0001104659-13-074919.txt : 20131009 0001104659-13-074919.hdr.sgml : 20131009 20131009165101 ACCESSION NUMBER: 0001104659-13-074919 CONFORMED SUBMISSION TYPE: 8-K/A PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20130726 ITEM INFORMATION: Completion of Acquisition or Disposition of Assets ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131009 DATE AS OF CHANGE: 20131009 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DEPOMED INC CENTRAL INDEX KEY: 0001005201 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943229046 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K/A SEC ACT: 1934 Act SEC FILE NUMBER: 001-13111 FILM NUMBER: 131143730 BUSINESS ADDRESS: STREET 1: 7999 GATEWAY BLVD. STREET 2: SUITE 300 CITY: NEWARK STATE: CA ZIP: 94560 BUSINESS PHONE: 510-744-8000 MAIL ADDRESS: STREET 1: 7999 GATEWAY BLVD. STREET 2: SUITE 300 CITY: NEWARK STATE: CA ZIP: 94560 8-K/A 1 a13-21932_18ka.htm 8-K/A

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 8-K/A

 

Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  July 26, 2013

 

DEPOMED, INC.

(Exact name of registrant as specified in its charter)

 

001-13111

(Commission File Number)

 

California

 

94-3229046

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation)

 

 

 

7999 Gateway Blvd, Suite 300, Newark, California 94560

(Address of principal executive offices, with zip code)

 

(510) 744-8000

(Registrant’s telephone number, including area code)

 

Not Applicable

(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 2.01              Completion of Acquisition or Disposition of Assets

 

On August 1, 2013, Depomed, Inc., a California corporation (“Depomed”), filed a Current Report on Form 8-K (the “Initial Report”) reporting Depomed’s acquisition from each of Archimedes Pharma US Inc., a Delaware corporation, Archimedes Pharma Ltd., a corporation registered under the laws of England and Wales, and Archimedes Development Ltd., a company registered under the laws of England and Wales (collectively, “Archimedes”), all of the U.S. and Canadian rights to Lazanda® (fentanyl) nasal spray (“Lazanda”).

 

This Current Report on Form 8-K/A (this “Current Report”) amends the Initial Report to include the financial statements, pro forma financial information and consent specified below.

 

Item 9.01              Financial Statements and Exhibits

 

(a)                                 Financial Statements of Businesses Acquired

 

Archimedes has advised Depomed that is impracticable to prepare complete financial statements related to Lazanda in order to enable Depomed to file such financial statements as required by Rule 3-05 of Regulation S-X in connection with Depomed’s acquisition of Lazanda.  Archimedes has further advised Depomed that Lazanda was not maintained within a separate legal entity of Archimedes and that separate audited financial statements relating to Lazanda were never prepared or maintained by Archimedes.  As a result, Depomed is filing as Exhibit 99.1 to this Current Report the following financial statements and notes thereto related to Lazanda for purposes of complying with the requirements of Rule 3-05 of Regulation S-X (collectively, the “Lazanda Financial Statements”), which are incorporated herein by reference:

 

·                  the audited statement of net revenues and direct expenses relating to Lazanda for the two year period ended December 31, 2012 ;

 

·                  the audited statement of assets acquired and liabilities assumed as of December 31, 2012 and 2011;

 

·                  the unaudited statement of assets acquired and liabilities assumed as of June 30, 2013; and

 

·                  the unaudited statements of net revenues and direct expenses relating to Lazanda for the six months ended June 30, 2013 and 2012.

 

Pursuant to a letter dated August 21, 2013 (the “Letter”) from the staff of the Division of Corporate Finance (the “Division”) of the Securities and Exchange Commission, the Division stated that it will not object to Depomed’s conclusion that the filing of the above-identified financial statements represents substantial compliance with the requirements of Rule 3-05 of Regulation S-X.

 

(b)         Pro Forma Financial Information

 

The unaudited pro forma condensed combined balance sheet as of June 30, 2013 reflecting Depomed’s acquisition of Lazanda is filed as Exhibit 99.2 to this Current Report and is incorporated herein by reference (the “Unaudited Pro Forma Balance Sheet”).

