EX-99.1 2 a09-6059_2ex99d1.htm EX-99.1

Exhibit 99.1

 

CONTACT:

Sheilah Serradell

 

Depomed, Inc.

 

650-462-5900

 

sserradell@depomed.com

 

DEPOMED REPORTS FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS

 

MENLO PARK, Calif., March 5, 2009 – Depomed, Inc. (NASDAQ: DEPO) today reported financial results for the fourth quarter and year ended December 31, 2008.

 

“In the fourth quarter, we consummated two very important transactions with Solvay and Covidien that further improved our current cash position and may result in additional future payments as we achieve certain development milestones.  We are very pleased to report a balance of $82.1 million in cash, cash equivalents and marketable securities at the end of 2008, which prepares us well for this challenging macroeconomic environment.  We are focused on execution for 2009 with three ongoing Phase 3 trials and related upcoming milestones,” stated Carl A. Pelzel, president and chief executive officer of Depomed.

 

2008  Financial Highlights

 

Revenue for the year ended December 31, 2008 was $34.8 million, and included a one-time recognition of $6.3 million in product sales of GLUMETZA related to previously deferred revenue, compared to $65.6 million for the year ended December 31, 2007, which included a one-time recognition of $48.6 million in revenue associated with the termination of the company’s license and supply agreements with Esprit Pharma in July 2007.

 

Operating expenses for the year ended December 31, 2008 were $46.2 million, and included a one-time gain of $7.5 million on litigation related to the IVAX settlement, which had the effect of reducing operating expenses for the year. Operating expenses for the year ended December 31, 2007 were $15.4 million, and included a one-time gain of $29.6 million on termination of the company’s promotion agreement with King Pharmaceuticals related to GLUMETZA, and a one-time gain of $5.0 million on termination of the Esprit agreements, both of which have the effect of reducing operating expenses for the year. Stock-based compensation expense was $2.5 million for the year ended December 31, 2008 compared to $2.3 million for the year ended December 31, 2007.

 

Net loss for the year ended December 31, 2008 was $15.3 million, or $0.32 per share, compared to net income of $49.2 million, or $1.05 per share, for the year ended December 31, 2007.

 

Cash, cash equivalents and marketable securities were $82.1 million as of December 31, 2008 compared to $69.5 million as of December 31, 2007.  The $25 million upfront cash payment due to the license agreement of DM-1796 with Solvay Pharmaceuticals was received on February 25, 2009.

 

Fourth Quarter 2008 and Subsequent to Year-End Highlights

 

·                  Initiated Breeze 2, the second of two pivotal Phase 3 clinical trials in Depomed’s registration program for DM-5689 for the treatment of menopausal hot flashes (October 2008).  The first Phase 3 trial, Breeze 1, started in September 2008.

 



 

·                  Licensed the exclusive rights for DM-1796 for the treatment of pain in the United States, Canada and Mexico to Solvay Pharmaceuticals (November 2008).

 

·                  Licensed worldwide rights to utilize Depomed’s AcuForm(TM) gastric retentive drug delivery technology for the exclusive development of four undisclosed products to Covidien (November 2008).

 

·                  Initiated Phase 1 trial for DM-1992 program in Parkinson’s patients following positive results of preclinical studies sponsored by The Michael J. Fox Foundation (February 2009)

 

·                  Received the $25 million upfront cash payment due to the license agreement of DM-1796 with Solvay Pharmaceuticals (February 2009)

 

Conference Call

 

Depomed will host a conference call today, Thursday, March 5, 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.depomedinc.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 approved products on the market and other product candidates in its pipeline.  The company utilizes its proven, proprietary AcuFormTM drug delivery technology 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.  GLUMETZAÒ (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States.  ProquinÒ XR (ciprofloxacin hydrochloride) is approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is being marketed in the United States within the urology, Ob/Gyn and long-term care specialties by Watson Pharmaceuticals.  Product candidate DM-1796 is in clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals.  Product candidate DM-5689 is in clinical development for menopausal hot flashes.  Additional information about Depomed may be found on its website, www.depomedinc.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 clinical development programs; potential benefits of our products and product candidates; 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.

