Gilead Sciences, Inc. (GILD) Tops Q2 EPS by 63c; Boosts FY14 Revenue Outlook
Gilead Sciences, Inc. (NASDAQ: GILD) reported Q2 EPS of $2.36, $0.63 better than the analyst estimate of $1.73. Revenue for the quarter came in at $6.53 billion versus the consensus estimate of $5.68 billion.
“During the second quarter, Gilead continued to make significant progress led by strong Sovaldi sales. Since December’s launch, Sovaldi has been prescribed for more than 80,000 patients in the U.S. and Europe, underscoring the medical community’s recognition of the benefits of this product,” said John C. Martin, PhD, Gilead’s Chairman and Chief Executive Officer. “We look forward to making Sovaldi available in additional countries.”
Gilead Sciences, Inc. sees FY2014 revenue of $21.0 - $23.0 billion, versus prior guidance of $11.3 - $11.5 billion and the consensus of $22.63 billion.
Product & Pipeline Updates Announced by Gilead During the Second Quarter of 2014 Include:
Antiviral Program
- Submission of a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of sofosbuvir (SOF), a once-daily nucleotide analog polymerase inhibitor for the treatment of chronic HCV infection. The NDA is based primarily on data from a Phase 3 clinical trial conducted in Japan among 153 treatment-naïve and treatment-experienced genotype 2 patients. In the study, 97 percent of HCV-infected patients receiving 12 weeks of an all-oral regimen of SOF plus ribavirin (RBV) 600-1,000 mg/day achieved a sustained virologic response 12 weeks after completing therapy (SVR12). If approved, SOF would form the basis of the first all-oral, interferon-free treatment regimen for genotype 2 patients in Japan.
- Positive results from a Phase 3 clinical trial in Japan evaluating the investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and SOF 400 mg, with and without RBV, for the treatment of genotype 1 chronic HCV infection. In the arm that utilized LDV/SOF without RBV, 100 percent of patients treated achieved SVR12, including the subset of patients with cirrhosis. Based on these data, Gilead plans to submit an NDA for the LDV/SOF fixed-dose combination with the Japanese PMDA by the end of 2014.
- U.S. Food and Drug Administration (FDA) acceptance of the company’s refiling of two NDAs for cobicistat and elvitegravir. FDA set target review dates under the Prescription Drug User Fee Act (PDUFA) of October 3, 2014 for cobicistat and October 4, 2014 for elvitegravir.
- Presentations of data on SOF-based regimens in chronic HCV patients at the 49th Annual Meeting of the European Association for the Study of the Liver included:
- Positive data from two Phase 2 studies and a compassionate access study in which a regimen containing once-daily Sovaldi was administered for the treatment of chronic HCV infection in patients with advanced liver disease.
- Positive data from two Phase 2 studies, evaluating investigational all-oral regimens containing SOF for the treatment of chronic HCV infection.
- Positive results from an open-label clinical trial, evaluating once-daily Sovaldi for the retreatment of chronic HCV infection among patients who failed prior therapy.
- Priority review granted by the FDA of the NDA for a once-daily fixed-dose combination of LDV/SOF for the treatment of chronic HCV genotype 1 infection in adults. The FDA set a target action date under PDUFA of October 10, 2014.
Oncology Program
- Updated interim results of a Phase 2 study evaluating GS-9973, Gilead's investigational oral inhibitor of spleen tyrosine kinase (Syk), for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) at the 50th Annual Meeting of the American Society of Clinical Oncology. Based on these data, Gilead plans to initiate new CLL study cohorts to include patients who have relapsed following treatment with other inhibitors of the B-cell receptor signaling pathway.
Other
- Positive results from a placebo-controlled, Phase 2a challenge study in healthy adult patients intranasally infected with respiratory syncytial virus (RSV) at the American Thoracic Society 2014 International Conference. The study of GS-5806, an investigational oral RSV fusion inhibitor, achieved its primary and secondary endpoints of lower viral load (the amount of virus detected in the nasal wash), improvements in total mucus weight (the amount of mucus produced) and also symptom score compared to placebo.
- Positive results from HARMONY, a randomized, double-blind, placebo-controlled Phase 2 study evaluating the effect of ranolazine and low-dose dronedarone, each given alone and in combination, on atrial fibrillation burden (AFB) in patients with paroxysmal atrial fibrillation at the annual meeting of the Heart Rhythm Society. In HARMONY, the combination of ranolazine and low-dose dronedarone provided greater reductions in AFB from baseline than either therapy used alone.
- Positive results from a Phase 1 clinical trial of GS-6615, an investigational, selective late sodium current inhibitor, showing a shortening of the QTc interval (the time interval between the start of the Q-wave and end of the T-wave in the heart’s electrical cycle) in patients with long QT-3 (LQT3) syndrome at the annual meeting of the Heart Rhythm Society. Based on these results, Gilead plans to initiate a Phase 2 study of GS-6615 in LQT3 patients later this year. Additionally, based on pre-clinical data for GS-6615 and clinical data involving the role of late sodium current inhibition in other cardiovascular diseases, Gilead plans to initiate Phase 2 clinical trials in patients with hypertrophic cardiomyopathy and ventricular tachycardia/ventricular fibrillation.
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