|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
(1) The Company and Summary of Significant Accounting Policies
The Company
Arena Pharmaceuticals, Inc., or Arena, was incorporated on April 14, 1997, and commenced operations in July 1997. We are a clinical-stage biopharmaceutical company with a pipeline of internally discovered small molecule drug candidates that target G protein-coupled receptors, and are being developed internally or with a collaborator. We operate in one business segment. In October 2010, the US Food and Drug Administration, or FDA, issued a Complete Response Letter, or CRL, regarding our New Drug Application, or NDA, for our most advanced drug candidate, lorcaserin, which is intended for weight management. In the CRL, the FDA stated that it completed its review of the NDA and determined that it could not approve the application in its then present form. In December 2011, we resubmitted the lorcaserin NDA, and the FDA has confirmed its acceptance of the resubmission for filing and review and assigned a new Prescription Drug User Fee Act target date of June 27, 2012.
Basis of Presentation
The accompanying consolidated financial statements reflect all of our activities, including those of our wholly owned subsidiaries. All material intercompany accounts and transactions have been eliminated in consolidation.
During the first quarter of 2011, we identified an error in our consolidated financial statements for the years ended December 31, 2003, through December 31, 2008, related to the dividends and accretion of discount on our Series B Convertible Preferred Stock, which is no longer outstanding. The error relates to dividends that were recorded to our accumulated deficit rather than to additional paid-in capital. To correct the error, we recorded a non-cash cumulative adjustment as of December 31, 2008, to reduce both our accumulated deficit and additional paid-in capital by $18.6 million. This adjustment is reflected on the accompanying consolidated balance sheets and consolidated statements of stockholders' equity and comprehensive loss. We determined that this adjustment was not material to our financial position for any previously reported period, and it had no impact on our results of operations and cash flows.
We have accumulated a large deficit since inception, and we expect that our losses will continue to be substantial for at least the short term. As of December 31, 2011, we had $57.6 million in cash and cash equivalents, which, with the additional cash we raised in January and March 2012 (see Note 17), we believe will be sufficient to fund our operations for at least the next 12 months.
Financial Statement Preparation
The preparation of financial statements in conformity with US generally accepted accounting principles, or GAAP, requires our 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. We use estimates for certain accruals including clinical and preclinical study fees and expenses, share-based compensation, and valuations of derivative liabilities, long-lived assets and contingencies, among others. Actual results could differ from those estimates.
Reclassifications
Certain prior year amounts have been reclassified to conform to the current year presentation.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and highly liquid investments with remaining maturities of three months or less when purchased.
Fair Value of Financial Instruments
Cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities are carried at cost, which we believe approximates fair value due to the short-term maturity of these instruments. Short-term investments and derivative liabilities are carried at fair value. Based on borrowing rates currently available to us for loans with similar terms, we estimate the fair value of the lease financing obligations and note payable to Deerfield to be $55.5 million and $20.4 million, respectively, at December 31, 2011. As of December 31, 2010, we estimated the fair value of the lease financing obligations, note payable to Siegfried and note payable to Deerfield to be $55.9 million, $9.3 million and $54.2 million, respectively.
Concentration of Credit Risk and Major Customers
Financial instruments, which potentially subject us to concentrations of credit risk, consist primarily of cash, cash equivalents and short-term investments. We limit our exposure to credit loss by holding our cash in US dollars or placing our cash and investments in US government, agency and government-sponsored enterprise obligations and in corporate debt instruments that are rated investment grade, in accordance with our board-approved investment policy.
We manufacture drug products for Siegfried Ltd, or Siegfried, under a manufacturing services agreement, and all of our manufacturing services revenues are attributable to Siegfried.
Percentages of our total revenues derived from our manufacturing services agreement and from our most significant collaborators for the years presented are as follows:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Collaboration with Eisai Inc. |
53.2 | % | 11.6 | % | 0.0 | % | ||||||
|
Manufacturing services agreement with Siegfried |
41.9 | % | 42.5 | % | 63.3 | % | ||||||
|
Former collaboration with Ortho-McNeil-Janssen Pharmaceuticals, Inc. |
4.3 | % | 19.1 | % | 36.2 | % | ||||||
|
Collaboration with TaiGen Biotechnology Co., Ltd. |
0.0 | % | 24.4 | % | 0 | % | ||||||
|
Others |
0.6 | % | 2.4 | % | 0.5 | % | ||||||
|
|
|
|
|
|
|
|||||||
|
Total percentage of revenues |
100.0 | % | 100.0 | % | 100.0 | % | ||||||
|
|
|
|
|
|
|
|||||||
Percentages of our total accounts receivable for the years presented are as follows:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Collaboration with Eisai Inc. |
91.3 | % | 0.0 | % | 0.0 | % | ||||||
|
Manufacturing services agreement with Siegfried |
8.0 | % | 64.5 | % | 64.7 | % | ||||||
|
Former collaboration with Ortho-McNeil-Janssen Pharmaceuticals, Inc. |
0.0 | % | 35.4 | % | 34.7 | % | ||||||
|
Others |
0.7 | % | 0.1 | % | 0.6 | % | ||||||
|
|
|
|
|
|
|
|||||||
|
Total percentage of accounts receivable |
100.0 | % | 100.0 | % | 100.0 | % | ||||||
|
|
|
|
|
|
|
|||||||
Property and Equipment
Property and equipment are stated at cost and depreciated over the estimated useful lives of the assets (generally three to 15 years) using the straight-line method. Buildings are stated at cost and depreciated over an estimated useful life of approximately 20 years using the straight-line method. Leasehold improvements are stated at cost and amortized over the shorter of the estimated useful lives of the assets or the lease term. Capital improvements are stated at cost and amortized over the estimated useful lives of the underlying assets.
Acquired Technology and Other Intangibles
We have intangible assets in connection with certain assets we acquired from Siegfried in January 2008, including manufacturing facility production licenses and an assembled workforce, as well as our February 2001 acquisition of Bunsen Rush Laboratories, Inc., or Bunsen Rush, and its Melanophore technology. These assets are measured based on their fair value at acquisition. The useful life of our intangible assets is determined based on the period over which the asset is expected to contribute directly or indirectly to our future cash flows. We amortize our intangible assets using the straight-line method over estimated useful lives ranging from two to 20 years.
Long-lived Assets
If indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted cash flow projections. If impairment is indicated, we measure the impairment loss by comparing the fair value of the asset, estimated using discounted cash flows expected to be generated from the asset, to the carrying value.
Deferred Rent
For financial reporting purposes, rent expense is recognized on a straight-line basis over the term of the lease. The difference between rent expense and amounts paid under lease agreements is recorded as deferred rent in the liability section of our consolidated balance sheets.
Derivative Liabilities
We account for our warrants and other derivative financial instruments as either equity or liabilities based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded as additional paid-in capital on our consolidated balance sheet and no further adjustments to their valuation are made. Some of our warrants were determined to be ineligible for equity classification because of provisions that may result in an adjustment to their exercise price. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on our consolidated balance sheet at their fair value on the date of issuance and are revalued on each balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. We estimate the fair value of these liabilities using option pricing models that are based on the individual characteristics of the warrants or instruments on the valuation date, as well as assumptions for expected volatility, expected life and risk-free interest rate.
Foreign Currency Translation
The functional currency of our wholly owned subsidiary in Switzerland is the Swiss franc. Accordingly, all assets and liabilities of this subsidiary are translated to US dollars based on the applicable exchange rate on the balance sheet date. Revenue and expense components are translated to US dollars at weighted-average exchange rates in effect during the period. Gains and losses resulting from foreign currency translation are reported as a separate component of accumulated other comprehensive income or loss in the stockholders' equity section of our consolidated balance sheets. Foreign currency transaction gains and losses are included in our results of operations and, to date, have not been material.
Share-based Compensation
Compensation expense for all share-based awards, which we recognize on a straight-line basis over the vesting period, is estimated based on the grant-date fair value using the Black-Scholes option pricing model. We estimate forfeitures at the time of grant and revise our estimate in subsequent periods if actual forfeitures differ from those estimates. Such compensation expense is included in the applicable expense line item on our consolidated statements of operations.
We recognized total share-based compensation expense for all share-based awards of $3.7 million, $5.5 million and $7.1 million during the years ended December 31, 2011, 2010 and 2009, respectively.
Revenue Recognition
Our revenues to date have been generated primarily through collaborative agreements and a manufacturing services agreement. Our collaborative agreements can include multiple elements including licenses, research services and manufacturing. Consideration we receive under these arrangements may include upfront payments, research funding and milestone payments. For our multiple element transactions, if fair value exists for the undelivered and delivered elements whereby such elements have stand-alone value, we allocate the consideration to the elements based on their relative fair values. In cases where fair value exists for the undelivered elements but does not exist for the delivered elements, we use the residual method to allocate the arrangement consideration. In cases where fair value does not exist for the undelivered elements in an arrangement, we account for the transaction as a single unit of accounting. We typically defer non-refundable upfront payments under our collaborations and recognize them over the period in which we have significant involvement or perform services, using various factors specific to each collaboration. Amounts we receive for research funding for a specified number of full-time researchers are recognized as revenue as the services are performed. Revenue from a milestone payment is recognized when earned, as evidenced by acknowledgment from our collaborator, provided that (i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the agreement, (ii) the milestone represents the culmination of an earnings process, (iii) the milestone payment is non-refundable and (iv) our performance obligations after the milestone achievement will continue to be funded by our collaborator at a level comparable to the level before the milestone achievement. If all of these criteria are not met, the milestone payment is recognized over the remaining minimum period of our performance obligations under the agreement. Any advance payments we receive in excess of amounts earned are classified as deferred revenues until earned.
