Q1 2025 Gilead Sciences Inc Earnings Call

April 24, 2025

Welcome to Gilead first quarter 2025 earnings Conference call. My name is Rebecca and I'll be today's host.

Speaker Change: In a moment, we'll begin our prepared remarks, followed by a Q&A session to ask a question. Please press star one and to withdraw your question Press Star two I will now hand, the call over to Jacky Ross Senior Vice President of Treasury and Investor Relations.

Jacky Ross: Thank you Rebecca just after market close today, we issued a press release with earnings results for the first quarter of 2025.

Yeah.

Okay.

Jacky Ross: The press release slides and supplementary data are available on the investors section of our website at Gilead Dot com.

Okay.

Daniel O'Day: 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.

Rebecca: Everyone, and welcome to Gilead's first quarter 2025 earnings conference call. My name is Rebecca and I'll be today's host.

Daniel O'Day: After that we'll open the call to Q&A with the team will be joined by Cindy Peretti, The executive Vice President of kite.

Speaker Change: In a moment, we'll begin our prepared remarks followed by our Q&A session. To ask a question, please press star one and to withdraw your question, press star two. I'll now hand the call over to Jackie Ross, Senior Vice President of Treasury and Investor Relations. Thank you.

Daniel O'Day: 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.

Dan: With that I'll turn the call over to Dan.

Daniel O'Day: Thank you Jackie and good afternoon, everyone.

Daniel O'Day: I am pleased to share our first quarter results, which reflect strong commercial and clinical execution across the business.

Speaker Change: 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.

Daniel O'Day: Our base business, excluding burglary grew 4% from the first quarter of 2024, primarily driven by growth in our HIV business.

Daniel O'Day: HIV sales were up 6% year over year with Vic Tarbey up 7% highlighting our demand led volume growth that was offset in part by the expected headwinds associated with the part D redesign.

Speaker Change: 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.

Speaker Change: 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.

Daniel O'Day: Live Delta continues its strong launch momentum with $40 million in sales in its second full quarter since launch.

Daniel O'Day: Year over year growth in our HIV and liver disease businesses was partially offset by softer than expected toward lv sales due to inventory dynamics that mast increase in demand as well as headwinds in cell therapy.

Dan: Thank you, Jackie, and good afternoon, everyone. I'm pleased to share our first quarter results, which reflect strong commercial and clinical execution across the business.

Speaker Change: Our base business, excluding BigQuery, grew 4% from the first quarter of 2024, primarily driven by growth in our HIV business.

Daniel O'Day: Total product sales, including victory were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations.

Dan: HIV sales were up 6% year-to-year with Bikkarbi up 7% highlighting our demand-led volume growth that was offset in part by the expected headwinds associated with the Part D redesign.

Daniel O'Day: Beyond our commercial results. We also saw impressive operational execution with strong operating margin and earnings per share results that highlight our continued focus on expense management and leverage in our business model.

Dan: Lev Delsey continues his strong launch momentum with $40 million in sales in its second full quarter-sense launch.

Daniel O'Day: Our diverse pipeline continues to deliver across HIV oncology and inflammation.

Daniel O'Day: In HIV, we are now only weeks away from the anticipated FDA decision on twice yearly Atlantic happier for prep.

Dan: Year-over-year growth in our HIV and liver disease businesses was partially offset by softer than expected trotelvy sales due to inventory dynamics that massed increase in demand as well as headwinds and cell therapy.

Daniel O'Day: We remain on track for the June 19th <unk> date, and the potential launch in the U S immediately following.

Dan: Total product sales, including victory were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations.

Daniel O'Day: As a reminder, this is one of up to nine potential HIV product launches. We are targeting before the end of 2033 building on Gilead has decades of leadership in HIV innovation.

Dan: Beyond our commercial results. We also saw impressive operational execution with strong operating margin and earnings per share results that highlight our continued focus on expense management and leverage in our business model.

Daniel O'Day: And oncology earlier this week, we announced the positive results from the Phase III <unk> study of <unk> in combination with <unk> for first line PD lone positive metastatic triple negative breast cancer.

Dan: Our diverse pipeline continues to deliver across HIV oncology and inflammation.

Daniel O'Day: The results showed a clinically meaningful and statistically significant improvement in progression free survival over the standard of care.

Dan: In HIV, we are now only weeks away from the anticipated FDA decision on twice yearly Atlantic cap here for prep.

Dan: We remain on track for the June 19th <unk> date, and the potential launch in the U S immediately following.

Daniel O'Day: This news represents an important potential benefit for patients.

Daniel O'Day: Metastatic T N B C is one of the most aggressive forms of breast cancer and has historically been very difficult to treat.

Dan: As a reminder, this is one of up to nine potential HIV product launches, we are targeting before the end of 'twenty thirty-three building on Gilead decades of leadership in HIV innovation.

Daniel O'Day: We expect to share the ascent Oh for data at a medical Congress in the near future and to file with global regulatory authorities as quickly as possible.

Dan: And oncology earlier this week, we announced the positive results from the phase III ascent for study of <unk> in combination with <unk> for first line PD lone positive metastatic triple negative breast cancer.

Daniel O'Day: We continue to expect an update later this quarter on the phase III ascent of three study evaluating <unk> monotherapy in first line metastatic triple negative breast cancer patients who are not candidates for PD one inhibitors.

Dan: The results showed a clinically meaningful and statistically significant improvement in progression free survival over the standard of care.

Daniel O'Day: Moving to cell therapy, we plan to provide an update on our Registrational phase two imagine one trial later this year and remain on track to potentially launch Anita cell in late line relapsed refractory multiple myeloma in 2026, we believe that the nito cells' clinical profile combined with kites exceptional man.

Dan: This news represents an important potential benefit for patients.

Dan: Metastatic T N B C is one of the most aggressive forms of breast cancer and has historically been very difficult to treat.

Dan: We expect to share the ascent O four data at a medical Congress in the near future and a file with global regulatory authorities as quickly as possible.

Daniel O'Day: Factoring capabilities and industry, leading turnaround time puts us in a strong position to address the unmet need for patients with multiple myeloma.

We continue to expect an update later this quarter on the phase III ascent or three study evaluating <unk> monotherapy in first line metastatic triple negative breast cancer patients who are not candidates for PD one inhibitors.

Daniel O'Day: In inflammation, we are launching lived lz in additional markets following approval from the European Commission in February we look forward to continued momentum as we bring lived LG to more people seeking to manage their primary biliary cholangitis with a differentiated option.

Dan: Moving to cell therapy, we plan to provide an update on our Registrational phase two imagine one trial later this year and remain on track to potentially launch Anita sell in late line relapsed or refractory multiple myeloma in 2020 six we believe that Anita cells' clinical profile combined with kites exceptional Manny.

Daniel O'Day: As we wrap up a strong first quarter performance, we can look forward to continuing positive momentum.

Daniel O'Day: We have multiple potential launches ahead, including lentic capa, there Anita cell and now tried lv.

Daniel O'Day: As a reminder, we have no major eloise until the end of 2033 and expect to drive topline growth overtime across all three of our therapeutic focus areas of urology oncology and inflammation.

Dan: Factoring capabilities and industry, leading turnaround time puts us in a strong position to address the unmet need for patients with multiple myeloma.

Dan: In inflammation, we are launching lived lz in additional markets following approval from the European Commission in February we look forward to continued momentum as we bring lived ellsey to more people seeking to manage their primary biliary cholangitis with a differentiated option.

Daniel O'Day: The overall strength of our business means we are well positioned to adapt to a range of potential policy outcomes in the United States.

Daniel O'Day: It is worth noting that gilead average corporate tax rate of approximately 20% reflects the fact that the substantial majority of our intellectual property is already registered in the United States. The 2017 tax reform was instrumental in us bolstering our U S investment and Gilead is.

Dan: As we wrap up a strong first quarter performance. We can look forward to continuing positive momentum we have multiple potential launches ahead, including Atlantic cap of air.

Dan: Nito cell and now tried lv.

Dan: As a reminder, we have no major eloise until the end of 'twenty thirty-three and expect to drive topline growth overtime across all three of our therapeutic focus areas of urology oncology and inflammation.

Daniel O'Day: <unk> and did almost 100% of our R&D capital infrastructure is in the U S.

Daniel O'Day: In addition, we have been increasing our investment in U S manufacturing over the last several years with two large scale cell therapy sites and we have additional investment projects underway that are expected to run through 2028.

Dan: The overall strength of our business means we are well positioned to adapt to a range of potential policy outcomes in the United States.

Daniel O'Day: Our focus is on delivering on our multiple upcoming launches and advancing our diverse pipeline and in the meantime, we continue to engage with the administration to encourage a balanced policy agenda that prioritizes innovation and the needs of patients.

Dan: It is worth noting that gilead average corporate tax rate of approximately 20% reflects the fact that the substantial majority of our intellectual property is already registered in the United States. The 2017 tax reform was instrumental in us bolstering our U S investment and Gilead is.

Daniel O'Day: With that I'll hand, it over to Joanna.

Joanna: Thanks, Dan and good afternoon, everyone.

Joanna: We've had a solid start to the year with our commercial execution delivering strong year over year sales growth in our base business.

Dan: <unk> ended almost 100% of our R&D capital infrastructure is in the U S.

Dan: In addition, we have been increasing our investment in U S manufacturing over the last several years with two large scale cell therapy sites and we have additional investment projects underway that are expected to run through 2028.

Joanna: Product sales, excluding declaring a $6 $3 billion were up 4% year over year, primarily driven by HIV and liver disease sales, partially offset by lower oncology sales.

Dan: Our focus is on delivering on our multiple upcoming launches and advancing our diverse pipeline and in the meantime, we continue to engage with the administration to encourage a balanced policy agenda that prioritizes innovation and the needs of patients.

Joanna: Sequentially.

Joanna: We're down 12% as expected mainly due to inventory dynamics, partially offset by higher sales in liver disease.

Speaker Change: Total product sales of $6 $6 billion were down 1% year over year, and 12% sequentially, reflecting lower back Larry Sam.

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

Joanna: Thanks, Dan and good afternoon, everyone.

Speaker Change: Moving to slide eight our HIV business delivered sales of $4 $6 billion up 6% year over year, driven by higher average realized price and higher demand sequentially.

Joanna: We've had a solid start to the year with our commercial execution delivering strong year over year sales growth in our base business.

Joanna: Product sales excluding victory at $6 $3 billion were up 4% year over year, primarily driven by HIV and liver disease sales, partially offset by lower oncology sales.

Speaker Change: Sequentially sales were down 16% consistent with our guidance.

Speaker Change: Collecting normal first quarter seasonality, including lower average realized price and volume following a particularly strong fourth quarter as well as the impact of Medicare part D redesign.

Joanna: Sequentially sales were down 12% as expected mainly due to inventory dynamics, partially offset by higher sales in liver disease.

Speaker Change: As a reminder.

Speaker Change: HIV growth is generally more variable and less indicative of overall trends and full year results with normal first quarter impacts, including inventory draw down following a build in the fourth quarter.

Joanna: Total products down at $6 $6 billion were down 1% year over year, and 12% sequentially, reflecting lower veterinary staff.

Speaker Change: And channel dynamics, including the resetting of patient Copays, and deductibles, which result in lower average realized price.

Joanna: Moving to slide eight.

Joanna: Our HIV business delivered sales of $4 $6 billion up 6% year over year, driven by higher average realized price and higher demand sequentially.

Speaker Change: Beyond these typical first quarter dynamics HIV revenues were also impacted by Medicare part D redesign in the first quarter of 2025.

Joanna: Sequentially sales were down 16% consistent with our guidance.

Collecting normal first quarter seasonality, including lower average realized price and volume following a particularly strong fourth quarter as well as the impact of Medicare part D redesign.

Speaker Change: This increase the manufacturer contribution and includes individuals' on low income subsidy for the first time.

Speaker Change: While we are still in the early stages of this implementation our assumptions remain unchanged.

As a reminder.

