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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

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

 

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2005

 

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 000-23267

 

 

DEPOMED, INC.

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 

CALIFORNIA

94-3229046

(STATE OR OTHER JURISDICTION OF

(I.R.S. EMPLOYER

INCORPORATION OR ORGANIZATION)

IDENTIFICATION NUMBER)

 

1360 O’BRIEN DRIVE

MENLO PARK, CALIFORNIA 94025

(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES, INCLUDING ZIP CODE)

 

(650) 462-5900

  (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 requirements for the past 90 days.

YES ý                       NO o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2). Yes  ý  No  o

 

 

                The number of issued and outstanding shares of the Registrant’s Common Stock, no par value, as of May 6, 2005 was 39,732,701.

 

 

 


 


 

 

DEPOMED, INC.

 

 

 

PART I — FINANCIAL INFORMATION

 

 

 

Item 1. Condensed Consolidated Financial Statements (Unaudited):

 

 

 

Condensed Consolidated Balance Sheets at March 31, 2005 and December 31, 2004

 

 

 

Condensed Consolidated Statements of Operations for the three-month periods ended March 31, 2005 and 2004, and for the period from inception (August 7, 1995) to March 31, 2005

 

 

 

Condensed Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2005 and 2004, and for the period from inception (August 7, 1995) to March 31, 2005

 

 

 

Notes to Condensed Consolidated Financial Statements

 

 

 

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

 

 

 

Item 4. Controls and Procedures

 

 

 

PART II — OTHER INFORMATION

 

 

 

Item 6. Exhibits

 

 

 

Signatures

 

 

 


 

 


 

 

PART I — FINANCIAL INFORMATION

ITEM 1.  CONSOLIDATED FINANCIAL STATEMENTS

 

DEPOMED, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

March 31,
2005

 

December 31,
2004

 

 

 

 

 

(See Note 1)

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

10,324,872

 

$

953,295

 

Marketable securities

 

22,147,070

 

17,151,544

 

Prepaid and other current assets

 

674,352

 

442,349

 

Total current assets

 

33,146,294

 

18,547,188

 

Property and equipment, net

 

3,694,148

 

3,941,127

 

Other assets

 

325,858

 

380,268

 

 

 

$

37,166,300

 

$

22,868,583

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

1,557,034

 

$

1,733,474

 

Accrued compensation

 

655,918

 

910,723

 

Other accrued liabilities

 

712,423

 

556,084

 

Capital lease obligation, current portion

 

13,497

 

32,412

 

Long-term debt, current portion

 

15,183

 

73,008

 

Deferred revenue, current portion

 

75,000

 

75,000

 

Other current liabilities

 

93,073

 

93,073

 

Promissory note, current

 

10,504,635

 

 

Total current liabilities

 

13,626,763

 

3,473,774

 

Promissory note, non-current

 

 

10,280,591

 

Deferred revenue, non-current portion

 

475,000

 

493,750

 

Other long-term liabilities

 

193,903

 

217,170

 

Commitments

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, no par value, 5,000,000 shares authorized; Series A convertible preferred stock, 25,000 shares designated, 15,821 shares issued and outstanding at March 31, 2005 and December 31, 2004

 

12,015,000

 

12,015,000

 

Common stock, no par value, 100,000,000 shares authorized; 39,732,701 and 34,691,190 shares issued and outstanding at March 31, 2005 and December 31, 2004, respectively

 

138,273,654

 

117,070,946

 

Deferred compensation

 

(557,947

)

(621,980

)

Deficit accumulated during the development stage

 

(126,760,062

)

(119,984,625

)

Accumulated other comprehensive loss

 

(100,011

)

(76,043

)

Total shareholders’ equity:

 

22,870,634

 

8,403,298

 

 

 

$

37,166,300

 

$

22,868,583

 

 

See accompanying notes to Condensed Consolidated Financial Statements.

 

 

3



 

 

 

DEPOMED, INC.

 (A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

 

 

Period From Inception (August 7, 1995) to
March 31, 2005

 

 

Three Months Ended March 31,

 

 

2005

 

2004

Revenue:

 

 

 

 

 

 

 

Collaborative agreements

 

$

 

$

119,725

 

$

4,964,332

 

Collaborative agreements with affiliates

 

 

 

5,101,019

 

License revenue

 

18,750

 

 

50,000

 

Total revenue

 

18,750

 

119,725

 

10,115,351

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

5,016,858

 

5,577,215

 

106,379,927

 

General and administrative

 

1,716,064

 

1,142,750

 

27,394,134

 

Purchase of in-process research and development

 

 

 

298,154

 

Total operating expenses

 

6,732,922

 

6,719,965

 

134,072,215

 

 

 

 

 

 

 

 

 

Loss from operations

 

(6,714,172

)

(6,600,240

)

(123,956,864

)

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

Equity in loss of joint venture

 

 

 

(19,817,062

)

Gain from Bristol-Myers legal settlement

 

 

 

18,000,000

 

Interest and other income

 

171,874

 

145,997

 

2,566,650

 

Interest expense

 

(233,139

)

(226,702

)

(3,453,786

)

Total other income (expenses)

 

(61,265

)

(80,705

)

(2,704,198

)

 

 

 

 

 

 

 

 

Net loss before income taxes

 

(6,775,437

)

(6,680,945

)

(126,661,062

)

 

 

 

 

 

 

 

 

Provision for income taxes

 

 

 

(99,000

)

 

 

 

 

 

 

 

 

Net loss

 

(6,775,437

)

(6,680,945

)

(126,760,062

)

 

 

 

 

 

 

 

 

Deemed dividend on preferred stock

 

(193,657

)

 

(193,657

)

 

 

 

 

 

 

 

 

Net loss applicable to common shareholders

 

$

(6,969,094

)

$

(6,680,945

)

$

(126,953,719

)

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.18

)

$

(0.19

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic and diluted net loss per common share

 

39,056,213

 

34,584,997

 

 

 

 

 

See accompanying notes to Condensed Consolidated Financial Statements.

 

 

4



 

 

 

DEPOMED, INC.

(A Development Stage Company)

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Three Months Ended March 31,

 

Period From Inception
(August 7, 1995) to

 

 

 

2005

 

2004

 

March 31, 2005

 

Operating Activities

 

 

 

 

 

 

 

Net loss

 

$

(6,775,437

)

$

(6,680,945

)

$

(126,760,062

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

Equity in loss of joint venture

 

 

 

19,817,062

 

Depreciation and amortization

 

352,580

 

417,489

 

5,039,595

 

Amortization of deferred compensation

 

199,058

 

64,103

 

1,555,101

 

Stock-based compensation issued to consultants

 

4,990

 

22,655

 

369,963

 

Purchase of in-process research and development

 

 

 

298,154

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

 

99,787

 

 

Prepaid and other current assets

 

(232,003

)

(65,603

)

(674,352

)

Other assets

 

54,410

 

(123,370

)

(326,016

)

Accounts payable and other accrued liabilities

 

(20,101

)

5,160

 

2,269,457

 

Accrued compensation

 

(254,805

)

(247,882

)

588,442

 

Accrued interest expense on notes

 

224,044

 

207,385

 

2,721,550

 

Deferred revenue

 

(18,750

)

 

550,000

 

Net cash used in operating activities

 

(6,466,014

)

(6,301,221

)

(94,551,106

)

 

 

 

 

 

 

 

 

Investing Activities

 

 

 

 

 

 

 

Investment in joint venture

 

 

 

(19,817,062

)

Expenditures for property and equipment

 

(170,904

)

(489,338

)

(7,784,577

)

Purchases of marketable securities

 

(8,441,442

)

(4,747,270

)

(95,276,282

)

Maturities and sales of marketable securities

 

3,464,758

 

3,996,017

 

72,774,200

 

Net cash used in investing activities

 

(5,147,588

)

(1,240,591

)

(50,103,721

)

 

 

 

 

 

 

 

 

Financing Activities

 

 

 

 

 

 

 

Payments on capital lease obligations

 

(19,689

)

(6,086

)

(393,592

)

Proceeds from equipment loans

 

 

 

1,947,006

 

Payments on equipment loans

 

(57,825

)

(107,593

)

(1,819,423

)

Proceeds from issuance of notes payable

 

 

 

8,846,703

 

Payments on notes payable

 

 

 

(1,000,000

)

Payments on shareholder loans payable

 

 

 

(294,238

)

Proceeds on issuance of common stock, net of issuance costs

 

21,062,693

 

102,306

 

135,678,243

 

Proceeds on issuance of preferred stock

 

 

 

12,015,000

 

Net cash provided by (used in) financing activities

 

20,985,179

 

(11,373

)

154,979,699

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

9,371,577

 

(7,553,185

)

10,324,872

 

Cash and cash equivalents at beginning of period

 

953,295

 

20,044,698

 

 

Cash and cash equivalents at end of period

 

$

10,324,872

 

$

12,491,513

 

$

10,324,872

 

 

See accompanying notes to Condensed Consolidated Financial Statements.

 

 

5



 

DEPOMED, INC.

 (A Development Stage Company)

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

 

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

These unaudited condensed consolidated financial statements and the related footnote information of Depomed, Inc. (the “Company” or “Depomed”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).  Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations.  In the opinion of the Company’s management, the accompanying interim unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information for the periods presented.  The results for the interim period ended March 31, 2005 are not necessarily indicative of results to be expected for the entire year ending December 31, 2005 or future operating periods.

 

The balance sheet at December 31, 2004 has been derived from the audited financial statements at that date.  The balance sheet does not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements.  For further information, refer to the financial statements and footnotes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2004 filed with the SEC.

 

As of March 31, 2005, the Company had approximately $32,472,000 in cash, cash equivalents and marketable securities, working capital of $19,520,000 and accumulated net losses of $126,760,000.  In the course of its development activities, the Company expects such losses to continue for at least the next two years.  Management plans to continue to finance the operations with its existing capital resources, a combination of equity and debt financing and revenue from corporate alliances and technology licenses.  If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its development programs.

