Year Established: 1987
Revenues: $22,127 (-15%)
Net Income: $5,455 (+18%)
R&D: $5,018 (+34%)
TOP SELLING DRUGS
|Epclusa||Pre-exposure prophylaxis (PrEP)||$1,966||-44%|
|Odefsey||Hepatitis C treatment||$1,598||44%|
|Biktarvy||Hepatitis C treatment||$1,184||n/a|
Climbing out of a two-year downturn, the light at the end of the tunnel revealed itself in the first quarter of 2019, with revenues up 4% to $5.3 billion and earnings up 28% to $2.0 billion. Still recovering financially from HCV franchise declines, Gilead has finally returned to growth thanks to its flagship HIV franchise and Yescarta, its first commercially available CAR-T cancer therapy.
While chronic hepatitis C virus (HCV) product sales, which consist of Epclusa, Harvoni, Vosevi, and Sovaldi, were down nearly 60% to $3.7 billion in 2018, and down 26% in the first quarter of 2019 to $790 million, HIV product sales were up 12% to $14.6 billion for the year, primarily due to the launch of Biktarvy and the continued uptake of Descovy, Genvoya and Odefsey. In 1Q19, HIV product sales were up 13% to $3.6 billion, thanks to Biktarvy.
Yescarta, a chimeric antigen receptor (CAR) T cell therapy launched in the U.S. in October 2017 to treat large B-cell lymphoma, generated $264 million in sales in 2018. Resulting from the 2017 acquisition of Kite Pharma, Yescarta was the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). Yescarta generated $96 million in sales in the first quarter compared to $40 million in 1Q18.
Kite Pharma, a Gilead company, is significantly expanding its ability to manufacture a variety of CAR-T therapies, including Yescarta, for both clinical and commercial use with a new biologics facility in Urbana, MD. Kite specializes in cancer treatments and the facility will focus on chimeric antigen receptor T (CAR-T) therapies, which uses a patient’s white blood cells to destroy cancer cells. Producing these therapies requires complex processes and the new facility aims to better meet these specifications. It will become part of Kite’s commercial manufacturing network that includes sites in CA and the Netherlands. Yescarta is also being investigated in solid tumors. To date, CAR-T therapies have only proven successful in blood cancers.
As of March 1, 2019, Daniel O’Day took the helm as Gilead’s chairman and chief executive officer, succeeding John F. Milligan, Ph.D., who stepped down after a 28-year career with the company. Mr. O’Day previously served as CEO of Roche Pharmaceuticals, a position he held since 2012, and prior to that led Roche Diagnostics. His career spans three decades of leadership roles across North America, Asia Pacific and Europe.
In other recent executive moves, Gilead appointed Johanna Mercier as its new chief commercial officer, joining the senior leadership team on July 1, and succeeding Laura Hamill, who is departing from Gilead after less than a year in the role.
Also, Robin Washington, executive vice president and chief financial officer, plans to retire from her role, effective March 1, 2020, and Alessandro Riva, MD, executive vice president, Oncology Therapeutics, has decided to leave the company to pursue another opportunity. The company has yet to name successors for these two roles.
Updates to Gilead’s HIV and liver diseases programs include approvals in China of Harvoni for the treatment of HCV genotype 1-6 infection, Vemlidy for the treatment of chronic HBV infection, and Descovy for the treatment of HIV-1 infection. Also, findings from two studies support the further development of GS-6207, a first-in-class, investigational capsid inhibitor, which may represent a novel approach to HIV treatment due to its long-acting characteristics and potent antiviral activity seen in vitro.
However, recent results from a Phase III study evaluating the safety and efficacy of selonsertib, an investigational, once daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), for patients with bridging fibrosis due to nonalcoholic steatohepatitis (NASH), did not meet its primary endpoint of improvement in fibrosis without worsening of NASH.
Gilead’s oncology and cell therapy programs recently achieved promising study results from a Phase I/II study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T cell therapy, in relapsed or refractory acute lymphoblastic leukemia. With a median follow-up of 15 months following a single infusion of KTE-X19, 69% of patients achieved complete tumor remission, and the rate of undetectable minimal residual disease in patients who achieved complete tumor remission was 100%.
Also, two-year efficacy and safety data of Yescarta in patients with refractory large B-cell lymphoma, showed 39% of patients were in an ongoing response with a median follow up of 27 months.
Additionally, results from an ongoing Phase III study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in moderate-to-severe active rheumatoid arthritis, achieved its primary endpoint of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 24. The proportion of patients achieving the primary endpoint was significantly higher for filgotinib 200 mg plus MTX and filgotinib 100 mg plus MTX compared with MTX alone.
Lastly, a Phase II study of filgotinib in severe active ankylosing spondylitis (AS) achieved its primary endpoint of significantly greater improvements in AS Disease Activity Score at Week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo. More patients receiving filgotinib also achieved an ASAS20 response compared to those treated with placebo.
In its most recent deal, Gilead will pay Nurix Therapeutics $45 million up front and as much as $2.3 billion in milestones under a global strategic collaboration to develop and commercialize a pipeline of innovative targeted protein degradation drugs for cancer and other challenging diseases. Dysregulated and/or mutated proteins play a central role in the development and progression of many human diseases. Nurix’s technology platform is focused on the manipulation of the ubiquitin system and its component E3 ligases, the key enzymes responsible for controlling protein levels in human cells.
Under an alliance with Agenus, Inc. focused on the development and commercialization of novel immuno-oncology therapies, Agenus will receive $150 million upfront including $30 million equity investment, and the agreement also includes approximately $1.7 billion in potential milestones.
A strategic collaboration with Scholar Rock Holding Corp. aims to discover and develop highly specific inhibitors of transforming growth factor beta activation for the treatment of fibrotic diseases. Scholar Rock will receive $80 million upfront in payments, including the purchase of Scholar Rock stock, and the company is eligible to receive up to an additional $1.4 billion in potential payments across three programs.
Moreover, a global strategic collaboration with Tango Therapeutics aims to develop and commercialize a pipeline of innovative targeted immuno-oncology treatments. Tango will receive $50 million upfront and is eligible to receive approximately $1.7 billion in additional payments across all programs.
Finally, Gilead is not giving up on nonalcoholic steatohepatitis (NASH) and has partnered with several companies to help advance its efforts. Gilead and Novo Nordisk are collaborating on a clinical trial combining compounds from their respective pipelines in NASH. The trial will combine Novo Nordisk’s semaglutide (GLP-1 analogue) and Gilead’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor). The companies are also exploring the potential to collaborate on preclinical research to advance understanding of the disease.
Under a licensing and collaboration deal with Yuhan Corp. to develop novel NASH candidates, Gilead acquired global rights to small molecules against two targets for $15 million upfront and up to an additional $770 million in potential milestones.
Lastly, Gilead and insitro partnered to discover and develop NASH therapies leveraging insitro’s Human (ISH) platform to create disease models for NASH and discover targets that have an influence on clinical progression and regression of the disease. The insitro Human (ISH) platform applies machine learning, human genetics and functional genomics to generate and optimize unique models to drive discovery and development. Gilead can advance up to five targets identified through this collaboration.