates, and the methods used to manufacture them, as well as successfully defending these patents against third-party challenges, including those from generic drug manufacturers.  Our ability to protect our product and product candidates from unauthorized making, using, selling, offering to sell or importing by third parties is dependent upon the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.

 

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.  No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date in the United States.  The biotechnology patent situation outside the United States is even more uncertain.  Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property.  Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our licensed patents, our patents or in third-party patents.

 

The degree of future protection for our proprietary rights is uncertain, because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.  For example:

 

·                  others may be able to make compounds that are similar to our product and product candidates but that are not covered by the claims of our pending patent applications or owned or licensed patents, or for which we are not licensed under our license agreements;

 

·                  others may be able to make competing pharmaceutical formulations containing our product and product candidates or components of our product formulations that are either not covered by the claims of our owned or licensed patents, not licensed to us under our license agreements or are subject to patents that expire;

 

·                  our licensors and we might not have been the first to make the inventions covered by our patents and patent applications or the pending patent applications and issued patents of our licensors;

 

·                  our licensors or we might not have been the first to file patent applications for these inventions;

 

·                  others may independently develop similar or alternative technologies or duplicate any of our technologies;

 

·                  it is possible that our pending patent applications or our licensed patent applications will not result in issued patents;

 

·                  our pending patent applications or the pending patent applications and issued patents we own or license may not provide us with any competitive advantages, may be designed around by our competitors, including generic drug companies, or may be held invalid or unenforceable as a result of legal challenges by third parties;

 

·                  we may not develop additional proprietary technologies that are patentable; or

 

·                  the patents of others may have an adverse effect on our business.

 

In addition, to the extent we are unable to obtain and maintain patent protection for our products and product candidates or in the event such patent protection expires, it may no longer be cost effective to extend our portfolio by pursuing additional development of a product candidate for follow-on indications for any product.

 

We have 13 pending patent applications and five issued patents related to fidaxomicin from the United States Patent and Trademark Office or U.S.P.T.O. These patents and patent applications related to fidaxomicin encompass various topics relating to:

 

·                  composition of matter for fidaxomicin;

 

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·                  pharmaceutical composition of fidaxomicin and use for CDI;

 

·                  polymorphic forms (issued in U.S.);

 

·                  composition comprising a polymorphic form (issued in the U.S.);

 

·                  manufacturing processes (issued in the U.S.);

 

·                  treatment of diseases with fidaxomicin (issued in the U.S.);

 

·                  formulation; and

 

·                  fidaxomicin-related compounds, including metabolites, e.g. OP-1118 (issued in the U.S.).

 

If we are unable to obtain a composition of matter patent, our competitors, including generic drug companies, may be able to design other similar formulations of the active ingredient of fidaxomicin.  Furthermore, our competitors, including generic drug companies, may be able to design around our existing patents and pending applications which may issue as patents for fidaxomicin. As a result, our competitors may be able to develop competing products.

 

We depend, in part, on our licensors and collaborators to protect a portion of our proprietary rights.  In such cases, our licensors and collaborators may be primarily or wholly responsible for the maintenance of patents and prosecution of patent applications relating to important areas of our business.  We may be dependent on Par to provide technical support for patent applications relating to fidaxomicin.  If Par fails to adequately protect fidaxomicin with issued patents, our business and prospects would be significantly harmed.

 

We also rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable.  However, trade secrets are difficult to protect.  Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our information to competitors.  Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable.  In addition, courts outside the United States are sometimes less willing to protect trade secrets.  Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

 

If our licensees or we fail to obtain or maintain patent protection or trade secret protection for our product candidates or our technologies, third parties could use our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.

 

We may incur substantial costs as a result of litigation or other proceedings relating to our patent, trademark and other intellectual property rights, and we may be unable to protect our rights to, or use, our technology.*

 

If we or, as applicable, our commercialization partners pursuant to their first right to enforce the patents licensed to them in their respective territories, choose to go to court to stop someone else from using our inventions, that individual or company has the right to ask the court to rule that the underlying patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and would consume time and other resources even if we or our commercialization partner were successful in stopping the infringement of these patents.  There is also the risk that, even if the validity of these patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our rights to these patents.

 

Furthermore, a third party may claim that we or our manufacturing or commercialization partners are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making, using or selling our product candidates.  These lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel.  There is a risk that a court would decide that we or our commercialization partners are infringing the third party’s patents and would order us or our partners to stop the activities covered by the patents.  In addition, there is a risk that a court will order us or our partners to pay the other party damages for having violated the other party’s patents.  We have indemnified our commercialization partners against patent infringement claims and thus would be responsible for any of their costs associated with such claims and actions.  The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use.  The coverage of patents is subject to interpretation by the courts and the interpretation is not always uniform.  If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the patent claims of the relevant patent and/or that the patent

 

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claims are invalid, and we may not be able to do this.  Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.

 

Although we have conducted searches of third-party patents with respect to DIFICID, these searches may not have identified all third-party patents relevant to this product and we have not conducted an extensive search of patents issued to third parties with respect to our product candidates.  Consequently, no assurance can be given that third-party patents containing claims covering our products, technology or methods do not exist, have not been filed, or could not be filed or issued.  Because of the number of patents issued and patent applications filed in our technical areas or fields, we believe there is a risk that third parties may allege they have patent rights encompassing our products, technology or methods.  In addition, we have not conducted an extensive search of third-party trademarks, so no assurance can be given that such third-party trademarks do not exist, have not been filed, could not be filed or issued, or could not exist under common trademark law.  While we have filed a trademark application for the names “Optimer”, and “Optimer Pharmaceuticals”, we are aware that the name “Optimer” has been registered as a trademark with the U.S. PTO by more than one third party, including one in the biotechnology space.  As such, we believe there is a significant risk that third parties may allege they have trademark rights encompassing the names for which we have applied for protection.

 

Because some patent applications in the United States may be maintained in secrecy until the patents are issued, because patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing and because publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our licensors’ issued patents or our pending applications or our licensors’ pending applications, or that we or our licensors were the first to invent the technology.  Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours.  Any such patent application may have priority over our or our licensors’ patent applications and could further require us to obtain rights to issued patents covering such technologies.  If another party has filed a U.S. patent application on inventions similar to ours, we may have to participate in an interference proceeding declared by the U.S. PTO to determine priority of invention in the United States.  The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S. patent position with respect to such inventions.

 

Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources.  In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

 

Risks Related to the Securities Market and Ownership of Our Common Stock

 

The market price of our common stock may be highly volatile.*

 

Before our initial public offering in February 2007, there was no public market for our common stock.  We cannot assure you that an active trading market will continue to exist for our common stock. You may not be able to sell your shares quickly or at the market price if trading in our common stock is not active.

 

The trading price of our common stock is likely to be highly volatile and could be subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including:

 

·                  general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors;

 

·                  actual or anticipated variations in our quarterly operating results, including fidaxomicin sales and royalties, and our quarterly expenses;

 

·                  announcement of foreign regulatory agency approval or non-approval of our or our competitors’ product candidates, or specific label indications for their use, or delays in the foreign regulatory agency review process;

 

·                  actions taken by the FDA or other regulatory agencies with respect to our product or product candidates, clinical trials, manufacturing process or marketing and sales activities;

 

·                  failure of fidaxomicin to achieve commercial success;

 

·                  changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals;

 

·                  the success of our development efforts and clinical trials, particularly with respect to DIFICID;

 

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·                  announcements by our collaborators with respect to clinical trial results, regulatory submissions and communications from the FDA or comparable foreign regulatory agencies;

 

·                  the success of our efforts to acquire or in-license additional products or product candidates;

 

·                  developments concerning our collaborations and partnerships, including but not limited to those with our sources of manufacturing supply and our development and commercialization partners;

 

·                  our dependence on our collaborators, such as APEL, Astellas Japan and STA, to commercialize and further develop our products in foreign countries in compliance with foreign regulatory schemes;

 

·                  our failure to successfully execute our commercialization strategy with respect to our products following marketing approval thereof;

 

·                  the success of our continuing efforts to establish and build marketing and sales capabilities;

 

·                  inability to obtain adequate commercial supply for any product following marketing approval thereof, or inability to do so at acceptable prices;

 

·                  announcements of technological innovations by us, our collaborators or our competitors;

 

·                  new products or services introduced or announced by us or our commercialization partners, or our competitors, and the timing of these introductions or announcements;

 

·                  the development of generic product alternatives to our or our competitors’ products;

 

·                  third-party coverage or reimbursement policies;

 

·                  changes in government regulations affecting product approvals, reimbursement or other aspects of our or our competitors’ business;

 

·                  actual or anticipated changes in earnings estimates or recommendations by securities analysts;

 

·                  conditions or trends in the biotechnology and biopharmaceutical industries;

 

·                  announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

 

·                  changes in the market valuations of similar companies;

 

·                  sales of common stock or other securities by us or our stockholders in the future;

 

·                  additions or departures of key scientific or management personnel;

 

·                  our ability to successfully integrate our new executive personnel into our organization;

 

·                  disputes or other developments relating to intellectual property, proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; and

 

·                  trading volume of our common stock.

 

In addition, the stock market in general, and the market for biotechnology and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated and/or disproportionate to the operating performance of those companies.  These broad market and industry factors may significantly harm the market price of our common stock, regardless of our operating performance.  In the past, following periods of volatility in the market, securities class-action litigation has often been instituted against companies.  Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could significantly harm our business, financial condition and prospects.

 

Future sales of our common stock in the public market could cause our stock price to decline.*

 

We have registered all common stock that we have issued under our employee benefits plans. As a result, these shares can be freely sold in the public market upon issuance, subject to any applicable restrictions under the securities laws. In addition, certain of our directors and executive officers have established, and others may in the future establish, programmed selling plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended, for the purpose of effecting sales of our common stock. If any of these events cause a large number of our shares to be sold in the public market, the sales could reduce the trading price of our common stock and impede our ability to raise future capital.

 

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We will continue to incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.*

 

As a public company, we will continue to incur significant legal, accounting and other expenses.  In addition, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well as rules subsequently implemented by the Securities and Exchange Commission, or SEC, and the Nasdaq Stock Market, or Nasdaq, impose various requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Our management and other personnel need to devote a substantial amount of time to these compliance initiatives.  Moreover, these rules and regulations result in increased legal and financial compliance costs and will make some activities more time-consuming and costly.  For example, these rules and regulations make it more difficult and more expensive for us to maintain director and officer liability insurance, and we may be required to incur substantial costs in the future to maintain the same or similar coverage.  The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. We are required to perform an evaluation of our internal controls over financial reporting to allow management to report on the effectiveness of those controls, as required by Section 404 of the Sarbanes-Oxley Act. Additionally, our independent auditors are required to perform a similar evaluation and report on the effectiveness of our internal controls over financial reporting. While we anticipate maintaining the integrity of our internal controls over financial reporting and all other aspects of Section 404, we cannot be certain that a material weakness will not be identified when we test the effectiveness of our control systems in the future. If a material weakness is identified, we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities, which would require additional financial and management resources, costly litigation or a loss of public confidence in our internal controls, which could have an adverse effect on the market price of our stock.

 

Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.

 

Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us, even if doing so would benefit our stockholders, or remove our current management.  These provisions include:

 

·                                    a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time;

 

·                                    authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;

 

·                                    limiting the removal of directors by the stockholders;

 

·                                    prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;

 

·                                    eliminating the ability of stockholders to call a special meeting of stockholders; and

 

·                                    establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.

 

These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.  In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with a stockholder owning 15% or more of our outstanding voting stock for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our board of directors.  This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders.  Such a delay or prevention of a change of control transaction could cause the market price of our stock to decline.

 

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Item 6.  Exhibits

 

Exhibit No.

 

Description of Document

3.1

(1)

Certificate of Incorporation of Optimer Pharmaceuticals, Inc., as amended and restated.

3.2

(2)

Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Optimer Pharmaceuticals, Inc.

3.3

(3)

Bylaws of Optimer Pharmaceuticals, Inc., as amended.

4.1

(4)

Common Stock Certificate of Optimer Pharmaceuticals, Inc.

4.2

(5)

Registration Rights Agreement, dated October 23, 2007, by and between Optimer Pharmaceuticals, Inc. and the purchasers listed on the signature pages thereto.

10.1

(6)+

Offer letter between Optimer Pharmaceuticals, Inc. and Stephen W. Webster dated May 30, 2012.

10.2*

 

Second Amendment to API Manufacturing and Supply Agreement between Optimer Pharmaceuticals, Inc. and Biocon Limited, dated May 20, 2011.

10.3

+

Separation Agreement between Optimer Pharmaceuticals, Inc. and John D. Prunty dated April 6, 2012.

10.4

(2)+

Optimer Pharmaceuticals, Inc. 2012 Equity Incentive Plan.

10.5

+

Form of Option Grant Notice and Agreement under 2012 Equity Incentive Plan.

10.6

+

Form of Employee Restricted Stock Unit Notice and Agreement under 2012 Equity Incentive Plan.

10.7

+

Form of Director Restricted Stock Unit Notice and Agreement under 2012 Equity Incentive Plan.

31.1

 

Certification of principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a).

31.2

 

Certification of principal financial officer required by Rule 13a-14(a) or Rule 15d-14(a).

32

 

Certification by the Chief Executive Officer and the Chief Financial Officer of the Registrant, as required by Rule 13a-14(b) or 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

101.INS

 

XBRL Instance Document

101.SCH

 

XBRL Taxonomy Extension Schema Document

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 


+                                    Indicates management contract or compensatory plan.

*                                    Confidential treatment has been requested with respect to certain portion of this exhibit.  Omitted portions have been filed separately with the Securities and Exchange Commission.

(1)                             Filed with Registrant’s Amendment No. 3 to Registration Statement on Form S-1 January 22, 2007.

(2)                             Filed with Registrant’s Current Report on Form 8-K on May 10, 2012.

(3)                             Filed with Registrant’s Current Report on Form 8-K on September 18, 2007.

(4)                             Filed with Registrant’s Amendment No. 4 to Registration Statement on Form S-1 February 5, 2007.

(5)                             Filed with Registrant’s Current Report on Form 8-K on October 29, 2007.

(6)                             Filed with Registrant’s Current Report on Form 8-K on June 5, 2012.

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

OPTIMER PHARMACEUTICALS, INC.

 

 

 

Dated: August 3, 2012

By:

/s/ Stephen W. Webster

 

Name:

Stephen W. Webster

 

Title:

Chief Financial Officer

 

 

(Duly Authorized Officer and Principal Financial and Accounting Officer)

 

50


EX-10.2 2 a12-13878_1ex10d2.htm EX-10.2

Exhibit 10.2

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

 

AMENDMENT TO

API MANUFACTURING AND SUPPLY AGREEMENT

 

This AMENDMENT TO MANUFACTURING AND SUPPLY AGREEMENT (this “Amendment”), is entered into as of May 20, 2011 by and between OPTIMER PHARMACEUTICALS, INC. (“Optimer”) and BIOCON LIMITED (“Biocon”). Capitalized terms used herein which are not defined herein shall have the definitions ascribed to them in the Agreement (defined below).

 

RECITALS

 

WHEREAS, Optimer and Biocon have previously entered into an API Manufacturing and Supply Agreement dated May 18, 2010 (the “Agreement”); and

 

WHEREAS, the parties wish to amend the Agreement as set forth in this Amendment.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Optimer and Biocon agree as follows:

 

AGREEMENT

 

1.                                      Section 3.1(c) of the Agreement is hereby amended and restated as follows:

 

“(c)                            Cause the [***] Equipment at Park to be commissioned and fully qualified by [***].”

 

2.                                      Section 5.3 of the Agreement is hereby amended and restated as follows:

 

“5.3                         Subject to the provisions of section 6, during the term of this Agreement, Biocon shall cause the [***] Equipment to be dedicated solely to the manufacture and supply of Product under this Agreement and shall ensure that the [***] Equipment is not subject to any lien, pledge, security interest or other encumbrances that could reasonably be expected to materially impair Biocon’s ability to perform its obligations under this Agreement, without prior written approval from Optimer. The foregoing sentence notwithstanding, in the event Park is not successfully made a Validated Facility by [***] due to Optimer’s failure to perform its obligations under the Work Plan or in the event Optimer has not successfully obtained a Marketing Authorization in the Territory by the date specified in clause (ii) of section 5.1, Biocon shall be free to make other uses of the [***] Equipment which would not impair Biocon’s ability to later use the [***] Equipment for the manufacture of Product; provided, however, that if and when the Park becomes a Validated Facility, Biocon shall promptly cease such other uses and re-dedicate the [***] Equipment solely to the manufacture of Product, provided Optimer has also obtained a Marketing Authorization in the Territory at that time, and subject to the provisions of section 6.”

 


*** Confidential Treatment Requested

 



 

3.                                      The Agreement, as amended by this Amendment, embodies the entire understanding of the parties and shall supersede all previous communications, representations and understandings, whether oral, written or otherwise, between the parties relating to the subject matter hereof. Except as specifically amended by this Amendment, the terms and conditions of the Agreement shall remain in full force and effect.

 

4.                                      The parties agree that Section 19 of the Agreement shall apply to this Amendment.

 

5.                                      This Amendment may be executed in counterparts, each of which shall be deemed an original document, and all of which, together with this writing, shall be deemed one instrument.

 

IN WITNESS WHEREOF, the parties have executed this AMENDMENT TO API MANUFACTURING AND SUPPLY AGREEMENT as of the date first set forth above.

 

 

OPTIMER PHARMACEUTICALS, INC.

 

BIOCON LIMITED

 

 

 

 

 

 

By:

/s/ Pedro Lichtinger

 

By:

/s/ Sandeep Rao

Name:

Pedro Lichtinger

 

Name:

Sandeep Rao

Title:

President and CEO

 

Title:

VP — Business Development and Licensing

 

2


EX-10.3 3 a12-13878_1ex10d3.htm EX-10.3

Exhibit 10.3

 

GRAPHIC

 

April 6, 2012

 

John Prunty

c/o Optimer Pharmaceuticals, Inc.

5355 Mira Sorrento Place

San Diego, CA 92121

 

Re:  Separation from Optimer Pharmaceuticals, Inc.

 

Dear John:

 

This letter sets forth the terms and conditions of our agreement (the “Agreement”) regarding the termination of your employment with OPTIMER PHARMACEUTICALS, INC. (the “Company”).  This Agreement shall be effective as of the Effective Date as defined in Section 12(d) herein.  As part of this Agreement, and pursuant to and subject to the terms of the Company’s Amended and Restated Severance Benefit Plan (the “Severance Plan”), the Company will provide you the Regular Covered Termination Severance Benefits outlined below (the “Severance Benefits”).  All initially capitalized terms not otherwise defined herein shall have the meaning ascribed to such terms in the Severance Plan.

 

1.                                      SEPARATION DATE.  Your last day of work with the Company and your employment termination date shall be April 6, 2012 (the “Separation Date”).  Such employment termination will be considered a Covered Termination pursuant to the Severance Plan.

 

2.                                      SEVERANCE BENEFITS.  Pursuant to the Severance Plan, if you sign, date and return this Agreement to the Company within twenty-one (21) days of the date hereof, you do not revoke it, and you comply with your continuing obligations under this Agreement and the Severance Plan (including your continuing obligations under your Employee Proprietary Information Agreement), the Company will provide you with the following Severance Benefits:

 

(a)                                 Base Salary Continuation Benefit.  The Company will pay you cash severance in an amount equivalent to fifteen (15) months of your Base Salary (totaling $400,000), subject to standard payroll deductions and withholdings (the “Base Salary Severance”).  The Base Salary Severance will be paid to you in substantially equal installments on the Company’s normal payroll periods during the fifteen (15) month period following your Separation Date, provided, however, that any payments scheduled to be made prior to the Effective Date of this Agreement (as defined in Section 11(d)), shall instead accrue and be paid to you in a single lump sum during the first payroll period following the Effective Date.

 

(b)                                 Continued Group Health Plan Benefit.  To the extent provided by the federal COBRA law or, if applicable, state insurance laws (collectively, “COBRA”), and by the Company’s current group health insurance policies, you will be eligible to continue your group health insurance benefits after the Separation Date at your own expense.  Later, you may be able to convert to an individual policy through the provider of the Company’s health insurance, if you wish.  You will be provided with a separate notice describing your rights and obligations under the applicable state and/or federal insurance laws on or after the Separation Date. Additionally, if you timely elect continued group health coverage pursuant to

 

10110 SORRENTO VALLEY ROAD, SUITE C, SAN DIEGO, CALIFORNIA 92121  TEL: 858-909-0736  FAX: 858-909-0737

 

101 HUDSON STREET, SUITE 3501, JERSEY CITY, NJ 07302  TEL: 201-333-8819  FAX: 201-333-8870

 



 

COBRA, as an additional Severance Benefit, the Company will pay for the full amount of your COBRA premium payments for continued medical, dental and vision insurance premiums that it paid for you and your qualified dependants during your employment for a maximum period of fifteen (15) months following the Separation Date (the “COBRA Premium Payment Benefits”); provided that, the Company’s obligation to pay your COBRA premium payments will terminate earlier if you cease to be eligible for COBRA coverage or you become eligible for coverage under a group health plan of a subsequent employer.  You are required to immediately notify the Company’s Senior Vice President of Human Resources in writing if you become eligible for coverage under a group health plan of a subsequent employer.

 

Notwithstanding anything to the contrary set forth herein, if the Company determines, in its sole discretion, that it cannot provide the COBRA Premium Payment Benefits without potentially violating applicable law (including, without limitation, Section 2716 of the Public Health Service Act), the Company shall in lieu thereof provide to you a taxable monthly amount to continue your group health insurance coverage in effect on the Separation Date (which amount shall be based on the premium for the first month of COBRA coverage), which payments shall be made regardless of whether you elect COBRA continuation coverage (the “Health Care Benefit Payment”).  The Health Care Benefit Payment shall be paid in monthly installments on the same schedule that the COBRA Premium Payment Benefits would otherwise have been paid to the insurer, and shall end on the earlier of (i) the expiration of the COBRA Premium Payment Benefit period as detailed above, or (ii) the date you cease to be eligible for COBRA coverage or you become eligible for coverage under a group health plan of a subsequent employer.

 

(c)                                  Vesting Acceleration for Non-Performance Vesting Equity Awards.  In connection with your employment, you were granted Non-Performance Vesting Equity Award stock options covering a total of 291,536 shares of the Company’s common stock (the “Options”).  As of the Separation Date, 210,286 shares subject to the Options are vested and 81,250 shares are unvested. Pursuant to the Severance Plan, as an additional Severance Benefit, the Company will accelerate vesting of the Options, effective as of the Separation Date, to provide for vesting of an additional 38,430 shares subject to the Options (equal to fifteen (15) more months of vesting), which then shall be exercisable by you (resulting in a total of 248,716 vested shares subject to the Options).  All remaining unvested Options, and all unvested Performance Vesting Equity Awards shall terminate on the Separation Date.  Your rights to exercise your vested shares subject to the Options are governed by the terms of your stock option agreement and the applicable equity plan pursuant to which each Option was granted.

 

3.                                      ACCRUED SALARY, VACATION AND EMPLOYEE STOCK PURCHASE PLAN (ESPP) CONTRIBUTIONS FOR CURRENT PERIOD.  The Company will pay you all accrued salary at full employment rates, and all accrued and unused vacation, subject to standard withholdings and deductions, as of the Separation Date.  Additionally, you will also be reimbursed for contributions made in the current period under the Company’s ESPP, if any.  You are entitled to these payments regardless of whether or not you sign this Agreement.

 

4.                                      EXPENSE REIMBURSEMENT.  Within fifteen (15) business days following the Separation Date, you agree to submit all final documented expense reimbursement statements reflecting all business expenses you incurred prior to and including the date hereof, if any, for which you seek reimbursement.  The Company shall reimburse your expenses pursuant to Company policy and regular business practice.

 

5.                                      OTHER COMPENSATION AND BENEFITS/EQUITY.  Except as expressly provided herein, you acknowledge and agree that you are not entitled to and will not receive any additional compensation, severance (pursuant to the Severance Plan or otherwise), bonuses, stock options, stock or benefits from the Company.

 



 

6.                                      RETURN OF COMPANY PROPERTY.  Pursuant to the Severance Plan, you will not be entitled to any Severance Benefits under the Severance Plan unless and until you return all Company Property.  For this purpose, “Company Property” means all Company documents (and all copies thereof) and other Company property which you had in your possession at any time, including, but not limited to, Company files, notes, drawings records, plans, forecasts, reports, studies, analyses, proposals, agreements, financial information, research and development information, sales and marketing information, operational and personnel information, specifications, code, software, databases, computer-recorded information, tangible property and equipment (including, but not limited to, leased vehicles, computers, facsimile machines, mobile telephones, servers), credit cards, entry cards, identification badges and keys; and any materials of any kind which contain or embody any proprietary or confidential information of the Company (and all reproductions thereof in whole or in part).  Further, as a condition to receiving the Severance Benefits under the Severance Plan, you must not make or retain copies, reproductions or summaries of any such Company Property.

 

7.                                      EMPLOYEE PROPRIETARY INFORMATION AGREEMENT.  You acknowledge your continuing obligation to comply with your Employee Proprietary Information Agreement, a copy of which is attached hereto as Exhibit A.

 

8.                                      CONFIDENTIALITY.  The provisions of this Agreement shall be held in strictest confidence by you and the Company and shall not be publicized or disclosed in any manner whatsoever.  Notwithstanding the prohibition in the preceding sentence: (a) you may disclose this Agreement, in confidence, to your immediate family; (b) the parties may disclose this Agreement in confidence to their respective attorneys, accountants, auditors, tax preparers, and financial advisors; (c) the Company may disclose this Agreement as necessary to fulfill standard or legally required corporate reporting or disclosure requirements; and (d) the parties may disclose this Agreement insofar as such disclosure may be necessary to enforce its terms.

 

9.                                      NONDISPARAGEMENT.  You agree not to disparage the Company and its officers, directors, employees, shareholders, investors, and agents, in any manner likely to be harmful to them or their business, business reputations or personal reputations; provided that you may respond accurately and fully to any question, inquiry or request for information when required by legal process (e.g., a valid subpoena or other similar compulsion of law) or as part of a government investigation.

 

10.                               COOPERATION AND ASSISTANCE.  You agree that you will not voluntarily provide assistance, information or advice, directly or indirectly (including through agents or attorneys), to any person or entity in connection with any claim or cause of action of any kind brought against the Company, nor shall you induce or encourage any person or entity to bring such claims; provided that you may respond accurately and fully to any question, inquiry or request for information when required by legal process (e.g., a valid subpoena or other similar compulsion of law) or as part of a government investigation.  Further, you agree to cooperate fully with the Company in connection with its actual or contemplated defense, prosecution, or investigation of any claims or demands by or against third parties, or other matters arising from events, acts, or failures to act that occurred during the period of your employment by the Company.  Such cooperation includes, without limitation, making yourself available to the Company upon reasonable notice, without subpoena, to provide complete, truthful and accurate information in witness interviews, depositions, and trial testimony.  The Company will reimburse you for reasonable out-of-pocket expenses you incur in connection with any such cooperation (excluding forgone wages, salary, or other compensation) and will make reasonable efforts to accommodate your scheduling needs.  In addition, you agree to execute all documents (if any) necessary to carry out the terms of this Agreement.

 



 

11.                               RELEASE OF CLAIMS.

 

(a)                                 General Release.  In exchange for the consideration provided to you under this Agreement and the Severance Plan to which you would not otherwise be entitled, including but not limited to the Severance Benefits, you hereby generally and completely release the Company and its current and former directors, officers, employees, shareholders, investors, partners, agents, attorneys, predecessors, successors, parent and subsidiary entities, insurers, affiliates, and assigns (collectively, the “Released Parties”) of and from any and all claims, liabilities and obligations, both known and unknown, that arise out of or are in any way related to events, acts, conduct, or omissions occurring prior to or on the date you sign this Agreement (collectively, the “Released Claims”).

 

(b)                                 Scope of Release.  The Released Claims include, but are not limited to: (i) all claims arising out of or in any way related to your employment with the Company, or the termination of that employment; (ii) all claims related to your compensation or benefits from the Company, including salary, bonuses, commissions, vacation pay, expense reimbursements, severance pay (pursuant to the Severance Plan or otherwise), fringe benefits, stock, stock options, or any other ownership interests in the Company; (iii) all claims for breach of contract, wrongful termination, and breach of the implied covenant of good faith and fair dealing (including, but not limited to, claims arising under or based on the Severance Plan); (iv) all tort claims, including claims for fraud, defamation, emotional distress, and discharge in violation of public policy; and (v) all federal, state, and local statutory claims, including claims for discrimination, harassment, retaliation, attorneys’ fees, or other claims arising under the federal Civil Rights Act of 1964 (as amended), the federal Americans with Disabilities Act of 1990 (as amended), the federal Family and Medical Leave Act (as amended) (“FMLA”), the federal Age Discrimination in Employment Act of 1967 (as amended) (the “ADEA”), the California Fair Employment and Housing Act (as amended), the California Labor Code, and the California Family Rights Act (“CFRA”).

 

(c)                                  Excluded Claims.  Notwithstanding the foregoing, the following are not included in the Released Claims (the “Excluded Claims”): (i) any rights or claims for indemnification you may have pursuant to any written indemnification agreement with the Company to which you are a party, the charter, bylaws, or operating agreements of the Company, or under applicable law; (ii) any rights which are not waivable as a matter of law; and (iii) any claims for breach of this Agreement.  In addition, nothing in this Agreement prevents you from filing, cooperating with, or participating in any proceeding before the Equal Employment Opportunity Commission, the Department of Labor, or any other government agency, except that you acknowledge and agree that you are hereby waiving your right to any monetary benefits in connection with any such claim, charge or proceeding.  You hereby represent and warrant that, other than the Excluded Claims, you are not aware of any claims you have or might have against any of the Released Parties that are not included in the Released Claims.

