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EX-31.2 - EXHIBIT 31.2 - Pernix Sleep, Inc. | c18711exv31w2.htm |
EX-32.2 - EXHIBIT 32.2 - Pernix Sleep, Inc. | c18711exv32w2.htm |
EX-32.1 - EXHIBIT 32.1 - Pernix Sleep, Inc. | c18711exv32w1.htm |
EX-31.1 - EXHIBIT 31.1 - Pernix Sleep, Inc. | c18711exv31w1.htm |
EXCEL - IDEA: XBRL DOCUMENT - Pernix Sleep, Inc. | Financial_Report.xls |
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2011
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number: 000-51665
Somaxon Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware (State or other jurisdiction of incorporation or organization) |
20-0161599 (I.R.S. Employer Identification No.) |
|
3570 Carmel Mountain Road, Suite 100, San Diego CA (Address of principal executive offices) |
92130 (Zip Code) |
(858) 876-6500
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
(Former name, former address and formal fiscal year, if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. þ Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o
(Do not check if a smaller reporting company) |
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Act). o Yes þ No
The number of outstanding shares of the registrants common stock, par value $0.0001 per
share, as of July 15, 2011 was 47,198,093.
SOMAXON PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
For the Quarter Ended June 30, 2011
TABLE OF CONTENTS
Table of Contents
PART I FINANCIAL INFORMATION
Item 1. | Financial Statements |
CONDENSED BALANCE SHEETS
(Unaudited)
(In thousands, except par value)
(Unaudited)
(In thousands, except par value)
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
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 | | ||||||
Commitments and contingencies (see Note 6) |
||||||||
Stockholders equity |
||||||||
Preferred stock, $0.0001 par value; 10,000
shares authorized, none issued and
outstanding |
| | ||||||
Common stock, $0.0001 par value; 100,000
shares
authorized; 47,198 and 45,004 shares outstanding
at June 30, 2011 and December 31, 2010,
respectively |
5 | 5 | ||||||
Additional paid-in capital |
278,701 | 271,112 | ||||||
Accumulated deficit |
(248,839 | ) | (216,852 | ) | ||||
Accumulated other comprehensive income (loss) |
| (1 | ) | |||||
Total stockholders equity |
29,867 | 54,264 | ||||||
Total liabilities and stockholders equity |
$ | 39,099 | $ | 65,131 | ||||
The Accompanying Notes are an Integral Part of these Unaudited Condensed Financial Statements
F-1
Table of Contents
SOMAXON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share amounts)
(Unaudited)
(In thousands, except per share amounts)
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue |
||||||||||||||||
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 |
The Accompanying Notes are an Integral Part of these Unaudited Condensed Financial Statements
F-2
Table of Contents
SOMAXON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
(Unaudited)
(In thousands)
Six Months Ended June 30, | ||||||||
2011 | 2010 | |||||||
Cash flows from operating activities |
||||||||
Net loss |
$ | (31,987 | ) | $ | (9,886 | ) | ||
Adjustments to reconcile net loss to net cash used
in operating activities: |
||||||||
Share-based compensation expense |
2,588 | 3,525 | ||||||
Depreciation |
116 | 99 | ||||||
Amortization |
74 | | ||||||
Amortization of investment discount |
145 | | ||||||
Realized gain on sale of short-term investments |
1 | | ||||||
Loss on disposal of equipment |
| 13 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
3,631 | | ||||||
Inventory |
(108 | ) | (531 | ) | ||||
Other current and non-current assets |
(1,230 | ) | (344 | ) | ||||
Accounts payable |
(34 | ) | 1,514 | |||||
Accrued liabilities |
1,362 | (40 | ) | |||||
Deferred revenue |
(2,962 | ) | | |||||
Net cash used in operating activities |
(28,404 | ) | (5,650 | ) | ||||
Cash flows from investing activities |
||||||||
Purchases of property and equipment |
(318 | ) | (110 | ) | ||||
Payments for intangible assets |
(161 | ) | (1,000 | ) | ||||
Purchases of marketable securities |
(3,508 | ) | | |||||
Sales and maturities of marketable securities |
34,777 | | ||||||
Net cash provided by (used in) investing activities |
30,790 | (1,110 | ) | |||||
Cash flows from financing activities |
||||||||
Issuance of common stock, net of costs |
5,000 | 52,745 | ||||||
Exercise of warrants |
| 1,474 | ||||||
Exercise of stock options |
1 | 1,884 | ||||||
Purchase of treasury stock |
| (44 | ) | |||||
Net cash provided by financing activities |
5,001 | 56,059 | ||||||
Increase in cash and cash equivalents |
7,387 | 49,299 | ||||||
Cash and cash equivalents at beginning of the period |
21,008 | 5,165 | ||||||
Cash and cash equivalents at end of the period |
$ | 28,395 | $ | 54,464 | ||||
Non-cash investing and financing activities |
||||||||
Common stock issued to settle severance obligation |
$ | | $ | 860 |
The Accompanying Notes are an Integral Part of these Unaudited Condensed Financial Statements
F-3
Table of Contents
SOMAXON PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF STOCKHOLDERS EQUITY AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except per share amounts)
(Unaudited)
(In thousands, except per share amounts)
Accumulated | ||||||||||||||||||||||||
Additional | Other | |||||||||||||||||||||||
Common Stock | Paid-in | Accumulated | Comprehensive | |||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income (Loss) | Total | |||||||||||||||||||
Balance at December 31, 2010 |
45,004 | $ | 5 | $ | 271,112 | $ | (216,852 | ) | $ | (1 | ) | $ | 54,264 | |||||||||||
Net loss |
| | | (31,987 | ) | | (31,987 | ) | ||||||||||||||||
Unrealized gains in short-term
investments |
| | | | 1 | 1 | ||||||||||||||||||
Comprehensive loss |
| | | | | (31,986 | ) | |||||||||||||||||
Issuance of common stock |
2,185 | | 5,000 | | | 5,000 | ||||||||||||||||||
Issuance of common stock
pursuant to vesting of
restricted stock units |
8 | | | | | | ||||||||||||||||||
Exercise of stock options |
1 | | 1 | | | 1 | ||||||||||||||||||
Share-based compensation expense |
| | 2,588 | | | 2,588 | ||||||||||||||||||
Balance at June 30, 2011 |
47,198 | $ | 5 | $ | 278,701 | $ | (248,839 | ) | $ | | $ | 29,867 | ||||||||||||
The Accompanying Notes are an Integral Part of these Unaudited Condensed Financial
Statements
F-4
Table of Contents
Note 1. Organization
Business
Somaxon Pharmaceuticals, Inc. (Somaxon, the Company, we, us or our), 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. In March 2010, the U.S. Food and Drug
Administration (FDA), approved our New Drug Application (NDA) for Silenor® 3 mg and
6 mg tablets for the treatment of insomnia characterized by difficulty with sleep maintenance.
Silenor was made commercially available by prescription in the United States in September 2010. We
operate in one reportable segment, which is the development and commercialization of pharmaceutical
products.
Basis of Presentation
The accompanying condensed balance sheet as of December 31, 2010, which has been derived from
our audited financial statements, and the unaudited interim condensed financial statements have
been prepared in accordance with U.S. generally accepted accounting principles and the rules and
regulations of the Securities and Exchange Commission (SEC) related to a quarterly report on Form
10-Q. Certain information and note disclosures normally included in annual financial statements
prepared in accordance with accounting principles generally accepted in the United States have been
condensed or omitted pursuant to those rules and regulations, although we believe that the
disclosures made are adequate to make the information presented not misleading. The unaudited
interim condensed financial statements reflect all adjustments which, in the opinion of our
management, are necessary for a fair statement of the results for the periods presented. All such
adjustments are of a normal and recurring nature. These unaudited condensed financial statements
should be read in conjunction with the financial statements and the notes thereto included in our
Annual Report on Form 10-K for the year ended December 31, 2010. The operating results presented in
these unaudited condensed financial statements are not necessarily indicative of the results that
may be expected for any future periods.
Capital Resources
Since inception, our operations have been financed primarily through the sale of equity
securities and the proceeds from the exercise of warrants and stock options. We have incurred
losses from operations and negative cash flows since the inception of the Company, and we expect to
continue to incur substantial losses for the foreseeable future as we continue our commercial
activities for Silenor, commercialize any other products to which we obtain rights and potentially
pursue the development of other product candidates.
We believe we have sufficient financial resources to fund our operations for at least the next
twelve months. We have received $14.9 million in net proceeds pursuant to a loan and security
agreement with Silicon Valley Bank (SVB) and Oxford Finance LLC (together with SVB, the
Lenders). We may need to obtain additional funds to finance our operations, particularly if we
are unable to access adequate or timely funds under our at-the-market equity sales agreement with
Citadel Securities LLC, (Citadel). Until we can generate significant cash from our operations, we
intend to obtain any additional funding we require through strategic relationships, public or
private equity or debt financings, assigning receivables or royalty rights, or other arrangements
and we cannot assure such funding will be available on reasonable terms, or at all. Additional
equity financing will be dilutive to stockholders, and debt financing, if available, may involve
restrictive covenants.
If our efforts in raising additional funds when needed are unsuccessful, we may be required to
delay, scale-back or eliminate plans or programs relating to our business, relinquish some or all
rights to Silenor or renegotiate less favorable terms with respect to such rights than we would
otherwise choose or cease operating as a going concern. In addition, if we do not meet our payment
obligations to third parties as they come due, we may be subject to litigation claims. Even if we
were successful in defending against these claims, litigation could result in substantial costs and
be a distraction to management, and may result in unfavorable results that could further adversely
impact our financial condition.
If we are unable to continue as a going concern, we may have to liquidate our assets and may
receive less than the value at which those assets are carried on our financial statements, and it
is likely that investors will lose all or a part of their investments. These financial statements do
not include any adjustments that might result from the outcome of this uncertainty.
F-5
Table of Contents
Note 2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from these estimates.
Cash and Cash Equivalents
All highly liquid investments with maturities of three months or less at the time of purchase
are considered to be cash equivalents. Investments with maturities at the date of purchase greater
than three months are classified as marketable securities. At June 30, 2011, our cash and cash
equivalents consisted primarily of money market funds and other available-for-sale securities that
have an original maturity date of three months or less. All of our cash equivalents have liquid
markets and high credit ratings.
Marketable Securities
Our investments in marketable securities are classified as available-for-sale securities.
Available-for-sale securities are carried at fair market value, with unrealized gains and losses
reported as a component of stockholders equity in accumulated other comprehensive income/loss.
Interest and dividend income is recorded when earned and included in interest income. Premiums and
discounts on marketable securities are amortized and accreted, respectively, to maturity and
included in interest income. Marketable securities with a maturity date of less than one year as of
the balance sheet date are classified as short-term investments. Marketable securities with a
maturity of more than one year as of the balance sheet date are classified as long-term
investments. We assess the risk of impairment related to securities held in our investment
portfolio on a regular basis and noted no impairment during the three and six months ended June 30,
2011.
Concentration of Credit Risk, Significant Customers and Sources of Supply
Financial instruments that potentially subject us to concentrations of credit risk consist
primarily of cash and cash equivalents, short-term investments, and accounts receivable. We
maintain accounts in federally insured financial institutions in excess of federally insured
limits. We also maintain investments in money market funds and similar short-term investments that
are not federally insured. However, management believes we are not exposed to significant credit
risk due to the financial positions of the depository institutions in which these deposits are held
and of the money market funds and other entities in which these investments are made. Additionally,
we have established guidelines regarding the diversification of our investments and their
maturities that are designed to maintain safety and liquidity.
We sell our product primarily to established wholesale distributors in the pharmaceutical
industry. The following table sets forth customers who represented 10% or more of our product sales
for the three and six months ended June 30, 2011:
Three Months Ended | Six Months Ended | |||||||
June 30, 2011 | June 30, 2011 | |||||||
Cardinal Health |
42 | % | 45 | % | ||||
McKesson |
41 | % | 37 | % | ||||
AmerisourceBergen |
11 | % | 11 | % |
The majority of our accounts receivable balance as of June 30, 2011 represents amounts due
from these three wholesale distributors. Credit is extended based on an evaluation of the
customers financial condition. Based upon the review of these factors, we did not record an
allowance for doubtful accounts at June 30, 2011.
We rely on third-party manufacturers for the production of Silenor and single source
third-party suppliers to manufacture key components of Silenor. If our third-party manufacturers
are unable to continue manufacturing Silenor, or if we lost our single source suppliers used in the manufacturing process, we may not be able
to meet market demand for our product.
F-6
Table of Contents
Inventory
Our inventories are valued at the lower of weighted average cost or net realizable value. We
analyze our inventory levels quarterly and write down inventory that has become obsolete or has a
cost basis in excess of its expected net realizable value, as well as any inventory quantities in
excess of expected requirements. We did not record a reserve for potentially obsolete or excess
inventory as of June 30, 2011.
Intangible Assets
Our intangible assets consist of the costs incurred to in-license our product and technology
development costs relating to our websites. Prior to the FDA approval of our NDA for Silenor, we
had expensed all license fees and milestone payments for acquired development and commercialization
rights to operations as incurred since the underlying technology associated with these expenditures
related to our research and development efforts and had no alternative future use at the time.
Costs related to our intellectual property are capitalized once technological feasibility has been
established. Capitalized amounts are amortized on a straight line basis over the expected life of
the intellectual property. License fees began being amortized upon the first sale of Silenor to our
wholesaler in August 2010 and are being amortized over approximately ten years. Costs incurred in
the planning stage of a website are expensed, while costs incurred in the development stage are
capitalized and will be amortized over the expected life of the product associated with the website
once the asset is placed in service. Costs incurred for other intangible assets to be used
primarily on our website are capitalized and amortized over the expected useful life, which we
estimate to be two years. The carrying values of our intangible assets are periodically reviewed to
determine if the facts and circumstances suggest that a potential impairment may have occurred. We
had no impairment of our intangible assets for the three and six months ended June 30, 2011.
Revenue Recognition
Product Sales
We sell Silenor to wholesale pharmaceutical distributors. Our returned goods policy generally
permits our customers to return products up to six months before and up to twelve months after the
expiration date of the product. We authorize returns for expired products in accordance with our
returned goods policy and issue credit to our customers for expired returned product. We do not
exchange product from inventory for returned product. As of June 30, 2011, the dollar amount of
returns received in 2011 has been negligible.
We recognize product revenue from product sales when it is realized or realizable and earned.
Revenue is realized or realizable and earned when all of the following criteria are met: (1)
persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been
rendered; (3) our price to the buyer is fixed or determinable; and (4) collectability is reasonably
assured. Revenue from sales transactions where the buyer has the right to return the product is
recognized at the time of sale only if (1) our price to the buyer is substantially fixed or
determinable at the date of sale, (2) the buyer has paid us, or the buyer is obligated to pay us
and the obligation is not contingent on resale of the product, (3) the buyers obligation to us
would not be changed in the event of theft or physical destruction or damage of the product, (4)
the buyer acquiring the product for resale has economic substance apart from that provided by us,
(5) we do not have significant obligations for future performance to directly bring about resale of
the product by the buyer, and (6) the amount of future returns can be reasonably estimated.
Prior to the second quarter of 2011, we were unable to reasonably estimate returns. We
therefore deferred revenue recognition until the right of return no longer existed, which was the
earlier of Silenor being dispensed through patient prescriptions or the expiration of the right of
return. We estimated patient prescriptions dispensed using an analysis of third-party information.
In order to develop a methodology to reliably estimate product returns and provide a basis for
recognizing revenue on sales to customers at the time of product shipment, we analyzed many
factors, including, without limitation, industry data regarding product return rates, and tracked
the Silenor product return history, taking into account product expiration dating at the time of
shipment and levels of inventory in the wholesale channel compared to prescription units dispensed
and the sell-down of our launch inventory. During the second quarter of 2011, the sell-down of our
launch inventory was completed, which we believe demonstrates sufficient market acceptance of
F-7
Table of Contents
our
product for purposes of our revenue recognition analysis. In addition, since product launch, we have sold product to
wholesale pharmaceutical distributors at standard commercial terms utilized in the industry. As a
result, we believe we can analogize to industry data regarding product return rates. Based on the
sell-down of our launch inventory and the industry and internal data gathered, we believe we have
the information needed to reasonably estimate product returns. As a result, in the second quarter
of 2011, we began recognizing revenue for Silenor sales at the time of delivery of the product to
wholesale pharmaceutical distributors and our other customers.