Joanna: HIV growth is generally more variable and less indicative of overall trends and full year results with normal first quarter impacts, including inventory draw down following a build in the fourth quarter.

Speaker Change: In the meantime, we continue to expect robust demand led volume growth for the full year, though as shared back in February this will be obscured this year due to part D headwinds, resulting in flat reported HIV sales overall for 2025 with a return to growth in 2026.

Joanna: And channel dynamics, including the resetting of patient Copays, and deductibles, which result in lower average realized price.

Speaker Change: On slide nine in HIV treatment, but how do you stay at the $3 $1 billion were up 7% year over year, primarily driven by higher demand.

Joanna: Beyond these typical first quarter dynamics HIV revenues were also impacted by Medicare part D redesign in the first quarter of 2025.

Speaker Change: Sequentially sales were down 17% as we expected, reflecting first quarter seasonality, including lower average realized price and volume.

Joanna: This increase the manufacturer contribution and includes individuals' on low income subsidy for the first time.

Speaker Change: The tabby once again increased the U S market share in the first quarter to 51% outpacing the growth of alternative regimens and remains the regimen of choice across Jeannine markets.

Joanna: While we are still in the early stages of this implementation our assumptions remain unchanged.

Joanna: In the meantime, we continue to expect robust demand led volume growth for the full year, though as shared back in February this will be obscured this year due to part D headwinds, resulting in flat reported HIV sales overall for 2025 with a return to growth in 2026.

Speaker Change: Overall, the HIV treatment market continues to grow in line with our expectations of $2 to 3% annually.

Speaker Change: <unk> sales of $586 million increased 38% year over year, primarily driven by higher average realized price and higher demand.

Joanna: On slide nine in HIV treatment the kv stay at the $3 $1 billion were up 7% year over year, primarily driven by higher demand.

Speaker Change: HIV prevention continues to represent a significant majority of <unk> sales and growth. This quarter was driven by broader awareness growing unrestricted access and associated pricing favorability as well as focused commercial execution that contributed to approximately 16% U S prep market growth year over year.

Sequentially sales were down 17% as we expected, reflecting first quarter seasonality, including lower average realized price and volume.

Joanna: It's Harvey once again increased the U S market share in the first quarter to 51% outpacing the growth of alternative regimens and remains the regimen of choice across G nine markets.

Speaker Change: Additionally, discovery maintains over 40% market share and grew more than 2% year over year.

Joanna: Overall, the HIV treatment market continues to grow in line with our expectations of $2 to 3% annually.

Sequentially sales were down 5%, reflecting typical seasonal inventory dynamics, partially offset by higher average realized price and higher demand.

Joanna: <unk> sales of $586 million increased 38% year over year, primarily driven by higher average realized price and higher demand.

Speaker Change: Growing awareness and adoption of HIV prevention is encouraging ahead of our upcoming potential U S launch of <unk> for prep.

Joanna: HIV prevention continues to represent the significant majority of <unk> sales and growth. This quarter was driven by broader awareness growing unrestricted access and associated pricing favorability as well as focused commercial execution that contributed to approximately 16% U S prep market growth year over year.

Speaker Change: I'm excited to have our field teams across market access commercial medical community and our nurse educators mobilized to ensure we're ready for launch.

Building on our deep expertise and success of HIV launches and with strong engagement across the ecosystem from community leaders to health care providers. Our teams are ready to build awareness drive adoption and overall deliver a seamless customer experience.

Joanna: Additionally, discovery maintains over 40% market share and grew more than 2% year over year.

Joanna: Sequentially sales were down 5%, reflecting typical seasonal inventory dynamics, partially offset by higher average realized price and higher demand.

Speaker Change: Additionally, we're working with health authorities policymakers and other organizations outside of the U S. As we look to bring Lana cap of your for profit to more people globally once approved.

Joanna: Growing awareness and adoption of the HIV prevention is encouraging ahead of our upcoming potential U S launch of learner Carpathia for prep.

Speaker Change: Moving to liver disease on slide 10.

Speaker Change: Sales of $758 million were up 3% year over year, reflecting increased demand across PBC, HBV and H D D, partially offset by lower average realized price for HCV products in the U S.

Joanna: I'm excited to have our field teams across market access commercial medical community and our nurse educators mobilized to ensure we're ready for launch.

Joanna: Building on our deep expertise and success of HIV launches and with strong engagement across the ecosystem from community leaders to health care providers. Our teams are ready to build awareness drive adoption and overall deliver a seamless customer experience.

Speaker Change: Sequentially liver disease sales were up 5%, primarily driven by increased demand and inventory dynamics, partially offset by lower average realized price.

Speaker Change: For lift out the first quarter sales of $40 million reflect continued early momentum in the launch of PBC and we're proud of the market share we've achieved so far.

Joanna: Additionally, we're working with health authorities policymakers and other organizations outside of the U S. As we look to bring lot of Carpathia for perhaps two more people globally once approved.

Speaker Change: We're also pleased that in February the European Commission granted conditional marketing authorization for lived healthy we.

Joanna: Moving to liver disease on slide 10.

Speaker Change: We have just launched in Germany, a few weeks ago, and we expect to expand into other major European markets in the coming months.

Joanna: Sales of $758 million were up 3% year over year, reflecting increased demand across P. D C HBV and H D D, partially offset by lower average realized price for HCV products in the U S.

Speaker Change: Moving to slide 11.

Speaker Change: Secondary sales of $302 million were down 45% year over year, and 10% quarter over quarter, reflecting lower rates of COVID-19 related hospitalizations due to a milder winter season.

Sequentially liver disease sales were up 5%, primarily driven by increased demand and inventory dynamics, partially offset by lower average realized price.

<unk> consistently high share of over 60% of treated hospitalized patients in the U S reinforces its clinical benefit and position as the standard of care, particularly among patients with renal and hepatic impairment.

Joanna: For lived healthy first quarter sales of $40 million reflect continued early momentum in the launch of P. B C and we're proud of the market share we've achieved so far.

Speaker Change: Despite the variability of the path of the pandemic, we expect the clarice important vote to continue.

Joanna: We're also pleased that in February the European Commission granted conditional marketing authorization for lived healthy.

Joanna: We've just launched in Germany, a few weeks ago, and we expect to expand into other major European markets in the coming months.

Speaker Change: On slide 12 to debbie's sales of $293 million were down 5% year over year, reflecting inventory dynamics and lower average realized price, partially offset by higher demand.

Joanna: Moving to slide 11 secondary sales of $302 million were down 45% year over year, and 10% quarter over quarter, reflecting lower rates of COVID-19 related hospitalizations due to a milder winter season.

Speaker Change: Sequentially sales were down, 17%, primarily driven by inventory dynamics and lower demand.

Speaker Change: <unk> remains the leading regimen in second line metastatic triple negative breast cancer in both the United States and Europe with stable share in pretreated HR positive <unk> negative metastatic breast cancer.

Joanna: <unk> consistently high share of over 60% of treated hospitalized patients in the U S reinforces its clinical benefit and position as the standard of care, particularly among patients with renal and hepatic impairment.

Speaker Change: We also look forward to potentially bringing the benefits of qdoba to triple negative breast cancer patients in earlier lines of treatment given the clinically meaningful progression free survival benefit seen in the center for and with data from a center three expected later this quarter. These.

Joanna: Despite the variability of the path of the pandemic, we expect the clarice important role to continue.

Joanna: On slide 12 to the RV sales of $293 million were down 5% year over year, reflecting inventory dynamics and lower average realized price, partially offset by higher demand.

Speaker Change: These studies could further strengthen our position in triple negative breast cancer with almost double the addressable population compared to the second line setting.

Joanna: Sequentially sales were down, 17%, primarily driven by inventory dynamics and lower demand.

Speaker Change: Moving to cell therapy on slide 13 sales of $464 million were down 3% year over year, and 5% sequentially, reflecting accelerating competitive headwinds, notably outside the U S and more specifically for Jakarta.

Speaker Change: To Delphi remains the leading regimen in second line metastatic triple negative breast cancer in both the United States and Europe with stable share in pretreated HR positive <unk> negative metastatic breast cancer.

Speaker Change: It's got a sales of $386 million were up 2% year over year, driven by higher average realized price and increased rest of world demand, partially offset by lower demand in the U S.

Speaker Change: We also look forward to potentially bringing the benefits of two debbie to triple negative breast cancer patients in earlier lines of treatment given the clinically meaningful progression free survival benefit seen in our center for and with data from a center three expected later this quarter. These.

Speaker Change: Sequentially sales were down 1%, reflecting European pricing favorability in the prior quarter that did not repeat partially offset by higher demand outside the U S.

Speaker Change: These studies could further strengthen our position in triple negative breast cancer with almost double the addressable population compared to the second line setting.

Takeda sales of $78 million were down 22% year over year, and 20% sequentially, reflecting increased in and out of class competition.

Speaker Change: Our work to increase car T cost penetration is ongoing and we continue to make progress in breaking down barriers to adoption in the community setting, including in accreditation and commercial reimbursement.

Speaker Change: You scared of sales of $386 million were up 2% year over year, driven by higher average realized price and increased rest of world demand, partially offset by lower demand in the U S.

Speaker Change: More broadly we continue to raise awareness of the strength of our data the advantages of a one time treatment and the potential benefits of earlier car T.

Speaker Change: Sequentially sales were down 1%, reflecting European pricing favorability in the prior quarter that did not repeat partially offset by higher demand outside the U S.

Speaker Change: Notwithstanding the ongoing competitive headwinds that we continue to expect to extend through 2025, we remain very excited about the overall opportunity in future for cell therapy with the potential launch of <unk> in multiple myeloma in 2026 and exciting early stage data in our next generation products across lymphoma.

Speaker Change: Takeda sales of $78 million were down 22% year over year, and 20% sequentially, reflecting increased in and out of class competition.

Speaker Change: Our work to increase car T Cross penetration is ongoing and we continue to make progress in breaking down barriers to adoption in the community setting, including in accreditation and commercial reimbursement.

Speaker Change: And solid tumors at <unk>.

Speaker Change: Before I hand over to Dietmar I'd like to thank the commercialization team for delivering a great start to the year, we remain focused on expanding the reach of our current portfolio. But are also very excited about the rich pipeline of near term launches over the next 12 to 18 months.

Speaker Change: More broadly we continue to raise awareness of the strength of our data the advantages of a one time treatment and the potential benefits of earlier car T.

Speaker Change: In addition to the ongoing launch of the Delta E and the potential launch of <unk> for prep in 2025.

Speaker Change: Notwithstanding the ongoing competitive headwinds that we continue to expect to extend through 2025.

Speaker Change: We're also looking forward to the potential launch of Anita sell in multiple myeloma and <unk> in first line metastatic triple negative breast cancer in 2026.

Speaker Change: We remain very excited about the overall opportunity in future for cell therapy with the potential launch of an E. S. L. In multiple myeloma in 2026 and exciting early stage data in our next generation products across lymphoma and solid tumors at <unk>.

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

Thank you Donna and good afternoon, everyone. We have made a lot of progress in the first quarter with some exciting line of kept of your updates at crime and our first pivotal phase III topline readout for through that'll be in breast cancer since 2022.

Speaker Change: Before I hand over to Dietmar I'd like to thank the commercialization teams for delivering a great start to the year, we remain focused on expanding the reach of our current portfolio. But are also very excited about the rich pipeline of near term launches over the next 12 to 18 months.

Speaker Change: The quality of these readouts highlights the breadth and depth of clinical expertise across gilead with the potential to support growth in our target therapeutic areas with new commercial launches in the years ahead.

Speaker Change: In addition to the ongoing launch of the Delta E and the potential launch of lentic happier for prep in 2025.

Speaker Change: We're also looking forward to the potential launch of the nito sell in multiple myeloma and <unk> in first line metastatic triple negative breast cancer in 2026.

Speaker Change: Starting with HIV on Slide 15, we shed 20 abstracts that crying, including data that showcased <unk> potentially even beyond the remarkable results. We saw in purpose, one and purpose to last year.

