Q2 2024 Gilead Sciences Inc Earnings Call

August 8, 2024

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Operator: Good afternoon, everyone, and welcome to Gilead's second quarter 2024 earnings conference call, my name is Rebecca, and I'll be your host for today. In a moment, we'll begin with our prepared remarks, followed by our Q&A session, at that time, 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, Vice President of Investor Relations and Corporate Strategic Finance.

Rebecca: Good afternoon, everyone, and welcome to Gilead's second quarter 2024 earnings conference call. My name is Rebecca, and I'll be your host for today.

Rebecca: In a moment, we'll begin with our prepared remarks, followed by our Q&A session. At that time, 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.

Jacquie Ross: I'll now hand the call over to Jackie Ross, Vice President of 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 second 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 the call to 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 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 second quarter of 2024. The press release, slides, and supplementary data are available on the Investors section of our website at gilead.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, Merdad Parsey, and our Chief Financial Officer, Andrew Dickinson.

Speaker Change: After that, we'll open the call to Q&A, where the team will be joined by Cindy Perettie, the Executive Vice President of KITE.

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. Thank you, Jackie, and good afternoon, everyone. I'm pleased to share that this was another strong quarter of commercial execution with growth across HIV, liver disease, and oncology. The cost of Vic Tarvey for HIV treatment was up 8% year over year. Krodelvy was up 23%, and cell therapy was up 11%. In addition, we continue to demonstrate disciplined operating expense management and deliver exceptional bottom-line growth, highlighting the leverage in our business model. Given the results for the first half of the year, we are raising our non-GAAP operating income and EPS guidance for the full year.

Jackie 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.

Speaker Change: 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.

Dan: Thank you, Jackie, and good afternoon, everyone. I'm pleased to share that this was another strong quarter of commercial execution with growth across HIV, liver disease, and oncology. The cost of Vic Tarvey for HIV treatment was up 8% year over year. Krodelvy was up 23%, and cell therapy was up 11%. In addition, we continue to demonstrate disciplined operating expense management and deliver exceptional bottom-line growth, highlighting the leverage in our business model. Given the results for the first half of the year, we are raising our non-GAAP operating income and EPS guidance for the full year.

Daniel O'Day: Thank you, Jackie, and good afternoon, everyone. I'm pleased to share that this was another strong quarter of commercial execution with growth across HIV, liver disease, and oncology. BIKTARVY for HIV treatment was up 8% year over year, TRODELVY was up 23%, and cell therapy was up 11%, in addition, we continue to demonstrate disciplined operating expense management and deliver exceptional bottom-line growth, highlighting the leverage in our business model. Given the results for the first half of the year, we are raising our non-GAAP operating income and EPS guidance for the full year. Moving to clinical updates, this is an important time for our virology and inflammation therapeutic area. A key highlight of the quarter was the readout of our Phase 3, Purpose 1 trial evaluating Lenacapivir for HIV prevention. The results showed 100% efficacy with zero HIV infections in cisgender women.

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

Dan: Thank you, Jackie, and good afternoon, everyone. I'm pleased to share that this was another strong quarter of commercial execution with growth across HIV, liver disease, and oncology.

Dan: Bictarvy for HIV treatment was up 8% year-over-year, Crodelvy was up 23%, and Celltherapy was up 11%.

Speaker Change: In addition, we continue to demonstrate disciplined operating expense management and delivered exceptional bottom-line growth, highlighting the leverage in our business model. Given the results for the first half of the year, we are raising our non-GAAP operating income and EPS guidance for the full year.

Dan: Moving to clinical updates, this is an important time for our virology and inflammation therapeutic area. A key highlight of the quarter was the readout of our Phase 3, Purpose 1 trial evaluating Lenacapivir for HIV prevention. The results showed 100% efficacy with zero HIV infections in cisgender women.

Daniel O'Day: Moving to clinical updates, this is an important time for our virology and inflammation therapeutic areas, a key highlight of the quarter was the readout of our Phase 3, PURPOSE 1 trial evaluating LENACAPAVIR for HIV prevention. The results showed 100% efficacy with zero HIV infections in cisgender women, the presentation of these results at AIDS 2024 in Munich generated considerable excitement, and we're delighted to have reached this milestone with such a positive outcome. LENACAPAVIR, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen. The PURPOSE program, which is expected to include more than 9,000 participants in over 10 countries, is designed to highlight the efficacy of HIV prevention in a wide range of groups, including cisgender women, transgender men and woman, black and latino individuals and young adults. We expect an update for PURPOSE 2 late this year or early next year, with a commercial launch as early as late 2025.

Dan: Moving to clinical updates, this is an important time for our virology and inflammation therapeutic areas.

Dan: A key highlight of the quarter was the readout of our Phase 3, Purpose 1 trial evaluating Lenacapivir for HIV prevention.

Dan: The results showed 100% efficacy with zero HIV infections in cisgender women. The presentation of these results at AIDS 2024 in Munich generated considerable excitement, and we're delighted to have reached this milestone with such a positive outcome.

Dan: The presentation of these results at AIDS 2024 in Munich generated considerable excitement, and we're delighted to have reached this milestone with such a positive outcome. Lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen. The PURPOSE program, which is expected to include more than 9,000 participants in over 10 countries, is designed to highlight the efficacy of HIV prevention in a wide range of groups, including cisgender women, transgender men and We expect an update for PURPOSE 2 late this year or early next year, with a commercial launch as early as late 2025.

Dan: Lenacapavir, with its twice yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen.

Daniel O'Day: The PURPOSE program, which is expected to include more than 9,000 participants in over 10 countries, is designed to highlight the efficacy of HIV prevention in a wide range of groups, including cisgender women, transgender men and woman, black and latino individuals and young adults. We expect an update for PURPOSE 2 late this year or early next year, with a commercial launch as early as late 2025. The PURPOSE data were part of several updates at AIDS 2024 that highlight the strength of Gilead's innovation in HIV for both prevention and treatment, our pipeline has the promise to extend our HIV leadership well into the late 2030s and beyond. Updates at AIDS 2024 included data from our daily oral combination of BICTEGRAVIR and LENACAPAVIR, which is now in pivotal Phase III trials for people with HIV, including those on complex regimens. We also shared data from our broad, long-acting program, including our once-weekly orals, GS-4182 and GS-1720.

Dan: The PURPOSE program, which is expected to include more than 9,000 participants in over 10 countries, is designed to highlight the efficacy of HIV prevention in a wide range of groups, including cisgender women,

Dan: transgender men and women, black and Latino individuals, and young adults.

Speaker Change: We expect an update for Purpose 2 late this year or early next year, with a commercial launch as early as late 2025. The Purpose data were part of several updates at AIDS 2024 that highlight the strength of Gilead's innovation in HIV for both prevention and treatment.

Dan: The purpose data were part of several updates at AIDS 2024 that highlighted the strength of Gilead's innovation in HIV for both prevention and treatment. Our pipeline has the promise to extend our HIV leadership well into the late 2030s and beyond. Updates at AIDS 2024 included data from our daily oral combination of Bectegravir and Lenacapavir, which is now in pivotal phase 3 trials for people with HIV, including those on complex regimens. We also shared data from our broad, long-acting program, including our once-weekly oral medicines, GS-4182 and GS-1720.

Dan: Our pipeline has the promise to extend our HIV leadership well into the late 2030s and beyond.

