Executive Summary

Solid Q3 with revenue and EPS beats vs consensus; total revenue $7.77B and non-GAAP EPS $2.47, aided by a non-recurring $400M “royalty, contract and other revenue” item contributing ~$0.25 to EPS; base business (ex-Veklury) grew 4% YoY on HIV and Livdelzi strength .
HIV outperformed: Biktarvy +6% YoY to $3.69B; Descovy +20% YoY to $701M. Yeztugo (lenacapavir) achieved ~75% U.S. payer coverage nearly three months ahead of plan, setting up a 2026 ramp .
Guidance raised: FY25 total product sales low end +$100M to $28.4–$28.7B and GAAP EPS to $6.65–$6.85; non-GAAP EPS nudged up to $8.05–$8.25 .
Strategic catalysts: Biktarvy LOE in the U.S. pushed out to 2036 via settlements; Trodelvy 1L mTNBC data (ASCENT-03) positive and in NEJM; PEPFAR partnership for lenacapavir PrEP accelerates global access .

What Went Well and What Went Wrong

What Went Well
- HIV momentum: HIV product sales +4% YoY to $5.28B; Biktarvy +6% YoY to $3.69B; Descovy +20% YoY to $701M driven by demand and prevention market growth .
- Coverage and launch execution: “We have already achieved our 75% access goal, nearly three months ahead of our target,” on Yeztugo, positioning for 2026 acceleration .
- Oncology progress: ASCENT-03 showed PFS 9.7 vs 6.9 months (38% risk reduction), published in NEJM; potential 2026 1L mTNBC launch .
What Went Wrong
- Cell Therapy pressure: Product sales -11% YoY and sequentially to $432M on competitive headwinds; FY25 Cell Therapy now forecast ~10% decline YoY .
- Veklury normalization: Sales -60% YoY to $277M on lower COVID-19 hospitalizations, weighing on total product sales YoY .
- Pricing headwinds: HIV growth partially offset by lower average realized price; Trodelvy down 2% sequentially on inventory dynamics and lower ex-U.S. ARP .

Financial Results

Metric	Q1 2025	Q2 2025	Q3 2025
Total Revenues ($M)	$6,667	$7,082	$7,769
Product Sales ($M)	$6,613	$7,054	$7,345
GAAP Diluted EPS ($)	$1.04	$1.56	$2.43
Non-GAAP Diluted EPS ($)	$1.81	$2.01	$2.47

Segment revenue mix ($M):

Segment	Q1 2025	Q2 2025	Q3 2025
HIV	$4,587	$5,088	$5,277
Liver Disease	$758	$795	$819
Oncology	$757	$849	$788
Other	$209	$202	$184
Veklury	$302	$121	$277
Total Product Sales	$6,613	$7,054	$7,345

Select product sales ($M):

Product	Q1 2025	Q2 2025	Q3 2025
Biktarvy	$3,150	$3,530	$3,686
Descovy	$586	$653	$701
Trodelvy	$293	$364	$357
Cell Therapy (Yescarta+Tecartus)	$464	$485	$432
Veklury	$302	$121	$277

KPIs and cash flow:

KPI	Q1 2025	Q2 2025	Q3 2025
Product Gross Margin (GAAP)	76.7%	78.7%	78.6%
Product Gross Margin (Non-GAAP)	85.5%	86.9%	86.5%
Operating Margin (GAAP)	33.6%	34.9%	42.8%
Operating Margin (Non-GAAP)	43.4%	46.5%	50.5%
Operating Cash Flow ($M)	$1,757	$827	$4,109
Free Cash Flow ($M)	$1,653	$720	$3,962

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Product Sales	FY 2025	$28.3–$28.7B	$28.4–$28.7B	Raised low end
Product Sales ex Veklury	FY 2025	$27.3–$27.7B	$27.4–$27.7B	Raised low end
Veklury	FY 2025	$1.0B	$1.0B	Maintained
GAAP Diluted EPS	FY 2025	$5.85–$6.15	$6.65–$6.85	Raised
Non-GAAP Diluted EPS	FY 2025	$7.95–$8.25	$8.05–$8.25	Raised low end
Non-GAAP Operating Income	FY 2025	$13.0–$13.4B	$13.1–$13.4B	Raised low end
GAAP Effective Tax Rate	FY 2025	~21%	~16% (incl. Oct tax settlement)	Lowered
Non-GAAP Effective Tax Rate	FY 2025	~19%	~19%	Maintained
Quarterly Dividend	Q3 vs Q4 2025	$0.79 declared for Q3’25	$0.79 declared for Q4’25	Maintained

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
HIV franchise growth	Q1: HIV +6% YoY; Biktarvy +7% YoY; Descovy +38% YoY . Q2: HIV +7% YoY; Yeztugo approved; Global Fund access plan .	HIV +4% YoY; raised FY HIV growth to ~5% despite ~$900M Part D headwind .	Strengthening; resilient through policy headwinds.
PrEP/Yeztugo launch	Q1: PDUFA set for June 2025 . Q2: U.S. approval; WHO/EMA support; Global Fund agreement .	75% U.S. access achieved ahead of plan; 3Q sales $39M; ramp sets up 2026; white-bagging > buy-and-bill near-term .	Accelerating access; gradual volume ramp.
Cell Therapy	Q1: -3% YoY; mixed Yescarta/Tecartus . Q2: -7% YoY; competitive headwinds persist .	-11% YoY & seq; FY25 now ~10% decline; pipeline advancing, center additions .	Pressured near-term; pipeline optionality.
Trodelvy	Q1: positive topline 1L PD‑L1+ mTNBC with pembro . Q2: positive topline ASCENT‑03/04 showcased .	ASCENT‑03 detailed: PFS 9.7 vs 6.9 months; 38% risk reduction; NEJM; sBLAs filed; 2026 decision targeted .	Building toward earlier-line launch.
Biktarvy LOE	Prior: LOE a watch item.	Settlements push earliest U.S. generic to Apr 1, 2036, >2 years later than prior projection .	Major de‑risking.
Tariffs/IRA/macro	Prior: IRA headwinds monitored .	Known tariffs manageable in 2025; Part D redesign ~$900M HIV headwind unchanged .	Managed.