License and Royalty Revenue
In June 2011, we entered into a license agreement with Paladin Labs Inc. (Paladin) pursuant
to which Paladin will commercialize Silenor in Canada, South America, the Caribbean and Africa
subject to the receipt of marketing approval in each such territory. We received an upfront
payment of $500,000 in connection with the execution of this agreement. We recorded the upfront
payment as deferred revenue and are recognizing the upfront payment as license revenue over the
period of our significant involvement under the agreement, which we are estimating to be 15 years.
As of June 30, 2011, the deferred revenue balance associated with the license agreement is
$497,000. We recognized $3,000 as revenue during each of the three and six months ended June 30,
2011, which is recorded in other income and expense.
Once Silenor is commercialized in the licensed territories, we will 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. Due to the uncertainty surrounding the achievement of
these future sales-based milestones and royalties, these potential payments will not be recognized
as revenue until they are realized and earned.
Product Sales Discounts and Allowances
We record product sales discounts and allowances at the time of sale and report revenue net of
such amounts in the same period that product sales are recorded. In determining the amount of
product sales discounts and allowances, we must make significant judgments and estimates. If actual
results vary from our estimates, we may need to adjust these estimates, which could have an effect
on product revenue in the period of adjustment. Our product sales discounts and allowances and the
specific considerations we use in estimating these amounts include:
Prompt Pay Discounts. As an incentive for prompt payment, we offer a 2% cash discount to
customers. We expect that all customers will comply with the contractual terms to earn the
discount. We record the discount as an allowance against accounts receivable and a corresponding
reduction of revenue. At June 30, 2011 and December 31, 2010, the allowance for prompt pay
discounts was $40,000 and $114,000, respectively.
Patient Discount Programs. We offer discount programs to patients of Silenor under which the
patient receives a discount on his or her prescription. We reimburse pharmacies for these discounts
through third-party vendors. We estimate the total amount that will be redeemed based on the dollar
amount of the discounts, the timing and quantity of distribution and historical redemption rates.
We accrue the discounts and recognize a corresponding reduction of revenue. At June 30, 2011 and
December 31, 2010, the accrual for patient discount programs was $376,000 and $182,000,
respectively.
Distribution Service Fees. We pay distribution services fees to each wholesaler for
distribution and inventory management services. We accrue for these fees based on contractually
defined terms with each wholesaler and recognize a corresponding reduction of revenue. At June 30,
2011 and December 31, 2010, the accrual for distribution service fees was $240,000 and $276,000,
respectively.
Chargebacks. We provide discounts to federal government qualified entities with whom we have
contracted. These federal entities purchase products from the wholesalers at a discounted price,
and the wholesalers then charge back to us the difference between the current retail price and the
contracted price the federal entity paid for the product. We accrue chargebacks based on contract
prices and sell-through sales data obtained from third party information. At June 30, 2011 and
December 31, 2010, the accrual for chargebacks was $13,000 and $9,000, respectively.
Rebates. We participate in certain rebate programs, which provide discounted prescriptions to
qualified insured patients. Under these rebate programs, we pay a rebate to the third-party
administrator of the program. We accrue rebates based on contract prices, estimated percentages of
product sold to qualified patients and estimated levels of inventory in the
distribution channel. At June 30, 2011 and December 31, 2010, the accrual for rebates was
$536,000 and $6,000, respectively.
F-8
Table of Contents
Product Returns. We estimate future product returns based upon actual returns history, product
expiration dating analysis, estimated inventory levels in the distribution channel, and industry
data regarding product return rates for similar products. There may be a significant time lag
between the date we determine the estimated allowance and when we receive product returns and issue
credits to customers. Due to this time lag, we may record adjustments to our estimated allowance
over several periods, which would impact our operating results in those periods. At June 30, 2011,
the allowance for product returns was $85,000.
Cost of Sales
Cost of sales includes the costs to manufacture, package, and ship Silenor, including
personnel costs associated with manufacturing oversight, as well as royalties and amortization of
capitalized license fees associated with our license agreement with ProCom One, Inc. (ProCom).
Share-Based Compensation Expense
Share-based compensation expense for employees and directors is recognized in the statement of
operations based on estimated amounts, including the grant date fair value, the probability of
achieving performance conditions and the expected service period for awards with conditional
vesting provisions. We estimate the grant date fair value for our stock option awards using the
Black-Scholes valuation model which requires the use of multiple subjective inputs including
estimated future volatility, expected forfeitures and the expected terms of the stock option
awards. Our stock did not have a readily available market prior to our initial public offering in
December 2005, creating a relatively short history from which to obtain data to estimate the
volatility of our stock price. Consequently, we estimate expected future volatility based on a
combination of both comparable companies and our own stock price volatility to the extent such
history is available. The expected term for stock options is estimated using guidance provided by
the SEC in Staff Accounting Bulletin (SAB) No. 107 and SAB 110. This guidance provides a
formula-driven approach for determining the expected term. Share-based compensation is based on
awards expected to ultimately vest and has been reduced for estimated forfeitures. The estimated
forfeiture rates may differ from actual forfeiture rates which would affect the amount of expense
recognized during the period. Estimated forfeitures are adjusted to actual amounts as they become
known.
We recognize the value of the portion of the awards that are ultimately expected to vest on a
straight-line basis over the awards requisite service period. The requisite service period is
generally the time over which our share-based awards vest. Some of our share-based awards vested
upon achieving certain performance conditions, generally pertaining to the commercial performance
of Silenor or the achievement of other strategic objectives. Share-based compensation expense for
awards with performance conditions is recognized over the period from the date the performance
condition is determined to be probable of occurring through the time the applicable condition is
met. If the performance condition is not considered probable of being achieved, no expense is
recognized until such time the meeting of the performance condition is considered probable.
Income Taxes
Our income tax expense consists of current and deferred income tax expense or benefit. Current
income tax expense or benefit is the amount of income taxes expected to be payable or refundable
for the current year. A deferred income tax asset or liability is recognized for the future tax
consequences attributable to tax credits and loss carryforwards and to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax
bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management,
it is more likely than not that some portion or all of the deferred tax assets will not be
realized. As of December 31, 2010, we have established a valuation allowance to fully reserve our
net deferred tax assets. It is expected that the amount of unrecognized tax benefits may change
over the course of the year; however, because our deferred tax assets are fully reserved, we do not
expect the change to have a significant impact on our results of operations, cash flows or
financial position. Tax rate changes are reflected in income during the period such changes are
enacted. Changes in ownership may limit the amount of net operating loss carryforwards that can be
utilized in the future to offset taxable income.
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Net Loss per Share
Basic earnings per share (EPS) excludes the effects of common stock equivalents. EPS is
calculated by dividing net income or loss applicable to common stockholders by the weighted average
number of common shares outstanding for the period, reduced by the weighted average number of
unvested common shares outstanding subject to repurchase. Diluted EPS is computed in the same
manner as basic EPS, but includes the effects of common stock equivalents to the extent they are
dilutive, using the treasury-stock method. For us, basic and diluted net loss per share are
equivalent because we have incurred a net loss in all periods presented, causing any potentially
dilutive securities to be anti-dilutive.
Net loss per share was determined as follows (in thousands, except per share amounts):
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Numerator: |
||||||||||||||||
Net loss |
$ | (14,949 | ) | $ | (5,721 | ) | $ | (31,987 | ) | $ | (9,886 | ) | ||||
Denominator: |
||||||||||||||||
Weighted average common shares outstanding |
45,492 | 34,890 | 45,250 | 30,311 | ||||||||||||
Weighted average unvested common shares subject to
repurchase |
| | | (43 | ) | |||||||||||
Denominator |
45,492 | 34,890 | 45,250 | 30,268 | ||||||||||||
Basic and diluted net loss per share |
$ | (0.33 | ) | $ | (0.16 | ) | $ | (0.71 | ) | $ | (0.33 | ) | ||||
Weighted average anti-dilutive securities not
included in diluted net loss per share
calculation: |
||||||||||||||||
Weighted average stock options outstanding |
4,645 | 3,283 | 4,207 | 3,391 | ||||||||||||
Weighted average restricted stock units outstanding |
563 | 716 | 404 | 794 | ||||||||||||
Weighted average warrants outstanding |
2,418 | 2,921 | 2,418 | 3,544 | ||||||||||||
Weighted average unvested common shares subject to
repurchase |
| | | 44 | ||||||||||||
Total weighted average anti-dilutive securities
not included in diluted net loss per share |
7,626 | 6,920 | 7,029 | 7,773 | ||||||||||||
Recent Accounting Pronouncements
In October 2009, the Financial Accounting Standards Board (FASB) issued Accounting Standards
Update (ASU) No. 2009-13 Revenue Recognition, which provides guidance on recognizing revenue in
arrangements with multiple deliverables. This standard impacts the determination of when the
individual deliverables included in a multiple element arrangement may be treated as a separate
unit of accounting. It also modifies the manner in which the consideration received from the
transaction is allocated to the multiple deliverables and no longer permits the use of the residual
method of allocating arrangement consideration. This accounting standard is effective for the first
year beginning on or after June 15, 2010, with early adoption permitted. The adoption of ASU
2009-13 did not have a material impact on our financial statements.
In December 2010, the FASB issued ASU No. 2010-27 Other Expenses: Fees Paid to the Federal
Government by Pharmaceutical Manufacturers, which provides guidance concerning the recognition and
classification of the new annual fee payable by branded prescription drug manufacturers and
importers on branded prescription drugs which was mandated under the health care reform legislation
enacted in the United States in March 2010. Under this new authoritative guidance, the annual fee
should be estimated and recognized in full as a liability upon the first qualifying commercial sale
with a corresponding deferred cost that is amortized to operating expenses using a straight-line
method unless another method better allocates the fee over the calendar year in which it is
payable. This new guidance is effective for calendar years beginning on or after December 31, 2010,
when the fee initially becomes effective. The adoption of ASU 2010-27 did not have a material
impact on our financial statements.
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In May 2011, the FASB issued ASU No. 2011-04 Fair Value Measurement: Amendments to Achieve
Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. Some of the
amendments clarify the FASBs intent about the application of existing fair value measurement
requirements. Other amendments change a particular principle or requirement for measuring fair
value or for disclosing information about fair value measurements. This guidance is effective for
interim and annual periods beginning after December 15, 2011. We are still evaluating the potential
future effects of this guidance.
In June 2011, the FASB issued ASU No. 2011-05 Comprehensive Income: Presentation of
Comprehensive Income. Under the new guidance, an entity has the option to present the total of
comprehensive income, the components of net income, and the components of other comprehensive
income either in a single continuous statement of comprehensive income or in two separate but
consecutive statements. This guidance is effective for interim and annual periods beginning after
December 15, 2011. We have evaluated the potential future
effects of this guidance and do not expect the adoption of ASU 2011-05 to have a material impact on our financial statements.
Note 3. Fair Value of Financial Instruments
Cash and investment holdings, accounts receivable, accounts payable and accrued liabilities
are presented in the financial statements at their carrying amounts, which are reasonable estimates
of fair value due to their short maturities.
The fair value of financial assets and liabilities is measured under a framework that
establishes levels which are defined as follows: Level 1 fair value is determined from
observable, quoted prices in active markets for identical assets or liabilities. Level 2 fair value
is determined from quoted prices for similar items in active markets or quoted prices for identical
or similar items in markets that are not active. Level 3 fair value is determined using the
entitys own assumptions about the inputs that market participants would use in pricing an asset or
liability.
The fair value of our investment holdings at June 30, 2011 and December 31, 2010 is summarized
in the following tables (in thousands).
June 30, 2011 | ||||||||||||||||
Total Fair | Fair Value Determined Under: | |||||||||||||||
Value | (Level 1) | (Level 2) | (Level 3) | |||||||||||||
Commercial paper |
$ | 600 | $ | | $ | 600 | $ | | ||||||||
U.S. government agency securities |
4,009 | | 4,009 | | ||||||||||||
Money market funds |
25,288 | 25,288 | | | ||||||||||||
Total |
$ | 29,897 | $ | 25,288 | $ | 4,609 | $ | | ||||||||
December 31, 2010 | ||||||||||||||||
Total Fair | Fair Value Determined Under: | |||||||||||||||
Value | (Level 1) | (Level 2) | (Level 3) | |||||||||||||
Commercial paper |
$ | 18,415 | $ | | $ | 18,415 | $ | | ||||||||
U.S.
government agency securities |
30,628 | | 30,628 | | ||||||||||||
Total |
$ | 49,043 | $ | | $ | 49,043 | $ | | ||||||||
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Commercial paper and U.S. government agency securities are classified as part of either cash
and cash equivalents or short-term investments in the condensed consolidated balance sheets. The
carrying value of short-term investments consisted of the following as of June 30, 2011 and
December 31, 2010 (in thousands).
June 30, 2011 | ||||||||||||||||
Amortized | Unrealized | Unrealized | Fair Market | |||||||||||||
Cost | Gains | Losses | Value | |||||||||||||
Commercial paper |
$ | 600 | $ | | $ | | $ | 600 | ||||||||
U.S. government agency securities |
4,009 | | | 4,009 | ||||||||||||
Total |
$ | 4,609 | $ | | $ | | $ | 4,609 | ||||||||
December 31, 2010 | ||||||||||||||||
Amortized | Unrealized | Unrealized | Fair Market | |||||||||||||
Cost | Gains | Losses | Value | |||||||||||||
Commercial paper |
$ | 18,415 | $ | | $ | | $ | 18,415 | ||||||||
U.S. government agency securities |
30,629 | 2 | (3 | ) | 30,628 | |||||||||||
Total |
$ | 49,044 | $ | 2 | $ | (3 | ) | $ | 49,043 | |||||||
Available-for-sale marketable securities with maturities of three months or less from date of
purchase have been classified as cash equivalents, and amounted to $2.2 million and $15.2 million
as of June 30, 2011 and December 31, 2010, respectively.
Note 4. Composition of Certain Balance Sheet Items
Accounts Receivable
Accounts receivable, net consisted of the following (in thousands): |
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Accounts receivable for product sales, gross |
$ | 1,993 | $ | 5,975 | ||||
Allowances for discounts |
(40 | ) | (391 | ) | ||||
Total accounts receivable |
$ | 1,953 | $ | 5,584 | ||||
Inventory
Inventory consisted of the following (in thousands):
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Work in process |
$ | 441 | $ | 207 | ||||
Finished goods inventory held by the Company |
539 | 515 | ||||||
Finished goods inventory held by others |
| 269 | ||||||
Total inventory |
$ | 980 | $ | 991 | ||||
Other Current Assets
Other current assets consisted of the following (in thousands):
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Deposits and other prepaid expenses |
$ | 1,680 | $ | 641 | ||||
Prepaid sales and marketing expenses |
1,467 | 529 | ||||||
Interest receivable |
20 | 206 | ||||||
Other current assets |
| 506 | ||||||
Total other current assets |
$ | 3,167 | $ | 1,882 | ||||
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Property and Equipment
Property and equipment consisted of the following (in thousands):
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Tooling |
$ | 832 | $ | 832 | ||||
Computer equipment |
481 | 354 | ||||||
Furniture and equipment |
256 | 66 | ||||||
Property and equipment, at cost |
1,569 | 1,252 | ||||||
Less: accumulated depreciation |
(613 | ) | (497 | ) | ||||
Property and equipment, net |
$ | 956 | $ | 755 | ||||
Intangible Assets
Intangible assets consisted of the following (in thousands):
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
License fees |
$ | 1,000 | $ | 1,000 | ||||
Technology development costs relating to websites |
147 | 147 | ||||||
Other intangible assets |
161 | | ||||||
Less: accumulated amortization |
(118 | ) | (45 | ) | ||||
Total intangible assets, net |
$ | 1,190 | $ | 1,102 | ||||
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
Accrued fees and royalties |
$ | 2,070 | $ | 1,566 | ||||
Other accrued expenses |
2,036 | 1,489 | ||||||
Accrued compensation and benefits |
1,285 | 1,329 | ||||||
Accrued product discounts, allowances and returns |
1,250 | 473 | ||||||
Accrued liability to third party sales organization |
453 | 842 | ||||||
Total accrued liabilities |
$ | 7,094 | $ | 5,699 | ||||
Note 5. License Agreements
ProCom. In August 2003, we entered into an exclusive worldwide in-license agreement with
ProCom to develop and commercialize Silenor for the treatment of insomnia. This agreement was
amended and restated in September 2010. The term of the license extends until the last licensed
patent expires, which is expected to occur no earlier than 2020. The license agreement is
terminable by us at any time with 30 days notice if we believe that the use of the product poses an
unacceptable safety risk or if it fails to achieve a satisfactory level of efficacy. Either party
may terminate the agreement with 30 days notice if the other party commits a material breach of its
obligations and fails to remedy the breach within 90 days, or upon the filing of bankruptcy,
reorganization, liquidation, or receivership proceedings. Costs related to the licensed
intellectual property made after approval of the Silenor NDA by the FDA in March 2010 have been
capitalized and included in intangibles in our balance sheet as of December 31, 2010. Capitalized
amounts are amortized on a straight line basis over approximately ten years. Royalty payments due
under the terms of the agreement are recorded in accrued liabilities as of June 30, 2011. The
royalty payments are recognized as an expense in cost of sales when the related shipments of
product are recognized as revenue.