 

(d)                                 ADEA Waiver/Effective Date of the Agreement.  You acknowledge that you are knowingly and voluntarily waiving and releasing any rights you may have under the ADEA (the “ADEA Waiver”), and that the consideration given for the ADEA Waiver in this Section 11(d) is in addition to anything of value to which you are already entitled.  You further acknowledge that you have been advised, as required by the ADEA, that: (i) the ADEA Waiver does not apply to any rights or claims that may arise after the date that you sign this Agreement; (ii) you should consult with an attorney prior to signing this Agreement (although you may choose voluntarily not to do so); (iii) you have twenty-one (21) days in which to consider this Agreement (although you may choose voluntarily to sign it earlier); (iv) you have seven (7) days following the date you sign this Agreement to revoke the ADEA Waiver (by providing written notice of your revocation to the Company’s Chief Executive Officer); and (v) this ADEA Waiver will not be effective until the date upon which the revocation period has expired unexercised, which will be the eighth day after the date that this Agreement is signed by you provided that you do not revoke it (the “Effective Date”).  Nevertheless, except for the ADEA Waiver in this

 



 

Section 11(d), your general release of claims in Sections 11(a) and 11(b) herein, is effective immediately, and not revocable.

 

(e)                                  Waiver of Unknown Claims.  In giving the releases set forth in this Agreement, which include claims which may be unknown to you at present, you acknowledge that you have read and understand Section 1542 of the California Civil Code which reads as follows:  “A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor.”  You hereby expressly waive and relinquish all rights and benefits under that section and any law or legal principle of similar effect in any jurisdiction with respect to the releases granted herein, including but not limited to the release of unknown and unsuspected claims granted in this Agreement.

 

12.                               NO ADMISSIONS.  The parties hereto hereby acknowledge that this is a compromise settlement of various matters, and it shall not be construed to be an admission of any liability or obligation by either party to the other party or to any other person whomsoever.

 

13.                               REPRESENTATIONS.  You hereby represent that you have been paid all compensation owed for all time worked, you have received all the leave and leave benefits and protections for which you are eligible pursuant to FMLA, CFRA, or any applicable laws or Company policies, and you have not suffered any work-related injury or illness for which you have not already filed a workers’ compensation claim.

 

14.                               ENTIRE AGREEMENT.  This Agreement, including Exhibit A and the Severance Plan, constitutes the complete, final and exclusive embodiment of the entire Agreement between you and the Company with regard to the subject matter hereof.  This Agreement is entered into without reliance on any promise or representation, written or oral, other than those expressly contained herein, and supersedes any such promises or representations.  This Agreement may not be modified except in a writing signed by you and a duly authorized officer of the Company.  Each party has carefully read this Agreement, has been afforded the opportunity to be advised of its meaning and consequences by his or its respective attorneys, and signed the same of his or its free will.

 

15.                               SUCCESSORS AND ASSIGNS.  This Agreement shall bind the heirs, personal representatives, successors, assigns, executors, and administrators of each party, and inures to the benefit of each party, its agents, directors, officers, employees, servants, heirs, successors and assigns.

 

16.                               SEVERABILITY.  If a court, arbitrator, or other authority of competent jurisdiction determines that any term or provision of this Agreement is invalid or unenforceable, in whole or in part, then the remaining terms and provisions hereof shall be unimpaired, and the invalid or unenforceable term or provision shall be replaced with a valid and enforceable term or provision that most accurately represents the parties’ intention with respect to the invalid or unenforceable term or provision.

 

17.                               AUTHORITY.  You warrant and represent that there are no liens or claims of lien or assignments in law or equity or otherwise of or against any of the claims or causes of action released herein and that you are duly authorized to give the release granted herein.

 

18.                               COUNTERPARTS.  This Agreement may be executed in counterparts, each of which shall be deemed to be part of one original, and facsimile signatures and signatures transmitted by PDF shall be equivalent to original signatures.

 

19.                               SECTION HEADINGS.  The section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.

 



 

If this Agreement is acceptable to you, please sign below and return the fully signed Agreement to me within twenty-one (21) days of your receipt of this Agreement.  If you do not sign and return it to the Company within the aforementioned timeframe, the Company’s offer to enter into this Agreement will expire.

 

Let me know if you have any questions.  We wish you the best in your future endeavors.

 

Sincerely,

 

OPTIMER PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

 

/s/ Pedro Lichtinger

 

 

Pedro Lichtinger

 

 

Chief Executive Officer

 

 

 

 

 

Attachment: Exhibit A — Employee Proprietary Information Agreement

 

 

 

HAVING READ THE FOREGOING, I HEREBY AGREE TO THE TERMS AND CONDITIONS STATED ABOVE.

 

 

 

 

 

 

/s/ John Prunty

 

Dated:

4/25/2012

JOHN PRUNTY

 

 

 



 

EXHIBIT A

 

EMPLOYEE PROPRIETARY INFORMATION AGREEMENT

 


EX-10.5 4 a12-13878_1ex10d5.htm EX-10.5

Exhibit 10.5

 

OPTIMER PHARMACEUTICALS, INC.
STOCK OPTION GRANT NOTICE
(2012 EQUITY INCENTIVE PLAN)

 

Optimer Pharmaceuticals, Inc. (the “Company”), pursuant to its 2012 Equity Incentive Plan (the “Plan”), hereby grants to Optionholder an option to purchase the number of shares of the Company’s Common Stock set forth below.  This option is subject to all of the terms and conditions as set forth in this notice, in the Option Agreement, the Plan and the Notice of Exercise, all of which are attached hereto and incorporated herein in their entirety.  Capitalized terms not explicitly defined herein but defined in the Plan or the Option Agreement will have the same definitions as in the Plan or the Option Agreement. If there is any conflict between the terms in this notice and the Plan, the terms of the Plan will control.

 

Optionholder:

 

 

Date of Grant:

 

 

Vesting Commencement Date:

 

 

Number of Shares Subject to Option:

 

 

Exercise Price (Per Share):

 

 

Total Exercise Price:

 

 

Expiration Date:

 

 

 

Type of Grant:

¨ Incentive Stock Option(1)

o Nonstatutory Stock Option

 

 

 

Exercise Schedule:

¨  Same as Vesting Schedule

o Early Exercise Permitted

 

 

 

Vesting Schedule:

[                                                          ], subject to Optionholder’s Continuous Service as of each such date.]

 

 

 

Payment:

By one or a combination of the following items (described in the Option Agreement):

 

 

 

 

x By cash, check, bank draft or money order payable to the Company

 

o Pursuant to a Regulation T Program if the shares are publicly traded

 

o By delivery of already-owned shares if the shares are publicly traded

 

o If and only to the extent this option is a Nonstatutory Stock Option, and subject to the Company’s consent at the time of exercise, by a “net exercise” arrangement

 


(1)  If this is an Incentive Stock Option, it (plus other outstanding Incentive Stock Options) cannot be first exercisable for more than $100,000 in value (measured by exercise price) in any calendar year.  Any excess over $100,000 is a Nonstatutory Stock Option.

 



 

Additional Terms/Acknowledgements:  Optionholder acknowledges receipt of, and understands and agrees to, this Stock Option Grant Notice, the Option Agreement and the Plan.  Optionholder acknowledges and agrees that this Stock Option Grant Notice and the Option Agreement may not be modified, amended or revised except as provided in the Plan.  Optionholder further acknowledges that as of the Date of Grant, this Stock Option Grant Notice, the Option Agreement, and the Plan set forth the entire understanding between Optionholder and the Company regarding this option award and supersede all prior oral and written agreements, promises and/or representations on that subject with the exception of (i) options previously granted and delivered to Optionholder, (ii) any compensation recovery policy that is adopted by the Company or is otherwise required by applicable law and (iii) any written employment or severance arrangement that would provide for vesting acceleration of this option award upon the terms and conditions set forth therein.  By accepting this option, Optionholder consents to receive such documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 

OPTIMER PHARMACEUTICALS, INC.

 

OPTIONHOLDER:

 

 

 

By:

 

 

 

Signature

 

Signature

 

 

 

Title:

 

 

Date:

 

 

 

 

Date:

 

 

 

 

ATTACHMENTS:  Option Agreement, 2012 Equity Incentive Plan and Notice of Exercise

 



 

ATTACHMENT I

 

OPTIMER PHARMACEUTICALS, INC.
2012 EQUITY INCENTIVE PLAN

 

OPTION AGREEMENT
(INCENTIVE STOCK OPTION OR NONSTATUTORY STOCK OPTION)

 

Pursuant to your Stock Option Grant Notice (“Grant Notice”) and this Option Agreement, Optimer Pharmaceuticals, Inc. (the “Company”) has granted you an option under its 2012 Equity Incentive Plan (the “Plan”) to purchase the number of shares of the Company’s Common Stock indicated in your Grant Notice at the exercise price indicated in your Grant Notice.  The option is granted to you effective as of the date of grant set forth in the Grant Notice (the “Date of Grant”).  If there is any conflict between the terms in this Option Agreement and the Plan, the terms of the Plan will control. Capitalized terms not explicitly defined in this Option Agreement or in the Grant Notice but defined in the Plan will have the same definitions as in the Plan.

 

The details of your option, in addition to those set forth in the Grant Notice and the Plan, are as follows:

 

1.                                      VESTING.  Your option will vest as provided in your Grant Notice.  Vesting will cease upon the termination of your Continuous Service.

 

2.                                      NUMBER OF SHARES AND EXERCISE PRICE.  The number of shares of Common Stock subject to your option and your exercise price per share in your Grant Notice will be adjusted for Capitalization Adjustments.

 

3.                                      EXERCISE RESTRICTION FOR NON-EXEMPT EMPLOYEES.  If you are an Employee eligible for overtime compensation under the Fair Labor Standards Act of 1938, as amended (that is, a “Non-Exempt Employee”), and except as otherwise provided in the Plan, you may not exercise your option until you have completed at least six (6) months of Continuous Service measured from the Date of Grant, even if you have already been an employee for more than six (6) months. Consistent with the provisions of the Worker Economic Opportunity Act, you may exercise your option as to any vested portion prior to such six (6) month anniversary in the case of (i) your death or disability, (ii) a Corporate Transaction in which your option is not assumed, continued or substituted, (iii) a Change in Control or (iv) your termination of Continuous Service on your “retirement” (as defined in the Company’s benefit plans).

 

4.                                      EXERCISE PRIOR TO VESTING (“EARLY EXERCISE”).  If permitted in your Grant Notice (i.e., the “Exercise Schedule” indicates “Early Exercise Permitted”) and subject to the provisions of your option, you may elect at any time that is both (i) during the period of your Continuous Service and (ii) during the term of your option, to exercise all or part of your option, including the unvested portion of your option; provided, however, that:

 



 

(a)                                 a partial exercise of your option will be deemed to cover first vested shares of Common Stock and then the earliest vesting installment of unvested shares of Common Stock;

 

(b)                                 any shares of Common Stock so purchased from installments that have not vested as of the date of exercise will be subject to the purchase option in favor of the Company as described in the Company’s form of Early Exercise Stock Purchase Agreement;

 

(c)                                  you will enter into the Company’s form of Early Exercise Stock Purchase Agreement with a vesting schedule that will result in the same vesting as if no early exercise had occurred; and

 

(d)                                 if your option is an Incentive Stock Option, then, to the extent that the aggregate Fair Market Value (determined at the Date of Grant) of the shares of Common Stock with respect to which your option plus all other Incentive Stock Options you hold are exercisable for the first time by you during any calendar year (under all plans of the Company and its Affiliates) exceeds one hundred thousand dollars ($100,000), your option(s) or portions thereof that exceed such limit (according to the order in which they were granted) will be treated as Nonstatutory Stock Options.

 

5.                                      METHOD OF PAYMENT.  You must pay the full amount of the exercise price for the shares you wish to exercise.  You may pay the exercise price in cash or by check, bank draft or money order payable to the Company or in any other manner permitted by your Grant Notice, which may include one or more of the following:

 

(a)                                 Provided that at the time of exercise the Common Stock is publicly traded, pursuant to a program developed under Regulation T as promulgated by the Federal Reserve Board that, prior to the issuance of Common Stock, results in either the receipt of cash (or check) by the Company or the receipt of irrevocable instructions to pay the aggregate exercise price to the Company from the sales proceeds.  This manner of payment is also known as a “broker-assisted exercise”, “same day sale”, or “sell to cover”.

 

(b)                                 Provided that at the time of exercise the Common Stock is publicly traded, by delivery to the Company (either by actual delivery or attestation) of already-owned shares of Common Stock that are owned free and clear of any liens, claims, encumbrances or security interests, and that are valued at Fair Market Value on the date of exercise.  “Delivery” for these purposes, in the sole discretion of the Company at the time you exercise your option, will include delivery to the Company of your attestation of ownership of such shares of Common Stock in a form approved by the Company.  You may not exercise your option by delivery to the Company of Common Stock if doing so would violate the provisions of any law, regulation or agreement restricting the redemption of the Company’s stock.

 

(c)                                  If this option is a Nonstatutory Stock Option, subject to the consent of the Company at the time of exercise, by a “net exercise” arrangement pursuant to which the Company will reduce the number of shares of Common Stock issued upon exercise of your option by the largest whole number of shares with a Fair Market Value that does not exceed the aggregate exercise price.  You must pay any remaining balance of the aggregate exercise price

 



 

not satisfied by the “net exercise” in cash or other permitted form of payment.  Shares of Common Stock will no longer be outstanding under your option and will not be exercisable thereafter if those shares (i) are used to pay the exercise price pursuant to the “net exercise,” (ii) are delivered to you as a result of such exercise, and (iii) are withheld to satisfy your tax withholding obligations.

 

6.                                      WHOLE SHARES.  You may exercise your option only for whole shares of Common Stock.

 

7.                                      SECURITIES LAW COMPLIANCE.  In no event may you exercise your option unless the shares of Common Stock issuable upon exercise are then registered under the Securities Act or, if not registered, the Company has determined that your exercise and the issuance of the shares would be exempt from the registration requirements of the Securities Act.  The exercise of your option also must comply with all other applicable laws and regulations governing your option, and you may not exercise your option if the Company determines that such exercise would not be in material compliance with such laws and regulations (including any restrictions on exercise required for compliance with Treas. Reg. 1.401(k)-1(d)(3), if applicable).

 

8.                                      TERM.  You may not exercise your option before the Date of Grant or after the expiration of the option’s term.  The term of your option expires, subject to the provisions of Section 5(h) of the Plan, upon the earliest of the following:

 

(a)                                 immediately upon the termination of your Continuous Service for Cause;

 

(b)                                 three (3) months after the termination of your Continuous Service for any reason other than Cause, your Disability or your death (except as otherwise provided in Section 8(d) below); provided, however, that if during any part of such three (3) month period your option is not exercisable solely because of the condition set forth in the section above relating to “Securities Law Compliance,” your option will not expire until the earlier of the Expiration Date or until it has been exercisable for an aggregate period of three (3) months after the termination of your Continuous Service; provided further, that if (i) you are a Non-Exempt Employee, (ii) your Continuous Service terminates within six (6) months after the Date of Grant, and (iii) you have vested in a portion of your option at the time of your termination of Continuous Service, your option will not expire until the earlier of (x) the later of (A) the date that is seven (7) months after the Date of Grant, and (B) the date that is three (3) months after the termination of your Continuous Service, and (y) the Expiration Date;

 

(c)                                  twelve (12) months after the termination of your Continuous Service due to your Disability (except as otherwise provided in Section 8(d)) below;

 

(d)                                 eighteen (18) months after your death if you die either during your Continuous Service or within three (3) months after your Continuous Service terminates for any reason other than Cause;

 

(e)                                  the Expiration Date indicated in your Grant Notice; or

 

(f)                                   the day before the tenth (10th) anniversary of the Date of Grant.

 



 

If your option is an Incentive Stock Option, note that to obtain the federal income tax advantages associated with an Incentive Stock Option, the Code requires that at all times beginning on the Date of Grant and ending on the day three (3) months before the date of your option’s exercise, you must be an employee of the Company or an Affiliate, except in the event of your death or Disability.  The Company has provided for extended exercisability of your option under certain circumstances for your benefit but cannot guarantee that your option will necessarily be treated as an Incentive Stock Option if you continue to provide services to the Company or an Affiliate as a Consultant or Director after your employment terminates or if you otherwise exercise your option more than three (3) months after the date your employment with the Company or an Affiliate terminates.

 

9.                                      EXERCISE.

 

(a)                                 You may exercise the vested portion of your option (and the unvested portion of your option if your Grant Notice so permits) during its term by (i) delivering a Notice of Exercise (in a form designated by the Company) or completing such other documents and/or procedures designated by the Company for exercise and (ii) paying the exercise price and any applicable withholding taxes to the Company’s Secretary, stock plan administrator, or such other person as the Company may designate, together with such additional documents as the Company may then require.

 

(b)                                 By exercising your option you agree that, as a condition to any exercise of your option, the Company may require you to enter into an arrangement providing for the payment by you to the Company of any tax withholding obligation of the Company arising by reason of (i) the exercise of your option, (ii) the lapse of any substantial risk of forfeiture to which the shares of Common Stock are subject at the time of exercise, or (iii) the disposition of shares of Common Stock acquired upon such exercise.

 

(c)                                  If your option is an Incentive Stock Option, by exercising your option you agree that you will notify the Company in writing within fifteen (15) days after the date of any disposition of any of the shares of the Common Stock issued upon exercise of your option that occurs within two (2) years after the Date of Grant or within one (1) year after such shares of Common Stock are transferred upon exercise of your option.

 

10.                               Transferability.  Except as otherwise provided in this Section 10, your option is not transferable, except by will or by the laws of descent and distribution, and is exercisable during your life only by you.

 

(a)                                 Certain Trusts.  Upon receiving written permission from the Board or its duly authorized designee, you may transfer your option to a trust if you are considered to be the sole beneficial owner (determined under Section 671 of the Code and applicable state law) while the option is held in the trust.  You and the trustee must enter into transfer and other agreements required by the Company.

 

(b)                                 Domestic Relations Orders.  Upon receiving written permission from the Board or its duly authorized designee, and provided that you and the designated transferee enter into transfer and other agreements required by the Company, you may transfer your option

 



 

pursuant to the terms of a domestic relations order, official marital settlement agreement or other divorce or separation instrument as permitted by Treasury Regulation 1.421-1(b)(2) that contains the information required by the Company to effectuate the transfer.  You are encouraged to discuss the proposed terms of any division of this option with the Company prior to finalizing the domestic relations order or marital settlement agreement to help ensure the required information is contained within the domestic relations order or marital settlement agreement.  If this option is an Incentive Stock Option, this option may be deemed to be a Nonstatutory Stock Option as a result of such transfer.

 

(c)                                  Beneficiary Designation.  Upon receiving written permission from the Board or its duly authorized designee, you may, by delivering written notice to the Company, in a form approved by the Company and any broker designated by the Company to handle option exercises, designate a third party who, on your death, will thereafter be entitled to exercise this option and receive the Common Stock or other consideration resulting from such exercise.  In the absence of such a designation, your executor or administrator of your estate will be entitled to exercise this option and receive, on behalf of your estate, the Common Stock or other consideration resulting from such exercise.

 

11.                               OPTION NOT A SERVICE CONTRACT.  Your option is not an employment or service contract, and nothing in your option will be deemed to create in any way whatsoever any obligation on your part to continue in the employ of the Company or an Affiliate, or of the Company or an Affiliate to continue your employment.  In addition, nothing in your option will obligate the Company or an Affiliate, their respective stockholders, boards of directors, officers or employees to continue any relationship that you might have as a Director or Consultant for the Company or an Affiliate.

 

12.                               WITHHOLDING OBLIGATIONS.

 

(a)                                 At the time you exercise your option, in whole or in part, and at any time thereafter as requested by the Company, you hereby authorize withholding from payroll and any other amounts payable to you, and otherwise agree to make adequate provision for (including by means of a “same day sale” pursuant to a program developed under Regulation T as promulgated by the Federal Reserve Board to the extent permitted by the Company), any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or an Affiliate, if any, which arise in connection with the exercise of your option.

 

(b)                                 If this option is a Nonstatutory Stock Option, then upon your request and subject to approval by the Company, and compliance with any applicable legal conditions or restrictions, the Company may withhold from fully vested shares of Common Stock otherwise issuable to you upon the exercise of your option a number of whole shares of Common Stock having a Fair Market Value, determined by the Company as of the date of exercise, not in excess of the minimum amount of tax required to be withheld by law (or such lower amount as may be necessary to avoid classification of your option as a liability for financial accounting purposes).  If the date of determination of any tax withholding obligation is deferred to a date later than the date of exercise of your option, share withholding pursuant to the preceding sentence shall not be permitted unless you make a proper and timely election under Section 83(b) of the Code, covering the aggregate number of shares of Common Stock acquired upon such exercise with

 



 

respect to which such determination is otherwise deferred, to accelerate the determination of such tax withholding obligation to the date of exercise of your option.  Notwithstanding the filing of such election, shares of Common Stock shall be withheld solely from fully vested shares of Common Stock determined as of the date of exercise of your option that are otherwise issuable to you upon such exercise.  Any adverse consequences to you arising in connection with such share withholding procedure shall be your sole responsibility.

 

(c)                                  You may not exercise your option unless the tax withholding obligations of the Company and/or any Affiliate are satisfied.  Accordingly, you may not be able to exercise your option when desired even though your option is vested, and the Company will have no obligation to issue a certificate for such shares of Common Stock or release such shares of Common Stock from any escrow provided for herein, if applicable, unless such obligations are satisfied.

 

13.                               TAX CONSEQUENCES. You hereby agree that the Company does not have a duty to design or administer the Plan or its other compensation programs in a manner that minimizes your tax liabilities. You will not make any claim against the Company, or any of its Officers, Directors, Employees or Affiliates related to tax liabilities arising from your option or your other compensation. In particular, you acknowledge that this option is exempt from Section 409A of the Code only if the exercise price per share specified in the Grant Notice is at least equal to the “fair market value” per share of the Common Stock on the Date of Grant and there is no other impermissible deferral of compensation associated with the option.

 

14.                               NOTICES.  Any notices provided for in your option or the Plan will be given in writing (including electronically) and will be deemed effectively given upon receipt or, in the case of notices delivered by mail by the Company to you, five (5) days after deposit in the United States mail, postage prepaid, addressed to you at the last address you provided to the Company.  The Company may, in its sole discretion, decide to deliver any documents related to participation in the Plan and this option by electronic means or to request your consent to participate in the Plan by electronic means.  By accepting this option, you consent to receive such documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 

15.                               GOVERNING PLAN DOCUMENT.  Your option is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your option, and is further subject to all interpretations, amendments, rules and regulations, which may from time to time be promulgated and adopted pursuant to the Plan.  If there is any conflict between the provisions of your option and those of the Plan, the provisions of the Plan will control.  In addition, your option (and any compensation paid or shares issued under your option) is subject to recoupment in accordance with The Dodd—Frank Wall Street Reform and Consumer Protection Act and any implementing regulations thereunder, any clawback policy adopted by the Company and any compensation recovery policy otherwise required by applicable law.

 

16.                               OTHER DOCUMENTS.  You hereby acknowledge receipt of and the right to receive a document providing the information required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus.  In addition, you acknowledge receipt of the

 



 

Company’s policy permitting certain individuals to sell shares only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.

 

17.                               EFFECT ON OTHER EMPLOYEE BENEFIT PLANS.  The value of this option will not be included as compensation, earnings, salaries, or other similar terms used when calculating your benefits under any employee benefit plan sponsored by the Company or any Affiliate, except as such plan otherwise expressly provides. The Company expressly reserves its rights to amend, modify, or terminate any of the Company’s or any Affiliate’s employee benefit plans.

 

18.                               VOTING RIGHTS.  You will not have voting or any other rights as a stockholder of the Company with respect to the shares to be issued pursuant to this option until such shares are issued to you.  Upon such issuance, you will obtain full voting and other rights as a stockholder of the Company.  Nothing contained in this option, and no action taken pursuant to its provisions, will create or be construed to create a trust of any kind or a fiduciary relationship between you and the Company or any other person.

 

19.                               SEVERABILITY.  If all or any part of this Option Agreement or the Plan is declared by any court or governmental authority to be unlawful or invalid, such unlawfulness or invalidity will not invalidate any portion of this Option Agreement or the Plan not declared to be unlawful or invalid.  Any Section of this Option Agreement (or part of such a Section) so declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section or part of a Section to the fullest extent possible while remaining lawful and valid.

 

20.                               MISCELLANEOUS.

 

(a)                                 The rights and obligations of the Company under your option will be transferable to any one or more persons or entities, and all covenants and agreements hereunder will inure to the benefit of, and be enforceable by the Company’s successors and assigns.

 

(b)                                 You agree upon request to execute any further documents or instruments necessary or desirable in the sole determination of the Company to carry out the purposes or intent of your option.

 

(c)                                  You acknowledge and agree that you have reviewed your option in its entirety, have had an opportunity to obtain the advice of counsel prior to executing and accepting your option, and fully understand all provisions of your option.

 

(d)                                 This Option Agreement will be subject to all applicable laws, rules, and regulations, and to such approvals by any governmental agencies or national securities exchanges as may be required.

 

(e)                                  All obligations of the Company under the Plan and this Option Agreement will be binding on any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation, or otherwise, of all or substantially all of the business and/or assets of the Company.

 



 

*                                         *                                         *

 

This Option Agreement will be deemed to be signed by you upon the signing by you of the Stock Option Grant Notice to which it is attached.

 


EX-10.6 5 a12-13878_1ex10d6.htm EX-10.6

Exhibit 10.6

 

OPTIMER PHARMACEUTICALS, INC.
RESTRICTED STOCK UNIT GRANT NOTICE
(2012 EQUITY INCENTIVE PLAN)

 

Optimer Pharmaceuticals, Inc. (the “Company”) hereby awards to Participant the number of restricted stock units specified and on the terms set forth below (the “Award”).  The Award is subject to all of the terms and conditions as set forth herein and in the Company’s 2012 Equity Incentive Plan (the “Plan”) and the Restricted Stock Unit Agreement (the “Agreement”), both of which are attached hereto and incorporated herein in their entirety.  Capitalized terms not explicitly defined herein but defined in the Plan or the Agre

ement shall have the meanings set forth in the Plan or the Agreement.  Except as explicitly provided herein or in the Agreement, in the event of any conflict between the terms in the Award and the Plan, the terms of the Plan shall control.

 

Participant:

 

 

Date of Grant:

 

 

Vesting Commencement Date:

 

 

Number of Restricted Stock Units:

 

 

Consideration:

Participant’s Services

 

 

Vesting Schedule:                    [                                                             ].   Notwithstanding the foregoing, vesting shall terminate upon the Participant’s termination of Continuous Service.

 

Issuance Schedule:               One share of Common Stock will be issued for each restricted stock unit which vests at the time set forth in Section 6 of the Agreement.

 

Additional Terms/Acknowledgements:  The undersigned Participant acknowledges receipt of, and understands and agrees to, this Restricted Stock Unit Grant Notice, the Agreement, the Plan prospectus and the Plan.  Participant further acknowledges that as of the Date of Grant, this Restricted Stock Unit Grant Notice, the Agreement and the Plan set forth the entire understanding between Participant and the Company regarding the Award and supersedes all prior oral and written agreements on that subject, with the exception of: (i) any written employment or severance arrangement that would provide for vesting acceleration of the Award upon the terms and conditions set forth therein, or (ii) any compensation recovery policy that is adopted by the Company or is otherwise required by applicable law.  By accepting this Award, the undersigned Participant consents to receive Plan documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 

OPTIMER PHARMACEUTICALS, INC.

 

PARTICIPANT:

 

 

 

By:

 

 

 

 

Signature

 

Signature

 

 

 

Title:

 

 

Date:

 

 

 

 

 

Date

 

 

 

 



 

OPTIMER PHARMACEUTICALS, INC.

 

2012 EQUITY INCENTIVE PLAN

 

RESTRICTED STOCK UNIT AGREEMENT

 

Pursuant to the Restricted Stock Unit Grant Notice (the “Grant Notice”) and this Restricted Stock Unit Agreement (the “Agreement”) and in consideration of your services, Optimer Pharmaceuticals, Inc. (the “Company”) has awarded you a Restricted Stock Unit Award (the “Award”) under its 2012 Equity Incentive Plan (the “Plan”) for the number of restricted stock units set forth on the Grant Notice.  Capitalized terms not explicitly defined in this Agreement shall have the same meanings given to them in the Plan or the Grant Notice, as applicable.  Except as otherwise explicitly provided herein, in the event of any conflict between the terms in this Agreement and the Plan, the terms of the Plan shall control.

 

The details of your Award, in addition to those set forth in the Grant Notice and the Plan, are as follows.

 

1.                                      GRANT OF THE AWARD.  This Award represents your right to be issued on a future date the number of shares of Common Stock that is equal to the number of restricted stock units indicated in the Grant Notice (the “Stock Units”).  As of the Date of Grant, the Company will credit to a bookkeeping account maintained by the Company for your benefit (the “Account”) the number of Stock Units subject to the Award.  This Award was granted in consideration of your services to the Company.  Except as otherwise provided herein, you will not be required to make any payment to the Company (other than past and future services to the Company) with respect to your receipt of the Award, the vesting of the Stock Units or the delivery of the Common Stock to be issued in respect of the Award.

