EX-99.1 2 a09-20120_1ex99d1.htm EX-99.1

 

Exhibit 99.1

 

CONTACT:

Sheilah Serradell

Depomed, Inc.

650-462-5900

sserradell@depomed.com

 

DEPOMED REPORTS SECOND QUARTER 2009 FINANCIAL RESULTS

 

MENLO PARK, Calif., July 30, 2009 – Depomed, Inc. (NASDAQ: DEPO) today reported financial results for the second quarter ended June 30, 2009.

 

Revenue for the three months ended June 30, 2009 was $11.6 million compared to $6.3 million for the three months ended June 30, 2008.

 

Operating expenses for the three months ended June 30, 2009 were $20.0 million and included $5.6 million in promotion fee expense related to the Company’s promotion agreement for GLUMETZA® with Santarus. Operating expenses for same period in 2008 were $2.4 million and included a one-time gain of $7.5 million on litigation related to the settlement of the Company’s patent litigation against IVAX Corporation in April 2008, which had the effect of reducing operating expenses for the quarter. The increases in operating expenses in 2009 were due to the Santarus promotion fees and the Company’s ongoing Phase 3 clinical trials for SeradaTM for the treatment of menopausal hot flashes, which began in September 2008.  Stock-based compensation expense was $0.6 million for each of the three months ended June 30, 2009 and June 30, 2008.

 

Net loss for the three months ended June 30, 2009 was $9.6 million, or $0.19 per share, compared to net income of $3.5 million, or $0.07 per share, for the three months ended June 30, 2008. Net income for the three months of 2008 was primarily attributable to a one-time gain of $7.5 million on litigation related to the settlement of the patent infringement suit against IVAX Corporation.

 

Cash, cash equivalents and marketable securities were $84.0 million as of June 30, 2009 compared to $82.1 million as of December 31, 2008. The company will receive an additional $10.0 million in August 2009 pursuant to the transaction with Merck & Co., Inc. described below.

 

“We are excited to have completed enrollment for both our Phase 3 clinical programs in menopausal hot flashes and post-herpetic neuralgia, and we look forward to reporting top-line results early next quarter.  We are also pleased to have closed a patent licensing deal with Merck.  With the $10 million upfront fee from the Merck transaction, and potential for further milestone and royalty payments, along with Glumetza’s recent all-time high prescription numbers, we are executing our strategy to strengthen our cash position by leveraging our technology and portfolio assets while advancing our key pipeline products,” said Carl A. Pelzel, president and chief executive officer of Depomed.

 

Second Quarter 2009 and Recent Highlights

 

·                  Licensed patents covering metformin extended-release technology to Merck & Co., Inc. on a non-exclusive basis for a $10 million upfront fee, a milestone payment upon filing of the NDA, and modest royalties on net product sales  (July 2009)

 



 

·                  Completed enrollment of Phase 3 clinical program of DM-1796 in post-herpetic neuralgia (June 2009)

 

·                  Named Shay Weisbrich vice president of marketing (June 2009)

 

·                  Hosted Investor Day in New York City (May 2009)

 

Conference Call

 

Depomed will host a conference call today, Thursday, July 30, beginning at 5:00 p.m. ET, 2:00 p.m. PT to discuss its results.  The conference call will be available via a live webcast on the investor relations section of Depomed’s website at http://www.depomed.com.  Access the website 15 minutes prior to the start of the call to download and install any necessary audio software.  An archived webcast replay will be available on the Company’s website for three months.

 

About Depomed

 

Depomed, Inc. is a specialty pharmaceutical company with two product candidates in Phase 3 clinical development, two approved products on the market and other product candidates in its early stage pipeline. Product candidate DM-1796 is in Phase 3 clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals. Product candidate SeradaTM is in Phase 3 clinical development for menopausal hot flashes. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States.  Depomed formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of Acuform-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Additional information about Depomed may be found on its website, www.depomed.com.

 

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995.

 

The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our business strategy; potential business development transactions; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

-Financial Tables Follow-

 



 

DEPOMED, INC.