Daniel O'Day: Updates at AIDS 2024 included data from our daily oral combination of BICTEGRAVIR and LENACAPAVIR, which is now in pivotal Phase III trials for people with HIV, including those on complex regimens. We also shared data from our broad, long-acting program, including our once-weekly orals, GS-4182 and GS-1720. We plan to start the Phase II study evaluating these in combination before the end of the year, this is in addition to the once-weekly oral combination of LENACAPAVIR and ISLATRAVIR, in partnership with Merck, that will begin phase three also before the end of the year. On the Immediate Horizon, our PDUFA date for SELADELPAR is next week, the body of clinical evidence behind SELADELPAR for the treatment of Primary Biliary Cholangitis, or PBC, continues to grow, most recently with the Phase III ASSURE data shared at EASL.

Dan: Updates at AIDS 2024 included data from our daily oral combination of Bectegravir and Lenacapavir, which is now in pivotal phase 3 trials for people with HIV, including those on complex regimens.

Dan: We also shared data from our broad, long-acting program, including our once-weekly orals, GS-4182 and GS-1720. We plan to start the Phase II study evaluating these in combination before the end of the year.

Dan: We plan to start the Phase II study evaluating these in combination before the end of the year, this is in addition to the once-weekly oral combination of LENACAPAVIR and ISLATRAVIR, in partnership with Merck, that will begin phase three also before the end of the year. On the Immediate Horizon, our PDUFA date for CELADELPAR is next week. The body of clinical evidence behind CELADELPAR for the treatment of primary biliary cholangitis, or PBC, continues to grow, most recently with the Phase III Assured data shared at EDS.

Speaker Change: This, in addition to the once-weekly oral combination of Lenacaprivir and Aslatrivir in partnership with Merck that will begin Phase 3 also before the end of the year.

Daniel O'Day: On the Immediate Horizon, our PDUFA date for SELADELPAR is next week, the body of clinical evidence behind SELADELPAR for the treatment of Primary Biliary Cholangitis, or PBC, continues to grow, most recently with the Phase III ASSURE data shared at EASL. The Gilead team is excited by the opportunity to launch SELADELPAR and bring a promising new treatment to patients who could benefit. Moving to oncology, we are ready to manufacture a Anito-cel for multiple myeloma at our Maryland Kite facility, and we are preparing to support the Phase III iMMagine-3 trial from the site starting later this year. The iMMagine-3 trial is expected to reach a broader set of second to fourth-line multiple myeloma patients with our potentially best-in-class BCMA CAR T.

Speaker Change: On the immediate horizon, our PDUFA date for Celadelpar is next week. The body of clinical evidence behind Celadelpar for the treatment of primary biliary cholangitis, or PBC, continues to grow, most recently with the Phase III assured data shared at ESL.

Dan: The Gilead team is excited by the opportunity to launch Celladelpar and bring a promising new treatment to patients who could benefit. Moving to oncology, we are ready to manufacture a needle cell for multiple myeloma at our Maryland Kite facility, and we are preparing to support the Phase 3 Imagine 3 trial from the site starting later this year. The Imagine 3 trial is expected to reach a broader set of second to fourth-line multiple myeloma patients with our potentially best in class BCMA cards.

Speaker Change: The Gilead team is excited by the opportunity to launch Celladelpar and bring a promising new treatment to the patients who could benefit.

Speaker Change: Moving to oncology, we are ready to manufacture a needle cell for multiple myeloma at our Maryland KITE facility, and we are preparing to support the Phase 3 Imagine 3 trial from the site starting later this year.

Daniel O'Day: The iMMagine-3 trial is expected to reach a broader set of second to fourth-line multiple myeloma patients with our potentially best-in-class BCMA CAR T, at ASCO, we shared new data from our Phase 2 EVOKE-02 program, evaluating TRODELVY in combination with Pembro in first-line metastatic non-small cell lung cancer. The results showed meaningful efficacy compared to the historical standard of care, supporting the Phase III of the EVOKE-03 trial currently underway. We continue to assess the path for TRODELVY in second-line metastatic non-small cell lung cancer and metastatic bladder cancer following the EVOKE-01 and TROPiCS-04 readouts earlier this year.

Speaker Change: The Imagine 3 trial is expected to reach a broader set of second to fourth line multiple myeloma patients, with our potentially best-in-class BCMA CARTE.

Dan: At ASCO, we shared new data from our Phase 2 Evoco2 program, evaluating Tordelvie in combination with Pembro in first-line metastatic non-small cell lung cancer. The results showed meaningful efficacy compared to the historical standard of care, supporting the phase three of the VOC03 trial currently underway. We continue to assess the path for Tredelvi in second-line metastatic non-small cell lung cancer and metastatic bladder cancer following the Evoque-01 and Tropix-04 readouts earlier this year.

Speaker Change: At ASCO, we shared new data from our Phase 2 Evoco2 program, evaluating Trodelvie in combination with Pembro in first-line metastatic non-small-cell lung cancer.

Speaker Change: The results showed meaningful efficacy compared to the historical standard of care, supporting the Phase III of VOC-03 trial currently underway.

Speaker Change: We continue to assess the path for Tredelby in second-line metastatic non-small-cell lung cancer and metastatic bladder cancer following the EVOKE-01 and TROPICS-04 readouts earlier this year.

Daniel O'Day: In the meantime, I'd highlight the strong commercial results this quarter in breast cancer, where TRODELVY remains the first and only approved TROP-2-directed ADC on the market and is the standard of care for second-line metastatic triple negative breast cancer. To date, we have served over 40,000 cancer patients and remain confident that TRODELVY will continue to be an important treatment option. We also shared Phase II EDGE-Gastric data at ASCO for DOMVANALIMAB+ZIMBERELIMAB and chemotherapy in first-line upper GI cancers, these results showed compelling efficacy that supports the Phase III STAR-221 program, which has completed enrollment. Moving to our 2024 key milestones on slide 6.

Speaker Change: In the meantime, I'd highlight the strong commercial results this quarter in breast cancer, where Tredelby remains the first and only approved Trope 2-directed ABC on the market and is the standard of care for second-line metastatic triple negative breast cancer.

Speaker Change: To date, we have served over 40,000 cancer patients and remain confident that TRODELVY will continue to be an important treatment option.

Speaker Change: We also shared Phase 2 EDGE gastric data at ASCO for donvanilumab plus zimbrilumab and chemotherapy in first-line upper GI cancers. These results showed compelling efficacy that supports the Phase 3 STAR-221 program, which has completed enrollment.

Daniel O'Day: We look forward to the upcoming updates from the Phase III ASCENT-03 trial, and the Phase II iMMagine-1 trial. ASCENT-03 is an event-driven trial evaluating TRODELVY in first-line PD-L1-negative metastatic triple-negative breast cancer patients. A positive progression-free survival outcome would support global filings, potentially moving TRODELVY into earlier lines of triple negative breast cancer. Our iMMagine-1 trial could support regulatory filings for a Anito-Cel in later-line relapsed or refractory multiple myeloma. Overall, the second quarter was a strong performance for the Gilead team, with the highlights including some remarkable clinical results in HIV, solid revenue growth across therapeutic areas, tangible impact from our discipline cost management initiatives, and planning for the imminent launch of SELADELPAR. With that, I'll hand it over to Joanne.

Speaker Change: Moving to our 2024 key milestones on slide 6.

Speaker Change: We look forward to the upcoming updates from the Phase 3 ASCENT-03 trial and Phase 2 IMAGINE-1 trial. ASCENT-03 is an event-driven trial evaluating Tredelby and first-line PD-L1-negative metastatic triple-negative breast cancer patients.

Speaker Change: A positive progression-free survival outcome would support global filings, potentially moving Tredelvi into earlier lines of triple-negative breast cancer.

Speaker Change: Our IMAGINE-1 trial could support regulatory filings for a needle cell in later-line relapsed or refractory multiple myeloma.