We manufacture drug products under a manufacturing services agreement for a single customer, Siegfried. Upon Siegfried's acceptance of drug products manufactured by us, we recognize manufacturing services revenues at agreed upon sales prices for such drug products. We have also contracted with Siegfried for them to provide us with administrative and other services in exchange for a fee. We determined that we are receiving an identifiable benefit for these services from Siegfried, and are recording such fees in the operating expense section of our consolidated statements of operations.
Research and Development Costs
Research and development expenses, which consist primarily of salaries and other personnel costs, costs associated with external clinical and preclinical study fees, manufacturing costs for non-commercial products and other related expenses, and the development of earlier-stage programs and technologies, are expensed as incurred when these expenditures have no alternative future uses.
Clinical Trial Expenses
We accrue clinical trial expenses based on work performed. In determining the amount to accrue, we rely on estimates of total costs incurred based on the enrollment of subjects, the completion of trials and other events. We follow this method because we believe reasonably dependable estimates of the costs applicable to various stages of a clinical trial can be made. However, the actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending on a number of factors. Differences between the actual clinical trial costs and the estimated clinical trial costs that we have accrued in any prior period are recognized in the subsequent period in which the actual costs become known. Historically, these differences have not been material; however, material differences could occur in the future.
Patent Costs
We record costs related to filing and prosecuting patent applications in general and administrative expenses as incurred, as recoverability of such expenditures is uncertain.
Comprehensive Income (Loss)
We report all components of comprehensive income (loss), including foreign currency translation gain and loss and unrealized gains and losses on investment securities, in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources.
Net Loss Per Share
We calculate basic and diluted net loss per share allocable to common stockholders using the weighted-average number of shares of common stock outstanding during the period, less any shares subject to repurchase or forfeiture. There were no shares of our common stock subject to repurchase or forfeiture for the years ended December 31, 2011, 2010 or 2009.
Because we are in a net loss position, we have excluded outstanding unvested performance-based restricted stock unit awards, which are subject to forfeiture, warrants and stock options, as well as unvested restricted stock in our deferred compensation plan, from our calculation of diluted net loss per share because including these securities in the calculation would be antidilutive for all years presented. The table below presents our securities that would otherwise be included in our calculation of diluted net loss per share allocable to common stockholders at December 31, 2011, 2010 and 2009.
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Warrants |
30,868,111 | 30,445,127 | 30,138,263 | |||||||||
|
Stock options |
10,309,972 | 8,358,594 | 7,226,824 | |||||||||
|
Performance-based restricted stock unit awards |
1,171,250 | 1,666,650 | 1,714,350 | |||||||||
|
Unvested restricted stock |
79,169 | 84,169 | 101,669 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total |
42,428,502 | 40,554,540 | 39,181,106 | |||||||||
|
|
|
|
|
|
|
|||||||
New Accounting Guidance
In June 2011, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2011-05, "Presentation of Comprehensive Income," which amends the presentation requirements for comprehensive income. Under ASU 2011-05, we will have the option to present the components of net income and comprehensive income as one single continuous statement or in two separate but consecutive statements. The current option to present other comprehensive income in the statement of stockholders' equity has been eliminated. ASU 2011-05 does not change the items that must be reported in comprehensive income. In December 2011, the FASB issued ASU 2011-12, "Presentation of Comprehensive Income," which defers the requirement to present reclassification adjustments on the face of the financial statements for items that are reclassified from other comprehensive income to net income in the statement(s) where the components of net income and the components of other comprehensive income are presented. These amendments are effective for us in the first quarter of 2012, and the impact will be presentation only.
In September 2011, the FASB issued ASU No. 2011-09, "Disclosures about an Employer's Participation in a Multiemployer Plan," which requires additional disclosures about an employer's participation in a multiemployer pension plan. ASU 2011-09 does not change the current measurement and recognition guidance. This guidance is effective for us for the year ended December 31, 2011. The adoption of ASU 2011-09 did not have a material impact on our consolidated financial statements (see Note 13).
|
|||
(2) Fair Value Disclosures
We measure our financial assets and liabilities at fair value, which is defined as the exit price, or the amount that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
We use the following three-level valuation hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value our financial assets and liabilities:
|
Level 1— |
Observable inputs such as unadjusted quoted prices in active markets for identical instruments. | |
|
Level 2— |
Quoted prices for similar instruments in active markets or inputs that are observable for the asset or liability, either directly or indirectly. | |
|
Level 3— |
Significant unobservable inputs based on our assumptions. | |
The following table presents our valuation hierarchy for our financial assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2011, in thousands:
| Fair Value Measurements at December 31, 2011 | ||||||||||||||||
| Balance at December 31, 2011 |
Quoted Prices in Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
|||||||||||||
|
Assets: |
||||||||||||||||
|
Money market funds and cash equivalents(1) |
$ | 35,307 | $ | 35,307 | $ | 0 | $ | 0 | ||||||||
|
Liabilities: |
||||||||||||||||
|
Warrants and other derivative instruments |
$ | 1,617 | $ | 0 | $ | 0 | $ | 1,617 | ||||||||
| (1) |
Included in cash and cash equivalents on our consolidated balance sheets. |
The following table presents our valuation hierarchy for our financial assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2010, in thousands:
| Fair Value Measurements at December 31, 2010 | ||||||||||||||||
| Balance at December 31, 2010 |
Quoted Prices in Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
|||||||||||||
|
Assets: |
||||||||||||||||
|
Money market funds and cash equivalents(1) |
$ | 138,195 | $ | 138,195 | $ | 0 | $ | 0 | ||||||||
|
Liabilities: |
||||||||||||||||
|
Warrants and other derivative instruments |
$ | 2,271 | $ | 0 | $ | 0 | $ | 2,271 | ||||||||
| (1) |
Included in cash and cash equivalents on our consolidated balance sheets. |
The following table presents the activity for our derivative liabilities, which are classified as Level 3 in our valuation hierarchy, during the years ended December 31, 2011, 2010 and 2009, in thousands:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Beginning balance |
$ | 2,271 | $ | 6,642 | $ | 2,118 | ||||||
|
Issuance of Deerfield derivative liabilities |
0 | 0 | 9,942 | |||||||||
|
Termination of Deerfield Additional Loan Election (see Note 7) |
(607 | ) | 0 | 0 | ||||||||
|
Gain from valuation of derivative liabilities |
(47 | ) | (4,371 | ) | (5,418 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Ending balance |
$ | 1,617 | $ | 2,271 | $ | 6,642 | ||||||
|
|
|
|
|
|
|
|||||||
|
|||
(3) Land, Property and Equipment
Land, property and equipment consisted of the following, in thousands:
| December 31, | ||||||||
| 2011 | 2010 | |||||||
|
Land |
$ | 10,854 | $ | 10,854 | ||||
|
Building and capital improvements |
67,081 | 67,086 | ||||||
|
Leasehold improvements |
19,092 | 19,272 | ||||||
|
Machinery and equipment |
48,906 | 49,278 | ||||||
|
Computers and software |
9,276 | 9,187 | ||||||
|
Furniture and office equipment |
2,121 | 2,573 | ||||||
|
|
|
|
|
|||||
| 157,330 | 158,250 | |||||||
|
Less accumulated depreciation and amortization |
(75,264 | ) | (66,717 | ) | ||||
|
|
|
|
|
|||||
|
Land, property and equipment, net |
$ | 82,066 | $ | 91,533 | ||||
|
|
|
|
|
|||||
Depreciation and amortization expense for our land, property and equipment totaled $10.1 million, $10.4 million and $11.0 million for the years ended December 31, 2011, 2010 and 2009, respectively.
|
|||
(4) Acquired Technology and Other Intangibles
In February 2001, we acquired Bunsen Rush for $15.0 million in cash and assumed $0.4 million in liabilities. We allocated $15.4 million to the patented Melanophore screening technology acquired in such transaction. We amortized this technology over its estimated useful life of 10 years.
In January 2008, we acquired from Siegfried certain drug product facility assets, including manufacturing facility production licenses and an assembled workforce originally valued at $12.1 million and $1.6 million, respectively. We amortized the acquired workforce over its estimated benefit of two years, and we are amortizing the manufacturing facility production licenses, which are necessary for us to produce and package tablets and other dosage forms in such facility, over their estimated useful life of 20 years.
Acquired technology and other intangibles, net, consisted of the following at December 31, 2011, and 2010, in thousands:
|
December 31, 2011 |
Gross Carrying Amount |
Accumulated Amortization |
Net | |||||||||
|
Acquired Melanophore screening technology |
$ | 15,378 | $ | (15,378 | ) | $ | 0 | |||||
|
Acquired manufacturing facility production licenses |
13,789 | (2,757 | ) | 11,032 | ||||||||
|
Acquired workforce |
1,786 | (1,786 | ) | 0 | ||||||||
|
|
|
|
|
|
|
|||||||
|
Total acquired technology and other intangibles, net |
$ | 30,953 | $ | (19,921 | ) | $ | 11,032 | |||||
|
|
|
|
|
|
|
|||||||
|
December 31, 2010 |
Gross Carrying Amount |
Accumulated Amortization |
Net | |||||||||
|
Acquired Melanophore screening technology |
$ | 15,378 | $ | (15,114 | ) | $ | 264 | |||||
|
Acquired manufacturing facility production licenses |
13,844 | (2,077 | ) | 11,767 | ||||||||
|
Acquired workforce |
1,793 | (1,793 | ) | 0 | ||||||||
|
|
|
|
|
|
|
|||||||
|
Total acquired technology and other intangibles, net |
$ | 31,015 | $ | (18,984 | ) | $ | 12,031 | |||||
|
|
|
|
|
|
|
|||||||
We recognized amortization expense of $0.3 million in the year ended December 31, 2011, and $1.5 million in both of the years ended December 31, 2010, and 2009 for the acquired Melanophore technology, $0.7 million, $0.6 million and $1.2 million in the years ended December 31, 2011, 2010 and 2009, respectively, for the manufacturing facility production licenses, and $0.8 million in the year ended December 31, 2009, for the acquired workforce. Using the exchange rate in effect on December 31, 2011, we expect to record amortization expense of $0.7 million per year through 2027 for the manufacturing facility production licenses.
