Q3 2025 Gilead Sciences Inc Earnings Call

Speaker #1: Good afternoon , everyone , and welcome to Gilead . S third quarter 2020 earnings conference call . My name is Rebecca , and I'll be today's host in a moment .

Rebecca: Good afternoon, everyone, and welcome to Gilead Sciences' Q3 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, press star one. To withdraw your question, press star two. Now, I'll hand the call over to Jacquie Ross, Senior Vice President of Treasury and Investor Relations.

Speaker #1: We'll begin our prepared remarks , followed by our Q&A session . To ask a question , press Star one . To withdraw your question , press star two .

Speaker #1: Now , I'll hand the call over to Jackie Ross , senior vice president of treasury and investor relations .

Speaker #2: Thank you . The Executive vice president of Kite . Let me remind you that we will be making forward looking statements . Please refer to slide two regarding the risks and uncertainties relating to forward looking statements that could cause actual results to differ materially .

Speaker #2: Rebecca . Just after market closed today , we issued a press release with earnings results for the third quarter of 2025 . The press release slides and supplementary data are available on the investor section of our website at Gilead .

[Analyst]: Thank you, Rebecca. Just after market close today, we issued a press release with earnings results for Q3, 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 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 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 #2: With that , I'll turn the call over to Dan .

Speaker #3: Thank you , Jackie , and good afternoon , everyone . We appreciate you joining today as we take you through another very strong set of quarterly results .

[Analyst]: Thank you, Jacquie, and good afternoon, everyone. We appreciate you joining today as we take you through another very strong set of quarterly results. Our Q3 earnings underscore the growing momentum you're seeing from Gilead Sciences today, which is driven by our strong portfolio and the impressive execution of our teams. As you'll hear during the call, our progress is visible in both our quarterly results and in our strong clinical pipeline. Highlights of our Q3 include commercial outperformance across our HIV therapies and Livdelvy. This resulted in 6% year-over-year growth for Biktarvy, 20% year-over-year growth for Descovy, and 35% sequential growth for Livdelvy. Disciplined operating expense management contributed to 22% year-over-year growth in non-GAAP EPS. Even excluding a $0.25 benefit from a non-recurring accounting item, non-GAAP EPS grew 10% compared to 4% base business growth year-over-year, highlighting the leverage in our business model.

Speaker #3: Our third quarter earnings underscore the growing momentum you're seeing from Gilead today , which is driven by our strong portfolio and the impressive execution of our teams .

Speaker #3: As you'll hear during the call , our progress is visible in both our quarterly results and in our strong clinical pipeline . Highlights of our third quarter include commercial outperformance across our HIV therapies and lobdell's .

Speaker #3: This resulted in 6% year over year growth for Biktarvy , 20% year over year growth for Descovy , and 35% sequential growth for Lobdell's .

Speaker #3: Disciplined operating expense management contributed to 22% year over year growth in non-GAAP EPs , even excluding a 25 cent benefit from non-recurring accounting item .

Speaker #3: non-GAAP EPs grew 10% compared to 4% base business growth year over year , highlighting the leverage in our business model as a reflection of our strong performance year to date .

[Analyst]: As a reflection of our strong performance year to date, we are increasing our full-year HIV revenue growth expectations to approximately 5%. This is despite the $900 million headwind for our HIV business in 2025 associated with the Medicare Part D redesign. Our newest addition to the HIV portfolio, Sunlenca for HIV prevention, delivered Q3 sales of $39 million, or $54 million, including the first few weeks of launch in June. Of course, our initial priority has been securing payer coverage, and I'm very pleased to share that we've already achieved our 75% coverage goal, nearly three months ahead of our target. This sets a strong foundation for continued growth in 2026. Our confidence in our HIV business comes from both our existing on-market product leadership and our innovative pipeline.

Speaker #3: We are increasing our full-year HIV revenue growth expectations to approximately 5%. This is despite the $900 million headwind for the HIV business in 2025, associated with the Medicare Part D redesign.

Speaker #3: Our newest addition to the HIV portfolio has to go for HIV prevention . Delivered third quarter sales of $39 million , or $54 million , including the first few weeks of launch in June .

Speaker #3: Of course , our initial priority has been securing payer coverage , and I'm very pleased to share that we've already achieved our 75% coverage goal .

Speaker #3: Nearly three months ahead of our target. This sets a strong foundation for continued growth in 2026. Our confidence in our HIV business comes from both our existing on-market product leadership and our innovative pipeline.

Speaker #3: We look forward to sharing progress on one of our next generation HIV treatments . Before the end of the year . With an update on the artistry one and Artistry two studies .

[Analyst]: We look forward to sharing progress on one of our next-generation HIV treatments before the end of the year, with an update on the ARTISTRY-1 and ARTISTRY-2 studies. These Phase III programs are evaluating an investigational single-tablet regimen of bictegravir and lenacapavir, and we continue to target a product launch in early 2027. As I mentioned, Livdelvy was a standout of the quarter, contributing to 12% year-over-year growth in our liver portfolio. Livdelvy exceeded $100 million in quarterly sales for the first time and is already the number one treatment for second-line primary biliary cholangitis in the U.S. We're also pleased to share that we have filed for FDA approval of Hepcludex for the treatment of chronic hepatitis delta virus. This therapy has been available in Europe since 2020 under the brand name of Hepcludex, and we expect to bring it to patients in the U.S. in 2026.

Speaker #3: These phase three programs are evaluating and investigational single tablet regimen of bictegravir and Lenacapavir , and we continue to target a product launch in early 2027 .

Speaker #3: As I mentioned , Lobdell was a standout of the quarter , contributing to 12% year over year growth in our liver portfolio . Ldl-c exceeded $100 million in quarterly sales for the first time , and is already the number one treatment for second line PBC in the US .

Speaker #3: We're also pleased to share that we have filed for FDA approval of Bulevirtide for the treatment of chronic hepatitis delta virus. This therapy has been available in Europe since 2020 under the brand name Hepcludex, and we expect to bring it to patients in the U.S. in 2026.

Speaker #3: Turning to oncology , we continue to make significant clinical progress , most recently with the presentation of our ascent oh three detailed data at Ismo and simultaneous publication in the New England Journal of Medicine .

[Analyst]: Turning to oncology, we continue to make significant clinical progress, most recently with the presentation of our ASCENT-03 detailed data at ESMO and simultaneous publication in the New England Journal of Medicine. Given the particularly aggressive nature of this disease, we are moving as quickly as we can to bring Trodelvy to first-line metastatic triple-negative breast cancer patients. We have submitted SBLAs with the FDA and are targeting a potential commercial launch in 2026 that could extend Trodelvy's leadership in breast cancer. We also continue to target commercial launch for Anita cell for multiple myeloma in 2026 and look forward to sharing an update from the pivotal Imagine One study before the end of this year. In summary, we are very pleased with our performance in Q3, building on a very strong 2025 overall, and just as importantly, we have significant potential ahead.

Speaker #3: Given the particularly aggressive nature of this disease , we are moving as quickly as we can to bring Trodelvy to first line metastatic triple negative breast cancer patients .

Speaker #3: We have submitted surplus with the FDA and are targeting a potential commercial launch in 2026 that could extend Trodelvy's leadership in breast cancer .

Speaker #3: We also continue to target commercial launch for Anita cell for multiple myeloma in 2026 . And look forward to sharing an update from the pivotal Imagine One study before the end of this year .

Speaker #3: In summary , we are very pleased with our performance in the third quarter , building on a very strong 2025 overall , and just as importantly , we have significant potential ahead .

Speaker #3: The quality , breadth and diversity we built into the portfolio over the past years is now presenting us with multiple opportunities to drive benefits for patients , with several just launched or soon to be launched products across HIV oncology and liver disease .

[Analyst]: The quality, breadth, and diversity we built into the portfolio over the past years is now presenting us with multiple opportunities to drive benefits for patients. With several just launched or soon-to-be-launched products across HIV, oncology, and liver disease, and clinical readouts on the horizon with further commercial potential, this continues to be an exciting phase of growth. The fact that we now have no major LOEs until 2036 reinforces our strong position. My thanks, as always, to the Gilead Sciences team for their incredible work this quarter and their continued dedication to doing more for the communities we serve. With that, I'll hand it over to Johanna.

Speaker #3: And clinical readouts on the horizon . With further commercial potential . This continues to be an exciting phase of growth . The fact that we now have no major loss until 2036 reinforces our strong position .

Speaker #3: My thanks , as always to the Gilead team for their incredible work this quarter and their continued dedication to doing more for the communities we serve .

Speaker #3: With that , I'll hand it over to Joanna .

Speaker #4: Thanks , Dan and good afternoon , everyone . I'm pleased to share our third quarter results , representing another strong quarter of commercial execution with exciting momentum in our most recently launched products .

[Analyst]: Thanks, Dan, and good afternoon, everyone. I'm pleased to share our Q3 results, representing another strong quarter of commercial execution, with exciting momentum in our most recently launched products, Sunlenca and Livdelvy, in addition to continued robust Biktarvy and Descovy growth. Starting on slide seven, Q3 product sales, excluding Veklury, were $7.1 billion, up 4% year-over-year and up 2% sequentially, driven by strength across our HIV portfolio, offset in part by lower oncology revenue. Including Veklury sales of $277 million, Q3 total product sales were $7.3 billion, up 4% sequentially and down 2% year-over-year, primarily reflecting lower Veklury sales associated with fewer COVID-19-related hospitalizations. Moving to slide eight, HIV sales of $5.3 billion represented 4% growth versus prior year and prior quarter, primarily driven by higher demand and favorable inventory dynamics, partially offset by lower average realized price.

Speaker #4: Yes , To-Go and Z . In addition to continued robust Tavi and Descovy growth starting on slide seven . Third quarter product sales excluding Veklury were $7.1 billion , up 4% year over year and up 2% sequentially , driven by strength across our HIV portfolio , offset in part by lower oncology revenue , including Veklury sales of $277 million .

Speaker #4: Third quarter total product sales were $7.3 billion , up 4% sequentially and down 2% year over year , primarily reflecting lower veklury sales associated with fewer Covid 19 related hospitalizations .

Speaker #4: Moving to slide eight . HIV sales of $5.3 billion represented 4% growth versus prior year and prior quarter , primarily driven by higher demand and favorable inventory dynamics , partially offset by lower average realized price year to date .

[Analyst]: Year to date, our HIV business has grown more than 5%, which is particularly impressive as we managed through a $900 million headwind for the full year related to the Medicare Part D redesign. Consistent with our performance year to date, we are increasing our guidance for full-year HIV revenue growth to approximately 5%, up from 3% last quarter. On slide nine, Biktarvy sales of $3.7 billion were up 6% year-over-year and 4% sequentially due to higher demand, reflecting continued market growth of 2% to 3% and strong commercial execution. Biktarvy's year-over-year market share in the U.S. has grown every quarter since launch and achieved a record high of approximately 52% in the Q3. Given Biktarvy's clear differentiation and market leadership, we're pleased that the expected loss of exclusivity in the U.S. for Biktarvy has been extended into 2036.

Speaker #4: Our HIV business has grown more than 5%, which is particularly impressive as we manage through a $900 million headwind for the full year.

Speaker #4: Related to the Medicare Part D redesign . Consistent with our performance year to date , we are increasing our guidance for full year HIV revenue growth to approximately 5% , up from 3% last quarter .

Speaker #4: On slide nine , Biktarvy sales of $3.7 billion were up 6% year over year , and 4% sequentially due to higher demand , reflecting continued market growth of 2 to 3% .