 

Principles of Consolidation

The consolidated financial statements for the quarter ended March 31, 2005, include the accounts of the Company and Depomed Development, Ltd., DDL, formerly a joint venture with Elan Corporation, plc, Elan Pharma International, Ltd. and Elan International Services, Ltd. (together, “Elan”), which became a wholly owned subsidiary in the second quarter of 2004. On July 1, 2003, the Company consolidated DDL, a variable interest entity in which the Company is the primary beneficiary, pursuant to the Financial Accounting Standards Board (FASB) Interpretation No. 46 (FIN 46) Consolidation of Variable Interest Entities, an interpretation of Accounting Research Bulletin No. 51.  In June 2004, the Company acquired Elan’s 19.9% interest in DDL for $50,000 and DDL became a wholly owned subsidiary of the Company.  Intercompany accounts and transactions have been eliminated.

 

6



 

 

Stock-Based Compensation

As permitted under Statement of Financial Accounting Standards No. 123 (FAS 123), Accounting for Stock-Based Compensation, the Company has elected to follow Accounting Principles Board Opinion No. 25 (APB No. 25), Accounting for Stock Issued to Employees in accounting for stock-based awards to its employees.  Accordingly, the Company accounts for grants of stock options to its employees and directors according to the intrinsic value method and, thus, recognizes no stock-based compensation expense for options granted with exercise prices equal to or greater than the fair value of the Company’s common stock on the date of grant.  The Company records deferred stock-based compensation when the deemed fair value of the Company’s common stock for financial accounting purposes exceeds the exercise price of the stock options or purchase rights on the measurement date (generally, the date of grant).  Any such deferred stock-based compensation is amortized ratably over the vesting period of the individual options.

 

Pro forma net loss information using the fair value method accounting for grants of stock options to employees and directors is included in the table shown below:

 

 

 

Three Months Ended March 31,

 

 

 

2005

 

2004

 

Net loss applicable to common shareholders—as reported

 

$

(6,969,094

)

$

(6,680,945

)

Add: Total stock-based employee

 

 

 

 

 

compensation expense, included in the

 

 

 

 

 

determination of net loss as reported,

 

 

 

 

 

net of related tax effect

 

199,058

 

64,103

 

Deduct: Total stock-based employee

 

 

 

 

 

compensation expense determined

 

 

 

 

 

under the fair value based method

 

 

 

 

 

for all awards, net of related tax effect

 

(559,146

)

(525,170

)

Net loss applicable to common shareholders—pro forma

 

$

(7,329,182

)

$

(7,142,012

)

 

 

 

 

 

 

Net loss per share—as reported

 

$

(0.18

)

$

(0.19

)

Net loss per share—pro forma

 

$

(0.19

)

$

(0.21

)

 

Options granted to non-employees are accounted for at fair value using the Black-Scholes Option Valuation Model in accordance with FAS 123 and Emerging Issues Task Force Consensus No. 96-18, and may be subject to periodic revaluation over their vesting terms.  The resulting stock-based compensation expense is recorded over the service period in which the non-employee provides services to the Company.

 

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 those estimates.

 

7



 

Revenue Recognition

Revenue relates primarily to research and development services rendered in connection with collaborative arrangements, and to a lesser extent, the achievements of milestones under such arrangements.  Revenue related to collaborative research agreements with corporate partners is recognized as the expenses are incurred under each contract.  The Company is required to perform research activities as specified in each respective agreement on a best or commercially reasonable efforts basis, and the Company is reimbursed based on the costs associated with supplies and the hours worked by employees on each specific contract.  Nonrefundable substantive milestone payments are recognized pursuant to collaborative agreements upon the achievement of specified milestones where no further obligation to perform exists under that milestone provision of the arrangement.  The revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the client and whether there is objective and reliable evidence of the fair value of the undelivered items.  The consideration received is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units.  Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

 

Revenue from license arrangements, including license fees creditable against future royalty obligations (if any), of the licensee, is recognized when an arrangement is entered into if the Company has no significant continuing involvement under the terms of the arrangement. If the Company has significant continuing involvement under such an arrangement, license fees are deferred and recognized over the estimated performance period.

 

Recent Accounting Pronouncements

In December 2004, the Financial Accounting Standard Board (FASB) issued Statement No. 123R, Share-Based Payment (FAS 123R), which is a revision of FAS 123. FAS 123R supersedes APB No. 25 and amends Statement No. 95, Statement of Cash Flows.  Generally, the approach in FAS 123R is similar to the approach described in FAS 123. FAS 123R requires all share-based payments to employees and directors including grants of employee and director stock options, to be recognized in the statement of operations based on their fair values. Pro forma disclosure is no longer an alternative.  In April 2005, the SEC adopted a new rule amending the compliance dates for FAS 123R.  In accordance with the new rule, the Company will adopt FAS 123R on January 1, 2006.

 

FAS 123R permits public companies to adopt its requirement using one of two methods:  1) a “modified prospective” method in which compensation cost is recognized beginning with the effective date (a) based on the requirements of FAS 123R for all share-based payments granted after the effective date and (b) based on the requirements of FAS 123R for all awards granted to employees and directors prior to the effective date of FAS 123R that remain unvested on the effective date; or 2) a “modified retrospective” method which includes the requirements of the modified prospective method described above, but also permits entities to restate based on the amounts previously recognized under FAS 123 for purposes of pro forma disclosures either (a) all prior periods presented or (b) prior interim periods of the year of adoption.  The Company plans to adopt FAS 123R using the modified prospective method.

 

8



 

As permitted by FAS 123, the Company currently accounts for share-based payments to employees and directors using APB No. 25’s intrinsic value method and, as such, recognizes no compensation cost for employee and director stock options where the exercise price equals the fair market value of the underlying common shares on the measurement date.  Accordingly, the adoption of FAS 123R’s fair value method will have a significant impact on the Company’s results of operations, although it will have no impact on our overall financial position. The impact of adoption of FAS 123R cannot be predicted at this time because it will depend on levels of share-based payments granted in the future.  However, had the Company adopted FAS 123R in prior periods, the impact of that standard would have approximated the impact of FAS 123 as described in the disclosure of pro forma net loss and loss per share in Note 1, Summary of Significant Accounting Policies, Stock-Based Compensation, of the Company’s condensed consolidated financial statements.

 

2. CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES

 

The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents.  Cash and cash equivalents consist of cash on deposit with banks and money market instruments.  The Company places its cash and cash equivalents with high quality, U.S. financial institutions and, to date, has not experienced material losses on its balances. The Company records cash and cash equivalents at amortized cost, which approximates the fair value.  All marketable securities are classified as available-for-sale since these instruments are readily marketable. These securities are carried at fair value with unrealized gains and losses included in accumulated other comprehensive income (loss) within shareholders’ equity.  If the fair value of a marketable security is below its carrying value due to a significant adverse event, the impairment is considered to be other-than-temporary and the security is written down to its estimated fair value. Other-than-temporary declines in fair value of all marketable securities would be charged to “other expense”.  The Company uses the specific identification method to determine the amount of realized gains or losses on sales of marketable securities.  Realized gains or losses have been insignificant and are included in “interest and other income”.  At March 31, 2005, the individual contractual period for all available-for-sale debt securities is within two years.

The following table shows the gross unrealized losses and fair value of the Company’s investments with unrealized losses that are not deemed to be other-than-temporarily impaired, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position, at March 31, 2005:

 

 

 

Less than 12 months

 

12 months or greater

 

Total

 

U.S. Debt Securities

 

Fair Value

 

Gross Unrealized Losses

 

Fair Value

 

Gross Unrealized Losses

 

Fair Value

 

Gross Unrealized Losses

 

U.S. corporate debt securities

 

$

11,199,150

 

$

(25,740

)

$

 

$

 

$

11,199,150

 

$

(25,740

)

U.S. government debt securities

 

10,947,920

 

(74,271

)

 

 

10,947,920

 

(74,271

)

Total available-for-sale

 

$

22,147,070

 

$

(100,011

)

$

 

$

 

$

22,147,070

 

$

(100,011

)

 

The Company’s investment in U.S. corporate debt securities consists primarily of investments in investment grade corporate bonds and notes. The Company’s investment in U.S. government debt securities consists of low risk government agency bonds typically with a rating of A or higher.  The unrealized losses on the Company’s investments in U.S. corporate debt and U.S. government debt securities were caused by interest rate increases. Due to the fact that the decline in market value is attributable to changes in interest rates and not credit quality, that the severity and duration of the unrealized losses were not significant, and that the Company has the intent and ability to hold these instruments until such losses are recovered, which may be at maturity, the Company considers these unrealized losses to be temporary at March 31, 2005.

 

 

9



 

Reclassification

Certain account reclassifications have been made to the financial statements of the prior years in order to conform to classifications used in the current year.  These reclassifications have no impact on previously stated net losses of the Company.

3. NET LOSS PER COMMON SHARE

 

Net loss per common share is computed using the weighted-average number of shares of common stock outstanding.  Common stock equivalent shares from outstanding stock options, warrants and other convertible securities and convertible loans are not included as their effect is antidilutive.  As of March 31, 2005 and 2004, the total number of outstanding common stock equivalent shares excluded from the loss per share computation was 16,326,931 and 13,837,016, respectively.

 

4. COMPREHENSIVE LOSS

 

Total comprehensive loss for the three months ended March 31, 2005 and 2004 approximates net loss and includes unrealized losses on marketable securities.

 

5. COLLABORATIVE ARRANGEMENTS AND CONTRACTS

 

Elan Corporation, plc

In January 2000, the Company and Elan Corporation, plc formed Depomed Development Ltd. (DDL), a Bermuda limited liability company and joint venture, to develop products using drug delivery technologies of both Elan and Depomed, Inc. DDL was owned 80.1% by Depomed and 19.9% by Elan.  In August 2002, DDL discontinued all product development activity.  In September 2003, the joint venture partners amended or terminated the contracts governing the operation of DDL, which included the termination of Elan’s participation in the management of DDL.  In June 2004, the Company acquired Elan’s 19.9% interest in DDL for $50,000.

