Q4 2024 Earnings Summary
- Gilead's Trodelvy has received FDA Breakthrough Therapy designation for extensive-stage small cell lung cancer, supported by impressive Phase II data showing clear TROP2 expression and potential to be foundational in the second-line setting.
- Gilead has the most robust and diverse pipeline in its history, with recent and imminent launches across all three therapeutic areas, no major loss of exclusivity on the horizon, and disciplined expense management, positioning the company to deliver compelling returns for shareholders.
- Consistent revenue quarter after quarter and strong demand across all three therapeutic areas are driving momentum into 2025, providing a solid foundation for Gilead's growth in the months and years ahead.
- Trodelvy's potential in small cell lung cancer faces significant competition from other targets like DLL3 and B7-H3, which are also being pursued by competitors, potentially limiting its market share in this indication.
- The time to market for Trodelvy in small cell lung cancer may be prolonged since Gilead is planning to start the study during the first half of the year, providing competitors with an opportunity to advance their own treatments.
- The efficacy of Trodelvy in small cell lung cancer, while showing impressive Phase II data, still requires further validation, and there is uncertainty until the Phase III data are available, which could pose a risk to its future success in this indication.
| Metric | YoY Change | Reason |
|---|---|---|
Total Revenue | +6% (Q4 2024: $7,569M vs Q4 2023: $7,114M) | Strong revenue growth driven by a 16% increase in HIV sales and a 10% boost in Oncology revenue, which more than offset the significant (>50%) decline in Veklury sales due to reduced COVID‐19 demand compared to the previous period. |
HIV Revenue | +16% (Q4 2024: $5,452M vs Q4 2023: $4,692M) | Robust performance in key therapies such as Biktarvy and Descovy, supported by increased demand and improved average realized pricing, contributed significantly to this growth relative to Q4 2023. |
Oncology Revenue | +10% (Q4 2024: $843M vs Q4 2023: $765M) | Increased demand in oncology segments, particularly through enhanced performance of therapies like Trodelvy, resulted in solid growth compared to last year, reflecting an improved market acceptance. |
Cell Therapy Revenue | +4.5% (Q4 2024: $487M vs Q4 2023: $466M) | Modest growth in cell therapy was observed, with incremental gains likely driven by favorable regional dynamics and steady adoption of innovations, continuing a stable trend from the prior period. |
Veklury Revenue | ->50% (Q4 2024: $338M vs Q4 2023: $719M) | A drastic decline in Veklury sales occurred as lower COVID-19–related hospitalizations and a reduced need for remdesivir reversed the high pandemic-driven demand seen in Q4 2023. |
U.S. Revenue | +6% (Q4 2024: $5,484M vs Q4 2023: $5,185M) | Improved U.S. performance was driven by higher HIV and Oncology sales, indicating stronger domestic market conditions relative to the previous year. |
Europe Revenue | -4% approx (Q4 2024: $1,117M vs Q4 2023: $1,164M) | A modest decline in Europe is attributed to challenging pricing dynamics and possibly market saturation in key therapeutic areas compared to Q4 2023. |
Rest of World Revenue | -11% sequential (Q4 2024: $824M vs Q3 2024: $929M) | The 11% drop in Rest of World revenue reflects regional challenges and changing demand dynamics outside the core markets, as noted in the sequential comparison. |
Operating Income | +52% (Q4 2024: $2,451M vs Q4 2023: $1,612M) | Operating income surged by over 50% due to an improved profit mix from robust HIV and Oncology performance combined with tighter cost management, leading to better margins relative to last year’s performance. |
Net Income | +26% (Q4 2024: $1,783M vs Q4 2023: $1,417M) | Enhanced profitability resulted from the favorable revenue mix and cost controls, with the strong growth in high-margin segments supporting a 26% increase in net income compared to Q4 2023. |
Basic EPS | +24% (Q4 2024: $1.43 vs Q4 2023: $1.15) | Basic EPS improvement reflects the higher net income and disciplined expense management, combined with a stable share count, thereby raising EPS by approximately 24% over the prior period. |
Net Change in Cash | Q4 2024: +$4,954M vs Q3 2024: +$2,264M | Stronger liquidity management drove cash generation improvement, with increased operating cash flows and adjustments in investing and financing activities resulting in more than double the net cash increase compared to Q3 2024. |
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Total Product Sales | FY 2025 | no prior guidance | $28.2B to $28.6B | no prior guidance |
Product Sales (ex. Veklury) | FY 2025 | no prior guidance | $26.8B to $27.2B | no prior guidance |
Veklury Sales | FY 2025 | no prior guidance | ~$1.4B | no prior guidance |
Product Gross Margin (Non-GAAP) | FY 2025 | no prior guidance | 85% to 86% | no prior guidance |
R&D Expense | FY 2025 | no prior guidance | roughly flat vs. 2024 | no prior guidance |
Acquired In-Process R&D | FY 2025 | no prior guidance | ~$400M | no prior guidance |
SG&A | FY 2025 | no prior guidance | decline by high single-digit % vs. 2024 | no prior guidance |
