Gilead Sciences Q4 2025 Gilead Sciences Inc Earnings Call | AllMind AI Earnings | AllMind AI
Q4 2025 Gilead Sciences Inc Earnings Call
Speaker #1: Good afternoon, everyone, and welcome to GILEAD's fourth quarter and full year 2025 earnings conference call. My name is Rebecca, and I'll be today's host.
Operator: Good afternoon, everyone, and welcome to Gilead's Fourth Quarter and Full-Year 2025 Earnings Conference Call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks followed by our Q&A session. To ask a question, please press star 1. To withdraw your question, press star 2. Now I'll hand the call over to Jacquie Ross, Senior Vice President of Treasury and Investor Relations.
Operator: Good afternoon, everyone, and welcome to Gilead's Fourth Quarter and Full-Year 2025 Earnings Conference Call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks followed by our Q&A session. To ask a question, please press star 1. To withdraw your question, press star 2. Now I'll hand the call over to Jacquie Ross, Senior Vice President of Treasury and Investor Relations.
Speaker #1: In a moment, we'll begin our prepared remarks, followed by our Q&A session. To ask a question, please press star one. To withdraw your question, press star two.
Speaker #1: Now, I'll hand the call over to Jacquie Ross, Senior Vice President of Treasury and Investor Relations.
Speaker #1: Relations. Thank you,
Jacquie Ross: Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full-year 2025. The press release, slides, and supplementary data are available on the investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer Daniel O'Day, our Chief Commercial and Corporate Affairs Officer Johanna Mercier, our Chief Medical Officer Dietmar Berger, and our Chief Financial Officer Andrew Dickinson. After that, we'll open the call to Q&A, where the team will be joined by Cindy Perettie, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements. Please refer to slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.
Jacquie Ross: Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full-year 2025. The press release, slides, and supplementary data are available on the investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer Daniel O'Day, our Chief Commercial and Corporate Affairs Officer Johanna Mercier, our Chief Medical Officer Dietmar Berger, and our Chief Financial Officer Andrew Dickinson. After that, we'll open the call to Q&A, where the team will be joined by Cindy Perettie, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements.
Speaker #2: Rebecca. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full year 2025. The press release, slides, and supplementary data are available on the Investors section of our website at gilead.com.
Speaker #2: The speakers on today’s call will be our Chairman and Chief Executive Officer, Daniel O’Day; our Chief Commercial and Corporate Affairs Officer, Johanna Mercier; our Chief Medical Officer, Dietmar Berger; and our Chief Financial Officer, Andrew Dickinson.
Speaker #2: After that, we'll open the call to Q&A, where the team will be joined by Cindy Peretti, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements.
Jacquie Ross: Please refer to slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.
Speaker #2: Please refer to slide two regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.
Speaker #3: Thank you, Jacquie, and good afternoon, everyone. I'm pleased to share another very strong set of results for Gilead, closing out a remarkable year for the company with clinical, commercial, and operational achievements that set the stage for a very promising 2026.
Daniel O'Day: Thank you, Jacquie, and good afternoon, everyone. I'm pleased to share another very strong set of results for Gilead, closing out a remarkable year for the company with clinical, commercial, and operational achievements that set the stage for a very promising 2026. Starting with our full-year results, our HIV business grew 6% year-over-year, driven by 7% growth in Biktarvy and 47% growth in our HIV prevention portfolio. This was despite an estimated $900 million headwind in 2025 associated with the Part D redesign. Absent this headwind, our HIV business growth was 10% in 2025. Yes2Go, our twice-yearly HIV prevention injectable, has already exceeded our coverage goals and is rapidly gaining market share in addition to expanding the reach of HIV prevention to new users.
Daniel O'Day: Thank you, Jacquie, and good afternoon, everyone. I'm pleased to share another very strong set of results for Gilead, closing out a remarkable year for the company with clinical, commercial, and operational achievements that set the stage for a very promising 2026. Starting with our full-year results, our HIV business grew 6% year-over-year, driven by 7% growth in Biktarvy and 47% growth in our HIV prevention portfolio. This was despite an estimated $900 million headwind in 2025 associated with the Part D redesign. Absent this headwind, our HIV business growth was 10% in 2025. Yes2Go, our twice-yearly HIV prevention injectable, has already exceeded our coverage goals and is rapidly gaining market share in addition to expanding the reach of HIV prevention to new users.
Speaker #3: Starting with our full year results, our HIV business grew 6% year over year, driven by 7% growth in Biktarvy and 47% growth in our HIV prevention portfolio.
Speaker #3: This was despite an estimated $900 million headwind in 2025 associated with the Part D redesign. Absent this headwind, our HIV business growth was 10% in 2025.
Speaker #3: Yes, too go our twice-yearly HIV prevention injectable has already exceeded our coverage goals and is rapidly gaining market share in addition to expanding the reach of HIV prevention to new users.
Speaker #3: With its unique potential to bend the curve of the HIV epidemic, yes, too go is a transformative medicine that we expect to drive durable, steady, and long-term growth in our HIV prevention business in the coming quarters and years.
Daniel O'Day: With its unique potential to bend the curve of the HIV epidemic, Sunlenca is a transformative medicine that we expect to drive durable, steady, and long-term growth in our HIV prevention business in the coming quarters and years. Our liver business grew 6% in 2025 compared to 2024, largely driven by the rapid adoption of Livdelzi for primary biliary cholangitis. In oncology, Trodelvy also grew 6% in 2025, driven by momentum in metastatic triple-negative breast cancer following positive phase 3 updates. Cell therapy was down about 7% year-over-year, largely in line with our expectations and reflecting continuing competitive headwinds.
Daniel O'Day: With its unique potential to bend the curve of the HIV epidemic, Sunlenca is a transformative medicine that we expect to drive durable, steady, and long-term growth in our HIV prevention business in the coming quarters and years. Our liver business grew 6% in 2025 compared to 2024, largely driven by the rapid adoption of Livdelzi for primary biliary cholangitis. In oncology, Trodelvy also grew 6% in 2025, driven by momentum in metastatic triple-negative breast cancer following positive phase 3 updates. Cell therapy was down about 7% year-over-year, largely in line with our expectations and reflecting continuing competitive headwinds.
Speaker #3: Our liver business grew 6% in 2025 compared to 2024, largely driven by the rapid adoption of Libdelzi for primary biliary cholangitis. And in oncology, Trodelvi also grew 6% in 2025, driven by momentum in metastatic triple-negative breast cancer following positive Phase 3 updates.
Speaker #3: And cell therapy was down about 7% year over year, largely in line with our expectations and reflecting continuing competitive headwinds. Moving to clinical progress, following a very productive year in 2025, we have a catalyst-rich year ahead, including Phase 3 updates from the Island-1 and Island-2 trials evaluating a slattravir plus lenacapavir, the potential first once-weekly oral treatment for people with virologically suppressed HIV.
Daniel O'Day: Moving to clinical progress, following a very productive year in 2025, we have a catalyst-rich year ahead, including phase 3 updates from ILIN-1 and II trials evaluating Islatravir plus lenacapavir, the potential first once-weekly oral treatment for people with virologically suppressed HIV. Two phase 3 updates for Trodelvy, including the EVOKE-03 trial in metastatic non-small cell lung cancer and the ASCENT-GYN-01 trial in advanced endometrial cancer. Lastly, we expect an update on the phase 3 IDEAL study evaluating Livdelzi in second-line primary biliary cholangitis patients with only incomplete response to UDCA. The strength and the pace of progress in our clinical pipeline is driving a steady cadence of product launches.
Daniel O'Day: Moving to clinical progress, following a very productive year in 2025, we have a catalyst-rich year ahead, including phase 3 updates from ILIN-1 and II trials evaluating Islatravir plus lenacapavir, the potential first once-weekly oral treatment for people with virologically suppressed HIV. Two phase 3 updates for Trodelvy, including the EVOKE-03 trial in metastatic non-small cell lung cancer and the ASCENT-GYN-01 trial in advanced endometrial cancer. Lastly, we expect an update on the phase 3 IDEAL study evaluating Livdelzi in second-line primary biliary cholangitis patients with only incomplete response to UDCA. The strength and the pace of progress in our clinical pipeline is driving a steady cadence of product launches.
Speaker #3: Two phase three updates for Trodelvi, including the EVOKE-03 trial in metastatic non-small cell lung cancer, and the ASCENT GYNE-01 trial in advanced endometrial cancer.
Speaker #3: Lastly, we expect an update on the Phase 3 IDEAL study evaluating Libdelzi in second-line primary biliary cholangitis patients with only incomplete response to UDCA.
Speaker #3: The strength and the pace of progress in our clinical pipeline is driving a steady cadence of product launches. And on the heels of Libdelzi in 2024 and yes, too go in 2025, we are targeting four commercial launches this year, including Trodelvi for first-line metastatic triple-negative breast cancer, extending beyond second-line treatment for what's Trodelvi is a standard of care, following positive results from the phase three Ascent 03 and Ascent 04 studies, a new daily oral combination of Biktagravir and lanacapavir for HIV treatment, following positive updates from the phase three artistry one and artistry two trials, Anitosel, our potential best in-disease BCMA CAR-T for fourth-line or later relapsed or refractory multiple myeloma, and Bulavertide in the US following approval in the EU for treatment of chronic hepatitis delta.
Daniel O'Day: On the heels of Livdelzi in 2024 and Sunlenca in 2025, we are targeting four commercial launches this year, including Trodelvy for first-line metastatic triple-negative breast cancer, extending beyond second-line treatment for which Trodelvy is a standard of care, following positive results from the phase 3 ASCENT-03 and ASCENT-04 studies. A new daily oral combination of bictegravir and lenacapavir for HIV treatment, following positive updates from the phase 3 ARTISTRY-1 and ARTISTRY-2 trials. Anito-cel, our potential best-in-disease BCMA CAR-T for fourth-line or later relapsed or refractory multiple myeloma. And Bulevirtide in the US following approval in the EU for treatment of chronic hepatitis delta. These commercial and clinical milestones reflect the success of our diversification strategy that has been shaping Gilead over the last six years. We have up to 10 ongoing and potential new launches through 2027, and the strongest pipeline in our almost 40-year history.
Daniel O'Day: On the heels of Livdelzi in 2024 and Sunlenca in 2025, we are targeting four commercial launches this year, including Trodelvy for first-line metastatic triple-negative breast cancer, extending beyond second-line treatment for which Trodelvy is a standard of care, following positive results from the phase 3 ASCENT-03 and ASCENT-04 studies. A new daily oral combination of bictegravir and lenacapavir for HIV treatment, following positive updates from the phase 3 ARTISTRY-1 and ARTISTRY-2 trials. Anito-cel, our potential best-in-disease BCMA CAR-T for fourth-line or later relapsed or refractory multiple myeloma. And Bulevirtide in the US following approval in the EU for treatment of chronic hepatitis delta.
Daniel O'Day: These commercial and clinical milestones reflect the success of our diversification strategy that has been shaping Gilead over the last six years. We have up to 10 ongoing and potential new launches through 2027, and the strongest pipeline in our almost 40-year history. At the same time, we remain committed to operating expense and M&A discipline, continued delivery of exceptional operating results, and growing returns to shareholders. With many of the policy-related uncertainties behind us and no major product LOEs until 2036, Gilead is entering 2026 in a position of strength. With that, I will hand it over to Johanna.
Speaker #3: These commercial and clinical milestones reflect the success of our diversification strategy that has been shaping GILEAD over the last six years. We have up to 10 ongoing and potential new launches through 2027, and the strongest pipeline in our almost 40-year history.
Speaker #3: At the same time, we remain committed to operating expense and M&A discipline, continued delivery of exceptional operating results, and growing returns to shareholders. With many of the policy-related uncertainties behind us and no major product LOEs until 2036, GILEAD is entering 2026 in a position of strength.
Daniel O'Day: At the same time, we remain committed to operating expense and M&A discipline, continued delivery of exceptional operating results, and growing returns to shareholders. With many of the policy-related uncertainties behind us and no major product LOEs until 2036, Gilead is entering 2026 in a position of strength. With that, I will hand it over to Johanna.
Speaker #3: With that, I will hand it over to
Speaker #3: Joanna: Thanks, Dan, and good afternoon,
Johanna Mercier: Thanks, Dan, and good afternoon, everyone. 2025 was another strong year of commercial execution, with base business sales up 4% compared to 2024, or nearly 8% excluding impact from Medicare Part D redesign. This underscores the durability of our base business and our sustained launch momentum, with up to 10 ongoing and potential new launches through 2027. Beginning on slide 7, fourth-quarter total product sales excluding Veklury were $7.7 billion, up 7% year-over-year and 9% sequentially, primarily driven by higher sales across HIV and Livdelzi. Including Veklury sales of $212 million, fourth-quarter total product sales were $7.9 billion, up 5% year-over-year and 8% sequentially.
Johanna Mercier: Thanks, Dan, and good afternoon, everyone. 2025 was another strong year of commercial execution, with base business sales up 4% compared to 2024, or nearly 8% excluding impact from Medicare Part D redesign. This underscores the durability of our base business and our sustained launch momentum, with up to 10 ongoing and potential new launches through 2027. Beginning on slide 7, fourth-quarter total product sales excluding Veklury were $7.7 billion, up 7% year-over-year and 9% sequentially, primarily driven by higher sales across HIV and Livdelzi. Including Veklury sales of $212 million, fourth-quarter total product sales were $7.9 billion, up 5% year-over-year and 8% sequentially.
Speaker #2: everyone. 2025 was another strong year of commercial execution, with base business sales up 4% compared to 2024 or nearly 8%, excluding impact from Medicare Part D redesign.
Speaker #2: This underscores the durability of our base business and our sustained launch momentum, with up to 10 ongoing and potential new launches through 2027. Beginning on slide seven, fourth-quarter total product sales excluding Veklury were $7.7 billion, up 7% year over year and 9% sequentially, primarily driven by higher sales across HIV and Libdelduzzi.
Speaker #2: Including Veklury sales of $212 million, fourth-quarter total product sales were $7.9 billion, up 5% year over year and 8% sequentially. Turning to the full year on slide eight, total product sales excluding Veklury were $28 billion in 2025, more than $300 million above the high end of our full-year guidance range, driven by outperformance in our HIV business and partially offset by lower cell therapy sales.
Johanna Mercier: Turning to the full year on slide 8, total product sales excluding Veklury were $28 billion in 2025, more than $300 million above the high end of our full-year guidance range, driven by outperformance in our HIV business and partially offset by lower cell therapy sales. Including Veklury, total product sales were $28.9 billion, up 1% compared to 2024, or 5% excluding Medicare Part D redesign impact, highlighting the strength of our overall business. Moving to slide 9, our HIV business delivered record sales of $5.8 billion for Q4, up 6% year over year, driven by higher demand for Biktarvy and Descovy as well as the launch of Sunlenca. Sequentially, HIV sales were up 10%, primarily driven by seasonal inventory dynamics, higher average realized price due to favorable channel mix, in addition to demand.
Johanna Mercier: Turning to the full year on slide 8, total product sales excluding Veklury were $28 billion in 2025, more than $300 million above the high end of our full-year guidance range, driven by outperformance in our HIV business and partially offset by lower cell therapy sales. Including Veklury, total product sales were $28.9 billion, up 1% compared to 2024, or 5% excluding Medicare Part D redesign impact, highlighting the strength of our overall business. Moving to slide 9, our HIV business delivered record sales of $5.8 billion for Q4, up 6% year over year, driven by higher demand for Biktarvy and Descovy as well as the launch of Sunlenca. Sequentially, HIV sales were up 10%, primarily driven by seasonal inventory dynamics, higher average realized price due to favorable channel mix, in addition to demand.
Speaker #2: Including Veklury, total product sales were $28.9 billion, up 1% compared to 2024, or 5% excluding the Medicare Part D redesign impact, highlighting the strength of our overall business.
Speaker #2: Moving to slide nine, our HIV business delivered record sales of $5.8 billion for the fourth quarter, up 6% year over year, driven by higher demand for Biktarvy and Descovy as well as the launch of Yes, To Go.
Speaker #2: Sequentially, HIV sales were up 10%, primarily driven by seasonal inventory dynamics and higher average realized price, due to favorable channel mix in addition to demand.
Speaker #2: For the full year, HIV sales
Johanna Mercier: For the full year, HIV sales of $20.8 billion were up 6% year-over-year, driven by strong underlying demand growth. Our exceptional commercial performance and higher-than-expected average realized price exceeded our updated guidance of 5% growth. Excluding the estimated $900 million headwind associated with the Medicare Part D redesign, our HIV business grew 10% year-over-year. Looking at HIV treatment in more detail on slide 10, Biktarvy fourth-quarter sales were $4 billion, up 5% year-over-year, and full-year sales were $14.3 billion, up 7% year-over-year, both driven by higher demand, partially offset by lower average realized price. This demand-led growth reflects 2% to 3% treatment market growth annually and continued Biktarvy share gains. In the US, for example, Biktarvy's share is more than 52%, with year-over-year gains every quarter since launch.
