-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NtEMU/30AnLKXpcBFTH5a9IFYLM1xvRoc0fkMaQ/z2h8lU48s6PMzVyrDFyg4g9W 21owmlHwzMXqsXwX7QJsyQ== 0001104659-10-026150.txt : 20100506 0001104659-10-026150.hdr.sgml : 20100506 20100506112112 ACCESSION NUMBER: 0001104659-10-026150 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100506 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Submission of Matters to a Vote of Security Holders ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100506 DATE AS OF CHANGE: 20100506 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: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33291 FILM NUMBER: 10804693 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 8-K 1 a10-9570_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported)

May 6, 2010

 


 

OPTIMER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-33291

 

33-0830300

(State or other jurisdiction of

 

(Commission File Number)

 

(IRS Employer

incorporation)

 

 

 

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)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02    Results of Operations and Financial Condition.

 

On May 6, 2010, the Company issued a press release announcing its unaudited financial results for the first quarter ended March 31, 2010.  A copy of this press release is attached hereto as Exhibit 99.1.

 

This information and the exhibits hereto are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 5.07.  Submission of Matters to a Vote of Security Holders.

 

At the Company’s 2010 Annual Meeting of Stockholders held on May 5, 2010, our stockholders voted on two items, the outcomes of which are set forth below.

 

Proposal 1 – Election of Directors

 

Our stockholders re-elected Mark Auerbach and Joseph Y. Chang, Ph.D. to serve as directors of the Company until the 2013 Annual Meeting of Stockholders and until their respective successors are elected and qualified. The following votes were tabulated with respect to the election of directors:

 

Director Elected

 

Number of Shares
Voted For

 

Number of Shares Voted
Against or Withheld

 

Mark Auerbach

 

23,248,550

 

58,692

 

Joseph Y. Chang, Ph.D.

 

23,232,277

 

74,965

 

 

Proposal 2 – Ratification of the Selection of Ernst & Young, LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2010.

 

Our stockholders ratified the selection of Ernst & Young, LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2010. The following votes were tabulated with respect to the ratification:

 

For

 

Against

 

Abstain

 

30,329,191

 

197,558

 

7,793

 

 

Item 9.01     Financial Statements and Exhibits.

 

(d)  Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated May 6, 2010.

 

2



 

SIGNATURES

 

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 hereunto duly authorized.

 

 

 

OPTIMER PHARMACEUTICALS, INC.

 

 

 

 

By:

/s/ John D. Prunty

 

 

John D. Prunty
Chief Financial Officer (Duly Authorized Officer and
Principal Financial and Accounting Officer)

 

Date:  May 6, 2009

 

3


 

EX-99.1 2 a10-9570_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Optimer Pharmaceuticals Reports First Quarter 2010 Financial Results

 

SAN DIEGO — May 6, 2010 - Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced its financial results for the quarter ended March 31, 2010.

 

Optimer reported a net loss for the first quarter of 2010 of $13.5 million, or $0.39 per share which was in line with the Company’s expectations.  This compares to a net loss for the first quarter of 2009 of $10.9 million, or $0.36 per share.  Research and development expenses in the first quarter of 2010 were $11.4 million compared to $8.9 million in the first quarter of 2009.  The increase was primarily due to the accrual of a $5.0 million milestone payment due to Par Pharmaceutical Companies, Inc. and related to the successful completion of the second fidaxomicin Phase 3 trial, and was partially offset by a decrease in Pruvel™ development related expenses.

 

As of March 31, 2010, Optimer held cash, cash equivalents and short-term investments of $81.2 million.

 

“In the first quarter of 2010, we announced results from our second fidaxomicin Phase 3 study confirming results from our first fidaxomicin Phase 3 study and are now focused on our regulatory filings for both fidaxomicin and Pruvel™,” said Michael N. Chang, Ph.D., Chairman of Optimer’s Board of Directors. “Pedro Lichtinger joining the team as chief executive officer comes at the optimal time to lead the company in its transition into a commercial organization.”