 

Pursuant to the Company’s adoption of FIN 46 on July 1, 2003, the Company consolidated the accounts of DDL as of July 1, 2003.  Since September 2003, the Company has recognized 100% of DDL’s operating results.  For the three months ended March 31, 2005 and 2004, the Company consolidated general and administrative expense of approximately $7,000 and $6,000, respectively, related to DDL.  The Company expects to consolidate general and administrative expense of approximately $10,000 annually related to DDL.  DDL does not have any fixed assets, liabilities or employees and will not perform any further product development on behalf of Depomed or any other entity.  The Company has not made a determination as to DDL’s future.

 

 

10



 

6. COMMITMENTS AND CONTINGENCIES

 

Elan Promissory Note

In connection with the formation of DDL, Elan made a loan facility available to the Company for up to $8,010,000 in principal to support Depomed’s 80.1% share of the joint venture’s research and development costs pursuant to a convertible promissory note issued by Depomed to Elan.  The note has a six-year term, is due in January 2006, and bears interest at 9% per annum, compounded semi-annually, on any amounts borrowed under the facility.  At Elan’s option, the note is convertible into the Company’s common stock.  An anti-dilution provision of the note was triggered by the Company’s November 2000, March 2002, October 2003 and January 2005 financings, which together adjusted the price at which the amount borrowed under the facility and the accrued interest convert into the Company’s common stock from $10.00 per share to $7.30 per share.  Since the adjusted conversion price was still greater than the fair market value of the common stock on the date of the each draw under the loan facility, there was no beneficial conversion feature.  The funding term of the loan expired in November 2002.  As of March 31, 2005, a total of $10,505,000 was outstanding on the note, including $2,708,000 of accrued interest.

 

7. SHAREHOLDERS’ EQUITY

 

Registered Direct Public Offering

In January 2005, the Company completed a registered direct public offering of 5,036,000 shares of its common stock at $4.50 per share with net proceeds of $21,053,000.

 

Series A Preferred Stock

The Series A Preferred Stock accrues a dividend of 7% per annum, compounded semi-annually and payable in shares of Series A Preferred Stock. The Series A Preferred Stock is convertible at anytime between January 2002 and January 2009 into the Company’s common stock (including the impact of a warrant issued to the Series A Preferred stockholder in December 2004). The original conversion price of the Series A Preferred Stock was $12.00; however, as a result of the Company’s March 2002 and October 2003 financings, the conversion price had been adjusted to $9.51 per share.  In December 2004, the Company entered into an agreement with the Series A Preferred stockholder to resolve a misunderstanding between the Company and the stockholder relating primarily to prior adjustments to the conversion price of the Series A Preferred Stock.  Pursuant to the agreement, among other matters, the Company agreed to adjust the conversion price to $7.50 per share.  The Company and the stockholder also agreed to binding interpretations of certain other terms related to the Series A conversion price.

Prior to December 2004, the amounts calculated as Series A Preferred stock dividends were accounted for as an adjustment to the conversion price following EITF Issue No. 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios (Issue No. 98-5). As a result of the modifications to the preferred stock agreement in December 2004, the Company determined that a “significant modification” of the agreement had been made, and, therefore, a new “commitment date” for accounting purposes had been established on December 10, 2004.  The Company measured the difference between the carrying value of the preferred stock and the fair value of the modified preferred stock pursuant to EITF Topic No. D-42, The Effect on the Calculation of Earnings per Share for the Redemption or Induced Conversion of Preferred Stock and determined that the fair value of the modified security was less than the carrying value of the security prior to the modification.  The Company also evaluated the effective conversion rate, after considering the reset rate of $7.50 per share in addition to the common stock issuable upon conversion of the unpaid, accumulated dividends.  The fair value of the underlying common stock on December 10, 2004 was $5.06 per share.  The Company determined that the conversion rate, after including the effect of the unpaid dividends, did not result in a beneficial conversion feature, which could have had the effect of also providing a deemed dividend to the preferred stockholder.  However, an anti-dilution provision of the Series A Preferred Stock was triggered by the Company’s January 2005 financing, which adjusted the conversion price of the Series A Preferred Stock to $7.12.

 

 

11



 

As a result of the adjusted conversion price and an increase in the amount of common stock issuable upon conversion of the Series A Preferred Stock due to additional accumulated dividends, the Series A Preferred Stock now contains a “beneficial conversion feature” subject to recognition pursuant to Issue No. 98-5.  For the period ended March 31, 2005, the Company recognized Series A Preferred Stock deemed dividends of approximately $194,000 attributable to the beneficial conversion feature.  The Company will continue to recognize Series A Preferred Stock deemed dividends until the earlier of, the time the Series A Preferred Stock is converted to common stock or until January 2009.

 

As of March 31, 2005, the Series A Preferred Stock and accrued dividends were convertible into 2,412,778 shares of common stock.  The aggregate liquidation preference of the Series A Preferred Stock, including accrued dividends, was $17,179,000 as of March 31, 2005.

Warrant and Option Exercises

During the three months ended March 31, 2005, employees exercised options to purchase 5,511 shares of the Company’s common stock with net proceeds to the Company of approximately $9,000.

 

Stock-Based Compensation

In July 2003, the Board of Directors approved an amendment to all stock options granted to non-employee members of the Company’s Board of Directors.  In the case of the death of a non-employee director, the amendment provides for the director’s beneficiary to exercise the director’s stock options at anytime over the remaining life of the stock option. A non-cash compensation expense related to the amended stock options will be recognized if and when a director’s beneficiary benefits from this modified provision. The maximum stock-based compensation expense would be $369,000 if all non-employee directors benefited from this provision with respect to outstanding options. During the first quarter of 2005, the Company recognized approximately $135,000 related to these options.

 

8.  SUBSEQUENT EVENTS

 

Shareholder Rights Plan

On April 21, 2005, the Company adopted a shareholder rights plan, (the Rights Plan). Under the Rights Plan, the Company distributed one preferred share purchase right for each share of common stock outstanding at the close of business on May 5, 2005. If a person or group acquires 20% or more of the Company’s common stock in a transaction not pre-approved by the Company’s Board of Directors, each right will entitle its holder, other than the acquirer, to buy the Company’s common stock at 50% of its market value for the right’s then current exercise price (initially $35.00). In addition, if an unapproved party acquires more than 20% of the Company’s common stock, and the Company is later acquired by the unapproved party or in a transaction in which all shareholders are not treated alike, shareholders with unexercised rights, other than the unapproved party, will be entitled to purchase common stock of the merger party or asset buyer with a value of twice the exercise price of the rights.  Each right also becomes exercisable for one one-thousandth of a share of the Company’s Series RP preferred stock at the right’s then current exercise price ten days after an unapproved third party makes, or announces an intention to make, a tender offer or exchange offer that, if completed, would result in the unapproved party acquiring 20% or more of the Company’s common stock. The Board of Directors may redeem the rights for a nominal amount before an event that causes the rights to become exercisable. The rights will expire on April 21, 2015.

 

 In connection with the Rights Plan, the Company designated 100,000 no par shares of preferred stock to be Series RP preferred stock. These shares, if issued, will be entitled to receive quarterly dividends and liquidation preferences. There are no shares of Series RP preferred stock issued and outstanding and the Company does not anticipate issuing any shares of Series RP preferred stock except as may be required under the Rights Plan.

 

 

12



 

Collaboration Agreement

In April 2005, the Company entered into an agreement with Boehringer Ingelheim Pharmaceuticals, Inc. to begin feasibility studies with an undisclosed drug.  Under the agreement, all research and development work with the partner’s drug will be funded by the partner.

 

 

13


 


 

ITEM 2.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND

RESULTS OF OPERATIONS

 

FORWARD-LOOKING INFORMATION

 

Statements made in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q that are not statements of historical fact are 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.  Forward-looking statements include, but are not necessarily limited to, those relating to:

               regulatory approval of Glumetza™ (Metformin GR™) and Proquin™ (Ciprofloxacin GR™);

               results and timing of our clinical trials, including the results of the Furosemide GR™ and Gabapentin GR™ trials and publication of those results;

               our ability to raise additional capital;

•     our ability to obtain a marketing partner for Proquin or our other products; and

•     our plans to develop other product candidates.

 

Factors that could cause actual results or conditions to differ from those anticipated by these and other forward-looking statements include those more fully described in the “ADDITIONAL FACTORS THAT MAY AFFECT FUTURE RESULTS” section and elsewhere in this Quarterly Report on Form 10-Q.  We are not obligated to update or revise these forward-looking statements to reflect new events or circumstances.

 

ABOUT DEPOMED

We are an emerging specialty pharmaceutical company engaged in the development of pharmaceutical products based on our proprietary oral drug delivery technologies. Our collaborative partner has received an approvable letter in response to a New Drug Application (NDA) submitted to the Food and Drug Administration (FDA) for one product we developed and we have submitted an NDA to the FDA for another proprietary product.  In addition, we have two products in Phase II clinical trials.  Our primary oral drug delivery system is our patented Gastric Retention System, or the GR™ System. The GR System is a tablet designed to be retained in the stomach for an extended period of time while it delivers the incorporated drug or drugs on a continuous, controlled-release basis. By incorporation into the GR System, some drugs currently taken two or three times a day may be administered only once a day. We also have a product containing two different drug compounds incorporated in the GR System in preclinical development. The principal patent on our GR System covers the controlled delivery of a broad range of drugs from a gastric retained polymer matrix tablet to maximize therapeutic benefits. Our intellectual property position includes nine issued patents and twelve patent applications pending in the United States.

