Gilead Sciences (NASDAQ:GILD) Chairman and Chief Executive Officer Daniel O’Day said the company is entering a period of strength after several years of efforts to diversify its business, pointing to a broad launch schedule, a strong balance sheet and continued expense discipline.
Speaking at an investor event, O’Day said Gilead has “the strongest portfolio” in its history and is positioned for “robust and sustainable growth.” He said the company expects up to 10 ongoing or anticipated launches between now and the end of 2027 across its three therapeutic areas. For this year, he cited four potential new medicine approvals, including the recent approval of HEPCLUDEX, and five Phase 3 readouts.
Policy, Manufacturing and Investment Plans
O’Day said Gilead’s U.S. footprint helps limit exposure to potential tariffs, noting that more than 90% of its research and development is in the United States and that the “vast majority” of its manufacturing base and intellectual property are also in the U.S. He said Gilead announced about $32 billion of investment over the next several years in U.S. manufacturing and research facilities, including buildings underway at its Foster City, California, headquarters and facilities tied to its cell therapy business.
HIV Prevention and Treatment Remain Central
O’Day emphasized the growth opportunity in HIV prevention, particularly for YeztuGo, which the event moderator described as a twice-yearly injectable prevention product. He said the HIV treatment market grows about 2% to 3% annually, while the PrEP market is growing about 14%. Gilead’s PrEP business grew 87% in the first quarter, he said.
O’Day said the Centers for Disease Control and Prevention recently increased its estimate of people in the U.S. who could benefit from PrEP from about 1.2 million to about 2.2 million. He said about 200,000 to 250,000 people were on PrEP in 2022, compared with about 500,000 today, and that the company expects the market to reach at least 1 million people by the mid-2030s.
He also said daily oral adherence remains a challenge, with compliance below 50% for people on PrEP today. Longer-acting options could improve adherence and expand use among populations facing stigma, limited access to care or unstable housing, O’Day said. He added that Gilead has a once-yearly program fully enrolled and could potentially launch a once-yearly version as early as 2028.
In HIV treatment, O’Day said BIKTARVY remains a major product, while Gilead is developing additional options, including Biclen, a daily doublet combining lenacapavir and bictegravir, and a weekly oral regimen with Merck involving islatravir and lenacapavir. He said Gilead does not face a major loss of exclusivity in its portfolio until BIKTARVY in 2036.
Oncology and Recent Acquisitions
O’Day said Gilead’s oncology business is anchored by TRODELVY and its cell therapy franchise. He said TRODELVY is pending with the Food and Drug Administration for first-line triple-negative breast cancer, an indication that he said would more than double the market for the product. He also referenced expected TRODELVY readouts in lung cancer and gynecologic cancers later this year.
Gilead recently announced acquisitions of Tubulis, Ouro Medicines and Arcellx. O’Day said the transactions were not a sign of weakness in Gilead’s internal pipeline, but reflected opportunities that met the company’s strategic and valuation criteria.
- Arcellx: O’Day said the deal gives Gilead full ownership of anito-cel, a one-time cell therapy for multiple myeloma with a December FDA PDUFA date. He said Gilead has not seen neurotoxicity side effects with anito-cel and believes owning the asset outright will help accelerate development into earlier lines of therapy.
- Tubulis: O’Day described Tubulis as a differentiated antibody-drug conjugate platform with a lead ovarian cancer program and broader potential across cancers.
- Ouro Medicines: He said Ouro gives Gilead an earlier-stage opportunity in B-cell depletion for autoimmune disease and inflammation.
O’Day said Gilead typically targets about $1 billion in early-stage M&A annually and larger transactions every couple of years. After the three acquisitions, totaling roughly $11 billion combined, he said Gilead expects to end the year at the same net debt level as before the deals.
R&D, AI and Margins
O’Day said Gilead is comfortable with R&D spending at about 20% of revenue, up from the low-teens percentage level when he joined the company. He said that level supports the pipeline while allowing Gilead to remain disciplined on operating expenses and maintain top-quartile operating margins.
On artificial intelligence, O’Day said Gilead has rolled out Copilot to all employees and is looking for productivity gains across development, manufacturing, sales and general administrative functions. He said AI is already helping improve clinical trial site selection and reduce the time between last patient data and regulatory filing by weeks or months.
O’Day said AI may also shorten early-stage drug discovery timelines, though he cautioned that biological science remains complex and that much of human biology is still not fully understood. He said Gilead is focused on using AI to improve productivity while continuing to prioritize “transformational innovation.”
About Gilead Sciences (NASDAQ:GILD)
Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.
Gilead’s product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.