 

Pursuant to the Letter, the Division further stated that it would waive the requirement to provide a pro forma statement of operations if the use of forward-looking information is necessary to meaningfully present the effects of the acquisition of Lazanda by Depomed. Depomed’s expense structure and commercialization infrastructure related to Lazanda are anticipated to differ significantly from the expense structure and commercialization infrastructure maintained by Archimedes with regard to Lazanda.  As a result, Depomed has concluded that the use of forward-looking information is necessary to meaningfully present the effects of the acquisition. Based on the guidance provided by the Division in the Letter, Depomed is not filing a pro forma statement of operations with this Current Report.

 

2



 

(d)           Exhibits

 

Exhibit
Number

 

Description

 

 

 

23.1

 

Consent of KPMG LLP

 

 

 

99.1

 

Lazanda Financial Statements

 

 

 

99.2

 

Unaudited Pro Forma Condensed Combined Balance Sheet and the notes related thereto

 

Cautionary Note Regarding Forward-Looking Statements

 

This current report on Form 8-K/A contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended.  We have based these forward-looking statements on our current expectations and projections about future events.  Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “will,” “may” and other similar expressions.  In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.

 

3



 

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.

 

 

 

DEPOMED, INC.

 

 

 

 

Date: October 9, 2013

By:

/s/ Matthew M. Gosling

 

 

Matthew M. Gosling

 

 

Senior Vice President and General Counsel

 

4



 

EXHIBIT INDEX

 

Exhibit
Number

 

Description

 

 

 

23.1

 

Consent of KPMG LLP

 

 

 

99.1

 

Lazanda Financial Statements

 

 

 

99.2

 

Unaudited Pro Forma Condensed Combined Balance Sheet and the notes related thereto

 

5


EX-23.1 2 a13-21932_1ex23d1.htm EX-23.1

Exhibit 23.1

 

CONSENT OF INDEPENDENT AUDITORS

 

We consent to the incorporation by reference in the registration statements (Nos. 333-156539 and 333-181709) on Form S-3, and (Nos. 333-66923, 333-85419, 333-54982, 333-101796, 333-105994, 333-167015, 333-116697, 333-145291, 333-156538 and 333-181710) on Form S-8 of Depomed, Inc. (Depomed) of our report dated September 27, 2013, with respect to the statements of assets acquired and liabilities assumed by Depomed pursuant to an Asset Purchase Agreement dated July 29, 2013, of Lazanda (a Product Line of Archimedes Pharma Ltd.) as of December 31, 2012 and 2011 and related statements of net revenues and direct expenses for the years then ended which report appears in the Form 8-K/A of Depomed dated October 9, 2013.

 

 

/s/ KPMG LLP

 

Short Hills, New Jersey

October 9, 2013

 


EX-99.1 3 a13-21932_1ex99d1.htm EX-99.1

Exhibit 99.1

 

LAZANDA

(A Product Line of Archimedes Pharma Ltd.)

 

Financial Statements

 

December 31, 2012 and 2011

 

(With Independent Auditors’ Report Thereon)

 



 

Independent Auditors’ Report

 

The Board of Directors

Archimedes Pharma Ltd.:

 

Report on the Financial Statements

 

We have audited the accompanying statements of assets acquired and liabilities assumed by Depomed, Inc. (Depomed) pursuant to an Asset Purchase Agreement (Asset Purchase Agreement) dated July 29, 2013, of Lazanda (a Product Line of Archimedes Pharma Ltd.) as of December 31, 2012 and 2011 and related statements of net revenues and direct expenses for the years then ended, and the related notes to the financial statements.

 

Management’s Responsibility for the Financial Statements

 

Management is responsible for the preparation and fair presentation of the financial statements in accordance with U.S. generally accepted accounting principles; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of the financial statements that are free from material misstatement, whether due to fraud or error.

 

Auditors’ Responsibility

 

Our responsibility is to express an opinion on the financial statements based on our audits. We conducted our audit in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.