Paladin. In June 2011, we entered into a license agreement, a supply agreement and a stock
purchase agreement with Paladin. Under the license agreement, Paladin will commercialize Silenor in
Canada, South America, the Caribbean and Africa, subject to the receipt of marketing approval in
each such territory. We received $500,000 in connection with the execution of the agreements, and
Paladin purchased 2,184,769 shares of our common stock for an aggregate purchase price
of $5.0 million. Once Silenor is commercialized in the licensed territories, we 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. Paladin will be responsible for
regulatory submissions for Silenor in the licensed territories and will have the exclusive right to
commercialize Silenor in the licensed territories. Governance of the collaboration will occur
through a joint committee. We have also granted to Paladin a right of first negotiation with
respect to additional doxepin products we may develop in the licensed territories and, subject to
the rights we have previously granted to Procter & Gamble (P&G), a right of first negotiation
relating to rights to develop and market Silenor as an over-the-counter medication in the licensed
territories.
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The term of the license agreement runs through the longer of the last date on which Silenor is
sold by Paladin in the licensed territories or 15 years from the first commercial sale of Silenor
in the licensed territories. We may terminate the license agreement on a country-by-country basis
in specified key countries upon 60 days prior written notice if the first commercial sale has not
occurred in such country within 12 months of the date on which marketing approval was obtained in
such country. We may also terminate the license agreement upon 60 days prior written notice if
marketing approval in Canada has not been received by December 7, 2013. Either party may terminate
the license agreement upon an uncured material breach by the other party, upon the bankruptcy or
insolvency of the other party, or a force majeure event that lasts for at least 120 days. We may
also terminate the license agreement upon 60 days prior written notice and payment of a
termination fee if we are unable to license rights to a third partys intellectual property and
such failure would reasonably be expected to result in a claim from such third party alleging
intellectual property infringement or misappropriation. Pursuant to the license agreement, we also
entered into the supply agreement, under which we will supply Paladin all of its requirements for
Silenor during the term of the license agreement or until Paladin procures its own supply of
Silenor. Paladin may terminate the supply agreement upon 10 business days notice if we are
materially unable to supply Silenor to Paladins requirements as defined in the supply agreement,
and at any time if Paladin enters into a direct contractual relationship with our manufacturer of
Silenor. We may terminate the supply agreement upon 180 days prior written notice if there is a
regulatory change or safety consideration that would have a material adverse effect on the global
supply chain and at any time on six months prior notice after April 30, 2013.
Other Agreement. In October 2006, we entered into a supply agreement pertaining to a certain
ingredient used in the formulation for Silenor. In August 2008, this supply agreement was amended
to provide us with the exclusive right to use this ingredient in combination with doxepin. Pursuant
to the amendment, we are obligated to pay a royalty on worldwide net sales of Silenor beginning as
of the expiration of the statutory exclusivity period for Silenor in each country in which Silenor
is marketed. Such royalty is only payable if one or more patents under the license agreement
continue to be valid in each such country and a patent relating to our formulation for Silenor has
not issued in such country.
Note 6. Commitments and Contingencies
Commitments
Publicis Touchpoint Solutions, Inc. (Publicis). In July 2010, we entered into a professional
detailing services agreement with Publicis under which Publicis agreed to provide sales support to
promote Silenor in the U.S. through 110 full-time sales representatives, together with
management coordination personnel, all of whom will be employees of Publicis. On February 7, 2011
we entered into an amended and restated agreement with Publicis under which Publicis deployed for
us an additional 35 sales representatives that are exclusively promoting Silenor, together with
management coordination personnel. We recognize the revenue from Silenor product sales generated by
the promotional efforts of the sales organization. Under the terms of the agreement, we were
required to pay a one-time start up fee, and we are required to pay a fixed monthly fee, which is
subject to certain quarterly adjustments based on actual staffing and spending levels. During the
term of the agreement, a portion of Publicis management fee will be subject to payment by us only
to the extent that specified performance targets are achieved. The performance targets relate to
initial scale-up activities, turnover and vacancy rates, call attainment and specified sales goals.
In addition, we are obligated to reimburse the sales organization for approved pass-through costs,
which primarily include bonuses, meeting and travel costs and certain administrative expenses. The
agreement has an initial two-year term, and may be extended by us by providing Publicis with
written notification no later than 90 days prior to the expiration of the initial term, subject to
agreement on compensation terms with Publicis. We have the right to terminate the services
agreement upon 90 days written notice. We may also terminate the services agreement by hiring a
specified number of sales representatives. In addition, either party may terminate the services
agreement upon an uncured material breach by the other party, upon the bankruptcy or insolvency of
the other party or if a change in law renders the performance of a material obligation of the services
agreement unlawful. If termination occurs during the initial two-year term, we assume financial
responsibility for the remaining lease payments for the sales representatives vehicles which have
a two-year lease term.
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Table of Contents
Procter & Gamble. In August 2010, we entered into a co-promotion agreement with P&G under
which P&G provides sales support to promote Silenor in the U.S. through its team of full-time sales
representatives. We recognize the revenue from Silenor product sales generated by the promotional
efforts of P&G. Under the terms of the agreement, we are required to pay P&G a fixed fee and a
royalty fee as a percentage of U.S. net sales, in each case on a quarterly basis during the term of
the agreement. The fees are recognized as a sales, general, and administrative expense and are
recorded in accrued liabilities as of June 30, 2011. The agreement also provides for financial
penalties in the event that either party fails to deliver specified minimum detailing requirements
under certain circumstances. Each party will be responsible for the costs of training, maintaining
and operating its own sales force, and we are responsible for all other costs pertaining to the
commercialization of Silenor. The term of the agreement is from August 2010 through December 2012,
and we will pay P&G a reduced royalty fee based on U.S. net sales of Silenor for one year after the
expiration of the agreement or its earlier termination under certain circumstances. Beginning as of
June 30, 2012, the parties will discuss in good faith the continuation of the collaboration upon
mutually-agreed terms and conditions. We have the right to terminate the agreement upon 90 days
written notice if P&G fails to provide at least 75% of its minimum detailing obligations. Beginning
October 1, 2011, P&G may cure such shortfall for a calendar quarter one time each calendar year
during the calendar quarter immediately following such shortfall. Either party may terminate the
agreement upon 90 days written notice to the other party, although no such termination may be
effective prior to December 31, 2011. P&G may terminate the agreement if Silenor is withdrawn from
the market for longer than three months as the result of a legal requirement or 30 days after the
end of a calendar quarter in which the market share for Silenor is less than 75% of the Silenor
market share immediately prior to the loss of Silenors market exclusivity in the U.S. In addition,
either party may terminate the agreement upon a large scale recall or withdrawal of Silenor from
the U.S. resulting from a significant safety risk that is not due to tampering, a remediable
manufacturing problem or other defect that can be cured after such risk is discovered. Either party
may also terminate the agreement upon an uncured material breach by the other party, upon the
bankruptcy or insolvency of the other party or a force majeure event that lasts for at least six
months.
Comerica Bank (Comerica). On February 7, 2011, we entered into a loan agreement with
Comerica, pursuant to which we may request advances in an aggregate outstanding amount not to
exceed $15.0 million. The revolving loan bears interest at a variable rate of interest, per annum,
at our option of either LIBOR plus 3.00% or Comericas prime rate plus 0.50%. Interest payments on
advances made under the loan agreement are due and payable in arrears on the first business day of
each month during the term of the loan agreement. Amounts borrowed under the loan agreement may be
repaid and re-borrowed at any time prior to February 7, 2013, subject to certain conditions. Once
we have two consecutive quarters of profitability, the amounts we borrow are limited to a
percentage of our accounts receivable. There is a non-refundable unused commitment fee equal to
0.25% per annum on the difference between the amount of the revolving line and the average daily
balance outstanding thereunder during the term of the loan agreement, payable quarterly in arrears.
The loan agreement will remain in full force and effect for so long as any obligations remain
outstanding or Comerica has any obligation to make credit extensions under the loan agreement.
Amounts borrowed under the loan agreement are secured by substantially all of our personal
property, excluding intellectual property. Under the loan agreement, we are subject to certain
affirmative and negative covenants, including limitations on our ability to: undergo certain change
of control events; convey, sell, lease, license, transfer or otherwise dispose of assets, other
than in certain specified circumstances; create, incur, assume, guarantee or be liable with respect
to certain indebtedness; grant liens; pay dividends and make certain other restricted payments; and
make certain investments. In addition, under the loan agreement, we are required to maintain a cash
balance with Comerica in an amount of not less than $5.0 million and to maintain 50% of any other
cash balances with Comerica and any other cash or investments must be covered by a control
agreement for the benefit of Comerica. We are also subject to specified financial covenants with
respect to a minimum liquidity ratio and, once we have two consecutive quarters of profitability,
minimum EBITDA requirements. We met all of our obligations under the loan agreement. This agreement
was terminated on July 28, 2011 in connection with our new loan and security agreement with the
Lenders as discussed below in Note 9. Subsequent Events.
Other Commitments. We have contracted with various consultants, drug manufacturers,
wholesalers, and other vendors to assist in clinical trial work, data analysis, and
commercialization activities for Silenor. The contracts are terminable at any time, but obligate us
to reimburse the providers for any time or costs incurred through the date of termination. We have
employment agreements with certain of our current employees that provide for severance payments and
accelerated vesting for certain share-based awards if their employment is terminated under
specified circumstances.
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Lease
In May 2011, we entered into a new lease arrangement to rent approximately 12,100 square feet
of office space, which we plan to use as our new corporate headquarters. The lease will commence on
the date that the premises are delivered to us after tenant improvements have been completed, which
has not occurred as of June 30, 2011. The lease will expire 64 months after the date that the lease
term commences, and we will have the option to extend the term for an additional five years at the
then-current fair market rental rate (as defined in the lease).
We have paid the first months rent of approximately $30,000 and the monthly rent following
lease commencement will be approximately $30,000. However, the second through thirteenth months
rent will be abated by one-half, provided that we are not in default of the lease. After the first
year, the monthly rent will increase by 3.5% per year. We also have a $200,000 letter of credit in
favor of our landlord to secure our obligations under the lease.
Litigation
We have received notices from each of Actavis Elizabeth LLC and Actavis Inc. (collectively,
Actavis), Mylan Pharmaceuticals Inc. and Mylan, Inc. (collectively, Mylan), Par Pharmaceutical,
Inc. and Par Pharmaceutical Companies, Inc. (collectively, Par), and Zydus Pharmaceuticals USA,
Inc. and Cadila Healthcare Limited (d/b/a Zydus Cadila) (collectively, Zydus) that each has filed
with the FDA an Abbreviated New Drug Application (ANDA) for a generic version of Silenor 3 mg and
6 mg tablets. The notices included paragraph IV certifications with respect to eight of the nine
patents listed in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations,
commonly known as the Orange Book, for Silenor. A paragraph IV certification is a certification by
a generic applicant that in the opinion of that applicant, the patent(s) listed in the Orange Book
for a branded product are invalid, unenforceable, and/or will not be infringed by the manufacture,
use or sale of the generic product.
We, together with ProCom, have filed suit in the United States District Court for the District
of Delaware against each of Actavis, Mylan, Par and Zydus. The lawsuits allege that each of
Actavis, Mylan, Par and Zydus have infringed U.S. Patent No. 6,211,229 (the 229 patent) by
seeking approval from the FDA to market generic versions of Silenor 3 mg and 6 mg tablets prior to
the expiration of this patent.
In addition, we have filed suit in the United States District Court for the District of
Delaware against each of Actavis, Mylan, Par and Zydus alleging that such parties have infringed
U.S. Patent No. 7,915,307 (the 307 patent) by seeking approval from the FDA to market generic
versions of Silenor 3 mg and 6 mg tablets prior to the expiration of this patent.
Pursuant to the provisions of the Hatch-Waxman Act, FDA final approval of the Actavis and
Mylan ANDAs can occur no earlier than May 3, 2013, FDA final approval of the Par ANDA can occur no
earlier than June 23, 2013 and FDA final approval of the Zydus ANDA can occur no earlier than
November 13, 2013, unless in each case there is an earlier court decision that the 229 patent and
the 307 patent are not infringed and/or invalid or unless any party to the action is found to have
failed to cooperate reasonably to expedite the infringement action.
At this time, the other patents included in Orange Book have not been asserted against these
parties.
We intend to vigorously enforce our intellectual property rights relating to Silenor, but
cannot predict the outcome of these matters.
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Note 7. Share-based Compensation and Equity
Share-based Compensation Expense
Somaxon has restricted stock units (RSUs) and stock options outstanding under its equity
incentive award plans. Share-based expense for employees and directors is based on the grant-date
fair value of the award. The following table summarizes non-cash share-based compensation expense
(in thousands).
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
Composition of share-based compensation expense: | 2011 | 2010 | 2011 | 2010 | ||||||||||||
Included in research and development expense |
$ | 148 | $ | 209 | $ | 294 | $ | 760 | ||||||||
Included in selling, general and administrative expense |
1,245 | 1,136 | 2,294 | 2,765 | ||||||||||||
Total share-based compensation expense |
$ | 1,393 | $ | 1,345 | $ | 2,588 | $ | 3,525 | ||||||||
Certain of our share-based awards will vest upon the achievement of performance conditions.
Compensation expense for share-based awards granted to employees and directors is recognized based
on the grant date fair value for the portion of the awards for which performance conditions are
considered probable of being achieved. Such expense is recorded over the period the performance
condition is expected to be performed. No expense is recognized for awards with performance
conditions that are considered improbable of being achieved. On March 18, 2010, the FDA notified us
that it approved our NDA for Silenor 3 mg and 6 mg tablets. FDA approval of the Silenor NDA caused
105,000 shares of restricted stock to vest, 129,000 RSUs to vest, and 275,000 stock options to
vest. The Company recognized an aggregate of $1,384,000 of share-based compensation expense during
the first quarter of 2010 from the vesting of these awards.
Included in these tables for 2010 is the effect of a modification of the option agreements
with certain terminated employees as a result of an extension of the term of their post-employment
consulting agreements. We recognized $233,000 of share-based compensation expense during 2010 as a
result of this modification.
Equity
In June 2011, we entered into agreements with Paladin pursuant to which Paladin purchased
2,184,769 shares of our common stock for an aggregate purchase price of $5.0 million (see Note 5,
License Agreements) in a private placement pursuant to Rule 506 of the Securities Act of 1933, as
amended.
Note 8. Related Party Transaction
We have in-licensed certain intellectual property from ProCom (see Note 5, License
Agreements). In March 2010, we paid $1.0 million to ProCom pursuant to the terms of this
agreement. During 2011, we recognized in costs of sales $470,000 of ProCom royalty payments in
connection with this arrangement. At June 30, 2011, $196,000 is recorded in accrued liabilities for
ProCom royalty payments. As part of the in-license agreement, ProCom has the right to designate one
nominee for election to our board of directors (Terrell Cobb, a principal of ProCom).
Note 9. Subsequent Events
On
August 1, 2011, we entered into an at-the-market equity sales agreement with Citadel (the
Sales Agreement) pursuant to which we may sell, at our option, up to an aggregate of $30.0
million in shares of our common stock through Citadel, as sales agent. Sales of the common stock
made pursuant to the Sales Agreement, if any, will be made on the NASDAQ Stock Market under our
currently-effective Registration Statements on Form S-3 by means of ordinary brokers transactions
at then-prevailing market prices. Additionally, under the terms of the Sales Agreement, we may also
sell shares of our common stock through Citadel, on the NASDAQ Stock Market or otherwise, at
negotiated prices or at prices related to the prevailing market price. Under the terms of the Sales
Agreement, we may also sell shares to Citadel as principal for Citadels own account at a price
agreed upon at the time of sale pursuant to a separate terms agreement to be entered into with
Citadel at such time. We will pay Citadel a commission equal to 3% of the gross proceeds from the
sale of shares of our common stock under the Sales Agreement. The offering of common stock pursuant
to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the common stock
subject to the Sales Agreement or (b) the termination of the Sales Agreement by us or Citadel.