Speaker #4: And strong commercial execution . Biktarvy's year over year market share in the US has grown every quarter since launch , and achieved a record high of approximately 52% in the third quarter .

Speaker #4: Given Biktarvy's clear differentiation and market leadership , we're pleased that the expected loss of exclusivity in the U.S. for Biktarvy has been extended into 2036 .

Speaker #4: Moving to Descovy, third quarter sales were a record $701 million, increasing 20% year over year, primarily due to higher demand for Descovy for PrEP sequentially.

[Analyst]: Moving to Descovy, Q3 sales were a record $701 million, increasing 20% year-over-year, primarily due to higher demand for Descovy for PrEP. Sequentially, sales were up 7%, driven by higher demand and average realized price due to channel mix, partially offset by inventory dynamics. As a reminder, roughly three-quarters of Descovy sales are for HIV prevention. This highlights the incredible momentum in the prevention market, driven by the growing awareness and increasing unrestricted access, as well as excellent commercial execution. Descovy for PrEP achieved a new record market share of more than 45% in the U.S. in the Q3. This reflects the strength of our PrEP team and the impact they're having in ensuring HIV PrEP reaches more of the people who could benefit from it. Overall, the PrEP market grew approximately 14% year-over-year.

Speaker #4: Sales were up 7%, driven by higher demand in average realized price due to channel mix, partially offset by inventory dynamics. As a reminder.

Speaker #4: Roughly three quarters of Descovy sales are for HIV prevention . This highlights the incredible momentum in the prevention market , driven by the growing awareness and increasing unrestricted access , as well as excellent commercial execution .

Speaker #4: Descovy for PrEP achieved a new record market share of more than 45% in the U.S. in the third quarter. This reflects the strength of our PrEP team and the impact they're having in ensuring HIV PrEP reaches more of the people who could benefit from it.

Speaker #4: Overall , the Prep market grew approximately 14% year over year . Moving to slide ten and one quarter in . We're really excited with the initial positive reception to our yes to go launch across consumers , clinicians and payers .

[Analyst]: Moving to slide ten, and one quarter in, we're really excited with the initial positive reception to our Sunlenca launch across consumers, clinicians, and payers. Sunlenca is increasingly recognized in clinical guidelines, including most recently the U.S. CDC. This strong endorsement of Sunlenca offers healthcare providers, public health leaders, and communities clear guidance on an innovation that could help shift the trajectory of the HIV epidemic. As we've discussed previously, expanding payer coverage is a critical indicator in our initial launch, and we're working with every payer to accelerate access. I'm thrilled that we have already achieved 75% access in the U.S., almost three months ahead of our target. This includes coverage by UnitedHealthcare and Express Scripts, as well as 20 of the top 25 state Medicaid plans. In most cases, payers do not require prior authorizations or copays.

Speaker #4: Yes , To-Go is increasingly recognized in clinical guidelines , including most recently , the US , CDC . This strong endorsement of yes To-Go offers healthcare providers , public health leaders and communities clear guidance on an innovation that could help shift the trajectory of the HIV epidemic .

Speaker #4: As we've discussed previously , expanding payer coverage is a critical indicator in our initial launch , and we're working with every payer to accelerate access .

Speaker #4: I'm thrilled that we have already achieved 75% access in the US , almost three months ahead of our target . This includes coverage by UnitedHealthCare and Express Scripts , as well as 20 of the top 25 state Medicaid plans .

Speaker #4: In most cases , payers do not require prior authorizations or co-pays . Keep in mind that much of our progress to the 75% access goal has been made in the last several weeks .

[Analyst]: Keep in mind that much of our progress to the 75% access goal has been made in the last several weeks. We continue to work on an account-by-account basis to help clinicians navigate the new logistics and reimbursement process, and the benefits of this access will pull through in 2026. Looking forward, we're moving quickly to expand access beyond 75% and continue to target 90% by the end of the first half of 2026. Altogether, Sunlenca is off to a strong start, delivering $39 million in sales in the Q3. From launch in the middle of June to the end of the Q3, Sunlenca revenue was $54 million, including $15 million of new launch-related stocking at the end of the Q2. As we expected, most early prescribers are existing HIV PrEP clinicians who are leveraging white bagging to simplify the logistic and reimbursement arrangements.

Speaker #4: We continue to work on an account by account basis to help clinicians navigate the new logistics and reimbursement process , and the benefits of this access will pull through in 2026 .

Speaker #4: Looking forward , we're moving quickly to expand access beyond 75% and continue to target 90% by the end of the first half of 2026 .

Speaker #4: Altogether, yes, Hugo is off to a strong start, delivering $39 million in sales in the third quarter, from launch in the middle of June to the end of the third quarter.

Speaker #4: Yes , Hugo revenue was $54 million , including $15 million of new launch related stocking at the end of the second quarter . As we expected , most early prescribers are existing HIV Prep clinicians who are leveraging white bagging to simplify the logistic and reimbursement arrangements .

Speaker #4: In August, the European Commission approved Lenacapavir for PrEP under the name H2O. We look forward to further regulatory decisions across other geographies.

[Analyst]: In August, the European Commission approved lenacapavir for PrEP under the name Sunlenca. We look forward to further regulatory decisions across other geographies. Additionally, as part of our broader commitment to access, Gilead Sciences has agreed with the Global Fund and the U.S. State Department, through PEPFAR, to supply enough doses of lenacapavir for PrEP to reach up to 2 million people over three years in certain low and lower-middle-income countries. Moving to liver disease on slide 11. Sales of $819 million were up 12% year-over-year and 3% sequentially, driven almost entirely by Livdelvy for primary biliary cholangitis. Livdelvy grew 35% sequentially, driven by strong commercial execution, including some new launches outside the U.S. and withdrawal of a competitor's product in the U.S. We are particularly pleased to see strong levels of persistence among users and believe Livdelvy shows clear differentiation and value to those with PBC.

Speaker #4: Additionally , as part of our broader commitment to access , Gilead has agreed with the Global Fund and the US State Department through PEPFAR to supply enough doses of Lenacapavir for Prep to reach up to 2 million people over three years in certain low and lower middle income countries .

Speaker #4: Moving to liver disease on slide 11 . Sales of $819 million were up 12% year over year and 3% sequentially , driven almost entirely by Lindsay for primary biliary cholangitis .

Speaker #4: Lindsay grew 35% sequentially , driven by strong commercial execution , including some new launches outside the US and withdrawal of a competitor's product in the US .

Speaker #4: We are particularly pleased to see strong levels of persistence among users and believe it shows clear differentiation and value to those with PBC .

Speaker #4: Liv is now the market leader in second line PBC in the US and quarterly revenue topped $100 million for the first time . Moving to slide 12 , Trodelvy sales of $357 million were up 7% year over year , primarily due to higher demand and down 2% sequentially , with higher demand offset by unfavorable inventory dynamics and lower ex-US average realized price .

[Analyst]: Livdelvy is now the market leader in second-line PBC in the U.S., and quarterly revenue topped $100 million for the first time. Moving to slide 12, Trodelvy's sales of $357 million were up 7% year-over-year, primarily due to higher demand, and down 2% sequentially, with higher demand offset by unfavorable inventory dynamics and lower ex-U.S. average realized price. Trodelvy's continued strength in the U.S. and international markets across metastatic breast cancer more than offset on a year-over-year basis the expected impact from the bladder cancer withdrawal in the U.S. With Trodelvy's potential launch in first-line metastatic TNBC following the potentially practice-changing ASCENT-03 and ASCENT-04 readouts this year, we look forward to expanding the options available for patients in this earlier line setting. There are almost twice as many patients in the first-line metastatic setting compared to second-line, and patients typically have a longer duration of therapy.

Speaker #4: Trodelvy continued strength in the US and international markets across metastatic breast cancer , more than offset on a year over year basis . The expected impact from the bladder cancer withdrawal in the US with trodelvy's potential launch in first line metastatic TNBC , following the potentially practice changing Acento three and Acento four readouts , this year , we look forward to expanding the options available for patients in this earlier line setting .

Speaker #4: There are almost twice as many patients in the first line metastatic setting compared to second line , and patients typically have a longer duration of therapy for cell therapy .

[Analyst]: For cell therapy on slide 13, and on behalf of Cindy and the Kite team, Q4 sales of $432 million were down 11% both year-over-year and sequentially with continued competitive headwinds from in- and out-of-class therapies. We anticipate these headwinds to continue in the near future. We remain committed to increasing the adoption and utilization of cell therapies, given their curative potential for many patients. Year to date, we've added more than 40 authorized treatment centers and now have more than 570 globally. As shared in prior quarters, our efforts to lower the hurdles to community adoption are progressing, but it's clear that we have more to do before all eligible patients have the opportunity to benefit from these cell therapies.

Speaker #4: On slide 13 . And on behalf of Cindy and the kite team , third quarter sales of $432 million were down 11% both year over year , and sequentially , with continued competitive headwinds from in and out of class therapies .

Speaker #4: We anticipate these headwinds to continue in the near future. We remain committed to increasing the adoption and utilization of cell therapies, given their curative potential for many patients.

Speaker #4: Year to date , we've added more than 40 authorized treatment centers , and now have more than 570 globally as shared in prior quarters .

Speaker #4: Our efforts to lower the hurdles to community adoption are progressing, but it's clear that we have more to do before all eligible patients have the opportunity to benefit from these cell therapies.

Speaker #4: In addition to the team's work to expand the reach of cell therapies, Kite is also progressing its next-generation pipeline to offer similar efficacy with better safety, which would result in enhanced outpatient usage potential.

[Analyst]: In addition to the team's work to expand the reach of cell therapies, Kite is also progressing its next-generation pipeline to offer similar efficacy with better safety, which would result in enhanced outpatient usage potential. Additionally, we're very excited by the development of Anita cell, which continues to show potential best-in-class safety and efficacy as a BCMA CAR-T therapy for late-line relapsed refractory multiple myeloma. We look forward to providing an update from the Imagine One study later this year. Wrapping up our Q4, I'd like to thank the commercial teams who are executing relentlessly across both our in-line portfolio as well as our newer opportunities like Sunlenca and Livdelvy. Looking to 2026, we're preparing for a number of additional potential launches across our therapeutic areas of focus and are excited by the opportunity to extend our reach and impact on the patients and communities we serve.

Speaker #4: Additionally , we're very excited by the development of cell , which continues to show potential best in class safety and efficacy as a BCmA .

Speaker #4: Car-T therapy for late line relapsed refractory multiple myeloma . We look forward to providing an update from the Imagine One study later this year .

Speaker #4: Wrapping up our third quarter . I'd like to thank the commercial teams who are executing relentlessly across both our in-line portfolio as well as our newer opportunities .

Speaker #4: Like Yasuko and Lizzie, looking to 2026, we're preparing for a number of additional potential launches across our therapeutic areas of focus, and we’re excited by the opportunity to extend our reach and impact on the patients and communities we serve.

Speaker #4: And with that , I'll hand the call over to Dietmar .

[Analyst]: With that, I'll hand the call over to Dietmar.

Speaker #5: Thank you . Johanna , and good afternoon , everyone . In the third quarter , the team progressed 56 clinical programs across our three therapeutic focus areas , with four additions since last quarter .

[Analyst]: Thank you, Johanna, and good afternoon, everyone. In the Q4, the team progressed 56 clinical programs across our three therapeutic focus areas, with four additions since last quarter, as we advance our research with the most meaningful potential scientific and patient impact into the clinic. Building on Johanna's comments on our Sunlenca launch, we continue to lead HIV innovation with 10 clinical programs across treatment and prevention. Lenacapavir and its prodrugs are foundational in our treatment and prevention programs, and in July, we initiated the registrational phase three Purpose 365 trial, evaluating lenacapavir as HIV prevention with once-yearly injections. This is a single-arm PK and safety study, which, along with the unprecedented efficacy seen in the phase three Purpose 1 and 2 studies, is expected to support a regulatory filing with potential for approval in 2028.

