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- Full Year Total Revenues of $5.34 Billion, Up 26 Percent over 2007 -
- Full Year Product Sales of $5.08 Billion, Up 36 Percent over 2007 -
- Fourth Quarter EPS of $0.60 per Share -
- Fourth Quarter Non-GAAP EPS of $0.63 per Share -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 27, 2009--Gilead Sciences, Inc. (Nasdaq:GILD) announced today its results of operations for the fourth quarter and full year of 2008. Total revenues for the fourth quarter of 2008 were $1.43 billion, up 30 percent compared to total revenues of $1.09 billion for the fourth quarter of 2007. Full year 2008 total revenues were $5.34 billion, up 26 percent compared to full year total revenues of $4.23 billion for 2007. Net income for the fourth quarter of 2008 was $568.2 million, or $0.60 per diluted share, including after-tax stock-based compensation expense of $30.3 million. Non-GAAP net income for the fourth quarter of 2008, which excludes after-tax stock-based compensation expense, was $598.5 million, or $0.63 per diluted share, compared to non-GAAP net income for the fourth quarter of 2007, which excludes after-tax stock-based compensation expense of $25.1 million, of $426.8 million, or $0.44 per diluted share. As more fully described under the discussion of "Income Taxes," we recorded certain income tax benefits in the fourth quarter of 2008 that had the effect of increasing earnings by $0.04 per diluted share.
Product Sales
Product sales increased 35 percent to a record $1.39 billion for the fourth quarter of 2008, compared to $1.03 billion in the fourth quarter of 2007. For 2008, product sales increased 36 percent to $5.08 billion when compared to 2007. This was driven primarily by Gilead's antiviral franchise, including the strong growth in sales of Atripla(R) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), as well as the continued growth in sales of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate).
Antiviral Franchise
Antiviral product sales increased 35 percent to $1.27 billion in the fourth quarter of 2008 from $941.1 million for the same period in 2007. For 2008, antiviral product sales increased 36 percent to $4.67 billion when compared to 2007. The increases were driven primarily by the sales volume growth of Atripla and Truvada, as well as a favorable foreign currency exchange impact.
-- Truvada
Truvada sales increased 25 percent to $562.1 million for the fourth quarter of 2008 from $448.8 million in the fourth quarter of 2007. For 2008, Truvada sales increased 33 percent to $2.11 billion from $1.59 billion in 2007. The increase in Truvada sales in the fourth quarter and full year of 2008 compared to the same periods of 2007 was driven primarily by sales volume growth in the United States and Europe and a favorable foreign currency exchange impact.
-- Atripla
Atripla sales increased 79 percent to $465.5 million for the fourth quarter of 2008 from $259.7 million in the fourth quarter of 2007. For 2008, Atripla sales increased 74 percent to $1.57 billion from $903.4 million in 2007. The increase in Atripla sales in the fourth quarter and full year of 2008 compared to the same periods of 2007 was driven primarily by the continued uptake in the United States, as well as launches of the product in most European countries.
-- Other Antiviral Products
Other antiviral product sales, including Viread(R) (tenofovir disoproxil fumarate), Hepsera(R) (adefovir dipivoxil) and Emtriva(R) (emtricitabine), increased five percent to $245.3 million for the fourth quarter of 2008 from $232.5 million in the fourth quarter of 2007. For 2008, these other antiviral product sales increased five percent to $993.3 million from $947.4 million in 2007.
AmBisome
Sales of AmBisome(R) (amphotericin B) liposome for injection for severe fungal infections increased 12 percent to $76.0 million for the fourth quarter of 2008 from $67.8 million for the fourth quarter of 2007. For 2008, AmBisome sales increased by 10 percent to $289.7 million from $262.6 million in 2007. The increase in sales of AmBisome in the fourth quarter of 2008 compared to the same period of 2007 was driven primarily by sales volume growth in certain European markets. The increase in sales of AmBisome for the full year of 2008 compared to the same period of 2007 was driven primarily by a favorable foreign currency exchange impact and sales volume growth in certain European markets.
