Q1 2024 Gilead Sciences Inc Earnings Call

April 25, 2024

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Andrew Dickinson: Good afternoon, everyone, and welcome to Gilead's Q1 2024 earnings conference call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin our prepared remarks. After that, we'll have a Q&A session. If you'd like to ask a question, please press star one on your telephone keypad. If you'd like to withdraw your question, please press star two. I'll now hand the call over to Jackie Ross, VP, Investor Relations and Corporate Strategic Finance.

Operator: Good afternoon, everyone, and welcome to Gilead's Q1 2024 earnings conference call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin our prepared remarks. After that, we'll have a Q&A session. If you'd like to ask a question, please press star one on your telephone keypad. If you'd like to withdraw your question, please press star two. I'll now hand the call over to Jackie Ross, VP, Investor Relations and Corporate Strategic Finance.

Rebecca: Good afternoon, everyone and welcome to Gilead first quarter 2024 earnings Conference call. My name is Rebecca and I'll be your host.

Operator: Good afternoon, everyone, and welcome to Gilead's first quarter 2024 earnings conference call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin our prepared remarks. After that, we'll have a Q&A session. If you'd like to ask a question, please press Star 1 on your telephone keypad. If you'd like to withdraw your question, please press Star 2. I'll now hand the call over to Jacquie Ross, VP, investor relations and corporate strategic finance.

Rebecca: For today in a moment, we'll begin our prepared remarks after that we'll have a Q&A session.

If you'd like to ask a question. Please press star one on your telephone keypad, if you'd like to withdraw your question. Please press star two.

Speaker Change: Now hand, the call over to Jacky, Ross VP Investor Relations and corporate strategic finance.

Jacquie Ross: Thank you, Rebecca. Just after market close today, we issued a press release with earnings results for the first quarter of 2024. The press release, slides, and supplementary data are available on the investors' section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Johanna Mercier, our Chief Medical Officer, Mehrdad Parsey, and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A, where the team will be joined by Cindy Peretti, the Executive Vice President of Kite. Before we get started, 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.

Jacquie Ross: Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the first quarter of 2024. The press release, slides, and supplementary data are available on the Investors section of our website at gilead.com. The speakers on today's call will be our chairman and chief executive officer, Daniel O'Day; our chief commercial officer, Johanna Mercier; our chief medical officer, Merdad Parsey; and our chief financial officer, Andrew Dickinson. After that, we'll open Q&A where the team will be joined by Cindy Perettie, the executive vice president of Kite. Before we get started, let me remind you that we will be making forward-looking statements. Please refer to Slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.

Jacquie Ross: Thank you Rebecca.

Jacquie Ross: Just after market closed today, we issued a press release with earnings results for the first quarter of 2020 for the press release slides and supplementary data are available on the investors section of our website at Gilead Dot com.

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, Mehrdad, Parsi and our Chief Financial Officer, Andrew Dickinson After that we'll open the call to Q&A, where the team will be joined by Cindy Peretti, The executive Vice President of kite.

Jacquie Ross: Before we get started, let me remind you that we will be making forward-looking statements. Please refer to slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.

Jacquie Ross: Before we get started 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: Thank you, Jackie, and good afternoon, everyone. I want to start by thanking the Gilead teams for delivering a strong first quarter, which you see in our commercial performance and our clinical execution. Total product sales, excluding Veclury, grew 6% year over year to $6.1 billion, driven by higher demand across HIV, oncology, and liver disease. Veclury's sales continued to track with the rates of hospitalization for COVID-19 and reached a total of $555 million. Once again, sales growth for the quarter reflected the diversity of our portfolio. HIV product sales grew 4% year over year. Oncology product sales were up 18%, driven by Trodelvy, which is well established as the number one regimen for second-line metastatic triple-negative breast cancer, and by our transformative cell therapies.

Daniel O'Day: Thank you Jackie and good afternoon, everyone I wanted to start by thanking the gilead teams for delivering a strong first quarter, what you see in our commercial performance and our clinical execution.

Daniel O'Day: Thank you, Jacquie, and good afternoon, everyone. I want to start by thanking the Gilead teams for delivering a strong first quarter, which you see in our commercial performance and our clinical execution. Total product sales, excluding VEKLURY, grew 6% year over year to $6.1 billion, driven by higher demand across HIV, oncology, and liver disease. VEKLURY sales continue to track with the rates of hospitalization for COVID-19 and reached a total of $555 million. Once again, sales growth for the quarter reflected the diversity of our portfolio. HIV product sales grew 4% year over year. Oncology product sales were up 18%, driven by TRODELVY, which is well established as the No. 1 regimen for second-line metastatic triple-negative breast cancer, and by our transformative cell therapies.

Dan: <unk> product sales, excluding victory grew 6% year over year to $6 $1 billion, driven by higher demand across HIV oncology and liver disease.

<unk> sales continued to track with the rates of hospitalization for COVID-19, and reached a total of $555 million.

Daniel O'Day: Once again sales growth for the quarter reflected the diversity of our portfolio.

Dan: HIV product sales grew 4% year over year. Oncology product sales were up 18%, driven by Tordelvi, which is well-established as the number one regimen for second-line metastatic triple negative breast cancer, and Biotransformative Cell Therapy. As we outlined at the recent Kite Analysts event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy, such as expanding into community networks in the U.S., more than double our manufacturing capacity, and move into new indications and disease areas with next generation products.

HIV product sales grew 4% year over year. Oncology product sales were up 18%, driven by Tordelvi, which is well-established as the number one regimen for second-line metastatic triple negative breast cancer, and Biotransformative Cell Therapy.

Daniel O'Day: <unk> product sales grew 4% year over year oncology product sales were up 18% driven by <unk>, which is well established as the number one regimen for second line metastatic triple negative breast cancer.

Daniel O'Day: And by our transformative cell therapies.

Daniel O'Day: As we outlined at the recent Kite analyst event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy, such as expand into community networks in the U.S., more than double our manufacturing capacity, and move into new indications and disease areas with next-generation products. From an EPS perspective, first-quarter results reflect the close of the CymaBay acquisition with an inquired IP R&D charge of $3.9 billion or an expense of $3.14 per share. Excluding this charge, non-GAAP diluted EPS would have been $1.82 for the first quarter, which is above expectations, driven by higher product sales. The CymaBay acquisition brings us an important registrational medicine, seladelpar, which has the potential to address significant unmet need in liver disease. We have filed for regulatory approval of seladelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August. If approved, we will leverage our industry-leading commercial infrastructure and long-standing expertise in liver disease to bring seladelpar a potentially transformative therapy to people with PBC who might benefit. Moving to clinical execution. We're very pleased with momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI.

Daniel O'Day: As we outlined at the recent Kite Analysts event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy, such as expanding the community networks in the US, more than double our manufacturing capacity, and move into new indications and disease areas with next-generation products. From an EPS perspective, Q1 results reflect the close of the CymaBay acquisition with an acquired IPR&D charge of $3.9 billion, or an expense of $3.14 per share. Excluding this charge, non-GAAP diluted EPS would have been $1.82 for Q1, which is above expectations, driven by higher product sales. The CymaBay acquisition brings us an important registrational medicine, Seladelpar, which has the potential to address significant unmet need in liver disease.

As we outlined at the recent Kite Analysts event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy, such as expanding the community networks in the US, more than double our manufacturing capacity, and move into new indications and disease areas with next-generation products. From an EPS perspective, Q1 results reflect the close of the CymaBay acquisition with an acquired IPR&D charge of $3.9 billion, or an expense of $3.14 per share. Excluding this charge, non-GAAP diluted EPS would have been $1.82 for Q1, which is above expectations, driven by higher product sales. The CymaBay acquisition brings us an important registrational medicine, Seladelpar, which has the potential to address significant unmet need in liver disease.

Daniel O'Day: As we outlined at the recent Kate analyst event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy.

Daniel O'Day: Chaz expand into community networks in the U S more than double our manufacturing capacity and move into new indications and disease areas with next generation products from an EPS perspective first quarter results reflect the close of the <unk> acquisition with an acquired IP R&D charge of $3 9 billion.

Dan: From an EPS perspective, first-quarter results reflect the close of the SEMA Bay acquisition with an acquired IPR&D charge of $3.9 billion, or an expense of $3.14 per share. Excluding this charge, non-GAAP diluted EPS would have been $1.82 for the first quarter, which is above expectations driven by higher product sales. The CIMAB acquisition brings us an important registrational medicine, Seladelpar, which has the potential to address significant unmet needs in liver disease. We have filed for regulatory approval of Celadelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August. If approved, we will leverage our industry-leading commercial infrastructure and longstanding expertise in liver disease to bring Celadelpar, a potentially transformative therapy, to people with PBC who might benefit. Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI.

Daniel O'Day: Or an expense of $3 14 per share.

Daniel O'Day: Excluding this charge non-GAAP diluted EPS would have been $1 82 for the first quarter, which is above expectations driven by higher product sales.

The <unk> acquisition brings us an important registrational Madison sell Adele par, which has the potential to address significant unmet need in liver disease.

Dan: The CIMAB acquisition brings us an important registrational medicine, Seladelpar, which has the potential to address significant unmet needs in liver disease. We have filed for regulatory approval of Celadelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August. If approved, we will leverage our industry-leading commercial infrastructure and longstanding expertise in liver disease to bring Celadelpar, a potentially transformative therapy, to people with PBC who might benefit. Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI.

Daniel O'Day: We have filed for regulatory approval of seladelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August. If approved, we will leverage our industry-leading commercial infrastructure and longstanding expertise in liver disease to bring seladelpar, a potentially transformative therapy, to people with PBC who might benefit. Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI. Based on the strength of the data, we've initiated phase 3 trials for bictegravir and lenacapavir, our novel once-daily oral regimen, and plan to advance once-weekly oral programs, including lenacapavir plus islatravir, into phase 3.

We have filed for regulatory approval of seladelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August. If approved, we will leverage our industry-leading commercial infrastructure and longstanding expertise in liver disease to bring seladelpar, a potentially transformative therapy, to people with PBC who might benefit. Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI. Based on the strength of the data, we've initiated phase 3 trials for bictegravir and lenacapavir, our novel once-daily oral regimen, and plan to advance once-weekly oral programs, including lenacapavir plus islatravir, into phase 3.

Daniel O'Day: We have filed for regulatory approval of <unk> as a treatment for primary biliary cholangitis or PBC with both FDA and EMA and we expect an FDA regulatory decision in August.

Daniel O'Day: If approved we will leverage our industry, leading commercial infrastructure and long standing expertise in liver disease to bring cell Adele par a potentially transformative therapy to people with PBC who might benefit.

Dan: Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI. Based on the strength of the data, we've initiated Phase 3 trials for Bictegravir and Lenacapivir, our novel once-daily oral regimen, and plan to advance once-weekly oral programs, including Lenacapivir plus Islatrevir, into Phase 3. Later this year, we will host an HIV analyst event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment, including the next wave of long-acting therapies.

Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI.

Daniel O'Day: Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline whats reflected in our 80 data abstracts at <unk> based on the strength of the data we've initiated phase III trials for Big Tegra <unk> Atlantic cap of <unk>, our novel once daily oral regimen and plan to advance once weekly.

Daniel O'Day: Based on the strength of the data, we've initiated Phase III trials for bictegravir and lenacapavir, our novel once-daily oral regimen, and plan to advance once-weekly oral programs, including lenacapavir plus islatravir into Phase III. Later this year, we will host an HIV analyst event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment, including the next wave of long-acting therapies. Before I pass it to Johanna, I will briefly recap our 2024 milestones on Slide 6. We have already achieved first patient in for the Phase III ARTISTRY-1 and ARTISTRY-2 trials, evaluating once-daily lenacapavir in combination with bictegravir as well as Phase II first patient in for SWIFT evaluating GS-1427, our oral alpha-4-beta-7 inhibitor. We are also on track for our upcoming milestones, including updates from three Phase III clinical trials for Trodelvy and lenacapavir. Looking ahead to the rest of 2024, this is a time of focused execution for Gilead. We will stay disciplined and agile in our approach, and we will focus the organization on both near-term execution and longer-term plans. With 54 clinical programs in play, no major patent expiration for the decade, and many opportunities for growth, we have a lot of potential and a lot to deliver. My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Johanna.

Daniel O'Day: All programs, including Atlantic cap of your plus <unk> into phase III.

Daniel O'Day: Later this year, we will host an HIV Analysts event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment, including the next wave of long-acting therapies. Before I pass it to Johanna, I will briefly recap our 2024 milestones on slide six. We have already achieved first patient in for the phase 3 ARTISTRY-1 and ARTISTRY-2 trials, evaluating once-daily lenacapavir in combination with bictegravir, as well as phase 2 first patient in for SWIFT, evaluating GS-1427, our oral alpha-4 beta-7 inhibitor. We are also on track for our upcoming milestones, including updates from three phase 3 clinical trials for Trodelvy and lenacapavir. Looking ahead to the rest of 2024, this is a time of focused execution for Gilead.

Later this year, we will host an HIV Analysts event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment, including the next wave of long-acting therapies. Before I pass it to Johanna, I will briefly recap our 2024 milestones on slide six. We have already achieved first patient in for the phase 3 ARTISTRY-1 and ARTISTRY-2 trials, evaluating once-daily lenacapavir in combination with bictegravir, as well as phase 2 first patient in for SWIFT, evaluating GS-1427, our oral alpha-4 beta-7 inhibitor. We are also on track for our upcoming milestones, including updates from three phase 3 clinical trials for Trodelvy and lenacapavir. Looking ahead to the rest of 2024, this is a time of focused execution for Gilead.

Later this year, we will host an HIV analyst event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment, including the next wave of long acting therapies.

Dan: Before I pass it to Johanna, I will briefly recap our 2024 milestones on slides. We have already achieved first patient in for the Phase 3, Artistry 1, and Artistry 2 trials, evaluating once-daily Lenacapavir in combination with Bictegravir, as well as first patient in for the SWIFT trial, evaluating GS1427, our oral alpha-4 beta-7 inhibitor. We are also on track for our upcoming milestones, including updates from three phase three clinical trials for Tornelve and Lenacappa. Looking ahead to the rest of 2024, this is a time of focused execution for Gilead. We will stay disciplined and agile in our approach. And we will focus the organization on both near-term execution and longer-term planning. With 54 clinical programs in play, no major patent expiries through the end of the decade, and many opportunities for growth, we have a lot of potential and a lot to deliver. My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Johanna.

Daniel O'Day: Before I pass it to Joanna I will briefly recap our 2024 milestones on slide six we have already achieved first patient in for the phase III artistry, one and artistry two trials evaluating once daily Atlantic cap of your in combination with Vic Tegra <unk>.

Joanna: As well as phase II first patient in for Swift evaluating <unk>, our oral alpha four beta seven inhibitor.

Joanna: We are also on track for our upcoming milestones, including updates from three phase III clinical trials for <unk> and <unk>.

Dan: Looking ahead to the rest of 2024, this is a time of focused execution for Gilead. We will stay disciplined and agile in our approach. And we will focus the organization on both near-term execution and longer-term planning. With 54 clinical programs in play, no major patent expiries through the end of the decade, and many opportunities for growth, we have a lot of potential and a lot to deliver. My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Johanna.

Joanna: Looking ahead to the rest of 2024. This is a time of focused execution for Gilead, we will stay disciplined and agile in our approach and we will focus the organization on both near term execution and longer term plans with 54 clinical programs in play no major patent expertise through the end of the decade.

Daniel O'Day: We will stay disciplined and agile in our approach, and we will focus the organization on both near-term execution and longer-term plans. With 54 clinical programs in play, no major patent expiration to the end of the decade, and many opportunities for growth, we have a lot of potential and a lot to deliver. My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Johanna.

We will stay disciplined and agile in our approach, and we will focus the organization on both near-term execution and longer-term plans. With 54 clinical programs in play, no major patent expiration to the end of the decade, and many opportunities for growth, we have a lot of potential and a lot to deliver. My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Johanna.

And many opportunities for growth, we have a lot of potential and a lot to deliver.

Joanna: My Thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies with that I'll hand, it over to Joanna.

Jacquie Ross: Thanks, Dan, and good afternoon, everyone. With Q1 marking the ninth consecutive quarter of year-over-year growth for our base business, our teams delivered a strong start to 2024, notably navigating the seasonal Q1 dynamics and establishing a firm base on which we can continue to build this year. Beginning on slide eight, total product sales, excluding Veclury, were $6.1 billion for Q1, up 6% year over year, reflecting solid growth across our HIV, oncology, and liver disease businesses. Including Veclury, total product sales were $6.6 billion, up 5% year over year. Moving to HIV on slide nine, sales were up 4% year over year to $4.3 billion, primarily driven by higher demand, as well as favorable pricing dynamics in Europe that are not expected to repeat.

Johanna Mercier: Thanks, Dan, and good afternoon, everyone. With Q1 marking the ninth consecutive quarter of year-over-year growth for our base business, our teams delivered a strong start to 2024, notably navigating the seasonal Q1 dynamics and establishing a firm base on which we can continue to build this year. Beginning on slide eight, total product sales, excluding Veclury, were $6.1 billion for Q1, up 6% year over year, reflecting solid growth across our HIV, oncology, and liver disease businesses. Including Veclury, total product sales were $6.6 billion, up 5% year over year. Moving to HIV on slide nine, sales were up 4% year over year to $4.3 billion, primarily driven by higher demand, as well as favorable pricing dynamics in Europe that are not expected to repeat.

Joanna: Thanks, Dan and good afternoon, everyone.

Johanna Mercier: Thanks, Dan, and good afternoon, everyone. With the first quarter marking the ninth consecutive quarter of year-over-year growth for our base business, our teams delivered a strong start to 2024, notably navigating the seasonal first-quarter dynamics and establishing a firm base on which we can continue to build this year. Beginning on Slide 8, total product sales, excluding VEKLURY, were $6.1 billion for the first quarter, up 6% year 1, reflecting solid growth of our HIV, oncology, and liver disease businesses. Including VEKLURY, total product sales were $6.6 billion, up 5% year over year. Moving to HIV on Slide 9. Sales were up 4% year over year to $4.3 billion, primarily driven by higher demand as well as favorable pricing dynamics in Europe that are not expected to repeat. Quarter-over-quarter sales were down 7%, driven by the typical seasonality we experienced in the first quarter of the year, partially offset by higher demand. As a reminder, quarterly HIV growth is, in general, more variable and less indicative of overall trends than the full year.

Joanna: With the first quarter, marking the ninth consecutive quarter of year over year growth for our base business.

Joanna: Teams delivered a strong start to 2024.

Joanna: Notably navigating the seasonal first quarter dynamics and establishing a firm base on which we can continue to build this year.

Joanna: Beginning on slide eight total product sales excluding victory were $6 $1 billion for the first quarter up 6% year over year, reflecting solid growth across our HIV oncology and liver disease businesses.

Joanna: Including <unk> total product sales were $6 6 billion up 5% year over year.

Joanna: Moving to HIV on slide nine.

Johanna Mercier: Sales were up 4% year-over-year to $4.3 billion, primarily driven by higher demand, as well as favorable pricing dynamics in Europe that are not expected to repeat. Quarter over quarter, sales were down 7%, driven by the typical seasonality we experience in the first quarter of the year, partially offset by higher demand. As a reminder, quarterly HIV growth is, in general, more variable and less indicative of overall trends than the full year. This is evident in the first quarter of every year, where inventory drawdown typically occurs following a build that generally happens towards the end of the prior year, and patient co-pays and deductibles reset at the start of every year, and together with shifts in channel mix lowers average realized prices in the first quarter. As always, we typically see these quarterly pricing and inventory dynamics normalize as we progress throughout the year.

Sales were up 4% year-over-year to $4.3 billion, primarily driven by higher demand, as well as favorable pricing dynamics in Europe that are not expected to repeat. Quarter over quarter, sales were down 7%, driven by the typical seasonality we experience in the first quarter of the year, partially offset by higher demand. As a reminder, quarterly HIV growth is, in general, more variable and less indicative of overall trends than the full year.

Joanna: Sales were up 4% year over year to $4 $3 billion, primarily driven by higher demand as well as favorable pricing dynamics in Europe that are not expected to repeat.

Jacquie Ross: Quarter-over-quarter sales were down 7%, driven by the typical seasonality we experienced in the first quarter of the year, partially offset by higher demand. As a reminder, quarterly HIV growth is, in general, more variable and less indicative of overall trends than the full year. This is evident in the first quarter of every year, where inventory drawdown typically occurs following a build that generally happens towards the end of the prior year, and patient copays and deductibles reset at the start of every year, and together with shifts in channel mix, lowers average realized price in the first quarter. As always, we typically see these quarterly pricing and inventory dynamics normalize as we progress throughout the year. We continue to expect approximately 4% HIV sales growth for 2024. Supporting that outlook, the treatment market grew in line with our expectations, as shown on slide 10.

Quarter-over-quarter sales were down 7%, driven by the typical seasonality we experienced in the first quarter of the year, partially offset by higher demand. As a reminder, quarterly HIV growth is, in general, more variable and less indicative of overall trends than the full year. This is evident in the first quarter of every year, where inventory drawdown typically occurs following a build that generally happens towards the end of the prior year, and patient copays and deductibles reset at the start of every year, and together with shifts in channel mix, lowers average realized price in the first quarter. As always, we typically see these quarterly pricing and inventory dynamics normalize as we progress throughout the year. We continue to expect approximately 4% HIV sales growth for 2024. Supporting that outlook, the treatment market grew in line with our expectations, as shown on slide 10.

Joanna: Quarter over quarter sales were down 7% driven by the typical seasonality we experienced in the first quarter of the year, partially offset by higher demand.

Joanna: As a reminder, quarterly HIV growth is in general more variable and less indicative of overall trends and the full year.

Johanna Mercier: This is evident in the first quarter of every year where inventory drawdown typically occurs following a build that generally happens toward the end of the prior year and patient co-pays and deductibles start of every year, and together with shifts in channel mix lowers average realized price in the first quarter. As always, we typically see these quarterly pricing and inventory dynamics normalize as we progress throughout the year. We continue to expect approximately 4% HIV sales growth for 2024. Supporting that outlook, the treatment market grew in line with our expectations, as shown on Slide 10. BIKTARVY remains the leading regimen for HIV treatment across major markets for new starts as well as for those switching regimens with sales up 10% year over year to $2.9 billion, reflecting strong demand. Quarter over quarter, sales were down 5% as the higher demand was offset by the typical seasonal factors discussed earlier. It's notable that six years after launch, BIKTARVY continues to gain market share in the U.S., up three percentage points year over year to approximately 49% share and once again, outpacing all other branded regimens for HIV treatment. Moreover, we continue to see BIKTARVY's benefit extend into broader populations of people with HIV.

Joanna: This is evident in the first quarter of every year, where inventory drawdown typically occurs following a build to generally happens towards the end of the prior year and patient Copays and deductibles reset at the start of every year and together with shifts in channel mix lower average realized price in the first quarter.

Joanna: As always we typically see these quarterly pricing and inventory dynamics normalize as we progress throughout the year, we continue to.

Johanna Mercier: We continue to expect approximately 4% HIV sales growth for 2024. Supporting that outlook, the treatment market grew in line with our expectations, as shown on slide 10. Bctarvy remains the leading regimen for HIV treatment across major markets for new starts, as well as for those switching regimens, with sales up 10% year-over-year to $2.9 billion, reflecting strong demand. However, quarter over quarter, sales were down 5% as the higher demand was offset by the typical seasonal factors discussed earlier. It's notable that 6 years after launch, Bctarvy continues to gain market share in the US, up 3 percentage points year over year to approximately 49% of the market, and once again outpacing all other branded regimens for HIV treatment. Moreover, we continue to see BigTARBI's benefit extend into broader populations of people with HIV.

Joanna: We expect approximately 4% HIV sales growth for 2024.

Joanna: Supporting that outlook the treatment market grew in line with our expectations.

Joanna: On slide 10.

Jacquie Ross: Biktarvy remains the leading regimen for HIV treatment across major markets for new starts, as well as for those switching regimens, with sales up 10% year over year to $2.9 billion, reflecting strong demand. Quarter-over-quarter, sales were down 5% as the higher demand was offset by the typical seasonal factors discussed earlier. It's notable that six years after launch, Biktarvy continues to gain market share in the US, up 3 percentage points year over year to approximately 49% share, and once again outpacing all other branded regimens for HIV treatment. Moreover, we continue to see Biktarvy's benefit extend into broader populations of people with HIV. Most recently, Biktarvy was granted FDA approval for use in virologically suppressed individuals with known or suspected M184 resistance, a common form of treatment resistance.

Biktarvy remains the leading regimen for HIV treatment across major markets for new starts, as well as for those switching regimens, with sales up 10% year over year to $2.9 billion, reflecting strong demand. Quarter-over-quarter, sales were down 5% as the higher demand was offset by the typical seasonal factors discussed earlier. It's notable that six years after launch, Biktarvy continues to gain market share in the US, up 3 percentage points year over year to approximately 49% share, and once again outpacing all other branded regimens for HIV treatment. Moreover, we continue to see Biktarvy's benefit extend into broader populations of people with HIV. Most recently, Biktarvy was granted FDA approval for use in virologically suppressed individuals with known or suspected M184 resistance, a common form of treatment resistance.

Joanna: <unk> remains the leading regimen for HIV treatment across major markets for new starts as well as for those switching regimen with sales up 10% year over year to $2 $9 billion, reflecting strong demand.

Joanna: Quarter over quarter sales were down 5% at the higher demand was offset by the typical seasonal factors discussed earlier.