Daniel O'Day: Overall, the second quarter was a strong performance for the Gilead team, with the highlights including some remarkable clinical results in HIV, solid revenue growth across therapeutic areas, tangible impact from our discipline cost management initiatives, and planning for the imminent launch of SELADELPAR. With that, I'll hand it over to Joanne. Thanks Dan, and good afternoon everyone. I'm very pleased to report the continued momentum we saw in the second quarter and would like to thank the Gilead teams who contributed to another strong quarter of execution. As shown on slide 8, total product sales, excluding Vic Lurie, were $6.7 billion in the second quarter, up 6% year-over-year, with growth across HIV, liver disease, and oncology. Including Vicklery, total product sales were $6.9 billion, up 5% year over year.

Speaker Change: Overall, the second quarter was a strong performance for the Gilliad team.

Speaker Change: with the highlights including some remarkable clinical results in HIV, solid revenue growth across therapeutic areas, tangible impacts from our discipline and cost management initiatives, and planning for the imminent launch of Celadel Par. With that, I'll hand it over to Joanna.

Johanna Mercier: Thanks Dan, and good afternoon everyone, I'm very pleased to report the continued momentum we saw in the second quarter, and would like to thank the Gilead teams who contributed to another strong quarter of execution. As shown on slide 8, total product sales, excluding VEKLURY, were $6.7 billion in the second quarter, up 6% year-over-year, with growth across HIV, liver disease, and oncology. Including VEKLURY, total product sales were $6.9 billion, up 5% year over year. Starting with HIV on slide nine, sales of $4.7 billion were up 3% year-over-year, driven by strong demand across treatment and prevention, partially offset by lower average realized prices due to channel mix. Quarter over quarter, sales were up 9%, reflecting favorable pricing and inventory build following the typical first quarter dynamics, as well as higher demand. Looking to the full year, we remain on track to deliver HIV sales growth of approximately 4%. Turning to slide 10, total second quarter Big Tar V sales of $3.2 billion were up 8% year-over-year, primarily due to higher demand. sequentially, sales were up 10%, largely reflecting favorable pricing and inventory following the typical first quarter dynamic.

Joanne: Thanks Dan, and good afternoon everyone. I'm very pleased to report the continued momentum we saw in the second quarter and would like to thank the Gilead teams who contributed to another strong quarter of execution. As shown on slide 8, total product sales, excluding Vic Lurie, were $6.7 billion in the second quarter, up 6% year-over-year, with growth across HIV, liver disease, and oncology. Including Vicklery, total product sales were $6.9 billion, up 5% year over year.

Joanna: Thanks Dan and good afternoon everyone. I'm very pleased to report the continued momentum we saw in the second quarter and would like to thank the Gilead teams who contributed to another strong quarter of execution.

Joanna: As shown on slide 8, total product sales, excluding Vicklory, were $6.7 billion in the second quarter, up 6% year-over-year, with growth across HIV, liver disease, and oncology.

Speaker Change: Including Declarie, Total Product Sales were $6.9 billion of 5% year over year.

Joanne: Starting with HIV on slide nine, sales of $4.7 billion were up 3% year-over-year, driven by strong demand across treatment and prevention, partially offset by lower average realized prices due to channel mix. Quarter over quarter, sales were up 9%, reflecting favorable pricing and inventory build following the typical first quarter dynamics, as well as higher demand. Looking to the full year, we remain on track to deliver HIV sales growth of approximately 4%. Turning to slide 10, total second quarter Big Tar V sales of $3.2 billion were up 8% year-over-year, primarily due to higher demand. sequentially, sales were up 10%, largely reflecting favorable pricing and inventory following the typical first quarter dynamic.

Speaker Change: Starting with HIV on slide 9, sales of $4.7 billion for up 3% year over year, driven by strong demand across treatment and prevention, partially offset by lower average realized price due to channel mix.

Johanna Mercier: Quarter over quarter, sales were up 9%, reflecting favorable pricing and inventory build following the typical first quarter dynamics, as well as higher demand, looking to the full year, we remain on track to deliver HIV sales growth of approximately 4%. Turning to slide 10, total second quarter BIKTARVY sales of $3.2 billion were up 8% year-over-year, primarily due to higher demand. Sequentially, sales were up 10%, largely reflecting favorable pricing and inventory following the typical first quarter dynamic, highlighting our leadership position, BIKTARVY represents more than 49% of the treatment market in the US. This was up almost 3% year-over-year, our 24th consecutive quarter of year-over-year market share gains, with a meaningful share lead over all other branded regimens for HIV treatment. BIKTARVY firmly remains the HIV treatment of choice, particularly for those starting or switching regimens in the US as well as across other major markets. Overall, the HIV treatment market continues to grow in line with our expectations of 2-3% annually.

Speaker Change: Quarter over quarter, sales were up 9%, reflecting favorable pricing and inventory build following the typical first quarter dynamics, as well as higher demand.

Speaker Change: Looking to the full year, we remain on track to deliver HIV sales growth of approximately 4%.

Speaker Change: Turning to $5.10, total second-quarter big-turvy sales of $3.2 billion, were up 8% year-over-year, primarily due to higher demand.

Speaker Change: sequentially, sales were up 10%, largely reflecting favorable pricing and inventory, following the typical first quarter dynamics.

Joanne: Highlighting our leadership position, Bitarvi represents more than 49% of the treatment market in the US. This was up almost 3% year-over-year, our 24th consecutive quarter of year-over-year market share gains, with a meaningful share lead over all other branded regimens for HIV treatment. Victarvi firmly remains the HIV treatment of choice, particularly for those starting or switching regimens in the U.S. as well as across other major markets. Overall, the HIV treatment market continues to grow in line with our expectations of 2-3% annually.

Speaker Change: Highlighting our leadership position, Victoria represents more than 49% share of the treatment market in the US.

Johanna Mercier: This was up almost 3% year-over-year, our 24th consecutive quarter of year-over-year market share gains, with a meaningful share lead over all other branded regimens for HIV treatment. BIKTARVY firmly remains the HIV treatment of choice, particularly for those starting or switching regimens in the US as well as across other major markets. Overall, the HIV treatment market continues to grow in line with our expectations of 2-3% annually. Turning to DESCOVY, we continue to see higher demand, with sales of $485 million in the second quarter, year over year, sales were down 6% as demand growth was more than offset by a lower average realized price due to channel mix.

Speaker Change: This was up almost 3% year-over-year, our 24th consecutive quarter of year-over-year market share gain.

Speaker Change: With a meaningful share lead over all other branded regimens for HIV treatment, Big Tarvy firmly remains the HIV treatment of choice, particularly for those starting or switching regimens in the U.S. as well as across other major markets.

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

Joanne: Turning to Discovi, we continue to see higher demand, with sales of $485 million in the second quarter. However, year over year, sales were down 6% as demand growth was more than offset by a lower average realized price due to channel mix.

Speaker Change: Turning to Discovery, we continued to see higher demand with sales of $485 million in the second quarter. Year of year, sales were down 6% as demand growth was more than offset by lower average realized price due to channel mix.

Johanna Mercier: As a reminder, shifts in channel mix will continue to impact average realized price, in addition to our ongoing efforts to ensure people who want or need PrEP have access to the prevention regimen of their choice. Sequentially, sales were up 14%, reflecting favorable inventory and pricing following typical first quarter seasonality, in addition to higher demand. Discovery for PrEP once again maintained its over 40% PrEP market share in the US despite the availability of other regimens, including generics. We're particularly excited to note that the HIV PrEP market in the US continues to expand, with total volumes up more than 12% in the second quarter of 2024 compared to the same period last year.

Speaker Change: As a reminder, shifts in channel mix will continue to impact average real life price. In addition to our ongoing efforts to ensure people who want or need prep have access to the prevention regimen of their choice.

