NEWARK, Calif., Feb. 20, 2013 /PRNewswire/ -- Depomed, Inc. (Nasdaq: DEPO) today reported financial results for the quarter and twelve months ended December 31, 2012.
2012 Financial and Business Highlights
"We believe we made very strong operational and financial progress in 2012. We solidified our pain franchise by growing Gralise prescriptions throughout the year and acquiring and relaunching Zipsor mid-year. Our recurring revenue, consisting of our product sales and royalties, exceeded an annualized run rate of $100 million for the first time in the fourth quarter 2012. We expanded our portfolio of royalty producing agreements with our license to Janssen for Nucynta® ER and filed Serada with the FDA," said Jim Schoeneck, President and Chief Executive Officer of Depomed. "As we enter 2013, we are focused on growing our product revenues and royalties to become a sustainably profitable specialty pharmaceutical company."
Depomed Fourth Quarter and Full Year 2012 ResultsTotal revenues for the fourth quarter of 2012 were $26.6 million, consisting of $7.6 million of Gralise product sales, $4.9 million of Zipsor product sales, $13.3 million of royalties and $0.8 million of license and other revenue. Fourth quarter 2012 revenues more than doubled total revenues for the fourth quarter of 2011 of $12.1 million. The increase in revenues in the fourth quarter of 2012 was driven by product sales of Gralise and Zipsor and increased Glumetza royalties.Gralise product sales in the fourth quarter of 2012 included a one-time increase of $1.6 million related to the recognition of previously deferred revenue resulting from a change in revenue recognition to a sell-in model. Prior to the fourth quarter of 2012, the Company was unable to reasonably estimate product returns of Gralise at the time of shipment and deferred recognition of revenue until the product was dispensed to the end user through estimated patient prescriptions. The Company has determined it had the information needed during the fourth quarter of 2012 to reasonably estimate returns. Beginning in the fourth quarter of 2012, the Company began recognizing revenue on shipments of Gralise when title transfers to the customer, providing for estimates on future product returns.
Total revenues for the year ended December 31, 2012 were $90.8 million, consisting primarily of $17.3 million of Gralise product sales, $9.8 million of Zipsor product sales, $44.5 million of royalties and $18.8 million of license and other revenue. Total revenues for the year ended December 31, 2011 were $133.0 million. The decrease in revenues for the year ended December 31, 2012 was primarily due to the recognition of a $48 million milestone payment from Abbott in 2011 related to FDA approval of Gralise and our restructured Glumetza agreement with Santarus.
Selling general and administrative expense was $24.0 million for the fourth quarter of 2012 as compared to $21.5 million for fourth quarter of 2011. The increase is primarily due to sales and marketing expenses associated with Zipsor which was acquired in June 2012, and the addition of the part-time contract sales force of 78 sales representatives in June 2012 to support our existing sales efforts.
Selling general and administrative expense was $97.6 million for the year ended December 31, 2012 as compared to $81.5 million for the year ended December 31, 2011. The increase in 2012 was primarily due to a full year of expense related to our commercial infrastructure, as we began selling Gralise in October 2011. This was partially offset by the removal of promotion fees resulting from the restructuring of the Glumetza agreement with Santarus in August 2011.
Research and development expense was $3.2 million for the fourth quarter of 2012 as compared to $2.8 million for the fourth quarter of 2011. Research and development expense was $15.5 million for the year ended December 31, 2012 as compared to $15.2 million for the year ended December 31, 2011.
Net loss for the fourth of quarter of 2012 was ($3.7) million, or ($0.07) per share, compared to net loss of ($13.8) million, or ($0.25) per share for the fourth quarter of 2011. Net loss for the year ended December 31, 2012 was ($29.8) million, or ($0.53) per share, compared to net income of $70.7 million, or $1.26 per share for the year ended December 31, 2011. Net income for 2011 included the $48 million milestone from Abbott and a $40 million gain on termination of our agreement with Abbott.
Cash and marketable securities were $77.9 million as of December 31, 2012 as compared to $139.8 million as of December 31, 2011.
2013 Financial OutlookDepomed is introducing its financial outlook for the full year of 2013. Because of the uncertainty surrounding the outcomes of the Serada FDA advisory committee on March 4, 2013 and the FDA review with a PDUFA date of May 31, 2013, the following financial guidance currently excludes any additional investment in Serada after the date of the FDA advisory committee meeting.
Depomed will host a conference call today, Wednesday, February 20, beginning at 4:30 p.m. EST (1:30 p.m. PST) to discuss its results. Participants can access the call by dialing 877-317-6789 (United States) or 412-317-6789 (international). The conference call will also 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.
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults.
Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed has also submitted a New Drug Application to the FDA for Serada®, a non-hormonal investigational product for menopausal hot flashes. The company 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 release of medications to the upper gastrointestinal tract when dosed with food. 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 the commercial launch of Gralise, our ability to sell Zipsor and regulatory filings for Serada; the efforts of our collaboration partners to commercialize products; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2011 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. 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.
August J. Moretti
DEPOMED, INC.CONDENSED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts)Three Months Ended December 31,Twelve Months Ended December 31,2012201120122011(Unaudited)(Unaudited)(Unaudited)(1)Revenues:Product sales$
41,178Royalties13,3367,58644,5359,997License and other revenue7654,03818,79881,798Total revenues26,59012,13290,816132,973Costs and expenses:Cost of sales2,3166196,0395,544Research and development expense3,1852,78215,46215,187Selling, general and administrative expense:Promotion fee expense———27,339Other selling, general and administrative expense24,02121,53897,64654,205Total selling, general and administrative expense24,02121,53897,64681,544Amortization of intangible asset959—2,022—Gain on settlement agreement ———(40,000)Total costs and expenses30,48124,939121,16962,275Income (loss) from operations(3,891)(12,807)(30,353)70,698Other income (expense)76(288)481424Benefit from (provision for) income taxes111(741)91(396)Net income (loss)$
70,726Basic net income (loss) per common share$
1.30Diluted net income (loss) per common share$
1.26Shares used in computing basic net income (loss) per common share56,184,21455,438,17455,892,56354,562,820Shares used in computing diluted net income (loss) per common share56,184,21455,438,17455,892,56356,089,796
DEPOMED, INC.CONDENSED BALANCE SHEETS(in thousands, except share amounts)December 31,December 31,20122011(Unaudited)(1)Cash, cash equivalents and marketable securities$
139,793Accounts receivable, net3,6144,420Receivables from collaborative partners 10,0788,135Inventories9,5875,395Property and equipment, net8,2371,070Intangible assets, net25,078—Prepaid and other assets7,1675,559Total Assets$
164,372Accounts payable and accrued liabilities$
26,784Deferred product sales—6,960Deferred license revenue18,78923,964Other liabilities6,350746Shareholders' equity83,936105,918Total liabilities and shareholders' equity $
Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2011.
|SOURCE Depomed, Inc.|
Copyright©2012 PR Newswire.
All rights reserved