Johanna Mercier: It's notable that 6 years after launch, Bctarvy continues to gain market share in the US, up 3 percentage points year over year to approximately 49% of the market, and once again outpacing all other branded regimens for HIV treatment. Moreover, we continue to see BigTARBI's benefit extend into broader populations of people with HIV. Most recently, Victari was granted FDA approval for use in virologically suppressed individuals with known or suspected M184 resistance. A Common Form of Treatment

It's notable that 6 years after launch, Bctarvy continues to gain market share in the US, up 3 percentage points year over year to approximately 49% of the market, and once again outpacing all other branded regimens for HIV treatment. Moreover, we continue to see BigTARBI's benefit extend into broader populations of people with HIV.

Joanna: It is notable that six years after launch victory continues to gain market share in the U S up three percentage points year over year to approximately 49% share and once again outpacing all other branded regimens for HIV treatment.

Joanna: Moreover, we continue to see <unk> benefit extend into broader populations of people with HIV.

Joanna: Most recently <unk> was granted FDA approval for use in barrel logically suppressed individuals with known or suspected and 184 resistance.

Johanna Mercier: Most recently, BIKTARVY was granted FDA approval for use in virologically suppressed individuals with known or suspected M184 resistance, a common form of treatment resistance. Turning to prevention. DESCOVY sales were down 5% year over year to $426 million, driven by lower average realized price due to channel mix, partially offset by higher demand. Sequentially, sales were down 16%, reflecting the seasonal dynamics discussed earlier, partially offset by higher demand. While market volumes in February were temporarily disrupted by the cyberattack on Change Healthcare, volumes readily recovered in March. Overall, the PrEP market continued to demonstrate robust growth, up over 11% in the first quarter, with DESCOVY maintaining over 40% PrEP market share in the U.S. despite the availability of other regimens, including generics. This is a solid setup as we look to potentially launch lenacapavir as early as late next year as the first and only twice-yearly subcutaneous prevention option.

Joanna: Common form of treatment resistance.

Jacquie Ross: Turning to prevention, Descovy sales were down 5% year over year to $426 million, driven by lower average realized price due to channel mix, partially offset by higher demand. Sequentially, sales were down 16%, reflecting the seasonal dynamics discussed earlier, partially offset by higher demand. While market volumes in February were temporarily disrupted by the cyber attack on Change Healthcare, volumes readily recovered in March. Overall, the prep market continued to demonstrate robust growth, up over 11% in the first quarter, with Descovy maintaining over 40% prep market share in the US, despite the availability of other regimens, including generics. This is a solid setup as we look to potentially launch lenacapavir as early as late next year as the first and only twice-yearly subcutaneous prevention option.

Turning to prevention, Descovy sales were down 5% year over year to $426 million, driven by lower average realized price due to channel mix, partially offset by higher demand. Sequentially, sales were down 16%, reflecting the seasonal dynamics discussed earlier, partially offset by higher demand. While market volumes in February were temporarily disrupted by the cyber attack on Change Healthcare, volumes readily recovered in March. Overall, the prep market continued to demonstrate robust growth, up over 11% in the first quarter, with Descovy maintaining over 40% prep market share in the US, despite the availability of other regimens, including generics. This is a solid setup as we look to potentially launch lenacapavir as early as late next year as the first and only twice-yearly subcutaneous prevention option.

Joanna: Turning to prevention <unk> sales were down 5% year over year to $426 million driven by lower average realized price due to channel mix.

Johanna Mercier: Turning to prevention, DSCOVI sales were down 5% year-over-year to $426 million, driven by lower average realized price due to channeling, partially offset by higher demand. Sequentially, sales were down 16%, reflecting the seasonal dynamics discussed earlier, partially offset by higher demand. While market volumes in February were temporarily disrupted by the cyber attack on change healthcare, volumes readily recovered in March. Overall, the PrEP market continued to demonstrate robust growth, up over 11% in the first quarter, with DSCOVI maintaining over 40% of the PrEP market share in the U.S., despite the availability of other regimens, including generics. This is a solid setup as we look to potentially launch Lenacapavir as early as late next year as the first and only twice-yearly subcutaneous prevention option.

Joanna: Partially offset by higher demand.

Joanna: Sequentially sales were down 16%, reflecting the seasonal dynamics discussed earlier, partially offset by higher demand.

Joanna: While market volumes in February were temporarily disrupted by the cyber attack on change healthcare <unk>.

Johanna Mercier: While market volumes in February were temporarily disrupted by the cyber attack on change healthcare, volumes readily recovered in March. Overall, the PrEP market continued to demonstrate robust growth, up over 11% in the first quarter, with DSCOVI maintaining over 40% of the PrEP market share in the U.S., despite the availability of other regimens, including generics. This is a solid setup as we look to potentially launch Lenacapavir as early as late next year as the first and only twice-yearly subcutaneous prevention option.

Joanna: <unk> readily recovered in March.

Joanna: Overall, the market continued to demonstrate robust growth up over 11% in the first quarter with the scobey maintaining over 40% market share in the U S. Despite the availability of other regimens, including generics.

Joanna: This is a solid setup as we look to potentially launch Atlanta catheter as early as late next year as the first and only twice yearly subcutaneous prevention option.

Jacquie Ross: Given Gilead's strong commercial foundation across treatment and prevention, we are well positioned to maintain leadership in HIV as we look to the evolving marketplace of daily orals, long-acting orals, and long-acting injectables. Moving to liver disease on slide 11, sales for Q1 were $737 million, up 9% year over year, primarily driven by favorable inventory dynamics and the timing of purchases by the Department of Corrections for our HCV products, as well as higher demand across HCV, HBV, and HDV. Sequentially, sales were up 7%, primarily reflecting the timing of HCV purchases. Despite fewer HCV starts globally year over year, our viral hepatitis portfolio overall has remained stable and continues to be a meaningful contributor to our commercial performance. This strength is underpinned by our extensive global footprint and expertise in the treatment of liver diseases.

Given Gilead's strong commercial foundation across treatment and prevention, we are well positioned to maintain leadership in HIV as we look to the evolving marketplace of daily orals, long-acting orals, and long-acting injectables. Moving to liver disease on slide 11, sales for Q1 were $737 million, up 9% year over year, primarily driven by favorable inventory dynamics and the timing of purchases by the Department of Corrections for our HCV products, as well as higher demand across HCV, HBV, and HDV. Sequentially, sales were up 7%, primarily reflecting the timing of HCV purchases. Despite fewer HCV starts globally year over year, our viral hepatitis portfolio overall has remained stable and continues to be a meaningful contributor to our commercial performance. This strength is underpinned by our extensive global footprint and expertise in the treatment of liver diseases.

Johanna Mercier: Given Gilead's strong commercial foundation across treatment and prevention, we are well-positioned to maintain leadership in HIV as we look to the evolving marketplace of daily orals, long-acting orals, and long-acting injectables. Moving to liver disease on Slide 11. Sales for the first quarter were $737 million, up 9% year over year, primarily driven by favorable inventory dynamics and the timing of purchases by the Department of Corrections for our HCV products as well as higher demand across HCV, HBV, and HDV. Sequentially, sales were up 7%, primarily reflecting the timing of HCV purchases. Despite fewer HCV starts globally year over year, our viral hepatitis portfolio overall has remained stable and continues to be a meaningful contributor to our commercial performance. This strength is underpinned by our extensive global footprint and expertise in the treatment of liver diseases. To that end, pending approval, Gilead is excited to bring seladelpar to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the U.S. and about 125,000 people in Europe.

Joanna: Given gilead strong commercial foundation across treatment and prevention, we are well positioned to maintain leadership in HIV as we look to the evolving marketplace of daily oral long acting and long acting injectables.

Joanna: Moving to liver disease on slide 11 sales for the first quarter was $737 million up 9% year over year, primarily driven by favorable inventory dynamics and the timing of purchases by the department of corrections for HCV products as well as higher demand across HCV, HBV and H D D.

Joanna: <unk>.

Johanna Mercier: Sequentially, sales were up 7%, primarily reflecting the timing of HCV purchases. Despite fewer HCV starts globally year over year, our viral hepatitis portfolio overall has remained stable and continues to be a meaningful contributor to our commercial performance. This strength is underpinned by our extensive global footprint and expertise in the treatment of liver disease. To that end, pending approval, Gilead is excited to bring Celladel Parka to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the U.S. and about 125,000 people in Europe.

Joanna: Sequentially sales were up 7%, primarily reflecting the timing of HCV purchases.

Joanna: Despite fewer HCV starts globally year over year, our viral hepatitis portfolio. Overall has remained stable and continues to be a meaningful contributor to our commercial performance.

Joanna: This strength is underpinned by our extensive global footprint and expertise in the treatment of liver diseases.

Jacquie Ross: To that end, pending approval, Gilead is excited to bring seladelpar to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the US and about 125,000 people in Europe. With a sales force that covers almost 80% of the US prescriber base for PBC, we expect to readily make seladelpar available to patients upon approval in the second half of this year. Seladelpar has demonstrated the potential to be best in class with a differentiated clinical profile to existing and emerging therapies, particularly on a key symptom of the disease, pruritus. Following its launch in 2024, we expect seladelpar to contribute modestly to sales and more meaningfully in 2025 and beyond. Turning to slide 12, Veclury continues to be the standard of care antiviral for hospitalized patients treated with COVID-19, with market share well over 60% in the United States.

To that end, pending approval, Gilead is excited to bring seladelpar to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the US and about 125,000 people in Europe. With a sales force that covers almost 80% of the US prescriber base for PBC, we expect to readily make seladelpar available to patients upon approval in the second half of this year. Seladelpar has demonstrated the potential to be best in class with a differentiated clinical profile to existing and emerging therapies, particularly on a key symptom of the disease, pruritus. Following its launch in 2024, we expect seladelpar to contribute modestly to sales and more meaningfully in 2025 and beyond. Turning to slide 12, Veclury continues to be the standard of care antiviral for hospitalized patients treated with COVID-19, with market share well over 60% in the United States.

Johanna Mercier: To that end, pending approval, Gilead is excited to bring Celladel Parka to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the U.S. and about 125,000 people in Europe. With a sales force that covers almost 80% of the U.S. prescriber base for PBC, we expect to readily make Celladelpar available to patients upon approval in the second half of this year. Cella Del Par has demonstrated the potential to be best in class with a differentiated clinical profile compared to existing and emerging therapies, particularly for a key symptom of the disease, pruritus.

To that end, pending approval, Gilead is excited to bring Celladel Parka to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the U.S. and about 125,000 people in Europe.

Joanna: To that end pending approval Gilead is excited to bring salad out part of patients for the treatment of certain adults with PBC impacting approximately 130000 people in the U S and about 125000 people in Europe.

Johanna Mercier: With the sales force that covers almost 80% of the U.S. prescriber base for PBC, we expect to readily make seladelpar available to patients upon approval in the second half of this year. SELADELPAR has demonstrated the potential to be best-in-class with a differentiated clinical profile to existing and emerging therapies, particularly on a key symptom of the disease, pruritus. Following its launch in 2024, we expect seladelpar to contribute modestly to sales and more meaningfully in 2025 and beyond. Turning to Slide 12. VEKLURY continues to be the standard of care antiviral for hospitalized patients treated with COVID-19, with market share well over 60% in the United States. COVID-related hospitalizations were lower in the first quarter with the winter wave peaking earlier than expected in the U.S. and Europe as compared to other regions such as Japan.

Joanna: With a sales force that covers almost 80% of the U S. Prescriber base for PBC, we expect to readily make sell Adele power available to patients upon approval in the second half of this year.

Joanna: <unk> has demonstrated the potential to be best in class with a differentiated clinical profile to existing and emerging therapies, particularly on a key symptom of the disease pruritus.

Joanna: Following its launch in 2024, we expect sell Adele part to contribute modestly to sales and more meaningfully in 2025 and beyond.

Johanna Mercier: Following its launch in 2024, we expect CELADELPAR to contribute modestly to sales and more meaningfully in 2025 and beyond. Turning to slide 12, VicLary continues to be the standard of care antiviral for hospitalized patients treated with COVID-19, with a market share well over 60% in the United States. COVID-related hospitalizations were lower in the first quarter, with the winter wave peaking earlier than expected in the U.S. and Europe as compared to other regions such as Japan.

Joanna: Turning to slide 12.

Joanna: <unk> continues to be the standard of care antiviral for hospitalized patients treated with COVID-19 with market share well over 60% in the United States.

Jacquie Ross: COVID-related hospitalizations were lower in Q1, with the winter wave peaking earlier than expected in the US and Europe as compared to other regions such as Japan. As a result, Veclury sales overall were down 3% year over year and down 23% sequentially to $555 million. Shifting to oncology on slide 13, sales were up 18% year over year to $789 million and are now firmly above a $3 billion annual runway. Having treated over 50,000 patients to date, we look forward to bringing our portfolio of medicines and future treatments across lines of therapies and tumor types to many more patients around the world. Moving to slide 14, Trodelvy's sales for Q1 exceeded $300 million, up 39% year over year, reflecting continued demand.

COVID-related hospitalizations were lower in Q1, with the winter wave peaking earlier than expected in the US and Europe as compared to other regions such as Japan. As a result, Veclury sales overall were down 3% year over year and down 23% sequentially to $555 million. Shifting to oncology on slide 13, sales were up 18% year over year to $789 million and are now firmly above a $3 billion annual runway. Having treated over 50,000 patients to date, we look forward to bringing our portfolio of medicines and future treatments across lines of therapies and tumor types to many more patients around the world. Moving to slide 14, Trodelvy's sales for Q1 exceeded $300 million, up 39% year over year, reflecting continued demand.

Joanna: Covid related hospitalizations were lower in the first quarter with the winter wave, peaking earlier than expected in the U S and Europe as compared to other regions such as Japan.

Johanna Mercier: As a result, VEKLURY sales overall were down 3% year over year and down 23% sequentially to $555 million. Shifting to oncology on Slide 13. Sales were up 18% year over year to $789 million and are now firmly above a $3 billion annual run rate. Having treated over 50,000 patients to date, we look forward to bringing our portfolio of medicines and future treatments across lines of therapies and tumor types to many more patients around the world. Moving to Slide 14. TRODELVY sales for the first quarter exceeded $300 million, up 39% year over year, reflecting continued demand. Sequentially, sales were up 3%, primarily driven by demand outside the U.S. as well as unfavorable fourth-quarter pricing dynamics in Europe that did not repeat. This was partially offset by inventory dynamics in the U.S. where we saw a drawdown in the first quarter. Overall, TRODELVY's strong market share reflects its awareness among providers and patients. In second-line metastatic triple-negative breast cancer, TRODELVY remains the leading regimen with approximately one-third shares in the U.S.

Joanna: As a result victory sales overall were down 3% year over year and down 23% sequentially to $555 million.

Joanna: Shifting to oncology on slide 13.

Joanna: Sales were up 18% year over year to $789 million and are now firmly above a 3 billion dollar annual run rate.

Joanna: Having treated over 50000 patients to date, we look forward to bringing our portfolio of medicines and future treatment across lines of therapies and tumor types to many more patients around the world.

Joanna: Moving to slide 14 to.

Johanna Mercier: Todelvie's sales for the first quarter exceeded $300 million, up 39% year-over-year, reflecting continued demand. Sequentially, sales were up 3%, primarily driven by demand outside the U.S., as well as unfavorable fourth-quarter pricing dynamics in Europe that did not repeat. This was partially offset by inventory dynamics in the U.S., where we saw a drawdown in the first quarter. Overall, Toudelhi's strong market share reflects its awareness amongst providers and patients. In second-line metastatic triple negative breast cancer, Trudelby remains the leading regimen with approximately one-third share in the U.S.,

Joanna: <unk> sales for the first quarter exceeded $300 million up 39% year over year, reflecting continued demand.

Jacquie Ross: Sequentially, sales were up 3%, primarily driven by demand outside the US, as well as unfavorable fourth quarter pricing dynamics in Europe that did not repeat. This was partially offset by inventory dynamics in the US, where we saw a drawdown in the first quarter. Overall, Trodelvy's strong market share reflects its awareness among providers and patients. In second-line metastatic triple-negative breast cancer, Trodelvy remains the leading regimen with approximately 1/3 share in the US. And in the pretreated HR-positive HER2-negative metastatic breast cancer setting, Trodelvy has demonstrated continued adoption, most notably in the IHC0 setting. We are confident Trodelvy continues to differentiate itself with its safety profile and clinically meaningful survival benefits, with over 30,000 patients across tumor types already treated to date.

Sequentially, sales were up 3%, primarily driven by demand outside the US, as well as unfavorable fourth quarter pricing dynamics in Europe that did not repeat. This was partially offset by inventory dynamics in the US, where we saw a drawdown in the first quarter. Overall, Trodelvy's strong market share reflects its awareness among providers and patients. In second-line metastatic triple-negative breast cancer, Trodelvy remains the leading regimen with approximately 1/3 share in the US. And in the pretreated HR-positive HER2-negative metastatic breast cancer setting, Trodelvy has demonstrated continued adoption, most notably in the IHC0 setting. We are confident Trodelvy continues to differentiate itself with its safety profile and clinically meaningful survival benefits, with over 30,000 patients across tumor types already treated to date.

Joanna: Sequentially sales were up 3%, primarily driven by demand outside the U S as well as unfavorable fourth quarter pricing dynamics in Europe that did not repeat.

Joanna: This was partially offset by inventory dynamics in the U S, where we saw a drawdown in the first quarter.

Joanna: Overall, two Dolby strong market share reflects its awareness amongst providers and patients.

Johanna Mercier: Overall, Toudelhi's strong market share reflects its awareness amongst providers and patients. In second-line metastatic triple negative breast cancer, Trudelby remains the leading regimen with approximately one-third share in the U.S., and in the pre-treated HR-positive, HER2-negative metastatic breast cancer setting, Tredelby has demonstrated continued adoption, most notably in the IHC0 setting. We are confident Trudelvy continues to differentiate itself with its safety profile and clinically meaningful survival benefits, with over 30,000 patients across tumor types already treated today.

Overall, Toudelhi's strong market share reflects its awareness amongst providers and patients. In second-line metastatic triple negative breast cancer, Trudelby remains the leading regimen with approximately one-third share in the U.S.,

Joanna: In second line metastatic triple negative breast cancer, two dalby remains the leading regimen with approximately one third share of the U S.

Joanna: And in the Pretreated HR positive <unk> negative metastatic breast cancer setting to Dolby has demonstrated continued adoption most notably in the IH zero setting.

Johanna Mercier: And in the pre-treated HR+/HER2- metastatic breast cancer setting, TRODELVY has demonstrated continued adoption, most notably in the IHC0 setting. We are confident Trodelvy continues to differentiate itself with its safety profile and clinically meaningful survival benefits, with over 30,000 patients across tumor types already treated to date. We look forward to potentially extending TRODELVY's reach to many more patients in the years ahead, particularly in bladder cancer, earlier-line breast cancer settings, and lung cancer. Turning to Slide 15 and on behalf of Cindy and the Kite team, Cell Therapy sales were $480 million in the first quarter, up 7% year over year. Sequentially, sales were up 3%, in-line with our guidance of flat to slightly up. We're pleased to see continued demand for YESCARTA and TECARTUS in both existing and new markets across Europe and other geographies, such as in Japan where we have seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date. In the U.S., and consistent with our recent updates, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites, while also driving increased referrals from the community setting. For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in the first quarter.

Joanna: We are confident to Debbie continues to differentiate itself with its safety profile and clinically meaningful survival benefit with over 30000 patients across tumor types already treated to date.

Jacquie Ross: We look forward to potentially extending Trodelvy's reach to many more patients in the years ahead, particularly in bladder cancer, earlier line breast cancer settings, and lung cancer. Turning to slide 15, and on behalf of Cindy and the Kite team, cell therapy sales were $480 million in the first quarter, up 7% year over year. Sequentially, sales were up 3% in line with our guidance of flat to slightly up. We're pleased to see continued demand for Yescarta and Tecartus in both existing and new markets across Europe and other geographies, such as in Japan, where we've seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date.

We look forward to potentially extending Trodelvy's reach to many more patients in the years ahead, particularly in bladder cancer, earlier line breast cancer settings, and lung cancer. Turning to slide 15, and on behalf of Cindy and the Kite team, cell therapy sales were $480 million in the first quarter, up 7% year over year. Sequentially, sales were up 3% in line with our guidance of flat to slightly up. We're pleased to see continued demand for Yescarta and Tecartus in both existing and new markets across Europe and other geographies, such as in Japan, where we've seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date.

Joanna: We look forward to potentially extending <unk> reach to many more patients in the years ahead, particularly in bladder cancer earlier line breast cancer settings and lung cancer.

Johanna Mercier: We look forward to potentially extending Trudelvy's reach to many more patients in the years ahead, particularly in bladder cancer, earlier-line breast cancer settings, and lung cancer. Turning to slide 15, and on behalf of Cindy and the KITE team, cell therapy sales were $480 million in the first quarter at 7% year-over-year. Sequentially, sales were up 3% in line with our guidance of flat to slightly up. We're pleased to see continued demand for Yaskarta and Takarta in both existing and new markets across Europe and other geographies, such as in Japan, where we've seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date. In the U.S., and consistent with our recent updates, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites while also driving increased referrals from the community setting. For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in the first quarter.

Speaker Change: Turning to slide 15, and on behalf of Cindy and the kite team cell therapy sales were $480 million in the first quarter up 7% year over year.

Speaker Change: Sequentially sales were up 3% in line with our guidance of flat to slightly up.

Joanna: We're pleased to see continued demand for <unk> and <unk> in both existing and new markets across Europe, and other geographies such as in Japan, where we've seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date.

Jacquie Ross: In the US, and consistent with our recent updates, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites, while also driving increased referrals from the community setting. For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in Q1. We've identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy, and we will continue to refine this blueprint so that we become more efficient at onboarding new centers over time. We expect to start seeing the impact from this initiative toward the end of 2024. Wrapping up Q1, we had a strong start to the year, primarily driven by higher demand across each of our core businesses year over year.

In the US, and consistent with our recent updates, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites, while also driving increased referrals from the community setting. For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in Q1. We've identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy, and we will continue to refine this blueprint so that we become more efficient at onboarding new centers over time. We expect to start seeing the impact from this initiative toward the end of 2024. Wrapping up Q1, we had a strong start to the year, primarily driven by higher demand across each of our core businesses year over year.

Joanna: In the U S and consistent with our recent updates we see opportunity for growth.

Johanna Mercier: We're pleased to see continued demand for Yaskarta and Takarta in both existing and new markets across Europe and other geographies, such as in Japan, where we've seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date. In the U.S., and consistent with our recent updates, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites while also driving increased referrals from the community setting. For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in the first quarter.

Joanna: Through expanding the number of authorized treatment centers and affiliated satellites, while also driving increased referrals from the community setting.

Joanna: For example, we're proud to have established our flagship community collaboration with Tennessee oncology in the first quarter.

Joanna: We've identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy.

Joanna: And we will continue to refine this blueprint that we become more efficient at Onboarding new centers over time, we expect to start seeing the impact from this initiative towards the end of 2024.

Joanna: Wrapping up the first quarter, we had a strong start to the year, primarily driven by higher demand across each of our core businesses year over year.

Johanna Mercier: For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in the first quarter. We've identified many critical learnings about how we can partner effectively with community oncology practices for cell therapy. And we will continue to refine this blueprint so that we become more efficient at onboarding new centers over time. We expect to start seeing the impact of this initiative towards the end of 2024. Wrapping up the first quarter, we had a strong start to the year, primarily driven by higher demand across each of our core businesses year over year.

For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in the first quarter.

Jacquie Ross: We look forward to carrying this momentum through 2024, as we bring seladelpar to market later this year following approval. I'd like to thank the commercial teams and cross-functional partners across Gilead and Kite for their strong execution as we diligently expand our therapies to new populations, positively impacting more people all around the world. With that, I'll hand the call over to Mehrdad.

We look forward to carrying this momentum through 2024, as we bring seladelpar to market later this year following approval. I'd like to thank the commercial teams and cross-functional partners across Gilead and Kite for their strong execution as we diligently expand our therapies to new populations, positively impacting more people all around the world. With that, I'll hand the call over to Mehrdad.

Joanna: We look forward to carrying this momentum through 2024 and as we bring solid all parts of market later this year following approval.

Johanna Mercier: We've identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy, and we will continue to refine this "blueprint" so that we become more efficient at onboarding new centers over time. We expect to start seeing the Impact from this initiative toward the end of 2024. Wrapping up the first quarter, we had a strong start to the year, primarily driven by higher demand across each of our core businesses year over year. We look forward to carrying this momentum through 2024 and as we bring SELADELPAR to market later this year following approval. I'd like to thank the commercial teams and cross-functional partners across Gilead and Kite for their strong execution as we diligently expand our therapies to new populations, positively impacting more people all around the world. And with that, I'll hand the call over to Merdad.

Joanna: I'd like to thank the commercial teams and cross functional partners across Gilead and kite for their strong execution as we diligently expand our therapies to new populations positively impacting more people all around the world.

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

Daniel O'Day: Thank you, Johanna. We've had a busy first quarter at Gilead, with a cadence of clinical readouts that will continue throughout the rest of the year. Importantly, we anticipated an FDA regulatory decision on seladelpar and three phase 3 updates across HIV prevention, bladder cancer, and breast cancer. Starting on slide 17, we continue to progress our industry-leading virology pipeline, which is building momentum following a data-rich presence at CROI in March. This included robust virologic suppression data from our one-pill oral combination of bictegravir with lenacapavir from the phase 2 portion of the ARTISTRY-1 trial. This novel combination has the potential to benefit people with HIV on complex regimens. We have since started two phase 3 trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in H1 2025.

