Gilead Sciences Announces Third Quarter 2014 Financial Results

Gilead Sciences Announces Third Quarter 2014 Financial Results

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 & Pipeline Updates Announced by Gilead During the Third Quarter of 2014 Include:

Antiviral Program

Announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, adopted a positive opinion on Gilead's Marketing Authorization Application for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg).
Announced topline results from two Phase 3 clinical trials (Studies 104 and 111), which demonstrated that an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. The studies demonstrated that the single tablet regimen (E/C/F/TAF) comprising elvitegravir, cobicistat, emtricitabine and TAF, was non-inferior to Gilead's Stribild (elvitegravir /cobicistat /emtricitabine /tenofovir disoproxil fumarate) based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 48 weeks of therapy. In addition, E/C/F/TAF demonstrated more favorable renal and bone safety compared to Stribild.
Submitted a New Drug Application (NDA) to Japan's Pharmaceutical and Medical Devices Agency for approval of a once-daily fixed-dose combination of ledipasvir (LDV) 90 mg and sofosbuvir (SOF) 400 mg for the treatment of chronic genotype 1 HCV infection in adults. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin.
Announced that Gilead has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic HCV medicines in developing countries. The agreements allow the companies to manufacture SOF and the single tablet regimen of LDV/SOF for distribution in 91 developing countries.
Announced a new agreement with the Medicines Patent Pool (MPP) to expand access to TAF for HIV and hepatitis B, contingent on the medicine's U.S. regulatory approval. Under the agreement, the MPP can sub-license TAF to generic drug companies in India and China, who may manufacture and distribute it in 112 developing countries.
Oncology Program

Received U.S. Food and Drug Administration approval for Zydelig for the treatment of three B-cell blood cancers. Zydelig is indicated in combination with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy and as monotherapy for patients with relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.
The European Commission granted marketing authorization for Zydelig for CLL and FL. For the treatment of CLL, Zydelig has been approved for use in combination with rituximab for patients who have received at least one prior therapy; or in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. For the treatment of FL, Zydelig has been approved as a monotherapy in patients who are refractory to two prior lines of treatment.
Cardiovascular Program

Announced positive results from the AMBITION study (a randomized, double-blind, multicenter study of first-line combination therapy with AMBrIsentan and Tadalafil in patients with pulmonary arterial hypertensION), which was conducted in collaboration with GlaxoSmithKline plc. In AMBITION, first-line treatment of pulmonary arterial hypertension with the combination of ambrisentan 10 mg and tadalafil 40 mg reduced the risk of clinical failure by 50 percent compared to the pooled ambrisentan and tadalafil monotherapy arm. The combination was also statistically significant versus the individual ambrisentan and tadalafil monotherapy groups for the primary endpoint.
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).

Source: Gilead Sciences, Inc.

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