 

2.                                      VESTING.    Subject to the limitations contained herein, your Award will vest, if at all, in accordance with the vesting schedule provided in the Grant Notice, provided that vesting will cease upon the termination of your Continuous Service.   Upon such termination of your Continuous Service, the Stock Units credited to the Account that were not vested on the date of such termination will be forfeited at no cost to the Company and you will have no further right, title or interest in such Stock Units or the shares of Common Stock to be issued in respect of such portion of the Award.

 

3.                                      NUMBER OF STOCK UNITS AND SHARES OF COMMON STOCK.

 

(a)                                 The number of Stock Units subject to your Award may be adjusted from time to time for Capitalization Adjustments, as provided in the Plan.

 

(b)                                 Any additional Stock Units that become subject to the Award pursuant to this Section 3, if any, shall be subject, in a manner determined by the Board, to the same forfeiture restrictions, restrictions on transferability, and time and manner of delivery as applicable to the other Stock Units covered by your Award.

 



 

(c)                                  Notwithstanding the provisions of this Section 3, no fractional shares or rights for fractional shares of Common Stock shall be created pursuant to this Section 3.  The Board shall, in its discretion, determine an equivalent benefit for any fractional shares or fractional shares that might be created by the adjustments referred to in this Section 3.

 

4.                                      SECURITIES LAW COMPLIANCE.  You may not be issued any shares in respect of your Award unless either (i) the shares are registered under the Securities Act; or (ii) the Company has determined that such issuance would be exempt from the registration requirements of the Securities Act. Your Award also must comply with other applicable laws and regulations governing the Award, and you will not receive such shares if the Company determines that such receipt would not be in material compliance with such laws and regulations.

 

5.                                      TRANSFER RESTRICTIONS.  Your Award is not transferable, except by will or by the laws of descent and distribution.  In addition to any other limitation on transfer created by applicable securities laws, you agree not to assign, hypothecate, donate, encumber or otherwise dispose of any interest in any of the shares of Common Stock subject to the Award until the shares are issued to you in accordance with Section 6 of this Agreement.  After the shares have been issued to you, you are free to assign, hypothecate, donate, encumber or otherwise dispose of any interest in such shares provided that any such actions are in compliance with the provisions herein, any applicable Company policies (including, but not limited to, insider trading and window period policies) and applicable securities laws.  Notwithstanding the foregoing, by delivering written notice to the Company, in a form satisfactory to the Company, you may designate a third party who, in the event of your death, shall thereafter be entitled to receive any distribution of Common Stock to which you were entitled at the time of your death pursuant to this Agreement.

 

6.                                      DATE OF ISSUANCE.

 

(a)                                 To the extent the Award is exempt from application of Section 409A of the Code and any state law of similar effect (collectively Section 409A), the Company will deliver to you a number of shares of Common Stock equal to the number of vested Stock Units subject to your Award, including any additional Stock Units received pursuant to Section 3 above that relate to those vested Stock Units, on the applicable vesting date(s).  However, if a scheduled delivery date falls on a date that is not a business day, such delivery date shall instead fall on the next following business day.  Notwithstanding the foregoing, in the event that (i) any shares covered by your Award are scheduled to be delivered on a day (the “Original Distribution Date”) that does not occur: (A) during an open “window period” applicable to you under the Company’s policy permitting officers, directors and other designated individuals to sell shares only during certain “window” periods, in effect from time to time (the “Policy”), (B) on a

 



 

day on which you are permitted to sell shares of Common Stock pursuant to a written plan that meets the requirements of Rule 10b5-1 under the Exchange Act, as determined by the Company in accordance with the Policy, or (C) on a date when you are otherwise permitted to sell shares of Common Stock on the open market, and (ii) the Company elects not to satisfy its tax withholding obligations by withholding shares from your distribution or withholding from other compensation otherwise payable to you by the Company, then such shares shall not be delivered on such Original Distribution Date and shall instead be delivered on the first business day of the next occurring open “window period” applicable to you pursuant to such Policy (regardless of whether you are still providing continuous services at such time) or the next business day when you are not prohibited from selling shares of Common Stock in the open market, but in no event later than the fifteenth (15th) day of the third calendar month of the calendar year following the calendar year in which the applicable shares covered by the Award vest.  Delivery of the shares pursuant to the provisions of this Section 6(a) is intended to comply with the requirements for the short-term deferral exemption available under Treasury Regulations Section 1.409A-1(b)(4) and shall be construed and administered in such manner.  The form of such delivery of the shares (e.g., a stock certificate or electronic entry evidencing such shares) shall be determined by the Company.

 

(b)                                 The provisions of Appendix A will apply to the extent your Award is subject to, and not exempt from, application of Section 409A (a “Non-Exempt Award”).

 

7.                                      DIVIDENDS.   You shall receive no benefit or adjustment to your Award with respect to any cash dividend, stock dividend or other distribution that does not result from a Capitalization Adjustment as provided in the Plan; provided, however, that this sentence shall not apply with respect to any shares of Common Stock that are delivered to you in connection with your Award after such shares have been delivered to you.

 

8.                                      RESTRICTIVE LEGENDS.  The shares issued in respect of your Award shall be endorsed with appropriate legends determined by the Company.

 

9.                                      AWARD NOT A SERVICE CONTRACT.

 

(a)                                 Your Continuous Service with the Company or an Affiliate is not for any specified term and may be terminated by you or by the Company or an Affiliate at any time, for any reason, with or without cause and with or without notice.  Nothing in this Agreement (including, but not limited to, the vesting of your Award pursuant to the schedule set forth in the Grant Notice or the issuance of the shares in respect of your Award), the Plan or any covenant of good faith and fair dealing that may be found implicit in this Agreement or the Plan shall:  (i) confer upon you any right to continue in the employ of, or affiliation with, the Company or any Affiliate; (ii) constitute any promise or commitment by the Company or any Affiliate regarding the fact or nature of future positions, future work assignments, future compensation or any other term or condition of employment or affiliation; (iii) confer any right or benefit under this

 



 

Agreement or the Plan unless such right or benefit has specifically accrued under the terms of this Agreement or Plan; or (iv) deprive the Company of the right to terminate you at will and without regard to any future vesting opportunity that you may have.

 

(b)                                 By accepting this Award, you acknowledge and agree that the right to continue vesting in the Award pursuant to the vesting schedule provided in the Grant Notice is earned only by continuing as an employee, director or consultant at the will of the Company (not through the act of being hired, being granted this Award or any other award or benefit) and that the Company has the right to reorganize, sell, spin-out or otherwise restructure one or more of its businesses or Affiliates at any time or from time to time, as it deems appropriate (a “reorganization”).  You further acknowledge and agree that such a reorganization could result in the termination of your Continuous Service, or the termination of Affiliate status of your employer and the loss of benefits available to you under this Agreement, including but not limited to, the termination of the right to continue vesting in the Award.  You further acknowledge and agree that this Agreement, the Plan, the transactions contemplated hereunder and the vesting schedule set forth herein or any covenant of good faith and fair dealing that may be found implicit in any of them do not constitute an express or implied promise of continued engagement as an employee or consultant for the term of this Agreement, for any period, or at all, and shall not interfere in any way with your right or the Company’s right to terminate your Continuous Service at any time, with or without cause and with or without notice.

 

10.                               WITHHOLDING OBLIGATIONS.

 

(a)                                 On or before the time you receive a distribution of the shares subject to your Award, or at any time thereafter as requested by the Company, you hereby authorize any required withholding from the Common Stock issuable to you and/or otherwise agree to make adequate provision in cash for any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or any Affiliate which arise in connection with your Award (the “Withholding Taxes”).  Additionally, the Company may, in its sole discretion, satisfy all or any portion of the Withholding Taxes obligation relating to your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company; (ii) causing you to tender a cash payment; (iii) permitting or requiring you to enter into a “same day sale” commitment with a broker-dealer that is a member of the Financial Industry Regulatory Authority (a “FINRA Dealer”) whereby you irrevocably elect to sell a portion of the shares to be delivered in connection with your Restricted Stock Units to satisfy the Withholding Taxes and whereby the FINRA Dealer irrevocably commits to forward the proceeds necessary to satisfy the Withholding Taxes directly to the Company and/or its Affiliates; or (iv) withholding shares of Common Stock from the shares of Common Stock issued or otherwise issuable to you in connection with the Award with a Fair Market Value (measured as of the date shares of Common Stock are issued to pursuant to Section 6) equal to the amount of such Withholding Taxes; provided, however, that the number of such shares of Common Stock so withheld shall not exceed the amount necessary to satisfy

 



 

the Company’s required tax withholding obligations using the minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are applicable to supplemental taxable income; and provided further, that to the extent necessary to qualify for an exemption from application of Section 16(b) of the Exchange Act, such share withholding procedure shall be subject to the express prior approval of the Board or a duly authorized committee thereof.

 

(b)                                 Unless the tax withholding obligations of the Company and/or any Affiliate are satisfied, the Company shall have no obligation to deliver to you any Common Stock pursuant to this Award.

 

(c)                                  In the event the Company’s obligation to withhold arises prior to the delivery to you of Common Stock or it is determined after the delivery of Common Stock to you that the amount of the Company’s withholding obligation was greater than the amount withheld by the Company, you agree to indemnify and hold the Company harmless from any failure by the Company to withhold the proper amount.

 

11.                               UNSECURED OBLIGATION.  Your Award is unfunded, and as a holder of a vested Award, you shall be considered an unsecured creditor of the Company with respect to the Company’s obligation, if any, to issue shares pursuant to this Agreement.  You shall not have voting or any other rights as a stockholder of the Company with respect to the shares to be issued pursuant to this Agreement until such shares are issued to you pursuant to Section 6 of this Agreement.   Upon such issuance, you will obtain full voting and other rights as a stockholder of the Company.  Nothing contained in this Agreement, and no action taken pursuant to its provisions, shall create or be construed to create a trust of any kind or a fiduciary relationship between you and the Company or any other person.

 

12.                               OTHER DOCUMENTS.  You hereby acknowledge receipt or the right to receive a document providing the information required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus.  In addition, you acknowledge receipt of the Company’s policy permitting officers, directors and other specified individuals to sell shares only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.

 

13.                               NOTICES.  Any notices provided for in your Award or the Plan shall be given in writing (including electronically) and shall be deemed effectively given upon receipt or, in the case of notices delivered by the Company to you, five (5) days after deposit in the United States mail, postage prepaid, addressed to you at the last address you provided to the Company.  Notwithstanding the foregoing, the Company may, in its sole discretion, decide to deliver any documents related to participation in the Plan and this Award by electronic means or to request your consent to participate in the Plan by electronic means.  By accepting this Award you consent to receive such documents by electronic delivery and, if requested, to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 



 

14.                               GOVERNING PLAN DOCUMENT.  Your Award is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your Award, and is further subject to all interpretations, amendments, rules and regulations which may from time to time be promulgated and adopted pursuant to the Plan.  Except as expressly provided in this Agreement, in the event of any conflict between the provisions of your Award and those of the Plan, the provisions of the Plan shall control.  In addition, your Award (and any compensation paid or shares issued under your Award) is subject to recoupment in accordance with The Dodd—Frank Wall Street Reform and Consumer Protection Act and any implementing regulations thereunder, any clawback policy adopted by the Company and any compensation recovery policy otherwise required by applicable law.

 

15.                               OTHER DOCUMENTS.  You hereby acknowledge receipt of and the right to receive a document providing the information required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus.  In addition, you acknowledge receipt of the Company’s policy permitting certain individuals to sell shares only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.

 

16.                               SEVERABILITY.  If all or any part of this Agreement or the Plan is declared by any court or governmental authority to be unlawful or invalid, such unlawfulness or invalidity shall not invalidate any portion of this Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Agreement (or part of such a Section) so declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section or part of a Section to the fullest extent possible while remaining lawful and valid.

 

17.                               EFFECT ON OTHER EMPLOYEE BENEFIT PLANS.  The value of the Award subject to this Agreement shall not be included as compensation, earnings, salaries, or other similar terms used when calculating the Employee’s benefits under any employee benefit plan sponsored by the Company or any Affiliate, except as such plan otherwise expressly provides. The Company expressly reserves its rights to amend, modify, or terminate any of the Company’s or any Affiliate’s employee benefit plans.

 

18.                               AMENDMENT.  This Agreement may not be modified, amended or terminated except by an instrument in writing, signed by you and by a duly authorized representative of the Company. Notwithstanding the foregoing, this Agreement may be amended solely by the Board by a writing which specifically states that it is amending this Agreement, so long as a copy of such amendment is delivered to you, and provided that no such amendment adversely affecting your rights hereunder may be made without your written consent. Without limiting the foregoing, the Board reserves the right to change, by written notice to you, the provisions of this Agreement in any way it may deem necessary or advisable to carry out the purpose of the grant

 



 

as a result of any change in applicable laws or regulations or any future law, regulation, ruling, or judicial decision, provided that any such change shall be applicable only to rights relating to that portion of the Award which is then subject to restrictions as provided herein.

 

19.                               NO OBLIGATION TO MINIMIZE TAXES.  The Company has no duty or obligation to minimize the tax consequences to you of this Award and will not be liable to you for any adverse tax consequences to you arising in connection with this Award.  You are hereby advised to consult with your own personal tax, financial and/or legal advisors regarding the tax consequences of this Award and by signing the Grant Notice, you have agreed that you have done so or knowingly and voluntarily declined to do so.

 

20.                               MISCELLANEOUS.

 

(a)                                 The rights and obligations of the Company under this Award will be transferable to any one or more persons or entities, and all covenants and agreements hereunder will inure to the benefit of, and be enforceable by the Company’s successors and assigns.

 

(b)                                 You agree upon request to execute any further documents or instruments necessary or desirable in the sole determination of the Company to carry out the purposes or intent of your Award.

 

(c)                                  You acknowledge and agree that you have reviewed your Award in its entirety, have had an opportunity to obtain the advice of counsel prior to executing and accepting your Award, and fully understand all provisions of your Award.

 

(d)                                 This Agreement will be subject to all applicable laws, rules, and regulations, and to such approvals by any governmental agencies or national securities exchanges as may be required.

 

(e)                                  All obligations of the Company under the Plan and this Agreement will be binding on any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation, or otherwise, of all or substantially all of the business and/or assets of the Company.

 

*                                         *                                         *

 

This Agreement will be deemed to be signed by you upon the signing by you of the Grant Notice to which it is attached.

 



 

Appendix A

 

The provisions set forth on this Appendix A shall apply to the extent the Award is a Non-Exempt Award and shall supersede any provisions to the contrary set forth in the Plan or in any other section of the Agreement to which this Appendix A is attached.

 

1.                                      The provisions of this Section 1 are intended to apply to the extent your Award is a Non-Exempt Award because of the terms of a severance arrangement or other agreement between you and the Company, if any, that provide for acceleration of vesting of your Award and issuance of the shares in respect of the Award upon your termination of employment or separation from service (as such term is defined in Section 409A(a)(2)(A)(i) of the Code (and without regard to any alternative definition thereunder) (“Separation from Service”) and such severance benefit does not satisfy the requirements for an exemption from application of Section 409A provided under Treasury Regulations Section 1.409A-1(b)(4) or 1.409A-1(b)(9) (“Non-Exempt Severance Arrangement”).  To the extent your Award is a Non-Exempt Award due to application of a Non-Exempt Severance Arrangement, the following provisions in this Section 1 of Appendix A shall supersede anything to the contrary in Section 6(a) of the Award Agreement.

 

(a)                                 If your Award vests in the ordinary course during your Continuous Service in accordance with the vesting schedule set forth in the Grant Notice, without accelerating vesting under the terms of a Non-Exempt Severance Arrangement, in no event will the shares be issued in respect of your Award any later than the later of: (i) December 31st of the calendar year that includes the applicable vesting date and (ii) the 60th day that follows the applicable vesting date.

 

(b)                                 If vesting of your Award accelerates under the terms of a Non-Exempt Severance Arrangement in connection with your Separation from Service, and such vesting acceleration provisions were in effect as of the date of grant of your Award and, therefore, are part of the terms of your Award as of the date of grant, then the shares will be earlier issued in respect of your Award upon your Separation from Service in accordance with the terms of the Non-Exempt Severance Arrangement, but in no event later than the 60th day that follows the date of your Separation from Service.  However, if at the time the shares would otherwise be issued you are subject to the distribution limitations contained in Section 409A applicable to “specified employees,” as defined in Section 409A(a)(2)(B)(i) of the Code, such shares shall not be issued before the date that is six (6) months following the date of your Separation from Service, or, if earlier, the date of your death that occurs within such six month period.

 

(c)                                  If vesting of your Award accelerates under the terms of a Non-Exempt Severance Arrangement in connection with your Separation from Service, and such vesting acceleration provisions were not in effect as of the date of grant of the Award and, therefore, are not a part of the terms of your Award on the date of grant, then such acceleration of vesting of your Award shall not accelerate the issuance date of the shares, but the shares shall instead be

 



 

issued on the same schedule as set forth in the Grant Notice as if they had vested in the ordinary course during your Continuous Service, notwithstanding the vesting acceleration of the Award.  Such issuance schedule is intended to satisfy the requirements of payment on a specified date or pursuant to a fixed schedule, as provided under Treasury Regulations Section 1.409A-3(a)(4).

 

2.                                      The provisions in this Section 2 shall apply and shall supersede anything to the contrary that may be set forth in the Plan, Grant Notice or in any section of the Agreement with respect to the permitted treatment of your Non-Exempt Award in connection with a Corporate Transaction if you were either an Employee or Consultant upon the applicable date of grant of your Non-Exempt Award.

 

(a)                                 Vested Non-Exempt Awards:  To the extent your Non-Exempt Award has vested in accordance with its terms upon or prior to the date of a Corporate Transaction (such portion of your Non-Exempt Award is a “Vested Non-Exempt Award”), then the following provisions shall apply.

 

(i)                                    If the Corporate Transaction is also a change in the ownership or effective control of the Company, or in the ownership of a substantial portion of the Company’s assets, as described in Section 409A(a)(2)(A)(v) of the Code and Treasury Regulations Section 1.409A-3(i)(5) (a “409A Change of Control”), then the surviving or acquiring corporation (or its parent company) (the “Acquiring Entity”) may not assume, continue or substitute your Vested Non-Exempt Award.  Upon the 409A Change of Control the settlement of your Vested Non-Exempt Award will automatically be accelerated and the shares will be immediately issued in respect of your Vested Non-Exempt Award. Alternatively, the Company may instead provide that you will receive a cash settlement equal to the Fair Market Value of the shares that would otherwise be issued to you upon the 409A Change of Control.

 

(ii)                                If the Corporate Transaction is not also a 409A Change of Control, then the Acquiring Entity must either assume, continue or substitute your Vested Non-Exempt Award.  The shares to be issued in respect of your Vested Non-Exempt Award shall be issued to you by the Acquiring Entity on the same schedule that the shares would have been issued to you if the Corporate Transaction had not occurred.  In the Acquiring Entity’s discretion, in lieu of an issuance of shares, the Acquiring Entity may instead substitute a cash payment on each applicable issuance date, equal to the Fair Market Value of the shares that would otherwise be issued to you on such issuance dates, with the determination of the Fair Market Value of the shares made on the date of the Corporate Transaction.

 

(b)                                 Unvested Non-Exempt Awards.  To the extent your Non-Exempt Award has not vested in accordance with its terms upon or prior to the date of any Corporate Transaction, (such portion of your Non-Exempt Award is an “Unvested Non-Exempt Award”), then the following provisions shall apply.

 



 

(i)                                    If the Acquiring Entity will not assume, substitute or continue your Unvested Non-Exempt Award, then such Award shall automatically terminate and be forfeited upon the Corporate Transaction with no consideration payable to you in respect of your forfeited Unvested Non-Exempt Award.  Notwithstanding the foregoing, to the extent permitted and in compliance with the requirements of Section 409A, the Company may in its discretion determine to elect to accelerate the vesting and settlement of the Unvested Non-Exempt Award upon the Corporate Transaction, or instead substitute a cash payment equal to the Fair Market Value of such shares that would otherwise be issued to you, as further provided in Section 4(b) below.  In the absence of such discretionary election by the Company, your Unvested Non-Exempt Award shall be forfeited without payment of any consideration to you if the Acquiring Entity will not assume, substitute or continue your Unvested Non-Exempt Award in connection with the Corporate Transaction.

 

(ii)                                The foregoing treatment shall apply with respect to all Unvested Non-Exempt Awards upon any Corporate Transaction, and regardless of whether or not such Corporate Transaction is also a 409A Change of Control.

 

3.                                      General Superseding Provisions.  The provisions in this Section 3 shall apply and supersede anything to the contrary that may be set forth in the Plan, the Grant Notice or in any other section of the Agreement with respect to the permitted treatment of your Non-Exempt Award:

 

(a)                                 Any exercise by the Board of discretion to accelerate the vesting of your Non-Exempt Award shall not result in any acceleration of the scheduled issuance dates for the shares in respect of the Non-Exempt Award unless earlier issuance of the shares upon the applicable vesting dates would be in compliance with the requirements of Section 409A.

 

(b)                                 The Company explicitly reserves the right to earlier settle your Non-Exempt Award to the extent permitted and in compliance with the requirements of Section 409A, including pursuant to any of the exemptions available in Treasury Regulations Section 1.409A-3(j)(4)(ix).

 

(c)                                  To the extent the terms of your Non-Exempt Award provide that it will be settled upon a Change in Control or Corporate Transaction, to the extent it is required for compliance with the requirements of Section 409A, the Change in Control or Corporate Transaction event triggering settlement must also constitute a 409A Change of Control. To the extent the terms of your Non-Exempt Award provides that it will be settled upon a termination of your employment or termination of Continous Service, to the extent it is required for compliance with the requirements of Section 409A, the termination event triggering settlement must also constitute a Separation from Service.  However, if at the time the shares would otherwise be issued to you in connection with your “separation from service” you are subject to the distribution limitations contained in Section 409A applicable to “specified employees,” as

 



 

defined in Section 409A(a)(2)(B)(i) of the Code, such shares shall not be issued before the date that is six (6) months following the date of your Separation from Service, or, if earlier, the date of your death that occurs within such six month period.

 

4.                                      Section 409A Compliance.  The provisions in this Agreement for delivery of the shares in respect of the Non-Exempt Award are intended to comply with the requirements of Section 409A so that the delivery of the shares to you in respect of your Non-Exempt Award will not trigger the additional tax imposed under Section 409A, and any ambiguities herein will be so interpreted.

 


EX-10.7 6 a12-13878_1ex10d7.htm EX-10.7

Exhibit 10.7

 

OPTIMER PHARMACEUTICALS, INC.
RESTRICTED STOCK UNIT GRANT NOTICE
(2012 EQUITY INCENTIVE PLAN)

 

Optimer Pharmaceuticals, Inc. (the “Company”) hereby awards to Participant the number of restricted stock units specified and on the terms set forth below (the “Award”).  The Award is subject to all of the terms and conditions as set forth herein and in the Company’s 2012 Equity Incentive Plan (the “Plan”) and the Restricted Stock Unit Agreement (the “Agreement”), both of which are attached hereto and incorporated herein in their entirety.  Capitalized terms not explicitly defined herein but defined in the Plan or the Agreement shall have the meanings set forth in the Plan or the Agreement.  Except as explicitly provided herein or in the Agreement, in the event of any conflict between the terms in the Award and the Plan, the terms of the Plan shall control.

 

Participant:

 

 

Date of Grant:

 

 

Vesting Commencement Date:

 

 

Number of Restricted Stock Units:

 

 

Consideration:

Participant’s Services

 

 

Vesting Schedule:                    [                                                              ].  Notwithstanding the foregoing, vesting shall terminate upon the Participant’s termination of Continuous Service.

 

Issuance Schedule:               One share of Common Stock will be issued for each restricted stock unit which vests at the time set forth in Section 6 of the Agreement.

 

Additional Terms/Acknowledgements:  The undersigned Participant acknowledges receipt of, and understands and agrees to, this Restricted Stock Unit Grant Notice, the Agreement, the Plan prospectus and the Plan.  Participant further acknowledges that as of the Date of Grant, this Restricted Stock Unit Grant Notice, the Agreement and the Plan set forth the entire understanding between Participant and the Company regarding the Award and supersedes all prior oral and written agreements on that subject, with the exception of: (i) any written employment or severance arrangement that would provide for vesting acceleration of the Award upon the terms and conditions set forth therein, or (ii) any compensation recovery policy that is adopted by the Company or is otherwise required by applicable law.  By accepting this Award, the undersigned Participant consents to receive Plan documents by electronic delivery and to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 

OPTIMER PHARMACEUTICALS, INC.

 

PARTICIPANT:

 

 

 

By:

 

 

 

Signature

 

Signature

 

 

 

Title:

 

 

Date:

 

 

 

 

Date:

 

 

 

 

ATTACHMENTS:         Restricted Stock Unit Agreement, 2012 Equity Incentive Plan

 



 

OPTIMER PHARMACEUTICALS, INC.

2012 EQUITY INCENTIVE PLAN

 

RESTRICTED STOCK UNIT AGREEMENT

 

Pursuant to the Restricted Stock Unit Grant Notice (the “Grant Notice”) and this Restricted Stock Unit Agreement (the “Agreement”) and in consideration of your services, Optimer Pharmaceuticals, Inc. (the “Company”) has awarded you a Restricted Stock Unit Award (the “Award”) under its 2012 Equity Incentive Plan (the “Plan”) for the number of restricted stock units set forth on the Grant Notice.  Capitalized terms not explicitly defined in this Agreement shall have the same meanings given to them in the Plan or the Grant Notice, as applicable.  Except as otherwise explicitly provided herein, in the event of any conflict between the terms in this Agreement and the Plan, the terms of the Plan shall control.

 

The details of your Award, in addition to those set forth in the Grant Notice and the Plan, are as follows.

 

1.                                      GRANT OF THE AWARD.  This Award represents your right to be issued on a future date the number of shares of Common Stock that is equal to the number of restricted stock units indicated in the Grant Notice (the “Stock Units”).  As of the Date of Grant, the Company will credit to a bookkeeping account maintained by the Company for your benefit (the “Account”) the number of Stock Units subject to the Award.  This Award was granted in consideration of your services to the Company.  Except as otherwise provided herein, you will not be required to make any payment to the Company (other than past and future services to the Company) with respect to your receipt of the Award, the vesting of the Stock Units or the delivery of the Common Stock to be issued in respect of the Award.

 

2.                                      VESTING.  Subject to the limitations contained herein, your Award will vest, if at all, in accordance with the vesting schedule provided in the Grant Notice, provided that vesting will cease upon the termination of your Continuous Service.  Upon such termination of your Continuous Service, the Stock Units credited to the Account that were not vested on the date of such termination will be forfeited at no cost to the Company and you will have no further right, title or interest in such Stock Units or the shares of Common Stock to be issued in respect of such portion of the Award.

 

3.                                      NUMBER OF STOCK UNITS AND SHARES OF COMMON STOCK.

 

(a)                                 The number of Stock Units subject to your Award may be adjusted from time to time for Capitalization Adjustments, as provided in the Plan.

 



 

(b)                                 Any additional Stock Units that become subject to the Award pursuant to this Section 3, if any, shall be subject, in a manner determined by the Board, to the same forfeiture restrictions, restrictions on transferability, and time and manner of delivery as applicable to the other Stock Units covered by your Award.

 

(c)                                  Notwithstanding the provisions of this Section 3, no fractional shares or rights for fractional shares of Common Stock shall be created pursuant to this Section 3.  The Board shall, in its discretion, determine an equivalent benefit for any fractional shares or fractional shares that might be created by the adjustments referred to in this Section 3.

 

4.                                      SECURITIES LAW COMPLIANCE.  You may not be issued any shares in respect of your Award unless either (i) the shares are registered under the Securities Act; or (ii) the Company has determined that such issuance would be exempt from the registration requirements of the Securities Act. Your Award also must comply with other applicable laws and regulations governing the Award, and you will not receive such shares if the Company determines that such receipt would not be in material compliance with such laws and regulations.

 

5.                                      TRANSFER RESTRICTIONS.  Your Award is not transferable, except by will or by the laws of descent and distribution.  In addition to any other limitation on transfer created by applicable securities laws, you agree not to assign, hypothecate, donate, encumber or otherwise dispose of any interest in any of the shares of Common Stock subject to the Award until the shares are issued to you in accordance with Section 6 of this Agreement.  After the shares have been issued to you, you are free to assign, hypothecate, donate, encumber or otherwise dispose of any interest in such shares provided that any such actions are in compliance with the provisions herein, any applicable Company policies (including, but not limited to, insider trading and window period policies) and applicable securities laws.  Notwithstanding the foregoing, by delivering written notice to the Company, in a form satisfactory to the Company, you may designate a third party who, in the event of your death, shall thereafter be entitled to receive any distribution of Common Stock to which you were entitled at the time of your death pursuant to this Agreement.