Either party may terminate the Sales Agreement in its sole discretion at any time upon written
notice to the other party.
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On July 28, 2011, we terminated our existing loan agreement with Comerica Bank and on August
2, 2011, we entered into a new loan and security agreement (the Loan Agreement) with the Lenders
pursuant to which the Lenders made to us a term loan in the principal amount of $15.0 million. The
term loan bears interest at 7.5% per annum. We are obligated to pay interest on the loan through
December 31, 2011, and to thereafter pay the principal balance of the loan and interest in
24 equal monthly installments through December 31, 2013. At our option, we may prepay all or
any part of the outstanding principal balance, subject to a pre-payment fee of $150,000. We will be
required to repay the entire outstanding principal balance if a generic version of Silenor enters
the market while the loan is outstanding. We paid to the Lenders an initial fee of $150,000 upon
the closing of the term loan. In the event of the final payment of the loan, either through
repayment of the loan in full at maturity or upon any pre-payment, we are required to pay a final
payment fee of $637,500. In connection with the Loan Agreement, we granted the Lenders a security
interest in substantially all of our personal property now owned or hereafter acquired, excluding
intellectual property. Under the Loan Agreement, we are subject to certain affirmative and negative
covenants, including limitations on our ability to: undergo certain change of control events;
convey, sell, lease, license, transfer or otherwise dispose of assets, other than in certain
specified circumstances; create, incur, assume, guarantee or be liable with respect to certain
indebtedness; grant liens; pay dividends and make certain other restricted payments; and make
certain investments. In addition, under the Loan Agreement, subject to certain exceptions, we are
required to maintain with SVB our primary cash and investment accounts, which accounts are also
covered by control agreements for the benefit of the Lenders. We have currently met all of our
obligations under the loan agreement. We are also required to maintain the Sales Agreement unless
we raise at least $30 million in equity proceeds.
As
part of the financing, the Lenders received warrants to purchase up
to an aggregate of 583,152
fully paid and non-assessable shares of our common stock at an
exercise price equal to $1.5433 per
share. The warrants will expire ten years from the date of the grant.
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Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
The interim financial statements and this Managements Discussion and Analysis of Financial
Condition and Results of Operations should be read in conjunction with the financial statements and
notes thereto for the year ended December 31, 2010, and the related Managements Discussion and
Analysis of Financial Condition and Results of Operations, both of which are contained in our
Annual Report on Form 10-K for the year ended December 31, 2010. In addition to historical
information, this discussion and analysis contains forward-looking statements that involve risks,
uncertainties, and assumptions. Our actual results may differ materially from those anticipated in
these forward-looking statements as a result of certain factors, including but not limited to those
set forth under the caption Risk Factors in our Annual Report on Form 10-K for the year ended
December 31, 2010 and the caption Risk Factors in this Quarterly Report on Form 10-Q for the
quarter ended June 30, 2011.
Overview
Background
We are 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. In March 2010, the U.S.
Food and Drug Administration, or FDA, approved our New Drug Application, or NDA, for Silenor 3 mg
and 6 mg tablets for the treatment of insomnia characterized by difficulty with sleep maintenance.
Silenor was made commercially available by prescription in the United States in September 2010.
Our principal focus is on commercial activities relating to Silenor. We have increased our
headcount from 5 employees as of March 2010 to 44 employees as of July 15, 2011. We commercially
launched Silenor in September 2010 with 110 sales representatives provided to us on an exclusive
basis under our contract sales agreement with Publicis Touchpoint Solutions, Inc., or Publicis, and
an additional 105 sales representatives provided to us under our co-promotion agreement with
Procter and Gamble, or P&G. In February 2011, we engaged Publicis to provide us with an additional
35 sales representatives that were fully deployed as of early April 2011. We have also established
the manufacturing and distribution channel for Silenor through agreements with third-party
suppliers and service providers, and we have established reimbursement coverage for Silenor with
numerous private and government payors. In June 2011, we entered into agreements with Paladin Labs
Inc., or Paladin, under which Paladin will commercialize Silenor in Canada, South America, the
Caribbean and Africa.
Critical Accounting Policies and Estimates
Managements discussion and analysis of our financial condition and results of operations is
based on our condensed financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of these condensed financial
statements requires us to make estimates and assumptions that affect the reported amounts of
assets, liabilities, expenses and related disclosures. Actual results could differ from those
estimates. We believe the following accounting policies to be critical to the judgments and
estimates used in the preparation of our condensed financial statements.
Revenue Recognition
Product Sales
We sell Silenor to wholesale pharmaceutical distributors. Our returned goods policy generally
permits our customers to return products up to six months before and up to twelve months after the
expiration date of the product. We authorize returns for expired products in accordance with our
returned goods policy and issue credit to our customers for expired returned product. We do not
exchange product from inventory for returned product. As of June 30, 2011, the dollar amount of
returns received in 2011 has been negligible.
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We recognize product revenue from product sales when it is realized or realizable and earned.
Revenue is realized or realizable and earned when all of the following criteria are met: (1)
persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been
rendered; (3) our price to the buyer is fixed or determinable; and (4) collectability is reasonably
assured. Revenue from sales transactions where the buyer has the right to return the product is
recognized at the time of sale only if (1) our price to the buyer is substantially fixed or
determinable at the date of sale, (2) the buyer has paid us, or the buyer is obligated to pay us
and the obligation is not contingent on resale of the product, (3) the buyers obligation to us
would not be changed in the event of theft or physical destruction or damage of the product, (4)
the buyer acquiring the product for resale has economic substance apart from that provided by us,
(5) we do not have significant obligations for future performance to directly bring about resale of
the product by the buyer, and (6) the amount of future returns can be reasonably estimated.
Prior to the second quarter of 2011, we were unable to reasonably estimate returns. We
therefore deferred revenue recognition until the right of return no longer existed, which was the
earlier of Silenor being dispensed through patient prescriptions or the expiration of the right of
return. We estimated patient prescriptions dispensed using an analysis of third-party information.
In order to develop a methodology to reliably estimate product returns and provide a basis for
recognizing revenue on sales to customers at the time of product shipment, we analyzed many
factors, including, without limitation, industry data regarding product return rates, and tracked
the Silenor product return history, taking into account product expiration dating at the time of
shipment and levels of inventory in the wholesale channel compared to prescription units dispensed
and the sell-down of our launch inventory. During the second quarter of 2011, the sell-down of our
launch inventory was completed, which we believe demonstrates sufficient market acceptance of our
product for purposes of our revenue recognition analysis. In addition, since product launch, we
have sold product to wholesale pharmaceutical distributors at standard commercial terms utilized in
the industry. As a result, we believe we can analogize to industry data regarding product return
rates. Based on the sell-down of our launch inventory and the industry and internal data gathered,
we believe we have the information needed to reasonably estimate product returns. As a result, in
the second quarter of 2011, we began recognizing revenue for Silenor sales at the time of delivery
of the product to wholesale pharmaceutical distributors and our other customers.
License and Royalty Revenue
In June 2011, we entered into a license agreement with Paladin. Under the license agreement,
Paladin will commercialize Silenor in Canada, South America, the Caribbean and Africa. We received
an upfront payment of $500,000 in connection with the execution of this agreement. We recorded the
upfront payment as deferred revenue and are recognizing the upfront payment as license revenue over
the period of our significant involvement under the agreement, which we are estimating to be 15
years. As of June 30, 2011, the deferred revenue balance associated with the license agreement is
$497,000. We recognized $3,000 as revenue during each of the three and six months ended June 30,
2011 which is recorded in other income and expense.
Once Silenor is commercialized in the licensed territories, we will 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. Due to the uncertainty surrounding the achievement of
these future sales-based milestones and royalties, these potential payments will not be recognized
as revenue until they are realized and earned.
Product Sales Discounts and Allowances
We record product sales discounts and allowances at the time of sale and report revenue net of
such amounts in the same period that product sales are recorded. In determining the amount of
product sales discounts and allowances, we must make significant judgments and estimates. If
actual results vary from our estimates, we may need to adjust these estimates, which could have an
effect on product revenue in the period of adjustment. Our product sales discounts and allowances
and the specific considerations we use in estimating these amounts include:
Prompt Pay Discounts. As an incentive for prompt payment, we offer a 2% cash discount to
customers. We expect that all customers will comply with the contractual terms to earn the
discount. We record the discount as an allowance against accounts receivable and a corresponding
reduction of revenue. At June 30, 2011 and December 31, 2010, the allowance for prompt pay
discounts was $40,000 and $114,000, respectively.
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Patient Discount Programs. We offer discount programs to patients of Silenor under which the
patient receives a discount on his or her prescription. We reimburse pharmacies for these
discounts through third-party vendors. We estimate the total amount that will be redeemed based on
the dollar amount of the discounts, the timing and quantity of distribution and historical
redemption rates. We accrue the discounts and recognize a corresponding reduction of revenue. At
June 30, 2011 and December 31, 2010, the accrual for patient discount programs was $376,000 and
$182,000, respectively.
Distribution Service Fees. We pay distribution services fees to each wholesaler for
distribution and inventory management services. We accrue for these fees based on contractually
defined terms with each wholesaler and recognize a corresponding reduction of revenue. At June 30,
2011 and December 31, 2010, the accrual for distribution service fees was $240,000 and $276,000,
respectively.
Chargebacks. We provide discounts to federal government qualified entities with whom we have
contracted. These federal entities purchase products from the wholesalers at a discounted price,
and the wholesalers then charge back to us the difference between the current retail price and the
contracted price the federal entity paid for the product. We accrue chargebacks based on contract
prices and sell-through sales data obtained from third party information. At June 30, 2011 and
December 31, 2010, the accrual for chargebacks was $13,000 and $9,000, respectively.
Rebates. We participate in certain rebate programs, which provide discounted prescriptions to
qualified insured patients. Under these rebate programs, we pay a rebate to the third-party
administrator of the program. We accrue rebates based on contract prices, estimated percentages of
product sold to qualified patients and estimated levels of inventory in the distribution channel.
At June 30, 2011 and December 31, 2010, the accrual for rebates was $536,000 and $6,000,
respectively.
Product Returns. We estimate future product returns based upon actual returns history,
analysis of product expiration dating, estimated inventory levels in the distribution channel, and
industry data regarding product return rates for similar products. There may be a significant time
lag between the date we determine the estimated allowance and when we receive product returns and
issue credits to customers. Due to this time lag, we may record adjustments to our estimated
allowance over several periods, which would impact our operating results in those periods. At June
30, 2011, the allowance for product returns was $85,000.
As we expand our managed care rebate programs and discount programs to offset patients out of
pocket costs, we expect product sales discounts and allowances to increase.
The following table summarizes the activity for the six months ended June 30, 2011 associated
with product sales discounts and allowances, with amounts shown in thousands. From the initial
launch of Silenor through September 30, 2010, we offered additional discounts to wholesale
distributors for product purchased. At June 30, 2011 and December 31, 2010, the allowance for
product launch discounts was $0 and $277,000, respectively.
Total | ||||||||||||||||||||||||
Accrued | ||||||||||||||||||||||||
Sales | ||||||||||||||||||||||||
Prompt | Patient | Charge- | Discounts | |||||||||||||||||||||
Pay | Discount | Distribution | backs and | Product | and | |||||||||||||||||||
Discounts | Fees | Service Fees | Rebates | Returns | Allowances | |||||||||||||||||||
Balance at January 1, 2011 |
$ | 114 | $ | 182 | $ | 276 | $ | 15 | $ | | $ | 587 | ||||||||||||
Provision made for sales during period |
137 | 435 | 448 | 627 | 85 | 1,732 | ||||||||||||||||||
Payments |
(211 | ) | (241 | ) | (484 | ) | (93 | ) | | (1,029 | ) | |||||||||||||
Balance at June 30, 2011 |
$ | 40 | $ | 376 | $ | 240 | $ | 549 | $ | 85 | $ | 1,290 | ||||||||||||
Cost of Sales
Cost of sales includes the costs to manufacture, package, and ship Silenor, including
personnel costs associated with manufacturing oversight, as well as royalties and amortization of
capitalized license fees associated with our license agreement with ProCom One, Inc., or ProCom.
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Inventory
Our inventories are valued at the lower of weighted average cost or net realizable value. We
analyze our inventory levels quarterly and write down inventory that has become obsolete, or has a
cost basis in excess of its expected net realizable value, as well as any inventory quantities in
excess of expected requirements. Expired inventory is disposed of and the related costs are written
off.
Capitalized License Fees
License fees related to our intellectual property are capitalized once technological
feasibility has been established. Determining when technological feasibility has been achieved, and
determining the related amortization period for capitalized intellectual property, requires the use
of estimates and subjective judgment. Costs incurred to in-license our product candidates
subsequent to FDA approval of our NDA for Silenor have been capitalized and recorded as an
intangible asset. Capitalized amounts are amortized on a straight line basis over approximately ten
years.
Share-based Compensation
Share-based compensation expense for employees and directors is recognized in the statement of
operations based on estimated amounts, including the grant date fair value, the probability of
achieving performance conditions and the expected service period for awards with conditional
vesting provisions. For stock options, we estimate the grant date fair value using the
Black-Scholes valuation model which requires the use of multiple subjective inputs including an
estimate of future volatility, expected forfeitures and the expected terms of the awards. Our stock
did not have a readily available market prior to our initial public offering in December 2005,
creating a relatively short history from which to obtain data to estimate volatility for our stock
price. Consequently, we estimate our expected future volatility based on a combination of both
comparable companies and our own stock price volatility to the extent such history is available.
Our future volatility may differ from our estimated volatility at the grant date. We estimate the
expected term of our options using guidance provided by the Securities and Exchange Commission, or
SEC, in Staff Accounting Bulletin, or SAB, No. 107 and SAB No. 110. This guidance provides a
formula-driven approach for determining the expected term. Share-based compensation recorded in our
statement of operations is based on awards expected to ultimately vest and has been reduced for
estimated forfeitures. Our estimated forfeiture rates may differ from actual forfeiture rates which
would affect the amount of expense recognized during the period. Estimated forfeitures are adjusted
to actual amounts as they become known.
We recognize the value of the portion of the awards that are expected to vest on a
straight-line basis over the awards requisite service periods. The requisite service period is
generally the time over which our share-based awards vest. Some of our share-based awards vested
upon achieving certain performance conditions, generally pertaining to the commercial performance
of Silenor or the achievement of other strategic objectives. Share-based compensation expense for
awards with performance conditions is recognized over the period from the date the performance
condition is determined to be probable of occurring through the time the applicable condition is
met. If the performance condition is not considered probable of being achieved, then no expense is
recognized until such time the performance condition is considered probable of being met. At that
time, expense is recognized over the period during which the performance condition is likely to be
achieved. Determining the likelihood and timing of achieving performance conditions is a
subjective judgment made by management which may affect the amount and timing of expense related to
these share-based awards. Share-based compensation is adjusted to reflect the value of options
which ultimately vest as such amounts become known in future periods. As a result of these
subjective and forward-looking estimates, the actual value of our stock options realized upon
exercise could differ significantly from those amounts recorded in our financial statements.
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Results of Operations
Comparisons of the Three Months Ended June 30, 2011 and 2010
Product Sales. Product sales represent sales of Silenor for which we have recognized revenue.
Net product sales for 2011 and 2010 are summarized in the following table (in thousands, except
percentages).
Three Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Gross product sales |
$ | 8,234 | $ | | $ | 8,234 | N/A | |||||||||
Discounts and allowances |
(1,992 | ) | | (1,992 | ) | N/A | ||||||||||
Total net product sales |
$ | 6,242 | $ | | $ | 6,242 | N/A | |||||||||
We recognized net product sales of $6.2 million for the three months ended June 30, 2011 and
had no product sales for the comparable period in 2010 as sales of Silenor commenced in the third
quarter of 2010. Reductions from gross to net product sales, which include allowances for
discounts, patient discount programs, distribution service fees, chargebacks, rebates and returns,
totaled $2.0 million for the three months ended June 30, 2011, compared to $0 in the same period in
2010. As a percentage of gross sales, the reductions were 24.2% for the three months ended June 30,
2011. As a result of recognizing revenue upon delivery to our wholesale customers, we recognized
additional net product sales of Silenor of $3.2 million.