Mehrdad Parsey: Thank you, Johanna. We've had a busy first quarter at Gilead, with a cadence of clinical readouts that will continue throughout the rest of the year. Importantly, we anticipated an FDA regulatory decision on seladelpar and three phase 3 updates across HIV prevention, bladder cancer, and breast cancer. Starting on slide 17, we continue to progress our industry-leading virology pipeline, which is building momentum following a data-rich presence at CROI in March. This included robust virologic suppression data from our one-pill oral combination of bictegravir with lenacapavir from the phase 2 portion of the ARTISTRY-1 trial. This novel combination has the potential to benefit people with HIV on complex regimens. We have since started two phase 3 trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in H1 2025.

Merdad V. Parsey: Thank you Joanna.

Merdad V. Parsey: We've had a busy first quarter at Gilead with the cadence of clinical Readouts that will continue throughout the rest of the year importantly.

Merdad V. Parsey: Importantly, we anticipated an FDA regulatory decision on seller Dell par and three phase III updates across HIV prevention bladder cancer and breast cancer.

Merdad V. Parsey: Starting on slide 17, we continue to progress our industry, leading virology pipeline, which is building momentum following a data rich presence at Croix in March.

Johanna Mercier: We look forward to carrying this momentum through 2024, and as we bring CELADEL PAR to market later this year following a successful, I'd like to thank the commercial teams and cross-functional partners across Gilead and KITE for their strong execution as we diligently expand our therapies to new populations, positively impacting more people all around the world. And with that, I'll hand the call over to Merdad.

Joanna: This included robust virological suppression data from our once daily oral <unk> combination of the Tegra Revere with Linda <unk> from the phase II portion of the artistry one trial.

Joanna: This novel combination has the potential to benefit people with HIV on complex regimens.

Joanna: Since started two phase III trials of this combination.

Joanna: One and virological suppressed individuals and another and virological suppressed treatment experienced individuals.

Merdad V. Parsey: Thank you, Johanna. We have had a busy first quarter at Gilead, with a cadence of clinical readouts that will continue throughout the rest of the year. Importantly, we anticipate an FDA regulatory decision on SELADELPAR and three Phase III updates across HIV prevention, bladder cancer, and breast cancer. Starting on Slide 17, we continue to progress our industry-leading Virology pipeline, which is building momentum following a data-rich presence at CROI in March. This included robust virologic suppression data from our once-daily oral combination of bictegravir with lenacapavir from the Phase III portion of the ARTISTRY-1 trial. This novel combination has the potential to benefit people with HIV on complex regimens. We have since started two Phase III trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in the first half of 2025.

Joanna: We expect to complete enrollment in the first half of 2025. We also have to once weekly oral programs first the combination of <unk> with Merck's NR GTI as Latvia, and virological suppress people with HIV expected to advance into phase III. Later this year second the combination of the capsid inhibitor.

Daniel O'Day: We also have two once-weekly oral programs. First, a combination of Lenacapavir with Merck's NRTTI, Islatravir, in virologically suppressed people with HIV, expected to advance into phase 3 later this year. Second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a phase 2 study. The second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTIs are the standard of care treatment for HIV and an important treatment option for clinicians who continue to prefer INSTI-based regimens. Finally, we presented phase 1b data from our twice-yearly parenteral program of Lenacapavir plus our two broadly neutralizing antibodies for people with HIV at CROI, and we intend to share data from the phase 2 study in the second half of this year.

We also have two once-weekly oral programs. First, a combination of Lenacapavir with Merck's NRTTI, Islatravir, in virologically suppressed people with HIV, expected to advance into phase 3 later this year. Second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a phase 2 study. The second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTIs are the standard of care treatment for HIV and an important treatment option for clinicians who continue to prefer INSTI-based regimens. Finally, we presented phase 1b data from our twice-yearly parenteral program of Lenacapavir plus our two broadly neutralizing antibodies for people with HIV at CROI, and we intend to share data from the phase 2 study in the second half of this year.

Joanna: <unk> with GF 17, 'twenty, our novel oral integrates inhibitor.

Joanna: We're working to advance this combination into a phase III study.

Joanna: The second program has the potential to be the first once weekly oral regimen containing an <unk> agent <unk>.

Joanna: Since these are the standard of care treatment for HIV and an important treatment option for clinicians who continued to prefer <unk> based regimens.

Joanna: Finally, we presented phase <unk> data from our twice yearly parental program Atlantic <unk>, plus our two broadly neutralizing antibodies for people with HIV at Croix and we intend to share data from the phase II study in the second half of this year.

Merdad V. Parsey: This novel combination has the potential to benefit people with HIV on complex regimens. We have since started two phase three trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in the first half of 2020. We also have two once-weekly oral programs.

This novel combination has the potential to benefit people with HIV on complex regimens. We have since started two phase three trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in the first half of 2020.

Daniel O'Day: Moving to PrEP, we plan to share an update from our phase 3 PURPOSE 1 trial in the second half of this year. Data from PURPOSE 1, together with data from PURPOSE 2, is expected to support the filing of lenacapavir for HIV prevention. This PrEP option would not only offer a convenient dosing schedule as a first twice-yearly subcutaneous regimen, but could also be transformative in terms of adherence to HIV prevention regimens. Turning to slide 18, our Trodelvy program continues to be evaluated across a range of solid tumors with seven phase 3 trials currently underway across breast, bladder, and metastatic non-small cell lung cancers, with plans to start the phase 3 trial in endometrial cancer later this year. Abstract titles were just released yesterday for the upcoming ASCO meeting, and we're pleased to have over a dozen oncology presentations this year.

Moving to PrEP, we plan to share an update from our phase 3 PURPOSE 1 trial in the second half of this year. Data from PURPOSE 1, together with data from PURPOSE 2, is expected to support the filing of lenacapavir for HIV prevention. This PrEP option would not only offer a convenient dosing schedule as a first twice-yearly subcutaneous regimen, but could also be transformative in terms of adherence to HIV prevention regimens. Turning to slide 18, our Trodelvy program continues to be evaluated across a range of solid tumors with seven phase 3 trials currently underway across breast, bladder, and metastatic non-small cell lung cancers, with plans to start the phase 3 trial in endometrial cancer later this year. Abstract titles were just released yesterday for the upcoming ASCO meeting, and we're pleased to have over a dozen oncology presentations this year.

Joanna: Moving to prep, we plan to share an update from our phase III purpose, one trial in the second half of this year.

Joanna: Data from purpose, one together with data from purpose too is expected to support the filing of blended cap of year for HIV prevention.

Merdad V. Parsey: We also have two once-weekly oral programs. First, a combination of lenacapavir with Merck's NRTTI, which is latrivir, and virologically suppressed people with HIV, expected to advance into phase three later this year. Second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a Phase 2 study. This second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTEADs are the standard of care treatment for HIV and an important treatment option for clinicians who continue to prefer INSTEAD-based regimens. Finally, we presented Phase 1B data from our twice-yearly parenteral program of Lenacavivir plus our two broadly neutralizing antibodies for people with HIV at CROI, and we intend to share data from the Phase 2 study in the second half of this year. Moving to PrEP, we plan to share an update from our Phase 3, Purpose 1 trial in the second half of this year. Data from Purpose 1, together with data from Purpose 2, is expected to support the filing of lenacapavir for HIV prevention. This PrEP option would not only offer a convenient dosing schedule as a first-twice yearly subcutaneous regimen but could also be transformative in terms of adherence to HIV prevention regimens.

Merdad V. Parsey: We also have two once-weekly oral programs: first, a combination of lenacapavir with Merck's NRTTI, islatravir, in virologically suppressed people with HIV, expected to advance into Phase III later this year. And second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a Phase II study. This second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTIs are the standard-of-care treatment for HIV and an important treatment option for clinicians who continue to prefer INSTI-based regimens. Finally, we presented Phase I-B data from our twice-yearly parenteral program of lenacapavir plus our two broadly neutralizing antibodies for people with HIV at CROI, and we intend to share data from the Phase III study in the second half of this year. Moving to PrEP, we plan to share an update from our Phase III PURPOSE-1 trial in the second half of this year. Data from PURPOSE-01, together with data from PURPOSE-2, is expected to support the filing of lenacapavir for HIV prevention.

Joanna: This prep option with not only offer a convenient dosing schedule as the first twice yearly subcutaneous regimen, but could also be transformative in terms of adherence to HIV prevention regimens.

Merdad V. Parsey: First, a combination of lenacapavir with Merck's NRTTI, which is latrivir, and virologically suppressed people with HIV, expected to advance into phase three later this year. Second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a Phase 2 study. This second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTEADs are the standard of care treatment for HIV and an important treatment option for clinicians who continue to prefer INSTEAD-based regimens. Finally, we presented Phase 1B data from our twice-yearly parenteral program of Lenacavivir plus our two broadly neutralizing antibodies for people with HIV at CROI, and we intend to share data from the Phase 2 study in the second half of this year. Moving to PrEP, we plan to share an update from our Phase 3, Purpose 1 trial in the second half of this year. Data from Purpose 1, together with data from Purpose 2, is expected to support the filing of lenacapavir for HIV prevention. This PrEP option would not only offer a convenient dosing schedule as a first-twice yearly subcutaneous regimen but could also be transformative in terms of adherence to HIV prevention regimens.

Joanna: Turning to slide 18, our <unk> program continues to be evaluated across a range of solid tumors with seven phase III trials currently underway across breast bladder in metastatic non small cell lung cancers with plans to start the phase III trial in endometrial cancer later this year.

Merdad V. Parsey: Abstract titles were just released yesterday for the upcoming Astro meeting and we're pleased to have over a dozen oncology presentations this year.

Daniel O'Day: We'll be presenting late-breaking phase three data from our second-line plus metastatic non-small cell lung cancer trial, EVOKE-01. Updated data from first-line PD-L1 high subjects in cohort A of the phase two EVOKE-02 trial will also be shared. We plan on providing updates from cohort C and D evaluating Trodelvy plus Pembro and chemotherapy in PD-L1 all comers at a medical congress in the second half of this year. In addition, presentations for both the phase two EDGE-Gastric trial and the phase two ARC-9 studies will be highlighted. Depending on the timing of event accruals, we anticipate two more phase three updates this year for Trodelvy. These include overall survival data from our confirmatory phase three bladder cancer study, TROPiCS-04, that could support Trodelvy's submission for full regulatory approval in the US and enable ex-US filings.

We'll be presenting late-breaking phase three data from our second-line plus metastatic non-small cell lung cancer trial, EVOKE-01. Updated data from first-line PD-L1 high subjects in cohort A of the phase two EVOKE-02 trial will also be shared. We plan on providing updates from cohort C and D evaluating Trodelvy plus Pembro and chemotherapy in PD-L1 all comers at a medical congress in the second half of this year. In addition, presentations for both the phase two EDGE-Gastric trial and the phase two ARC-9 studies will be highlighted. Depending on the timing of event accruals, we anticipate two more phase three updates this year for Trodelvy. These include overall survival data from our confirmatory phase three bladder cancer study, TROPiCS-04, that could support Trodelvy's submission for full regulatory approval in the US and enable ex-US filings.

Merdad V. Parsey: We will be presenting late breaking phase III data from our second line plus metastatic non small cell lung cancer trial <unk> one.

Merdad V. Parsey: Updated data from first line PD Lone high subjects in cohort of the phase II <unk> trial will also be shared.

Joanna: We plan on providing updates from cohorts CND evaluating <unk> plus <unk> in chemotherapy and PD Lone all comers at a medical Congress in the second half of this year. In addition presentations for both the phase II edge gastric trial.

Merdad V. Parsey: Finally, we presented Phase 1B data from our twice-yearly parenteral program of Lenacavivir plus our two broadly neutralizing antibodies for people with HIV at CROI, and we intend to share data from the Phase 2 study in the second half of this year. Moving to PrEP, we plan to share an update from our Phase 3, Purpose 1 trial in the second half of this year. Data from Purpose 1, together with data from Purpose 2, is expected to support the filing of lenacapavir for HIV prevention. This PrEP option would not only offer a convenient dosing schedule as a first-twice yearly subcutaneous regimen but could also be transformative in terms of adherence to HIV prevention regimens.

Joanna: And the phase III <unk> studies will be highlighted.

Joanna: Depending on the timing of VAT accruals, we anticipate two more phase III data this year for <unk>. These.

Joanna: These include overall survival data from our confirmatory phase III bladder cancer study tropics, so for that could support for Dolby submission for full regulatory approval in the U S and enable X U S filings and CNBC Richard Elvey is the only ADC to have demonstrated statistically significant improvement in <unk>.

Daniel O'Day: In mTNBC, where Trodelvy is the only ADC to have demonstrated statistically significant improvement in overall survival in the second-line setting, we expect to share an update on the phase 3 ASCENT-03 trial in first-line PD-L1 negative patients later this year. Moving on to cell therapy, I'm pleased to share KITE's approach to the development of novel cell therapies that Cindy and the team presented at last month's investor event. As you can see on slide 19, Yescarta and Tecartus established KITE as a leader in cell therapy, and we plan to potentially extend this leadership into multiple myeloma while also paving the way for innovative next-generation constructs. On anito-cel in later line multiple myeloma, we expect to provide a phase 2 IMAGINE-1 trial update in the second half of this year.

In mTNBC, where Trodelvy is the only ADC to have demonstrated statistically significant improvement in overall survival in the second-line setting, we expect to share an update on the phase 3 ASCENT-03 trial in first-line PD-L1 negative patients later this year. Moving on to cell therapy, I'm pleased to share KITE's approach to the development of novel cell therapies that Cindy and the team presented at last month's investor event. As you can see on slide 19, Yescarta and Tecartus established KITE as a leader in cell therapy, and we plan to potentially extend this leadership into multiple myeloma while also paving the way for innovative next-generation constructs. On anito-cel in later line multiple myeloma, we expect to provide a phase 2 IMAGINE-1 trial update in the second half of this year.

Merdad V. Parsey: This PrEP option would not only offer a convenient dosing schedule as the first twice-yearly subcutaneous regimen but could also be transformative in terms of adherence to HIV prevention regimens. Turning to Slide 18. Our Trodelvy program continues to be evaluated across a range of solid tumors with seven Phase III trials currently underway across breast, bladder, and metastatic non-small cell lung cancers with plans to start the Phase III trial in endometrial cancer later this year. Abstract titles were just released yesterday for the upcoming ASCO meeting, and we're pleased to have over a dozen Oncology presentations this year. We will be presenting late-breaking Phase III data from our second-line plus metastatic non-small cell lung cancer trial, EVOKE-01. Updated data from first-line, PD-L1 high subjects in Cohort A of the Phase III EVOKE-02 trial will also be shared. We plan on providing updates from Cohorts C and D, evaluating TRODELVY plus pembro and chemotherapy in PD-L1 all-comers at a medical congress in the second half of this year. In addition, presentations for both the Phase II EDGE-Gastric trial and Phase II ARC-9 studies will be highlighted.

Joanna: We're all survival in the second line setting we expect to share an update on the phase III <unk> III trial in first line PD Lone negative patients later this year moved.

Joanna: Moving onto cell therapy, I am pleased to share kites approach to the development of novel cell therapies that Cindy and the team presented at last month's investor event.

Merdad V. Parsey: Turning to slide 18, our Tredelby program continues to be evaluated across a range of solid tumors, with seven phase three trials currently underway across breast, bladder, and metastatic non-small cell lung cancer, with plans to start the Phase 3 trial in endometrial cancer later this year. Abstract titles were just released yesterday for the upcoming ASCO meeting, and we're pleased to have over a dozen oncology presentations this year. We'll be presenting late-breaking phase 3 data from our second line plus metastatic non-small cell lung cancer trial, EVOCA-1. Updated data from first-line PD-L1 high subjects in Cohort A of the Phase 2 Evoco2 trial will also be shared. We plan on providing updates from cohorts C and D, evaluating TRDELV plus PEMBRO and chemotherapy in PD-L1 all comers at a medical congress in the second half of this year. In addition, presentations for both the phase two edge gastric trial and the phase two arc nine studies will be highlighted.

Joanna: As you can see on slide 19, yes, Garda and took artist established kite as a leader in cell therapy, and we plan to potentially extend this leadership into multiple myeloma, while also paving the way for innovative next generation construct.

Joanna: On an ido sell in later line multiple myeloma, we expect to provide a phase two imagine one trial update in the second half of this year.

Daniel O'Day: This update follows the highly encouraging phase 1 data presented at ASH last year, where anito-cel demonstrated durable responses with median progression-free survival not yet met at 26.5 months median follow-up, and no cases of parkinsonian symptoms observed in the trial. For our next-generation cell therapy assets, we have bicistronic and optimized manufacturing constructs in phase 1 trials, which are aimed at overcoming resistance mechanisms, providing potentially deeper and more sustained responses, and improving product potency. Beyond that, we have early research in allogeneic and in vivo CAR, with plans to expand into a range of other disease areas such as multiple myeloma with anito-cel, solid tumors, and autoimmune diseases. Moving to inflammation on slide 20, we recently completed our acquisition of CymaBay and added seladelpar, an investigational PPAR delta agonist, to our portfolio.

This update follows the highly encouraging phase 1 data presented at ASH last year, where anito-cel demonstrated durable responses with median progression-free survival not yet met at 26.5 months median follow-up, and no cases of parkinsonian symptoms observed in the trial. For our next-generation cell therapy assets, we have bicistronic and optimized manufacturing constructs in phase 1 trials, which are aimed at overcoming resistance mechanisms, providing potentially deeper and more sustained responses, and improving product potency. Beyond that, we have early research in allogeneic and in vivo CAR, with plans to expand into a range of other disease areas such as multiple myeloma with anito-cel, solid tumors, and autoimmune diseases. Moving to inflammation on slide 20, we recently completed our acquisition of CymaBay and added seladelpar, an investigational PPAR delta agonist, to our portfolio.

Joanna: This update follows the highly encouraging phase one data presented at Ash last year, where nito sell demonstrated durable responses with median progression free survival not yet met a $26 five months median follow up and no cases of parkinsonian symptoms observed in the trial.

Merdad V. Parsey: Updated data from first-line PD-L1 high subjects in Cohort A of the Phase 2 Evoco2 trial will also be shared. We plan on providing updates from cohorts C and D, evaluating TRDELV plus PEMBRO and chemotherapy in PD-L1 all comers at a medical congress in the second half of this year. In addition, presentations for both the phase two edge gastric trial and the phase two arc nine studies will be highlighted. Depending on the timing of event accruals, we anticipate two more Phase 3 updates this year for Tridel.

Updated data from first-line PD-L1 high subjects in Cohort A of the Phase 2 Evoco2 trial will also be shared. We plan on providing updates from cohorts C and D, evaluating TRDELV plus PEMBRO and chemotherapy in PD-L1 all comers at a medical congress in the second half of this year. In addition, presentations for both the phase two edge gastric trial and the phase two arc nine studies will be highlighted.

Joanna: For our next generation cell therapy assets, we have <unk> and optimized manufacturing constructs in phase one trials, which are aimed at overcoming resistance mechanisms, providing potentially deeper and more sustained responses and improving product potency.

Joanna: Beyond that we have early research in allogeneic and in vivo car with plans to expand into a range of other disease areas, such as multiple myeloma with Anita cell solid tumors and autoimmune diseases.

Joanna: Moving to inflammation on slide 20, we recently completed our acquisition of Sema Bay and added sell Adele Park, and investigational <unk> Delta agonist to our portfolio.

Merdad V. Parsey: Depending on the timing of event accruals, we anticipate two more Phase III updates this year for TRODELVY. These include overall survival data from our confirmatory Phase III bladder cancer study, TROPiCS-04, that could support TRODELVY's submission for full regulatory approval in the U.S. and enable ex-U.S. filings. In TNBC, where TRODELVY is the only ADC to have demonstrated statistically significant improvement in overall survival in the second-line setting, we expect to share an update on the Phase III ASCENT-03 trial in first-line PD-L1 negative patients later this year. Moving on to Cell Therapy. I'm pleased to share Kite's approach to the development of novel cell therapies that Cindy and the team presented at last month's investor event. As you can see on slide 19 YESCARTA and TECARTUS established Kite as the leader in Cell Therapy, and we plan to potentially extend this leadership into multiple myeloma, while also paving the way for innovative next-generation constructs.

Daniel O'Day: In phase 3 clinical trials, seladelpar demonstrated significant improvement in both pruritus and markers of cholestasis related to the risk of progression for PBC. As previously announced, FDA and EMA accepted our regulatory filings for seladelpar for the management of PBC in certain adult patients. We anticipate an FDA regulatory decision by 14 August 2024 and a decision from European regulators early next year. We continue to work with global regulatory authorities to expand the reach of seladelpar for PBC patients. Further, as we look at the rest of our innovation pipeline, we have several early phase assets that have progressed into phase 2 trials, including our potentially first-in-class oral TPL2 inhibitor, a potentially best-in-class oral alpha-4 beta-7 anti-integrin, and an oral IRAK4 inhibitor.

In phase 3 clinical trials, seladelpar demonstrated significant improvement in both pruritus and markers of cholestasis related to the risk of progression for PBC. As previously announced, FDA and EMA accepted our regulatory filings for seladelpar for the management of PBC in certain adult patients. We anticipate an FDA regulatory decision by 14 August 2024 and a decision from European regulators early next year. We continue to work with global regulatory authorities to expand the reach of seladelpar for PBC patients. Further, as we look at the rest of our innovation pipeline, we have several early phase assets that have progressed into phase 2 trials, including our potentially first-in-class oral TPL2 inhibitor, a potentially best-in-class oral alpha-4 beta-7 anti-integrin, and an oral IRAK4 inhibitor.

Joanna: And phase III clinical trials, so Dell par demonstrated significant improvement in both pruritus and markers of cholestasis related to the risk of progression for PVC.

Merdad V. Parsey: These include overall survival data from our confirmatory phase three bladder cancer study, TROPICS-04, that could support Tredelvi's submission for full regulatory approval in the U.S. and enable ex-U.S. filings. In TMBC, where Tredelvi is the only ADC to have demonstrated statistically significant improvement in overall survival in the second line setting, we expect to share an update on the phase three ASCENT-03 trial in first-line Moving on to cell therapy, I'm pleased to share Kite's approach to the development of novel cell therapies that Cindy and the team presented at last month's Investor Conference. As you can see on slide 19, Yaskarta and Ticardis established KITE as a leader in cell therapy, and we plan to potentially extend this leadership into multiple myeloma, while also paving the way for innovative next-generation constructs.

Joanna: As previously announced FDA and EMA accepted our regulatory filings for cell Adele par for the management of PBC in certain adult patients.

Joanna: We anticipate an FDA regulatory decision by August 14th and a decision from European regulators early next year.

Joanna: We continue to work with global regulatory authorities to expand the reach of cell Adele par for PBC patients.

Joanna: Further as we look at the rest of our information pipeline. We have several early phase assets that have progressed into phase III trials, including our potentially first in class oral <unk> inhibitor.

Joanna: A potentially best in class oral alpha four beta seven anti integrin and an oral <unk> inhibitor.

Daniel O'Day: Wrapping up on slide 21, we continue to progress on our clinical milestones for the year, and we have had two first patients in and one data readout completed in the first quarter, and we remain on track for our remaining milestones. Now I'll hand the call over to Andy.

Wrapping up on slide 21, we continue to progress on our clinical milestones for the year, and we have had two first patients in and one data readout completed in the first quarter, and we remain on track for our remaining milestones. Now I'll hand the call over to Andy.

Joanna: Wrapping up on slide 21, we continue to progress on our clinical milestones for the year and we have had two first patients in and one data readout completed in the first quarter and we remain on track for our remaining milestones.

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

Merdad V. Parsey: On anito-cel in later-line multiple myeloma, we expect to provide a Phase II iMMagine-1 trial update in the second half of this year. This update follows the highly encouraging Phase I data presented at ASH last year, where anito-cel demonstrated durable responses with median progression-free survival not yet met at 26.5 months median follow-up and no cases of parkinsonian symptoms observed in the trial. For our next-generation cell therapy assets, we have bicistronic and optimized manufacturing constructs in Phase I trials, which are aimed at overcoming resistance mechanisms, providing potentially deeper and more sustained responses, and improving product potency. Beyond that, we have early research in allogeneic and in vivo CAR, with plans to expand into a range of other disease areas such as multiple myeloma with anito-cel, solid tumors, and autoimmune diseases. Moving to Inflammation on Slide 20. We recently completed our acquisition of CymaBay and added SELADELPAR, an investigational PPAR-delta agonist to our portfolio. In Phase III clinical trials, SELADELPAR demonstrated significant improvement in both pruritus and markers of cholestasis related to the risk of progression for PBC. As previously announced, FDA and EMA accepted our regulatory filings for SELADELPAR for the management of PBC in certain adult patients.

Andrew Dickinson: Thank you, Mehrdad, and good afternoon, everyone. Beginning on slide 23, it was a strong start to the year with our base business up 6% year over year. The solid growth achieved across HIV, oncology, and liver disease offset the decline in Veclury, with total product sales up 5% year over year to $6.6 billion. As expected, our base business was down quarter over quarter, primarily driven by seasonal inventory and pricing dynamics in HIV. Moving beyond our revenue results, two items significantly impacted our EPS performance in the first quarter, as shown on slide 24. First, our GAAP and non-GAAP results included an acquired IPR&D charge of $3.9 billion, or $3.14 per share, associated with the close of the CymaBay acquisition. As an asset acquisition, this transaction was fully expensed in the first quarter.

Andy: Thank you Mary Anne and good afternoon, everyone.

Andy: Beginning on slide 23, it was a strong start to the year with our base business up 6% year over year.

