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gilead sciences inc (GIS) Snapshot

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gilead sciences inc (GIS) Details

Gilead Sciences, Inc., a biopharmaceutical company, discovers, develops, and commercializes medicines for the treatment of life threatening diseases in North America, South America, Europe, and the Asia-Pacific. The company’s products include Stribild, Complera/Eviplera, Atripla, Truvada, Viread, Emtriva, Tybost, and Vitekta for the treatment of human immunodeficiency virus (HIV) infection in adults; and Sovaldi, Viread, and Hepsera products for the treatment of liver disease. It also offers Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa, a tablet used for the treatment of chronic angina; Lexiscan/Rapiscan injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging; Cayston, an inhaled antibiotic for the treatment of respiratory systems in cystic fibrosis patients; and Tamiflu, an oral antiviral capsule for the treatment and prevention of influenza A and B. In addition, the company provides other products, such as AmBisome, an antifungal agent to treat serious invasive fungal infections; Vistide, an antiviral injection for the treatment of cytomegalovirus retinitis in adult patients with AIDS; and Macugen, an anti-angiogenic oligonucleotide to treat neovascular age-related macular degeneration. Further, it has product candidates in various stages for the treatment of HIV, liver, oncology/inflammation, cardiovascular, and respiratory diseases. The company markets its products through its commercial teams and/or in conjunction with third-party distributors and corporate partners. Gilead Sciences, Inc. has collaborations with BMS, Janssen, and Japan Tobacco to develop and commercialize various products. The company was founded in 1987 and is headquartered in Foster City, California.

6,100 Employees
Last Reported Date: 02/25/14
Founded in 1987

gilead sciences inc (GIS) Top Compensated Officers

Chairman and Chief Executive Officer
Total Annual Compensation: $1.6M
President and Chief Operating Officer
Total Annual Compensation: $1.0M
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $746.2K
Chief Scientific Officer and Executive Vice P...
Total Annual Compensation: $884.2K
Senior Advisor
Total Annual Compensation: $810.4K
Compensation as of Fiscal Year 2013.

gilead sciences inc (GIS) Key Developments

Sequent Scientific Announces Licensing Agreement with Gilead Sciences, Inc for New Hepatitis C Drug

SeQuent Scientific Limited announced that Gilead Sciences Inc. has licensed SeQuent to produce active pharmaceutical ingredients (APIs) sofosbuvir and ledipasvir for treatment of chronic hepatitis C. Under the agreement, SeQuent will receive a complete technology pack from Gilead to enable scale up production of the APIs as quickly as possible. The formulations using these APIs can be distributed in 91 developing countries, which account for more than 100 million people living with hepatitis C, globally representing 54% of the total global infected population. Sofosbuvir was approved under the trade name Sovaldi by the U.S. Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014.

Gilead Sciences Inc. Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries

Gilead Sciences Inc. announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies -- Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. -- to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries. The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54% of the total global infected population. Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.

Gilead Sciences, Inc. Announces Results from the AMBITION Study

Gilead Sciences Inc. announced 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 (GSK). In AMBITION, first-line treatment of pulmonary arterial hypertension (PAH) with the combination of ambrisentan 10 mg and tadalafil 40 mg reduced the risk of clinical failure by 50% compared to the pooled ambrisentan and tadalafil monotherapy arm (hazard ratio = 0.502; 95% CI: 0.348, 0.724; p=0.0002). The combination was also statistically significant versus the individual ambrisentan and tadalafil monotherapy groups for the primary endpoint (p<0.01). Rates of serious adverse events and events to discontinuation were similar across treatment arms. Detailed results from the study (Abstract #2916) will be presented during an oral session at ERS International Congress 2014, the annual meeting of the European Respiratory Society. Gilead plans to submit the AMBITION data in a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration by the end of this year. Combination use with ambrisentan and tadalafil is currently not approved. Ambrisentan, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union (EU) and other countries as once-daily treatments for PAH (WHO Group 1), in patients with WHO/NYHA functional class II and III symptoms. Ambrisentan is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. AMBITION was a randomized, double-blind study designed to compare the safety and efficacy of investigational first-line combination therapy (ambrisentan and tadalafil) to first-line monotherapy (ambrisentan or tadalafil) in patients with WHO/NYHA functional class II and III PAH. In the study, 500 patients were randomized (2:1:1) to receive ambrisentan and tadalafil (n=253) or monotherapy with ambrisentan (n=126) or tadalafil (n=121) (titrated from 5 mg to 10 mg once-daily and from 20 mg to 40 mg once-daily for ambrisentan and tadalafil, respectively). The primary endpoint was time to first clinical failure event, defined as time from randomization to the first occurrence of death (all-cause), hospitalization for worsening PAH, disease progression or unsatisfactory long-term clinical response (events adjudicated by an independent, blinded committee). The treatment effect observed with the primary endpoint was mainly driven by a reduction in hospitalizations. Time to first hospitalization was reduced by 63% (hazard ratio = 0.372; 95% CI: 0.217, 0.639; p=0.0002). Statistically significant improvements were also observed with the following secondary endpoints versus the pooled monotherapy arm: change from baseline at week 24 in N-terminal pro-B-type natriuretic peptide (NT-proBNP) (-67.4% vs. -49.7%; p<0.0001),% of patients with satisfactory clinical response at week 24 (39% vs. 29%; p=0.026) and median change from baseline to week 24 in six-minute walk distance (6MWD) (49.0 meters vs. 23.8 meters; p<0.0001). There was no difference between treatment groups in the change from baseline to week 24 for WHO Functional Class. No new safety signals were detected with the combination of ambrisentan and tadalafil. Adverse events occurring more frequently in the combination arm than in each monotherapy arm were peripheral edema (Combination: 45%; ambrisentan: 33%; tadalafil: 28%), headache (Combination: 42%; ambrisentan: 33%; tadalafil: 35%), nasal congestion (Combination: 21%; ambrisentan: 15%; tadalafil: 12%) and anemia (Combination: 15%; ambrisentan: 6%; tadalafil: 12%). The AMBITION study was cosponsored by Gilead and GSK. Eli Lilly and Company also provided funding and tadalafil drug supply for the trial. Gilead commercializes ambrisentan under the tradename Letairis(R) in the U.S. and GSK commercializes ambrisentan under the tradename Volibris(R) in territories outside of the United States.


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