Speaker Change: Sequentially, sales were up 14% reflecting favorable inventory and pricing following typical first quarter seasonality in addition to the higher demand.

Speaker Change: DSCOBY for PrEP once again maintained its over 40% PrEP market share in the U.S. despite the availability of other regimens, including generics.

Johanna Mercier: We're particularly excited to note that the HIV PrEP market in the US continues to expand, with total volumes up more than 12% in the second quarter of 2024 compared to the same period last year. With that in mind, we're thrilled with the unprecedented results seen in our Pivotal Phase III Purpose I trials, achieving 100% efficacy with zero cases of HIV infections in a broad population of cisgender women, including those who are pregnant or lactating. This is just the beginning of our larger, landmark purpose program, which includes multiple populations and communities where PrEP is underutilized or more difficult to access today, such as cisgender women, transgender men and women, black and Latino individuals, and young adults.

Joanne: We're particularly excited to note that the HIV PrEP market in the U.S. continues to expand, with total volumes up more than 12 percent in the second quarter of 2024 compared to the same period last year. With that in mind, we're thrilled with the unprecedented results seen in our Pivotal Phase III Purpose I trials, achieving 100% efficacy with zero cases of HIV infections in a broad population of cisgender women, including those who are pregnant or lactating.

We're particularly excited to note that the HIV PrEP market in the U.S. continues to expand, with total volumes up more than 12 percent in the second quarter of 2024 compared to the same period last year.

Speaker Change: We're particularly excited to note that the HIV prep market in the US continues to expand, with total volumes up more than 12% in the second quarter of 2024 compared to the same period last year.

With that in mind, we're thrilled with the unprecedented results seen in our Pivotal Phase III Purpose I trials, achieving 100% efficacy with zero cases of HIV infections in a broad population of cisgender women, including those who are pregnant or lactating.

Speaker Change: With that in mind, we're thrilled with the unprecedented results seen in our pivotal phase 3 Purpose One Child, achieving 100% efficacy with zero cases of HIV infections in a broad population of cisgender women, including those who are pregnant or lactating.

Joanne: This is just the beginning of our larger, landmark purpose program, which includes multiple populations and communities where PrEP is underutilized or more difficult to access today, such as cisgender women, transgender men and women, black and Latino individuals, and young adults.

Johanna Mercier: This is just the beginning of our larger, landmark purpose program, which includes multiple populations and communities where PrEP is underutilized or more difficult to access today, such as cisgender women, transgender men and women, black and Latino individuals, and young adults. Overall, we expect LENACAPAVIR will emerge as the regimen of choice for those who want or need prevention as the first and only long-acting option with twice yearly subcutaneous dosing. We are preparing for potential launch as early as late 2025. Moving to the liver disease portfolio on slide 11, sales were up 17% year-over-year and 13% sequentially, driven by higher demand and higher average realized price due to channel mix in the US. Our liver disease franchise continues to differentiate itself, with leading share in HCV, despite fewer HCV starts year-over-year, together with growing demand in HBV and HDV.

Speaker Change: This is just the beginning of our larger landmark purpose program, which includes multiple populations and communities where PrEP is underutilized or more difficult to access today, such as cisgender women, transgender men and women, Black and Latino individuals, and young adults.

Joanne: Overall, we expect Lenacapavir will emerge as the regimen of choice for those who want or need prevention as the first and only long-acting option with twice yearly subcutaneous. We are preparing for potential launch as early as late 2025. Moving to the liver disease portfolio on slide 11, sales were up 17% year-over-year and 13% sequentially, driven by higher demand and higher average realized price due to channel mix in the U.S. Our liver disease franchise continues to differentiate itself, with leading share in HCV, despite fewer HCV starts year-over-year, together with growing demand in HBV and HDV.

Speaker Change: Overall, we expect Lenna Capovier will emerge as the regimen of choice for those who want or need prevention as the first and only long acting option with twice yearly subcutaneous dosing.

Speaker Change: We are preparing for potential launch as early as late 2025.

Johanna Mercier: Moving to the liver disease portfolio on slide 11, sales were up 17% year-over-year and 13% sequentially, driven by higher demand and higher average realized price due to channel mix in the US. Our liver disease franchise continues to differentiate itself, with leading share in HCV, despite fewer HCV starts year-over-year, together with growing demand in HBV and HDV. As you know, our PDUFA date for SELADELPAR is next week, and we stand ready to launch commercially in the US, we are able to leverage our existing commercial footprint in liver diseases and continue building upon these relationships to quickly bring SELADELPAR to many of the 130,000 people impacted by PBC in the U.S. who progress after initial treatment. Outside the U.S., commercial preparations are well underway, and we look forward to the European regulatory decision in early 2025.

Speaker Change: Moving to the liver disease portfolio in slide 11, sales were up 17% year over year and 13% sequentially, driven by higher demand and higher average realized price due to channel mix in the US.

Johanna Mercier: Our liver disease franchise continues to differentiate itself, with leading share in HCV, despite fewer HCV starts year-over-year, together with growing demand in HBV and HDV. As you know, our PDUFA date for Celadel Power is next week, and we stand ready to launch commercially in the U.S. We are able to leverage our existing commercial footprint in liver diseases and continue building upon these relationships to quickly bring Saladelpar to many of the 130,000 people impacted by PBC in the U.S. who progress after initial treatment. Outside the U.S., commercial preparations are well underway, and we look forward to the European regulatory decision in early 2025.

Speaker Change: Our liver disease franchise continues to differentiate itself, with leading Sharon H.C.V., despite pure H.C.V. Starts the year, together with growing demand in H.B.V. and H.D.V. As you know, our producer date for Celadelle Parsey next week, and we stand ready to launch commercially in the U.S.

Joanne: As you know, our PDUFA date for Celadel Power is next week, and we stand ready to launch commercially in the U.S. We are able to leverage our existing commercial footprint in liver diseases and continue building upon these relationships to quickly bring Saladelpar to many of the 130,000 people impacted by PBC in the U.S. who progress after initial treatment. Outside the U.S., commercial preparations are well underway, and we look forward to the European regulatory decision in early 2025.

Speaker Change: We are able to leverage our existing commercial footprint in liver diseases and continue building upon these relationships to quickly bring Saladelpar to many of the 130,000 people impacted by PBC in the U.S. who progress after initial treatment.

Johanna Mercier: Outside the US, commercial preparations are well underway, and we look forward to the European regulatory decision in early 2025. Turning to slide 12, while the severity of COVID infections and hospitalization rates remain variable, VEKLURY continues to be recognized as an important part of the standard of care for hospitalized patients treated for COVID-19. This includes the US, where VEKLURY has maintained well over 60% share in this setting, for the second quarter, VEKLURY sales were down 16% year-over-year and down 61% sequentially, as expected. Moving to oncology, on slide 13, sales were up 15% year-over-year and up 7% quarter-over-quarter to $841 million dollars, with over 60,000 patients treated with a Gilead or Kite therapy to date, we're proud of the positive impact our oncology medicines have made across multiple cancer types. Looking in more detail at TRODELVY on slide 14, sales for the second quarter were $320 million, up 23% year-over-year and up 4% sequentially, primarily driven by higher demand in the U.S. and Europe across it's metastatic breast cancer indicators.

Speaker Change: Outside the U.S., commercial preparations are well underway, and we look forward to the European regulatory decision in early 2025.

Joanne: Turning to slide 12, while the severity of COVID infections and hospitalization rates remain variable, ficklery continues to be recognized as an important part of the standard of care for hospitalized patients treated for COVID-19. This includes the U.S., where Veclari has maintained well over 60% share in this setting. For the second quarter, Clery sales were down 16% year-over-year and down 61% sequentially, as expected.

