The paragraph is a segment from Gilead's Fourth Quarter and Full Year 2024 Earnings Conference Call. Rebecca, the operator, introduces the session and hands it over to Jacquie Ross, who mentions that earnings results for the period have been released and are accessible on Gilead's website. The call includes remarks from several key executives, including CEO Daniel O'Day, who highlights the company's strong financial performance. Gilead's total product sales, excluding their COVID-19 treatment Veklury, increased by 8% over the year to $26.8 billion, with the fourth quarter alone seeing a 13% increase to $7.2 billion. The company's HIV products, particularly Biktarvy, saw significant growth, exceeding expectations. The session will also include a Q&A segment.

The paragraph highlights the consistent growth of the company's HIV business, with increases in revenue over recent years, and anticipates a temporary impact from Medicare Part D reform in 2025. The company is positioned to maintain its leadership in HIV through its innovative portfolio, particularly lenacapavir, which is in the approval process for twice-yearly HIV prevention. The company is optimistic about the global potential of its preventive options, especially following promising results from Phase 3 trials. Additionally, the company plans to introduce up to nine new HIV treatment and prevention options by 2033 and expects to provide clinical updates throughout the year.

In the fourth quarter of 2024, Gilead observed strong sales of approximately $30 million for Livdelzi in the U.S., marking its successful commercial launch. The company anticipates a European Commission decision on Livdelzi soon and highlights the significance of its liver portfolio. Gilead is advancing its inflammation pipeline with new programs, including a STAT6 program and a bicistronic CAR-T for autoimmune diseases. In oncology, Gilead is expanding cell therapies' reach, collaborating with Arcellx on anito-cel, and sharing promising Phase 2 trial results, targeting a commercial launch in 2026. Trodelvy remains the only TROP2 ADC showing overall survival benefits in specific types of metastatic breast cancer and has six ongoing Phase 3 trials, with updates expected this year.

The paragraph discusses Gilead's plans and achievements, including the anticipated initiation of a Phase 3 trial for Trodelvy in small-cell lung cancer patients. It highlights the company's growth opportunities across various therapeutic areas, noting no major loss of exclusivity until 2033. The paragraph introduces Dietmar Berger as the new Chief Medical Officer, praising his expertise. It also acknowledges Merdad Parsey's contributions before his retirement. Gilead now has 54 ongoing clinical programs, up from 32 in 2019. Johanna Mercier reports on Gilead's commercial success in 2024, with an 8% sales increase and significant growth in HIV, oncology, and liver disease portfolios.

The paragraph discusses the financial performance of a company's product sales, highlighting a 7% year-over-year growth, excluding their COVID-related drug, Veklury. Total product sales reached $28.6 billion, with a 6% growth rate compared to the previous year. The HIV business performed strongly, with fourth-quarter sales of $5.5 billion, up 16% year-over-year, driven by demand and favorable pricing. Key HIV treatments, Biktarvy and Descovy, showed significant growth, with Biktarvy holding over 50% of the U.S. market and Descovy maintaining over 40% U.S. market share in PrEP. Full-year sales were $19.6 billion, up 8% year-over-year, driven by higher demand and pricing, in line with the overall 3% growth in the HIV treatment market for 2024.

The paragraph discusses the significant growth in the HIV prevention market, with a 16% year-over-year increase in the fourth quarter, driven by strong demand and the anticipated launch of lenacapavir for prevention. Preparations for its U.S. launch are in progress, and marketing applications have been submitted to the EU. The paragraph also addresses upcoming changes in the Medicare Part D model in 2025, which will require manufacturers to provide discounts, impacting revenue by $1.1 billion, mainly in HIV. Consequently, HIV revenue is expected to remain flat in 2025 despite strong demand. Excluding Medicare changes and currency effects, HIV revenue growth would have been 5% due to robust demand, though hindered by less favorable pricing.

In the first quarter of 2025, Gilead expects a seasonal inventory drawdown in HIV products, along with effects from patient co-pay and deductible resets, likely leading to a mid-teen percentage decline in HIV revenue compared to a strong fourth quarter. Despite these challenges, Gilead maintains a strong position in the HIV market with products like Biktarvy and Descovy. In liver diseases, fourth-quarter sales increased 4% year-over-year, with notable growth in products for PBC and HBV, although HCV product sales declined. Full-year liver disease sales rose 9%, driven by strong demand across the portfolio. The new PBC treatment, Livdelzi, launched well with $30 million in sales in its first quarter, surpassing expectations. Gilead highlights Livdelzi's unique therapeutic benefits and anticipates continued strong performance in 2025.

