Gilead Sciences NASDAQ: GILD reported first-quarter 2026 results highlighted by growth in its base business, a higher full-year revenue outlook, and multiple late-stage pipeline and launch milestones across HIV, oncology, liver disease, and inflammation. Executives repeatedly pointed to “consistent track record of commercial, clinical, and financial execution,” as Chairman and CEO Daniel O’Day framed the quarter as evidence of portfolio depth and “continued focus on financial discipline.”
First-quarter sales led by HIV, TRODELVY and LIVDELZI
Chief Commercial and Corporate Affairs Officer Johanna Mercier said first-quarter total product sales excluding VEKLURY were $6.8 billion, up 8% year-over-year, while total product sales including VEKLURY were $6.9 billion, up 5% year-over-year. She noted sequential sales declined 12% “in line with normal first quarter seasonality.”
HIV remained the primary growth driver. Mercier said HIV sales were $5.0 billion, up 10% year-over-year, led by BIKTARVY, YEZTUGO, and DESCOVY, “as well as pricing favorability.” BIKTARVY sales were $3.4 billion, up 7% year-over-year, and Mercier said U.S. share was “once again more than 52%,” continuing “year-over-year gains in every quarter since launch.”
In HIV prevention, Mercier said Gilead’s U.S. PrEP business grew 87% year-over-year, supported by DESCOVY and twice-yearly injectable YEZTUGO. DESCOVY sales were $807 million, up 38% year-over-year, and Mercier said that within PrEP—about 80% of DESCOVY’s business—first-quarter U.S. sales were up “approximately 50% year-over-year.” YEZTUGO posted first-quarter sales of $166 million, up 72% sequentially, which Mercier said exceeded expectations.
Outside HIV, Mercier highlighted liver and oncology growth. LIVDELZI sales were $133 million and “more than tripled year-over-year,” while TRODELVY sales were $402 million, up 37% year-over-year and up 5% sequentially. Mercier said TRODELVY was approved in “over 60 countries” and was “firmly established as the leading regimen in second-line metastatic TNBC across major markets.”
Cell therapy sales were a relative soft spot. Mercier, speaking “on behalf of Cindy and the Kite team,” said first-quarter cell therapy sales were $407 million, down 12% year-over-year, reflecting “expected ongoing in-class and out-of-class competition across regions.”
YEZTUGO launch metrics and raised guidance
Management emphasized early launch traction for YEZTUGO. Mercier said access has expanded to where “approximately 95% of individuals are covered in the U.S., of which 95% can access YEZTUGO with $0 copay.” She also pointed to early signals around persistency, stating that while it is “still early,” the company expects YEZTUGO persistency to be “the highest in the HIV prevention category.”
Asked about mix and adherence, Mercier said switch share remains higher than naïve but that naïve uptake is “coming along really quite nicely.” She described switch share as “a bit of a split across 1/3, 1/3, 1/3,” spanning long-acting injectable options, TRUVADA generics, and DESCOVY. On tracking return visits, she said claims data is “not perfect,” but that comeback for the second dose is “really positive and encouraging.”
Mercier also discussed the company’s direct-to-consumer campaign, which started in late February, saying it has driven a “huge increase in brand awareness and visibility,” though she cautioned it can take “six to 12 months” to see broader outputs.
Given first-quarter outperformance, Mercier said Gilead increased 2026 YEZTUGO guidance to $1 billion, “potentially achieving blockbuster status in its first full year.” She added that Gilead now expects 2026 total HIV sales growth of approximately 8% year-over-year, up from 6% previously communicated, inclusive of about a 2% headwind associated with Medicaid pricing and proposed Affordable Care Act changes.
Pipeline and regulatory catalysts: HIV, oncology, liver and inflammation
O’Day and Chief Medical Officer Dietmar Berger outlined a busy 2026 slate of regulatory decisions and clinical readouts.
- BIC/LEN for HIV treatment: O’Day said bictegravir + lenacapavir is under FDA priority review with an expected decision in August. Mercier said Gilead is “targeting a potential launch in late August” for virally suppressed people with HIV, including those on complex regimens. Berger said ARTISTRY-1 and ARTISTRY-2 showed viral suppression in switch patients with “no clinically meaningful emergent resistance.”
- Once-weekly oral treatment: Berger said phase III ISLEND-1 and ISLEND-2 updates (with Merck) are targeted for later this quarter, evaluating islatravir + lenacapavir in virally suppressed people with HIV.