 

Recent Corporate Highlights

 

·                 Pedro Lichtinger succeeded Michael N. Chang, Ph.D. as the Company’s President and Chief Executive Officer and also was appointed to the Company’s Board of Directors.  Dr. Chang will remain on the Company’s Board of Directors as the Chairman and serve as a consultant.  Mr. Lichtinger joins Optimer with more than 30 years of global experience in the pharmaceutical industry.  He served as an executive of Pfizer, Inc. from 1995 to 2009, most recently as President of Pfizer’s Global Primary Care Business Unit, where he oversaw operations in North America, Europe, Korea, and Australia with revenues of $23 billion and 15,000 employees.

 

·                 Additional data from Optimer’s second Phase 3 study of fidaxomicin showed that among subjects receiving concomitant antibiotics, treatment with fidaxomicin resulted in lower recurrence rates compared to vancomycin (17.6% vs. 29.5%, p=0.027) and improved global cure rates (67.5% vs. 53.4%, p=0.020).  Clinical investigator, Stuart Johnson, M.D., presented this data at the Digestive Disease Week (DDW) conference earlier this week.

 



 

·                 Top-line data from Optimer’s second Phase 3 study of fidaxomicin was presented for the first time by clinical investigator, Derrick Crook, M.D., at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in April. Dr. Crook also presented additional data on the strain type subgroups BI/NAP1/027 and non-BI/NAP1/027 which showed fidaxomicin had a clinically meaningful reduction in recurrence rates and higher global cure rates compared to vancomycin in both strain type subgroups.

 

·                 Raised $51.2 million in net proceeds in a public offering of common stock in March.

 

About Optimer Pharmaceuticals

 

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infectives to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection. Optmer has reported positive top-line results from two Phase 3 trials of fidaxomicin.  Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea.  Optimer has also successfully completed two Phase 3 trials with Pruvel.  Additional information can be found at http://www.optimerpharma.com.

 

Forward-looking Statements

 

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the development of fidaxomicin and Pruvel, anticipated benefits of Mr. Lichtinger joining the Company and the timing of anticipated regulatory submissions. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer’s business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs, uncertainty regarding regulatory requirements for approval and the timing of regulatory submissions, and other risks detailed in Optimer’s filings with the Securities and Exchange Commission.

 

Contacts

 

Optimer Pharmaceuticals, Inc.

John Prunty, CFO & VP, Finance

Christina Donaghy, Corporate Communications Manager

858-909-0736

 

Canale Communications, Inc.

Jason I. Spark, Senior Vice President

619-849-6005

 



 

Optimer Pharmaceuticals, Inc.

Consolidated Statements of Operations

(unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

Research grants

 

$

297,437

 

$

83,012

 

Operating expenses:

 

 

 

 

 

Research and development

 

11,361,579

 

8,914,072

 

Marketing

 

268,594

 

194,796

 

General and administrative

 

2,388,712

 

2,048,500

 

Total operating expenses

 

14,018,885

 

11,157,368

 

Loss from operations

 

(13,721,448

)

(11,074,356

)

Interest income and other, net

 

24,778

 

186,968

 

Consolidated net loss

 

$

(13,696,670

)

$

(10,887,388

)

Net loss attributable to noncontrolling interest

 

200,915

 

 

Net loss attributable to Optimer Pharmaceuticals, Inc.

 

$

(13,495,755

)

$

(10,887,388

)

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.39

)

$

(0.36

)

 

 

 

 

 

 

Shares used to compute basic and diluted net loss per share

 

35,001,596

 

30,535,577

 

 

Optimer Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

 

 

 

March 31

 

December 31,

 

 

 

2010

 

2009

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

48,181,074

 

$

17,054,328

 

Short-term investments

 

33,024,013

 

21,131,145

 

Prepaid expenses and other current assets

 

1,093,976

 

416,859

 

Total current assets

 

82,299,063

 

38,602,332

 

Property and equipment, net

 

727,303

 

672,896

 

Long-term investments

 

882,000

 

882,000

 

Other assets

 

499,150

 

498,762

 

Total assets

 

$

84,407,516

 

$

40,655,990

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

5,019,592

 

$

2,625,240

 

Accrued expenses

 

7,541,375

 

5,025,669

 

Total current liabilities

 

12,560,967

 

7,650,909

 

Deferred rent

 

226,143

 

253,474

 

Commitments and contingencies

 

 

 

Stockholders’ equity

 

71,620,406

 

32,751,607

 

Total liabilities and stockholders’ equity

 

$

84,407,516

 

$

40,655,990

 

 


 

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