Cost of Sales. Cost of sales includes the costs to manufacture, package, and ship Silenor,
including personnel costs associated with manufacturing oversight, as well as royalties and
amortization of capitalized license fees associated with our license agreement. Cost of sales for
2011 and 2010 are summarized in the following table (in thousands, except percentages).
Three Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Cost of sales |
$ | 661 | $ | | $ | 661 | N/A | |||||||||
We recognized cost of sales of $0.7 million for the three months ended June 30, 2011 relating
to product with respect to which revenue was recognized. We had no cost of sales for the
comparable period in 2010 as sales of Silenor commenced in the third quarter of 2010. Gross profit
was $5.6 million for the three months ended June 30, 2011. Expressed as a percentage of net
product sales, gross margin was 89.4% for the three months ended June 30, 2011.
Selling, General and Administrative Expense. Our selling, general and administrative expenses
consist primarily of salaries, benefits, share-based compensation expense, advertising and market
research costs, insurance and facility costs, and professional fees related to our marketing,
administrative, finance, human resources, legal and internal systems support functions. Selling,
general and administrative expense for 2011 and 2010 are summarized in the following tables (in
thousands, except percentages).
Three Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Sales and marketing |
$ | 14,849 | $ | 2,196 | $ | 12,653 | 576 | % | ||||||||
General and administrative |
5,224 | 2,706 | 2,518 | 93 | % | |||||||||||
Total selling, general and administrative expense |
$ | 20,073 | $ | 4,902 | $ | 15,171 | 309 | % | ||||||||
Selling and marketing expenses totaled $14.8 million and $2.2 million for the three months
ended June 30, 2011 and 2010, respectively. Of this, share-based compensation expense totaled $0.4
million and $0.2 million for the three months ended June 30, 2011 and the comparable period in
2010, respectively. The net increase of $12.6 million was due to the costs associated with the
commercial activities of Silenor. These costs included the costs of our sales representatives,
royalties paid to our co-promotion partner, personnel costs and other promotional spending and
consulting costs.
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General and administrative expenses totaled $5.2 million and $2.7 million for the three
months ended June 30, 2011 and 2010, respectively. Of this, share-based compensation expense
totaled $0.8 million and $0.9 million for the three months ended June 30, 2011 and 2010,
respectively. The net increase of $2.5 million was primarily due to an increase in salary and
benefits expense resulting from an increase in overall headcount during the three months ended June
30, 2011 compared to the comparable period in 2010.
Research and Development Expense. Our most significant research and development costs during
the three months ended June 30, 2011 were salaries, benefits and share-based compensation expense
related to our research and development personnel. Research and development expense for 2011 and
2010 are summarized in the following table (in thousands, except percentages).
Three Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Personnel and other costs |
$ | 309 | $ | 605 | $ | (296 | ) | (49 | )% | |||||||
Share-based compensation expense |
148 | 209 | (61 | ) | (29 | )% | ||||||||||
Total research and development expense |
$ | 457 | $ | 814 | $ | (357 | ) | (44 | )% | |||||||
Research and development expense decreased $0.4 million for the three months ended June 30,
2011 compared to the same period in 2010 primarily due to lower personnel and other costs.
Personnel and other costs attributable to research and development personnel decreased due to the
commercial launch of Silenor in September 2010.
Comparisons of the Six Months Ended June 30, 2011 and 2010
Product Sales. Product sales represent sales of Silenor for which we have recognized revenue.
Net product sales for 2011 and 2010 are summarized in the following table (in thousands, except
percentages).
Six Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Gross product sales |
$ | 11,112 | $ | | $ | 11,112 | N/A | |||||||||
Discounts and allowances |
(2,548 | ) | | (2,548 | ) | N/A | ||||||||||
Total net product sales |
$ | 8,564 | $ | | $ | 8,564 | N/A | |||||||||
We recognized net product sales of $8.6 million for the six months ended June 30, 2011 and had
no product sales for the comparable period in 2010 as sales of Silenor commenced in the third
quarter of 2010. Reductions from gross to net product sales, which include allowances for
discounts, patient discount programs, distribution service fees, chargebacks, rebates and returns,
totaled $2.5 million for the six months ended June 30, 2011, compared to $0 in the same period in
2010. As a percentage of gross sales, the reductions were 22.9% for the six months ended June 30,
2011. As a result of recognizing revenue upon delivery to our wholesale customers, in the second
quarter of 2011 we recognized additional net product sales of Silenor
of $3.2 million.
Cost of Sales. Cost of sales includes the costs to manufacture, package, and ship Silenor,
including personnel costs associated with manufacturing oversight, as well as royalties and
amortization of capitalized license fees associated with our license agreement. Cost of sales for
2011 and 2010 are summarized in the following table (in thousands, except percentages).
Six Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Cost of sales |
$ | 1,024 | $ | | $ | 1,024 | N/A | |||||||||
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We recognized cost of sales of $1.0 million for the six months ended June 30, 2011 relating to
product with respect to which revenue was recognized. We had no cost of sales for the comparable
period in 2010 as sales of Silenor commenced in the third quarter of 2010. Gross profit was $7.5
million for the six months ended June 30, 2011. Expressed as a percentage of net product sales,
gross margin was 88.0% for the six months ended June 30, 2011.
Selling, General and Administrative Expense. Our selling, general and administrative expenses
consist primarily of salaries, benefits, share-based compensation expense, advertising and market
research costs, insurance and facility costs, and professional fees related to our marketing,
administrative, finance, human resources, legal and internal systems support functions. Selling,
general and administrative expense for 2011 and 2010 are summarized in the following tables (in
thousands, except percentages).
Six Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Sales and marketing |
$ | 28,358 | $ | 2,982 | $ | 25,376 | 851 | % | ||||||||
General and administrative |
10,308 | 4,972 | 5,336 | 107 | % | |||||||||||
Total selling, general and administrative expense |
$ | 38,666 | $ | 7,954 | $ | 30,712 | 386 | % | ||||||||
Selling and marketing expenses totaled $28.4 million and $3.0 million for the six months ended
June 30, 2011 and 2010, respectively. Of this, share-based compensation expense totaled $0.7
million and $0.6 million for the six months ended June 30, 2011 and the comparable period in 2010,
respectively. The net increase of $25.4 million was due to the costs associated with the
commercial activities of Silenor. These costs included the costs of our sales representatives,
royalties paid to our co-promotion partner, personnel costs and other promotional spending and
consulting costs.
General and administrative expenses totaled $10.3 million and $5.0 million for the six months
ended June 30, 2011 and 2010, respectively. Of this, share-based compensation expense totaled $1.6
million and $2.2 million for the six months ended June 30, 2011 and 2010, respectively. The net
increase of $5.3 million was primarily due to an increase in salary and benefits expense resulting
from an increase in overall headcount during the six months ended June 30, 2011 compared to the
comparable period in 2010. This was offset by a decrease in share-based compensation expense due
to higher share-based compensation expense during the six months ended June 30, 2010 as a result of
vesting of performance-based equity awards upon FDA approval of the NDA for Silenor.
Research and Development Expense. Our most significant research and development costs during
the six months ended June 30, 2011 were salaries, benefits and share-based compensation expense
related to our research and development personnel. Research and development expense for 2011 and
2010 are summarized in the following table (in thousands, except percentages).
Six Months Ended | ||||||||||||||||
June 30, | Change | |||||||||||||||
2011 | 2010 | Dollar | Percent | |||||||||||||
Personnel and other costs |
$ | 582 | $ | 1,167 | $ | (585 | ) | (50 | )% | |||||||
Share-based compensation expense |
294 | 760 | (466 | ) | (61 | )% | ||||||||||
Total research and development expense |
$ | 876 | $ | 1,927 | $ | (1,051 | ) | (55 | )% | |||||||
Research and development expense decreased $1.1 million for the six months ended June 30,
2011 compared to the same period in 2010 primarily due to lower personnel and other costs and
share-based compensation expense. Personnel and other costs attributable to research and
development personnel decreased due to the commercial launch of Silenor in September 2010.
Share-based compensation expense attributable to research and development personnel
decreased due to recognition of compensation costs associated with the vesting of
performance-based equity awards upon FDA approval of the NDA for Silenor in the first half of 2010.
Liquidity and Capital Resources
We expect to continue to incur losses and have negative cash flows from operations in the
foreseeable future as we continue our commercial activities for Silenor, commercialize any other
products to which we obtain rights and potentially pursue the development of other product
candidates. As a result, we may need to obtain additional funds to finance our operations in the
future. Until we can generate significant cash from our operations, we intend to obtain any
additional funding we require through strategic relationships, public or private equity or debt
financings, assigning receivables or royalty rights, or other arrangements and we cannot assure
such funding will be available on reasonable terms, or at all.
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As of June 30, 2011, we had $30.9 million in cash, cash equivalents and short-term
investments. We have received $14.9 million in net proceeds pursuant to a loan and security
agreement with Silicon Valley Bank, or SVB, and Oxford Finance LLC, or together with SVB, the Lenders.
We believe we have sufficient financial resources to fund our operations for at least the next
twelve months. We may need to obtain additional funds to finance our operations, particularly if
we are unable to access adequate or timely funds under our at-the-market equity sales agreement
with Citadel Securities LLC, or Citadel. Actual financial results for the period of time through
which our financial resources will be adequate to support our operations could vary based upon many
factors, including but not limited to the rate of growth of Silenor sales, the actual cost of
commercial activities and any potential litigation expenses we may incur.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
| our success in generating cash flows from the commercialization of Silenor, together with our co-promotion partner P&G and our licensee Paladin; |
| the costs of establishing or contracting for commercial programs and resources; |
| the terms and timing of any future collaborative, licensing and other arrangements that we may establish; |
| the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
| the extent to which we acquire or in-license new products, technologies or businesses; |
| the rate of progress and cost of our non-clinical studies, clinical trials and other development activities; |
| the scope, prioritization and number of development programs we pursue; and |
| the effect of competing technological and market developments. |
If our efforts in raising additional funds when needed are unsuccessful, we may be required to
delay, scale-back or eliminate plans or programs relating to our business, relinquish some or all
rights to Silenor or renegotiate less favorable terms with respect to such rights than we would
otherwise choose or cease operating as a going concern. In addition, if we do not meet our payment
obligations to third parties as they come due, we may be subject to litigation claims. Even if we
were successful in defending against these claims, litigation could result in substantial costs and
be a distraction to management, and may result in unfavorable results that could further adversely
impact our financial condition.
If we are unable to continue as a going concern, we may have to liquidate our assets and may
receive less than the value at which those assets are carried on our financial statements, and it
is likely that investors will lose all or a part of their investments. These financial statements do
not include any adjustments that might result from the outcome of this uncertainty.
We have invested a substantial portion of our available cash in marketable securities and
money market funds. The capital markets have recently been highly volatile and there has been a
lack of liquidity for certain financial instruments, especially those with exposure to
mortgage-backed securities and auction rate securities. All of our investments in marketable
securities and money market funds are highly rated, highly liquid securities with readily
determinable fair values. As of June 30, 2011, none of our securities are considered to be
impaired.
We have two effective shelf registration statements on Form S-3 filed with the SEC under which
we may offer from time to time up to an aggregate of approximately $67.1 million in any combination
of debt securities, common and preferred stock and warrants. These registration statements could
allow us to seek additional financing, subject to the SECs rules and regulations relating to
eligibility to use Form S-3. Additional equity financing will be dilutive to stockholders, and
debt financing, if available, may involve restrictive covenants.
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Cash Flows
Net cash used in operating activities was $28.4 million for the six months ended June 30,
2011, compared to $5.7 million for the same period in 2010. The increase in net cash used in
operating activities was primarily due to an increase in our net loss in 2011 as compared to the
prior year.
Net cash provided by investing activities was $30.8 million for the six months ended June 30,
2011, compared to net cash used in investing activities of $1.1 million for the same period in
2010. Results for 2011 reflect net sales and maturities of marketable securities of $31.3 million
and payments for property and equipment of $0.3 million. Results for 2010 reflect a $1.0 million
milestone payment to ProCom under our license agreement which became due as a result of the
approval by the FDA of our NDA for Silenor.
Net cash provided by financing activities was $5.0 million for the six months ended June 30,
2011, compared to net cash provided by financing activities of $56.1 million for the same period in
2010. Results for 2011 reflect proceeds of $5.0 million received from Paladin from the sale by us
of 2.2 million shares of our common stock. Results for 2010 reflect cash proceeds of $52.7 million
from our follow-on offering and proceeds of $3.4 million from the exercise of warrants and stock
options.
Loan Agreement
On July 28, 2011, we terminated our existing loan agreement with Comerica Bank and we entered
into a new loan and security agreement with the Lenders, pursuant to which the Lenders made us a
term loan in the principal amount of $15.0 million. The term loan bears interest at 7.5% per annum.
We are obligated to pay interest on the loan through December 31, 2011, and to thereafter pay the
principal balance of the loan and interest in 24 equal monthly installments starting on January 1,
2012 and continuing through December 31, 2013. At our option, we may prepay all or any part of
the outstanding principal balance, subject to a pre-payment fee of $150,000. We will be required
to repay the entire outstanding principal balance if a generic version of Silenor enters the market
while the loan is outstanding. We paid to the Lenders an initial fee of $150,000 upon the closing
of the term loan. In the event of the final payment of the loan, either through repayment of the
loan in full at maturity or upon any pre-payment, we are required to pay a final payment fee of
$637,500. In connection with the loan agreement, we granted the Lenders a security interest in
substantially all of our personal property now owned or hereafter acquired, excluding intellectual
property. Under the loan agreement, we are subject to certain affirmative and negative covenants,
including limitations on our ability to: undergo certain change of control events; convey, sell,
lease, license, transfer or otherwise dispose of assets, other than in certain specified
circumstances; create, incur, assume, guarantee or be liable with respect to certain indebtedness;
grant liens; pay dividends and make certain other restricted payments; and make certain
investments. In addition, under the loan agreement, subject to certain exceptions, we are required
to maintain with SVB our primary cash and investment accounts, which accounts are also covered by
control agreements for the benefit of the Lenders. We have currently met all of our obligations
under the loan agreement. We are also required to maintain the at-the-market equity sales
agreement, or the sales agreement, with Citadel unless we raise at least $30 million in equity
proceeds.
As part of the financing, the Lenders received warrants to purchase up to an aggregate of
583,152 fully paid and non-assessable shares of our common stock at an exercise price equal to
$1.5433 per share. The warrants will expire ten years from the date of the grant.
Equity Sales Agreement
On August 1, 2011, we entered into the sales agreement with Citadel pursuant to which we agreed
to sell, at our option, up to an aggregate of $30.0 million in shares of our common stock through
Citadel, as sales agent. Sales of the common stock made pursuant to the sales agreement, if any,
will be made on the NASDAQ Stock Market under our currently-effective Registration Statements on
Form S-3 by means of ordinary brokers transactions at market prices. Additionally, under the terms
of the sales agreement, we may also sell shares of our common stock through Citadel, on the NASDAQ
Stock Market or otherwise, at negotiated prices or at prices related to the prevailing market
price. Under the terms of the sales agreement, we may also sell shares to Citadel as principal for
Citadels own account at a price agreed upon at the time of sale pursuant to a separate terms
agreement to be entered into with Citadel at such time. We will pay Citadel a commission equal to
3% of the gross proceeds from the sale of shares of our common stock under the sales agreement. We
or Citadel may terminate the sales agreement at any time. The offering of common stock pursuant to
the sales agreement will terminate upon the earlier of (a) the sale of all of the common stock
subject to the sales agreement or (b) the termination of the sales agreement by us or Citadel.
Either party may terminate the agreement in its sole discretion at any time upon written notice to
the other party.
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Litigation
We have received notices from each of Actavis Elizabeth LLC and Actavis Inc., or collectively,
Actavis, Mylan Pharmaceuticals Inc. and Mylan, Inc., or collectively, Mylan, Par Pharmaceutical,
Inc. and Par Pharmaceutical Companies, Inc., or collectively, Par, and Zydus Pharmaceuticals USA,
Inc. and Cadila Healthcare Limited (d/b/a Zydus Cadila), or collectively, Zydus, that each that
each has filed with the FDA an ANDA for a generic version of Silenor 3 mg and 6 mg tablets. The
notices included paragraph IV certifications with respect to eight of the nine patents listed in
the Orange Book for Silenor. A paragraph IV certification is a certification by a generic applicant
that in the opinion of that applicant, the patent(s) listed in the Orange Book for a branded
product are invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of
the generic product.