Dietmar Berger: And with that I'll hand, the call over to Dietmar.

Dietmar Berger: Thank you Donna and good afternoon, everyone. We have made a lot of progress in the first quarter with some exciting line of kept of your updates at crime and our first pivotal phase III top line readout for <unk> in breast cancer since 2022.

Speaker Change: For example, we shared our phase one data that showed once yearly intramuscular injections maintained learner kept their blood concentrations above those shown with twice yearly subcutaneous injections for more than 12 months.

Dietmar Berger: The quality of these readouts highlights the breadth and depth of clinical expertise across gilead with the potential to support growth in our target therapeutic areas with new commercial launches in the years ahead.

Speaker Change: The injections were generally well tolerated. These data were published in the lancet and we look forward to initiating a phase III study for once yearly Atlantic type of ear for HIV prevention in the second half of this year.

Dietmar Berger: Starting with HIV on Slide 15, we shared 20 abstracts at Croix, including data that showcased Atlanta kept <unk> potentially even beyond the remarkable results. We saw in purpose, one and purpose to last year.

As a reminder, for our twice yearly subcutaneous injection of Atlantic kept every year for HIV prevention, we have already submitted NDA MAA and EU medicines for all applications with FDA and EMA it.

Dietmar Berger: For example, we shared our phase one data that showed once yearly intramuscular injections maintained learner kept their blood concentrations above those shown with twice yearly subcutaneous injections for more than 12 months.

Speaker Change: Further we have submitted filings with regulatory bodies in South Africa, and Brazil and continue to make good progress in all our discussions with global regulatory bodies.

In particular, we have not experienced any disruptions in our interactions with FDA and we continue to expect a regulatory decision by June 19.

Dietmar Berger: The injections were generally well tolerated. These data were published in the lancet and we look forward to initiating a phase III study for once yearly Atlantic Hep of ear for HIV prevention in the second half of this year.

In HIV treatment, we shared phase II data at Croix evaluating twice yearly Atlantic Hep of Europe, plus two broadly neutralizing antibodies or be naps in biologically suppressed people with HIV genotype that are highly susceptible to both being <unk> at week 26, the combination regimen.

Dietmar Berger: As a reminder, for our twice yearly subcutaneous injection Atlantic kept every year for HIV prevention, we have already submitted NDA MAA and EU medicines for all applications with F. D. A N E M. A further.

Speaker Change: Maintained biologics suppression with high efficacy similar to the stable baseline regimen comparator there.

Dietmar Berger: <unk>, we've submitted filings with regulatory bodies in South Africa, and Brazil, and continue to make good progress in all our discussions with global regulatory bodies.

Speaker Change: There were no infusion related reactions to the <unk> and no discontinuation due to injection site reactions.

Dietmar Berger: In particular, we have not experienced any disruptions in our interactions with FDA and we continue to expect a regulatory decision by June 19th.

Speaker Change: <unk> has already received breakthrough therapy designation from FDA and these phase two data further underscore the potential for this combination to be the first complete twice yearly treatment regimen for virological suppressed people with HIV phase III planning is in.

Dietmar Berger: In HIV treatment, we shared phase II data at Croix evaluating twice yearly Atlantic happier plus two broadly neutralizing antibodies or be naps in viral logically suppressed people with HIV genotypes that are highly susceptible to both peanuts at week 26, the combination regimen.

Speaker Change: Aggress.

Speaker Change: Touching upon liver disease on slide 16, we announced the European Commission granted conditional marketing authorization for <unk> for the treatment of primary biliary cholangitis or PBC.

Dietmar Berger: Maintaining biologic suppression with high efficacy similar to the stable baseline regimen comparator there.

Dietmar Berger: There were no infusion related reactions with the B naps and no discontinuation due to injection site reactions.

Speaker Change: The decision to reflect slipped out of these clinical benefit across key biomarkers of PBC and related pruritus in the phase III response trial in.

Dietmar Berger: Then a cap of air plus be nabs has already received breakthrough therapy designation from FDA and these phase two data further underscore the potential for this combination to be the first complete twice yearly treatment regimen for virological suppressed people with HIV phase III planning is in Prague.

In addition, we continue to make progress on our phase III ideal trial, which is evaluating the efficacy of lived LG in PBC patients who are partial responders to U D C a potentially doubling the addressable patient population.

Speaker Change: Overall, we are excited by the opportunities to bring this differentiated treatment to more patients across the world.

Yes.

Dietmar Berger: Touching upon liver disease on slide 16, we announced the European Commission granted conditional marketing authorization for Leap day LLC for the treatment of primary biliary cholangitis or PBC.

Speaker Change: Moving to oncology on slide 17, I'm very pleased to share through Delta plus Pembroke demonstrated highly statistically significant and clinically meaningful progression free survival benefit over standard of care in the phase III ascent or four trial in first line <unk>.

Dietmar Berger: The decision reflects lived alethia its clinical benefit across key biomarkers of PBC and related pruritus in the phase III response trial in.

Dietmar Berger: In addition, we continue to make progress on our phase III ideal trial, which is evaluating the efficacy of lived LG in PBC patients who are partial responders to U D C a potentially doubling the addressable patient population.

<unk> positive metastatic triple negative breast cancer trip.

Triple negative breast cancer is the most aggressive type of breast cancer that disproportionately impacts younger and premenopausal women, we look forward to being able to potentially bring the benefits of toward there'll be two these metastatic triple negative breast cancer patients in the first line.

Dietmar Berger: Overall, we are excited by the opportunities to bring this differentiated treatment to more patients across the world.

Speaker Change: We will be submitting these data for presentation at a future medical Congress and will engage with global regulators as quickly as possible. Further we expect to provide an update from the phase III ascent <unk> three trial evaluating <unk> monotherapy in first line metastatic triple negative breast cancer patients who are not candidates for PD.

Dietmar Berger: Moving to oncology on slide 17, I'm very pleased to share through Delta plus Pembroke demonstrated highly statistically significant and clinically meaningful progression free survival benefit over standard of care in the phase III ascent or four trial in first line PD.

Dietmar Berger: One positive metastatic triple negative breast cancer trip.

Speaker Change: One inhibitors later this quarter.

Speaker Change: We also remain focused on clinical execution of our seven other ongoing phase III programs for Tordella V and dumb banality mab across six tumor types.

Dietmar Berger: Triple negative breast cancer is the most aggressive type of breast cancer that disproportionately impacts younger and premenopausal women, we look forward to being able to potentially bring the benefits of toward there'll be two these metastatic triple negative breast cancer patients in the first line.

Speaker Change: Moving to slide 18, and on behalf of Cynthia and the kite team. We are pleased to be sharing new data from our next generation products at the upcoming <unk> meeting in June including Phase one data from kite 363 hour basis Tronic, CD 19, CD 20 car T for <unk>.

Dietmar Berger: We will be submitting these data for presentation at a future medical Congress and will engage with global regulators as quickly as possible. Further we expect to provide an update from the phase III ascent or three trial evaluating <unk> monotherapy in first line metastatic triple negative breast cancer patients who are not candidates for PD.

Relapsed or refractory large b cell lymphoma, and phase one data from the biopsy Stronach Egfr bio storage and <unk> two car T for Glioblastoma in collaboration with the University of Pennsylvania Perelman School of Medicine.

Dietmar Berger: One inhibitors later this quarter.

Dietmar Berger: We also remain focused on clinical execution of our seven other ongoing phase III programs for Tordella V and dumb vanilla mab across six tumor types.

We believe tight 363 could offer deeper more sustained responses with the potential to overcome certain resistance mechanisms given its ability to target both CD 19, and CD 20. Additionally.

Dietmar Berger: Moving to slide 18, and on behalf of Cynthia and the kite team. We are pleased to be sharing new data from our next generation products at the upcoming <unk> meeting in June including Phase one data from kite 363 hour basis Tronic, CD 19, CD 20 car T for <unk>.

Speaker Change: Additionally, we believe its dual co stimulatory domains balance effects, such as rapid tumor cell, killing and car T cell proliferation and persistence in an optimum way. This could result in a potentially improved overall efficacy and safety profile in B cell malignancies.

Dietmar Berger: Relapsed or refractory large b cell lymphoma, and phase one data from the biopsy Stronach Egfr I authority or a two car T for Glioblastoma in collaboration with the University of Pennsylvania Perelman School of Medicine.

Speaker Change: Further we believe many of these potential benefits could translate to b cell driven autoimmune diseases and to file an IND to evaluate <unk> $3 six three in this area as well.

Dietmar Berger: We believe kite 363 could offer deeper more sustained responses with the potential to overcome certain resistance mechanisms given its ability to target both CD 19, and CD 20. Additionally.

Speaker Change: For <unk>, our pivotal imagine one study in fourth line, plus relapsed or refractory multiple myeloma is ongoing and we look forward to providing an update in 2025.

Dietmar Berger: Additionally, we believe its dual co stimulatory domains balance effects, such as rapid tumor cell, killing and car T cell proliferation and persistence in an optimum way. This could result in a potentially improved overall efficacy and safety profile in B cell malignancies.

In the second line plus setting we are pleased to announce the phase III imagine three protocol has been amended to include minimal residual disease negativity as a dual primary end point. In addition to progression free survival. We are excited for this positive step to potentially bring a needle or sell to patients in earlier line settings.

Dietmar Berger: Further we believe many of these potential benefits could translate to b cell driven autoimmune diseases and have filed an IND to evaluate kite 363 in this area as well.

Speaker Change: And remain confident in our need ourselves profile across efficacy and safety combined with kites, leading manufacturing capabilities.

Dietmar Berger: For <unk>, our pivotal imagine one study in fourth line, plus relapsed or refractory multiple myeloma is ongoing and we look forward to providing an update in 2025.

Speaker Change: Finally on slide 19, we achieved several important milestones this year, including European Commission conditional approval I believe LG <unk>.

Positive phase III top line readout from ascent of war and initiation of the phase III evoke small cell lung cancer study, we anticipate an update from the phase III ascent <unk> III trial later this quarter. Additionally in virology, we remain on track to provide an update on the data from our phase two one that was one.

Dietmar Berger: In the second line plus setting we are pleased to announce the phase III imagine three protocol has been amended to include minimal residual disease negativity as a dual primary end point. In addition to progression free survival. We excited for this positive step to potentially bring a need or sell to patients in earlier line settings.

Speaker Change: Trial, our wholly owned once weekly in C containing oral treatment for HIV at an upcoming medical meeting.

Dietmar Berger: And remain confident in our need ourselves profile across efficacy and safety combined with kites, leading manufacturing capabilities.

Andy: And now I'll hand, the call over to Andy.

Dietmar Berger: Finally on slide 19, we achieved several important milestones this year, including European Commission conditional approval I believe LG positive phase III top line readout from ascent of war and initiation of the phase III evoke small cell lung cancer study.

Andy: Thank you Dietmar and good afternoon, everyone.

Andy: Our first quarter results reflect both strong operating and commercial execution.

Andy: As shown on slide 21.

Andy: Our base business was up 4% year over year to $6 $3 billion, largely driven by growth in our HIV and liver disease business, partially offset by lower oncology sales.

Dietmar Berger: We anticipate an update from the phase III ascent or three trial later this quarter. Additionally in virology, we remain on track to provide an update on the data from our phase two one that's one trial our wholly owned once weekly instant containing oral treatment for HIV at an upcoming medical meeting.

Speaker Change: Like Larry sales were down 45% year over year, resulting in a 1% decline in our total product sales to $6 6 billion.

Andy: Moving to our non-GAAP results on slide 22.

Andy: For the first quarter product gross margin was flat year over year at 85% in line with our full year guidance expectation of $85 to 86%.

Andy: And now I'll hand, the call over to Andy.

Andy: Thank you Dietmar and good afternoon, everyone.

Andy: Our first quarter results reflect both strong operating and commercial execution.

Andy: R&D expenses were down 5% year over year, primarily due to lower clinical manufacturing activities.