|
|||
(5) Accounts Payable and Other Accrued Liabilities
Accounts payable and other accrued liabilities consisted of the following, in thousands:
| December 31, | ||||||||
| 2011 | 2010 | |||||||
|
Accounts payable |
$ | 2,363 | $ | 3,274 | ||||
|
Accrued expenses |
1,046 | 1,384 | ||||||
|
Accrued restructuring (see Note 12) |
17 | 0 | ||||||
|
Loss provision (see Note 6) |
1,203 | 0 | ||||||
|
Other accrued liabilities |
235 | 359 | ||||||
|
|
|
|
|
|||||
|
Total accounts payable and other accrued liabilities |
$ | 4,864 | $ | 5,017 | ||||
|
|
|
|
|
|||||
|
|||
(6) Note Payable to Siegfried and Related Agreements
In January 2008, Arena Pharmaceuticals GmbH, or Arena GmbH, our wholly owned subsidiary, acquired from Siegfried certain drug product facility assets, including manufacturing facility production licenses, fixtures, equipment, other personal property and real estate assets in Zofingen, Switzerland, under an asset purchase agreement between Siegfried and Arena GmbH. These assets are being used to manufacture lorcaserin and certain drug products for Siegfried. In connection with this transaction, Arena GmbH and Siegfried also entered into a long-term supply agreement for the active pharmaceutical ingredient of lorcaserin, a manufacturing services agreement and a technical services agreement. The purchase price under the asset purchase agreement was CHF 31.8 million in cash and 1,488,482 shares of our common stock valued at $8.0 million, which we issued to Siegfried in January 2008. We paid CHF 21.8 million, or $19.6 million, of the cash purchase price in January 2008 and paid the remaining CHF 10.0 million, or $11.1 million, in three separate installments during 2011.
In March 2011, Arena GmbH amended its agreements with Siegfried, effective January 1, 2011, whereby, among other changes, we agreed to pay Siegfried the last two CHF 3.3 million installments that were due in January 2012 and January 2013 in June 2011 and October 2011. Also under these amended agreements, Siegfried agreed (i) to order from Arena GmbH 400 million units of drug product for manufacture by Arena GmbH in 2011, (ii) to use its reasonable commercial effort to order from Arena GmbH 200 million units of drug product for manufacture by Arena GmbH from January 1, 2012, to June 30, 2012, and (iii) to reduce its fees for providing Arena GmbH with certain technical and business services. In exchange, Arena GmbH agreed to reduce its sales prices for the manufacturing services provided to Siegfried. The sales prices under this amended manufacturing services agreement are generally below Arena GmbH's cost to provide such services and are reduced from prior years.
In December 2011, Arena GmbH further amended its agreement with Siegfried related to the manufacture of drug product whereby Siegfried agreed to order 80% of its requirements of certain drug products from Arena GmbH for the calendar year 2012 at agreed upon sales prices in exchange for Arena GmbH providing further reductions to the sales prices for certain of the manufacturing services provided to Siegfried.
We recognized a total loss of $2.6 million in 2011 since our costs under the amended manufacturing services agreement will exceed the related revenues. Of this amount, $1.4 million related to services rendered in 2011 and $1.2 million relates to services expected to be rendered in 2012. This $1.2 million loss provision for the remaining services expected to be rendered through December 31, 2012, is recorded as part of our cost of manufacturing services on our consolidated statements of operations and in accounts payable and other accrued liabilities on our consolidated balance sheet.
Pursuant to the manufacturing services agreement, we recognized revenue of $5.3 million, $7.1 million and $6.6 million in the years ended December 31, 2011, 2010 and 2009, respectively, for manufacturing drug products for Siegfried. The revenue recognized in 2011 reflects the $1.4 million reduction related to the loss incurred for services rendered under the amended manufacturing services agreement. Upon Siegfried's acceptance of drug products manufactured by us, we recognize manufacturing services revenues at agreed upon sales prices for such drug products. The related cost to manufacture the drug products was $8.1 million, $7.4 million and $6.5 million in the years ended December 31, 2011, 2010 and 2009, respectively. The cost of manufacturing services recognized in 2011 included $1.2 million representing the estimated contract loss provision for services expected to be rendered through December 31, 2012, under the amended manufacturing services agreement.
We also recognized expenses of $3.0 million, $2.5 million and $2.3 million for services incurred under the technical services agreement in the years ended December 31, 2011, 2010 and 2009, respectively. The technical services agreement provides us with administrative and other services to operate the facility.
|
|||
(7) Note Payable to Deerfield
In July 2009, pursuant to a Facility Agreement we entered into in June 2009, or the Facility Agreement, with Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P., Deerfield International Limited, Deerfield Special Situations Fund, L.P., and Deerfield Special Situations Fund International Limited, or collectively Deerfield, Deerfield provided us with a $100.0 million secured loan. We received net proceeds of $95.6 million from this loan. In connection with the loan, we issued Deerfield warrants to purchase an aggregate of 28,000,000 shares of our common stock at an exercise price of $5.42 per share. We refer to these warrants as the $5.42 Warrants. Deerfield has the right to require us to accelerate principal payments under the loan under certain circumstances, including upon certain changes of control, and at any time we may prepay any or all of the outstanding principal at par.
Deerfield previously had the right to make a one-time election, which we refer to as the Deerfield Additional Loan Election, to loan us up to an additional $20.0 million under the Facility Agreement, with the additional loan maturing on the same date as the original loan, June 17, 2013. For each additional $1.0 million that Deerfield loaned us under the Facility Agreement, we would have been required to issue Deerfield warrants for 280,000 shares of our common stock at an exercise price of $5.42 per share. In addition, Deerfield previously had an additional right to require us to accelerate payments under the loan in connection with certain equity issuances. Each of these rights was terminated in March 2011 as described below.
In accordance with relevant guidance, we separately valued four components under the Facility Agreement as of the date of the initial loan. Since that date, as discussed below in this note, we have amended the terms of the Facility Agreement, repaid certain of the debt, and exchanged certain of the warrants, which affects how we value and account for the Facility Agreement. The four components under the Facility Agreement were previously valued as of July 6, 2009 as follows:
| (1) | The $100.0 million loan was valued at $47.9 million on a relative fair value basis, and was recorded as a long-term liability on our consolidated balance sheet. |
| (2) | The 2009 Warrants to purchase an aggregate of 28,000,000 shares of our common stock, net of issuance costs, were valued at $39.1 million on a relative fair value basis. The relative fair value of the warrants was recorded as additional paid-in capital on our consolidated balance sheet, and the resulting debt discount is being accreted to interest expense over the term of the loan or until paid using the effective interest rate method. These warrants were valued at their date of issuance using an option pricing model and the following assumptions: expected life of 3.95 years, risk-free interest rate of 2.0%, expected volatility of 66% and no dividend yield. Because these warrants are eligible for equity classification, no adjustments to the recorded value will be made on an ongoing basis. |
| (3) | The Deerfield Additional Loan Election was valued at $9.5 million. The Deerfield Additional Loan Election was classified as a liability on our consolidated balance sheet and, accordingly, was revalued on each subsequent balance sheet date until it was terminated, with any changes in the fair value between reporting periods recorded in the interest and other income (expense) section of our consolidated statements of operations (see Note 8). Until the Deerfield Additional Loan Election was terminated in 2011, we accreted the additional debt discount that resulted from the allocation of proceeds under the Facility Agreement to interest expense using the effective interest rate method. |
| (4) | Deerfield's ability to accelerate principal payments under the loan under certain circumstances, including upon certain changes of control, was valued at $0.5 million. The acceleration right was classified as a liability on our consolidated balance sheet and, accordingly, will be revalued on each subsequent balance sheet date until it is exercised or expires, with any changes in the fair value between reporting periods recorded in the interest and other income (expense) section of our consolidated statements of operations (see Note 8). This allocation of proceeds under the Facility Agreement resulted in additional debt discount that is being accreted to interest expense over the term of the loan or until paid using the effective interest rate method. |
As a result of the closing of our public offering of common stock in July 2009, which occurred after we entered into the Facility Agreement, we were required to repay Deerfield $10.0 million that was originally scheduled to be repaid in July 2010. In connection with this $10.0 million repayment, we retired a proportional share of the debt discount and issuance costs directly related to the repaid debt and recognized a non-cash loss on extinguishment of debt of $2.5 million in 2009.
In June 2010, we entered into a Purchase and Exchange Agreement, or the 2010 Purchase Agreement, with Deerfield, pursuant to which we sold Deerfield 11,000,000 shares of our common stock at a price of $3.23 per share, resulting in net proceeds to us of $35.5 million. Also pursuant to the 2010 Purchase Agreement, we exchanged a portion of the $5.42 Warrants to purchase an aggregate of 16,200,000 shares of our common stock at an exercise price of $5.42 per share for new warrants, which we refer to as the $3.45 Warrants, to purchase a like number of shares of our common stock at an exercise price of $3.45 per share. The outstanding $3.45 Warrants are exercisable until June 17, 2013. Other than the exercise price and certain provisions related to cashless exercise and early termination of the warrants, the $3.45 Warrants contain substantially the same terms as the $5.42 Warrants.
We valued the $3.45 Warrants at their June 2010 issuance date using an option pricing model and the following assumptions: expected life of 3.03 years, risk-free interest rate of 1.2%, expected volatility of 72% and no dividend yield. We determined that the incremental value of the $3.45 Warrants was $5.5 million, which was recorded as a component of the stock issuance and warrant exchange under the 2010 Purchase Agreement in the stockholders' equity section of our consolidated balance sheet. Because the $3.45 Warrants are eligible for equity classification, no adjustments to the recorded value will be made on an ongoing basis.