Johanna Mercier: For the full year, HIV sales of $20.8 billion were up 6% year-over-year, driven by strong underlying demand growth. Our exceptional commercial performance and higher-than-expected average realized price exceeded our updated guidance of 5% growth. Excluding the estimated $900 million headwind associated with the Medicare Part D redesign, our HIV business grew 10% year-over-year. Looking at HIV treatment in more detail on slide 10, Biktarvy fourth-quarter sales were $4 billion, up 5% year-over-year, and full-year sales were $14.3 billion, up 7% year-over-year, both driven by higher demand, partially offset by lower average realized price. This demand-led growth reflects 2% to 3% treatment market growth annually and continued Biktarvy share gains. In the US, for example, Biktarvy's share is more than 52%, with year-over-year gains every quarter since launch.
Speaker #1: Of $20.8 billion were up 6% year over year , driven by strong underlying demand growth . Our exceptional commercial performance and higher than expected average realized exceeded price our updated of guidance 5% demand growth .
Speaker #1: exceptional commercial Our performance and higher than expected realized average price associated with the guidance Part D $900 million headwind 5% growth . redesign Our HIV business grew 10% year year at HIV .
Speaker #1: slide ten , Biktarvy fourth quarter sales were $4 billion , Looking up 5% year over year , and full year sales were $14.3 billion , up 7% year over year .
Speaker #1: Both driven by higher demand , partially offset by . Market share greater than 45% . Similarly , To-Go continues to perform strongly across several key launch indicators .
Johanna Mercier: It's clear Biktarvy continues to set the bar for HIV treatment and remains the number one prescribed regimen for both treatment-naïve and SWITCH across major markets. We are rapidly advancing towards the launch of BICLED, our investigational once-daily oral combining bictegravir, the most prescribed integrase inhibitor, with our breakthrough capsid inhibitor lenacapavir in virologically suppressed people with HIV, including those on complex regimens. BICLED could further expand our lead in the SWITCH market, following potential launch in the second half of this year. This regimen represents the first of up to seven potential HIV product launches through 2033. Now moving to slide 11, we've had another exceptional quarter for our HIV prevention business, which grew 53% year over year, driven by favorable access, strong commercial execution, and continued U.S. market growth of approximately 13% year over year.
Johanna Mercier: It's clear Biktarvy continues to set the bar for HIV treatment and remains the number one prescribed regimen for both treatment-naïve and SWITCH across major markets. We are rapidly advancing towards the launch of BICLED, our investigational once-daily oral combining bictegravir, the most prescribed integrase inhibitor, with our breakthrough capsid inhibitor lenacapavir in virologically suppressed people with HIV, including those on complex regimens. BICLED could further expand our lead in the SWITCH market, following potential launch in the second half of this year. This regimen represents the first of up to seven potential HIV product launches through 2033. Now moving to slide 11, we've had another exceptional quarter for our HIV prevention business, which grew 53% year over year, driven by favorable access, strong commercial execution, and continued U.S. market growth of approximately 13% year over year.
Johanna Mercier: Our fourth-quarter sales of Descovy were up an impressive 33% year-over-year. For the full year, Descovy sales were $2.8 billion, up 31% year-over-year, driven by increased demand in HIV prevention and higher average realized price. Descovy's performance in HIV prevention, which accounts for roughly 80% of its sales, continues to exceed expectations with record U.S. market share greater than 45%. Similarly, Yes2Go continues to perform strongly across several key launch indicators. Yes2Go fourth-quarter sales were $96 million, and full-year Yes2Go sales were $150 million, in line with our guidance we shared in the third quarter. Building upon this early success, we recently launched our Yes2Go branded direct-to-consumer campaign, highlighting Yes2Go's dosing schedule and efficacy and reflecting the broad diversity represented in our purpose trials.
Johanna Mercier: Our fourth-quarter sales of Descovy were up an impressive 33% year-over-year. For the full year, Descovy sales were $2.8 billion, up 31% year-over-year, driven by increased demand in HIV prevention and higher average realized price. Descovy's performance in HIV prevention, which accounts for roughly 80% of its sales, continues to exceed expectations with record U.S. market share greater than 45%. Similarly, Yes2Go continues to perform strongly across several key launch indicators. Yes2Go fourth-quarter sales were $96 million, and full-year Yes2Go sales were $150 million, in line with our guidance we shared in the third quarter. Building upon this early success, we recently launched our Yes2Go branded direct-to-consumer campaign, highlighting Yes2Go's dosing schedule and efficacy and reflecting the broad diversity represented in our purpose trials.
Speaker #1: You have to go . Fourth quarter sales were $96 million and full year . Yes , To-Go sales were $150 million . In line with our in the guidance we third quarter Building upon this .
Speaker #1: early success , direct to branded we launched our recently consumer campaign , highlighting Hugo's dosing schedule and efficacy and diversity DTC . represented in our We expect campaign to trials this broaden awareness of yes To-Go and contribute to a consistent build in Hugo sales in the coming quarters .
Johanna Mercier: We expect this DTC campaign to broaden awareness of Yes2Go and contribute to a consistent build in Yes2Go sales in the coming quarters. Coverage for Yes2Go continues to grow, and I'm thrilled to share that we have achieved our goal of 90% coverage well ahead of our 1-year target. This includes all major payers. Additionally, approximately 90% of covered individuals can access Yes2Go with $0 copay. We continue to work on an account-by-account basis to support pull-through as quickly as possible. While we have more to do, we are making great progress here as we support clinicians and their offices navigate the new logistics associated with a twice-yearly injectable regimen.
Johanna Mercier: We expect this DTC campaign to broaden awareness of Yes2Go and contribute to a consistent build in Yes2Go sales in the coming quarters. Coverage for Yes2Go continues to grow, and I'm thrilled to share that we have achieved our goal of 90% coverage well ahead of our 1-year target. This includes all major payers. Additionally, approximately 90% of covered individuals can access Yes2Go with $0 copay. We continue to work on an account-by-account basis to support pull-through as quickly as possible. While we have more to do, we are making great progress here as we support clinicians and their offices navigate the new logistics associated with a twice-yearly injectable regimen.
Speaker #1: Coverage Hugo continues to grow , and I'm for thrilled to share that achieved we have our goal of 90% coverage . Well ahead of our one year target .
Speaker #1: This includes all major payers . Additionally , approximately 90% of covered individuals can access yes To-Go with $0 co-pay . We continue to work on an account by account to support pull through quickly as as possible .
Speaker #1: We have more to do. We are, while making great progress here as we support clinicians and their offices, navigating the new logistics associated with a twice-yearly regimen injectable.
Johanna Mercier: Given our expectations for a steady, durable, and long-term build in sales, we expect full-year 2026 Yes2Go revenue of approximately $800 million compared to $150 million in 2025, highlighting that Yes2Go is well on its way to achieving blockbuster status. We continue to offer the most compelling HIV prevention portfolio available, including the six-monthly Yes2Go injectable with its transformative potential on the HIV epidemic, in addition to Descovy for PrEP, the current market-leading branded oral. Our goal this year is to continue to drive rapid adoption of HIV prevention, and we expect both brands to demonstrate robust growth in 2026. For 2026, we expect total HIV sales, including both treatment and prevention, to grow approximately 6% compared to 2025, as shown on slide 12. Looking at quarterly trends and as a reminder, we expect our normal HIV seasonal inventory drawdown in Q1 2026.
Johanna Mercier: Given our expectations for a steady, durable, and long-term build in sales, we expect full-year 2026 Yes2Go revenue of approximately $800 million compared to $150 million in 2025, highlighting that Yes2Go is well on its way to achieving blockbuster status. We continue to offer the most compelling HIV prevention portfolio available, including the six-monthly Yes2Go injectable with its transformative potential on the HIV epidemic, in addition to Descovy for PrEP, the current market-leading branded oral. Our goal this year is to continue to drive rapid adoption of HIV prevention, and we expect both brands to demonstrate robust growth in 2026. For 2026, we expect total HIV sales, including both treatment and prevention, to grow approximately 6% compared to 2025, as shown on slide 12. Looking at quarterly trends and as a reminder, we expect our normal HIV seasonal inventory drawdown in Q1 2026.
Speaker #1: Given our expectations for a steady , durable , and long term build in sales . We expect full year 2026 . Yes , two revenue of approximately $800 million , compared to $150 million in 2025 .
Speaker #1: Highlighting that To-Go is well on its yes way to achieving blockbuster status . We continue to offer the most compelling HIV prevention portfolio available , including the six monthly yes To-Go injectable with its transformative potential on the HIV epidemic .
Speaker #1: In addition to Descovy for Prep , the current market leading branded oral . Our goal this year is to continue to drive rapid adoption of HIV we prevention , and expect both brands to demonstrate robust growth in 2026 .
Speaker #1: For 2026 , we expect total HIV sales , including both treatment and prevention , to . Grow proximately 6% compared to As shown on 12 , slide looking at quarterly 2025 .
Speaker #1: Trends and, as a reminder, we expect our normal HIV seasonal inventory drawdown in the first quarter of 2026, as announced in December.
Johanna Mercier: As announced in December, there are manageable headwinds associated with the drug pricing agreement with the US government to lower Medicaid pricing for some of our products, including Genvoya and Odefsey. Additionally, our guidance reflects some potential shifts into lower price channels associated with proposed changes to the Affordable Care Act. In total, these headwinds are expected to impact HIV growth by about 2% in 2026 compared to 2025. Absent these headwinds, our HIV business is expected to grow 8% in 2026, highlighting the underlying strength of our HIV business. Turning to liver disease on slide 13, full-year sales of $3.2 billion were up 6% year-over-year, primarily driven by higher demand and partially offset by lower average realized price.
Johanna Mercier: As announced in December, there are manageable headwinds associated with the drug pricing agreement with the US government to lower Medicaid pricing for some of our products, including Genvoya and Odefsey. Additionally, our guidance reflects some potential shifts into lower price channels associated with proposed changes to the Affordable Care Act. In total, these headwinds are expected to impact HIV growth by about 2% in 2026 compared to 2025. Absent these headwinds, our HIV business is expected to grow 8% in 2026, highlighting the underlying strength of our HIV business. Turning to liver disease on slide 13, full-year sales of $3.2 billion were up 6% year-over-year, primarily driven by higher demand and partially offset by lower average realized price.
Speaker #1: There are manageable headwinds associated with the drug pricing agreement with the US government to lower Medicaid pricing for some of our products, including Genvoya and Odefsey.
Speaker #1: Additionally , our guidance reflects some potential shifts into lower price channels associated with proposed changes to the Affordable Care Act . In total , these expected to headwinds are impact HIV growth by about 2% in 2026 compared to 2025 , absent these headwinds , our HIV business is expected to grow 8% in 2026 , highlighting the underlying strength of our HIV business .
Speaker #1: Turning to liver disease on slide 13. Full year sales of $3.2 billion were up 6% year over year, primarily driven by higher demand and partially offset by lower average realized price in the fourth quarter.
Johanna Mercier: In the fourth quarter, liver sales were $844 million, up 17% year-over-year and 3% sequentially, driven by another quarter of continued strength for Livdelzi in primary biliary cholangitis, or PBC. Livdelzi grew a remarkable 42% sequentially to $150 million, driven by strong patient demand, further accelerated by the withdrawal of a competitor product in the U.S. With much of this switching activity now behind us, we are pleased to start 2026 as the U.S. market share leader with more than 50% in second-line PBC. Moving to Trodelvy on slide 14, full-year 2025 sales increased 6% to $1.4 billion, primarily driven by higher demand in metastatic breast cancer treatment, which more than offset the expected impact from the bladder cancer withdrawal in the U.S. at the end of 2024.
Johanna Mercier: In the fourth quarter, liver sales were $844 million, up 17% year-over-year and 3% sequentially, driven by another quarter of continued strength for Livdelzi in primary biliary cholangitis, or PBC. Livdelzi grew a remarkable 42% sequentially to $150 million, driven by strong patient demand, further accelerated by the withdrawal of a competitor product in the U.S. With much of this switching activity now behind us, we are pleased to start 2026 as the U.S. market share leader with more than 50% in second-line PBC. Moving to Trodelvy on slide 14, full-year 2025 sales increased 6% to $1.4 billion, primarily driven by higher demand in metastatic breast cancer treatment, which more than offset the expected impact from the bladder cancer withdrawal in the U.S. at the end of 2024.
Speaker #1: Liver sales were $844 million , up 17% year over year , and 3% sequentially , driven by another quarter of continued strength for liver in primary biliary cholangitis , or PBC .
Speaker #1: Liver grew a remarkable 42% sequentially to $150 million , driven by strong patient demand . Further accelerated by the withdrawal of a competitor product in the US .
Speaker #1: With much of this switching activity now behind us, we are pleased to start US 2026 as the market share leader, with more than 50% in second-line PBC.
Speaker #1: Moving to slide 14 . Full year 2025 sales increased 6% to $1.4 billion , primarily driven by higher demand in metastatic breast cancer treatment , which more than offset the expected impact from the bladder cancer withdrawal in the US .
Johanna Mercier: In Q4, Trodelvy sales were $384 million, up 8% both year-over-year and sequentially, driven by higher demand. Building on Trodelvy's strong 2025 performance, we shared back-to-back positive phase 3 ASCENT-03 and ASCENT-04 readouts. These results contribute to the strong body of evidence for Trodelvy across lines of therapy in metastatic triple-negative breast cancer and continue to drive demand growth. In both these studies, the investigational Trodelvy regimens demonstrated a highly statistically significant and clinically meaningful progression-free survival benefit over the standard of care. These potentially practice-changing data have now been published in the New England Journal of Medicine and have been recognized by the NCCN in their updated breast cancer guidelines. Trodelvy is now the only antibody-drug conjugate to be recommended by the NCCN for first-line PD-L1 positive and PD-L1 negative, as well as second-line metastatic triple-negative breast cancer.
Johanna Mercier: In Q4, Trodelvy sales were $384 million, up 8% both year-over-year and sequentially, driven by higher demand. Building on Trodelvy's strong 2025 performance, we shared back-to-back positive phase 3 ASCENT-03 and ASCENT-04 readouts. These results contribute to the strong body of evidence for Trodelvy across lines of therapy in metastatic triple-negative breast cancer and continue to drive demand growth. In both these studies, the investigational Trodelvy regimens demonstrated a highly statistically significant and clinically meaningful progression-free survival benefit over the standard of care. These potentially practice-changing data have now been published in the New England Journal of Medicine and have been recognized by the NCCN in their updated breast cancer guidelines. Trodelvy is now the only antibody-drug conjugate to be recommended by the NCCN for first-line PD-L1 positive and PD-L1 negative, as well as second-line metastatic triple-negative breast cancer.
Speaker #1: At the end of 2024 . In the fourth quarter . Trodelvy sales were $384 million , up 8% both year over year and sequentially , driven by higher demand .
Speaker #1: Building on strong 2025 performance , we shared back to back positive phase three ascent three and Acento four readouts . These results contribute to the strong body of evidence for Trodelvy across lines of therapy and metastatic triple negative breast cancer , and continue to drive demand growth in both these studies , the investigational trodelvy regimens highly demonstrated a statistically significant and clinically meaningful progression free survival benefit over the standard of care .
Speaker #1: These potentially practice-changing data have now been published in the New England Journal of Medicine, and have been recognized by the NCCN in their updated breast cancer guidelines.
Speaker #1: Trodelvy is now the only antibody drug conjugate to be recommended by the NCCN for first line Pd-l1 positive and Pd-l1 negative , as well as second line metastatic triple negative breast cancer .
Johanna Mercier: As the leading regimen in second-line, Trodelvy is already well established with oncologists, and these updates build momentum for Trodelvy ahead of potential first-line launches expected later this year. Moving to cell therapy on slide 15, and on behalf of Cindy and the Kite team, full-year cell therapy sales were $1.8 billion, down 7% year-over-year, reflecting ongoing in-and-out-of-class competition. For the fourth quarter, cell therapy sales were $458 million, up 6% sequentially due to higher-than-expected patient treatments in advance of holidays, in addition to one-time pricing adjustments. Year-over-year, fourth-quarter cell therapy sales were down 6%, consistent with the trends we have discussed throughout 2025. For 2026, we continue to expect these competitive headwinds, including in several countries outside the US, where we expect new entrants this year.
Johanna Mercier: As the leading regimen in second-line, Trodelvy is already well established with oncologists, and these updates build momentum for Trodelvy ahead of potential first-line launches expected later this year. Moving to cell therapy on slide 15, and on behalf of Cindy and the Kite team, full-year cell therapy sales were $1.8 billion, down 7% year-over-year, reflecting ongoing in-and-out-of-class competition. For the fourth quarter, cell therapy sales were $458 million, up 6% sequentially due to higher-than-expected patient treatments in advance of holidays, in addition to one-time pricing adjustments. Year-over-year, fourth-quarter cell therapy sales were down 6%, consistent with the trends we have discussed throughout 2025. For 2026, we continue to expect these competitive headwinds, including in several countries outside the US, where we expect new entrants this year.
Speaker #1: As the leading regimen in second line, Trodelvy is already well established with oncologists, and these updates build momentum for Trodelvy ahead of potential first-line launches expected later this year.
Speaker #1: Moving to Therapy on South slide 15 . And on behalf of Cindy and the kite team , full year South therapy sales were $1.8 billion , down 7% year over year , reflecting ongoing in and out of class competition .
Speaker #1: For the fourth quarter, South therapy sales were $458 million, up 6% sequentially due to higher than expected patient treatments in advance of.
Speaker #1: In addition to one-time pricing adjustments year over year, fourth quarter cell therapy sales were down 6%, consistent with the trends we have discussed throughout 2025, including holidays.