Andy: As shown on slide 21, our base business was up 4% year over year to $6 $3 billion, largely driven by growth in our HIV and liver disease business, partially offset by lower oncology sales.

Andy: Acquired IP R&D expenses were $253 million, primarily driven by the Leo pharma Stat six collaboration we announced in January.

Andy: SG&A expenses were down 6% year over year, reflecting lower corporate expenses, partially offset by incremental selling and marketing spend in the United States.

Andy: Like Lori sales were down 45% year over year, resulting in a 1% decline in our total product sales to $6 $6 billion.

Andy: First quarter operating margin was 43% highlighting our ongoing commitment to continued operating expense discipline and delivering top quartile margins once again.

Andy: Moving to our non-GAAP results on slide 22.

For the first quarter product gross margin was flat year over year at 85% in line with our full year guidance expectation of 85% to 86%.

Andy: The non-GAAP effective tax rate was 16% this quarter below our historic average largely driven by tax benefits from stock based compensation.

Andy: R&D expenses were down 5% year over year, primarily due to lower clinical manufacturing activities.

Andy: And finally, non-GAAP diluted EPS was $1.81.

Andy: Acquired IP R&D expenses were $253 million, primarily driven by the Leo pharma Stat six collaboration we announced in January.

Andy: Moving to our full year guidance on slide 23, we are not making any changes to our revenue expectations or non-GAAP P&L guidance at this time.

Andy: SG&A expenses were down 6% year over year, reflecting lower corporate expenses, partially offset by incremental selling and marketing spend in the United States.

Andy: As we reflect on the tariffs that have been enacted to date. These.

Andy: These could increase some of our indirect costs, but are expected to be manageable in 2025 in part due to potentially lighter FX headwinds than previously expected.

Andy: First quarter operating margin was 43% highlighting our ongoing commitment to continued operating expense discipline and delivering top quartile margins once again.

Andy: For 2025, therefore, we continue to expect total product sales of approximately 28 to $28 $6 billion.

Andy: The non-GAAP effective tax rate was 16% this quarter below our historic average largely driven by tax benefits from stock based compensation.

Andy: Product sales, excluding VAT glory of approximately $26 8 billion to $27 $2 billion.

Andy: And finally, non-GAAP diluted EPS was $1.81.

Andy: Twenty-five HIV sales to be approximately flat compared to 2024 with demand driven growth offset by the impact of the Medicare part D redesign.

Andy: Moving to our full year guidance on slide 23, we are not making any changes to our revenue expectations or non-GAAP P&L guidance at this time.

Andy: As we reflect on the tariffs that have been enacted to date.

Andy: <unk> sales of approximately $1 $4 billion, while the first quarter was lighter than expected. We know this can be a highly variable business with that in mind and consistent with our approach last year, we do not expect to update our back Larry guidance until our third quarter earnings call.

Andy: These could increase some of our indirect costs, but are expected to be manageable in 2025 in part due to potentially lighter FX headwinds than previously expected.

Andy: For 2025, therefore, we continue to expect <unk>.

Andy: Moving to other parts of the P&L for full year 2025 on a non-GAAP basis, we continue to expect product gross margin to range between 85% to 86%.

Andy: Total product sales of approximately $28 two to $28 $6 billion pre.

Andy: Product sales, excluding VAT glory of approximately $26 8 billion to $27 $2 billion.

Andy: R&D expenses to be roughly flat from 2024.

Andy: 2025, HIV sales to be approximately flat compared to 2024 with demand driven growth offset by the impact of the Medicare part D redesign.

Andy: Acquired IP R&D to be approximately $400 million, including the $253 million of expenses in the first quarter as well as known commitments and expected milestone payments.

And <unk> sales of approximately $1 $4 billion, while the first quarter was lighter than expected. We know this can be a highly variable business with that in mind and consistent with our approach last year, we do not expect to update our back Larry guidance until our third quarter earnings call.

Andy: SG&A expenses to decline by a high single digit percentage compared to 2024.

Andy: Operating income to be between $12 $7 billion to $13 2 billion.

Andy: Effective tax rate to be approximately 19%.

Andy: Moving to other parts of the P&L for full year 2025 on a non-GAAP basis, we continue to expect product gross margin to range between 85% to 86%.

Andy: And finally diluted EPS to be between $7 70 to $8.10 for the full year.

Andy: Looking ahead, we will continue to monitor the macro landscape carefully and we expect that our disciplined approach to operating expense management positions us well to adapt as needed in the months ahead.

Andy: R&D expenses to be roughly flat from 2024.

Andy: Acquired IP R&D to be approximately $400 million, including the $253 million of expenses in the first quarter as well as known commitments at expected milestone payments.

Andy: Finally on slide 24.

Andy: Our capital priorities remain unchanged.

Andy: We have already returned $1 $7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases.

Andy: SG&A expenses to decline by high single digit percentage compared to 2024.

Andy: Operating income to be between $12 $7 billion to $13 $2 billion.

Andy: And we will continue to pursue disciplined expense management and careful investment in the most promising pipeline opportunities both internally and externally.

Andy: The effective tax rate to be approximately 19%.

I'm also pleased to note that S&P recently upgraded gilead as long term debt rating from Triple B, plus with a positive outlook to a minus with a stable outlook recognizing the outlook for our HIV franchise and other products combined with steady revenue growth and strong cash flow generation.

Andy: And finally diluted EPS to be between $7.70 to $8.10 for the full year.

Andy: Looking ahead, we will continue to monitor the macro landscape carefully.

Andy: And we expect that our disciplined approach to operating expense management positions us well to adapt as needed in the months ahead.

Andy: Overall Gilead is on track to continue delivering demand led volume growth a disciplined operating model and strong cash flow that positions us well for the rest of 2025 and beyond.

Andy: Finally on slide 24, our capital priorities remain unchanged.

Andy: We have already returned $1 $7 billion to shareholders in the first quarter of 2025 through dividends and share repurchases.

Andy: With that I'll invite Rebecca to begin the Q&A.

Andy: And we will continue to pursue disciplined expense management and careful investment in the most promising pipeline opportunities both internally and externally.

Rebecca: 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 your question Press Star one and to withdraw your question Press Star two.

Andy: I'm also pleased to note that S&P recently upgraded gilead as long term debt rating from Triple B, plus with a positive outlook to a minus with a stable outlook recognizing the outlook for our HIV franchise and other products combined with steady revenue growth and strong cash flow generation.

Michael <unk>: She comes from Michael <unk> at Jefferies. Go ahead. Your line is open.

Andy: Overall Gilead is on track to continue delivering demand led volume growth a disciplined operating model and strong cash flow that positions us well for the rest of 2025 and beyond.

Speaker Change: Hey, great. Thanks.

Speaker Change: Congrats on the quarter and our progress.

Speaker Change: The progress we wanted to ask about your expectations for the prep launch assuming approval on time.

Speaker Change: You think about the dynamics in the second half related to commercial reimbursement and Medicaid reimbursement and whether guideline changes in other factors also need to play a role.

Andy: With that I'll invite Rebecca to begin the Q&A.

Rebecca: Thank you Andy at this time, we'll invite your questions. Please.

Rebecca: 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 your question Press Star one and to withdraw your question Press Star two.

Speaker Change: Hi, Michael it's Joanna thanks.

Speaker Change: Thanks for the question Yeah. So we're excited about the opportunity with <unk> the data around the corner. We are counting I think Dan referred two weeks the team accounting days and <unk> and we are absolutely ready for the launch the from an access standpoint.

Michael: She comes from Michael <unk> at Jefferies. Go ahead. Your line is open.

Speaker Change: Hey, great. Thanks.

Speaker Change: That is we believe that around.

Speaker Change: Congrats on the quarter and our progress.

Speaker Change: It was going to take a couple of months I think bill.

Speaker Change: The progress we wanted to ask about your expectations for the prep launch assuming approval on time.

Speaker Change: As we think about 75% or so access within the first six months of peak hybrid lives at about 90% at a 12 month, Mark and that's gonna happen month. After month. It is not doesn't all happen in a bolus.

Michael: Hi, Michael it's Humana. Thanks.

Speaker Change: Thanks for the question Yeah. So we're excited about the opportunity with the use of data around the corner.

Speaker Change: And we believe then that just takes a little bit more time, but still can get through the process for those people that want them learn of Carpathia and so well work through that and we're excited about that opportunity as we build out through 2025 and of course into 2026 is much stronger access.

Speaker Change: Counting I think Dan referred two weeks the team accounting days and <unk> and we are absolutely ready for the launch the from an access standpoint, we what we said is we believe that around.

Speaker Change: It was going to take a couple of months right I think bill and access we think about 75% or so access within the first six months of peak covered lives at about 90% at a 12 month, Mark and that's gonna happen month. After month. It is not it doesn't all happen in a bolus.

Carter Gould: Our next question comes from Carter Gould at Cantor Fitzgerald harder go ahead. Your line is open.

Great. Thank you good afternoon, I guess sort of following on the prior question there have been.

Carter Gould: A number of cuts across HHS CDC to start the year across various teams divisions raising.

Speaker Change: We also believe it at the beginning that Theyre going to go through medical exception right and they'll go through the process just like they do for example, with live TV ads, we're building access there as well and we believe that just takes a little bit more time, but still could get through the process for those people that want them.

Carter Gould: Raising uncertainty around potential disruptions to messaging education awareness can you help maybe frame some of these in.

Speaker Change: Typically as they might impact the launch and are these sort of either roles or activities that gilead could maybe step into to do some with some of the heavy lifting and I guess really your confidence that we won't be pointing to these aspects are impacting the launch later in 'twenty five or into 'twenty six thank you.

Linda: Linda copies here, and so well work through that.

Linda: And we're excited about that opportunity as we build out through 2025 and of course into 2026 with much stronger access.

Daniel O'Day: Thanks Carter this is Dan I'll start and then Joanna can add or others.

Linda: Our next question comes from Carter Gould at Cantor Fitzgerald Carter go ahead. Your line is open.

Daniel O'Day: But I just want to be clear that to date, we haven't heard or seen anything that would cause us to alter our plans or expectations for.

Carter Gould: Great. Thank you good afternoon, I guess sort of following on the prior question <unk> bin.

Daniel O'Day: Or the land for prep launch or adversely affect in our HIV business. Obviously, we're staying very closely attuned to this and importantly, we're having discussions with policymakers.

Speaker Change: Number of cuts across HHS CDC to start the year across various teams divisions raising uncertainty around potential disruptions to messaging education awareness can you help maybe frame some of these.

Daniel O'Day: Emphasize the importance of let a catheter veer from prep and in particular in relation to their stated goals of addressing.

Speaker Change: Typically as it might impact the launch and are these sort of either roles our activities at Gilead could maybe step into to do some of it some of the heavy lifting.

Daniel O'Day: Diseases in this country and the value of prevention, we think that <unk> for prep is is really well positioned there.

Speaker Change: Really your confidence that we won't be pointing to these aspects are impacting the launch later in 2005 are under 26. Thank you.

Daniel O'Day: Specifically relative to the government support.

Speaker Change: Thanks Carter this is Dan I'll start and then Joanna can add or others.

Daniel O'Day: You know and in particular, you mentioned CDC.

Speaker Change: But I just want to be clear that to date, we haven't heard or seen anything that would cause us to alter our plans or expectations for.

Daniel O'Day: Carter obviously their responsibilities include research and surveillance of HIV.

Speaker Change: Or the land for prep launch or adversely affect in our HIV business. Obviously, we're staying very closely attuned to this and importantly, we're having discussions with policymakers.

Daniel O'Day: They include supporting efforts around diagnosis and linkage to care.

Speaker Change: We're also involved in those activities, but again nothing we've seen so far suggests that those core services.

Speaker Change: Emphasized the importance of let a catheter veer from prep and in particular in relation to their stated goals of addressing chronic diseases in this country and the value of prevention, we think that lend for prep is is really well positioned there.

Speaker Change: You know or are in a position to change our approach to the launch and maybe with that I'll hand, it over to Joanna if she has any other questions or if you want to comment on that too.

