Depomed Reports Fourth Quarter and Year-End 2008 Financial Results
MENLO PARK, Calif.--(BUSINESS WIRE)--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. 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. Proquin® 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.
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DEPOMED, INC. |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except share and per share amounts) |
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| 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 | ||||||||||||
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Shares used in computing diluted net income (loss) per common share |
51,065,355 | 47,966,459 | 48,778,764 | 46,353,207 | ||||||||||||
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(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. |
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DEPOMED, INC. |
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CONSOLIDATED BALANCE SHEETS |
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(in thousands, except share amounts) |
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December 31, | |||||||
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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 $18,159, respectively | — | 12,015 | ||||||
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Common stock, no par value, 100,000,000 shares authorized; 51,171,377 and 47,865,529 shares issued and outstanding at December 31, 2008 and 2007, respectively |
183,196 | 168,287 | ||||||
| Accumulated deficit | (150,194 | ) | (134,892 | ) | ||||
| Accumulated other comprehensive gain | 151 | 110 | ||||||
| Total shareholders’ equity | 33,153 | 45,520 | ||||||
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$ | 95,084 | $ | 80,645 | ||||
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(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. |
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