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 - 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].

Summary of Gilead Sciences (GILD) 2025 Conference Call Company Overview - **Company**: Gilead Sciences (GILD) - **Date of Conference**: June 04, 2025 - **Key Speakers**: Dietmar Berger (CMO), Cindy Paretti (Executive VP of Kite) Key Points on Pipeline and R&D Focus - **Therapeutic Areas**: Gilead is focusing on three key therapeutic areas: virology, oncology, and immunology [3][4][8] - **HIV Pipeline**: - **Lanacapavir**: Expected PDUFA date is June 19, 2025, focusing on prevention for HIV [4][10] - **Breakthrough Therapy Designation**: Positive interactions with the FDA regarding Lanacapavir, with no irregularities noted [10][11] - **Future Launches**: Potential for up to nine additional launches in the virology space by February 2023 [11] - **Oncology Pipeline**: - **Trodelvy**: Positive data for Trodelvy in first-line treatment for triple-negative breast cancer, addressing a significant unmet medical need [6][60] - **Patient Population**: Transitioning from second-line to first-line treatment could double the patient population [7][60] - **Emerging Studies**: Additional studies planned for Trodelvy in various cancer settings, including hormone receptor-positive breast cancer and non-small cell lung cancer [61] - **Immunology Portfolio**: - Development of oral therapies targeting alpha four beta seven and IRAK four, with ongoing clinical trials [7][66][68] Important Developments and Data - **Lanacapavir Launch Strategy**: Gilead is preparing for a cross-functional launch strategy, focusing on prescriber engagement and site readiness [13][14] - **Long-Acting Treatment Options**: Gilead is exploring longer-acting treatment options for HIV, including a once-a-year injection of Lanacapavir, which has shown promising pharmacokinetic data [17][18][24] - **CAR T Therapy**: Gilead is advancing its CAR T programs, with a focus on the Anita cell and Edacil BCMA programs, expecting to file for approval in 2026 [43][46] Market Dynamics and Competitive Landscape - **Yescarta Franchise**: Facing headwinds from both in-class and out-of-class competition, with a focus on increasing community access to CAR T therapies [52][53] - **Trodelvy Competition**: Trodelvy is positioned as a potential new standard of care in triple-negative breast cancer, with ongoing studies to support its growth [57][64] Additional Insights - **Inflammation Programs**: Gilead is developing an inflammation portfolio, including oral therapies and CAR T options for conditions like lupus and scleroderma [66][72] - **Regulatory Interactions**: Gilead is maintaining positive interactions with regulatory agencies, adapting to evolving requirements for clinical endpoints [46][50] This summary encapsulates the key discussions and insights from the Gilead Sciences conference call, highlighting the company's strategic focus areas, pipeline developments, and market positioning.

Gilead Sciences (GILD) Conference Summary Company Overview - **Company**: Gilead Sciences (GILD) - **Date of Conference**: June 04, 2025 Key Industry and Company Insights Pipeline Focus - Gilead's R&D pipeline is centered on three key therapeutic areas: virology, oncology, and immunology [3][4][8] - The company is particularly focused on HIV prevention with lanacapavir, which has a PDUFA date set for June 19, 2025 [4][10] - Positive data for Trodelvy in first-line treatment for triple-negative breast cancer has been reported, indicating a significant opportunity due to the large unmet medical need in this area [6][57] HIV Developments - Lanacapavir is positioned as a breakthrough therapy for HIV prevention, with no irregularities reported in FDA interactions [10][11] - Gilead is preparing for a successful launch of lanacapavir, emphasizing a cross-functional approach to ensure readiness across various aspects such as sales, medical, and reimbursement [13][14] - The company is also developing a once-a-year injection for HIV prevention, which has shown promising pharmacokinetic data [17][18] Oncology Insights - Trodelvy's recent data suggests it may become a new standard of care for first-line triple-negative breast cancer, potentially doubling the patient population accessible to Gilead [56][57] - Gilead is also advancing its CAR T-cell therapy programs, with a focus on improving manufacturing efficiency and expanding treatment center availability [35][39] - The company plans to file for regulatory approval for its new CAR T-cell therapy in 2026, contingent on positive data from ongoing studies [40] Competitive Landscape - Gilead faces competition in the CAR T-cell therapy space, particularly from new entrants and existing products like Carvicti and bispecific therapies [49][50] - The company acknowledges headwinds for its Yescarta franchise due to both in-class and out-of-class competition, but is optimistic about future growth through community engagement [49][51] Immunology and Inflammation - Gilead is building an early-stage inflammation portfolio, including oral and injectable therapies targeting conditions like inflammatory bowel disease [63][66] - The company is advancing several programs in this area, including IRAK4 inhibitors and STAT6 modulators, which are expected to enter clinical trials soon [65][66] Additional Important Points - Gilead's focus on optionality in HIV treatment is crucial, with plans for various dosing frequencies to cater to different patient needs [24][25] - The company is committed to maintaining high efficacy and safety standards across its product offerings, particularly in the context of HIV treatment and prevention [24][26] - Gilead's strategic emphasis on community access and education is seen as vital for unlocking the potential of its therapies in real-world settings [50][51] This summary encapsulates the key points discussed during the Gilead Sciences conference, highlighting the company's strategic focus areas, pipeline developments, competitive landscape, and future growth opportunities.