 

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditors’ judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

 

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

 

Opinion

 

In our opinion, the financial statements referred to above present fairly in all material respects, the assets acquired and liabilities assumed of Lazanda as of December 31, 2012 and 2011, and the net revenues and direct expenses for the years then ended, in accordance with U.S. generally accepted accounting principles.

 



 

Emphasis of Matter

 

As described in note 2, the financial statements referred to above have been prepared on a basis consistent with the Asset Purchase Agreement between Archimedes and Depomed and are not intended to be a complete presentation of the financial position or results of operations of Lazanda.

 

/s/ KPMG LLP

 

 

 

Short Hills, New Jersey

 

September 27, 2013

 

 

2



 

LAZANDA

(A Product Line of Archimedes Pharma Ltd.)

 

Statements of Assets Acquired and Liabilities Assumed

 

December 31, 2012 and 2011 and

June 30, 2013

 

(U.S. dollars in thousands)

 

 

 

December 31

 

June 30,

 

 

 

2012

 

2011

 

2013

 

 

 

 

 

 

 

(Unaudited)

 

Assets acquired:

 

 

 

 

 

 

 

Inventory, net:

 

 

 

 

 

 

 

Finished goods

 

$

792

 

1,041

 

145

 

Work in process

 

126

 

96

 

133

 

Raw materials and components

 

1,018

 

2,232

 

647

 

Total inventory, net

 

1,936

 

3,369

 

925

 

Machinery and equipment, net

 

407

 

470

 

375

 

Total assets acquired

 

$

2,343

 

3,839

 

1,300

 

Liabilities assumed:

 

 

 

 

 

 

 

Accrued expenses

 

$

240

 

 

240

 

Total liabilities assumed

 

$

240

 

 

240

 

 

See accompanying notes to financial statements.

 

3



 

LAZANDA

(A Product Line of Archimedes Pharma Ltd.)

 

Statements of Net Revenues and Direct Expenses

 

Years ended December 31, 2012 and 2011 and

the six-month periods ended June 30, 2013 and 2012

 

(U.S. dollars in thousands)

 

 

 

 

 

 

 

Six month periods ended

 

 

 

Year ended December 31

 

June 30

 

 

 

2012

 

2011

 

2013

 

2012

 

 

 

 

 

 

 

(Unaudited)

 

Net product revenue and cost of goods sold:

 

 

 

 

 

 

 

 

 

Net product revenue

 

$

984

 

52

 

1,622

 

510

 

Cost of product sold

 

1,610

 

1,349

 

1,032

 

36

 

Gross profit(loss)

 

(626

)

(1,297

)

590

 

474

 

Direct costs and operating expenses:

 

 

 

 

 

 

 

 

 

Marketing and selling

 

16,056

 

17,227

 

4,410

 

12,140

 

Distribution and supply

 

1,122

 

945

 

110

 

560

 

Research and development

 

4,159

 

3,665

 

1,220

 

2,480

 

General and administrative

 

7,073

 

5,287

 

1,770

 

5,560

 

Total direct costs and operating expenses

 

28,410

 

27,124

 

7,510

 

20,740

 

Net revenue less product expenses

 

$

(29,036

)

(28,421

)

(6,920

)

(20,266

)

 

See accompanying notes to financial statements.

 

4



 

LAZANDA

(A Product Line of Archimedes Pharma Ltd.)

 

Notes to Financial Statements

 

December 31, 2012 and 2011

 

(1)                            Description of Business

 

Pursuant to an Asset Purchase Agreement, dated as of July 29, 2013 (the Asset Purchase Agreement), Archimedes Pharma U.S. Inc., Archimedes Development Ltd. and Archimedes Pharma Ltd (collectively, Archimedes) agreed to sell to Depomed, Inc. the rights to sell the Lazanda product in the United States (U.S.) and Canada, along with certain related assets and agreements including supply, distribution, and manufacturing contracts.