 

6.                                      DATE OF ISSUANCE.

 

(a)                                 To the extent the Award is (1) exempt from application of Section 409A of the Code and any state law of similar effect (collectively Section 409A) and (2) not subject to Section 6(b) below, the Company will deliver to you a number of shares of Common Stock equal to the number of vested Stock Units subject to your Award, including any additional Stock Units received pursuant to Section 3 above that relate to those vested Stock Units, on the applicable vesting date(s).  However, if a scheduled delivery date falls on a date that is not a business day, such delivery date shall instead fall on the next following business day.  Notwithstanding the foregoing, in the event that (i) any shares covered by your Award are

 



 

scheduled to be delivered on a day (the “Original Distribution Date”) that does not occur: (A) during an open “window period” applicable to you under the Company’s policy permitting officers, directors and other designated individuals to sell shares only during certain “window” periods, in effect from time to time (the “Policy”), (B) on a day on which you are permitted to sell shares of Common Stock pursuant to a written plan that meets the requirements of Rule 10b5-1 under the Exchange Act, as determined by the Company in accordance with the Policy, or (C) on a date when you are otherwise permitted to sell shares of Common Stock on the open market, and (ii) the Company elects not to satisfy its tax withholding obligations by withholding shares from your distribution or withholding from other compensation otherwise payable to you by the Company, then such shares shall not be delivered on such Original Distribution Date and shall instead be delivered on the first business day of the next occurring open “window period” applicable to you pursuant to such Policy (regardless of whether you are still providing Continuous Service at such time) or the next business day when you are not prohibited from selling shares of Common Stock in the open market, but in no event later than the fifteenth (15th) day of the third calendar month of the calendar year following the calendar year in which the applicable shares covered by the Award vest.  Delivery of the shares pursuant to the provisions of this Section 6(a) is intended to comply with the requirements for the short-term deferral exemption available under Treasury Regulations Section 1.409A-1(b)(4) and shall be construed and administered in such manner.  The form of such delivery of the shares (e.g., a stock certificate or electronic entry evidencing such shares) shall be determined by the Company.

 

(b)                                 Notwithstanding the foregoing provisions, the following provisions will apply if you elect to defer delivery of the shares to be issued in respect of your Award beyond the vesting date in accordance with this Section:

 

(i)                                    If you elect to defer delivery of shares of Common Stock in respect of the Award beyond the vesting date and such election is made no later than the last day of the calendar year prior to the calendar year in which the Date of Grant occurs and shares commence vesting, or if you elect to defer delivery of the shares subject to your Award in a manner that otherwise complies with Section 409A, then the Company will not deliver such shares on the vesting date or dates provided in your Grant Notice, but will instead deliver such shares to you on the date or dates or permitted payment events that you so elect (the “Settlement Date”); provided, however, that in the event of your upon your termination of employment or separation from service (as such term is defined in Section 409A(a)(2)(A)(i) of the Code (and without regard to any alternative definition thereunder) (“Separation from Service”) prior to the Settlement Date, such vested shares of Common Stock will instead be delivered to you on the earlier date of your Separation from Service or pursuant to the objective payment formula commencing on your Separation from Service, if any, that you specified in your election to defer delivery.  If such deferral election is made, the Board or a duly authorized committee thereof will, in its sole discretion, establish the rules and procedures for such election which will be evidenced by a Restricted Stock Unit Election Agreement.

 



 

(ii)                                If at the time the shares would otherwise be issued to you in respect of your Award as a result of your Separation from Service, you are subject to the distribution limitations contained in Section 409A applicable to “specified employees” as defined in Section 409A(a)(2)(B)(i) of the Code and applicable guidance thereunder, share issuances to you as a result of your Separation from Service will not be made before the date which is six (6) months following the date of your Separation from Service, or, if earlier, the date of your death that occurs within such six (6) month period.

 

(iii)                            If the Company determines that you are subject to the Policy or you are otherwise prohibited from selling shares of the Company’s stock in the public market and any shares of Common Stock subject to your Award are scheduled to be delivered on a Settlement Date that does not occur (A) during an open “window period” applicable to you, (B) on a day on which you are permitted to sell shares of Common Stock pursuant to a written plan that meets the requirements of Rule 10b5-1 under the Exchange Act, as determined by the Company in accordance with the Policy, or (C) on a day when you are otherwise permitted to sell shares of Common Stock in the public market and the Company elects not to satisfy its tax withholding obligations by withholding shares from your distribution or by withholding from other compensation otherwise payable to you by the Company, then such shares will not be delivered on such Settlement Date and will instead be delivered as soon as practicable on the first business day within the next open “window period” applicable to you pursuant to such policy or the next day when you are not prohibited from selling shares of Common Stock in the public market (regardless of whether you are still providing Continuous Service at such time); provided, however, that unless the delay until the next open window period or the next day when you are not prohibited from selling shares of the Company’s stock in the public market would not result in the imposition of any additional taxes under the Code (including Section 409A of the Code), the delivery of the shares will not be delayed pursuant to this provision beyond 60 days following the selected Settlement Date.  The form of such delivery (e.g., a stock certificate or electronic entry evidencing such shares) will be determined by the Company.

 

(iv)                             In the event that you have a Separation from Service that is not a termination of your Continuous Service, then any unvested shares subject to your Award that vest in ordinary course pursuant to the vesting schedule set forth in the Grant Notice following your Separation from Service will be issued to you in accordance with the provisions of Section 6(a); provided, however, that the foregoing provision will not apply to the extent that your severance arrangement, if any, provides for acceleration of vesting of the Award upon your Separation from Service, in which case the shares will be issued to you in accordance with the provisions of Section 6(a) or 6(b), as applicable.

 

(c)                                  If your Award is subject to, and not exempt from, Section 409A (a “Non-Exempt Award”), the applicable provisions of Appendix A will apply and will supersede anything to the contrary that may be set forth in the Plan, Grant Notice or in any other section of

 



 

the Agreement with respect to the permitted treatment of your Non-Exempt Award in connection with certain terminations of your employment or service with the Company and certain change in control events.

 

7.                                      DIVIDENDS.  You shall receive no benefit or adjustment to your Award with respect to any cash dividend, stock dividend or other distribution that does not result from a Capitalization Adjustment as provided in the Plan; provided, however, that this sentence shall not apply with respect to any shares of Common Stock that are delivered to you in connection with your Award after such shares have been delivered to you.

 

8.                                      RESTRICTIVE LEGENDS.  The shares issued in respect of your Award shall be endorsed with appropriate legends determined by the Company.

 

9.                                      AWARD NOT A SERVICE CONTRACT.

 

(a)                                 Your Continuous Service with the Company or an Affiliate is not for any specified term and may be terminated by you or by the Company or an Affiliate at any time, for any reason, with or without cause and with or without notice.  Nothing in this Agreement (including, but not limited to, the vesting of your Award pursuant to the schedule set forth in the Grant Notice or the issuance of the shares in respect of your Award), the Plan or any covenant of good faith and fair dealing that may be found implicit in this Agreement or the Plan shall:  (i) confer upon you any right to continue in the employ of, or affiliation with, the Company or any Affiliate; (ii) constitute any promise or commitment by the Company or any Affiliate regarding the fact or nature of future positions, future work assignments, future compensation or any other term or condition of employment or affiliation; (iii) confer any right or benefit under this Agreement or the Plan unless such right or benefit has specifically accrued under the terms of this Agreement or Plan; or (iv) deprive the Company of the right to terminate you at will and without regard to any future vesting opportunity that you may have.

 

(b)                                 By accepting this Award, you acknowledge and agree that the right to continue vesting in the Award pursuant to the vesting schedule provided in the Grant Notice is earned only by continuing as an employee, director or consultant at the will of the Company (not through the act of being hired, being granted this Award or any other award or benefit) and that the Company has the right to reorganize, sell, spin-out or otherwise restructure one or more of its businesses or Affiliates at any time or from time to time, as it deems appropriate (a “reorganization”).  You further acknowledge and agree that such a reorganization could result in the termination of your Continuous Service, or the termination of Affiliate status of your employer and the loss of benefits available to you under this Agreement, including but not limited to, the termination of the right to continue vesting in the Award.  You further acknowledge and agree that this Agreement, the Plan, the transactions contemplated hereunder and the vesting schedule set forth herein or any covenant of good faith and fair dealing that may

 



 

be found implicit in any of them do not constitute an express or implied promise of continued engagement as an employee or consultant for the term of this Agreement, for any period, or at all, and shall not interfere in any way with your right or the Company’s right to terminate your Continuous Service at any time, with or without cause and with or without notice.

 

10.                               WITHHOLDING OBLIGATIONS.

 

(a)                                 On or before the time you receive a distribution of the shares subject to your Award, or at any time thereafter as requested by the Company, you hereby authorize any required withholding from the Common Stock issuable to you and/or otherwise agree to make adequate provision in cash for any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or any Affiliate which arise in connection with your Award (the “Withholding Taxes”).  Additionally, the Company may, in its sole discretion, satisfy all or any portion of the Withholding Taxes obligation relating to your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you by the Company; (ii) causing you to tender a cash payment; (iii) permitting or requiring you to enter into a “same day sale” commitment with a broker-dealer that is a member of the Financial Industry Regulatory Authority (a “FINRA Dealer”) whereby you irrevocably elect to sell a portion of the shares to be delivered in connection with your Restricted Stock Units to satisfy the Withholding Taxes and whereby the FINRA Dealer irrevocably commits to forward the proceeds necessary to satisfy the Withholding Taxes directly to the Company and/or its Affiliates; or (iv) withholding shares of Common Stock from the shares of Common Stock issued or otherwise issuable to you in connection with the Award with a Fair Market Value (measured as of the date shares of Common Stock are issued to pursuant to Section 6) equal to the amount of such Withholding Taxes; provided, however, that the number of such shares of Common Stock so withheld shall not exceed the amount necessary to satisfy the Company’s required tax withholding obligations using the minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are applicable to supplemental taxable income; and provided further, that to the extent necessary to qualify for an exemption from application of Section 16(b) of the Exchange Act, such share withholding procedure shall be subject to the express prior approval of the Board or a duly authorized committee thereof.

 

(b)                                 Unless the tax withholding obligations of the Company and/or any Affiliate are satisfied, the Company shall have no obligation to deliver to you any Common Stock pursuant to this Award.

 

(c)                                  In the event the Company’s obligation to withhold arises prior to the delivery to you of Common Stock or it is determined after the delivery of Common Stock to you that the amount of the Company’s withholding obligation was greater than the amount withheld by the Company, you agree to indemnify and hold the Company harmless from any failure by the Company to withhold the proper amount.

 



 

11.                               UNSECURED OBLIGATION.  Your Award is unfunded, and as a holder of a vested Award, you shall be considered an unsecured creditor of the Company with respect to the Company’s obligation, if any, to issue shares pursuant to this Agreement.  You shall not have voting or any other rights as a stockholder of the Company with respect to the shares to be issued pursuant to this Agreement until such shares are issued to you pursuant to Section 6 of this Agreement.  Upon such issuance, you will obtain full voting and other rights as a stockholder of the Company.  Nothing contained in this Agreement, and no action taken pursuant to its provisions, shall create or be construed to create a trust of any kind or a fiduciary relationship between you and the Company or any other person.

 

12.                               OTHER DOCUMENTS.  You hereby acknowledge receipt or the right to receive a document providing the information required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus.  In addition, you acknowledge receipt of the Company’s policy permitting officers, directors and other specified individuals to sell shares only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.

 

13.                               NOTICES.  Any notices provided for in your Award or the Plan shall be given in writing (including electronically) and shall be deemed effectively given upon receipt or, in the case of notices delivered by the Company to you, five (5) days after deposit in the United States mail, postage prepaid, addressed to you at the last address you provided to the Company.  Notwithstanding the foregoing, the Company may, in its sole discretion, decide to deliver any documents related to participation in the Plan and this Award by electronic means or to request your consent to participate in the Plan by electronic means.  By accepting this Award you consent to receive such documents by electronic delivery and, if requested, to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party designated by the Company.

 

14.                               GOVERNING PLAN DOCUMENT.  Your Award is subject to all the provisions of the Plan, the provisions of which are hereby made a part of your Award, and is further subject to all interpretations, amendments, rules and regulations which may from time to time be promulgated and adopted pursuant to the Plan.  Except as expressly provided in this Agreement, in the event of any conflict between the provisions of your Award and those of the Plan, the provisions of the Plan shall control.  In addition, your Award (and any compensation paid or shares issued under your Award) is subject to recoupment in accordance with The Dodd—Frank Wall Street Reform and Consumer Protection Act and any implementing regulations thereunder, any clawback policy adopted by the Company and any compensation recovery policy otherwise required by applicable law.

 



 

15.                               OTHER DOCUMENTS.  You hereby acknowledge receipt of and the right to receive a document providing the information required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus.  In addition, you acknowledge receipt of the Company’s policy permitting certain individuals to sell shares only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.

 

16.                               SEVERABILITY.  If all or any part of this Agreement or the Plan is declared by any court or governmental authority to be unlawful or invalid, such unlawfulness or invalidity shall not invalidate any portion of this Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Agreement (or part of such a Section) so declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section or part of a Section to the fullest extent possible while remaining lawful and valid.

 

17.                               EFFECT ON OTHER EMPLOYEE BENEFIT PLANS.  The value of the Award subject to this Agreement shall not be included as compensation, earnings, salaries, or other similar terms used when calculating the Employee’s benefits under any employee benefit plan sponsored by the Company or any Affiliate, except as such plan otherwise expressly provides. The Company expressly reserves its rights to amend, modify, or terminate any of the Company’s or any Affiliate’s employee benefit plans.

 

18.                               AMENDMENT.  This Agreement may not be modified, amended or terminated except by an instrument in writing, signed by you and by a duly authorized representative of the Company. Notwithstanding the foregoing, this Agreement may be amended solely by the Board by a writing which specifically states that it is amending this Agreement, so long as a copy of such amendment is delivered to you, and provided that no such amendment adversely affecting your rights hereunder may be made without your written consent. Without limiting the foregoing, the Board reserves the right to change, by written notice to you, the provisions of this Agreement in any way it may deem necessary or advisable to carry out the purpose of the grant as a result of any change in applicable laws or regulations or any future law, regulation, ruling, or judicial decision, provided that any such change shall be applicable only to rights relating to that portion of the Award which is then subject to restrictions as provided herein.

 

19.                               NO OBLIGATION TO MINIMIZE TAXES.  The Company has no duty or obligation to minimize the tax consequences to you of this Award and will not be liable to you for any adverse tax consequences to you arising in connection with this Award.  You are hereby advised to consult with your own personal tax, financial and/or legal advisors regarding the tax consequences of this Award and by signing the Grant Notice, you have agreed that you have done so or knowingly and voluntarily declined to do so.

 



 

20.                               MISCELLANEOUS.

 

(a)                                 The rights and obligations of the Company under this Award will be transferable to any one or more persons or entities, and all covenants and agreements hereunder will inure to the benefit of, and be enforceable by the Company’s successors and assigns.

 

(b)                                 You agree upon request to execute any further documents or instruments necessary or desirable in the sole determination of the Company to carry out the purposes or intent of your Award.

 

(c)                                  You acknowledge and agree that you have reviewed your Award in its entirety, have had an opportunity to obtain the advice of counsel prior to executing and accepting your Award, and fully understand all provisions of your Award.

 

(d)                                 This Agreement will be subject to all applicable laws, rules, and regulations, and to such approvals by any governmental agencies or national securities exchanges as may be required.

 

(e)                                  All obligations of the Company under the Plan and this Agreement will be binding on any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation, or otherwise, of all or substantially all of the business and/or assets of the Company.

 

*                                         *                                         *

 

This Agreement will be deemed to be signed by you upon the signing by you of the Grant Notice to which it is attached.

 



 

Appendix A

 

The provisions set forth on this Appendix A shall apply to the extent the Award is a Non-Exempt Award and shall supersede any provisions to the contrary set forth in the Plan or in any other section of the Agreement to which this Appendix A is attached.

 

1.                                      TREATMENT OF NON-EXEMPT AWARDS UPON TERMINATION OF SERVICE.  The provisions of this Section 1 are intended to apply to the extent your Award is a Non-Exempt Award because of the terms of a severance arrangement or other agreement between you and the Company, if any, that provide for acceleration of vesting of your Award and issuance of the shares in respect of the Award upon your termination of employment or Separation from Service and such severance benefit does not satisfy the requirements for an exemption from application of Section 409A provided under Treasury Regulations Section 1.409A-1(b)(4) or 1.409A-1(b)(9) (“Non-Exempt Severance Arrangement”).  To the extent your Award is a Non-Exempt Award due to application of a Non-Exempt Severance Arrangement, the following provisions in this Section 1 of Appendix A shall supersede anything to the contrary in Section 6(a) or (b) of the Agreement.

 

(a)                                 If your Award vests in the ordinary course during your Continuous Service in accordance with the vesting schedule set forth in the Grant Notice, without accelerating vesting under the terms of a Non-Exempt Severance Arrangement, in no event shall the shares be issued in respect of your Award any later than the later of: (i) December 31st of the calendar year that includes the applicable vesting date and (ii) the 60th day that follows the applicable vesting date.

 

(b)                                 If vesting of your Award accelerates under the terms of a Non-Exempt Severance Arrangement in connection with your Separation from Service, and such vesting acceleration provisions  were in effect as of the date of grant of your Award and, therefore, are part of the terms of your Award as of the date of grant, then the shares shall be earlier issued in respect of your Award upon your Separation from Service in accordance with the terms of the Non-Exempt Severance Arrangement, but in no event later than the 60th day that follows the date of your Separation from Service.  However, if at the time the shares would otherwise be issued you are subject to the distribution limitations contained in Section 409A applicable to “specified employees,” as defined in Section 409A(a)(2)(B)(i) of the Code, such shares shall not be issued before the date that is six (6) months following the date of your Separation from Service, or, if earlier, the date of your death that occurs within such six month period.

 

(c)                                  If vesting of your Award accelerates under the terms of a Non-Exempt Severance Arrangement in connection with your Separation from Service, and such vesting acceleration provisions were not in effect as of the date of grant of the Award and, therefore, are not a part of the terms of your Award on the date of grant, then such acceleration of vesting of

 



 

your Award shall not accelerate the issuance date of the shares, but the shares shall instead be issued on the same schedule as set forth in the Grant Notice as if they had vested in the ordinary course during your Continuous Service, notwithstanding the vesting acceleration of the Award.  Such issuance schedule is intended to satisfy the requirements of payment on a specified date or pursuant to a fixed schedule, as provided under Treasury Regulations Section 1.409A-3(a)(4).

 

2.                                      TREATMENT OF NON-EXEMPT AWARDS UPON A CORPORATE TRANSACTION FOR EMPLOYEES AND CONSULTANTS WHO ARE NOT DIRECTORS.  The provisions in this Section 2 shall apply and shall supersede anything to the contrary that may be set forth in the Plan, Grant Notice or in any section of the Agreement with respect to the permitted treatment of your Non-Exempt Award in connection with a Corporate Transaction if you were either an Employee or Consultant upon the applicable date of grant of your Non-Exempt Award.

 

(a)                                 Vested Non-Exempt Awards:  To the extent your Non-Exempt Award has vested in accordance with its terms upon or prior to the date of a Corporate Transaction (such portion of your Non-Exempt Award is a “Vested Non-Exempt Award”), then the following provisions shall apply.

 

(i)                                    If the Corporate Transaction is also a change in the ownership or effective control of the Company, or in the ownership of a substantial portion of the Company’s assets, as described in Section 409A(a)(2)(A)(v) of the Code and Treasury Regulations Section 1.409A-3(i)(5) (a “409A Change of Control”), then the surviving or acquiring corporation (or its parent company) (the “Acquiring Entity”) may not assume, continue or substitute your Vested Non-Exempt Award.  Upon the 409A Change of Control the settlement of your Vested Non-Exempt Award shall automatically be accelerated and the shares shall be immediately issued in respect of your Vested Non-Exempt Award. Alternatively, the Company may instead provide that you shall receive a cash settlement equal to the Fair Market Value of the shares that would otherwise be issued to you upon the 409A Change of Control.

 

(ii)                                If the Corporate Transaction is not also a 409A Change of Control, then the Acquiring Entity must either assume, continue or substitute your Vested Non-Exempt Award.  The shares to be issued in respect of your Vested Non-Exempt Award shall be issued to you by the Acquiring Entity on the same schedule that the shares would have been issued to you if the Corporate Transaction had not occurred.  In the Acquiring Entity’s discretion, in lieu of an issuance of shares, the Acquiring Entity may instead substitute a cash payment on each applicable issuance date, equal to the Fair Market Value of the shares that would otherwise be issued to you on such issuance dates, with the determination of the Fair Market Value of the shares made on the date of the Corporate Transaction.

 

(b)                                 Unvested Non-Exempt Awards.  To the extent your Non-Exempt Award has not vested in accordance with its terms upon or prior to the date of any Corporate Transaction, (such portion of your Non-Exempt Award is an “Unvested Non-Exempt Award”), then the following provisions shall apply.

 



 

(i)                                    If the Acquiring Entity shall not assume, substitute or continue your Unvested Non-Exempt Award, then such Award shall automatically terminate and be forfeited upon the Corporate Transaction with no consideration payable to you in respect of your forfeited Unvested Non-Exempt Award.  Notwithstanding the foregoing, to the extent permitted and in compliance with the requirements of Section 409A, the Company may in its discretion determine to elect to accelerate the vesting and settlement of the Unvested Non-Exempt Award upon the Corporate Transaction, or instead substitute a cash payment equal to the Fair Market Value of such shares that would otherwise be issued to you, as further provided in Section 4(b) below.  In the absence of such discretionary election by the Company, your Unvested Non-Exempt Award shall be forfeited without payment of any consideration to you if the Acquiring Entity shall not assume, substitute or continue your Unvested Non-Exempt Award in connection with the Corporate Transaction.

 

(ii)                                The foregoing treatment shall apply with respect to all Unvested Non-Exempt Awards upon any Corporate Transaction, and regardless of whether or not such Corporate Transaction is also a 409A Change of Control.

 

3.                                      TREATMENT OF NON-EXEMPT AWARDS UPON A CORPORATE TRANSACTION FOR NON-EMPLOYEE DIRECTORS.  The provisions in this Section 3 shall apply and shall supersede anything to the contrary that may be set forth in the Plan, Grant Notice or in any section of the Agreement with respect to the permitted treatment of your Non-Exempt Award in connection with a Corporate Transaction if you were a Director but not an Employee upon the applicable date of grant of your Non-Exempt Award.

 

(a)                                 If the Corporate Transaction is also a 409A Change of Control, then the Acquiring Entity may not assume, continue or substitute your Non-Exempt Award.  Upon the 409A Change of Control the vesting and settlement of your Non-Exempt Award shall automatically be accelerated and the shares shall be immediately issued to you in respect of the Non-Exempt Award.

 

(b)                                 If the Corporate Transaction is not also a 409A Change of Control, then the Acquiring Entity must either assume, continue or substitute your Non-Exempt Award.  Unless otherwise determined by the Board, your Non-Exempt Award shall not vest upon the Corporate Transaction. The shares to be issued in respect of your Non-Exempt Award shall be issued to you by the Acquiring Entity on the same schedule that the shares would have been issued to you if the Corporate Transaction had not occurred.

 

4.                                      GENERAL SUPERSEDING PROVISIONS.  The provisions in this Section 4 shall apply and supersede anything to the contrary that may be set forth in the Plan, the Grant Notice or in any other section of the Agreement with respect to the permitted treatment of your Non-Exempt Award:

 



 

(a)                                 Any exercise by the Board of discretion to accelerate the vesting of your Non-Exempt Award shall not result in any acceleration of the scheduled issuance dates for the shares in respect of the Non-Exempt Award unless earlier issuance of the shares upon the applicable vesting dates would be in compliance with the requirements of Section 409A.

 

(b)                                 The Company explicitly reserves the right to earlier settle your Non-Exempt Award to the extent permitted and in compliance with the requirements of Section 409A, including pursuant to any of the exemptions available in Treasury Regulations Section 1.409A-3(j)(4)(ix).

 

(c)                                  To the extent the terms of your Non-Exempt Award provide that it shall be settled upon a Change in Control or Corporate Transaction, to the extent it is required for compliance with the requirements of Section 409A, the Change in Control or Corporate Transaction event triggering settlement must also constitute a 409A Change of Control. To the extent the terms of your Non-Exempt Award provides that it shall be settled upon a termination of your employment or termination of Continuous Service, to the extent it is required for compliance with the requirements of Section 409A, the termination event triggering settlement must also constitute a Separation from Service.  However, if at the time the shares would otherwise be issued to you in connection with your “separation from service” you are subject to the distribution limitations contained in Section 409A applicable to “specified employees,” as defined in Section 409A(a)(2)(B)(i) of the Code, such shares shall not be issued before the date that is six (6) months following the date of your Separation from Service, or, if earlier, the date of your death that occurs within such six month period.

 

5.                                      SECTION 409A COMPLIANCE.  The provisions in this Agreement for delivery of the shares in respect of the Non-Exempt Award are intended to comply with the requirements of Section 409A so that the delivery of the shares to you in respect of your Non-Exempt Award shall not trigger the additional tax imposed under Section 409A, and any ambiguities herein shall be so interpreted.

 


EX-31.1 7 a12-13878_1ex31d1.htm EX-31.1

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

 

I, Pedro Lichtinger, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Optimer Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)             designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)             designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)              evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)             disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)             all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)             any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 3, 2012

 

/s/ Pedro Lichtinger

 

Pedro Lichtinger

 

President and Chief Executive Officer

 

(Principal Executive Officer)

 

 


EX-31.2 8 a12-13878_1ex31d2.htm EX-31.2

Exhibit 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

 

I, Stephen W. Webster, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Optimer Pharmaceuticals, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a)             designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)             designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)              evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)             disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a)             all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)             any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 3, 2012

 

/s/ Stephen W. Webster

 

Stephen W. Webster

 

Chief Financial Officer

 

(Principal Financial and Accounting Officer)

 

 


EX-32 9 a12-13878_1ex32.htm EX-32

Exhibit 32

 

CERTIFICATION

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. § 1350, as adopted), Pedro Lichtinger, the Chief Executive Officer of Optimer Pharmaceuticals, Inc. (the “Company”), and Stephen W. Webster, the Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

 

1.         The Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, to which this Certification is attached as Exhibit 32 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and

 

2.         The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Quarterly Report and results of operations of the Company for the period covered by the Quarterly Report.