Management Commentary

“We continue to deliver on Gilead's robust portfolio… multiple potential product launches in 2026… and no major loss of exclusivity expected until 2036.” — Daniel O’Day, CEO .
“We benefited from a $400M contribution in royalty, contract and other revenues… a nonrecurring accounting item… contributing approximately $0.25 after tax.” — Andrew Dickinson, CFO .
“We have already achieved our 75% [Yeztugo] access goal, nearly three months ahead of our target.” — Joanna Mercier, CCO .
“Trodelvy… 9.7-month median PFS vs 6.9 months… 38% reduction in disease progression or death… results published in NEJM.” — Dietmar Berger, CMO .

Q&A Highlights

Yeztugo patient flow and mix: Early switches from long-acting injectable competitor, branded oral (Descovy), and generics; white-bagging currently ~70–80% of channel mix with buy-and-bill to build after J‑code adoption .
Access quality: High-80s percent of covered lives with zero copays; limited and simple prior auth/step edits; aim for ~90% coverage by end of first year .
PrEP market growth: Management frames U.S. PrEP market growth at ~14–15% as a reasonable assumption into 2026 .
HIV growth vs Part D: HIV growth would be ~8–9% absent ~$900M Medicare Part D redesign headwind; FY HIV growth raised to ~5% .
HDV (Hepcludex) U.S. filing confidence supported by additional data and EU real‑world experience; market opportunity aligns with Gilead’s HBV footprint .

Estimates Context

Actuals vs S&P Global consensus (Primary EPS, Revenue, EBITDA):

Metric	Q1 2025	Q2 2025	Q3 2025
EPS (Primary) – Consensus Mean	1.78*	1.96*	2.14*
EPS (Primary) – Actual	1.81*	2.01*	2.47*
Revenue ($) – Consensus Mean	6,823,316,310*	6,964,468,030*	7,458,523,190*
Revenue ($) – Actual	6,667,000,000*	7,082,000,000*	7,769,000,000*
EBITDA ($) – Consensus Mean	3,423,000,000*	4,109,622,820*	4,586,668,920*
EBITDA ($) – Actual	3,262,000,000*	3,464,000,000*	4,200,000,000*

Values retrieved from S&P Global.
Context: Q3 delivered EPS and revenue beats; EBITDA trailed consensus. Management emphasized a one-time $400M “other revenue” that added ~$0.25 to EPS and does not recur, which should be considered in models .

Key Takeaways for Investors

Core beat with caveat: Strong EPS/revenue beats vs consensus, but ~3–4% of total revenue and ~$0.25 of EPS were from a non-recurring other-revenue recognition; underlying base business grew 4% YoY ex‑Veklury .
HIV engine accelerating: Biktarvy and Descovy remain robust; Yeztugo access milestones achieved early, supporting a 2026 ramp; FY HIV growth raised to ~5% despite ~$900M Medicare Part D headwind .
De-risked LOE: Biktarvy U.S. LOE pushed to 2036 via settlements, materially improving medium-term cash flows and strategic optionality .
Oncology optionality: Trodelvy first-line mTNBC data de-risks 2026 launch potential; broader oncology pipeline (domvanalimab/zimberelimab) has upcoming readouts .
Kite near-term drag: Cell Therapy remains pressured; FY25 guided to ~10% decline; monitor competitive dynamics and 2026 anito-cel launch timeline .
Guidance bias: Raised FY product sales (low end), GAAP EPS, and non-GAAP EPS (low end); tax rate guidance lowered on settlement; room for HIV upside and Cell Therapy downside intra-quarter .
Policy and access: Tariffs manageable; PEPFAR/Global Fund partnership accelerates global lenacapavir access at no profit, reinforcing strategic positioning .

Management Commentary (Extended)

“With multiple potential product launches in 2026… strongest clinical pipeline in Gilead’s history… no major loss of exclusivity expected until 2036” — Daniel O’Day .
“$400M… nonrecurring accounting item… did not impact product gross margin… ~$.25 after tax” — Andrew Dickinson .
“Biktarvy’s… U.S. market share… record high of ~52% in the third quarter” — Joanna Mercier .
“Yes2Go… strong endorsement in new U.S. CDC guidelines… 75% access… with very limited prior auth and basically zero copays” — Joanna Mercier .

Additional Q3 Press Release (Relevance)

PEPFAR partnership to deliver lenacapavir PrEP for up to 2 million people over three years in LLMICs; coordinated with Global Fund; provided at no profit until generics meet demand .

Why the Quarter Looked the Way It Did

Beat drivers: HIV demand and mix; Livdelzi momentum; non-recurring $400M other revenue uplift; disciplined OpEx drove non-GAAP margin expansion to 50.5% .
Misses/pressures: Cell Therapy competition; Veklury normalization; price/mix headwinds in HIV partially offsetting demand .
Guidance: HIV outperformance offset by weaker Cell Therapy; tax settlement lowered GAAP ETR; Veklury maintained at $1B .

GILEAD SCIENCES, INC. (GILD)·Q3 2025 Earnings Summary