Letairis
Sales of Letairis(R) (ambrisentan) for the treatment of pulmonary arterial hypertension increased two-fold to $36.2 million for the fourth quarter of 2008 from $14.8 million for the fourth quarter of 2007. For 2008, Letairis sales increased five-fold to $112.9 million from $21.0 million in 2007. The increase in sales of Letairis in the fourth quarter and full year of 2008 compared to the same periods of 2007 was driven primarily by sales volume growth in the United States as Letairis was launched in June 2007.
Royalty, Contract and Other Revenues
For the fourth quarter of 2008, royalty, contract and other revenues resulting primarily from collaborations with corporate partners were $40.4 million, a decrease of 41 percent from $68.8 million in the fourth quarter of 2007. The decrease during the fourth quarter was driven primarily by lower Tamiflu(R) (oseltamivir phosphate) royalties from F. Hoffmann-La Roche Ltd (Roche) of $16.0 million in the fourth quarter of 2008, compared to Tamiflu royalties of $46.1 million in the fourth quarter of 2007. For 2008, royalty, contract and other revenues were $251.0 million, a decrease of 49 percent from $496.9 million in 2007. The decrease during 2008 compared to 2007 was driven primarily by Tamiflu royalties from Roche of $155.5 million in 2008, compared to Tamiflu royalties of $414.5 million in 2007. The decrease in Tamiflu royalties in the fourth quarter and full year of 2008 compared to the same periods of 2007 was due primarily to decreased Roche sales related to pandemic planning initiatives worldwide.
Research and Development
Research and development (R&D) expenses in the fourth quarter of 2008 were $201.9 million compared to $184.6 million for the same quarter in 2007. Non-GAAP R&D expenses, which exclude stock-based compensation expense, for the fourth quarter of 2008 were $185.3 million, compared to $168.7 million for the same quarter in 2007. For 2008, R&D expenses were $721.8 million compared to $591.0 million for 2007. Non-GAAP R&D expenses, which exclude stock-based compensation expense, for 2008 were $655.2 million, compared to $518.9 million for 2007. Non-GAAP R&D expenses for the fourth quarter and full year of 2008 were higher primarily as a result of increased clinical study activity as well as higher headcount related to the growth in Gilead's business, partially offset by a net decrease in payments incurred related to its collaborations.
Selling, General and Administrative
Selling, general and administrative (SG&A) expenses in the fourth quarter of 2008 were $193.7 million compared to $180.0 million for the same quarter in 2007. Non-GAAP SG&A expenses, which exclude stock-based compensation expense, for the fourth quarter of 2008 were $174.7 million, compared to $165.4 million for the same quarter in 2007. For 2008, SG&A expenses were $797.3 million compared to $705.7 million for 2007. Non-GAAP SG&A expenses, which exclude stock-based compensation expense, for 2008 were $720.8 million, compared to $604.4 million for 2007. Non-GAAP SG&A expenses for the fourth quarter were higher primarily as a result of increased compensation and benefits as well as infrastructure and technology costs to support the continued growth in Gilead's business. For the full year of 2008, non-GAAP SG&A expenses were higher compared to 2007 primarily as a result of increased compensation and benefits and infrastructure and technology costs, as well as increased marketing and promotional expenses to support Gilead's expanding commercial activities.
Income Taxes
The full year 2008 effective tax rate was 26.5 percent compared to 28.9 percent for 2007. The decrease in the 2008 effective tax rate was driven primarily by various fourth quarter 2008 items, including the resolution of certain tax audits with taxing authorities and the extension of the federal research and development tax credit. As a result of these items, the fourth quarter 2008 tax rate was 22.1 percent. The income tax benefits recorded in the fourth quarter of 2008 had the effect of increasing GAAP and non-GAAP earnings by $0.04 per diluted share.
