The paragraph introduces the Gilead Sciences First Quarter 2025 Earnings Conference Call. Rebecca, the host, introduces Jackie Ross, who shares that the earnings results and related materials are available on the company's website. Key speakers include Daniel O'Day, the CEO, and other senior executives. They discuss forward-looking statements and the first-quarter results, highlighting a 4% growth in their base business, excluding the COVID-19 treatment, Veclury. The HIV business saw a 6% increase in sales, driven by demand for Biktarvy, although impacted by expected challenges from Part D redesign. Additionally, Livedelta shows strong sales momentum, achieving $40 million in its second full quarter.

The paragraph discusses Gilead Sciences, Inc.'s recent performance and future prospects. It highlights a slight decline in total product sales due to less demand for Trodelvy and fewer COVID-19 hospitalizations, despite strong performance in HIV and liver disease sectors, and effective expense management. The company anticipates a potential FDA decision on lenacapavir for PrEP by June 19, with plans for releasing up to nine HIV products by 2033. Notably, Gilead announced positive results from the phase three ASCENT-04 study, showing Trodelvy's effectiveness in combination with pembrolizumab for treating PD-L1 positive metastatic triple-negative breast cancer. Future data sharing and regulatory filings are planned, along with updates on ongoing Trodelvy research.

The paragraph discusses Gilead Sciences, Inc.'s progress and future plans in their cell therapy and inflammation pipeline. They aim to update on the phase two IMagineOne trial and potentially launch anetocel for multiple myeloma by 2026, leveraging Kite's manufacturing capabilities. The company is also expanding the market for Libdelzi, approved by the European Commission, for primary biliary cholangitis. They anticipate multiple product launches, including lenacapavir, anetocel, and Trodelvy, without major loss of exclusivity (LOE) until 2033. Gilead is well-positioned for policy changes in the US, with a significant portion of their intellectual property registered there. They have reinforced US investments and manufacturing, including two large-scale cell therapy sites, with ongoing projects expected to continue through 2028. The company's average corporate tax rate is approximately 20%, aided by the 2017 tax reform.

The paragraph discusses a company’s financial performance and strategic focus. The company is concentrating on upcoming launches and engaging with policymakers to support innovation and patient needs. Joanna Mercier reports that the company saw strong year-over-year sales growth in its base business, with $6.3 billion in product sales (excluding Veclury), driven primarily by HIV and liver disease sales, despite a decrease in oncology sales. Overall product sales were down 1% year-over-year due to lower Veclury sales. The HIV business generated $4.6 billion in sales, a 6% increase year-over-year, but a 16% decrease sequentially due to normal first-quarter seasonality, Medicare Part D changes, and inventory drawdowns. The first-quarter HIV revenue was particularly impacted by the redesign of Medicare Part D in 2025, affecting manufacturer contributions, especially for individuals on low-income subsidies.

The paragraph discusses the early stages of implementing a strategy for robust demand-led volume growth, despite anticipating flat reported HIV sales for 2025 due to Part D headwinds and a return to growth in 2026. Biktarvy's sales grew by 7% year-over-year, driven by higher demand, increasing its U.S. market share to 51%. Descovy sales rose by 38% year-over-year, fueled by higher prices, demand, and growing awareness in HIV prevention, maintaining over 40% market share. Seasonal factors led to sequential sales declines for both drugs. The company is looking forward to launching lenacapavir for PrEP in the U.S., with teams prepared to support the market access and commercialization efforts.

The paragraph discusses the company's efforts and performance in various healthcare sectors. They are leveraging their HIV expertise to prepare for the global launch of lenacapavir. In liver disease, sales increased by 3% due to higher demand, despite a decrease in HCV product prices. Livedelzi achieved $40 million in first-quarter sales, with a recent European expansion starting in Germany. Veclury sales dropped by 45% year over year, due to lower COVID-19 hospitalizations, but it remains a leading treatment for hospitalized patients. Trodelvy sales fell by 5%, attributed to inventory changes and pricing, although demand increased.

The paragraph discusses the sales performance and strategic developments related to two cancer treatments, Trodelvy and cell therapies Yescarta and Tecartus. Trodelvy remains a leader in treating second-line metastatic triple-negative breast cancer, with plans to expand its use in earlier treatment lines based on promising clinical trial results. Cell therapy sales totaled $464 million, with Yescarta experiencing a slight year-over-year increase due to higher prices and demand outside the U.S., despite a small sequential decline. Tecartus sales faced significant declines both year-over-year and sequentially due to intensified competition. Efforts continue to enhance CAR T therapy adoption by addressing community-level barriers and promoting its benefits.