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Revenues:

 

 

 

 

 

 

 

 

 

Product sales

 

$

8,408

 

$

5,519

 

$

15,248

 

$

10,745

 

Royalties

 

529

 

433

 

993

 

545

 

License revenue

 

2,671

 

363

 

5,239

 

727

 

Total revenues

 

11,608

 

6,315

 

21,480

 

12,017

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

1,229

 

962

 

2,261

 

2,171

 

Research and development

 

10,024

 

4,680

 

20,045

 

10,750

 

Selling, general and administrative

 

9,945

 

5,241

 

18,947

 

11,748

 

Gain on litigation settlement

 

 

(7,500

)

 

(7,500

)

Total costs and expenses

 

21,198

 

3,383

 

41,253

 

17,169

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

(9,590

)

2,932

 

(19,773

)

(5,152

)

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest and other income

 

236

 

553

 

550

 

1,356

 

Interest expense

 

(263

)

(5

)

(548

)

(5

)

Total other income (expense)

 

(27

)

548

 

2

 

1,351

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) before income taxes

 

(9,617

)

3,480

 

(19,771

)

(3,801

)

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

2

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

(9,615

)

3,480

 

(19,770

)

(3,801

)

 

 

 

 

 

 

 

 

 

 

Deemed dividend on preferred stock

 

 

(180

)

 

(355

)

 

 

 

 

 

 

 

 

 

 

Net income (loss) applicable to common stock shareholders

 

$

(9,615

)

$

3,300

 

$

(19,770

)

$

(4,156

)

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) applicable to common stock shareholders per common share

 

$

(0.19

)

$

0.07

 

$

(0.39

)

$

(0.09

)

Diluted net income (loss) applicable to common stock shareholders per common share

 

$

(0.19

)

$

0.07

 

$

(0.39

)

$

(0.09

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic net income (loss) per common share

 

51,263,620

 

48,041,855

 

51,235,735

 

47,954,052

 

Shares used in computing diluted net income (loss) per common share

 

51,263,620

 

48,405,333

 

51,235,735

 

47,954,052

 

 



 

DEPOMED, INC.

CONDENSED BALANCE SHEETS

(in thousands, except share amounts)

 

 

 

June 30,
2009

 

December 31,
2008

 

 

 

(Unaudited)

 

(1)

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

8,153

 

$

22,127

 

Marketable securities

 

59,659

 

59,932

 

Accounts receivable

 

4,154

 

3,099

 

Unbilled accounts receivable

 

564

 

576

 

Inventories

 

2,366

 

2,849

 

Prepaid and other current assets

 

1,979

 

5,404

 

Total current assets

 

76,875

 

93,987

 

Marketable securities

 

16,169

 

 

Property and equipment, net

 

666

 

900

 

Other assets

 

197

 

197

 

 

 

$

93,907

 

$

95,084

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

865

 

$

559

 

Accrued compensation

 

1,559

 

2,601

 

Accrued clinical trial expense

 

1,098

 

661

 

Other accrued liabilities

 

8,229

 

9,027

 

Deferred product sales

 

1,618

 

1,702

 

Deferred license revenue

 

10,684

 

4,362

 

Other current liabilities

 

132

 

110

 

Current portion of long-term debt

 

3,528

 

3,356

 

Total current liabilities

 

27,713

 

22,378

 

Deferred license revenue, non-current portion

 

46,648

 

33,209

 

Long-term debt, non-current portion

 

4,099

 

5,775

 

Other long-term liabilities

 

542

 

569

 

Commitments

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, no par value, 5,000,000 shares authorized; Series A convertible preferred stock, 25,000 shares designated, 18,158 shares issued, and zero shares outstanding at June 30, 2009 and December 31, 2008

 

 

 

Common stock, no par value, 100,000,000 shares authorized; 51,352,266 and 51,171,377 shares issued and outstanding at June 30, 2009 and December 31, 2008, respectively

 

184,747

 

183,196

 

Accumulated deficit

 

(169,964

)

(150,194

)

Accumulated other comprehensive gain

 

122

 

151

 

Total shareholders’ equity

 

14,905

 

33,153

 

 

 

$

93,907

 

$

95,084

 


(1)          Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008.