Speaker #1: For 2026, we continue to expect these competitive headwinds, including in several countries outside the US, where we expect new entrants this year.
Johanna Mercier: Additionally, cell therapy volumes are being impacted by a growing number of clinical trials, which is exciting for our industry and for the patients who could benefit from innovative new therapies from Kite and others. That said, this represents another near-term headwind. Overall, we expect Kite revenue to decline approximately 10% in 2026 compared to 2025. Looking to the second half of the year, the team is preparing for the potential launch of an Anito-cel in fourth-line and later relapsed or refractory multiple myeloma. We believe Anito-cel's potential best-in-disease profile, combined with Kite's exceptional manufacturing capabilities and industry-leading turnaround times, puts us in a favorable position ahead of a potential commercial launch.
Johanna Mercier: Additionally, cell therapy volumes are being impacted by a growing number of clinical trials, which is exciting for our industry and for the patients who could benefit from innovative new therapies from Kite and others. That said, this represents another near-term headwind. Overall, we expect Kite revenue to decline approximately 10% in 2026 compared to 2025. Looking to the second half of the year, the team is preparing for the potential launch of an Anito-cel in fourth-line and later relapsed or refractory multiple myeloma. We believe Anito-cel's potential best-in-disease profile, combined with Kite's exceptional manufacturing capabilities and industry-leading turnaround times, puts us in a favorable position ahead of a potential commercial launch.
Speaker #1: Additionally, cell therapy volumes are being impacted by a growing number of clinical trials, which is exciting for our industry and for the patients who could benefit from innovative new therapies from Kite and others.
Speaker #1: That said, this represents another near-term headwind. Overall, we expect Kite revenue to decline approximately 10% in 2026 compared to 2025.
Speaker #1: Looking to the second half of the year, the team is preparing for the potential launch of an IDO cell in fourth-line and later relapsed or refractory multiple myeloma.
Speaker #1: We believe Anita Cell's potential disease profile, combined with Kite's exceptional manufacturing capabilities and industry-leading turnaround times, puts us in a favorable position ahead of a potential commercial launch.
Johanna Mercier: Wrapping up our fourth quarter and 2025 on slide 16, I'd like to highlight the exceptional strength of our existing commercial portfolio, as well as our robust launch pipeline with the potential for four launches later this year. We are committed to remaining focused on our ongoing launches of Livdelzi and Sunlenca, in addition to ensuring that we are prepared to have an immediate impact with the potential launches of Anito-cel in multiple myeloma, Trodelvy in first-line metastatic triple-negative breast cancer, Biktarvy in HIV treatment, and bulevirtide in chronic hepatitis D. The addition of these potentially transformative therapies to our portfolio is incredibly energizing for our teams. We look forward to extending the reach of Gilead therapies to many more patients who can benefit from them in 2026. With that, I'll hand the call over to Dietmar.
Johanna Mercier: Wrapping up our fourth quarter and 2025 on slide 16, I'd like to highlight the exceptional strength of our existing commercial portfolio, as well as our robust launch pipeline with the potential for four launches later this year. We are committed to remaining focused on our ongoing launches of Livdelzi and Sunlenca, in addition to ensuring that we are prepared to have an immediate impact with the potential launches of Anito-cel in multiple myeloma, Trodelvy in first-line metastatic triple-negative breast cancer, Biktarvy in HIV treatment, and bulevirtide in chronic hepatitis D. The addition of these potentially transformative therapies to our portfolio is incredibly energizing for our teams.
Speaker #1: Wrapping up our fourth quarter and 2025 . On slide 16 , I'd like to highlight the exceptional strength of our commercial existing portfolio , as well as our robust launch pipeline , with the potential for four launches later this year .
Speaker #1: We are committed to remaining focused on our ongoing launches of Live and Hugo, in addition to ensuring that we are prepared to have an immediate impact with the potential launches of Anita Cell in multiple myeloma.
Speaker #1: Trodelvy in first line metastatic triple negative breast cancer , Biklin in HIV treatment and Bulevirtide in chronic hepatitis D . The addition of these potentially transformative therapies to our portfolio is incredibly energizing for our teams .
Johanna Mercier: We look forward to extending the reach of Gilead therapies to many more patients who can benefit from them in 2026. With that, I'll hand the call over to Dietmar.
Speaker #1: We look forward to extending the reach of Gilead's therapies to many more patients who can benefit from them in 2026. And with that, I'll hand over to the call, Dietmar.
Jacquie Ross: Thank you, Johanna, and good afternoon, everyone. I'd like to start by reflecting on 2025 and thanking the research and development teams and partners for an exceptional year of clinical execution. As shown in our 2025 milestones on slide 18, we received regulatory approvals for Lenacapavir, our first-in-class capsid inhibitor for HIV prevention in the US, EU, and 12 other countries. Additionally, we provided updates on seven phase 3 or pivotal phase 2 trials, including positive updates for bictegravir plus Lenacapavir, Trodelvy, and Anito-cel. Looking ahead to 2026 and beyond, we are well positioned to progress our clinical programs across our three core therapeutic areas. Starting with HIV on slide 19, we continue to advance a comprehensive pipeline with Lenacapavir as the backbone. Our HIV pipeline could support up to seven additional daily, weekly, monthly, twice-yearly, or yearly HIV product launches by the end of 2033.
Dietmar Berger: Thank you, Johanna, and good afternoon, everyone. I'd like to start by reflecting on 2025 and thanking the research and development teams and partners for an exceptional year of clinical execution. As shown in our 2025 milestones on slide 18, we received regulatory approvals for Lenacapavir, our first-in-class capsid inhibitor for HIV prevention in the US, EU, and 12 other countries. Additionally, we provided updates on seven phase 3 or pivotal phase 2 trials, including positive updates for bictegravir plus Lenacapavir, Trodelvy, and Anito-cel. Looking ahead to 2026 and beyond, we are well positioned to progress our clinical programs across our three core therapeutic areas. Starting with HIV on slide 19, we continue to advance a comprehensive pipeline with Lenacapavir as the backbone.
Speaker #2: Thank you . Joanna , and good afternoon , everyone . I'd like to start by reflecting on 2025 and thanking the research and development teams and partners for an exceptional year of clinical execution , as shown in 2025 our milestones on slide 18 .
Speaker #2: We received regulatory approvals for Lenacapavir , our first in class capsid inhibitor for HIV prevention in the US . EU and 12 other countries .
Speaker #2: Additionally , we provided updates on seven phase three or pivotal phase two trials , positive updates including for Bictegravir plus Lenacapavir , Trodelvy and a cell .
Speaker #2: Looking ahead to 2026 and beyond, we are well-positioned to progress our clinical programs across our three core therapeutic areas, starting with HIV on Slide 19.
Dietmar Berger: Our HIV pipeline could support up to seven additional daily, weekly, monthly, twice-yearly, or yearly HIV product launches by the end of 2033. In the fourth quarter, we announced positive top-line results from ARTISTRY-1 and ARTISTRY-2, evaluating once-daily bictegravir, the most prescribed integrase inhibitor, with lenacapavir, our breakthrough capsid inhibitor. We expect to share detailed results from our positive phase 3 trials at the CROI meeting in February with a potential FDA decision by the end of the year. Looking at our long-acting programs, we plan to share phase 3 updates from our ILAND 1 and ILAND 2 trials, evaluating islatravir plus lenacapavir in the first half of 2026. For our twice-yearly treatment program, we plan to initiate our phase 3 trial, evaluating lenacapavir plus broadly neutralizing antibodies, in the second half of the year.
Speaker #2: We continue to advance a comprehensive pipeline with Lenacapavir as the backbone . Our HIV pipeline could support up to seven additional daily , weekly , monthly , twice yearly or yearly HIV product launches by the end of 2033 .
Jacquie Ross: In the fourth quarter, we announced positive top-line results from ARTISTRY-1 and ARTISTRY-2, evaluating once-daily bictegravir, the most prescribed integrase inhibitor, with lenacapavir, our breakthrough capsid inhibitor. We expect to share detailed results from our positive phase 3 trials at the CROI meeting in February with a potential FDA decision by the end of the year. Looking at our long-acting programs, we plan to share phase 3 updates from our ILAND 1 and ILAND 2 trials, evaluating islatravir plus lenacapavir in the first half of 2026. For our twice-yearly treatment program, we plan to initiate our phase 3 trial, evaluating lenacapavir plus broadly neutralizing antibodies, in the second half of the year. Further, we have now completed our evaluation of the phase 1 data for our long-acting injectable candidates GS-3242 and GS-1219, as well as GS-1614 and islatravir prodrug.
Speaker #2: In the fourth quarter , we announced positive topline results from artistry one and two , evaluating once daily bictegravir the most prescribed integrase inhibitor with Lenacapavir , our breakthrough capsid inhibitor , we expect to share detailed results from our positive phase three trials at the Croix meeting in February , with a potential FDA the end decision by of the year .
Speaker #2: Looking at our long acting programs , we plan to share phase three updates from our island one and Island two trials evaluating Islatravir plus Lenacapavir in the first half of 2026 .
Speaker #2: And for our twice-yearly treatment program, we plan to initiate our Phase 3 trial, evaluating lenacapavir plus broadly neutralizing antibodies, in the second half of the year.
Dietmar Berger: Further, we have now completed our evaluation of the phase 1 data for our long-acting injectable candidates GS-3242 and GS-1219, as well as GS-1614 and islatravir prodrug. Consistent with the timeline shared during our HIV analyst event in December 2024, we have identified GS-3242 as the most promising program with lenacapavir and prioritized its development as a potential twice-yearly HIV treatment. As a result and as a reminder, we have discontinued the development of a twice-yearly regimen with GS-1219 and a quarterly regimen with GS-1614.
Speaker #2: Further , we have now completed our evaluation of the phase one data for our long acting Insti candidates . GS 32 , 42 and GS 1219 , as well as GS 1614 and is a Pro-drug .
Jacquie Ross: Consistent with the timeline shared during our HIV analyst event in December 2024, we have identified GS-3242 as the most promising program with lenacapavir and prioritized its development as a potential twice-yearly HIV treatment. As a result and as a reminder, we have discontinued the development of a twice-yearly regimen with GS-1219 and a quarterly regimen with GS-1614. Turning to liver disease on slide 20, we remain committed to further evaluating Livdelzi to potentially improve the standard of care for more patients with PBC. At the liver meeting in November, we presented late-breaking real-world data showing that Livdelzi is an effective and well-tolerated alternative for PBC patients switching from obeticholic acid.
Speaker #2: Consistent with the timeline shared during our HIV analyst event in December 2024, we have identified GTS 3242 as the most promising program with lenacapavir and prioritized its development as a potential twice-yearly HIV treatment.
Speaker #2: As a result , and as a reminder , we have discontinued the development of a twice yearly regimen with GS 1219 and a quarterly regimen with GS 1614 .
Dietmar Berger: Turning to liver disease on slide 20, we remain committed to further evaluating Livdelzi to potentially improve the standard of care for more patients with PBC. At the liver meeting in November, we presented late-breaking real-world data showing that Livdelzi is an effective and well-tolerated alternative for PBC patients switching from obeticholic acid. Later this year, we expect to provide an update from our phase 3 IDEAL study evaluating Livdelzi in PBC patients with ALP levels between 1 and 1.67 times the upper limit of normal, patients typically excluded from phase 3 studies. If positive, these data could support the expansion of Livdelzi to incomplete responders to UDCA and potentially enable even more second-line PBC patients to achieve better biochemical and symptomatic control of their PBC.
Speaker #2: Turning to liver disease on slide 20 , we remain committed to further evaluating liver cells to potentially improve the standard of for care more patients with PBC at the liver meeting in November , we presented late breaking real world data showing that LC is an effective and well-tolerated alternative for PBC patients .
Jacquie Ross: Later this year, we expect to provide an update from our phase 3 IDEAL study evaluating Livdelzi in PBC patients with ALP levels between 1 and 1.67 times the upper limit of normal, patients typically excluded from phase 3 studies. If positive, these data could support the expansion of Livdelzi to incomplete responders to UDCA and potentially enable even more second-line PBC patients to achieve better biochemical and symptomatic control of their PBC. Moving to oncology on slide 21, Trodelvy has demonstrated clinically meaningful survival benefit in two phase 3 trials, establishing it as a leading regimen in its approved indications. Most recently, Trodelvy has demonstrated highly statistically significant and clinically meaningful progression-free survival benefit across first-line metastatic triple-negative breast cancer patients. Full data from the phase 3 ASCENT-03 and ASCENT-04 trials were published in the New England Journal of Medicine in October 2025 and January 2026.
Speaker #2: Switching from obeticholic acid later this We year . to expect provide an update from our phase three ideal study evaluating liver cells in PBC patients with ALP levels between 1 and 1.67 times the upper limit of normal patients , typically excluded from phase If positive , three studies .
Speaker #2: could support the expansion of LC to incomplete responders to UDCA and potentially enable even second-line, more PBC patients to achieve better biochemical and symptomatic control of their PBC.
Dietmar Berger: Moving to oncology on slide 21, Trodelvy has demonstrated clinically meaningful survival benefit in two phase 3 trials, establishing it as a leading regimen in its approved indications. Most recently, Trodelvy has demonstrated highly statistically significant and clinically meaningful progression-free survival benefit across first-line metastatic triple-negative breast cancer patients. Full data from the phase 3 ASCENT-03 and ASCENT-04 trials were published in the New England Journal of Medicine in October 2025 and January 2026.
Speaker #2: Moving to oncology on slide 21, Trodelvy has demonstrated clinically meaningful survival benefit in two Phase 3 trials, establishing it as a leading regimen in its approved indications.
Speaker #2: Most recently , Trodelvy has demonstrated highly statistically significant and clinically meaningful progression free survival benefit across first line cancer breast triple negative patients metastatic data from .
Speaker #2: the phase Full three ascent oh three and ascent zero four trials were published in the England Journal of New Medicine in October 2025 and January 2026 .
Jacquie Ross: We expect FDA decisions for Trodelvy in first-line metastatic TNBC patients who are not candidates for PD-1 inhibitors and for Trodelvy plus pembrolizumab in first-line PD-L1 positive metastatic TNBC in the second half of 2026. Ahead of the FDA decisions, the NCCN updated their breast cancer guidelines to reflect the practice-changing nature of these results, reinforcing our confidence in Trodelvy's clinical profile. We also have four phase 3 studies that continue to evaluate Trodelvy's potential in additional tumor types. Notably, we expect updates from two of the phase 3 trials this year, including ASCENT-GYN-01, evaluating Trodelvy in second-line metastatic endometrial cancer in the second half of this year, as well as EVOKE-03, exploring Trodelvy plus Pembro in first-line metastatic PD-L1 high non-small cell lung cancer.
Dietmar Berger: We expect FDA decisions for Trodelvy in first-line metastatic TNBC patients who are not candidates for PD-1 inhibitors and for Trodelvy plus pembrolizumab in first-line PD-L1 positive metastatic TNBC in the second half of 2026. Ahead of the FDA decisions, the NCCN updated their breast cancer guidelines to reflect the practice-changing nature of these results, reinforcing our confidence in Trodelvy's clinical profile. We also have four phase 3 studies that continue to evaluate Trodelvy's potential in additional tumor types. Notably, we expect updates from two of the phase 3 trials this year, including ASCENT-GYN-01, evaluating Trodelvy in second-line metastatic endometrial cancer in the second half of this year, as well as EVOKE-03, exploring Trodelvy plus Pembro in first-line metastatic PD-L1 high non-small cell lung cancer.
Speaker #2: We expect FDA decisions for trodelvy in first line metastatic TNBC patients who are not candidates for PD one inhibitors and for Trodelvy plus pembrolizumab in first line Pd-l1 positive metastatic TNBC in the second half of 2026 , ahead of the FDA decisions .
Speaker #2: The NCCN updated their breast cancer guidelines to reflect the practice-changing nature of these results, reinforcing our confidence in Trodelvy's clinical profile.
Speaker #2: also We have four phase three studies that continue to evaluate trodelvy potential in additional tumor types . Notably , we expect updates from two of the phase three trials this year , including ascent Gyno , one evaluating Trodelvy in cancer in endometrial the second half of this second line metastatic year , as as evoke well zero three exploring Trodelvy plus pembro in first line metastatic Pd-l1 .
Jacquie Ross: Moving to cell therapy on slide 22, and on behalf of Cindy and the Kite team, I will touch upon some of our updates on our Anito-cel program. Notably, we have filed Anito-cel based on our update from the phase 2 iMMagine-1 trial in fourth-line or later relapsed or refractory multiple myeloma at ASH in December. Anito-cel demonstrated clinically meaningful efficacy with 96% overall response, including 74% complete response, and 95% measurable residual disease negativity. Additionally, Anito-cel demonstrated a predictable and manageable safety profile with no delayed or non-ICANS neurotoxicities and no immune effector cell-associated enterocolitis. Based on these exciting data, we are energized to potentially bring Anito-cel to patients in the second half of this year.
Dietmar Berger: Moving to cell therapy on slide 22, and on behalf of Cindy and the Kite team, I will touch upon some of our updates on our Anito-cel program. Notably, we have filed Anito-cel based on our update from the phase 2 iMMagine-1 trial in fourth-line or later relapsed or refractory multiple myeloma at ASH in December. Anito-cel demonstrated clinically meaningful efficacy with 96% overall response, including 74% complete response, and 95% measurable residual disease negativity. Additionally, Anito-cel demonstrated a predictable and manageable safety profile with no delayed or non-ICANS neurotoxicities and no immune effector cell-associated enterocolitis. Based on these exciting data, we are energized to potentially bring Anito-cel to patients in the second half of this year.