 

In this Quarterly Report on Form 10-Q, the “company,” “Depomed,” “we,” “us,” and “our,” refer to Depomed, Inc.

 

We are developing our own proprietary products and are also developing products utilizing our GR technology in collaboration with other pharmaceutical and biotechnology companies.  Regarding our collaborative programs, we apply our proprietary technology to the partner’s compound and from these collaborations we generally expect we will receive research and development funding, milestone payments, license fees and royalties. For our internal development programs, we apply our proprietary technology to existing drugs and typically fund development at least through Phase II clinical trials.  Upon the completion of Phase II clinical trials, we evaluate, on a case-by-case basis, the feasibility of retaining marketing or co-marketing rights to our product candidates in the United States, taking into account such factors as the marketing and sales efforts required for each of the product candidates, the

 

 

14



 

 

potential collaborative partners and the proposed terms of any such collaboration. When we license marketing rights to a collaborative partner, we generally expect the partner to fund the completion of the clinical trials and to pay us license fees, milestones and royalties on sales of the product.

 

Glumetza™ (Metformin GR™ )

In April 2004, our collaborative partner, Biovail Laboratories, submitted an NDA for our internally developed once-daily metformin product for Type II diabetes, Metformin GR, also known as the 500mg strength version of Glumetza.  The FDA accepted the application for review in June 2004.  In February 2005, Biovail received an approvable letter from the FDA requiring certain additional steps be taken prior to approval of the drug.  The earliest that we expect to obtain FDA approval to market Glumetza is in the second quarter of 2005, if at all.

 

Proquin™ (Ciprofloxacin GR™ )

In July 2004, we submitted an NDA to the FDA for Proquin, our internally developed once-daily formulation of the antibiotic drug ciprofloxacin, for urinary tract infections.  The FDA accepted the application for review in September 2004.  The earliest that we expect to obtain FDA approval to market Proquin is in the second quarter of 2005, if at all.   We are seeking potential marketing or co-marketing partners for Proquin.

 

Gabapentin GR™

 We have developed Gabapentin GR, an extended release gabapentin product.  Gabapentin is marketed by Pfizer Inc. for adjunctive therapy for epileptic seizures and postherpetic pain under the label Neurontin®.  We initiated a Phase II clinical trial for Gabapentin GR in the first quarter of 2005 for post-herpetic neuralgia, which we expect to complete in the third quarter of 2005.

 

Furosemide GR™

In September 2004, we completed a Phase II clinical trial for Furosemide GR.  Furosemide is a widely prescribed diuretic marketed as an immediate release formulation and sold by Aventis as Lasix®, as well as by several other pharmaceutical companies as a generic.  The results of the Phase II trial in moderate to severe congestive heart failure patients met the primary endpoints, which indicated that patients in the Furosemide GR treatment group experienced excretion of urine and electrolytes comparable to that of the furosemide immediate release treatment group.  However, we have extended the Phase II clinical trial with some of the patients to evaluate the extent to which an improvement in the frequency and urgency of diuresis can be achieved with Furosemide GR in congestive heart failure patients.  We expect to obtain the results of the clinical trial later in the second quarter of 2005.

 

Other Research and Development Activities

We are developing other product candidates expected to benefit from incorporation into our drug delivery system. For example, we are collaborating with AVI BioPharma, Inc. on a project for the delivery of large molecules, such as antisense compounds, from the GR System. We have also completed preclinical studies of a combination product comprising our Glumetza (500mg) once-daily formulation of metformin with a once-daily sulfonylurea for Type II diabetes. Under our agreement with Biovail, Biovail has an exclusive option to license this product from us. We expect that a Phase I clinical trial for this product will commence only if we enter into a development and licensing agreement with Biovail or another third party.

 

In April 2005, we entered into an agreement with Boehringer Ingelheim Pharmaceuticals, Inc. to begin feasibility studies with an undisclosed pharmaceutical compound.  Under the agreement, all research and development work with the partner’s drug will be funded by the partner.

 

Other Information

 Future clinical progress of our products depends primarily on the results of each ongoing study. There can be no assurance that a clinical trial will be successful or that the product will gain regulatory approval.  For a more complete discussion of the risks and uncertainties associated with completing development of a potential product, see the section entitled “Additional Factors that May Affect Future Results” and elsewhere in this Form 10-Q.

 

 

15



 

In addition to research and development conducted on our own behalf and through collaborations with pharmaceutical partners, our activities since inception (August 7, 1995) have included establishing our offices and research facilities, recruiting personnel, filing patent applications, developing a business strategy and raising capital. To date, we have received only limited revenue, all of which has been from these collaborative research and feasibility arrangements. We intend to continue investing in the further development of our drug delivery technologies and the GR System. We may need to make additional capital investments in laboratories and related facilities.  However, since NDAs for our two lead products have been submitted to the FDA in the second and third quarters of 2004 and our new product candidates are still in the earlier stages of development, we believe that our research and development expenses will remain relatively flat or decrease slightly during 2005.

 

We have generated a cumulative net loss of approximately $126,760,000 for the period from inception through March 31, 2005.

 

Critical Accounting Policies

Critical accounting policies are those that require significant judgment and/or estimates by management at the time that the financial statements are prepared such that materially different results might have been reported if other assumptions had been made.  We consider certain accounting policies related to revenue recognition, accrued liabilities and stock-based compensation to be critical policies.  There have been no changes to our critical accounting policies since we filed our 2004 Annual Report on Form 10-K with the Securities and Exchange Commission on March 16, 2005.  For a description of our critical accounting policies, please refer to our 2004 Annual Report on Form 10-K.

 

 

RESULTS OF OPERATIONS

 

Three and Three Months Ended March 31, 2005 and 2004

 

Revenues

Revenue for the three months ended March 31, 2005 and 2004 was $19,000 and $120,000, respectively.  In 2005, revenue from licenses increased to $19,000 due to revenue recognized under a license agreement signed with LG Life Sciences in August 2004.  Pursuant to our agreement with LG Life Sciences, we expect to recognize additional license fees of approximately $19,000 per quarter until 2012.  Revenue from collaborative agreements decreased due to a reduction in product development services performed for ActivBiotics and another collaborative partner.  We completed product development services for these partners in 2004 and we do not expect to perform additional product development services under these respective agreements.

 

Research and Development Expense

Research and development expense decreased to $5,017,000 in the three months ended March 31, 2005 from $5,577,000 for the same period of 2004.  The net decrease of $560,000 was due to a decrease of $568,000 in expense related to external research and development services, including clinical trial expense as our Glumetza and Proquin Phase III trials, which concluded in the second quarter of 2004.  Other expense decreases of $73,000 for regulatory legal expense related to our FDA filings and $87,000 for computer software upgrades, equipment and office supplies used in research and development, were offset by $152,000 in additional expense related to the depreciation and amortization of lab equipment and leasehold improvements.  Since NDAs for our two lead products have been submitted to the FDA in the second and third quarters of 2004 and our new product candidates are still in earlier stages of development, we believe that our research and development expenses will remain relatively flat or decrease slightly during 2005.

 

Our research and development expenses currently include costs for scientific personnel, supplies, equipment, outsourced clinical and other research activities, consultants, depreciation, facilities and utilities.  The scope and magnitude of future research and development expenses cannot be predicted at this time for our product candidates in the early phases of research and development, as it is not possible to determine the nature, timing and extent of clinical trials and studies, the FDA’s requirements for a particular drug and the requirements and level of participation, if any, by potential partners.  As potential products proceed through the development process, each

 

 

16



 

step is typically more extensive, and therefore more expensive, than the previous step.  Success in development therefore, generally, results in increasing expenditures until actual product launch.  Furthermore, our business strategy involves licensing certain of our drug candidates to collaborative partners.  Depending upon when such collaborative arrangements are executed, the amount of costs incurred solely by us will be impacted.  Since Glumetza has been licensed to Biovail and submitted to the FDA for approval, we can be reasonably certain of our remaining development and regulatory responsibilities and the associated expenses. Therefore, we are able to estimate that, as of March 2005, the costs to complete our activities related to Glumetza will not exceed $450,000, including costs for regulatory management, analytical testing and support.  Based on the uncertainty of future events related to Proquin, such costs cannot be predicted at this time.

 

General and Administrative Expense

General and administrative expense for the first quarter of 2005 and 2004 was $1,716,000 and $1,143,000, respectively.   The increase of $573,000 was due primarily to $325,000 for increased salaries and the hiring of additional employees.  Other increases of $141,000 were for consulting related to increased costs to comply with the Sarbanes-Oxley Act of 2002, and $75,000 related to fees for the recruitment of sales and marketing personnel who will assist us with preparation for the possible launch of Proquin.  We expect that general and administrative expense will continue to increase as personnel are hired in 2005.

 

Consolidated Subsidiary Expense

In January 2000, we formed Depomed Development Limited (DDL) with Elan to develop products using drug delivery technologies and expertise of both Elan and Depomed.  In August 2002, all product development activities ceased.  In September 2003, the joint venture partners amended or terminated the contracts governing the operation of DDL, which included the termination of Elan’s participation in the management of DDL.  Pursuant to our adoption of FIN 46 on July 1, 2003, we consolidated the accounts of DDL for all subsequent periods.  Since September 2003, we have been responsible for 100% of the expenses incurred by DDL. In June 2004, we acquired Elan’s 19.9% interest in DDL for $50,000.

 

For the three months ended March 31, 2005 and 2004, we consolidated approximately $7,000 and $6,000, respectively, of DDL expenses, which are included in general and administrative expenses in the condensed consolidated statements of operations.  We expect to consolidate general and administrative expense of approximately $10,000 annually related to DDL.  DDL does not have any fixed assets, liabilities or employees and will not perform any further product development.  We have not made a determination as to DDL’s future.

 

Elan made available to us a convertible loan facility to assist us in funding our portion of the joint venture’s losses up to a principal maximum of $8,010,000.  The funding term of the loan expired in September 2002.  (See the Contractual Obligations section below).