The paragraph discusses the promising future of cell therapy despite competitive challenges expected to continue through 2025. It highlights upcoming potential product launches, including anetocel for multiple myeloma and Trodelvy for breast cancer in 2026, as well as the ongoing launch of Libdelzi and lenacapavir for PrEP in 2025. The speaker thanks the commercialization team and notes the near-term expansion of the company's portfolio. Dietmar Berger then mentions significant progress made in the first quarter, particularly with lenacapavir updates and Trodelvy's Phase III readout. Additionally, the paragraph touches on the promising potential of lenacapavir demonstrated through presentations at CROI, showcasing advances in HIV treatment with once-yearly injections.

The paragraph discusses recent developments in HIV prevention and treatment involving lenacapavir, including data published in The Lancet and plans for a phase three study for a once-yearly version. Regulatory submissions for a twice-yearly subcutaneous injection have been made globally, with expectations for a decision by June 19. Additionally, phase two studies reveal promising results for lenacapavir combined with broadly neutralizing antibodies in maintaining viral suppression in HIV treatment. The combination has received FDA breakthrough therapy designation, with phase three planning underway. The paragraph also mentions the European Commission's conditional marketing authorization for Livedelzi for treating primary biliary cholangitis based on positive phase three trial results.

The paragraph outlines progress in various clinical trials for specific medical treatments. It details advancements in the phase III IDEAL trial for Livedelzi in PBC patients and highlights the promising results of Trodelvy combined with pembro in the phase III ASCENT-04 trial for PD-L1 positive metastatic triple-negative breast cancer. Additionally, it mentions updates from the ASCENT-03 trial and seven other ongoing phase III programs for Trodelvy and domvanalimab across various cancer types. The paragraph also includes information about new data presentations at an upcoming ASCO meeting for KITE-363 and a bisistronic CAR T therapy for glioblastoma.

The paragraph discusses the developments and future plans related to KITE-363 and anetocel. KITE-363 is highlighted for its potential to provide improved efficacy and safety in B cell malignancies and autoimmune diseases due to its dual targeting of CD19 and CD20. An IND has been filed to explore its use in autoimmune diseases. For anetocel, ongoing studies include the IMagine I study for multiple myeloma and the IMerge III study with a new dual primary endpoint. Kite also achieved milestones such as European conditional approval of Livedelzi, positive results from the ASCENT-04 trial, and the start of the EVOQUE lung cancer study. Updates on other trials and virology advancements are expected soon. Finally, Andrew Dickinson mentions strong operational and commercial performance in the first quarter.

The paragraph reports on the financial performance and outlook for the company. The base business grew by 4% to $6.3 billion due to increased sales in HIV and liver disease, though oncology sales declined. Total product sales fell by 1% to $6.6 billion, primarily due to a 45% drop in Veclury sales. Non-GAAP product gross margin remained flat at 85%. R&D expenses decreased by 5%, and SG&A expenses declined by 6%, leading to a first-quarter operating margin of 43%. The company reported a non-GAAP diluted EPS of $1.81 and maintained its full-year revenue and non-GAAP P&L guidance. For 2025, total product sales are expected to be $28.2 to $28.6 billion, with flat HIV sales and Veclury sales of $1.4 billion, despite manageable tariff impacts.

In the paragraph, Andrew Dickinson discusses Gilead Sciences, Inc.'s financial outlook for the full year 2025. He notes that, due to business variability, they will update their Veclury guidance in the third-quarter earnings call. The company expects product gross margins to be between 85% and 86% and R&D expenses to remain flat from 2024. Acquired IPR&D expenses are anticipated to be around $400 million, and SG&A expenses to decrease by a high single-digit percentage compared to 2024. Operating income is projected to be $12.7 to $13.2 billion, with an effective tax rate of around 19% and diluted EPS between $7.70 and $8.10. Gilead is focused on disciplined expense management and investment in promising pipeline opportunities. The company has already returned $1.7 billion to shareholders in 2025. S&P upgraded its long-term debt rating to A- with a stable outlook. Overall, Gilead is positioned for demand-led growth, a strong cash flow, and a disciplined operating model through 2025 and beyond.

In the paragraph, during an analyst call, Rebecca invites questions, with Michael Yee from Jefferies asking about the expectations for PrEP's approval and its commercial and Medicaid reimbursement dynamics. Johanna Mercier responds, expressing excitement about the upcoming PDUFA date and emphasizing that the team is prepared for the launch. She outlines access expectations, stating that around 75% access is anticipated within the first six months, gradually increasing to 90% by the twelve-month mark. She also mentions that the process will involve medical exceptions initially and compares it to their experience with Libdelzi. Finally, Johanna looks forward to building stronger access through 2025 and 2026. Carter Gould from Fitzgerald then asks the next question.