 

Dated: August 3, 2012

 

/s/ Pedro Lichtinger

 

/s/ Stephen W. Webster

Pedro Lichtinger

 

Stephen W. Webster

Chief Executive Officer

 

Chief Financial Officer

(Principal Executive Officer)

 

(Principal Financial and Accounting Officer)

 

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

 


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Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized Additional shares of common stock reserved for issuance Share Based Compensation Arrangement by Share Based Payment Award Expiration Period Expiration period The period of time in which the equity-based award expires. Principal Ownership Percentage Threshold Threshold for principal owner (as a percent) Represents the threshold percentage for principal ownership. Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period Vesting period Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent Purchase price of common stock (as a percent) Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] Assumptions used to compute stock-based compensation expense Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Minimum Risk-free interest rate, minimum (as a percent) Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Maximum Risk-free interest rate, maximum (as a percent) Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate Risk-free interest rate (as a percent) Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate Dividend yield (as a percent) Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term Expected life of options Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate, Minimum Volatility, minimum (as a percent) Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate, Maximum Volatility, maximum (as a percent) Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate Volatility (as a percent) Research and Development Expense [Member] Research and development Selling and Marketing Expense [Member] Marketing General and Administrative Expense [Member] General and administrative Selling, General and Administrative Expenses [Member] Selling, general and administrative Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] Stock-based compensation expense Allocated Share-based Compensation Expense Stock-based compensation expense (in dollars) Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized Unrecognized compensation expense related to unvested awards (in dollars) Schedule of Collaborative Arrangements and Non-collaborative Arrangement Transactions [Table Text Block] Summary of activity related to our collaboration and the location in the consolidated statements Cubist Pharmaceuticals Inc [Member] Cubist Represents the information pertaining to Cubist Pharmaceuticals, Inc. Astellas Pharma Europe Ltd [Member] APEL Represents the information pertaining to Astellas Pharma Europe Ltd. Par Pharmaceuticals Inc [Member] Par Represents the information pertaining to Par Pharmaceuticals, Inc. Biocon Limited [Member] Biocon Represents the information pertaining to Biocon Limited. Patheon Inc [Member] Patheon Represents the information pertaining to Patheon Inc. Cempra Pharmaceuticals Inc [Member] Cempra Represents the information pertaining to Cempra Pharmaceuticals, Inc. Optimer Biotechnology Inc [Member] OBI Represents the information pertaining to Optimer Biotechnology, Inc. Memorial Sloan Kettering Cancer Center [Member] MSKCC Represents the information pertaining to Memorial Sloan-Kettering Cancer Center. Scripps Research Institute [Member] TSRI Represents the information pertaining to Scripps Research Institute. Achievement of Milestone [Domain] Different categories of achievement of milestones. Regulatory and Commercial Milestones [Member] Regulatory and commercial milestones Represents information pertaining to certain regulatory and commercial events on the basis of which certain milestones are achieved. Launch of Product in Major Countries or EMA Approval Milestones [Member] Launch of product in major countries or EMA approval milestones Represents information pertaining to launch of product in major countries or EMA approval milestones on the basis of which certain milestones are achieved. Launch of Product in Own Territory Milestones [Member] Commercial launch of DIFICLIR in the APEL territories milestones Represents information pertaining to launch of product in own territory milestones on the basis of which certain milestones are achieved. Commercial Milestones [Member] Commercial milestones Represents information pertaining to certain commercial events on the basis of which certain milestones are achieved. EMA Approval Milestones [Member] EMA approval milestones Represents information pertaining to EMA approval milestones on the basis of which certain milestones are achieved. Sublicense Revenue Milestones [Member] Sublicense revenue milestones Represents information pertaining to certain sublicense revenue on the basis of which certain milestones are achieved. Regulatory Milestones [Member] Regulatory approval in ASEAN countries milestones Represents information pertaining to certain regulatory approval in ASEAN countries on the basis of which certain milestones are achieved. Phase 3 Clinical Studies Commencement Milestones [Member] Commencement of Phase 3 clinical studies milestones Represents information pertaining to the commencement of Phase 3 clinical studies on the basis of which certain milestones are achieved. Filing of First NDA Milestones [Member] Filing of the first NDA milestones Represents information pertaining to the filing of the first NDA on the basis of which certain milestones are achieved. Domestic Marketing Approval Milestones [Member] Marketing approval in the United States milestones Represents information pertaining to the domestic marketing approval on the basis of which certain milestones are achieved. Foreign Marketing Approval Milestones [Member] Marketing approval in each and any of Japan and certain European countries milestones Represents information pertaining to the foreign marketing approval on the basis of which certain milestones are achieved. North America and Israel [Member] North America and Israel Represents details pertaining to North America and Israel. Other Countries [Member] Rest of the world Represents details pertaining to rest of the world. Achievement of Milestone [Axis] Information by categories of milestones achieved. All Countries [Axis] Represents geopolitical areas recognized by governments of the world as a country. Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] Revenue and Other Collaborative Agreements Collaborative Arrangement Notice Period for Termination of Agreement Notice period for termination of agreements prior to expiration Represents the notice period for termination of agreements prior to expiration under the collaborative arrangement. Collaborative Arrangement Initial Term Initial term Represents the initial term of the collaborative arrangement. Collaborative Arrangement Quarterly Fee Quarterly fee in exchange of co-promotion activities and personnel commitments Represents the amount of quarterly fee under the collaborative arrangement. Collaborative Arrangement Fee Per Year Fee per year Represents the amount of fee per year under the collaborative arrangement. Collaborative Arrangement Additional Milestone Payment after First Commercial Sale in Year One Additional payments after first commercial sale in year one Represents additional payments after first commercial sale payable under the collaborative arrangement. Collaborative Arrangement Additional Milestone Payment on after First Commercial Sale Achievement of Sales and Gross Profits Level in Year Two Additional payments in the second year after first commercial sale if mutually agreed upon annual sales and gross profits targets are achieved Represents additional payments in the second year after first commercial sale if mutually agreed upon annual sales and gross profits targets are achieved under the collaborative arrangement. Collaborative Arrangement Renewal Term Renewal term Represents the period by which the collaborative arrangement may be consecutively renewed, after the initial agreement expires, by the mutual agreement of the parties. Revenue Recognition Milestone Method Gross Margin Net of Amortization of Upfront Fee Gross margin cost-sharing, net of amortization of up-front payments Represents the amount of gross margin, net of amortization of up-front payments during the period for the milestone or milestones under the collaborative arrangement. Collaborative Arrangement Cost Sharing Development Expense Payments Received Development expense cost-sharing payments received Represents the amount of development expense cost-sharing payments received during the period under the collaborative arrangement. Collaborative Arrangement Cost Sharing Sales Force Expenses Marketing Expenses and Other Commercial or Operational Support Payments Received Cost-sharing payments received for shares sales force expenses, marketing expenses and other commercial or operational support Represents the amount of cost-sharing payments received for shares sales force expenses, marketing expenses and other commercial or operational support under the collaborative arrangement. Collaborative Arrangement Period after Launch of Product in Major Countries or EMA Approval for Additional Cash Payments Receivables Period subsequent to the earlier to occur of launch in two major countries or six months after EMA approval Represents the period subsequent to the earlier to occur of launch in two major countries or six months after EMA approval and which will entitle the receipt of additional cash payments due under the collaborative arrangement. Collaborative Arrangement Launch of Product in Number of Major Countries for Receipt of Additional Cash Payments Number of countries in which launch of product will entitle receipt of additional cash payments Represents the number of countries in which the launch of product will entitle receipt of additional cash payments under the collaborative arrangement. Collaborative Arrangement Period of EMA Approval for Receipt of Additional Cash Payments Period after EMA approval, which will entitle receipt of additional cash payments Represents the period after EMA approval, which will entitle the receipt of additional cash payments under the collaborative arrangement. Collaborative Arrangement Account Receivable Receivable recorded Represents the amount of receivable recorded by the entity under the collaborative arrangement. Collaborative Arrangement Percentage of Royalties at Par on Net Sales of Products Percentage of royalties at par on net sales of products Represents the percentage of royalties at par on net sales of products under the collaborative arrangement. Collaborative Arrangement Milestone Payment Milestone payments Represents the milestone payment by the entity under the collaborative arrangement. Collaborative Arrangement Percentage of Royalties at Par on Net Revenues Percentage of royalties at par on net revenues Represents the percentage of royalties at par on net revenues under the collaborative arrangement. Collaborative Arrangement Royalty Payment Period Royalty payment period Represents the period for which royalty is payable under the collaborative arrangement. Long Term Purchase Commitment Amount Price Recovery Discounted Prices Recovery amount in the form of discounted prices Represents the recovery amount in the form of discounted prices under the supply agreement. Long Term Purchase Commitment Period after which Notice Can be Given Period after which notice can be given Represents the period after which notice can be given under the supply agreement. Collaborative Arrangement Termination of Agreement Number of Quarters for which No Firm Orders Delivered Termination of agreement, number of quarters for which no firm orders are delivered Represents the number of quarters for which if no firm orders are delivered, which would entitle to terminate the collaborative agreement. Collaborative Arrangement Termination of Agreement Number of Consecutive Calendar Quarters for which Firm Order to be Delivered Number of consecutive calendar quarters for which firm orders are to be delivered Represents the number of consecutive calendar quarters for which firm orders are to be delivered under the collaborative arrangement. Collaborative Arrangement Potential Milestone Payments to be Received Aggregate Potential milestone payments the company may receive Represents the potential milestone payments to be received under the collaborative arrangement. Collaborative Arrangement Number of Products for which Milestone Payments are Receivable Number of products for which milestone payments are receivable Represents the number of products for which milestone payments are receivable under the collaborative arrangement. Collaborative Arrangement License Fee Partial Consideration Paid in Stock License fee partial consideration paid in stock (in shares) Represents the license fee partial consideration paid in stock under the collaborative arrangement. Collaborative Arrangement Number of Non Core Programs for which Funding Available Number of early-stage, non-core programs for which funding is available for the development Represents the number of non-core programs for which funding is available under the collaborative arrangement. Sale of Stock Percentage of Ownership Sold Percentage of equity interest sold Represents the percentage of subsidiary's equity interest sold by the entity during the reporting period. Collaborative Arrangement Number of License Agreements Number of separate license agreements Represents the number of license agreements entered into by the entity under the collaborative arrangement. Collaborative Arrangement Number of Patent Rights Number of exclusive, worldwide patent rights Represents the number of exclusive, worldwide patent rights under the collaborative arrangement. Collaborative Arrangement Number of Agreements Number of agreements Represents the number of agreements entered into by the entity under the collaborative arrangement. Collaborative Arrangement License Fee Partial Consideration Paid in Stock Value Deemed aggregate fair market value of shares of common stock issued Represents the fair value of license fee partial consideration paid in stock under the collaborative arrangement. Collaborative Arrangement Number of Agreements Assigned to Subsidiary Number of agreements assigned to subsidiary Represents the number of agreements assigned to subsidiary under the collaborative arrangement. Collaborative Arrangement Number of Agreements Based on Specified Milestones Number of agreements based on successful completion of a Phase 2 trial or its foreign equivalent, the submission of an NDA or its foreign equivalent and government marketing and distribution approval Represents the number of agreements based on specified milestones entered into by the entity under the collaborative arrangement. Research Grants [Abstract] Revenues from Research Grants Research Grants Number of Active Grants Number of active grants Represents the number of active grants as of the balance sheet date. Research Grants Initial Term Initial term Represents the initial term of the grants. Research Grants Number of Patients Safety Report for which Award Used Number of patients safety report for which award was used Represents the number of patients safety reports for which award was used by the entity. Revenue Recognition, Milestone Method, Revenue Recognized Milestone revenue and amortization of up-front payment Payments for Royalties Royalties paid Royalty Expense Royalty recorded Long-term Purchase Commitment, Amount Amount paid for certain equipment purchases and manufacturing scale-up activities Payments to Acquire Additional Interest in Subsidiaries Shares purchased Grants Receivable Amount of grants awarded Revenue from Grants Revenue recognized from research grants Deferred Revenue Revenue remaining to be recognized under the grant Other comprehensive income (loss): Other Comprehensive Income (Loss), Net of Tax, Portion Attributable to Parent [Abstract] Change in foreign currency translation adjustment Other Comprehensive Income (Loss), Foreign Currency Transaction and Translation Adjustment, Net of Tax, Portion Attributable to Parent Unrealized gains (losses) on securities: Other Comprehensive Income (Loss), Available-for-sale Securities Adjustment, Net of Tax, Portion Attributable to Parent [Abstract] Net unrealized gains (losses) on securities Other Comprehensive Income (Loss), Available-for-sale Securities Adjustment, Net of Tax, Portion Attributable to Parent Total comprehensive loss Comprehensive Income (Loss), Net of Tax, Attributable to Parent Interim Financial Information Business Description and Basis of Presentation [Text Block] Cash and Cash Equivalents [Line Items] Cash, Cash Equivalents and Investments Cash and Cash Equivalents, Fair Value Disclosure Cash equivalents Performance Shares [Member] Performance-Based Restricted Stock Units Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized, Period for Recognition Weighted-average period for recognition of unrecognized compensation expense Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Gain (Loss) Included in Earnings Realized net income Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Gain (Loss) Included in Other Comprehensive Income (Loss) Unrealized in accumulated other comprehensive income Schedule of Collaborative Arrangements and Non-collaborative Arrangement Transactions [Table] All Countries [Domain] Range [Axis] Range [Domain] Schedule of Cash and Cash Equivalents [Table] Schedule of Share-based Compensation Arrangements by Share-based Payment Award [Table] Plan Name [Axis] Plan Name [Domain] Award Type [Axis] Award Type [Domain] Title of Individual [Axis] Title of Individual with Relationship to Entity [Domain] Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table] Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs, by Report Line [Axis] Employee Service Share-based Compensation, Allocation of Recognized Period Costs, Report Line [Domain] Summary of Significant Accounting Policies Organization, Consolidation and Presentation of Financial Statements Disclosure and Significant Accounting Policies [Text Block] Summary of Significant Accounting Policies Reclassifications Reclassification, Policy [Policy Text Block] Allowance for Prompt Pay Allowance for prompt pay A payment discount provided to customers. The company accrues an allowance for the prompt payment discount based on the gross amount of each eligible invoice, at the time of sale. The accrual is adjusted quarterly to reflect actual earned discounts. Due in one year to two years Amount of available-for-sale debt securities at fair value maturing in the second rolling twelve months following the latest balance sheet presented. Available For Sale Securities Debt Maturities Rolling Year Two Fair Value Available For Sale Securities Debt Maturities Rolling Year Two Amortized Cost Basis Due in one year to two years Amount of available-for-sale debt securities at cost, net of adjustments, maturing in the second rolling twelve months following the latest balance sheet presented. Adjustments include, but are not limited to, accretion, amortization, collection of cash, previous other-than-temporary impairments (OTTI) recognized in earnings (less any cumulative-effect adjustments, as defined) and fair value hedge accounting adjustments. Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] Short-term Investments Upfront fee Proceeds from Collaborators Other than temporary unrealized loss recognized Other than Temporary Impairment Losses, Investments, Portion Recognized in Earnings, Net, Available-for-sale Securities Change in unrealized gains (losses) included in net income related to assets still held Fair Value, Assets Measured on Recurring Basis, Change in Unrealized Gain (Loss) Included in Investment Income Incremental Common Shares Attributable to Share Based Payment, Arrangements Common Share Equivalents Additional shares included in the calculation of diluted EPS as a result of the potentially dilutive effect of common share equivalents issued under the share based payment arrangements using the treasury stock method. Stock award common share equivalents (in shares) Investment in Cempra Equity Securities [Member] Equity Method Investments Equity investment in OBI Investment in OBI Marketing and Advertising Expense Co-promotion expenses with Cubist Deconsolidation, Gain (Loss), Amount Gain on de-consolidation of OBI Gain on de-consolidation of OBI Gain attributed to the deconsolidation of OBI Income (Loss) from Equity Method Investments Equity in net loss of OBI Equity in net loss of OBI Cash Divested from Deconsolidation Reduction of cash due to deconsolidation of OBI Reduction of cash due to de-consolidation of OBI Proceeds from Sale of Equity Method Investments Proceeds from sale of OBI common stock Equity Method Investments, Policy [Policy Text Block] Investment in OBI Foreign Currency Transactions and Translations Policy [Policy Text Block] Foreign Currency Translation Number Of Subsidiaries Owned Number of subsidiaries owned Represents the number of wholly-owned subsidiaries of the entity with operational activities. Schedule of Inventory, Current [Table Text Block] Schedule of net inventory Inventory, Raw Materials, Gross Raw materials Inventory, Work in Process, Gross Work in process Inventory, Finished Goods, Gross Finished goods Inventory, Gross Inventory, gross Inventory Valuation Reserves Reserves Auction Rate Preferred Securities [Member] Auction rate preferred securities Number of Investments with Immaterial Amount Number of investments with an immaterial Represents the number of investments with an immaterial amount. Available-for-sale Securities, Continuous Unrealized Loss Position, Aggregate Losses Net unrealized loss position Investment Owned, at Fair Value Fair value of investment Sale of Stock, Price Per Share Sale price of stock per share (in dollars per share) Incremental Common Shares Attributable to Share Based Payment Arrangements Restricted Stock Units Restricted stock units (in shares) Additional shares included in the calculation of diluted EPS as a result of the potentially dilutive effect of restricted stock units issued under the share-based payment arrangements using the treasury stock method. Incremental Common Shares Attributable to Share Based Payment Arrangements Employee Stock Purchase Plan Shares Employee stock purchase plan (in shares) Additional shares included in the calculation of diluted EPS as a result of the potentially dilutive effect of employee stock purchase plan shares issued under the share-based payment arrangements using the treasury stock method. Equity Plan 2012 [Member] 2012 Plan Represents information pertaining to the 2012 Equity Plan. Chief Executive Officer [Member] Pedro Lichtinger Chief Executive officer Director [Member] Michael Chang Performance Based Stock Options and Performance Shares [Member] Performance-Based Stock Options and Performance-Based Restricted Stock Units Represents information pertaining to performance-based stock options and performance-based restricted stock units. Performance Based Stock Options [Member] Performance-Based Stock Options Represents information pertaining to performance-based stock options. Number of Performance Criteria Met Number of performance criteria met Represents the number of performance criterias met. Vesting Rights Percentage on First Anniversary of Achievement of Applicable Goal Portion of award vesting on the one-year anniversary of the achievement of the applicable goal (as a percent) Description of award terms as to how many shares or portion of an award are no longer contingent on the one-year anniversary of the achievement of the applicable goal, thereby giving the employee the legal right to convert the award to shares, shown as a percentage. Share Based Compensation Arrangement by Share Based Payment Award Period after which Shares Vest After Achievement of Applicable Goal Period after which shares vest after achievement of the applicable goal Represents the period after which shares vest after achievement of the applicable goal. Share Based Compensation Arrangement by Share Based Payment Award Number of Monthly Installments in which Shares will be Vested Number of monthly installments in which shares will be vested Represents the number of monthly installments in which remaining shares will be vested. Share Based Compensation Arrangement by Share Based Payment Award Options Vested in Period Options vested (in shares) The number of shares under options that were vested during the reporting period. Specialised Therapeutics Australia Pty Ltd [Member] STA Represents information pertaining to Specialised Therapeutics Australia Pty. Ltd. Achievement of Cumulative Net Sales Targets [Member] Achievement of cumulative net sales targets Represents information pertaining to certain cumulative net sales targets on the basis of which certain milestones are achieved. EMA Approval Milestones and Commercial Launch of Product in APEL Territories [Member] Attaining EMA approval and the commercial launch of DIFICLIR in the APEL territory Represents information related to attaining EMA approval and the commercial launch of DIFICLIR in the APEL territory on the basis of which certain milestones are achieved. Enrollment of Patients in Phase two Clinical Trial [Member] Enrollment of patients in a phase 2 clinical trial Represents information related to enrollment of patients in a phase 2 clinical trial on the basis of which certain milestones are achieved. USDIFICID Net Sales [Member] U.S. DIFICID net sales Represents information related to U.S. DIFICID net sales, on the basis of which certain milestones are achieved. Collaborative Arrangement Potential Milestone Payments Receivable Contingent payments which the entity is entitled to receive Represents the contingent payments which the entity is entitled to receive under the collaborative arrangement. Collaborative Arrangement Additional Payment Expense Recorded Amount accrued based on the level of sale target achieved Represents the amount of expenses recorded from service fees, target bonus and a portion of gross profit. Collaborative Arrangement Additional Milestone Payment after first Commercial Sale in Year One Expense Recognized Bonus accrued attributable to payments after first commercial sale in year one Represents the amount of bonus accrued during the period from milestone payment made after first commercial sale in year one, under the terms of license and collaboration agreements. Collaborative Arrangement Co Promotion Agreement Expenses Accrued [Abstract] Accrued expenses related to the company's co-promotion agreement Collaborative Arrangement Co Promotion Agreement Expenses Attributable to Target Bonus and Portion of Gross Profit Payments Target bonus and portion of gross profit payments Represents the expenses accrued related to entity's co-promotion agreement attributable to target bonus and portion of gross profit payments. Collaborative Arrangement Co Promotion Agreement Expenses Attributable to Service Fees Service fees Represents the expenses accrued related to the entity's co-promotion agreement attributable to service fees. Collaborative Arrangement Co Promotion Agreement Expenses Accrued Total Represents the expenses accrued related to the entity's co-promotion agreement. Collaborative Arrangement Potential Milestone Payments Received Cash payment to the entity Represents the milestone payment received by the entity under the collaborative arrangement. Collaberative Arrangement Expected Royalties Payable Expected royalties payable Represents the expected royalties payable under the collaborative arrangement. Collaborative Arrangement Milestone Payments Receivable Milestone payments receivable Represents the milestone payments receivable by the entity under the collaborative arrangement. Collaborative Arrangement Milestone Payment Revenue Recognized Revenue recognized from milestone payments received Represents the revenue recognized from milestone payments received during the period under the terms of license and collaboration agreements. Number of Affiliates Recieving Offer to Obtain Exclusive Royalty Bearing License Number of affiliates receiving any offer to obtain an exclusive, royalty-bearing license for the entity to exercise right of first refusal Represents the number of affiliates receiving any offer to obtain an exclusive, royalty-bearing license for the entity to exercise right of first refusal under the executed letter of agreement. Letter of Agreement Expiration Term Expiration term of the executed letter of agreement Represents the expiration term of the executed letter of agreement. Investment in OBI Investment in OBI Available-for-sale Securities [Abstract] Available-for-sale Securities Collaboration Milestones and Royalties Revenues This element represents collaboration, milestone and royalties revenues earned during the reporting period. Contract revenue Other Other Revenue, Net Comprehensive income (loss) Comprehensive Income (Loss), Net of Tax, Including Portion Attributable to Noncontrolling Interest Net Product Sales [Policy Text Block] Net Product Sales Disclosure of the entity's accounting policy for net product sales. Contract Revenue [Policy Text Block] Contract Revenue Disclosure of the entity's accounting policy for contract revenue. Sales Revenue, Goods, Net [Abstract] Net Product Sales Cash and Cash Equivalents and Investments [Abstract] Cash, Cash Equivalents and Investments Common Stock, Shares Purchased under Equity Method Investments Shares purchased at cost Represents the shares purchased under equity method investments. Common Stock, Value of Shares Purchased under Equity Method Investments Value of shares purchased Represents the value of shares purchased under equity method investments. Equity Method Investment, Ownership Percentage Ownership interest (as a percent) Upfront payment from APEL Upfront Payment from Astellas Pharma Europe Ltd [Member] Represents information related to upfront payment from Astellas Pharma Europe Ltd , on the basis of which certain milestones are achieved. Schedule of Collaborative Arrangements Accrued Expenses Related to Co Promotion Agreement [Table Text Block] Tabular disclosure of accrued expenses related to co-promotion agreement under collaborative arrangements. Summary of accrued expenses related to co-promotion agreement with Cubist Equity Method Investments and Joint Ventures Disclosure [Text Block] Investment in OBI Unrealized gain on available-for-sale securities Available-for-sale Securities, Change in Net Unrealized Holding Gain (Loss), Net of Tax Purchase of OBI common stock Payments to Acquire Equity Method Investments Deferred Revenue, Current Deferred revenue Cost of Collaboration Milestones and Royalties Revenues Cost of contract revenue This element represents costs and expenses assoicated with collaboration, milestone and royalties revenues earned during the reporting period. Increase (Decrease) in Other Receivables Accounts receivable, other Collaborative Arrangement Potential Milestone Payments to be Paid Represents the potential milestone payments to be paid under the collaborative arrangement. Aggregate Potential milestone payments the company may pay Segment Reporting, Policy [Policy Text Block] Segment Reporting Segment Reporting [Abstract] Segment Reporting Number of operating segment Number of Operating Segments Potentially dilutive shares of common stock not included in the diluted net income per share calculations Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount Collaborative Arrangement Up Front Fee Recognized Up-front fees recognized Represents the amount of upfront fees recognized during the period under the terms of the collaborative and licensing agreement. Amount Recieved Pursuant To Collaboration Agreement Amount received pursuant to collaboration agreement Amount of one-time payment received pursuant to collaboration agreement. 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Short-term Investments (Details) (USD $)
6 Months Ended
Jun. 30, 2012
item
Dec. 31, 2011
Determination of estimated fair value of the available-for-sale securities based on quoted market prices    
Gross Amortized Cost $ 29,743,040 $ 78,671,277
Gross Unrealized Gains 1,191,749 119,789
Gross Unrealized Losses (15)  
Market Value 30,934,774 78,791,066
Number of investments with an immaterial 1  
Government agencies
   
Determination of estimated fair value of the available-for-sale securities based on quoted market prices    
Gross Amortized Cost 25,727,803 69,241,792
Gross Unrealized Gains 14,497 106,347
Gross Unrealized Losses (15)  
Market Value 25,742,285 69,348,139
Corporate bonds
   
Determination of estimated fair value of the available-for-sale securities based on quoted market prices    
Gross Amortized Cost 4,015,237 9,429,485
Gross Unrealized Gains 1,205 13,442
Market Value 4,016,442 9,442,927
Investment in Cempra
   
Determination of estimated fair value of the available-for-sale securities based on quoted market prices    
Gross Unrealized Gains 1,176,047  
Market Value $ 1,176,047  
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XML 20 R9.htm IDEA: XBRL DOCUMENT v2.4.0.6
Short-term Investments
6 Months Ended
Jun. 30, 2012
Short-term Investments  
Short-term Investments

 

 

4.     Short-term Investments

 

The following is a summary of the Company’s consolidated investment securities, all of which are classified as available-for-sale. Determination of estimated fair value is based upon quoted market prices, pricing vendors or quotes from brokers/dealers as of the dates presented.

 

 

 

June 30, 2012

 

 

 

Gross
Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Market Value

 

Government agencies

 

$

25,727,803

 

$

14,497

 

$

(15

)

$

25,742,285

 

Corporate bonds

 

4,015,237

 

1,205

 

 

4,016,442

 

Investment in Cempra

 

 

1,176,047

 

 

1,176,047

 

 

 

$

29,743,040

 

$

1,191,749

 

$

(15

)

$

30,934,774

 

 

 

 

December 31, 2011

 

 

 

Gross
Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Market Value

 

Government agencies

 

$

69,241,792

 

$

106,347

 

$

 

$

69,348,139

 

Corporate bonds

 

9,429,485

 

13,442

 

 

9,442,927

 

 

 

$

78,671,277

 

$

119,789

 

$

 

78,791,066

 

 

As of June 30, 2012, we had one investment with an immaterial net unrealized loss position.

 

In February 2012, Cempra completed its initial public offering and the Company has determined that its equity in Cempra had readily determinable value at that time and recorded its fair value in the Company’s books. Prior to February 2012, the Company assigned no value to its equity in Cempra.

 

The amortized cost and estimated fair value of securities available-for-sale at June 30, 2012, by contractual maturity, are as follows:

 

 

 

Amortized Cost

 

Estimated Fair Value

 

Due in one year or less

 

$

29,743,040

 

$

29,758,727

 

 

The weighted-average maturity of the Company’s short-term investments as of June 30, 2012 and December 31, 2011 was approximately three months and seven months, respectively.

 

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Stock Based Compensation (Details)
3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 6 Months Ended
Jun. 30, 2012
Stock options
Jun. 30, 2011
Stock options
Jun. 30, 2012
Stock options
Jun. 30, 2011
Stock options
Jun. 30, 2012
Stock options
Minimum
Jun. 30, 2011
Stock options
Minimum
Jun. 30, 2012
Stock options
Minimum
Jun. 30, 2011
Stock options
Minimum
Jun. 30, 2012
Stock options
Maximum
Jun. 30, 2011
Stock options
Maximum
Jun. 30, 2012
Stock options
Maximum
Jun. 30, 2011
Stock options
Maximum
May 28, 2011
Performance-Based Stock Options and Performance-Based Restricted Stock Units
Pedro Lichtinger
item
Feb. 28, 2011
Performance-Based Stock Options and Performance-Based Restricted Stock Units
Pedro Lichtinger
item
Jun. 30, 2012
Performance-Based Stock Options
Pedro Lichtinger
item
May 31, 2010
Performance-Based Stock Options
Pedro Lichtinger
Apr. 30, 2012
Performance-Based Stock Options
Michael Chang
May 31, 2010
Performance-Based Stock Options
Michael Chang
Feb. 29, 2012
Performance-Based Restricted Stock Units
Jun. 30, 2012
Performance-Based Restricted Stock Units
Pedro Lichtinger
item
May 31, 2010
Performance-Based Restricted Stock Units
Pedro Lichtinger
Jun. 30, 2012
ESPP
Jun. 30, 2011
ESPP
Jun. 30, 2012
ESPP
Jun. 30, 2011
ESPP
May 31, 2012
2012 Plan
Stock options
Jun. 30, 2012
2012 Plan
Stock options
May 09, 2012
2012 Plan
Stock options
Jun. 30, 2012
2012 Plan
Stock options
10% or greater stockholder
Jun. 30, 2012
2006 Plan
Stock options
Jun. 30, 2012
2006 Plan
Stock options
10% or greater stockholder
Jun. 30, 2012
1998 Plan
Stock options
Jun. 30, 2012
1998 Plan
Stock options
10% or greater stockholder
Stock Based Compensation                                                                  
Number of shares of common stock that may be issued                               480,000   400,000 250,000   120,000             11,289,455          
Additional shares of common stock reserved for issuance                                                   3,400,000              
Expiration period                                                     10 years   5 years 10 years 5 years 10 years 5 years
Threshold for principal owner (as a percent)                                                         10.00%   10.00%   10.00%
Vesting period                                                     4 years     4 years   4 years  
Number of performance criteria met                         1 1                                      
Portion of award vesting on the one-year anniversary of the achievement of the applicable goal (as a percent)                             25.00%         25.00%                          
Number of monthly installments in which shares will be vested                             36         36                          
Options vested (in shares)                                 248,437                                
Purchase price of common stock (as a percent)                                               85.00%                  
Assumptions used to compute stock-based compensation expense                                                                  
Risk-free interest rate (as a percent) 1.22%                                                                
Risk-free interest rate, minimum (as a percent)   2.10% 1.22% 2.10%                                   0.10% 0.14% 0.09% 0.14%                
Risk-free interest rate, maximum (as a percent)   3.46% 2.17% 3.46%                                   0.13% 0.16% 0.13% 0.18%                
Dividend yield (as a percent) 0.00% 0.00% 0.00% 0.00%                                   0.00% 0.00% 0.00% 0.00%                
Expected life of options         6 years 29 days 6 years 29 days 6 years 29 days 5 years 3 months 7 days 8 years 29 days 9 years 29 days 8 years 3 months 29 days 9 years 5 months 26 days                   6 months 6 months 6 months 6 months                
Volatility, minimum (as a percent) 70.72% 69.13% 69.71% 69.13%                                   37.16% 41.05% 37.16% 40.01%                
Volatility, maximum (as a percent) 72.54% 72.20% 72.54% 73.63%                                   42.75% 44.29% 42.75% 44.29%                
XML 23 R28.htm IDEA: XBRL DOCUMENT v2.4.0.6
Net Income (Loss) Per Share Attributable to Common Stockholders (Details) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Numerator:        
Net income (loss) basic and diluted $ (296,204) $ (24,238,846) $ (11,216,658) $ 20,894,024
Denominator:        
Weighted average number of shares of common stock outstanding - basic 47,234,371 46,479,395 46,978,497 44,581,010
Effect of dilutive securities:        
Restricted stock units (in shares)       43,560
Employee stock purchase plan (in shares)       39,381
Stock award common share equivalents (in shares)       783,310
Weighted average number of shares of common stock outstanding - diluted 47,234,371 46,479,395 46,978,497 45,447,261
Net income (loss) per share        
Net income (loss) per share - basic $ (0.01) $ (0.52) $ (0.24) $ 0.47
Net income (loss) per share - diluted $ (0.01) $ (0.52) $ (0.24) $ 0.46
Potentially dilutive shares of common stock not included in the diluted net income per share calculations 4,800,000 5,800,000 5,000,000 4,100,000
XML 24 R30.htm IDEA: XBRL DOCUMENT v2.4.0.6
Stock Based Compensation (Details 2) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Stock-based compensation expense        
Stock-based compensation expense (in dollars) $ 3,953,366 $ 2,456,996 $ 7,041,063 $ 4,588,229
Unrecognized compensation expense related to unvested awards (in dollars) 28,700,000   28,700,000  
Weighted-average period for recognition of unrecognized compensation expense     3 years 1 month 6 days  
OBI
       
Stock-based compensation expense        
Stock-based compensation expense (in dollars)     17,646 99,451
Research and development
       
Stock-based compensation expense        
Stock-based compensation expense (in dollars) 1,249,360 637,374 2,214,142 1,312,897
Research and development | OBI
       
Stock-based compensation expense        
Stock-based compensation expense (in dollars)     8,465 27,727
Selling, general and administrative
       
