Somaxon Pharmaceuticals Reports First Quarter 2011 Financial Results
Conference call scheduled today at
Simultaneous webcast at http://investors.somaxon.com/eventdetail.cfm
“During the first quarter of 2011, we continued to lay the foundation for Silenor’s® long-term commercial success by growing Silenor net product sales 73% and the number of new Silenor patients by approximately 50% over the previous quarter,” said
“For the remainder of 2011, we expect to continue to increase the growth of Silenor through the combined efforts of the Somaxon and
Recent Highlights
- Somaxon has continued to make significant progress in expanding access to Silenor at affordable co-pays. Recently,
RxSolutions, Inc. ,Express Scripts, Inc. andMedco Health , national pharmacy benefit managers that manage commercial healthcare plans covering a total of approximately 50 million lives, agreed to add Silenor to their commercial formularies. Silenor will be covered in a Tier 2 unrestricted position atMedco Health , which is a preferred position relative to the other branded insomnia products on this formulary. Silenor will be covered in a Tier 3 unrestricted position at RxSolutions andExpress Scripts . Including these agreements, Silenor is currently contracted for reimbursement on commercial plans covering over 110 million lives, most frequently in an unrestricted position, and Silenor is currently reimbursed on other commercial plans representing approximately an additional 90 million lives, with final formulary positioning subject to final negotiation with such plans. - Somaxon has come to agreement with
Medicare Part D health insurance plans covering a total of over 3 million lives. The company has also reached agreement with theU.S. Department of Veteran’s Affairs to make Silenor eligible for formulary inclusion by the regional Veterans Integrated Services Network plans. - Beginning in early
April 2011 , Somaxon implemented the eVoucher co-pay assistance program under which co-pay amounts of$85 or below for patients having access to commercial health insurance will be automatically reduced to$15 at the time of payment at approximately 33,000 participating pharmacies. This program is intended to support Somaxon’s goal of making Silenor available and affordable to anyone whose physician determines they may benefit from Silenor’s unique safety and efficacy profile. The company’s existing Sleep Saver program will continue to be available to patients that are unable to take advantage of the eVoucher program. - On
March 29, 2011 , Somaxon announced that it had received from the U.S. Patent and Trademark Office U.S. patent no. 7,915,307, entitled “Methods of Improving the Pharmacokinetics of Doxepin.” This patent 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. This patent will expire no earlier thanAugust 2027 and has been listed in the Orange Book. - As of early
April 2011 , Somaxon, through its contract sales force partnerPublicis Touchpoint Solutions, Inc. , had fully deployed an additional 35 sales representatives that are exclusively promoting Silenor. As a result of this expansion, Silenor is now promoted by 250 sales representatives between Somaxon’s sales force and that of its co-promotion partnerProcter & Gamble . - As of early
April 2011 , Somaxon deployed a team of eight contracted Federal Account Managers who will focus specifically on generating Silenor demand at Military Treatment Facilities and otherDepartment of Defense institutions where Silenor is currently contracted.
First Quarter 2011 Financial Results
For the first quarter of 2011, Somaxon recorded shipments of Silenor to its wholesale distributors totaling
Cost of sales was
Total operating expenses for the first quarter of 2011 were
SG&A expense was
Research and development expense was
Net loss for the first quarter of 2011 was
At
Conference Call Information and Forward-Looking Statements
On
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 (888) 549-7880 (domestic) or (480) 629-9867 (international), conference call ID 4435541. 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 4435541.
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 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
Headquartered in
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 ability to broaden its business and estimates regarding product prescriptions and returns 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; the market potential for insomnia treatments, and Somaxon’s ability to compete within that market; Somaxon’s reliance on its co-promotion partner,
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 March 31, | ||||||||||||||||||
2011 | 2010 | |||||||||||||||||
|
(in thousands, except per share amounts) |
|||||||||||||||||
Gross product sales | $ | 2,877 | $ | - | ||||||||||||||
Less: discounts and allowances | (555 | ) | - | |||||||||||||||
Net product sales | 2,322 | - | ||||||||||||||||
Less: cost of sales | ) | - | ||||||||||||||||
Gross profit | 1,959 | - | ||||||||||||||||
Operating expenses | ||||||||||||||||||
Selling, general and administrative | 18,593 | 3,052 | ||||||||||||||||
Research and development | 419 | 1,113 | ||||||||||||||||
Total operating expenses | 19,012 | 4,165 | ||||||||||||||||
Loss from operations | (17,053 | ) | (4,165 | ) | ||||||||||||||
Interest and other income | 15 | 1 | ||||||||||||||||
Interest and other (expense) | - | (1 | ) | |||||||||||||||
Net loss | $ | (17,038 | ) | $ | (4,165 | ) | ||||||||||||
Basic and diluted net loss per share | $ | (0.38 | ) | $ | (0.16 | ) | ||||||||||||
Shares used to calculate net loss per share | 45,005 | 25,662 |
SOMAXON PHARMACEUTICALS, INC. | |||||||||||||||||||||
SUMMARY BALANCE SHEETS | |||||||||||||||||||||
March 31, | December 31, | ||||||||||||||||||||
2011 | 2010 | ||||||||||||||||||||
(in thousands) | |||||||||||||||||||||
ASSETS | |||||||||||||||||||||
Current assets | |||||||||||||||||||||
Cash and cash equivalents | $ | 25,360 | $ | 21,008 | |||||||||||||||||
Short-term investments | 17,935 | 33,809 | |||||||||||||||||||
Accounts receivable, net | 881 | 5,584 | |||||||||||||||||||
Inventory | 1,488 | 991 | |||||||||||||||||||
Other current assets | 1,932 | 1,882 | |||||||||||||||||||
Total current assets | 47,596 | 63,274 | |||||||||||||||||||
Property and equipment, net | 787 | 755 | |||||||||||||||||||
Intangibles, net | 1,216 | 1,102 | |||||||||||||||||||
Total assets | $ | 49,599 | $ | 65,131 | |||||||||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||||||||||||
Current liabilities | |||||||||||||||||||||
Accounts payable | $ | 2,965 | $ | 1,709 | |||||||||||||||||
Accrued liabilities | 5,192 | 5,699 | |||||||||||||||||||
Deferred revenue | 3,016 | 3,459 | |||||||||||||||||||
Total current liabilities | 11,173 | 10,867 | |||||||||||||||||||
Total stockholders’ equity | 38,426 | 54,264 | |||||||||||||||||||
Total liabilities and stockholders' equity | $ | 49,599 | $ | 65,131 |
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