Speaker #5: As we advance our research with the most meaningful potential scientific and patient impact into the clinic , building on Johanna's comments on our yes to go launch , we continue to lead HIV innovation with ten clinical programs across treatment and prevention .

Speaker #5: Lenacapavir and its Prodrugs are foundational in our treatment and prevention programs and in July , we initiated the Registrational phase three purpose 365 trial evaluating Lenacapavir as HIV prevention with once yearly injections .

Speaker #5: This is a single arm PK and safety study , which , along with the unprecedented efficacy seen in the phase three purpose one and two studies , is expected to support a regulatory filing with potential for approval in 2028 .

Speaker #5: Moving to treatment , we have seven ongoing clinical programs evaluating daily , weekly , monthly , quarterly and twice yearly regimens based on Lenacapavir or one of its prodrugs .

[Analyst]: Moving to treatment, we have seven ongoing clinical programs evaluating daily, weekly, monthly, quarterly, and twice-yearly regimens based on lenacapavir or one of its prodrugs. Beginning with our next-generation daily oral regimen, BICLEN, we continue to expect an update from our phase three Artistry studies later this year. Artistry 1 and Artistry 2 are evaluating the potential of Gilead Sciences' investigational complete regimen that combines bictegravir, the key integrase inhibitor in Biktarvy, and lenacapavir, our breakthrough capsid inhibitor. The regimen is a potential option for virologically suppressed people with HIV, including many people currently on complex regimens. Further, we have a suite of long-acting oral and injectable agents in development for a range of dosing frequencies, from once-weekly oral to twice-yearly injectables. Our strategy has been to set up our pipeline for multiple shots on goal and then choose the best option for each dosing frequency.

Speaker #5: Beginning with our next generation daily oral regimen , Big Len , we continue to expect an update from our phase three art history studies later this year .

Speaker #5: Artistry one and R3 two are evaluating the potential of Gilead's investigational complete regimen that combines Bictegravir , the key integrase inhibitor in biktarvy and Lenacapavir .

Speaker #5: Our breakthrough capsid inhibitor . The regimen is a potential option for virologically suppressed people with HIV , including many people currently on complex regimens .

Speaker #5: Further , we have a suite of long acting , oral and injectable agents in development for a range of dosing frequencies from once weekly oral to twice yearly injectables .

Speaker #5: Our strategy has been to set up our pipeline for multiple shots on goal, and then choose the best option for each dosing frequency.

Speaker #5: Notably, for our development of a twice-a-year treatment regimen combining a novel integrase inhibitor with lenacapavir, we took two INSTI agents to Phase One.

[Analyst]: Notably, for our development of a twice-yearly treatment regimen combining a novel integrase inhibitor with lenacapavir, we took two INSTE agents to phase one, GS1219 and GS3242. Aligned with the guidance we shared at our HIV analyst event last year, we have now chosen to prioritize the development of GS3242 over GS1219, and we expect to share more details on GS3242 at a virology conference in 2026. On slide 16, I'm pleased to highlight that we have completed the BLA filing for bulevirtide in chronic hepatitis delta virus, or HDV. We're excited by the potential to bring bulevirtide to HDV patients in the U.S., with a potential regulatory decision in 2026. As a reminder, HDV affects approximately 2% of patients with HBV, or about 40,000 people in the U.S.

Speaker #5: G 1219 and GS 3242 . Aligned with the guidance we shared at our HIV analyst event last year . We have now chosen to prioritize the development of GS 3242 over GS 1219 , and we expect to share more details on GS 3242 at a virology conference in 2026 .

Speaker #5: On slide 16 . I'm pleased to highlight that we have completed the Bla filing for Bulevirtide in chronic hepatitis Delta virus or HDV .

Speaker #5: We are excited by the potential to bring Bulevirtide to HDV patients in the US with a potential regulatory decision in 2026 . As a reminder , HDV affects approximately 2% of patients with HBV or about 40,000 people in the US .

Speaker #5: Patients with chronic , untreated HDV infection can experience accelerated development of cirrhosis or severe scarring of the liver , and have higher risk of liver cancer and potentially end stage liver disease and failure .

[Analyst]: Patients with chronic untreated HDV infection can experience accelerated development of cirrhosis or severe scarring of the liver and have higher risk of liver cancer and potentially end-stage liver disease and failure. Beyond bulevirtide, we are also evaluating next-generation approaches to HDV treatment. Specifically, we have advanced GS4321, a pre-S1 neutralizing antibody, into phase one clinical development. We believe GS4321 has significant potential given its preclinical safety profile and long half-life with potentially quarterly subcutaneous dosing. Moving to Trodelvy on slide 17, earlier this month at the ESMO meeting, we presented detailed, potentially practice-changing phase three ASCENT-03 data in first-line metastatic triple-negative breast cancer patients who are not candidates for PD-L1 inhibitors. Specifically, Trodelvy demonstrated a 9.7-month median progression-free survival compared to 6.9 months for standard-of-care chemotherapy. This reflects a statistically significant and clinically meaningful 38% reduction in disease progression or death versus standard-of-care chemotherapy.

Speaker #5: Beyond bulevirtide , we are also evaluating next generation approaches to HDV treatment , specifically , we have advanced GS 4321 , a Pre-s1 neutralizing antibody into phase one clinical development .

Speaker #5: We believe GS 4321 has significant potential given its preclinical safety profile and long half life , with potentially quarterly subcutaneous dosing . Moving to Trodelvy on slide 17 .

Speaker #5: Earlier this month at the meeting , we presented detailed , potentially practice changing phase three ascent zero three data in first line metastatic triple negative breast cancer patients who are not candidates for Pd-l1 inhibitors .

Speaker #5: Specifically , Trodelvy demonstrated a 9.7 month median progression free survival compared to 6.9 months for standard of care chemotherapy . This reflects a statistically significant and clinically meaningful 38% reduction in disease progression or death versus standard of care chemotherapy .

Speaker #5: As we expected , when we initiated the study , the median overall survival data are not yet mature . These results were simultaneously published in the New England Journal of Medicine .

[Analyst]: As we expected when we initiated the study, the median overall survival data are not yet mature. These results were simultaneously published in the New England Journal of Medicine. Additionally, the detailed results from ASCENT-04 were shared at the ESMO meeting in May. These data, combined with ASCENT-03, highlight the potential for Trodelvy to be a backbone treatment across first-line metastatic triple-negative breast cancer. Based on these positive phase three updates from ASCENT-03 and 04, we have submitted two supplemental biologics license applications for Trodelvy in first-line metastatic TNBC and expect regulatory decisions in 2026. This is incredibly important for patients as metastatic TNBC is the most aggressive subtype of breast cancer with limited treatment options and poor prognosis. Historically, progress in first-line therapy has been minimal, and nearly half of patients do not progress beyond first-line treatment, meaning they may never access Trodelvy if it remains a later-line option.

Speaker #5: Additionally , the detailed results from ascend four were shared at the Asco meeting in May . These data , combined with ascent oh three , highlight the potential for Trodelvy to be a backbone treatment across first line metastatic triple negative breast cancer .

Speaker #5: Based on these positive phase three updates from ascent oh three and oh four , we have submitted two supplemental biologics License applications for Trodelvy in first line metastatic TNBC and expect regulatory decisions in 2026 .

Speaker #5: This is incredibly important for patients as metastatic TNBC is the most aggressive subtype of breast cancer , with limited treatment options and poor prognosis .

Speaker #5: Historically , progress in first line therapy has been minimal and nearly half of patients do not progress beyond first line treatment , meaning they may never access trodelvy if it remains a later line option .

Speaker #5: Similarly , we are currently exploring for first line post endocrine hormone receptor positive , Her2 negative metastatic breast cancer patients in the phase three ascent , oh seven trial .

[Analyst]: Similarly, we are currently exploring Trodelvy for first-line post-endocrine hormone receptor-positive, HER2-negative metastatic breast cancer patients in the phase three ASCENT-07 trial. We now expect to provide an update from this trial before the end of the year. On slide 18, we are highlighting overall survival results shared at ASCO earlier this month from arm A1 of the phase two EDGE gastric study, evaluating domvanalimab, our Fc silent anti-TIGIT, plus zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic upper gastrointestinal cancers. In the 41 patients who received the novel regimen in this analysis, the median overall survival was 26.7 months. These findings were simultaneously published in Nature Medicine. These data are in a small number of patients.

Speaker #5: We now expect to provide an update from this trial before the end of the year. On slide 18, we are highlighting overall survival results shared at ASCO earlier this month from ARM A, one of the Phase 2 EDGE gastric studies evaluating Domvanalimab.

Speaker #5: Our FC silent Anti-tigit plus Zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic upper gastrointestinal cancers . In the 41 patients who received the novel regimen in this analysis , the median overall survival was 26.7 months .

Speaker #5: These findings were simultaneously published in Nature Medicine . These data are in a small number of patients . Survival results for this patient population still need to be confirmed in our ongoing phase three star , 2 to 1 trial .

[Analyst]: Survival results for this patient population still need to be confirmed in our ongoing phase three STAR-221 trial, evaluating domvanalimab plus zimberelimab and chemotherapy in patients with metastatic upper gastrointestinal cancers. We continue to expect an update from the event-driven STAR-221 trial in 2026. We also continue to develop domvanalimab plus zimberelimab and chemotherapy in first-line metastatic non-small cell lung cancer in the phase three STAR-121 trial. Moving to cell therapy on slide 19, and on behalf of Cindy and the Kite team, you can see that we have strengthened our in vivo capabilities. The in vivo cell therapies are potentially off-the-shelf products that could shorten the time it takes to treat patients and are also expected to have more simplified and cost-effective manufacturing processes. Given these potential advantages over autologous CAR-T, we believe in vivo could unlock broad access to cell therapies.

Speaker #5: Evaluating Domvanalimab plus Zimberelimab and chemotherapy in patients with metastatic upper gastrointestinal cancers. We continue to expect an update from the event-driven STAR 2 to 1 trial in 2026.

Speaker #5: We also continue to develop Domvanalimab plus Zimberelimab and chemotherapy in first line metastatic non-small cell lung cancer . In the phase three star 121 trial .

Speaker #5: Moving to cell therapy on slide 19 and on behalf of Cindy and the kite team , you can see that we have strengthened our in vivo capabilities .

Speaker #5: The in vivo cell therapies are potentially off the shelf products that could shorten the time it takes to treat patients and are also expected to have more simplified and cost effective manufacturing processes .

Speaker #5: Given these potential advantages over autologous Car-T , we believe in vivo could unlock broad access to cell therapies . With that in mind , we have welcomed the interiors team into the kite family , adding a novel in vivo platform and a strong IP portfolio .

[Analyst]: With that in mind, we have welcomed the INTERIOUS team into the Kite family, adding a novel in vivo platform and a strong IP portfolio. We have also entered into a new research and licensing collaboration with PREGENE Biopharma. It's early days for in vivo, but we're excited to accelerate our exploration of the opportunities these technologies could bring to patients. As we step up our investment in in vivo therapies, we remain committed to our current Yescarta and Tecartus portfolios. For example, FDA recently granted priority review for Yescarta in primary CNS lymphoma, with a PDUFA date in February 2026. Primary CNS lymphoma is a rare yet aggressive subtype of non-Hodgkin's lymphoma that affects the central nervous system. Additionally, CD19 CAR-T products, including Yescarta, have recently received a category 2A recommendation from the NCCN for Richter's transformation.

