January 18, 2017: Hearing vague takeover rumors circulating about Gilead Sciences. Could not verify the source of the rumors. Reminder: back on January 6, 2017 heard rumors circulating that an activist investor like Carl Icahn could get involved.
January 10, 2017: Gilead Sciences announced that the European Commission has granted marketing authorization for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
The marketing authorization allows for the marketing of TAF in the 28 countries of the European Union, Norway and Iceland.
TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gileads Viread(tenofovir disoproxil fumarate, TDF) 245 mg, but at one-tenth the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes (cells of the liver) compared to TDF, it can be given at a lower dose, which means there is less tenofovir in the bloodstream. By reducing exposure to tenofovir, TAF is associated with improved renal and bone laboratory safety parameters compared to TDF in clinical trials.
TAFs approval is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) in 1,298 adult chronic HBV patients. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. Both studies met their primary endpoint of non-inferiority to TDF based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy. Patients in the TAF arm of the trials also experienced numerically higher rates of normalization of blood serum alanine aminotransferase (ALT) levels. Both studies showed TAF and TDF to be well-tolerated by patients and discontinuations due to adverse events were 1% and 1.2%, respectively. The most common reported adverse events with TAF were diarrhea, vomiting, nausea, abdominal pain, abdominal distension, flatulence, fatigue, headache, dizziness, rash, pruritus, increased ALT and arthralgia.
While the primary efficacy assessment was performed at week 48, data show that at week 72 viral suppression as well as biochemical responses were maintained with continued TAF treatment. The safety assessment includes analyses performed at both week 48 and week 72 of treatment (median duration of exposure of 88 weeks), and safety endpoints included changes from baseline in bone mineral density at the hip and spine, and changes from baseline in serum creatinine and in eGFR, key indicators of renal health. In both studies, at weeks 48 and 72, changes in renal and bone laboratory safety parameters favored the TAF treatment groups.
Vemlidy was approved by the U.S. Food and Drug Administration on November 10, 2016 for the treatment of chronic HBV infection in adults with compensated liver disease, and by the Japanese Ministry of Health, Labour and Welfare on December 19, 2016 for the suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.
January 9, 2017: Biotechnology firm Gilead Sciences stock is putting in a multiple bottom as Barclays reiterates an Overweight rating on the stock and sets a price target of $105. Gilead Sciences stock trades at a P/E of 7.04 and a forward P/E of 7.02. Barclays says that Gileads comments seem to imply that near-term expectations are mostly reasonable, but it did not address the issue of M&A and business development, which are more pressing topics in the minds of investors. While Barclays did not expect management to identify specific markets or therapeutic categories, they did expect a more proactive stance to be taken in the presentation. That said, managements tone seem to be positive overall with regard to operational trends and the pipeline, and Barclays sees relatively low risk of further multiple compression at current levels.
Gilead Sciences Stock Chart
The Finviz screener settings used to find Gilead Sciences are: P/E Under 10, Forward P/E Under 10, EPS growth this year 60% – 65%, EPS growth past 5 years 40% – 50%
Gilead Sciences Inc. is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.