Andy: The solid growth achieved across HIV oncology and liver disease offset the decline in fact, Larry with total product sales up 5% year over year to $6 $6 billion as.

Joanna: As expected our base business was down quarter over quarter, primarily driven by seasonal inventory and pricing dynamics in HIV.

Joanna: Moving beyond our revenue results two items significantly impacted our EPS performance in the first quarter as shown on slide 24.

Merdad V. Parsey: First our GAAP and non-GAAP results included an acquired IP R&D charge of $3 9 billion or $3 14 per share associated with the close of the <unk> acquisition as.

Merdad V. Parsey: Beyond that, we have early research in allogeneic and in vivo CAR with plans to expand into a range of other disease areas, such as multiple myeloma with Aneta cell, solid tumors, and autoimmune disease. Moving to inflammation, on slide 20, we recently completed our acquisition of Sima Bay and added Saladelpar, an investigational PPAR delta agonist, to our portfolio. In phase 3 clinical trials, Celadelpar demonstrated significant improvement in both pruritus and markers of cholestasis related to the risk of progression for PVC, as previously announced. FDA and EMA accepted our regulatory filings for Saladel-PAR for the management of PVC in certain adult patients.

Joanna: As an asset acquisition. This transaction was fully expensed in the first quarter. This was a nondeductible expense item and as a result impacted our effective tax rate excluding.

Andrew Dickinson: This was a non-deductible expense item and, as a result, impacted our effective tax rate. Excluding this expense, our non-GAAP EPS would have been $1.82 for Q1, above expectations, primarily driven by higher sales. The second item shown on the right-hand side is an impairment charge that is included in our GAAP results and excluded from our non-GAAP results. As a reminder, this relates to the carrying value of the IPR&D indefinite-lived intangible assets acquired from Immunomedics. At the end of 2023, the carrying value was $5.9 billion, all associated with non-small cell lung cancer. As a result of the EVOKE-01 readout in late January, we have reassessed and reduced the remaining value to $3.5 billion.

This was a non-deductible expense item and, as a result, impacted our effective tax rate. Excluding this expense, our non-GAAP EPS would have been $1.82 for Q1, above expectations, primarily driven by higher sales. The second item shown on the right-hand side is an impairment charge that is included in our GAAP results and excluded from our non-GAAP results. As a reminder, this relates to the carrying value of the IPR&D indefinite-lived intangible assets acquired from Immunomedics. At the end of 2023, the carrying value was $5.9 billion, all associated with non-small cell lung cancer. As a result of the EVOKE-01 readout in late January, we have reassessed and reduced the remaining value to $3.5 billion.

Joanna: Excluding this expense our non-GAAP EPS would have been $1 82 for the first quarter above expectations, primarily driven by higher sales.

Joanna: The second item shown on the right hand side is an impairment charge that is included in our GAAP results and excluded from our non-GAAP results.

Merdad V. Parsey: As a reminder, this relates to the carrying value of the IP R&D indefinite lived intangible assets acquired from Immunomedics.

Merdad V. Parsey: FDA and EMA accepted our regulatory filings for Saladel-PAR for the management of PVC in certain adult patients. We anticipate an FDA regulatory decision by August 14th and a decision from European regulators early next year. We continue to work with global regulatory authorities to expand the reach of Celladelpar for PVC patients. Furthermore, as we look at the rest of our inflammation pipeline, we have several early phase assets that have progressed into phase two trials, including our potentially first-in-class oral TIPL-2 inhibitor, a potentially best-in-class oral alpha-4 beta-7 anti-endocrine, and an oral IRAC-4 inhibitor.

FDA and EMA accepted our regulatory filings for Saladel-PAR for the management of PVC in certain adult patients.

Joanna: At the end of 2023, the carrying value was $5 $9 billion, all associated with non small cell lung cancer.

Merdad V. Parsey: We anticipate an FDA regulatory decision by August 14th and a decision from European regulators early next year. We continue to work with global regulatory authorities to expand the reach of seladelpar for PBC patients. Further, as we look at the rest of our Inflammation pipeline, we have several early phase assets that have progressed into Phase II trials, including our potentially first-in-class oral TPL2 inhibitor, a potentially best-in-class oral alpha-4-beta-7 anti-integrin, and an oral IRAK4 inhibitor. Wrapping up on Slide 21. We continue to progress on our clinical milestones for the year, and we have had two first patients in and one data readout completed in the first quarter, and we remain on-track for our remaining milestones. And now, I'll hand the call over to Andy.

Merdad V. Parsey: As a result of the evoke a one readout in late January we have reassessed and reduce the remaining value to $3 5 billion.

Andrew Dickinson: This primarily reflects the smaller addressable market that Trodelvy could serve among second-line plus metastatic non-small cell lung cancer patients, a delay in expected launch timing, and associated competitive activity. We remain confident that Trodelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots on goal in new indications, as well as earlier lines of therapy, including some opportunities not included in our initial deal model. In the meantime, you can see that the impairment impacted Q1 GAAP EPS by $1.46 per share. Moving to the rest of our non-GAAP results on slide 25. For Q1, product gross margin was down modestly to 85.4%, primarily due to product mix. R&D and SG&A were each down 2% year over year.

This primarily reflects the smaller addressable market that Trodelvy could serve among second-line plus metastatic non-small cell lung cancer patients, a delay in expected launch timing, and associated competitive activity. We remain confident that Trodelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots on goal in new indications, as well as earlier lines of therapy, including some opportunities not included in our initial deal model. In the meantime, you can see that the impairment impacted Q1 GAAP EPS by $1.46 per share. Moving to the rest of our non-GAAP results on slide 25. For Q1, product gross margin was down modestly to 85.4%, primarily due to product mix. R&D and SG&A were each down 2% year over year.

Joanna: This primarily reflects the smaller addressable market that your Dolby conserve among second line plus metastatic non small cell lung cancer patients a delay unexpected launch timing and associated competitive activity. We remain confident that <unk> will deliver attractive returns over time with sales now exceeding $1 billion a year.

Joanna: <unk> IP portfolio and a development program with multiple shots on goal and new indications as well as earlier lines of therapy, including some opportunities not included in our initial deal model.

Merdad V. Parsey: Wrapping up on slide 21, we continue to progress on our clinical milestones for the year, and we have had two first patients in and one data readout completed in the first quarter, and we remain on track for our remaining milestones. Now, I'll hand the call over to Andy.

Joanna: In the meantime, you can see that the impairment impacted first quarter GAAP EPS by $1 46 per share moved.

Joanna: Moving to the rest of our non-GAAP results on slide 25.

Joanna: For the first quarter product gross margin was down modestly to 85, 4% primarily due to product mix.

Andrew D. Dickinson: Thank you, Merdad, and good afternoon, everyone. Beginning on Slide 23. It was a strong start to the year with our base business up 6% year over year. The solid growth achieved across HIV, Oncology, and Liver Disease offset the decline in VEKLURY, with total product sales up 5% year over year to $6.6 billion. As expected, our base business was down quarter over quarter, primarily driven by seasonal inventory and pricing dynamics in HIV. Moving beyond our revenue results, two items significantly impacted our EPS performance in the first quarter, as shown on Slide 24. First, our GAAP and non-GAAP results included an acquired IPR&D charge of $3.9 billion or $3.14 per share, associated with the close of the CymaBay acquisition. As an asset acquisition, this transaction was fully expensed in the first quarter.

Joanna: R&D and SG&A were each down 2% year over year. This is the second consecutive quarter of operating expense declines on a year over year basis, reflecting our continued focus on disciplined expense management our.

Andrew Dickinson: This is the second consecutive quarter of operating expense declines on a year-over-year basis, reflecting our continued focus on disciplined expense management. Our effective tax rate in the first quarter was a negative 30%, reflecting the non-deductibility of the CymaBay acquired IPR&D charge. Overall, our diluted earnings per share was a negative $1.32 compared to a positive $1.37 for the same period last year, primarily reflecting the $3.14 per share expense related to the CymaBay acquisition. Switching to full-year guidance on slide 26, there is no change to our revenue expectations for 2024 at this time. We continue to expect total product sales in the range of $27.1 to $27.5 billion, and we continue to expect total product sales, excluding Veclury, in the range of $25.8 to $26.2 billion, representing growth of 4% to 6% for our base business year over year.

This is the second consecutive quarter of operating expense declines on a year-over-year basis, reflecting our continued focus on disciplined expense management. Our effective tax rate in the first quarter was a negative 30%, reflecting the non-deductibility of the CymaBay acquired IPR&D charge. Overall, our diluted earnings per share was a negative $1.32 compared to a positive $1.37 for the same period last year, primarily reflecting the $3.14 per share expense related to the CymaBay acquisition. Switching to full-year guidance on slide 26, there is no change to our revenue expectations for 2024 at this time. We continue to expect total product sales in the range of $27.1 to $27.5 billion, and we continue to expect total product sales, excluding Veclury, in the range of $25.8 to $26.2 billion, representing growth of 4% to 6% for our base business year over year.

Joanna: Our effective tax rate in the first quarter was a negative 30%, reflecting the non deductibility of the <unk> acquired IP R&D charge overall, our diluted earnings per share was a negative $1.32 compared to a positive $1 37 for the same period last year, primarily reflecting the $3 14.

Andrew D. Dickinson: First, our GAAP and non-GAAP results included an acquired IPR&D charge of $3.9 billion, or $3.14 per share, associated with the close of the Sima Bay acquisition. As an asset acquisition, this transaction was fully expensed in the first quarter. This was a non-deductible expense item, and as a result, it impacted our effective tax rate.

First, our GAAP and non-GAAP results included an acquired IPR&D charge of $3.9 billion, or $3.14 per share, associated with the close of the Sima Bay acquisition. As an asset acquisition, this transaction was fully expensed in the first quarter.

Joanna: Per share expense related to the <unk> acquisition.

Andrew D. Dickinson: Switching to full year guidance on slide 26, there is no change to our revenue expectations for 2024 at this time.

Joanna: We continue to expect total product sales in the range of 27.1 to 27 $5 billion.

Andrew D. Dickinson: This was a nondeductible expense item, and as a result, impacted our effective tax rate. Excluding this expense, our non-GAAP EPS would have been $1.82 for the first quarter, above expectations, primarily driven by higher sales. The second item shown on the right-hand side is an impairment charge that is included in our GAAP results and excluded from our non-GAAP results. As a reminder, this relates to the carrying value of the IPR&D indefinite-lived intangible assets acquired from Immunomedics. At the end of 2023, the carrying value was $5.9 billion, all associated with non-small cell lung cancer. As a result of the EVOKE-01 readout in late January, we have reassessed and reduced the remaining value to $3.5 billion. This primarily reflects the smaller addressable market that TRODELVY could serve among 2L+ metastatic non-small cell lung cancer patients, a delay in expected launch timing, and associated competitive activity. We remain confident that TRODELVY will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots-on-goal in new indications as well as earlier-lines of therapy, including some opportunities not included in the initial deal model.

Joanna: And we continue to expect total product sales, excluding VAT glory in the range of 25, eight to $26 $2 billion representing.

Andrew D. Dickinson: Excluding this expense, our non-GAAP EPS would have been $1.82 for the first quarter, above expectations, primarily driven by higher sales. The second item on the right-hand side is an impairment charge that is included in our GAAP results and excluded from our non-GAAP results. As a reminder, this relates to the carrying value of the IPR&D Indefinite Live Intangible Assets acquired from Immunometics. At the end of 2023, the carrying value is $5.9 billion, all associated with non-small cell lung cancer. As a result of the EVOKE-01 readout in late January, we have reassessed and reduced the remaining value to $3.5 billion. This primarily reflects the smaller addressable market that Tridelvy could serve among second-line plus metastatic non-small cell lung cancer patients, a delay in expected launch timing, and associated competitive activity. We remain confident that Tridelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots on goal and new indications, as well as earlier lines of therapy, including some opportunities not included in our initial deal model.

Joanna: Growth of 4% to 6% for our base business year over year.

Andrew Dickinson: Additionally, there's no change to our Veclury guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veclury guidance until our Q3 earnings call, absent a very clear trend in COVID-19 infections. Shifting to the other parts of the P&L for 2024 on a non-GAAP basis, there is no change to our gross margin guidance, where we continue to expect product gross margin in the range of 85% to 86%. We now expect R&D to grow at the higher end of our previous low to mid-single-digit growth range, reflecting the incremental expenses associated with the CymaBay acquisition. We continue to expect SG&A expenses to decline a mid-single-digit percentage relative to 2023. On a dollar basis, SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate CymaBay expenses.

Additionally, there's no change to our Veclury guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veclury guidance until our Q3 earnings call, absent a very clear trend in COVID-19 infections. Shifting to the other parts of the P&L for 2024 on a non-GAAP basis, there is no change to our gross margin guidance, where we continue to expect product gross margin in the range of 85% to 86%. We now expect R&D to grow at the higher end of our previous low to mid-single-digit growth range, reflecting the incremental expenses associated with the CymaBay acquisition. We continue to expect SG&A expenses to decline a mid-single-digit percentage relative to 2023. On a dollar basis, SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate CymaBay expenses.

Joanna: Additionally, there is no change to our veterinary guidance of approximately $1 $3 billion for the full year.

Andrew D. Dickinson: As discussed last quarter, we do not expect to update our regulatory guidance until our third quarter earnings call absent a very clear trend in COVID-19 infections.

Joanna: If they can do the other parts of the P&L for 2024 on a non-GAAP basis.

Joanna: There is no change to our gross margin guidance, where we continue to expect product gross margin in the range of 85% to 86%.

Joanna: We now expect R&D to grow at the higher end of our previous low to mid single digit growth range, reflecting the incremental expenses associated with the <unk> acquisition.

Andrew D. Dickinson: As a result of the EVOKE-01 readout in late January, we have reassessed and reduced the remaining value to $3.5 billion. This primarily reflects the smaller addressable market that Tridelvy could serve among second-line plus metastatic non-small cell lung cancer patients, a delay in expected launch timing, and associated competitive activity. We remain confident that Tridelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots on goal and new indications, as well as earlier lines of therapy, including some opportunities not included in our initial deal model.

Joanna: We continue to expect SG&A expenses to decline a mid single digit percentage relative to 2023.

Joanna: On a dollar basis SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate semih Bey expenses. However, we can manage this within the window of the previously issued operating expense guidance acquired IP R&D is now expected to be approximately $4 $4 billion due to the <unk> transaction.

Andrew Dickinson: However, we can manage this within the window of the previously issued operating expense guidance. Acquired IPR&D is now expected to be approximately $4.4 billion due to the CymaBay transaction, as well as milestones anticipated throughout the rest of the year. Operating income is now expected to be in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the CymaBay transaction. Given the non-deductible impact of the CymaBay acquisition, the effective tax rate for 2024 is expected to be approximately 30%. This includes a negative impact of approximately 11% from the one-time charge for the acquisition of CymaBay. We therefore now expect diluted EPS in the range of $3.45 to $3.85.

However, we can manage this within the window of the previously issued operating expense guidance. Acquired IPR&D is now expected to be approximately $4.4 billion due to the CymaBay transaction, as well as milestones anticipated throughout the rest of the year. Operating income is now expected to be in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the CymaBay transaction. Given the non-deductible impact of the CymaBay acquisition, the effective tax rate for 2024 is expected to be approximately 30%. This includes a negative impact of approximately 11% from the one-time charge for the acquisition of CymaBay. We therefore now expect diluted EPS in the range of $3.45 to $3.85.

Andrew D. Dickinson: We remain confident that Tridelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots on goal and new indications, as well as earlier lines of therapy, including some opportunities not included in our initial deal model. In the meantime, you can see that the impairment impacted first quarter gap EPS by $1.46 per share. Moving to the rest of our non-GAAP results, on slide 25, product gross margin was down modestly to 85.4%, primarily due to product mix.

We remain confident that Tridelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots on goal and new indications, as well as earlier lines of therapy, including some opportunities not included in our initial deal model.

Joanna: As well as milestones anticipated throughout the rest of the year.

Joanna: Operating income is now expected to be in the range of 7 billion to $7 $5 billion, reflecting the updated acquired IP R&D guidance and a modest increase to operating expenses associated with the <unk> transaction.

Andrew D. Dickinson: In the meantime, you can see that the impairment impacted our first-quarter GAAP EPS by $1.46 per share. Moving to the rest of our non-GAAP results on Slide 25. For the first quarter, product gross margin was down modestly to 85.4%, primarily due to product mix. R&D and SG&A were each down 2% year over year. This is the second consecutive quarter of operating expense declines on a year-over-year basis, reflecting our continued focus on disciplined expense management. Our effective tax rate in the first quarter was a negative 30%, reflecting the nondeductibility of the CymaBay acquired IPR&D charge. Overall, our diluted earnings per share was a negative $1.32 compared to a positive $1.37 for the same period last year, primarily reflecting the $3.14 per share expense related to the CymaBay acquisition. Switching to full-year guidance on Slide 26. There is no change to our revenue expectations for 2024 at this time. We continue to expect total product sales in the range of $27.1 to $27.5 billion; and we continue to expect total product sales, excluding VEKLURY, in the range of $25.8 to $26.2 billion, representing growth of 4% to 6% for our base business year over year. Additionally, there is no change to our VEKLURY guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our VEKLURY guidance until our third-quarter earnings call, absent a very clear trend in COVID-19 infections.

Andrew D. Dickinson: Given the nondeductible impact of this <unk> acquisition, the effective tax rate for 2024 is expected to be approximately 30%.

Joanna: This includes a negative impact of approximately 11% from the one time charge for the acquisition of Silver Bay. We therefore now expect diluted EPS in the range of $3 45 to $3 85.

Andrew D. Dickinson: R&D and SG&A were each down 2% year over year. This is the second consecutive quarter of operating expense declines on a year over year basis, reflecting our continued focus on disciplined expense management. Our effective tax rate in the first quarter was a negative 30%, reflecting the non-deductibility of the Sima Bay acquired IPR&D charge. Overall, our diluted earnings per share was a negative $1.32, compared to a positive $1.37 for the same period last year, primarily reflecting the $3.14 per share expense related to the Sima Bay acquisition. Switching to full-year guidance on slide 26, there is no change to our revenue expectations for 2024 at this time. We continue to expect total product sales in the range of $27.1 to $27.5 billion, and we continue to expect total product sales excluding Vecluri in the range of $25.8 to $26.2 billion, representing growth of four to six percent for our base business year over year. Additionally, there was no change to our veterinary guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veclurie guidance until our third quarter earnings call, absent a very clear trend in COVID-19.

Andrew Dickinson: As shown on slide 27, this has only been updated to reflect the transactions that were closed in the first quarter of 2024. Excluding these charges, you can see that we are comfortably within the range of the EPS guidance we shared back in early February. On a GAAP basis, we expect full-year 2024 diluted EPS to be in the range of $0.10 to $0.50. Moving to slide 28, our capital allocation priorities remain unchanged with sufficient flexibility in our balance sheet. Specifically, as demonstrated in the first quarter, we announced a 2.7% increase to our quarterly dividend and returned approximately $1.4 billion to shareholders. In addition, we acquired CymaBay for $4.3 billion, adding seladelpar to our portfolio.

As shown on slide 27, this has only been updated to reflect the transactions that were closed in the first quarter of 2024. Excluding these charges, you can see that we are comfortably within the range of the EPS guidance we shared back in early February. On a GAAP basis, we expect full-year 2024 diluted EPS to be in the range of $0.10 to $0.50. Moving to slide 28, our capital allocation priorities remain unchanged with sufficient flexibility in our balance sheet. Specifically, as demonstrated in the first quarter, we announced a 2.7% increase to our quarterly dividend and returned approximately $1.4 billion to shareholders. In addition, we acquired CymaBay for $4.3 billion, adding seladelpar to our portfolio.

Joanna: As shown on slide 27. This has only been updated to reflect the transactions that were closed in the first quarter of 2024.

Joanna: Excluding these charges you can see that we are comfortably within the range of the EPS guidance, we shared back in early February.

Joanna: On a GAAP basis, we expect full year 2024 diluted EPS to be in the range of 10 cents and 50.

Joanna: Moving to slide 28, our capital allocation priorities remain unchanged with sufficient flexibility in our balance sheet.

Andrew D. Dickinson: Overall, our diluted earnings per share was a negative $1.32, compared to a positive $1.37 for the same period last year, primarily reflecting the $3.14 per share expense related to the Sima Bay acquisition. Switching to full-year guidance on slide 26, there is no change to our revenue expectations for 2024 at this time. We continue to expect total product sales in the range of $27.1 to $27.5 billion, and we continue to expect total product sales excluding Vecluri in the range of $25.8 to $26.2 billion, representing growth of four to six percent for our base business year over year. Additionally, there was no change to our veterinary guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veclurie guidance until our third quarter earnings call, absent a very clear trend in COVID-19.

Andrew D. Dickinson: Specifically as demonstrated in the first quarter, we announced a two 7% increase to our quarterly dividend and returned approximately $1 $4 billion to shareholders. In addition, we acquired silver Bay for $4 $3 billion, adding cell adult parts of our portfolio overall will continue to be disciplined in our use of.

Andrew Dickinson: Overall, we'll continue to be disciplined in our use of capital, and while we will continue to be flexible and opportunistic, it is unlikely that Gilead will be engaging in any sizable M&A transactions in the near term. Before I wrap it up, on slide 29, a quick note on our expectations now that the CymaBay transaction has closed. Pending regulatory approval, we expect to launch seladelpar in the US before the end of 2024, as Johanna highlighted earlier, with a modest revenue contribution expected this year. Additionally, we have shared that the transaction is expected to add to operating expenses this year as we make incremental investments to support the launch, as well as other R&D efforts, all of which we are able to manage within the window of the previously issued operating expense guidance.

Overall, we'll continue to be disciplined in our use of capital, and while we will continue to be flexible and opportunistic, it is unlikely that Gilead will be engaging in any sizable M&A transactions in the near term. Before I wrap it up, on slide 29, a quick note on our expectations now that the CymaBay transaction has closed. Pending regulatory approval, we expect to launch seladelpar in the US before the end of 2024, as Johanna highlighted earlier, with a modest revenue contribution expected this year. Additionally, we have shared that the transaction is expected to add to operating expenses this year as we make incremental investments to support the launch, as well as other R&D efforts, all of which we are able to manage within the window of the previously issued operating expense guidance.

Joanna: Capital and while we will continue to be flexible and opportunistic it is unlikely that gilead will be engaging in any sizable M&A transactions in the near term before.

Joanna: Before I wrap it up on slide 29, a quick note on our expectations now that the semi bay transaction has closed.

Joanna: Pending regulatory approval, we expect to launch sell Dell power in the U S. Before the end of 'twenty 'twenty four is Joanna highlighted earlier with a modest revenue contribution expected this year.

Andrew D. Dickinson: Additionally, there was no change to our veterinary guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veclurie guidance until our third quarter earnings call, absent a very clear trend in COVID-19. Moving to the other parts of the P&L for 2024 on a non-gap basis.

Additionally, there was no change to our veterinary guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veclurie guidance until our third quarter earnings call, absent a very clear trend in COVID-19.

Andrew D. Dickinson: <unk>, we have shared that the transaction is expected to add to operating expenses. This year as we make incremental investments to support the launch as well as other R&D efforts all of which we are able to manage within the window of the previously issued operating expense guidance and as we look ahead, while the transaction will be dilutive to our EPS.

Andrew D. Dickinson: Shifting to the other parts of the P&L for 2024 on a non-GAAP basis. There is no change to our gross margin guidance where we continue to expect product gross margin in the range of 85% to 86%. We now expect R&D to grow at the higher end of our previous low-to-mid single-digit growth range, reflecting the incremental expenses associated with the CymaBay acquisition. We continue to expect SG&A expenses to decline a mid-single-digit percentage relative to 2023. On a dollar basis, SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate CymaBay expenses. However, we can manage this within the window of the previously issued operating expense guidance. Acquired IPR&D is now expected to be approximately $4.4B, due to the CymaBay transaction as well as milestones anticipated throughout the rest of the year. Operating income is now expected in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the CymaBay transaction.

Andrew Dickinson: As we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be break-even to earnings in 2025 and significantly accretive in 2026 onwards. And now I'll invite Rebecca to begin the Q&A.

As we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be break-even to earnings in 2025 and significantly accretive in 2026 onwards. And now I'll invite Rebecca to begin the Q&A.

Andrew D. Dickinson: There is no change to our gross margin guidance, where we continue to expect product gross margin in the range of 85 to 86 percent. However, we now expect R&D to grow at the higher end of our previous low- to mid-single-digit growth range, reflecting the incremental expenses associated with the Semibay acquisition. We continue to expect SG&A expenses to decline by a mid-single-digit percentage relative to 2023. However, on a dollar basis, SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate SEMA Bay expenses. However, we can manage this within the window of the previously issued operating expense guide. The required IPR&D is now expected to be approximately $4.4 billion due to the Simit Bay transaction, as well as milestones anticipated throughout the rest of the year. Operating income is now expected to be in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the Sima Bay transaction.

Joanna: This year, we expect the deal to be breakeven to earnings in 2025 and significantly accretive in 2026 onwards.

Joanna: And now I'll invite Rebecca to begin the Q&A.

Jacquie Ross: Thank you, Andy. At this time, we'll open up the call for questions. We ask that you be courteous and limit yourself to one question so that we can get to as many analysts as possible during today's call. As a reminder, to ask a question, please press star one on your telephone keypad. If you'd like to withdraw your question, please press star two. Thank you.