Speaker #5: We have also entered into a new research and licensing collaboration with Prejean Biopharma . It's early days for in vivo , but we're excited to accelerate our exploration of the opportunities these technologies could bring to patients .

Speaker #5: As we step up our investment in in vivo therapies , we remain committed to our current Yescarta and tecartus portfolios . For example , FDA recently granted priority review for Yescarta in primary CNS lymphoma with a date in February 2026 .

Speaker #5: Primary CNS lymphoma is a rare yet aggressive subtype of non-Hodgkin's lymphoma that affects the central nervous system . Additionally , Cd19 , Car-T products , including Yescarta , have recently received a category two recommendation from the NCCN for Richter's transformation .

Speaker #5: We are pleased with these review and guideline decisions , which will provide HCP with additional opportunities to prescribe Yescarta for our next generation Car-ts .

[Analyst]: We are pleased with these review and guideline decisions, which will provide HCPs with additional opportunities to prescribe Yescarta. For our next-generation CAR-Ts, we look forward to sharing phase one data from Kite 753 and Kite 363 in lymphoma at an upcoming medical congress later this year, as well as pivotal phase two initiation of Kite 753 for third-line large B-cell lymphoma in the first quarter of 2026. In autoimmune diseases, Kite 363 is enrolling patients for its phase one trial in rheumatology, and a phase one study in neuroinflammatory conditions is expected to start in the first quarter of 2026. We look forward to providing updates from these earlier stage programs. Together with our partner, Arcellx, we plan to share additional follow-up data from the pivotal IMAGINE-1 trial of anidocabtagene autoleucel at an upcoming medical meeting.

Speaker #5: We look forward to sharing phase one data from Kite 753 and kite 363 . In lymphoma at an upcoming medical congress later this year , as well as pivotal phase two initiation of Chi 753 for third line large B cell lymphoma in the first quarter of 2026 .

Speaker #5: In autoimmune diseases , kite 363 is enrolling patients for its phase one trial in rheumatology , and a phase one study in neuro conditions is expected to start in the first quarter of 2026 .

Speaker #5: We look forward to providing updates from these early stage programs together with our partner , our Caelyx . We plan to share additional follow up data from the pivotal imagine one trial of Anido cell at an upcoming medical meeting .

Speaker #5: We continue to believe Anido cell has the potential to offer a best in class efficacy and safety profile for patients with relapsed and or refractory multiple myeloma .

[Analyst]: We continue to believe anidocabtagene autoleucel has the potential to offer a best-in-class efficacy and safety profile for patients with relapsed and/or refractory multiple myeloma. The target commercial launch in fourth-line plus relapsed and/or refractory multiple myeloma remains in 2026. On slide 20, I will quickly highlight the key milestone updates. First, we have received European Commission marketing authorization of Hepcludex and remain on track to provide updates for our phase three ARTISTRY-1 and ARTISTRY-2 trials for Biktarvy and for our pivotal phase two IMAGINE-1 trial for anidocabtagene autoleucel in the fourth quarter. Finally, we now also expect ASCENT-07 data in the fourth quarter. With that, I'll turn over the call to Andy. Thank you, Dietmar, and good afternoon, everyone. Starting on slide 22, our third-quarter results showed continued strong execution across the company.

Speaker #5: The target commercial launch in fourth line plus relapsed and or refractory multiple myeloma remains in 2026 . On slide 20 . I will quickly highlight the key milestone updates .

Speaker #5: First, we have received European Commission marketing authorization of year 12 and remain on track to provide updates for our Phase 3 artistry.

Speaker #5: One and artistry two . Trials for Biglen and for our pivotal phase two . Imagine one trial for Anido cell in the fourth quarter .

Speaker #5: Finally , we now also expect a Centos7 data in the fourth quarter . With that , I'll turn over the call to Andy .

Speaker #6: Thank you . Dietmar , and good afternoon everyone . Starting on slide 22 , our third quarter results showed continued strong execution across the company .

Speaker #6: Our base business was up 4% year over year to $7.1 billion , driven by growth in Biktarvy , Descovy and Lib Ze Veklury .

[Analyst]: Our base business was up 4% year-over-year to $7.1 billion, driven by growth in Biktarvy, Descovy, and Livdelvy. Veklury sales were down 60% year-over-year to $277 million, which continued to reflect fewer COVID-related hospitalizations. Including Veklury sales, total product sales were $7.3 billion. Moving to slide 23, you can see we benefited from a $400 million contribution in royalty, contract, and other revenues in the third quarter. This relates to an IP asset sale from 2018. Given we are now able to reasonably estimate future royalty and milestone payments, we are required to recognize this revenue in the third quarter. This is a non-recurring accounting item and does not reflect cash received during the quarter.

Speaker #6: Sales were down 60% year over year to $277 million , which continued to reflect fewer Covid related hospitalizations , including veklury sales . Total product sales were $7.3 billion .

Speaker #6: Moving to slide 23, you can see we benefited from a $400 million contribution in royalty contract and other revenues in the third quarter.

Speaker #6: This relates to an IP asset sale from 2018 . Given we are now able to reasonably estimate future royalty and milestone payments . We are required to recognize this revenue in the third quarter .

Speaker #6: This is a non-recurring accounting item and does not reflect cash received during the quarter . As a reminder , this contribution was not part of our product sales and therefore did not impact our product gross margin .

[Analyst]: As a reminder, this contribution was not part of our product sales and therefore did not impact our product gross margin in the third quarter, but it does otherwise flow through to the bottom line, contributing approximately $0.25 after tax. Moving to our non-GAAP results on slide 24. Third-quarter product gross margin was 86%, in line with 87% in the third quarter of 2024. R&D expenses of $1.3 billion were down 3% compared to the third quarter of 2024. Year-to-date, 2025 R&D expenses were $4.1 billion, in line with 2024, suggesting we are on track for our full-year goal. Acquired IP R&D expenses were $170 million in the third quarter, including a $120 million upfront payment to PREGENE Biopharma for a research and licensing collaboration in the in vivo cell therapy space.

Speaker #6: In the third quarter . But it does otherwise flow through to the bottom line , contributing approximately $0.25 after tax . Moving to our non-GAAP results on slide 24 .

Speaker #6: Third quarter product gross margin was 86% , in line with 87% in the third quarter of 2020 . For R&D expenses of $1.3 billion were down 3% compared to the third quarter of 2020 .

Speaker #6: For year to date , 2025 , R&D expenses were $4.1 billion , in line with 2020 . For suggesting we are on track for our full year goal .

Speaker #6: Acquired IP , R&D expenses were 170 million in the third quarter , including a $120 million upfront payment to pre for a research and licensing collaboration in the in vivo cell therapy space .

Speaker #6: SG&A expenses of $1.4 billion were down 4% compared to the third quarter of 2020, four modestly lower than we expected due to the timing of spending.

[Analyst]: SG&A expenses of $1.4 billion were down 4% compared to the third quarter of 2024, modestly lower than we expected due to the timing of spending. Third-quarter operating margin was 50%, reflecting the continued focus on operating expense discipline and leverage. The non-GAAP effective tax rate was 18% this quarter, slightly below our expectations due to a $79 million tax settlement. Finally, non-GAAP diluted EPS was $2.47 for the quarter. Excluding the $400 million non-recurring other revenue, non-GAAP diluted EPS would have been $2.22 for the third quarter. Moving to our full-year guidance on slide 25, we are raising the low end of our product sales range by $100 million to reflect our strong performance year-to-date. As a reminder, the $400 million included in our royalty, contracts, and other revenue in the third quarter does not impact our full-year guidance, as we do not guide to total revenue.

Speaker #6: Third quarter operating margin was 50% , reflecting the continued focus on operating expense , discipline and leverage . The non-GAAP effective tax rate was 18% this quarter , slightly below our expectations due to a $79 million tax settlement and finally , non-GAAP diluted EPs was $2.47 for the quarter .

Speaker #6: Excluding the $400 million non-recurring other revenue , non-GAAP diluted EPs would have been $2.22 for the third quarter . Moving to our full year guidance on slide 25 , we are raising the low end of our product sales range by $100 million to reflect our strong performance year to date as a reminder , the 400 million included in our royalty contracts and other revenue in the third quarter does not impact our full year guidance , as we do not guide to total revenue .

Speaker #6: We now expect total product sales excluding Veklury , to be between 27.4 billion and 27.7 billion , primarily reflecting higher HIV growth driven by the outperformance of both Biktarvy and Descovy .

[Analyst]: We now expect total product sales, excluding Veklury, to be between $27.4 billion and $27.7 billion, primarily reflecting higher HIV growth. Driven by the outperformance of both Biktarvy and Descovy year-to-date, we now anticipate our HIV franchise will grow approximately 5% year-over-year versus our prior guidance of 3%. Consistent with last quarter, I'll note that our assumptions for the impact of the Medicare Part D redesign remain unchanged from the beginning of the year, and we continue to expect approximately $900 million of impact to our HIV business in 2025. Our 2025 assumptions for Sunlenca also remain unchanged, and we remain very encouraged by the launch so far, particularly the accelerated timeline for payer coverage. In other parts of our business, strength in HIV is expected to be partially offset by weaker cell therapy estimates, where we now forecast approximately a 10% decline for full-year 2025 versus full-year 2024.

Speaker #6: Year to date , we now anticipate our HIV franchise will grow approximately 5% year over year versus our prior guidance of 3% . Consistent with last quarter .

Speaker #6: I'll note that our assumptions for the impact of the Medicare Part D redesign remain unchanged from the beginning of the year , and we continue to expect approximately $900 million of impact to our HIV business in 2025 .

Speaker #6: Our 2025 assumptions for Yaz To-Go also remain unchanged , and we remain very encouraged by the launch . So far . Particularly the accelerated timeline for payer coverage in other parts of our business .

Speaker #6: Strength in HIV is expected to be partially offset by weaker cell therapy estimates , where we now forecast approximately a 10% decline for full year 2025 versus full year 2024 .

Speaker #6: For Veklury . We continue to expect full year revenue of approximately $1 billion as a result , total product sales are anticipated to be in the range of 28.4 to $28.7 billion .

[Analyst]: For Veklury, we continue to expect full-year revenue of approximately $1 billion. As a result, total product sales are anticipated to be in the range of $28.4 to $28.7 billion. As noted earlier, this reflects a $100 million increase at the low end of the range from our previous guidance. Finally, we continue to expect the impact of known tariffs to be manageable in 2025. Moving to the rest of the P&L, there is no change to our prior non-GAAP guidance for product gross margin, R&D, and SG&A expenses. We continue to expect product gross margin of approximately 86%. R&D expenses to be roughly flat on a dollar basis from 2024, and SG&A expenses to decline by a mid to high single-digit % compared to 2024. Similar to last year, we expect a step up in both R&D and SG&A expenses in the fourth quarter, reflecting normal end-of-year trends.

Speaker #6: As noted earlier , this reflects a $100 million increase at the low end of the range from our previous guidance . Finally , we continue to expect the impact of known tariffs to be manageable in 2025 .

Speaker #6: Moving to the rest of the PNL . There is no change to our prior non-GAAP guidance for product gross margin , R&D and SG&A expenses .

Speaker #6: We continue to expect product gross margin of approximately 86% , R&D expenses to be roughly flat on a dollar basis from 2024 , and G&A expenses to decline by a mid to high single digit percentage compared to 2024 .

Speaker #6: Similar to last year . We expect a step up in both R&D and G&A expenses in the fourth quarter , reflecting normal end of year trends .