The paragraph discusses the potential impact of budget cuts in health organizations like HHS and CDC on the launch of lenacapavir for PrEP by Gilead Sciences, Inc. Despite the cuts, Daniel O'Day expresses confidence that these changes will not affect their plans or the broader HIV business. He highlights ongoing discussions with policymakers to emphasize the importance of lenacapavir in preventing HIV as part of addressing chronic diseases. The role of organizations like CDC in research, surveillance, diagnosis, and care linkage is acknowledged, but there's no indication that these services' changes will alter their launch strategy. Johanna Mercier adds that Gilead Sciences is also focused on expanding the PrEP market.

The paragraph discusses the growth and development of the PrEP market, highlighting efforts in market development initiatives for screening, diagnosis, and education. There was significant market growth in Q4, continuing into Q1 with a 16% year-over-year increase. Lenacapavir's anticipated FDA decision is expected by June 19, with no issues reported in its filing or clinical trials. Additionally, there is notable growth in Descovy (about 38% year-on-year), attributed to higher prices and increased demand, as well as effective commercial execution, resulting in a market share increase.

The paragraph discusses the factors contributing to Gilead Sciences' 38% year-on-year growth, highlighting the effective performance of their commercial team and increased market access with lower copays. It underscores the potential of lenacapavir in the PrEP market. Additionally, Salveen Richter from Goldman Sachs inquires about Gilead's exposure to tariff risks related to ex-US manufacturing and tax implications. Daniel O'Day addresses the question by explaining how indirect tariffs, including those on materials like steel and chemicals, are managed within their current financial guidance.

The paragraph discusses the potential impact of pharmaceutical-specific tariffs on Gilead Sciences, Inc. Although these tariffs have not been enacted, the company believes its U.S.-based intellectual property and profit recognition reduce potential tariff impacts on pharmaceutical imports. Gilead leverages both domestic and global manufacturing to ensure supply chain continuity and has significantly invested in U.S. manufacturing and R&D infrastructure. The paragraph also notes that the company's guidance reflects anticipated impacts from announced tariffs, reciprocal tariffs, and potential inflationary pressures. Andy confirms this guidance update and mentions ongoing large-scale investment projects in the U.S., expected to be completed by 2028.

In the paragraph, it is discussed how strong expense management and favorable foreign exchange conditions are helping the company to manage additional costs and reconfirm its guidance for the year, despite impacts like tariffs and Part D redesign. Johanna Mercier mentions that Medicare claims related to the Part D redesign lag by a quarter, with expectations of a $1.1 billion total impact, $900 million of which is specific to HIV. The company is pleased with its Q1 results, noting a 6% year-over-year growth in the HIV business, which would be 9% excluding the Part D redesign. They are navigating seasonal dynamics and Part D impacts effectively. The call then opens for questions from analysts.

In the paragraph, Tyler Van Buren asks about the lower demand for Trodelvy in the recent quarter, questioning whether it's due to issues with bladder cancer treatment or breast cancer demand. Johanna Mercier explains that the decline is due to inventory dynamics and a lower average realized price, not a decrease in demand, and emphasizes the strong market position of Trodelvy in breast cancer treatments. Daina Graybosch then inquires about the process of adding lenacapavir to the USPSTF mandate for cost-sharing coverage. Johanna explains that while it may take time, there is already progress with guidelines aligning to lenacapavir's integration, anticipating additional medical updates once approval is fully established.

The paragraph discusses the position and strategy of a company regarding the rollout of lenacapavir, a transformative agent for HIV treatment. They plan to enhance access to lenacapavir across various channels over the next six to twelve months, drawing parallels to previous agents like Descovy. While anticipating that USPSTF support might not be immediate, their strategy is grounded on the value proposition of lenacapavir. In a subsequent question by Geoff Meacham regarding their HIV treatment plan, Dietmar Berger responds, emphasizing the company's focus on offering flexible treatment options, including monthly, weekly, and potentially once-a-year regimes, and highlights the upcoming launch of lenacapavir for PrEP.

The paragraph discusses the progress and strategy regarding certain medical products and trials. Lenacapavir is being explored for annual PrEP, which is a focus area for the company. Chris Schott from JPMorgan inquires about the loyalty launch and its competitiveness. Johanna Mercier responds positively about Libdelzi's market uptake, stating it achieved a third of the market share in the second-line product segment, with notable growth and positive feedback from healthcare providers. Coverage with commercial plans is above 80% and projected to exceed 90% soon. Terence Flynn from Morgan Stanley inquires about anetocel's Phase III trial, noting that MRD negativity was added as a co-primary endpoint.