 

Archimedes received U.S. Food and Drug Administration (FDA) approval in June 2011 to market Lazanda (fentanyl pectin nasal spray) (Lazanda or the Product) in the U.S. for the management of break-through pain in opioid-tolerant cancer patients. Archimedes launched the Product in the U.S. in October 2011.

 

(2)                            Basis of Presentation

 

The statements of net revenues and direct expenses of Lazanda have been prepared in accordance with accounting principles generally accepted in the United States of America. These statements were prepared for the purpose of complying with the rules and regulations of Rule 3-05 of Regulation S-X of the Securities and Exchange Commission. The net revenues and direct expenses have been derived from the historical accounting records of the Archimedes. Historically, financial statements have not been prepared for Lazanda as Archimedes did not maintain separate discrete financial statements of the Lazanda product line. The statements of net revenues and direct expenses set forth the net revenues and direct expenses attributable to Lazanda and do not purport to reflect all the costs, expenses, and resultant results of operations had Lazanda been operated as a stand-alone, separate company. Net revenues include gross sales less product-specific sales returns, cash discounts, government and commercial rebates, and customer chargebacks. Direct expenses consist principally of Product related cost of sales, distribution, marketing, selling, regulatory, development and administrative expenses.

 

As noted in note 6, general corporate overhead such as corporate management and administrative services are performed by Archimedes and allocated to its business units. These costs have been excluded from the statements of net revenues and direct expenses as there is no reasonable basis to allocate them to the Product. Costs of product sold primarily includes the purchase price of raw materials, components and packaging materials, contract manufacturing service costs and shipping costs to the warehouse. Cost of product sold also includes third party royalty expense which amounted to $41,000 and $2,000 for the years ended December 31, 2012 and 2011, respectively.

 

Marketing and selling expense includes the cost of the Lazanda commercial team, including product line management, sales force, marketing, trade relations and commercial contracting and expenses related to promotional activities, educational materials, sales meetings and conferences, and market research. Lazanda was launched in late 2011 and therefore these expenses represent a significant portion of total operating expense in 2012 and 2011.

 

Distribution and supply expense includes the management of Product logistics including warehousing, order processing, shipments, billing and collections.

 

Research and development expense includes clinical, medical affairs, regulatory affairs and pharmacovigilance personnel costs, systems costs and related fees.

 

(Continued)

 

5



 

LAZANDA

(A Product Line of Archimedes Pharma Ltd.)

 

Notes to Financial Statements

 

December 31, 2012 and 2011

 

General and administrative expense includes direct Product support costs for functional areas such as finance, human resources, IT, legal and facilities.

 

Included in marketing and selling expenses and general and administrative expenses for the six month period June 30, 2012 are one-time charges for consulting expenses of $950,000 related to a study of the U.S. market for Lazanda and competing products as well as a charge of $2,200,000 related to the downsizing of the U.S. Lazanda workforce in late May 2012.

 

(3)                            Summary of Significant Accounting Policies

 

(a)                     Revenue Recognition

 

Lazanda is sold to wholesale pharmaceutical distributors, our customers, at wholesale acquisition cost and are subject to specified rights of return. We defer recognition of revenue on product shipments of Lazanda to our customers until the right of return no longer exists, which occurs at the earlier of the time Lazanda units are dispensed through patient prescriptions or expiration of the right of return. Revenue from the sale of the Product is recognized net of applicable discounts and allowances. We estimate patient prescriptions dispensed based on TIRF REMS (Risk Evaluation and Mitigation Strategy) mandated data. REMS is required by the FDA to minimize the risk of misuse, abuse, addiction, overdose and other complications. Pharmacies, distributors, and prescribers are required to enroll in the REMS program to dispense, distribute and prescribe Lazanda. Patients must also enroll in REMS to use the Product.

 

(b)                     Use of Estimates

 

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from these estimates. As discussed in note 2, the financial statements exclude certain amounts that are not necessarily indicative of the costs and expenses that would have resulted if the Lazanda Product Line had been operated as a separate entity.