We, together with ProCom, have filed suit in the United States District Court for the District
of Delaware against each of Actavis, Mylan, Par and Zydus. The lawsuits allege that each of
Actavis, Mylan, Par and Zydus have infringed U.S. Patent No. 6,211,229, or the 229 patent, by
seeking approval from the FDA to market generic versions of Silenor 3 mg and 6 mg tablets prior to
the expiration of this patent.
In addition, we have filed suit in the United States District Court for the District of
Delaware against each of Actavis, Mylan, Par and Zydus alleging that such parties have infringed
U.S. Patent No. 7,915,307, or the 307 patent, by seeking approval from the FDA to market generic
versions of Silenor 3 mg and 6 mg tablets prior to the expiration of this patent.
Pursuant to the provisions of the Hatch-Waxman Act, FDA final approval of the Actavis and
Mylan ANDAs can occur no earlier than May 3, 2013, FDA final approval of the Par ANDA can occur no
earlier than June 23, 2013 and FDA final approval of the Zydus ANDA can occur no earlier than
November 13, 2013, unless in each case there is an earlier court decision that the 229 patent and
the 307 patent are not infringed and/or invalid or unless any party to the action is found to have
failed to cooperate reasonably to expedite the infringement action.
At this time, the other patents included in Orange Book have not been asserted against these
parties.
We intend to vigorously enforce our intellectual property rights relating to Silenor, but we
cannot predict the outcome of these matters.
The prosecution of the lawsuits against Actavis, Mylan, Par and Zydus will increase our cash
expenditures. Any adverse outcome in this litigation could result in one or more generic versions
of Silenor being launched before the expiration of the listed patents, which could adversely affect
our ability to successfully execute our business strategy to increase sales of Silenor and would
negatively impact our financial condition and results of operations, including causing a
significant decrease in our revenues and cash flows.
Contractual Obligations
In May 2011, we entered into a new lease arrangement to rent approximately 12,100 square feet
of office space, which we plan to use as our new corporate headquarters. The lease will
commence on the date that the premises are delivered to us after tenant improvements have been
completed. The lease will expire 64 months after the date that the lease term commences, and we
will have the option to extend the term for an additional five years at the then-current fair
market rental rate (as defined in the lease).
We have paid the first months rent of approximately $30,000 and the monthly rent following
lease commencement will be approximately $30,000. However, the second through thirteenth months
rent will be abated by one-half provided that we are not in default of the lease. If the lease has
not commenced by September 1, 2011, then we shall receive one day of free rent and the abated rent
shall also be extended for an additional day for each day that the commencement of the lease is
delayed, other than due to delays by us. After the first year, the monthly rent will increase by
3.5% per year, and we will provide reimbursements for our proportional share of any increases in
operating expenses over the first years operating expenses (as defined in the lease). We have
also have a $200,000 letter of credit in favor of our landlord to secure our obligations under the
lease.
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A summary of our other minimum contractual obligations related to our major outstanding
contractual commitments is included in our Annual Report on Form 10-K for the year ended December
31, 2010.
Off-Balance Sheet Arrangements
We do not have any relationships with unconsolidated entities or financial partnerships, such
as entities often referred to as structured finance or special purpose entities, which would have
been established for the purpose of facilitating off-balance sheet arrangements or other
contractually narrow or limited purposes.
Recent Accounting Pronouncements
In October 2009, the FASB issued ASU No. 2009-13 Revenue Recognition, which provides
guidance on recognizing revenue in arrangements with multiple deliverables. This standard impacts
the determination of when the individual deliverables included in a multiple element arrangement
may be treated as a separate unit of accounting. It also modifies the manner in which the
consideration received from the transaction is allocated to the multiple deliverables and no longer
permits the use of the residual method of allocating arrangement consideration. This accounting
standard is effective for the first reporting period beginning on or after June 15, 2010, with
early adoption permitted. The adoption of ASU 2009-13 did not have a material impact on the
financial statements.
In December 2010, the FASB issued ASU No. 2010-27 Other Expenses: Fees Paid to the Federal
Government by Pharmaceutical Manufacturers, which provides guidance concerning the recognition and
classification of the new annual fee payable by branded prescription drug manufacturers and
importers on branded prescription drugs which was mandated under the health care reform legislation
enacted in the United States in March 2010. Under this new authoritative guidance, the annual fee
should be estimated and recognized in full as a liability upon the first qualifying commercial sale
with a corresponding deferred cost that is amortized to operating expenses using a straight-line
method unless another method better allocates the fee over the calendar year in which it is
payable. This new guidance is effective for calendar years beginning on or after December 31, 2010,
when the fee initially becomes effective. The adoption of ASU 2010-27 did not have a material
impact on our financial statements.
In May 2011, the FASB issued ASU No. 2011-04 Fair Value Measurement: Amendments to Achieve
Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. Some of the
amendments clarify the Boards intent about the application of existing fair value measurement
requirements. Other amendments change a particular principle or requirement for measuring fair
value or for disclosing information about fair value measurements. This guidance is effective for
interim and annual periods beginning after December 15, 2011. We are still evaluating the
potential future effects of this guidance.
In June 2011, the FASB issued ASU No. 2011-05 Comprehensive Income: Presentation of
Comprehensive Income. Under the new guidance, an entity has the option to present the total of
comprehensive income, the components of net income, and the components of other comprehensive
income either in a single continuous statement of comprehensive income or in two separate but
consecutive statements. This guidance is effective for interim and annual periods beginning after
December 15, 2011. We have evaluated the potential future effects of this guidance and do not expect
the adoption of ASU 2011-05 to have a material impact on our financial statements.
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Caution on Forward-Looking Statements
Any statements in this report about our expectations, beliefs, plans, objectives, assumptions
or future events or performance are not historical facts and are forward-looking statements. You
can identify these forward-looking statements by the use of words or phrases such as believe,
may, could, will, estimate, continue, anticipate, intend, seek, plan, expect,
should or would. Among the factors that could cause actual results to differ materially from
those indicated in the forward-looking statements are risks and uncertainties inherent in our
business including, without limitation: our ability to successfully commercialize Silenor; the
market potential for insomnia treatments, and our ability to compete within that market; our
reliance on our co-promotion partner, P&G, and our contract sales force provider, Publicis, for
critical aspects of the commercial sales process for Silenor; the performance of P&G and Publicis
and their adherence to the terms of their contracts with us; the ability of our sales management
personnel to effectively manage the sales representatives employed by Publicis; our ability to
successfully enforce our intellectual property rights and defend our patents, including any
developments relating to the recent submission of ANDAs for generic versions of Silenor 3 mg and 6
mg tablets and related patent litigation; 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
possible introduction of generic competition of Silenor; our ability to ensure adequate and
continued supply of Silenor to successfully meet anticipated market demand; our ability to raise
sufficient capital to fund our operations, including patent infringement litigation, and the impact
of any financing activity on the level of our stock price; the impact of any inability to raise
sufficient capital to fund ongoing operations, including any patent infringement litigation; our
ability to comply with the covenants under the Loan Agreement with the Lenders; 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; our ability to fully
utilize the sales agreement with Citadel as a source of future financings, whether due to market
conditions, our 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 our stock price, which may decline, in connection with the implementation of the sales agreement
or the occurrence of any sales under the agreement; changes in healthcare regulation and
reimbursement policies; our ability to operate our business without infringing the intellectual
property rights of others; our reliance on our 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 us; inadequate therapeutic efficacy or unexpected
adverse side effects relating to Silenor 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 our interpretation of such results; and other risks detailed in this report under Part II
Item 1A Risk Factors below and previously disclosed in our Annual Report on Form 10-K.
Although we believe that the expectations reflected in our forward-looking statements are
reasonable, we cannot guarantee future results, events, levels of activity, performance or
achievement. We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, unless required by
law. This caution is made under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
Our cash and cash equivalents at June 30, 2011 consisted primarily of money market funds and
marketable securities. The primary objective of our investment activities is to preserve principal
while maximizing the income we receive from our investments without significantly increasing risk.
Historically, our primary exposure to market risk is interest rate sensitivity. This means that a
change in prevailing interest rates may cause the value of the investment to fluctuate. For
example, if we purchase a security that was issued with a fixed interest rate and the prevailing
interest rate later rises, the value of our investment will probably decline. Currently, our
holdings are in money market funds and marketable securities, and therefore this interest rate risk
is minimal. To minimize our interest rate risk going forward, we intend to continue to maintain
our portfolio of cash, cash equivalents and marketable securities in a variety of securities
consisting of money market funds and United States government debt securities, all with various
maturities. In general, money market funds are not subject to market risk because the interest
paid on such funds fluctuates with the prevailing interest rate. We also generally time the
maturities of our investments to correspond with our expected cash needs, allowing us to avoid
realizing any potential losses from having to sell securities prior to their maturities.
Our cash is invested in accordance with a policy approved by our board of directors which
specifies the categories, allocations, and ratings of securities we may consider for investment.
We do not believe our cash and cash equivalents and short-term investments have significant risk of
default or illiquidity. We made this determination based on discussions with our treasury managers
and a review of our holdings. While we believe our cash and cash equivalents and short-term
investments are well diversified and do not contain excessive risk, we cannot provide absolute
assurance that our investments will not be subject to future adverse changes in market value.
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Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our reports made under the Securities Exchange Act of 1934, as amended,
or the Exchange Act, is recorded, processed, summarized and reported within the time periods
specified in the SECs rules and forms and that such information is accumulated and communicated to
our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate,
to allow for timely decisions regarding required disclosure. In designing and evaluating the
disclosure controls and procedures, management recognizes that any controls and procedures, no
matter how well designed and operated, can provide only reasonable assurance of achieving the
desired control objectives, and management is required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the period covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were
effective at the reasonable assurance level as of June 30, 2011.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. | Legal Proceedings |
We have received notices from each of Actavis, Mylan, Par, and Zydus that each has filed with
the FDA an ANDA for a generic version of Silenor 3 mg and 6 mg tablets. The notices included
paragraph IV certifications with respect to eight of the nine patents listed in the Orange Book
for Silenor.
We, together with ProCom, have filed suit in the United States District Court for the District
of Delaware against each of Actavis, Mylan, Par and Zydus. The lawsuits allege that each of
Actavis, Mylan, Par and Zydus have infringed the 229 patent by seeking approval from the FDA to
market generic versions of Silenor 3 mg and 6 mg tablets prior to the expiration of this patent.
In addition, we have filed suit in the United States District Court for the District of
Delaware against each of Actavis, Mylan, Par and Zydus alleging that such parties have the 307
patent by seeking approval from the FDA to market generic versions of Silenor 3 mg and 6 mg tablets
prior to the expiration of this patent.
Pursuant to the provisions of the Hatch-Waxman Act, FDA final approval of the Actavis and
Mylan ANDAs can occur no earlier than May 3, 2013, FDA final approval of the Par ANDA can occur no
earlier than June 23, 2013 and FDA final approval of the Zydus ANDA can occur no earlier than
November 13, 2013, unless in each case there is an earlier court decision that the 229 patent and
the 307 patent are not infringed and/or invalid or unless any party to the action is found to have
failed to cooperate reasonably to expedite the infringement action. We do not know when there will
be a court decision on the merits in any of these cases.
At this time, the other patents included in Orange Book have not been asserted against these
parties.
We intend to vigorously enforce our intellectual property rights relating to Silenor, but we
cannot predict the outcome of these matters.
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Item 1A. | Risk Factors |
Investing in our common stock involves a high degree of risk. Our Annual Report on Form 10-K
for the year ended December 31, 2010 includes a detailed discussion of our risk factors under the
heading Part I, Item 1ARisk Factors. Set forth below are certain changes from the risk factors
previously disclosed in our Annual Report on Form 10-K. You should carefully consider the risk
factors discussed in our Annual Report on Form 10-K and in this report, as well as the other
information in this report, before deciding whether to invest in shares of our common stock. The
occurrence of any of the risks discussed in the Annual Report on Form 10-K or this report could
harm our business, financial condition, results of operations or growth prospects. In that case,
the trading price of our common stock could decline, and you may lose all or part of your
investment. Except with respect to our trademarks, the trademarks, trade names and service marks
appearing in this report are the property of their respective owners.
Risks Related to Our Business
We may require substantial additional funding and may be unable to raise capital when needed,
which could force us to delay, reduce or eliminate planned activities or result in our inability
to continue as a going concern.
We began generating revenues from the commercialization of Silenor late in the third quarter
of 2010, and our operations to date have generated substantial needs for cash. We expect our
negative cash flows from operations to continue until we are able to generate significant cash
flows from the commercialization of Silenor.
In November 2010, we completed a public offering of 8,800,000 shares of our common stock at a
public offering for aggregate net proceeds of approximately $24.8 million. In June 2011, we
completed a private placement of 2,184,769 shares of our common stock to Paladin Labs Inc. for
aggregate net proceeds of approximately $5.0 million in connection with a license of the rights to
market Silenor in Canada, South America, Africa and the Caribbean.
At June 30, 2011 we had cash, cash equivalents, and short-term investments totaling $30.9
million. We have received $14.9 million in net loan proceeds pursuant to a loan and security agreement
with Silicon Valley Bank, or SVB and Oxford Finance LLC, or together with SVB, the Lenders. We believe
we have sufficient financial resources to fund our operations for at least next the twelve months.
We may need to obtain additional funds to finance our operations, particularly if we are unable to
access adequate or timely funds under our at-the-market equity sales agreement with Citadel Securities LLC, or Citadel.
Actual financial results for the period of time through which our financial resources will be
adequate to support our operations could vary based upon many factors, including but not limited to
the rate of growth of Silenor sales, the actual cost of commercial activities and any potential
litigation expenses we may incur.
We are responsible for the costs relating to the commercialization of Silenor in the U.S.
As a result, commercial activities relating to Silenor are likely to result in the need for
substantial additional funds. Our future capital requirements will depend on, and could increase
significantly as a result of, many factors, including:
| our success in generating cash flows from the commercialization of Silenor, together with our co-promotion partner P&G and our licensee Paladin; |
| the costs of establishing or contracting for commercial programs and resources; |
| the terms and timing of any future collaborative, licensing and other arrangements that we may establish; |
| the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
| the extent to which we acquire or in-license new products, technologies or businesses; |
| the rate of progress and cost of our non-clinical studies, clinical trials and other development activities; |
| the scope, prioritization and number of development programs we pursue; and |
| the effect of competing technological and market developments. |
On July 28, 2011, we terminated the existing loan agreement with Comerica Bank and entered into
a new loan and security agreement on August 2, 2011 with the Lenders,
pursuant to which the Lenders made to us a term loan in the principal amount of $15.0 million. The
term loan bears interest at 7.50% per annum. We will make monthly interest-only payments through
December 2011, and the principal, together with interest, thereafter will be paid in monthly
installments thereafter through December 2013.
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In addition, on August 1, 2011, we entered into an at-the-market equity sales agreement,
or the sales agreement, with Citadel, pursuant to which we agreed to
sell, at our option, up to an aggregate of $30,000,000 in shares of our common stock through
Citadel, as sales agent. Sales of the common stock made pursuant to the sales agreement, if any,
will be made on the NASDAQ Stock Market under our currently-effective Registration Statements on
Form S-3 by means of ordinary brokers transactions at market prices. Additionally, under the terms
of the sales agreement, we may also sell shares of our common stock through Citadel, on the NASDAQ
Stock Market or otherwise, at negotiated prices or at prices related to the prevailing market
price.
In addition to the amounts available under our sales agreement with Citadel, we intend
to obtain any additional funding we may require through strategic relationships, public or private
equity or debt financings, assigning receivables or royalty rights, or other arrangements and
cannot assure that such funding will be available on reasonable terms, or at all. If we are
unsuccessful in raising additional required funds, we may be required to delay, scale-back or
eliminate plans or programs relating to our business, relinquish some or all rights to Silenor, or
renegotiate less favorable terms with respect to such rights than we would otherwise choose or
cease operating as a going concern. In addition, if we do not meet our payment obligations to third
parties as they come due, we may be subject to litigation claims. Even if we are successful in
defending against these claims, litigation could result in substantial costs and distract
management, and may result in unfavorable results that could further adversely impact our financial
condition.
