Core Viewpoint - Gilead Sciences' experimental single-tablet HIV treatment demonstrates low discontinuation rates and high patient satisfaction, indicating its potential as a viable option for patients after viral suppression [1] Group 1: Treatment Efficacy - The experimental treatment showed discontinuation rates due to adverse events of 1.6% and 0.5% in the two treatment arms, which are considered low [1] - After 48 weeks, 0.8% of patients on the combination pill had detectable virus levels, compared to 1.1% of those on multi-tablet regimens, suggesting better viral suppression [1] Group 2: Patient Satisfaction - Participants reported higher treatment satisfaction after switching to the experimental single-tablet regimen, as noted in a paper published in The Lancet [1] Group 3: Regulatory Plans - Gilead plans to submit data from the trials to regulatory authorities, although the combination treatment has not yet received approval [1]

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from three pivotal Phase 3 trials evaluating the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg), (MK- 8591A)] in adults with HIV-1. The findings were shared in late-breaking presentations at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) being held in Denver. "We are proud to contin ...

Core Insights - Gilead Sciences, Inc. (GILD) reported strong fourth-quarter and full-year 2025 results, with HIV product sales increasing by 6%, driven by a 7% growth in Biktarvy and a 47% surge in its prevention portfolio [1][2][10] Group 1: HIV Product Performance - Biktarvy holds over 52% market share in the HIV treatment market and is the most prescribed therapy for both treatment-naïve and switch patients [2] - Descovy's sales increased by 31% year over year to $2.8 billion, accounting for more than 45% of the U.S. market share in pre-exposure prophylaxis (PrEP) [3] - The FDA approved injectable lenacapavir (Yeztugo), which offers a twice-yearly dosing schedule, enhancing adherence compared to daily oral regimens [4] Group 2: Financial Projections and Growth Drivers - Despite a $900 million headwind from the Medicare Part D redesign, HIV sales grew 10% when excluding this impact, surpassing management's annual target of 5% growth [2][10] - Gilead expects total HIV sales to grow approximately 6% year over year in 2026, with potential growth of 8% when excluding pricing pressures and channel mix shifts [6] - Early uptake of Yeztugo generated $150 million in 2025, with projected revenues of approximately $800 million in 2026 [5] Group 3: Research and Development Initiatives - Positive phase III results from ARTISTRY-1 and ARTISTRY-2 studies for the investigational BIC/LEN regimen increase the likelihood of regulatory approval, potentially launching by year-end [7] - Gilead is collaborating with Merck to advance its HIV pipeline, with data from studies on islatrovir plus lenacapavir expected in 2026 [8] - Plans to initiate a phase III study evaluating lenacapavir plus broadly neutralizing antibodies are set for the second half of the year [9] Group 4: Competitive Landscape - Gilead faces competition from major players like GSK and Merck in the HIV treatment market, with GSK's growth driven by long-acting injectable medicines [11] - Merck markets doravirine and is evaluating a once-daily oral regimen for treatment-naïve adults with HIV-1 infection [12] Group 5: Stock Performance and Valuation - GILD shares surged 45.9% over the past year, outperforming the industry's growth of 19.6% [15] - The current price/earnings ratio for GILD is 17.46x forward earnings, higher than its historical mean but lower than the large-cap pharma industry average of 18.51x [16]

Q425 & FY25 Financial Results 1 0 D e c e m b e r 2 0 2 4 F e b r u a r y 1 0 , 2 0 2 6 Forward-Looking Statements Statements included in this document that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilea ...

Core Insights - Gilead Sciences, Inc. (GILD) maintains a leading position in the HIV market, primarily driven by its flagship therapies Biktarvy and Descovy, which have significantly contributed to the company's revenue growth in recent quarters [1][9] Gilead's HIV Portfolio - The FDA approved lenacapavir, branded as Yeztugo, as the first and only twice-yearly injectable HIV-1 capsid inhibitor for prevention, enhancing GILD's HIV portfolio amid generic competition for Truvada [2][9] - Yeztugo's competitive edge lies in its biannual dosing, appealing to a broader population compared to daily oral medications [3] - Gilead's investigational single-tablet regimen combining bictegravir and lenacapavir has met primary endpoints in phase III studies, indicating potential for regulatory submission [4][5] Competitive Landscape - The HIV treatment market includes major competitors like GSK and Merck, with GSK's HIV portfolio benefiting from strong demand for long-acting injectables and Dovato, while Merck markets doravirine in various formulations [7][8][10] Financial Performance - Gilead's stock has increased by 31.2% over the past year, outperforming the industry average growth of 15% [11] - The company's shares are trading at a price/earnings ratio of 14.32x forward earnings, which is above its historical mean of 10.93x but below the large-cap pharma industry's average of 17.11x [12] - Earnings estimates for 2025 have risen to $8.17 from $8.07, while the estimate for 2026 has slightly decreased to $8.50 from $8.51 [13]