In August 2010, we sold 8,955,224 shares of our common stock at a price of $6.70 per share in a registered direct public offering to Deerfield. As part of this transaction, we entered into an amendment to the Facility Agreement, pursuant to which $30.0 million of the proceeds from this transaction was used to prepay the portion of the principal amount that was originally scheduled to be repaid in July 2012. Net proceeds to us from this transaction, after prepayment of the $30.0 million, were approximately $30.0 million. In connection with this $30.0 million prepayment, we retired a proportional share of the debt discount and issuance costs directly related to the repaid debt and recognized a non-cash loss on extinguishment of debt of $12.4 million in 2010.
To reduce our interest payments, in January 2011, we prepaid $20.0 million of the principal amount that was originally scheduled to be repaid to Deerfield in July 2011. In connection with this $20.0 million prepayment, we retired a proportional share of the debt discount and issuance costs directly related to the repaid debt and recognized a non-cash loss on extinguishment of debt of $2.5 million.
In March 2011, we and Deerfield entered into (i) an Exchange Agreement, (ii) a Securities Purchase Agreement and (iii) a Second Amendment to the Facility Agreement, or the Second Amendment.
Under the Exchange Agreement, we agreed to exchange 14,368,590 of the $3.45 Warrants for new warrants, which we refer to as the $1.68 Warrants, to purchase a like number of shares of our common stock at an exercise price of $1.68 per share. The $1.68 Warrants are exercisable until June 17, 2015. Other than the exercise period, the exercise price and certain provisions related to cashless exercise and early termination of the warrants, the $5.42 Warrants, the $3.45 Warrants and the $1.68 Warrants each contain substantially the same terms.
Under the Securities Purchase Agreement, Deerfield purchased 12,150,000 shares of our common stock for a purchase price of $1.46 per share and 12,150 shares of our Series C Convertible Preferred Stock, or Series C Preferred, for a purchase price of $1,460.00 per share. Each share of Series C Preferred was convertible into 1,000 shares of our common stock at any time at the option of the holder, subject to certain limitations. In April 2011, Deerfield converted all of the Series C Preferred into a total of 12,150,000 shares of common stock. The fair value of the common stock into which the Series C Preferred was convertible on the date of issuance exceeded the proceeds allocated to the Series C Preferred on a relative fair value basis by $2.3 million, resulting in a beneficial conversion feature that we recognized as a decrease to additional paid-in capital and a deemed dividend to the Series C Preferred stockholders.
Under the Second Amendment, we prepaid $17.7 million of the principal amount that was originally scheduled to be repaid to Deerfield in June 2013. After deducting such prepayment, net proceeds to us under the Securities Purchase Agreement were approximately $17.6 million. In connection with this $17.7 million prepayment, we retired a proportional share of the debt discount and issuance costs directly related to the repaid debt and recognized a non-cash loss on extinguishment of debt of $8.0 million.
The Second Amendment also eliminated the Deerfield Additional Loan Election and our obligation to accelerate payments under the loan in connection with certain equity issuances.
We valued the $1.68 Warrants at their March 2011 issuance date using an option pricing model and the following assumptions: expected life of 4.21 years, risk-free interest rate of 1.9%, expected volatility of 82% and no dividend yield. We determined that the incremental value of the $1.68 Warrants was $6.0 million, which was recorded as a component of the stock issuance and warrant exchange in the stockholders' equity section of our consolidated balance sheet. Because the $1.68 Warrants are eligible for equity classification, no adjustments to the recorded value will be made on an ongoing basis.
At December 31, 2011, the outstanding principal balance on the Deerfield loan, which is due on June 17, 2013, was $22.3 million. See Note 17 regarding the principal prepayment made subsequent to December 31, 2011. The difference between the $14.7 million recorded value and the $22.3 million outstanding principal balance of the loan as of December 31, 2011, represents the remaining debt discount, which we will accrete over the term of the loan or until paid. The outstanding principal accrues interest at the contractual rate of 7.75% per annum on the stated principal balance, payable quarterly in arrears. Total interest expense of $6.6 million, $14.0 million and $11.2 million, including accretion of the debt discount attributable to the warrants and the other derivative financial instruments and amortization of capitalized issuance costs, was recognized in connection with this loan in the years ended December 31, 2011, 2010 and 2009, respectively. In the year ended December 31, 2010, a non-cash correction of prior period errors resulted in a $3.0 million decrease to interest expense. The current effective annual interest rate on the loan is 38.4%.
|
|||
(8) Derivative Liabilities
In June 2006 and August 2008, we issued seven-year warrants, which we refer to as the Series B Warrants, to purchase 829,856 and 1,106,344 shares of our common stock, respectively, at an exercise price of $15.49 and $7.71 per share, respectively. The Series B Warrants are related to our Series B Convertible Preferred Stock, which we redeemed in 2008 and is no longer outstanding. These warrants contain an anti-dilution provision and, as a result of subsequent equity issuances at prices below the adjustment price of $6.72 defined in the warrants, as of December 31, 2011, the number of shares issuable upon exercise of the outstanding June 2006 and August 2008 Series B Warrants was increased to 1,227,743 and 1,640,368, respectively, at an exercise price of $10.47 and $5.20 per share, respectively. See Note 17 regarding further adjustments made to the number of shares issuable upon exercise and the exercise prices subsequent to December 31, 2011. The Series B Warrants are classified as a liability on our consolidated balance sheets.
In accordance with relevant guidance, we have revalued these warrants on each subsequent balance sheet date, and will continue to do so until they are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. The June 2006 and August 2008 Series B Warrants were valued at December 31, 2011, and 2010 using an option pricing model and the following assumptions:
| December 31, 2011 | December 31, 2010 | |||||||||||||||
| June 2006 Series B Warrants |
August 2008 Series B Warrants |
June 2006 Series B Warrants |
August 2008 Series B Warrants |
|||||||||||||
|
Risk-free interest rate |
0.2 | % | 0.6 | % | 0.8 | % | 1.8 | % | ||||||||
|
Dividend yield |
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
|
Expected volatility |
90 | % | 99 | % | 96 | % | 83 | % | ||||||||
|
Expected life (years) |
1.50 | 3.62 | 2.50 | 4.62 | ||||||||||||
As of the July 2009 issuance date of the Deerfield loan, we separately valued the Deerfield Additional Loan Election, including the 5,600,000 contingently issuable warrants to purchase up to 5,600,000 shares of our common stock. Because the Deerfield Additional Loan Election was classified as a liability on our consolidated balance sheet until this right was terminated in March 2011 (see Note 7), it was revalued on each subsequent balance sheet date, with any changes in the fair value between reporting periods recorded as other income or expense. Upon its termination in March 2011, the $0.6 million value recorded for the Deerfield Additional Loan Election was recorded as a component of the stock issuance and warrant exchange in the stockholders' equity section of our consolidated balance sheet.
We also separately valued Deerfield's right to require us to accelerate payments under the loan under certain circumstances, including upon certain changes of control, at $0.5 million as of the July 2009 issuance date of the Deerfield loan (see Note 7). The value of this acceleration right is classified as a liability on our consolidated balance sheet and, accordingly, will be revalued on each subsequent balance sheet date until it is exercised or expires, with any changes in the fair value between reporting periods recorded as other income or expense. At each reporting date, this acceleration right was valued using a discounted cash flow model.
Our derivative liabilities consisted of the following, as of December 31, 2011, and 2010, in thousands:
| December 31 | ||||||||
| 2011 | 2010 | |||||||
|
Deerfield Additional Loan Election |
$ | 0 | $ | 607 | ||||
|
|
|
|
|
|||||
|
Total current derivative liabilities |
0 | 607 | ||||||
|
|
|
|
|
|||||
|
Series B Warrants |
1,562 | 1,234 | ||||||
|
Deerfield acceleration right |
55 | 430 | ||||||
|
|
|
|
|
|||||
|
Total long-term derivative liabilities |
1,617 | 1,664 | ||||||
|
|
|
|
|
|||||
|
Total derivative liabilities |
$ | 1,617 | $ | 2,271 | ||||
|
|
|
|
|
|||||
The change in the fair value of our derivative liabilities is recorded in the interest and other income (expense) section of our consolidated statements of operations. The following table presents the gain (loss) we recognized in the years ended December 31, 2011, 2010 and 2009, in thousands:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Series B Warrants |
$ | (328 | ) | $ | 1,152 | $ | (268 | ) | ||||
|
Deerfield acceleration right |
375 | (5 | ) | 34 | ||||||||
|
Deerfield Additional Loan Election |
0 | 3,224 | 5,652 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total gain from valuation of derivative liabilities |
$ | 47 | $ | 4,371 | $ | 5,418 | ||||||
|
|
|
|
|
|
|
|||||||
|
|||
(9) Commitments
We lease one of our US properties under an operating lease that expires in 2013 with two five-year options to extend the lease term beyond 2013. The terms of this lease stipulate annual increases in monthly rental payments of 2.75%. We lease space in various facilities in Switzerland that can be terminated with 12 months written notice under an agreement that expires in 2032. The agreement stipulates that the annual rental payments are indexed to the Swiss Consumer Price Index. We also have four other US properties that we occupy under sale and leaseback agreements that allow us the option to repurchase these properties at various dates between 2012 and 2027 and, in some cases, include renewal options. We have also assigned an option to purchase one of our leased US properties under these sale and leaseback agreements. The terms of these leases stipulate annual increases in monthly rental payments of 2.0% to 2.5%. We account for our sale and leaseback transactions using the required financing method because our options to repurchase these properties in the future are considered continued involvement. Under the financing method, the book value of the properties and related accumulated depreciation remain on our balance sheet and no sale is recognized. Instead, the sales price of the properties is recorded as a financing obligation, and a portion of each lease payment is recorded as interest expense. We recorded interest expense of $7.3 million, $7.4 million and $7.3 million in the years ended December 31, 2011, 2010 and 2009, respectively, related to these leases. We expect interest expense related to our facilities to total $71.2 million from December 31, 2011, through the terms of the leases. As of December 31, 2011, the total financing obligation for these facilities was $75.8 million. The aggregate residual value of the facilities at the end of the lease terms is $10.0 million.