Speaker #6: We have updated our IP , R&D expectations for the full year to reflect our actuals through the third quarter , and our known fourth quarter commitments , including $300 million relating to the interior acquisition .

[Analyst]: We have updated our IP R&D expectations for the full year to reflect our actual through the third quarter and our known fourth-quarter commitments, including $300 million relating to the INTERIOUS acquisition. We now expect full-year acquired IP R&D to be $900 million. Rounding out the P&L, we expect operating income to be between $13.1 billion and $13.4 billion, reflecting an increase of $100 million at the low end of the prior guidance range. We continue to expect our effective tax rate to be approximately 19%. Finally, we expect non-GAAP EPS in the range of $8.05 and $8.25, raising non-GAAP EPS by $0.10 at the low end of the range. GAAP EPS is expected to be in the range of $6.65 to $6.85. On slide 26, our capital priorities remain unchanged, and we returned $1.4 billion to shareholders in the third quarter, which included $435 million of share repurchases.

Speaker #6: We now expect full year acquired IPR to be $900 million . Rounding out the PNL , we expect operating income to be between 13.1 billion and $13.4 billion , reflecting an increase of 100 million at the low end of the prior guidance range .

Speaker #6: We continue to expect our effective tax rate to be approximately 19% . And finally , we expect non-GAAP EPs in the range of $8.05 and $8.25 , raising non-GAAP EPs by $0.10 at the low end of the range , GAAP EPs is expected to be in the range of $6.65 to $6.85 .

Speaker #6: On slide 26 , our capital priorities remain unchanged , and we returned $1.4 billion to shareholders in the third quarter , which included 435 million of share repurchases .

Speaker #6: These repurchases are intended to offset equity dilution at a minimum , but can also be used opportunistically . As you've seen in the first three quarters of 2025 , overall , we are pleased with the strong performance this quarter , highlighted by our clinical and commercial execution and supported by our disciplined operating model .

[Analyst]: These repurchases are intended to offset equity dilution at a minimum but can also be used opportunistically, as you've seen in the first three quarters of 2025. Overall, we are pleased with the strong performance this quarter, 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. 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, and to withdraw your question, press star two. First question comes from Geoff Meacham at Citigroup. Geoff, go ahead. Your line is open. Oh, great. Okay. Hey, guys.

Speaker #6: 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 #1: 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 #1: Again , to ask a question , press star one and to withdraw your question , press star two .

Speaker #7: First question comes from Geoff Meacham at Citigroup . Jeff , go ahead . Your line is open .

Speaker #8: Oh , great . Okay . Hey , guys . Thanks so much for the question . Congrats on the quarter . And Hugo , I know it's early .

[Analyst]: Thanks so much for the question. Congrats on the quarter. On Sunlenca, I know it's early. I wanted to see if you had any color on patients switching from Descovy versus those who were brand new to PrEP. Related, just looking to the balance of the year, are there any demand drivers that could give you some momentum going into 2026? Thank you. Thanks, Geoff, and welcome. I'll hand it right over to Johanna. Great. Thanks, Geoff. Yeah, so we're really excited about the launch so far and really much in line with our expectations of an injectable into an oral market. To your point about where the Sunlenca sourcing is coming from, it's really across the board.

Speaker #8: I wanted to see if you had any color on patients switching from Descovy versus those who are brand new to Prep . And then related , but just looking to the balance of the year , are there any demand drivers that could you could give you some momentum going into 2026 ?

Speaker #8: Thank you . Thanks ,

Speaker #9: Jeff, and welcome. I'll hand it right over to Joanna.

Speaker #7: Great . Thanks , Jeff .

Speaker #4: Yeah . So we're really excited about the launch so far . And and really much in line with our expectations of an injectable into an oral market .

Speaker #4: To your point , about where the . Yes . Goes sourcing is coming from , it's really across the board . So it's more switches , as you'd expect in this marketplace versus naive .

[Analyst]: It's more switches, as you'd expect, in this marketplace versus naive, but really across the switches, what we're really pleased to see is that we're getting the source of business actually coming from the long-acting injectable currently on the market, also the oral branded, such as Descovy, but also oral generics. You're seeing a real nice balanced mix across the board for switches, and we expect that to continue. Of course, as the market grows and continues to grow and the awareness of Sunlenca increases, we also believe that the naive patient population will also grow with time as well. Our next question comes from Umar Rifaat. Umar, go ahead. Your line is open. Thank you, guys. Quick question. I noticed a $39 million sales number in Q3, and I'm trying to make sense of it. By my rough math, it sounds like about 3,000 patients initiated in Q3.

Speaker #4: But really across the switches , what we're really pleased to .

Speaker #7: See is that we're getting the source of business is actually . coming from the long acting injectable currently on the market . Also , the oral branded , such as Descovy , but also oral generics .

Speaker #7: And so you're seeing a real nice balanced mix across the board for switches . And we we expect that to continue . And of course , as , as the market grows and continues to grow in the the awareness of yes to go increases , we also believe that the naive patient population will also grow with time as well .

Speaker #7: Our next .

Speaker #1: Question comes from Umer Raffat Umer . Go ahead , your line is open .

Speaker #10: Thank you guys . Quick question . I noticed $39 million sales number in three . Q And I'm trying to make sense of it by my rough math , it sounds like it sounds like about 3000 patients initiated in three .

Speaker #10: Q is that consistent with how you see it ? And I ask because IMS was implying something like 2300 patients . So I'm just trying to get a sense of it all .

[Analyst]: Is that consistent with how you see it? I ask because IMS was implying something like 2,300 patients, so I'm just trying to get a sense of it all. Thank you. Thanks, Umar, for the question. Maybe I'll give a little bit more context to Sunlenca in light of your question. Not that we've been sharing patients per se. But we do have year-to-date about. Year-to-date as of the Q3 quarter, about $54 million in sales. Some of that was in early June, right? In late June for inventory purposes, about $15 million of that. We've really seen that inventory flow through, so there's really no more stocking left in the system. We've been tracking a lot of different indicators to make sure that our launch is on the right track. We're really excited because we see the access piece as one of the most important indicators for the future.

Speaker #10: Thank you .

Speaker #7: Thanks for the question . Maybe I'll give a little bit more context to Yasuko in light of your question . And not that we've been sharing patients per se , but we do have year to date , about year to date .

Speaker #7: As of the Q3 quarter , about $54 million in sales . Some of that was in early June . In late June , for inventory purposes , about $15 million of that .

Speaker #7: And we've really seen that inventory flow through . So there's really no more stocking left in the system . We we've been tracking a lot of different indicators to make sure that we our launches on the right track .

Speaker #7: And so we're really excited because we see the .

Speaker #4: Access piece as one of the most important indicators for the future . And and meeting the 75% coverage for access , almost three months ahead of schedule , with very limited prior auth and basically zero co-pays .

[Analyst]: Meeting the 75% coverage for access almost three months ahead of schedule with very limited prior auths and basically zero copays really sets us up nicely, actually, as you think about 2026 and beyond. UnitedHealth, ESI, many other commercial plans are on board. We have about 20 out of the 25 large PrEP states for Medicaid. That represents just over 80% of the Medicaid volume. That's really been our focus. Of course, the J code coming on as of October 1, all of this would support buy-and-bill modeling as well. These access wins are recent, and obviously, it's going to take a little bit of time account by account to pull it through and integrate it within the practices. I think it really provides that platform for us to accelerate the uptake for Sunlenca. We've also seen conversion rates basically from script to approval really drop dramatically.

Speaker #4: It really sets us up nicely , actually , as you think about 2026 and beyond , the the UnitedHealth Esai , many other commercial plans are on board .

Speaker #4: We have about 20 out of the 25 large prep states for Medicaid . That represents just over 80% of the Medicaid volume . So that's really been our focus .

Speaker #4: And of course , the j-code coming on as of October 1st . All of this would support buy and Bill modeling as well .

Speaker #4: And so these access plans are recent. Obviously, it's going to take a little bit of time, account by account, to pull it through.

Speaker #4: And integrate it within the practices . But I think it really provides that platform for us to accelerate the uptake for us to go .

Speaker #4: We've also seen conversion rates basically from script to approval really drop dramatically . And so we continue to focus on the logistics to make sure we get the drug and the patient schedules aligned .

[Analyst]: We continue to focus on the logistics to make sure we get the drug and the patient schedules aligned shortly after the reimbursement approval. I would say from an overall standpoint, super pleased about what we track are the intakes, the access, HCP awareness and interest, the conversion rates that I just referred to, and everything is going in the right direction. We do expect full-year Sunlenca sales of around $150 million or so, including the $54 million year-to-date. Hopefully, that gives you a bit of perspective. As you get the full year, you can have a better understanding of patient numbers. Our next question comes from Mohit Bansal. Mohit, go ahead. Your line is open. Great. Thank you very much for taking my question and congrats on all the progress.

Speaker #4: Shortly after the reimbursement approval . And so I would say , you know , from a from a overall standpoint , super pleased about the what we track are the intakes , the access HCP awareness and interest , the conversion rates that I just referred to and everything is going in the right direction .

Speaker #4: So we do expect full year . Yes , to go sales of around $150 million or so , including the $54 million year to date .

Speaker #4: So hopefully that gives you a bit of perspective . And then as you get the full year , you can have a better understanding of patient numbers .

Speaker #11: Our next question comes from Mohit Bansal . Mohit go ahead . Your line is open .

Speaker #12: Great . Thank you very much for taking my question and congrats on all the progress . Switching a little bit to HIV treatment , now that you're guiding for 5% year over year growth , combined that with the $900 million of Pardi redesign impact you're taking does seem like HIV is at , what , 9 to 10% ?

[Analyst]: Switching a little bit to HIV treatment, now that you are guiding for 5% year-over-year growth, combine that with the $900 million of Part D redesign impact you are taking, it does seem like HIV is growing at, what, 9 to 10%. I mean, can you talk a little bit about that? How should we think about it going forward, given that you have had such an impressive growth this year? Thanks, Mohit, for that. I do agree with you. I think we've had such an impressive growth, and it's really driven by a couple of things. It's driven by the market, both in treatment and in PrEP, and real demand-driven growth, specifically Biktarvy, Descovy are really the ones that are impacting this year's growth. As you think about Biktarvy growing year-on-year about 6%. As to your point, despite Part D redesign, those assumptions have not changed.

Speaker #12: I mean , can you can you talk a little bit about that ? How should we think about it going forward , given that you have had such an impressive growth this year ?

Speaker #4: Thanks , Mohit , for that . The I do agree with you . I think we've had such an impressive growth and it's really driven by a couple of things .

Speaker #4: It's driven by the market both in treatment and in Prep and real demand driven growth . Specifically with Tavi . Descovy are really the ones that are impacting .

Speaker #4: This year's growth . So as you think about the growing year on year , about 6% . On this and this , to your point is , despite part D redesign and those assumptions have not changed .

Speaker #4: And Biktarvy Biktarvy growing at six points , but also descovy growing at about 20% . And if you think about just for prep , when if you think about the three quarters of that product being driven by prevention , you're looking at almost over 30% growth

[Analyst]: Biktarvy growing at 6 points, but also Descovy growing at about 20%. If you think about just for PrEP, if you think about the three-quarters of that product being driven by prevention, you're looking at almost over 30% growth for Descovy, let alone if you think about HIV prevention at Gilead, it's over 40%. Both HIV treatment and HIV prevention are really driving the growth. You could assume that actually, if Part D redesign hadn't played out, we would probably be around the numbers you were talking about, 8 to 9%. Our next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead. Your line is open. Good afternoon. Thanks for taking my question. Could you just comment on the inventory impact for Sunlenca in the third quarter and also how the CVS pricing discussions are progressing? Thank you. Sure, Salveen. It's Johanna again. A couple of things.