Net Foreign Currency Exchange Impact
The net foreign currency exchange impact on fourth quarter 2008 revenues and pre-tax earnings, which includes revenues and expenses generated from outside the United States, was a favorable $4.6 million and $12.6 million, respectively, compared to the same period in 2007. The impact on full year 2008 revenues and pre-tax earnings was a favorable $148.2 million and $92.6 million, respectively, compared to 2007.
Cash, Cash Equivalents and Marketable Securities
As of December 31, 2008, Gilead had cash, cash equivalents and marketable securities of $3.24 billion compared to $2.72 billion as of December 31, 2007. For the year, Gilead generated $2.20 billion of operating cash flows including $646.1 million in the fourth quarter.
Corporate Highlights
In October 2008, Gilead entered into an agreement to repurchase $750.0 million of its common stock under an accelerated share repurchase program. Gilead repurchased these shares under the $3.0 billion share repurchase program announced in October 2007. In 2008, Gilead repurchased and retired 39.2 million shares of its common stock for an aggregate purchase price of $1.97 billion. As of December 31, 2008, the remaining authorized amount of stock repurchases that may be made under this stock repurchase program which expires in December 2010 was $998.1 million.
Product and Pipeline Highlights
In November 2008, Gilead announced two-year (96-week) data from two Phase III pivotal clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread among adult patients with chronic hepatitis B. These data were presented during oral sessions at the annual meeting of the American Association for the Study of Liver Diseases in San Francisco.
In December 2008, Gilead announced the publication of the detailed one year (48-week) data from Studies 102 and 103 in the December 4, 2008 issue of The New England Journal of Medicine.
Cardiovascular Franchise
In October 2008, Gilead announced results of a two-year (104-week), open-label, uncontrolled, extension study (ARIES-E) of Letairis in patients with pulmonary arterial hypertension (WHO Group 1). Data from this study were presented at the annual meeting of the American College of Chest Physicians in Philadelphia.
Conference Call
At 4:30 p.m. Eastern Time today, Gilead will host a conference call and a simultaneous webcast to discuss the results of its fourth quarter and full year of 2008. During this call/webcast, Gilead's management will discuss the Company's fourth quarter and full year of 2008 results and provide a general business update. The webcast will be available live via the internet by accessing Gilead's website at www.gilead.com. To access the webcast, please connect to the Company's website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternatively, please call 1-800-901-5247 (U.S.) or 1-617-786-4501 (international) and dial the participant passcode 74401137 to access the call.
A replay of the webcast will be archived on the Company's website for one year, and a phone replay will be available approximately two hours following the call through January 31, 2009. To access the phone replay, please call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international) and dial the participant passcode 89437661.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Gilead's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Non-GAAP Financial Information
Non-GAAP net income and net income per diluted share for the three months ended December 31, 2008 and 2007, and the year ended December 31, 2007, are presented excluding the after-tax impact of stock-based compensation expense and adjusted for the application of APB 25 in computing non-GAAP dilutive securities. Non-GAAP net income and net income per diluted share for the year ended December 31, 2008 are presented excluding the after-tax impact of the purchased in-process research and development expense incurred in connection with the acquisition of Navitas Assets, LLC's assets related to its cicletanine business and the after-tax impact of stock-based compensation expense, and adjusted for the application of APB 25 in computing non-GAAP dilutive securities. Non-GAAP R&D expenses and SG&A expenses for the fourth quarter and full year of 2008 and 2007 are presented excluding the impact of stock-based compensation expense. Management believes this non-GAAP information is useful for investors, taken in conjunction with Gilead's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company's operating results as reported under United States generally accepted accounting principles.
Forward-looking Statements
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include: Gilead's ability to sustain growth in revenues for its antiviral and cardiovascular franchises; unpredictable variability of Tamiflu royalties and the strong relationship between this royalty revenue and global pandemic planning and supply; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products; Gilead's ability to successfully commercialize any products that receive regulatory approvals; Gilead's ability to successfully develop its respiratory and cardiovascular franchises; initiating and completing clinical trials may take longer or cost more than expected; fluctuations in the foreign exchange rate of the U.S. dollar that may reduce or eliminate the favorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; our ability to consummate additional purchases under our share repurchase program due to changes in our stock price, corporate or other market conditions; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market-specific and other relevant assumptions that it believes 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. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking.