 

Interest Income and Expense

Interest expense was approximately $233,000 and $227,000 for the three months ended March 31, 2005 and 2004, respectively.  The net increase of approximately $6,000 in interest expense for the period was due to increased interest of approximately $17,000 accrued on the Elan convertible loan facility, which was partially offset by a decrease of approximately $10,000 in interest expense on our other loan and lease obligations as they neared the end of their terms.  Interest on the Elan loan facility increased due to compounding of interest on the loan balance.  Interest and other income was approximately $172,000 for the three months ended March 31, 2005 compared to $146,000 in the same period of 2004.  The increase, year over year, was due to higher investment balances in 2005 as a result of our public offering in the first quarter of 2005 and also due to higher interest rates earned on our investment portfolio.  Interest and other income also included immaterial gains and losses realized on some of our marketable securities.

 

Series A Preferred Stock and Dividends

In January 2000, we issued 12,015 shares of Series A Preferred Stock at a price of $1,000 per share to fund our 80.1% share of the initial capitalization of DDL. The Series A Preferred Stock accrues a dividend of 7% per annum, compounded semi-annually and payable in shares of Series A Preferred Stock. The Series A Preferred Stock and dividends are convertible at anytime between January 2002 and January 2009 into our common stock (including the

 

 

17



 

impact of a warrant issued to the Series A Preferred stockholder in December 2004). The original conversion price of the Series A Preferred Stock was $12.00. However, as a result of our March 2002 and October 2003 financings, the conversion price had been adjusted to $9.51 per share. In December 2004, we entered into an agreement with the Series A Preferred stockholder to resolve a misunderstanding between us and the stockholder relating primarily to prior adjustments to the conversion price of the Series A Preferred Stock (the December 2004 Agreement).  Pursuant to the December 2004 Agreement, among other matters, we agreed to adjust the conversion price to $7.50 per share.  We and the stockholder also agreed to binding interpretations of certain other terms related to the Series A conversion price.

 

Prior to December 2004, the amounts calculated as Series A Preferred stock dividends were accounted for as an adjustment to the conversion price following EITF Issue No. 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios (Issue No. 98-5). As a result of the December 2004 Agreement, we determined that a significant modification of the preferred stock agreement had occurred, and, therefore, a new commitment date was established for the Series A Preferred Stock.  Further, we determined that the fair value of the modified preferred stock was below the carrying value of such securities as of the date of the modification, therefore, no deemed dividend resulted from this modification. Also, we determined that although a new commitment date had been established, this change did not result in a beneficial conversion feature subject to recognition pursuant to Emerging Issues Task Force Issue No. 00-27, Application of Issue No. 98-5 to Certain Convertible Instruments.  However, an anti-dilution provision of the Series A Preferred Stock was triggered by the Company’s January 2005 financing, which adjusted the conversion price of the Series A Preferred Stock to $7.12.  As a result of the adjusted conversion price and an increase in the amount of common stock issuable upon conversion of the Series A Preferred Stock due to additional accumulated dividends, the Series A Preferred Stock now contains a “beneficial conversion feature” subject to recognition pursuant to Issue No. 98-5. For the period ended March 31, 2005, we recognized Series A Preferred Stock deemed dividends of approximately $194,000 attributable to the beneficial conversion feature.  We will continue to recognize Series A Preferred Stock deemed dividends until the earlier of, the time the Series A Preferred Stock is converted to common stock or until January 2009.

 

Stock-Based Compensation Expense

In July 2003, our Board of Directors approved an amendment to all stock options granted to non-employee members of our Board of Directors. In the case of the death of a non-employee director, the amendment provides for the director’s beneficiary to exercise the director’s stock options at anytime over the remaining life of the stock option. A non-cash compensation expense related to the amended stock options will be recognized if and when a director’s beneficiary benefits from this modified provision. The maximum stock-based compensation expense would be $369,000 if all non-employee directors benefit from this provision with respect to outstanding options. In the first quarter of 2005, we recognized $135,000 in stock-based compensation expense related to these options.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Operating Activities

Cash used in operating activities in the three months ended March 31, 2005 was approximately $6,466,000, compared to approximately $6,301,000 for the three months ended March 31, 2004. During the three months ended March 31, 2005, the cash used in operations was due primarily to the net loss adjusted for depreciation.  In 2004, the cash used in operations was also due primarily to the net loss adjusted for depreciation.

 

Investing Activities

Cash used in investing activities in the three months ended March 31, 2005 totaled approximately $5,148,000 and consisted of a $4,977,000 net increase in marketable securities and $171,000 in purchases of leasehold improvements, laboratory and office equipment.  Net cash used in investing activities in the three months ended March 31, 2004 totaled approximately $1,241,000 and consisted primarily of a $751,000 net increase in marketable securities and $489,000 in purchases of leasehold improvements, laboratory and office equipment.  We expect that future capital expenditures will include additional product development and quality control laboratory equipment to maintain current Good Manufacturing Practices in our laboratories.

 

 

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Financing Activities

Cash provided by financing activities in the three months ended March 31, 2005 was approximately $20,985,000 compared to $11,000 in cash used in financing activities for the same period of 2004.  In 2005, the amount consisted primarily of $21,053,000 of net proceeds from our registered direct public offering of 5,036,000 shares of common stock for $4.50 per share in January 2005, which was partially offset by $78,000 of payments on our equipment loans and capital lease obligations.  In 2004, the amount consisted of $114,000 of payments on our equipment loans and capital lease obligations, which were partially offset by $102,000 of net proceeds from exercises of stock options and warrants.

 

Contractual Obligations

As of March 31, 2005, there was $10,505,000 outstanding related to the loan facility provided by Elan.  The outstanding amounts include accrued interest of $2,708,000 at March 31, 2005.  The funding term of the loan expired on September 30, 2002.  The loan and accrued interest are payable in January 2006 in cash or our common stock, at Elan’s option.

 

As of March 31, 2005, our aggregate contractual obligations for the next four years are as shown in the following table.  We have no contractual obligations with maturities greater than four years.

 

 

 

 

Payments Due by Period

 

Contractual Obligations

 

Total

 

Less than 1 year

 

1 to 3 years

 

4 years

 

Operating leases

 

$

3,042,213

 

$

980,768

 

$

1,977,955

 

$

83,490

 

Capital leases

 

13,650

 

13,650

 

 

 

Long-term debt

 

22,327

 

22,327

 

 

 

Elan convertible loan and accrued interest

 

11,283,300

 

11,283,300

 

 

 

 

 

$

14,361,490

 

$

12,300,045

 

$

1,977,955

 

$

83,490

 

 

Financial Condition

As of March 31, 2005, we had approximately $32,472,000 in cash, cash equivalents and marketable securities, working capital of $19,520,000, and accumulated net losses of $126,760,000.  We expect to continue to incur operating losses for at least the next two years.  We anticipate that our existing capital resources, exclusive of potential payments from licensing partners, will permit us to meet our capital and operational requirements through at least January 2006.  However, we base this expectation on our current operating plan, which may change as a result of many factors.  Our cash needs may also vary materially from our current expectations because of numerous factors, including:

   •     results of research and development efforts;

   •     financial terms of definitive license agreements or other commercial agreements we enter into, if any;

   •     relationships with collaborative partners;

   •     changes in the focus and direction of our research and development programs;

   •     technological advances;

   •     results of clinical testing, requirements of the FDA and comparable foreign regulatory agencies; and

   •     acquisitions or investment in complimentary businesses, products or technologies.

 

We will need substantial funds of our own or from third parties to:

   •     conduct research and development programs;

   •     conduct preclinical and clinical testing; and

   •     manufacture (or have manufactured) and market (or have marketed) potential products using the GR System.

 

Our existing capital resources may not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to support our operations.  We have limited credit facilities and no other committed

 

19



 

sources of capital.  To the extent that our capital resources are insufficient to meet our future capital requirements, we will have to raise additional funds through the sale of our equity securities or from development and licensing arrangements to continue our development programs.  We may not be able to raise such additional capital on favorable terms, or at all.  If we raise additional capital by selling our equity or convertible debt securities, the issuance of such securities could result in dilution of our shareholders’ equity positions.  If adequate funds are not available we may have to:

          •     delay, postpone or terminate clinical trials;

   •     curtail other operations significantly; and/or

   •     obtain funds through entering into collaboration agreements on unattractive terms.

 

The inability to raise capital would have a material adverse effect on our company.

 

Recently Issued Accounting Standards

In December 2004, the FASB issued Statement No. 123R, “Share-Based Payment” (FAS 123R), which is a revision of FAS 123. FAS 123R supersedes APB No. 25 and amends FAS No. 95, Statement of Cash Flows.  Generally, the approach in FAS 123R is similar to the approach described in FAS 123. FAS 123R requires all share-based payments to employees and directors, including grants of employee and director stock options, to be recognized in the statement of operations based on their fair values. Pro forma disclosure is no longer an alternative.  In April 2005, the Securities and Exchange Commission adopted a new rule amending the compliance dates for FAS 123R.  In accordance with the new rule, we will adopt FAS 123R on January 1, 2006.

 

FAS 123R permits public companies to adopt its requirement using one of two methods:  1) a “modified prospective” method in which compensation cost is recognized beginning with the effective date (a) based on the requirements of FAS 123R for all share-based payments granted after the effective date and (b) based on the requirements of FAS 123R for all awards granted to employees and directors prior to the effective date of FAS 123R that remain unvested on the effective date; or 2) a “modified retrospective” method which includes the requirements of the modified prospective method described above, but also permits entities to restate based on the amounts previously recognized under Statement 123 for purposes of pro forma disclosures either (a) all prior periods presented or (b) prior interim periods of the year of adoption.  We plan to adopt FAS 123R using the modified prospective method.