Speaker #4: for Descovy , let alone if you think about HIV prevention at Gilead , is over 40% . So both HIV growing treatment and HIV prevention are really driving the growth and you could assume that actually , if part D , we design hadn't played out , we would probably be around the numbers you were talking about 8 to 9% .

Speaker #11: Our next question comes from Salveen Richter at Goldman Sachs . Salveen . Go ahead .

Speaker #1: Your line is open .

Speaker #13: Good afternoon . Thanks for taking my question . Could you just comment on the inventory impact for you ? In the third quarter ?

Speaker #13: And also how the CVS pricing discussions are progressing ? Thank you . Sure .

Speaker #4: It's Joanna again , a couple of things . One is in the Q3 , there's really no inventory buy in . It really happened in the first two weeks .

[Analyst]: One is, in the Q3, there's really no inventory buy-in. It really happened in the first two weeks, the last two weeks of June, sorry, the first two weeks of our launch. That really got pulled through in the first months of Q3. What you're seeing in the 39 is really true demand coming through. That's the inventory piece of the puzzle. From a CVS access standpoint, payers all have different timelines as to how they make formulary decisions. We're working with every single one of the payers to make sure we go as quickly as possible to secure access while also ensuring that the innovative value of Sunlenca gets recognized. Our discussions with the remaining 25% of payers, including CVS, are ongoing. We're very confident about our ability to reach the goals that we've set forth, which is the 90% at the first year of launch.

Speaker #4: The last two weeks of June . Sorry , the first two weeks of our launch and and that really got pulled through in the first months of Q3 .

Speaker #4: And then what you're seeing in the 39 is really true . Demand coming through . So that's the inventory piece of the puzzle from a CVS access standpoint .

Speaker #4: You know , payers all have different timelines as to how they make formulary decisions . And we're working with every single one of the payers to make sure we go as quickly as possible to secure access , while also ensuring that the innovative value of Hugo gets recognized .

Speaker #4: And so our discussions with the remaining 25% of payers , including CVS , are ongoing , and we're very confident about our ability to reach the goals that we've set forth , which is the 90% .

Speaker #4: At the first year of launch . So we're very confident to that . We're on track to reach those numbers .

[Analyst]: We're very confident that we're on track to reach those numbers. Our next question comes from Evan Seigerman at BMO Capital Markets. Evan, go ahead. Your line is open. Hi, all. Thank you so much for taking my question. Livdelvy continues to perform exceptionally well and appears to be succeeding as a clear strategic fit to your business. Can you just talk to me about the level of appetite for additional BD and liver-focused indications such as NASH? Andy, why don't you start there? Sure. Hi, Evan. Thanks for the question. Look, I mean, as we've said, we don't comment specifically on any subsectors. We are looking actively at opportunities across the BD spectrum in all of our areas of strategic interest. That includes liver disease as well as oncology, cell therapy broadly, virology, and immunology.

Speaker #1: Our next question comes from Evan Seigerman at BMO Capital Markets . Evan , go ahead . Your line is open .

Speaker #14: Hi. Thank you so much for taking my question. It continues to perform exceptionally well, and it appears to be succeeding as a clear, strategic fit to your business.

Speaker #14: Can you just talk to me about the level of appetite for additional BD and liver focused indications such as Nash ?

Speaker #9: Andy , why don't you start there ?

Speaker #15: Sure . Hi . Thanks for the question . Look , I mean , as we've said , we don't comment specifically on on any subsectors .

Speaker #15: We are looking actively at opportunities across the BD spectrum in all of our areas of strategic interest . That includes liver disease as well as oncology , cell therapy .

Speaker #15: Broadly , virology and immunology . And we've said consistently and continue to believe that we would like to add more therapies just like liver cells that are best in class therapies that that serve patients in need on a regular basis .

[Analyst]: We've said consistently and continue to believe that we would like to add more therapies just like Livdelvy that are best-in-class therapies that serve patients in need on a regular basis. We would look for those late-stage de-risked assets every two to three years at a minimum to kind of add them to our portfolio. When you step back, I think we are really pleased with the size and shape of our portfolio, all of the growth drivers that we have, the additional launches that you heard Dietmar talk about in his prepared remarks. We would like to add additional growth drivers. Of course, we'll be disciplined in doing that. Yes, you should expect that we're going to be looking at deals across all of our sectors, including liver disease. Our next question comes from Chris Schott at JPMorgan. Chris, go ahead. Your line is open. Great. Thanks so much.

Speaker #15: And we would look for those late stage de-risked assets every 2 to 3 years at a minimum , to kind of add them to our portfolio .

Speaker #15: So we're , you know , when you step back , I think we are really pleased with the size and shape of our portfolio .

Speaker #15: All of the growth drivers that we have , the additional launches that you heard Dietmar talk about in the prepared , his prepared remarks , and we would like to add growth , additional growth drivers .

Speaker #15: And of course , we'll be disciplined in doing that . So but yes , you should expect that we're going to be looking at deals across all of our sectors , including liver disease .

Speaker #1: Our next question comes from Chris shot at JPMorgan . Chris , go ahead . Your line is open .

Speaker #16: Great . Thanks so much . Can I just dig into just to go in for Q and heading into 26 and a little bit more detail , I mean , it seems like you're pointing to a step up in in sales next quarter , but we're getting obviously a lot of coverage .

[Analyst]: Can I just dig into Sunlenca in Q4 and heading into 2026 in a little bit more detail? I mean, it seems like you're pointing to a step up in sales next quarter, but we're getting, obviously, a lot of coverage. I'm just trying to understand a little bit more about how you're envisioning the shape of the curve. Is this kind of like a gradual acceleration or a bigger step function as we move into 2026? I'm just trying to get, again, a little bit more color on that dynamic. Thanks so much. Chris, it's Johanna. I think that's a fair question. I think what we're seeing is a lot of the access to get us to the 75% goal most recently really happened in the last couple of weeks. It's important to understand that those don't turn on just overnight.

Speaker #16: I'm just trying to understand a little bit more about how you're envisioning the shape of the curve . Is this kind of like a gradual acceleration or a bigger step function as we move into 2026 ?

Speaker #16: I'm just trying to get , again , a little bit more color on that , that dynamic . Thanks so much .

Speaker #4: So Chris , is Joanna . I think that's a fair question . I think what we're seeing is a lot of the access to get us to the 75% goal .

Speaker #4: Most recently really happened in the last couple of weeks . And so it's important to understand that , you know , those don't turn on , you know , just overnight .

Speaker #4: And so practices need to actually integrate these changes into their working practices . And so we're working with them to make sure that happens .

[Analyst]: Practices need to actually integrate these changes into their working practices. We're working with them to make sure that happens. Same thing goes for the J code. Some people will update right away. Some people update biannually. January 1st could be, for some, that update to really help the buy-and-bill. Folks that are interested in buy-and-bill. We do believe it's going to be a gradual ramp-up. For us, it really sets up the platform for the ramp for Sunlenca in 2026. That's what we're kind of focusing on. Our next question comes from James Shin at Deutsche Bank. James, go ahead. Your line is open. Hi. Thank you for the question. Johanna, could you just give us an update on Sunlenca's buy-and-bill and white bagging mix? Does reaching this 75% ahead of schedule equate to reaching a bigger portion of white bagging sooner? Thank you. Sure.

Speaker #4: Same thing goes for the J-code . Some people will update right away . Some people update biannually . And so and so January 1st could be kind of for some that update to really help the buy and build folks that are interested in buy and bill .

Speaker #4: And so we do believe it's going to be a gradual ramp up . And then for us it really sets up the platform for the ramp for us to go in 2026 .

Speaker #4: And so that's what we're kind of focusing on.

Speaker #1: Our next question comes from James Shin at Deutsche Bank . James go ahead . Your line is open .

Speaker #17: Hi . Thank you for the question , Joanna . Could you just give us an update on buy and Bill and white mix and does reaching this 75% ahead of schedule equate to reaching a bigger portion of white bagging sooner ?

Speaker #17: Thank .

Speaker #13: Sure .

Speaker #4: So the white bagging and the buy and bill , you'd expect if you remember at our HIV day in 2024 , we did kind of share that would be heavier to the white bagging and and buy and bill would build over time .

[Analyst]: The white bagging and the buy-and-bill, you'd expect, and if you remember, at our HIV day in 2024, we did kind of share that it would be heavier to the white bagging. Buy-and-bill would build over time. That's exactly what we're seeing. Much more in this coming through, the scripts are going to specialty pharmacy, going through that process, and then white bagging back to the clinic. Probably more towards about three-quarter range, in the 70 to 80%. The rest of that is buy-and-bill. That's not steady state, obviously, and that's going to change over time as people get more comfortable and as they integrate the J code as well into their practice. All of those things will evolve. For right now, that's what we're seeing. Our next question comes from Daina Graybosch at Leerink Partners. Daina, go ahead. Your line. Thank you. Another one on Sunlenca.

Speaker #4: And that's exactly what we're seeing . So much more in this , you know , coming through the scripts are going to specialty pharmacy going through that process and then white bagging back to the clinic , probably more towards about three quarters range in the 70 to 80% .

Speaker #4: And then the rest of that is buy and bill . That not steady state obviously . And that's going to change over time as people get more comfortable and get in and as they integrate the j-code as well into their practice .

Speaker #4: So all of those things will evolve . But for right now , that's what we're seeing .

Speaker #1: Our next question comes from Dana Grabosch at Leerink Partners . Dana , go ahead . Your line .

Speaker #13: Is .

Speaker #18: Thank you . Another one on just Hugo . I mean , you've said several times that in the 75% covered lives , you've been pleased by the level of restriction .

[Analyst]: You've said several times that in the 75% covered lives, you've been pleased by the level of restriction. I wonder if you could give us a little more detail to how much of the lives have prior auths or copay or any other restrictions to certain types of practices, for instance. What we're seeing thus far, and it's still early, right, because we're trying to see how this all plays out. Most of the plans so far have added Sunlenca to their formulary with zero copays. High 80s, if you're looking for a number, and very few step edits and prior auths. If they are, they're very simple. We do think it's really important. It's one thing to have access. The quality of the access is also very important for us. To make sure that the people who may want or need PrEP can have access to it.

Speaker #18: I wonder if you could give us a little more detail about how much of the lives have prior authorizations or co-pays, or any other restrictions, such as limitations to certain types of practices.

Speaker #18: For instance .

Speaker #13: So .

Speaker #4: What we're seeing thus far , and it's still early , right ? Because we're trying to . See how this all plays out .

Speaker #4: But most of the plans so far have added yes to go to their formulary with zero copays . So high 80 . If you're looking for a number and a very few step edits and prior offs , and if they are , they're very simple .

Speaker #4: And so we do think it's really important . It's one thing to have access the quality of the access is also very important for us .

Speaker #4: And and to make sure that the people who may want or need Prep can have access to it . And that's very much in line .

[Analyst]: That's very much in line. Those goals were set because of Descovy. Descovy, as of September, access is at about 99% of lives covered with about 88% no restrictions. That gives you a little bit of a flavor of the direction of where Sunlenca is going. Not there yet, but definitely well on its way. Our next question comes from Brian Abrahams at RBC Capital Markets. Brian, go ahead. Your line is open. Hi there. Thanks so much for taking my question. Maybe just another one on Sunlenca. Johanna, can you maybe talk a bigger picture about what the patient journey is like here for getting an appointment with a physician, obtaining and getting Sunlenca administered, maybe how that's comparing to your expectations, how that could evolve? Really just wondering, what are the biggest barriers for a patient wanting to switch to do so? Thanks. Yeah, sure, Brian.

