Gilead's HIV Franchise, CAR T Therapy Likely to Propel Growth

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Shares of biotech bigwig Gilead Sciences, Inc. GILD have inched up 0.4% in the past six months, against the industry’s 10.3% decline.

Headquartered in Foster City, CA, Gilead is a biopharmaceutical company, focused on developing drugs for the treatment of human immunodeficiency virus (HIV), liver diseases such as chronic hepatitis C virus (HCV) infection and chronic hepatitis B virus (HBV) infection, and cardiovascular, hematology/oncology and inflammation/respiratory diseases.

While the legacy HCV business has declined significantly of late due to competitive pressure from the likes of AbbVie ABBV, among others, the company’s HIV business has maintained momentum.

Gilead is a dominant player in the HIV market with an impressive product portfolio. The company was the first to bring to market a single-tablet regimen (STR) for the treatment of HIV — Atripla. Additional STRs for HIV in the market include Complera/Eviplera and Stribild, among others. TAF-based products like Genvoya, Odefsey and Descovy are performing well with strong adoption in both the United States and Europe. The company received a major boost when the FDA approved its once-daily single tablet regimen (“STR”), Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF) for HIV-1 infection. The approval, which comes ahead of the PDUFA date of Feb 12, 2018, significantly boosts Gilead’s HIV franchise. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (“INSTI”) bictegravir, with the demonstrated safety and efficacy profile of the Descovy, (FTC/TAF). The approval of this new HIV therapy will pose stiff competition to GlaxoSmith’s GSK existing therapies, Tivicay and Triumeq. The recent approval in Europe will further strengthen the company’s HIV franchise.

Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to help the top line. The initial uptake of Yescarta (from the Kite Pharma acquisition) is slow but encouraging.

We expect the HIV franchise and CAR-T therapy Yescarta to drive growth for the company.

Gilead has a robust pipeline with several development programs currently underway, ranging from phase I through phase III. The company has quite a few programs targeting non-alcoholic steatohepatitis (NASH) with advanced fibrosis, including selonsertib (ASK-1 inhibitor; phase III), GS-9674 (FXR agonist; phase II) and GS-0976 (ACC inhibitor; phase II).  Meanwhile, Gilead has been developing a pipeline targeting inflammatory diseases. Phase III studies on filgotinib for the treatment of RA and Crohn's disease are currently ongoing.

The company also has a collaboration agreement with Sangamo Therapeutics, Inc. SGMO to use Sangamo’s zinc finger nuclease technology platform for the development of next-generation ex vivo cell therapies in oncology.

Zacks Rank

Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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