Gilead Sciences (NasdaqGS:GILD) Q3 2025 Earnings Call October 30, 2025 04:30 PM ET Speaker0Good afternoon, everyone, and welcome to Gilead's Third Quarter twenty twenty five Earnings Conference Call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks followed by our Q and A session. Now I'll hand the call over to Jackie Ross, Senior Vice President of Treasury and Investor Relations.Speaker1Thank you, Rebecca. Just after market closed today, we issued a press release ...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced its upcoming participation in the 20th European AIDS Conference (EACS) to be held in Paris, France from October 15-18. As the leader in HIV innovation, Gilead will provide an update on its strategic initiatives, key collaborations, and share new scientific data from its HIV research and development programs. The research that will be presented at EACS 2025, along with the Gilead-led symposia and supported. ...

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]