In accordance with the lease terms for certain of our US properties, we are required to maintain deposits for the benefit of the landlord throughout the term of the leases. A total of $1.4 million was recorded in other non-current assets on our consolidated balance sheets as of December 31, 2011, and 2010 related to such leases.
We recognize rent expense on a straight-line basis over the term of each lease. Rent expense of $1.2 million was recognized in each of the years ended December 31, 2011, 2010 and 2009.
Annual future obligations as of December 31, 2011, are as follows, in thousands:
|
Year ending December 31, |
Financing Obligations |
Operating Leases |
||||||
|
2012 |
$ | 7,700 | $ | 882 | ||||
|
2013 |
8,601 | 256 | ||||||
|
2014 |
8,816 | 0 | ||||||
|
2015 |
9,036 | 0 | ||||||
|
2016 |
9,262 | 0 | ||||||
|
Thereafter |
93,606 | 0 | ||||||
|
|
|
|
|
|||||
|
Total minimum lease payments |
137,021 | $ | 1,138 | |||||
|
|
|
|||||||
|
Less amounts representing interest |
(71,240 | ) | ||||||
|
Add amounts representing residual value |
9,990 | |||||||
|
|
|
|||||||
|
Lease financing obligations |
75,771 | |||||||
|
Less current portion |
(1,313 | ) | ||||||
|
|
|
|||||||
| $ | 74,458 | |||||||
|
|
|
|||||||
|
|||
(10) Stockholders' Equity
Preferred Stock
In October 2002, and in conjunction with the stockholders' rights plan (see "Stockholders' Rights Plan" below in this note), our board of directors created a series of preferred stock, consisting of 350,000 shares with a par value of $.0001 per share, designated as Series A Junior Participating Preferred Stock, or the Series A Preferred Stock. Such number of shares may be increased or decreased by our board of directors, provided that no decrease shall reduce the number of shares of Series A Preferred Stock to a number less than the number of shares then outstanding, plus the number of shares reserved for issuance upon the exercise of outstanding options, rights or warrants or upon the conversion of any of our outstanding securities convertible into Series A Preferred Stock. As of December 31, 2011, and 2010, no shares of Series A Preferred Stock were issued or outstanding.
Treasury Stock
In October 2003, Biotechnology Value Fund, L.P., and certain of its affiliates accepted our offer of $23.1 million to purchase from them 3,000,000 shares of our common stock at a cash price of $7.69 per share, which shares are recorded on our consolidated balance sheets as treasury stock.
Warrants
In July 2009, we issued to Deerfield the $5.42 Warrants to purchase an aggregate of 28,000,000 shares of our common stock at an exercise price of $5.42 per share in connection with our receipt of a $100.0 million loan. We valued the $5.42 Warrants, which are recorded as additional paid-in capital on our consolidated balance sheet, at $39.1 million on a relative fair value basis as of the July 6, 2009 issuance date, net of allocated issuance costs (see Note 7).
As part of our June 2010 sale of common stock to Deerfield (see Note 7), we exchanged 16,200,000 of the $5.42 Warrants for the $3.45 Warrants to purchase a like number of shares of our common stock. We valued the incremental value of the $3.45 Warrants at $5.5 million as of their issuance date.
As part of our March 2011 sale of common and preferred stock to Deerfield (see Note 7), we exchanged 14,368,590 of the $3.45 Warrants for the $1.68 Warrants to purchase a like number of shares of our common stock, and extended the expiration date of these warrants to June 17, 2015. We valued the incremental value of the $1.68 Warrants at $6.0 million as of their issuance date.
In June 2006 and August 2008, we issued our Series B Warrants (see Note 8). These warrants contain an anti-dilution provision and, as a result of subsequent equity issuances at prices below the adjustment price of $6.72 defined in the warrants, as of December 31, 2011, the outstanding June 2006 and August 2008 Series B Warrants were exercisable for 1,227,743 and 1,640,368 shares, respectively, at exercise prices of $10.47 and $5.20 per share, respectively.
The following table summarizes our outstanding warrants as of December 31, 2011:
| Balance Sheet Classification |
Number of Warrants |
Exercise Price |
Expiration Date |
|||||||||||||
|
Deerfield $1.68 Warrants |
Equity | 14,368,590 | $ | 1.68 | June 17, 2015 | |||||||||||
|
Deerfield $5.42 Warrants |
Equity | 11,800,000 | $ | 5.42 | June 17, 2013 | |||||||||||
|
Deerfield $3.45 Warrants |
Equity | 1,831,410 | $ | 3.45 | June 17, 2013 | |||||||||||
|
August 2008 Series B Warrants |
Liability | 1,640,368 | $ | 5.20 | August 14, 2015 | |||||||||||
|
June 2006 Series B Warrants |
Liability | 1,227,743 | $ | 10.47 | June 30, 2013 | |||||||||||
|
|
|
|||||||||||||||
|
Total number of warrants outstanding |
30,868,111 | |||||||||||||||
|
|
|
|||||||||||||||
See Note 17 regarding the warrant exchange and related adjustments made subsequent to December 31, 2011.
Equity Compensation Plans
In June 2009, our stockholders approved our 2009 Long-Term Incentive Plan, or 2009 LTIP. When our 2006 Long-Term Incentive Plan, as amended, or 2006 LTIP, was adopted, our Amended and Restated 1998 Equity Compensation Plan, Amended and Restated 2000 Equity Compensation Plan, and 2002 Equity Compensation Plan (or together with the 2006 LTIP, the "Prior Plans") were terminated. Upon stockholder approval of the 2009 LTIP, the 2006 LTIP was also terminated. However, notwithstanding such termination of the Prior Plans, all outstanding awards under the Prior Plans will continue to be governed under the terms of the Prior Plans.
There were 6,488,112 shares available for issuance under the 2009 LTIP as of the date of stockholder approval in June 2009, and 4,144,008 shares were available for issuance at December 31, 2011. Such shares may be granted as incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance awards. Subject to certain limited exceptions, (i) stock options and stock appreciation rights granted under the 2009 LTIP reduce the available number of shares by one share for every share issued while awards other than stock options and stock appreciation rights granted under the 2009 LTIP reduce the available number of shares by 1.3 shares for every share issued, and (ii) shares that are released from awards granted under the Prior Plans or the 2009 LTIP because the awards expire, are forfeited or are settled for cash will increase the number of shares available under the 2009 LTIP by one share for each share released from a stock option or stock appreciation right and by 1.3 shares for each share released from a restricted stock award or restricted stock unit award.
Stock options granted under the 2009 LTIP generally vest 25% a year over four years and are exercisable for up to 10 years from the date of grant. The recipient of a restricted stock award has all rights of a stockholder at the date of grant, subject to certain restrictions on transferability and a risk of forfeiture. The minimum performance period under a performance award is 12 months. Neither the exercise price of an option nor the grant price of a stock appreciation right may be less than 100% of the fair market value of the common stock on the date such option or stock appreciation right is granted, except in specified situations. The 2009 LTIP prohibits repricings of options and stock appreciation rights (other than to reflect stock splits, spin-offs or certain other corporate events) unless stockholder approval is obtained.
In 2003, we set up a deferred compensation plan for our executive officers, whereby executive officers elected to contribute their shares of restricted stock into the plan. At December 31, 2011, 2010 and 2009, there were 79,169, 84,169 and 101,669 shares, respectively, of restricted stock in the plan.
The following table summarizes our stock option activity under the Prior Plans and the 2009 LTIP, or collectively, our Equity Compensation Plans, for the year ended December 31, 2011:
| Options | Weighted- Average Exercise Price |
Weighted-Average Remaining Contractual Term (in years) |
Aggregate Intrinsic Value (in thousands) |
|||||||||||||
|
Outstanding at December 31, 2010 |
8,358,594 | $ | 7.63 | |||||||||||||
|
Granted |
3,549,062 | 1.46 | ||||||||||||||
|
Exercised |
0 | |||||||||||||||
|
Forfeited/cancelled/expired |
(1,597,684 | ) | 6.85 | |||||||||||||
|
|
|
|
|
|||||||||||||
|
Outstanding at December 31, 2011 |
10,309,972 | $ | 5.63 | 6.22 | $ | 1,372 | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Vested and expected to vest at December 31, 2011 |
9,952,135 | $ | 5.77 | 6.12 | $ | 1,258 | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Vested and exercisable at December 31, 2011 |
5,974,887 | $ | 8.11 | 4.36 | $ | 166 | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
The aggregate intrinsic value in the above table is calculated as the difference between the closing price of our common stock at December 31, 2011, of $1.87 per share and the exercise price of stock options that had strike prices below the closing price. There were no stock options exercised in 2011, and the intrinsic value of all stock options exercised during the years ended December 31, 2010 and 2009 was $55,000 and $38,000, respectively.
We granted 1,690,500 and 371,800 performance-based restricted stock unit awards under the 2006 LTIP in February 2007 and March 2008, respectively. The awards provide employees until February 26, 2012, to achieve four specific drug development and strategic performance goals. A fixed number of awards will be earned for each goal that is successfully achieved. Once earned, the awards will remain unvested until the performance period is complete. Any awards that have been earned at February 26, 2012, will vest and be settled in shares of our common stock, with the holder receiving one share of common stock for each award earned and vested. Termination of employment prior to vesting will result in the forfeiture of any earned (as well as unearned) awards, except in limited circumstances such as termination due to death, disability or a change in control. No compensation expense has been recognized to date related to these awards as achievement of the performance goals has not been deemed probable. The following table summarizes activity with respect to such awards during the year ended December 31, 2011:
| Performance Units |
Weighted-Average Grant-Date Fair Value |
|||||||
|
Outstanding at December 31, 2010 |
1,666,650 | $ | 12.50 | |||||
|
Granted |
0 | |||||||
|
Vested |
0 | |||||||
|
Forfeited/cancelled |
(495,400 | ) | 12.22 | |||||
|
|
|
|
|
|||||
|
Outstanding at December 31, 2011 |
1,171,250 | $ | 12.62 | |||||
|
|
|
|
|
|||||
|
Vested at December 31, 2011 |
0 | |||||||
|
|
|
|
|
|||||
Employee Stock Purchase Plans
In June 2009, our stockholders approved our 2009 Employee Stock Purchase Plan, or 2009 ESPP, which provides for the issuance of up to 1,500,000 shares of our common stock and qualifies under Section 423 of the Internal Revenue Code. As of December 31, 2011, a total of 945,367 shares had been issued under the 2009 ESPP, and 554,633 shares of common stock were available for issuance under the 2009 ESPP.