 

As permitted by FAS 123, we currently account for share-based payments to employees and directors using APB No. 25’s intrinsic value method and, as such, recognizes no compensation cost for employee and director stock options where the exercise price equals the fair market value of the underlying common shares on the measurement date.  Accordingly, the adoption of FAS 123R’s fair value method will have a significant impact on our results of operations, although it will have no impact on our overall financial position. The impact of adoption of FAS 123R cannot be predicted at this time because it will depend on levels of share-based payments granted in the future.  However, had we adopted FAS 123R in prior periods, the impact of that standard would have approximated the impact of FAS 123 as described in the disclosure of pro forma net loss and loss per share in Note 1, Summary of Significant Accounting Policies, Stock-Based Compensation to our condensed consolidated financial statements.

 

 

ADDITIONAL FACTORS THAT MAY AFFECT FUTURE RESULTS

 

          In addition to other information in this report, the following factors should be considered carefully in evaluating Depomed.  We believe the following are the material risks and uncertainties we face at the present time.  If any of the following risks or uncertainties actually occurs, our business, financial condition or results of operations could be materially adversely affected.  See also “Forward-Looking Statements.”

 

We are at an early stage of development and are expecting operating losses in the future.

        To date, we have had no revenues from product sales and only minimal revenues from our collaborative research and development arrangements and feasibility studies.  For the three months ended March 31, 2005, we had total revenues of $19,000 and for the years ended December 31, 2002, 2003 and 2004, we had total revenues of,

 

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$1.7 million in 2002, $1.0 million in 2003 and $200,000 in 2004. For the three months ended March 31, 2005, we incurred net losses of $6.8 million and for the years ended December 31, 2002, 2003 and 2004, we incurred losses of  $13.5 million in 2002, $30.0 million in 2003 and $26.9 million in 2004. As we continue our research and development efforts, preclinical testing and clinical trial activities, we anticipate that we will continue to incur substantial operating losses for at least the next two years. Therefore, we expect our cumulative losses to increase.  These losses, among other things, have had, and we expect that they will continue to have, an adverse impact on our total assets, shareholders’ equity and working capital.

We depend heavily on the successful development and commercialization of our lead product candidates, Glumetza (500mg) and Proquin, each of which is still subject to approval by the FDA, and our other product candidates, which are in early stages of development, and on our core technology platform, the GR System.

          To date, we have not commercialized any products.  Two of our product candidates, Glumetza and Proquin, each have an NDA filed with the FDA.  Our other product candidates are in earlier stages of clinical or preclinical development.  We anticipate that in the near term our ability to generate revenues will depend principally on the successful commercialization of Glumetza (500mg) and Proquin.  If we fail to obtain regulatory approval for, or successfully commercialize, Glumetza (500mg) or Proquin, our ability to raise financing and our business, financial condition and results of operations will be materially and adversely affected.  Also, our various product candidates use the GR System.  If it is discovered that the GR System could have adverse effects or other characteristics that indicate it is unlikely to be effective as a delivery system for drugs or therapeutics, our product development efforts and our business would be significantly harmed.

We will receive future payments from Biovail related to Glumetza only if Glumetza is approved by the FDA.

          In May 2002, we entered into an exclusive license agreement with Biovail to manufacture and market Glumetza in the United States and Canada.  We were responsible for completing the clinical development of Glumetza.  Biovail will not reimburse us for any of our expenses incurred in connection with the development of Glumetza.  In February 2005, Biovail received an approvable letter from the FDA requiring certain additional steps be taken prior to approval of the drug. Only if we receive FDA approval of Glumetza will Biovail be required to make a $25.0 million milestone payment to us.  We will not receive any other payments from Biovail unless the FDA approves Glumetza for marketing in the United States, which we do not expect to occur until the second quarter of 2005, if at all.  Biovail can sublicense its rights to Glumetza, and has indicated that it plans to do so, in which event we would depend on the sub licensee to commercialize Glumetza.

Our quarterly operating results may fluctuate and affect our stock price.

          The following factors will affect our quarterly operating results and may result in a material adverse effect on our stock price:

•  our success or failure in entering into further collaborative relationships;

•  variations in revenues obtained from collaborative agreements, including milestone payments, royalties, license fees and other contract revenues;

•  decisions by collaborative partners to proceed or not to proceed with subsequent phases of a collaboration or program;

•  the timing of any future product introductions by us or our collaborative partners;

•  market acceptance of the GR System;

•  regulatory actions;

•  adoption of new technologies;

•  developments concerning proprietary rights, including patents, infringement allegations and litigation matters;

•  the introduction of new products by our competitors;

•  manufacturing costs and difficulties;

•  results of clinical trials for our products;

•  changes in government funding;

•  third-party reimbursement policies; and

•  the status of our compliance with the provisions of the Sarbanes-Oxley Act of 2002.

 

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Our collaborative arrangements may give rise to disputes over commercial terms, contract interpretation and ownership of our intellectual property and may adversely affect the commercial success of our products.

We currently have a collaboration agreement with Biovail to develop Glumetza. In addition, we have entered into other collaborative arrangements, some of which have been based on less definitive agreements, such as memoranda of understanding, material transfer agreements, options or feasibility agreements and we may not execute definitive agreements formalizing these arrangements. Collaborative relationships are generally complex and may give rise to disputes regarding the relative rights, obligations and revenues of the parties, including the ownership of intellectual property and associated rights and obligations, especially when the applicable provisions have not been fully negotiated. Such disputes can delay collaborative research, development or commercialization of potential products, or can lead to lengthy, expensive litigation or arbitration. The terms of collaborative arrangements may also limit or preclude us from developing products or technologies developed pursuant to such collaborations. Additionally, the collaborators under these arrangements might breach the terms of their respective agreements or fail to prevent infringement of the licensed patents by third parties.  Moreover, negotiating collaborative arrangements often takes considerably longer to conclude than the parties initially anticipate, which could cause us to agree to less favorable agreement terms that delay or defer recovery of our development costs and reduce the funding available to support key programs.

We may not be able to enter into future collaborative arrangements on acceptable terms, which would harm our ability to commercialize our products. Further, even if we do enter into collaboration arrangements, it is possible that our collaborative partners may not choose to develop and commercialize products using the GR System technologies. Other factors relating to collaborations that may adversely affect the commercial success of our products include:

             • any parallel development by a collaborative partner of competitive technologies or products;

             • arrangements with collaborative partners that limit or preclude us from developing products or technologies;

             • premature termination of a collaboration agreement; or

             • failure by a collaborative partner to devote sufficient resources to the development and commercial sales of products using the GR System.

Generally, our collaborative arrangements do not restrict our collaborative partners from competing with us or restrict their ability to market or sell competitive products. Our current and any future collaborative partners may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with us. Our collaborative partners may also terminate their collaborative relationships with us or otherwise decide not to proceed with development and commercialization of our products.

We may be unable to protect our intellectual property and may be liable for infringing the intellectual property of others.

Our success will depend in part on our ability to obtain and maintain patent protection for our technologies and to preserve our trade secrets. Our policy is to seek to protect our proprietary rights, by among other methods, filing patent applications in the United States and foreign jurisdictions to cover certain aspects of our technology. We currently hold nine issued United States patents and twelve United States patent applications are pending. In addition, we are preparing patent applications relating to our expanding technology for filing in the United States and abroad. We have also applied for patents in numerous foreign countries. Some of those countries have granted our applications and other applications are still pending. Our pending patent applications may lack priority over others’ applications or may not result in the issuance of patents. Even if issued, our patents may not be sufficiently broad to provide protection against competitors with similar technologies and may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products or may not provide us with competitive advantages against competing products.

We also rely on trade secrets and proprietary know-how, which are difficult to protect. We seek to protect such information, in part, through entering into confidentiality agreements with employees, consultants, collaborative partners and others before such persons or entities have access to our proprietary trade secrets and know-how. These confidentiality agreements may not be effective in certain cases, due to, among other things, the lack of an adequate remedy for breach of an agreement or a finding that an agreement is unenforceable. In addition, our trade secrets may otherwise become known or be independently developed by competitors.

 

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Our ability to develop our technologies and to make commercial sales of products using our technologies also depends on not infringing others’ patents or other intellectual property rights. We are not aware of any intellectual property claims against us. However, the pharmaceutical industry has experienced extensive litigation regarding patents and other intellectual property rights. For example, Pfizer has initiated several suits against companies seeking to market formulations of gabapentin that compete with Neurontin, claiming that these formulations of gabapentin infringe Pfizer’s patents. The results of this litigation could adversely impact our ability to commercialize Gabapentin GR. Also, we are aware that patents issued to third parties relating to sustained release drug formulations or particular pharmaceutical compounds could in the future be asserted against us, although we believe that we do not infringe any valid claim of any patents.  If claims concerning any of our products were to arise and it was determined that these products infringe a third party’s proprietary rights, we could be subject to substantial damages for past infringement or be forced to stop or delay our activities with respect to any infringing product, unless we can obtain a license or we may have to redesign our product so that it does not infringe upon others’ patent rights, which may not be possible or could require substantial funds or time.  Such a license may not be available on acceptable terms, or at all.  Even if we, our collaborators or our licensors were able to obtain a license, the rights may be nonexclusive, which would give our competitors access to the same intellectual property.  In addition, any public announcements related to litigation or interference proceedings initiated or threatened against us, even if such claims are without merit, could cause our stock price to decline.

From time to time, we may become aware of activities by third parties that may infringe our patents.  Infringement by others of our patents may reduce our market shares (if a related product is approved) and, consequently, our potential future revenues and adversely affect our patent rights if we do not take appropriate enforcement action.  We may need to engage in litigation in the future to enforce any patents issued or licensed to us or to determine the scope and validity of third-party proprietary rights. Our issued or licensed patents may not be held valid by a court of competent jurisdiction. Whether or not the outcome of litigation is favorable to us, defending a lawsuit takes significant time, may be expensive and may divert management attention from other business concerns. We may also be required to participate in interference proceedings declared by the United States Patent and Trademark Office for the purpose of determining the priority of inventions in connection with our patent applications or other parties’ patent applications. Adverse determinations in litigation or interference proceedings could require us to seek licenses which may not be available on commercially reasonable terms, or at all, or subject us to significant liabilities to third parties.  If we need but cannot obtain a license, we may be prevented from marketing the affected product.

