GS-6212

Dietmar Berger said Gilead is in a “unique situation” as he assumes the role of chief medical officer, touting a “well-diversified” pipeline, potential launches and an eight-year stretch of no major patent cliffs. Berger will be tasked with leading Gilead’s R&D comeback, following a tough year for its cancer pipeline that brought disappointing readouts and a withdrawal for Trodelvy in urothelial cancer. Six weeks in, Berger told investors and analysts Tuesday that he is “impressed with the outstanding talent we have across therapeutic areas here at Gilead, and the depth of innovation across our 54 clinical programs.” Gilead’s HIV franchise will be a big part of Berger’s plans, including an anticipated US launch this year for Sunlenca in HIV pre-exposure prophylaxis (PrEP), and ongoing programs assessing daily, weekly and monthly oral treatment options and quarterly and twice-annual injectable options. Sunlenca, also known as lenacapavir, is already approved for use in combination with other antiretroviral drugs to treat people with multidrug-resistant HIV infection. Two of Gilead’s programs aren’t making the R&D pivot: a Phase 1 long-acting injectable for HIV treatment called GS-6212, and an Arcus-partnered combination regimen in Phase 2 for metastatic non-small cell lung cancer. Discontinuation of GS-6212 was announced in December, as the company chose to advance another program called GS-1614 in combination with Sunlenca instead. A Gilead spokesperson called the removal of its Arcus-partnered combination a “strategic prioritization decision.” The program was evaluating domvanalimab, zimberelimab and etrumadenant, and Gilead continues to study those molecules in other combination studies. Executives also touted a strong launch for Livdelzi, Gilead’s primary biliary cholangitis drug that was approved in August. The company said fourth-quarter liver disease sales totaled $719 million, up 4% from the year prior, driven in part by the Livdelzi launch. “Not only are we seeing the progression, but it’s definitely exceeding our internal expectations,” chief commercial officer Johanna Mercier said on the company’s earnings call. However, Mizuho analysts said Tuesday that Sunlenca’s potential launch in HIV PrEP this summer is “arguably the most anticipated” milestone for Gilead this year. “Our many near-term opportunities across HIV, oncology and inflammation will help to drive the next wave of growth for Gilead,” CEO Daniel O’Day said. “We have no major loss of exclusivity until late 2033 and we have significant potential across the entire portfolio.”