GILD Q2 2025: Descovy drives 35% growth; YES2Go shows early momentum
- Strong Early Uptake for YES2Go: The Q&A highlights that despite being only six weeks post-launch, YES2Go has seen rapid adoption with early prescription, swift product shipping, and high provider awareness (72% unaided, 95% aided), which bodes well for exponential market momentum in HIV prevention.
- Robust HIV Portfolio Performance: Executives emphasized that Descovy is posting its strongest quarter ever with 35% YoY growth and nearly unrestricted access (88% access with minimal patient cost), reflecting a strong competitive position in the expanding PrEP market.
- Effective Launch Execution and Cross-Functional Strategy: The leadership detailed strategic flexibility in logistics (e.g., multiple channel options such as buy-and-bill and specialty pharmacy) and comprehensive field support initiatives, indicating that the robust infrastructure and coordinated approach will drive sustained revenue growth.
- Uncertain YES2Go Uptake: Although early metrics (e.g., the first prescription within hours and rapid initial shipments) appear positive, the launch is only six weeks in, and the full momentum depends on scaling access, overcoming reimbursement delays, and converting initial customer calls into sustained injections.
- Potential Policy/Medicaid Risks: Considerable exposure to Medicaid in the HIV segment means that potential changes—such as an MFN proposal or shifts in Medicaid reimbursement policies—could negatively impact net revenue due to the low patient copays and overall reliance on government programs.
- Logistical and Adoption Challenges for Injectable Therapy: Transitioning prescribers and clinics from oral to injectable prevention presents hurdles around education, reimbursement, and process complexity which could delay broader market uptake despite flexible multi-channel strategies.
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Product Sales Excluding Vecluri | FY 2025 | $26.8B to $27.2B | $27.3B to $27.7B | raised |
Total Product Sales | FY 2025 | $28.2B to $28.6B | $28.3B to $28.7B | raised |
Veklury Sales | FY 2025 | Approximately $1.4B | Approximately $1.0B | lowered |
HIV Sales | FY 2025 | Approximately flat | Approximately 3% | raised |
Product Gross Margin | FY 2025 | 85% to 86% | Approximately 86% | no change |
R&D Expenses | FY 2025 | Roughly flat | Roughly flat | no change |
Acquired IPR&D Expenses | FY 2025 | Approximately $400M | Approximately $400M | no change |
SG&A Expenses | FY 2025 | Decline by a high single-digit percentage | Decline by a mid to high single-digit percentage | no change |
Operating Income | FY 2025 | $12.7B to $13.2B | $13.0B to $13.4B | raised |
Effective Tax Rate | FY 2025 | Approximately 19% | Approximately 19% | no change |
Diluted EPS | FY 2025 | $7.70 to $8.10 | $7.95 to $8.25 | raised |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
HIV Portfolio Performance | Q1 2025 noted HIV sales at $4.6B with 6% YoY growth ; Q4 2024 reported robust overall growth with 16% YoY in Q4 and full‐year favorable outcomes ; Q3 2024 showed consistent growth with $5.1B in sales and strong channel mix | Q2 2025 reported HIV sales of $5.1B with 7% YoY growth and Descovy sales up 35% YoY, driven by awareness, improved demand and pricing dynamics | Consistent strong performance with improved sequential dynamics as growth drivers and patient demand remain robust |
Lenacapavir for PrEP | Q1 2025 discussed anticipated regulatory decisions (FDA decision expected by June 19, 2025) and launch preparedness ; Q4 2024 focused on regulatory submissions and breakthrough therapy designation with a planned mid-2025 launch ; Q3 2024 highlighted robust efficacy data and breakthrough status, with regulatory filings targeted before end‐2024 | Q2 2025 announced FDA approval of YES2Go (marketed lenacapavir for PrEP) with rapid launch execution, high prescriber awareness, and detailed launch dynamics including early cannibalization considerations for Descovy | Evolving from regulatory anticipation to commercial approval and active launch with an increasingly positive sentiment and aggressive rollout |
YES2Go Injection Therapy Adoption | No mentions were recorded in Q1 2025, Q4 2024, or Q3 2024 [N/A] | Q2 2025 provided detailed insights into early uptake, logistical flexibility (multiple delivery options), coordinated cross-functional teams, and state-level wins, creating high pre-launch awareness (72% unaided, 95% aided) | New and emerging topic with strong initial performance; the focus on operational execution and rapid adoption indicates a promising future impact |
Healthcare Policy and Reimbursement Risks | Q1 2025 addressed Medicare Part D redesign impact (estimated $1.1B impact, $900M for HIV) and Medicaid exposure with emphasis on the 340B channel ; Q4 2024 emphasized the Part D redesign impact ($1.1B, with $900M from HIV) and noted Medicare-related revenue resets ; Q3 2024 discussed Medicaid exposure (mid- to high 20% contribution) with monitoring of 340B growth | Q2 2025 continued discussion on Medicare Part D redesign impacting HIV (approximately $900M impact) and detailed monitoring of Medicaid exposure amid potential legislative changes, while reinforcing safety nets | Steady concern with persistent headwinds; while the overall sentiment remains cautious, proactive monitoring and strategies are in place to mitigate evolving reimbursement dynamics |