 

(c)                      Rebates and Chargebacks, Cash Discounts, and Sales Returns

 

Revenue is recorded net of provision, made at the time of sale for rebates, chargebacks and cash discounts, as described below. Archimedes entered into contracts with certain managed care organizations to provide access to Lazanda through formularies. Based on the managed care organization’s market share performance and utilization of Lazanda, the organization receives managed care rebates from Archimedes. Managed care rebates charged to Lazanda are determined by estimating the actual usage of the Product by managed care participants covered by the contracted prices. In addition, during 2011 a discount of $215,000 was provided to wholesalers for the initial stocking of Lazanda during the product launch.

 

Wholesaler Fee for Services are amounts credited to wholesalers to reimburse the wholesaler for certain expenses in connection with the storage and distribution services provided.

 

Archimedes offers a cash discount to customers if invoices are paid within a certain time period.

 

(Continued)

 

6



 

LAZANDA

(A Product Line of Archimedes Pharma Ltd.)

 

Notes to Financial Statements

 

December 31, 2012 and 2011

 

(d)                     Inventory

 

Inventory is stated at the lower of cost or market. Cost is generally determined on a first in, first out basis and includes expenditures incurred in acquiring the inventory, production or conversion costs and other costs to bring the inventory to its finished goods condition. A provision for impairment of inventories is established when there is objective evidence that the inventory cannot be sold due to, for example, the expiry of product life. The amount of the provision is the difference between the asset’s carrying amount and the net realizable value.

 

(e)                      Subsequent Events

 

The Company evaluated subsequent events through September 27, 2013, the date on which the financial statements were issued. The Company concluded there were no subsequent events to disclose.

 

(4)                          Net Product Revenues

 

Returns, chargebacks, and discounts and rebates charged to gross product revenues are as follows (U.S. dollars in thousands):

 

 

 

Years ended December 31

 

 

 

2012

 

2011

 

Lazanda:

 

 

 

 

 

Gross product revenues

 

$

1,389

 

724

 

Returns

 

(30

)

(87

)

Wholesaler Fee for Service

 

(289

)

(283

)

Discounts and rebates

 

(86

)

(302

)

 

 

$

984

 

52

 

 

(5)                            Assets Acquired and Liabilities Assumed

 

In addition to the assets included in the Statement of Assets Acquired and Liabilities Assumed, certain other assets and liabilities were included in the Asset Purchase Agreement. Those assets are primarily intangible assets and royalty payments to be paid by Depomed, Inc. to Archimedes Pharma, Ltd. on a go forward basis. The intangible assets had no historical cost book value as of the transaction date.

 

In addition, cost of product sold includes a charge of $1,538,000 and $1,337,000 for the years ended December 31, 2012 and 2011, respectively, and a charge of $961,000 for the six months ended June 30, 2013 for obsolete stock which is recorded on the statements of net revenues and direct expenses. Machinery and equipment has an estimated useful life of 10 years and was acquired primarily in 2009, with some additional acquisitions in 2010 and 2011. Liabilities of $240,000 were assumed in connection with obligations related to retaining exclusivity over certain manufacturing and supply agreements.

 

(Continued)

 

7



 

LAZANDA

(A Product Line of Archimedes Pharma Ltd.)

 

Notes to Financial Statements

 

December 31, 2012 and 2011

 

(6)                            Corporate Services (Unaudited)

 

Archimedes performed certain corporate functions for its businesses for the years ended December 31, 2012 and 2011, including, but not limited to, corporate management and administrative services. Cost allocations were made on a business unit basis, not on a product line basis. The costs of these corporate services allocated to Archimedes Pharma US Inc. were $6,400,000 and $9,920,000 in 2012 and 2011, respectively. These costs have been excluded from the statements of net revenues and direct expenses as there is no reasonable basis to allocate them to the Product.

