Attached files
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8-K - FORM 8-K - Pernix Sleep, Inc. | c20676e8vk.htm |
EX-4.2 - EX-4.2 - Pernix Sleep, Inc. | c20676exv4w2.htm |
EX-5.1 - EX-5.1 - Pernix Sleep, Inc. | c20676exv5w1.htm |
EX-4.3 - EX-4.3 - Pernix Sleep, Inc. | c20676exv4w3.htm |
EX-4.1 - EX-4.1 - Pernix Sleep, Inc. | c20676exv4w1.htm |
EX-10.1 - EX-10.1 - Pernix Sleep, Inc. | c20676exv10w1.htm |
EX-10.2 - EX-10.2 - Pernix Sleep, Inc. | c20676exv10w2.htm |
Exhibit 99.1

Contacts: | Tran Nguyen / CFO | |||
Somaxon Pharmaceuticals, Inc. | ||||
(858) 876-6500 | ||||
Rob Whetstone/Matt Sheldon | ||||
PondelWilkinson, Inc. | ||||
(310) 279-5963 |
SOMAXON PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS; COMPANY ANNOUNCES ACCESS TO UP TO $45
MILLION IN FINANCING
| Total Net Product Sales Grow to $6.2 Million |
| Company Secures $15 Million Term Loan and Enters into $30 Million At-the-Market Offering Program |
| Company Reduces Total Annual Operating Expense Guidance to $75-$78 Million |
Conference call scheduled today at 4:30 p.m. ET (1:30 p.m. PT);
Simultaneous webcast at http://investors.somaxon.com/eventdetail.cfm
Simultaneous webcast at http://investors.somaxon.com/eventdetail.cfm
SAN DIEGO, CA August 2, 2011 - Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty
pharmaceutical company, today announced financial results for the quarter ended June 30, 2011. For
the second quarter of 2011, Somaxon reported net product sales of $6.2 million, compared to net
product sales of $2.3 million in the first quarter of 2011. The company had no product sales in
the second quarter of 2010. The net loss for the second quarter of 2011 was $14.9 million, or a
loss of $0.33 per share, compared to a net loss of $5.7 million, or a loss of $0.16 per share, in
the second quarter of 2010.
Somaxon also announced that it has obtained a $15 million term loan from Oxford Finance Corporation
and Silicon Valley Bank. Additionally, the company has entered into an At-the-Market (ATM)
equity offering sales agreement with Citadel Securities LLC, under which Somaxon may from time to
time offer and sell shares of its common stock having an aggregate offering price of up to $30
million through Citadel. Somaxon expects to use the aggregate funds of up to $45 million to, among
other things, satisfy working capital needs in the commercial activities relating to Silenor®, the
companys first FDA-approved product indicated for the treatment of insomnia characterized by
difficulty with sleep maintenance.
During the second quarter of 2011, we continued to make positive strides towards Silenors
long-term commercial success by increasing Silenor net product sales to $6.2 million and growing
Silenor prescriptions by over 36% over the previous quarter, said Richard W. Pascoe, Somaxons
President and Chief Executive Officer. In addition, we continued to make solid progress with our
managed care contracting efforts, so that we now have approximately 159 million covered lives in a
Tier 2, 3 or 4 unrestricted position and approximately 110 million covered lives on contracted
formularies.
Moreover, having access to additional working capital further supports our financial position as
we continue these commercial activities and as we seek to leverage our sales force to broaden our
product portfolio, with the goal of building a sustainable business dedicated to delivering
long-term stockholder value, continued Pascoe.
Recent Highlights
| Somaxon secured a $15.0 million term loan from Oxford Finance and Silicon Valley Bank. General terms of the loan arrangement include interest-only payments through December 2011, and the principal, together with interest, must be repaid by December 2013. |
| Under the At-the-Market equity offering sales agreement, Somaxon may from time to time offer and seek to sell up to $30 million of its common stock through Citadel at prevailing market prices, at prices related to prevailing market prices or at negotiated prices. |
| In June 2011, Somaxon entered into a license agreement with Paladin Labs, Inc., pursuant to which Paladin will commercialize Silenor in Canada, South America, the Caribbean and Africa. Somaxon received $5.5 million through a combination of an up-front payment and an equity investment from Paladin. Once Silenor is commercialized in the licensed territories, Somaxon will also be eligible to receive sales-based milestone payments of up to $128.5 million, as well as a tiered double-digit percentage of net sales in the licensed territories. |
| Somaxon has continued to make significant progress in expanding access to Silenor to patients at affordable co-pays. CVS/CaremarkPCS Health agreed to improve its current commercial formulary position for Silenor to Tier 2 unrestricted from Tier 3 unrestricted, beginning October 1, 2011. CVS/CaremarkPCS Health manages commercial healthcare plans covering approximately 50 million lives. This important agreement will position Silenor more favorably on the CVS/CaremarkPCS Health formulary than any other branded product for the treatment of insomnia. |
| Somaxon has come to agreement with Medicare Part D health insurance plans covering a total of over 3 million lives, and the company continues to actively seek to add coverage on additional Part D plans. The company has also reached agreement with the U.S. Department of Veterans Affairs to make Silenor eligible for formulary inclusion by the regional Veterans Integrated Services Network plans, and the company has continued its efforts to establish Silenor as the insomnia treatment of choice within the Department of Defense institutions where Silenor is currently contracted. |
| Beginning in early April 2011, Somaxon implemented the eVoucher co-pay assistance program under which co-pay amounts of $85 or below for patients with a commercial health insurance pharmacy benefit will be automatically reduced to $15 at the time of payment at approximately 33,000 participating pharmacies (a list of participating pharmacies is available at www.silenor.com). The companys Sleep Saver program, which offers up to $25 off of patient co-pay amounts at the point of sale, also continues to be available to commercial plan patients who are unable to take advantage of the eVoucher program. |
Second Quarter 2011 Financial Results
Net product sales of Silenor for the second quarter of 2011 was $6.2 million. As expected and in
accordance with U.S. generally accepted accounting principles, the company has revised its revenue
recognition methodology to record sales of Silenor when units are sold to its wholesale
distributors, rather than when units are dispensed through patient prescriptions. Net product sales
to wholesale distributors in the second quarter of 2011 was $3.5 million, and the remainder of net
product sales for the quarter consists of net product sales previously deferred.