Speaker Change: Turning to slide 12, while severity of COVID infections and hospitalization rates remain variable, victory continues to be recognized as an important part of the standard of care for hospitalized patients treated for COVID-19.

Speaker Change: This includes the U.S., where veterinary has maintained well over 60% share in this setting.

Speaker Change: For the second quarter, the Cleary South were down 16% year-over-year and down 61% sequentially as expected.

Joanne: Moving to oncology, on slide 13, sales were up 15% year-over-year and up 7% quarter-over-quarter to $841 million. With over 60,000 patients treated with a Gilead or CHITE therapy to date, we're proud of the positive impact our oncology medicines have made across multiple cancer types. Looking in more detail at Tridelby on slide 14, sales for the second quarter were $320 million, up 23% year-over-year and up 4% sequentially, primarily driven by higher demand in the U.S. and Europe across its metastatic breast cancer indicators.

Johanna Mercier: Moving to oncology, on slide 13, sales were up 15% year-over-year and up 7% quarter-over-quarter to $841 million dollars, with over 60,000 patients treated with a Gilead or Kite therapy to date, we're proud of the positive impact our oncology medicines have made across multiple cancer types. Looking in more detail at TRODELVY on slide 14, sales for the second quarter were $320 million, up 23% year-over-year and up 4% sequentially, primarily driven by higher demand in the US and Europe across it's metastatic breast cancer indicators. TRODELVY is the only approved and available TROP-2-directed ADC to demonstrate clinically meaningful survival benefits across two types of metastatic breast cancer. And with increasing awareness amongst physicians, TRODELVY has remained the leading regimen in the U.S. and Europe for second-line metastatic triple negative breast cancer, with growing adoption in pre-treated HR-positive, HER2-negative metastatic breast cancer. We are working to expand TRODELVY's reach beyond the 40,000+ patients treated to date across multiple tumor types as we look to new and existing markets, as well as new indications.

Speaker Change: Moving to oncology on Flight 13

Speaker Change: Sales were up 15% year-over-year and up 7% quarter-over-quarter to $841 million.

Speaker Change: With over 60,000 patients treated with the Gilead Orkite Therapy to date, we're proud of the positive impact our oncology medicines have made across multiple cancer types.

Johanna Mercier: Looking in more detail at TRODELVY on slide 14, sales for the second quarter were $320 million, up 23% year-over-year and up 4% sequentially, primarily driven by higher demand in the U.S. and Europe across it's metastatic breast cancer indicators.

Speaker Change: Looking in more detail at Trudeau beyond slide 14, still for the second quarter with 320 million, up 23% year over year, and up 4% sequentially, primarily driven by higher demand in the US and Europe, across its metastatic breast cancer indication.

Joanne: Trudelvy is the only approved and available CHOPE II-directed ADC to demonstrate clinically meaningful survival benefits across two types of metastatic breast cancer. And with increasing awareness amongst physicians, Tridelby has remained the leading regimen in the U.S. and Europe for second-line metastatic triple negative breast cancer, with growing adoption in pre-treated HR-positive, HER2-negative metastatic breast cancer. We are working to expand Tredelvi's reach beyond the 40,000-plus patients treated to date across multiple tumor types as we look to new and existing markets, as well as new indications.

Speaker Change: Trudelvy is the only approved and available CHOPE 2-directed ADC to demonstrate clinically meaningful survival benefits across two types of metastatic breast cancers.

Johanna Mercier: And with increasing awareness amongst physicians, TRODELVY has remained the leading regimen in the U.S. and Europe for second-line metastatic triple negative breast cancer, with growing adoption in pre-treated HR-positive, HER2-negative metastatic breast cancer. We are working to expand TRODELVY's reach beyond the 40,000+ patients treated to date across multiple tumor types as we look to new and existing markets, as well as new indications. In bladder cancer, we are planning to further discuss the results of TROPiCS-O4 and next steps with the FDA. At this time, TRODELVY continues to be available under an accelerated approval in the U.S. for second-line plus metastatic or advanced bladder cancer.

Speaker Change: And we've been increasing awareness amongst physicians. Trudely has remained the leading regimen in the U.S. in Europe for second-line metastatic triple negative breath cancer.

Speaker Change: with growing adoption in the pre-treated HR positive, HER2 negative, metastatic breast cancer setting.

Speaker Change: We are working to expand Tredelvi's reach beyond the 40,000-plus patients treated to date across multiple tumor types, as we look to new and existing markets, as well as new indications.

Joanne: In bladder cancer, we are planning to further discuss the results of TropixO4 and next steps with the FDA. At this time, Chidelby continues to be available under an accelerated approval in the U.S. for second-line plus metastatic or advanced bladder cancer.

Speaker Change: In bladder cancer, we are planning to further discuss the results of TROPIC-SO-4 and next steps with the FDA.

Speaker Change: At this time, Tidelby continues to be available under an accelerated approval in the U.S. for second-line plus metastatic or advanced bladder cancer.

Johanna Mercier: Turning to slide 15, and on behalf of Cindy and the Kite team, cell therapy sales in the second quarter were $521 million dollars, up 11% year-over-year, and up 9% quarter-over-quarter, with solid growth in all regions. In the US, sales were up 11% sequentially, as we've begun to see momentum from our focused efforts at the authorized treatment centers, including further educating providers and patients on the curative potential of our cell therapies. Despite these efforts, in-class and out-of-class competition remains a near-term headwind in the US, as we extend the reach of cell therapy, we're making important inroads with key community practices, including working with national payers to unlock broader commercial reimbursement. And as a reminder, expect impact from these initiatives towards the end of 2024, we'll continue to refine this blueprint as we work to onboard new centers and patients over time. Outside the US, demand for YESCARTA and TECARTUS across Europe and other international geographies remains strong, and we're encouraged by the solid progress in our newly launched markets, such as Japan and Saudi Arabia. Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market, first with SELADELPAR for PBC next week, and then LENACAPAVIR for HIV prevention as early as late next year. And with that, I'll hand the call over to Merdad.

Speaker Change: Turning to slide 15, and on behalf of Cindy and the KITE team, cell therapy sales in the second quarter were $521 million, up 11% year-over-year, and up 9% quarter-over-quarter, with solid growth in all regions.

Speaker Change: In the US, sales were up 11 percent sequentially as we've begun to see momentum from our focused efforts at the authorized treatment centers, including further educating providers and patients on the curative potential of our cell therapies.

Johanna Mercier: Despite these efforts, in-class and out-of-class competition remains a near-term headwind in the US, as we extend the reach of cell therapy, we're making important inroads with key community practices, including working with national payers to unlock broader commercial reimbursement. And as a reminder, expect impact from these initiatives towards the end of 2024, we'll continue to refine this blueprint as we work to onboard new centers and patients over time. Outside the US, demand for YESCARTA and TECARTUS across Europe and other international geographies remains strong, and we're encouraged by the solid progress in our newly launched markets, such as Japan and Saudi Arabia. Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market, first with SELADELPAR for PBC next week, and then LENACAPAVIR for HIV prevention as early as late next year. And with that, I'll hand the call over to Merdad.

Speaker Change: Despite these efforts, in-class and out-of-class competition remain a near-term headwind in the U.S.

Speaker Change: As we extend the reach of South therapy, we're making important inroads with key community practices, including working with national pairs to unlock broader commercial reimbursement, and as a reminder, expect impact from these initiatives towards the end of 2024.