Speaker Change: Sure, maybe just add a point Carter around prep market growth and kind of what you you asked what gilead can do I think that Gilead has been incredibly focused on making sure. We continue to have market development initiatives.

Speaker Change: So specifically relative to the government support.

Speaker Change: You know and in particular, you mentioned CVC.

Carter Gould: Carter obviously their responsibilities include research and surveillance of HIV.

Speaker Change: Sure screening diagnosis for treatment, but also to.

Speaker Change: They include supporting efforts around diagnosis and linkage to care.

Speaker Change: To ensure awareness and within the market and make sure there's education, there as well and I think you've seen that as you think about the prep market growth. We had a lot of activities in Q4 of last year and that kind of playing out we saw a nice uplift of the growth of the market in Q4, and you kind of see that come through again in Q1 at about 16% year over.

Speaker Change: We're also involved in those activities, but again nothing we've seen so far suggests that those core services.

Speaker Change: A year or so really well positioned as you think about lentic half of the year.

Joanna: Sure Yeah, maybe just to add a point Carter around and prep market growth and kind of what you you asked what gilead can do I think that Gilead has been incredibly focused on making sure. We continue to have market development initiatives to ensure screening diagnosis for treatment, but also to ensure.

Around the corner.

Speaker Change: Yeah and on the FDA side at this time all of our interactions with the FDA have been on track have been as expected without any surprises. So we've not experienced any impact to our land for pep filing or any of our clinical trials actually to date and.

Speaker Change: And we continue to expect the Atlantic heavier decision by June 19.

Joanna: Awareness and within the market and make sure there's education, there as well and I think you've seen that as you think about the prep market growth. We had a lot of activities in Q4 of last year and that kind of playing out we saw a nice uplift of the growth of the market in Q4, and you kind of see that come through again in Q1 at about 16% year over year.

Speaker Change: Yeah.

Speaker Change: Our next question comes from James Sheehan and Deutsche Bank. James Go ahead. Your line is open.

James Sheehan: Thank you I have a question for Joanna go ahead, the strength and the scope for this quarter is there any read through or.

James Sheehan: Applications out there it looks like there was some price discovery, but is there any read through or implications to lens launch.

Joanna: So really well positioned as you think about lentic half of the year.

Joanna: Around the corner.

Joanna: Yeah, and then on the FDA side at this time, all our <unk>.

James Sheehan: Yeah. There is thanks for the question. So yeah, we saw really nice growth year on year of about 38% growth for discovery that was driven by higher average realized price that you mentioned as well as higher demand. Those are the two big drivers and Theres a couple of reasons behind that one is definitely the prep market.

Joanna: Our actions with the FDA have been on track have been as expected without any surprises. So we've not experienced any impact to our land for pep filing or any of our clinical trials actually to date.

Joanna: We continue to expect the Atlantic capital decision by June 19th.

James Sheehan: Growth that I was referring to earlier of around 16% year on year, driven really by the market development that we've done that in leading.

Joanna: Okay.

Speaker Change: Our next question comes from James Sheehan and Deutsche Bank. James Go ahead. Your line is open.

James Sheehan: And second was around focused commercial execution, we've actually grown the share of the <unk> year on year by about just over three percentage point, which is really amazing and that's driven by the commercial team, which have been doing an amazing job, but also.

James Sheehan: Thank you I have a question for Joanna good the strengthen the scope for this quarter is there any read through or.

Speaker Change: <unk>.

Speaker Change: Looks like there was some price discovery, but is there any read through or implications to lens lunch.

James Sheehan: Supported by growing unrestricted access that we've seen even just in the last quarter to be honest as well as associated lower co pays which also helps our pricing. So all of those pieces together gets you to that 38% year on year and I do believe actually because of that market growth because of the set up from an access standpoint really supports the opportunity with.

Lee: Lee Yeah, there is.

Lee: Thanks for the question. So yeah, we saw really nice growth year on year of about 38% growth for discovery that was driven by higher average realized price that you mentioned as well as higher demand. Those are the two big drivers and Theres a couple of reasons behind that.

Lee: One is definitely the prep market growth that I was referring to you earlier about 16% year on year, driven really by the market development that we've done that in leading.

James Sheehan: <unk>.

James Sheehan: Hopefully in June.

Salvina: Our next question comes from <unk> Richter with Goldman Sachs. Salvina go ahead. Your line is open.

Lee: And second was around focused commercial execution, we've actually grown its share of the <unk> year on year by about just over three percentage point, which is really amazing and that's driven by the commercial team, which have been doing an amazing job, but also.

Salvina: Good afternoon. Thanks for taking my question and you touched on this a little earlier, but well gilead seems fairly.

Salvina: Unexposed to terrorists risk here can you just share any details on how much of the U S market is supplied by ex U S manufacturing, either API and finished product and to what degree you can ship it to the U S and is it fair to say limited risk to the business from <unk>.

Lee: Supported by growing unrestricted access that we've seen even just in the last quarter to be honest as well as associated lower co pays which also helps our pricing. So all of those pieces together gets you to that 38% year on year and I do believe actually because of that prep market growth because of this set up from an access standpoint really supports the opportunity with.

Salvina: <unk> transfer pricing perspective.

Salvina: And if I could also just get a.

Lee: Planet cap or they are in.

Salvina: A clarification with regard to earnings earlier on D redesign with regard to whether your assumptions are unchanged here and whether you could.

Lee: Hopefully in June.

Speaker Change: Our next question comes from Celgene Richter Goldman Sachs. Salvina go ahead. Your line is open.

Salvina: Just comment on how this is taking shape relative to your 2025 guide given the dynamics today. Thank you.

Speaker Change: Good afternoon. Thanks for taking my question and you touched on this a little earlier, but while gilead seems fairly unexplored unexposed to terrorists risk here can you just share any details on how much of the U S market is supplied by ex U S manufacturing, either API and finished product into what.

Speaker Change: Great. Thanks, <unk>, let me just start at a high level and then I'll hand, it over to Andy or Joanna to comment a little more deeply.

Speaker Change: To emphasize what you said around the tariffs I think at the highest level of course, we separate them into two different categories. One is kind of indirect tariffs which are related to <unk>.

Speaker Change: <unk> you can shift as to the U S and is it fair to say limited risk to the business from an ex.

Speaker Change: Ex transfer pricing perspective.

Speaker Change: All businesses and for us are things like steel supplies chemicals reagents.

Speaker Change: And if I could also just get a clare.

A clarification with regard to earnings earlier on D redesign with regard to whether your assumptions are unchanged caring whether you could.

Speaker Change: And obviously there we have some known understanding of what those tariffs will be.

Speaker Change: And what we see so far today.

Speaker Change: Just comment on how this is taking shape relative to your 2025 guide given the dynamics today. Thank you.

Speaker Change: <unk> into our guidance without changing our guidance for the rest of the year and Andy can comment a little further on that and then the other category of tariffs are obviously, the pharmaceutical specific tariffs, which are not enacted today they've only been.

Speaker Change: Great. Thanks, Helane, let me just start at a high level and then I'll hand, it over to Andy or Joanna to comment a little more deeply.

Custom and chatted about it we obviously havent speculated on those nor included those but to your point I think that there is there is a difference relative to gilead.

Speaker Change: Emphasize what you said around the tariffs I think at the highest.

Speaker Change: <unk> of course, we separate them into two different categories. One is kind of indirect tariffs, which are related to you know all businesses and for us are things like steel supplies chemicals reagents.

Speaker Change: Makeup and setup because its important when you consider those tariffs and that is that the vast majority of Gilead IP is in the U S.

Speaker Change: And what that suggests is lower value for its pharmaceutical imports at the end of the day, which is the.

And obviously there we have some known understanding of what those tariffs will be.

Speaker Change: The value on whats tariffs would be placed in fact more than 80% of gilead as profits are recognized in the U S.

Speaker Change: And what we see so far today.

Speaker Change: Question around the supply chain, it's quite a complicated answer we do have the strongest footprint. We have is in the United States like most companies, we leverage both internal and external manufacturing on a global basis.

Speaker Change: And chatted about we obviously havent speculated on those nor included those but to your point I think that there is there is a difference relative to gilead.

Speaker Change: And we're always looking to adapt that to make sure that we have good continuity of supply across the.

Speaker Change: Across the world. So that we can do that accordingly, I would also say that we've invested significantly in our manufacturing infrastructure in the United States over the past many years.

Speaker Change: Makeup and setup that is important when you consider those tariffs and that is that the vast majority of Gilead IP is in the U S and what that suggests there's lower value for its pharmaceutical imports at the end of the day, which is the.

Speaker Change: At our R&D infrastructure, including.

Speaker Change: Opening.

Speaker Change: Cell therapy manufacturing sites.

Speaker Change: The value on whats tariffs would be placed in fact more than 80% of gilead as profits are recognized in the U S to your question around the supply chain is quite a complicated answer we do have the strongest footprint. We have is in the United States like most companies, we leverage both internal and external manufacturing on a global basis and we're all.

And we have four large scale U S investment projects in progress are expected to run through 2028, so it's difficult to get into the detail of every product every supply chain, but I think we're well positioned overall I would ask Andy to comment and maybe in New York or Joanna on the Medicare part D. Sure Hi, Savi. This is Andy.

Speaker Change: Always looking to adapt that to make sure that we have good continuity of supply across.

Just to confirm what Dan said, our updated guidance does reflect the expected impact of the increase in indirect cost that we've seen from both announced tariffs and where.

Speaker Change: Typical tariff as well as our general expectations for the inflationary environment that we may be moving into.

Speaker Change: At our R&D infrastructure, including.

Speaker Change: As you can expect there are a number of puts and takes in the P&L, but as you look again at another very strong quarter of disciplined expense management that helps us absorb some of those additional costs.

Speaker Change: Opening self.

Speaker Change: Cell therapy manufacturing sites.

Speaker Change: And we have four large scale U S investment projects and projects in progress are expected to run through 2028, so it's difficult to get into the detail of every product every supply chain, but I think we're well positioned overall.

Speaker Change: There's also a bit of a tailwind as you have heard from our peers in terms of as the U S. Dollar has weakened for those of US that are based in the United States, There's a tailwind relative to our budgeted FX amount.

Speaker Change: I'd ask Andy to comment and maybe Andrew or Joanne on the Medicare part a good reason for sure.

Speaker Change: It will help to help offset some of those as well. So we're very confident today that with the strong growth you saw in the base business in the first quarter. Despite the part D impact with Joanna can speak to.

Andy: It's Andy.

Andy: Just to confirm what Dan said, our updated guidance does reflect the expected impact of the increase in indirect cost that we've seen from both announced tariffs and reciprocal tariffs as well as our general expectations for the inflationary environment that we may be moving into and as you can expect there are a number of puts and takes.

Speaker Change: Even with the tariffs were happy to reconfirm, our guidance for the year and we feel like we're in a good spot.

Speaker Change: And maybe just specific to your part D. Redesign question, although it's still quite early in the stages of implementation.

Andy: The P&L, but as you look again at another very strong quarter of disciplined expense management that helps us absorb some of those additional costs.

Speaker Change: Just important to note that Medicare claims will lag by a quarter. So it's still kind of looking for that data and we will get that sometime late Q2.

Andy: There is also a bit of a tailwind as you've heard from our peers in terms of as the U S. Dollar has weakened for those of US that are based in the United States as a tailwind relative to our budgeted FX amount no.

Speaker Change: For the first quarter of this year, our assumptions haven't changed we continue to expect about that $1 $1 billion that we shared a total impact of which about $900 million or so is specific to HIV.

Andy: Will help offset some of those as well so we're very confident today that with the strong growth you saw in the base business in the first quarter. Despite the part D impact, but Joanna can speak to.

Speaker Change: And in terms of phasing do you expect a linear progression over the quarter is that in part driven by the cost of our medicine.