Stock-based compensation expense        
Stock-based compensation expense (in dollars) 2,704,006 1,819,622 4,826,921 3,275,332
Selling, general and administrative | OBI
       
Stock-based compensation expense        
Stock-based compensation expense (in dollars)     $ 9,181 $ 71,724
XML 25 R31.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other Collaborative Agreements (Details)
1 Months Ended 3 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 12 Months Ended 1 Months Ended 3 Months Ended 6 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 3 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended
Sep. 30, 2007
Jun. 30, 2011
USD ($)
Jun. 30, 2012
USD ($)
item
Jun. 30, 2011
USD ($)
Jun. 30, 2012
STA
Achievement of cumulative net sales targets
USD ($)
Jun. 30, 2012
STA
Achievement of cumulative net sales targets
Minimum
USD ($)
Jun. 30, 2012
APEL
Commercial launch of DIFICLIR in the APEL territories milestones
EUR (€)
Jun. 30, 2012
APEL
EMA approval milestones
EUR (€)
Dec. 31, 2011
APEL
EMA approval milestones
EUR (€)
Jun. 30, 2012
Par
U.S. DIFICID net sales
USD ($)
Jun. 30, 2012
Par
Upfront payment from APEL
USD ($)
Jun. 30, 2012
Cempra
Enrollment of patients in a phase 2 clinical trial
USD ($)
Apr. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Astellas Japan
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Astellas Japan
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Astellas Japan
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Astellas Japan
Regulatory and commercial milestones
Maximum
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Cubist
USD ($)
Mar. 31, 2011
Collaboration agreement, license agreement, or manufacturing supply agreement
APEL
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
APEL
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
APEL
Commercial milestones
Maximum
EUR (€)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
APEL
EMA approval milestones
EUR (€)
Mar. 31, 2011
Collaboration agreement, license agreement, or manufacturing supply agreement
Par
USD ($)
Jun. 30, 2010
Collaboration agreement, license agreement, or manufacturing supply agreement
Par
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Par
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Par
North America and Israel
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Par
Rest of the world
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Biocon
Dec. 31, 2009
Collaboration agreement, license agreement, or manufacturing supply agreement
Biocon
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Biocon
Maximum
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Patheon
item
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Patheon
Feb. 29, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Cempra
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Cempra
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Cempra
Sublicense revenue milestones
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
Cempra
Regulatory approval in ASEAN countries milestones
USD ($)
item
Jan. 31, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
OBI
item
Oct. 31, 2009
Collaboration agreement, license agreement, or manufacturing supply agreement
OBI
item
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
OBI
Maximum
USD ($)
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
MSKCC
Jul. 31, 1999
Collaboration agreement, license agreement, or manufacturing supply agreement
TSRI
item
Jun. 30, 2012
Collaboration agreement, license agreement, or manufacturing supply agreement
TSRI
USD ($)
item
Oct. 31, 2009
Collaboration agreement, license agreement, or manufacturing supply agreement
TSRI
item
Revenue and Other Collaborative Agreements                                                                                    
Contingent payments which the entity is entitled to receive           $ 1,500,000                                                               $ 10,000,000        
Amount received pursuant to collaboration agreement         500,866                                                                          
Up-front fee                         20,000,000         69,200,000                                                
Additional cash payments receivable                               70,000,000       65,000,000                                            
Notice period for termination of agreements prior to expiration                             180 days       180 days               2 years 6 months           30 days                  
Initial term                                 2 years                   7 years 6 months           10 years                  
Up-front fees recognized                           19,900,000                                                        
Quarterly fee in exchange of co-promotion activities and personnel commitments                                 3,800,000                                                  
Additional payments after first commercial sale in year one                                 5,000,000                                                  
Additional payments in the second year after first commercial sale if mutually agreed upon annual sales and gross profits targets are achieved                                 12,500,000                                                  
Amount accrued based on the level of sale target achieved                                 10,400,000                                                  
Bonus accrued attributable to payments after first commercial sale in year one                                 5,000,000                                                  
Renewal term                                 1 year                           2 years                      
Accrued expenses related to the company's co-promotion agreement                                                                                    
Target bonus and portion of gross profit payments                                 7,880,000                                                  
Service fees                                 2,523,000                                                  
Total                                 10,403,000                                                  
Milestone revenue and amortization of up-front payment                 40,000,000                                                                  
Cash payment to the entity             10,000,000 40,000,000                         50,000,000                                          
Milestone payments                                             5,000,000                       1,000,000              
Percentage of royalties at par on net revenues                                               6.25% 5.00% 1.50%                                
Royalty payment period                                               7 years                                    
Royalties paid                                           4,300,000   1,300,000                                    
Expected royalties payable                   800,000 3,000,000                                                              
Amount paid for certain equipment purchases and manufacturing scale-up activities                                                       2,500,000                            
Recovery amount in the form of discounted prices                                                         1,500,000                          
Period after which notice can be given                                                     5 years                              
Termination of agreement, number of quarters for which no firm orders are delivered                                                           2                        
Number of consecutive calendar quarters for which firm orders are to be delivered                                                           4                        
Aggregate Potential milestone payments the company may receive                                                                   24,500,000                
Aggregate Potential milestone payments the company may pay                                                                                 11,100,000  
Number of affiliates receiving any offer to obtain an exclusive, royalty-bearing license for the entity to exercise right of first refusal                                                                       1            
License fee partial consideration paid in stock (in shares)                                                               125,646             55,383   239,996  
Milestone payments receivable                       1,000,000                                                            
Revenue recognized from milestone payments received                       1,500,000                                                            
Expiration term of the executed letter of agreement                                                                       10 years            
Number of products for which milestone payments are receivable                                                                     2              
Number of early-stage, non-core programs for which funding is available for the development                                                                         2          
Number of separate license agreements                                                                               3    
Number of exclusive, worldwide patent rights                                                                               20    
Number of agreements                                                                                 4  
Deemed aggregate fair market value of shares of common stock issued                                                                                 46,400  
Number of agreements assigned to subsidiary                                                                                   1
Number of agreements based on successful completion of a Phase 2 trial or its foreign equivalent, the submission of an NDA or its foreign equivalent and government marketing and distribution approval                                                                                 2  
Revenues from Research Grants                                                                                    
Number of active grants     1                                                                              
Amount of grants awarded     3,000,000                                                                              
Initial term 3 years                                                                                  
Revenue recognized from research grants   $ 33,294 $ 2,106 $ 144,933                                                                            
XML 26 R8.htm IDEA: XBRL DOCUMENT v2.4.0.6
Fair Value of Financial Instruments
6 Months Ended
Jun. 30, 2012
Fair Value of Financial Instruments  
Fair Value of Financial Instruments

 

 

3.     Fair Value of Financial Instruments

 

The following table summarizes the Company’s financial assets measured at fair value as of June 30, 2012:

 

 

 

Quoted Prices in
Active Markets

(Level 1)

 

Other
Observable
Inputs

(Level 2)

 

Unobservable
Inputs

(Level 3)

 

Total

 

Cash equivalents

 

$

98,131,193

 

$

 

$

 

$

98,131,193

 

Marketable securities

 

 

29,758,727

 

 

29,758,727

 

Auction rate preferred securities

 

 

 

882,000

 

882,000

 

Investment in Cempra

 

1,176,047

 

 

 

1,176,047

 

 

 

$

99,307,240

 

$

29,758,727

 

$

882,000

 

$

129,947,967

 

 

Level 1:           Quoted prices in active markets for identical assets and liabilities; or

 

Level 2:           Quoted prices for identical or similar assets and liabilities in markets that are not active, or observable inputs other than quoted prices in active markets for identical assets and liabilities; or

 

Level 3:  Unobservable inputs.

 

Marketable Securities.  With the exception of auction rate preferred securities, the Company obtains pricing information from quoted market prices, pricing vendors or quotes from brokers/dealers. The Company conducts reviews of its primary pricing vendors to determine whether the inputs used in the vendors’ pricing processes are deemed to be observable. As of June 30, 2012, the marketable securities included government agencies and corporate bonds.

 

The fair value of government-related securities and corporate bonds generally are determined using standard observable inputs, including reported trades, quoted market prices and broker/dealer quotes and thus these securities are in Level 2.

 

The fair value of auction rate preferred securities is estimated by the Company using a discounted cash flow model that incorporates transaction details such as contractual terms, maturity and timing and amount of cash flows and the expected holding period of the ARPS. The Company’s ARPS is classified as a long-term investment on the consolidated balance sheets, as the Company does not believe it could liquidate the security in the near term. The ARPS does not have observable inputs and thus the ARPS is included in Level 3.

 

Investment in Cempra.  Equity securities that have readily determinable fair values not classified as trading securities or as held-to-maturity securities are classified as available-for-sale securities.  Any unrealized gains and losses are reported in other comprehensive income until realized. In February 2012, Cempra became a publicly-traded company and, as such, the Company assigned a value to the shares it received in March 2006 (see Note 8) and recorded the entire amount as an unrealized gain. The Company considers the equity it owns in Cempra as available-for-sale.  For the quarter ended June 30, 2012, the Company recorded an unrealized gain of $227,420 and has included the fair value of $1,176,047 in short-term investments. Cempra’s stock is publicly traded and thus is in Level 1.

 

A reconciliation of the beginning and ending balances of assets measured at fair value on a recurring basis using Level 3 inputs is as follows:

 

 

 

Auction Rate
Preferred
Securities

 

Beginning balance at January 1, 2012

 

$

882,000

 

Total gains and losses:

 

 

 

Realized net income

 

 

Unrealized in accumulated other comprehensive income

 

 

Purchases, sales, issuances and settlements

 

 

Transfers in (out) of Level 3

 

 

Ending balance at June 30, 2012

 

$

882,000

 

Change in unrealized gains (losses) included in net income related to assets still held

 

$

 

 

As of June 30, 2012, the Company held one ARPS valued at $882,000 with a perpetual maturity date that resets every 28 days. Although as of June 30, 2012 this ARPS continued to pay interest according to its stated terms, the market in these securities continues to be illiquid. Based on a discounted cash flow model used to determine the estimated fair value of its investment in the ARPS, the Company has previously recognized in the consolidated statement of operations an unrealized loss of approximately $118,000 in investment income since the Company had determined that the decline in value was other than temporary. The assumptions used for the discontinued cash flow model include estimates for interest rates, timing and amount of cash flows and the expected holding period of the ARPS.  The Company’s ARPS is classified as a long-term investment on the consolidated balance sheets, as the Company does not believe it could liquidate this security in the near term.

 

XML 27 R2.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Balance Sheets (USD $)
Jun. 30, 2012
Dec. 31, 2011
Current assets:    
Cash and cash equivalents $ 99,703,307 $ 31,787,512
Short-term investments 30,934,774 78,791,066
Trade accounts receivable, net 5,312,432 6,563,645
Accounts receivable, other 3,181,320 52,289,290
Inventory, net 7,962,112 3,947,380
Prepaid expenses and other current assets 2,326,122 3,781,830
Total current assets 149,420,067 177,160,723
Equity investment in OBI 29,013,792  
Property, equipment and other, net 3,693,670 2,590,715
Long-term investments 882,000 882,000
Other assets 1,411,026 1,389,734
Total assets 184,420,555 182,023,172
Current liabilities:    
Accounts payable 6,697,835 9,860,462
Accrued expenses 30,243,749 21,447,544
Deferred revenue 245,319  
Total current liabilities 37,186,903 31,308,006
Deferred rent 177,874 151,141
Stockholders' equity:    
Preferred stock, par value $0.001, 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2012 and December 31, 2011 respectively      
Common stock, $0.001 par value, 75,000,000 shares authorized, 47,531,412 shares and 46,689,951 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively 47,531 46,690
Additional paid-in capital 372,132,440 358,895,471
Accumulated other comprehensive income (loss) 1,085,248 (46,725)
Accumulated deficit (226,209,441) (214,992,783)
Total Optimer Pharmaceuticals, Inc. stockholders' equity 147,055,778 143,902,653
Non-controlling interest   6,661,372
Total stockholders' equity 147,055,778 150,564,025
Total liabilities and stockholders' equity $ 184,420,555 $ 182,023,172
XML 28 R6.htm IDEA: XBRL DOCUMENT v2.4.0.6
Interim Financial Information
6 Months Ended
Jun. 30, 2012
Interim Financial Information  
Interim Financial Information

 

 

1.              Interim Financial Information

 

Organization and Business Activities

 

Optimer Pharmaceuticals, Inc. (“Optimer” or the “Company”) is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products.  The Company currently markets one product in the United States and Canada, DIFICID® (fidaxomicin).  DIFICID is a macrolide antibacterial drug that is approved in the United States for the treatment of Clostridium difficile-associated diarrhea (“CDAD”) in adults.  CDAD is the most common symptom of Clostridium difficile infection (“CDI”).  DIFICID is approved in Canada for the treatment of CDI. Fidaxomicin also is approved in Europe for the treatment of CDI, where it is marketed by a licensee as DIFICLIR™. Optimer is pursuing regulatory approval in other territories through collaboration partners.  The Company also is moving forward with life-cycle management initiatives for fidaxomicin.

 

Optimer was incorporated in Delaware on November 18, 1998. Optimer has two wholly-owned subsidiaries with active operations, Optimer Pharmaceuticals Canada, Inc. (“Optimer Canada”), which is incorporated and located in Canada, and Optimer Luxembourg 2 S.à r.l. (“Optimer Europe”), which is incorporated in Luxembourg. During the first quarter of 2012, the Company established, as part of its international structure strategy, additional wholly-owned subsidiaries, including Optimer Pharmaceuticals U.S. Holdings LLC, Optimer Bermuda LP and Optimer Luxembourg 1 S.à r.l.  As of June 30, 2012, none of these additional wholly-owned subsidiaries was conducting operational activities.

 

Basis of Presentation

 

The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals, considered necessary for a fair presentation of the results of these interim periods have been included. The results of operations for the three months and six months ended June 30, 2012 are not necessarily indicative of the results that may be expected for the full year. These unaudited consolidated financial statements should be read in conjunction with the audited financial statements and related notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011, which was filed with the Securities and Exchange Commission (“SEC”) on March 8, 2012.

 

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

 

XML 29 R22.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies (Details) (USD $)
6 Months Ended
Jun. 30, 2012
item
Dec. 31, 2011
Cash, Cash Equivalents and Investments    
Number of ARPS 1  
Cash, Cash Equivalents and Investments    
Cash, cash equivalents and short-term investments $ 130,600,000  
Accounts Receivable    
Allowance for prompt pay 1,400,000 1,600,000
Inventory    
Raw materials 6,633,880 1,815,696
Work in process 553,186 1,321,763
Finished goods 1,316,863 809,921
Inventory, gross 8,503,929 3,947,380
Reserves (541,817)  
Inventory, net 7,962,112 3,947,380
Investment in OBI    
Investment in OBI 29,013,792  
Net Product Sales    
Prompt payment discount recognized (as a percent) 100.00%  
Average period of rebates payout 6 months  
Period prior to product expiration date for which returns of DIFICID are accepted 6 months  
Period after product expiration date for which returns of DIFICID are accepted 12 months  
Segment Reporting    
Number of operating segment 1  
OBI
   
Investment in OBI    
Investment in OBI $ 29,000,000  
XML 30 R24.htm IDEA: XBRL DOCUMENT v2.4.0.6
Fair Value of Financial Instruments (Details 2) (USD $)
6 Months Ended
Jun. 30, 2012
Reconciliation of the beginning and ending balances of assets measured at fair value on a recurring basis using Level 3 inputs  
Number of ARPS 1
Auction rate securities
 
Reconciliation of the beginning and ending balances of assets measured at fair value on a recurring basis using Level 3 inputs  
Balance at the beginning of the period $ 882,000
Balance at the end of the period 882,000
Period for resetting rates 28 days
Other than temporary unrealized loss recognized $ 118,000
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XML 32 R7.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2012
Summary of Significant Accounting Policies  
Summary of Significant Accounting Policies

 

 

2.     Summary of Significant Accounting Policies

 

Principles of Consolidation

 

The consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. Prior to February 7, 2012, Optimer Biotechnology Inc. (“OBI”) was consolidated for financial reporting purposes.  All intercompany balances and transactions have been eliminated in consolidation.

 

Cash, Cash Equivalents and Investments

 

Investments with original maturities of less than 90 days at the date of purchase are considered to be cash equivalents.  Except for one auction rate preferred security (“ARPS”), all other investments are classified as short-term investments which are deemed by management to be available-for-sale and are reported at fair value with net unrealized gains or losses reported within comprehensive income (loss).  Realized gains and losses, and declines in value judged to be other than temporary, are included in investment income or interest expense.  The cost of securities sold is computed using the specific identification method. As of June 30, 2012, cash, cash equivalents and short-term investments totaled approximately $130.6 million.

 

Accounts Receivable

 

Trade accounts receivable are recorded net of reserves for estimated chargeback obligations, prompt-payment discounts, service fee arrangements and any allowance for doubtful accounts. Reserves for other sales-related allowances such as rebates, distribution and other fees, and product returns are included in accrued expenses in the Company’s consolidated balance sheet. The allowance for prompt-pay discounts and service fee arrangements was $1.4 million and $1.6 million at June 30, 2012 and December 31, 2011, respectively.

 

Inventory

 

Inventory is stated at the lower of cost or market.  Cost is determined in a manner which approximates the first-in, first-out (“FIFO”) method. The Company capitalized inventory produced in preparation for product launches upon FDA approval, as costs are expected to be recoverable through the commercialization of the product.  The Company reserves for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales.  Net inventory consisted of the following as of the dates indicated:

 

 

 

June 30,

 

December 31,

 

 

 

2012

 

2011

 

Raw materials

 

$

6,633,880

 

$

1,815,696

 

Work in process

 

553,186

 

1,321,763

 

Finished goods

 

1,316,863

 

809,921

 

 

 

8,503,929

 

3,947,380

 

Reserves

 

(541,817

)

 

 

 

$

7,962,112

 

$

3,947,380

 

 

Investment in OBI

 

Beginning as of February 7, 2012, the Company accounted for its investment in OBI under the equity method of accounting as the Company ceased to have voting control or other elements of control that would require consolidation. Prior to February 7, 2012, OBI was consolidated for financial reporting purposes. The investment is subsequently adjusted for the Company’s share in equity in net income (loss) and cash contributions and distributions. In addition, the Company records adjustments to reflect the amortization of basis differences attributable to the fair values in excess of net book values of identified tangible and intangible assets which were generated at the date of deconsolidation.  Any difference between the carrying amount of the investment on the Company’s balance sheet and the underlying equity in net assets is evaluated for impairment at each reporting period. As of June 30, 2012, the Company’s investment in OBI was $29.0 million.

 

Foreign Currency Translation

 

The functional currency for the Company’s foreign subsidiaries is the local currency. Assets and liabilities denominated in foreign currencies are translated using the exchange rates on the balance sheet dates. Net revenues and expenses are translated using the average exchange rates prevailing during the period. Any translation adjustments resulting from this process are shown separately as a component of accumulated other comprehensive income (loss) within stockholders’ equity in the consolidated balance sheets. Foreign currency transaction gains and losses are reported in operating expenses, net in the consolidated statements of operations.

 

Fair Value of Financial Instruments

 

The carrying amount of cash and cash equivalents, short-term investments, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of these instruments.  The fair value of available-for-sale securities is based upon quoted market prices for these securities.

 

Reclassifications

 

The Company has reclassified certain prior-period amounts to conform to the current period presentation.  Specifically, it has consolidated its sales and marketing expense and its general and administrative expenses into a single selling, general and administrative expense category.  This reclassification has no impact on the net loss from operations or stockholders’ equity as previously reported.

 

Net Product Sales

 

DIFICID is available in the United States and Canada through national and regional wholesalers that provide DIFICID to hospital and retail pharmacies and to long-term care facilities. The Company recognizes revenue from product sales when there is persuasive evidence of an arrangement, delivery has occurred, title has passed to the customer, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, the amount of returns can be reasonably estimated and collectability is reasonably assured. The Company recognizes revenue from product sales of DIFICID upon delivery of product to the wholesalers.

 

The Company’s net product sales represent total product sales less allowances for customer credits, including estimated rebates, chargebacks, discounts and returns. These allowances are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Allowances for rebates, chargebacks, discounts and returns are established based on the contractual terms with customers, communications with customers as well as expectations about the market for the product and anticipated introduction of competitive products.  Product shipping and handling costs are included in cost of product sales.

 

Product Sales Allowances.  The Company establishes reserves for prompt-payment discounts, fee-for-service arrangements, government rebates, product returns and other applicable allowances.

 

Allowances relate to prompt-payment discounts and fee-for-service arrangements with the Company’s contracted wholesalers and are recorded at the time of sale, resulting in a reduction in product sales revenue.  Accruals related to government rebates, product returns and other applicable allowances are recognized at the time of sale, resulting in a reduction in product sales revenue and an increase in accrued expenses.

 

Prompt-payment Discounts.  The Company offers a prompt-payment discount to its contracted wholesalers.  Since the Company expects its customers will take advantage of this discount, the Company accrues 100% of the prompt payment discount that is based on the gross amount of each invoice, at the time of sale.  The accrual is adjusted quarterly to reflect actual earned discounts.

 

Government Rebates and Chargebacks.  The Company estimates government-mandated rebates and discounts relating to federal and state programs such as Medicaid, Veterans’ Administration (“VA”) and Department of Defense programs, the Medicare Part D Coverage Discount Program and certain other qualifying federal and state government programs.  The Company estimates the amount of these reductions based on DIFICID patient data, actual sales data and market research data related to payor mix.  These allowances are adjusted each period based on actual experience.

 

Medicaid rebate reserves relate to the Company’s estimated obligations to states under statutory “best price” obligations which also may include supplemental rebate agreements with certain states.  Rebate accruals are recorded during the same period in which the related product sales are recognized.  Actual rebate amounts are determined at the time of claim by the state, and the Company will generally make cash payments for such amounts after receiving billings from the state.

 

VA rebates or chargeback reserves represent the Company’s estimated obligations resulting from contractual commitments to sell DIFICID to qualified healthcare providers at a price lower than the list price charged to the Company’s distributors.  The distributor will charge the Company for the difference between what the distributor pays for the product and the ultimate selling price to the qualified healthcare provider.  Rebate accruals are established during the same period in which the revenue from the related product sales is recognized. Actual chargeback amounts for Public Health Service are determined at the time of resale to the qualified healthcare provider from the distributor, and the Company will generally issue credits for such amounts after receiving notification from the distributor.

 

Although allowances and accruals are recorded at the time of product sale, certain rebates generally will be paid, on average, up to six months or longer after the sale.  Reserve estimates are evaluated quarterly and, if necessary, adjusted to reflect actual results.  Any such adjustments will be reflected in the Company’s operating results in the period of the adjustment.

 

Product Returns.  The Company’s policy is to accept returns of DIFICID for six months prior to, and twelve months after, the product expiration date.  The Company also permits returns if the product is damaged or defective when received by its customers. The Company will provide a credit for such returns to customers with whom the Company has a direct relationship. Once product is dispensed, it cannot be returned, but the Company allows partial returns in states where such returns are mandated. The Company does not exchange product from inventory for the returned product.

 

Allowances for product returns are recorded during the period in which the related product sales are recognized, resulting in a reduction to product revenue.  The Company estimates product returns based upon historical trends in the pharmaceutical industry and trends for similar products sold by others.

 

Contract Revenue

 

In order to determine the revenue recognition for contingent milestones, the Company evaluates the contingent milestones at the inception of a collaboration agreement.

 

Accounting Standard Codification (“ASC”) Topic 605-28, Revenue Recognition — Milestone Method (“ASC 605-28”), established the milestone method as an acceptable method of revenue recognition for certain contingent, event-based payments under research and development arrangements.  Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved.  A milestone is an event (i) that can be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company.  The determination that a milestone is substantive is judgmental and is made at the inception of the arrangement.  Milestones are considered substantive when the consideration earned from the achievement of the milestone is (i) commensurate with either the Company’s performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from the Company’s performance to achieve the milestone, (ii) relates solely to past performance and (iii) is reasonable relative to all deliverables and payment terms in the arrangement.

 

Other contingent, event-based payments received for which payment is either contingent solely upon the passage of time or the results of a collaborative partner’s performance are not considered milestones under ASC 605-28.  In accordance with ASC Topic 605-25, Revenue Recognition — Multiple-Element Arrangements, such payments will be recognized as revenue when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured.

 

Revenues recognized for royalty payments, if any, are recognized as earned in accordance with the terms of various research and collaboration agreements.

 

For collaboration agreements with multiple deliverables, the Company recognizes collaboration revenues and expenses by analyzing each element of the agreement to determine if it is to be accounted for as a separate element or single unit of accounting. If an element is to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue is to be recognized. If an element is not to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue is to be recognized.

 

Cash received in advance of services being performed is recorded as deferred revenue and recognized as revenue as services are performed over the applicable term of the agreement. In connection with certain research and collaboration agreements, revenues are recognized from non-refundable up-front fees, that the Company does not believe are specifically tied to a separate earnings process, ratably over the term of the agreement.  Research fees are recognized as revenue as the related research activities are performed.

 

With respect to revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with grants, where the Company acts as a principal, with discretion to choose suppliers, bears credit risk and performs part of the services required in the transaction, the Company records revenue for the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in the consolidated statements of operations.

 

None of the payments that the Company has received from collaborators to date, whether recognized as revenue or deferred, is refundable even if the related program is not successful.

 

Research and Development Expense

 

The Company expenses costs related to research and development until technological feasibility has been established for the product.  Once technological feasibility is established, all product costs are generally capitalized until the product is available for general release to customers.  The Company has determined that technological feasibility for its product candidates will be reached when the requisite regulatory approvals are obtained to make the product available for sale which, in the United States, generally occurs upon the approval of the New Drug Application (“NDA”) for such product.

 

The Company’s research and development expenses consist primarily of license fees, salaries and related employee benefits, costs associated with clinical trials managed by contract research organizations and costs associated with non-clinical activities and regulatory approvals.  The Company uses external service providers and vendors to conduct clinical trials, to manufacture supplies of product candidates to be used in clinical trials and to provide various other research and development-related products and services.

 

When non-refundable payments for goods or services to be received in the future for use in research and development activities are made, the Company defers and capitalizes these types of payments. The capitalized amounts are expensed when the related goods are delivered or the services are performed.

 

Net Income (Loss) per Share Attributable to Common Stockholders

 

Basic net income (loss) per common share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted-average number of common shares and dilutive common stock equivalents then outstanding. Common stock equivalents consist of common shares issuable upon the exercise of stock options and warrants and upon the vesting of restricted stock units.

 

Income Taxes

 

Income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income in the period that includes the enactment date.  The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized.

 

Segment Reporting

 

Our management has determined that we operate in one business segment which is the development and commercialization of pharmaceutical products.

 

XML 33 R3.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Balance Sheets (Parenthetical) (USD $)
Jun. 30, 2012
Dec. 31, 2011
Consolidated Balance Sheets    
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized 75,000,000 75,000,000
Common stock, shares issued 47,531,412 46,689,951
Common stock, shares outstanding 47,531,412 46,689,951
XML 34 R17.htm IDEA: XBRL DOCUMENT v2.4.0.6
Short-term Investments (Tables)
6 Months Ended
Jun. 30, 2012
Short-term Investments  
Schedule of investment securities classified as available-for-sale

 

 

 

June 30, 2012

 

 

 

Gross
Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Market Value

 

Government agencies

 

$

25,727,803

 

$

14,497

 

$

(15

)

$

25,742,285

 

Corporate bonds

 

4,015,237

 

1,205

 

 

4,016,442

 

Investment in Cempra

 

 

1,176,047

 

 

1,176,047

 

 

 

$

29,743,040

 

$

1,191,749

 

$

(15

)

$

30,934,774

 

 

 

 

December 31, 2011

 

 

 

Gross
Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Market Value

 

Government agencies

 

$

69,241,792

 

$

106,347

 

$

 

$

69,348,139

 

Corporate bonds

 

9,429,485

 

13,442

 

 

9,442,927

 

 

 

$

78,671,277

 

$

119,789

 

$

 

78,791,066

 

 

Schedule of the amortized cost and estimated fair value of securities available-for-sale, by contractual maturity

The amortized cost and estimated fair value of securities available-for-sale at June 30, 2012, by contractual maturity, are as follows:

 

 

 

Amortized Cost

 

Estimated Fair Value

 

Due in one year or less

 

$

29,743,040

 

$

29,758,727

 

 

XML 35 R1.htm IDEA: XBRL DOCUMENT v2.4.0.6
Document and Entity Information
6 Months Ended
Jun. 30, 2012
Jul. 27, 2012
Document and Entity Information    
Entity Registrant Name OPTIMER PHARMACEUTICALS INC  
Entity Central Index Key 0001142576  
Document Type 10-Q  
Document Period End Date Jun. 30, 2012  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Current Reporting Status Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   47,556,034
Document Fiscal Year Focus 2012  
Document Fiscal Period Focus Q2  
XML 36 R18.htm IDEA: XBRL DOCUMENT v2.4.0.6
Net Income (Loss) Per Share Attributable to Common Stockholders (Tables)
6 Months Ended
Jun. 30, 2012
Net Income (Loss) per Share Attributable to Common Stockholders  
Schedule of computation of basic and diluted net income (loss) per share

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss) — basic and diluted

 

$

(296,204

)

$

(24,238,846

)

$

(11,216,658

)

$

20,894,024

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average number of shares of common stock outstanding - basic

 

47,234,371

 

46,479,395

 

46,978,497

 

44,581,010

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Restricted stock units

 

 

 

 

43,560

 

Employee stock purchase plan

 

 

 

 

39,381

 

Stock award common share equivalents

 

 

 

 

783,310

 

Weighted average number of shares of common stock outstanding - diluted

 

47,234,371

 

46,479,395

 

46,978,497

 

45,447,261

 

Net income (loss) per share - basic

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.47

 

Net income (loss) per share - diluted

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.46

 

 

XML 37 R4.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Statements of Operations and Comprehensive Income (Loss) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Revenues:        
Product sales, net $ 15,232,087   $ 29,612,628  
Contract revenue 34,525,485   34,525,485 69,165,000
Other   33,294 2,106 144,933
Total revenues 49,757,572 33,294 64,140,219 69,309,933
Costs and expenses:        
Cost of product sales 2,269,331   4,553,591  
Cost of contract revenue 1,744,182   1,744,182 4,273,532
Research and development 11,557,217 10,290,760 22,625,184 18,668,769
Selling, general and administrative 28,856,929 14,760,723 54,379,211 26,566,998
Co-promotion expenses with Cubist 5,001,583   15,083,166  
Total operating expenses 49,429,242 25,051,483 98,385,334 49,509,299
Income (loss) from operations 328,330 (25,018,189) (34,245,115) 19,800,634
Gain on de-consolidation of OBI     23,782,229  
Equity in net loss of OBI (668,852)   (1,154,821)  
Interest income and other, net 44,318 95,860 120,705 119,102
Consolidated net income (loss) (296,204) (24,922,329) (11,497,002) 19,919,736
Net loss attributable to non-controlling interest   683,483 280,344 974,288
Net income (loss) attributable to Optimer Pharmaceuticals, Inc. (296,204) (24,238,846) (11,216,658) 20,894,024
Net income (loss) per share - basic (in dollars per share) $ (0.01) $ (0.52) $ (0.24) $ 0.47
Net income (loss) per share - diluted (in dollars per share) $ (0.01) $ (0.52) $ (0.24) $ 0.46
Weighted average number of shares used to compute net income (loss) per share - basic (in shares) 47,234,371 46,479,395 46,978,497 44,581,010
Weighted average number of shares used to compute net income (loss) per share - diluted (in shares) 47,234,371 46,479,395 46,978,497 45,447,261
Comprehensive income (loss) $ (177,625) $ (23,954,597) $ (10,084,685) $ 21,417,416
XML 38 R12.htm IDEA: XBRL DOCUMENT v2.4.0.6
Stock Based Compensation
6 Months Ended
Jun. 30, 2012
Stock Based Compensation  
Stock Based Compensation

 

 

7.              Stock Based Compensation

 

Stock Options

 

In November 1998, the Company adopted the 1998 Stock Plan (the “1998 Plan”).  The Company terminated and ceased granting options under the 1998 Plan upon the closing of the Company’s initial public offering in February 2007.