If we raise additional funds by issuing equity securities, substantial dilution to existing
stockholders would result. If we raise additional funds by incurring debt financing, the terms of
the debt may involve significant cash payment obligations as well as covenants and specific
financial ratios that may restrict our ability to operate our business. If we are unable to
continue as a going concern, we may have to liquidate our assets and may receive less than the
value at which those assets are carried on our financial statements, and it is likely that
investors will lose all or a part of their investments.
We, our co-promotion partner, P&G, and our contract sales force provider, Publicis, will need to
retain qualified sales and marketing personnel and collaborate in order to successfully
commercialize Silenor.
We have entered into a co-promotion agreement with P&G, under which its sales representatives
will provide a minimum number of primary details to certain healthcare professionals and a minimum
number of calls to pharmacists promoting Silenor. We have retained Publicis to provide 145 sales
representatives to promote Silenor under the terms of a contract sales agreement. These
representatives are employees of Publicis but were hired to our specifications and are managed by
our team of Somaxon sales management personnel. To the extent we, P&G and Publicis are not
successful in retaining qualified sales and marketing personnel, we may not be able to effectively
market Silenor.
We and P&G each have the right to terminate the co-promotion agreement at any time following
December 31, 2011 by providing at least 90 days prior written notice, as well as other more limited
termination rights. While our agreement with P&G requires its field sales representatives to
promote our products in a minimum number of primary details to target physicians and a minimum
number of pharmacy calls, we cannot be sure that P&Gs efforts will be successful.
Our agreement with Publicis will cause us to incur significant costs, and we cannot be sure
that the efforts of the contract sales force, together with any efforts made by P&G to promote our
products, will generate sufficient awareness or demand for our products. If we determine that the
contract sales force is not successful and we decide to terminate our agreement with Publicis prior
to the one-year anniversary of the deployment of the contract sales force, we will incur
termination fees.
Any revenues we receive from sales of Silenor will largely depend upon the efforts P&G and
Publicis, which in many instances will not be within our control. If we are unable to maintain our
co-promotion agreement with P&G, to maintain our contract sales agreement with Publicis or to
effectively establish alternative arrangements to market our products, our business could be
adversely affected. In addition, despite our arrangements with P&G and Publicis, we still may not
be able to cover all of the prescribing physicians for insomnia at the same level of reach and
frequency as our competitors, and we ultimately may need to further expand our selling efforts in
order to effectively compete.
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Restrictions on or challenges to our patent rights relating to our products and limitations on or
challenges to our other intellectual property rights may limit our ability to prevent third
parties from competing against us.
Our success will depend on our ability to obtain and maintain patent protection for Silenor
and any other product candidate we develop or commercialize, preserve our trade secrets, prevent
third parties from infringing upon our proprietary rights and operate without infringing upon the
proprietary rights of others. The patent rights that we have in-licensed relating to Silenor are
limited in ways that may affect our ability to exclude third parties from competing against us. In
particular, we do not hold composition of matter patents covering the active pharmaceutical
ingredient, or API, of Silenor. Composition of matter patents on APIs are a particularly effective
form of intellectual property protection for pharmaceutical products as they apply without regard
to any method of use or other type of limitation. As a result, competitors who obtain the requisite
regulatory approval can offer products with the same active ingredients as our products so long as
the competitors do not infringe any method of use or formulation patents that we may hold.
The principal patent protection that covers, or that we expect will cover, Silenor consists of
method of use patents. This type of patent protects the product only when used or sold for the
specified method. However, this type of patent does not limit a competitor from making and
marketing a product that is identical to our product for an indication that is outside of the
patented method. Moreover, physicians may prescribe such a competitive identical product for
off-label indications that are covered by the applicable patents. Some physicians are prescribing
generic 10 mg doxepin capsules and generic oral solution doxepin for insomnia in this off-label
indication. In addition, some managed health care plans are requiring the substitution of these
generic doxepin products for Silenor, and some pharmacies are suggesting such substitution.
Although such off-label prescriptions may induce or contribute to the infringement of method of use
patents, the practice is common and such infringement is difficult to prevent or prosecute.
Because products with active ingredients identical to ours have been on the market for many
years, there can be no assurance that these other products were never used off-label or studied in
such a manner that such prior usage would not affect the validity of our method of use patents. Due
to some prior art that we identified, we initiated a reexamination of one of the patents we have
in-licensed covering Silenor, (specifically, U.S. Patent No. 5,502,047, Treatment for Insomnia)
which claims the treatment of chronic insomnia using doxepin in a daily dosage of 0.5 mg to 20 mg
and expires in March 2013. The reexamination proceedings terminated and the U.S. Patent and
Trademark Office, or USPTO, issued a reexamination certificate narrowing certain claims, so that
the broadest dosage ranges claimed by us are 0.5 mg to 20 mg for otherwise healthy patients with
chronic insomnia and for patients with chronic insomnia resulting from depression, and 0.5 mg to 4
mg for all other chronic insomnia patients. We also requested reissue of this same patent to
consider some additional prior art and to add intermediate dosage ranges below 10 mg. In two office
actions relating to this reissue request, the USPTO raised no prior art objections to 32 of the 34
claims we were seeking and raised a prior art objection to the other two, as well as some technical
objections. Each of the claims objected to by the USPTO related to dosages above 10 mg. After
further review of the prior art submitted, the USPTO withdrew all of its prior art objections. We
then determined that the proposed addition of the intermediate dosage ranges and the resolution of
the technical objections no longer warranted continuation of the reissue proceeding. As a result,
we elected not to continue that proceeding.
We also have multiple internally developed pending patent applications. No assurance can be
given that the USPTO or other applicable regulatory authorities will allow pending applications to
result in issued patents with the claims we are seeking, or at all.
Patent applications in the United States are confidential for a period of time until they are
published, and publication of discoveries in scientific or patent literature typically lags actual
discoveries by several months. As a result, we cannot be certain that the inventors of issued
patents to which we hold rights were the first to conceive of inventions covered by pending patent
applications or that the inventors were the first to file patent applications for such inventions.
In addition, third parties may challenge issued patents to which we hold rights and any
additional patents that we may obtain, which could result in the invalidation or unenforceability
of some or all of the relevant patent claims, or could attempt to develop products utilizing the
same APIs as our products that do not infringe the claims of our in-licensed patents or patents
that we may obtain.
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When a third party files an ANDA for a product containing doxepin for the treatment of
insomnia at any time during which we have patents listed for Silenor in the FDAs Orange Book
publication, the applicant will be required to certify to the FDA concerning the listed patents.
Specifically, the applicant must certify that: (1) the required patent information relating to the
listed patent has not been filed in the NDA for the approved product; (2) the listed patent has
expired; (3) the listed patent has not expired, but will expire on a particular date and approval
is sought after patent expiration; or (4) the listed patent is invalid or will not be infringed by
the manufacture, use or sale of the new product. A certification that the new product will not
infringe the Orange Book-listed patents for Silenor or that such patents are invalid is called a
paragraph IV certification.
We have received notices from each of Actavis, Mylan, Par, and Zydus that each has filed with
the FDA an ANDA for a generic version of Silenor 3 mg and 6 mg tablets. The notices included
paragraph IV certifications with respect to eight of the nine patents listed in the Orange Book for
Silenor.
We, together with ProCom, have filed suit in the United States District Court for the District
of Delaware against each of Actavis, Mylan, Par and Zydus. The lawsuits allege that each of
Actavis, Mylan, Par and Zydus have infringed the 229 patent by seeking approval from the FDA to
market generic versions of Silenor 3 mg and 6 mg tablets prior to the expiration of this patent.
In addition, we have filed suit in the United States District Court for the District of
Delaware against each of Actavis, Mylan, Par and Zydus alleging that such parties have infringed
the 307 patent by seeking approval from the FDA to market generic versions of Silenor 3 mg and 6
mg tablets prior to the expiration of this patent
Pursuant to the provisions of the Hatch-Waxman Act, FDA final approval of the Actavis and
Mylan ANDAs can occur no earlier than May 3, 2013, FDA final approval of the Par ANDA can occur no
earlier than June 23, 2013 and FDA final approval of the Zydus ANDA can occur no earlier than
November 13, 2013, unless in each case there is an earlier court decision that the 229 patent and
the 307 patent are not infringed and/or invalid or unless any party to the action is found to have
failed to cooperate reasonably to expedite the infringement action. We do not know when there will
be a court decision on the merits in any of these cases. At this time, the other patents included
in Orange Book have not been asserted against these parties.
We intend to vigorously enforce our intellectual property rights relating to Silenor, but we
cannot predict the outcome of these matters. Any adverse outcome in this litigation could result
in one or more generic versions of Silenor being launched before the expiration of the listed
patents, which could adversely affect our ability to successfully execute our business strategy to
increase sales of Silenor and would negatively impact our financial condition and results of
operations, including causing a significant decrease in our revenues and cash flows.
Certain pharmaceutical companies patent settlement agreements with generic pharmaceutical
companies have been challenged by the U.S. Federal Trade Commission alleging a violation of Section
5(a) of the Federal Trade Commission Act, and any patent settlement agreement that we may enter
into with any generic pharmaceutical company may be subject to similar challenges, which will be
both expensive and time consuming and may render such settlement agreements unenforceable. In
addition, legislation has been proposed by Congress that, if passed, would subject patent
settlement agreements to further restrictions.
We also rely upon unpatented trade secrets and improvements, unpatented know-how and
continuing technological innovation to develop and maintain our competitive position, which we seek
to protect, in part, by confidentiality agreements with our collaborators, employees and
consultants. We also have invention or patent assignment agreements with our employees and certain
consultants. There can be no assurance that inventions relevant to us will not be developed by a
person not bound by an invention assignment agreement with us. There can be no assurance that
binding agreements will not be breached, that we would have adequate remedies for any breach, or
that our trade secrets will not otherwise become known or be independently discovered by our
competitors.
Litigation or other proceedings to enforce or defend intellectual property rights is often
very complex in nature, expensive and time-consuming, may divert our managements attention from
our core business and may result in unfavorable results that could adversely impact our ability to
prevent third parties from competing with us.
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We expect intense competition in the marketplace for Silenor and any other product to which we
acquire rights, and new products may emerge that provide different and/or better therapeutic
alternatives for the disorders that our products are intended to treat.
Silenor competes with well established drugs approved for the treatment of insomnia, including
the branded and generic versions of Sanofi-Synthélabo, Inc.s Ambien and Ambien CR, Pfizer Inc.s
Sonata, and Lunesta, marketed by Sunovion Pharmaceuticals Inc., a wholly-owned subsidiary of
Dainippon Sumitomo Pharma Co., Ltd., all of which are GABA-receptor agonists, and Takeda
Pharmaceuticals North America, Inc.s Rozerem, a melatonin receptor antagonist.
A number of companies are marketing reformulated versions of previously approved GABA-receptor
agonists. For example, Meda AB and Orexo AB launched Edluar, formerly known as Sublinox, a
sublingual tablet formulation of zolpidem in the third quarter of 2009. ECR Pharmaceuticals
Company, Inc., a wholly owned subsidiary of Hi-Tech Pharmacal Co., Inc., launched NovaDel Pharma,
Inc.s ZolpiMist, an oral mist formulation of zolpidem, in the United States in February 2011.
In addition to the currently approved products for the treatment of insomnia, a number of new
products may enter the insomnia market over the next several years. Transcept Pharmaceuticals, Inc.
resubmitted an NDA for Intermezzo, a low-dose sublingual tablet formulation of zolpidem in January
2011, and on July 14, 2011, Transcept announced that it received a complete response letter from
the FDA relating to such NDA. Transcept is currently evaluating the letter and its plan for future
regulatory development of Intermezzo. Transcept and Purdue Pharmaceutical Products L.P. have
entered into an exclusive license and collaboration agreement to commercialize Intermezzo in the
United States. It has been reported that Neurim Pharmaceuticals Ltd. is seeking FDA approval of
Circadin, a prescription form of melatonin that is already approved in the EU and several other
countries and Neu-P11, a melatonin and serotonin agonist is in clinical development.
Alexza Pharmaceuticals, Inc. has announced positive results from a Phase 1 clinical trial
of an inhaled formulation of zaleplon, the API in Sonata. In July 2010, Alexza announced that it
was advancing this product candidate into Phase 2 clinical trials during the first half of 2011 for
the treatment of insomnia in patients who have difficulty falling asleep, including those patients
who awake in the middle of the night and have difficulty falling back asleep, but has not yet done
so. Somnus Therapeutics, Inc. has announced positive results from two Phase 1 clinical trials of a
delayed-release formulation of zaleplon and has initiated Phase 2 clinical trials of that product
candidate.
Vanda Pharmaceuticals Inc. has completed two Phase 3 clinical trials of tasimelteon, a
melatonin receptor agonist. Tasimelteon received orphan drug designation status for non-24 hour
sleep/wake disorder in blind individuals with no light perception. Vanda has initiated Phase 3
clinical trials for tasimelteon to treat this disorder and plans to file an NDA with the FDA in the
first half of 2013.
Merck & Co., Inc. has suvorexant, an orexin antagonist, in Phase 3 clinical trials for the
treatment of insomnia and MK-6096 and MK-3697 in Phase 2 clinical trials for the treatment of
insomnia. Merck has announced that it plans to file regulatory applications for suvorexant in
2012.
Several other companies, including Sunovion Pharmaceuticals, are evaluating 5HT2 antagonists
as potential hypnotics, and Eli Lilly and Company is evaluating a potential hypnotic that is a dual
histamine/5HT2 antagonist. Additionally, several other companies are evaluating new formulations of
existing compounds and other compounds for the treatment of insomnia.
Furthermore, generic versions of Ambien, Ambien CR and Sonata have been launched and are
priced significantly lower than approved, branded insomnia products. Some managed health care
plans require that patients try generic versions of these branded insomnia products before the
patient can be reimbursed for Silenor. Sales of all of these drugs may reduce the available market
for, and could put downward pressure on, the price we are able to charge for Silenor, which could
ultimately limit our ability to generate significant revenues.
The active ingredient of Silenor is doxepin, which has been used at higher doses for over 40
years for the treatment of depression and anxiety. Doxepin is available generically in strengths
as low as 10 mg in capsule form, as well as in a concentrated liquid form dispensed by a marked
dropper and calibrated for 5 mg. Some physicians are prescribing generic 10 mg doxepin capsules
and generic oral solution doxepin for insomnia off-label for insomnia. In addition, some managed
health care plans are requiring the substitution of these generic doxepin products for Silenor, and
some pharmacies are suggesting such substitution. Such off label uses of generic doxepin may
reduce the sales of Silenor and may put a downward pressure on the price we are able to charge for
Silenor, which could ultimately limit our ability to generate significant revenues.
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Upon the expiration of, or successful challenge to, our patents covering Silenor, generic
competitors may introduce a generic version of Silenor at a lower price. Some generic
manufacturers have also demonstrated a willingness to launch generic versions of branded products
before the final resolution of related patent litigation (known as an at-risk launch). A launch
of a generic version of Silenor could have a material adverse effect on our business and we could
suffer a significant loss of sales and market share in a short period of time.
We have received notices from each of Actavis, Mylan, Par, and Zydus that each has filed with
the FDA an ANDA for a generic version of Silenor 3 mg and 6 mg tablets. The notices included
paragraph IV certifications with respect to eight of the nine patents listed in the Orange Book for
Silenor.
We, together with ProCom, have filed suit in the United States District Court for the District
of Delaware against each of Actavis, Mylan, Par and Zydus. The lawsuits allege that each of
Actavis, Mylan, Par and Zydus have infringed the 229 patent by seeking approval from the FDA to
market generic versions of Silenor 3 mg and 6 mg tablets prior to the expiration of this patent.
In addition, we have filed suit in the United States District Court for the District of
Delaware against each of Actavis, Mylan, Par and Zydus alleging that such parties have infringed
the 307 patent by seeking approval from the FDA to market generic versions of Silenor 3 mg and 6
mg tablets prior to the expiration of this patent
Pursuant to the provisions of the Hatch-Waxman Act, FDA final approval of the Actavis and
Mylan ANDAs can occur no earlier than May 3, 2013, FDA final approval of the Par ANDA can occur no
earlier than June 23, 2013 and FDA final approval of the Zydus ANDA can occur no earlier than
November 13, 2013, unless in each case there is an earlier court decision that the 229 patent and
the 307 patent are not infringed and/or invalid or unless any party to the action is found to have
failed to cooperate reasonably to expedite the infringement action. We do not know when there will
be a court decision on the merits in any of these cases. At this time, the other patents included
in the Orange Book have not been asserted against these parties.
