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- Product Sales of $5.97 billion -
- Sovaldi Sales of $2.80 billion -
- Non-GAAP EPS of $1.84 per share -
- Revised 2014 Full Year Guidance -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 28, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the quarter ended September 30, 2014. Total revenues for the third quarter of 2014 increased to $6.04 billion compared to $2.78 billion for the third quarter of 2013. Product sales for the third quarter of 2014 increased to $5.97 billion compared to $2.71 billion for the third quarter of 2013. Net income for the third quarter of 2014 was $2.73 billion, or $1.67 per diluted share compared to $788.6 million or $0.47 per diluted share for the third quarter of 2013. Included in our GAAP and Non-GAAP earnings per share amounts for the third quarter of 2014 is a cumulative catch-up of $337 million ($0.21 per diluted share) related to the non-tax deductible Branded Prescription Drug (BPD) Fee for the final regulations in the Affordable Care Act issued during the quarter. Non-GAAP net income for the third quarter of 2014, which excludes acquisition-related, restructuring and stock-based compensation expenses, was $3.01 billion, or $1.84 per diluted share compared to $879.1 million or $0.52 per diluted share for the third quarter of 2013. Excluding the $0.21 impact of the non-tax deductible BPD cumulative catch-up fee, Non-GAAP diluted EPS would have been $2.05 for the third quarter of 2014.
“To date approximately 117,000 patients have been treated with Sovaldi and with the introduction of Harvoni - a single tablet regimen for the treatment of HCV-infected individuals which does not require either interferon or ribavirin - many more patients will have the potential to be cured of HCV infection,” said John C. Martin, PhD, Gilead's Chairman and Chief Executive Officer.
Product Sales
U.S. product sales for the third quarter of 2014 increased to $4.21 billion from $1.67 billion and Europe product sales increased to $1.44 billion from $823.6 million compared to the third quarter of 2013.
Antiviral Product Sales
Antiviral product sales increased to $5.54 billion for the third quarter of 2014, up from $2.33 billion for the third quarter of 2013 primarily due to sales of Sovaldi® (sofosbuvir 400 mg), which launched in December 2013.
Cardiovascular Product Sales
Cardiovascular product sales increased to $278.9 million for the third quarter of 2014, compared to $250.9 million for the third quarter of 2013.
Operating Expenses
During the third quarter of 2014, compared to the same period in 2013:
Note:
Non-GAAP R&D and SG&A expenses exclude the impact of acquisition-related, restructuring and stock-based compensation expenses.
Cash, Cash Equivalents and Marketable Securities
As of September 30, 2014, Gilead had $7.69 billion of cash, cash equivalents and marketable securities compared to $9.58 billion as of June 30, 2014. During the third quarter of 2014, Gilead generated $4.04 billion in operating cash flow and utilized $5.79 billion to repurchase shares and settle the warrants related to the 2014 convertible senior notes, which were retired in May 2014.
Revised 2014 Full Year Guidance
Gilead updated its full year 2014 guidance, which it initially provided on February 4, 2014, updated on July 23, 2014, and further revised on October 28, 2014:
Initially ProvidedFebruary 4, 2014;Reiterated April 22,2014
UpdatedJuly 23, 2014
Provided onOctober 28, 2014
Product & Pipeline Updates Announced by Gilead During the Third Quarter of 2014 Include:
Antiviral Program
Oncology Program
Cardiovascular Program
Conference Call
At 4:30 p.m. Eastern Time today, Gilead's management will host a conference call and a simultaneous webcast to discuss results from its third quarter 2014 as well as provide a general business update. To access the webcast live via the internet, please connect to the company's website at www.gilead.com 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 1-877-359-9508 (U.S.) or 1-224-357-2393 (international) and dial the conference ID 8029073 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 October 30, 2014. To access the phone replay, please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international) and dial the conference ID 8029073.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to transform and simplify care for people with life-threatening illnesses around the world. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia-Pacific.
Non-GAAP Financial Information
Gilead has presented certain financial information in accordance with U.S. generally accepted accounting principles (GAAP) and also on a non-GAAP basis. Management believes this non-GAAP information is useful for investors, when considered 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 Gilead's operating results as reported under GAAP. A reconciliation between GAAP and non-GAAP financial information is provided in the table on pages 7 and 8.
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 achieve its anticipated full year 2014 financial results; Gilead's ability to sustain growth in revenues for its antiviral, cardiovascular and respiratory programs; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; the possibility of unfavorable results from clinical trials involving TAF, including in combination with other products; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Gilead's ability to submit NDAs for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including SOF and the fixed-dose combination of LDV/SOF in Japan and the fixed-dose combination of LDV/SOF in the European Union; Gilead's ability to successfully commercialize its products, including Sovaldi, Harvoni, Stribild, Vitekta, Tybost and Zydelig; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; the risk that estimates of patients with HCV or anticipated patient demand may not be accurate; the risk that private and public payers may be reluctant to provide coverage or reimbursement for new products, including Sovaldi and Harvoni; Gilead's ability to successfully develop its respiratory, cardiovascular, oncology and inflammation programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates; the potential for additional austerity measures in European countries that may increase the amount of discount required on Gilead's products; Gilead's ability to complete its May 2014 share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (SEC). 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 press releases, Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 and other subsequent disclosure documents filed with the SEC. 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.
Gilead owns or has rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, SOVALDI®, HARVONI®, STRIBILD®, COMPLERA®, EVIPLERA®, TRUVADA®, VIREAD®, EMTRIVA®, TYBOST®, ZYDELIG®, HEPSERA®, VITEKTA®, LETAIRIS®, RANEXA®, CAYSTON®, AMBISOME®, VISTIDE®, VOLIBRIS®, and RAPISCAN®.
ATRIPLA® is a registered trademark belonging to Bristol-Myers Squibb & Gilead Sciences, LLC. LEXISCAN® is a registered trademark belonging to Astellas U.S. LLC. MACUGEN® is a registered trademark belonging to Eyetech, Inc. SUSTIVA® is a registered trademark of Bristol-Myers Squibb Pharma Company. TAMIFLU® is a registered trademark belonging to Hoffmann-La Roche Inc.
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)
2014
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(in thousands, except percentages and per share amounts)
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(1) Derived from the audited consolidated financial statements as of December 31, 2013.
(2) As of September 30, 2014, there were 1,513,593 shares of common stock issued and outstanding.
PRODUCT SALES SUMMARY
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.InvestorsRobin Washington, 650-522-5688Patrick O'Brien, 650-522-1936orMediaAmy Flood, 650-522-5643