Gilead Sciences Q4 Earnings Call Highlights

Gilead Sciences (NASDAQ:GILD) executives highlighted what they described as a “remarkable year” of clinical, commercial, and operational execution in the company’s fourth-quarter and full-year 2025 earnings call, pointing to growth in HIV, momentum in liver disease and oncology, and a pipeline that management expects to support multiple launches through 2027 and beyond.

2025 results: HIV and liver gains offset Veklury decline and policy headwinds

For full-year 2025, Gilead reported total product sales of $28.9 billion, up 1% from 2024 and above its guidance range of $28.4 billion to $28.7 billion. Chief Financial Officer Andrew Dickinson said the results reflected demand-led HIV growth that more than offset a $1.1 billion headwind tied to the Medicare Part D redesign and a $900 million decline in Veklury revenue.

Base business sales (excluding Veklury) were $28.0 billion, up 4% year-over-year and above guidance. Excluding Part D redesign impacts, management said base business growth would have been 8%.

In the fourth quarter, total product sales including Veklury were $7.9 billion, up 5% year-over-year. Excluding Veklury, fourth-quarter product sales were $7.7 billion, up 7% year-over-year.

HIV: Biktarvy growth, strong prevention performance, and rising expectations for Sunlenca/“Yes2Go”

Management emphasized HIV as the key growth driver. Full-year HIV sales were $20.8 billion, up 6% year-over-year, and fourth-quarter HIV sales were a record $5.8 billion, up 6%. Gilead said the HIV business faced an estimated $900 million headwind in 2025 from the Part D redesign; excluding that impact, management said HIV grew 10%.

Within treatment, Biktarvy delivered fourth-quarter sales of $4.0 billion, up 5% year-over-year, and full-year sales of $14.3 billion, up 7%. Chief Commercial and Corporate Affairs Officer Johanna Mercier said demand-led growth reflected treatment market expansion and continued share gains, noting Biktarvy’s U.S. share exceeded 52%.

In prevention, Mercier said the company posted “another exceptional quarter,” citing 53% year-over-year growth in the HIV prevention business. Descovy fourth-quarter sales rose 33% year-over-year, and full-year Descovy sales were $2.8 billion, up 31%, driven by increased demand in prevention and higher average realized price. She said Descovy’s U.S. market share in PrEP exceeded 45%.

Gilead also discussed the launch of its twice-yearly injectable HIV prevention product, referred to during the call as Sunlenca and “Yes2Go.” Fourth-quarter sales were $96 million and full-year sales were $150 million, which management said was in line with guidance shared in the third quarter. Mercier said coverage reached about 90% ahead of the company’s one-year target, including all major payers, and that roughly 90% of covered individuals could access the product with $0 copay.

For 2026, management guided to approximately $800 million in revenue for the product, compared with $150 million in 2025. In Q&A, Mercier said key launch indicators—access, health care provider awareness, conversion rates, and intakes—were tracking at or above expectations. She said it was still early to set firm persistency assumptions given the mid-2025 launch timing, but added the company is monitoring second-dose behavior and investing in reminders and pull-through initiatives.

When asked about cannibalization, Mercier said Descovy is expected to continue growing through 2026, with longer-term erosion anticipated as the injectable becomes the leading share product in HIV prevention over time. On pricing, she said the company does not discuss gross-to-net but described the product’s value proposition as “differentiated,” pointing to the pace of access wins.

Liver, oncology, and cell therapy: Livdelzi adoption and Trodelvy momentum; Kite pressured by competition

Gilead’s liver disease business grew 6% in 2025 to $3.2 billion. Fourth-quarter liver sales were $844 million, up 17% year-over-year. Mercier attributed performance largely to rapid adoption of Livdelzi in primary biliary cholangitis (PBC). Livdelzi sales were $150 million in the fourth quarter, up 42% sequentially, which management said was helped by strong demand and switching following a competitor’s product withdrawal in the U.S. Mercier said Gilead entered 2026 as U.S. market share leader with more than 50% share in second-line PBC.

In oncology, Trodelvy sales rose 6% in 2025 to $1.4 billion, with fourth-quarter sales of $384 million, up 8% year-over-year and sequentially. Management said performance was driven by metastatic breast cancer demand and helped offset the expected impact from the U.S. bladder cancer withdrawal at the end of 2024. Executives highlighted positive phase III ASCENT-03 and ASCENT-04 readouts in metastatic triple-negative breast cancer (TNBC), saying the investigational regimens showed statistically significant and clinically meaningful progression-free survival benefits over standard of care. Mercier said the data were published in The New England Journal of Medicine and recognized by updated NCCN breast cancer guidelines, adding that Trodelvy is the only antibody-drug conjugate recommended by NCCN for first-line PD-L1 positive and negative, as well as second-line metastatic TNBC.

