Gilead Raises 2026 Base-Business Outlook as Q3 HIV Sales Drive 16% Growth

Gilead Sciences (NASDAQ: GILD) raised its 2026 base-business outlook after third-quarter sales excluding Veklury climbed 16% year over year to $8.2 billion, the company’s strongest underlying growth in more than a decade. HIV products led the increase, while Trodelvy and Livdelzi added momentum and helped offset continued weakness in cell therapy.

Total product sales rose 13% to $8.3 billion in the quarter ended September 30, 2026, and increased 9% from the second quarter. Veklury sales fell 69% year over year to $86 million because of fewer COVID-19-related hospitalizations, widening the difference between total sales growth and performance in the base business.

Gilead now expects full-year base-business sales to grow 10% to 11%, supported by projected HIV growth of 12%, compared with its previous HIV forecast of 9% to 10%. The company increased its base-business sales guidance by $900 million following the third-quarter performance and said the outlook was $1.65 billion higher than at the beginning of the year.

Full-year product sales are expected to reach approximately $31.0 billion to $31.3 billion, including $30.7 billion to $31.0 billion excluding Veklury. The company continues to expect about $300 million in annual Veklury sales.

HIV Growth Drives the Quarter

HIV product sales increased 18% year over year and 10% sequentially to $6.25 billion, marking the portfolio’s strongest annual growth in more than seven years. Gilead attributed the year-over-year increase to higher average realized prices, stronger demand and favorable inventory movements.

Biktarvy sales rose 10% to $4.1 billion and increased 8% from the prior quarter. The company said the treatment reached an all-time high U.S. market share of about 53%. Demand and pricing supported the annual gain, while sequential growth reflected inventory and demand, partly offset by lower realized prices due to channel mix.

Gilead also expanded its treatment portfolio with the August U.S. launch of Bixlenvo, a once-daily single-tablet regimen for virologically suppressed adults switching HIV therapies. The company reported rapid initial uptake among patients using complex regimens, though it did not provide sales for the new product.

The HIV prevention business, comprising Descovy for PrEP and Yeztugo, generated $1.0 billion in sales, up 49% year over year and 8% sequentially. Yeztugo recorded quarterly sales of $305 million, a 31% sequential increase, and Gilead maintained its expectation for approximately $1 billion in full-year sales. The company said Yeztugo had become the leading injectable PrEP regimen in the U.S. and reported a 12-month persistence rate above 70%.

Trodelvy and Livdelzi Offset Cell-Therapy Pressure

Oncology product sales rose 9% year over year to $860 million, although they declined 2% sequentially. Trodelvy was the principal growth driver, with sales increasing 42% from a year earlier and 11% from the second quarter to $506 million. Gilead cited demand across metastatic triple-negative breast cancer and previously treated HR-positive/HER2-negative metastatic breast cancer.

Trodelvy, in combination with pembrolizumab, also received European approval for first-line treatment of PD-L1-positive metastatic triple-negative breast cancer. The drug is approved across PD-L1 status in the first-line setting in the U.S. and Europe, either alone for eligible PD-L1-negative patients or in combination with pembrolizumab for PD-L1-positive disease.

Liver-disease sales advanced 13% year over year and 6% sequentially to $927 million. Livdelzi sales reached $203 million, up 93% from the prior-year quarter and 21% sequentially, driven by higher demand in the U.S. and Europe. The company said Livdelzi held more than half of the U.S. second-line primary biliary cholangitis market. Favorable pricing in hepatitis C and hepatitis B also supported the liver portfolio, partly offset by fewer hepatitis C treatment starts.

Cell-therapy sales fell 18% year over year and 15% sequentially to $355 million as competitive pressure persisted. Gilead is preparing for a potential U.S. launch of anitocabtagene autoleucel, or anito-cel, for fourth-line and later relapsed or refractory multiple myeloma. The FDA decision date is December 23, 2026, and approval remains subject to regulatory review.

Higher Spending Limits Earnings Growth

Non-GAAP operating income rose 6% to $4.17 billion, while the non-GAAP operating margin remained about 50%. Product gross margin improved by 165 basis points to 88%.

Non-GAAP diluted earnings per share increased 3% to $2.55, from $2.47 a year earlier. Gilead said the comparison was affected by a $0.25-per-share benefit from intellectual-property asset sales in the third quarter of 2025. Excluding that prior-year benefit, non-GAAP diluted EPS increased 15%.

Research and development expense rose 19% to $1.59 billion, reflecting higher compensation accruals tied to year-to-date financial performance and increased clinical costs. Selling, general and administrative expense grew 14% to $1.54 billion, primarily because of HIV promotional activity, legal costs and higher compensation accruals. Acquired in-process research and development expense declined to $18 million from $170 million.

For the full year, Gilead expects mid- to high-single-digit R&D growth and high-single-digit SG&A growth. Acquired IPR&D is projected at approximately $12.9 billion, including about $1.4 billion of upfront payments expected in the fourth quarter for the planned PepStar Therapeutics transaction and a collaboration with Vir.

Pipeline Milestones and Risks

Gilead initiated two Phase 3 DAYBREAK trials evaluating lenacapavir with broadly neutralizing antibodies for HIV treatment and two Phase 2 PULSAR trials studying injectable GS-3242 with lenacapavir. A regulatory decision on a once-weekly oral Yeztugo regimen for PrEP is expected in February 2027.

In inflammation, the company reported promising Phase 2 SWIFT data for emvistegrast in ulcerative colitis and expects to begin Phase 3 development in 2027. It also expects updates on edecesertib in cutaneous lupus and gamgertamig in immune thrombocytopenia during the second half of 2026.

The outlook remains exposed to regulatory and clinical uncertainty. Gilead identified pending clinical holds affecting GS-3107 and KITE-753, and noted that the EVOKE-03 Trodelvy study did not meet its primary endpoint and was discontinued. Other stated risks include U.S. drug-pricing reforms, the Biktarvy Medicare maximum fair price determination, reimbursement and payer-mix pressure, generic competition, patent expirations, potential manufacturing disruptions and the possibility that clinical or regulatory milestones may be delayed or unsuccessful.