Cost of sales was $0.7 million for the second quarter of 2011. Gross profit was $5.6 million for
the second quarter of 2011, and gross margin was 89%.
Total operating expenses for the second quarter of 2011 were $20.5 million, including $1.4 million
of non-cash, share-based compensation expense, compared with $5.7 million, including $1.3 million
of non-cash,
share-based compensation expense, for the second quarter of 2010. These increases in total
operating expenses are primarily due to an increase in selling, general and administrative (SG&A)
expenses relating to commercial activities for Silenor.
SG&A expense was $20.1 million for the second quarter of 2011, compared to $4.9 million for the
second quarter of 2010. This increase reflected the costs associated with commercial activities
relating to Silenor and an increase in salary and personnel-related expenses due to an increase in
overall headcount.
Research and development expense was $0.5 million for the second quarter of 2011, compared to $0.8
million for the second quarter of 2010.
Net loss for the second quarter of 2011 was $14.9 million, or a loss of $0.33 per share, compared
with a net loss of $5.7 million, or a loss of $0.16 per share, for the second quarter of 2010.
At June 30, 2011, Somaxon had cash, cash equivalents and short-term investments totaling $30.9
million, compared to $54.8 million at December 31, 2010.
Revised Operating Expense Guidance for Full Year of 2011
For the full year of 2011, Somaxon is lowering the range of its expected total operating expense to
be approximately $75-$78 million, including non-cash, share-based compensation expense. Non-cash,
share-based compensation expense is expected to be approximately $4 million. The projected decrease
in full year of 2011 total operating expense compared to previous guidance primarily relates to
decreases in SG&A expense.
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.
$15 Million Term Loan
Under the loan agreement, Somaxon will repay interest on a monthly basis at the fixed, per-annum
rate of 7.50% through December 31, 2011, and thereafter Somaxon will repay the principal and
interest on a monthly basis through the maturity date of December 31, 2013. The loan is secured by
a first priority security interest in all of the companys assets, other than its intellectual
property and its rights under license agreements granting it rights to intellectual property. In
connection with entering into the loan agreement, Somaxon issued to the lenders warrants to
purchase shares of the companys common stock, and Somaxon terminated its previous loan agreement
with Comerica Bank.
$30 Million At-the-Market Offering Program
Under the ATM equity offering sales agreement, sales of common stock, if any, through Citadel, will
be made by means of ordinary brokers transactions, in private negotiated transactions, or
otherwise, at market prices prevailing at the time of sales, prices related to prevailing market
prices or negotiated prices.
Somaxon has filed registration statements (including prospectuses) and prospectus supplements with
the Securities and Exchange Commission (SEC) to enable the offering of common stock described in
this communication. Current and potential investors should read the prospectuses in those
registration statements, the prospectus supplements relating to the at-the-market offering and
other documents the company has filed with the SEC for more complete information about Somaxon and
the at-the-market offering program. These documents may be obtained for free by visiting EDGAR on
the SEC Web site at www.sec.gov. Alternatively, Somaxon or Citadel will send the prospectus
supplements (including the prospectuses) upon request. Such requests may be made by contacting
Citadel Securities LLC, 601 Lexington Avenue, 28th Floor, New York, NY 10003, or by calling
212-847-8880, or 877-219-5193 (toll free).
This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor
may there be any sale of Somaxons common stock in any state or jurisdiction in which such an
offer, solicitation or sale would be unlawful prior to registration or qualification under the
securities law of any state or jurisdiction.
Conference Call Information and Forward-Looking Statements
On Tuesday, August 2, 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 second quarter
ended June 30, 2011.