 

In December 2006, the Company’s board of directors approved the 2006 Equity Incentive Plan (“2006 Plan”) which became effective upon the closing of the Company’s initial public offering.  The 2006 Plan was succeeded by the 2012 Equity Plan (“2012 Plan”) which became effective upon approval by the Company’s stockholders on May 9, 2012. After May 9, 2012, no additional stock awards will be awarded under the 2006 Plan.  However, all outstanding stock awards granted under the 2006 Plan remain subject to the terms of the 2006 Plan.

 

The 2012 Plan is a continuation of the 2006 Plan.  The aggregate number of shares of the Company’s common stock that may be issued under the 2012 Plan will not exceed 11,289,455, which consists of (a) 3,400,000 new shares and (b) the number of unallocated shares remaining available for grant of new awards under the 2006 Plan as of May 9, 2012 and the shares subject to outstanding stock awards granted under the 2006 Plan that (i) expire or terminate for any reason prior to exercise or settlement; (ii) are forfeited because of the failure to meet a contingency or condition required to vest such shares or repurchased at the original issuance price; or (iii) are re-acquired or withheld (or not issued) to satisfy a tax withholding obligation in connection with an award other than a stock option or stock appreciation right.

 

Options granted under the 1998 Plan, the 2006 Plan and the 2012 Plan generally expire 10 years from the date of grant (five years for a 10% or greater stockholder) and vest over a period of four years.  The exercise price of options granted must at least be equal to the fair market value of the Company’s common stock on the date of grant.

 

Restricted Stock Units

 

From time to time the Company grants restricted stock units (“RSUs”) to its executives, board members and employees. RSUs are valued based on the fair market value of the Company’s stock on the date of grant.

 

Performance-based Stock Options and Performance-based Restricted Stock Units

 

In February 2012, the Compensation Committee granted to certain executives performance-based RSUs covering up to an aggregate of 250,000 shares of common stock, which vest over time beginning on the date the Company determines that a specified product revenue goal has been achieved.

 

In May 2010, the Company’s Board of Directors appointed Pedro Lichtinger as its President and CEO and as a member of the Board.  Pursuant to Mr. Lichtinger’s offer letter, he received performance-based stock options to purchase up to an aggregate of 480,000 shares of common stock and performance-based restricted stock units covering up to an aggregate of 120,000 shares of common stock, which vest over time beginning on the dates the Company achieves specified development and commercialization goals.  In February 2011, one of the performance criteria was met and, in May 2011, another of the performance criteria was met. As a result, 1/4th of the performance-based stock options and performance-based restricted stock units related to each goal vested in February 2012 and the remaining shares will vest in 36 equal monthly installments thereafter.

 

Simultaneously with Mr. Lichtinger’s appointment, Michael Chang resigned as the Company’s President and CEO.  The Company entered into a consulting agreement with Dr. Chang to provide consulting services. Pursuant to his consulting agreement and as part of his compensation, Dr. Chang received performance-based stock options to purchase up to an aggregate of 400,000 shares of common stock which vested over time beginning on the dates certain regulatory filings were accepted and approved. Dr. Chang’s consulting agreement was terminated in April 2012 and, as a result, the unvested portion of the performance-based options was cancelled.  Prior to the termination of his consulting agreement, 248,437 options vested.  However, due to Dr. Chang’s continuing role as a director, his other equity awards remain outstanding and continue to vest as per the vesting term of the awards.

 

Employee Stock Purchase Plan

 

Optimer issues stock awards under its employee stock purchase plan (“ESPP”). Under the terms of the ESPP, eligible employees may purchase shares of Optimer’s common stock at the lesser of 85% of the fair market value of Optimer’s common stock on the offering date or the purchase date.

 

Valuations

 

Stock options are valued using the Black-Scholes option pricing model on the date of grant. This option pricing model involves a number of estimates, including the expected lives of stock options, the Company’s anticipated stock volatility and applicable interest rates.  The Company recognizes compensation expense for performance-based stock awards granted to employees under the accelerated attribution method.  The following table shows the assumptions used to compute stock-based compensation expense for the stock options, restricted stock units and ESPP purchase rights during the three months and six months ended June 30, 2012 and 2011, using the Black-Scholes option pricing model:

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

Stock Options

 

2012

 

2011

 

2012

 

2011

 

Risk-free interest rate

 

1.22

%

2.10-3.46

%

1.22-2.17

%

2.10-3.46

%

Dividend yield

 

0.00

%

0.00

%

0.00

%

0.00

%

Expected life of options (years)

 

6.08-8.08

 

6.08-9.08

 

6.08-8.33

 

5.27-9.49

 

Volatility

 

70.72-72.54

%

69.13-72.20

%

69.71-72.54

%

69.13-73.63

%

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

ESPP

 

2012

 

2011

 

2012

 

2011

 

Risk-free interest rate

 

0.10-0.13

%

0.14-0.16

%

0.09-0.13

%

0.14-0.18

%

Dividend yield

 

0.00

%

0.00

%

0.00

%

0.00

%

Expected life of options (years)

 

0.5

 

0.5

 

0.5

 

0.5

 

Volatility

 

37.16-42.75

%

41.05-44.29

%

37.16-42.75

%

40.01-44.29

%

 

The risk-free interest rate assumption was based on the United States Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.  The assumed dividend yield was based on the Company’s expectation of not paying dividends for the foreseeable future.  The weighted-average expected life of options was calculated using the simplified method.  Due to the Company’s limited historical data as a commercial entity, the Company used the historical volatility of comparable companies whose share prices are publicly available to estimate the Company’s options volatility rate.

 

Total stock-based compensation expense related to all of the Company’s stock options, RSUs and other stock awards issued to employees and consultants, and employee stock purchases, recognized for the three months and six months ended June 30, 2012 and 2011, was as follows:

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Research and development

 

$

1,249,360

 

$

637,374

 

$

2,214,142

 

$

1,312,897

 

Selling, general and administrative

 

2,704,006

 

1,819,622

 

4,826,921

 

3,275,332

 

Stock-based compensation expense

 

$

3,953,366

 

$

2,456,996

 

$

7,041,063

 

$

4,588,229

 

 

At June 30, 2012, the total unrecognized compensation expense related to unvested stock options and restricted stock units issued to employees was approximately $28.7 million and the related weighted-average period over which such expense is expected to be recognized is approximately 3.1 years.

 

Optimer Biotechnology, Inc.

 

Stock Options

 

Until February 7, 2012, we consolidated OBI into our results of operations and recorded stock based compensation related to options granted by OBI. The following table summarizes the stock-based compensation expense for OBI included in each operating expense line item in Optimer’s consolidated statements of operations for the six months ended June 30, 2012 and 2011:

 

 

 

Six months ended
June 30,

 

 

 

2012

 

2011

 

Research and development

 

$

8,465

 

$

27,727

 

Selling, general and administrative

 

9,181

 

71,724

 

Stock-based compensation expense

 

$

17,646

 

$

99,451

 

 

XML 39 R11.htm IDEA: XBRL DOCUMENT v2.4.0.6
Net Income (Loss) per Share Attributable to Common Stockholders
6 Months Ended
Jun. 30, 2012
Net Income (Loss) per Share Attributable to Common Stockholders  
Net Income (Loss) per Share Attributable to Common Stockholders

 

 

6.              Net Income (Loss) per Share Attributable to Common Stockholders

 

The following table sets forth the computation of basic and diluted net income (loss) per share for the periods indicated:

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss) — basic and diluted

 

$

(296,204

)

$

(24,238,846

)

$

(11,216,658

)

$

20,894,024

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average number of shares of common stock outstanding - basic

 

47,234,371

 

46,479,395

 

46,978,497

 

44,581,010

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Restricted stock units

 

 

 

 

43,560

 

Employee stock purchase plan

 

 

 

 

39,381

 

Stock award common share equivalents

 

 

 

 

783,310

 

Weighted average number of shares of common stock outstanding - diluted

 

47,234,371

 

46,479,395

 

46,978,497

 

45,447,261

 

Net income (loss) per share - basic

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.47

 

Net income (loss) per share - diluted

 

$

(0.01

)

$

(0.52

)

$

(0.24

)

$

0.46

 

 

For the three months ended June 30, 2012 and 2011, 4.8 million and 5.8 million, respectively, of potentially dilutive shares of common stock were not included in the diluted net income per share calculations because they would have been antidilutive.

 

For the six months ended June 30, 2012 and 2011, 5.0 million and 4.1 million, respectively, of potentially dilutive shares of common stock were not included in the diluted net income per share calculations because they would have been antidilutive.

 

XML 40 R23.htm IDEA: XBRL DOCUMENT v2.4.0.6
Fair Value of Financial Instruments (Details) (USD $)
3 Months Ended
Jun. 30, 2012
Dec. 31, 2011
Jun. 30, 2012
Investment in Cempra
Jun. 30, 2012
Quoted Prices in Active Markets (Level 1)
Jun. 30, 2012
Quoted Prices in Active Markets (Level 1)
Investment in Cempra
Jun. 30, 2012
Other Observable Inputs (Level 2)
Jun. 30, 2012
Other Observable Inputs (Level 2)
Marketable securities
Jun. 30, 2012
Unobservable Inputs (Level 3)
Jun. 30, 2012
Unobservable Inputs (Level 3)
Auction rate preferred securities
Jun. 30, 2012
Total
Jun. 30, 2012
Total
Marketable securities
Jun. 30, 2012
Total
Auction rate preferred securities
Jun. 30, 2012
Total
Investment in Cempra
Fair Value of Financial Instruments                          
Cash equivalents       $ 98,131,193           $ 98,131,193      
Fair Value       99,307,240 1,176,047 29,758,727 29,758,727 882,000 882,000 129,947,967 29,758,727 882,000 1,176,047
Available-for-sale Securities                          
Unrealized gain on available-for-sale securities     227,420                    
Short-term investments $ 30,934,774 $ 78,791,066 $ 1,176,047                    
XML 41 R19.htm IDEA: XBRL DOCUMENT v2.4.0.6
Stock Based Compensation (Tables)
6 Months Ended
Jun. 30, 2012
Stock Based Compensation  
Schedule of assumptions used to compute stock-based compensation expense for the stock options, restricted stock units and ESPP purchase rights

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

Stock Options

 

2012

 

2011

 

2012

 

2011

 

Risk-free interest rate

 

1.22

%

2.10-3.46

%

1.22-2.17

%

2.10-3.46

%

Dividend yield

 

0.00

%

0.00

%

0.00

%

0.00

%

Expected life of options (years)

 

6.08-8.08

 

6.08-9.08

 

6.08-8.33

 

5.27-9.49

 

Volatility

 

70.72-72.54

%

69.13-72.20

%

69.71-72.54

%

69.13-73.63

%

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

ESPP

 

2012

 

2011

 

2012

 

2011

 

Risk-free interest rate

 

0.10-0.13

%

0.14-0.16

%

0.09-0.13

%

0.14-0.18

%

Dividend yield

 

0.00

%

0.00

%

0.00

%

0.00

%

Expected life of options (years)

 

0.5

 

0.5

 

0.5

 

0.5

 

Volatility

 

37.16-42.75

%

41.05-44.29

%

37.16-42.75

%

40.01-44.29

%

 

Stock Based Compensation  
Schedule of total stock-based compensation expense related to stock options, RSUs, and other stock awards issued to employees and consultants, and employee stock purchases

 

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Research and development

 

$

1,249,360

 

$

637,374

 

$

2,214,142

 

$

1,312,897

 

Selling, general and administrative

 

2,704,006

 

1,819,622

 

4,826,921

 

3,275,332

 

Stock-based compensation expense

 

$

3,953,366

 

$

2,456,996

 

$

7,041,063

 

$

4,588,229

 

 

OBI
 
Stock Based Compensation  
Schedule of total stock-based compensation expense related to stock options, RSUs, and other stock awards issued to employees and consultants, and employee stock purchases

 

 

 

Six months ended
June 30,

 

 

 

2012

 

2011

 

Research and development

 

$

8,465

 

$

27,727

 

Selling, general and administrative

 

9,181

 

71,724

 

Stock-based compensation expense

 

$

17,646

 

$

99,451

 

 

XML 42 R15.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies (Tables)
6 Months Ended
Jun. 30, 2012
Summary of Significant Accounting Policies  
Schedule of net inventory

 

 

 

June 30,

 

December 31,

 

 

 

2012

 

2011

 

Raw materials

 

$

6,633,880

 

$

1,815,696

 

Work in process

 

553,186

 

1,321,763

 

Finished goods

 

1,316,863

 

809,921

 

 

 

8,503,929

 

3,947,380

 

Reserves

 

(541,817

)

 

 

 

$

7,962,112

 

$

3,947,380

 

 

XML 43 R13.htm IDEA: XBRL DOCUMENT v2.4.0.6
Other Collaborative Agreements
6 Months Ended
Jun. 30, 2012
Other Collaborative Agreements  
Other Collaborative Agreements

 

 

8.     Other Collaborative Agreements

 

Specialised Therapeutics Australia Pty. Ltd. (“STA”)

 

In June 2012, the Company entered into a distribution and license agreement with STA to register and commercialize fidaxomicin tablets in Australia and New Zealand for the treatment of Clostridium difficile infection.  Under the agreement, STA is responsible for all costs associated with the registration and commercialization of fidaxomicin tablets in Australia and New Zealand. Pursuant to the agreement, STA made a one-time payment of $500,866. Additionally, the Company is entitled to receive contingent payments, which may exceed $1.5 million, upon the achievement of cumulative net sales targets and also will receive payments for the supply of fidaxomicin tablets to STA.

 

The Company has assessed that the achievement of the performance conditions associated with the payments is solely based on the performance of STA and has determined that the payments do not meet the criteria for a milestone under the revised authoritative guidance for contingent milestones. We will recognize the revenue for the contingent payment when the contingency is relieved.

 

Astelllas Pharma Inc. (“Astellas Japan”)

 

In March 2012, the Company entered into a collaboration and license agreement with Astellas Japan pursuant to which the Company granted to Astellas Japan an exclusive, royalty-bearing license under certain of its know-how and intellectual property to develop and commercialize fidaxomicin in Japan.  Under the terms of the license agreement, and at its expense, Astellas Japan agreed to use commercially reasonable efforts to develop and commercialize fidaxomicin in Japan and achieve certain additional regulatory and commercial diligence milestones with respect to fidaxomicin in Japan.  In addition, under the terms of the license agreement, Astellas Japan granted to the Company an exclusive, royalty-free license under know-how and intellectual property generated by Astellas Japan and its sublicensees in the course of developing fidaxomicin and controlled by Astellas Japan or its affiliates for use by the Company and any of its sublicensees in the development and commercialization of fidaxomicin outside Japan and, following termination of the license agreement and subject to payment by the Company of a single-digit royalties, in Japan.  In addition, under the terms of a supply agreement entered into by Astellas Japan and Optimer Europe, on the same date, Optimer Europe will be the exclusive supplier of fidaxomicin to Astellas Japan for Astellas Japan’s development and commercialization activities in Japan during the term of the supply agreement.

 

Under the terms of the license agreement, Astellas Japan paid the Company an up-front fee equal to $20.0 million in April 2012. The Company also is eligible to receive additional cash payments totaling up to $70.0 million upon the achievement by Astellas Japan of specified regulatory and commercial milestones.  In addition, the Company will be entitled to receive high-single-digit royalties on net sales of fidaxomicin products in Japan above an agreed threshold, which royalties are subject to reduction in certain limited circumstances.  Such royalties will be payable by Astellas Japan on a product-by-product basis until a generic product accounts for a specified market share of the applicable fidaxomicin product in Japan. Under the supply agreement, in exchange for commercial supply of fidaxomicin, Astellas Japan is obligated to pay Optimer Europe a price equal to net sales of fidaxomicin products in Japan minus a discount that is based on a high-double-digit percentage of such net sales and a mark-up to cost of goods.  This price will be payable by Astellas Japan on a product-by-product basis for commercial supply until a generic product accounts for a specified market share of the applicable fidaxomicin product in Japan.

 

The license agreement will continue in effect on a product-by-product basis until expiration of Astellas Japan’s obligation to pay royalties with respect to each fidaxomicin product in Japan, unless terminated early by either party.  Following expiration of the license agreement, Astellas Japan’s license to develop and commercialize the applicable fidaxomicin product will become non-exclusive.  Each of the Company and Astellas Japan may terminate the license agreement prior to expiration upon the material breach of such agreement by the other party or upon the bankruptcy or insolvency of the other party.  In addition, the Company may terminate the license agreement prior to expiration in the event Astellas Japan or any of its affiliates or sublicensees commences an interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any patent licensed to it under the license agreement. Astellas Japan may terminate the license agreement prior to expiration for any reason upon 180 days’ prior written notice to the Company.  Upon any such termination, the license granted to Astellas Japan (in total or with respect to the terminated product, as applicable) will terminate and revert to the Company.  The supply agreement will continue in effect until terminated by either party.  Each of Optimer Europe and Astellas Japan may terminate the supply agreement (i) upon the material breach of such agreement by the other party, (ii) upon the bankruptcy or insolvency of the other party or (iii) on a product-by-product basis following expiration of Astellas Japan’s obligation to pay the price described above with respect to the applicable fidaxomicin product, or in its entirety following expiration of Astellas Japan’s obligation to pay the price described above with respect to all fidaxomicin products.

 

The Company assessed the deliverables under the authoritative guidance for multiple element arrangements. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset or another performance obligation.  Once the Company identified the deliverables under the arrangement, the Company determined whether or not the deliverables can be accounted for as separate units of accounting, and the appropriate method of revenue recognition for each element. During the quarter ended June 30, 2012, the Company recognized $19.9 million of the $20.0 million up-front payment, as the Company determined that revenue was earned upon the delivery of license rights and related know-how.

 

Cubist Pharmaceuticals, Inc. (“Cubist”)

 

In April 2011, the Company entered into a co-promotion agreement with Cubist pursuant to which the Company engaged Cubist as its exclusive partner for the promotion of DIFICID in the United States.  Under the terms of the agreement, the Company and Cubist have agreed to co-promote DIFICID to physicians, hospitals, long-term care facilities and other healthcare institutions as well as jointly provide medical affairs support for DIFICID. In conducting their respective co-promotion activities, each party is obligated under the agreement to commit minimum levels of personnel, and Cubist is obligated to tie a portion of the incentive compensation paid to its sales representatives to the promotion of DIFICID in the United States.  Under the terms of the agreement, the Company is responsible for the distribution of DIFICID in the United States and for recording revenue from sales of DIFICID, and agreed to use commercially reasonable efforts to maintain adequate inventory and third-party logistics support for the supply of DIFICID in the United States.  In addition, Cubist agreed to not promote competing products in the United States during the term of the agreement and, subject to certain exceptions, for a specified period of time thereafter. The initial term of the agreement is two years ending July 31, 2013, subject to renewal or early termination as described below.

 

In exchange for Cubist’s co-promotion activities and personnel commitments, the Company is obligated to pay a quarterly fee of approximately $3.8 million to Cubist beginning upon the commencement of the sales program of DIFICID in the United States.  Except for the first quarterly payment which the Company paid in advance, all subsequent payments are paid in arrears. Cubist also is eligible to receive an additional $5.0 million in the first year after first commercial sale and $12.5 million in the second year after first commercial sale if mutually agreed upon annual sales targets are achieved, as well as a portion of the Company’s gross profits derived from net sales above the specified annual targets, if any.  In the quarter ended June 30, 2012, the Company achieved the first-year sales target and, as of June 30, 2012, accrued $10.4 million representing service fees, the $5.0 million bonus as well as a pro-rated portion of estimated gross profit on sales above the sales target which will be payable to Cubist in August 2012.

 

The agreement may be renewed by mutual agreement of the parties for additional, consecutive one-year terms.  The Company and Cubist each may terminate the agreement prior to expiration upon the uncured material breach of the agreement by the other party, upon the bankruptcy or insolvency of the other party.  In addition, the Company may terminate the agreement, subject to certain limitations, if (i) the Company withdraws DIFICID from the market in the United States, (ii) Cubist fails to comply with applicable laws in performing its obligations, (iii) Cubist undergoes a change of control, (iv) certain market events occur related to Cubist’s product CUBICIN® (daptomycin for injection) in the United States or (v) Cubist undertakes certain restructuring activities with respect to its sales force.  In addition, Cubist may terminate the agreement, subject to certain limitations, if (i) the Company experiences certain supply failures in relation to the demand for DIFICID in the United States, (ii) the Company is acquired by certain types of entities, including competitors of Cubist, (iii) certain market events occur related to CUBICIN in the United States or (iv) the Company fails to comply with applicable laws in performing its obligations.

 

The following is a summary of accrued expenses related to the Company’s co-promotion agreement with Cubist:

 

Expenses

 

Six Months
Ended
June 30, 2012

 

Target bonus and portion of gross profit payments

 

$

7,880,000

 

Service fees

 

2,523,000

 

Total

 

$

10,403,000

 

 

Astellas Pharma Europe Ltd. (“APEL”)

 

In February 2011, the Company entered into a collaboration and license agreement with APEL pursuant to which the Company granted to APEL an exclusive, royalty-bearing license under certain of the Company’s know-how and intellectual property to develop and commercialize fidaxomicin in Europe, and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (“CIS”). In March 2011, the parties amended the agreements to include certain additional countries in the CIS and all additional territories in Africa (all such countries and territories are referred to as the APEL territories). Under the terms of the agreement, APEL has agreed to use commercially reasonable efforts to develop and commercialize fidaxomicin in the APEL territories at its expense, and to achieve certain additional regulatory and commercial diligence milestones with respect to fidaxomicin in the APEL territories.  The Company and APEL also may agree to collaborate in, and share data resulting from, global development activities with respect to fidaxomicin, in which case the Company and APEL will be obligated to co-fund such activities.  In addition, under the terms of the agreement, APEL granted the Company an exclusive, royalty-free license under know-how and intellectual property generated by APEL and its sublicensees in the course of developing fidaxomicin and controlled by APEL or its affiliates for use by the Company and any of its sublicensees in the development and commercialization of fidaxomicin outside the APEL territories and, following termination of the agreement and subject to payment by the Company of single-digit royalties, in the APEL territories.  In addition, under the terms of a supply agreement entered into between the Company and APEL on the same date, the Company will be the exclusive supplier of fidaxomicin to APEL for APEL’s development and commercialization activities in the APEL territories during the term of the supply agreement, and APEL is obligated to pay the Company an amount equal to cost plus an agreed mark-up for such supply.

 

Under the terms of the license agreement, APEL paid the Company an up-front fee of $69.2 million in March 2011 and the Company recognized a milestone payment of 40 million Euros in December 2011 as the result of APEL attaining EMA approval of DIFICLIR.  APEL paid the Company 50.0 million Euros in June 2012, which consisted of the 40 million Euro approval milestone payment and a 10 million Euro milestone payment for the first commercial launch of DIFICLIR in the APEL territories. The Company is eligible to receive additional cash payments totaling up to 65.0 million Euros upon the achievement by APEL of additional specified commercial milestones.

 

In addition, the Company will be entitled to receive escalating double-digit royalties ranging from the high teens to low twenties on net sales of DIFICLIR products in the APEL territories, which royalties are subject to reduction in certain, limited circumstances.  Such royalties will be payable by APEL on a product-by-product and country-by-country basis until a generic product accounts for a specified market share of the applicable DIFICLIR product in the applicable country.

 

When determining whether or not to account for the additional cash payments under the milestone method, the Company makes a determination of whether or not each milestone is considered substantive. During this assessment the Company considers if the milestone is achieved based in whole or in part on its performance or on the occurrence of a separate outcome resulting from its performance, if there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and if achievement will result in additional payments being due.  Based on the Company’s assessment process it was determined that additional payments due related to regulatory approval and product launch will be accounted for under the milestone method as technological hurdles create uncertainty as to whether or not the milestones will be met and the achievement of the milestones is based in part on the occurrence of a separate outcome resulting from its performance.

 

The Company assessed the deliverables under the authoritative guidance for multiple element arrangements. Based on the results of the Company’s analysis, it determined that the up-front payment was earned upon the delivery of the license and related know-how, which occurred by March 31, 2011.

 

The agreements with APEL will continue in effect on a product-by-product and country-by-country basis until expiration of APEL’s obligation to pay royalties with respect to each fidaxomicin product in each country in the APEL territory, unless terminated early by either party as more fully described below.  Following expiration, APEL’s license to develop and commercialize the applicable fidaxomicin product in the applicable country will become non-exclusive.  The Company and APEL each may terminate either of the agreements prior to expiration upon the material breach of such agreement by the other party or upon the bankruptcy or insolvency of the other party.  In addition, the Company may terminate the agreements prior to expiration in the event APEL or any of its affiliates or sublicensees commences an interference or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of or the grant of a supplementary protection certificate with respect to, any patent licensed to it. APEL may terminate the agreements prior to expiration for any reason on a product-by-product and country-by-country basis upon 180 days’ prior written notice to the Company.  Upon any such termination, the license granted to APEL (in total or with respect to the terminated product or terminated country, as applicable) will terminate and revert to the Company.

 

Par Pharmaceuticals, Inc. (“Par”)

 

In February 2007, the Company repurchased the rights to develop and commercialize DIFICID in North America and Israel from Par under a prospective buy-back agreement.  The Company paid Par a one-time $5.0 million milestone payment in June 2010 for the successful completion by the Company of its second pivotal Phase 3 trial for DIFICID.  The Company is obligated to pay Par a 5% royalty on net sales by the Company its affiliates or its licensees of DIFICID in North America and Israel, and a 1.5% royalty on net sales by the Company or its affiliates, of fidaxomicin in the rest of the world.  In addition, in the event the Company licenses its right to market fidaxomicin in the rest of the world, the Company will be required to pay Par a 6.25% royalty on net revenues received by it related to the licensing of fidaxomicin.  The Company is obligated to pay each of these royalties, on a country-by-country basis, for seven years commencing on the applicable commercial launch in each such country. In March 2011, the Company paid Par $4.3 million in royalties for net revenues received by the Company under the APEL agreement.  During the second quarter, the Company paid Par $1.3 million in royalties in association with the $20.0 million up-front payment from Astellas Japan.  In the third quarter, the Company will pay Par approximately $3.0 million in royalties in connection with the milestone payments from APEL and $0.8 million from net product sales of DIFICID during the second quarter.

 

Biocon Limited (“Biocon”)

 

In May 2010, the Company entered into a long-term supply agreement with Biocon for the commercial manufacture of fidaxomicin active pharmaceutical ingredient (“API”).  Pursuant to the agreement, Biocon agreed to manufacture and supply the Company, up to certain limits, fidaxomicin API and, subject to certain conditions, the Company agreed to purchase from Biocon at least a portion of its requirements for fidaxomicin API in the United States and Canada.  The Company previously paid to Biocon $2.5 million for certain equipment purchases and manufacturing scale-up activities, and it may be entitled to recover up to $1.5 million of this amount under the supply agreement in the form of discounted prices for fidaxomicin API.  Unless both the Company and Biocon agree to extend the term of the supply agreement, it will terminate seven and one-half years from the date the Company obtained marketing authorization for DIFICID in the United States.  In addition, the supply agreement may be earlier terminated (i) by either party by giving two and one-half years notice after the fifth anniversary of the Effective Date or upon a material breach of the supply agreement by the other party, (ii) by the Company upon the occurrence of certain events, including Biocon’s failure to supply requested amounts of fidaxomicin API, or (iii) by Biocon upon the occurrence of certain events, including the Company’s failure to purchase amounts of fidaxomicin API that it indicates in binding forecasts.

