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]