Johanna Mercier: And as a reminder, expect impact from these initiatives towards the end of 2024, we'll continue to refine this blueprint as we work to onboard new centers and patients over time. Outside the US, demand for YESCARTA and TECARTUS across Europe and other international geographies remains strong, and we're encouraged by the solid progress in our newly launched markets, such as Japan and Saudi Arabia. Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market, first with SELADELPAR for PBC next week, and then LENACAPAVIR for HIV prevention as early as late next year. And with that, I'll hand the call over to Merdad.

Joanne: And as a reminder, expect impact from these initiatives by the end of 2024. We'll continue to refine this blueprint as we work to onboard new centers and patients over time. Outside the U.S., demand for Yaskarta and Takarta across Europe and other international geographies remains strong, and we're encouraged by the solid progress in our newly launched markets, such as Japan and Saudi Arabia. Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market, first with Seladelpar for PBC next week, and then Lenac And with that, I'll hand the call over to Merdad.

Speaker Change: We'll continue to refine this blueprint as we work to onboard new centers and patients over time.

Johanna Mercier: Outside the US, demand for YESCARTA and TECARTUS across Europe and other international geographies remains strong, and we're encouraged by the solid progress in our newly launched markets, such as Japan and Saudi Arabia. Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market, first with SELADELPAR for PBC next week, and then LENACAPAVIR for HIV prevention as early as late next year. And with that, I'll hand the call over to Merdad.

Speaker Change: Outside the U.S., demand for Yaskarta and Takartas across Europe and other international geographies remains strong, and we're encouraged by the solid progress in our newly launched markets such as Japan and Saudi Arabia.

Johanna Mercier: Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market, first with SELADELPAR for PBC next week, and then LENACAPAVIR for HIV prevention as early as late next year. And with that, I'll hand the call over to Merdad.

Speaker Change: Overall, it was a strong second quarter for our commercial portfolio, and the teams are energized by the potential to bring two more transformational therapies to market.

Speaker Change: First with Celadelle Par for PBC next week, and then let a cap of ear for HIV prevention as early as late next year. And with that, I'll hand the collar over to Murdad.

Merdad V. Parsey: Thank you, Johanna. We are very pleased to wrap up the second quarter with two New England Journal of Medicine publications and a number of important readouts across our portfolio. Most exciting was a readout of our Phase III PURPOSE-1 trial, evaluating twice-yearly subcutaneous LENACAPAVIR for the prevention of HIV infection in cisgender women. As you can see on slide 17, this was the first Phase III, HIV prevention trial to ever achieve 100% efficacy. We have since shared data at the International AIDS Society meeting in July, where our presentation was the highlight of the plenary session, the data were simultaneously published in the New England Journal of Medicine.

Murdad: Thank you, Johanna. We are very pleased to wrap up the second quarter with two New England Journal of Medicine publications and a number of important readouts across our portfolio.

Murdad: Most exciting was a readout of our Phase III, Purpose I trial, evaluating twice-yearly subcutaneous linacabavir for the prevention of HIV infection in cisgender women.

Murdad: As you can see on slide 17, this was the first phase 3 HIV prevention trial to ever achieve 100% efficacy.

Murdad: We have since shared data at the International AIDS Society meeting in July , where our presentation was the highlight of the plenary session.

Murdad: The data were simultaneously published in the New England Journal of Medicine.

Merdad V. Parsey: Our second registrational trial for LENACAPAVIR, PURPOSE-2, has enrolled approximately 3,300 men, trans women, and non-binary people who have sex with men, this trial completed enrollment globally in December 2023, approximately four months after Purpose One. As a result, we expect to provide an update in late 2024 or early 2025, assuming positive data from PURPOSE-2, we plan to file based on data from both trials, with the goal of bringing transformative HIV prevention to people at risk of HIV as early as late 2025. Beyond our registrational trials, we are generating Phase II data from the PURPOSE 3, 4, and 5 trials in key populations across the US, UK, and France, including people who inject drugs. These trials reflect our commitment to evaluate LENACAPAVIR across diverse populations that could benefit. These studies are also intended to drive greater awareness amongst physicians and patients, including geographies where prevention options have not been effective historically.

Murdad: Our second registrational trial for Lenacapivir, Purpose 2, has enrolled approximately 3,300 men, trans women, and non-binary people who have sex with men.

Murdad: This trial completed enrollment globally in December 2023, approximately four months after Purpose 1. As a result, we expect to provide an update in late 2024 or early 2025.

Merdad: Assuming positive data from Purpose 2, we plan to file based on data from both trials, with the goal of bringing transformative HIV prevention to people at risk of HIV as early as late 2025. Beyond our registrational trials, we are generating Phase 2 data from the Purpose 3, 4, and 5 trials in key populations across the U.S., U.K., and France, including people who inject drugs. These trials reflect our commitment to evaluate Lenacapavir across diverse populations that could benefit. These studies are also intended to drive greater awareness amongst physicians and patients, including geographies where prevention options have not been effective historically.

Murdad: Assuming positive data from Purpose 2, we plan to file based on data from both trials with the goal of bringing transformative HIV prevention to people at risk of HIV as early as late 2025.

Merdad V. Parsey: Beyond our registrational trials, we are generating Phase II data from the PURPOSE 3, 4, and 5 trials in key populations across the US, UK, and France, including people who inject drugs. These trials reflect our commitment to evaluate LENACAPAVIR across diverse populations that could benefit, these studies are also intended to drive greater awareness amongst physicians and patients, including geographies where prevention options have not been effective historically. In addition to HIV prevention, we are, of course, intensely focused on next-generation HIV treatment options, and slide 18 highlights our comprehensive HIV treatment pipeline. Our recent updates at the AIDS Society meeting included longer-term Phase II data from our once-daily oral combination of BICTEGRAVIR and LENACAPAVIR that showed the regimen was highly effective in maintaining viral suppression. These results further support our ongoing Phase III studies in people with HIV, including those on complex regimens.

Murdad: Beyond our registrational trials, we are generating Phase II data from the Purpose III, IV, and V trials in key populations across the U.S., U.K., and France, including people who inject drugs. These trials reflect our commitment to evaluate Lenacapavir across diverse populations that could benefit.

Merdad V. Parsey: These trials reflect our commitment to evaluate LENACAPAVIR across diverse populations that could benefit. These studies are also intended to drive greater awareness amongst physicians and patients, including geographies where prevention options have not been effective historically.

Merdad V. Parsey: Our recent updates at the AIDS Society meeting included longer-term Phase II data from our once-daily oral combination of BICTEGRAVIR and LENACAPAVIR that showed the regimen was highly effective in maintaining viral suppression. These results further support our ongoing Phase III studies in people with HIV, including those on complex regimens. We also reported safety and PK data for both GS-4182, an oral prodrug of LENACAPAVIR designed to provide two to three times greater oral bioavailability, and GS-1720, our long-acting oral integration inhibitor. Initiation of the Phase II trial evaluating the combination of these agents as a once-weekly oral regimen is expected later this year. Additionally, we are on track to initiate our Phase III ISLEND-1 and ISLEND-2, evaluating once-weekly LENACAPAVIR in combination with Merck's ISLATRAVIR, this regimen is expected to be the first once-weekly oral treatment option. Looking at our longer-duration treatments, we expect to provide Phase I updates from our every-three-month injectable programs and to initiate the Phase I studies for our potentially every-six-month integrase inhibitors in the second half of the year. Moving to our liver disease portfolio, on slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the Easel Conference in June, highlighting our continued leadership. Importantly, as shown on the right of the slide, new interim results from the open-label Phase III ASSURE study of SELADELPAR for PBC were consistent with the pivotal response study that formed the basis of our global regulatory filings.

Murdad: These studies are also intended to drive greater awareness amongst positions and patients, including geographies where prevention options have not been effective historically.