Speaker Change: And then last but not least we're really quite pleased with our Q1 results. If you think about our HIV business growing six point year over year. If you were to take out part D redesign you'd be looking at a 9% growth year over year. So we're really pleased with how HIV is Ah is playing out.

Joanna Good: Even with the tariffs were happy to reconfirm, our guidance for the year and we feel like we're in a good spot and maybe just specific to your part D. Redesign question, although it's still quite early in the stages of implementation.

Joanna Good: So it's important to note that Medicare claims will lag by a quarter. So still kind of looking for that data and we'll get that sometime late Q2.

Speaker Change: And and being able to navigate the seasonal dynamics of inventory that we always see in Q1, but also the part D redesign dynamic.

Joanna Good: For the first quarter of this year, our assumptions haven't changed we continue to expect about that $1 $1 billion that we shared a total impact of which about $900 million or so is specific to HIV.

Speaker Change: As a reminder, we ask that you. Please limit yourself to one question. So we can get to as many analysts as possible. During today's call. Our next question comes from Tyler Van Buren at TD Cowen Hi, Tyler go ahead.

Joanna Good: And in terms of phasing, we do expect linear progression over the quarter is that in part driven by the cost of our medicine.

Speaker Change: Hey, guys. Thanks, very much a portrait Dolby is a lower demand quarter over quarter due to bladder coming out or lower demand in breast would be helpful. If you could elaborate on that.

Joanna Good: And then last but not least we're really quite pleased with our Q1 results. If you think about our HIV business growing six points year over year. If you were to take out part D redesign you'd be looking at a 9% growth year over year. So we're really pleased with how HIV is ah is playing out and and being able to navigate.

Speaker Change: Sure.

Speaker Change: Joanne I'll take that one.

Speaker Change: Yeah, so quarter over quarter has to do with inventory and a little bit of lower demand. Just because Q4 was really strong performance and if you look at our year on year at about minus 5%, that's really just inventory dynamic.

Joanna Good: The seasonal dynamics of inventory that we always see in Q1, but also the part D redesign dynamics.

Speaker Change: Lower average realized price due to channel mix and higher demand. So we are trending nicely with <unk> and holding a really nice position. Both in second line metastatic triple negative breast cancer and as long as the HR positive <unk> negative they feel confident.

Speaker Change: Hey, guys. Thanks, very much a portrait Dolby is the lower demand quarter over quarter due to bladder coming out or lower demand in breast would be helpful. If you could elaborate on that.

Speaker Change: With what's to come in 2025, let alone.

Speaker Change: Yeah.

Speaker Change: Great positive news on essential for that just reinforces our confidence for physicians in the second line setting with the data that we had originally started with ascent.

Speaker Change: Sure.

Speaker Change: Joanna I'll take that one yeah.

So quarter over quarter has to do with inventory and a little bit of lower demand just because Q4 was really strong performance, but if you look at our year on year at about minus 5%, that's really just inventory dynamic.

Speaker Change: Our next question comes from Dana Great Bosch at Leerink Partners. Dana go ahead. Your line is open.

Dana: Hi, Thanks for the question I Wonder if you can talk about the process the AD when a cap of ear to the U S. P. S. T S mandate for coverage without cost sharing.

Speaker Change: Lower average realized price due to channel mix and higher demand. So we are trending nicely with fidelity and holding a really nice position. Both in second line metastatic triple negative breast cancer and as well as the HR positive <unk> negative so feel confident.

Speaker Change: Assuming skodas upheld the constitutionality.

Dana: In June.

Dana: What's the timing of that being added and how much impact or uplift do you expect.

Speaker Change: With what's to come in 2025, let alone.

Dana: And revenue on growth in the U S. When it's added to the mandate. Thank you.

Speaker Change: Yeah.

Speaker Change: Great positive news on our central for it that just reinforces the confidence for physicians in the second line setting with the data that we had originally started with ascent.

Joanna: Thanks, Dan for your question Joanna again.

Joanna: And I think what's important is that we are assuming that it's going to take a little bit of time for U S. P. S. T. F Q2 Atlantic halfway or is the process, obviously from a guideline standpoint, you've already kind of seen those guidelines play out when you think about Ias guidelines, we already have line of Carpathia there prior to even approval, but usually they wait for approved.

Dana: Our next question comes from Dana <unk> at Leerink Partners. Dana go ahead. Your line is open.

Speaker Change: Hi, Thanks for the question I Wonder if you can talk about the process. The AD when a cast of ear to the U S. P. S T assay mandate for coverage without cost sharing.

Joanna: And then we kind of go forward with them.

Joanna: Trying to get medical update through the through and through including U S. P. S. T. S. We do believe though that despite that we feel we're incredibly well positioned because of the transformative nature of Atlanta cap are there to build access across the different channels that oh.

Dana: Assuming skodas upheld the constitutionality.

Speaker Change: And Julia.

Speaker Change: What's the timing of that being added and how much impact are uplift do you expect.

Speaker Change: And revenue on growth in the U S. When it's added to the mandate. Thank you.

Joanna Good: Thanks, Dana for your question Joanna again.

Joanna: We're prepared to do that and that's again going to take a little bit of time over the next six to 12 months, but we feel that that would be in line with them.

Joanna Good: I think what's important is that we are assuming that it's going to take a little bit of time for U S. P. S. T F. Two to Atlantic halfway or is the process, obviously from a guideline standpoint, you've already kind of seen those guidelines play out when you think about Ias guidelines, we already have a copy of their prior to even approval, but usually they wait for approval and then.

What we've seen in the past with other other agents, including <unk> and we're going to be leveraging all the guidelines possible to make sure that there's a real value. That's displayed for access to go as quickly as possible U S. P. S. T F would be nice to have to be honest with you, but in the first six months to 12 months, we're assuming that that's not.

Joanna Good: We kind of go forward with them.

Joanna Good: Trying to get medical update through the through Latin through including U S. P. S. T. F. We do believe though that despite this we feel we're incredibly well positioned because of the transformative nature of Atlantic half of there to build access across the different channels that.

Joanna: Gonna be in play and we our plans are really based on our value proposition to Atlantic happier.

Joanna: Yeah.

Speaker Change: Our next question comes from Geoff Meacham at Citigroup. Jeff Go ahead. Your line is open.

Joanna Good: We're prepared to do that and that's again again I'm going to take a little bit of time over the next six to 12 months, but we feel that that would be in line with with what we've seen in the past with other other agents, including <unk>.

Geoff Meacham: Great afternoon, guys. Thanks, so much for the question.

Speaker Change: I want for Dietmar, so on the HIV treatment.

Speaker Change: Opportunity and looking to your long acting oral <unk> I guess the question is what's the gating factor for selecting the best Phase III combo.

Joanna Good: And we're going to be leveraging all the guidelines possible to make sure that there's a real value that's displayed for access to go as quickly as possible U S. P. S. T F would be nice to have to be honest with you, but in the first six to 12 months, we're assuming that that's not going to be in play and we our plans are really based on our value proposition.

Related to that.

Speaker Change: You haven't seen resistance with Atlanta hasn't really been an issue when it still makes sense to have.

Speaker Change: In the in the treatment setting a three drug versus a two drug combo just to mitigate the lower risk.

Speaker Change: Thank you.

Speaker Change: Atlantic catheter.

Joanna Good: Yeah.

Speaker Change: Thank you Jeff for the question right. That's a really early in our development program here I think the important piece is that we're looking for Optionality, we're really looking for the breadth and depth of the portfolio to deliver.

Speaker Change: Our next question comes from Geoff Meacham at Citigroup. Jeff Go ahead. Your line is open.

Speaker Change: Great afternoon, guys. Thanks, so much for the question.

Speaker Change: I want for Dietmar, so on the HIV treatment opportunity and looking into your long acting oral I guess the question is what's the gating factor for selecting the best phase III combo and related to that.

Speaker Change: People basically.

With monthly and weekly and.

Speaker Change: In the prep setting obviously.

Speaker Change: Once every six months and potentially also once every year or options.

Speaker Change: You haven't seen resistance with Atlanta, it hasn't really been an issue when it still makes sense to have.

Speaker Change: In the immediate future obviously, we're really looking forward as discussed right to the length of prep launch.

Speaker Change: In the in the treatment setting a three drug versus a two drug combo, just too to mitigate the lower risk.

Speaker Change: But then we also had data at Crawley right, who we're talking about.

Speaker Change: The potential of lending capability for once every year.

Speaker Change: Thank you.

Speaker Change: Thank you Jeff for the question right. That's really early in our development program here I think the important piece is that we're looking for Optionality, we're really looking for the breadth and depth of the portfolio to deliver.

Speaker Change: And that of course, some of our focus areas. Obviously, we will look at the overall portfolio.

Speaker Change: And see you know with the options that we want to develop.

Speaker Change: Which ones we can take forward.

Moderator: Our next question comes from Chris Schott at Jpmorgan. Chris Go ahead. Your line is open.

Speaker Change: Four people basically.

Speaker Change: With monthly and weekly and then in the prep setting obviously.

Chris Schott: Great. Thanks, so much just was hoping to get a little bit more color on the <unk> launch so far.

Speaker Change: Once every six months and potentially also once every year or options.

Speaker Change: The immediate future obviously, we're really looking forward to as discussed right to the length of prep launch.

Chris Schott: Elaborate a bit more on what youre seeing from a competitive standpoint, and how that ramp is progressing relative to your internal expectations. Thank you.

Speaker Change: But then we also had data at Crawley right, who we're talking about.

Chris Schott: Yeah.

Speaker Change: Thanks, Chris Joanna and Yeah, we're really pleased with the progression of lift LLC right in a full second quarter.

Speaker Change: The potential of lending capability for once every year.

Speaker Change: And that of course, some of our focus areas. Obviously, we will look at the overall portfolio.

Speaker Change: <unk> 40 million, but most importantly, it actually has to do with the share uptake that we've seen.

Speaker Change: And C with the options that we want to develop.

Speaker Change: We are looking at about <unk>.

Speaker Change: Which ones we can take forward.

Speaker Change: Third of the market today out of the second line on products that are currently indicated.

Speaker Change: Our next question comes from Chris Schott at Jpmorgan. Chris Go ahead. Your line is open.

Speaker Change: And growing incredibly rapidly we grew about 10 point share in one quarter or so.

Chris Schott: Great. Thanks, so much just was hoping to get a little bit more color on the <unk> launch so far.

Speaker Change: We are really building that momentum with a lot of positive feedback that we're getting from our from our health care providers around the efficacy both E. L. P. The biochemical response and the pruritus.

Chris Schott: Elaborate a bit more on what youre seeing there from a competitive standpoint, and how that ramp is progressing relative to your internal expectations. Thank you.

Speaker Change: And coverage right now is in line with our expectations, they're worried about just over 80% or so coverage with commercial plans and we think that's going to keep growing probably within the next couple of months to just well above 90. So so I think right now we are well on our way to continue to drive lives Galaxy.

Joanna Good: Thanks, Chris Joanna.

Joanna Good: Yeah, we're really pleased with the progression of the golf Galaxy right in a full second quarter.

Joanna Good: 40 million, but most importantly, it actually has to do with the share uptake that we've seen.

Joanna Good: We are looking at about a third of the market today out of the second line on products that are currently indicated and growing incredibly rapidly. We grew about 10 point share in one quarter. So we are really building that momentum we.

And really differentiate it in PBC.

Speaker Change: Our next question comes from Terence Flynn at Morgan Stanley parents go ahead. Your line is open.

Speaker Change: Great. Thanks for taking the question.

Joanna Good: A lot of positive feedback that we're getting from our from our health care providers around the efficacy both E. L. P. The biochemical response and the pruritus.

Terence Flynn: I noticed you mentioned that you added <unk> negativity as a co primary endpoint and DNA to sell phase III trial I'm just wondering what if you could comment on what the regulators would want to see there to approve that on an <unk> negativity endpoint in terms of kind of like what Delta you would need or if you'd also have to have other supportive data suggest.

