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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

Gilead Sciences, Inc. Announces Encouraging Results from Hepatitis C Virus Trial

Gilead Sciences Inc. has announced results from an open-label clinical trial, or Study GS-US-334-0109, evaluating once-daily Sovaldi 400mg tablets for the retreatment of chronic hepatitis C virus, or HCV, infection among patients who failed prior therapy. In Study GS-US-334-0109, patients with genotype 1 HCV infection (n=80) received 12 weeks of treatment with once-daily Sovaldi plus weight-based ribavirin (RBV) twice-daily (1,000 or 1,200 mg/day) and pegylated interferon (peg-IFN; 180 ìg/week). Patients in the study had failed prior regimens containing peg-IFN, RBV and an investigational NS3 protease inhibitor, with or without investigational direct-acting antivirals (DAAs) (NS5A and/or non-nucleoside NS5B inhibitors). Forty-five of patients (n=36) had received more than one course of prior therapy, and 90% (n=72) had at least one viral mutation associated with HCV NS3, NS5A or NS5B drug resistance. Among the 50 patients for whom sustained virologic response data was available 12 weeks after the end of treatment (SVR12), 74% (n=37/50) achieved SVR12. Additionally, 80% (n=28/35) of patients with baseline resistance against two or more DAAs achieved SVR12. Importantly, Sovaldi has now demonstrated efficacy among genotype 1 HCV infected patients who failed prior treatment with three or four drug regimens and have developed viral resistance to some of the components of those regimens. In a separate presentation, retreatment with Sovaldi in genotype 2 (n=11) or genotype 3 (n=96) HCV infected patients who previously failed treatment with 12 or 16 weeks of Sovaldi plus RBV in the Phase III studies FISSION, FUSION and POSITRON was evaluated. 36% of these patients (39/107) had cirrhosis. Patients were retreated either with a 12-week regimen of Sovaldi, RBV and peg-IFN, or a 24-week, interferon-free regimen of Sovaldi plus RBV. The choice of regimen was determined by study investigators. Among patients with available SVR12 data, 63% (n=25/40) of those who received the 24-week all-oral regimen and 92% (n=24/26) of those who received the 12-week regimen of Sovaldi, RBV, and peg-IFN achieved SVR12.

Gilead Sciences, Inc. Announces Data from Two Phase 2 Studies

Gilead Sciences Inc. announced data from two phase 2 studies and a compassionate access study in which a regimen containing once-daily Sovaldi(R) (sofosbuvir) 400 mg was administered for the treatment of chronic hepatitis C virus (HCV) infection in patients with advanced liver disease. These data are being presented at the 49th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress 2014) in London. The first study, Study GS-US-334-0125 (Oral #068), is an ongoing open-label Phase 2 clinical trial evaluating HCV patients with cirrhosis and portal hypertension, with or without decompensation, who were randomized 1:1 to an immediate treatment arm in which Sovaldi and ribavirin (RBV) was administered for 48 weeks (n=25) or to a deferred treatment arm in which this regimen was initiated after a 24-week observation period (n=25). 80% of participants were treatment-experienced. Of the 22 patients who completed 24 weeks of therapy, 95% (n=21/22) achieved virologic suppression on treatment. Additionally, patients taking Sovaldi-based therapy experienced trends in clinical and laboratory parameter improvements compared to patients in the observation arm. Sovaldi-based therapy was well tolerated in the study, and only one patient discontinued treatment due to an adverse event. The most common adverse events occurring in more than 25% of patients included nausea and pruritis. Patients in both arms of the study will be followed to determine their 12-week sustained virologic response rates (SVR12) after 48 weeks of Sovaldi-based therapy. A third, compassionate access study (Oral #62), evaluated Sovaldi therapy among 104 post-transplant patients with severe recurrent HCV, including fibrosing cholestatic hepatitis, who had exhausted all other treatment options and received pre-approval access to Sovaldi via Gilead's compassionate use program. Patients received up to 48 weeks of Sovaldi plus RBV, with some patients also receiving pegylated interferon (peg-IFN) (180 g/week) at their physician's discretion. The majority of patients in the study experienced clinical improvements on treatment. Overall, 62% of patients achieved SVR12. Sovaldi-based therapy was well tolerated.

Gilead Sciences Inc. Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C

Gilead Sciences Inc. announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection. These data are being presented this week at the 49th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress 2014) in London. The first study, ELECTRON2 (Oral #6), is an ongoing, open-label Phase 2 clinical trial evaluating a once-daily fixed-dose combination of SOF 400 mg and the NS5A inhibitor ledipasvir (LDV) 90 mg, with and without ribavirin (RBV) twice-daily (1,000 or 1,200 mg/day), among HCV-infected patient populations. In this study, 100% (n=26/26) of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF plus RBV and 64% (n=16/25) of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF without RBV achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100% (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. Additionally, 65% (n=13/20) of genotype 1-infected patients with decompensated or Child-Turcotte-Pugh Class B cirrhosis receiving 12 weeks of LDV/SOF without RBV achieved SVR12. LDV/SOF with and without RBV was well-tolerated, including among patients with more advanced liver disease. A second study, Study GS-US-342-0102 (Oral #111), is an ongoing randomized Phase 2 clinical trial in which treatment-naïve, non-cirrhotic patients with genotypes 1-6 HCV infection received a 12-week course of SOF plus the pan-genotypic NS5A inhibitor GS-5816. Patients received SOF 400 mg and either GS-5816 25 mg (n=77) or GS-5816 100 mg (n=77). In this study, 94.8% (n=73/77) of patients receiving the 25 mg dose of GS-5816 and 96.1% (n=74/77) of patients receiving the 100 mg dose achieved SVR12.


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