In cell therapy, full-year sales were $1.8 billion, down 7% year-over-year, reflecting competition. Fourth-quarter cell therapy sales were $458 million, up 6% sequentially due to higher-than-expected treatments ahead of holidays and one-time pricing adjustments, but down 6% year-over-year. Management said it expects Kite revenue to decline about 10% in 2026 amid continued competitive headwinds and the impact of clinical trial enrollment on volumes.

Pipeline and launch outlook: multiple catalysts in 2026

Chief Medical Officer Dietmar Berger outlined several expected updates and regulatory events in 2026, while CEO Daniel O’Day said the company is targeting four commercial launches during the year. Management’s list included:

• Trodelvy for first-line metastatic TNBC, building beyond second-line use
• A daily oral combination of bictegravir and lenacapavir (“Biclen”) for HIV treatment following phase III ARTISTRY-1 and ARTISTRY-2 updates
• Anito-cel, a BCMA CAR T therapy, for fourth-line or later relapsed/refractory multiple myeloma
• Bulevirtide in the U.S. for chronic hepatitis delta, following E.U. approval

Berger said detailed results from ARTISTRY-1 and ARTISTRY-2 are expected to be shared at CROI in February, with a potential FDA decision by year-end. He also said Gilead plans phase III updates from ISLEND-1 and ISLEND-2 (islatravir plus lenacapavir) in the first half of 2026 and plans to initiate a phase III trial of lenacapavir plus broadly neutralizing antibodies for twice-yearly HIV treatment in the second half.

Berger added that the company prioritized GS-3242 as the most promising long-acting integrase inhibitor program to pair with lenacapavir for potential twice-yearly HIV treatment, and discontinued development of a twice-yearly regimen with GS-1219 and a quarterly regimen with GS-1614.

For liver disease, Berger said Gilead expects an update later in 2026 from the phase III IDEAL study evaluating Livdelzi in PBC patients with incomplete response to UDCA, including those with ALP levels between 1 and 1.67 times the upper limit of normal.

For oncology, Berger said the company expects FDA decisions in the second half of 2026 for Trodelvy in first-line metastatic TNBC in patients not candidates for PD-1 inhibitors and for Trodelvy plus pembrolizumab in first-line PD-L1 positive metastatic TNBC. He also pointed to potential 2026 updates from EVOKE-03 (Trodelvy plus pembrolizumab in first-line metastatic PD-L1 high non-small cell lung cancer) and ASCENT-GYN01 (second-line metastatic endometrial cancer).

On anito-cel, Berger said the company has filed the therapy based on phase II IMAGINE-1 data presented at ASH in December, citing 96% overall response, 74% complete response, and 95% measurable residual disease negativity, along with a “predictable and manageable” safety profile. In Q&A, Kite executive Cindy Perettie said the company expects modest contributions in 2026 given a potential second-half launch and the need to activate authorized treatment centers, while expressing confidence it can become a market leader over time based on efficacy, safety, and manufacturing turnaround times.

2026 guidance: product sales growth and higher EPS expected despite headwinds

For 2026, Gilead guided to total product sales of $29.6 billion to $30.0 billion. The company expects Veklury sales of approximately $600 million, which Dickinson characterized as a $300 million headwind. Base business sales are expected to be $29.0 billion to $29.4 billion, representing 4% to 5% growth versus 2025.

Management expects product gross margin of about 87%, R&D expense growth in the low single digits, and SG&A to rise in the mid-single digits as the company invests in sales and marketing to support launches. Gilead guided to non-GAAP diluted EPS of $8.45 to $8.85 and a non-GAAP effective tax rate of about 20%.

Mercier and Dickinson also highlighted anticipated headwinds in 2026, including an estimated ~2% impact to HIV growth tied to a drug pricing agreement to lower Medicaid pricing for certain products and potential shifts to lower-price channels from proposed Affordable Care Act changes. Even with those pressures, management expects total HIV sales to grow about 6% in 2026.

Gilead also reiterated its capital return priorities. Dickinson said the company returned $5.9 billion to shareholders in 2025, including $1.9 billion in share repurchases, and remains committed to returning on average at least 50% of free cash flow to shareholders.

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.