 

Patheon Inc. (“Patheon”)

 

In June 2011, the Company entered into a commercial manufacturing services agreement with Patheon to manufacture and supply fidaxomicin drug products, including DIFICID, in North America, Europe and other countries, subject to agreement by the parties to any additional fees for such countries.  The Company agreed to purchase a specified percentage of its fidaxomicin product requirements for North America and Europe from Patheon or its affiliates.

 

The term of the agreement extends through December 31, 2016 and will automatically renew for subsequent two-year terms unless either party provides a timely notice of its intent not to renew or unless the agreement is terminated early pursuant to its terms. The Company and Patheon may terminate the agreement prior to expiration upon the uncured material breach of the agreement by the other party or upon the bankruptcy or insolvency of the other party. In addition, the agreement will terminate with respect to any fidaxomicin product if the Company provides notice to Patheon that it no longer requires manufacturing services for such product because the product has been discontinued. Additionally, the Company may terminate the agreement, subject to certain limitations, (i) with respect to any fidaxomicin product, if any regulatory authority takes any action or raises any objection that prevents the Company from importing, exporting, purchasing or selling such product or if the Company determines to discontinue development or commercialization of such product for safety or efficacy reasons, (ii) if any regulatory authority takes an enforcement action against Patheon’s manufacturing site that relates to fidaxomicin products or that could reasonably be expected to adversely affect Patheon’s ability to supply fidaxomicin products to the Company, (iii) if Patheon is unable to deliver or supply any firm orders for any two calendar quarters during any four consecutive calendar quarters, (iv) if Patheon uses any debarred or suspended person in the performance of its service obligations under the agreement or (v) if Patheon fails to meet certain production yield requirements in relation to fidaxomicin API.

 

Cempra Pharmaceuticals, Inc. (“Cempra”)

 

In March 2006, the Company entered into a collaborative research and development and license agreement with Cempra.  The Company granted to Cempra an exclusive worldwide license, except in the Association of Southeast Asian Nations (“ASEAN”), with the right to sublicense the Company’s patent and know-how related to the Company’s macrolide and ketolide antibacterial program.  As partial consideration for granting Cempra the licenses, the Company obtained equity of Cempra and the Company assigned no value to such equity.  The Company may receive milestone payments as product candidates are developed and/or co-developed by Cempra, in addition to milestone payments based on certain sublicense revenue.  The aggregate potential amount of such milestone payments is not capped and, based in part on the number of products developed under the agreement, may exceed $24.5 million. The milestone payments will be triggered upon the completion of certain clinical development milestones and in certain instances, regulatory approval of products.  The Company also may receive royalty payments based on a percentage of net sales of licensed products.

 

Pursuant to the agreement, Cempra also granted the Company an exclusive license whereby Cempra may receive milestone payments from the Company in the amount of $1.0 million for each of the first two products the Company develops which receive regulatory approval in ASEAN countries, as well as royalty payments on the net sales of such products.

 

Subject to certain exceptions, on a country-by-country basis, the general terms of this agreement continue until the later of: (i) the expiration of the last to expire patent rights of a covered product in the applicable country or (ii) ten years from the first commercial sale of a covered product in the applicable country.  Either party may terminate the agreement in the event of a material breach by the other party, subject to prior notice and the opportunity to cure.  Either party also may terminate the agreement for any reason upon 30 days’ prior written notice provided that all licenses granted by the terminating party to the non-terminating party will survive upon the express election of the non-terminating party.

 

The Company has assessed milestones under the revised authoritative guidance for research and development milestones and determined that the preclinical milestone payments, as defined in the agreement, meet the definition of a milestone as they are (i) events that can only be achieved in part on the Company’s past performance or upon the occurrence of a specific outcome resulting from the Company’s performance, (ii) there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) they result in additional payments being due to the Company. Clinical development and commercial milestone payments, however, currently do not meet these criteria as their achievement is solely based on the performance of Cempra.

 

In February 2012, Cempra completed an initial public offering at which time the Company’s equity interest in Cempra was converted to 125,646 shares of common stock.  The Company considers its equity interest in Cempra as available-for-sale (see Note 3).

 

In June 2012, Cempra completed its first Phase 2 clinical trial of solithromycin (CEM101) in patients with community-acquired bacterial pneumonia, which triggered a $1.0 million milestone payment in June 2012 to the Company.  The Company recorded the $1.0 million as a receivable in the second quarter of 2012 and expects to receive the payment from Cempra during the subsequent quarter. To date the Company has recognized $1.5 million in payments from this collaboration.

 

Optimer Biotechnology, Inc.

 

In October 2009, the Company entered into certain transactions involving OBI, its then wholly-owned subsidiary, to provide funding for the development of two of its early-stage programs.  The transactions with OBI included an Intellectual Property Assignment and License Agreement, pursuant to which the Company assigned to OBI certain patent rights, information and know-how related to OPT-822/821.  In anticipation of these transactions, the Company also assigned, and OBI assumed, its rights and obligations under a related license agreement with Memorial Sloan-Kettering Cancer Center (“MSKCC”).  Under the agreement, the Company is eligible to receive up to $10.0 million in milestone payments related to the development of OPT-822/821 and also is eligible to receive royalties on net sales of any product which is commercialized under the program.  The term of the Intellectual Property Assignment and License Agreement continues until the last to expire of the certain patents assigned to and licensed by the Company to OBI.

 

In January 2012, the Company and OBI executed a letter of agreement which provided the Company the right of first refusal if OBI or one of its affiliates receives any offer to obtain an exclusive, royalty-bearing license (including the right to sublicense) under the OPT-822/821 patents and the OBI OPT-822/821 technology to develop, make, have made, use, sell, offer for sale, have sold and import OPT-822/821 products in a specified territory.  As consideration for the grant of the right of first refusal, the Company waived certain of OBI’s obligations under the Intellectual Property Assignment and License Agreement. The agreement expires 10 years from the effective date of the agreement.

 

Memorial Sloan-Kettering Cancer Center

 

In July 2002, the Company entered into a license agreement with MSKCC to acquire, together with certain non-exclusive licenses, exclusive, worldwide licensing and sublicensing rights to certain patented and patent-pending carbohydrate-based cancer immunotherapies.  As partial consideration for the licensing rights, the Company paid to MSKCC a one-time fee consisting of both cash and 55,383 shares of its common stock.  In anticipation of the various transactions involving OBI which the Company completed in October 2009, the Company assigned its rights and obligations under this agreement to OBI.

 

The Scripps Research Institute (“TSRI”)

 

In July 1999, the Company acquired exclusive, worldwide rights to its OPopS technology from TSRI.  This agreement includes the license to the Company of patents, patent applications and copyrights related to OPopS technology.  The Company also acquired, pursuant to three separate license agreements with TSRI, exclusive, worldwide rights to over 20 TSRI patents and patent applications related to other potential drug compounds and technologies, including HIV/FIV protease inhibitors, aminoglycoside antibiotics, polysialytransferase, selectin inhibitors, nucleic acid binders, carbohydrate mimetics and osteoarthritis.  Under the four agreements with TSRI, the Company paid TSRI license fees consisting of an aggregate of 239,996 shares of the Company’s common stock with a deemed aggregate fair market value of $46,400, as determined on the dates of each such payment. In October 2009, the Company assigned to OBI one of the agreements with TSRI related to OPT-88 which, after further evaluation, OBI decided not to pursue. In February 2011, OBI and TSRI agreed to terminate the agreement and OBI returned the patents related to OPT-88. Under each of the three remaining agreements, the Company owes TSRI royalties based on net sales by the Company, the Company’s affiliates and sublicensees of the covered products and royalties based on revenue the Company generates from sublicenses granted pursuant to the agreements.  For the first licensed product under each of the three remaining agreements, the Company also will owe TSRI payments upon achievement of certain milestones.  In two of the three TSRI agreements, the milestones are the successful completion of a Phase 2 trial or its foreign equivalent, the submission of an NDA or its foreign equivalent and government marketing and distribution approval.  In the remaining TSRI agreement, the milestones are the initiation of a Phase 3 trial or its foreign equivalent, the submission of an NDA or its foreign equivalent and government marketing and distribution approval.  The aggregate potential amount of milestone payments the Company may be required to pay TSRI under the three remaining TSRI agreements is approximately $11.1 million.

 

Revenues from Research Grants

 

The Company has one grant from the National Institute of Allergy and Infectious Diseases. This $3.0 million grant was awarded in September 2007 for three years and was subsequently extended to August 2012. The award has been used to conduct supplementary studies to the DIFICID trials to confirm narrow-spectrum activity and potency of DIFICID against hypervirulent epidemic strains and to support additional toxicology studies.  The award is currently being used for microbiological studies to demonstrate the safety and efficacy of DIFICID and its major metabolite in CDAD patients and to support surveillance studies of C. difficile isolates across North America to compare the activity of DIFICID with existing CDAD treatments.  For the three months ended June 30, 2012 and 2011, the Company recognized revenues related to research grants of $0, and $33,294, respectively. For the six months ended June 30, 2012 and 2011, the Company recognized revenues related to research grants of $2,106, and $144,933, respectively.

 

XML 44 R14.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2012
Summary of Significant Accounting Policies  
Principles of Consolidation

Principles of Consolidation

 

The consolidated financial statements include all the accounts of the Company and its wholly-owned subsidiaries. Prior to February 7, 2012, Optimer Biotechnology Inc. (“OBI”) was consolidated for financial reporting purposes.  All intercompany balances and transactions have been eliminated in consolidation.

Cash, Cash Equivalents and Investments

Cash, Cash Equivalents and Investments

 

Investments with original maturities of less than 90 days at the date of purchase are considered to be cash equivalents.  Except for one auction rate preferred security (“ARPS”), all other investments are classified as short-term investments which are deemed by management to be available-for-sale and are reported at fair value with net unrealized gains or losses reported within comprehensive income (loss).  Realized gains and losses, and declines in value judged to be other than temporary, are included in investment income or interest expense.  The cost of securities sold is computed using the specific identification method. As of June 30, 2012, cash, cash equivalents and short-term investments totaled approximately $130.6 million.

 

Accounts Receivable

Accounts Receivable

 

Trade accounts receivable are recorded net of reserves for estimated chargeback obligations, prompt-payment discounts, service fee arrangements and any allowance for doubtful accounts. Reserves for other sales-related allowances such as rebates, distribution and other fees, and product returns are included in accrued expenses in the Company’s consolidated balance sheet. The allowance for prompt-pay discounts and service fee arrangements was $1.4 million and $1.6 million at June 30, 2012 and December 31, 2011, respectively.

 

Inventory

Inventory

 

Inventory is stated at the lower of cost or market.  Cost is determined in a manner which approximates the first-in, first-out (“FIFO”) method. The Company capitalized inventory produced in preparation for product launches upon FDA approval, as costs are expected to be recoverable through the commercialization of the product.  The Company reserves for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales.  Net inventory consisted of the following as of the dates indicated:

 

 

 

June 30,

 

December 31,

 

 

 

2012

 

2011

 

Raw materials

 

$

6,633,880

 

$

1,815,696

 

Work in process

 

553,186

 

1,321,763

 

Finished goods

 

1,316,863

 

809,921

 

 

 

8,503,929

 

3,947,380

 

Reserves

 

(541,817

)

 

 

 

$

7,962,112

 

$

3,947,380

 

 

Investment in OBI

Investment in OBI

 

Beginning as of February 7, 2012, the Company accounted for its investment in OBI under the equity method of accounting as the Company ceased to have voting control or other elements of control that would require consolidation. Prior to February 7, 2012, OBI was consolidated for financial reporting purposes. The investment is subsequently adjusted for the Company’s share in equity in net income (loss) and cash contributions and distributions. In addition, the Company records adjustments to reflect the amortization of basis differences attributable to the fair values in excess of net book values of identified tangible and intangible assets which were generated at the date of deconsolidation.  Any difference between the carrying amount of the investment on the Company’s balance sheet and the underlying equity in net assets is evaluated for impairment at each reporting period. As of June 30, 2012, the Company’s investment in OBI was $29.0 million.

 

Foreign Currency Translation

Foreign Currency Translation

 

The functional currency for the Company’s foreign subsidiaries is the local currency. Assets and liabilities denominated in foreign currencies are translated using the exchange rates on the balance sheet dates. Net revenues and expenses are translated using the average exchange rates prevailing during the period. Any translation adjustments resulting from this process are shown separately as a component of accumulated other comprehensive income (loss) within stockholders’ equity in the consolidated balance sheets. Foreign currency transaction gains and losses are reported in operating expenses, net in the consolidated statements of operations.

 

Fair Value of Financial Instruments

Fair Value of Financial Instruments

 

The carrying amount of cash and cash equivalents, short-term investments, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of these instruments.  The fair value of available-for-sale securities is based upon quoted market prices for these securities.

 

Reclassifications

Reclassifications

 

The Company has reclassified certain prior-period amounts to conform to the current period presentation.  Specifically, it has consolidated its sales and marketing expense and its general and administrative expenses into a single selling, general and administrative expense category.  This reclassification has no impact on the net loss from operations or stockholders’ equity as previously reported.

Net Product Sales

Net Product Sales

 

DIFICID is available in the United States and Canada through national and regional wholesalers that provide DIFICID to hospital and retail pharmacies and to long-term care facilities. The Company recognizes revenue from product sales when there is persuasive evidence of an arrangement, delivery has occurred, title has passed to the customer, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, the amount of returns can be reasonably estimated and collectability is reasonably assured. The Company recognizes revenue from product sales of DIFICID upon delivery of product to the wholesalers.

 

The Company’s net product sales represent total product sales less allowances for customer credits, including estimated rebates, chargebacks, discounts and returns. These allowances are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Allowances for rebates, chargebacks, discounts and returns are established based on the contractual terms with customers, communications with customers as well as expectations about the market for the product and anticipated introduction of competitive products.  Product shipping and handling costs are included in cost of product sales.

 

Product Sales Allowances.  The Company establishes reserves for prompt-payment discounts, fee-for-service arrangements, government rebates, product returns and other applicable allowances.

 

Allowances relate to prompt-payment discounts and fee-for-service arrangements with the Company’s contracted wholesalers and are recorded at the time of sale, resulting in a reduction in product sales revenue.  Accruals related to government rebates, product returns and other applicable allowances are recognized at the time of sale, resulting in a reduction in product sales revenue and an increase in accrued expenses.

 

Prompt-payment Discounts.  The Company offers a prompt-payment discount to its contracted wholesalers.  Since the Company expects its customers will take advantage of this discount, the Company accrues 100% of the prompt payment discount that is based on the gross amount of each invoice, at the time of sale.  The accrual is adjusted quarterly to reflect actual earned discounts.

 

Government Rebates and Chargebacks.  The Company estimates government-mandated rebates and discounts relating to federal and state programs such as Medicaid, Veterans’ Administration (“VA”) and Department of Defense programs, the Medicare Part D Coverage Discount Program and certain other qualifying federal and state government programs.  The Company estimates the amount of these reductions based on DIFICID patient data, actual sales data and market research data related to payor mix.  These allowances are adjusted each period based on actual experience.

 

Medicaid rebate reserves relate to the Company’s estimated obligations to states under statutory “best price” obligations which also may include supplemental rebate agreements with certain states.  Rebate accruals are recorded during the same period in which the related product sales are recognized.  Actual rebate amounts are determined at the time of claim by the state, and the Company will generally make cash payments for such amounts after receiving billings from the state.

 

VA rebates or chargeback reserves represent the Company’s estimated obligations resulting from contractual commitments to sell DIFICID to qualified healthcare providers at a price lower than the list price charged to the Company’s distributors.  The distributor will charge the Company for the difference between what the distributor pays for the product and the ultimate selling price to the qualified healthcare provider.  Rebate accruals are established during the same period in which the revenue from the related product sales is recognized. Actual chargeback amounts for Public Health Service are determined at the time of resale to the qualified healthcare provider from the distributor, and the Company will generally issue credits for such amounts after receiving notification from the distributor.

 

Although allowances and accruals are recorded at the time of product sale, certain rebates generally will be paid, on average, up to six months or longer after the sale.  Reserve estimates are evaluated quarterly and, if necessary, adjusted to reflect actual results.  Any such adjustments will be reflected in the Company’s operating results in the period of the adjustment.

 

Product Returns.  The Company’s policy is to accept returns of DIFICID for six months prior to, and twelve months after, the product expiration date.  The Company also permits returns if the product is damaged or defective when received by its customers. The Company will provide a credit for such returns to customers with whom the Company has a direct relationship. Once product is dispensed, it cannot be returned, but the Company allows partial returns in states where such returns are mandated. The Company does not exchange product from inventory for the returned product.

 

Allowances for product returns are recorded during the period in which the related product sales are recognized, resulting in a reduction to product revenue.  The Company estimates product returns based upon historical trends in the pharmaceutical industry and trends for similar products sold by others.

 

Contract Revenue

Contract Revenue

 

In order to determine the revenue recognition for contingent milestones, the Company evaluates the contingent milestones at the inception of a collaboration agreement.

 

Accounting Standard Codification (“ASC”) Topic 605-28, Revenue Recognition — Milestone Method (“ASC 605-28”), established the milestone method as an acceptable method of revenue recognition for certain contingent, event-based payments under research and development arrangements.  Under the milestone method, a payment that is contingent upon the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved.  A milestone is an event (i) that can be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company.  The determination that a milestone is substantive is judgmental and is made at the inception of the arrangement.  Milestones are considered substantive when the consideration earned from the achievement of the milestone is (i) commensurate with either the Company’s performance to achieve the milestone or the enhancement of value of the item delivered as a result of a specific outcome resulting from the Company’s performance to achieve the milestone, (ii) relates solely to past performance and (iii) is reasonable relative to all deliverables and payment terms in the arrangement.

 

Other contingent, event-based payments received for which payment is either contingent solely upon the passage of time or the results of a collaborative partner’s performance are not considered milestones under ASC 605-28.  In accordance with ASC Topic 605-25, Revenue Recognition — Multiple-Element Arrangements, such payments will be recognized as revenue when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured.

 

Revenues recognized for royalty payments, if any, are recognized as earned in accordance with the terms of various research and collaboration agreements.

 

For collaboration agreements with multiple deliverables, the Company recognizes collaboration revenues and expenses by analyzing each element of the agreement to determine if it is to be accounted for as a separate element or single unit of accounting. If an element is to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue is to be recognized. If an element is not to be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue is to be recognized.

 

Cash received in advance of services being performed is recorded as deferred revenue and recognized as revenue as services are performed over the applicable term of the agreement. In connection with certain research and collaboration agreements, revenues are recognized from non-refundable up-front fees, that the Company does not believe are specifically tied to a separate earnings process, ratably over the term of the agreement.  Research fees are recognized as revenue as the related research activities are performed.

 

With respect to revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with grants, where the Company acts as a principal, with discretion to choose suppliers, bears credit risk and performs part of the services required in the transaction, the Company records revenue for the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in the consolidated statements of operations.

 

None of the payments that the Company has received from collaborators to date, whether recognized as revenue or deferred, is refundable even if the related program is not successful.

 

Research and Development Expense

Research and Development Expense

 

The Company expenses costs related to research and development until technological feasibility has been established for the product.  Once technological feasibility is established, all product costs are generally capitalized until the product is available for general release to customers.  The Company has determined that technological feasibility for its product candidates will be reached when the requisite regulatory approvals are obtained to make the product available for sale which, in the United States, generally occurs upon the approval of the New Drug Application (“NDA”) for such product.

 

The Company’s research and development expenses consist primarily of license fees, salaries and related employee benefits, costs associated with clinical trials managed by contract research organizations and costs associated with non-clinical activities and regulatory approvals.  The Company uses external service providers and vendors to conduct clinical trials, to manufacture supplies of product candidates to be used in clinical trials and to provide various other research and development-related products and services.

 

When non-refundable payments for goods or services to be received in the future for use in research and development activities are made, the Company defers and capitalizes these types of payments. The capitalized amounts are expensed when the related goods are delivered or the services are performed.

 

Net Income (Loss) Per Share Attributable to Common Stockholders

Net Income (Loss) per Share Attributable to Common Stockholders

 

Basic net income (loss) per common share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted-average number of common shares and dilutive common stock equivalents then outstanding. Common stock equivalents consist of common shares issuable upon the exercise of stock options and warrants and upon the vesting of restricted stock units.

 

Income Taxes

Income Taxes

 

Income taxes are accounted for under the asset and liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income in the period that includes the enactment date.  The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized.

 

Segment Reporting

Segment Reporting

 

Our management has determined that we operate in one business segment which is the development and commercialization of pharmaceutical products.

 

XML 45 R16.htm IDEA: XBRL DOCUMENT v2.4.0.6
Fair Value of Financial Instruments (Tables)
6 Months Ended
Jun. 30, 2012
Fair Value of Financial Instruments  
Schedule of the Company's financial assets measured at fair value

The following table summarizes the Company’s financial assets measured at fair value as of June 30, 2012:

 

 

 

Quoted Prices in
Active Markets

(Level 1)

 

Other
Observable
Inputs

(Level 2)

 

Unobservable
Inputs

(Level 3)

 

Total

 

Cash equivalents

 

$

98,131,193

 

$

 

$

 

$

98,131,193

 

Marketable securities

 

 

29,758,727

 

 

29,758,727

 

Auction rate preferred securities

 

 

 

882,000

 

882,000

 

Investment in Cempra

 

1,176,047

 

 

 

1,176,047

 

 

 

$

99,307,240

 

$

29,758,727

 

$

882,000

 

$

129,947,967

 

 

Reconciliation of the beginning and ending balances of assets measured at fair value on a recurring basis using Level 3 inputs

 

 

 

Auction Rate
Preferred
Securities

 

Beginning balance at January 1, 2012

 

$

882,000

 

Total gains and losses:

 

 

 

Realized net income

 

 

Unrealized in accumulated other comprehensive income

 

 

Purchases, sales, issuances and settlements

 

 

Transfers in (out) of Level 3

 

 

Ending balance at June 30, 2012

 

$

882,000

 

Change in unrealized gains (losses) included in net income related to assets still held

 

$

 

 

XML 46 R21.htm IDEA: XBRL DOCUMENT v2.4.0.6
Interim Financial Information (Details)
6 Months Ended
Jun. 30, 2012
item
Interim Financial Information  
Number of approved anti-infective products for the treatment of CDAD 1
Number of subsidiaries owned 2
XML 47 R26.htm IDEA: XBRL DOCUMENT v2.4.0.6
Short-term Investments (Details 2) (USD $)
3 Months Ended 12 Months Ended
Jun. 30, 2012
Dec. 31, 2011
Amortized Cost    
Due in one year or less $ 29,743,040  
Fair value, by contractual maturity    
Due in one year or less $ 29,758,727  
Weighted-average maturity of short-term investments 3 months 7 months
XML 48 R5.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Statements of Cash Flows (USD $)
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Operating activities:    
Net income (loss) $ (11,497,002) $ 19,919,736
Adjustments to reconcile net income (loss) to net cash provided (used) in operating activities:    
Depreciation and amortization 390,874 206,406
Stock-based compensation 7,058,709 4,687,680
Issuance of common stock for consulting services and other 1,923,763 2,793,514
Deferred rent 26,733 42,377
Gain on de-consolidation of OBI (23,782,229)  
Equity in net loss of OBI 1,154,821  
Changes in operating assets and liabilities:    
Trade accounts receivable, net 1,251,213  
Accounts receivable, other 48,889,506 (5,380,204)
Inventory (4,014,732) (25,405)
Prepaid expenses and other current assets (1,131,761) (1,369,482)
Other assets (88,424) (734,333)
Accounts payable and accrued expenses 8,336,602 7,126,305
Deferred revenues 245,319  
Net cash provided in operating activities 28,763,392 27,266,594
Investing activities:    
Purchases of short-term investments   (91,899,393)
Sales or maturities of short-term investments 38,744,220 25,165,000
Purchases of property and equipment (1,721,109) (1,681,166)
Reduction of cash due to de-consolidation of OBI (4,010,680)  
Purchase of OBI common stock (468,748)  
Proceeds from sale of OBI common stock 2,027,109  
Net cash provided (used) by investing activities 34,570,792 (68,415,559)
Financing activities:    
Proceeds from sale of common stock 4,255,338 82,270,022
Net cash provided by financing activities 4,255,338 82,270,022
Effect of exchange rate changes on cash and cash equivalents 326,273 419,548
Net increase in cash and cash equivalents 67,915,795 41,540,605
Cash and cash equivalents at beginning of period 31,787,512 19,861,924
Cash and cash equivalents at end of period $ 99,703,307 $ 61,402,529
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Investment in OBI
6 Months Ended
Jun. 30, 2012
Investment in OBI  
Investment in OBI

 

 

5.              Investment in OBI

 

In February 2012, OBI issued 36 million newly-issued shares of its common stock resulting in gross proceeds of approximately 540 million New Taiwan dollars (approximately $18.3 million based on then-current exchange rates).  The Company did not participate in the February 2012 financing.  In March 2012, the Company sold 1.5 million shares of its equity interest in OBI.  These transactions reduced the Company’s ownership interest in OBI from a majority interest to a 42.9% interest and triggered consideration regarding whether or not to continue consolidating OBI, as well as an evaluation to consider whether OBI was a variable interest entity (‘VIE”).  As a result of its evaluation, the Company determined that OBI was not a VIE and that Optimer no longer had voting control or other forms of control over the operations and decision making of OBI. As a result of this evaluation, the Company de-consolidated OBI as of February 7, 2012 and de-recognized the OBI assets, liabilities and non-controlling interest from its financial statements. Management applied de-consolidation accounting guidance, which included analyzing Optimer’s investment in OBI at February 7, 2012 to determine the fair value on the date of de-consolidation and the related gain or loss upon de-consolidation. Based on a preliminary valuation, management determined that the fair value of Optimer’s investment in OBI at February 7, 2012 was $29.7 million.  This fair value was based primarily on OBI’s financing transaction in February 2012 in which shares of common stock were sold at approximately $0.51 per share (based on then-current exchange rates).  As a significant portion of the additional investment in OBI was made by outside investors in an arms-length transaction, management determined that this price per share approximated fair market value as of February 7, 2012. In the financing transaction, OBI sold common shares which have the same rights and preferences as the shares held by Optimer.

 

For the six months ended June 30, 2012, the gain attributed to the de-consolidation of OBI was $23.8 million. During the period ended June 30, 2012, Optimer provided consulting, purchasing and other services to OBI. At this time there is no written contract or agreement for services between OBI and Optimer.

 

As of the date of de-consolidation, the Company accounts for its investment in OBI under the equity method. The investment is subsequently adjusted for Optimer’s share in the equity in net income (loss) and cash contributions and distributions. In addition, the Company records adjustments to reflect the amortization of basis differences attributable to the fair values in excess of net book values of identified tangible and intangible assets.  Based on a preliminary valuation, the fair value in excess of book value can be attributed to in-process research and development related to a License and Collaboration Agreement for fidaxomicin and an Intellectual Property Assignment and License Agreement related to OBI’s OPT-822/821 program (see Note 8). For the period post de-consolidation, the Company’s equity method investment in OBI has been reduced by $1.2 million to reflect its share in OBI losses during that period. Any difference between the carrying amount of the investment on the Company’s balance sheet and the underlying equity in net assets is evaluated for impairment at each reporting period.

 

On May 2, 2012, the Company purchased, at cost, 924,000 shares in OBI from the Company’s President and Chief Executive Officer for approximately $0.5 million, resulting in an increase in the fair value of the Company’s investment in OBI. As of June 30, 2012, the Company had a 43.6% ownership interest in OBI that was valued at $29.0 million.

 

XML 50 R27.htm IDEA: XBRL DOCUMENT v2.4.0.6
Investment in OBI (Details)
3 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended
Jun. 30, 2012
USD ($)
Jun. 30, 2012
USD ($)
Mar. 31, 2012
OBI
Feb. 29, 2012
OBI
USD ($)
Feb. 29, 2012
OBI
TWD
Jun. 30, 2012
OBI
USD ($)
Feb. 07, 2012
OBI
USD ($)
May 02, 2012
OBI
Chief Executive officer
USD ($)
Noncontrolling Interest                
Shares of common stock issued       36,000,000 36,000,000      
Gross proceeds from newly-issued shares of common stock       $ 18,300,000 540,000,000      
Equity interest sold (in shares)     1,500,000          
Ownership interest (as a percent)           42.90%    
Fair value of investment             29,700,000  
Sale price of stock per share (in dollars per share)       $ 0.51        
Gain attributed to the deconsolidation of OBI   23,782,229       23,800,000    
Equity in net loss of OBI 668,852 1,154,821       1,200,000    
Shares purchased at cost               924,000
Value of shares purchased               500,000
Ownership interest (as a percent)           43.60%    
Investment in OBI $ 29,013,792 $ 29,013,792       $ 29,000,000    
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Other Collaborative Agreements (Tables)
6 Months Ended
Jun. 30, 2012
Other Collaborative Agreements  
Summary of accrued expenses related to co-promotion agreement with Cubist

 

 

Expenses

 

Six Months
Ended
June 30, 2012

 

Target bonus and portion of gross profit payments

 

$

7,880,000

 

Service fees

 

2,523,000

 

Total

 

$

10,403,000