Notes to Financial Statements | |
| 6 Months Ended
Jun. 30, 2009
USD / shares
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Notes to Financial Statements [Abstract] | |
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that the management of Gilead Sciences, Inc. (Gilead, we or our) believes are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.
The preparation of these Condensed Consolidated Financial Statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies and estimates related to revenue recognition, allowance for doubtful accounts, prepaid royalties, intangible assets, clinical trial accruals, our tax provision and stock-based compensation. We base our estimates on historical experience and on various other market specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates.
The accompanying Condensed Consolidated Financial Statements include the accounts of Gilead, our wholly-owned subsidiaries and our joint ventures with Bristol-Myers Squibb Company (BMS), for which we are the primary beneficiary as determined under Financial Accounting Standards Board (FASB) Interpretation No.46 (revised December 2003), Consolidation of Variable Interest Entities. We record a noncontrolling interest in our Condensed Consolidated Financial Statements to reflect BMSs interest in the joint ventures. Significant intercompany transactions have been eliminated. The Condensed Consolidated Financial Statements include the operating results of companies acquired by us from the date of each acquisition for the applicable reporting periods.
The accompanying Condensed Consolidated Financial Statements and related financial information should be read in conjunction with the audited Consolidated Financial Statements and the related notes thereto for the year ended December31, 2008, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission. The condensed consolidated balance sheet at December31, 2008 has been derived from audited consolidated financial statements at that date. Certain prior year amounts have been revised for the retrospective application of FASB Staff Position (FSP) Accounting Principles Board Opinion No.14-1,Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)(FSP APB 14-1) and Statement of Financial Accounting Standards (SFAS) No.160, Noncontrolling Interests in Consolidated Financial State |
2. DERIVATIVE FINANCIAL INSTRUMENTS |
2. DERIVATIVE FINANCIAL INSTRUMENTS
In March 2008, the FASB issued SFAS No.161,Disclosures about Derivative Instruments and Hedging Activities, an amendment of SFAS No.133, Accounting for Derivative Instruments and Hedging Activities (SFAS 161). SFAS 161 is intended to improve financial reporting of derivative instruments and hedging activities by requiring enhanced qualitative and quantitative disclosures to enable financial statement users to better understand the effects of derivatives and hedging on an entitys financial position, financial performance and cash flows in the context of an entitys risk exposures. SFAS 161 is effective for interim periods and fiscal years beginning after November15, 2008.On January1, 2009, we adopted the provisions of SFAS 161 on a prospective basis for our derivative instruments.
We operate in foreign countries which exposes us to market risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and various foreign currencies, the most significant of which is the Euro. In order to manage the risk related to changes in foreign currency exchange rates, we hedge certain of our foreign currency exposures related to outstanding monetary assets and liabilities and forecasted product sales with foreign currency exchange forward contracts and foreign currency exchange option contracts. In general, the market risks of our foreign currency exchange contracts are offset by corresponding gains and losses on the transactions being hedged. Our exposure to credit risk from these contracts is a function of changes in interest and currency exchange rates and, therefore, varies over time. We limit the risk that counterparties to these contracts may be unable to perform by transacting only with major banks, all of which we monitor closely in the context of current market conditions. We also limit risk of loss by entering into contracts that provide for net settlement at maturity. Therefore, our overall risk of loss in the event of a counterparty default is limited to the amount of any unrecognized gains on outstanding contracts (i.e., those contracts that have a positive fair value) at the date of default. We do not enter into derivative financial contracts for trading purposes. We do not hedge our net investment in any of our foreign subsidiaries.
We enter into foreign currency exchange contracts to hedge our market risk exposure associated with foreign currency exchange rate fluctuations for certain monetary assets and liabilities of our foreign subsidiaries that are denominated in a non-functional currency. As these derivative instruments are not designated as hedges under SFAS Nos. 133 and 138, Accounting for Derivative Instruments and Hedging Activities (collectively referred to as SFAS 133), we record the changes in the fair value of such instruments in interest and other income, net on our Condensed Consolidated Statements of Income.