- Long-acting treatment (GS-3242): O’Day referenced phase I data for GS-3242 and said additional data later this year could support combining GS-3242 with lenacapavir as a potential twice-yearly injectable treatment. Berger said the 2031–2033 potential launch window reflects conservative planning around trial designs, adding the company will move “as quickly as possible.”
- HIV prevention (once-yearly lenacapavir): Berger said enrollment is complete in the phase III PURPOSE 365 study evaluating once-yearly intramuscular lenacapavir for PrEP, with a target U.S. approval in 2028.
- TRODELVY expansion: O’Day said the company anticipates regulatory decisions for first-line metastatic TNBC in the second half of the year, and Berger added the company also anticipates European Commission decisions later this year. Phase III updates from EVOKE-03 (first-line metastatic NSCLC) and ASCENT-GYN (endometrial cancer) are expected in the second half of 2026.
- Anito-cel (BCMA CAR-T): O’Day said a regulatory decision is expected in December. Mercier said with a late December PDUFA date and site activation time, the company expects revenue to begin in early 2027. Cindy Perettie, EVP of Kite, said enthusiasm is evident in iMMagine-3 enrollment, which is “faster than we expected,” and said the company expects “a majority” of authorized treatment centers to be activated within the first quarter of 2027.
- Liver disease (LIVDELZI and HEPCLUDEX): O’Day said LIVDELZI revenue for second-line primary biliary cholangitis more than tripled year-over-year, with a phase III IDEAL study update expected in the second half of the year. Berger said the company expects an FDA decision for bulevirtide (HEPCLUDEX in the EU) for chronic hepatitis delta virus infection later this quarter.
- Inflammation: Berger highlighted the pending acquisition of Ouro Medicines and its lead asset gamgertamig (a BCMAxCD3 bispecific T-cell engager). He also said the company expects to share updates this year from the phase II SWIFT study for GS-1427 (emvistegrast, an oral α4β7 inhibitor) and the phase II-A COSMIC study for edecesertib (an IRAK4 inhibitor). Asked about timing for the oral α4β7 update, Berger said investors should “not read anything into the current timeline” and that the company will update “very soon.”
Acquisitions: Arcellx closed; Tubulis and Ouro expected to close later in the quarter
O’Day said Gilead would share more on Arcellx, Ouro, and Tubulis in coming quarters. Berger said that with Arcellx closed, Gilead’s pipeline includes 47 clinical programs and gains the D-Domain binder portfolio.
On Tubulis, Berger said the company was attracted to “unprecedented data in ovarian cancer” for TUB-040, including objective response rate, durability, and tolerability, and noted the data were in a “not biomarker selected population.” He highlighted two platform elements: a linker technology he described as enabling stable payload delivery with limited general toxicity, and a conjugation platform intended to support different payloads, creating synergy with Gilead’s medicinal chemistry capabilities.
CFO Andrew Dickinson added that “the ovarian opportunity alone is very large” and said the financial return in ovarian cancer alone “can justify the transaction price,” while acknowledging potential upside in lung cancer “as the data develops.”
Margins, EPS, and updated 2026 outlook
Dickinson said the base business grew 8% year-over-year to $6.8 billion in the quarter. On profitability, he reported non-GAAP product gross margin of 87%, up two percentage points year-over-year, driven in part by expiration of “a long-standing TAF-related royalty obligation” and product mix. Non-GAAP diluted EPS was $2.03, up 12% year-over-year.
For full-year 2026, Dickinson said Gilead increased revenue ranges by $400 million. The company now expects base business revenue of $29.4 billion to $29.8 billion and total product sales (including VEKLURY) of $30.0 billion to $30.4 billion. VEKLURY guidance remained approximately $600 million.
Dickinson also detailed how transaction-related costs flow through guidance, saying “upfront IPR&D of $11.5 billion” and financing expenses totaling about $9.50 per share are reflected in updated EPS expectations. Gilead’s updated non-GAAP loss per share guidance is $1.05 to $0.65, but excluding the transaction-related impact, Dickinson said non-GAAP diluted EPS would be $8.45 to $8.85, “in line with” prior guidance.
On capital returns, Dickinson said Gilead returned more than $1.4 billion to shareholders in the first quarter, including over $400 million of share repurchases, totaling about 60% of free cash flow returned through buybacks and dividends.
Looking ahead, Dickinson said near-term business development focus is on closing and integrating current transactions, adding it is “less likely” the company will pursue additional sizable M&A this year, while leaving room for strategic opportunities.
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.
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