Speaker #2: Non-small cell lung cancer—moving to cell therapy on slide 22, and on behalf of Cindy and the Kite team, I will touch upon some of our updates on our Anido cell program.
Speaker #2: Notably , we have filed a cell based on our update from the phase two . Imagine one trial in fourth line or later relapsed or refractory multiple myeloma at ash in December , a cell demonstrated clinically meaningful efficacy with response , 96% overall including 74% complete response and 95% measurable residual disease negativity .
Speaker #2: Additionally , Anita Cell demonstrated a predictable and manageable safety profile with no delayed or neurotoxicities and no immune effector cell associated enterocolitis . Based on these exciting data , we are energized to potentially bring Anita cell to patients in the second half of this year .
Jacquie Ross: Longer term, we see additional opportunity for Anito-cel with our phase 3 iMMagine-3 study in second, third, and fourth-line relapsed or refractory multiple myeloma enrolling in record time. We are also planning a pivotal program in newly diagnosed multiple myeloma. With our broader and rapidly advancing clinical development program, we expect Anito-cel to potentially reach more patients earlier in the treatment paradigm. Wrapping up on slide 23, our key milestones for 2026 include five phase 3 readouts as well as five FDA decisions for Bulevirtide for chronic hepatitis delta, Bicled for virologically suppressed people with HIV, Trodelvy in first-line PD-L1 positive and negative metastatic triple-negative breast cancer, and Anito-cel in fourth-line and later relapsed or refractory multiple myeloma.
Dietmar Berger: Longer term, we see additional opportunity for Anito-cel with our phase 3 iMMagine-3 study in second, third, and fourth-line relapsed or refractory multiple myeloma enrolling in record time. We are also planning a pivotal program in newly diagnosed multiple myeloma. With our broader and rapidly advancing clinical development program, we expect Anito-cel to potentially reach more patients earlier in the treatment paradigm. Wrapping up on slide 23, our key milestones for 2026 include five phase 3 readouts as well as five FDA decisions for Bulevirtide for chronic hepatitis delta, Bicled for virologically suppressed people with HIV, Trodelvy in first-line PD-L1 positive and negative metastatic triple-negative breast cancer, and Anito-cel in fourth-line and later relapsed or refractory multiple myeloma.
Speaker #2: Longer term , we see additional opportunity for Anita Cell with our phase three imagine three study in second , third and fourth line relapsed or refractory multiple myeloma enrolling in record time .
Speaker #2: We are also planning a pivotal program in newly diagnosed multiple myeloma with our broader and rapidly advancing clinical development program , we expect Anita Cell to potentially reach more patients earlier in the treatment paradigm .
Speaker #2: Wrapping up on slide 23 , our key milestones for 2026 include five phase three readouts , as well as five FDA decisions for bulevirtide for chronic hepatitis , Delta Biglen for people suppressed virologically with HIV Trodelvy in first line Pd-l1 positive and negative metastatic triple negative breast cancer and Anita cell in fourth line and later relapsed or refractory multiple myeloma .
Jacquie Ross: While these pipeline milestones reflect some of our later-stage catalysts, I would like to remind you we have 53 ongoing clinical programs and will continue our progress across our portfolio, including KITE-753, our next generation CD19/CD20 bicistronic CAR-T enrolling for its pivotal trial for third-line large B-cell lymphoma, GS-1427, a once-daily oral alpha-4 beta-7 inhibitor for inflammatory bowel disease, and Litaserib, our IRAK4 inhibitor for cutaneous lupus erythematosus. With that, I'll turn over the call to Andy.
Dietmar Berger: While these pipeline milestones reflect some of our later-stage catalysts, I would like to remind you we have 53 ongoing clinical programs and will continue our progress across our portfolio, including KITE-753, our next generation CD19/CD20 bicistronic CAR-T enrolling for its pivotal trial for third-line large B-cell lymphoma, GS-1427, a once-daily oral alpha-4 beta-7 inhibitor for inflammatory bowel disease, and Litaserib, our IRAK4 inhibitor for cutaneous lupus erythematosus. With that, I'll turn over the call to Andy.
Speaker #2: While these pipeline milestones reflect some of our latest stage catalysts , I would like to remind you we have 53 ongoing clinical programs and will continue our progress across our portfolio , including kite 753 , our next generation Cd19 , Cd20 , bias , Car-T , enrolling for its pivotal trial for third line large B-cell lymphoma , 1427 , GS a once daily oral alpha four beta seven inhibitor for inflammatory bowel disease , and it is assertive .
Speaker #2: Our IRAK4 inhibitor for cutaneous lupus erythematosus, and with that, I'll turn over the call to Andy.
Speaker #2: Our Irak4 inhibitor for cutaneous lupus erythematosus and with that , I'll turn over the call to Andy . Thank you
Daniel O'Day: Thank you, Dietmar, and good afternoon, everyone. Starting on slide 25, full year 2025 total product sales of $28.9 billion were up 1% from 2024 and above our $28.4 to 28.7 billion guidance range driven by demand-led HIV sales growth that more than offset the $1.1 billion headwind related to Part D redesign and $900 million lower Veklury revenue. Excluding the Part D redesign impact, our total product sales grew nearly 5%. Base business revenue, which reflects total product sales excluding Veklury, was $28 billion, up nearly $1.2 billion or 4% from 2024, exceeding our $27.4 to 27.7 billion guidance range. Excluding the impact of the Part D redesign, our base business grew 8%.
Andrew Dickinson: Thank you, Dietmar, and good afternoon, everyone. Starting on slide 25, full year 2025 total product sales of $28.9 billion were up 1% from 2024 and above our $28.4 to 28.7 billion guidance range driven by demand-led HIV sales growth that more than offset the $1.1 billion headwind related to Part D redesign and $900 million lower Veklury revenue. Excluding the Part D redesign impact, our total product sales grew nearly 5%. Base business revenue, which reflects total product sales excluding Veklury, was $28 billion, up nearly $1.2 billion or 4% from 2024, exceeding our $27.4 to 27.7 billion guidance range. Excluding the impact of the Part D redesign, our base business grew 8%.
Speaker #3: , Dietmar , and afternoon , good everyone . Starting on slide 25 , full year 2025 total product sales of $28.9 billion were up 1% from 2024 and above our 28.4 billion to 28.7 billion guidance range , driven by demand led HIV sales growth that more than offset the $1.1 billion headwind to related part D redesign and $900 million lower Veklury revenue .
Speaker #3: the Excluding part D redesign impact , our total product sales grew nearly 5% . Base business revenue , which reflects total product sales excluding Veklury , was $28 billion , up nearly $1.2 billion , 4% , or from 2024 , exceeding our 27.4 billion to 27.7 billion guidance range .
Daniel O'Day: Our strong revenue results reflected HIV growth of 6% or $1.1 billion to $20.8 billion driven by strong growth for Biktarvy and Descovy, which grew 7% and 31% respectively from 2024 as well as the launch of Sunlenca. Our liver business grew 6% to $3.2 billion, reflecting growing demand primarily driven by Livdelzi. Full year 2025 Veklury revenue was $911 million, a decline of $900 million or 49% from 2024, and mostly in line with our expectations given lower COVID-19-related hospitalization trends. Moving to our full year non-GAAP results on slide 26, product gross margin was 86.4% in line with our guidance of 86%. R&D expenses of $5.7 billion were down 1% compared to 2024 and in line with our guidance of R&D flat on a dollar basis for 2025.
Andrew Dickinson: Our strong revenue results reflected HIV growth of 6% or $1.1 billion to $20.8 billion driven by strong growth for Biktarvy and Descovy, which grew 7% and 31% respectively from 2024 as well as the launch of Sunlenca. Our liver business grew 6% to $3.2 billion, reflecting growing demand primarily driven by Livdelzi. Full year 2025 Veklury revenue was $911 million, a decline of $900 million or 49% from 2024, and mostly in line with our expectations given lower COVID-19-related hospitalization trends. Moving to our full year non-GAAP results on slide 26, product gross margin was 86.4% in line with our guidance of 86%. R&D expenses of $5.7 billion were down 1% compared to 2024 and in line with our guidance of R&D flat on a dollar basis for 2025.
Speaker #3: Excluding the impact of part D the our redesign , base business grew 8% . Our strong revenue results reflected HIV growth of 6% , or $1.1 billion , to $20.8 billion , driven by strong growth for Biktarvy and Descovy , which grew 7% and 31% , respectively , from 2024 , as well as the launch of yes To-Go and our liver business grew 6% to $3.2 billion , reflecting growing demand primarily driven by .
Speaker #3: Full year 2025 Veklury revenue was 911 million , a decline of 900 million , or 49% , from 2024 , and mostly in line with our expectations given lower Covid 19 related hospitalization trends .
Speaker #3: Moving to our full year non-GAAP results on slide 26 , product gross margin was 86.4% , in line with our guidance of 86% R&D expenses of 5.7 billion were down 1% compared to 2024 , and in line with our guidance of R&D , flat on a dollar basis for 2025 , acquired IP , R&D expenses were approximately $1 billion .
Daniel O'Day: Acquired IP R&D expenses were approximately $1 billion, in line with our expected annual investment in earlier-stage opportunities that are part of our normal course of business development. SG&A expenses of $5.6 billion were down 5% compared to 2024 within our guidance range, reflecting lower general and administrative expenses partially offset by sales and marketing investments to support Yes2Go's launch. Overall, our operating margin for full year 2025 was 45%. Excluding acquired IP R&D and the $400 million non-recurring other revenue related to the IP asset sale in the third quarter, our operating margin was roughly 48% for the full year. This underscores our ability to continue expense discipline while increasing investment in new and ongoing launches.
Andrew Dickinson: Acquired IP R&D expenses were approximately $1 billion, in line with our expected annual investment in earlier-stage opportunities that are part of our normal course of business development. SG&A expenses of $5.6 billion were down 5% compared to 2024 within our guidance range, reflecting lower general and administrative expenses partially offset by sales and marketing investments to support Yes2Go's launch. Overall, our operating margin for full year 2025 was 45%. Excluding acquired IP R&D and the $400 million non-recurring other revenue related to the IP asset sale in the third quarter, our operating margin was roughly 48% for the full year. This underscores our ability to continue expense discipline while increasing investment in new and ongoing launches.
Speaker #3: In line with our expected annual investment in earlier stage opportunities that are part of our normal course of business development and SG&A expenses of $5.6 billion were down 5% compared to 2024 .
Speaker #3: Within our guidance range , reflecting lower general and administrative expenses , partially offset by sales and marketing investments to support us launch . Overall , our operating margin for full year 2025 was 45% , excluding acquired IPR and the 400 million non-recurring other revenue related to the IP asset sale .
Speaker #3: In the third quarter , operating margin was year roughly . This underscores our ability to continue expense while discipline increasing investment in new and ongoing launches .
Daniel O'Day: The non-GAAP effective tax rate was 18.3%, roughly in line with our guidance of approximately 19% and down from 25.9% in 2024, primarily driven by the prior year non-deductible acquired IP R&D charge for the acquisition of CymaBay. Finally, non-GAAP diluted EPS was $8.15, in line with our 2025 guidance of $8.05 to $8.25 and driven by lower acquired IP R&D expenses, higher revenues, and lower SG&A expenses. Excluding the approximately $3.14 per share impact related to the CymaBay transaction, non-GAAP diluted EPS increased by $0.40 compared to 2024. To quickly recap the fourth quarter on slide 27, total product sales were $7.9 billion, up 5% year-over-year, with base business growth partially offset by the expected decline in Veklury sales.
Andrew Dickinson: The non-GAAP effective tax rate was 18.3%, roughly in line with our guidance of approximately 19% and down from 25.9% in 2024, primarily driven by the prior year non-deductible acquired IP R&D charge for the acquisition of CymaBay. Finally, non-GAAP diluted EPS was $8.15, in line with our 2025 guidance of $8.05 to $8.25 and driven by lower acquired IP R&D expenses, higher revenues, and lower SG&A expenses. Excluding the approximately $3.14 per share impact related to the CymaBay transaction, non-GAAP diluted EPS increased by $0.40 compared to 2024. To quickly recap the fourth quarter on slide 27, total product sales were $7.9 billion, up 5% year-over-year, with base business growth partially offset by the expected decline in Veklury sales.
Speaker #3: The non-GAAP effective tax rate was 18.3%, roughly in line with our guidance of approximately 19%, and down from 25.9% in 2024, primarily driven by the prior year.
Speaker #3: Nondeductible acquired IPR&D charge for the acquisition of CymaBay, and finally, non-GAAP diluted EPS was $8.15, in line with our 2025 guidance of $8.05 to $8.25.
Speaker #3: And driven by lower acquired IPR expenses , higher revenues and lower G&A expenses . Excluding the approximately $3.14 per share impact related to the Bay transaction , non-GAAP diluted EPs increased by $0.40 compared to 2024 on recap , fourth quarter to the quickly slide 27 , total product sales were $7.9 billion , up 5% year over year , with base business growth partially offset by the expected decline in Veklury sales .
Daniel O'Day: Excluding Veklury, total product sales were $7.7 billion, up 7% from the same period in 2024, primarily driven by higher sales for our HIV and liver disease products. Moving to the fourth quarter P&L on slide 28, R&D expenses were $1.6 billion, down 3% relative to the same period in 2024, and SG&A expenses were $1.7 billion, down 9% year over year, primarily due to lower G&A expenses. Overall, our non-GAAP diluted earnings per share was $1.86 in the fourth quarter of 2025 compared to $1.90 in the same period in 2024, primarily due to higher acquired IP R&D expenses, partially offset by higher product sales, and lower SG&A expenses. Looking at our full year guidance on slide 29, we expect 2026 total product sales between $29.6 and $30 billion.
Andrew Dickinson: Excluding Veklury, total product sales were $7.7 billion, up 7% from the same period in 2024, primarily driven by higher sales for our HIV and liver disease products. Moving to the fourth quarter P&L on slide 28, R&D expenses were $1.6 billion, down 3% relative to the same period in 2024, and SG&A expenses were $1.7 billion, down 9% year over year, primarily due to lower G&A expenses. Overall, our non-GAAP diluted earnings per share was $1.86 in the fourth quarter of 2025 compared to $1.90 in the same period in 2024, primarily due to higher acquired IP R&D expenses, partially offset by higher product sales, and lower SG&A expenses. Looking at our full year guidance on slide 29, we expect 2026 total product sales between $29.6 and $30 billion.
Speaker #3: Excluding Veklury . Total product sales $7.7 billion , were up 7% from the same period in 2024 , primarily driven by higher sales .
Speaker #3: For our HIV and liver disease products . Moving to the fourth quarter , PNL on slide 28 , R&D expenses were $1.6 billion , down 3% relative to the same period in 2024 and G&A expenses were $1.7 billion , down 9% year over year , primarily due to lower G&A expenses .
Speaker #3: Overall, our non-GAAP diluted earnings per share was $1.86 in the fourth quarter of 2025, compared to the same period of $1.90 in 2020.
Speaker #3: For acquired primarily due to IPR and expenses, partially offset by higher product sales and lower G&A expenses. Looking at our full year guidance on slide 29, we expect 2026 total product sales between $29.6 and $30 billion.
Daniel O'Day: We expect total Veklury sales of approximately $600 million, highlighting a $300 million headwind that we expect to more than offset in our base business. We therefore expect base business sales between $29 and $29.4 billion, growth of 4% to 5% compared to 2025. Moving to the non-GAAP P&L for the full year 2026, we expect product gross margin of approximately 87%, R&D expenses to increase a low single-digit percentage from 2025, acquired IP R&D investments of approximately $300 million, reflecting known commitments associated with prior collaborations and partnerships. Consistent with our approach in 2025, we will highlight incremental acquired IP R&D expenses as we announce new transactions throughout the year. SG&A expenses to increase by a mid-single-digit percentage relative to 2025, reflecting higher investments in sales and marketing to support our commercial launches, offset in part by lower G&A expenses.
Andrew Dickinson: We expect total Veklury sales of approximately $600 million, highlighting a $300 million headwind that we expect to more than offset in our base business. We therefore expect base business sales between $29 and $29.4 billion, growth of 4% to 5% compared to 2025. Moving to the non-GAAP P&L for the full year 2026, we expect product gross margin of approximately 87%, R&D expenses to increase a low single-digit percentage from 2025, acquired IP R&D investments of approximately $300 million, reflecting known commitments associated with prior collaborations and partnerships. Consistent with our approach in 2025, we will highlight incremental acquired IP R&D expenses as we announce new transactions throughout the year.
Speaker #3: We expect total Veklury sales of approximately $600 million, highlighting a $300 million headwind that we expect to more than offset in our base business.
Speaker #3: We therefore expect base business sales between $29 billion and $29.4 billion, growth of 4 to 5% compared to 2025. Moving to the non-GAAP P&L for the full year 2026, we expect product gross margin of approximately 87%.
Speaker #3: R&D expenses to increase a low single digit percentage from 2025 , acquired IPR and investments of approximately $300 million . Reflecting commitments known associated with prior collaborations and partnerships consistent with our approach .
