Key Takeaways AZN will report Q4 results on Feb. 10, with cancer and diabetes drugs expected to drive quarterly sales.INCY and VRTX's Q4 results to be supported by Jakafi growth and CF drug demand, respectively.GILD and MRNA look to product portfolio strength as vaccine and liver disease sales shape results.The fourth-quarter earnings season continues to be in full swing this week, with many large drugmakers like AstraZeneca (AZN) , Incyte (INCY) , Gilead Sciences (GILD) , Vertex Pharmaceuticals (VRTX) and ...

Biotech investors often chase early-stage companies in the hope that a single breakthrough trial will deliver massive returns. While those clinical-stage biotech stocks can offer enormous upside, they also come with outsized risk. However, sometimes established biotech companies like Gilead Sciences (GILD), which can deliver steadier and sometimes surprising growth, are overlooked. GILD stock has surged 22% so far this year, outperforming the broader market gain. As Gilead prepares to report its fourth-q ...

Key Takeaways GILD reports Q4 results on Feb. 10, with consensus estimates of $7.57B in sales and $1.83 in EPS.Gilead's HIV franchise remains the growth engine, led by Biktarvy, Descovy and contributions from Yeztugo.GILD faces pressure in cell therapy sales, while liver disease drugs and Trodelvy support revenues.Biotech bigwig Gilead Sciences, Inc. (GILD) is scheduled to report fourth-quarter and full-year 2025 results on Feb. 10, after market close. The Zacks Consensus Estimate for fourth-quarter sales a ...

Summary of Gilead's Conference Call Company Overview - **Company**: Gilead Sciences - **Industry**: Biotechnology and Pharmaceuticals Key Points 1. Growth and Pipeline - Gilead's growth story is highlighted for 2026 and beyond, with a strong focus on the HIV business and the launch of Lenacapavir, which is crucial for ending the HIV epidemic globally [2][4] - The company has the strongest and most diverse pipeline in its nearly 40-year history, with significant launch activities expected [2][5] - Gilead has no major loss of exclusivity (LOE) for another decade, providing a stable backdrop for growth [3] 2. HIV Business - The HIV revenue growth was reported at 7% through Q3 of the previous year, despite a $900 million headwind from Part D [6] - Gilead plans to launch up to seven HIV prevention and treatment products by the end of 2033, with Biktarvy remaining the standard of care [7][14] - The company is investing in Biktarvy and Lenacapavir, with an FDA decision for a daily oral combination expected in the second half of the year [8][19] 3. Prevention Market - Gilead is the market leader in PrEP (pre-exposure prophylaxis) and has achieved a revenue target of $150 million for the Yes To Go product in 2025 [10][11] - The PrEP market is larger than official estimates, with significant growth potential [11] - Lenacapavir was launched in sub-Saharan Africa, marking a significant milestone in Gilead's efforts to combat HIV globally [13] 4. Treatment Pipeline - Gilead is preparing for the launch of Trodelvy in the first-line setting for triple-negative breast cancer, which could double patient opportunities [16] - Anito-cel, targeting fourth-line multiple myeloma, is expected to launch in the second half of the year, with a strong safety profile [17][45] - The company is confident in its treatment pipeline, with multiple options for patients, including daily, weekly, and monthly therapies [38][41] 5. Financial Management - Gilead has maintained strong financial discipline, with operating margins in the top quartile of peers and a commitment to returning at least 50% of free cash flow to shareholders [23][25] - Since 2020, Gilead has distributed over $22 billion in dividends, with a 16% growth in dividends during that period [24] - The company is actively pursuing bolt-on acquisitions to enhance its portfolio and financial performance [26][55] 6. Regulatory and Market Position - Gilead is focused on addressing affordability issues in the U.S. healthcare system and is engaged in dialogue with the administration regarding pricing and access [59][60] - The company has a robust plan for managing the MFN (Most Favored Nation) agreements, viewing them as manageable for future operations [59][60] 7. Future Expectations - Gilead anticipates continued growth in its base business, with a projected 7% to 8% growth in 2023 and 2024 [25] - The company is committed to maintaining a strong pipeline and optimizing its operations to support long-term shareholder value [27][52] Additional Insights - Gilead's commitment to innovation and addressing unmet medical needs is evident in its diverse pipeline and proactive approach to market challenges [15][26] - The company emphasizes the importance of having multiple treatment options available to cater to different patient needs and preferences [41][44]

Core Insights - Gilead Sciences has exercised its option to exclusively license Assembly Biosciences' herpes simplex virus helicase-primase inhibitor programs, marking the first advancement under their collaboration [1][2] Licensing Agreement - Gilead entered a 12-year partnership with Assembly Biosciences in 2023 to develop novel antiviral therapies, with Assembly Bio receiving a $35 million payment upon Gilead's exercise of its option [2] - Gilead will obtain exclusive rights to ABI-5366 and ABI-1179, taking full responsibility for their clinical development and commercialization [2] Financial Milestones - Assembly Biosciences is eligible for up to $330 million in regulatory and commercial milestones, along with tiered royalties on net sales [3][7] Product Development - ABI-1179 and ABI-5366 are long-acting helicase-primase inhibitors showing strong antiviral activity and significant reduction in virus-positive lesions in interim data from early-stage studies [8][9] - Over four million people in the U.S. and some European countries suffer from recurrent genital herpes, indicating a substantial market opportunity for these new therapies [9][10] Market Context - No new HSV therapies have been approved in the U.S. or Europe in over 25 years, highlighting the potential impact of ABI-5366 and ABI-1179 if successfully developed [9][10] Gilead's HIV Portfolio - Gilead has a leading HIV franchise, with products like Biktarvy and Descovy driving top-line growth [11] - The recent FDA approval of lenacapavir for HIV prevention enhances Gilead's portfolio, especially as Truvada faces generic competition [12]

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 has had a strong performance in 2025, leading to an increase in guidance for the year [2] - The company boasts a durable portfolio, with flagship HIV therapies Biktarvy and Descovy driving significant growth, alongside promising new launches [3] - Gilead has the strongest pipeline in its history, indicating a steady flow of clinical data that could enhance product offerings [4] Financial Performance - The third quarter results reflect a terrific start to 2025, showcasing overall business momentum [2] Product Portfolio - The base business is significantly supported by Biktarvy and Descovy, with new products like Yeztugo and Livdelzi showing strong initial performance [3] - Yeztugo is highlighted as a transformational HIV prevention medicine with a unique six-month injection schedule [3] Pipeline Development - Gilead's pipeline is described as the deepest and broadest in the company's history, suggesting ongoing clinical developments that may lead to new product introductions [4]

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]