Summary of Gilead Sciences Conference Call Company Overview - **Company**: Gilead Sciences (NasdaqGS: GILD) - **Date of Conference**: November 10, 2025 Key Industry Insights - **Policy Environment**: Ongoing discussions with the U.S. administration regarding Medicaid and pricing disparities between the U.S. and Europe, with a focus on maintaining innovation in the biotech sector [6][7][8] - **R&D Commitment**: Gilead has committed $32 billion to U.S. R&D and manufacturing investments over the next five years [8] Core Business Segments HIV Business - **Market Position**: Gilead has the largest HIV treatment and prevention business, with a projected 5% growth in 2025 despite headwinds from Medicare Part D reforms [12][23] - **Yeztugo Launch**: Yeztugo, a new long-acting HIV prevention injection, generated $39 million in sales in Q3 and is expected to reach $150 million for the year [15][17] - **Access and Adoption**: Over 75% access to covered lives in the U.S. achieved within three months of launch, with major Medicaid plans including Yeztugo on their formularies [17][22] - **Descovy Performance**: Descovy, the existing daily pill for HIV prevention, grew 32% year-over-year, contributing significantly to the overall HIV prevention business growth of 42% [14][26] Oncology and Liver Disease - **Livdelzi Performance**: Livdelzi, a drug for primary biliary cholangitis, achieved $105 million in sales with a 35% quarter-over-quarter growth, partly due to the withdrawal of a competitor's product [42][44] - **Hepcludex Update**: Hepcludex for hepatitis D is expected to be refiled in the U.S. after successful performance in Europe, representing a growth opportunity in Gilead's liver portfolio [50][52] Cell Therapy - **Anito-cel Development**: Anito-cel, a BCMA cell therapy for multiple myeloma, is expected to launch in 2026, with potential for significant market share [55][56] - **Trodelvy Growth**: Trodelvy is projected to grow significantly as it moves into first-line treatment for triple-negative breast cancer, with a current run rate of approximately $1.4 billion [58][59] Financial Performance and Guidance - **Sales Growth**: Gilead's overall business is experiencing strong growth, particularly in HIV prevention and treatment, with a robust pipeline of new products [11][12][52] - **Capital Allocation Strategy**: Gilead plans to remain active in business development but will be selective due to a strong existing portfolio and no immediate patent cliffs until 2036 [65][68] Additional Considerations - **Market Dynamics**: Gilead is observing competitive pressures in the cell therapy market but remains committed to expanding its offerings [56][57] - **Therapeutic Focus**: The company will continue to focus on virology, liver disease, inflammation, and oncology, with no immediate plans to enter new therapeutic areas [70][71] This summary encapsulates the key points discussed during the conference call, highlighting Gilead Sciences' strategic direction, market performance, and future growth opportunities.

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]

Group 1 - Gilead Sciences, Inc. will participate in the 20th European AIDS Conference (EACS) in Paris from October 15-18 [1] - The company will provide updates on its strategic initiatives and key collaborations [1] - Gilead will share new scientific data from its HIV research and development programs at the conference [1]