Andrew Dickinson: SG&A expenses to increase by a mid-single-digit percentage relative to 2025, reflecting higher investments in sales and marketing to support our commercial launches, offset in part by lower G&A expenses. We expect full year 2026 non-GAAP operating income of between $13.8 and $14.3 billion, a tax rate of approximately 20%, and non-GAAP diluted EPS in the range of $8.45 to $8.85 per share. As Johanna mentioned and is shown on slide 30, we expect an approximate 2% headwind to growth in 2026, primarily associated with the impact of the drug pricing agreement announced in December 2025, and the expected impact of updates to the Affordable Care Act. I'll note that absent these updates, our full year growth would be in the range of 6% to 7%.
Speaker #3: In 2025 , we will highlight incremental acquired IPR and expenses as we announced new transactions throughout the year and SG&A expenses to increase by a mid-single digit percentage .
Speaker #3: Relative to 2025 , reflecting higher investments in sales and marketing . To support our commercial launches , offset in part by lower G&A expenses .
Daniel O'Day: We expect full year 2026 non-GAAP operating income of between $13.8 and $14.3 billion, a tax rate of approximately 20%, and non-GAAP diluted EPS in the range of $8.45 to $8.85 per share. As Johanna mentioned and is shown on slide 30, we expect an approximate 2% headwind to growth in 2026, primarily associated with the impact of the drug pricing agreement announced in December 2025, and the expected impact of updates to the Affordable Care Act. I'll note that absent these updates, our full year growth would be in the range of 6% to 7%. Additionally, we expect HIV to grow approximately 6% in 2026, and within HIV, we expect 2026 Yes2Go revenue of approximately $800 million. In cell therapy, we expect full year 2026 revenues to decline approximately 10% compared to 2025, reflecting continued competitive headwinds related to our Kite portfolio.
Speaker #3: We expect full year 2026 non-GAAP operating income of between 13.8 billion and $14.3 billion , a tax rate of approximately 20% , and non-GAAP diluted EPs in the range of $8.45 and $8.85 per share .
Speaker #3: As Joanna mentioned , and as shown on slide 30 , we expect an approximate 2% headwind to growth in 2026 , primarily associated with the impact of the drug pricing agreement announced in December 2025 and the expected impact of updates to the Affordable Care Act .
Andrew Dickinson: Additionally, we expect HIV to grow approximately 6% in 2026, and within HIV, we expect 2026 Yes2Go revenue of approximately $800 million. In cell therapy, we expect full year 2026 revenues to decline approximately 10% compared to 2025, reflecting continued competitive headwinds related to our Kite portfolio. On slide 31, we returned $5.9 billion to shareholders in 2025, and we remain committed to returning, on average, at least 50% of our free cash flow to shareholders. In 2025, this included $1.9 billion of share repurchases, primarily intended to offset equity dilution at a minimum, in addition to opportunistic repurchases. Combined with our dividend, we returned approximately 63% of our free cash flow to shareholders in 2025. In terms of business development, we are confident that we have built a robust and diverse portfolio that can support Gilead's growth.
Speaker #3: I'll note that absent these updates are , full year growth would be in the range of 6 to 7% . Additionally , we expect HIV to grow approximately 6% in 2026 , and within HIV , we expect 2026 years revenue of approximately $800 million in cell therapy .
Speaker #3: We expect full year 2026 revenues to decline approximately 10% compared to 2025 , reflecting continued competitive headwinds related to our portfolio . On slide 31 , we returned $5.9 billion to shareholders in 2025 , and we remain committed to returning on average , at least 50% of our free cash flow to shareholders in 2025 .
Daniel O'Day: On slide 31, we returned $5.9 billion to shareholders in 2025, and we remain committed to returning, on average, at least 50% of our free cash flow to shareholders. In 2025, this included $1.9 billion of share repurchases, primarily intended to offset equity dilution at a minimum, in addition to opportunistic repurchases. Combined with our dividend, we returned approximately 63% of our free cash flow to shareholders in 2025. In terms of business development, we are confident that we have built a robust and diverse portfolio that can support Gilead's growth. At the same time, we are carefully strengthening our early-stage pipeline to position Gilead well for the long term, typically investing about $1 billion annually in smaller licensing deals, partnerships, and acquisitions. Additionally, we are proactive and disciplined in our approach to later-stage acquisitions that support our strategic goals and add new growth opportunities.
Speaker #3: This included $1.9 billion of share repurchases , primarily intended to offset equity dilution at a minimum , in addition to . Opportunistic repurchases .
Speaker #3: Combined with our dividend , we returned approximately 63% of our free cash flow to shareholders in 2025 . In terms of business development , we are confident that we have built a robust and diverse portfolio that can support Gilead's growth .
Andrew Dickinson: At the same time, we are carefully strengthening our early-stage pipeline to position Gilead well for the long term, typically investing about $1 billion annually in smaller licensing deals, partnerships, and acquisitions. Additionally, we are proactive and disciplined in our approach to later-stage acquisitions that support our strategic goals and add new growth opportunities. Overall, we are pleased with Gilead's consistent, strong performance, highlighted by our clinical and commercial execution, and supported by our disciplined operating model. We continue to be well-positioned for near-term and long-term growth, and we remain focused on delivering on our strategic commitments. With that, I'll invite Rebecca to begin the Q&A.
Speaker #3: At the same time , we are carefully strengthening our early stage pipeline to position Gilead well for the long term . Typically , investing about $1 billion annually in smaller licensing deals , partnerships and acquisitions .
Speaker #3: Additionally , we are proactive and disciplined in our approach to later stage acquisitions that support our strategic goals and add new growth opportunities .
Daniel O'Day: Overall, we are pleased with Gilead's consistent, strong performance, highlighted by our clinical and commercial execution, and supported by our disciplined operating model. We continue to be well-positioned for near-term and long-term growth, and we remain focused on delivering on our strategic commitments. With that, I'll invite Rebecca to begin the Q&A.
Speaker #3: Overall , we are pleased with Gilead's consistent , strong performance highlighted clinical commercial execution and our disciplined operating model . We continue term and positioned for long to be well near growth , and we remain focused on delivering on our strategic commitments .
Johanna Mercier: Thank you, Andy. At this time, we'll invite your questions. Please be courteous and limit yourself to one question so we can get to as many analysts as possible during today's call. Again, to ask a question, press star one. To withdraw your question, press star two. Our first question comes from Chris Schott at JPM. Chris, go ahead. Your line is open.
Operator: Thank you, Andy. At this time, we'll invite your questions. Please be courteous and limit yourself to one question so we can get to as many analysts as possible during today's call. Again, to ask a question, press star one. To withdraw your question, press star two. Our first question comes from Chris Schott at JPM. Chris, go ahead. Your line is open.
Speaker #3: With that , I'll invite Rebecca to begin the Q&A .
Speaker #4: Thank you . Andy . At this time , we'll invite your questions . Please be courteous and limit yourself to one question so we can get to as many analysts as possible during today's call .
Speaker #4: Again , to ask a question , press star one and to withdraw your question , press star two . Our first question comes from Chris shot at JPM .
Chris Schott: Great. Thanks so much. Just wanted to kick off with a question on Yes2Go. Could you just elaborate a little bit more on the assumptions driving the $800 million guidance? And maybe as part of that, as we start to think about patients now needing to be redosed on the drug, what type of refill rates are you anticipating as we think about kind of going through 2026 and beyond? Thank you.
Chris Schott: Great. Thanks so much. Just wanted to kick off with a question on Yes2Go. Could you just elaborate a little bit more on the assumptions driving the $800 million guidance? And maybe as part of that, as we start to think about patients now needing to be redosed on the drug, what type of refill rates are you anticipating as we think about kind of going through 2026 and beyond? Thank you.
Speaker #4: Chris go ahead . Your line is open .
Speaker #5: Great . Thanks so much . Just wanted to kick off with a question on just Hugo , could you just elaborate a little bit more on the assumptions driving the $800 million guidance ?
Speaker #5: And maybe as part of that , as we start to think about patients now needing to be redosed on the drug , what type of refill rates are you anticipating as we think about kind of going through 2026 and beyond ?
Daniel O'Day: Yeah. Thanks, Chris, Daniel O'Day. Welcome to the call. I'd invite Johanna to cover that point. Thank you.
Daniel O'Day: Yeah. Thanks, Chris, Daniel O'Day. Welcome to the call. I'd invite Johanna to cover that point. Thank you.
Cindy Perettie: Thanks, Dan. And thanks, Chris, for the question. So yeah. So one, let me start with how excited we are with Yes2Go. I think as we closed out 2025 and really building momentum coming into 2026, all of our key launch indicators are basically tracking or exceeding our expectation. And that includes, of course, access, which is where it starts, with about 90% payer coverage. So all major payers are now covering Yes2Go. About 90% of those with $0 copay. So that's really important for people that want to have access to this medicine. I would just remind everyone that as we pull through this great access, it takes a little bit of time, right, because you do it by account by account. And you're basically navigating logistics for HCPs and their clinics around an injectable versus a very oral market to begin with. So that's scheduling, coordination, administration.
Johanna Mercier: Thanks, Dan. And thanks, Chris, for the question. So yeah. So one, let me start with how excited we are with Yes2Go. I think as we closed out 2025 and really building momentum coming into 2026, all of our key launch indicators are basically tracking or exceeding our expectation. And that includes, of course, access, which is where it starts, with about 90% payer coverage. So all major payers are now covering Yes2Go. About 90% of those with $0 copay. So that's really important for people that want to have access to this medicine. I would just remind everyone that as we pull through this great access, it takes a little bit of time, right, because you do it by account by account.
Speaker #5: Thank you .
Speaker #6: Chris . welcome to the Thanks , call . I'd invite Joanna to cover you . point .
Speaker #6: Chris, welcome to the call. Thanks. I'd invite Johanna to cover you. Point. Thank you.
Speaker #1: Thanks , Dan , and thanks , Chris , for the question . So so yeah , one , let me start with how excited we are with yes , Hugo , I think as we closed out 2025 and really building momentum coming into 2026 , all of our launch key indicators are basically tracking or exceeding our expectation .
Speaker #1: that And includes , of course , access , which is where it starts with about 90% payer coverage . So all major payers are now covering yes , Hugo , about 90% of those with $0 copays .
Speaker #1: So that's really important for people that want to have access to to this medicine . I would just remind everyone that , you know , as we pull through this access , it takes a little bit of time , right ?
Johanna Mercier: And you're basically navigating logistics for HCPs and their clinics around an injectable versus a very oral market to begin with. So that's scheduling, coordination, administration. So that just takes a little bit of time. And the teams are working diligently to make sure that happens as quickly as possible. We also launched, you might have seen, a very recent DTC campaign. Our whole campaign is One Two Prep campaign, which is really meant to increase awareness for HIV prevention and, of course, brand recognition for Sunlenca as it really differentiates itself both from its efficacy as well as its dosing and really intended to appeal to a much broader audience than past HIV prevention campaigns. And hopefully, folks are seeing that. It's a very consumer-friendly campaign.
Speaker #1: Because you do it by account, by account, and you're basically navigating logistics for HCPs and their clinics around an injectable versus a very oral market to begin with.
Cindy Perettie: So that just takes a little bit of time. And the teams are working diligently to make sure that happens as quickly as possible. We also launched, you might have seen, a very recent DTC campaign. Our whole campaign is One Two Prep campaign, which is really meant to increase awareness for HIV prevention and, of course, brand recognition for Sunlenca as it really differentiates itself both from its efficacy as well as its dosing and really intended to appeal to a much broader audience than past HIV prevention campaigns. And hopefully, folks are seeing that. It's a very consumer-friendly campaign. And we expect that to kind of pull through as well and make sure that people are talking to their physicians about the potential opportunities of Sunlenca. So all of our indicators, intakes, access, HCP awareness, conversion rates are all tracking in the right direction.
Speaker #1: that So scheduling , coordination , administration . So that just takes a little bit of time . And the teams are working diligently to make sure that happens as quickly as possible .
Speaker #1: We also launched you might have seen a very recent DTC campaign . Our whole campaign is one to prep campaign , which is really meant to increase awareness for HIV prevention .
Speaker #1: And of course, brand recognition for Hugo. It really differentiates itself from its efficacy as well as its dosing, and is really intended to appeal to a much broader audience than past HIV prevention campaigns.
Johanna Mercier: And we expect that to kind of pull through as well and make sure that people are talking to their physicians about the potential opportunities of Sunlenca. So all of our indicators, intakes, access, HCP awareness, conversion rates are all tracking in the right direction. So we're excited about that. Looking ahead, we really expect to drive very durable, sustained, long-term growth of Yes2Go. That's not just 2026 continued growth. Momentum's quarter on quarter will build on that but also well beyond 2026 as we expand the HIV and normalize HIV prevention for everyone. To your point around persistency, we don't have an assumption at this point in time because it's still really quite early.
Speaker #1: And hopefully for seeing that it's a very consumer friendly campaign , and we expect that to kind of pull through as well . And make sure that people are talking to their physicians about the potential opportunities of yes , Hugo .
Cindy Perettie: So we're excited about that. Looking ahead, we really expect to drive very durable, sustained, long-term growth of Yes2Go. That's not just 2026 continued growth. Momentum's quarter on quarter will build on that but also well beyond 2026 as we expand the HIV and normalize HIV prevention for everyone. To your point around persistency, we don't have an assumption at this point in time because it's still really quite early. As you think about a late launch in June of last year with very little access as we launched and building access into Q3, there's really only a small number of individuals that are eligible for that second dose or second injection. But we're really quite encouraged by early data. We're tracking it closely and continue to focus on ensuring that individuals return for their second injection and then well beyond that.
Speaker #1: So all of our indicators , intakes , access HDP awareness , conversion rates are all tracking in the right direction . So we're excited about that .
Speaker #1: And looking ahead , we really expect to drive very durable , sustained long term growth of Hugo . not So that's just continued 2026 growth and momentum quarter on quarter will will build on that .
Speaker #1: But also well beyond 2026 as we expand HIV and normalize HIV prevention for everyone. To your point around persistency, we don't have an assumption at this point in time because it's still really quite early.
Johanna Mercier: As you think about a late launch in June of last year with very little access as we launched and building access into Q3, there's really only a small number of individuals that are eligible for that second dose or second injection. But we're really quite encouraged by early data. We're tracking it closely and continue to focus on ensuring that individuals return for their second injection and then well beyond that.
Speaker #1: As you think about a late launch in June of last year with very little access, as we launched and built access into Q3, there's really only a small number of individuals that are eligible for that second dose or second injection.
Speaker #1: But we're really quite encouraged by early data . We're tracking it closely and continue to focus on ensuring that individuals return for their second injection and then well beyond that , we have a lot of activities planned that are ongoing and have started ever since we started the launch of Hugo around making sure HCP are thinking about that auto refill script , making sure that our pharmacy partners are specialty reaching out proactively to individuals that are on prep and making sure they're reminding them , as well as the work that we do here at Gilead , both with digital reminders as well as proactive outreach with our access programs .
Cindy Perettie: We have a lot of activities planned that are ongoing and have started ever since we started the launch of Yes2Go around making sure HCPs are thinking about that auto-refill script, making sure that our specialty pharmacy partners are reaching out proactively to all of their individuals that are on prep, and making sure they're reminding them, as well as the work that we do here at Gilead, both with digital reminders as well as proactive outreach with our access programs. So more to come on that. But we're excited about what Yes2Go has to offer for individuals looking or wanting to need HIV prep. So more to come. Our next question comes from Louise Chen at Scotiabank. Louise, go ahead. Your line is open.
Johanna Mercier: We have a lot of activities planned that are ongoing and have started ever since we started the launch of Yes2Go around making sure HCPs are thinking about that auto-refill script, making sure that our specialty pharmacy partners are reaching out proactively to all of their individuals that are on prep, and making sure they're reminding them, as well as the work that we do here at Gilead, both with digital reminders as well as proactive outreach with our access programs. So more to come on that. But we're excited about what Yes2Go has to offer for individuals looking or wanting to need HIV prep. So more to come.
Speaker #1: So more to come on that . But we're excited about what Hugo has to offer for individuals looking or wanting to need and need HIV Prep .
Operator: Our next question comes from Louise Chen at Scotiabank. Louise, go ahead. Your line is open.
Speaker #1: So more to come .
Louis Chen: Hi. Thank you for taking my question. I wanted to ask you what type of share gains you expect for Anito-cel in the fourth-line setting if you're approved, especially in light of competition from entrenched players. Thank you.
Louise Chen: Hi. Thank you for taking my question. I wanted to ask you what type of share gains you expect for Anito-cel in the fourth-line setting if you're approved, especially in light of competition from entrenched players. Thank you.
Speaker #4: Our next question comes from Luis Chen at Scotiabank. Please go ahead, your line is open.
Speaker #7: Hi . Thank you for taking my question . I wanted to ask you what type of share gains you expect for Anido cell in the fourth line setting .
Daniel O'Day: Thanks, Louise. Dan here. I'll turn it over to Cindy, who's with us here.
Daniel O'Day: Thanks, Louise. Dan here. I'll turn it over to Cindy, who's with us here.
Speaker #7: If you're approved , especially in light of competition from entrenched players . Thank you .
