Executive Summary

Base business sales excluding Veklury rose 4% to $6.3B, while total revenue was flat at $6.67B; non-GAAP diluted EPS was $1.81. Gilead beat Street EPS but missed on revenue: EPS $1.81 vs consensus $1.776*, revenue $6.67B vs $6.82B* .
HIV strength offset oncology softness and COVID normalization: Biktarvy +7% to $3.1B and Descovy +38% to $586M; Veklury -45% to $302M; Trodelvy -5% to $293M; Cell Therapy -3% to $464M .
FY25 guidance largely unchanged except GAAP EPS lowered to $5.65–$6.05 (from $5.95–$6.35); product sales $28.2–$28.6B, ex‑Veklury $26.8–$27.2B, Veklury $1.4B, non‑GAAP EPS $7.70–$8.10 unchanged .
Near-term catalysts: FDA PDUFA June 19 for twice‑yearly lenacapavir PrEP; ASCENT-03 readout later in Q2; S&P upgraded Gilead to A- (stable), highlighting HIV outlook and cash flow .

What Went Well and What Went Wrong

What Went Well
- Base business growth and disciplined costs drove strong non‑GAAP margins: product gross margin 85.5% and operating margin 43.4% .
- HIV leadership continued: “Our base business grew 4% year-over-year, primarily led by Biktarvy’s continued strength,” — CEO Daniel O’Day . Biktarvy U.S. share reached 51% per CCO .
- Pipeline/regulatory momentum: FDA accepted NDAs for lenacapavir PrEP with June 19 PDUFA; EMA validated MAA and EU‑M4all applications under accelerated review; EC granted conditional approval for seladelpar (Livdelzi) in PBC .
What Went Wrong
- COVID normalization: Veklury sales down 45% YoY to $302M on lower hospitalization rates .
- Oncology softness: Trodelvy -5% YoY on inventory/pricing mix; Cell Therapy -3% (Yescarta +2% offset by Tecartus -22%) amid competitive headwinds .
- Part D redesign headwind: management expects HIV reported sales to be flat in 2025 despite demand growth, with ~$1.1B total impact (≈$0.9B to HIV) and increased manufacturer contribution .

Financial Results

Summary vs prior quarters and estimates

Metric	Q3 2024	Q4 2024	Q1 2025	Q1 2025 Consensus
Total Revenues ($USD Billions)	$7.545	$7.569	$6.667	$6.823*
GAAP Diluted EPS ($)	$1.00	$1.42	$1.04	—
Non-GAAP Diluted EPS ($)	$2.02	$1.90	$1.81	$1.776*
GAAP Product Gross Margin (%)	79.1%	79.0%	76.7%	—
Non-GAAP Product Gross Margin (%)	86.8%	86.7%	85.5%	—
GAAP Operating Margin (%)	11.8%	32.4%	33.6%	—
Non-GAAP Operating Margin (%)	43.2%	41.1%	43.4%	—

Values marked * are from S&P Global consensus estimates (Primary EPS Consensus Mean; Revenue Consensus Mean). Values retrieved from S&P Global.

Segment breakdown (Q1 2025 vs Q1 2024)

Segment	Q1 2024 ($MM)	Q1 2025 ($MM)	YoY Change
HIV	$4,342	$4,587	+6%
Liver Disease	$737	$758	+3%
Oncology	$789	$757	-4%
Other	$224	$209	-7%
Total Product Sales ex‑Veklury	$6,092	$6,311	+4%
Veklury	$555	$302	-45%
Total Product Sales	$6,647	$6,613	-1%
Royalty/Contract/Other Revenues	$39	$54	+37%
Total Revenues	$6,686	$6,667	~flat

Product KPIs (Q1 2025 vs Q1 2024)

Product	Q1 2024 ($MM)	Q1 2025 ($MM)	YoY Change
Biktarvy	$2,946	$3,150	+7%
Descovy	$426	$586	+38%
Veklury	$555	$302	-45%
Yescarta	$380	$386	+2%
Tecartus	$100	$78	-22%
Trodelvy	$309	$293	-5%
Livdelzi (PBC)	—	$40	launch momentum

Consensus detail (Q1 2025)

Metric	Q1 2025 Estimate	# of Estimates	Q1 2025 Actual
Revenue ($USD Billions)	$6.823*	17*	$6.667
Primary EPS ($)	$1.776*	17*	$1.81

Values marked * are from S&P Global consensus estimates (Primary EPS Consensus Mean; Revenue Consensus Mean; counts). Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance (Feb 11, 2025)	Current Guidance (Apr 24, 2025)	Change
Product Sales ($B)	FY 2025	$28.2–$28.6	$28.2–$28.6	Maintained
Product Sales ex‑Veklury ($B)	FY 2025	$26.8–$27.2	$26.8–$27.2	Maintained
Veklury ($B)	FY 2025	$1.4	$1.4	Maintained
GAAP Diluted EPS ($)	FY 2025	$5.95–$6.35	$5.65–$6.05	Lowered
Non-GAAP Diluted EPS ($)	FY 2025	$7.70–$8.10	$7.70–$8.10	Maintained
GAAP Product Gross Margin (%)	FY 2025	77–78%	77–78%	Maintained
Non-GAAP Product Gross Margin (%)	FY 2025	85–86%	85–86%	Maintained
GAAP Operating Income ($B)	FY 2025	$10.2–$10.7	$10.2–$10.7	Maintained
Non-GAAP Operating Income ($B)	FY 2025	$12.7–$13.2	$12.7–$13.2	Maintained
GAAP ETR (%)	FY 2025	~20%	~21%	Slightly higher
Non-GAAP ETR (%)	FY 2025	~19%	~19%	Maintained
Dividend/Capital Return	Q2 2025	—	Quarterly dividend $0.79 declared	Ongoing

