Key Takeaways Gilead shares fell 2.2% after CVS chose not to cover its new HIV prevention drug Yeztugo.Yeztugo, FDA-approved in June, is the first and only twice-yearly PrEP option in the U.S.Gilead's Kite will acquire Interius BioTherapeutics for $350M, impacting EPS by $0.23-$0.25.Shares of Gilead Sciences, Inc. ((GILD) tumbled 2.2% on Aug. 21, after pharmacy benefit manager CVS Health ((CVS) decided not to add the former’s new HIV prevention drug, Yeztugo (lenacapavir), to its commercial plans for now.As ...

Core Viewpoint - Analysts expect Gilead Sciences (GILD) to report quarterly earnings of $1.95 per share, reflecting a year-over-year decline of 3%, with revenues projected at $6.95 billion, down 0.1% from the previous year [1]. Earnings Estimates - The consensus EPS estimate has been revised 1.1% higher in the last 30 days, indicating a collective reevaluation by analysts [1][2]. - Changes in earnings estimates are crucial for predicting investor reactions, as empirical studies show a strong correlation between earnings estimate revisions and short-term stock performance [2]. Revenue Projections - Analysts project 'Revenues- Royalty contract and other revenues' to reach $38.09 million, indicating a decline of 7.1% year-over-year [3]. - The average prediction for 'Total product sales- Total' is $6.91 billion, showing no change from the prior year [4]. Product Sales Estimates - 'Product Sales- Oncology- Cell Therapy- Tecartus- Total' is estimated at $92.76 million, reflecting a decrease of 13.3% from the previous year [4]. - 'Product Sales- Veklury- Total' is expected to be $211.34 million, down 1.2% year-over-year, while 'Product Sales- HIV- Odefsey- U.S.' is projected at $215.50 million, down 7.5% [5]. - 'Product Sales- Other- Other- U.S.' is anticipated to be $54.28 million, indicating a significant decline of 44.6% [5]. - 'Product Sales- HIV- Descovy- U.S.' is expected to reach $509.35 million, reflecting a growth of 17.4% year-over-year [6]. - 'Product Sales- Oncology- Trodelvy- U.S.' is projected at $224.58 million, showing a slight increase of 0.3% [6]. - 'Product Sales- Oncology- Cell Therapy- Tecartus- U.S.' is estimated at $49.56 million, down 21.3% year-over-year [7]. - 'Product Sales- Liver Disease- Sofosbuvir / Velpatasvir- U.S.' is expected to be $225.96 million, down 15.4% [7]. - 'Product Sales- HIV- Genvoya- U.S.' is projected at $333.57 million, reflecting a decline of 10.3% [8]. - 'Product Sales- Veklury- U.S.' is expected to reach $69.13 million, down 9% year-over-year [8]. Market Performance - Gilead shares have increased by 1.3% over the past month, compared to a 0.6% increase in the Zacks S&P 500 composite [8].

Core Viewpoint - Gilead Sciences, Inc. is set to report its Q2 2025 results on August 7, with consensus estimates for sales at $6.95 billion and earnings per share (EPS) at $1.95, reflecting a positive trend in earnings estimates for 2025 and 2026 [1][4][6]. Financial Performance - The earnings estimate for 2025 has risen to $8.02 from $7.91 per share over the past 60 days, while the estimate for 2026 has increased to $8.53 from $8.39 [1]. - Gilead's earnings surprise history shows that the company has beaten estimates in three of the last four quarters, with an average surprise of 16.48% [2][3]. Sales Drivers - Strong sales from Gilead's HIV drugs, particularly Biktarvy and Descovy, are expected to support top-line growth in Q2, with estimates for Biktarvy at $3.4 billion and Descovy at $577 million [4][8]. - The company has recently received FDA approval for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, which is anticipated to enhance its HIV portfolio [8][16]. Market Dynamics - The introduction of a new Medicare Part D model may have impacted HIV sales due to increased cost-sharing obligations for low-income patients, which could affect overall sales [7][6]. - Gilead's liver disease portfolio is expected to benefit from higher demand for viral hepatitis medicines, with incremental sales from the newly approved drug Livdelzi [9][10]. Competitive Landscape - Gilead's cell therapy sales, particularly for Yescarta and Tecartus, are likely to have declined due to competitive pressures in both the U.S. and global markets [11][17]. - The oncology portfolio, including Trodelvy, is showing strong demand, although the cell therapy segment faces ongoing challenges [13][17]. Stock Performance and Valuation - Gilead's shares have increased by 22.5% year-to-date, outperforming the industry and the S&P 500 [14]. - The stock currently trades at a price/earnings ratio of 13.60x forward earnings, which is higher than its historical mean but lower than the large-cap pharma industry average [15]. Strategic Outlook - Gilead's strategic deals and acquisitions are seen as positive for diversifying its business, with ongoing collaborations to enhance its HIV treatment offerings [18][22]. - The company is viewed as a safe haven for investors in the biotech sector, with a strong dividend yield adding to its attractiveness [19][23].

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]

Financial Data and Key Metrics Changes - The base business, excluding Veclury, grew 4% year over year, primarily driven by growth in the HIV business [6][50] - Total product sales, including Veclury, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations [8][50] - Non-GAAP diluted EPS was $1.81, with a product gross margin flat year over year at 85% [52][54] Business Line Data and Key Metrics Changes - HIV sales were up 6% year over year, with Biktarvy sales increasing by 7% [7][22] - Livedelzi achieved first-quarter sales of $40 million, reflecting early momentum in its launch [27] - Veclury sales were down 45% year over year, reflecting lower rates of COVID-19 related hospitalizations [28] - Trodelvy sales were down 5% year over year, impacted by inventory dynamics and lower average realized price [29][98] - Cell therapy sales were down 3% year over year, with Yescarta sales up 2% year over year [31] Market Data and Key Metrics Changes - The HIV treatment market continues to grow at an expected rate of 23% annually [22] - Descovy sales increased by 38% year over year, driven by higher average realized price and demand [23][78] - The liver disease segment saw sales of $758 million, up 3% year over year [26] Company Strategy and Development Direction - The company is focused on multiple upcoming launches, including lenacapavir, anetocel, and Trodelvy [13][34] - Gilead Sciences, Inc. has no major loss of exclusivity (LOE) until the end of 2033, positioning itself for top-line growth across therapeutic areas [14] - The company is increasing investment 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 well-positioned to adapt to potential policy outcomes in the US [14] - Management noted that the first quarter was lighter than expected but emphasized the variability of the business [54][93] Other Important Information - Gilead Sciences, Inc. received an upgrade in its long-term debt rating from BBB+ to A- [58] - The company 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 and reimbursement dynamics - Management is excited about the upcoming PDUFA date and expects around 75% access within the first six months post-launch, reaching about 90% at the twelve-month mark [62] Question: Impact of HHS and CDC cuts on launch dynamics - Management has not seen anything that would alter plans for the lenacapavir launch and is actively engaging with policymakers [68] Question: Implications of COVID-19 on Descovy and lenacapavir - Descovy saw a 38% growth year over year, driven by market development initiatives, which supports the opportunity for lenacapavir [78] Question: Tariff risks and US market supply - Management indicated that the majority of Gilead's IP is in the US, which suggests lower value for pharmaceutical imports, and they have invested significantly in US manufacturing [86][89] Question: Cannibalization of Descovy by lenacapavir - Management believes lenacapavir will attract both switch patients from daily orals and naive patients, potentially accelerating market growth [124]