It is difficult to develop a successful product. If we do not develop a successful product we may not be able to raise additional funds.

The drug development process is costly, time-consuming and subject to unpredictable delays and failures. Before we or others make commercial sales of products using the GR System, we, our current and any future collaborative partners will need to:

             • conduct preclinical and clinical tests showing that these products are safe and effective; and

             • obtain regulatory approval from the FDA or foreign regulatory authorities.

We will have to curtail, redirect or eliminate our product development programs if we or our collaborative partners find that:

             • the GR System has unintended or undesirable side effects; or

             • products that appear promising in preclinical or early-stage clinical studies do not demonstrate efficacy in later-stage, larger scale clinical trials.

Even if our products obtain regulatory approval, successful commercialization would require:

             • market acceptance;

             • cost-effective commercial scale production; and

             • reimbursement under private or governmental health plans.

 

Any material delay or failure in the governmental approval process and/or the commercialization of our potential products, particularly Glumetza or Proquin, would adversely impact our financial position and liquidity and would make it difficult for us to raise financing on favorable terms, if at all.

 

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If we do not achieve our projected development goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed.

For planning purposes, we estimate the timing of the accomplishment of various scientific, clinical, regulatory and other product development goals.  These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings.  From time to time, we may publicly announce the expected timing of some of these milestones.  All of these milestones are based on a variety of assumptions.  The actual timing of these milestones can vary considerably from our estimates depending on numerous factors, some of which are beyond our control, including:

             • our ability to obtain adequate funding;

             • the rate of progress, costs and results of our clinical trial and research and development activities, including the extent of scheduling conflicts with participating clinicians and clinical institutions and our ability to identify and enroll patients who meet clinical trial eligibility criteria;

             • our receipt of approvals by the FDA and other regulatory agencies and the timing thereof;

• other actions by regulators;

• our ability to access sufficient, reliable and affordable supplies of components used in the manufacture of our product candidates, including insulin and materials for our GR System; and

• the costs of ramping up and maintaining manufacturing operations, as necessary;

If we fail to achieve our announced milestones in the timeframes we announce and expect, our business and results of operations may be harmed and the price of our stock may decline.

If we are unable to obtain or maintain regulatory approval, we will be limited in our ability to commercialize our products, and our business will be harmed.

Our collaborative partner, Biovail, submitted the NDA to the FDA for Glumetza in April 2004.  The FDA accepted the NDA for review in June 2004.  Because the NDA submitted by Biovail for the Glumetza 500 mg tablet (Metformin GR) also seeks approval for Biovail’s 1000 mg metformin tablet, which has a different extended release technology, any issues that may arise in the FDA review process with respect to the Biovail tablet could delay approval of the 500mg Glumetza tablet.  In February 2005, Biovail received an approvable letter from the FDA requiring certain additional steps be taken prior to approval of the drug.  The earliest that we expect to be able to obtain FDA approval to market Glumetza is in the second quarter of 2005, if at all.

In July 2004, we filed an NDA to the FDA for our internally developed once-daily formulation of the antibiotic drug ciprofloxacin for uncomplicated urinary tract infection, called Proquin.  The FDA accepted the NDA for review in September 2004.  The earliest that we expect to be able to obtain FDA approval to market Proquin is in the second quarter of 2005, if at all.

We believe that the application submitted to the FDA for Proquin will be reviewed as a full, stand-alone NDA under Section 505(b)(1) of the Federal Food, Drug and Cosmetic Act, or FDC Act.  There is the possibility, however, that to the extent that any such application refers to information in the scientific literature, the FDA will deem it to be what is known as a “505(b)(2) NDA,” named after the section of the FDC Act that permits it to be filed.  Section 505(b)(2) of the FDC Act permits the filing of an NDA for which at least some of the information required for product approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.  If the FDA deems that an application is a 505(b)(2) NDA, we will be required to identify the listed drug.  The listed drug is the drug for which the FDA has made a finding of safety and effectiveness on which the applicant relies to seek approval of its product.  In addition to identifying the listed drug, we will be required to certify in the application as to whether or not its product may infringe any relevant patents on the listed drug.  In addition, a 505(b)(2) NDA would be subject to any market exclusivity of the listed drug.  If the FDA determines that an application is a 505(b)(2) NDA, and the application is approved, these additional requirements may result in a delay of the effective date of the approval of the application.

The regulatory process is expensive and time consuming. Even after investing significant time and expenditures on clinical trials, we may not obtain regulatory approval of our products. Data obtained from clinical trials are susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Significant clinical trial delays would impair our ability to commercialize our products and could allow our competitors to bring products to

 

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market before we do. In addition, changes in regulatory policy for product approval during the period of product development and regulatory agency review of each submitted new application may cause delays or rejections. Even if we receive regulatory approval, this approval may entail limitations on the indicated uses for which we can market a product.

Further, once regulatory approval is obtained, a marketed product and its manufacturer are subject to continual review. The discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer or manufacturing facility, including withdrawal of the product from the market. Manufacturers of approved products are also subject to ongoing regulation, including compliance with FDA regulations governing current Good Manufacturing Practices (cGMP). Failure to comply with manufacturing regulations can result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to renew marketing applications and criminal prosecution.

Pharmaceutical marketing is subject to substantial regulation in the United States.

          Even if we obtain approval to market our products in the United States, our marketing activities will be subject to numerous federal and state laws governing the marketing and promotion of pharmaceutical products.  The FDA regulates post-approval promotional labeling and advertising to ensure that they conform with statutory and regulatory requirements.  In addition to FDA restrictions, the marketing of prescription drugs is subject to laws and regulations prohibiting fraud and abuse under government healthcare programs.  For example, the federal healthcare program antikickback statute prohibits giving things of value to induce the prescribing or purchase of products that are reimbursed by federal healthcare programs, such as Medicare and Medicaid.  In addition, federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government.  Under this law, the federal government in recent years has brought claims against drug manufacturers alleging that certain marketing activities caused false claims for prescription drugs to be submitted to federal programs.  Many states have similar statutes or regulations, which apply to items and services reimbursed under Medicaid and other state programs, or, in some states, regardless of the payor.  If we, or our collaborative partners, fail to comply with applicable FDA regulations or other laws or regulations relating to the marketing of our products, we could be subject to criminal prosecution, civil penalties, seizure of products, injunction, exclusion of our products from reimbursement under government programs, as well as other regulatory actions against our product candidates, our collaborative partners or us.

The approval process outside the United States is uncertain and may limit our ability to develop, manufacture and sell our products internationally.

To market any of our products outside of the United States, we and our collaborative partners are subject to numerous and varying foreign regulatory requirements, implemented by foreign health authorities, governing the design and conduct of human clinical trials and marketing approval for drug products. The approval procedure varies among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA approval. The foreign regulatory approval process includes all of the risks associated with obtaining FDA approval set forth above, and approval by the FDA does not ensure approval by the health authorities of any other country, nor does the approval by foreign health authorities ensure approval by the FDA.

If we are unable to obtain acceptable prices or adequate reimbursement for our products from third-party payors, we will be unable to generate significant revenues.

In both domestic and foreign markets, sales of our product candidates will depend in part on the availability of adequate reimbursement from third-party payors such as:

• government health administration authorities;

• private health insurers;

• health maintenance organizations;

• pharmacy benefit management companies; and

• other healthcare-related organizations.

If reimbursement is not available for our product candidates, demand for these products may be limited. Further, any delay in receiving approval for reimbursement from third-party payors would have an adverse effect on our revenues. Third-party payors are increasingly challenging the price and cost-effectiveness of medical products

 

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and services. Significant uncertainty exists as to the reimbursement status of newly approved healthcare products, including pharmaceuticals. Our product candidates may not be considered cost effective, and adequate third-party reimbursement may be unavailable to enable us to maintain price levels sufficient to realize an acceptable return on our investment.

Federal and state governments in the United States and foreign governments continue to propose and pass new legislation designed to contain or reduce the cost of healthcare. Existing regulations affecting pricing may also change before any of our product candidates are approved for marketing. Cost control initiatives could decrease the price that we receive for any product we may develop in the future.

We may not be able to compete successfully in the pharmaceutical product and drug delivery system industries.

Other companies that have oral drug delivery technologies competitive with the GR System include Bristol-Myers Squibb, IVAX Corporation, ALZA Corporation (a subsidiary of Johnson & Johnson), SkyePharma plc, Biovail Corporation, Flamel Technologies S.A., Ranbaxy Laboratories, Ltd., Kos Pharmaceuticals, Inc., XenoPort, Inc., Intec Pharma and Alpharma, Inc., all of which develop oral tablet products designed to release the incorporated drugs over time. Each of these companies has patented technologies with attributes different from ours, and in some cases with different sites of delivery to the gastrointestinal tract.

Bristol-Myers Squibb is currently marketing a sustained release formulation of metformin, Glucophage XR, with which Glumetza will compete. The limited license that Bristol-Myers Squibb obtained from us under our November 2002 settlement agreement extends to certain current and internally-developed future compounds, which may increase the likelihood that we will face competition from Bristol-Myers Squibb in the future on products in addition to Glumetza. IVAX Corporation, Par Pharmaceutical, Inc. and Alpharma, Inc. have received FDA approval for and are selling a controlled-release metformin product.  Flamel Technologies has a controlled-release metformin product in clinical trials.

Bayer Corporation is currently marketing a once-daily ciprofloxacin product for the treatment of urinary tract infections. There may be other companies developing products competitive with Glumetza and Proquin of which we are unaware.