Operator: Thank you, Andy. At this time, we'll open up the call for questions. We ask that you be courteous and limit yourself to one question so that we can get to as many analysts as possible during today's call. As a reminder, to ask a question, please press star one on your telephone keypad. If you'd like to withdraw your question, please press star two. Thank you.

Rebecca: Thank you Andy at this time, we'll open up the call for questions. We ask that you be courteous and limit yourself to one question. So that we can get to as many analysts as possible during today's call. As a reminder to ask a question. Please press star one on your telephone keypad, if you'd like to withdraw your question. Please press star two thank you.

Joanna: Okay.

Operator: Our first question comes from Chris Schott at JPMorgan. Chris, go ahead. Your line is open.

Andrew D. Dickinson: Our first question comes from Chris Schott at Jpmorgan. Chris Go ahead. Your line is open.

Chris Schott: Great. Thanks so much for the question. Just had a question on the HIV franchise and the impact from the Medicare redesign as we think about 2025, and this is coming from more and more conversations. Can you just talk a little bit about how you're thinking about that impact to your franchise? And maybe just more broadly, can we directionally still think about top-line growth and margin expansion for Gilead next year despite this headwind? So any color you can provide there would be appreciated. Thank you.

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

Speaker Change: Just had a question on on the HIV franchise and the impact from the Medicare redesign as we think about 2025 and it was just coming more and more conversations can you just talk a little bit about how you're thinking about that impact to your franchise and maybe just more broadly can we directionally still think about topline growth.

Andrew D. Dickinson: The required IPR&D is now expected to be approximately $4.4 billion due to the Simit Bay transaction, as well as milestones anticipated throughout the rest of the year. Operating income is now expected to be in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the Sima Bay transaction. Given the non-deductible impact of the Semibay acquisition, the effective tax rate for 2024 is expected to be approximately 30%. This includes a negative impact of approximately 11% from the one-time charge for the acquisition of CineBay.

The required IPR&D is now expected to be approximately $4.4 billion due to the Simit Bay transaction, as well as milestones anticipated throughout the rest of the year. Operating income is now expected to be in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the Sima Bay transaction.

Andrew D. Dickinson: Margin expansion for Gilead next year. Despite this headwind sort of any color you can provide there would be appreciated. Thank you.

Daniel O'Day: Yeah, great, Chris. Welcome, everybody. This is Dan. I'm going to have Johanna cover this question. Thank you.

Joanna: Okay, Great Chris and welcome everybody. This is Dan I'm going to have Joanna cover. This question. Thank you.

Andrew D. Dickinson: Given the non-deductible impact of the CymaBay acquisition, the effective tax rate for 2024 is expected to be approximately 30%. This includes a negative impact of approximately 11% from the one-time charge for the acquisition of CymaBay. We therefore now expect diluted EPS in the range of $3.45 to $3.85. As shown on Slide 27, this has only been updated to reflect the transactions that were closed in the first quarter of 2024. Excluding these charges, you can see that we are comfortably within the range of the EPS guidance we shared back in early February. On a GAAP basis, we expect full-year 2024 diluted EPS to be in the range of $0.10 and $0.50. Moving to Slide 28. Our capital allocation priorities remain unchanged with sufficient flexibility in our balance sheet. Specifically, as demonstrated in the first quarter, we announced a 2.7% increase to our quarterly dividend and returned approximately $1.4 billion to shareholders. In addition, we acquired CymaBay for $4.3 billion, adding seladelpar to our portfolio. Overall, we'll continue to be disciplined in our use of capital. And while we will continue to be flexible and opportunistic, it is unlikely that Gilead will be engaging in any sizable M&A transactions in the near term.

Operator: Thanks, Chris, for the question. So we do expect an impact of the Part D redesign to be weighted towards our HIV business, and expect our HIV growth in 2025 to be offset by the Part D redesign impact. So as a result, we expect our HIV sales to be roughly flat year on year in 2025. Having said that, overall, we expect our total business to grow despite the impact of the Part D redesign in 2025, with the top-line building momentum beyond 2025, right, 2026 and beyond. So we do expect growth in 2025, but our HIV business, the demand of HIV will offset the impact of Part D.

Johanna Mercier: Thanks, Chris, for the question. So we do expect an impact of the Part D redesign to be weighted towards our HIV business, and expect our HIV growth in 2025 to be offset by the Part D redesign impact. So as a result, we expect our HIV sales to be roughly flat year on year in 2025. Having said that, overall, we expect our total business to grow despite the impact of the Part D redesign in 2025, with the top-line building momentum beyond 2025, right, 2026 and beyond. So we do expect growth in 2025, but our HIV business, the demand of HIV will offset the impact of Part D.

Joanna: Thanks, Kristen for the question.

Joanna: So we do expect an impact of the part D redesign to be weighted towards our HIV business.

Joanna: And expect our HIV growth in 2025 to be offset by the part D redesign impact.

Andrew D. Dickinson: We therefore now expect diluted EPS in the range of $3.45 to $3.85. As shown on slide 27, this has only been updated to reflect the transactions that were closed in the first quarter of 2024. Excluding these charges, you can see that we are comfortably within the range of the EPS guidance we shared back in early February. On a GAAP basis, we expect full-year 2024 diluted EPS to be in the range of $0.10 and $0.50. Moving to slide 28, our capital allocation priorities remain unchanged with sufficient flexibility in our balance. Specifically, as demonstrated in the first quarter, we announced a 2.7% increase in our quarterly dividend and returned approximately $1.4 billion to shareholders. In addition, we acquired Simba Bay for $4.3 billion, adding Celladelpar to our portfolio. Overall, we'll continue to be disciplined in our use of capital, and while we will continue to be flexible and opportunistic, it is unlikely that Gilead will be engaging in any sizable M&A transactions in the near term.

Johanna Mercier: We expect our HIV sales to be roughly flat year on year in 2025, having said that overall, we expect our total business to grow despite the impact of the part D. Redesign in 2025 with the top line building momentum in 2020.

Joanna: In 2025, 26 and beyond so we do expect growth in 'twenty, five, but our HIV business the demand of HIV will offset the impact of part D.

Andrew Dickinson: Chris, it's Andy. I'll take the question on margin expansion. As you know, we don't provide more specific guidance for 2025 beyond what Johanna just mentioned. What we have said historically, and I'd underscore, is that we are very focused on disciplined expense management. That will be true in 2025 as it is today. You've seen that in the last two quarters. I think on a non-GAAP basis for this quarter, if you look at our operating margin, if you strip out the CymaBay transaction, you see an improvement in our operating margin, and we expect that to continue over time. So we do expect broadly for our operating margin to improve over time as you see the continued top-line growth and the disciplined expense management. So thanks for the question. More details, of course, to be provided early next year when we provide our 2025 guidance specifically.

Andrew D. Dickinson: Chris It's Andy I'll take the question on margin expansion as you know we don't provide more specific guidance for 2025 beyond what John just mentioned, what we have said historically I'd underscore is that we.

Andrew D. Dickinson: Moving to slide 28, our capital allocation priorities remain unchanged with sufficient flexibility in our balance. Specifically, as demonstrated in the first quarter, we announced a 2.7% increase in our quarterly dividend and returned approximately $1.4 billion to shareholders. In addition, we acquired Simba Bay for $4.3 billion, adding Celladelpar to our portfolio. Overall, we'll continue to be disciplined in our use of capital, and while we will continue to be flexible and opportunistic, it is unlikely that Gilead will be engaging in any sizable M&A transactions in the near term.

Andy: We are very focused on disciplined expense management that will be true in 2025 as it is today you've seen that in the last two quarters I think on a non-GAAP basis for this quarter. If you look at our operating margin. If you strip out the silver Bay transaction, you see an improvement in our operating margin and we expect that to continue over time. So we do expect.

Andrew D. Dickinson: <unk> broadly for our operating margin to improve over time as you see the continued topline growth and the disciplined expense management. So thanks for the question more details of course to be provided.

Andrew D. Dickinson: Early next year, when we provide our 2025 guidance specifically.

Operator: Our next question comes from Daina Graybosch at Leerink Partners. Daina, your line is open.

Andrew D. Dickinson: Our next question comes from Dana <unk> at Leerink Partners Dana Your line is open.

Andrew D. Dickinson: Before I wrap it up, on Slide 29, a quick note on our expectations now that the CymaBay transaction has closed. Pending regulatory approval, we expect to launch seladelpar in the U.S. before the end of 2024, as Johanna highlighted earlier, with a modest revenue contribution expected this year. Additionally, we have shared that the transaction is expected to add to operating expenses this year as we make incremental investments to support the launch as well as other R&D efforts, all of which we are able to manage within the window of the previously issued operating expense guidance. And as we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be breakeven to earnings in 2025, and significantly accretive in 2026 onwards. And now, I'll invite Rebecca to begin the Q&A.

Daina Graybosch: Great. Thanks for the question. It's for Kite. FDA's ODAC recently had two important meetings of relevance for multiple myeloma and CAR-T there. One dealt with the early death risk from CAR-T and Abecma, and the second was to recommend MRD as an intermediate endpoint for accelerated approval in multiple myeloma. And I wonder how you're thinking about both of these ODACs in relation to an anito-cel in your earlier line trial design. Thank you.

Speaker Change: Great. Thanks for the question it's for kite.

Dana: Oh that recently had two important meetings are relevant for multiple myeloma and car T. There.

Joanna: One.

Dana: <unk> dealt with the early death threat from car T and are back in the second.

Speaker Change: Was to recommend MRV.

Andrew D. Dickinson: Intermediate endpoint for accelerated approval.

Andrew D. Dickinson: And I wonder how youre thinking about both of these <unk> in relation to a need also in your earlier line Ah trial design. Thank you.

Andrew D. Dickinson: And as we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be breakeven to earnings in 2025 and significantly accretive in 2026 onward. Now I'll invite Rebecca to begin the Q&A. Thank you, Randy.

And as we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be breakeven to earnings in 2025 and significantly accretive in 2026 onward. Now I'll invite Rebecca to begin the Q&A.

Daniel O'Day: Thanks, Daina. We've got Cindy Perettie here, so we'll go right over to her.

Speaker Change: And then we've got the Sydney proud of yourself go right over to her.

Cindy Perettie: Thanks, Daina. So if I start off with the early line ODAC, I think we believe this is positive for everybody. What it's shown is that people recognize the value of having CAR-T therapies earlier in their disease. They value the disease-free intervals that they get from that. So we were very happy to see that. I think we were equally as excited to see the second ODAC around MRD, minimal residual disease, as an additional endpoint. And I think the piece around this is that we're really encouraged that the ODAC decision is going to open up the door for us to potentially bring an anito-cel to market faster for patients. And we're in the process right now of understanding how the MRD surrogate endpoint can be used with regulatory agencies, and the application of our program, and so more to come on that front.

Speaker Change: So if I start off with the early line O DAC I think we believe this is positive for everybody. What it's shown is that people recognize the value of having a car T therapies earlier in their disease they value the disease free intervals that they get from that so we were very happy to see that I think we were equally as.

Operator: Thank you, Andy. At this time, we'll open up the call for questions. We ask that you be courteous and limit yourself to one question so that we can get to as many analysts as possible during today's call. As a reminder, to ask a question, please press Star 1 on your telephone keypad. If you'd like to withdraw your question, please press Star 2. Thank you. Our first question comes from Chris Schott at JP Morgan. Chris, go ahead, your line is open.

Rebecca: Thank you, Randy. At this time, we'll open up the call to questions. We ask that you be courteous and limit yourself to one question so that we can get to as many analysts as possible during today's call. As a reminder, to ask a question, please press star 1 on your telephone keypad. If you'd like to withdraw your question, please press star 2. Thank you. Our first question comes from Chris Schott at J.P. Morgan. Chris, go ahead; your line is open.

Speaker Change: Good to see the second Oh DAC around M. R D minimal residual disease as a secondary isn't as an additional endpoint I think the piece around this is that we're really encouraged that the hodac decision is going to open up the door for us to potentially bring a need to sell to market faster for patients and we're in the process right now of understanding how the mrna surrogate end point can be used with regulatory.

Chris Schott: Great. Thanks so much for the question. Just had a question on the HIV franchise and the impact from the Medicare redesign as we think about 2025, I know this is coming from more and more conversations. Can you just talk a little bit about how you're thinking about that impact to your franchise? And maybe just more broadly, can we directionally still think about top-line growth and margin expansion for Gilead next year despite this headwind? So, any color you can provide there would be appreciated. Thank you.

Speaker Change: For agencies in the application of our program and so more to come on that front.

Operator: Our next question comes from Umer Raffat at Evercore ISI. Umer, your line is open.

Speaker Change: Our next question comes from Evercore.

Speaker Change: Evercore ISI your line is open.

Umer Raffat: Hi, guys. Thanks for taking my question. I just thought I'll spend a quick second on CymaBay given the recent deal. My question is, did Gilead, during the diligence process, deploy independent pathologists to evaluate the cases of "possible liver pathology" that happened in the NASH trial previously, as well as the paired liver biopsy data from the PBC trial of the lower dose where CymaBay didn't think it would need safety adjudication? I'd be very curious how you guys did that and if you would ever publish that. Thank you.

Christopher Thomas Schott: Hi, guys. Thanks for taking my question I, just thought I'll spend a quick second one in the Bay.

Christopher Thomas Schott: Given the recent deal my question is did gilead during the diligence process deploy independent pathologists to evaluate the cases up quote unquote possible liver pathology that happened in the Nash trial previously as well as the paired liver biopsy data from the PBC trial at the lower dose were similarly, I didn't think it would need safety adjudication I'd be very clear.

Chris Schott: So any color you can provide there would be appreciated. Thank you.

Daniel O'Day: Yeah. Great, Chris. Welcome, everybody. This is Dan. I'm going to have Johanna cover this question. Thank you.

Johanna Mercier: Thanks, Chris, for the question. So, we do expect an impact of the Part D redesign to be weighted toward our HIV business and expect our HIV growth in 2025 to be offset by the Part D redesign impact. So, as a result, we expect our HIV sales to be roughly flat year on year in 2025. Having said that, overall, we expect our total business to grow despite the impact of the Part D we designed in 2025 with the top line, building momentum in 2020 - beyond 2025, right, '26 and beyond. So, we do expect growth in '25, but our HIV business, the demand of HIV will offset the impact of Part D.

Speaker Change: How you guys did that and if it would ever published that thank you.

Speaker Change: Yeah.

Daniel O'Day: Thanks, Umer. Umer's here, so we'll let him answer.

Speaker Change: Thanks, you remember that in here, so I'll, let him answer.

Mehrdad Parsey: Thanks, Umer. Let me start by saying we think Seladelpar is one of those medicines that will bring a lot of benefit to patients, and really some near-term expansion of our liver portfolio and what we think will synergize with many of the other work, much of the other work that we're doing in liver disease overall. We obviously did thorough diligence in our approach to Seladelpar and CymaBay. We didn't do a third party. I think your question was around whether we did an independent third-party review of the pathology. We did not do that. However, we did a lot of thorough diligence on the data itself and the outcomes, and we are confident around the outcome and what it means for patients over time.

Speaker Change: Thanks, So much and let me start by saying that we think Philadelphia is one of those medicines that will bring a lot of benefit to patients.

Johanna Mercier: Hum.

Speaker Change: Some near term.

Speaker Change: Expansion of our liver portfolio in our and what we think will synergize with many of the other.

Johanna Mercier: Much of the other work that we're doing in.

Johanna Mercier: And liver disease overall.

Speaker Change: We obviously did thorough diligence and.

Speaker Change: And our approach to selling <unk> and Sema Bay.

Johanna Mercier: We didn't do a third I think your question was around whether we did an independent third party review of the pathology, we did not do that.

Andrew D. Dickinson: Chris, it's Andy. I'll take the question on margin expansion. As you know, we don't provide more specific guidance for 2025 beyond what Johanna just mentioned. What we have said historically, and I've underscored, is that we are very focused on disciplined expense management. That will be true in 2025 as it is today. You've seen that in the last two quarters. I think on a non-GAAP basis for this quarter, if you look at our operating margin, if you strip out the CymaBay transaction, you see an improvement in our operating margin, and we expect that to continue over time. So, we do expect broadly for our operating margin to improve over time as you see the continued top-line growth and the disciplined expense management. So, thanks for the question. More details, of course, to be provided early next year when we provide our 2025 guidance specifically.

Speaker Change: However, we did a lot of thorough diligence on the on the data itself and in the outcomes.

Speaker Change: Outcomes and we are confident around the outcome and what it means for patients over time.

Mehrdad Parsey: Obviously, we're awaiting right now our upcoming PDUFA date and also the filing in the EMA, which we are optimistic about, and following the questions and all those sorts of items that we're in. So we're looking forward to providing an update on that as those filings proceed.

Obviously, we're awaiting right now our upcoming PDUFA date and also the filing in the EMA, which we are optimistic about, and following the questions and all those sorts of items that we're in. So we're looking forward to providing an update on that as those filings proceed.

Speaker Change: Obviously, we're awaiting right now the.

Speaker Change: Our upcoming <unk> date.

Speaker Change: And also the file in the EMA, which we are optimistic about.

Andy: I think on a non-GAAP basis for this quarter, if you look at our operating margin, if you strip out the Sima Bay transaction, you see an improvement in our operating margin. We expect that to continue over time. We do expect, broadly, our operating margin to improve over time, as you see the continued top-line growth and the disciplined expense management. Thanks for the question. More details, of course, will be provided early next year when we provide our 2025 guidance.

Andy: And following the questions and all those sorts of items that were in so.

Andy: Looking forward to providing an update on that as those filings proceed.

Operator: Our next question comes from Tyler Van Buren at TD Cowen. Tyler, your line is open.

Speaker Change: Our next question comes from Tyler Van Buren at TD Cowen Tyler Your line is open.

Chris Schott: Hey, guys. Good afternoon. Thanks very much for the question. I was hoping you could help set expectations for the EVOKE-01 and 02 presentations at ASCO. For EVOKE-02, the late breaker tag is interesting. So is that related to the three-month OS benefit in the PD-1 refractory patients, or should we be expecting something more? And for EVOKE-02, what should we hope to see with the cohort A data that should leave us confident in the EVOKE-03 readout next year?

Tyler Van Buren: Hey, guys. Good afternoon. Thanks very much for the question. I was hoping you could help set expectations for the EVOKE-01 and 02 presentations at ASCO. For EVOKE-02, the late breaker tag is interesting. So is that related to the three-month OS benefit in the PD-1 refractory patients, or should we be expecting something more? And for EVOKE-02, what should we hope to see with the cohort A data that should leave us confident in the EVOKE-03 readout next year?

Speaker Change: Hey, guys. Good afternoon. Thanks, very much for the question I was hoping you could help set expectations for the <unk>, one and O. Two presentations at <unk> revoke go to the late breaker tag. It's interesting. So is that related to the three month OS benefit in the PD, one refractory patients or could we or should we be expecting something.

Operator: Our next question comes from Daina Graybosch at Leerink Partners. Daina, your line is open.

Daina Graybosch: Great. Thanks for the question. It's for Kite. FDA's ODAC recently had two important meetings of relevance for multiple myeloma and CAR-T there. One dealt with the early death risk from CARVYKTI and ABECMA. And the second was to recommend MRD as an intermediate endpoint for accelerated approval in multiple myeloma. And I wonder how you're thinking about both of these ODACs in relation to anito-cel in your earlier line trial design. Thank you.

Daina Graybosch: FDA's ODAC recently had two important meetings of relevance for multiple myeloma and CAR-T there. One dealt with the early death risk from CAR-VIC-T and abecma. And the second was to recommend MRD as an intermediate endpoint for accelerated approval in multiple myeloma. And I wonder how you're thinking about both of these ODACs in relation to a needle cell in your earlier line trial design. Thank you.

Daina Graybosch: More and for evoke go to what should we hope to see with the cohort data that should leave us confident in the <unk> III readout next year.

Daina Graybosch: Yes.

Daina Graybosch: Yeah.

Andrew Dickinson: Tyler. It's me again here. So it's a little challenging because I can't share too many details now because we're under embargo for both of those, and obviously happy to fill in a lot of the blanks once the data are released and we can talk about them at ASCO. I think for EVOKE-01, we think there are a number of pipeline updates in our ASCO presentations that we have upcoming, which we see as a real change for us and a real evolution of our pipeline overall and our ability to build our oncology pipeline and bring new options for patients. As part of the late breaker session for EVOKE-01, as you mentioned, we will include data on overall survival and PFS, ORR, and duration of response, as well as the safety profile, of course.

Mehrdad Parsey: Tyler. It's me again here. So it's a little challenging because I can't share too many details now because we're under embargo for both of those, and obviously happy to fill in a lot of the blanks once the data are released and we can talk about them at ASCO. I think for EVOKE-01, we think there are a number of pipeline updates in our ASCO presentations that we have upcoming, which we see as a real change for us and a real evolution of our pipeline overall and our ability to build our oncology pipeline and bring new options for patients. As part of the late breaker session for EVOKE-01, as you mentioned, we will include data on overall survival and PFS, ORR, and duration of response, as well as the safety profile, of course.

Speaker Change: Thanks, Tyler and smeared out again here.

Speaker Change: It's a little challenging because I can't share too. Many details now because were under embargo for both of those and obviously happy to fill in a lot of the blanks. Once the data are are released and we can talk about them at <unk>.

Daniel O'Day: Thanks, Daina. We've got Cindy Perettie here, so we'll go right over to her.

Cindy Perettie: Thanks, Daina. So, if I start off with the early line ODAC, I think we believe this is positive for everybody. What it's shown is that people recognize the value of having CAR-Ts therapies earlier in their disease. They value the disease-free intervals that they get from that. So, we were very happy to see that. I think we were equally as excited to see the second ODAC around MRD, minimal residual disease, as a secondary - as an additional endpoint. I think the piece around this is that we're really encouraged that the ODAC decision is going to open up the door for us to potentially bring anito-cel to market faster for patients. And we're in the process right now of understanding how the MRD surrogate endpoint can be used with regulatory agencies and the application of our program and so more to come on that front.

Cindy Perettie: I think for for Ivanka, one we.

Cindy Perettie: We think there are a number of pipeline updates in our ESCO presentations that we have upcoming widget, which where we see isn't real change for us and a real.

Cindy Perettie: So we were very happy to see that. I think we were equally as excited to see the second ODAC around MRD, minimal residual disease, as a secondary, as an additional endpoint. I think the piece around this is that we're really encouraged and excited that the ODAC decision is going to open up the door for us to potentially bring IndidaCell to market faster for patients. And we're in the process right now of understanding how the MRD surrogate endpoint can be used with regulatory agencies and the application of our program, and there will be some more to come on that front. The next question comes from Umer Raffat at Evercore ISI. Umer, your line is open. Hi guys, thanks for taking my question. I just thought I'd spend a quick second on Simba Bay, given the recent deal.

So we were very happy to see that. I think we were equally as excited to see the second ODAC around MRD, minimal residual disease, as a secondary, as an additional endpoint. I think the piece around this is that we're really encouraged and excited that the ODAC decision is going to open up the door for us to potentially bring IndidaCell to market faster for patients. And we're in the process right now of understanding how the MRD surrogate endpoint can be used with regulatory agencies and the application of our program, and there will be some more to come on that front.

Umer Raffat: Uh huh.

Umer Raffat: Evolution of our pipeline overall, and our ability to build our oncology pipeline and bring new options for patients.

Umer Raffat: As part of the late breaker session for evoke a one as you mentioned we will include data on overall survival on PFS or R and duration of response as well as the safety profile of course.

Andrew Dickinson: I wish I could give you more details, but I can't at this point. As you say, we will also be providing other updates there, including the EVOKE-02 cohort A data, looking at the PD-L1 high non-small cell population. And again, I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and talking about the implications of that for our broader lung cancer, and especially the front-line lung cancer EVOKE-03 study that we are conducting right now, which is underway with our partners at Merck.

I wish I could give you more details, but I can't at this point. As you say, we will also be providing other updates there, including the EVOKE-02 cohort A data, looking at the PD-L1 high non-small cell population. And again, I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and talking about the implications of that for our broader lung cancer, and especially the front-line lung cancer EVOKE-03 study that we are conducting right now, which is underway with our partners at Merck.

Umer Raffat: And I wish I could give you more details, but I can at this point.

Umer Raffat: As you say, we will also be providing other updates there, including vivo co two cohort AAN data looking at the PD Lone high non small cell population.

The next question comes from Umer Raffat at Evercore ISI. Umer, your line is open. Hi guys, thanks for taking my question. I just thought I'd spend a quick second on Simba Bay, given the recent deal.

Operator: Our next question comes from Umer Raffat of Evercore ISI. Umer, your line is open.

Umer Raffat: Hi, guys, thanks for taking my question. I just thought I'll spend a quick second on CymaBay, given the recent deal. My question is, did Gilead, during the diligence process, deploy independent pathologists to evaluate the cases of "possible" liver pathology that happened in the NASH trial previously as well as the paired liver biopsy data from the PBC trial at the lower dose where CymaBay didn't think it would need safety adjudication? I'd be very curious how you guys did that and if you would ever publish that. Thank you.

Cindy Perettie: And.

Umer Raffat: Again, it's I can't really talk about the details of those data but.

Umer Raffat: Our next question comes from Umer Raffat at Evercore ISI. Umer, your line is open.

Umer Raffat: But we are looking forward to sharing the.

Speaker Change: Those results with everyone.

Daniel O'Day: Thanks, Umer. And Merdad's here, so we'll let him answer.

Umer Raffat: Talking about the implications of that for our broader lung.