Merdad: In addition to HIV prevention, we are, of course, intensely focused on next-generation HIV treatment options, and slide 18 highlights our comprehensive HIV treatment pipeline. Our recent updates at the AIDS Society meeting included longer-term Phase II data from our once-daily oral combination of Bictegravir and Lenacapavir that showed the regimen was highly effective in maintaining viral suppression. These results further support our ongoing Phase III studies in people with HIV, including those on complex regimens.

Murdad: In addition to HIV prevention, we are of course intensely focused on next-generation HIV treatment options.

Merdad V. Parsey: We also reported safety and PK data for both GS-4182, an oral prodrug of lenacapavir designed to provide two to three times greater oral bioavailability, and GS-1720, our long-acting oral integration. Initiation of the Phase 2 trial evaluating the combination of these agents as a once-weekly oral regimen is expected later this year. Additionally, we are on track to initiate our Phase 3 ISLAND1 and This regimen is expected to be the first once-weekly oral treatment.

Murdad: and Slide 18 Highlights are Comprehensive HIV Treatment Pipeline.

Murdad: Our recent updates at the AIDS Society meeting included longer-term Phase II data from our once-daily oral combination of Bictegravir and Lenacapavir that showed the regimen was highly effective in maintaining viral suppression.

Murdad: These results further support are ongoing phase three studies and people with HIV, including those on complex regimens.

Merdad V. Parsey: Initiation of the Phase II trial evaluating the combination of these agents as a once-weekly oral regimen is expected later this year. Additionally, we are on track to initiate our Phase III ISLEND-1 and ISLEND-2, evaluating once-weekly LENACAPAVIR in combination with Merck's ISLATRAVIR, this regimen is expected to be the first once-weekly oral treatment option. Looking at our longer-duration treatments, we expect to provide Phase I updates from our every-three-month injectable programs and to initiate the Phase I studies for our potentially every-six-month integrase inhibitors in the second half of the year. Moving to our liver disease portfolio, on slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the Easel Conference in June, highlighting our continued leadership. Importantly, as shown on the right of the slide, new interim results from the open-label Phase III ASSURE study of SELADELPAR for PBC were consistent with the pivotal response study that formed the basis of our global regulatory filings.

Merdad V. Parsey: Initiation of the Phase II trial evaluating the combination of these agents as a once-weekly oral regimen is expected later this year.

Murdad: We also reported safety and PK data for both GS4182 and oral pro-drug of Lenna Capovier designed to provide two to three times greater oral bioavailability and GS1720, our long-acting oral integration inhibitor.

Merdad V. Parsey: Additionally, we are on track to initiate our Phase III ISLEND-1 and ISLEND-2, evaluating once-weekly LENACAPAVIR in combination with Merck's ISLATRAVIR, this regimen is expected to be the first once-weekly oral treatment option. Looking at our longer-duration treatments, we expect to provide Phase I updates from our every-three-month injectable programs and to initiate the Phase I studies for our potentially every-six-month integrase inhibitors in the second half of the year. Moving to our liver disease portfolio, on slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the Easel Conference in June, highlighting our continued leadership. Importantly, as shown on the right of the slide, new interim results from the open-label Phase III ASSURE study of SELADELPAR for PBC were consistent with the pivotal response study that formed the basis of our global regulatory filings.

Murdad: Initiation of the Phase 2 trial, evaluating the combination of these agents as a once weekly oral regimen is expected later this year.

Murdad: Additionally, we are on track to initiate our Phase 3 Islam One and Islam Two trials, evaluating one Weekly Lenna Capavir and Combination with Merks is Latravir.

Murdad: This regimen is expected to be the first once weekly oral treatment option.

Merdad: Looking at our longer-duration treatments, we expect to provide Phase I updates from our every-three-month injectable programs and to initiate the Phase I studies for our potentially every-six-month integrase inhibitors in the second half of the year. Moving to our liver disease portfolio, on slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the Easel Conference in June, highlighting our continued leadership. Importantly, as shown on the right of the slide, new interim results from the open-label Phase III Assure study of Celadelpar for PBC were consistent with the pivotal response study that formed the basis of our global regulatory filings.

Murdad: Looking at our longer-duration treatments, we expect to provide Phase I updates from our every three-month injectable programs and to initiate the Phase I studies for our potentially every six-month integrase inhibitors in the second half of the year.

Murdad: Moving to our liver disease portfolio, on slide 19, we presented more than 25 abstracts across both viral and inflammatory liver diseases at the EASL conference in June , highlighting our continued leadership.

Merdad V. Parsey: Importantly, as shown on the right of the slide, new interim results from the open-label Phase III ASSURE study of SELADELPAR for PBC were consistent with the pivotal response study that formed the basis of our global regulatory filings, as you know, we expect an FDA regulatory decision shortly, with a decision from European regulators to follow in early 2025. In viral hepatitis, Gilead shared the final week 144 results of the Phase III MYR-301 trial at easel. These data continue to support monotherapy BULEVIRTIDE 2 mg as a chronic treatment for HDV. Additionally, we presented promising Phase IIb data evaluating BULEVIRTIDE 10 mg with interferon alpha-2a as a finite regimen, the post-treatment response rates were the highest ever reported in HDV and were simultaneously published in the New England Journal of Medicine. We're encouraged by the data and continue to be engaged with KOLs and health authorities, including the FDA, as we work to bring BULEVIRTIDE to patients as quickly as possible. Switching to oncology, on slide 20, we're pleased with the progress across our mid to late stage programs.

Murdad: Importantly, as shown on the right of the slide, new interim results from the Open Label Phase III Assure Study of CELADELPAR for PBC were consistent with the Pivotal Response Study that formed the basis of our global regulatory filings.

Merdad: As you know, we expect an FDA regulatory decision shortly, with a decision from European regulators to follow in early 2025. In viral hepatitis, Gilead shared the final week 144 results of the phase 3 MIR 301 trial at easel. These data continue to support monotherapy bilabatide 2 mg as a chronic treatment for HDV.

Murdad: As you know, we expect an FDA regulatory decision shortly, with a decision from European regulators to follow in early 2025.

Speaker Change: In Viral Hepatitis, Gilead shared final Week 144 results of the Phase 3 MIR 301 trial at Eazl. These data continue to support monotherapy bilevitide 2mg as a chronic treatment for HDV.

Merdad V. Parsey: Additionally, we presented promising Phase IIb data evaluating BULEVIRTIDE 10 mg with interferon alpha-2a as a finite regimen, the post-treatment response rates were the highest ever reported in HDV and were simultaneously published in the New England Journal of Medicine. We're encouraged by the data and continue to be engaged with KOLs and health authorities, including the FDA, as we work to bring BULEVIRTIDE to patients as quickly as possible. Switching to oncology, on slide 20, we're pleased with the progress across our mid to late stage programs. In the frontline setting, we shared mature cohort A data at ASCO from our Phase 2 EVOK-02 trial with TRODELVY plus Pembro, demonstrating a median progression-free survival of 13.1 months. These data exceed the historical performance of PD-1 monotherapy in first-line PD-L1 high, non-small cell lung cancer and support our ongoing phase three EVOKE-03 trial, where enrollment is going well. In an all-comer, non-small-cell lung cancer population, our Phase III STAR-121 study evaluating DOM plus ZIM is ongoing.

Merdad: Additionally, we presented promising Phase IIb data evaluating bilabratide 10 mg with interferon alpha-2a as a finite regimen. The post-treatment response rates were the highest ever reported in HDV and were simultaneously published in the New England Journal of Medicine. We're encouraged by the data and continue to be engaged with KOLs and health authorities, including the FDA, as we work to bring Bilebertide to patients as quickly as possible. Switching to oncology, on slide 20, we're pleased with the progress across our mid to late stage program.