Merck & Co (MRK) HIV Investor Event Summary Company Overview - **Company**: Merck & Co, Inc. - **Event Date**: July 17, 2025 - **Location**: Rahway, New Jersey, USA - **Focus**: HIV treatment and prevention pipeline Core Industry Insights - **HIV Landscape**: Approximately 40 million people are living with HIV globally, with 1.3 million new infections in 2023, equating to about 3,500 new infections per day [12][43] - **Market Growth**: The HIV treatment market is expected to grow to approximately $25 billion by the mid-2030s, driven by demand for PrEP (pre-exposure prophylaxis) [43] Key Points from the Call Pipeline and Innovations - **NRTTI Class**: Merck is focusing on a new class of antiretrovirals called NRTTIs (nucleoside reverse transcriptase translocation inhibitors), with islatravir as a leading candidate [10][11] - **Clinical Trials**: - Islatravir is being studied in various regimens, including a once-daily oral treatment and a once-weekly regimen in collaboration with Gilead [22][16] - A once-monthly oral PrEP option, MK8527, is on the cusp of starting Phase III trials [22][35] - **Regulatory Milestones**: - The NDA for derabenuclatrovir has been filed in the US, with a PDUFA date set for April 28, 2026 [16][51] - The company anticipates four new product approvals in the near term, with a potential revenue opportunity exceeding $5 billion from the late-stage HIV portfolio [50][52] Treatment and Prevention Strategies - **Simplification of Regimens**: There is a growing demand for simpler, two-drug regimens that do not include integrase inhibitors, which can reduce pill burden and improve adherence [45][48] - **Addressing Stigma**: New formulations aim to provide discreet dosing options to reduce stigma associated with HIV treatment [46][49] - **Long-Acting Options**: Merck is exploring long-acting formulations and injectable options for both treatment and PrEP, with a focus on convenience and adherence [19][61] Market Research Insights - **Patient Preferences**: Market research indicates that about one-third of individuals prefer a monthly oral option for PrEP, highlighting the need for convenient and discreet dosing [68][69] - **Aging Population**: Half of people living with HIV in the US are 50 or older, necessitating treatment options that consider comorbidities and tolerability [45][43] Competitive Landscape - **Market Positioning**: Merck aims to capture market share against existing treatments by offering differentiated benefits, such as a smaller pill size and rapid onset of protection for PrEP [80][82] - **Resistance Management**: The company emphasizes the importance of having agents with a strong barrier to resistance in their regimens, particularly with the introduction of two-drug combinations [105][108] Additional Important Insights - **Community Engagement**: Merck has a long history of working with global partners to ensure broad access to HIV innovations, including collaborations with the Gates Foundation [42][50] - **Future Innovations**: The company is committed to exploring new therapies and long-acting formulations to address the ongoing unmet needs in HIV treatment and prevention [19][54] This summary encapsulates the key points discussed during the Merck & Co HIV Investor Event, highlighting the company's strategic focus on innovation, market opportunities, and community engagement in the fight against HIV.

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew by 4% year-over-year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, decreased by 1% year-over-year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was reported at $1.81 [56] Business Line Data and Key Metrics Changes - HIV sales increased by 6% year-over-year, with Biktarvy sales up by 7% [7][19] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year-over-year, totaling $302 million [28] - Trodelvy sales decreased by 5% year-over-year, totaling $293 million [29] - Cell therapy sales were down 3% year-over-year, totaling $464 million [31] Market Data and Key Metrics Changes - The HIV treatment market is expected to grow at an annual rate of 23% [22] - Descovy sales increased by 38% year-over-year, driven by higher average realized price and demand [23] - The liver disease segment saw sales of $758 million, up 3% year-over-year [26] Company Strategy and Development Direction - The company plans to launch multiple products, including lenacapavir and anetocel, to drive growth in HIV and oncology [14][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning it well for sustained growth [14] - The company is increasing investments in US manufacturing and R&D infrastructure [15][89] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming FDA decision on lenacapavir for PrEP, with a potential launch immediately following [9][38] - The company remains focused on expense management and expects to adapt to macroeconomic changes [56][57] - Management noted that the average corporate tax rate is approximately 20%, reflecting a strong US investment [14] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company has returned $1.7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases [58] Q&A Session Summary Question: Expectations for lenacapavir for PrEP - Management is excited about the upcoming PDUFA date and anticipates building access to about 75% within the first six months post-launch [62] Question: Impact of HHS and CDC cuts on launch - Management has not seen any changes that would affect the launch plans for lenacapavir for PrEP [68] Question: Implications of COVID-19 on Descovy sales - Descovy saw a 38% year-over-year growth, driven by higher average realized price and demand, which supports the opportunity for lenacapavir [77] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's profits are recognized in the US, which mitigates tariff risks [86] Question: Impact of lenacapavir on Descovy sales - Management believes lenacapavir will provide a switch strategy for patients currently on daily oral medications, potentially accelerating market growth [124]