Cross-Functional Launch Execution and Operational Strategy | Q1 2025 showcased readiness across multiple new product launches (Lenacapavir, Livdelzi, Trodelvy, Anito-cel) with coordinated operational planning ; Q4 2024 described launch operations with preparedness for lenacapavir and Livdelzi using specialized distribution models ; Q3 2024 highlighted rapid mobilization for Livdelzi, with direct engagement of over 1,000 prescribers and specialty distribution | Q2 2025 emphasized the “best planned commercial launch” for YES2Go with cross-functional pods, comprehensive customer engagement (over 25,000 calls), state-level successes, and early wins like securing a J-code for reimbursement | Consistently positive with continuous improvement in execution accuracy and customer engagement; operational strategy remains a key pillar driving successful market launches |
Competitive Pressures and Regulatory Uncertainties in Oncology and Cell Therapy | Q1 2025 acknowledged competitive pressures on Trodelvy from channel mix and cell therapy challenges (e.g., Tecartus facing increased competition) with regulatory engagement on key trials ; Q4 2024 described headwinds in the oncology space and competitive challenges in cell therapy while noting breakthrough designations for Trodelvy ; Q3 2024 detailed discontinuation decisions for some indications (e.g. Trodelvy in certain NSCLC settings) and outlined regulatory uncertainties for CAR T therapies | Q2 2025 reported continued competitive pressure in cell therapy with a 7% YoY decline despite sequential gains, and noted regulatory strategies for advancing Trodelvy in first-line metastatic TNBC with expected FDA decision timelines, alongside cautious cannibalization impacts | Persistent challenges amid proactive regulatory strategies; while competitive pressures remain a concern, ongoing adjustments and targeted regulatory filings indicate a balanced, cautiously optimistic sentiment |
Pipeline Diversification and Emerging Product Launches | Q1 2025 highlighted a diverse pipeline (covering virology, oncology, inflammation) with multiple near-term launches for Lenacapavir, Anito-cel, Trodelvy and strong emphasis on long-acting therapies ; Q4 2024 focused on Livdelzi’s strong launch performance and lenacapavir’s Breakthrough designation, signaling broad pipeline momentum ; Q3 2024 underscored early launch achievements for Livdelzi, advancements in long‐acting HIV therapies, and expanding oncology programs | Q2 2025 showcased significant pipeline progress with Livdelzi’s revenue nearly doubling, the robust YES2Go launch in HIV prevention, positive Trodelvy sales performance, and continued momentum in cell therapy and long-acting HIV treatment programs | Strong and consistent pipeline expansion, with milestones across multiple therapeutic areas now transitioning to commercialization; sentiment is very positive regarding long-term growth potential and diversification |
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YES-two Go Uptake
Q: How is early YES-two Go uptake trending?
A: Management is very pleased with the rapid uptake—high awareness (72% unaided, 95% aided) and immediate script and injection initiation—but they caution it’s still early days, expecting further momentum as access issues are resolved. -
Descovy Growth
Q: Is Descovy’s strong growth sustainable?
A: They highlighted robust Descovy performance with 35% growth driven by better access and reduced co-pays, though as YES-two Go ramps up, a slight mix shift is expected; IQVIA data is seen as directionally aligned but early. -
Medicaid Impact
Q: How might MFN Medicaid affect revenue?
A: Management noted that Medicaid represents a significant but low patient out-of-pocket component in HIV, with potential legislative impacts expected only from late 2026 or 2027; meanwhile, safety net programs ensure consistent access. -
Weekly Therapy Pipeline
Q: What is the status of the weekly treatment combo?
A: Confidence remains high in the broader treatment pipeline; despite a clinical hold on the current candidate, they are analyzing data and exploring alternative molecules, with further updates expected around 2026. -
International Opportunity
Q: Can Yes-two Go outperform overseas market expectations?
A: Management sees a strong international opportunity for Yes-two Go, as markets without generic competition may mirror or even surpass U.S. performance, yet note that reimbursement complexities may moderate uptake. -
Injection Logistics
Q: How are you addressing injection administration challenges?
A: The company has instituted flexible models—offering buy-and-bill, specialty pharmacy, and alternate sites—to simplify the transition from oral to injection, relying on proactive, cross-functional teams to educate providers. -
Launch Guidance Caution
Q: Why wasn’t launch guidance raised despite early success?
A: Management remains cautious because the launch is only six weeks old; they prefer to see a continued increase in covered lives and sustained access before adjusting guidance expectations. -
Regulatory Strategy
Q: How confident are you in single-arm cell therapy approval?
A: They reiterated ongoing discussions with the FDA regarding their regulatory strategy, maintaining optimism about approval without abandoning previous feedback, and expect to file as planned with no significant strategic changes.
Research analysts covering GILEAD SCIENCES.