Summary of Gilead Sciences (GILD) 2025 Conference Call Company Overview - **Company**: Gilead Sciences (GILD) - **Focus**: CAR T franchise, specifically the development of a new BCMA CAR T therapy for myeloma Key Points Efficacy and Safety of BCMA CAR T Therapy - **Efficacy Data**: - Average follow-up of 12.6 months shows a high overall response rate of 97% and a complete response (CR) rate of 68% [3][4] - Minimal residual disease (MRD) rate is reported at 93% [3] - **Safety Profile**: - Grade 3 or above CRS or ICANS events are at 1% or less, indicating a favorable safety profile [4][5] - No delayed neurotoxicity, such as parkinsonism or Guillain-Barré syndrome, has been observed [5][6] Manufacturing and Production - **Manufacturing Facilities**: - Three manufacturing facilities are operational, with production for clinical trials occurring at the Maryland facility [7][8] - Aiming for 96% reliability in turnaround times comparable to existing products like Yescarta and TACARTIS [9][15] - **Tech Transfer**: - Successful tech transfer with no reported issues, allowing for efficient production processes [16][18] Market Opportunity and Patient Access - **Target Population**: - Launching into the fourth-line plus population for myeloma, where currently only 10% of eligible patients receive CAR T therapy [20][21] - Emphasis on outpatient therapy to increase patient access, as 90% of myeloma patients are treated in community settings [21][22] - **Authorized Treatment Centers**: - Currently have 555 authorized treatment centers globally, with plans for expansion by the time of product launch in 2026 [25] Competitive Landscape - **Market Challenges**: - Facing competition from new entrants in the CAR T space and T cell engagers, leading to a 22% decline in the TACARTICE franchise [29] - Despite challenges, lymphoma segment grew by 2% [30] Future Developments - **New Constructs**: - Development of bisistronic constructs targeting CD19 and CD20, with a focus on improving efficacy and safety [40][42] - Plans to expand into autoimmune diseases and solid tumors, with ongoing studies in conditions like lupus and glioblastoma [50][52] Regulatory and Data Expectations - **Regulatory Strategy**: - Engaging with regulatory agencies for the submission of data from ongoing studies, including the IMGIGN-one trial [13] - **Upcoming Data Releases**: - Anticipated data presentations at ASCO and EHA, including updates on new constructs and manufacturing improvements [38][52] Additional Insights - **Patient-Centric Approach**: - Emphasis on reaching patients in community settings and exploring outpatient treatment options to alleviate hospital capacity issues [22][24] - **Innovative Manufacturing Techniques**: - Implementation of automation and rapid sterility testing to enhance production efficiency [34][36] This summary encapsulates the critical insights from the Gilead Sciences conference call, highlighting the company's strategic focus on CAR T therapies, manufacturing capabilities, market opportunities, and future developments.

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]