Operating Income (Non-GAAP) | FY 2025 | no prior guidance | $12.7B to $13.2B | no prior guidance |
Effective Tax Rate | FY 2025 | no prior guidance | ~19% | no prior guidance |
Non-GAAP EPS | FY 2025 | no prior guidance | $7.70 to $8.10 | no prior guidance |
GAAP EPS | FY 2025 | no prior guidance | $5.95 to $6.35 | no prior guidance |
Dividend | FY 2025 | no prior guidance | $0.79 per share (quarterly) | no prior guidance |
Foreign Exchange (FX) Impact | FY 2025 | no prior guidance | $250M headwind | no prior guidance |
HIV Revenue | Q1 2025 | no prior guidance | decline in mid-teen % range QoQ | no prior guidance |
| Metric | Period | Guidance | Actual | Performance |
|---|---|---|---|---|
Product Sales (Excluding Veklury) | FY 2024 | $26B – $26.3B | ~$26.81B (Calculated by summing Total Revenue Q1–Q4Minus Royalty & Veklury) | Surpassed |
Total Product Sales (Including Veklury) | FY 2024 | $27.8B – $28.1B | ~$28.61B (Calculated by summing Total Revenue Q1–Q4Minus Royalty revenue) | Surpassed |
Veklury Revenue | FY 2024 | ~$1.8B | ~$1.799B (Summation of Q1: 555+ Q2: 214+ Q3: 692+ Q4: 338) | Met |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
HIV Business Durability & Reforms | • Q1 2024: Emphasized durability with no major expiries until late 2020s/2030s; noted growing concerns around Medicare Part D impacting 2025 flat HIV sales. <br>• Q3 2024: Reiterated no significant patent expiries until Biktarvy in 2033; confident in late-2030s leadership, closely monitoring Medicaid exposure (mid- to high 20% of HIV business). | • Q4 2024: Reaffirmed HIV durability beyond 2030s with lenacapavir as foundation; expects ~US$1.1B revenue impact from Medicare Part D reform in 2025, including ~US$900M in HIV. | Consistent emphasis on HIV durability; heightened focus on Medicare/Medicaid reform impacts. |
Lenacapavir for PrEP | • Q1 2024: Positioned as transformational; first twice-yearly subcutaneous PrEP option with expected launch in late 2025. <br>• Q3 2024: Highlighted strong growth driver; potential to expand beyond current demographics; targeting a 2025 commercial launch. | • Q4 2024: Seen as a significant future driver; potential U.S. launch in summer 2025; may cannibalize existing HIV revenue but considered part of a broader strategy. | Continued importance; clearer launch timeline and acknowledgment of potential product cannibalization. |
Trodelvy in Small Cell Lung Cancer | • Q1 2024: Mostly focused on breast cancer adoption; lung cancer mentioned without detail on small cell specifically. <br>• Q3 2024: Promising Phase II TROPiCS-03 data in extensive-stage small cell lung cancer; Phase III plans; noted a prior intangible write-down related to second-line NSCLC, but not for SCLC. | • Q4 2024: Received FDA Breakthrough Therapy designation for SCLC; Phase II TROPiCS-03 showed 13.6-month median OS; Phase III EVOKE SCLC trial planned H1 2025; acknowledges DLL3, B7-H3 competition. | Heightened optimism in SCLC with Breakthrough status; increased competition recognized. |
Robust Pipeline & Expense Management | • Q1 2024: 54+ active clinical programs; disciplined spending; no major loss of exclusivity until end of decade. <br>• Q3 2024: General references to pipeline progress (HIV, oncology, inflammation); continued expense discipline; no explicit “54+” mention. | • Q4 2024: Pipeline expanded from 30 to 54 programs since 2019; no major LOE until late 2033; disciplined expenses supporting strong financial performance. | Consistent pipeline breadth messaging; reaffirmed no near-term LOE risks and controlled spend. |
Seladelpar (CymaBay) | • Q1 2024: Acquisition for ~US$4.3B; seladelpar for PBC with regulatory filings; modest 2024 revenue; expected stronger contributions in 2025+. <br>• Q3 2024: Launched as Livdelzi in U.S. for PBC; low single-digit million sales; patient demand exceeded early forecasts. | • Q4 2024: Brief mention of ongoing seladelpar trials (AFFIRM, IDEAL); no major acquisition updates; overshadowed by other pipeline priorities. | Less emphasis in Q4; still in the pipeline but not a primary focus. |
Flat HIV Sales in 2025 | • Q1 2024: Projected flat HIV sales in 2025 due to Medicare Part D redesign; overall company growth still expected. <br>• Q3 2024: No explicit reiteration on flat HIV sales [no references provided]. | • Q4 2024: Again cited ~US$900M HIV revenue impact from Medicare Part D in 2025, effectively offsetting underlying volume growth. | Reiterated projection of flat HIV in 2025; consistent with earlier Q1 guidance. |
High-Impact Future Themes | • Q1 2024: Emphasized oncology advancements (Trodelvy, cell therapy), HIV PrEP potential (lenacapavir), and broad pipeline. <br>• Q3 2024: Highlighted Trodelvy expansion, lenacapavir market growth, pipeline across HIV/oncology. | • Q4 2024: Emphasis on Trodelvy’s SCLC Breakthrough designation, lenacapavir for PrEP launch, and 54+ pipeline programs. | Ongoing priority on oncology, HIV prevention, and pipeline breadth for future growth. |
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Lenacapavir Launch Expectations
Q: What's included for lenacapavir for PrEP in the '25 revenue guide? Should we assume margin expansion is steady into '26?
