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Gilead(GILD) - 2025 Q3 - Earnings Call Transcript
2025-10-30 21:30
Financial Data and Key Metrics Changes - The company reported third quarter product sales of $7.3 billion, a 4% increase year over year and a 2% increase sequentially, driven by strength across the HIV portfolio, offset by lower oncology revenue [11][42] - Non-GAAP EPS grew 22% year over year, with a 10% increase excluding a $0.25 benefit from a non-recurring accounting item [5][43] - The company raised its full-year HIV revenue growth expectations to approximately 5%, up from 3% previously, despite a $900 million headwind from Medicare Part D redesign [5][46] Business Line Data and Key Metrics Changes - HIV sales reached $5.3 billion, representing a 4% growth year over year, primarily driven by higher demand and favorable inventory dynamics [12] - Biktarvy sales were $3.7 billion, up 6% year over year, achieving a record market share of approximately 52% in the U.S. [12][13] - Descovy sales increased to $701 million, a 20% year over year growth, with a record market share of over 45% for PrEP [14][15] - Libdelzi contributed to 12% year over year growth in the liver portfolio, exceeding $100 million in quarterly sales for the first time [7][20] Market Data and Key Metrics Changes - The PrEP market grew approximately 14% year over year, with Yes2Go achieving $39 million in third quarter sales and $54 million since its launch [15][18] - The company achieved 75% payer coverage for Yes2Go nearly three months ahead of target, setting a strong foundation for continued growth [6][18] Company Strategy and Development Direction - The company is focused on expanding its HIV portfolio and pipeline, with upcoming updates on next-generation HIV treatments expected before the end of the year [6][9] - The company plans to launch Trodelvy for first-line metastatic triple-negative breast cancer in 2026, following positive clinical trial results [8][34] - The company is actively seeking additional business development opportunities across liver disease and oncology [70][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the HIV business, citing strong product leadership and an innovative pipeline [6][9] - The company anticipates continued growth driven by strong demand for Biktarvy and Descovy, despite challenges from Medicare Part D redesign [62][64] - Management highlighted the importance of access and reimbursement logistics for Yes2Go, indicating a gradual ramp-up in sales as practices integrate new coverage [76][90] Other Important Information - The company reported a third quarter operating margin of 50%, reflecting disciplined operating expense management [43] - The company returned $1.4 billion to shareholders in the third quarter, including $435 million in share repurchases [49] Q&A Session Summary Question: Insights on Yes2Go patient demographics and demand drivers - Management noted that Yes2Go is attracting a balanced mix of patients switching from existing therapies and new patients, with expectations for continued growth as market awareness increases [52][53] Question: Clarification on Yes2Go sales figures - Management provided context on the $39 million sales figure, indicating that it reflects true demand rather than inventory stocking, with a focus on achieving 75% coverage ahead of schedule [56][57] Question: Discussion on HIV treatment growth despite Medicare Part D impact - Management confirmed that strong growth in the HIV segment is driven by both treatment and prevention, with Biktarvy and Descovy leading the way [62][64] Question: Update on inventory impact for Yes2Go and CVS pricing discussions - Management clarified that there was no significant inventory buy-in during Q3, and discussions with CVS and other payers are ongoing to secure access [66][67] Question: Appetite for additional business development in liver-focused indications - Management expressed interest in pursuing additional late-stage assets in liver disease and other strategic areas, emphasizing a disciplined approach to business development [70][72]
Gilead(GILD) - 2025 Q2 - Earnings Call Transcript
2025-08-07 21:30
Financial Data and Key Metrics Changes - The company reported base business sales of $6.9 billion, a 4% year-over-year increase, driven by growth in Biktarvy, Descovy, Libdelzi, and Trodelvy [6][42] - Total product sales reached $7.1 billion, reflecting a 2% year-over-year growth, with a notable decline in Vecluri sales by 44% due to fewer COVID-19 related hospitalizations [6][42] - Non-GAAP diluted EPS for the quarter was $2.01, with an operating margin of 46% [42][44] Business Line Data and Key Metrics Changes - HIV sales amounted to $5.1 billion, showing a strong 7% year-over-year growth, primarily driven by increased demand and higher average realized prices [14][42] - Biktarvy sales grew 9% year-over-year to $3.5 billion, while Descovy saw a remarkable 35% increase to $653 million, marking its strongest quarter ever [7][16] - Trodelvy sales increased by 14% year-over-year to $364 million, reflecting continued strength in metastatic breast cancer [24][42] Market Data and Key Metrics Changes - The U.S. PrEP market has expanded to over 5 million active users, growing in the mid-teens year-over-year, with Descovy capturing over 40% market share [17][21] - The company anticipates HIV sales to grow approximately 3% in 2025, up from a previous assumption of flat revenue year-over-year [21][44] - The company is experiencing strong demand for Libdelzi, with revenue almost doubling from $40 million in Q1 to $78 million in Q2 [22][42] Company Strategy and Development Direction - The company is focused on expanding its HIV product portfolio, targeting up to eight additional product launches by 2033, including five by 2030 [32] - The recent FDA approval of lenacapavir (YES2Go) for HIV prevention is seen as a transformative opportunity to address the epidemic [5][32] - The company is committed to facilitating access to lenacapavir globally, partnering with the Global Fund to reach approximately 2 million people in low-income countries over three years [20][32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance in both HIV treatment and prevention, leading to an increase in full-year sales guidance [21][44] - The company remains cautious about potential impacts from the Medicare Part D redesign, which is expected to affect the HIV business by approximately $900 million in 2025 [21][44] - Management emphasized the importance of maintaining operational discipline and adapting to macroeconomic changes while driving forward with new product launches [44][49] Other Important Information - The company returned $1.5 billion to shareholders in Q2, including $527 million in share repurchases, and announced a new $6 billion repurchase program [48] - R&D expenses were up 9% year-over-year, reflecting investments in clinical manufacturing and study activities, with expectations for flat expenses for the full year [42][44] Q&A Session Summary Question: Early uptake of YES2Go and expected trends - Management reported over 25,000 customer calls executed in the field, with a target base of about 15,000, indicating strong early engagement [51][56] - The company anticipates achieving 75% access for YES2Go within six months of launch and 90% within twelve months [58][60] Question: Durability of Descovy's growth rate - Management noted that the PrEP market is growing at about 15% year-over-year, with Descovy's performance driven by favorable access and reduced co-pays [66][69] - There may be a slight decline in Descovy's growth as YES2Go gains traction, but overall market growth is expected to continue [66][70] Question: Impact of MFN proposal on Medicaid - Management acknowledged ongoing discussions regarding the MFN proposal and emphasized the importance of maintaining patient access to medications [74][76] - The company highlighted that HIV treatment has a strong safety net, ensuring coverage for patients even in changing legislative environments [78][79] Question: Changes in commercialization approach if PrEP is removed as a preventative medicine - Management expressed confidence in the current guidelines supporting prevention services and noted that the market has been growing robustly even before recent guidelines [82][84] Question: Confidence in the WONDERS program following clinical hold - Management expressed high confidence in the treatment pipeline, emphasizing a variety of approaches being explored [87]