The paragraph discusses several updates from a pharmaceutical company's recent developments. It highlights the approval of Livdelzi in the UK for treating primary biliary cholangitis (PBC) and pending approval from the European Commission. Veklury's sales were down due to decreased COVID-19 hospitalizations, while full-year oncology sales increased by 12%, showcasing growth especially in Trodelvy's role in metastatic breast cancer treatment. Trodelvy sales increased significantly and it remains a standard-of-care for certain breast cancer types. The cell therapy division, led by Kite, reported strong sales and patient treatment numbers, underscoring its leadership in CAR-T therapy.

The paragraph discusses the challenges and progress in Gilead's cell therapy sales, which remained flat sequentially but grew 5% year-over-year in the fourth quarter, amidst competitive pressures and slow uptake in the market, particularly in the U.S. and Europe. Efforts are underway to expand access to CAR-T treatments by addressing accreditation and reimbursement hurdles, collaborating with policy groups, and seeking accreditation with organizations like FACT. Gilead's commercialization teams are preparing for future medicine launches, including lenacapavir for PReP. Dietmar Berger, Gilead's new Chief Medical Officer, expresses his commitment to advancing the company's innovative clinical programs alongside his colleagues.

The paragraph discusses the recognition of Gilead's lenacapavir, a capsid inhibitor, as the 2024 breakthrough of the year by Science for its potential to transform HIV treatment. Lenacapavir, which received the FDA's breakthrough therapy designation, is advancing towards regulatory approval with a possible decision expected in the summer. Gilead is actively working to promote global health equity by filing with the EMA and participating in the EU Medicines for all initiative, aiming to expedite the review process in up to 138 countries. The European Commission's decision is anticipated in the latter half of the year. Furthermore, Gilead is developing multiple treatment formulations using lenacapavir for various dosing schedules to enhance HIV treatment.

The paragraph discusses upcoming updates and developments in HIV and liver disease treatments by the year 2025. It mentions the expected updates from the Phase 2 WONDERS-1 trial and Phase 3 ARTISTRY-1 trial for HIV treatments involving new drug combinations targeting virologically suppressed individuals. Furthermore, it highlights the approval of Livdelzi in the UK for primary biliary cholangitis (PBC) and its potential availability throughout Europe following a positive CHMP opinion for seladelpar. The development of seladelpar continues with the AFFIRM trial aiming for FDA approval, and the IDEAL trial focusing on patients with PBC who have incomplete ALP control. The paragraph concludes by transitioning to developments in oncology.

The paragraph focuses on the ongoing clinical trials and future plans for Trodelvy and domvanalimab in various cancer treatments. The company is conducting eight Phase 3 trials across five tumor types, with important updates expected in 2025 for trials involving Trodelvy in metastatic triple-negative breast cancer. Successful outcomes could allow Trodelvy to be used in first-line settings as soon as 2026. Additionally, Trodelvy is being tested in other cancers, such as non-small cell lung cancer and small cell lung cancer, where it has shown promising results. The FDA has granted it breakthrough therapy designation for extensive-stage small cell lung cancer, and a new Phase 3 trial for this indication is planned for 2025. Updates from the ASH Congress were also shared.

The paragraph discusses preliminary results from the Phase 2 iMMagine-1 trial, showcasing the efficacy and safety of anito-cel in treating fourth-line or later relapsed or refractory multiple myeloma. Anito-cel demonstrated high response rates and manageable safety, with no delayed neurotoxicities observed. The commercial launch is targeted for 2026, with further data anticipated in 2025. Additionally, the Phase 3 iMMagine-3 trial has begun dosing patients. Updates on Yescarta and Tecartus reveal durable responses in non-Hodgkin's lymphoma, and Kite has filed an IND application to evaluate KITE-363 for autoimmune conditions.

The paragraph discusses Gilead's advancements and achievements in the biopharma industry. It highlights KITE-363, a CAR-T product targeting CD19 and CD20, and notes the potential of cell therapy in addressing significant patient needs. The company is working on over 100 pre-IND and clinical-stage programs and shares milestones for 2023, including regulatory decisions, Phase 3 updates, and new trial initiations in areas such as HIV and oncology. The financial update reports a year-end total product sales of $28.6 billion, a 6% increase from 2023, driven by HIV and oncology sectors, with notable growth in Biktarvy and Trodelvy products.

