Last €80.53 EUR
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gilead sciences inc (GIS) Snapshot

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€80.65
Previous Close
€79.82
Day High
€80.82
Day Low
€79.94
52 Week High
10/31/14 - €93.51
52 Week Low
04/11/14 - €45.70
Market Cap
121.5B
Average Volume 10 Days
29.4K
EPS TTM
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Shares Outstanding
1.5B
EX-Date
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P/E TM
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Current Stock Chart for GILEAD SCIENCES INC (GIS)

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 Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment

Gilead Sciences Inc. announced results from several Phase 2 and Phase 3 studies evaluating investigational uses of Harvoni(R) (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic hepatitis C virus (HCV) infection in patients with limited or no treatment options, including patients with decompensated cirrhosis, patients with HCV recurrence following a liver transplant and patients who failed previous treatment with other direct acting antivirals. These data will be presented this week at the 65(th) Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2014) in Boston. Harvoni was approved by the U.S. Food and Drug Administration and Health Canada in October 2014 and is the first once-daily single tablet regimen for the treatment of chronic HCV genotype 1 infection in adults. Applications are pending in the European Union, Japan and New Zealand. In a pooled analysis of Phase 2 and Phase 3 open-label studies (Oral #82) in more than 500 genotype 1 HCV infected patients with compensated cirrhosis who received Harvoni alone or with ribavirin (RBV) for 12 or 24 weeks, 96% of patients achieved sustained virologic response (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. Two prospective analyses from a Phase 2 open-label study (Study GS-US-337-0123) evaluating patients with decompensated cirrhosis and those with HCV recurrence following liver transplantation also are being presented. In the first subgroup (Oral #239), 108 genotype 1 and 4 infected patients with decompensated cirrhosis, including those with moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Class B) and severe hepatic impairment (CPT Class C), received Harvoni plus RBV for 12 or 24 weeks. Overall, SVR12 rates were 87% (n=45/52) in the 12-week arm and 89% (n=42/47) in the 24-week arm. The second subgroup (Oral #8) evaluated 12 or 24 weeks of Harvoni plus RBV among 223 genotype 1 and 4 patients who developed HCV recurrence following liver transplantation. Among non-cirrhotic patients, SVR12 rates were 96% (n=53/55) and 98% (n=55/56) following 12 and 24 weeks of treatment, respectively. For patients with compensated cirrhosis, SVR12 rates were 96% for both 12 weeks (n=25/26) and 24 weeks (n=24/25) of therapy. SVR12 rates among patients with decompensated cirrhosis were 81% for both 12 weeks (n=25/31) and 24 weeks (n=17/21) of therapy. Study GS-US-337-0121 (Late Breaker Oral #LB-6) evaluated 155 genotype 1 patients with compensated cirrhosis who had failed prior treatment with pegylated interferon (PegIFN)/RBV and subsequently PegIFN/RBV plus a protease inhibitor. In this study, patients were randomized (1:1) to receive Harvoni plus RBV for 12 weeks or Harvoni alone for 24 weeks. 96%(n=74/77) of those receiving Harvoni plus RBV for 12 weeks and 97% (n=75/77) of those receiving Harvoni for 24 weeks achieved SVR12. In a second study (Oral #235), 51 genotype 1 patients who previously failed SOF/PegIFN/RBV, SOF/RBV or a SOF placebo/PegIFN/RBV treatment regimen received Harvoni plus RBV for 12 weeks. 29% of study patients (n=15/51) had cirrhosis. 98%(n=50/51) achieved SVR12 following 12 weeks of treatment with Harvoni plus RBV. In all of these studies, Harvoni was well tolerated and its safety profile was generally consistent with that observed in clinical trials of Harvoni. Adverse events included fatigue, headache, nausea and anemia, which was more common among patients taking RBV. Grade 3/4 laboratory abnormalities were infrequent and included decreases in hemoglobin, which is consistent with RBV-associated anemia.

Gilead Sciences, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Revises Earnings Guidance for the Year 2014

Gilead Sciences Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company’s total revenues increased to $6.04 billion compared to $2.78 billion for the third quarter of 2013. Net income attributable to the company 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. Non-GAAP net income attributable to the company, net of tax 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. Income from operations was $3,479.223 million against $1,147.861 million a year ago. Income before provision for income taxes was $3,370.820 million against $1,079.689 million a year ago. For the nine months, the company reported total revenues of $17,575.731 million against $8,081.862 million a year ago. Income from operations was $10,934.628 million against $3,326.958 million a year ago. Income before provision for income taxes was $10,626.395 million against $3,095.436 million a year ago. Net income attributable to the company was $8,614.277 million or $5.18 per diluted share against $2,283.397 million or $1.35 per diluted share a year ago. Non-GAAP net income attributable to the company, net of tax was $9,431.033 million or $5.68 per diluted share against $2,520.749 million or $1.49 per diluted share a year ago. The company 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. The company expects net product sales between $21,000 million to $23,000 million against previously expected range of $22,000 million to $23,000 million; non-GAAP product gross margin between 85% to 88% against previously expected range of 86% to 88%; effective tax rate between 17.5% to 20.5% against previously expected range of 17.5% to 19.5%; and diluted EPS impact of acquisition-related, restructuring and stock-based compensation expenses between $0.63 to $0.66 against previously expected range of $0.63 to $0.66.

Health Canada Issues Notice of Compliance for Gilead Sciences Inc.'S Harvoni

Gilead Sciences Inc. announced that Health Canada has issued a Notice of Compliance for Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single table regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, granted marketing authorization under the tradename Sovaldi in December 2013. The efficacy of Harvoni has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL. Gilead filed a New Drug Submission for Harvoni in Canada on March 19, 2014 and was granted Priority Review by Health Canada. Gilead has filed private and public payer reimbursement submissions for Harvoni and was granted a Priority Review under the Common Drug Review process on October 6, 2014. Harvoni was approved in the United States on October 10, 2014 and granted a positive opinion by the Committee for Medicinal Products for Human Use in the European Union on September 25, 2014. Applications are pending in Australia and New Zealand. The marketing authorization for Harvoni is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99%. For full study details, see the Clinical Studies section of the Product Monograph. Harvoni was well tolerated in the ION studies. 0%, less than 1% and 1% of patients treated for eight, 12 and 24 weeks, respectively, discontinued treatment due to adverse events, and fewer adverse events were observed in the ribavirin-free arms compared to the ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (>= 5%) were fatigue, headache, nausea, diarrhea and insomnia.

 

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