Joanna Good: And coverage right now is in line with our expectations, they're worried about just over 80% or so coverage with commercial plans and we think that's going to keep growing probably within the next couple of months to just well above 90. So so I think right now.

Speaker Change: A final approval. Thank you.

Joanna Good: And we are well on our way to continue to drive lives Galaxy and really differentiate it in PBC.

Speaker Change: But 10 to 70 per Eddie.

Speaker Change: I'll comment on the Delta that Theyre looking for but what I would share is that this is a dual primary end point and so being able to use them or D. We know today that that correlates to PFS and it also allows us to assess them.

Speaker Change: Our next question comes from Terence Flynn at Morgan Stanley parents go ahead. Your line is open.

Terence Flynn: Great. Thanks for taking the question.

Speaker Change: Within months of the treatment if the patient is having a response, though our goal is to use the <unk> negativity and 0.1st and then followed that up with progression free survival, but the correlation between the two is what we're talking to regulators about it.

Terence Flynn: Noticed you mentioned that you added <unk> negativity as a co primary endpoint and do you need to sell phase III trial I'm just wondering what if you could comment on what the regulators would want to see there to approve that on an <unk> negativity endpoint in terms of kind of like what Delta you would need or if you would also have to have other supportive data suggested.

Speaker Change: Our next question comes from Tim Anderson at Bofa. Tim Go ahead. Your line is open.

Terence Flynn: <unk> approval. Thank you.

Speaker Change: Los Angeles Sandeep already we don't comment on the Delta that Theyre looking for but what I would share is that this is a dual primary end point and so being able to use a mardi we know today that that correlates to PFS and it also allows us to assess.

Tim Anderson: Thank you on this Kobe, how much will an a cap of <unk> for prep cannibalize could use <unk> sales go X growth as soon as 2026, and then can you just give us any sort of ballpark estimate for how many patients could be Atlantic catheter for prep.

Terence Flynn:

Terence Flynn: Within months of the treatment if the patient is having a response, though our goal is to use the <unk> negativity endpoint first and then followed that up with progression free survival, but the correlation between the two is what we're talking to regulators about.

Speaker Change: By the end of the year.

Speaker Change: Thanks for the question, Tim Yeah, we don't give product specific guidance.

Speaker Change: Here's what I can say I do think that as you think about Atlantic catheter or in its offering.

Speaker Change: Our next question comes from Tim Anderson at Bofa. Tim Go ahead. Your line is open.

Speaker Change: Twice a year there really is an opportunity when you think about switch switch strategy right. When you think about 95% of the market today, our daily oral which obviously that includes discovery and generic truvada and that so that will definitely be where I think the first patients come through.

Tim Anderson: Thank you on <unk>, how much will an a cap severe for prep cannibalize <unk> sales go X growth as soon as 2026, and then can you just give us any sort of ballpark estimate for how many patients could be Atlantic catheter <unk> for prep.

Speaker Change: In addition to naive patients naive as well that are had been waiting for Atlantic cap. It there because there is definitely a lot of noise in the system from the communities that people are kind of hanging in there until the approval Atlanta happier. So those two pieces are what's exciting as we think about the launch and as I think about that.

Speaker Change: By the end of the year.

Tim Anderson: Thanks for the question, Tim Yeah, we don't give product specific guidance.

Tim Anderson: But here's what I can say I do think that as you think about Atlanta cap, there and it's offering a twice a year. There really is an opportunity. When you think about switch switch strategy right. When you think about 95% of the market today, our daily orally, which obviously that includes <unk> and generic truvada.

Speaker Change: Both of this market right. We basically said that we're just over about 400 450000 folks or so on prep today in the U S. We think.

Speaker Change: That number will.

Speaker Change: Definitely continue to grow quite rapidly, especially with the acceleration I think it will accelerate with the launch of learner cap of the air.

Tim Anderson: And that so that will definitely be where I think the first patients come through.

Speaker Change: Yeah, and I think that number could be quite exponential as you think about the next 10 years or so so we're looking forward to.

Tim Anderson: In addition to naive patients naive folks as well that are had been waiting for Atlantic capital. There because there is definitely a lot of noise in the system from the communities that people are kind of hanging in there until the approval Atlanta happier. So so those two pieces are.

Speaker Change: You're seeing a little bit more.

Speaker Change: In in gross adds were 16% year on year today, I think youre going to see a bit of an acceleration. If you think about Atlanta catheter launch around the corner.

Moderator: Our next question comes from Evan Thank urban at BMO. Evan go ahead. Your line is open.

Tim Anderson: What's exciting is we think about the launch and as I think about the growth in this market right. We basically said that we're just over about 400 450000 folks are so on prep today in the U S. We think that number will definitely continue to grow quite rapidly, especially with the acceleration I think it will accelerate with the launch of <unk>.

Well. Thank you so much for taking my question I wanted to drill down a little bit on some of the dynamics. We're seeing in cell therapy. You know are you seeing more share of competitive share capture from.

Moderator: Competitive cell therapy products or bi specifics.

Moderator: The flip side, what folks you know what the central might use a different cell therapy products do tend to see them switch over kind of what are the dynamics behind that thank you so much.

Tim Anderson: And <unk> and I think that number could be quite exponential as you think about the next 10 years or so so we're looking forward to.

Tim Anderson: We're seeing a little bit more.

Moderator: Eddie.

Moderator: Thank you for the question I think that we have shared publicly in the previous quarter and this quarter, we're seeing the dynamics from both bi specifics as well as in class competition that I think it depends as you look at your garden into Cardiff on those dynamics, we have a number of new approved indication in class within cars com.

Tim Anderson: In growth at 16% year on year today, I think youre going to see a bit of an acceleration as you think about Atlanta catheter launch around the corner.

Speaker Change: Our next question comes from Evan Pinkerman at BMO. Evan go ahead. Your line is open.

Evan Pinkerman: Well. Thank you so much for taking my question I wanted to drill down a little bit on some of the dynamics. We're seeing in cell therapy. You know are you seeing more share a competitive share capture from.

Moderator: Petition outside of the U S and that some of the dynamics you're observing.

Moderator: Outside of the U S within the U S and some.

Evan Pinkerman: Competitive cell therapy products or bi specifics and the flip side, what folks you don't want to have central might use a different cell therapy products do tend to see them switch over kind of what are the dynamics behind that thank you so much.

Moderator: Some of the more smaller markets at Jakarta's is competing in we're seeing new indications as well with in class competitors.

Moderator: But we're also seeing new indications in the U S and Europe with the bi specifics. So it's both that we're observing right now so hopefully that answers your question.

Evan Pinkerman: Betty.

Speaker Change: Thank you for the question I think that we have shared publicly in the previous quarter and this quarter, we're seeing the dynamics from both bi specifics as well as in class competition and I think it depends as you look at your garden to Carlos on those dynamics, we have a number of new approved indications in class within class competition.

Speaker Change: Our next question comes from Matt Biegler, Matt Go ahead. Your line is open.

Matt Biegler: Great. Thanks, so much I had another question on <unk> and the decreased demand Q O. Q are you seeing any headwind from natural ways recent approval in HR positive and I guess that kind of leads to a broader question could you just comment on the patient mix you're trading in terms of triple negative versus HR positive. Thanks.

Speaker Change: And outside of the U S and that some of the dynamics sure them serving them outside of the U S within the U S and some.

Speaker Change: Some of the more smaller markets at Jakarta's is competing in we're seeing new indications as well within class competitors, but we're also seeing new indications in the U S and Europe with the bi specific so it's both that we're observing right now so hopefully that answers your question.

Speaker Change: Sure.

Speaker Change: Basically with and with competitive impact, we havent seen any impact thus far really and as.

Speaker Change: As we think about new entrants in the marketplace and and we continue to really see a really strong dynamic in triple negative breast cancer HR positive remember the indications are a little bit different in triple negative. We're looking at a second line metastatic indication and HR positive <unk> negative you later lines of therapy fourth line. So.

Speaker Change: Our next question comes from Matt Biegler, Matt Go ahead. Your line is open.

Matt Biegler: Great. Thanks, so much I had another question on <unk> and the decreased demand Q O. Q are you seeing any headwind from <unk> recent approval in HR positive and I guess that kind of leads to a broader question. I mean could you just comment on the patient mix Youre trading in terms of triple negative versus HR positive. Thanks.

Speaker Change: Youre definitely the trop two ADC of choice in HR positive <unk> negative.

Nope.

Speaker Change: First is either adcs that are used much earlier in line.

Speaker Change: And and first and second line for example, and then in Triple negative breast cancer, we are absolutely the ADC of choice in that setting.

Speaker Change: Sure.

Speaker Change: Basically with with comparative impact, we havent seen any impacts thus far really.

Speaker Change: Our next question comes from Courtney, bringing at Bernstein. Courtney go ahead. Your line is open.

Speaker Change: We think about new entrants in the marketplace.

Speaker Change: And we continue to really see a really strong dynamic in triple negative breast cancer. Two HR positive remember the indications are a little bit different in triple negative. We're looking at a second line metastatic indication and HR positive or negative you later lines of therapy fourth line. So youre definitely the trop two ADC of choice in HR positive <unk> negative.

Courtney: Hi, all thanks, so much for taking the question.

Speaker Change: Wanted to ask a little bit about the one theatre Atlantic captive and we obviously saw the early data presented at Croix.

Courtney: It seems with the timeline.

Courtney: And associated with that press release that there could be a different trial design than what we've seen in petsmart and purpose to them.

Speaker Change: The trove.

Courtney: Can you just talk about whether there is any potential for an expedited PK O P. D package relative to an efficacy trial of what might be needed to get once yearly to market footprint.

Speaker Change: First is either adcs that are used much earlier in line and.

Speaker Change: And first and second line for example, and then in Triple negative breast cancer, we are absolutely the ADC of choice in that setting.

Thanks for the question, that's very insightful right.

Speaker Change: Our next question comes from Courtney <unk> at Bernstein. Courtney go ahead. Your line is open.

Courtney: We are currently looking into the different study designs right. We have not commented exactly on what they're planning on doing at this point in time, but you're absolutely right. There are different study designs that you can utilize and potentially a PK based approach is a possibility that we're discussing.

Speaker Change: Hi, all thanks, so much for taking the question I just wanted to ask a little bit about the once yearly Atlanta captive there won't be too saw the.

Speaker Change: Early data presented at Croix.

Speaker Change: It seems with the timeline.

Speaker Change: Associated with that press release that there could be a different trial design than what we've seen in fact, just one purpose to.

Our next question comes from Brian Abrahams RBC capital markets. Brian Go ahead. Your line is open.

Speaker Change: Can you just talk about whether there is any potential for an expedited PK O P. D package relative to an efficacy trial of what might be needed to get <unk> to market for prep.

Brian Abrahams: Hi, there. Thanks, so much for taking my question a question for Joanna around the potential underground dynamics for Atlantic happier and perhaps could you give us a sense of the awareness across the target physician practices of the drug.

Speaker Change: Thanks, Craig for the question, that's very insightful right.

Brian Abrahams: Number of sites or maybe proportion of your target practices that are going to be ready to ordered administered the drug at launch and we're provider stands with regards to capacity and bandwidth to administer it.

Speaker Change: We are currently looking into the different study designs right.

Speaker Change: Have not commented exactly on what they're planning on doing at this point in time, but you're absolutely right. There are different study designs that you can utilize and potentially a PK based approach is a possibility that you were discussing.

Brian Abrahams: Okay.

Brian Abrahams: So I think from an awareness standpoint, the awareness is actually quite high though that the health care provider level, but also at the within the community and I think we're leveraging both of those pieces as we think about how do we prepare for our launch. We're also very targeted right, we know that about 75% of <unk>.

Speaker Change: Okay.

Speaker Change: Our next question comes from Brian Abrahams RBC capital markets. Brian Go ahead. Your line is open.

Brian Abrahams: Hi, there. Thanks, so much for taking my question a question for Joanna around the potential on the ground dynamics for Atlantic capital here, and perhaps could you give us a sense of the awareness across the target physician practices of the drug.

