Gilead: Long-held CAR-T Still Fails to Take Center Stage — Revenue Remains Highly Dependent on HIV Business

On August 5, 2025, Gilead Sciences released its Q2 2025 financial results. Overall revenue rose by just 2%, while the core HIV franchise performed strongly. Sales of the COVID-19 drug Veklury (remdesivir) and cell-therapy products continued to decline. The company raised its full-year revenue and earnings guidance and announced a new share buyback program, indicating management confidence in future growth.

Key Financial Data

Revenue and Earnings

Total revenue was $7.1 billion, up 2% year-over-year and slightly below market expectations. Product sales were $7.05 billion, up 2%. Excluding Veklury, product sales grew 4% to $6.9 billion. GAAP diluted earnings per share (EPS) were $1.56, up 21% (Q2 2024: $1.29). Non-GAAP EPS was $2.01, flat year-over-year, mainly affected by higher R&D spending.

Cash Flow and Capital Allocation

Cash and cash equivalents totaled $7.1 billion, down from $10.0 billion at the end of 2024, primarily due to a $1.7 billion transition tax payment. Operating cash flow was $827 million, reduced by tax impacts. Dividends paid amounted to $994 million; share repurchases were $527 million. The board approved a new $6.0 billion share repurchase program, signalling management's confidence in long-term value.

Business Segment Performance

1. HIV Business: Strong Biktarvy Growth; Yeztugo Approval a Highlight

HIV product sales were $5.1 billion, up 7% year-over-year, accounting for 72% of total revenue.

• Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide): Global sales of $3.5 billion, up 9%; the U.S. contributed $2.8 billion (+8%). Europe grew 16% ($429 million), and emerging markets grew 9% ($302 million).
• Descovy (emtricitabine/tenofovir alafenamide): Sales of $653 million, up 35%, driven primarily by price increases and higher demand.
• Yeztugo (lenacapavir, long-acting HIV prevention): The FDA approved the world’s first six-month PrEP regimen, with launch expected in the second half of 2025. Gilead reached an agreement with the Global Fund to supply 2 million doses to low-income countries over the next three years.

2. Liver Disease: Livdelzi Growth Offsets HCV Decline

Liver disease product sales were $795 million, down 4% year-over-year. HCV (hepatitis C) revenues fell due to market contraction and generic competition. Livdelzi (seladelpar, for primary biliary cholangitis) showed significant growth, though specific figures were not disclosed. Hepcludex (bulevirtide, for hepatitis D) remained steady in Europe but is not yet approved in the U.S.

3. Oncology: Trodelvy Grows, but CAR-T Therapies Face Headwinds

Oncology product sales were $849 million, up 1%.

• Trodelvy (sacituzumab govitecan, for triple-negative breast cancer): Sales of $364 million, up 14%, driven by higher demand and inventory adjustments. Positive ASCENT-03 Phase III results could expand first-line indications.
• CAR-T cell therapies (Yescarta / Tecartus): Combined sales were $485 million, down 7%. Yescarta (for large B-cell lymphoma) generated $393 million (-5%), facing intensified competition. Tecartus (for mantle cell lymphoma) generated $92 million (-14%), with a noticeable drop in demand.

4. Other Products: Continued Decline in Veklury

Veklury (remdesivir) sales were $121 million, plunging 44% year-over-year due to lower COVID-19 hospitalization rates. Other products (including AmBisome and others) totaled $202 million, down 28%.

R&D and Strategic Progress

1.Key R&D Milestones

• HIV: Yeztugo (long-acting PrEP) received FDA approval and is included in WHO guideline recommendations. PURPOSE 1 & 2 trial data support its use in pregnant women and adolescents. However, GS-1720 / GS-4182 (HIV treatment candidates) faced an FDA clinical hold, affecting development timelines.
• Oncology: Trodelvy plus Keytruda (pembrolizumab) ASCENT-04 data were positive and may expand use in PD-L1+ patients. Gilead is collaborating with Kymera to develop CDK2 degrader candidates to broaden the oncology pipeline.
• Inflammation / Liver disease: Long-term safety data for Livdelzi from the ASSURE study support its potential in liver disease indications.

2. Cost Control and Operational Optimization

Non-GAAP product gross margin was 86.9%, up 90 basis points year-over-year, benefiting from portfolio optimization. R&D expense was $1.5 billion, up 9%, mainly due to increased clinical manufacturing and research activities. SG&A expenses were flat; higher promotional spend was offset by lower corporate costs.

2025 Full-Year Guidance (Raised)

Gilead raised its full-year financial guidance to reflect solid performance in core businesses.

Metric	2025 New Guidance	Prior Guidance	Change
Product sales	$28.3–28.7 billion	$28.2 billion	+1.8%
Product sales (ex-Veklury)	$27.3–27.7 billion	$26.8 billion	+3.7%
GAAP EPS	$5.85–6.15	$5.65–7.70	Median raised
Non-GAAP EPS	$7.95–8.25	$7.70–8.10	Upper end increased

Market Impact and Outlook

Investor Reaction

After the results, Gilead’s stock showed modest after-hours movement. Market attention is centered on Yeztugo’s commercial potential — whether it can become a new growth engine — and on whether CAR-T offerings like Yescarta can withstand competition from rivals such as Novartis and BMS. Investors are also watching Trodelvy’s label expansion prospects and whether it can capture a larger share of the breast cancer market.

Long-term Strategic Challenges

• Heavy reliance on HIV: Biktarvy still represents an outsized share of revenue, underscoring the need to accelerate contributions from oncology and inflammation pipelines.
• Pressure in cell therapy market: Manufacturing and pricing improvements are needed to compete effectively.
• Policy risk: U.S. legislation such as the Inflation Reduction Act (IRA) could affect drug pricing and requires strategic market adjustments.