Cindy Perettie: Thanks, Louise. Just as a reminder, our expectation is that we would be launching this second half of this year. And once we have approval, there's a period of time where we turn on our qualified authorized treatment centers so that they're able to treat. So there's that component right after approval. The market for fourth-line multiple myeloma is a $3.5 billion market. We expect, because the launch is the second half of the year and we need to turn on our authorized treatment centers, modest contributions in 2026. However, in 2027, we will have a full year of sales. We expect, over time, to become the market leader given our excellent efficacy profile and differentiated safety profile, in particular with the delayed neurotoxicities and enterocolitis. I think the last piece I would add is that we're bringing forward our world-class manufacturing. And so we are ready for launch.
Cindy Perettie: Thanks, Louise. Just as a reminder, our expectation is that we would be launching this second half of this year. And once we have approval, there's a period of time where we turn on our qualified authorized treatment centers so that they're able to treat. So there's that component right after approval. The market for fourth-line multiple myeloma is a $3.5 billion market. We expect, because the launch is the second half of the year and we need to turn on our authorized treatment centers, modest contributions in 2026. However, in 2027, we will have a full year of sales. We expect, over time, to become the market leader given our excellent efficacy profile and differentiated safety profile, in particular with the delayed neurotoxicities and enterocolitis.
Speaker #6: Thanks , Dan . Here , I'll turn it over to Cindy , who's with us here .
Speaker #8: Thanks , Luis . Just as a reminder , our expectation is that we would be launching this of next second half of this year .
Speaker #8: And once approval , we have there's a period of time where we turn on our qualified , authorized treatment centers so that they're able to treat .
Speaker #8: there's So there's that component right after approval . The market for fourth line multiple myeloma is a $3.5 billion market . We expect because the launch is the second half of the year , and we need to turn on our authorized treatment centers .
Speaker #8: Modest contributions in 2026 . However , in 2027 , we will have a full year of sales . We expect over time to become the market leader given our .
Cindy Perettie: I think the last piece I would add is that we're bringing forward our world-class manufacturing. And so we are ready for launch. We will have the ability to serve the market at launch with 99% reliability and 16-day turnaround times, which again is very differentiated from the existing products on the market today.
Speaker #8: Excellent efficacy profile and differentiated safety profile . In particular , with the delayed neurotoxicities and enterocolitis . I think the last piece I would add is that we're bringing forward our world class manufacturing , and so we are ready for launch .
Cindy Perettie: We will have the ability to serve the market at launch with 99% reliability and 16-day turnaround times, which again is very differentiated from the existing products on the market today. Our next question comes from Tazeen Ahmad at Bank of America. Tazeen, go ahead. Your line is open.
Speaker #8: We will have the ability to serve the market at launch with 99% reliability and 16-day turnaround times, which, again, is very differentiated from the existing products on the market today.
Operator: Our next question comes from Tazeen Ahmad at Bank of America. Tazeen, go ahead. Your line is open.
Speaker #8: . Our next
Tim Anderson: Okay. Great. Thanks for taking my questions. On Yes2Go, how should we be thinking about the growth outlook? Are you expecting to begin to see cannibalization of the Descovy PrEP sales as early as this year? And then connected to that, how should we be thinking about the evolution of net price for Yes2Go throughout the launch? Should we expect to see a decay over time like we've seen with other HIV therapies? Thanks.
Tazeen Ahmad: Okay. Great. Thanks for taking my questions. On Yes2Go, how should we be thinking about the growth outlook? Are you expecting to begin to see cannibalization of the Descovy PrEP sales as early as this year? And then connected to that, how should we be thinking about the evolution of net price for Yes2Go throughout the launch? Should we expect to see a decay over time like we've seen with other HIV therapies? Thanks.
Speaker #4: question comes from Tazeen Ahmad at Bank of America . Tazeen . Go ahead . Your line is open .
Speaker #9: Okay . Great . Thanks for taking my questions . Just to go . How should we be thinking about the growth outlook ? Are you expecting to begin to see cannibalization of Descovy prep sales as early as this year ?
Speaker #9: And then connected to that ? How should we be thinking about the evolution of net price for us the throughout launch ? Should we expect to see a decay over time like we've seen with other HIV therapies ?
Cindy Perettie: Sure. Hi. It's Johanna again. Thanks, Tazeen, for the question. So we do expect, as we come into 2026, we have strong growth momentum already. So Q1, we'll start with modest growth and then kind of build on that quarter after quarter in light of all the different pieces, including access, including the DTC awareness campaign, including a lot of the work that we're doing in the field to drive Yes2Go awareness. So all of that will build on that growth momentum. And in addition to that, we're also doing it market expansion strategies as well with very targeted communities. And so we do believe that Yes2Go is going to be the strong performer. And over time, we believe that Yes2Go will be the market leader in HIV prevention just because of the incredible profile that it offers for folks.
Johanna Mercier: Sure. Hi. It's Johanna again. Thanks, Tazeen, for the question. So we do expect, as we come into 2026, we have strong growth momentum already. So Q1, we'll start with modest growth and then kind of build on that quarter after quarter in light of all the different pieces, including access, including the DTC awareness campaign, including a lot of the work that we're doing in the field to drive Yes2Go awareness. So all of that will build on that growth momentum. And in addition to that, we're also doing it market expansion strategies as well with very targeted communities. And so we do believe that Yes2Go is going to be the strong performer.
Speaker #9: Thanks .
Speaker #1: Sure . Hi , it's Joanna again . Thanks for the question . So we do expect as we come into 2026 , we have strong growth momentum already .
Speaker #1: So Q1 will be we'll start with modest growth and then kind of build on that quarter after quarter . In light of all the different pieces , including access , including the DTC awareness campaign , including a lot of the work that we're doing in the field to drive us to go awareness .
Speaker #1: of that So all will that growth build on momentum . And in addition to that , we're also doing it market expansion strategies as well .
Speaker #1: With very targeted communities . And so we do believe that Es2 going to go is be the strong performer . And over time we believe that , yes .
Johanna Mercier: And over time, we believe that Yes2Go will be the market leader in HIV prevention just because of the incredible profile that it offers for folks. Having said that, in 2026, we believe that Descovy continues to grow through 2026. As you saw, in 2025, we had the highest performance share for Descovy we've ever seen. This is driven by many factors, namely commercial execution, really strong market, of course, but also unrestricted access. So all the pieces are coming together. And all the boats are rising. And it has a lot to do with the awareness in HIV PrEP because of the PURPOSE 1 and PURPOSE 2 trials for Sunlenca, really building up the market. So we believe Descovy will continue to grow through 2026.
Speaker #1: Two go will be the market leader in HIV prevention . Just because of the incredible profile that it offers for folks . Having said that , in 2026 , we believe that Descovy continues to grow through in 2026 .
Cindy Perettie: Having said that, in 2026, we believe that Descovy continues to grow through 2026. As you saw, in 2025, we had the highest performance share for Descovy we've ever seen. This is driven by many factors, namely commercial execution, really strong market, of course, but also unrestricted access. So all the pieces are coming together. And all the boats are rising. And it has a lot to do with the awareness in HIV PrEP because of the PURPOSE 1 and PURPOSE 2 trials for Sunlenca, really building up the market. So we believe Descovy will continue to grow through 2026. And over time, of course, that will erode as Sunlenca takes the leading share in HIV prevention. I think the final point you were asking about was growth to nets. We obviously don't discuss growth to nets for our products.
Speaker #1: As you saw in 2025, we had the highest performance share for Descovy we've ever seen. This is driven by many factors, namely commercial execution.
Speaker #1: Really strong market. Of course, but also unrestricted access. So all the pieces are coming together, and all the boats are rising.
Speaker #1: And it has a lot to do with awareness in HIV PrEP because of the purpose, line, and purpose. Two trials for yes to go, really building up the market.
Johanna Mercier: And over time, of course, that will erode as Sunlenca takes the leading share in HIV prevention. I think the final point you were asking about was growth to nets. We obviously don't discuss growth to nets for our products. But I would say that Sunlenca's value proposition is quite differentiated. We feel strongly that that is being recognized. That's in line with the 90% access in less than 6 months that we've been able to achieve. Really pleased so far with what we've been seeing and making sure that value continues to get recognized for HIV PrEP users. Thank you.
Speaker #1: So we believe Descovy will continue to grow through 2026, and over time, of course, that will erode as Hugo takes the leading share in HIV prevention.
Cindy Perettie: But I would say that Sunlenca's value proposition is quite differentiated. We feel strongly that that is being recognized. That's in line with the 90% access in less than 6 months that we've been able to achieve. Really pleased so far with what we've been seeing and making sure that value continues to get recognized for HIV PrEP users. Thank you. Our next question comes from Michael Yee at UBS. Michael, go ahead. Your line is open.
Speaker #1: I think the final point you were asking about was gross to nets . We obviously don't discuss gross to nets for our products , but I would say that yes , Tuco's value proposition is quite differentiated and we feel strongly that that is being recognized .
Speaker #1: And that's in line with the 90% access in less than six months that we've been able to achieve. So, really pleased so far with what we've been seeing and making sure the value continues to get recognized for HIV.
Operator: Our next question comes from Michael Yee at UBS. Michael, go ahead. Your line is open.
Speaker #1: Prep users . Thank you .
Michael Yee: Great. Thank you, guys. Maybe a question for Dietmar or the team. Your long-acting Q6 month treatment drug, which I guess could be a super big bictegravir, long-acting 32/42, I think you said entered phase 2. Can you tell us a little bit about the profile of that drug and what you're seeing in phase 1 to get you excited? Is that going to be at CROI, I guess, coming up in a week or two? And how do you compare that to, I think, Shionogi's product or their investment into ViiV? And I'm sure you're aware that they're also excited about their Q6M as well. So maybe compare and contrast and what gets you excited about your product. Thank you.
Michael Yee: Great. Thank you, guys. Maybe a question for Dietmar or the team. Your long-acting Q6 month treatment drug, which I guess could be a super big bictegravir, long-acting 32/42, I think you said entered phase 2. Can you tell us a little bit about the profile of that drug and what you're seeing in phase 1 to get you excited? Is that going to be at CROI, I guess, coming up in a week or two? And how do you compare that to, I think, Shionogi's product or their investment into ViiV? And I'm sure you're aware that they're also excited about their Q6M as well. So maybe compare and contrast and what gets you excited about your product. Thank you.
Speaker #4: Our next question comes from Michael Yee at UBS . Michael , go ahead . Your line is open .
Speaker #10: Great . Thank you guys . Maybe a question for Dietmar or the team . Your long acting Q6 month treatment drug , which I guess could be a super bictegravir long acting 3242 I you said think entered phase two .
Speaker #10: Can you tell us a little bit about the profile of that drug you're seeing and what you're seeing in Phase One to get you excited?
Speaker #10: Is that going to be at Croix? I guess coming up in a week or two? And how do you compare that to?
Speaker #10: I think Shionogi's product , which or their investment into Veev . And I'm sure you're aware that they're also excited about their Q six as well .
Daniel O'Day: Yeah. Thank you, Michael, for the question. I mean, first of all, I really want to say that I'm excited about the breadth of the program that we have right now, not only the Q6 month, also the upcoming, for example, weekly treatment that we have with Islatravir and then lenacapavir, and really the options between the daily, weekly, monthly, and then every six months treatments that we're developing. Specifically for the ones every six months, I also want to point out that we have two programs in development. One is for lenacapavir plus broadly neutralizing antibodies. Obviously, that is an infusion and comes with everything that you need to do from an infusion perspective. However, there's a real unmet need. And the interest in the study is really high. So we feel that will be an important addition.
Dietmar Berger: Yeah. Thank you, Michael, for the question. I mean, first of all, I really want to say that I'm excited about the breadth of the program that we have right now, not only the Q6 month, also the upcoming, for example, weekly treatment that we have with Islatravir and then lenacapavir, and really the options between the daily, weekly, monthly, and then every six months treatments that we're developing. Specifically for the ones every six months, I also want to point out that we have two programs in development. One is for lenacapavir plus broadly neutralizing antibodies. Obviously, that is an infusion and comes with everything that you need to do from an infusion perspective.
Speaker #10: So maybe compare and contrast and and what gets you excited about your product . Thank you .
Speaker #6: Yeah .
Speaker #2: Thank you Michael , for the question . I mean , first of really all , I want to say that , you know , I'm excited about the breadth of the program that we have , right ?
Speaker #2: Not only the Q six month , also the the upcoming , for example , weekly treatment that we have with , with Islatravir and Lenacapavir and really the options , you know , between the daily , weekly , monthly and then every six months , treatments that we're developing specifically for the ones every six months , I also want to point out that we have two programs in development .
Speaker #2: One is for Lenacapavir plus broadly neutralizing antibodies . Obviously , that is an infusion and and comes with , you know , everything that you that you need to do from an from an infusion perspective .
Dietmar Berger: However, there's a real unmet need. And the interest in the study is really high. So we feel that will be an important addition. That will come even a little earlier than the 32/42-based combination. Now, 32/42 is obviously a long-acting INSTI. We firmly believe that an integrase inhibitor is important in this combination. And I think that also sets it apart from some of the other options that are out there. And you know all the benefits of the INSTIs, starting with, for example, the tolerability, but then also really the resistance profile and the forgiveness. And then we feel that that translates also into the once every six months treatment. And then obviously, the combination with lenacapavir.
Speaker #2: However , there's a there's a real unmet need . And the study the interest in the study is really high . So we feel that will be an important addition .
Daniel O'Day: That will come even a little earlier than the 32/42-based combination. Now, 32/42 is obviously a long-acting INSTI. We firmly believe that an integrase inhibitor is important in this combination. And I think that also sets it apart from some of the other options that are out there. And you know all the benefits of the INSTIs, starting with, for example, the tolerability, but then also really the resistance profile and the forgiveness. And then we feel that that translates also into the once every six months treatment. And then obviously, the combination with lenacapavir. So you have the INSTI again plus the capsid inhibitor, which we feel is a really important combination. So yes, you will see more data, more information about 32/42 during the year. And we're really looking forward to detail that. I don't want to go too much into the comparison to the competitors.
Speaker #2: And that will come even a little earlier than the 30 to 42 based combination . Now , 3242 is obviously a long acting insti .
Speaker #2: We firmly believe that that an integrase inhibitor is important in this combination , and I think that also sets it apart from from some of the other options that are out there .
Speaker #2: And , you know , all the benefits of the instis , you know , starting with , for example , the tolerability , but then also really the , the resistance forgiveness .
Speaker #2: profile and the And , and we feel that , that translates also into the every six month once And then the obviously combination with Epivir .
Dietmar Berger: So you have the INSTI again plus the capsid inhibitor, which we feel is a really important combination. So yes, you will see more data, more information about 32/42 during the year. And we're really looking forward to detail that. I don't want to go too much into the comparison to the competitors. But please keep in mind that they cannot base once every six months treatment on one product only. They also need a combination. So we need to look at the overall development program that they have and that they'll put together to then really bring their products forward as compared to the two options that I've laid out that we have in development.
Speaker #2: So you have the Insti again , plus the capsid inhibitor , which feel we is a really important combination . So yes , you will see more data , more information about 30 to 42 during the year .
Speaker #2: And we're really looking forward to to detail that . I don't want to go too much into the comparison to the to the competitors , but please keep in that you know , they cannot base once every six months treatment on one product only .
Daniel O'Day: But please keep in mind that they cannot base once every six months treatment on one product only. They also need a combination. So we need to look at the overall development program that they have and that they'll put together to then really bring their products forward as compared to the two options that I've laid out that we have in development. Our next question comes from Brian Abrahams at RBC Capital Markets. Brian, go ahead. Your line is open.
Speaker #2: They also need a combination . So we need to look at the overall development program that they have and that they'll put together to then really bring their products forward as I've laid that the two options compared to out that we have in development .
Operator: Our next question comes from Brian Abrahams at RBC Capital Markets. Brian, go ahead. Your line is open.
Brian Abrahams: Hey, guys. Congrats on the quarter. Thanks for taking my question. We noticed a little bit more detail on your once-yearly injectable lenacapavir for prep on the slides today. I was wondering if you could maybe just talk about what you need to show out of PURPOSE 365 in order to support approval and how you're planning to position that in the market if successful. Thanks.
Brian Abrahams: Hey, guys. Congrats on the quarter. Thanks for taking my question. We noticed a little bit more detail on your once-yearly injectable lenacapavir for prep on the slides today. I was wondering if you could maybe just talk about what you need to show out of PURPOSE 365 in order to support approval and how you're planning to position that in the market if successful. Thanks.
Speaker #4: Our question next comes from Brian Abrahams at RBC Capital Markets . Brian , go ahead . line is Your open .
Speaker #11: Hey , guys . Congrats on the quarter . Thanks . Thanks for taking my question . I noticed a little bit more detail on your once yearly injectable lenacapavir for Prep on the on the slides today .
Speaker #11: And I was wondering if you could maybe just talk about what you need to show out of purpose . Hundred 65 in order to support approval ?
Daniel O'Day: Thanks, Brian. Go back to Dietmar.
Daniel O'Day: Thanks, Brian. Go back to Dietmar.
Andrew Dickinson: Yeah. I'll start with the profile. Really what is so great about Lenacapavir is that it's such a versatile product, right? We do understand the pharmacokinetics and the target coverage and some of the scientific underpinnings of Lenacapavir for prevention really well. So the study, PURPOSE 365, is a PK-based study. It's a smaller study, obviously. It has been recruiting very well and continues to recruit very well. But it's a smaller study where we basically need to demonstrate target coverage and the right pharmacokinetic thing, peak levels, trough levels, etc., so that we can demonstrate effective prevention. That's how the study has been designed. Obviously, we're looking forward to see the data, right? Looking at PK, looking at safety. It will be an intramuscular injection, which is also an important differentiation that we're looking forward to demonstrate.