 

2



 

-Financial Tables Follow-

 

3



 

DEPOMED, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

(unaudited)

 

(unaudited)

 

(unaudited)

 

(1)

 

Revenue:

 

 

 

 

 

 

 

 

 

Product sales

 

$

7,295

 

$

4,836

 

$

31,051

 

$

12,502

 

Royalties

 

522

 

82

 

1,582

 

2,707

 

License revenue

 

834

 

364

 

2,145

 

50,367

 

Collaborative and other revenue

 

64

 

3

 

64

 

6

 

Total revenues

 

8,715

 

5,285

 

34,842

 

65,582

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of sales

 

1,205

 

999

 

5,772

 

2,597

 

Research and development

 

9,520

 

3,912

 

27,268

 

23,337

 

Selling, general and administrative

 

9,399

 

5,661

 

26,397

 

26,694

 

Gain on termination of King agreement

 

 

(29,584

)

 

(29,584

)

Gain on termination of Esprit agreements

 

 

 

 

(5,000

)

Gain on litigation settlement

 

 

 

(7,500

)

 

Total costs and expenses

 

20,124

 

(19,012

)

51,937

 

18,044

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

(11,409

)

24,297

 

(17,095

)

47,538

 

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Interest and other income

 

478

 

769

 

2,349

 

2,273

 

Interest expense

 

(301

)

 

(555

)

 

Total other income (expenses)

 

177

 

769

 

1,794

 

2,273

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) before income taxes

 

(11,232

)

25,066

 

(15,301

)

49,811

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

3

 

(340

)

(1

)

(592

)

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

(11,229

)

24,726

 

(15,302

)

49,219

 

 

 

 

 

 

 

 

 

 

 

Deemed dividend on preferred stock

 

(3

)

(174

)

(541

)

(685

)

 

 

 

 

 

 

 

 

 

 

Net income (loss) applicable to common stock shareholders

 

$

(11,232

)

$

24,552

 

$

(15,843

)

$

48,534

 

 

 

 

 

 

 

 

 

 

 

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

 

$

(0.22

)

$

0.51

 

$

(0.32

)

$

1.06

 

 

 

 

 

 

 

 

 

 

 

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

 

$

(0.22

)

$

0.51

 

$

(0.32

)

$

1.05

 

 

 

 

 

 

 

 

 

 

 

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

 

51,065,355

 

47,781,585

 

48,778,764

 

45,951,127

 

 

 

 

 

 

 

 

 

 

 

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

 

51,065,355

 

47,966,459

 

48,778,764

 

46,353,207

 

 


(1) Derived from the audited consolidated financial statements included in the Company’s Annual Report of Form 10-K for the year ended December 31, 2007.

 

4



 

DEPOMED, INC.
CONSOLIDATED BALANCE SHEETS

(in thousands, except share amounts)

 

 

 

December 31,

 

 

 

2008

 

2007

 

 

 

(unaudited)

 

(1)

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

22,127

 

$

14,374

 

Marketable securities

 

59,932

 

39,091

 

Accounts receivable

 

3,099

 

3,390

 

Unbilled accounts receivable

 

576

 

233

 

Inventories

 

2,849

 

3,263

 

Prepaid and other current assets

 

5,404

 

2,418

 

Total current assets

 

93,987

 

62,769

 

Marketable securities

 

 

16,058

 

Property and equipment, net

 

900

 

1,621

 

Other assets

 

197

 

197

 

 

 

$

95,084

 

$

80,645

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

559

 

$

1,134

 

Accrued compensation

 

2,601

 

1,558

 

Accrued clinical trial expense

 

661

 

322

 

Other accrued liabilities

 

9,027

 

3,322

 

Deferred product sales

 

1,702

 

6,489

 

Deferred license revenue

 

4,362

 

1,453

 

Other current liabilities

 

110

 

56

 

Current portion of long-term debt

 

3,356

 

 

Total current liabilities

 

22,378

 

14,334

 

Deferred license revenue, non-current portion

 

33,209

 

20,763

 

Long-term debt, net of current portion

 

5,775

 

 

Other long-term liabilities

 

569

 

28

 

Commitments

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, no par value, 5,000,000 shares authorized; Series A convertible preferred stock, 25,000 shares designated, zero and 18,158 shares issued and outstanding as of December 31, 2008 and 2007, with an aggregate liquidation preference of zero and $18,159, respectively

 

 

12,015

 

Common stock, no par value, 100,000,000 shares authorized; 51,171,377 and 47,865,529 shares issued and outstanding at December 31, 2008 and 2007, respectively

 

183,196

 

168,287

 

Accumulated deficit

 

(150,194

)

(134,892

)

Accumulated other comprehensive gain

 

151

 

110

 

Total shareholders’ equity

 

33,153

 

45,520

 

 

 

$

95,084

 

$

80,645

 

 


(1) Derived from the audited consolidated financial statements included in the Company’s Annual Report of Form 10-K for the year ended December 31, 2007.

 

5