- On February 22, 2011, Somaxon announced that it had received from the U.S. Patent and Trademark Office a Notice of Allowance for claims in U.S. patent application no. 11/781,165, which significantly strengthened the Silenor intellectual property portfolio. This patent application generally relates to dosing Silenor at least three hours after a meal to promote faster onset of action and reduce the potential for next-day residual sedation. Because this food effect is described in the Silenor prescribing information, Somaxon will list the patent in the Orange Book once it is issued.
- On February 8, 2011, Somaxon announced that based upon positive commercial trends in the fourth quarter of 2010, it had engaged its contract sales force partner Publicis Touchpoint Solutions, Inc. to recruit and deploy for Somaxon an additional 35 sales representatives that will exclusively promote Silenor. Somaxon expects the majority of these additional sales representatives to be deployed in the field by the end of the first quarter of 2011.
- Somaxon has come to agreement with CVS/Caremark PCS Health, Blue Shield of California and Prime Therapeutics for unrestricted Tier 3 formulary placement of Silenor, and with the U.S. Department of Defense/TRICARE for Tier 2 formulary placement of Silenor. The CVS/Caremark entities and Prime Therapeutics are pharmacy benefit managers that manage commercial healthcare plans covering approximately 50 million lives and 2 million lives, respectively, Blue Shield of California covers approximately 3 million lives and TRICARE covers approximately 10 million lives. Silenor is currently reimbursed on other commercial plans representing approximately an additional 145 million lives, with final formulary positioning subject to final negotiation with such plans.
- On February 8, 2011, Somaxon announced that it had obtained from Comerica Bank a two-year, revolving line of credit for up to $15 million for working capital needs and general corporate purposes. To date no amount of the revolving line of credit has been drawn down.
- On February 3, 2011, Somaxon announced that it strengthened its senior management team through the hiring of Robert Cutler as Vice President of Business Development, responsible for driving Somaxon’s corporate growth strategy.
Cost of sales was $0.2 million for both the full year and the fourth quarter of 2010, which represented the costs of product dispensed through prescriptions. Gross profit was $1.1 million for both the full year and the fourth quarter of 2010. Expressed as a percentage of net product sales, gross margin was 82.3% and 82.1% for the full year and the fourth quarter of 2010, respectively.Total operating expenses for the full year of 2010 were $40.1 million, including $6.7 million of non-cash, share-based compensation expense, compared with $14.2 million, including $6.2 million of non-cash, share-based compensation expense, for the full year of 2009. Total operating expenses for the fourth quarter of 2010 were $17.3 million, including $1.4 million of non-cash, share-based compensation expense, compared with $1.9 million, including $0.6 million of non-cash, share-based compensation expense, for the fourth quarter of 2009. These increases in total operating expenses are primarily due to an increase in selling, general and administrative (SG&A) expenses relating to commercialization activities for Silenor. SG&A expense was $36.6 million and $16.7 million for the full year and the fourth quarter of 2010, respectively, compared to $10.9 million and $1.1 million for the full year and the fourth quarter of 2009, respectively. These increases reflected the costs associated with the commercial launch of Silenor and an increase in salary and personnel-related expenses due to an increase in overall headcount. Research and development expense was $3.6 million and $0.6 million for the full year and the fourth quarter of 2010, respectively, compared to $4.3 million and $0.8 million for the full year and the fourth quarter of 2009, respectively. For the full year of 2010, net loss was $38.8 million, or $1.16 per share, compared with $14.4 million, or $0.69 per share, for the full year of 2009. For the fourth quarter of 2010, net loss was $16.0 million, or $0.42 per share, compared with $1.9 million, or $0.08 per share, for the fourth quarter of 2009.
At December 31, 2010, Somaxon had cash, cash equivalents and short-term investments totaling $54.8 million, compared to $5.2 million at December 31, 2009. The company believes, based on its current operating plan, that its cash, cash equivalents and short-term investments as of December 31, 2010 will be sufficient to fund its operations through at least the first quarter of 2012.Financial Guidance for Full Year of 2011 For the full year of 2011, total operating expense is expected to be approximately $78 to $83 million, including non-cash, share-based compensation expense. Non-cash, share-based compensation expense is expected to be approximately $4 million. The projected increase compared to the full year of 2010 primarily relates to expected increases in SG&A expense to support a full year of commercial operations. Actual financial results for the full year of 2011 could vary based upon many factors, including but not limited to the rate of growth of Silenor sales and the actual cost of commercial activities. Conference Call Information and Forward-Looking Statements On Thursday, March 3, 2011, Somaxon will conduct a conference call with interested parties beginning at 4:30 p.m. ET (1:30 p.m. PT) to discuss results and highlights of the fourth quarter and full year ended December 31, 2010. The conference call will be available to interested parties through a live audio Internet broadcast at http://investors.somaxon.com/eventdetail.cfm. The call will also be archived and accessible at this site for approximately two weeks. Alternatively, callers may participate in the conference call by dialing (877) 941-8609 (domestic) or (480) 629-9820 (international), conference call ID 4415379. A telephonic replay will be available for approximately two weeks following the conclusion of the call by dialing (800) 406-7325 (domestic) or (303) 590-3030 (international), and entering passcode 4415379. Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s commercial activities relating to Silenor, prescription trends, the company’s financial status and performance, including its 2011 financial guidance, the expected issuance of a new patent, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.