Foreign currency exchange contracts used to hedge forecasted product sales are designated as cash flow hedges under SFAS 133. These derivative instruments are employed to eliminate or minimize certain foreign currency exposures that can be confide |
3. ACQUISITION OF CV THERAPEUTICS, INC. |
3. ACQUISITION OF CV THERAPEUTICS, INC.
In December 2007, the FASB issued SFAS No.141 (revised 2007),Business Combinations(SFAS 141R). SFAS 141R establishes principles and requirements for recognizing and measuring assets acquired, liabilities assumed and any noncontrolling interests in the acquiree in a business combination. SFAS 141R also provides guidance for recognizing and measuring goodwill acquired in a business combination; requires purchased in-process research and development (IPRD) to be capitalized at fair value as intangible assets at the time of acquisition; requires acquisition-related expenses and restructuring costs to be recognized separately from the business combination; expands the definition of what constitutes a business; and requires the acquirer to disclose information that users may need to evaluate and understand the financial effect of the business combination. SFAS 141R is effective for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December15, 2008. On January1, 2009, we adopted the provisions of SFAS 141R on a prospective basis and applied it to the acquisition of CV Therapeutics, Inc. (CV Therapeutics) as discussed below.
On April15, 2009, we acquired CV Therapeutics through a cash tender offer under the terms of an agreement and plan of merger entered into in March 2009. CV Therapeutics was a publicly held biopharmaceutical company based in Palo Alto, California, primarily focused on applying molecular cardiology to the discovery, development and commercialization of small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics had two marketed products, Ranexa (ranolazine) for the treatment of chronic angina and Lexiscan (regadenoson) injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. CV Therapeutics also had several product candidates in clinical development for the treatment of atrial fibrillation, pulmonary diseases and diabetes. We believe the acquisition will provide us with an opportunity to further expand into the cardiovascular therapeutic area.
The CV Therapeutics acquisition was accounted for as a business combination in accordance with SFAS 141R. The results of operations of CV Therapeutics since April15, 2009 have been included in our Condensed Consolidated Statement of Operations, and were not significant. The acquisition date, in accordance with the provisions of SFAS 141R, was determined to be April15, 2009 as that is the date on which we acquired approximately 89% of the outstanding shares of common stock of CV Therapeutics and obtained effective control of the company. The acquisition was completed two days later on April17, 2009, at which time CV Therapeutics became a wholly-owned subsidiary.
The aggregate consideration transferred to acquire CV Therapeutics was $1.39 billion, and consisted of cash paid for common stock and other equity instruments at or prior to closing of $1.38 billion and the fair value of vested stock options assumed of $15.7 million.
In acco |
4. ACQUISITION OF REAL ESTATE |
4. ACQUISITION OF REAL ESTATE
In January 2009, we completed the purchase of an officebuilding andapproximately 30 acres ofland located in Foster City, California, for an aggregate purchase price of $140.1 million. The purchase price was allocated based on the estimated relative fair values primarily to land of $71.6 million, building of $64.3 million, land improvements of $2.7 million and office furniture and equipment of $1.1 million. |
5. INVENTORIES |
5. INVENTORIES
Inventories are summarized as follows (in thousands):
June30, 2009 December31, 2008
Raw materials $ 410,021 $ 505,106
Work in process 214,123 140,333
Finished goods 345,827 282,429
Total inventories $ 969,971 $ 927,868
As of June30, 2009 and December31, 2008, the joint ventures formed by Gilead and BMS, which are included in our Condensed Consolidated Financial Statements, held $621.6 million and $607.7 million in inventory, respectively, of efavirenz active pharmaceutical ingredient, purchased from BMS at BMSs estimated net selling price of Sustiva. |
6. AVAILABLE-FOR-SALE SECURITIES |
6. AVAILABLE-FOR-SALE SECURITIES
In April 2009, the FASB issued FSP No. FAS 115-2 and FAS No. 124-2, Recognition and Presentation of Other-Than-Temporary Impairments (FSP FAS 115-2). FSP FAS 115-2 provides new guidance on the recognition and presentation of an other-than-temporary impairment, provides some new disclosure requirements as well as extends certain annual disclosure requirements to interim periods. FSP FAS 115-2 is effective for interim periods and fiscal years ending after June15, 2009, with early adoption permitted for periods ending after March15, 2009. On April1, 2009, we adopted the provisions of FSP FAS 115-2 on a prospective basis for available-for-sale securities.