Under the 2009 ESPP, substantially all of our employees can choose to have up to 15% of their compensation withheld to purchase up to 625 shares of common stock per purchase period, subject to certain limitations. The shares of common stock may be purchased over an offering period with a maximum duration of 24 months and at a price of not less than 85% of the lesser of the fair market value of the common stock on (i) the first trading day of the applicable offering period or (ii) the last trading day of the applicable three-month purchase period.
During the years ended December 31, 2011, 2010 and 2009, 272,014, 399,095 and 364,096 shares, respectively, were purchased under our employee stock purchase plans.
Share-based Compensation
We use the Black-Scholes option pricing model to estimate the grant-date fair value of share-based awards in determining our share-based compensation expense. The table below sets forth the weighted-average assumptions and estimated fair value of stock options we granted under our Equity Compensation Plans during the years ended December 31, 2011, 2010 and 2009:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Risk-free interest rate |
2.2 | % | 2.4 | % | 2.0 | % | ||||||
|
Dividend yield |
0 | % | 0 | % | 0 | % | ||||||
|
Expected volatility |
86 | % | 73 | % | 86 | % | ||||||
|
Expected life (years) |
5.86 | 5.76 | 5.72 | |||||||||
|
Weighted-average estimated fair value per share of stock options granted |
$ | 1.06 | $ | 2.03 | $ | 2.87 | ||||||
The table below sets forth the assumptions and estimated fair value of the options to purchase stock granted under our employee stock purchase plans for multiple offering periods during the years ended December 31, 2011, 2010 and 2009:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Risk-free interest rate |
0.0% - 1.1% | 0.1% - 1.6% | 0.1% - 3.3% | |||||||||
|
Dividend yield |
0% | 0% | 0% | |||||||||
|
Expected volatility |
71% - 106% | 71% - 85% | 53% - 82% | |||||||||
|
Expected life (years) |
0.25 - 2.0 | 0.25 - 2.0 | 0.25 - 2.0 | |||||||||
|
Range of fair value per share of options granted under our employee stock purchase plans |
$ | 0.56 to $3.28 | $ | 0.74 to $3.28 | $ | 1.45 to $2.85 | ||||||
Expected volatility is based on a combination of 75% historical volatility of our common stock and 25% market-based implied volatilities from traded options on our common stock, with historical volatility being more heavily weighted due to the historically low volume of traded options on our common stock. The expected life of options is determined based on historical experience of similar awards, giving consideration to the contractual terms of the share-based awards, vesting schedules and post-vesting terminations. The risk-free interest rates are based on the US Treasury yield curve, with a remaining term approximately equal to the expected term used in the option pricing model.
Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Based on historical experience, forfeitures of unvested options were estimated to be 6.3% and 7.0% for the years ended December 31, 2011, and 2010. Forfeitures were estimated to be 6.4% in the first quarter of 2009 and 8.5% for the balance of 2009. As a result, we recorded additional share-based compensation expense of $0.3 million and $0.4 million for the years ended December 31, 2011, and 2010, respectively, and we reduced our share-based compensation expense by $0.5 million for the year ended December 31, 2009. If actual forfeitures vary from estimates, we will recognize the difference in compensation expense in the period the actual forfeitures occur or when stock options vest.
We recognized share-based compensation expense as follows, in thousands, except per share data:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Research and development |
$ | 1,958 | $ | 3,404 | $ | 4,078 | ||||||
|
General and administrative |
1,696 | 2,091 | 2,765 | |||||||||
|
Restructuring charges |
94 | 0 | 306 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total share-based compensation expense and impact on net loss allocable to common stockholders |
$ | 3,748 | $ | 5,495 | $ | 7,149 | ||||||
|
|
|
|
|
|
|
|||||||
|
Impact on net loss per share allocable to common stockholders, basic and diluted |
$ | 0.03 | $ | 0.05 | $ | 0.08 | ||||||
|
|
|
|
|
|
|
|||||||
At December 31, 2011, total unrecognized estimated compensation cost, including estimated forfeitures, related to unvested stock options was $3.5 million, which is expected to be recognized over a weighted-average remaining requisite service period of 2.69 years.
There were no stock options exercised during the year ended December 31, 2011. Cash of $0.3 million was received from stock purchases under the employee stock purchase plans during the year ended December 31, 2011. There is no tax impact related to share-based compensation or stock option exercises because we are in a net operating loss position with a full valuation allowance.
Common Shares Reserved for Future Issuance
The following shares of our common stock are reserved for future issuance at December 31, 2011:
|
Outstanding warrants |
30,868,111 | |||
|
Equity Compensation Plans |
15,625,230 | |||
|
2009 ESPP |
554,633 | |||
|
Deferred compensation plan |
79,169 | |||
|
|
|
|||
|
Total |
47,127,143 | |||
|
|
|
Stockholders' Rights Plan
In October 2002, our board of directors adopted a stockholders' rights plan, or the Rights Agreement, under which all stockholders of record as of November 13, 2002, received rights to purchase shares of the Series A Preferred Stock, or the Rights. Each Right entitles the registered holder to purchase from us one one-hundredth of a share of the Series A Preferred Stock at an initial exercise price of $36.00 per share, subject to adjustment. The Rights are not exercisable until the 10th day after such time as a person or group acquires beneficial ownership of 10% or more, or announces a tender offer for 10% or more, of our common stock. At such time, all holders of the Rights, other than the acquiror, will be entitled to purchase shares of our common stock at a 50% discount to the then current market price.
The Rights will trade with our common stock, unless and until they are separated due to a person or group acquiring beneficial ownership of 10% or more, or announcing a tender offer for 10% or more, of our common stock. Our board of directors may terminate the Rights Agreement at any time or redeem the Rights prior to the time a person acquires 10% or more of the common stock.
In November 2006, the Rights Agreement was amended to provide, among other things, that the triggering percentage for when a Beneficial Owner (as defined in the Rights Agreement) of our common stock would be an Acquiring Person (as further defined in the Amendment) increased from 10% to 15%.
|
|||
(11) Collaborations
Eisai Inc.
In July 2010, our wholly owned subsidiary, Arena GmbH, entered into a marketing and supply agreement with Eisai. Under this agreement, Arena GmbH granted Eisai exclusive rights to commercialize lorcaserin in the United States and its territories and possessions subject to FDA approval of the lorcaserin NDA. As part of the agreement, Arena GmbH is obligated to manufacture lorcaserin at our facility in Switzerland, and Eisai is obligated to purchase all of its requirements of lorcaserin from Arena GmbH. Under this agreement, Eisai and we will share equally the development expenses for certain additional development work required by the FDA prior to approval of our NDA for lorcaserin. If the FDA requires development work following approval of lorcaserin, Eisai will bear 90% and we will bear 10% of such expenses, except that Eisai and we will share equally the costs of certain pediatric or adolescent studies.
We received a non-refundable, upfront payment of $50.0 million from Eisai, and, following US regulatory approval of lorcaserin and upon the delivery of product supply for launch, will receive an additional $40.0 million or $60.0 million, depending on the approved drug label. We recorded the $50.0 million upfront payment as deferred revenues and were originally recognizing it as revenue ratably over 13 years, which represented the period in which we expected to have significant involvement. In 2011, based on revised expectations of the timing of regulatory approval for lorcaserin, if ever, we re-assessed such period and are now recognizing this revenue ratably over 14.5 years. Accordingly, at December 31, 2011, our consolidated balance sheet included $3.5 million and $41.2 million for the current and non-current portion, respectively, of such deferred revenues.
From the inception of the Eisai collaboration through December 31, 2011, we have recognized revenues of $5.4 million from amortization of the $50.0 million upfront payment we received in 2010 and $3.3 million for reimbursement of additional development expenses. In 2011, we recognized revenues totaling $6.8 million, of which $3.5 million was from amortization of the upfront payment and $3.3 million was for reimbursement of additional development expenses. In 2010, we recognized revenues of $1.9 million, all of which was from amortization of the upfront payment.
We are obligated to sell lorcaserin to Eisai for a purchase price starting at 31.5% of Eisai's annual net product sales, and the purchase price will increase on a tiered basis to 36.5% on the portion of annual net product sales exceeding $750.0 million, subject to reduction in the event of generic competition and certain other circumstances. We are also eligible to receive up to an aggregate of $1.19 billion in purchase price adjustment payments based on Eisai's annual net sales of lorcaserin, with the first and last amounts payable with annual net sales of $250.0 million and $2.5 billion, respectively. Of these purchase price adjustment payments, Eisai is obligated to pay us a total of $330.0 million for annual net sales of up to $1.0 billion. We are also eligible to receive up to an additional $70.0 million in regulatory and development milestone payments.
Eisai and we have agreed to not commercialize outside of our marketing and supply agreement any product that competes with lorcaserin in the United States. Our marketing and supply agreement includes a stand-still provision limiting Eisai's ability to acquire our securities and assets.