In the paragraph, the company reports on its 2024 financial performance, highlighting a 9% increase in liver treatment sales to $3 billion and a decrease in Veklury revenue by 18% to $1.8 billion, aligning with pandemic trends. The full-year non-GAAP results demonstrated steady expense management, with R&D expenditures remaining flat at $5.7 billion and SG&A declining by 3% to $5.9 billion. The acquisition of CymaBay in the first quarter impacted financials, aligning operating income at $8.5 billion, above the expected range, and reducing the operating margin to 30%. Excluding the acquisition, margins would have been 43%, and non-GAAP EPS would rise significantly to $7.75. The fourth-quarter results showed a 13% increase in product sales, excluding Veklury, and a 7% increase overall. Additionally, product gross margin slightly improved, while R&D expenses rose due to expanded clinical investments. A favorable adjustment linked to the CymaBay acquisition offset acquired IPR&D expenses. Future results will incorporate costs from acquiring rights to LEO's STAT6 program.

In the paragraph, SG&A expenses rose 16% to $1.9 billion partly due to a potential litigation settlement with the U.S. Attorney's Office related to HIV medicine promotions, alongside increased sales and marketing for new product launches. The operating margin improved to 41% and the effective tax rate increased to 19.2% due to prior year settlements. Non-GAAP diluted EPS grew to $1.90. Revenue expectations for 2025 are influenced by Medicare Part D reform, which will affect revenue by $1.1 billion, Veklury expectations which are $400 million lower, and a $250 million foreign exchange impact, all contributing to a projected 4% revenue growth impact. Excluding these factors, the company anticipates a 5% to 6% product revenue growth.

The company anticipates stable financial performance in 2025 with total product sales projected between $28.2 billion and $28.6 billion, excluding Veklury sales of $1.4 billion. Product gross margin is expected to be 85-86%, while R&D spending will remain flat compared to 2024. Anticipated acquired IPR&D is $400 million, including $250 million for the acquisition of LEO Pharma's STAT6 program. SG&A is expected to decrease by a high-single digit percentage, or mid-single digit excluding 2024's litigation accrual. Operating income is projected between $12.7 billion and $13.2 billion, with an effective tax rate of around 19%. Non-GAAP EPS is estimated at $7.70 to $8.10, while GAAP EPS is expected to be $5.95 to $6.35.

The paragraph provides a business update for the company, specifically regarding financial expectations and strategies for the upcoming years. In the first quarter of 2025, the company anticipates a mid-teen percentage decline in HIV revenue due to inventory drawdown and the impact of the IRA. The company's capital allocation priorities remain unchanged, having returned $5.1 billion to shareholders in 2024 through dividends and share repurchases. For 2025, a 2.6% increase in the quarterly cash dividend to $0.79 per share has been announced, with continued commitment to dividend growth and investments in the business. Share repurchases will be used to manage equity dilution and may be pursued further as opportunities arise. The paragraph ends with the beginning of a Q&A session, where Geoff Meacham from Citigroup asks about the company's strategy for HIV treatments, specifically around Len and Biktarvy.

The paragraph discusses Gilead's strategy for HIV treatment, emphasizing the shift towards long-acting oral or injectable options following the success of Biktarvy, which has set the standard of care. The speaker highlights the potential for new treatments to capture market share, thinking of the long-term outlook beyond Biktarvy's patent expiration in 2033. The conversation shifts to a question about the company's revenue guidance, particularly concerning lenacapavir for PrEP and margin expansion in 2025. Andrew Dickinson responds, mentioning that lenacapavir is expected to launch mid-year with meaningful access, which will grow over time.

The article discusses a company's launch strategy, aiming for 75% U.S. access within six months and increasing thereafter. Despite unexpected expenses in 2024, including a litigation reserve and costs from the Livdelzi acquisition, the company maintained strong expense control and plans to keep expenses flat while leveraging their model's growth. Future guidance will be provided for 2026 and 2027. Tim Anderson from Bank of America inquires about the potential discrepancy between high market expectations and the actual performance of Lenacapavir and PReP products post-launch, seeking clarification on ramp dynamics.

In the paragraph, Johanna Mercier discusses the anticipated launch of lenacapavir, indicating excitement for its potential release this summer but noting that no product-specific guidance will be provided. She mentions that access is expected to ramp up over several months, with about 75% access projected by six months and 90% by a year. The drug's administration, due to its injectable nature, may experience delays as it navigates through specialty pharmacy or a buy-and-bill model. She expresses confidence in the drug's impact by 2025. The operator then introduces a question from Umer Raffat regarding anito-cel data, specifically about nine ICANS cases in the iMMagine-1 trial. Raffat inquires about the presence of tremors, bradykinesia, or other motor dysfunction in those cases and their timing post-administration. Cindy Perettie responds, acknowledging the question.