Dietmar Berger: Yeah. I'll start with the profile. Really what is so great about Lenacapavir is that it's such a versatile product, right? We do understand the pharmacokinetics and the target coverage and some of the scientific underpinnings of Lenacapavir for prevention really well. So the study, PURPOSE 365, is a PK-based study. It's a smaller study, obviously. It has been recruiting very well and continues to recruit very well. But it's a smaller study where we basically need to demonstrate target coverage and the right pharmacokinetic thing, peak levels, trough levels, etc., so that we can demonstrate effective prevention. That's how the study has been designed. Obviously, we're looking forward to see the data, right? Looking at PK, looking at safety.
Speaker #11: And how are you planning to position that in the market ? If successful ? Thanks .
Speaker #6: Thanks, Brad. Go back to Dietmar. Yeah.
Speaker #2: I'll start with the profile and really what what is so great about Lenacapavir is that it's such a versatile product . Right . And we do understand the pharmacokinetics and the target coverage and some of the scientific , you know , underpinnings of of lenacapavir for prevention really well .
Speaker #2: So the study purpose , 365 is a PK based study . It's smaller a . Obviously it has been recruiting very well and continues to recruit very well .
Speaker #2: But it's a smaller study where we basically need to demonstrate target coverage and the right pharmacokinetics in peak levels, trough levels, etc.
Speaker #2: that , so that we can demonstrate effective prevention . That's how the study has been designed . Obviously , we're looking forward to see the data , but looking at PK , looking at safety , it will be an intramuscular injection , which is also an important differentiation that we that we're looking forward to demonstrate .
Dietmar Berger: It will be an intramuscular injection, which is also an important differentiation that we're looking forward to demonstrate. But we feel it can really bring a very important benefit with a longer-term interval to patients. I'll hand over to Johanna for the market.
Andrew Dickinson: But we feel it can really bring a very important benefit with a longer-term interval to patients. I'll hand over to Johanna for the market.
Speaker #2: But we feel it can really bring a very important benefit with a longer term interval . Two patients I'll hand over to Johanna for the for the market .
Cindy Perettie: Yeah. Thanks, Brian. I would just add to what Dietmar was saying, is the fact that it's 12 months. We've been very clear with the market research that we've seen that frequency, or less frequency, in the HIV prep setting specifically is the most important. And that's why Yes2Go, being such an important innovation to this marketplace every 6 months, let alone the potential of going to every 12 months, really would potentially attract a larger population if you were thinking that you just had to go to the physician's office once a year for that injection. So I think there is an opportunity to broaden the addressable population, as well as there are some folks as well that might have unstable housing or situations that once a year would also be ideal for them.
Johanna Mercier: Yeah. Thanks, Brian. I would just add to what Dietmar was saying, is the fact that it's 12 months. We've been very clear with the market research that we've seen that frequency, or less frequency, in the HIV prep setting specifically is the most important. And that's why Yes2Go, being such an important innovation to this marketplace every 6 months, let alone the potential of going to every 12 months, really would potentially attract a larger population if you were thinking that you just had to go to the physician's office once a year for that injection.
Speaker #1: Yeah . Thanks , Brian . The I would just add to what Dietmar was saying is the fact that it's 12 months we've been very clear with the market research that we've seen that or less frequency frequency in the HIV Prep setting is the specifically , most important .
Speaker #1: And that's why , yes , To-Go being such an important innovation to this marketplace every six months , let alone the potential of going to every 12 months , really would potentially attract a larger population .
Johanna Mercier: So I think there is an opportunity to broaden the addressable population, as well as there are some folks as well that might have unstable housing or situations that once a year would also be ideal for them. So it's a real market expansion opportunity for us as we see this with that potential with 365.
Speaker #1: If you were thinking that you just had to go to the physician's office once a year for that injection . So I an think there's opportunity to broaden the addressable population as well as there are folks as some well that might have unstable housing or situations that once a year would also be ideal for them .
Cindy Perettie: So it's a real market expansion opportunity for us as we see this with that potential with 365.
Daniel O'Day: Great. And Brian, I would just remind what we've already stated, which is this could be available as early as 2028. The trial is recruiting well. Thank you. Our next question comes from Umer Raffat at Evercore ISI. Umer, go ahead. Your line is open.
Daniel O'Day: Great. And Brian, I would just remind what we've already stated, which is this could be available as early as 2028. The trial is recruiting well. Thank you.
Speaker #1: So it's a real market expansion opportunity for us , as we see this with that potential , with three , six , five great .
Speaker #6: And Brian, I'll just remind what we've already stated, which is this could be available as early as 2028. The trial is recruiting well.
Operator: Our next question comes from Umer Raffat at Evercore ISI. Umer, go ahead. Your line is open.
Brian Abrahams: Hi, guys. Thanks for taking my question. I was quite intrigued by your mention of the Trodelvy phase 3 in endometrial, perhaps in second half of this year, which makes me wonder it's probably an interim analysis you're effectively guiding to. Can you speak to your confidence overall heading into this interim? And is it fair to say that the size of the indication is generally similar to triple-negative breast? Thank you.
Umer Raffat: Hi, guys. Thanks for taking my question. I was quite intrigued by your mention of the Trodelvy phase 3 in endometrial, perhaps in second half of this year, which makes me wonder it's probably an interim analysis you're effectively guiding to. Can you speak to your confidence overall heading into this interim? And is it fair to say that the size of the indication is generally similar to triple-negative breast? Thank you.
Speaker #6: Thank you .
Speaker #4: Our next question comes from Umer Raffat at Evercore . Umer . Go ahead . Your line is open .
Speaker #12: Hi guys . Thanks for taking my by quite I was your question . intrigued mention of the endometrial . phase three and Perhaps in second half of this year , which makes me wonder .
Speaker #12: It's probably an interim analysis. You're effectively guiding to that. But can you speak to your confidence overall heading into this interim? And is it fair to say that the size of the indication is generally similar to triple-negative breast?
Daniel O'Day: So let me just talk about the study. And then later on, Johanna can chime in. Thanks for the question, Umer. Obviously, we are primarily intrigued about endometrial because of the earlier study, right? Because of the phase 2 TROPiCS-03 study, the basket trial that we did, where we saw a median OS of 15 months in that population. That data was published at ESMO 2024. We feel with data like that, this would be a really important addition to the treatment options for second-line endometrial cancer patients. We're not providing details regarding the exact evaluation that we're going to do. But we're really looking forward to seeing the data later this year. I want to say second-line endometrial cancer is, of course, more of an incremental opportunity. But I'll hand over to Johanna if she wants to comment on that further.
Dietmar Berger: So let me just talk about the study. And then later on, Johanna can chime in. Thanks for the question, Umer. Obviously, we are primarily intrigued about endometrial because of the earlier study, right? Because of the phase 2 TROPiCS-03 study, the basket trial that we did, where we saw a median OS of 15 months in that population. That data was published at ESMO 2024. We feel with data like that, this would be a really important addition to the treatment options for second-line endometrial cancer patients. We're not providing details regarding the exact evaluation that we're going to do. But we're really looking forward to seeing the data later this year. I want to say second-line endometrial cancer is, of course, more of an incremental opportunity.
Speaker #12: Thank you .
Speaker #2: So let me just talk about the study and then later on Johanna can can chime in . for the Thanks question . Umar .
Speaker #2: Obviously we are primarily intrigued about about endometrial because of the earlier study , right ? Because of the phase two oh three study , the basket trial that we did where we saw a median OS of 15 months in that population , that data was was published that as Mo 2024 , we feel , you know , with with data like that , really be a important addition to options treatment the for , for second line endometrial cancer patients .
Speaker #2: We're not providing details regarding the exact evaluation that we're going to do , but we're really looking forward to seeing the data later this year .
Dietmar Berger: But I'll hand over to Johanna if she wants to comment on that further.
Speaker #2: I want to say second line endometrial cancer is , of course , more of an incremental opportunity . But I'll hand over to Johanna if she wants to comment on that further .
Cindy Perettie: Yeah. Sure. So I think you're right, Umer. It's basically in line with second-line metastatic TNBC, so more or less about 5,000 or so addressable population in the US. So small opportunity, but very important unmet medical need as well for us. So this is where the focus and just the breadth of data for Trodelvy just expands. In addition to ASCENT-GYN-01 that Dietmar was talking about, we also have a potential with EVOKE-03 earlier this year in our PD-L1 high non-small cell lung cancer setting as well, which would be a much larger market expansion for Trodelvy as well if that was to play out. So we're excited about what's to come for Trodelvy. Next, we have Geoff Meacham at Citigroup. Jeff, go ahead. Your line is open.
Johanna Mercier: Yeah. Sure. So I think you're right, Umer. It's basically in line with second-line metastatic TNBC, so more or less about 5,000 or so addressable population in the US. So small opportunity, but very important unmet medical need as well for us. So this is where the focus and just the breadth of data for Trodelvy just expands. In addition to ASCENT-GYN-01 that Dietmar was talking about, we also have a potential with EVOKE-03 earlier this year in our PD-L1 high non-small cell lung cancer setting as well, which would be a much larger market expansion for Trodelvy as well if that was to play out. So we're excited about what's to come for Trodelvy.
Speaker #1: Yeah , sure . So I think you're right . It's basically in line with second line metastatic TNBC . So more or less about 5000 or so addressable population in the US .
Speaker #1: So , so small opportunity , but very important unmet medical need as well for us . So so where the this is focus the breadth and just of data for trodelvy just expands .
Speaker #1: In addition to that guy that Dietmar was talking about, we also have a potential with Iveco three earlier this year in our PD-L1-high non-small cell lung cancer setting as well, which would be a much larger market expansion for Tridevi as well.
Operator: Next, we have Geoff Meacham at Citigroup. Jeff, go ahead. Your line is open.
Speaker #1: If that was to play out. So we're excited about what's to come for Trodelvy.
Geoff Meacham: Oh, great. Hey, guys. Afternoon. Thanks so much for the question. I had a bigger picture one for Andy or Dan. You guys have done a ton of Phase 3 CAR-Ts and takeovers this year and also some launches. You haven't done a larger-scale deal in a while. So I guess I wanted to get a sense from you guys as to what voids you think you need to fill. Is it further diversification of, say, therapeutic areas? Is it a new product cycle looking to the maybe mid-2030s? Or is there no real BD urgency from you guys at this point? Thank you.
Geoff Meacham: Oh, great. Hey, guys. Afternoon. Thanks so much for the question. I had a bigger picture one for Andy or Dan. You guys have done a ton of Phase 3 CAR-Ts and takeovers this year and also some launches. You haven't done a larger-scale deal in a while. So I guess I wanted to get a sense from you guys as to what voids you think you need to fill. Is it further diversification of, say, therapeutic areas? Is it a new product cycle looking to the maybe mid-2030s? Or is there no real BD urgency from you guys at this point? Thank you.
Speaker #4: Next . We have Jeff Meacham at Citibank . Jeff , go ahead . Your line is open .
Speaker #6: Oh , great . Hey , guys .
Speaker #13: Thanks so Afternoon . much for the question . I had a picture . One for for Andy or Dan . You guys have done a ton of phase three cards that turnover this year .
Speaker #13: And also some launches . You know , you haven't done a larger scale deal in a while . So I guess I wanted to get a sense from you guys as to what voids you think you need to fill .
Speaker #13: Is it further diversification of , say , therapeutic areas ? Is it a new product cycle ? Looking to the maybe mid 2030s , or is there no real urgency from you guys at this point ?
Daniel O'Day: Thanks a lot, Geoff. I'll start and certainly invite Andy to add. I think we've all been reflecting here at Gilead about the progress that's made over the past five or six years. I think some of the greatest evidence of that is the fact that we have up to 10 launches now, either ongoing or to be introduced between now and 2027. That includes four additional launches this year that have already been articulated and five phase 3 readouts. Importantly, back to your question, Geoff, that's across really all therapeutic areas, which is exactly the design. We're building this very robust internal portfolio that's been built through original research, early-stage partnerships and collaborations, and M&A. What I would say is that as we approach additional partnerships and M&As, there's two pieces to that, of course.
Daniel O'Day: Thanks a lot, Geoff. I'll start and certainly invite Andy to add. I think we've all been reflecting here at Gilead about the progress that's made over the past five or six years. I think some of the greatest evidence of that is the fact that we have up to 10 launches now, either ongoing or to be introduced between now and 2027. That includes four additional launches this year that have already been articulated and five phase 3 readouts. Importantly, back to your question, Geoff, that's across really all therapeutic areas, which is exactly the design. We're building this very robust internal portfolio that's been built through original research, early-stage partnerships and collaborations, and M&A. What I would say is that as we approach additional partnerships and M&As, there's two pieces to that, of course.
Speaker #13: Thank you .
Speaker #6: Thanks a lot, Jeff. I'll start and certainly invite Andy to add. You know, I think we've all been reflecting here at Gilead about the progress that's been made over the past 5 or 6 years.
Speaker #6: And I think some of the greatest that is , is the fact that , you know , we have up to ten launches now , either ongoing or to be to be introduced over between now and 2027 .
Speaker #6: That includes four additional launches this year that have already been articulated , and five phase three readouts . And importantly , back to your question , Jeff .
Speaker #6: That's across really all therapeutic is areas , which exactly the design . So we're building this very robust internal portfolio that's been built through original research , early stage partnerships and collaborations , and and M&A .
Daniel O'Day: The first one is that we have to stay active in what we call kind of earlier-stage transactions, sometimes referred to as normal course. We spend roughly around $1 billion every year on that. Again, we can be agnostic to the three therapeutic areas and go for the most interesting science. That's what we've been doing to build this portfolio that is now coming through to us. As we approach later-stage acquisitions, we do it in the context of the fact that we have the most robust clinical and launch pipeline in our company's history with no major LOEs until 2026. So we're uniquely positioned. We're very ready. We're very proactive and disciplined. But we may not have the urgency of other companies in the sector. We're going to be disciplined around that.
Daniel O'Day: The first one is that we have to stay active in what we call kind of earlier-stage transactions, sometimes referred to as normal course. We spend roughly around $1 billion every year on that. Again, we can be agnostic to the three therapeutic areas and go for the most interesting science. That's what we've been doing to build this portfolio that is now coming through to us. As we approach later-stage acquisitions, we do it in the context of the fact that we have the most robust clinical and launch pipeline in our company's history with no major LOEs until 2026. So we're uniquely positioned. We're very ready. We're very proactive and disciplined. But we may not have the urgency of other companies in the sector. We're going to be disciplined around that.
Speaker #6: So you know what I would say is that as we approach additional partnerships and M&A , there's two pieces to that . Of course , the first one is that we have to stay active in what we call kind of earlier stage transactions , sometimes referred to as normal course .
Speaker #6: And we spend roughly around $1 billion every year on that . Again , we can be agnostic to the three therapeutic areas and go most for the interesting that's what science .
Speaker #6: we've And been doing to build this portfolio that is now coming through to us . And as we approach later stage acquisitions , we do it in the context of the fact that we have the most robust clinical and launch pipeline in our company's history , with no major lows until 2026 .
Speaker #6: So we're uniquely positioned. We're very ready. We're very proactive and disciplined, but we may not have the urgency of other companies in the sector.
Daniel O'Day: But I would say that we very much want to continue to add to our pipeline with appropriate M&A over the course of the coming years as well. If I haven't said everything, Andy, would you like to add anything to that?
Daniel O'Day: But I would say that we very much want to continue to add to our pipeline with appropriate M&A over the course of the coming years as well. If I haven't said everything, Andy, would you like to add anything to that?
Speaker #6: So we're going to be disciplined around that . But but I would say that we we very much want to continue to add to our pipeline with appropriate M&A over the course of the coming years , as well .
Andrew Dickinson: Oh, I think you covered it well. I mean, if you look at the growth that's ahead of us and the cycle that we're entering with all of the launches that are underway or the additional launches that are coming, a reasonable portion of that is driven by our corporate development activities historically. We continue to want to supplement both, as Dan said, the early-stage, late preclinical, early clinical pipeline through more of the ordinary course deals. We would like to add synergistic, de-risk, late-stage assets that will further—I define it as—turbocharge our top-line growth and drive even more outsized bottom-line growth. We will be disciplined in that. But we've been very active in this space. We'll continue to be active. I'm confident that we'll add exciting new products over time when we find the right ones.
Andrew Dickinson: Oh, I think you covered it well. I mean, if you look at the growth that's ahead of us and the cycle that we're entering with all of the launches that are underway or the additional launches that are coming, a reasonable portion of that is driven by our corporate development activities historically. We continue to want to supplement both, as Dan said, the early-stage, late preclinical, early clinical pipeline through more of the ordinary course deals. We would like to add synergistic, de-risk, late-stage assets that will further—I define it as—turbocharge our top-line growth and drive even more outsized bottom-line growth. We will be disciplined in that. But we've been very active in this space. We'll continue to be active.
Speaker #6: And if I haven't said everything , Andy , would you like to add anything ?
Speaker #14: I think you covered it well. I mean, if you look at the growth that's ahead of us and the cycle that we're entering with all of the launches that are underway or the additional launches that are coming, you reasonably know, a portion of that is driven by our corporate development activities historically.