We intend to vigorously enforce our intellectual property rights relating to Silenor, but we
cannot predict the outcome of these matters. Any adverse outcome in this litigation could result
in one or more generic versions of Silenor being launched before the expiration of the listed
patents, which could adversely affect our ability to successfully execute our business strategy to
increase sales of Silenor and would negatively impact our financial condition and results of
operations, including causing a significant decrease in our revenues and cash flows.
The biotechnology and pharmaceutical industries are subject to rapid and intense technological
change. We face, and will continue to face, competition in the development and marketing of Silenor
or any other product candidate to which we acquire rights from academic institutions, government
agencies, research institutions and biotechnology and pharmaceutical companies. There can be no
assurance that developments by others, including the development of other drug technologies and
methods of preventing the incidence of disease, will not render Silenor or any other product
candidate that we develop obsolete or noncompetitive.
Compared to us, many of our potential competitors have substantially greater:
| capital resources; |
| manufacturing, distribution and sales and marketing resources and experience; |
| research and development resources, including personnel and technology; |
| regulatory experience; |
| experience conducting non-clinical studies and clinical trials, and related resources; and |
| expertise in prosecution of intellectual property rights. |
As a result of these factors, our competitors may develop drugs that are more effective and
less costly than ours and may be more successful than we are in manufacturing, marketing and
selling their products. Our competitors may also obtain patent protection or other intellectual
property rights or seek to invalidate or otherwise challenge our intellectual property rights,
limiting our ability to successfully commercialize products.
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In addition, manufacturing efficiency and selling and marketing capabilities are likely to be
significant competitive factors. We currently have no commercial manufacturing capability and more
limited sales and marketing infrastructure than many of our competitors and potential competitors.
We, Paladin or any other future licensee may never receive approval or commercialize our products
outside of the United States, or their activities may not be effective or in compliance with
applicable laws.
We have licensed to Paladin the rights to commercialize Silenor in Canada, South America, the
Caribbean and Africa. Silenor has not been approved for marketing in any jurisdiction outside of
the United States. Paladin will be responsible for regulatory submissions for Silenor in the
licensed territories and will have the exclusive right to commercialize Silenor in the licensed
territories. We may license rights to Silenor or other future products to others for territories
outside the United States in the future. In order to market any products outside of the United
States, we or our licensees must establish and comply with numerous and varying regulatory
requirements of other countries regarding safety and efficacy. Approval procedures vary among
countries and can involve additional product testing and additional administrative review periods.
Any additional clinical studies that may be required to be conducted as part of the regulatory
approval process may not corroborate the results of the clinical studies we have conducted or may
have adverse results or effects on our ability to maintain regulatory approvals in the United
States or obtain them in other countries. The time required to obtain approval in other countries
might differ from that required to obtain FDA approval. The regulatory approval process in other
countries may include all of the risks regarding FDA approval in the U.S. as well as other risks.
Regulatory approval in one country does not ensure regulatory approval in another, but a failure or
delay in obtaining regulatory approval in one country may have a negative effect on the regulatory
process in others. Failure to obtain regulatory approval in other countries or any delay or setback
in obtaining such approval could limit the uses of the product candidate and have an adverse effect
on potential royalties and product sales. Such approval may be subject to limitations on the
indicated uses for which the product may be marketed or require costly, post-marketing follow-up
studies. In addition, any revenues we receive from sales of Silenor outside the United States will
depend upon the efforts of Paladin or any other future licensees, which in many instances will not
be within our control. If we are unable to maintain our ex-U.S. license agreement or to
effectively establish alternative arrangements to market our products outside of the United States,
or if Paladin or any future licensees do not perform adequately under such agreements or
arrangements or comply with applicable laws, our business could be adversely affected and we could
be subject to regulatory sanctions.
Risks Related to Our Finances and Capital Requirements
Capital raising activities, such as issuing securities, incurring debt, assigning receivables or
royalty rights or entering into collaborations or other strategic transactions, may cause
dilution to existing stockholders or a reduction in our stock price, restrict our operations or
require us to relinquish proprietary rights and may be limited by applicable laws and
regulations.
Based on our recurring losses, negative cash flows from operations and working capital
levels, we may need to raise substantial additional funds. If we are unable to maintain sufficient
financial resources, including by raising additional funds when needed, our business, financial
condition and results of operations will be materially and adversely affected.
Because we may need to raise additional capital to fund our business, among other things, we
may conduct substantial equity offerings. For example, in August 2011 we entered into the sales agreement with Citadel pursuant to which we agreed to sell, at our
option, up to an aggregate of $30.0 million in shares of our common stock through Citadel, as sales
agent. Sales of the common stock made pursuant to the sales agreement, if any, will be made on the
NASDAQ Stock Market under our currently-effective Registration Statements on Form S-3 by means of
ordinary brokers transactions at then-prevailing market prices. Additionally, under the terms of
the sales agreement, we may also sell shares of our common stock through Citadel, on the NASDAQ
Stock Market or otherwise, at negotiated prices or at prices related to the prevailing market
price. We also may offer from time to time up to an aggregate of approximately $37 million in any
combination of debt securities, common and preferred stock and warrants under our two effective
shelf registration statements on Form S-3 filed with the SEC.
To the extent that we raise any required additional capital by issuing equity securities, our
existing stockholders ownership will be diluted. Any such dilution of the holdings of our current
stockholders may result in downward pressure on the price of our common stock.
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Any debt, receivables or royalty financing we enter into may involve covenants that
restrict our operations or conditions that require repayment. For example, under our new loan
agreement with the Lenders, we will be required to repay the entire outstanding principal balance
if a generic version of Silenor enters the market while the loan is outstanding. In addition, we
are subject to certain affirmative and negative covenants, including limitations on our ability to:
undergo certain change of control events; convey, sell, lease, license, transfer or otherwise
dispose of assets, other than in certain specified circumstances; create, incur, assume, guarantee
or be liable with respect to certain indebtedness; grant liens; pay dividends and make certain
other restricted payments; and make certain investments. We are also required to maintain the sales
agreement unless we raise at least $30 million in equity proceeds. In addition, under the loan
agreement, we are required to maintain with SVB our primary cash and investment accounts, which
accounts are also covered by control agreements for the benefit of the Lenders. To secure our
performance of our obligations under the Loan Agreement, we pledged substantially all of our assets
other than intellectual property assets to the Lenders and agreed to maintain certain minimum cash
and investment balances. We also agreed not to pledge our intellectual property assets to others,
subject to specified exceptions. Our failure to comply with the covenants in the loan agreement
could result in an event of default that, if not cured or waived, could result in the acceleration
of all or a substantial portion of our debt. We believe we have currently met all of our
obligations under the loan agreement.
Debt financing, receivables assignments, royalty interest assignments and other types of financing
are often coupled with an equity component, such as warrants to purchase stock. For example, in
connection with our August 2011 loan agreement with the Lenders, we issued to the Lenders warrants
to purchase up to 583,152 shares of our common stock with an exercise price of $1.5433 per share.
To the extent that any of these warrants, or any additional warrants that are outstanding or that
we may issue in the future, are exercised by their holders, dilution of our existing stockholders
ownership interests will result.
If we raise additional funds through collaborations or other strategic transactions, it may be
necessary to relinquish potentially valuable rights to our potential products or proprietary
technologies, or grant licenses on terms that are not favorable to us.
In addition, rules and regulations of the SEC or other regulatory agencies may restrict our
ability to conduct certain types of financing activities, or may affect the timing of and the
amounts we can raise by undertaking such activities. For example, under current SEC regulations, if
the aggregate market value of our common stock held by non-affiliates, or our public float, is less
than $75 million, the amount that we can raise through primary public offerings of securities in
any twelve-month period using one or more registration statements on Form S-3 may be limited to an
aggregate of one-third of our public float.
We may not be able to sell shares of our common stock under our equity sales agreement with
Citadel at times, prices or quantities that we desire and if such sales do occur, they may result
in dilution to our existing stockholders.
In August 2011, we entered into the sales agreement with Citadel. Under the terms of the
sales agreement, Citadel will use its commercially reasonable efforts to sell shares of our common stock
designated by us. However, there can be no assurance that Citadel will be successful in
consummating such sales based on prevailing market conditions or in the quantities or at the prices
that we deem appropriate. In addition, we will not be able to make sales of our common stock
pursuant to the sales agreement unless certain conditions are met, which include the accuracy of
representations and warranties made to Citadel under the sales agreement; compliance with laws; and the
continued listing of our stock on the Nasdaq Capital Market. In addition, Citadel is permitted to
terminate the sales agreement at any time. If we are unable to access funds through sales under
the sales agreement, or it is terminated by Citadel, we may be unable to access capital on
favorable terms or at all.
Should we sell shares pursuant to the sales agreement, it will have a dilutive effective on
the holdings of our existing stockholders, and may result in downward pressure on the price of our
common stock. If we sell shares under the sales agreement at a time when our share price is
decreasing, we will need to issue more shares to raise the same amount than if our stock price was
higher. Issuances in the face of a declining share price will have an even greater dilutive effect
than if our share price were stable or increasing, and may further decrease our share price.
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Our indebtedness under our loan agreement could adversely affect our financial health.
Under our new loan agreement, we have incurred $15.0 million of indebtedness. We are
obligated to pay interest on the loan through December 31, 2011, and to thereafter pay the
principal balance of the loan and interest in 24 equal monthly installments starting on January 1,
2012 and continuing through December 31, 2013. Such indebtedness could have important
consequences to our business. For example, it could:
| impair our ability to obtain additional financing in the future for working capital needs, capital expenditures and general corporate purposes; |
| increase our vulnerability to general adverse economic and industry conditions; |
| make it more difficult for us to satisfy other debt obligations we may incur in the future; |
| require us to dedicate a substantial portion of our cash flows from operations to the payment of principal and interest on our indebtedness, thereby reducing the availability of our cash flows to fund working capital needs, capital expenditures and other general corporate purposes; |
| limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate; and |
| place us at a disadvantage compared to our competitors that have less indebtedness. |
Covenants in our new loan agreement may limit our ability to operate our business.
Under the new loan agreement, we are required to maintain with SVB our primary cash and
investment accounts, which accounts are also covered by control agreements for the benefit of the
Lenders, we are also subject to certain affirmative covenants, including, but not limited to the obligations to maintain good standing, provide various notices to
the Lenders, deliver financial statements to the Lenders, maintain adequate insurance, promptly
discharge all taxes, protect our intellectual property and protect the collateral. We are also
subject to certain negative covenants customary for loans of this type, including but not limited
to prohibitions against certain mergers and consolidations, certain management and ownership
changes constituting a change of control, and the imposition of additional liens on collateral or
other of our assets, as well as prohibitions against additional indebtedness, certain dispositions
of property, changes in our business, name or location, payment of dividends, prepayment of certain
other indebtedness, certain investments or acquisitions, and certain transactions with affiliates,
in each case subject to certain customary exceptions, including exceptions that allow us to enter
into non-exclusive and/or exclusive licenses and similar agreements providing for the use of our
intellectual property in collaboration with third parties provided certain conditions are met. We
are also required to maintain the sales agreement unless we raise at least $30 million in equity
proceeds.
Although we believe we were in compliance with all of our non-financial and financial
covenants as of entering into the loan agreement, our future ability to comply with these covenants
may be affected by events beyond our control, including prevailing economic, financial, and
industry conditions. If we default under the loan agreement because of a covenant breach or
otherwise, any outstanding amounts could become immediately due and payable, which would negatively
impact our liquidity and reduce the availability of our cash flows to fund working capital needs,
capital expenditures and other general corporate purposes.
We have never been profitable and we may not be able to generate revenues sufficient to achieve
profitability.
We only began generating revenues from the commercialization of Silenor late in the third
quarter of 2010, we have not been profitable since inception, and it is possible that we will not
achieve profitability. We incurred net losses of $32.0 million for the six months ended June 30,
2011, and have accumulated losses totaling $248.8 million since inception. We expect to continue
to incur significant operating losses and capital expenditures. As a result, we will need to
generate significant revenues to achieve and maintain profitability. We cannot assure you that we
will achieve significant revenues, or that we will ever achieve profitability. Even if we do
achieve profitability, we cannot assure you that we will be able to sustain or increase
profitability on a quarterly or annual basis in the future. If revenues grow more slowly than we
anticipate or if operating expenses exceed our expectations or cannot be adjusted accordingly, our
business, results of operations and financial condition will be materially and adversely affected.
If we are unable to maintain sufficient financial resources, including by raising additional funds
when needed, our business, financial condition and results of operations will be materially and
adversely affected and we may be unable to continue as a going concern. If we are unable to
continue as a going concern, it is likely that investors will lose all or a part of their
investment.
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Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
In June 2011, we entered into agreements with Paladin pursuant to which Paladin purchased
2,184,769 shares of our common stock for an aggregate purchase price of $5.0 million in a private
placement pursuant to Rule 506 of the Securities Act of 1933, as amended.
Item 3. | Defaults Upon Senior Securities |
Not applicable.
Item 4. | (Removed and Reserved) |
Item 5. | Other Information |
Not applicable.
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Item 6. | Exhibits |
EXHIBIT INDEX
Exhibit | ||||
Number | Description | |||
3.1 | (1) | Amended and Restated Certificate of Incorporation of the Registrant |
||
3.2 | (2) | Amended and Restated Bylaws of the Registrant |
||
4.1 | (3) | Form of the Registrants Common Stock Certificate |
||
4.2 | (4) | Amended and Restated Investor Rights Agreement dated June 2, 2005 |
||
4.3 | (5) | Warrant dated May 21, 2008 issued to Silicon Valley Bank |
||
4.4 | (5) | Warrant dated May 21, 2008 issued to Oxford Finance Corporation |
||
4.5 | (5) | Warrant dated May 21, 2008 issued to Kingsbridge Capital Limited |
||
4.6 | (6) | Form of Warrant dated July 2, 2009 issued to certain Purchasers under the Securities
Purchase Agreement dated July 2, 2009 |
||
10.1 | (7) | License Agreement between the Registrant and Paladin Labs Inc. dated June 7, 2011 |
||
10.2 | (7) | Supply Agreement between the Registrant and Paladin Labs Inc. dated June 7, 2011 |
||
10.3 | (7) | Purchase Agreement between the Registrant and Paladin Labs Inc. dated June 7, 2011 |
||
10.4 | (8) | Lease Agreement between the Registrant and TREA Pacific Plaza, LLC dated May 24, 2011 |
||
31.1 | Certification of chief executive officer pursuant to Rule 13a-14 and Rule 15d-14 of
the Securities Exchange Act of 1934, as amended |
|||
31.2 | Certification of chief financial officer pursuant to Rule 13a-14 and Rule 15d-14 of
the Securities Exchange Act of 1934, as amended |
|||
32.1 | * | Certification of chief executive officer pursuant to 18 U.S.C. 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
||
32.2 | * | Certification of chief financial officer pursuant to 18 U.S.C. 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
||
(1) | Filed with Amendment No. 3 to the Registrants Registration Statement on Form S-1 on
November 30, 2005. |
|||
(2) | Filed with Registrants Current Report on Form 8-K on December 6, 2007 |
|||
(3) | Filed with Amendment No. 4 to the Registrants Registration Statement on Form S-1 on
December 13, 2005. |
|||
(4) | Filed with the Registrants Registration Statement on Form S-1 on October 7, 2005. |
|||
(5) | Filed with Registrants Current Report on Form 8-K on May 22, 2008. |
|||
(6) | Filed with Registrants Current Report on Form 8-K on July 8, 2009. |
|||
(7) | Filed with Registrants Current Report on Form 8-K on June 13, 2011. |
|||
(8) | Filed with Registrants Current Report on Form 8-K on May 25, 2011. |
| Confidential treatment has been granted as to certain portions, which portions have been omitted and filed separately with the Securities and Exchange Commission. | |
* | These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not subject to the liability of that section. These certifications are not to be incorporated by reference into any filing of Somaxon Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
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Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SOMAXON PHARMACEUTICALS, INC. Dated: August 3, 2011 |
||||
/s/ Richard W. Pascoe | ||||
Richard W. Pascoe | ||||
President and Chief Executive Officer (Principal Executive Officer) |
||||
Dated: August 3, 2011 | /s/ Tran B. Nguyen | |||
Tran B. Nguyen | ||||
Senior Vice President and Chief Financial Officer (Principal Financial Officer) |
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