Key Takeaways GILD stock has surged 27.2% in six months, outpacing its industry, sector, and the S&P 500 index. FDA approval of Yeztugo, the first twice-yearly PrEP, strengthens GILD's HIV portfolio and market edge. New liver drug Livdelzi and rising earnings estimates support GILD's growth and dividend sustainability.Shares of Gilead Sciences, Inc. (GILD) have gained 27.2% in the past six months against the industry’s decline of 2.2%. The stock has also outperformed the sector and the S&P 500 index in th ...

Core Insights - Gilead Sciences is focusing on executing its strategy across core franchises, particularly in HIV and oncology, while also diversifying into inflammation [2][3] - The company has developed a strategy over the past 5 to 6 years to maintain leadership in virology and expand into other therapeutic areas [3] - Gilead currently has three growing franchises: virology and HIV, oncology, and inflammation, with promising data from recent presentations at ASCO [4] Financial Position - Gilead has a strong balance sheet and robust cash flows, positioning the company well for future growth opportunities [4]

Core Insights - GSK's new drug application for linerixibat has been accepted by the FDA for review, with a decision expected on March 24, 2026 [1][7] - If approved, linerixibat could fulfill a significant unmet medical need for patients suffering from cholestatic pruritus associated with primary biliary cholangitis (PBC) [2][5] GSK's Drug Development - The NDA for linerixibat is based on positive results from the phase III GLISTEN study, which demonstrated significant improvement in cholestatic pruritus and related sleep interference compared to placebo [4][7] - Cholestatic pruritus is a common symptom of PBC, a rare autoimmune disease that can lead to liver failure [5] Competitive Landscape - Other companies are also pursuing treatments for PBC, including Gilead Sciences, which received accelerated approval for seladelpar in August 2024 [8] - Seladelpar was acquired by Gilead for $4.3 billion and is now part of their liver disease portfolio [9] - Mirum Pharmaceuticals is developing volixibat, another oral IBAT inhibitor, currently in phase IIb trials [9]

Core Viewpoint - Gilead Sciences, Inc. has demonstrated strong performance in a volatile market, with shares up 21.1% year-to-date, significantly outperforming the industry and the S&P 500 Index, which declined by 4.7% [1][8]. Group 1: HIV Market Leadership - Gilead is a dominant player in the HIV market, with its flagship drug Biktarvy accounting for over 51% of the treatment market share in the U.S. [4] - The company’s Descovy for pre-exposure prophylaxis (PrEP) maintains over 40% market share in the U.S. [5] - The FDA has accepted new drug applications for lenacapavir for HIV prevention, with a target action date of June 19, 2025, which could enhance Gilead's HIV franchise [5][6]. Group 2: Liver Disease Portfolio - The FDA approval of seladelpar (Livdelzi) for primary biliary cholangitis (PBC) strengthens Gilead's liver disease portfolio and validates its CymaBay acquisition [7][9]. Group 3: Oncology Business Challenges - Gilead's oncology portfolio, including the Cell Therapy franchise and Trodelvy, faces competitive pressures, particularly in the U.S. and Europe, which are expected to continue into 2025 [10]. - Despite challenges, positive results from the phase III ASCENT-03 study on Trodelvy indicate potential for improvement in the oncology business [11]. Group 4: Financial Performance and Estimates - Gilead's shares trade at a price/earnings ratio of 13.70x forward earnings, lower than the large-cap pharma industry's average of 14.62x but higher than its historical mean of 10.53x [12]. - Earnings estimates for Gilead have increased, with the 2025 bottom-line estimate rising to $7.91 from $7.87, and the 2026 estimate improving to $8.39 from $8.31 [14]. Group 5: Strategic Positioning and Dividends - Gilead's strategic deals and acquisitions are aimed at diversifying its business, although Biktarvy sales may face pressure due to Medicare Part D redesign [17]. - The company has a strong cash position of $7.9 billion as of March 31, 2025, and has consistently increased dividends, declaring a quarterly dividend of $0.79 per share for Q2 2025, indicating a sustainable yield of 2.91% [18].

Core Viewpoint - Gilead Sciences, Inc. reported disappointing first-quarter 2025 results, with adjusted earnings per share (EPS) of $1.81 and total revenues of $6.7 billion, both missing consensus estimates [1][2][3] Financial Performance - Adjusted EPS of $1.81 missed the Zacks Consensus Estimate by a penny, compared to a loss per share of $1.32 in the same quarter last year [1] - Total revenues of $6.7 billion were flat year over year and missed the Zacks Consensus Estimate of $6.8 billion [1] - Total product sales decreased 1% year over year to $6.6 billion, while excluding Veklury, product sales increased 4% to $6.3 billion [3] Product Sales Breakdown - HIV product sales grew 6% year over year to $4.6 billion, exceeding both the Zacks Consensus Estimate and model estimate of $4.5 billion [3] - Biktarvy sales increased 7% year over year to $3.15 billion but missed the Zacks Consensus Estimate of $3.2 billion [4] - Descovy sales surged 38% year over year to $586 million, beating the Zacks Consensus Estimate of $479 million [5] - Liver Disease portfolio sales rose 3% to $758 million, driven by higher demand for HBV and HDV drugs [6] - Veklury sales plummeted 45% to $302 million, missing the Zacks Consensus Estimate of $387 million [7] - Cell Therapy product sales decreased 3% to $464 million, missing the Zacks Consensus Estimate of $491 million [7] Cost and Margin Analysis - Adjusted product gross margin slightly increased to 85.5% from 85.4% in the year-ago quarter [11] - Research and development expenses totaled $1.3 billion, down from $1.4 billion in the previous year [11] - SG&A expenses amounted to $1.2 billion, down from $1.3 billion [11] Dividend and Guidance - Gilead declared a quarterly dividend of $0.79 per share for Q2 2025, payable on June 27, 2025 [12] - The company reiterated its 2025 guidance, projecting product sales between $28.2 billion and $28.6 billion, with adjusted EPS anticipated in the range of $7.70-$8.10 [13] Pipeline Updates - The FDA accepted new drug application submissions for lenacapavir for HIV prevention, with a target action date of June 19, 2025 [14] - Gilead received conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis [14] Overall Performance Assessment - Gilead's first-quarter results were disappointing, particularly due to a decline in oncology drugs affecting revenue growth [15] - Despite challenges, Biktarvy maintained its dominant position in the HIV market, and Descovy showed strong performance [15] - The potential approval of lenacapavir could further strengthen Gilead's HIV franchise amid increasing competition [16]