Strong HIV Franchise Growth and Market Leadership
HIV business grew 6% year-over-year in 2025 (driven by Biktarvy +7%), with full-year HIV sales of $20.8 billion. Biktarvy full-year sales were $14.3 billion, up 7% YoY and remains >52% share in the U.S. switch/treatment market. Company noted that excluding an estimated ~ $900M Part D headwind, HIV growth would have been ~10% in 2025.
Robust HIV Prevention Momentum (YES2GO & Descovy)
YES2GO launch exceeded coverage goals (90% payer coverage and ~90% of covered individuals with $0 copay). YES2GO sales: $96M in Q4 and $150M for full-year 2025; management guides ~ $800M revenue for YES2GO in 2026. HIV prevention momentum: Q4 prevention sales grew ~53% YoY; Descovy full-year sales $2.8B, up 31% YoY (Q4 Descovy +33% YoY; Descovy accounts for ~80% of its sales from prevention).
Overall Revenue and Base Business Outperformance
Full-year total product sales were $28.9 billion (up 1% YoY). Base business (excluding Vecluri) was $28.0 billion, more than $300 million above the high end of guidance and up ~4% YoY (or ~8% excluding Medicare Part D redesign impact). Q4 product sales excluding Vecluri were $7.7 billion, +7% YoY and +9% sequentially.
Strong Liver and Trodelvy Performance
Liver business grew 6% YoY to $3.2 billion in 2025. Libdelzi showed strong adoption: Q4 Libdelzi sales were $150M (a 42% sequential increase) and U.S. market share leader >50% in second-line PBC. Trodelvy full-year sales grew 6% to $1.4 billion; Q4 sales $384M, +8% YoY and sequentially.
Clinical & Pipeline Momentum — Multiple Near-Term Catalysts
Company highlighted a ‘‘catalyst-rich’’ 2026 with multiple Phase III readouts and up to four potential commercial launches (Trodelvy first-line TNBC, Viclen (bictegravir+lenacapavir), Anidocel, and bruleviratide). Management emphasized up to 10 potential launches through 2027 and 53 ongoing clinical programs, and positive Phase III readouts already published (e.g., Trodelvy ASCENT-03/04 in NEJM and NCCN guideline recognition).
Solid Profitability and Capital Returns
Non-GAAP product gross margin was 86.4% (in line with guidance). Full-year non-GAAP operating margin ~45% (roughly 48% excluding acquired IPR&D and a $400M one-time item). Non-GAAP diluted EPS was $8.15 for 2025; excluding ~$3.14/share Simbae impact, EPS increased by $0.40 vs 2024. Returned $5.9 billion to shareholders in 2025 and returned ~63% of free cash flow to shareholders (dividends + buybacks).
Kite/Anidocel: Highly Differentiated Clinical Data
Anidocel (BCMA CAR-T) data from Phase II IMagine I: 96% overall response rate, 74% complete response, and 95% MRD negativity with a predictable/manageable safety profile. Anidocel filing submitted and company is preparing for potential H2 2026 launch (modest 2026 contribution expected with larger 2027 opportunity).