Unless terminated earlier, our marketing and supply agreement will continue in effect until terminated by Eisai following the later of the expiration of all issued lorcaserin patents for the United States and 12 years after the first commercial sale of lorcaserin in the United States. Either party has the right to terminate this agreement early in certain circumstances, including (i) if the other party is in material breach, (ii) for certain commercialization concerns and (iii) for certain intellectual property infringement. Eisai also has the right to terminate this agreement early in certain circumstances, including (a) if sales of generic equivalents of lorcaserin in the United States exceed sales of lorcaserin in the United States (based on volume) and (b) if Eisai is acquired by a company that has a product that competes with lorcaserin.
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Our collaboration and license agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc., or Ortho-McNeil-Janssen, terminated in December 2010. Upon termination, all rights to the compounds developed under the collaboration, and related intellectual property and other information (including the investigational new drug, or IND, application relating to APD597) reverted to us. We entered into the collaboration in December 2004 to further develop compounds for the potential treatment of type 2 diabetes and other disorders. Under the collaboration, Ortho-McNeil-Janssen advanced APD668 and APD597, first and second generation GPR119 agonists for the treatment of type 2 diabetes, respectively, into clinical trials.
From the inception of this collaboration through December 31, 2011, we received $27.5 million from Ortho-McNeil-Janssen in upfront and milestone payments, $7.2 million in research funding and $21.0 million for patent activities and additional sponsored research. For the year ended December 31, 2011, we recognized revenues of $0.5 million under this agreement, primarily for patent activities. For the year ended December 31, 2010, we recognized $3.2 million of revenues under this agreement, all of which was reimbursement for patent activities. For the year ended December 31, 2009, we recognized revenues of $3.8 million, of which $3.7 million was reimbursement for patent activities and $0.1 million was for additional sponsored research.
|
|||
(12) Restructuring Charges
In March 2011, we completed a reduction of our US workforce of approximately 25%, or a total of 65 employees, that was announced in January 2011. We accounted for our restructuring activities in accordance with relevant guidance that requires a liability for costs associated with an exit or disposal activity to be recognized when the liability is incurred. As a result of this restructuring, we recorded a charge of $3.5 million during the first quarter of 2011, including non-cash, share-based compensation charges of $0.1 million, which is reflected as a separate line item in the accompanying consolidated statements of operations. As of December 31, 2011, $17,000 remains accrued and will be paid in the first quarter of 2012.
|
|||
(13) Employee Benefit Plans
401(k) Plan
All of our US employees are eligible to participate in our defined contribution retirement plan that complies with Section 401(k) of the Internal Revenue Code. We match 100% of each participant's voluntary contributions, subject to a maximum of 6% of the participant's eligible compensation. Our matching portion, which totaled $1.2 million, $1.6 million and $1.8 million in the years ended December 31, 2011, 2010 and 2009, respectively, vests over a five-year period from the date of hire.
Pension Plan
Our wholly owned subsidiary in Switzerland, Arena GmbH, contributes to a multiemployer defined benefit pension plan, established under an affiliated group of employers, for the purpose of providing mandatory occupational pension benefits for its employees. The risks of participating in a multiemployer plan are different from a single-employer plan in that (i) assets contributed to the multiemployer plan by one employer may be used to provide benefits to employees of other participating employers, (ii) if a participating employer stops contributing to the plan, the unfunded obligations of the plan may be borne by the remaining participating employers, (iii) if Arena GmbH elects to stop participating in the multiemployer plan, Arena GmbH may be required to pay the plan an amount based on the underfunded status of the plan, referred to as a withdrawal liability, and (iv) Arena GmbH has no involvement in the management of the multiemployer plan's investments. We currently have no intention of withdrawing from the multiemployer plan.
Arena GmbH's contributions to the multiemployer plan were $0.6 million in the year ended December 31, 2011, and $0.5 million in both of the years ended December 31, 2010 and 2009.
|
|||
(14) Income Taxes
Our loss before provision (benefit) for income taxes is summarized by region as follows, in thousands:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
United States |
$ | (75,209 | ) | $ | (85,471 | ) | $ | (97,754 | ) | |||
|
Foreign |
(34,015 | ) | (39,063 | ) | (56,145 | ) | ||||||
|
|
|
|
|
|
|
|||||||
|
Total loss before income taxes |
$ | (109,224 | ) | $ | (124,534 | ) | $ | (153,899 | ) | |||
|
|
|
|
|
|
|
|||||||
Our provision (benefit) for income taxes, which is included in the interest and other income (expense) section of our consolidated statements of operations, consists of the following, in thousands:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Current: |
||||||||||||
|
Federal |
$ | 0 | $ | 0 | $ | (68 | ) | |||||
|
Deferred: |
||||||||||||
|
Federal |
0 | 0 | (84 | ) | ||||||||
|
State |
0 | 0 | (9 | ) | ||||||||
|
Foreign |
0 | 0 | (534 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
|
Total deferred provision (benefit) |
0 | 0 | (627 | ) | ||||||||
|
|
|
|
|
|
|
|||||||
|
Total provision (benefit) |
$ | 0 | $ | 0 | $ | (695 | ) | |||||
|
|
|
|
|
|
|
|||||||
The tax benefit in 2009 was due to a change in accounting treatment of an intangible asset from being considered an indefinite lived asset to a definite lived asset. The initial recognition of the indefinite lived intangible asset resulted in the recognition of a deferred tax expense, as the deferred tax liability was not available to offset deferred tax assets. Upon the change to a definite lived asset in 2009, the related deferred tax liability became available to offset deferred tax assets, and the previously recognized tax expense was reversed.
For the year ended December 31, 2009, we were required to allocate our total income tax benefit of $0.6 million between continuing operations and other comprehensive income in our consolidated financial statements. Accordingly, we charged $0.1 million directly to other comprehensive income and recorded a tax benefit of $0.7 million in continuing operations in 2009.
Our provision (benefit) for income taxes differs from the statutory Federal rate of 34% at December 31, 2011, 2010 and 2009, due to the following, in thousands:
| December 31, | ||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
|
Provision (benefit) for income taxes at statutory Federal rate |
$ | (37,136 | ) | $ | (42,342 | ) | $ | (52,330 | ) | |||
|
State income tax, net of Federal benefit |
(3,857 | ) | (3,954 | ) | (3,530 | ) | ||||||
|
Permanent items and other |
(1,284 | ) | (3,366 | ) | (488 | ) | ||||||
|
Share-based compensation expense |
822 | 1,346 | 1,969 | |||||||||
|
Foreign losses at lower effective rates |
8,509 | 12,155 | 18,162 | |||||||||
|
Research and development credit |
(1,955 | ) | (3,512 | ) | (5,430 | ) | ||||||
|
Revaluation of deferred tax assets due to state rate changes |
0 | 0 | 7,989 | |||||||||
|
Unrecognized net operating losses, or NOLs, and research and development credits |
7,086 | 14,947 | 32,696 | |||||||||
|
Addition of Federal NOLs |
0 | (170,399 | ) | 0 | ||||||||
|
Indefinite life intangible amortization |
0 | 0 | (534 | ) | ||||||||
|
Valuation allowance |
28,354 | 192,287 | (1,964 | ) | ||||||||
|
Other |
(539 | ) | 2,838 | 2,765 | ||||||||
|
|
|
|
|
|
|
|||||||
|
Provision (benefit) for income taxes |
$ | 0 | $ | 0 | $ | (695 | ) | |||||
|
|
|
|
|
|
|
|||||||
The components of our deferred tax assets are as follows, in thousands:
| December 31, | ||||||||
| 2011 | 2010 | |||||||
|
Deferred tax assets: |
||||||||
|
Foreign NOL carryforwards |
$ | 6,835 | $ | 3,915 | ||||
|
Federal NOL carryforwards |
191,826 | 170,399 | ||||||
|
Capitalized research and development (state) |
169 | 375 | ||||||
|
Deferred revenues |
20,421 | 21,942 | ||||||
|
Depreciation |
6,640 | 5,375 | ||||||
|
Share-based compensation expense |
4,967 | 4,378 | ||||||
|
Other, net |
6,860 | 2,706 | ||||||
|
|
|
|
|
|||||
|
Total deferred tax assets |
237,718 | 209,090 | ||||||
|
Deferred tax liabilities |
(1,575 | ) | (1,300 | ) | ||||
|
|
|
|
|
|||||
|
Net deferred tax assets |
236,143 | 207,790 | ||||||
|
Valuation allowance |
(236,143 | ) | (207,790 | ) | ||||
|
|
|
|
|
|||||
|
Net deferred tax liabilities |
$ | 0 | $ | 0 | ||||
|
|
|
|
|
|||||
A valuation allowance has been established against all of our deferred tax assets, as realization of such assets is not more-likely-than-not. The valuation allowance increased by $28.4 million in 2011 compared to 2010.
At December 31, 2011, we had Federal NOL carryforwards of $568.8 million that will begin to expire in 2023 unless previously utilized. At the same date, we had California NOL carryforwards of $675.1 million, which will begin to expire in 2014, and foreign NOL carryforwards of $6.8 million, which will begin to expire in 2012. At December 31, 2011, we had $4.6 million of both Federal and California NOL carryforwards related to stock option exercises, which will result in an increase to additional paid-in capital and a decrease in income taxes payable at the time when the tax loss carryforwards are utilized. We also had Federal and California research and development tax credit carryforwards of $39.5 million and $26.1 million, respectively. The Federal research and development credit carryforwards will begin to expire in 2025 unless previously utilized. The California research and development credit carryforwards carry forward indefinitely.
Sections 382 and 383 of the Internal Revenue Code limit the utilization of tax carryforwards that arise prior to certain cumulative changes in a corporation's ownership. The Section 382/383 analysis for Federal NOLs with respect to potential ownership changes was completed in 2010 and, accordingly, the Federal NOLs that are available to be utilized are included in our deferred tax asset schedule. We have reviewed our changes in ownership for Federal NOLs through December 31, 2011, and have not identified any additional changes. We have yet to complete a Section 382/383 analysis for our California NOL deferred tax assets of $39.4 million or our Federal and California research and development credits of $56.8 million and, accordingly, such amounts have been excluded from our deferred tax asset schedule.