Speaker #4: I mean , those goals were set because of Descovy , and Descovy is as of September , access is at about 99% of lives covered with about 88% unrestricted in no restrictions .

Speaker #4: And so that gives you a little bit of a flavor of kind of the direction of where US two go is going , not there yet , but definitely well on its way .

Speaker #1: Our next question comes from Brian Abrahams at RBC Capital Markets . Brian go ahead . Your line is open .

Speaker #19: Hi there . Thanks so much for taking my question . Maybe just another one on your two . Can you maybe talk a bigger picture about what the patient journey is like here for getting an appointment with the physician , obtaining and getting as to go administered .

Speaker #19: Maybe . How that's comparing to your expectations , how that could evolve and really just wondering like what are the biggest barriers for a patient wanting to switch to do so ?

Speaker #19: Thanks .

Speaker #4: Yeah , sure . Brian . Happy to do so . And they're changing right . So I'm going to share with you kind of where we're at .

[Analyst]: Happy to do so. They are changing, right? I am going to share with you kind of where we're at, but it's been an evolution even from July on. We're seeing a big difference in the time it takes from prescription. As a physician writes a prescription for someone for Sunlenca and the prescription goes to a specialty pharmacy, for example, and goes through the process, the approval process used to take over a month, and it could take four or five, six weeks. Now, it's more than half down from that timeframe because the access is starting to play in.

Speaker #4: But it's been an evolution even from July on . We're seeing a big difference in the time it takes from prescriptions . So as a physician writes a prescription for someone for us to go and the prescription goes to a specialty pharmacy , for example , and goes through the process .

Speaker #4: It I mean , the approval process used to take over a month . And so it could take 4 or 5 , six weeks .

Speaker #4: Now it's more than half down from that time frame because the access is starting to play in . But then you also have the piece that you just said , which is then how do you make sure that the logistics play out where you get the approval and make sure that the drug gets to the office at the same time as the patient gets back into the office as well .

[Analyst]: You also have the piece that you just said, which is then how do you make sure that the logistics play out where you get the approval and make sure that the drug gets to the office at the same time as the patient gets back into the office as well? That obviously can take a week or two, sometimes more, depending on the patient's availability and the doctor's availability, of course. That is kind of what we're playing out. That is definitely something that was part of our assumptions. Those conversion rates, both from prescription to approval, but approval to office to injection, because that's really when it gets shipped is when it gets captured by IQVIA, for example, that's really what we've been tracking to make sure we minimize that time and support the offices in the logistics of doing so.

Speaker #4: And so that obviously can take , you know , a week or two , sometimes more , depending on the patient's availability and the doctor's availability .

Speaker #4: Of course . And so that's kind of what we're playing out . So that is definitely something that was part of our assumptions .

Speaker #4: But those conversion rates both from prescription to approval but approval to office to injection because that's really when it gets shipped is when it gets captured by Iqvia , for example .

Speaker #4: That's really what we've been tracking to make sure we minimize that time and support the offices in the logistics of doing so . So we're seeing benefits every single month .

[Analyst]: We are seeing benefits every single month and seeing those numbers come down. Obviously, as people get more in tune with the practice, it's going to get easier. On the flip side, I would say buy-and-bill is. Obviously, it cuts out one piece of that because then it's directly within the doctor's office. They get approval, they get product, and then they can kind of start, as buy-and-bill builds, you're going to see a little bit faster turnaround there as well. Hopefully, that helps give you a little bit of a picture of the patient's journey. Our next question comes from Carter Gould at Cantor Fitzgerald. Carter, go ahead. Your line is open. Great. Thank you. Good afternoon. Thanks for taking the question. I hope you'll indulge me on a relatively short-term minded question here on Sunlenca, but we've seen pretty volatile scripts over here the past couple of weeks.

Speaker #4: And seeing those numbers come down . And obviously as people get more in tune with the practice , it's going to get easier .

Speaker #4: On the flip side , I would say by and Bill is is , you know , obviously it cuts out one piece of that because then it , it , it's directly within the doctor's office .

Speaker #4: They get approval , they get product , and then they can kind of start as buy and bill builds . You're going to see a little bit faster turnaround there as well .

Speaker #4: Hopefully that helps give you a little bit of a picture of the patient's journey .

Speaker #1: Our next question comes from Carter Gould at Cantor Fitzgerald Carter . Go ahead . Your line is open .

Speaker #20: Great . Thank you . Good afternoon . Thanks for taking the question . I hope you'll indulge me on relatively short term minded question here on is to go .

Speaker #20: But we've seen pretty volatile scripts over here the past couple of weeks . And I guess my question is , are the TRPs that we're seeing reflective of what you're seeing ?

[Analyst]: I guess my question is, are the TRX that we're seeing reflective of what you're seeing? Is that impacted by third-party PrEP campaigns or more standard demand growth or early impacts from the J code? Any color would be appreciated. Sure, Carter. There's a lot of week-to-week variability with IQVIA versus what we're seeing. Obviously, we track as well. It really depends on the reports that you're looking at within IQVIA as well. I think it's going to take a couple of quarters for this to stabilize a little bit. I think it's a good directional indicator. Depending on the report, just make sure you're looking at both the SP intakes, but also the buy-and-bill and kind of merging those two pieces together. Those two pieces together, although sometimes accounts are missing, directionally are in line with the overall of what we're seeing.

Speaker #20: Is that is that impacted by third party prep campaigns or more standard demand growth or early impacts from the J code ? Any color would be appreciated .

Speaker #4: Dr. Carter , there's a lot of week to week variability with Iqvia versus what we're seeing . Obviously , we track as well , and it really depends on the port that you're looking at within Iqvia as well .

Speaker #4: I think it's going to take a couple of quarters for this to stabilize a little bit . I think it's a good directional indicator and depending on the reports , just make sure you're looking at both .

Speaker #4: You know , the the the SP and intakes , but also the buy and bill and kind of merging those two pieces together .

Speaker #4: Those two pieces together . Although sometimes accounts are missing directionally are in line with the overall of what we're seeing . But the volatility with Iqvia is definitely real right now .

[Analyst]: The volatility with IQVIA is definitely real right now, and I think it's going to take a little while to settle. We've seen that before with other products as well. Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead. Your line is open. Hi. Thanks for taking the questions. Congrats on the quarter. Johanna, just wondering if you can comment at all high level about how we should think about overall PrEP market growth. Obviously, it's been very strong the last couple of quarters, 14%. This quarter, 15%. Last quarter, is that kind of the level we should think about at a franchise for you guys as we head into 2026? Thank you. Sure, Terence. I think that's the right way to think about it. I think 14, 15% is the right approach for this market growth.

Speaker #4: And I think it's going to take a little while to settle . We've seen that before with other products as well .

Speaker #1: Our next question comes from Terrence at Morgan Stanley . Parents , go ahead . Your line is open .

Speaker #21: Hi . Thanks for taking the questions . Congrats on the quarter , Joanna . Just wondering if you can comment at all . High level about , you know , how we should think about overall prep , market growth .

Speaker #21: Obviously , it's been very strong the last couple quarters , 14% this quarter , 15% last quarter . Is that kind of the level we should think about at a franchise for you guys as we head into 2026 ?

Speaker #21: Thank you .

Speaker #4: Sure . Terrance , I think that's the right way to think about it . I think 1,415% is the right approach for this market growth .

Speaker #4: This is obviously fueled by , you know , by many of us to make sure that there's increased awareness of the options within Prep .

[Analyst]: This is obviously fueled by many of us to make sure that there's increased awareness of the options within PrEP. I think that'll continue to be fueled as the noise kind of increases as we go into 2026, whether it's through social media or direct-to-consumer advertising. I would assume about a 14% to 15% growth continuing with PrEP. Our next question comes from Tyler Van Buren at TD Cowen. Tyler, go ahead. Your line is open. Hey, guys. Thanks. Congratulations on the good quarterly results. For Anita Cell, could the filing happen any day or in the very near future? What is left that's required for the filing? We're excited for the data at ASH. Should the expectation be similar efficacy to Carvicti with improved safety, or do you believe there's still room to improve on efficacy? Tyler, we'll hand it over to Cindy to give Johanna a break.

Speaker #4: And I think that will continue to be fueled as the noise kind of increases as we go into 2026 , whether it's through social media or direct to consumer advertising .

Speaker #4: And so I would assume about a 14 , 15% growth continuing with Prep .

Speaker #1: Our next question comes from Tyler Van Buren at TD. Tyler, go ahead. Your line is open.

Speaker #22: Hey , guys . Thanks . Congratulations on a good quarterly results . So for Anita . So could the filing happen any day or in the very near future ?

Speaker #22: What is left that's required for the filing . And we're excited for the data at ash . So should the expectation be similar ?

Speaker #22: Efficacy to Carvykti with improved safety ? Or do you believe there's still room to improve on efficacy ?

Speaker #9: Tyler . We'll hand it over to Cindy to give Joanna a break . Thanks .

Speaker #23: So with Anita , we haven't communicated what our filing dates are , nor will we , but what we have communicated is that we're very much looking forward to a launch second half of next year , and we're definitely on track for that .

[Analyst]: With Anita Cell, we haven't communicated what our filing dates are, nor will we. What we have communicated is that we're very much looking forward to a launch second half of next year, and we're definitely on track for that. As Dan spoke to and Dietmar earlier, we will be sharing a data cut of Anita Cell at ASH. I would say we're looking forward to sharing that data with everyone. You were asking particularly about similar efficacy and improved safety. We continue to see—we're continuing to be impressed with the safety we're seeing, similar to what we shared at EHA, and we look forward to sharing that data cut at ASH. Our next question comes from Simon Baker at Rothschild & Co. Simon, go ahead. Your line is open. Thanks for taking the question. Sorry, back to Johanna after that very short break.

Speaker #23: As Dan spoke to and Dietmar earlier , we will be sharing a data cut of Anita cell at Ash and I would say we're looking forward to sharing that data with everyone .

Speaker #23: And there's you were asking particularly about similar efficacy and improved safety . We continue to see we're continuing to be impressed with the safety we're seeing , similar to what we shared at AA , and we look forward to sharing that data .

Speaker #23: Ash .

Speaker #1: Our next question comes from Simon Baker at Rothschild and Co . Go ahead . Your line is open .

Speaker #24: Thanks for taking the question . And sorry back to Johanna after that very short break . Back on year two . Go . I just wonder if you could give us some of your feedback on the patient and physician experience and reaction to to .

[Analyst]: Back on Sunlenca, I just wondered if you could give us some of your feedback on the patient and physician experience and reaction to Sunlenca. Obviously, your competitor has been suggesting a preference for their product over yours, but I'd be intrigued to hear what you're actually experiencing on the ground. Thanks so much. Absolutely. Happy to do so. Yeah. As we look at—I think you're referring to any ISRs or any injection site reactions, which is kind of normal when you have an injectable. That is common with any injection. Having said that, we've done a really nice job, I think, making sure that we educated not only the HCPs, but obviously everybody in their practice to make sure that they know how to give the injection. They know how to pre and post-treat. Basically, just a short-term ice helps the whole situation.

Speaker #24: Yes , To-Go . Obviously your your competitor has been suggesting a preference for their product over yours , but I'd be I'd be intrigued to hear what you're actually experiencing on the ground .

Speaker #24: Thanks very much .

Speaker #4: Absolutely happy to do so . Yeah . So so listen , we as we look at , I think you're referring to any icers or any injection site reactions , which is kind of normal when you have an injectable .