 

(7)                            Selected Cash Flow Information (Unaudited)

 

The preparation of complete statements of cash flows was not practicable because of the integration of Lazanda into the total operations of Archimedes Pharma Ltd. prior to the divestiture of Lazanda. As such, below is selected cash flow information specific to Lazanda (U.S. dollars in thousands):

 

 

 

Years ended December 31

 

Six months ended June 30

 

 

 

2012

 

2011

 

2013

 

2012

 

Source/(use) of cash:

 

 

 

 

 

 

 

 

 

Net revenue less operating expenses

 

$

(29,036

)

(28,421

)

(6,920

)

(20,266

)

Change in inventory

 

1,433

 

(4,350

)

1,011

 

50

 

Purchases of equipment

 

 

(28

)

 

 

Net selected cash flows

 

$

(27,603

)

(32,799

)

(5,909

)

(20,216

)

 

8


EX-99.2 4 a13-21932_1ex99d2.htm EX-99.2

Exhibit 99.2

 

UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET

 

The following unaudited pro forma condensed combined balance sheet of Depomed, Inc. (“Depomed” or the “Company”) is presented to illustrate the effects of Depomed’s acquisition of the U.S. and Canadian rights to Lazanda® (fentanyl) nasal spray (“Lazanda”) on July 29, 2013. The unaudited pro forma condensed combined balance sheet as of June 30, 2013 presented herein is based on the historical financial statements of Depomed and on the financial statements of Lazanda described below, as well as on the assumptions and adjustments described in the accompanying notes to these unaudited pro forma condensed combined balance sheet.

 

The unaudited pro forma condensed combined balance sheet as of June 30, 2013 gives effect to Depomed’s acquisition of Lazanda as if it had occurred on June 30, 2013, and combines the historical balance sheet of Depomed as of June 30, 2013 with the statement of assets acquired and liabilities assumed as part of the Lazanda acquisition, which statement is included as Exhibit 99.1 to the Company’s Current Report on Form 8-K/A to which this unaudited pro forma condensed combined balance sheet is attached as Exhibit 99.2. The Company has determined that the acquisition of Lazanda as of July 29, 2013 constitutes a business acquisition as defined by Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 805, Business Combinations. Accordingly, the assets acquired and the liabilities assumed are presented at their acquisition-date fair values as required by that statement. Fair values are determined based on the requirements of FASB ASC 820, Fair Value Measurements and Disclosures. Management has made a preliminary allocation of the purchase price to the assets acquired and liabilities assumed based on various estimates, as noted in Note 3 to the unaudited pro forma condensed combined balance sheet. Management is continuing to refine those estimates and consequently, the final determination of these estimated fair values may differ materially from those presented.

 

Pursuant to a letter dated August 21, 2013 (the “Letter”) from the staff of the Division of Corporate Finance (the “Division”) of the Securities and Exchange Commission, the Division stated that it would waive the requirement to provide a pro forma statement of operations if the use of forward-looking information is necessary to meaningfully present the effects of the acquisition of Lazanda by Depomed.  Depomed’s expense structure and commercialization infrastructure related to Lazanda are anticipated to differ significantly from the expense structure and commercialization infrastructure maintained by Archimedes with regard to Lazanda.  As a result, Depomed has concluded that the use of forward-looking information is necessary to meaningfully present the effects of the acquisition. Based on the guidance provided by the Division in the Letter, Depomed is not filing a pro forma statement of operations with this Current Report.

 

Depomed anticipates expenses and revenues relating to Lazanda will be modest through the end of 2013. In 2013, Depomed expects total revenues, including Lazanda, to be in the range of $125 to $135 million and operating expenses, including Lazanda, to be in the range of $118 to $125 million.

 

In 2014, Depomed anticipates that revenues relating to Lazanda will increase significantly as compared to 2013 as new commercialization efforts are finalized and fully implemented. Depomed’s anticipated revenues attributable to Lazanda in 2014 and beyond will depend on a number of factors including the success of such commercialization efforts, market acceptance of Lazanda and the success of competitive products. Depomed will incur additional expenses in 2014 in connection with the commercialization efforts relating to Lazanda. Depomed expects these costs will be significantly less than those incurred by Archimedes in 2013 and are not expected to have a material impact on Depomed’s total operating expenses in 2014.