Merdad V. Parsey: Thanks, Umer. Let me start by saying we think SELADELPAR is one of those medicines that will bring a lot of benefit to patients and really some near-term expansion of our liver portfolio and our - and what we think will synergize with many of the other - much of the other work that we're doing in liver disease overall. We obviously did thorough diligence in our approach to seladelpar and CymaBay. We didn't do a third - I think your question was around whether we did an independent third-party review of the pathology. We did not do that. However, we did a lot of thorough diligence on the data itself and the outcomes. And we are confident around the outcome and what it means for patients over time. Obviously, we're waiting right now the - our upcoming PDUFA date and also the file in the EMA, which we are optimistic about. And following the questions and all those sorts of items that we're in. So, we're looking forward to providing an update on that as those filings proceed.

Speaker Change: Lung cancer, and especially the frontline lung cancer as I'll go three study that that we are conducting right now is underway.

Merdad V. Parsey: Our partners at Merck.

Operator: Our next question comes from the line of Geoff Meacham at Bank of America. Jeff, your line is open.

Merdad V. Parsey: Our next question comes from the line of Geoff Meacham Bank of America, Jeff Your line is open.

Geoff Meacham: Good afternoon, everyone. Thanks for the question. Mert, I had a question for you. On the cell therapy front, you obviously have the NEDO cell update later this year, which is big. But beyond that, I wasn't sure what the priority was among the next-gen CAR assets that you've got kind of cartooned on slide 19. There's a lot of competition in this space, but you guys are among the only players that have real scale, and you could move the next-gen stuff, I think, pretty fast. But if you had to pick sort of a priority list, it would be good to know. Thank you.

Speaker Change: Great afternoon, everyone. Thanks for the question.

Merdad V. Parsey: Mehrdad question for you on the cell therapy front.

Merdad V. Parsey: So you have the Anita cell update later this year, which is big but beyond that I wasn't sure what the priority was among the Nextgen car assets that you've got.

Merdad V. Parsey: We did not do that. However, we did a lot of due diligence on the data itself and the outcomes. I'm confident about the outcome and what it means for patients over time. Obviously, we're awaiting right now our upcoming PDUFA date and also the file in the EMA, which we are optimistic about, and following the questions and all those sorts of things that we're dealing with. So we're looking forward to providing an update on that as those filings progress...

Merdad V. Parsey: Kind of cartoon on slide 19, with a lot of competition in this space, but you guys are among the only players.

Speaker Change: Real scale and you can move the next Gen stuff I think pretty fast, but if.

Speaker Change: If you had to take sort of a priority list would be it will be good to know thank you.

Merdad V. Parsey: Yeah.

Daniel O'Day: Thanks, Jeff. This is Dan. We're going to have Cindy Peretti answer that question, if you don't mind. So Cindy, over to you.

Speaker Change: Thanks, Jeff. This is Dan we're going to have Cindy <unk> answer that question, if you don't mind.

Operator: This question comes from Tyler Van Buren at TD Talon. Tyler, your line is open. Hey guys, good afternoon. Thanks very much for the question. I was hoping you could help set expectations for the EVOC01 and EVOC02 presentations.

Operator: Our next question comes from Tyler Van Buren at TD Cowen. Tyler, your line is open.

Merdad V. Parsey: So sidney over to you.

Cindy Perettie: Hi, Jeff. So we have three products right now or three constructs that are in phase 1a and 1b clinical trials. The first one is a bicistronic CD19, CD20 that has 4-1BB and CD28. The second one is that same construct with fast manufacturing, three-day manufacturing. And the other one is a CD19 like Yescarta with three-day manufacturing. So we're looking at all three of those in parallel with the goal of picking the winner to advance that rapidly into our pivotal trials. So that's what's coming up next. Obviously, we've shared a lot around anito-cel as well. With anito-cel, we have the IMAGINE-1 readouts, and we expect to move quickly into earlier lines as it relates to anito-cel. And you'll hear more about that later this year. Hopefully, that answers your question.

Speaker Change: Yeah. So we have three products right now are three contracts that are in phase one <unk> clinical trials. The first one is the <unk> CD 19, CD 20 that has or one DB and CD 28. The second one is that same construct with fast manufacturing three day manufacturing and the other one is a CD 19.

Tyler Van Buren: Hey, guys, good afternoon. Thanks very much for the question. I was hoping you could help set expectations for EVOKE-01 and 02 presentations at ASCO. For EVOKE-02, the late breaker tag is interesting. So, is that related to the 3-month OS benefit in the PD-1 refractory patients? Or could we - or should we be expecting something more? And for EVOKE-02, what should we hope to see with the Cohort A data that should leave us confident in the EVOKE-03 readout next year?

Tyler Van Buren: Our next question comes from Tyler Ben-Buren at TD Calendars. Tyler, your line is open.

Tyler Van Buren: Like you start out with three day manufacturing. So we're looking at all three of those in parallel with the goal of picky.

Merdad V. Parsey: Thanks, Tyler. It's Merdad again here. So, it's a little challenging because I can't share too many details now because we're under embargo for both of those. And obviously, happy to fill in a lot of the blanks once the data are released, and we can talk about it in ASCO. I think for EVOKE-01, we think there are a number of pipeline updates in our ASCO presentations that we have upcoming, which were - we see as a real change for us and a real evolution of our pipeline overall and our ability to build our oncology pipeline and bring new options for patients. As part of the late breaker session for EVOKE-01, as you mentioned, we will include data on overall survival, on PFS, ORR, and duration of response as well as the safety profile, of course. And I wish I could give you more details, but I can't at this point. As you say, we will also be providing other updates there, including the EVOKE-02 Cohort A data looking at the PD-L1 high non-small cell population. And again, I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and talking about the implications of that for our broader lung cancer and especially the frontline lung cancer EVOKE-03 study that we are conducting right now is underway with our partners at Merck.

Merdad V. Parsey: So, you know, it's a little challenging because I can't share too many details now because we're under embargo for both of those, but I will obviously be happy to fill in a lot of the blanks once the data are released and we can talk about them at ASCO. I think for EVOCA-1, we think there are a number of pipeline updates in our ASCO presentations that we have upcoming, which we see as a real change for us and a real... evolution of our pipeline overall and our ability to build our oncology pipeline and bring new options for patients. As part of the late breakers session for EVOCA 1, as you mentioned, we will include data on overall survival, on PFS, ORR, and direction of response, as well as the safety profile, of course. And I wish I could give you more details, but I can't at this point. As you say, we will also be providing other updates there, including the EVOCA 2 Cohort A data looking at the PD-L1 high, non-small cell population. And again, I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and discussing the implications of that for our broader lung cancer, and especially the frontline lung cancer, EVOCO3 study that we are conducting right now with our partners at Merck.

Merdad V. Parsey: Picking the winner to advance that rapidly into our pivotal trials. So that's what's coming up next obviously, we've shared a lot around the need to sell as well.

Merdad V. Parsey: The need to sell we have imagine one readouts and we expect them to move quickly into earlier lines as it relates to a need to sell and you'll hear more about that.

Merdad V. Parsey: Later this year.

Merdad V. Parsey: Hopefully that answers. Your question, we certainly have a number of plays in early research, but we would we would plan to advance our next generation lymphoma as it quickly and obviously with the scale that we had.

Cindy Perettie: We certainly have a number of plays in early research, but we would plan to advance our next-generation lymphoma asset quickly and obviously with the scale that we have at Kite, as well as the integrated fact that we can create the vector as well as the construct in-house.

We certainly have a number of plays in early research, but we would plan to advance our next-generation lymphoma asset quickly and obviously with the scale that we have at Kite, as well as the integrated fact that we can create the vector as well as the construct in-house.

Merdad V. Parsey: Right as well as the integrator in fact that we can create the vector as well as the construct in health.

Merdad V. Parsey: As part of the late breakers session for EVOCA 1, as you mentioned, we will include data on overall survival, on PFS, ORR, and direction of response, as well as the safety profile, of course. And I wish I could give you more details, but I can't at this point. As you say, we will also be providing other updates there, including the EVOCA 2 Cohort A data looking at the PD-L1 high, non-small cell population. And again, I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and discussing the implications of that for our broader lung cancer, and especially the frontline lung cancer, EVOCO3 study that we are conducting right now with our partners at Merck.

Operator: Our next question comes from Michael Yee at Jefferies. Michael, go ahead. Your line is open.

Andrew D. Dickinson: Our next question comes from Michael <unk> at Jefferies. Michael Go ahead. Your line is open.

Michael Yee: Hi, guys. Thanks. Following up on the Trodelvy data coming at ASCO and your enthusiasm for front-line, can you just remind us, A, do you believe that your data in EVOKE second-line that will be at ASCO is at least as competitive or better than AstraZeneca? And that is why you're excited about front-line. And B, if you are, do you have a triple therapy on top of chemo combo, or is your whole first-line strategy just on top of PD-1? Thank you.

Merdad V. Parsey: Hey, guys. Thanks, following up on the <unk> data coming at <unk> and your enthusiasm for what line can you just remind US do you believe that your data and evoke.

Merdad V. Parsey: And again, I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and discussing the implications of that for our broader lung cancer, and especially the frontline lung cancer, EVOCO3 study that we are conducting right now with our partners at Merck. Our next question comes from the line of Geoff Meacham at Bank of America. Geoff, your line is open. Great afternoon, everyone. Thanks for the question. Merdad, question for you on the cell therapy front, you know; you obviously have the Anita cell update later this year.

And again, I can't really talk about the details of those data, but we are looking forward to sharing those results with everyone and discussing the implications of that for our broader lung cancer, and especially the frontline lung cancer, EVOCO3 study that we are conducting right now with our partners at Merck.

Geoff Meacham: Second line that will get US go is at least as competitive or better than Astra and that is why you're excited about frontline and B. If you are do you have a triple therapy on top of chemo combo as you hold first line strategy just on top of PD one. Thank you.

Merdad V. Parsey: Yeah.

Our next question comes from the line of Geoff Meacham at Bank of America. Geoff, your line is open. Great afternoon, everyone. Thanks for the question. Merdad, question for you on the cell therapy front, you know; you obviously have the Anita cell update later this year.

Operator: Our next question comes from the line of Geoff Meacham at Bank of America. Geoff, your line is open.

Andrew Dickinson: Thanks, Michael. This is Mehrdad again. As we've noted, I think, and as you talked about, the EVOKE-01 data in second-line will be something that we discuss at ASCO, and showing those data in the full data set does motivate us to go forward in lung cancer, including with discussions with regulators. The unmet need in this population is great, and the data give us options, including discussions with health authorities and conducting follow-up trials. We'll be able to share more once the data are provided at ASCO. And so we'll look forward to having those deeper discussions once we can speak directly to the data. Sorry, and the second part of your question was around the frontline. Again, I think once we are able to share the EVOKE-02 data, the update on EVOKE-02 data, we'll be able to talk more.

Mehrdad Parsey: Thanks, Michael. This is Mehrdad again. As we've noted, I think, and as you talked about, the EVOKE-01 data in second-line will be something that we discuss at ASCO, and showing those data in the full data set does motivate us to go forward in lung cancer, including with discussions with regulators. The unmet need in this population is great, and the data give us options, including discussions with health authorities and conducting follow-up trials. We'll be able to share more once the data are provided at ASCO. And so we'll look forward to having those deeper discussions once we can speak directly to the data. Sorry, and the second part of your question was around the frontline. Again, I think once we are able to share the EVOKE-02 data, the update on EVOKE-02 data, we'll be able to talk more.

Geoff Meacham: Thanks, Michael.

Marty: This is Marty again.

Geoff Meacham: As we've noted I think as you.

Geoff Meacham: And as you.

Geoff Meacham: Good afternoon, everyone. Thanks for the question. Merdad, a question for you. On the cell therapy front, you usually have the anito-cel update later this year, which is big. But beyond that, I wasn't sure what the priority was among the next-gen CAR assets that you've got kind of cartooned on Slide 19. There's a lot of competition in this space, but you guys are among the only players that have real scale and you could move the next-gen stuff, I think, pretty fast. But if you had to pick sort of a priority list, will be good to know. Thank you.

Geoff Meacham: Talked about Dave I'll go one data in second line will be something that we discuss at Astro and show those data in the full dataset.

Geoff Meacham: Doesn't motivate us to go forward.

Geoff Meacham: Our next question comes from the line of Geoff Meacham at Bank of America. Geoff, your line is open.

Geoff Meacham: In lung cancer, and including with this discussions with regulators.

Geoff Meacham: The unmet need in this population is great and the data give us.

Daniel O'Day: Thanks, Geoff. This is Dan. We're going to have Cindy Perettie answer that question if you don't mind. So, Cindy, over to you.

Cindy Perettie: Options, including discussions with health authorities and conducting follow up trials, we will be able to share more once the data are provided.

Cindy Perettie: Hi, Geoff. So, we have three products right now or three constructs that are in Phase I-A and B clinical trials. The first one is a bicistronic CD19, CD20 that has 41BB and CD28. The second one is that same construct with fast manufacturing, 3-day manufacturing. And the other one is a CD19 like Yescarta with three-day manufacturing. So, we're looking at all three of those in parallel with the goal of picking the winner to advance that rapidly into our pivotal trials. So, that's what's coming up next. Obviously, we've shared a lot around anito-cel as well. With anito-cel, we have the iMMagine-1 readout, and we expect to move quickly into earlier lines as it relates to anito-cel, and you'll hear more about that later this year. Hopefully, that answers your question. We certainly have a number of plays in early research, but we would plan to advance our next-generation lymphoma assets quickly. And obviously, with the scale that we have at Kite as well as the integrated fact that we can create the vector as well as the construct in-house.

Cindy Perettie: Provided vasco.

Cindy Perettie: And so we'll look forward to having those deeper discussions once we can speak directly to the data.

Cindy Perettie: And sorry, and then the second part of your question was around the frontline.

Cindy Perettie: Again, I think once we are able to share the <unk> data the update on <unk> two data will be able to talk more but it does continue to.

Cindy Perettie: So we're looking at all three of those in parallel with the goal of picking the winner to advance that rapidly into our pivotal trials. So that's what's coming up next. Obviously, we've shared a lot around AnitaCell as well. With AnitaCell, we have the Imagine 1 readouts, and we expect to move quickly into earlier lines as it relates to AnitaCell, and you'll hear more about that later this year. Hopefully, that answers your question. We certainly have a number of plays in early research, but we would plan to advance our next generation lymphoma asset quickly and, obviously, with the scale that we have at KITE as well as the integrated fact that we can create the vector as well as the construct in-house.

Andrew Dickinson: But it does continue to allow us to think about the frontline and our confidence around EVOKE-03. And then the last part of your question on other combinations, we do think about our intra-portfolio combinations. For example, we have a combination of domvanilumab and Trodelvy in a trial where we're looking to see if we can get additional efficacy from those sorts of combinations. So we do continuously look at our portfolio and look for opportunities for moving the needle with combinations from within our portfolio.

But it does continue to allow us to think about the frontline and our confidence around EVOKE-03. And then the last part of your question on other combinations, we do think about our intra-portfolio combinations. For example, we have a combination of domvanilumab and Trodelvy in a trial where we're looking to see if we can get additional efficacy from those sorts of combinations. So we do continuously look at our portfolio and look for opportunities for moving the needle with combinations from within our portfolio.

Speaker Change: Allow us to think.

Cindy Perettie: The frontline and our confidence around the Bogo three and then the last part of your question on on other combinations we do.

Cindy Perettie: Think about our intra portfolio combinations.

Cindy Perettie: For example, we have a combination of Dom vanilla Mab and <unk>.

Michael J. Yee: We certainly have a number of plays in early research, but we would plan to advance our next generation lymphoma asset quickly and, obviously, with the scale that we have at KITE as well as the integrated fact that we can create the vector as well as the construct in-house. Our next question comes from Michael Yee at Jeffrey. Michael, go ahead. Your line is open. Hi guys, thanks. Following up on the Tridelvi data coming out of ASCO and your enthusiasm for Frontline.

We certainly have a number of plays in early research, but we would plan to advance our next generation lymphoma asset quickly and, obviously, with the scale that we have at KITE as well as the integrated fact that we can create the vector as well as the construct in-house.

Michael J. Yee: Lv and a trial, where we're looking to see if we can get additional <unk>.

Michael J. Yee: Efficacy from those sorts of combination. So we do continuously look at our portfolio and look for opportunities for moving the needle within with combinations from within our portfolio.

Our next question comes from Michael Yee at Jeffrey. Michael, go ahead. Your line is open. Hi guys, thanks. Following up on the Tridelvi data coming out of ASCO and your enthusiasm for Frontline.

Operator: Our next question comes from Michael Yee at Jefferies. Michael, go ahead. Your line is open.

Operator: Our next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead. Your line is open.

Michael J. Yee: Our next question comes from Celgene Richter of Goldman Sachs. Go ahead. Your line is open.

Michael Yee: Hi, guys. Thanks. Following up on the Trodelvy data coming at ASCO and your enthusiasm for frontline, can you just remind us, a, do you believe that your data in EVOKE second line that will be at ASCO is at least as competitive or better than Astra, and that is why you're excited about frontline? And b, if you are, do you have a triple therapy on top of chemo combo or is your whole first-line strategy just on top of PD-1? Thank you.

Daina Graybosch: Good afternoon. Thanks for taking my question. So you currently have about $5 billion in cash and noted leverage is back to pre-Immunomedics deal levels. How are you thinking about meaningful or bolt-on BD post the CymaBay acquisition, and is there any preference now between virology, INI, and oncology? Thank you.

Salveen Richter: Good afternoon. Thanks for taking my question. So you currently have about $5 billion in cash and noted leverage is back to pre-Immunomedics deal levels. How are you thinking about meaningful or bolt-on BD post the CymaBay acquisition, and is there any preference now between virology, INI, and oncology? Thank you.

Michael J. Yee: Good afternoon. Thanks for taking my question. So you currently have about $5 billion in cash and noted leverages back to pre immunomedics deal levels. How are you thinking about meaningful or bolt on BD post the <unk> acquisition and is there any preference now between virology ini in oncology. Thank you.

Merdad V. Parsey: Our next question comes from Michael Yee at Jeffrey. Michael, go ahead; your line is open.

Merdad V. Parsey: Thanks, Michael. This is Merdad again. As we've noted, I think, and as you talked about, the EVOKE-01 data in second line will be something that we discuss at ASCO and show those data. And the full data set is - does motivate us to go forward in lung cancer and including discussions with regulators. The unmet need in this population is great, and the data give us options, including discussions with health authorities and conducting follow-up trials. We'll be able to share more once the data are provided at ASCO, and so we look forward to having those deeper discussions once we can speak directly to the data. And I'm sorry, and the second part of your question was around the front line. Again, I think once we are able to share the EVOKE-02 data, the update on EVOKE-02 data, we'll be able to talk more. But it does continue to allow us to think about the frontline and our confidence around about EVOKE-03. And then the last part of your question on other combinations. We do think about our intra-portfolio combinations. For example, we have a combination of dambinelumab and TRODELVY in a trial where we're looking to see if we can get additional efficacy from those sorts of combinations. So, we do continuously look at our portfolio and look for opportunities for moving the needle with combinations from within our portfolio.

Merdad V. Parsey: As we've noted, I think, and as you talked about, the EVOCA-1 data in the second line will be something that we discuss at ASCO and show those data in the full data set. It does motivate us to go forward in lung cancer, including with discussions with regulators. The unmet need in this population is great, and the data give us options, including discussions with health authorities and conducting follow-up trials. We'll be able to share more once the data are provided at ASCO, and so we'll look forward to having those deeper discussions once we can speak directly to the data. And I'm sorry, and the second part of your question was about the front line. Again, I think once we are able to share the Evoco2 data, the update on Evoco2 data, we'll be able to talk more, but it does continue to allow us to think about the front line and our confidence around Evoco3. And then, the last part of your question on other combinations, we do think about our intra-portfolio combinations. For example, we have a combination of Dominoamab and Tredel-V in a trial where we're looking to see if we can get additional efficacy from those sorts of combinations. So we do continuously look at our portfolio and look for opportunities to move the needle with combinations from within our portfolio.

Andrew Dickinson: Hey, Salveen. It's Andy. Maybe I'll start with that one. In our prepared remarks, I highlighted that in the near term, we don't expect sizable M&A. We have a lot of execution ahead of us. We have a deep portfolio, a lot of growth drivers, including seladelpar. We're very clearly highlighting that in the short term, we will continue to do ordinary course business development, the standard licensing deals. You saw a couple of those in Q1, but it's unlikely that we would pursue any meaningful M&A in the near term. We've also said historically that deals like CymaBay are exactly what we're looking for and that we should do deals like that on a regular basis over the cycle. Whether that's every two years on average or more or less, that's a general ballpark.

Merdad V. Parsey: Hey, Savi, it's Andrew maybe I'll start with that one.

Merdad V. Parsey: In our prepared remarks.

Merdad V. Parsey: <unk> I highlighted that in the near term, we don't expect sizable M&A. So we have we have a lot of execution ahead of us we have a deep portfolio a lot of growth drivers, including cell Adele par. So we're very clearly highlighting that in the short term. We will continue to do ordinary course business development. The standard licensing deals you saw.

Merdad V. Parsey: A couple of those in the first quarter, but it's unlikely that we would pursue any meaningful M&A in the near term.

Merdad V. Parsey: So is that historically the deals like <unk> Bay are exactly what we're looking for and that we should do deals like that on a regular basis over the cycle and whether Thats every two years on average are more or less that's a general Paul Park. So.

Merdad V. Parsey: Again, I think once we are able to share the Evoco2 data, the update on Evoco2 data, we'll be able to talk more, but it does continue to allow us to think about the front line and our confidence around Evoco3. And then, the last part of your question on other combinations, we do think about our intra-portfolio combinations. For example, we have a combination of Dominoamab and Tredel-V in a trial where we're looking to see if we can get additional efficacy from those sorts of combinations. So we do continuously look at our portfolio and look for opportunities to move the needle with combinations from within our portfolio.

Andrew Dickinson: So I think you're appropriately highlighting we generate a lot of operating cash flow. You saw that again in Q1. We will rebuild our cash over time. We're going to continue to invest in the pipeline, but at least in the short run, we don't expect any meaningful M&A in the short run, so.

So I think you're appropriately highlighting we generate a lot of operating cash flow. You saw that again in Q1. We will rebuild our cash over time. We're going to continue to invest in the pipeline, but at least in the short run, we don't expect any meaningful M&A in the short run, so.

Merdad V. Parsey: I think you are appropriately highlighting we have we generate a lot of operating cash flow you saw that again in the first quarter, we will rebuild our cash over time, we're going to continue to invest in the pipeline, but at least in the short run.

Merdad V. Parsey: We don't expect any any meaningful M&A in the short run.

Daniel O'Day: And Salveen, this is Dan just to answer the end of your question. I mean, we're always therapeutic area agnostic when we approach these. I mean, first of all, we've got very robust portfolios around both virology, oncology, and a building portfolio in inflammation. So we look, frankly, across those spectrums. Seladelpar is a great example of finding an opportunity within our liver disease franchise and being able to use that channel. But equally, we'll look for opportunities and synergies that complement our portfolio across therapeutic areas. And that's our approach. We think that makes sense. We look for the most attractive science. And as Andy said, we have a lot in our hands right now to work through and to execute on. And so we'll keep the bar very high.

Merdad V. Parsey: <unk>. This is Dan just to answer your question I mean, we're always therapeutic area agnostic. When we approach. These I mean first of all we've got very robust portfolios around both for allergy in oncology and in building portfolio in inflammation. So we look we look frankly across the spectrum.

Merdad V. Parsey: So we do continuously look at our portfolio and look for opportunities to move the needle with combinations from within our portfolio. Next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead, your line is open. Good afternoon. Thanks for taking my question. So you currently have about

So we do continuously look at our portfolio and look for opportunities to move the needle with combinations from within our portfolio.

Next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead, your line is open. Good afternoon. Thanks for taking my question. So you currently have about

Operator: Next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead, your line is open.

Salveen Richter: Good afternoon. Thanks for taking my question. So, you currently have about $5 billion in cash, and noted leverage is back to pre-Immunomedics deal levels. How are you thinking about meaningful or bolt-on BD post the CymaBay acquisition? And is there any preference now between virology, I&I, and oncology? Thank you.

Salveen Jaswal Richter: Our next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead; your line is open.

Salveen Jaswal Richter: <unk> is a great example of finding an opportunity within our liver disease.

Andrew D. Dickinson: Hey, Salveen, it's Andy. Maybe I'll start with that one. In our prepared remarks, I highlighted that in the near term, we don't expect sizable M&A. So, we have a lot of execution ahead of us. We have a deep portfolio, a lot of growth drivers, including seladelpar. So, we're very clearly highlighting that in the short term, we will continue to do ordinary course business development, the standard licensing deals. You saw a couple of those in the first quarter. But it's unlikely that we'd pursue any meaningful M&A in the near term. We've also said historically that deals like CymaBay are exactly what we're looking for and that we should do deals like that on a regular basis over the cycle and whether that's every two years on average or more or less, that's a general ballpark. So, I think you're appropriately highlighting we have - we generate a lot of operating cash flow. You saw that again in the first quarter. We will rebuild our cash over time. We're going to continue to invest in the pipeline. But at least in the short run, we don't expect any meaningful M&A in the short run.

Andy: Franchise and be able to use that channel.

Andy: But equally we'll look for opportunities and synergies that complement our portfolio across therapeutic areas and that's our approach. We think it makes sense. We look for the most attractive science and as Andy said, we have a lot in our hands right now two to work through and to execute on and so we will keep the bar very high.

Operator: Our next question comes from James Shin at Deutsche Bank. James, your line is open.

Andy: Our next question comes from Jamie Shen Deutsche Bank James Your line is open.