The following is a summary of available-for-sale debt and equity securities recorded in cash equivalents or marketable securities in our Condensed Consolidated Balance Sheet. Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services (in thousands):
Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value
June30, 2009
Debt securities:
U.S. treasury securities $ 165,642 $ 522 $ (38 ) $ 166,126
U.S. government sponsored entity debt securities 675,318 9,157 (68 ) 684,407
Municipal debt securities 180,969 3,523 (4 ) 184,488
Corporate debt securities 587,475 8,861 (313 ) 596,023
Residential mortgage-backed securities 115,800 2,157 (222 ) 117,735
Student loan-backed securities 117,050 (14,885 ) 102,165
Other debt securities 31,680 481 (338 ) 31,823
Total debt securities 1,873,934 24,701 (15,868 ) 1,882,767
Equity securities 1,451 334 1,785
Total $ 1,875,385 $ 25,035 $ (15,868 ) $ 1,884,552
December31, 2008
Debt securities:
U.S. treasury securities $ 199,962 $ 2,281 $ $ 202,243
U.S. government sponsored entity debt securities 669,721 12,105 (52 ) 681,774
Municipal debt securities 328,776 3,987 (126 ) 332,638
Corporate debt securities 450,567 2,146 (1,983 ) 450,730
Residential mortgage-backed securities 134,409 926 (574 ) 134,761
Student loan-backed securities 122,400 (20,602 ) 101,798
Other debt securities 58,468 735 (1,221 ) 57,982
Total debt securities 1,964,303 22,180 (24,558 ) 1,961,926
Equity securities 1,451 (692 ) 759
Total $ 1,965,754 $ 22,180 $ (25,250 ) $ 1,962,685
As of June30, 2009 and December31, 2008, other debt securities consisted primarily of foreign government and agency securities as well as asset-backed securities that exclude student loans and residential mortg |
7. REVOLVING CREDIT FACILITY |
7. REVOLVING CREDIT FACILITY
Under our amended and restated credit agreement, we, along with our wholly-owned subsidiary, Gilead Biopharmaceutics Ireland Corporation, may borrow up to an aggregate of $1.25 billion in revolving credit loans. The credit agreement also includes a sub-facility for swing-line loans and letters of credit. Loans under the credit agreement bear interest at an interest rate of either LIBOR plus a margin ranging from 0.20 percent to 0.32 percent or the base rate, as defined in the credit agreement. In April 2009, in connection with the acquisition of CV Therapeutics, we borrowed $400.0 million under the credit agreement to partially fund the acquisition. The credit agreement will terminate and all outstanding amounts owing thereunder shall be due and payable on December17, 2012. We may reduce the commitments and may prepay loans under the credit agreement in whole or in part at any time without penalty, subject to certain conditions. We expect to repay the $400.0 million loan within the next 12 months using cash flow generated from operations. As of June30, 2009, we had letters of credit outstanding under this credit facility of $3.8 million, and the amount available under this credit facility was approximately $846.2 million. We are required to comply with certain covenants under this credit facility and as of June30, 2009, we were in compliance with all such covenants. |
8. COMMITMENTS AND CONTINGENCIES |
8. COMMITMENTS AND CONTINGENCIES
Legal Proceedings
On May12, 2006, the United States District Court for the Northern District of California executed orders dismissing in its entirety and with prejudice the fourth consolidated amended complaint associated with a purported class action lawsuit against us and our Chairman and Chief Executive Officer; President and Chief Operating Officer; former Executive Vice President of Operations; Executive Vice President of Research and Development and Chief Scientific Officer; Senior Vice President of Manufacturing; and Senior Vice President of Research, alleging that the defendants violated federal securities laws, specifically Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated by the Securities Exchange Commission, by making certain alleged false and misleading statements. The plaintiffs have appealed the dismissal. On August11, 2008, the United States Court of Appeals for the Ninth Circuit reversed the district courts decision and remanded the case to the district court. On February6, 2009, we filed a petition for a writ of certiorari with the Supreme Court of the United States, requesting that the court review the judgment of the court of appeals. In April 2009, the Supreme Court of the United States denied our petition. The case continues before the district court. On February13, 2009, we filed a further motion to dismiss the fourth consolidated amended complaint on alternative grounds. On June3, 2009, the district court granted in part and denied in part our motion to dismiss and gave plaintiffs leave to amend the complaint. On July10, 2009, plaintiffs filed a fifth consolidated amended complaint. Our deadline to respond to the fifth consolidated amended complaint is August12, 2009. It is not possible to predict the outcome of this case, and as such, no amounts have been accrued related to the outcome of this case.