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) 941-6010 (domestic) or (480) 629-9643 (international), conference
call ID 4459273. 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 4459273.
Discussion during the conference call may include forward-looking statements regarding such topics
as, but not limited to, the companys commercial activities relating to Silenor, prescription
trends, the companys financial status and performance, including its financing activities and
plans, and any comments the company may make about its future plans or prospects in response to
questions from participants on the conference call.
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. Somaxons 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 companys web site at www.somaxon.com.
To be added to Somaxons e-mail list, please visit http://bit.ly/Somaxon-email-list.
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, Somaxons ability to broaden its business and product
portfolio, estimates regarding product prescriptions and returns, the expected range of operating
expense to be incurred for the full year of 2011, Somaxons ability to raise additional funds
through the ATM offering program, and the ability of Paladin to gain marketing approvals and
successfully commercialize Silenor in the licensed territories 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 Somaxons business, including, without
limitation, Somaxons ability to successfully commercialize Silenor; the market potential for
insomnia treatments, and Somaxons ability to compete within that market; Somaxons 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
Somaxons sales management
personnel to effectively manage the sales representatives employed by Publicis; 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; Somaxons
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 for Silenor; changes in healthcare reform measures and reimbursement policies;
the ability of Somaxon to ensure adequate and continued supply of Silenor to successfully meet
anticipated market demand; Somaxons 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; Somaxons ability to comply with the covenants under the loan agreement with Silicon
Valley Bank and Oxford Finance Corporation; the potential for an event of default under the loan
agreement, and the corresponding risk of acceleration of repayment and potential foreclosure on the
assets pledged to secure the loan; Somaxons ability to fully utilize the equity sales agreement
with Citadel as a source of future financings, whether due to market conditions, Somaxons ability
to satisfy various conditions required to sell shares under the agreement, Citadels performance
of its obligations under the agreement or otherwise; the impact on the level of Somaxons stock
price, which may decline, in connection with the implementation of the equity sales facility or the
occurrence of any sales under the facility; Somaxons ability to operate its business without
infringing the intellectual property rights of others; Somaxons reliance on its licensee, Paladin,
for critical aspects of the commercial sales process for Silenor outside of the United States; the
performance of Paladin and its adherence to the terms of its contracts with Somaxon; inadequate
therapeutic efficacy or unexpected adverse side effects relating to Silenor that could adversely
impact commercial success, 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 FDAs agreement with
Somaxons interpretation of such results; and other risks detailed in Somaxons 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.
# # #
FINANCIAL TABLES FOLLOW
SOMAXON PHARMACEUTICALS, INC. SUMMARY
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS
Quarter ended June 30, | Six months ended June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||
Revenues |
||||||||||||||||
Net product sales |
$ | 6,242 | $ | | $ | 8,564 | $ | | ||||||||
Operating costs and expenses |
||||||||||||||||
Cost of sales |
661 | | 1,024 | | ||||||||||||
Selling, general and administrative |
20,073 | 4,902 | 38,666 | 7,954 | ||||||||||||
Research and development |
457 | 814 | 876 | 1,927 | ||||||||||||
Total operating costs and expenses |
21,191 | 5,716 | 40,566 | 9,881 | ||||||||||||
Loss from operations |
(14,949 | ) | (5,716 | ) | (32,002 | ) | (9,881 | ) | ||||||||
Other income and (expense) |
| (5 | ) | 15 | (5 | ) | ||||||||||
Net loss |
$ | (14,949 | ) | $ | (5,721 | ) | $ | (31,987 | ) | $ | (9,886 | ) | ||||
Basic and diluted net loss per share |
$ | (0.33 | ) | $ | (0.16 | ) | $ | (0.71 | ) | $ | (0.33 | ) | ||||
Shares used to calculate net loss per share |
45,492 | 34,890 | 45,250 | 30,268 |
SOMAXON PHARMACEUTICALS, INC.
SUMMARY BALANCE SHEETS
SUMMARY BALANCE SHEETS
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
(in thousands) | ||||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | 28,395 | $ | 21,008 | ||||
Short-term investments |
2,458 | 33,809 | ||||||
Accounts receivable, net |
1,953 | 5,584 | ||||||
Inventory |
980 | 991 | ||||||
Other current assets |
3,167 | 1,882 | ||||||
Total current assets |
36,953 | 63,274 | ||||||
Property and equipment, net |
956 | 755 | ||||||
Intangibles, net |
1,190 | 1,102 | ||||||
Total assets |
$ | 39,099 | $ | 65,131 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 1,674 | $ | 1,709 | ||||
Accrued liabilities |
7,094 | 5,699 | ||||||
Deferred revenue, current portion |
| 3,459 | ||||||
Total current liabilities |
8,768 | 10,867 | ||||||
Deferred revenue, non-current portion |
464 | | ||||||
Total stockholders equity |
29,867 | 54,264 | ||||||
Total liabilities and stockholders equity |
$ | 39,099 | $ | 65,131 | ||||