Jacquie Ross: Hi. Thanks for my question. I wanted to ask on Trodelvy's efforts in HR-positive, HER2-negative. DESTINY-Breast06 is going to have data pretty soon, it seems, and then you also have ASCENT-07. Sort of sounds familiar to DESTINY-Breast04 versus TROPiCS-02. Can you share how you think this landscape will play out with these two trials?

James Shin: Hi. Thanks for my question. I wanted to ask on Trodelvy's efforts in HR-positive, HER2-negative. DESTINY-Breast06 is going to have data pretty soon, it seems, and then you also have ASCENT-07. Sort of sounds familiar to DESTINY-Breast04 versus TROPiCS-02. Can you share how you think this landscape will play out with these two trials?

Speaker Change: Alright, Thanks for my question.

Andy: But it's unlikely that we'd pursue an extremely meaningful M&A deal in the near term. We've also said historically that deals like Simabay are exactly what we're looking for, and that we should do deals like that on a regular basis over the cycle. And whether that's every two years on average, or more or less, that's a general ballpark. So I think you're appropriately highlighting that we generate a lot of operating cash flow. You saw that again in the first quarter. We will rebuild our cash over time. We're going to continue to invest in the pipeline, but at least in the short run, we don't expect any meaningful M&A in the short run.

Andy: Wanted to ask on <unk> efforts in HR positive <unk> negative.

Andy: Definitely breath of fixed they're going to have data pretty soon it seems and then you also have a set of seven.

Andy: Sort of sounds familiar to definitely brookdale or versus tropics or two can you share like how do you think this landscape will play out with these two trials.

Andrew Dickinson: Thanks for the question, James. Well, I've learned to try to keep away from prognostication, so that's harder to do. Look, maybe the way I would put it is we are proud of the fact that Trodelvy is still the only TROP2 ADC that is approved, and that is in large part driven by the important role that Trodelvy plays in breast cancer right now for patients. We do continue to want to push that along with ASCENT-07. We have a number of other trials ongoing to expand our footprint in breast cancer. I think we are right now in mTNBC the leading regimen. As we are continuing to advance our HR-positive, HER2-negative, and in particular in the IHC0 population, I think we remain confident around our place there.

Daniel O'Day: Thanks for the question, James. Well, I've learned to try to keep away from prognostication, so that's harder to do. Look, maybe the way I would put it is we are proud of the fact that Trodelvy is still the only TROP2 ADC that is approved, and that is in large part driven by the important role that Trodelvy plays in breast cancer right now for patients. We do continue to want to push that along with ASCENT-07. We have a number of other trials ongoing to expand our footprint in breast cancer. I think we are right now in mTNBC the leading regimen. As we are continuing to advance our HR-positive, HER2-negative, and in particular in the IHC0 population, I think we remain confident around our place there.

Speaker Change: Thanks for the question James.

Andy: Well it's a.

Andy: I've learned to try to keep away from prognostication. So that's harder to do we look at maybe.

Andy: Maybe the way I would put it is we.

Andy: Are proud of the fact that <unk> is.

Andy: The still the only trop two ADC that is approved and.

Daniel O'Day: And Salveen, this is Dan. Just to answer the end of your question. I mean, we're always therapeutic area agnostic when we approach these. I mean, first of all, we've got robust portfolios around both urology and oncology and a building portfolio in inflammation. So, we look, frankly, across those spectrums. SELADELPAR is a great example of finding an opportunity within our liver disease or - franchise and be able to use that channel. But equally, we'll look for opportunities and synergies that complement our portfolio across therapeutic areas. And that's our approach. We think that makes sense. We look for the most attractive science. And as Andy said, we have a lot in our hands now to work through and to execute on. And so, we'll keep the bar very high.

Dan: That is in large part driven by.

Dan: By the important role that <unk> plays in breast cancer right now.

Dan: For patients and we do continue.

Dan: Want to push.

Dan: That along with our centers seven we have a number of other trials ongoing to expand.

Dan: Our footprint in breast cancer.

Dan: But, equally, we'll look for opportunities and synergies that complement our portfolio across therapeutic areas. And that's our approach. We think that makes sense. We look for the most interesting science. And, as Andy said, we have a lot in our hands right now to work through and to execute on. And so, we'll keep the bar very high. The next question comes from James Shin at Deutsche Bank. Your line is open. Hi, thanks for my question. I wanted to ask about Trudelvy's efforts in HR policy.

But, equally, we'll look for opportunities and synergies that complement our portfolio across therapeutic areas. And that's our approach. We think that makes sense. We look for the most interesting science. And, as Andy said, we have a lot in our hands right now to work through and to execute on. And so, we'll keep the bar very high.

Dan: I think I think we are right now in and TWC, the leading regimen and.

James Shin: As we are.

James Shin: Continuing to advance our HR positive for her two negative.

James Shin: And in particular in the <unk> zero population I think we remain confident around our place there we've shown benefit in randomized clinical trials.

Andrew Dickinson: We've shown benefit in randomized clinical trials there, and that's been the basis for our regulatory filings and approvals. So I don't think we can assume success. We'll have to see what the data are, but looking forward into the year that's coming with ASCENT-03 coming up, I think that will provide us additional information to further expand our potential in breast cancer.

We've shown benefit in randomized clinical trials there, and that's been the basis for our regulatory filings and approvals. So I don't think we can assume success. We'll have to see what the data are, but looking forward into the year that's coming with ASCENT-03 coming up, I think that will provide us additional information to further expand our potential in breast cancer.

James Shin: They're at.

The next question comes from James Shin at Deutsche Bank. Your line is open. Hi, thanks for my question. I wanted to ask about Trudelvy's efforts in HR policy.

Operator: Our next question comes from James Shin at Deutsche Bank. James, your line is open.

James Shin: And that's been the basis for our regulatory filings and approvals.

James Shin: Hi. Thanks for my question. I wanted to ask on TRODELVY's efforts in HR+/HER2-. DESTINY-Breast06 is going to have data pretty soon it seems. And you also have ASCENT-07. Sort of sounds similar to DESTINY-Breast04 versus TROPiCS-02. Can you share like how you think this landscape will play out with these two trials?

Dan: So.

James Shin: I don't think we can.

James Shin: Assume success, we'll have to see what the data are but looking forward into the year, that's coming with with a cent or three coming up I think that will provide us additional information too.

James Shin: Our next question comes from James Shin at Deutsche Bank. James, your line is open.

Merdad V. Parsey: Thanks for the question, James. Well, it's - I've learned to try to keep away from prognostication. So, that's harder to do. Look, maybe the way I would put it is we are proud of the fact that TRODELVY is still the only TROP2 ADC that is approved, and that is in large part driven by the important role that TRODELVY plays in breast cancer right now for patients. And we do continue to want to push that, along with the ASCENT-07. We have a number of other trials ongoing to expand our footprint in breast cancer. I think we are right now in TNBC, the leading regimen. And as we are continuing to advance our HR+/HER2- and in particular, in the IHC-0 population, I think we remain confident around our place there. We've shown a benefit in randomized clinical trials there, and that's been the basis for our regulatory filings and approvals. So, I don't think we can assume success. We'll have to see what the data are. But looking forward into the year that's coming with ASCENT-03 coming up, I think that will provide us additional information to further expand our potential in breast cancer. Johanna, do you want to add?

Merdad V. Parsey: To further expand our potential.

Merdad V. Parsey: Potential in breast cancer.

Operator: Thank you.

James Shin: Thank you.

Andrew Dickinson: Maybe, yeah, Johanna, do you want to add?

Daniel O'Day: Maybe, yeah, Johanna, do you want to add?

Speaker Change: Yes, Joanna do you want to add maybe just to add to that.

Jacquie Ross: So maybe just to add to that, I would also say that the more options these patients have, these women have in HR-positive in earlier lines of therapy, instead of cycling through chemotherapies, the better. So with DESTINY-Breast06 results and moving potentially that compound up earlier, it actually allows for Trodelvy to also play a more important role in a bigger population than it is today because of the profile of the TROPiCS-02 label. And so we do believe that there's opportunities for this TROPiCS-02 to move up and also differentiate itself versus other ADCs in this marketplace, depending on the side effect profile, the safety profile, not only on the efficacy.

Johanna Mercier: So maybe just to add to that, I would also say that the more options these patients have, these women have in HR-positive in earlier lines of therapy, instead of cycling through chemotherapies, the better. So with DESTINY-Breast06 results and moving potentially that compound up earlier, it actually allows for Trodelvy to also play a more important role in a bigger population than it is today because of the profile of the TROPiCS-02 label. And so we do believe that there's opportunities for this TROPiCS-02 to move up and also differentiate itself versus other ADCs in this marketplace, depending on the side effect profile, the safety profile, not only on the efficacy.

Merdad V. Parsey: I would also say that the more options. These pay these patients happy for them and have an HR positive in earlier lines of therapy instead of cycling through chemotherapy is the better.

Merdad V. Parsey: So with DBS sticks with us in moving potentially that compound earlier, it actually allowed for Qdoba Charlottesville play a more important role in a bigger population.

Merdad V. Parsey: I think we are right now in TMBC, the leading regimen, and as we continue to advance our HR-positive HER2-negative, and in particular in the IHC0 population, I think we remain confident about our place there. We've shown a benefit in randomized clinical trials there, and that's been the basis for our regulatory filings and approvals. So, I don't think we can assume success; we'll have to see what the data are, but looking forward into the year that's coming, with Ascent 03 coming up, I think that will provide us additional information to further expand our potential in breast cancer. Maybe, yeah, Johanna, do you want to add anything?

Speaker Change: Then it is today because of the profile of the topics, though too.

Johanna Mercier: Our label and so so we do believe that there is opportunity to trade. It took two ADC to move up and also differentiate itself versus other adcs in this market place depending on the side effect profile the safety profile not only on the efficacy and so in light of the IHT zero setting didnt really our strong foothold in HR positive hurts your neck.

Jacquie Ross: In light of the IHC0 setting being really our strong foothold in HR-positive, HER2-negative, we believe that'll continue, whether that's in later lines of therapy or earlier lines as these studies play out.

In light of the IHC0 setting being really our strong foothold in HR-positive, HER2-negative, we believe that'll continue, whether that's in later lines of therapy or earlier lines as these studies play out.

Johanna Mercier: We believe that will continue.

Johanna Mercier: That's in later lines of therapy or earlier lines of these studies play out.

Operator: Our next question comes from Mohit Bansal at Wells Fargo. Go ahead. Your line is open.

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

Johanna Mercier: Maybe just to add to that, I would also say that the more options these patients have, these women have, in HR+ in earlier lines of therapy instead of cycling through chemotherapies, the better. So, with DB06 results and moving potentially that compound up earlier, it actually allows for TRODELVY to also play a more important and a bigger population than it is today because of the profile of the TROPICS-02 label. And so, we do believe that there's opportunities for this ADC to move up and also differentiate itself versus other ADCs in this marketplace, depends effect profile, the safety profile, not only on the efficacy. And so, in light of the IHC-0 setting being really our strong foothold in HR+/HER2-, we believe that will continue, whether that's in later lines of therapy or earlier lines of these studies play out.

Mohit Bansal: Great. Thank you very much for taking my question. Maybe a big picture question if you think about medium to longer term, because, I mean, yes, you do not have an LOE, but I mean, HIV growth is somewhere around low single digits. And oncology, I mean, again, I mean, with Trodelvy and all, the expansion opportunities seem limited at this point. So just trying to understand how do you turn this low single digit to more like a high single digit kind of growth for overall company. CymaBay is definitely an addition, but how are you thinking about it from medium to long term, which probably people like us are missing?

Speaker Change: Great. Thank you very much for taking my question.

Speaker Change: Maybe a big picture question, if you think about medium to longer term because I mean, just you do not have an employee but HIV growth is somewhere around mid low single digits and in oncology I mean again.

Johanna Mercier: Doing all the expansion opportunities are seen limited at this point. So just trying to understand how do you turn this low single digit to more like a high single digit kind of growth for the overall company.

Johanna Mercier: And so we do believe that there are opportunities for this Tropic O2 ADC to move up and also differentiate itself versus other ADCs in this marketplace, depending on the side effect profile, the safety profile, not only on efficacy. And so in light of the IHC0 setting being really a strong foothold for HR positive, HER2 negative, we believe that'll continue, whether that's in later lines of therapy or earlier lines as these studies play out.

Johanna Mercier: Some of it is definitely an addition, but how are you thinking about it from medium to long term, which are probably people like us that are missing.

Daniel O'Day: Yeah, Mohit, maybe I'll start and then have others add. First of all, I think just stepping back and thinking about the portfolio that we've built over the past four years now, more than doubling the size of the portfolio, and with significant advances in our HIV portfolio, oncology, and with outside of cell therapy. So as we think about growth moving forward, I mean, first of all, I would say on the HIV side of the business, we have to constantly remind ourselves and others that in addition to the treatment market and the potential for long-acting treatment that we have a very robust program on, and we'll update you a little bit more on towards the second half of this year with an analyst event, we've got the PrEP market that is just beginning to kind of be dimensionalized.

Speaker Change: Yes, maybe I'll start and then have others.

Speaker Change: First of all I think just stepping back and thinking about.

Johanna Mercier: You know the portfolio that we've built over the past four years more than doubling the size of the portfolio.

Operator: Our next question comes from Mohit Bansal at Wells Fargo. Mohit, go ahead. Your line is open.

Johanna Mercier: And with significant advances in our HIV portfolio in oncology with an.

Mohit Bansal: With outside of cell therapy. So as we think about growth moving forward I mean first of all I would say on the HIV side of the business, we have to constantly remind ourselves and others. In addition to the treatment market and the potential for long acting treatment.

Mohit Bansal: Great. Thank you very much for taking my question. Maybe a big picture question, if you think about medium to longer term because, I mean, yes, you do not have an LOE. But I mean, HIV growth is somewhere around low single digits. And oncology, I mean, again, I mean, it dropped too and all. The expansion opportunities seem limited at this point. So, just trying to understand how do you turn this low single-digit to more like a high single-digit kind of growth for overall company. CymaBay is definitely an addition, but how are you thinking about it from medium to long term, which probably people like us are missing?

Dan: We have a very robust program and we will update you a little bit more towards.

Dan: Towards the second half of this year with an analyst event, we've got the prep market that is just beginning to kind of be.

Dan: Dimensionalize.

Daniel O'Day: And that is, I think, that provides significant growth opportunity when you think about your time frame, which you mentioned, which is until the end of the decade. So I think it allows us to think about accelerated HIV total growth prevention and treatment as we head towards the second half of the decade. On top of that, then we have the entirety of the oncology portfolio. So both cell therapy within the large B-cell lymphoma area, as well as potentially the multiple myeloma entry with the anito-cel. And then on top of that, a very robust oncology portfolio that has both Trodelvy and other novel agents that will read out over the course of this decade.

And that is, I think, that provides significant growth opportunity when you think about your time frame, which you mentioned, which is until the end of the decade. So I think it allows us to think about accelerated HIV total growth prevention and treatment as we head towards the second half of the decade. On top of that, then we have the entirety of the oncology portfolio. So both cell therapy within the large B-cell lymphoma area, as well as potentially the multiple myeloma entry with the anito-cel. And then on top of that, a very robust oncology portfolio that has both Trodelvy and other novel agents that will read out over the course of this decade.

Dan: That is I think that provides significant growth opportunity. When you think about your timeframe, which you mentioned, which is until the end of the decade.

Daniel O'Day: Mohit, maybe I'll start and then have others add. First of all, I think just stepping back and thinking about the portfolio that we've built over the past four years now more than doubling the size of the portfolio and with significant advances in our HIV portfolio and oncology and with outside of cell therapy. So, as we think about growth moving forward, I mean, first of all, I would say on the HIV side of the business, we have to constantly remind ourselves and others that in addition to the treatment market and the potential for long-acting treatment that we have a very robust program on, and we'll update you a little bit more on toward the second half of this year with an analyst event, we've got the PrEP market that is just beginning to kind of be dimensionalized. And that is - I think that provides significant growth opportunity when you think about your time frame, which you mentioned, which is until the end of the decade. So, I think it allows us to think about accelerated HIV total growth prevention and treatment as we head toward the second half of the decade. On top of that, then we have the entirety of the oncology portfolio. So, both cell therapy within the large B-cell lymphoma area as well as potentially the multiple myeloma entry with the anito-cel. And then on top of that, a very robust oncology portfolio that has both TRODELVY and other novel agents that we'll read out over the course of this decade.

Dan: So.

Speaker Change: I think it allows us to think about accelerated HIV total growth prevention and treatment as we head towards the second half of the decade that on top of that then we have the entirety of the oncology portfolio. So both cell therapy within the large b cell lymphoma area as well as.

Dan: Potentially the multiple myeloma entry with immuno cell and then on top of that a very robust oncology portfolio that has both trade lv.

Dan: And other novel agents that will read out over the course of this.

Daniel O'Day: And I'll just remind you, again, we've got close to 20 readouts this year, of which three of those are in phase 3, including lenacapavir for PrEP in the second half of this year, two Trodelvy phase 3 readouts. Then importantly, we've added seladelpar to the mix with a PDUFA date in August. Then finally, just the opportunity to update you on the anito-cel at the end of the year as well.

And I'll just remind you, again, we've got close to 20 readouts this year, of which three of those are in phase 3, including lenacapavir for PrEP in the second half of this year, two Trodelvy phase 3 readouts. Then importantly, we've added seladelpar to the mix with a PDUFA date in August. Then finally, just the opportunity to update you on the anito-cel at the end of the year as well.

Speaker Change: Okay and I'll just remind you again, we've got close to 20 Readouts this year of <unk>.

Dan: Three of those are in phase III, including Atlantic cap of your for prep in the second half of this year to treat Lv phase III readouts.

Dan: And then importantly, we've added <unk> to the next with the Paducah date.

Dan: In August and then finally just.

Dan: The opportunity to update you on the need to sell at the end of the year as well so we'll be providing more guidance as we continue to.

Daniel O'Day: So we'll be providing more guidance as we continue to look at the entirety of our portfolio, but we really think we have, within the company today, by the way, I'll just mention, in addition to complementing where needed from the outside, but within the company today, we have what it takes to drive a substantial growth in our business over the course of the next decade, with focus on expense management as well, to produce good returns for investors.

So we'll be providing more guidance as we continue to look at the entirety of our portfolio, but we really think we have, within the company today, by the way, I'll just mention, in addition to complementing where needed from the outside, but within the company today, we have what it takes to drive a substantial growth in our business over the course of the next decade, with focus on expense management as well, to produce good returns for investors.

Dan: So, I think it allows us to think about accelerated HIV total growth prevention and treatment as we head towards the second half of the decade. And on top of that, then, we have the entirety of the oncology portfolio. So, both cell therapy within the large B-cell lymphoma area, as well as, you know, potentially the multiple myeloma entry with the needle cell, and then on top of that, a very robust oncology portfolio that has both Tredelvi and other novel agents that we'll read out over the course of this decade.

Dan: Two to look at.

Dan: The entirety of our portfolio, but we really think we have within the company today by the way I'll just mentioned in addition to.

Dan: Complementing where where it needed from the outside but within the company today, we have what it takes to drive.

Dan: Substantial growth in our business over the course of the.

Dan: The next decade with focus on expense management as well to produce good returns for investors.

Daniel O'Day: And I'll just remind you, again, we've got close to 20 readouts this year, of which three of those are in Phase III, including lenacapavir for prep in the second half of this year, two TRODELVY Phase III readouts. And then importantly, we've added SELADELPAR to the mix with a PDUFA date in August. And then finally, just the opportunity to update you on the anito-cel at the end of the year as well. So, we'll be providing more guidance as we continue to look at the entirety of our portfolio, but we really think we have within the company today, by the way, I'll just mention, in addition to complementing where needed from the outside. But within the company today, we have what it takes to drive a substantial growth in our business over the course of the next decade with focus on expense management as well to produce good returns for investors.

Dan: Okay.

Operator: Our next question comes from Simon Baker at Redburn Atlantic. Go ahead, Simon. Your line is open.

Dan: Our next question comes from Simon Baker at Redburn Atlantic Go ahead, Simon Your line is open.

Simon Baker: Thank you for taking my question. One on seladelpar, if I may, and a question really around the competitive dynamics at launch. If all goes according to plan, you're launching August and Ipsen will launch alafibranor in June. So I was really wondering if that really makes any difference. You've obviously got far greater infrastructure than Ipsen. Is it too early for them to steal a march? Or paradoxically, does having somebody else on the market promoting PBC actually raise disease awareness and help the situation? So any color around the dynamics at launch would be very helpful. Thank you.

Speaker Change: Thank you for taking my question one.

Speaker Change: If I may a question really around the competitive dynamics at launch if all goes. According to plan you will launch in August and Ipsen will launch <unk> in.

Dan: In June.

Speaker Change: I was just wondering.

Dan: Is that really makes a difference.

Dan: You've obviously talked about your infrastructure.

Dan: So, you know, we'll be providing more guidance as we continue to look at the entirety of our portfolio, but we really think we have what it takes within the company today. By the way, I'll just mention, in addition to, you know, complementing where needed from the outside, but within the company today, we have what it takes. Thank you very much.

Dan: The nips and is it too early for them steal a march paradoxically, just having somebody else on the market promotion PBC.

Dan: Actually raise disease awareness and health situation and any color around the dynamics at launch.

Speaker Change: Thank you.

Jacquie Ross: Thanks, Simon. It's Johanna. Let me take that one. And I think you're absolutely right. I think the fact that there is more than one competitor hitting the market is great for patients, namely around increasing disease awareness around PBC and the fact that there are true options available. Having said that, I also feel incredibly confident that Seladelpar is well differentiated to potentially be best in disease when you think about the significant impact and clinically meaningful impact we have with the ALT normalization in the clinical phase three clinical trial we've seen, as well as the improvement in pruritus, which is a key symptom of the disease. And today, there really is no effective antipruritic options for PBC patients.

Speaker Change: Thanks dynamics, Joanna let me take that one and I think youre absolutely right I think the fact that there is one.

Operator: Our next question comes from Simon Baker at Redburn Atlantic. Go ahead, Simon. Your line is open.

Simon P. Baker: More than one competitor hitting the market is great for patients mainly around increasing disease awareness around PDC and the fact that there are true option available having said that I also feel incredibly confident that seller elkhart, well differentiated could potentially be.

Simon Baker: Thank you for taking my question. One on SELADELPAR if I may. And a question really around the competitive dynamics at launch. If all goes according to plan, your launch in August, and Ipsen will launch ELAFIBRANOR in June. So, I was just wondering if that really makes any difference. You've obviously got far greater infrastructure than Ipsen. Is it too early for them to steal in March? Or paradoxically thus having somebody else on the market promoting PBC actually raise disease awareness and help the situation? So, any color around the dynamics at launch would be very helpful. Thank you.

Johanna Mercier: Baskin disease, when you think about the significant impact in clinically meaningful impact we have with the AARP normalization in the clinical trial phase III clinical trial, we have seen as well as improvement in pruritus, which is the key symptoms of the disease and today. There really is no effective antipruritic options for PBC patients and so all of it.

Johanna Mercier: Thanks, Simon. It's Johanna. Let me take that one. And I think you're absolutely right. I think the fact that there is more than one competitor hitting the market is great for patients namely around increasing disease awareness around PDC and the fact that there are two options available. Having said that, I also feel incredibly confident that seladelpar is well differentiated to potentially be best in disease when you think about the significant impact and clinically meaningful impact we have with the ALP normalization in the clinical jet Phase III clinical trial we've seen as well as the improvement in pruritus which is a key symptom of the disease. And today, there really is no effective antipruritic options for PBC patients. And so, all of that put together, in addition to the fact that we believe our footprint, both commercial and medical is incredibly well established when it comes to liver disease. It already covers about 80% of all U.S. PBC prescribers. And with that strong differentiated profile we were just referring to, I don't think those three months make a difference. I think really, it's about best-in-class launch and that potential with SELADELPAR that we look forward for our PDUFA date.

Jacquie Ross: So all of that put together, in addition to the fact that we believe our footprint, both commercial and medical, is incredibly well established when it comes to liver disease. It already covers about 80% of all US PBC prescribers. With that strong differentiated profile we were just referring to, I don't think those three months make a difference. I think really it's about best-in-class launch and that potential with seladelpar that we look forward to for our PDUFA date.

So all of that put together, in addition to the fact that we believe our footprint, both commercial and medical, is incredibly well established when it comes to liver disease. It already covers about 80% of all US PBC prescribers. With that strong differentiated profile we were just referring to, I don't think those three months make a difference. I think really it's about best-in-class launch and that potential with seladelpar that we look forward to for our PDUFA date.

Johanna Mercier: That put together.

Johanna Mercier: In addition to the fact that we believe our footprint both commercial and medical.

Johanna Mercier: Credibly well established when it comes to liver disease. It already covers about 80% of all U S. PBC prescribers and with that strong differentiated profile. What you were just referring to and I don't think there are three months to make a difference I think really it's about best in class launch and that potential with that without power that we look forward.

Johanna Mercier: For a particular day.

Operator: Our next question comes from Brian Skorney at Baird. Brian, go ahead. Your line is open.

Johanna Mercier: Our next question comes from Brian scoring at Baird. Brian Go ahead. Your line is open.

[Analyst] (Baird): Hi. Thanks for taking the question. This is Charlie on for Brian. So again, to ask something about seladelpar, just wondering if you have any ambitions for potentially looking at a label for first line in the future, considering there's a lot of unmet need with pruritus there, as well as any potential synergies you may be considering with the remainder of your liver portfolio. Thank you.

Johanna Mercier: Hi, Thanks for taking the question. This is Charlie on for Brian So.