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2024, Q4 2024)	Current Period (Q1 2025)	Trend
Lenacapavir PrEP launch	FDA BTD; filings “before year-end”; market expansion plans	FDA PDUFA June 19; access ramp 75% at 6 months, ~90% at 12 months; launch readiness detailed	Advancing to approval/launch
HIV market dynamics & Biktarvy	Q3: HIV +9% YoY; Biktarvy share >49%	HIV +6% YoY; Biktarvy +7%; U.S. share 51%; Part D headwind noted	Demand strong; pricing headwinds
Part D redesign	Flagged for 2025 with flat HIV reported sales	~$1.1B total impact; ~$0.9B HIV; phasing through 2025	Headwind confirmed
Trodelvy	Q4: ES‑SCLC BTD; lung strategy refined	Q1: ASCENT‑04 PFS benefit in 1L PD‑L1+ TNBC; Q/Q inventory-driven softness	Positive clinical; near-term sales mixed
Cell Therapy competitive landscape	Q3: in/out‑of‑class competition; community expansion strategy	Continued headwinds; Tecartus -22%; Yescarta +2%; CAR‑T access initiatives ongoing	Competition persists; execution focus
Tariffs/FX/macro	Noted FX tailwinds and expense discipline	Tariffs manageable; potential lighter FX headwinds; guidance reaffirmed	Manageable cost impact
Regulatory/legal	DOJ settlement on PrEP patents; EMA seladelpar positive opinion	EMA validation for lenacapavir; EC conditional seladelpar approval	Broadening approvals

Management Commentary

“Gilead had a strong start to the year driven by excellent commercial and clinical execution along with disciplined expense management…our base business grew 4% year-over-year, primarily led by Biktarvy’s continued strength,” — Daniel O’Day, CEO .
“Product sales, excluding Veklury of $6.3 billion were up 4% year-over-year… Sequentially, sales were down 12% as expected, mainly due to inventory dynamics,” — Johanna Mercier, CCO .
“First quarter operating margin was 43%… non-GAAP diluted EPS was $1.81,” — Andrew Dickinson, CFO .
“We remain on track for the June 19 PDUFA date [lenacapavir for PrEP] and the potential launch in the U.S. immediately following,” — Daniel O’Day .
“Trodelvy plus pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in progression free survival in 1L PD‑L1+ mTNBC,” — Dietmar Berger, CMO .

Q&A Highlights

PrEP access ramp: ~75% coverage at 6 months, ~90% at 12 months; early medical exceptions expected; launch operations across buy‑and‑bill and specialty pharmacy pathways .
CDC/HHS budget uncertainty: No change to lenacapavir launch plans; Gilead engaging policymakers; continued market development for PrEP .
Part D redesign impact: Guidance assumptions unchanged; ~$1.1B total impact (≈$0.9B HIV); HIV demand‑led growth obscured in 2025 .
Trodelvy sales dynamics: Q/Q lower demand from strong Q4 and inventory; YoY -5% driven by inventory/pricing; competitive impact limited so far .
Tariffs: Indirect tariffs absorbed; FX tailwinds help offset; guidance reaffirmed .

Estimates Context

EPS beat, revenue miss: Q1 non‑GAAP EPS $1.81 vs $1.776* (+$0.03), revenue $6.67B vs $6.82B* (‑$0.16B). Beat driven by cost discipline and lower R&D/SG&A; miss driven by Veklury normalization and oncology softness . Values retrieved from S&P Global.
Estimate implications: HIV demand strong but Part D reduces reported growth; Veklury guidance held at $1.4B despite Q1 variability (update deferred until Q3), which may temper near‑term revenue revisions; Trodelvy clinical momentum could support 2026 trajectory despite near‑term inventory effects .

Key Takeaways for Investors

Core HIV franchise resilient: Biktarvy demand and share gains, Descovy PrEP strength; reported 2025 HIV sales likely flat due to Part D, but volume growth intact .
Near-term catalyst path: Lenacapavir PrEP PDUFA June 19 with launch readiness; potential ASCENT‑03 update later this quarter; Trodelvy ASCENT‑04 supports 1L TNBC expansion .
Margin quality: Non‑GAAP product gross margin 85.5% and operating margin 43.4% underscore disciplined execution; cash generation $1.76B operating cash flow in Q1 .
Oncology mixed near term: Trodelvy and cell therapy face inventory/competition headwinds, but medium‑term prospects buoyed by positive data and anito‑cel path to 2026 .
Guidance steady ex‑GAAP EPS: FY25 revenue/ex‑Veklury/non‑GAAP EPS maintained; GAAP EPS lowered on amortization/tax effects. Macro/tariffs manageable per CFO .
Capital & rating: Ongoing dividends/buybacks; S&P upgrade to A‑ reflects strong HIV outlook and cash flows—a supportive credit signal .
Trading lens: Near term, watch PrEP approval/access ramp and Trodelvy data cadence; medium term, HIV long‑acting portfolio and oncology execution drive thesis .

Notes: 
- Consensus values marked * are from S&P Global.

GILEAD SCIENCES, INC. (GILD)·Q1 2025 Earnings Summary