We are also a party to various other legal actions that arose in the ordinary course of our business. We do not believe that any of these other legal actions will have a material adverse impact on our business, consolidated results of operations or financial position. |
9. STOCK-BASED COMPENSATION EXPENSES |
9. STOCK-BASED COMPENSATION EXPENSES
The following table summarizes the stock-based compensation expenses included in our Condensed Consolidated Statements of Income (in thousands):
Three Months Ended June30, Six Months Ended June30,
2009 2008 2009 2008
Cost of goods sold $ 2,771 $ 2,848 $ 6,025 $ 4,542
Research and development expenses 24,321 15,370 41,276 32,265
Selling, general and administrative expenses 27,189 18,657 48,025 36,204
Stock-based compensation expenses included in total costs and expenses 54,281 36,875 95,326 73,011
Income tax effect (14,320 ) (10,466 ) (25,077 ) (20,601 )
Stock-based compensation expenses included in net income $ 39,961 $ 26,409 $ 70,249 $ 52,410
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10. STOCKHOLDERS' EQUITY |
10. STOCKHOLDERS EQUITY
Stock Option Plan
In May 2009, our stockholders approved an amendment to the Gilead Sciences, Inc. 2004 Equity Incentive Plan (2004 Plan) to increase the number of shares authorized for issuance under the 2004 Plan by 20,000,000 shares of our common stock. As of June30, 2009, there were 56,544,212 shares authorized and available for future grant under the 2004 Plan.
In connection with the acquisition of CV Therapeutics, we assumed CV Therapeutics 1994 Equity Incentive Plan, as amended and restated, Non-Employee Directors Stock Option Plan, as amended and restated, 2000 Equity Incentive Plan, as amended and restated, 2000 Nonstatutory Incentive Plan, as amended and restated and 2004 Employee Commencement Incentive Plan, as amended and restated (collectively, the CV Therapeutics Plans). The majority of options that were issued and outstanding under the CV Therapeutics Plans as of April15, 2009 were converted into options to purchase approximately 1.8million shares of our common stock and remain subject to their original terms and conditions. No shares are available for future grant under the CV Therapeutics Plans.
Stock Repurchase Programs
In October 2008, we entered into an accelerated share repurchase agreement with a financial institution to repurchase $750.0 million of our common stock on an accelerated basis. This accelerated share repurchase was part of the $3.00 billion stock repurchase program authorized by our board of directors (Board) in October 2007. Under the terms of the accelerated share repurchase agreement, we paid $750.0 million to settle the initial purchase transaction and received 14,874,519 shares of our common stock at an initial price of $50.42 per share. In March 2009, upon termination of the agreement and, in accordance with the share delivery provisions of the agreement, we received an additional 1,356,337 shares of our common stock based on the average of the daily volume weighted-average prices of our common stock during a specified period less a predetermined discount per share. As a result, the total number of shares repurchased and retired under this accelerated share repurchase agreement was 16,230,856 shares at an average purchase price of $46.21 per share.