Brian Abrahams: Ivy prescribers, either one prescribing prep today. So at launch that's really our target is really around differentiating lentic carpathia versus current options, making sure that.

Brian Abrahams: Number of sites or maybe proportion of your target practices that are going to be ready to order to administer the drug at launch and we are provider stands with regards to capacity and bandwidth to administer it.

Brian Abrahams: We are setting them up for success and creating a very smooth customer experience to your point about a number.

Brian Abrahams: A number of sites, we've been very targeted our approach in the first 30 days, we have a 30 day planned 90 day plan.

Brian Abrahams: Okay.

Brian Abrahams: And we're also very clear.

Brian Abrahams: Some clinics are set up to do buy and bill today than they currently do it those are clinics that might be a little bit more open to do buy and bill with Atlantic <unk>. So we know those and we're making sure that they're they have all of the training necessary to be able to do so as the post launch.

Brian Abrahams: Ivy prescribers, either one prescribing prep today. So at launch that's really our target is really around differentiating Linux half of the year versus current options, making sure that.

Brian Abrahams: And but then you also have a lot of clinics that do not have that set up and will need to go through more of a white bagging processed through specialty pharmacy and the optionality here, it's going to be really important and that's what we want to make sure we offer and that we trained folks not just the health care providers to be honest with you, but actually anybody in the clinic that managing that and.

Brian Abrahams: We are setting them up for success and creating a very smooth customer experience to your point about number.

Brian Abrahams: A number of sites, we have been very targeted in our approach in the first 30 days, we have a 30 day planned 90 day plan.

Brian Abrahams: So we have a team of folks ready to go not just our medical and sales teams, but we also have nurse educators, making sure people know how to inject making sure. They can help any with any questions. They might have but we also have field reimbursement managers that are going to be in the field basically.

Brian Abrahams: And we're also very clear as some some clinics are set up to do buy and bill today than they currently do it those are clinics that might be a little bit more open to do buy and bill with Atlantic <unk>. So we know those and we're making sure that they're they have all the training necessary to be able to do so as of <unk>.

Brian Abrahams: Making sure that we can track and follow them to make sure they get reimbursed, especially as you think about the first six months or so at plans are just coming online it's going to take a little bit of time and so most prescriptions will get a medical exceptions and we just want to make sure that we're tracking those to make sure we can help clinics.

Brian Abrahams: Health care providers follow through on that so that they can get started online account very quickly as possible.

Brian Abrahams: Net and so we have a team of folks ready to go not just our medical and sales teams, but we also have nurse educators, making sure people know how to inject making sure. They can help any with any questions. They might have but we also have field reimbursement managers that are going to be in the field basically.

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

Mohit Bansal: Great. Thank you for taking my question I would love two love for you to comment on a couple of macro themes that are that we hear a lot as it pertained to Gilead. One is of course about the about.

Brian Abrahams: And making sure that we can track and follow them to make sure they get reimbursed, especially as you think about the first six months or so as plans are just coming online it's going to take a little bit of time and so most of the prescriptions will get a medical exceptions and we just want to make sure that we're tracking those to make sure we can help clinics.

Mohit Bansal: About the NIH funding costs and potential for funding.

Mohit Bansal: Funding costs regarding something.

Mohit Bansal: Did the HIV awareness and awareness thing and then number two is potential for Medicaid cuts and how it pertains to gilead and Gilead can actually operate in an environment like that thank.

Brian Abrahams: And health care providers.

Brian Abrahams: Follow through on that so that they can get started online account very quickly as possible.

Mohit Bansal: Thank you.

Mohit Bansal: Thanks Mohit.

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

Mohit Bansal: Let me start this is Dan.

Mohit Bansal: And then Joanne concern, we have as well.

Mohit Bansal: Just want to repeat that we haven't seen or heard anything to date that would cause us to alter our plans or expectations.

Speaker Change: Great. Thank you for taking my question I would love two love for you to comment on a couple of macro themes that are.

In the HIV field, including the land for prep launch I mean, I think it's just too early to speculate on anything related to Medicaid at this stage. So there is no confirmed cuts at this time.

Speaker Change: We hear a lot as it pertained to Gilead one is of course about the about.

Speaker Change: About the NIH funding costs and potential for funding.

Mohit Bansal: I believe the administration understands the importance.

Speaker Change: <unk> funding cost regarding something which.

Speaker Change: The HIV awareness in February nesting and then number two is potential for Medicaid cuts and how it pertains to gilead and Gilead can actually operate in an environment like that thank you.

Mohit Bansal: Particularly chronic diseases and prevention as they approach that.

Mohit Bansal: I'd also say that the CDC side, obviously strong supporters of the CVC also the role that NIH plates, and Craig and I each placement.

Mohit Bansal: Writing a scientific community.

Speaker Change: Thanks Mohit.

Dan: Let me start this is Dan.

Mohit Bansal: But specifically relative to the CDC.

Speaker Change: And then Joanne concern, we have as well.

Mohit Bansal: It's still too early to understand any impact, particularly CDC program.

Speaker Change: Just want to repeat that we haven't seen or heard anything to date that would cause us to alter our plans our expectations.

Mohit Bansal: Generally focused on.

Mohit Bansal: Supporting prep utilization with community outrage provider training and education.

Speaker Change: In the HIV field, including the land for prep launch I mean, I think it's just too early to speculate on anything related to Medicaid at this stage. There is no confirmed cuts at this time.

Speaker Change: Those are also things that we do as well and maybe I'll turn it over to Joanna to say you know how she sees that in terms of.

Speaker Change: Believe the administration understands the importance.

Mohit Bansal: Some of our programs may be able to make sure that.

Particularly in chronic diseases and prevention as they approach that.

Mohit Bansal: Services are delivered to the people that need these medicines.

Speaker Change: I would also say that the CDC side.

Yeah, we've been tracking this very closely and obviously, making sure that the work that we do continues and in some areas gets accelerated or elevated where necessary.

Speaker Change: We see strong supporters of the CVC also the role that NIH sites and Craig NIH plays in and creating a scientific community but.

Speaker Change: Specifically relative to the CDC.

Mohit Bansal: E on gas and where necessary and we are HIV incidence of maybe higher as well right whether that greater need and we're very targeted in our approach.

Speaker Change: Still too early to understand any impact, particularly CDC programs are generally focused on.

Speaker Change: Supporting prep utilization with community outrage provided training and education.

Mohit Bansal: And then just going back to obviously theres nothing in play and we Wouldnt speculate about anything around Medicaid I just want to remind everybody that we're talking about HIV. These are individuals that if they need access to HIV medicines.

Speaker Change: These are also things that we do as well.

Speaker Change: And maybe I'll turn it over to Joanna to say you know how she sees it in terms of some of our programs may be able to make sure that.

Mohit Bansal: They will find other channels for coverage because they take don't Unfortunately, HIV will turn into AIDS in naval Guy and so they're in the past what we have seen as they say if one channel is closed they go to another and there are many different channels, where they can.

Speaker Change: Services are delivered to the people that need these medicines. Thanks, Dan Yes, we have been tracking this very closely and obviously, making sure that the work that we do continues and and in some areas gets accelerated or elevated where necessary with our bite me some gaps.

Mohit Bansal: They can go to today, including some credible that some states some states did approaches as well as gilead programs.

Speaker Change: And where necessary and we are HIV incidence is may be higher as well right, where there's a greater need that we're very targeted in our approach.

Mohit Bansal: That they can just make sure that they get over these access barriers so I.

Speaker Change: And then just going back to obviously theres nothing in play and we Wouldnt speculate about anything around Medicaid, but I just want to remind everybody that we're talking about HIV. These are individuals that if they need access to HIV medicines.

Mohit Bansal: I just wanted to.

Mohit Bansal: Pause on that.

Speaker Change: Our next question comes from Alex Hammond at most Alex go ahead. Your line is open.

Speaker Change: Thanks for taking the question how should we think about the potential impact of the 340 B channel mix on HIV pricing for 25, and how do you expect utilization to compare to what was seen in 2024. Thank you.

Speaker Change: We'll find other channels for coverage because if they don't Unfortunately, HIV will turn into AIDS in naval Guy and so they're in the past what we have seen is if they if one channel is closed they go to another and there are many different channels, where they can.

Speaker Change: Okay.

Speaker Change: So again at this time.

Speaker Change: There is nothing new that we are seeing for 340, B, we've seen our growth actually a 340 b over 'twenty.

They can go to today, including some credible that some states some state funded approaches as well as gilead programs.

Speaker Change: Every quarter from 24 into 2025.

Speaker Change: That they can just make sure that they get over these access barriers so am.

Speaker Change: We hope that stabilizes and we believe in the 340 B channel absolutely for what it was designed originally to do we just want a little bit more transparency.

Speaker Change: I just want to.

Speaker Change: Cause I'm not.

Moderator: Our next question comes from Alex Salmond Atmos. Alex go ahead. Your line is open.

Speaker Change: Because that would really help cut out some of the duplicate that we're currently seeing as lal across some of our different therapeutic areas.

Speaker Change: Thanks for taking the question how should we think about the potential impact of the 340 <unk> channel mix on HIV pricing for 25, and how do you expect utilization to compared to what was seen in 2024. Thank you.

Speaker Change: Our last question comes from Simon Baker at Redburn Atlanta. Simon Go ahead. Your line is open.

Speaker Change: Right.

Simon Baker: Thanks for taking my question going back to the part D. Redesign we've talked about the impact I was just wondering if you could give us some.

Moderator: Okay.

Moderator: So again at this time.

Moderator: There is nothing new that we are seeing for 340, B, we've seen our growth actually of $3 40 be over twice in.

Simon Baker: Some thoughts on when you are expecting to see a potential benefit.

Moderator: Every quarter from 24 into 2025.

Simon Baker: As the lower cost to patients increases stops increases stay time I'm guessing it's too early now, but as the year goes on when should we start to see.

Moderator: We hope that stabilizes.

Simon Baker: An offsetting positive impact from the changes that have been Mike. Thanks, So much.

Simon Baker: Yeah.

Simon Baker: Yeah. Thanks for the question.

Simon Baker: In terms of volume and giving them the number of safety net so I was just referring to earlier theres. So many programs that are available today that exist for HIV, we're not expecting to see a material uptick from the part D reform, we're obviously going to chocolate Super closely.

Simon Baker: If we were to see it would be later in the year.

Simon Baker: And just to remind people when you look at the Harvey for example, the level of the abandonment of the Kirby is incredibly low today and so very different maybe than other other therapeutic areas that you might see in chronic diseases, just because of the consequences of not being on in HIV treatment and so that's.

Simon Baker: We're monitoring the situation we haven't included in our numbers like we shared in the past and we'll obviously if we do see something we'll share with you as soon as we do but if it was to happen it would be later in the year.

Simon Baker: That completes the time that we have for questions today I'll now invite Dan to share any closing remarks.

Daniel O'Day: Terrific everybody, let me wrap up by thanking the Gilead teams that are responsible for this great start to the year I'll, just say that on behalf of all.

Daniel O'Day: All of US the strong base business growth of 4% year over year, and 6% growth in our HIV business.

Daniel O'Day: Bind with the continued success of <unk> launch and growing demand for <unk>.

Daniel O'Day: Alongside the impressive operating margin and earnings per share all demonstrate that we have a strong and efficient business today, which I think is extremely important given the current environment that we're all operating in now moving forward. We're also excited about what's next and our diverse pipeline and generating multiple upcoming potential launches including <unk>.

Daniel O'Day: <unk> for prep, which is weeks away lived LG and further marquez immuno cell and now <unk> based on the positive phase II results from your central for study all.

Daniel O'Day: Village with Great promise as we continue on the diversification approach.

Daniel O'Day: And confidence in our business overall. So this is an exciting time for gilead.

The ongoing work that we all do for patients and the communities, we serve and I just wanted to close by thanking you all for joining US today, we look forward to keeping you up to date on our progress as the year continues.

Q1 2025 Gilead Sciences Inc Earnings Call

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