A: Gilead assumes a mid-year lenacapavir launch, anticipating 75% U.S. access after six months and higher thereafter. Despite unexpected expenses in 2024, including a litigation reserve and Livdelzi acquisition costs, they saw strong expense control and expect to maintain flat expenses going forward, allowing leverage to drop to the bottom line. -
Lenacapavir Ramp Dynamics
Q: Could you refresh us on lenacapavir's expected ramp dynamics and whether this will be a fast, slow, or medium-paced launch?
A: Gilead expects lenacapavir access to ramp up over several months post-launch, with approximately 75% U.S. access by six months and 90% by twelve months. They acknowledge that the injectable administration via specialty pharmacy or buy-and-bill model may take time to ramp up but are confident it will impact communities in 2025 and be more meaningful in 2026 and beyond. -
HIV Treatment Strategy Post-Biktarvy
Q: Do you view lenacapavir treatment options as eventually replacing Biktarvy, and what's your approach to lifecycle management before Biktarvy's LOE?
A: Gilead focuses on meeting patient needs by exploring long-acting orals and injectables, including lenacapavir in daily, weekly, and potentially longer-term formulations. While these options may erode some Biktarvy share (currently over 50% market leader), they offer portfolio opportunities well before Biktarvy's LOE in late 2033. -
Expense Control and Margin Outlook
Q: Should we assume current margin expansion is steady into 2026?
A: Gilead experienced strong expense control in 2024 despite unexpected items. They plan to hold expenses relatively flat for the foreseeable future, allowing leverage to improve margins. -
Livdelzi Uptake and Trajectory
Q: Can you elaborate on Livdelzi's early uptake and this year's trajectory given high initial demand?
A: Livdelzi's progression is exceeding internal expectations, with positive feedback on efficacy and safety, including ALP normalization and reduced pruritus. There's strong week-over-week growth, building momentum into 2025, and payer access aligns with expectations for a rare disease. -
PrEP Market Growth and Lenacapavir Launch
Q: What led to the 16% year-over-year PrEP market growth, and will these factors benefit lenacapavir's launch?
A: The 16% PrEP market growth results from momentum around PURPOSE 1 and 2 studies and intensified market development efforts. Gilead believes this growth will carry through and potentially accelerate lenacapavir's launch. -
Oncology Portfolio Competitiveness
Q: How competitive is Gilead's late-stage oncology portfolio, particularly TIGIT and Trodelvy, as Phase III readouts approach?
A: Gilead views Trodelvy as a differentiated molecule, being the only TROP2 ADC demonstrating overall survival, with key studies like ASCENT-03 and ASCENT-04 expected soon. TIGIT is an interesting target with potential differentiation due to its Fc-silent design; ongoing Phase III studies STAR-121 and STAR-221 will define the path forward. -
Livdelzi Label Expansion Potential
Q: How is the IDEAL study in partial UDCA responders progressing, and what could this mean for Livdelzi's eligible patient population?
A: The IDEAL study is on track, assessing partial UDCA responders, potentially extending Livdelzi's reach to an additional 20,000–25,000 patients in the U.S. and a similar number in Europe. Approximately one-third of patients are partial responders. -
Small Cell Lung Cancer and Trodelvy
Q: How does Trodelvy fit into the competitive landscape of small cell lung cancer targets like TROP2, DLL3, and B7-H3?
A: Gilead is optimistic about Trodelvy in small cell lung cancer, with impressive Phase II data and Breakthrough Therapy Designation from the FDA. They believe TROP2 has potential to be foundational in second-line settings, while other targets have shown mixed results. -
HIV Sales Growth and Inventory Dynamics
Q: Did more-than-normal inventory buildup in Q4 impact HIV sales growth?
A: Strong demand drove HIV sales growth both quarter-over-quarter and year-over-year, with seasonal inventory dynamics contributing. In 2024, inventory build was heavily in Q4 rather than spread over Q3 and Q4 as in 2023, but demand for Biktarvy and Descovy remains the primary driver. -
Lenacapavir Approval Outlook
Q: Are interactions with the FDA and HHS progressing smoothly for lenacapavir's approval, and what about European reimbursement challenges?
A: Gilead's interactions with the FDA and HHS are on track, aiming for approval this summer, with Breakthrough Designation granted. In Europe, they plan a tiered approach, working with stakeholders to ensure access, and the EU filing will help extend access to over 138 low- and middle-income countries.
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