During the three and six months ended June30, 2009, in addition to the additional shares that we received under the terms of the accelerated share repurchase transaction, we repurchased and retired 5,317,686 and 10,326,133 shares, respectively, of our common stock at an average purchase price of $44.77 and $45.33 per share, respectively, for an aggregate purchase price of $238.1 million and $468.0 million, respectively, through open market transactions. As of June30, 2009, the remaining authorized amount of stock repurchases that may be made under our $3.00 billion Board-authorized stock repurchase program which expires in December 2010 was $530.0 million.
We use the par value method of accounting for our stock repurchases. Under the par value method, common stock is first charged with the par value of the shares involved. The excess of the cost of shares acquired over the par value is allocated to additional pa |
11. SEGMENT INFORMATION |
11. SEGMENT INFORMATION
We operate in one business segment, which primarily focuses on the development and commercialization of human therapeutics for life threatening diseases. All products are included in one segment, because our major products, Truvada, Atripla, Viread, Hepsera, Emtriva and AmBisome, which together accounted for substantially all of our total product sales for the three and six months ended June30, 2009 and 2008, have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment.
Product sales consisted of the following (in thousands):
Three Months Ended June30, Six Months Ended June30,
2009 2008 2009 2008
Antiviral products:
Truvada $ 608,079 $ 516,149 $ 1,198,432 $ 995,534
Atripla 569,142 355,101 1,079,025 679,318
Viread 158,925 150,681 319,530 303,348
Hepsera 67,074 90,365 139,788 173,387
Emtriva 7,096 8,088 14,272 16,477
Total antiviral products 1,410,316 1,120,384 2,751,047 2,168,064
AmBisome 73,310 69,768 137,581 140,796
Letairis 44,128 24,686 83,708 45,023
Ranexa 36,065 36,065
Other 4,559 2,378 7,557 4,639
Total product sales $ 1,568,378 $ 1,217,216 $ 3,015,958 $ 2,358,522
The following table summarizes total revenues from external customers and collaboration partners by geographic region (in thousands). Product sales and product related contract revenues are attributed to countries based on ship-to location. Royalty and non-product related contract revenues are attributed to countries based on the location of the collaboration partner.
Three Months Ended June30, Six Months Ended June30,
2009 2008 2009 2008
United States $ 871,273 $ 681,270 $ 1,674,433 $ 1,350,846
Outside of the United States:
Spain 109,541 90,706 207,612 168,430
France 111,771 97,499 205,299 189,845
United Kingdom 85,578 72,663 184,230 136,152
Italy 80,313 74,634 160,199 144,225
Germany 59,949 64,102 137,157 103,584
Switzerland 64,881 46,028 109,591 148,920
Other European countries 138,342 50,698 279,465 116,258
Other countries 125,507 100,525 219,629 178,017
Total revenues outside of the United States 775,882 596,855 1,503,182 1,185,431
Total revenues $ 1,647,155 $ 1,278,125 $ 3,177,615 $ 2,536,277
The following table summarizes revenues from each of our customers who individually accounted for 10% or more of our total revenues (as a % of total revenues):
ThreeMonthsEnded June30, SixMonthsEnde |
12. INCOME TAXES |
12. INCOME TAXES
Our income tax rate of 24.7% and 25.5% for the three and six months ended June30, 2009, respectively, differed from the U.S. federal statutory rate of 35% primarily due to tax credits, the resolution of certain tax positions with tax authorities and certain operating earnings from non-U.S subsidiaries that are considered indefinitely invested outside the United States, partially offset by state taxes. We do not provide for U.S. income taxes on undistributed earnings of our foreign operations that are intended to be permanently reinvested.
In May 2009, we reached agreement with the Internal Revenue Service (IRS) on several issues related to the examinations of our federal income tax returns for 2003 and 2004. We also amended our California income tax returns for 2003 through 2007 based on the resolution of certain tax positions with the IRS. As a result, we reduced our unrecognized tax benefits by $30.5 million in 2009.