Speaker #14: And we we continue to want to supplement Dan both , as said , the early stage , late preclinical , early clinical pipeline through more of the ordinary course deals .
Speaker #14: And we would like to add synergistic , de-risk , late stage assets that will further , you know , I define it as turbocharge our our top line growth and drive even more outsized .
Andrew Dickinson: I'm confident that we'll add exciting new products over time when we find the right ones.
Speaker #14: Bottom line growth . And you know , and we will be disciplined in that . But we've been very active in this space .
Speaker #14: We'll continue to be active . And and I'm confident that we'll add exciting new products over time when we find the right ones .
Andrew Dickinson: Our next question comes from Daina Graybosch at Leerink Partners. Daina, go ahead. Your line is open.
Operator: Our next question comes from Daina Graybosch at Leerink Partners. Daina, go ahead. Your line is open.
Geoff Meacham: Yeah. A little Anito-cel for me. I wonder, and maybe I'm being presumptuous, but what gives you confidence in a second-half launch? Does that assume priority review for FDA for Anito-cel? And then for your 2027 filing from iMMagine-3, is that going to be on the MRD endpoint or on a survival endpoint? Thank you.
Daina Graybosch: Yeah. A little Anito-cel for me. I wonder, and maybe I'm being presumptuous, but what gives you confidence in a second-half launch? Does that assume priority review for FDA for Anito-cel? And then for your 2027 filing from iMMagine-3, is that going to be on the MRD endpoint or on a survival endpoint? Thank you.
Speaker #4: Our next question comes from Dana Grabosch at Leerink Partners. Dana, your line is open. Go ahead.
Speaker #13: Yeah . I went .
Speaker #15: On a cell for me . I wonder , and maybe I'm being presumptuous , but what gives you confidence in a second half launch ?
Speaker #15: Does that assume priority review for FDA cell . NATO And then for your 2027 filing from imagine three , does that going to be on the MRD endpoint or on a survival endpoint ?
Cindy Perettie: Thanks, Daina. Cindy. So for the confidence in Anito-cel second-half launch, we can't say today if we have priority review or not. Obviously, that would come with the BLA acceptance. And we'll be sure to let you know as soon as we can on that. But we have confidence in our conversations with the agency around the filing and look forward to being able to share more soon. The second component you asked about around iMMagine-3, we have a dual endpoint, which is both MRD and PFS on the iMMagine-3 study. And that's in line with the guidance that you heard from the FDA not too long ago. Our next question comes from Tyler Van Buren, Tyler at TD Cowen. Tyler, go ahead. Your line is open.
Cindy Perettie: Thanks, Daina. Cindy. So for the confidence in Anito-cel second-half launch, we can't say today if we have priority review or not. Obviously, that would come with the BLA acceptance. And we'll be sure to let you know as soon as we can on that. But we have confidence in our conversations with the agency around the filing and look forward to being able to share more soon. The second component you asked about around iMMagine-3, we have a dual endpoint, which is both MRD and PFS on the iMMagine-3 study. And that's in line with the guidance that you heard from the FDA not too long ago.
Speaker #15: Thank you .
Speaker #8: Thanks , Cindy . So for the confidence in Anita cell second half launch . We can't say today if we have priority review or not .
Speaker #8: Obviously that would come with the with the Bla acceptance . And we'll be sure to let you know as soon as we we can on that .
Speaker #8: But we have confidence in our conversations with the agency around the filing and look forward to being able to share more soon . The second component you asked about around imagine three .
Speaker #8: We have a dual endpoint, which is both MRD and PFS, on the IMAGINE-3 study, and that's in line with the guidance that you heard from the FDA.
Operator: Our next question comes from Tyler Van Buren, Tyler at TD Cowen. Tyler, go ahead. Your line is open.
Speaker #8: Not too long ago .
Speaker #4: Our next question comes from Tyler Van Buren. Tyler, at Cowen, your line is open.
Daniel O'Day: Great. Thanks so much. For Trodelvy, are you guys starting to see off-label use in the front line in advance of formal approval given the very positive readouts and the NCCN recommendation in particular? And what do you expect the opportunity in the front line to be versus the current indication?
Tyler Van Buren: Great. Thanks so much. For Trodelvy, are you guys starting to see off-label use in the front line in advance of formal approval given the very positive readouts and the NCCN recommendation in particular? And what do you expect the opportunity in the front line to be versus the current indication?
Speaker #6: Great .
Speaker #16: Thanks so much . For Trodelvy . Are you guys starting to see off label use in the front line in advance of formal approval ?
Speaker #16: Given the very positive readouts and the NCCN recommendation ? In particular , and what do you expect the opportunity in the front line to be versus the current indication ?
Cindy Perettie: Yeah. Sure, Tyler. I'll take that one. It's Johanna. Yeah. So post-ASCENT-04 presentation at ASCO last June, that's when we started actually seeing a little bit more spontaneous use of Trodelvy, both in the first-line setting, but also strengthening our position, our leadership position in the second-line setting as well. So that's been kind of building. Obviously, that spontaneous use, there's no promotion against first-line. There's only education from our medical team, field teams around the data publications in the New England Journal of Medicine. And you highlighted as well the NCCN guidelines. Trodelvy is now the only ADC that is recommended both in first-line PD-L1-positive and PD-L1-negative metastatic TNBC as well as second-line setting. So we're excited about that and the impact it can have on patients because this disease is such an aggressive form of breast cancer.
Johanna Mercier: Yeah. Sure, Tyler. I'll take that one. It's Johanna. Yeah. So post-ASCENT-04 presentation at ASCO last June, that's when we started actually seeing a little bit more spontaneous use of Trodelvy, both in the first-line setting, but also strengthening our position, our leadership position in the second-line setting as well. So that's been kind of building. Obviously, that spontaneous use, there's no promotion against first-line. There's only education from our medical team, field teams around the data publications in the New England Journal of Medicine. And you highlighted as well the NCCN guidelines. Trodelvy is now the only ADC that is recommended both in first-line PD-L1-positive and PD-L1-negative metastatic TNBC as well as second-line setting.
Speaker #1: Tyler I'll take that Yeah , sure . one . It's Joanna . Yeah . So so post for presentation at Asco last June .
Speaker #1: That's when we started actually seeing a little bit more spontaneous use of of Trodelvy , both in the first line setting but also strengthening our position in our , our , our leadership position in the second line setting as well .
Speaker #1: So that's been kind of building, obviously, that spontaneous use. There's no promotion against first line. There's only education from our medical team, field teams around the data publications in the New England Journal of Medicine.
Speaker #1: you And highlighted as well the NCCN guidelines . We are is now the only ADC that is recommended . Both in . First line Pd-l1 positive and Pd-l1 negative metastatic as TNBC , well as second line setting .
Johanna Mercier: So we're excited about that and the impact it can have on patients because this disease is such an aggressive form of breast cancer. To your market opportunity, it's about double or so if you think about the second-line setting into the first-line setting. There's about 10,000 or so women in the first-line setting that are looking for care and really an opportunity for Trodelvy to have an impact here both in PD-L1 negative and PD-L1 positive with Pembro. The other opportunity, of course, as you think about it, is DOT. Your duration of treatment basically doubles, right? Second-line setting, because of the aggressiveness of this disease, is 4 to 5 months. So therefore, as you think about first-line, it's about double.
Speaker #1: So we're excited about that . And the impact it can have on patients . Because this disease is such an aggressive form of breast cancer .
Cindy Perettie: To your market opportunity, it's about double or so if you think about the second-line setting into the first-line setting. There's about 10,000 or so women in the first-line setting that are looking for care and really an opportunity for Trodelvy to have an impact here both in PD-L1 negative and PD-L1 positive with Pembro. The other opportunity, of course, as you think about it, is DOT. Your duration of treatment basically doubles, right? Second-line setting, because of the aggressiveness of this disease, is 4 to 5 months. So therefore, as you think about first-line, it's about double. It's 9 to 10 months, which gives a little bit more hope to these women. So definitely an important advancement in triple-negative breast cancer with Trodelvy at the lead. Our last question comes from Courtney Breen at AB Bernstein. Courtney, go ahead. Your line is open.
Speaker #1: To your market opportunity , it's about double or so . If you think about the second line setting into the first line setting , there's about 10,000 or so women in the first line setting that are looking for care .
Speaker #1: And and really an opportunity Trodelvy to for have an impact here , both in Pd-l1 negative and Pd-l1 positive , with Pembro , the other opportunity , of course , as you think about it , is dot your duration of treatment .
Speaker #1: Basically doubles right . Second line setting because of the aggressiveness of this disease is 4 to 5 months . And so therefore , as you think about it's about double .
Johanna Mercier: It's 9 to 10 months, which gives a little bit more hope to these women. So definitely an important advancement in triple-negative breast cancer with Trodelvy at the lead.
Speaker #1: It's it's 9 to 10 months , which gives a little bit more hope to these women . So definitely an important advancement in triple negative breast cancer with Trodelvy at the lead .
Operator: Our last question comes from Courtney Breen at AB Bernstein. Courtney, go ahead. Your line is open.
Courtney Breen: Hi, Gilead team. Thanks so much for squeezing me in at the end. I'm going to point us back to Yes2Go again and just kind of really trying to get our arms around the 2026 guide. By our calculations, you have to believe that there's no growth in new patient starts compared to what we've seen kind of through January for the rest of this year, and a more than 10% price cut year on year to kind of get to that $800 million guide for 2026. Given that, should we be thinking about the $800 million as a floor or as kind of a guide for 2026? Thanks so much.
Courtney Breen: Hi, Gilead team. Thanks so much for squeezing me in at the end. I'm going to point us back to Yes2Go again and just kind of really trying to get our arms around the 2026 guide. By our calculations, you have to believe that there's no growth in new patient starts compared to what we've seen kind of through January for the rest of this year, and a more than 10% price cut year on year to kind of get to that $800 million guide for 2026. Given that, should we be thinking about the $800 million as a floor or as kind of a guide for 2026? Thanks so much.
Speaker #4: Our last question comes from Courtney Breen at Bernstein. Courtney, go ahead. Your line is open.
Speaker #17: Hi . Thanks so much for squeezing me in at the end . I'm going to point us back to years to go again and just kind of really trying to get our arms around the 2026 guide by our calculations , you have to believe that there's no growth in new patient starts compared to what we've seen .
Speaker #17: Kind of through January for the rest of this year . And more than 10% price cut year on year to kind of get to that $800 million guide for 2026 , given that , should we be thinking about the $800 million as a floor or as kind of a guide for for 2026 ?
Cindy Perettie: Thanks, Courtney, for your question. I'm not sure I'm tracking your modeling because we are definitely assuming continued strong momentum for Yes2Go. I know all of you are looking at weeklies. We're obviously looking at weeklies, but we're also looking at monthlies and making sure that we're creating new growth numbers month to month. And so we do see that as an acceleration of our growth as we go into 2026. A lot of those pieces are supported by making sure that we're adding new patients on Yes2Go, new individuals on Yes2Go, and also bringing back people for their second injection. So those two pieces are considered in that guidance. And I think we're excited thus far about where we stand today with Yes2Go and all the pieces are coming together.
Johanna Mercier: Thanks, Courtney, for your question. I'm not sure I'm tracking your modeling because we are definitely assuming continued strong momentum for Yes2Go. I know all of you are looking at weeklies. We're obviously looking at weeklies, but we're also looking at monthlies and making sure that we're creating new growth numbers month to month. And so we do see that as an acceleration of our growth as we go into 2026. A lot of those pieces are supported by making sure that we're adding new patients on Yes2Go, new individuals on Yes2Go, and also bringing back people for their second injection. So those two pieces are considered in that guidance. And I think we're excited thus far about where we stand today with Yes2Go and all the pieces are coming together.
Speaker #17: Thanks so much .
Speaker #1: Courtney, for thanks, your question. I'm not sure I'm tracking your modeling because we are definitely assuming continued strong momentum for us to grow.
Speaker #1: I know all of you are looking at weeklies . We're obviously looking at weeklies , but we're also looking at monthlies and making sure that we're creating new , new growth numbers month to month .
Speaker #1: And so we do see that as an acceleration of our growth as we go into 2026 . A lot of those pieces are supported by making sure that we're adding new patients on new individuals on .
Speaker #1: Hugo Yes , , and also bringing back people for their second injection . So those two pieces are considered in that guidance . And and I think we're excited that far about where we stand today with yes To-Go and all the pieces are coming together .
Cindy Perettie: We are just making sure that as much as the access is strong right now, and I'm really proud of the team that pulled that through, we also need to pull it through at an account level. So we're doing that account by account and making sure people are navigating the logistics of an injectable and an oral market. And all of that takes a little bit of time. But the intent is we expect strong, consistent, durable growth for the long term for Yes2Go. So we're excited about what's to come. And I guess DTC will also have a pretty big impact, we believe, to bring people in asking and talking about Yes2Go. That completes the time that we have for questions. I'll now invite Dan to share any closing remarks.
Johanna Mercier: We are just making sure that as much as the access is strong right now, and I'm really proud of the team that pulled that through, we also need to pull it through at an account level. So we're doing that account by account and making sure people are navigating the logistics of an injectable and an oral market. And all of that takes a little bit of time. But the intent is we expect strong, consistent, durable growth for the long term for Yes2Go. So we're excited about what's to come. And I guess DTC will also have a pretty big impact, we believe, to bring people in asking and talking about Yes2Go.
Speaker #1: We are just making sure that as much as the access is really proud right now , strong and I'm of the team that pulled that through .
Speaker #1: We also need to pull it through account at an level . So we're doing that account by account and making sure people are navigating the logistics of an injectable and oral that takes market a little bit .
Speaker #1: And all of of time . But the intent is we expect strong , consistent , durable growth for the long term for us to go .
Speaker #1: So we're excited about what's to come and and I guess DTC will also have a pretty big impact . We believe , to bring people in asking and talking about Hugo .
Operator: That completes the time that we have for questions. I'll now invite Dan to share any closing remarks.
Daniel O'Day: Thanks, everybody. First of all, let me thank the Gilead teams again. It's such a pleasure to work with them and to see them deliver these really strong full-year performance measures and reinforcing that this is a time of impact and growth for the company. Our performance from last year gives us a really strong foundation for the coming year where we have a lot to deliver for the patients and communities we serve. Coming off of a year where we had just a really strong Yes2Go launch, as Johanna mentioned, several key launch indicators that have exceeded our expectations. We're firmly committed to continuing to drive that launch. But in addition, we have four potential launches this year and five pivotal phase 3 readouts across all three therapeutic areas: HIV, oncology, liver disease.
Daniel O'Day: Thanks, everybody. First of all, let me thank the Gilead teams again. It's such a pleasure to work with them and to see them deliver these really strong full-year performance measures and reinforcing that this is a time of impact and growth for the company. Our performance from last year gives us a really strong foundation for the coming year where we have a lot to deliver for the patients and communities we serve. Coming off of a year where we had just a really strong Yes2Go launch, as Johanna mentioned, several key launch indicators that have exceeded our expectations. We're firmly committed to continuing to drive that launch. But in addition, we have four potential launches this year and five pivotal phase 3 readouts across all three therapeutic areas: HIV, oncology, liver disease.
Speaker #4: That completes the time that we have for questions. I'll now invite Dan to share any closing remarks.
Speaker #6: Thanks , everybody . First of all , let me thank the Gilead teams again . It's pleasure such a to work with them and to see them deliver these really strong full year performance measures .
Speaker #6: And reinforcing that this is a time of impact and growth for the company . You know , our performance from last year gives us a really strong foundation for the coming year where we have a lot to deliver patients for the and communities we serve .
Speaker #6: Coming off of a year where we you just , know , a really strong yes , to grow launch as Joanna mentioned , several key launch indicators have exceeded our expectations .
Speaker #6: We are firmly committed to continuing to drive that launch . But in addition , we have four potential launches this year and five pivotal phase three readouts across all three therapeutic areas HIV oncology , liver disease .
Daniel O'Day: So you can expect us to show the same strong commercial and clinical execution you've seen in the past and disciplined focus on expense management as you've seen from us quarter after quarter. And with no major LOEs until 2036, the next 10 years, and a really proactive approach to business development, Gilead's business is secure, growing, and with the potential for much more to come. So thanks again for your time today. We look forward to keeping you informed on our progress. And as usual, if you have any follow-up questions, our investor relations team is very happy to support you with the answers to your questions. Thank you, everybody. Have a good rest of your day.
Daniel O'Day: So you can expect us to show the same strong commercial and clinical execution you've seen in the past and disciplined focus on expense management as you've seen from us quarter after quarter. And with no major LOEs until 2036, the next 10 years, and a really proactive approach to business development, Gilead's business is secure, growing, and with the potential for much more to come. So thanks again for your time today. We look forward to keeping you informed on our progress. And as usual, if you have any follow-up questions, our investor relations team is very happy to support you with the answers to your questions. Thank you, everybody. Have a good rest of your day.
Speaker #6: So you can expect us to show the same strong commercial and clinical execution . You've seen in the past . And disciplined focus on expense management , as you've seen from us , quarter after quarter and with no major lows until 2036 , the next ten years .
Speaker #6: And really proactive approach to business development , Gilead's business is secure . Growing and with the potential for much more to come . thanks So again for your time today .
Speaker #6: We look forward to keeping you informed on our progress . And as usual , if you have any follow up questions , our Investor Relations team is very happy to support you with the answers to your questions .