 

The following unaudited pro forma condensed combined balance sheet as of June 30, 2013 is presented for illustrative purposes only, in accordance with Article 11 of Regulation S-X, and should be read in conjunction with:

 

·                  the Company’s historical audited financial statements and accompanying notes as of and for the year ended December 31, 2012 included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 22, 2013;

 

·                  the Company’s historical unaudited financial statements and accompanying notes as of and for the six months ended June 30, 2013 included in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on August 8, 2013; and

 

·                  the Lazanda financial statements and accompanying notes included as Exhibit 99.1 to the Form 8-K/A.

 



 

DEPOMED, INC.

UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET

As of June 30, 2013

 

 

 

Depomed Inc

 

Lazanda

 

Pro Forma 
Adjustments

 

Notes

 

Pro Forma 
Combined

 

 

 

 

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

44,934

 

 

(4,000

)

3

 

$

40,934

 

Marketable securities

 

24,618

 

 

 

 

 

 

24,618

 

Accounts receivable

 

6,717

 

 

 

 

 

 

6,717

 

Receivables from collaborative partners

 

8,066

 

 

 

 

 

 

8,066

 

Inventories

 

7,226

 

925

 

933

 

3(c)

 

9,084

 

Prepaid and other current assets

 

5,953

 

 

 

 

 

5,953

 

Total current assets

 

97,514

 

925

 

(3,067

)

 

 

95,372

 

Marketable securities, long-term

 

4,669

 

 

 

 

 

 

4,669

 

Property and equipment, net

 

8,169

 

375

 

 

 

 

8,544

 

Intangible assets, net

 

23,304

 

 

10,360

 

3(b)

 

33,664

 

Other assets

 

324

 

 

 

 

 

 

324

 

 

 

$

133,980

 

$

1,300

 

7,293

 

 

 

$

142,573

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

24,357

 

 

 

 

 

 

$

24,357

 

Deferred license revenue

 

3,041

 

 

 

 

 

 

3,041

 

Other current liabilities

 

649

 

240

 

 

 

 

 

889

 

Total current liabilities

 

28,047

 

240

 

 

 

 

28,287

 

Deferred license revenue, non-current portion

 

13,995

 

 

 

 

 

 

13,995

 

Other long-term liabilities

 

9,007

 

 

8,032

 

3(a)

 

17,039

 

Commitments

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

 

 

 

 

 

Preferred stock, no par value, 5,000,000 shares authorized; Series A convertible preferred stock, 25,000 shares designated, 18,158 shares issued and surrendered, and zero shares outstanding at June 30, 2013 and December 31, 2012

 

 

 

 

 

 

 

 

Common stock, no par value, 100,000,000 shares authorized; 56,676,259 and 56,383,713 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively

 

215,317

 

 

 

 

 

 

215,317

 

Accumulated deficit

 

(132,363

)

 

321

 

3(d)

 

(132,042

)

Accumulated other comprehensive gain, net of tax

 

(23

)

 

 

 

 

 

(23

)

Total shareholders’ equity

 

82,931

 

 

321

 

 

 

83,252

 

 

 

$

133,980

 

240

 

8,353

 

 

 

$

142,573

 

 

The accompanying notes are an integral part of the pro forma condensed combined balance sheet.

 



 

DEPOMED, INC.

NOTES TO THE UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET

 

1.     Description of Transaction and Basis of Presentation

 

Description of Transaction

 

On July 29, 2013, the Company acquired certain assets from Archimedes Pharma US Inc., a Delaware corporation, Archimedes Pharma Ltd., a corporation registered under the laws of England and Wales, and Archimedes Development Ltd., a company registered under the laws of England and Wales (collectively, “Archimedes”), related to Archimedes’ proprietary fentanyl pectin nasal spray product for the management of break-through pain in opioid-tolerant cancer patients referred to as Lazanda® (the “Product”) and the use, development, formulation, distribution, testing, marketing, offer for sale, assembly, packaging, transportation and manufacture of the Product in the United States and Canada.  The purchase price for these assets included (i) a closing payment of $4,000,000, (ii) certain sales milestones payments totaling $16,000,000 if certain annual net sales milestones described in the Agreement are met and (iii) certain product royalties for sales occurring during a specified period.