Gilead directs readers to its Annual Report on Form 10-K for the year ended December 31, 2007, its Quarterly Reports on Form 10-Q for the first, second and third quarters of 2008 and its subsequent Current Reports on Form 8-K. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Truvada, Viread, Hepsera, AmBisome and Letairis are registered trademarks of Gilead Sciences, Inc.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
Tamiflu is a registered trademark of F. Hoffmann-La Roche Ltd.
For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) (in thousands, except per share amounts) Three Months Ended Year Ended December 31, December 31, 2008 2007 2008 2007 Revenues: Product sales $ 1,387,772 $ 1,025,895 $ 5,084,796 $ 3,733,109 Royalty, contract and 40,433 68,828 250,954 496,936 other revenues Total revenues 1,428,205 1,094,723 5,335,750 4,230,045 Costs and expenses: Cost of goods 321,531 215,542 1,127,246 768,771 sold (1) Research and 201,863 184,648 721,768 591,026 development (1) Selling, general and 193,665 180,048 797,344 705,741 administrative (1) Purchased in-process - - 10,851 - research and development (2) Total costs and 717,059 580,238 2,657,209 2,065,538 expenses Income from 711,146 514,485 2,678,541 2,164,507 operations Interest and other 19,038 29,528 59,401 109,823 income, net Interest expense (2,871 ) (2,857 ) (12,101 ) (13,100 ) Minority interest 2,369 2,076 8,564 9,108 Income before provision for income 729,682 543,232 2,734,405 2,270,338 taxes Provision for income 161,488 141,590 723,251 655,040 taxes (1) Net income $ 568,194 $ 401,642 $ 2,011,154 $ 1,615,298 Net income per share $ 0.62 $ 0.43 $ 2.18 $ 1.74 - basic Net income per share $ 0.60 $ 0.41 $ 2.10 $ 1.68 - diluted Shares used in per share calculation - 911,168 930,981 920,693 929,133 basic Shares used in per share calculation - 942,837 969,274 958,825 964,356 diluted Notes: The following is the stock-based compensation expense included in the (1) respective captions of the condensed consolidated statements of income above: Three Months Ended Year Ended December 31, December 31, 2008 2007 2008 2007 Stock-based compensation expense: Cost of goods $ 3,178 $ 2,874 $ 10,312 $ 11,224 sold Research and 16,578 15,953 66,523 72,082 development Selling, general and 19,003 14,616 76,529 101,299 administrative Income tax effect (8,451 ) (8,322 ) (40,565 ) (53,261 ) Total stock-based compensation $ 30,308 $ 25,121 $ 112,799 $ 131,344 expense, net of tax For the year ended December 31, 2008, Gilead incurred $10.9 million of (2) purchased in-process research and development expense as a result of the acquisition of all of Navitas Assets, LLC's assets related to its cicletanine business.