The paragraph discusses the progress and expectations for the approval of lenacapavir for PrEP (pre-exposure prophylaxis). Daniel O'Day and Johanna Mercier note that interactions with the FDA and HHS are on track, aiming for a summer approval in the U.S. with breakthrough designation already granted. They are preparing for the U.S. launch while also addressing the potential approval in Europe. There, prevention is market-specific, requiring a tiered approach to target key stakeholders effectively.

The paragraph discusses strategic efforts involving lenacapavir, a pharmaceutical product, to ensure its access in the UK, France, and over 138 low and lower-middle-income countries. It highlights the importance of collaboration among various stakeholders, including government, health ministers, and investigators, in achieving this goal. Additionally, the paragraph shifts focus to Gilead's oncology portfolio, mentioning Trodelvy and upcoming Phase 3 study readouts in triple-negative breast cancer. Dietmar Berger, a new member of Gilead, emphasizes the company's robust clinical pipeline, upcoming key launches, and the anticipation surrounding the ASCENT-03 and ASCENT-04 studies.

The paragraph discusses ongoing developments in cancer research and treatments, particularly focusing on Trodelvy and TIGIT in lung cancer and immuno-oncology studies, respectively. It mentions upcoming data from important Phase 3 studies (STAR-121 and STAR-221) that will guide future directions. Additionally, it includes a different topic regarding HIV sales growth, where Mohit Bansal from Wells Fargo inquires about inventory dynamics. Johanna Mercier from Gilead explains that there was a strong demand and some seasonal inventory changes, noting a notable inventory build in the fourth quarter of 2024 compared to previous patterns.

The paragraph discusses the promising early uptake and growth of Livdelzi, a medication exceeding internal expectations due to its efficacy and safety profile. Johanna Mercier highlights positive feedback on its differentiation in biochemical response and safety, which is driving week-over-week growth. The company anticipates continued momentum into 2025, supported by its experience and credibility in liver-related treatments. Payer access is meeting expectations, and there are no major barriers for appropriate rare disease patients, who are primarily second-line and treatment-naive in line with indications.

The paragraph discusses the performance and future expectations for two pharmaceutical products, Livdelzi and lenacapavir. Livdelzi, used in a second-line setting, is considered to have a strong trajectory, with significant momentum expected by 2025. Johanna Mercier addresses the 16% year-over-year growth in the PrEP market, attributing it to increased attention from PURPOSE 1 and PURPOSE 2 initiatives and enhanced market development efforts by the organization. These factors are anticipated to positively impact the upcoming launch of lenacapavir. Additionally, Ellie Merle inquires about the enrollment progress of the IDEAL study for Livdelzi in partial UDCA responders.

The paragraph is a discussion involving Dietmar Berger and Johanna Mercier about the potential expansion of the Livdelzi medication to a broader patient population. They mention a study that is on track to include a second-line population partially responsive to UDCA, potentially expanding Livdelzi's reach, especially in the U.S. They estimate around 20,000 to 25,000 potential patients in the U.S. and Europe who are partial responders. The conversation also switches to small cell lung cancer, where Courtney Breen asks about the role of various targets like TROP2, DLL3, and B7-H3 in treatment. Dietmar expresses optimism about advancements in small cell lung cancer treatments after a long period of reliance on chemotherapy, noting the impressive Phase 2 data for TROP2.

The paragraph discusses the potential of TROP2 expression as a meaningful treatment option, with breakthrough therapy designation received from the FDA and a study planned for the first half of the year. It mentions the competitive nature of targets like B7-H3 and DLL3, with TROP2 having potential in the second-line setting. Daniel O'Day appreciates the strong quarterly performance by Gilead, highlighting consistent revenue, strong demand across therapeutic areas, a robust pipeline, and recent and imminent launches. He emphasizes the absence of major loss of exclusivity and disciplined expense management, which positions Gilead to deepen its patient impact and deliver shareholder returns. Jacquie Ross confirms plans to release the first quarter 2025 earnings results on April 24, 2025.

The provisional date mentioned in the paragraph may change due to scheduling conflicts, and a confirmed date will be announced after the quarter ends. The message expresses gratitude for interest in Gilead and looks forward to providing updates in 2025.

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