Speaking at the 35th Annual J.P. Morgan Healthcare Conference on Monday Gilead Sciences’ CEO John Milligan revealed what could be expected of the company in the current year including Gilead’s leadership role in HIV, expansion into new therapeutic areas, and efficient use of its stock pile among other things.
Gilead is making a lot of money through its HIV drugs based on tenofovir disoproxil fumarate (TDF), but Milligan says that TDF era is over and that the company is increasingly looking forward to tenofovir alafenamide (TAF) drugs. Milligan said that the biotech intends to extend its leadership role in HIV in 2017 with TAF drugs Genvoya, Descovey, and Odefsey. Genvoya has managed to make a huge name for itself in a short time in its first year of launch by easily topping Stribild and Viiv Healthcare’s Triumeq. Atripla had held the top spot until 2016 — Genvoya’s first full year on the market. Gilead is also working on another TAF drug. Results of a late-stage clinical study of bictegravir are expected in mid-2017 with a potential regulatory submission in the third quarter.
Pegging hepatitis C virus (HCV) landscape as “kind of a different market”, Milligan says that Gilead’s drugs including Sovaldi, Harvoni, and Epclusa are treating patients and the treatment window has shortened over the course of last few years. The patients that do start aren’t as sick as the ones who took Sovaldi and Harvoni when they first launched. And the treatment periods now tend to be shorter. Gilead is now eyeing to get more patients for which it has started a number of marketing campaigns. Milligan noted that Gilead’s HCV franchise continues to generate great cash flow. The biotech isn’t looking for further growth in this market, but Gilead should keep making plenty of money from its HCV drugs for years to come.
With a lesser emphasis on HCV, Gilead is turning to other therapeutic indications for future growth. Milligan highlighted three areas in his comments at the J.P. Morgan conference. Expanding into the non-alcoholic steatohepatitis (NASH) market is a natural next step for Gilead. Around 12 million Americans suffer from the liver disease. Gilead intends to especially go after the roughly 3 million of them with NASH-related fibrosis. These patients are the hardest to treat and present the greatest unmet medical need.
Gilead has three pipeline candidates targeting NASH. Milligan gave the most attention to selonsertib (GS-4997), which showed promising results in a phase 2 study. Two late-stage clinical studies of the oral ASK1 inhibitor are being conducted in 2017 and 2018. Gilead also has a couple of experimental NASH therapies in mid-stage clinical trials — ACC inhibitor GS-0976 and FXR agonist GS-9674.
Another therapeutic focus area is oncology. Milligan emphasized two pipeline candidates that could hold promise. GS-5745 is currently in a late-stage study targeting treatment of gastric cancer. The experimental drug is also is in a phase 2 study in combination with Bristol-Myers Squibb’s Opdivo in treating gastric cancer. Syk inhibitor entospletinib is in a couple of phase 2 clinical studies. Milligan thinks the drug could have a “fast regulatory pathway” in the acute myeloid leukemia (AML) indication.
Milligan also mentioned Gilead’s foray into the autoimmune disease market with filgotinib. He thinks the pipeline candidate could become one of the first JAK inhibitors to win approval for treating Crohn’s disease. Filgotinib is in multiple late-stage clinical studies targeting treatment of Crohn’s disease, rheumatoid arthritis, and ulcerative colitis.
Milligan said during the presentation that Gilead had returned 98 per cent of its free cash flow to shareholders. Milligan said that investors and interested parties should expect to see the biotech continue to return cash to shareholders in 2017 in the form of nice dividends and stock buybacks.