In accordance with authoritative guidance, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained.
Our practice is to recognize interest and/or penalties related to income tax matters in income tax expense. We did not have any uncertain income tax positions or accrued interest or penalties included in our consolidated balance sheets at December 31, 2011, or 2010, and did not recognize any interest and/or penalties in our consolidated statements of operations during the years ended December 31, 2011, 2010 or 2009.
We are subject to income taxation in the United States at the Federal and state levels. Our tax years for 1997 and later are subject to examination by US and California tax authorities due to the carryforward of unutilized NOL and research and development credits. We are also subject to foreign income taxes in the countries in which we operate. To our knowledge, we are not currently under examination by any taxing authorities.
Our Swiss subsidiary, Arena GmbH, has been granted a conditional incentive tax holiday for its operations in Switzerland that is expected to exempt it from a majority of the potential Swiss income taxes. Should this tax holiday come into effect, it would continue for a period of up to 10 years, not to extend beyond December 31, 2022.
|
|||
(15) Legal Proceedings
Beginning on September 20, 2010, a number of complaints were filed in the US District Court for the Southern District of California against us and certain of our current and former employees and directors on behalf of certain purchasers of our common stock. The complaints have been brought as purported stockholder class actions, and, in general, include allegations that we and certain of our current and former employees and directors violated federal securities laws by making materially false and misleading statements regarding our lorcaserin program, thereby artificially inflating the price of our common stock. The plaintiffs are seeking unspecified monetary damages and other relief. On November 19, 2010, eight prospective lead plaintiffs filed motions to consolidate, appoint a lead plaintiff, and appoint lead counsel. The Court took the motions to consolidate under submission on January 14, 2011. On August 8, 2011, the Court consolidated the actions and appointed a lead plaintiff and lead counsel. On November 1, 2011, the lead plaintiff filed a consolidated amended complaint. On December 30, 2011, we filed a motion to dismiss the consolidated amended complaint, and a hearing on the motion to dismiss has been scheduled for April 13, 2012. In addition to the class actions, a complaint involving similar legal and factual issues has been brought by at least one individual stockholder and is pending in federal court. On December 30, 2011, we filed a motion to dismiss the stockholder's complaint, and a hearing on the motion to dismiss has been scheduled for April 13, 2012. We intend to defend against the claims advanced and to seek dismissal of these complaints. Due to the early stage of these proceedings, we are not able to predict or reasonably estimate the ultimate outcome or possible losses relating to these claims.
On September 24, 2010, a stockholder derivative complaint was filed in the Superior Court of California for the County of San Diego against certain of our current and former employees and directors, and other stockholder derivative complaints were subsequently filed in state court. On October 19, 2010, the Superior Court ordered that the pending state derivative actions be consolidated. The Superior Court also ordered that later filed, related state derivative actions be consolidated as well. We refer to the consolidated state derivative actions as the State Derivative Action. In November 2010, plaintiffs in the State Derivative Action filed a consolidated stockholder derivative complaint. We filed a demurrer to the consolidated stockholder derivative complaint on February 15, 2011. On October 6, 2010, a stockholder derivative complaint was filed in the US District Court for the Southern District of California. Thereafter, a number of other stockholder derivative complaints were also filed in federal court. On March 3, 2011, the federal court ordered that the pending federal derivative actions be consolidated. The federal court also ordered that later filed, related federal derivative actions be consolidated as well. We refer to the consolidated federal derivative actions as the Federal Derivative Action. We refer to the State Derivative Action and the Federal Derivative Action collectively as the Derivative Actions. The Derivative Actions allege breaches of fiduciary duties by the defendants and other violations of law. In general, the Derivative Actions allege that certain of our current and former employees and directors caused or allowed for the dissemination of materially false and misleading statements regarding our lorcaserin program, thereby artificially inflating the price of our common stock. On September 9, 2011, we and lead counsel for the plaintiffs in the Derivative Actions entered into a stipulation of settlement to resolve the Derivative Actions. The current and former employees and directors named as individual defendants in the Derivative Actions have also entered into the stipulation of settlement. On October 19, 2011, the Superior Court of California entered an order preliminarily approving the proposed settlement. On December 16, 2011, the Superior Court of California issued its final order and judgment approving the settlement and dismissing the State Derivative Action with prejudice. On December 29, 2011, the US District Court issued an order dismissing the Federal Derivative Action with prejudice. In accordance with the terms of the settlement, and in exchange for a release of all claims by the plaintiffs, among others, we have agreed to adopt certain corporate governance measures and cause our insurers to pay the plaintiffs' attorneys a total of $1.1 million.
|
|||
(16) Quarterly Financial Data (Unaudited)
The following tables present quarterly data for the years ended December 31, 2011, and 2010, in thousands, except per share data:
|
2011 |
Quarter ended December 31 |
Quarter ended September 30 |
Quarter ended June 30 |
Quarter ended March 31 |
Year ended December 31 |
|||||||||||||||
|
Revenues |
$ | 2,076 | $ | 3,459 | $ | 3,259 | $ | 3,925 | $ | 12,719 | ||||||||||
|
Net loss allocable to common stockholders |
$ | (23,682 | ) | $ | (22,736 | ) | $ | (22,908 | ) | $ | (42,158 | ) | $ | (111,484 | ) | |||||
|
Net loss per share allocable to common stockholders, basic and diluted |
$ | (0.16 | ) | $ | (0.16 | ) | $ | (0.16 | ) | $ | (0.35 | ) | $ | (0.80 | ) | |||||
|
2010 |
Quarter ended December 31 |
Quarter ended September 30 |
Quarter ended June 30 |
Quarter ended March 31 |
Year ended December 31 |
|||||||||||||||
|
Revenues |
$ | 4,012 | $ | 7,629 | $ | 2,459 | $ | 2,513 | $ | 16,613 | ||||||||||
|
Net loss allocable to common stockholders |
$ | (28,241 | ) | $ | (36,266 | ) | $ | (28,757 | ) | $ | (31,270 | ) | $ | (124,534 | ) | |||||
|
Net loss per share allocable to common stockholders, basic and diluted |
$ | (0.23 | ) | $ | (0.31 | ) | $ | (0.28 | ) | $ | (0.33 | ) | $ | (1.14 | ) | |||||
|
|||
(17) Subsequent Events
We have evaluated subsequent events after the balance sheet date of December 31, 2011, and up to the date we filed this report.
Deerfield Equity Purchase, Loan Prepayment and Warrant Exchange
In January 2012, we and Deerfield entered into (i) a Securities Purchase Agreement, (ii) an Exchange Agreement and (iii) a Third Amendment to the Facility Agreement, or the Third Amendment.
Under the Securities Purchase Agreement, Deerfield purchased 9,953,250 shares of our common stock for a purchase price of $1.65775 per share and approximately 9,953 shares of our Series D Convertible Preferred Stock, or Series D Preferred, for a purchase price of $1,657.75 per share. Each share of Series D Preferred was convertible into 1,000 shares of our common stock at any time at the option of the holder, subject to certain limitations. The fair value of the common stock into which the Series D Preferred was convertible on the date of issuance exceeded the proceeds allocated to the Series D Preferred on a relative fair value basis by $2.8 million, resulting in a beneficial conversion feature that we will recognize as a decrease to additional paid-in capital and a deemed dividend to the Series D Preferred stockholders during the quarter ending March 31, 2012.
Under the Exchange Agreement, we issued warrants to purchase 8,631,410 shares of our common stock at an exercise price of $1.745 per share in exchange for the cancellation of 11,800,000 outstanding warrants at an exercise price of $5.42 per share and 1,831,410 outstanding warrants at an exercise price of $3.45 per share. These new warrants will be exercisable until June 17, 2015. Other than the exercise period, the exercise price and certain provisions related to cashless exercise and early termination of the warrants, these new warrants contain substantially the same terms as the cancelled warrants. We determined that the incremental value of the $1.745 Warrants was $4.5 million, which will be recorded as a component of the stock issuance and warrant exchange in the stockholders' equity section of our consolidated balance sheet.
Under the Third Amendment, we prepaid $5.0 million of the principal amount that was originally scheduled to be repaid to Deerfield in June 2013. After deducting such prepayment, net proceeds to us under the Securities Purchase Agreement were approximately $27.9 million. In connection with this $5.0 million prepayment, we retired a proportional share of the debt discount and issuance costs directly related to the repaid debt and will recognize a non-cash loss on extinguishment of debt of $1.7 million during the quarter ending March 31, 2012.
Under the terms of our outstanding Series B Warrants, subsequent equity issuances at prices below $6.72 result in an adjustment to the number of common shares issuable under the warrants and the per share exercise price such that, upon the completion of this transaction, the number of shares issuable upon exercise of the outstanding June 2006 and August 2008 Series B Warrants was increased to 1,379,235 and 1,846,301, respectively, at an exercise price of $9.32 and $4.62 per share, respectively.
Deerfield Conversion of Preferred Stock
In February 2012, Deerfield converted all of its shares of our Series D Preferred into 9,953,250 shares of our common stock. After this conversion, which has no cash impact, we have no shares of Series D Preferred outstanding.
Equity Financing
In March 2012, we received aggregate net proceeds of $24.7 million (which is net of $0.3 million in estimated costs) from the sale of 14,414,370 shares of common stock under our equity line of credit with Azimuth Opportunity, L.P., or Azimuth.
Under the terms of our outstanding Series B Warrants, subsequent equity issuances at prices below $6.72 result in an adjustment to the number of common shares issuable under the warrants and the per share exercise price. Upon the issuance of shares to Azimuth under the equity financing commitment, the number of shares issuable upon exercise of the outstanding June 2006 and August 2008 Series B Warrants increased to 1,467,405 and 1,965,418, respectively, at an exercise price of $8.76 and $4.34 per share, respectively.