 

Basis of Presentation

 

The unaudited pro forma condensed combined balance sheet as of June 30, 2013 gives effect to Depomed’s acquisition of Lazanda as if it had occurred on June 30, 2013, and combines the historical balance sheet of Depomed as of June 30, 2013 with the statement of assets acquired and liabilities assumed as part of the Lazanda acquisition, which statement is included as Exhibit 99.1 to the Company’s Current Report on Form 8-K/A to which this unaudited pro forma condensed combined balance sheet is attached as Exhibit 99.2. The Company has determined that the acquisition of Lazanda as of July 29, 2013 constitutes a business acquisition as defined by Financial Accounting Standards Board Accounting Standards Codification (“FASB ASC”) 805, Business Combinations. Accordingly, the assets acquired and the liabilities assumed are presented at their acquisition-date fair values as required by that statement. Fair values are determined based on the requirements of FASB ASC 820, Fair Value Measurements and Disclosures. Management has made a preliminary allocation of the purchase price to the assets acquired and liabilities assumed based on various estimates, as noted in Note 3 to the unaudited pro forma condensed combined balance sheet. Management is continuing to refine those estimates and consequently, the final determination of these estimated fair values may differ materially from those presented.

 

2.   Summary of Significant Accounting Policies

 

The unaudited pro forma condensed combined balance sheet has been compiled in a manner consistent with the accounting policies adopted by the Company. A summary of the Company’s significant accounting policies can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, filed with the SEC on February 22, 2013. The accounting policies of Archimedes relating to the statement of assets acquired and liabilities assumed were not deemed to be materially different from those adopted by the Company.

 



 

DEPOMED, INC.

NOTES TO THE UNAUDITED PRO FORMA CONDENSED COMBINED BALANCE SHEET

 

3.     Pro Forma adjustments

 

The adjustments made in preparing the Pro Forma Financial Information reflect the total purchase price and related preliminary deficit of total purchase price over fair value of net assets acquired which is as follows (in thousands):

 

Cash for Lazanda and related inventories

 

4,000

 

Fair value of contingent consideration

 

8,032

 

Purchase price

 

$

12,032

 

 

 

 

 

Intangible asset - Lazanda product rights

 

10,360

 

Inventories

 

1,858

 

Property, plant and equipment

 

375

 

Current liabilities

 

(240

)

Bargain purchase

 

(321

)

 

 

$

12,032

 

 

(a) Fair value of contingent consideration:

 

The fair value of the contingent consideration of $8.0 million has been recorded in other long term liabilities in the accompanying unaudited pro forma condensed combined balance sheet. The Company determined the acquisition date fair value of contingent consideration obligations based on a probability-weighted income approach derived from revenue estimates and a probability assessment with respect to the likelihood of achieving the contingent payments in the form of milestone obligations and the royalty obligations. At each reporting date, the Company will re-measure the contingent consideration obligation to estimate fair value. Any changes in the fair value of contingent consideration will be recognized in operating expenses until the contingent consideration arrangement is settled.

 

(b) Intangible asset — Lazanda product rights:

 

The fair value of the Lazanda product rights of $10.4 million has been recorded as intangible assets on the accompanying unaudited pro forma condensed combined balance sheet and will be amortized over the estimated useful life of the asset on a straight-line basis through 2022. The fair value of the intangible assets was based on management’s forecasted cash inflows and outflows using a multi-period excess earnings method to calculate the fair value of assets purchased.

 

(c) Inventories:

 

The $0.6 million increase in inventories relates to the recognition of the fair value of these inventories. The fair value of inventories was determined based on quantities acquired, selling prices at the date of acquisition and management’s assumptions regarding units that have future value and costs to sell such inventories .

 

(d) Bargain purchase:

 

The adjustment of $0.3 million reflects the bargain purchase amount. This allocation is based on preliminary estimates; the final acquisition cost allocation may differ materially from the preliminary assessment outlined above. Any changes to the initial estimates of the fair value of the assets and liabilities will be allocated to the bargain purchase.