To be added to Somaxon’s e-mail list, please visit http://bit.ly/Somaxon-email-list.About Somaxon Pharmaceuticals, Inc. Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. Somaxon’s product Silenor, now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. For more information, please visit the company’s web site at www.somaxon.com. Safe Harbor Statement Somaxon cautions readers that statements included in this press release and the conference call that are not a description of historical facts are forward-looking statements. For example, statements regarding commercial activities and plans regarding Silenor, the revenues and the growth of the revenues from sales of Silenor, Somaxon’s and Publicis’ ability to effectively recruit additional sales representatives and the timing thereof, Somaxon’s ability to broaden its business, estimates regarding product prescriptions and returns, and the expected issuance of a new patent are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon’s business, including, without limitation, Somaxon’s ability to successfully commercialize Silenor; Somaxon’s reliance on its co-promotion partner, Procter & Gamble, and its contract sales force provider, Publicis, for critical aspects of the commercial sales process for Silenor; the performance of Procter & Gamble and Publicis and their adherence to the terms of their contracts with Somaxon; the ability of Somaxon’s sales management personnel to effectively manage the sales representatives employed by Publicis; Somaxon’s ability to comply with the covenants under the Comerica secured loan agreement; the potential for an event of default under the secured loan agreement, and the corresponding risk of acceleration of repayment and potential foreclosure on the assets pledged to secure the line of credit; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether the approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; the ability of Somaxon to ensure adequate and continued supply of Silenor to successfully meet anticipated market demand; Somaxon’s ability to successfully enforce its intellectual property rights and defend its patents, including any developments relating to the recent submission of abbreviated new drug applications for generic versions of Silenor 3 mg and 6 mg and related patent litigation; the possible introduction of generic competition of Silenor; Somaxon’s ability to raise sufficient capital to fund its operations, and the impact of any such financing activity on the level of its stock price; the impact of any inability to raise sufficient capital to fund ongoing operations, including any patent infringement litigation; Somaxon’s ability to operate its business without infringing the intellectual property rights of others; the market potential for insomnia treatments, and Somaxon’s ability to compete within that market; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could adversely affect commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of Silenor; the timing and results of post-approval regulatory requirements for Silenor, and the FDA’s agreement with Somaxon’s interpretation of such results; and other risks detailed in Somaxon’s prior press releases as well as in its periodic filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Somaxon undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.
|SOMAXON PHARMACEUTICALS, INC.|
|SUMMARY STATEMENTS OF OPERATIONS|
|Quarter ended December 31,||Year ended December 31,|
|(in thousands, except per share amounts)|
|Net product sales||$||1,344||$||-||$||1,382||$||-|
|Cost of sales||241||-||244||-|
|Selling, general and administrative||16,702||1,081||36,579||10,874|
|Research and development||625||840||3,566||4,337|
|Total operating expenses||17,327||1,921||40,145||14,212|
|Loss from operations||(16,224||)||(1,921||)||(39,007||)||(14,212||)|
|Interest and other income||252||4||262||30|
|Interest and other (expense)||(55||)||(2||)||(68||)||(261||)|
|Basic and diluted net loss per share||$||(0.42||)||$||(0.08||)||$||(1.16||)||$||(0.69||)|
|Shares used to calculate net loss per share||38,604||24,138||33,593||20,952|
|SOMAXON PHARMACEUTICALS, INC.|
|SUMMARY BALANCE SHEETS|
|December 31,||December 31,|
|Cash and cash equivalents||$||21,008||$||5,165|
|Accounts receivable, net||5,584||-|
|Other current assets||1,882||409|
|Total current assets||63,274||5,574|
|Property and equipment, net||755||777|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Total current liabilities||10,867||2,170|
|Total stockholders’ equity||54,264||4,241|
|Total liabilities and stockholders' equity||$||65,131||$||6,411|