Speaker #4: And so that is common with any injection . Having said that , we've done a really nice job . I think making sure that we educated our not only the HCP , but obviously everybody in their practice to make sure that they they know how to give the injection .

Speaker #4: They know how to pre and post treat , you know , basically just a short term ice helps the whole situation . And so we've had over 7000 HCPs that have been trained over 1500 accounts to date , with 98% satisfaction rate with their training .

[Analyst]: We have had over 7,000 HCPs that have been trained, over 1,500 accounts to date, with a 98% satisfaction rate with their training. This is led by our nurse educator team, basically across the board, across the country, making sure we get to every single clinic. I think that's been incredibly helpful for those that want to use Sunlenca. We really believe that just with a little bit of information, it can go a long way to make sure that patient and HCP experience is very smooth. Our next question comes from Courtney Breen at Bernstein. Courtney, go ahead. Your line is open. Fantastic. Thank you so much for taking the time for a question today. I wanted to, I guess, zoom out a little bit to the White House deals and drug pricing, particularly in the context of your HIV portfolio and higher Medicaid exposure.

Speaker #4: And so this is led by our nurse educator team , basically across the board , across the country , making sure we get to every single clinic .

Speaker #4: And I think that's been incredibly helpful for those that want to use . Yes . To go . We really believe that just with a little bit of information , it can go a long way to make sure that patient and HCP are is very smooth .

Speaker #1: Our next question comes from Courtney Breen at Bernstein . Courtney go ahead . Your line is open .

Speaker #4: Fantastic . Thank you so much for taking the time for our question today . I wanted to I guess , zoom out a little bit to the white House deals .

Speaker #25: And drug pricing , but particularly in the context of your HIV portfolio and higher Medicaid exposure . Obviously , this year you've dealt with the part D redesign and have grown through that .

[Analyst]: Obviously, this year, you've dealt with the Part D redesign and have grown through that. As you're looking at potential flexibility and any sort of deal with this administration on drug pricing, can you give any context to the scale that you're preparing for or your actions or flexibility that you're looking to garner in a deal that might ensure that impact is less than what you're experiencing with the Part D redesign this year? Thanks, Courtney. This is Dan. I'll take that one as well, and thank you for the question. I think it's important to note that we continue to have really ongoing, good, constructive engagements with the administration across the administration on a number of topics. I would say a couple of things. Every meeting that I and the team are in, I think the administration has been very clear that they want the U.S.

Speaker #25: As you're looking at potential flexibility and any sort of deal with this administration on drug pricing , can you give any context to kind of the scale that you're preparing for or your actions or flexibility that you're looking to garner in a deal that might ensure that that impact is less than what you're experiencing with the part D redesign this year ?

Speaker #9: Thanks , Courtney . This is Dan . I'll take that one as well . And thank you for the question . So I think it's important to note that we continue to have really ongoing good constructive engagements with the administration across the administration on a number of topics .

Speaker #9: And and I would say a couple of things that , you know , you know , every meeting that I and the team are in , you know , I think the administration has been very clear that they want the US to remain a leading innovator in the space and in the biotech pharma space .

[Analyst]: to remain a leading innovator in the space, in the biotech pharma space, and at the same time, addressing the issues relative to U.S. out-of-pocket patient costs and having countries outside the U.S. do more to appropriately value innovation. Those are the principles that address our conversations. I think we're making very, very good progress relative to any Gilead Sciences-specific information. I can only point to that as publicly disclosed, but I would say that recently, as a part of an example of this constructive dialogue, we had an announcement with the U.S. State Department related to PEPFAR and our partnership to bring lenacapavir to low and low and middle-income countries.

Speaker #9: And at the same time , addressing the issues relative to us out-of-pocket patient costs and having countries outside the US do more to appropriately value innovation .

Speaker #9: Those are the principles that address our conversations . And I think we're making very , very good progress relative to , you know , any Gilead specific information .

Speaker #9: I can only point to that . That's publicly disclosed . But I would say that , you know .

Speaker #3: Recently we had a as a part of an example of this constructive dialogue . We had an announcement with the US state Department related to PEPFAR and our partnership to bring Lenacapavir to low and low and middle income countries .

Speaker #3: So I think this concept of Gilead's unique role in ending epidemics globally , connecting with administration objectives , whether that be national defense , whether that be any epidemics , is something that I think has been very much appreciated by the administration .

[Analyst]: I think this concept of Gilead Sciences' unique role in ending epidemics globally, connecting with administration objectives, whether that be national defense or ending epidemics, is something that has been very much appreciated by the administration and continues to be a cornerstone in our conversations. I would just lastly remind Courtney of things we've said in the past, but I would remind you that as we have broader conversations with the administration, the vast majority of our IP is in the U.S. As such, tariffs as related to transfer pricing may have more of a limited impact on Gilead Sciences versus our peers. We recognize more than 80% of our IP in the U.S. 90% of our taxes are paid here. We have a strong footprint in the U.S. We have almost 100% of our R&D capital infrastructure here, and we've committed to significant additional investments in the U.S.

Speaker #3: And continues to be a cornerstone in our conversations . So and then I would just lastly , just to remind Courtney , things we've said in the past , but but I would I would remind you that as we have broader conversations with the agency that I'm sorry with the administration , you know , again , the vast majority of our IP is in the United States .

Speaker #3: As such . You know , tariffs as related to transfer pricing may have more of a limited impact on Gilead versus our peers .

Speaker #3: We recognize , you know , more than 80% of our IP in the United States , 90% of our taxes are paid here .

Speaker #3: We have a strong footprint in the United States . We have almost 100% of our R&D capital , infrastructure here . And we've committed to significant additional investments in the United States of the magnitude of 32 billion .

[Analyst]: of the magnitude of $32 billion. These conversations are wide, and I think that we will continue to update you as we have different announcements, just like we did with the State Department. I'd say we feel very good about the constructive nature of them and where they're going. Our last question comes from Joseph Stringer at Needham. Joey, go ahead. Your line is open. Hi. Thanks for taking our questions. Question on Hepcludex for HDV. You put a lot of effort into getting that resubmitted since the CRL. I guess, one, what gives you confidence that you'll get approval from FDA this time around? And two, what do you think the market opportunity for the drug is in HDV, just keeping in mind that there are two competitors in phase three development? Thanks. Great. We'll start with Dietmar. Welcome, Dietmar. Then we'll give each other another quick break.

Speaker #3: So these conversations are wide , and I think that , you know , we we will continue to update you as we have different announcements , just like we did with the State Department .

Speaker #3: But I'd say we feel very good about the constructive nature of them and where they're going .

Speaker #1: Our last question comes from Joseph Stringer at Needham . Joey , go ahead . Your line is open .

Speaker #26: Hi . Thanks for taking our questions . Question on Hepcludex for HCV . A lot of effort into getting that resubmitted since the CRL .

Speaker #26: So I guess one, what gives you confidence that you'll get approval from the FDA this time around? And two, what do you think the market opportunity for the drug is in HDV, just keeping in mind that there are two competitors in Phase Three development?

Speaker #26: Thanks .

Speaker #3: Great . So we'll start with Dietmar . Welcome . Dietmar Berger and and then .

Speaker #27: Hannah . Another another quick break . Yeah . So thank you for the question . I mean we're not of course , commenting in depth on the , on the regulatory strategy but different factors give us confidence when we we have additional data with regards to , you know , how is the medicine injected .

[Analyst]: Thank you for the question. We're not, of course, commenting in depth on the regulatory strategy, but different factors give us confidence. One, we have additional data with regards to how the medicine is injected, what's the experience also that patients would have with the injection. We also have the experience from Europe, where the drug is used now for some time, and that gives us additional data from the real-world setting that we can also utilize. Overall, these additional data sets, plus further work on the filing for the U.S., give us the confidence that we can move forward here. Maybe I'll just close and talk about the market opportunity. It kind of goes back to the comment that was made earlier about the strategic fit with Livdelvy and how perfect it is. This is kind of the same with Hepcludex.

Speaker #27: What's the experience also that that patients would have with the injection . And also we have really the experience from Europe where the drug is used .

Speaker #27: Now for some time . And that gives us additional data from the real world setting that we can also utilize . So overall , these additional data sets , plus then further work on the on the filing for the US gives us the confidence that we can move forward here .

Speaker #4: So maybe I'll just close and talk about the market opportunity . It kind of goes back to the comment that was made earlier about the strategic fit with Liv , and how perfect it is .

Speaker #4: This is kind of the same with Hepcludex . This is obviously these are people that have hepatitis B , and it's very small percentage .

[Analyst]: Obviously, these are people that have hepatitis B, and it's a very small %. It is a rare disease. A small % of these hep B patients have also hep D, but a much, unfortunately, worsening with liver cirrhosis and potentially even liver cancers and death. Therefore, it's important to get to these patients as quickly as possible. We do believe that because of our footprint in hep B, it's a really good fit for us to make a difference for these patients across the board. Much smaller, but again, a little change in our footprint overall. I think that's why we think Hepcludex is important, let alone the unmet need that is out there because there's nothing else out there today. That completes the time that we have for questions. I'll now invite Dan to share any closing remarks. Terrific.

Speaker #4: It is rare disease , small percentage of these hep B patients have also hep D , but a much unfortunately worse worsening with liver cirrhosis .

Speaker #4: And potentially even liver cancers . And death . And so therefore important to get to these patients as quickly as possible . And so we do believe that because of our footprint in in hep B , it's it's a really good fit for us to make a difference for these patients across the board .

Speaker #4: So much smaller . But again , little change in our footprint overall . So I think that's why we think Hepcludex is important , let alone the unmet need that is out there .

Speaker #4: There's nothing else out there today .

Speaker #1: That completes the time that we have . For questions . I'll now invite Dan to share any closing remarks .

Speaker #3: Terrific . So let me first of all , thank all of you for joining today . We really appreciate your interest and time .

[Analyst]: Let me, first of all, thank all of you for joining today. We really appreciate your interest and time. I also would be remiss not to thank the Gilead Sciences teams for another great quarter in our growth journey here. As you've seen, I just want to point this out. Strong commercial and clinical execution along with discipline expense management in a consistent way, quarter to quarter, is what you have seen from us and what you should continue to expect from us. We believe we're very well positioned as we go into 2026, not only with the current and upcoming product launches that we have today and spoke about a lot today, but also the strong clinical pipeline. I just want to point out we have some important readouts coming up in oncology and HIV in this quarter and into next year.

Speaker #3: I would also be remiss not to thank the Gilead teams for another great quarter in our growth journey here. And as you've seen, I just want to point this out.

Speaker #3: You know , strong commercial and clinical execution , along with disciplined expense management and a consistent way quarter to quarter is what you have seen from us and what you should continue to expect from us .

Speaker #3: We believe we're very well positioned as we go into 2026 , not only with the current and upcoming product launches that we have today and spoke about a lot today , but also the strong clinical pipeline .

Speaker #3: And I just want to point out we have some important readouts coming up in oncology and HIV in this quarter and into next year.

Speaker #3: And I just would remind you again that really , we're in a relatively unique position with no patent expertise before 2036 . So for that , I'd like to again , thank you for your time today .

[Analyst]: I just would remind you again that really we're in a relatively unique position.

[Analyst]: No patent expiry before 2036. I'd like to again thank you for your time today. Jacquie and team, as usual, are here to follow up with you on any of the questions that you have. Please don't hesitate to reach out, and I wish you all a good rest of your day. Thank you.

Speaker #3: Jackie and team , as usual , are here to to follow up with you on any of the questions that you have . Please don't hesitate to reach out .