Core Insights - Gilead Sciences, Inc. announced that its investigational single-tablet regimen of bictegravir and lenacapavir for HIV treatment met the primary endpoint in the ARTISTRY-2 study [1][6] Study Details - ARTISTRY-2 is a multicenter, double-blind, randomized phase III study comparing the safety and efficacy of the once-daily combination of bictegravir and lenacapavir (BIC/LEN) versus Biktarvy in virologically suppressed individuals with HIV [2] - The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at week 48, and BIC/LEN was found to be statistically non-inferior to Biktarvy [3][10] Product Information - Bictegravir is a globally recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, while lenacapavir is approved for pre-exposure prophylaxis (PrEP) and treatment of multi-drug-resistant HIV [4][5] - The single-tablet regimen combining bictegravir and lenacapavir could reshape the HIV treatment landscape by providing more options for maintaining virologic suppression [6] Market Position - Gilead has a leading HIV franchise, with Biktarvy accounting for over 52% of the treatment market in the U.S. and Descovy holding more than 45% of the U.S. PrEP market [8][9] - The approval of lenacapavir as a twice-yearly injectable option for HIV prevention enhances Gilead's portfolio, especially as it faces competition from generics [11][12] Financial Performance - Yeztugo, the brand name for lenacapavir, generated $39 million in sales in the third quarter, achieving a 75% coverage goal ahead of schedule [13] - Gilead's shares have increased by 29.7% year to date, outperforming the industry growth of 18.9% [11] Competitive Landscape - Positive data from the ARTISTRY studies is expected to strengthen Gilead's HIV franchise amid increasing competition from companies like GSK, which is expanding its HIV business with long-acting injectable medicines [14]

Core Insights - Gilead Sciences announced that its experimental HIV treatment successfully met the primary endpoint in a late-stage clinical trial [1] Company Summary - Gilead Sciences is advancing its HIV treatment, indicating progress in its clinical development pipeline [1]

Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of the year, with less than $100 million expected for the fourth quarter, indicating a strong start to the launch [2] - The operating margin improved to roughly 50% in the third quarter, reflecting a disciplined cost focus and operational efficiency [36][39] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, with Descovy growing 32% year over year in HIV prevention [6] - Sunlenca's launch is expected to drive steady, consistent, durable growth similar to Biktarvy, which had $3.5 billion in sales in the third quarter [3] Market Data and Key Metrics Changes - The CDC estimates that at least 2.2 million people in the U.S. would benefit from HIV prevention, indicating a significant market opportunity [8] - Currently, about 500,000 people are on HIV prevention therapy, suggesting substantial room for market expansion [12] Company Strategy and Development Direction - The company is focused on changing prescriber habits and building awareness for the new injectable options versus oral medications [2][5] - There is a strong emphasis on expanding the HIV prevention market, with plans for specific advertising campaigns to raise awareness [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the HIV prevention market, noting that the market is just beginning to develop [7][9] - The company highlighted the importance of building awareness and transitioning patients from existing therapies to new options [12][13] Other Important Information - The patent settlement for Biktarvy extends exclusivity until at least 2036, providing long-term stability for the company [15] - The company has a deep pipeline of next-generation HIV treatment alternatives, with multiple programs in clinical development [16][18] Q&A Session Summary Question: Can you discuss the strategy for educating patients and physicians on the benefits of the injectable option? - Management acknowledged that changing habits takes time and emphasized the importance of building a sales force and healthcare educators to raise awareness [5] Question: Where is the demand for Sunlenca coming from in the early days of the launch? - The company noted that there has been a surprising number of naive patients starting on Sunlenca, as well as patients switching from generic Truvada and other long-acting options [10][11] Question: What are the plans for Anito-cel in terms of clinical development? - Management confirmed that there are plans to move Anito-cel into earlier lines of treatment, with significant market opportunities identified [25][26] Question: Can you provide an update on Trodelvy's regulatory submissions and growth potential? - The company expects to receive an updated label for Trodelvy next year, which should drive significant growth [28] Question: How is the company approaching business development, particularly in China? - Management highlighted a shift towards innovative assets in China and noted that a significant portion of their corporate development interest is now sourced from that region [33][34]

Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of the year, with less than $100 million expected for the fourth quarter, indicating a strong start to the launch [2] - The operating margin improved to roughly 50% in the third quarter, reflecting a disciplined cost focus and operational efficiency [36][39] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, with Descovy growing 32% year over year in HIV prevention [6] - Sunlenca's launch is expected to drive steady, consistent, durable growth similar to Biktarvy, which had $3.5 billion in sales in the third quarter [3] Market Data and Key Metrics Changes - The CDC estimates that at least 2.2 million people in the U.S. would benefit from HIV prevention, indicating a significant market opportunity [8] - Currently, about 500,000 people are on HIV prevention therapy, suggesting substantial room for growth in the market [12] Company Strategy and Development Direction - The company is focused on changing prescriber habits and building awareness for the new injectable options versus oral medications [2][5] - There is a strong emphasis on expanding the HIV prevention market, with plans for specific advertising campaigns to raise awareness [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the HIV prevention market, noting that the market is just beginning to develop [7][9] - The company highlighted the importance of building awareness and transitioning patients from existing therapies to new options [12][13] Other Important Information - The patent settlement for Biktarvy extends exclusivity until at least 2036, providing long-term stability for the company [15] - The company has a deep pipeline of next-generation HIV treatment alternatives, with multiple programs in clinical development [16][18] Q&A Session Summary Question: Can you discuss the strategy for educating patients and physicians on the benefits of the injectable option? - Management acknowledged that changing habits takes time and emphasized the importance of building a sales force and healthcare educators to raise awareness [5] Question: Where is the demand for Sunlenca coming from in the early days of the launch? - The company noted that there has been a surprising number of naive patients starting on Sunlenca, as well as patients switching from generic Truvada and other long-acting options [10][11] Question: What are the plans for Anito-cel and its market potential? - Management indicated that Anito-cel is expected to launch in the fourth-line plus market by the end of next year, with significant growth opportunities in multiple myeloma [24][25] Question: Can you provide an update on Trodelvy's regulatory submissions and growth potential? - The company expects updated label expansion filings for Trodelvy in the U.S. next year, which should drive significant growth [28] Question: How is the company approaching business development, particularly in China? - Management highlighted a shift towards more innovative assets in China and noted that a significant portion of their corporate development interest is now sourced from that region [33][34]

Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of FY 2025, with less than $100 million expected in Q4 [2] - The operating margin improved to roughly 50% in Q3, up from just below 40% previously, indicating strong operational leverage [34][36] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, driven by the launch of Sunlenca and the growth of Descovy, which saw a 32% increase in the same period [6][10] - Biktarvy, a key HIV treatment, generated $3.5 billion in sales in Q3, showcasing its strong market position [3][15] Market Data and Key Metrics Changes - The HIV prevention market is estimated to have around 500,000 patients currently on therapy, with the CDC estimating that at least 2.2 million people in the U.S. could benefit from HIV prevention [7][11] - The company noted that the market opportunity for HIV prevention could be much larger, with 10-12 million people diagnosed with sexually transmitted diseases annually in the U.S. [7] Company Strategy and Development Direction - The company is focused on building awareness and changing prescriber habits to promote the shift from daily oral medications to long-acting injectables [2][5] - A patent settlement extended the exclusivity of Biktarvy until at least 2036, allowing the company to plan long-term without immediate competitive pressures [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the steady growth of the HIV prevention market and the potential for Sunlenca to capture a significant share [3][10] - The company is confident in its pipeline, with multiple launches expected in the coming years, which will support diversification and growth [29][36] Other Important Information - The company is actively pursuing business development opportunities, particularly in China, where it has seen a shift towards more innovative assets [31][32] - The company plans to continue investing in R&D while maintaining a disciplined approach to operational expenses [34][36] Q&A Session Summary Question: Can you discuss the early demand for Sunlenca? - Management noted that early demand is coming from naive patients and those switching from generic Truvada, with a significant portion also switching from other long-acting injectables [9][10] Question: What is the strategy for educating patients and physicians about Sunlenca? - The company is building a sales force and healthcare educators to work directly with physicians and is planning advertising campaigns to raise awareness [5][11] Question: How does the patent settlement for Biktarvy influence long-term planning? - The extended exclusivity until 2036 allows for strategic planning without immediate concerns about competition, supporting the development of next-generation treatments [14][15] Question: What are the growth opportunities for Anito-cel in multiple myeloma? - The company plans to move Anito-cel into earlier lines of treatment, targeting a sizable market opportunity in both second-line and first-line therapies [24][25] Question: What is the outlook for Trodelvy in triple-negative breast cancer? - Trodelvy is expected to continue growing, especially with label expansion anticipated next year, contributing to sustained growth over time [27]