Gilead Lifts 2026 Outlook as Base Business Grows 10% on HIV, Oncology and Liver Momentum

Gilead Sciences (NASDAQ: GILD) delivered its strongest second-quarter base business growth in three years and raised its full-year outlook, even as acquisition-related research and development charges pushed reported earnings into non-GAAP loss territory.

Base business sales, which exclude Veklury, rose 10% from a year earlier, supported by HIV treatments and prevention products, Trodelvy in oncology and Livdelzi in liver disease. Total product sales reached $7.6 billion, up 8% year over year, as base business gains were partly offset by lower COVID-related Veklury sales.

Chairman and Chief Executive Officer Daniel O'Day said the quarter demonstrated clinical and commercial momentum across the company's core therapeutic areas. "This was also an exciting quarter of clinical execution with positive updates across our core therapeutic areas," O'Day said.

HIV remains Gilead's largest franchise. Second-quarter HIV sales rose 12% year over year to $5.7 billion, and the company now expects full-year HIV sales growth of 9% to 10%, up from prior guidance of 8%. Biktarvy, the lead HIV treatment, posted $3.8 billion in sales, a 7% increase. Chief Commercial and Corporate Affairs Officer Johanna Mercier said the gain reflected higher average realized prices, inventory build and demand, with sequential growth partly offset by market dynamics, including a greater-than-expected impact from Affordable Care Act-related coverage changes.

Mercier added that HIV treatment market growth slowed in the quarter as patients adjusted to insurance coverage changes, though Gilead expects the market to return to its normal 2% to 3% annual growth rate.

The company's HIV prevention, or PrEP, business more than doubled year over year and exceeded $1 billion in quarterly sales for the first time, putting it on an annual run rate of $4 billion. Mercier said Yeztugo has become the leading long-acting PrEP option for treatment-naive users and the leading option in the PrEP switch market across oral and injectable products. Gilead also introduced a patient-support program called Ready to Go, which includes text-message reminders, education, support links and a nurse call center aimed at improving persistence.

On the pipeline side, Gilead expects an FDA decision by Aug. 27 for bictegravir plus lenacapavir, or BIC/LEN, a once-daily oral regimen for virally suppressed people with HIV. The company also plans global filings for its once-weekly islatravir plus lenacapavir regimen developed with Merck, following positive Phase III ISLEND-1 and ISLEND-2 results, and sees a potential 2027 launch.

In oncology, Trodelvy sales rose 26% year over year to $457 million, helped by demand in triple-negative breast cancer and pretreated HR-positive, HER2-negative metastatic breast cancer. The FDA approved Trodelvy for first-line metastatic triple-negative breast cancer across PD-L1 status during the quarter. Mercier said that first-line population is nearly twice the size of the second-line setting and has a longer median treatment duration, which should broaden adoption with updated NCCN guidelines.

Gilead also closed its acquisition of Tubulis, adding an antibody-drug conjugate platform and clinical-stage candidates. Chief Medical Officer Dietmar Berger highlighted Phase I data for GS-8824, formerly TUB-040, in platinum-resistant ovarian cancer. Across selected doses, the NaPi2b-directed antibody-drug conjugate showed a confirmed objective response rate of 61%, median progression-free survival of 11 months and a low rate of hematological toxicity, according to Berger. Gilead expects to enter registrational development in that indication as early as 2027 and has added early-stage programs in platinum-sensitive ovarian cancer and other advanced tumors.

Cell therapy sales were $417 million in the quarter, down 14% year over year amid regional competition, but rose 2% sequentially on higher Yescarta demand that was partly offset by pressure on Tecartus. Gilead is preparing for a potential launch of anito-cel in fourth-line or later relapsed or refractory multiple myeloma, with a Dec. 23 PDUFA date. The company completed its acquisition of Arcellx in April, giving it full ownership of anito-cel and the D-domain binder platform. Berger said enrollment in the iMMagine-3 second-line multiple myeloma trial was completed during the quarter, with a potential filing as early as 2027.

Liver disease added another growth layer. Livdelzi sales more than doubled year over year to $167 million, supported by U.S. demand and European uptake, and remains the leading second-line treatment for primary biliary cholangitis. Gilead also reported positive top-line Phase III IDEAL results in patients with inadequately controlled primary biliary cholangitis and lower alkaline phosphatase levels. Berger said the study showed statistically significant composite alkaline phosphatase normalization, with detailed findings expected at a medical conference later this year. Total liver disease sales rose 10% to $877 million. The company launched Hepcludex in the United States after receiving accelerated FDA approval in May, making it the first and only FDA-approved treatment for chronic hepatitis delta virus infection.

Gilead reduced its full-year Veklury sales forecast to approximately $300 million from approximately $600 million, citing fewer COVID-19-related hospitalizations.

Chief Financial Officer Andrew Dickinson said second-quarter acquired in-process R&D expenses were $11.2 billion, largely related to the Arcellx, Tubulis and Ouro Medicines acquisitions. As a result, Gilead reported non-GAAP diluted earnings per share of negative $6.75 and a non-GAAP operating margin of negative 94%. Excluding acquisition-related IPR&D expenses and nonrecurring other revenue, Dickinson said illustrative non-GAAP diluted EPS was $2.27 for the quarter.

For the full year, Gilead raised its base business sales outlook to $29.8 billion to $30.1 billion, representing growth of about 6% to 7% year over year. It forecast full-year non-GAAP EPS of negative $0.65 to negative $0.30, while illustrative EPS excluding specified acquisition-related effects and nonrecurring other revenue was projected at $8.50 to $8.85.

The company returned nearly $1.4 billion to shareholders in the second quarter, including $355 million in share repurchases. Dickinson said Gilead does not currently anticipate pursuing additional sizable acquisitions this year as it focuses on integrating the businesses and platforms acquired during the first half. The quarter underscores a strategic shift: Gilead remains anchored by HIV, but the fastest growth is coming from long-acting prevention, antibody-drug conjugates and liver disease. Management has signaled it will keep integrating recent deals rather than add more large acquisitions, a stance that could appeal to investors focused on balance sheet discipline.

Founded in 1987 and headquartered in Foster City, California, Gilead Sciences is a biopharmaceutical company focused on medicines for areas of high unmet medical need. Initially known for antiviral therapies, the company has expanded into oncology, cell therapy and inflammatory diseases while maintaining a portfolio anchored by HIV and viral hepatitis treatments.