As of June30, 2009, we believe it is reasonably possible that our unrecognized tax benefits will decrease by approximately $40 million in the next 12 months as we expect to have clarification from the IRS and other tax authorities around some of our uncertain tax positions. With respect to the remaining unrecognized tax benefits, we are currently unable to make a reasonable estimate as to the period of cash settlement, if any, with the respective tax authorities.
We file federal, state and foreign income tax returns in many jurisdictions in the United States and abroad. For U.S. federal and California income tax purposes, the statute of limitations remains open for all years from inception due to our utilization of net operating losses relating to prior years.
Our income tax returns are audited by federal, state and foreign tax authorities. We are currently under examination by the IRS for the 2005, 2006 and 2007 tax years and by various state and foreign jurisdictions. There are differing interpretations of tax laws and regulations, and as a result, significant disputes may arise with these tax authorities involving issues of the timing and amount of deductions and allocations of income among various tax jurisdictions. We periodically evaluate our exposures associated with our taxfiling positions.
We record liabilities related to uncertain tax positions in accordance with FASB Interpretation No.48, Accounting for Uncertainty in Income Taxes, an interpretation of SFAS No.109, Accounting for Income Taxes. We do not believe any such uncertain tax positions currently pending will have a material adverse effect on our Condensed Consolidated Financial Statements, although an adverse resolution of one or more of these uncertain tax positions in any period could have a material impact on the results of operations for that period. |
13. SUBSEQUENT EVENTS |
13. SUBSEQUENT EVENTS
In July 2009, we and our wholly-owned subsidiary, Gilead Sciences Limited, entered into a license and collaboration agreement with Tibotec Pharmaceuticals (Tibotec), a wholly-owned subsidiary of Johnson Johnson, to develop and commercialize a new once-daily fixed-dose combination (the Combination Product) containing our Truvada and Tibotecs non-nucleoside reverse transcriptase inhibitor, TMC278 (25 mg rilpivirine hydrochloride), which is currently in Phase 3 clinical trials. Under the agreement, Tibotec granted us an exclusive license to the Combination Product for administration to adults in a once daily, oral dosage form, worldwide excluding low-income countries and Japan. Neither party is restricted from combining its drug products with any other drugs.
In accordance with the terms of the agreement, we will pay up to 71.5million (approximately $100.0 million) of Tibotecs development costs for TMC278, and we are required to use commercially reasonable efforts to develop and formulate the Combination Product, including the completion of bioequivalence studies. Tibotec is required to use commercially reasonable efforts to develop TMC278 and obtain its approval in the United States and Europe. We will manufacture the Combination Product and assume the lead role in registration, distribution and, subject to regulatory approval, commercialization of the Combination Product in the licensed countries. Tibotec will have the right to detail the Combination Product in the licensed countries, and, at its option, can request that it be the distributor of the Combination Product in a limited number of such countries. The price of the Combination Product is expected to be the sum of the price of Truvada and the price of TMC278 purchased separately. We expect to recognize product sales revenue from future sales of the Combination Product if and when it is approved. The cost of TMC278 purchased by us from Tibotec for the Combination Product will approximate the market price of TMC278, less a specified percentage of up to 30%.
Either party may terminate the agreement if the Combination Product is withdrawn from the market, if a party materially breaches the agreement, or if certain clinical or regulatory conditions are not met. We may terminate the agreement in the United States and Canada on or after the expiration of the last to expire patent for tenofovir disoproxil fumarate in the United States, and may terminate the agreement in any other country on or after the expiration of the last to expire patent for tenofovir disoproxil fumarate in a country of the European Union. Tibotec may terminate the agreement in the United States and Canada on or after the expiration of the last to expire patent for TMC278 in the United States, and may terminate the agreement in any other country on or after the expiration of the last to expire patent for TMC278 in a country of the European Union.
We evaluated all subsequent events that occurred after the balance sheet date through August5, 2009. |