Brian Abrahams: I think really it's about the best in class launch and that potential with thaloepthalpar that we look forward to for our PDUFA date. Next question comes from Brian Scorney at Baird. Brian, go ahead, your line is open. Hi, thanks for taking the question. This is Charlie on for Brian. So, again, to ask something about Philadelphia.

I think really it's about the best in class launch and that potential with thaloepthalpar that we look forward to for our PDUFA date.

Johanna Mercier: Again to ask something about Sabadell part just wondering if you have any ambitions for.

Speaker Change: Potentially looking at a label for first line in the future.

Next question comes from Brian Scorney at Baird. Brian, go ahead, your line is open. Hi, thanks for taking the question. This is Charlie on for Brian. So, again, to ask something about Philadelphia.

Our next question comes from Brian Skorney at Baird. Brian, go ahead. Your line is open.

Speaker Change: Considering there is a lot of unmet need with pruritus, there as well as.

Brian Skorney: Hi. Thanks for taking the question. This is Charlie on for Brian. So, again, to ask something about SELADELPAR. Just wondering if you have any ambitions for potentially looking at a label for first line in the future, considering there's a lot of unmet need with pruritus there. As well as any potential synergies you may be considering with the remainder of your liver portfolio. Thank you.

Charlie: Any potential synergies you may be considering with the remainder of your liver portfolio. Thank you.

Brian Abrahams: Our next question comes from Brian Scorney at Baird. Brian, go ahead; your line is open.

Andrew Dickinson: Thanks, Charlie. This is Mehrdad. First line is a challenge given what is currently the standard of care. But as you know, we think that Seladelpar is going to bring a lot of benefit to a lot of patients, especially given the pruritus. And the potential for getting to patients earlier in their course will be really important for us. And so we have to see how the market starts to respond to the presence of Seladelpar in the second line. And I think the other thing to recall or think about is how long people actually get first line therapy before moving on to second line therapy.

Mehrdad Parsey: Thanks, Charlie. This is Mehrdad. First line is a challenge given what is currently the standard of care. But as you know, we think that Seladelpar is going to bring a lot of benefit to a lot of patients, especially given the pruritus. And the potential for getting to patients earlier in their course will be really important for us. And so we have to see how the market starts to respond to the presence of Seladelpar in the second line. And I think the other thing to recall or think about is how long people actually get first line therapy before moving on to second line therapy.

Brian Abrahams: Thanks, Charlie this is Mary.

Speaker Change: Frontline is is a challenge given.

Merdad V. Parsey: Thanks, Charlie. This is Merdad. Frontline is a challenge given the - what is currently the background standard of care. But as you know, we think that SELADELPAR is going to bring a lot of benefit to a lot of patients, especially given the pruritus and the potential for getting to patients earlier in their course will be really important for us. And so, we have to see how the market starts to respond to the presence of seladelpar in the second line. And recall - I think the other thing to recall or think about is the - how long people actually get frontline therapy before moving on to second-line therapy, given the efficacy profile of the frontline therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second-line therapy relatively early in their treatment course and making - moving up formally for registrational trials to the frontline potentially superfluous. So, I think we'll see how that plays out in the market. And once we see our label and all those sorts of things, so we'll be able to update more after that.

Merdad V. Parsey: You know, frontline is a challenge given what is currently the background standard of care, but as you note, we think that Saladelpar is going to bring a lot of benefit to a lot of patients, especially given the pruritus, and the potential for getting to patients earlier in their course will be really important for us. And so, you know. We have to see how the market starts to respond to the presence of Saladelpar in the second line. I think the other thing to recall or think about is how long people actually get frontline therapy before moving on to second-line therapy. Given the advocacy profile of the frontline therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second-line therapy relatively early in their treatment course and moved up formally for registrational trials to the front line. Potentially.

Speaker Change: What is currently the background standard of care, but as you as you know.

Merdad V. Parsey: We think that sell Adele par.

Merdad V. Parsey: Is going to bring a lot of benefit to a lot of patients, especially given the pruritus and and the potential for getting to patients earlier in their course.

Merdad V. Parsey: <unk> will be really important for us and so.

Merdad V. Parsey: No.

Merdad V. Parsey: We have to see how the market starts to respond to the presence of solid <unk> in the second line.

Merdad V. Parsey: And recall I think the other thing to recall or think about is that.

Merdad V. Parsey: I think the other thing to recall or think about is how long people actually get frontline therapy before moving on to second-line therapy. Given the advocacy profile of the frontline therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second-line therapy relatively early in their treatment course and moved up formally for registrational trials to the front line. Potentially. [inaudible] Our next question comes from Brian Abrams at RBC Capital Markets. Brian, go ahead; your line is open. Hi, good afternoon. Thanks so much for taking my question. Purpose One is obviously an important upcoming readout, so I

I think the other thing to recall or think about is how long people actually get frontline therapy before moving on to second-line therapy. Given the advocacy profile of the frontline therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second-line therapy relatively early in their treatment course and moved up formally for registrational trials to the front line. Potentially.

Brian Abrahams: How long people actually get frontline therapy before moving on to second line therapy give.

Andrew Dickinson: Given the efficacy profile of the front line therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second line therapy relatively early in their treatment course, and moving up formally for registrational trials of the front line potentially superfluous. So I think we'll see how that plays out in the market once we see our label and all those sorts of things. So we'll be able to update more after that.

Given the efficacy profile of the front line therapies and the fact that there haven't been any options, one could anticipate that patients are moved to second line therapy relatively early in their treatment course, and moving up formally for registrational trials of the front line potentially superfluous. So I think we'll see how that plays out in the market once we see our label and all those sorts of things. So we'll be able to update more after that.

Brian Abrahams: Given the efficacy profile of the frontline therapies.

Brian Abrahams: And the fact that there hasn't been any options.

Brian Abrahams: One could anticipate that patients were moved to second line therapy relatively early in their treatment course.

Brian Abrahams: And making.

Brian Abrahams: They are making moving up formally for Registrational trial in frontline.

Merdad V. Parsey: Potentially.

Merdad V. Parsey: Superfluous.

Brian Abrahams: I think we'll see how that plays out in the market and once we see our label and all those sorts of things. So we will be able to update more after that.

[inaudible] Our next question comes from Brian Abrams at RBC Capital Markets. Brian, go ahead; your line is open. Hi, good afternoon. Thanks so much for taking my question. Purpose One is obviously an important upcoming readout, so I

Operator: Our next question comes from Brian Abrahams at RBC Capital Markets. Brian, go ahead. Your line is open.

Operator: Our next question comes from Brian Abrams at RBC Capital Markets. Brian, go ahead. Your line is open.

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

Brian Abrams: Hi, good afternoon. Thanks so much for taking my question. PURPOSE 1 is obviously an important upcoming readout, so I wanted to clarify some elements of its unique design. Specifically, what's the sensitivity of assessing when HIV infection occurred to accurately project the control infection rate? And then how do you control for potential intrinsic differences in risk behavior that the screened-out group serving as the control may have versus individuals who may get into the trial? Thanks.

Brian Abrahams: Hi, good afternoon. Thanks, so much for taking my question.

Brian Abrahams: Hi. Good afternoon. Thanks so much for taking my question. PURPOSE 1 is obviously an upcoming readout. So, I wanted to clarify some elements of its unique design, specifically what's the sensitivity of assessing when HIV infection occurred to accurately project the control infection rate? And then how do you control for potential intrinsic differences in risk behavior that the screened-out group serving as the control may have versus individuals who are - who make it into the trial? Thanks.

Brian Abrahams: One is obviously an important upcoming readout. So I wanted to clarify some elements of its unique design specifically, what's the sensitivity of assessing when HIV infection occurred to accurately project. The control infection rate and then how do you control for potential intrinsic differences in risk behavior that the screened outgroup serving us.

Brian Abrahams: Our next question comes from Brian Abrams at RBC Capital Markets. Brian, go ahead; your line is open.

Merdad V. Parsey: Brian, thanks. It's Merdad again. And I could talk about this for a long time. I'll try to give a very concise answer. The recency assay that's been developed for HIV, it has been studied very thoroughly, and we can, based on the diagnosis at the time of screening, create a profile for anyone who's potentially HIV infected at that time as to how recently they were infected. And I think that's a key part. And that relates to the second part of your question in that the - we don't, in a sense, need to compare risk behaviors before and after randomization and that we'll be looking at the overall incidence of HIV at the time of screening and then comparing in this counterfactual design with what happens after people start therapy. So, I think between those two elements and all the discussions we've had with the regulators and the experts in the field, we're confident in that the design will provide the information necessary to get us to approval and for adoption.

Merdad: The control may have versus individuals who are making into the trial.

Merdad V. Parsey: I've been wanting to talk about this for a long time, so I'll try to give you a very concise answer. The recency assay that's been developed for HIV has been studied very thoroughly, and we can, based on the diagnosis at the time of screening, create a profile for anyone who's potentially HIV infected at that time as to how recently they were infected. I think that's a key part. And that relates to the second part of your question in that the... We don't, in a sense, compare risk behaviors before and after randomization, in that we'll be looking at the overall incidence of HIV at the time of screening and then comparing in this counterfactual design with what happens after people start therapy. So I think between those two elements and all the discussions we've had with the regulators and the experts in the field, we're confident that the design will provide the information necessary to get us to approval and adoption.

Andrew Dickinson: Brian, thanks. This is Mehrdad again. And I could talk about this for a long time. I'll try to give a very concise answer. The recency assay that's been developed for HIV has been studied very thoroughly, and we can, based on the diagnosis at the time of screening, create a profile for anyone who's potentially HIV infected at that time as to how recently they were infected. And I think that's a key part. And that relates to the second part of your question in that we don't, in a sense, need to compare risk behaviors before and after randomization in that we'll be looking at the overall incidence of HIV at the time of screening and then comparing in this counterfactual design with what happens after people start therapy.

Mehrdad Parsey: Brian, thanks. This is Mehrdad again. And I could talk about this for a long time. I'll try to give a very concise answer. The recency assay that's been developed for HIV has been studied very thoroughly, and we can, based on the diagnosis at the time of screening, create a profile for anyone who's potentially HIV infected at that time as to how recently they were infected. And I think that's a key part. And that relates to the second part of your question in that we don't, in a sense, need to compare risk behaviors before and after randomization in that we'll be looking at the overall incidence of HIV at the time of screening and then comparing in this counterfactual design with what happens after people start therapy.

Merdad V. Parsey: Brian. Thanks, This is Marty again.

Merdad V. Parsey: And I could talk about this for a long time, let me I'll try to give a very concise answer.

Merdad V. Parsey: The recency assay that's been developed for HIV has been studied.

Merdad V. Parsey: Very thoroughly and we.

Merdad V. Parsey: We can based on the diagnosis at the time of screening.

Merdad V. Parsey: Create a profile for anyone who is potentially HIV infected at that time as to how recently they were in fact, it I think that's a key key part.

Merdad V. Parsey: And that relates to the second part of your question in that.

Merdad V. Parsey: The.

Merdad V. Parsey: We don't.

Merdad V. Parsey: You need to compare risk behaviors before and after randomization and that we'll be looking at the overall incidents.

Merdad V. Parsey: HIV at the time of screening and then comparing in this counter factual design with what happens after our people.

Merdad V. Parsey: Mark.

Andrew Dickinson: I think between those two elements and all the discussions we've had with the regulators and the experts in the field, we're confident in that the design will provide the information necessary to get us to approval and for adoption.

I think between those two elements and all the discussions we've had with the regulators and the experts in the field, we're confident in that the design will provide the information necessary to get us to approval and for adoption.

Merdad V. Parsey: Therapy, So I think between those two elements.

Merdad V. Parsey: So I think between those two elements and all the discussions we've had with the regulators and the experts in the field, we're confident that the design will provide the information necessary to get us to approval and adoption. The next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead; your line is open. Great, thanks for taking the question. Just a two part on the CAR T franchise. So I just was wondering at a high level.

So I think between those two elements and all the discussions we've had with the regulators and the experts in the field, we're confident that the design will provide the information necessary to get us to approval and adoption.

Terence Flynn: And all the discussions we've had with.

Terence Flynn: The regulators and the experts in the field, where we're confident in the.

Terence Flynn: The design will provide the information necessary to get us to approval and for adoption.

Operator: Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead. Your line is open.

The next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead; your line is open. Great, thanks for taking the question. Just a two part on the CAR T franchise. So I just was wondering at a high level.

Operator: Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead. Your line is open.

Merdad V. Parsey: Our next question comes from Terence Flynn at Morgan Stanley parents go ahead. Your line is open.

Terrence Flynn: Great. Thanks for taking the question. Just a two-part on the CAR-T franchise. So just was wondering, high level, your commitment to anito-cel if it proves there is parkinsonism, so meaning it's less differentiated. And then the second part is curious where your progress stands with respect to developing the CAR-T for immunology. Obviously, a lot of focus here amongst a number of other companies in the industry. So just curious on Gilead's thoughts on the forward. Thank you.

Terence Flynn: Great. Thanks for taking the question just a two part on the car T franchise. So just was wondering high level.

Terence Flynn: Great. Thanks for taking the question. Two parts on the CAR-T franchise. So, just was wondering, high level, your comment to a anito-cel if it proves there is parkinsonism, so meaning it's less differentiated. And then the second part is, curious where your progress stands with respect to developing the CAR-T for immunology. Obviously, a lot of focus here among a number of other companies in the industry. So, just curious on Gilead's thoughts on the forward. Thank you.

Terence Flynn: Your commitment to Anita so if it proves there is parkinsonism, so meaning it's less differentiated and then the second part is curious where your progress stands with respect to developing the car T for immunology, obviously, a lot of focus here amongst a number of other companies in the industry. So just curious.

Terence Flynn: Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead; your line is open.

Terence Flynn: On Gilead thoughts on a forward. Thank you.

Cindy Perettie: Thanks, Terence, for the question. So, on the commitment to anito-cel, we're - as it relates to Parkinson's, we absolutely feel that we're differentiated potentially on both safety and efficacy. As we noted earlier, we have not observed the neurotox that some of the other constructs have observed, and we'll continue to monitor it, but we feel great about the profile right now. And then the efficacy profile, early signals are we think we will be equivalent or could be best-in-class. So, we're 100% behind anito-cel and we're looking forward to bringing those data soon. The second question around autoimmune space. So, we continue to monitor the autoimmune space. And as you've heard from Andy and others before, we will play in that space. We are taking time to take a look at what's in the space versus what we have in our portfolio, and we'll be - I don't have any updates further than that today.

Cindy Perettie: Thanks, Terence, for the question. So on the commitment to a needle cell, as it relates to Parkinson's, we absolutely feel that we're differentiated potentially on both safety and efficacy. As we noted earlier, we have not observed the neurotoxicity that some of the other constructs have observed, and we'll continue to monitor it, but we feel great about the profile right now. And then the efficacy profile early signals are, we think we will be equivalent or could be best in class. So we're 100% behind a needle cell, and we're looking forward to bringing those data soon. The second question around autoimmune space. So we continue to monitor the autoimmune space. And as you've heard from Andy and others before, we will play in that space. We're taking time to take a look at what's in the space versus what we have in our portfolio.

Cindy Perettie: Thanks, Sharon for the question so on the commitment to either sell it where as it relates to Parkinson's we absolutely feel that we are differentiated and potentially on both safety and efficacy.

Cindy Perettie: As we noted earlier, we have not observed a neuro tox that that some of the other constructs have observed and we will continue to monitor it but we feel great about the profile right now and then the efficacy profile early signals that we think will be equivalent or or could be best in class that we are 100% behind the need to sell and we're looking forward to.

Cindy Perettie: Those data.

Cindy Perettie: The second question around the autoimmune space, so we continue to monitor the autoimmune space, and as you've heard from Andy and others before, we will play in that space. We're taking time to take a look at what's in the space versus what we have in our portfolio, and we'll be. I don't have any updates further than that today.

Cindy Perettie: The second question around auto immune space that we continue to monitor the autoimmune space and as you've heard from Andy and others before we will play in that space.

Cindy Perettie: Taking time to take a look at what's in the space versus what we have in our portfolio and will be I don't have any updates further than that today.

Cindy Perettie: I don't have any updates further than that today.

I don't have any updates further than that today.

Operator: Our last question comes from Carter Gould at Barclays. Carter, go ahead. Your line is open.

Cindy Perettie: Our last question comes from Carter Gould at Barclays. Carter Go ahead. Your line is open.

Operator: Our last question comes from Carter Gould at Barclays. Carter, go ahead. Your line is open.

Carter Gould: Great. Good afternoon. Thanks for squeezing me in. Maybe just to round things out on cell therapy, you flagged the same dynamics that have been kind of persisting in the U.S. as far as the - some of the constraints of the ATCs. I also saw the Tennessee oncology reference. But I guess putting that all together, just your level of confidence you sort of hit that return to more meaningful growth in the second half of the year. I didn't hear that mentioned and clearly, that's a point of focus. Any commentary there would be appreciated.

Carter Gould: Great. Good afternoon. Thanks for squeezing me in. Maybe just to round things out on cell therapy, you flagged the same dynamics that have been kind of persisting in the US as far as some of the constraints at the ATCs. I also saw the Tennessee Oncology reference. But I guess putting that all together, just your level of confidence, you'll sort of hit that return to more meaningful growth in the second half of the year. I didn't hear that mentioned, and clearly that's a point of focus. Any commentary there would be appreciated.

Carter Gould: Great. Good afternoon. Thanks for squeezing me in maybe just to round things out on cell therapy.

Cindy Perettie: Thanks for squeezing me in. Maybe just to round things out on cell therapy. You flagged the same dynamics that have been kind of persisting in the U.S. as far as some of the constraints of the ATCs. I also saw the Tennessee oncology reference. But I guess, you know, putting that all together, just your level of confidence, you sort of hit that return to more meaningful growth in the second half of the year. I didn't hear that mentioned, and clearly that's a point of focus. Any commentary there would be appreciated.

Cindy Perettie: Amy if like the.

Cindy Perettie: Dynamics that have been kind of persisting in the U S as far as the.

Cindy Perettie: Some of the constraints at the ATC.

Cindy Perettie: For the Tennessee oncology referenced, but I guess putting that altogether.

Cindy Perettie: A level of confidence you sort of hit that return to more meaningful growth in the second half of the year I Didnt hear that mentioned and clearly that's a point of focus any commentary there would be appreciated.

Cindy Perettie: Yeah. No, we feel very confident that we're going to return to growth in the second half of the year, as we stated. I think just as a reminder, we had shared in quarter 4 our guidance was that we'd be flat to slightly down in quarter 1. And part of that is due to the restructure. So, we are putting our strategy into play. We feel very confident about the approach we're taking in the U.S. And we now are looking at having almost a fully stacked sales team back out and working hard. I think a piece that we need to talk about as well as the market dynamics. So, the things we're observing. We're observing out-of-class competition with the bispecifics, the ATC constraints that we've spoken about in the past based on multiple myeloma constructs coming in. But what we're seeing is a lot of the hospitals and ATCs are working through those constraints, and we feel really confident about the second half of this year.

Cindy Perettie: Yeah. No, we feel very confident that we're going to return to growth the second half of the year, as we stated. I think just as a reminder, we had shared in Q4, our guidance was that we would be flat to slightly down in Q1. And part of that is due to the restructure. So we are putting our strategy into play. We feel very confident about the approach we're taking in the US. And we now are looking at having almost a fully staffed sales team back out and working hard. I think a piece that we need to talk about as well is the market dynamic. So the things we're observing, we're observing out-of-class competition with the bispecifics, the ATC constraints that we've spoken about in the past based on multiple myeloma constructs coming in.

Cindy Perettie: Yeah, no we feel very confident that we're going to return to growth. The second half of the year. As we stated I think just as a reminder, we had shared in quarter four our guidance was that we would be flat to slightly down in quarter, one and part of that is due to the restructures that we are putting our strategy into play we feel very.

Cindy Perettie: And part of that is due to the restructuring. So we are putting our strategy into play, and we feel very confident about the approach we're taking in the US. And we are now looking at having almost a fully staffed sales team back out and working hard. I think this is a piece that we need to talk about as well as the market dynamics. So the things we're observing, we're observing out of class competition with the buy specifics, the ATC constraints that we've spoken about in the past, based on multiple myeloma constructs coming in. But what we're seeing is that a lot of hospitals and ATCs are working through those constraints, and we feel really confident about the second half of this year.

Cindy Perettie: And about the approach we're taking in the U S and we now are looking at having almost a fully SaaS sales team back out and working hard I think the piece that we need to talk about as well as the market dynamics of the things. We're observing we're observing out of class competition with the bi specifics.

Cindy Perettie: The ATC constraints that we've spoken about in the past based on multiple myeloma contracts coming in but what we're seeing is a lot of the hospitals and <unk> are working through those constraints and we felt really confident about the second half of this year.

Cindy Perettie: But what we're seeing is a lot of the hospitals and ATCs are working through those constraints, and we feel really confident about the second half of this year.

But what we're seeing is a lot of the hospitals and ATCs are working through those constraints, and we feel really confident about the second half of this year.

Daniel O'Day: Thank you, Cindy. This is Dan again. So, I appreciate all of you joining. Maybe just a bit of a summary statement. I want you all to know we at Gilead are very focused on the near-term execution and the long-term plans. We'll continue to stay disciplined and agile in our approach. Just as highlights, we've got 54 active clinical programs, no major patent expiries through the end of the decade, a variety of opportunities for growth, and a lot more to deliver. On top of that, we are on track to provide updates from three Phase III clinical trials for Trodelvy, lenacapavir. We've got the seladelpar PDUFA date in August. Any update on the anito-cel Phase II update with the management we'll have at the end of the year. So, rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I'll hand over to Jacquie for closing comments.

Daniel O'Day: Thank you, Cindy. This is Dan again. So, appreciate all of you joining. Maybe just a bit of a summary statement. I want you all to know we at Gilead are very focused on the near-term execution and the long-term plans. We'll continue to stay disciplined and agile in our approach. I mean, just as highlights, we've got 54 active clinical programs, no major patent expiries to the end of the decade, a variety of opportunities for growth, and a lot more to deliver. And on top of that, we are on track to provide updates from three phase 3 clinical trials for Trodelvy, lenacapavir. We've got the seladelpar PDUFA date in August and the update on the anito-cel phase 2 update with IMAGINE-1 at the end of the year.

Cindy Perettie: Thank you Sandy this is Dan again, so I appreciate all of you joining maybe just a bit of a summary statement I want you all to nowhere with Gilead are very focused on the near term execution and our long term plans will continue to stay disciplined and agile in our approach and just has highlighted we've got 54 active clinical programs.

Dan: So I appreciate all of you joining me. Maybe just a bit of a summary statement. I want you all to know we at Gilead are very focused on the near-term execution and the long-term plans. We'll continue to stay disciplined and agile in our approach. Just as a few highlights, we've got 54 active clinical programs, no major patent expiries through the end of the decade, a variety of opportunities for growth, and a lot more to deliver. And on top of that, you know, we are on track to provide updates from three phase three clinical trials for Tredelby and Lenacapivir. We've got the Celadelpar-Perdufa date in August and the update on the Anita cell phase two update with Imagine One at the end of the year. So rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I'll hand over to Jackie for closing comments.

Dan: Graham No major patent expirations through the end of the decade.

Dan: A variety of opportunities for growth and a lot more to deliver.

Dan: And on top of that, you know, we are on track to provide updates from three phase three clinical trials for Tredelby and Lenacapivir. We've got the Celadelpar-Perdufa date in August and the update on the Anita cell phase two update with Imagine One at the end of the year. So rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I'll hand over to Jackie for closing comments.

Dan: Top of that we are on track to provide updates from three phase III clinical trials for <unk> Atlantic catheter there.

Jackie: The cell Adele power producer date in August and the update on the Anita So phase two update with imagine one at the end of the year. So rest assured that we are we are firmly focused on the many opportunities we have and we have a lot more potential to deliver that.

Daniel O'Day: So rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I'll hand over to Jackie for closing comments.

So rest assured that we are firmly focused on the many opportunities we have, and we have a lot more potential to deliver. With that, I'll hand over to Jackie for closing comments.

Jackie: I hand over to Jacky for closing comments.

Operator: Thank you, Dan. To close, just one housekeeping item. I can share that we are tentatively planning to release our Q2 2024 earnings results on Thursday, 8 August 2024. Please note that this date is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of Q2. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter. With that, we'll close our call for today. Thank you.

Jacquie Ross: Thank you, Dan. To close, just one housekeeping item. I can share that we are tentatively planning to release our Q2 2024 earnings results on Thursday, 8 August 2024. Please note that this date is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of Q2. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter. With that, we'll close our call for today. Thank you.

Jacquie Ross: Thank you, Dan. To close, just one housekeeping item. I can share that we are tentatively planning to release our second quarter 2024 earnings results on Thursday, August 8. Please note that this date is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of the second quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter. With that, we'll close our call for today. Thank you.

Jackie: Thank you Dan.

Jackie: Just one housekeeping item I can share that we are tends to be planning to release, our second quarter 2024 earnings results on Thursday August eight. Please note that this state is provisional and could be changed to accommodate scheduling conflicts that arise between now and then as always we will announce our confirmed date following the close of the second quarter.

Jacquie Ross: I can share that we are tentatively planning to release our second quarter 2024 earnings results on Thursday, August 8th. Please note that this date is provisional and could be changed to accommodate scheduling conflicts that arise between now and then. As always, we will announce our confirmed date following the close of the second quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter. With that, we'll close our call for today. Thank you.

Jacquie Ross: We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter.

Jacquie Ross: That concludes our call for today. Thank you.

Q1 2024 Gilead Sciences Inc Earnings Call

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