To our knowledge, we are the only company currently developing a sustained release formulation of gabapentin for the United States market.

The competitive situation with respect to Gabapentin GR is complex and uncertain given the current regulatory and intellectual property status of gabapentin, which is currently marketed by Pfizer as Neurontin for adjunctive therapy for epileptic seizures and for postherpetic pain. Pfizer’s basic United States patents relating to Neurontin have expired, and at least seven companies are seeking or have received FDA approval for immediate release formulations of the drug. However, Pfizer has initiated several lawsuits against companies seeking to market formulations of gabapentin that compete with Neurontin, claiming that these formulations of gabapentin infringe Pfizer’s patents. In addition, Pfizer has developed a new product, Lyrica™ (pregabalin), which will be marketed as an improved version of Neurontin. It received FDA approval in December 2004.

To our knowledge, we are the only company currently developing a sustained release formulation of furosemide for the United States market, but other companies have published research data indicating that products may be developed that are competitive with Furosemide GR.

Competition in pharmaceutical products and drug delivery systems is intense. We expect competition to increase. Competing technologies or products developed in the future may prove superior to the GR System or products using the GR System, either generally or in particular market segments. These developments could make the GR System or products using the GR System noncompetitive or obsolete.

Most of our principal competitors have substantially greater financial, marketing, personnel and research and development resources than we do. In addition, many of our potential collaborative partners have devoted, and continue to devote, significant resources to the development of their own drug delivery systems and technologies.

 

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We depend on third parties for manufacturing of our products. Failure by these third parties would result in lost revenue.

Although we have established internal manufacturing facilities to manufacture supplies for our Phase I and Phase II clinical trials, we do not have, and we do not intend to establish in the foreseeable future, internal commercial scale manufacturing capabilities. Rather, we intend to use the facilities of third parties to manufacture products for Phase III clinical trials and commercialization. Our dependence on third parties for the manufacture of products using the GR System may adversely affect our ability to deliver such products on a timely or competitive basis. Although Biovail has made arrangements for the third party manufacture of Glumetza, there may not be sufficient manufacturing capacity available to us when, if ever, we are ready to seek commercial sales of other products using the GR System. The manufacturing processes of our third party manufacturers may be found to violate the proprietary rights of others. If we are unable to contract for a sufficient supply of required products on acceptable terms, or if we encounter delays and difficulties in our relationships with manufacturers, the market introduction and commercial sales of our products will be delayed, and our revenue will suffer.

Applicable current Good Manufacturing Practices (cGMP) requirements and other rules and regulations prescribed by foreign regulatory authorities will apply to the manufacture of products using the GR System. We will depend on the manufacturers of products using the GR System to comply with cGMP and applicable foreign standards. Any failure by a manufacturer of products using the GR System to maintain cGMP or comply with applicable foreign standards could delay or prevent their initial or continued commercial sale.

In 2004, we announced our determination to evolve from a solely product development focused company to an integrated organization with sales and marketing of our own products.  While preliminary staffing for these activities has begun in 2005, we anticipate this process will continue over the next several years.

We could become subject to product liability litigation and may not have adequate insurance to cover product liability claims.

Our business involves exposure to potential product liability risks that are inherent in the production and manufacture of pharmaceutical products. We have obtained product liability insurance for clinical trials currently underway, but:

             • we may not be able to obtain product liability insurance for future trials;

             • we may not be able to maintain product liability insurance on acceptable terms;

             • we may not be able to secure increased coverage as the commercialization of the GR System proceeds; or

             • our insurance may not provide adequate protection against potential liabilities.

Our inability to obtain adequate insurance coverage at an acceptable cost could prevent or inhibit the commercialization of our products. Defending a lawsuit would be costly and significantly divert management’s attention from conducting our business. If third parties were to bring a successful product liability claim or series of claims against us for uninsured liabilities or in excess of insured liability limits, our business, financial condition and results of operations could be materially harmed.

If we lose our key personnel or are unable to attract and retain key management and operating personnel, we may be unable to pursue our product development and commercialization efforts.

Our success is dependent in large part upon the continued services of John W. Fara, Ph.D., our Chairman, President and Chief Executive Officer, and other members of our executive management team, and on our ability to attract and retain key management and operating personnel. We do not have agreements with Dr. Fara or any of our other executive officers that provide for their continued employment with us. Management, scientific and operating personnel are in high demand in our industry and are often subject to competing offers. The loss of the services of one or more members of management or key employees or the inability to hire additional personnel as needed could result in delays in the research, development and commercialization of our potential product candidates.

We have implemented certain anti-takeover provisions.

      Certain provisions of our articles of incorporation and the California General Corporation Law could discourage a third party from acquiring, or make it more difficult for a third party to acquire, control of our company without approval of our board of directors. These provisions could also limit the price that certain investors might be willing to pay in the future for shares of our common stock. Certain provisions allow the board of directors to authorize the issuance of preferred stock with rights superior to those of the common stock. We are also subject to the provisions

 

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of Section 1203 of the California General Corporation Law which requires a fairness opinion to be provided to our shareholders in connection with their consideration of any proposed “interested party” reorganization transaction.

      We have adopted a shareholder rights plan, commonly known as a “poison pill”. The provisions described above, our poison pill and provisions of the California General Corporation Law may discourage, delay or prevent a third party from acquiring us.

Increased costs associated with corporate governance compliance may significantly impact our results of operations.

          Changing laws, regulations and standards relating to corporate governance, public disclosure and compliance practices, including the Sarbanes-Oxley Act of 2002, new SEC regulations and Nasdaq National Market rules, are creating uncertainty for companies such as ours in understanding and complying with these laws, regulations and standards.  As a result of this uncertainty and other factors, devoting the necessary resources to comply with evolving corporate governance and public disclosure standards may result in increased general and administrative expenses and a diversion of management time and attention to compliance activities.  We also expect these developments to increase our legal compliance and financial reporting costs.  In addition, these developments may make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.  Moreover, we may not be able to comply with these new rules and regulations on a timely basis.

          These developments could make it more difficult for us to attract and retain qualified members of our board of directors, or qualified executive officers.  We are presently evaluating and monitoring regulatory developments and cannot estimate the timing or magnitude of additional costs we may incur as a result.  To the extent these costs are significant, our general and administrative expenses are likely to increase.

If we are unable to timely satisfy new regulatory requirements relating to internal controls, our stock price could suffer.

Section 404 of the Sarbanes-Oxley Act of 2002 requires companies to do a comprehensive evaluation of their internal control over financial reporting.  Beginning December 31, 2004, we must perform an annual evaluation of our internal control over financial reporting, include in our annual report the results of the evaluation, and have our external auditors publicly attest to such evaluation.  If we fail to complete future evaluations on time, or if our external auditors cannot attest to our future evaluations, we could fail to meet our regulatory reporting requirements and be subject to regulatory scrutiny and a loss of public confidence in our internal controls, which could have an adverse effect on our stock price.

Business interruptions could limit our ability to operate our business.

Our operations are vulnerable to damage or interruption from computer viruses, human error, natural disasters, telecommunications failures, intentional acts of vandalism and similar events. In particular, our corporate headquarters are located in the San Francisco Bay area, which is known for seismic activity. We have not established a formal disaster recovery plan, and our back-up operations and our business interruption insurance may not be adequate to compensate us for losses that occur. A significant business interruption could result in losses or damages incurred by us and require us to cease or curtail our operations.

 

ITEM 4.  CONTROLS AND PROCEDURES

An evaluation was performed under the supervision and with the participation of our management, including the President and Chief Executive Officer along with the 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 quarterly report.  Based on that evaluation, the Company’s management, including the President and Chief Executive Officer along with the Chief Financial Officer, concluded that the Company’s disclosure controls and procedures were effective.

 

We intend to review and evaluate the design and effectiveness of our disclosure controls and procedures on an ongoing basis and to improve our controls and procedures over time and to correct any deficiencies that we may discover in the future.  Our goal is to ensure that our senior management has timely access to all material financial and non-financial information concerning our business.  While we believe the present design of our disclosure

 

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controls and procedures is effective to achieve our goal, future events affecting our business may cause us to significantly modify our disclosure controls and procedures.

 

 

PART II — OTHER INFORMATION

 

 

ITEM 6.  EXHIBITS AND REPORTS ON FORM 8-K

 

(a)          Exhibits

 

3.1

Certificate of Determination of Series RP Preferred Stock of Depomed, Inc.

3.2+

Bylaws, as amended

31.1

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of John W. Fara, Ph.D.

31.2

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of John F. Hamilton

32.1

Certification pursuant to 18 U.S.C. Section 1350 of John W. Fara, Ph.D.

32.2

Certification pursuant to 18 U.S.C. Section 1350 of John F. Hamilton


+

Incorporated by reference to the Company’s Form 8-K filed with the SEC on April 19, 2005

 

 

 

29


 


 
 
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 thereunto duly authorized.

 

 

Date: May 10, 2005                                          DEPOMED, INC.

 

 

 

By:

/s/ John F. Hamilton

John F. Hamilton

Vice President and

Chief Financial Officer

(Authorized Officer and

Principal Accounting

and Financial Officer)

 

 

By:

/s/ John W. Fara, Ph.D.

John W. Fara, Ph.D.

President, Chairman and

Chief Executive Officer

 

 

30



 

 

INDEX TO EXHIBITS

 

 3.1

 

Certificate of Determination of Series RP Preferred Stock of Depomed, Inc.

 3.2+

 

Bylaws, as amended

 31.1

 

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of John W. Fara, Ph.D.

 31.2

 

Certification pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 of John F. Hamilton

 32.1

 

Certification pursuant to 18 U.S.C. Section 1350 of John W. Fara, Ph.D.

 32.2

 

Certification pursuant to 18 U.S.C. Section 1350 of John F. Hamilton


+

 

Incorporated by reference to the Company’s Form 8-K filed with the SEC on April 19, 2005

 

 

31