In the paragraph, Cindy Perettie discusses the use of minimal residual disease (MRD) negativity as a dual primary endpoint to correlate with progression-free survival (PFS) in patient response assessments. She emphasizes the importance of this correlation when engaging with regulators. Meanwhile, Johanna Mercier addresses a question from Tim Anderson regarding potential sales impact of lenacapavir on Descovy. She highlights lenacapavir's twice-a-year dosing as an appealing switch opportunity from daily oral medications like Descovy and generic Truvada, especially for patients and communities eager for its approval. Specific sales guidance is not provided, but there's optimism around lenacapavir's market entry.

The paragraph discusses the growth and dynamics in the market for HIV prevention and cell therapy. Currently, there are about 400,000 to 450,000 people on PrEP in the US, and this number is expected to grow, particularly with the upcoming launch of lenacapavir, which is anticipated to accelerate this growth over the next decade. Furthermore, the discussion shifts to the cell therapy market, where Evan Seigerman from BMO asks about competition between cell therapy products and bispecifics. Cindy Perettie responds, explaining that there is competition from both bispecifics and in-class competitors, with dynamic shifts depending on specific markets and products like Yescarta and Tecartus, both in the US and internationally.

The paragraph is a transcript of a discussion involving pharmaceutical executives responding to questions about their cancer drug Trodelvy and another product, a treatment known as lenacapavir. Matt Biegler asks about the impact of competition on Trodelvy's demand, specifically in the context of its use for different breast cancer types. Johanna Mercier responds that there has been no significant competitive impact, outlining the drug's strong position in treating triple-negative breast cancer and HR positive, HER2 negative cases. Courtney Breen then asks about lenacapavir, referencing data from a recent conference and inquiring about potential expedited trial designs. Dietmar Berger replies that they are exploring study designs but have not disclosed specific plans yet.

In the paragraph, Johanna Mercier discusses the awareness and readiness of healthcare providers to administer lenacapavir for PrEP. She notes that awareness is high among both healthcare providers and the community. The launch strategy focuses on the 75% of HIV prescribers currently prescribing PrEP, aiming to differentiate lenacapavir from existing options and ensure a smooth launch experience. A targeted approach is in place for the initial 30 and 90 days, including identifying clinics already set up for the buy and bill process, while others will use a white bagging process through specialty pharmacies.

The paragraph discusses the introduction and support plan for lenacapavir, a medication related to HIV treatment, highlighting the importance of ensuring proper training and support for both healthcare providers and clinic staff. The strategy includes having nurse educators for training injections and field reimbursement managers to help with reimbursement processes, especially during the initial launch period when medical exceptions are common. Following this, Mohit Bansal asks about potential challenges for Gilead Sciences, Inc., such as NIH and Medicaid funding cuts. Daniel O'Day responds that they have not seen any indication to alter their plans for the HIV field, including the launch of lenacapavir for PrEP, suggesting it's too early to speculate on the impacts of Medicaid cuts.

The paragraph discusses the current state of health programs, specifically focusing on the CDC and its initiatives related to chronic diseases and HIV prevention. There are no confirmed budget cuts, but the speaker acknowledges the critical role of the CDC and NIH. Johanna Mercier highlights the targeted efforts to ensure the continuation and enhancement of programs, especially in areas with higher HIV incidence. The importance of ensuring access to HIV medications is emphasized, with various federal, state, and private channels available to circumvent access barriers, thereby preventing individuals from progressing to AIDS.

In this paragraph, Alex Hammond asks about the impact of the 340B channel on HIV pricing and utilization in 2025. Johanna Mercier responds by noting that the 340B program has been growing, and they hope it will stabilize, emphasizing the need for more transparency to reduce duplicates in therapeutic areas. Simon Baker then inquires about the Part D redesign and its potential benefits. Mercier explains that due to existing safety nets for HIV, they do not expect a significant increase in volume from the Part D reform. They will monitor the situation, but any positive impact would likely be seen later in the year. She mentions the low abandonment rate of Biktarvy, indicating differences in treatment adherence compared to other chronic diseases.

The paragraph is a closing statement by Daniel O'Day, thanking the Gilead Sciences, Inc. teams for their strong performance and promising outlook. He highlights the company's solid business growth, especially in the HIV sector, and the successful launches of Ladelzi and Trodelvy. O'Day emphasizes the potential of their diverse pipeline with upcoming launches like lenacapavir for PrEP and Trodelvy, expressing excitement and confidence in the company's future. He concludes by appreciating the ongoing efforts for patients and commits to keeping stakeholders informed of their progress.

This summary was generated with AI and may contain some inaccuracies.