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) (in thousands, except per share amounts) Below is a reconciliation of Gilead's GAAP net income and diluted per share amounts as reported in the attached press release. Non-GAAP net income and net income per diluted share for three months ended December 31, 2008 and 2007, and the year ended December 31, 2007, are presented excluding the after-tax impact of stock-based compensation expense and adjusted for the application of APB 25 in computing non-GAAP dilutive securities. Non-GAAP net income and net income per diluted share for the year ended December 31, 2008 are presented excluding the after-tax impact of the purchased in-process research and development expense incurred in connection with the acquisition of Navitas Assets, LLC's assets related to its cicletanine business and the after-tax impact of stock-based compensation expense, and adjusted for the application of APB 25 in computing non-GAAP dilutive securities. Management believes this non-GAAP information is useful for investors, taken in conjunction with Gilead's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company's operating results as reported under GAAP. Three Months Ended Year Ended December 31, December 31, 2008 2007 2008 2007 Net income (GAAP) $ 568,194 $ 401,642 $ 2,011,154 $ 1,615,298 Stock-based compensation 30,308 25,121 112,799 131,344 expense, net of tax Purchased in-process research and development expense, net of - - 7,769 - tax Net income (Non-GAAP) $ 598,502 $ 426,763 $ 2,131,722 $ 1,746,642 Shares used in per share 942,837 969,274 958,825 964,356 calculation - diluted (GAAP) Dilutive securities 683 2,227 1,686 2,123 Shares used in per share 943,520 971,501 960,511 966,479 calculation - diluted (Non-GAAP) Net income per share - diluted $ 0.60 $ 0.41 $ 2.10 $ 1.68 (GAAP) Net income per share - diluted $ 0.63 $ 0.44 $ 2.22 $ 1.81 (Non-GAAP)
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) December 31, December 31, 2008 2007 (unaudited) (Note 1) Cash, cash equivalents and marketable securities $ 3,239,639 $ 2,722,422 Accounts receivable, net 1,023,397 795,127 Inventories 927,868 599,966 Property, plant and equipment, net 528,799 447,696 Other assets 1,298,871 1,269,505 Total assets $ 7,018,574 $ 5,834,716 Current liabilities $ 1,220,992 $ 736,275 Long-term liabilities and minority interest 1,645,095 1,638,451 Stockholders' equity 4,152,487 3,459,990 Total liabilities and stockholders' equity $ 7,018,574 $ 5,834,716 Note: (1) Derived from audited consolidated financial statements at that date.
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) (in thousands) Three Months Ended Year Ended December 31, December 31, 2008 2007 2008 2007 (Note 1) (Note 1) Antiviral products: Truvada - U.S. $ 255,101 $ 209,984 $ 992,100 $ 789,709 Truvada - Europe 270,055 210,650 986,648 711,650 Truvada - Other 36,896 28,213 127,939 87,870 International 562,052 448,847 2,106,687 1,589,229 Atripla - U.S. 351,914 258,303 1,317,168 900,009 Atripla - Europe 103,027 276 225,754 276 Atripla - Other 10,573 1,134 29,533 3,096 International 465,514 259,713 1,572,455 903,381 Viread - U.S. 69,303 62,757 254,216 257,598 Viread - Europe 66,588 60,109 259,897 260,001 Viread - Other 25,990 25,620 107,074 95,570 International 161,881 148,486 621,187 613,169 Hepsera - U.S. 28,804 28,832 131,404 123,479 Hepsera - Europe 42,681 42,736 191,112 162,490 Hepsera - Other 4,934 5,364 18,507 16,753 International 76,419 76,932 341,023 302,722 Emtriva - U.S. 3,859 3,230 15,804 13,443 Emtriva - Europe 2,382 2,261 9,819 11,275 Emtriva - Other 728 1,614 5,457 6,775 International 6,969 7,105 31,080 31,493 Total Antiviral products - 708,981 563,106 2,710,692 2,084,238 U.S. Total Antiviral products - 484,733 316,032 1,673,230 1,145,692 Europe Total Antiviral products - 79,121 61,945 288,510 210,064 Other International 1,272,835 941,083 4,672,432 3,439,994 AmBisome 75,971 67,807 289,651 262,571 Letairis 36,176 14,754 112,855 21,020 Other products 2,790 2,251 9,858 9,524 114,937 84,812 412,364 293,115 Total product sales $ 1,387,772 $ 1,025,895 $ 5,084,796 $ 3,733,109 (1) Certain prior period amounts have been reclassified to conform to current period presentation.
CONTACT: Gilead Sciences, Inc. Investors Robin Washington, 650-522-5688 Susan Hubbard, 650-522-5715 Media Amy Flood, 650-522-5643 Source: Gilead Sciences, Inc.