Murdad: Additionally, we presented promising Phase 2B data evaluating glabrotide 10 milligrams with interferon alpha 2A as a finite regimen.

Murdad: The post-treatment response rates were the highest ever posted in HDV and were simultaneously published in the New England Journal of Medicine.

Merdad V. Parsey: We're encouraged by the data and continue to be engaged with KOLs and health authorities, including the FDA, as we work to bring BULEVIRTIDE to patients as quickly as possible. Switching to oncology, on slide 20, we're pleased with the progress across our mid to late stage programs.

Speaker Change: We're encouraged by the data and continue to be engaged with KOL's and health authorities, including the FDA, as we work to bring blevertide to patients as quickly as possible.

Speaker Change: Switching to oncology on slide 20, replies with the progress across our mid-to-late stage programs.

Merdad: In the frontline setting, we shared mature cohort A data at ASCO from our Phase 2 Evoco2 trial with Tredelby plus Pembroke, demonstrating a median progression-free survival of 13.1. These data exceed the historical performance of PD-1 monotherapy in first-line PD-L1 high, non-small cell lung cancer and support our ongoing phase three EVOCO3 trial, where enrollment is going well. In an all-comer, non-small-cell lung cancer population, our Phase 3 STAR-121 study evaluating DOM plus ZIM is ongoing.

Speaker Change: In the frontline setting, we shared mature Cohort A data at ASCO from our Phase II Evoco2 trial with Tredelby plus Pembro, demonstrating a median progression-free survival of 13.1 months.

Merdad V. Parsey: These data exceed the historical performance of PD-1 monotherapy in first-line PD-L1 high, non-small cell lung cancer and support our ongoing phase three EVOKE-03 trial, where enrollment is going well. In an all-comer, non-small-cell lung cancer population, our Phase III STAR-121 study evaluating DOM+ZIM is ongoing, our Phase 3 STAR-221 study in upper GI cancers, evaluating DOM with ZIM and chemo, has completed enrollment. The updated Phase II EDGE gastric data presented at ASCO supported the use of this combination. If successful, DOM+ZIM and Chemo would be the first tiget-based regimen for upper GI cancer patients. In addition, we have several phase three programs underway in earlier settings of breast cancer, including ASCENT-03 evaluating TRODELVY in PD-L1 negative metastatic triple negative breast.

Speaker Change: These data exceeded the historical performance of PD-1 monotherapy in first-line PD-L1-high, non-small-cell lung cancer, and support our ongoing Phase 3 of OCO-3 trial, where enrollment is going well.

Speaker Change: In an all-commer non-small cell lung cancer population, our Phase 3 star-121 study evaluating DOM-Plus-ZIM is ongoing. Our Phase 3 star-221 study in upper GI cancers, evaluating DOM with M&KMO has completed enrollment.

Merdad: Our Phase 3 STAR-221 study in upper GI cancers, evaluating DOM with ZIM and chemo, has completed enrollment. The updated Phase II EDGE gastric data presented at ASCO supported the use of this combination. If successful, DOM plus Zim and Chemo would be the first tiget-based regimen for upper GI cancer patients. In addition, we have several phase three programs underway in earlier settings of breast cancer, including ASCEN03 evaluating Tredelvi in PD-L1 negative metastatic triple negative breast.

Speaker Change: The updated Phase II EDGE gastric data presented at ASCO supported the use of this combination. If successful, DOM plus Zim and Chemo would be the first higit-based regimen for upper GI cancer patients.

Merdad V. Parsey: In addition, we have several phase three programs underway in earlier settings of breast cancer, including ASCENT-03 evaluating TRODELVY in PD-L1 negative metastatic triple negative breast. Turning to our second-line programs, we have discussed the results of EVOKE-01 in metastatic non-small cell lung cancer with regulators, and as expected, have confirmed that there is no immediate regulatory path based on EVOKE-01 alone. We're currently assessing next steps for TRODELVY in this setting. We will also provide updates on our bladder cancer program, including the full trial results, at a future scientific conference after discussions with FDA and KOLS. Moving to slide 21, and on behalf of Cindy and the Kite team, we shared updates for YESCARTA and TECARTUS at both ASCO and the European Hematology Association meeting. At ASCO, we shared encouraging new efficacy data from a pilot study of YESCARTA in 18 patients with relapsed or refractory primary or secondary central nervous system lymphoma in collaboration with the Dana-Farber Cancer Institute.

Speaker Change: In addition, we have several Phase III programs underway in earlier settings of breast cancer, including ASCEN03, evaluating Tredelvi and PD-L1-negative metastatic triple-negative breast cancer.

Merdad: Turning to our second-line programs, we have discussed the results of EVOCA1 in metastatic non-small cell lung cancer with regulators, and as expected, have confirmed that there is no immediate regulatory path based on EVOCA1 alone. We're currently assessing next steps for Tredelby in this setting.

Speaker Change: Turning to our second line programs, we have discussed the results of EVOCA1 in metastatic non-small cell lung cancer with regulators, and as expected, have confirmed there is no immediate regulatory path based on EVOCA1 alone. We're currently assessing next steps for Tredelby in this setting.

Merdad: We will also provide updates on our bladder cancer program, including the full trial results, at a future scientific conference after discussions with FDA and KOS. Moving to slide 21, and on behalf of Cindy and the CITE team, we shared updates for Yaskarta and Tacartas at both ASCO and the European Hematology Association meeting. At ASCO, we shared encouraging new efficacy data from a pilot study of Yaskarta in 18 patients with relapsed or refractory primary or secondary central nervous system lymphoma in collaboration with the Dana-Farber Cancer Institute.

Speaker Change: We will also provide updates on our bladder cancer program, including the full trial results at a future scientific conference after discussions with FDA and KOLs.

Merdad V. Parsey: Moving to slide 21, and on behalf of Cindy and the Kite team, we shared updates for YESCARTA and TECARTUS at both ASCO and the European Hematology Association meeting. At ASCO, we shared encouraging new efficacy data from a pilot study of YESCARTA in 18 patients with relapsed or refractory primary or secondary central nervous system lymphoma in collaboration with the Dana-Farber Cancer Institute. YESCARTA demonstrated greater than 26 months median overall survival with no reported treatment-limiting toxicities and no apparent additional risk of adverse events in these patients with high unmet needs, based on these results, we are engaging with regulators to expand the use of YESCARTA to include these patients. Additionally, we reported that treatment with TECARTUS resulted in a 40% four-year overall survival rate and median overall survival of almost 26 months in the Pivotal ZUMA-3 trial in relapsed or refractory adult B-cell acute lymphoblastic leukemia.

Speaker Change: Moving to slide 21, and on behalf of Cindy and the KITE team, we shared updates for Yaskarta and Takartas at both ASCO and the European Hematology Association meeting.

Speaker Change: At ASCO, we shared encouraging new efficacy data from a pilot study of Yaskarta in 18 patients with relapsed or refractory primary or secondary central nervous system lymphoma in collaboration with the Dana-Farber Cancer Institute.

Merdad: Yaskarta demonstrated greater than 26 months median overall survival with no reported treatment-limiting toxicities and no apparent additional risk of adverse events in these patients with high unmet needs. Based on these results, we are engaging with regulators to expand the use of YesCarda to include these patients. Additionally, we reported that treatment with Ticardis resulted in a 40% four-year overall survival rate and median overall survival of almost 26 months in the Pivotal Zuma 3 trial in relapsed or refractory adult B-cell acute lymphoblastic leukemia.

Speaker Change: He escorted demonstrated greater than 26 months, median overall survival, with no reported treatment-limiting toxicities and no apparent additional risk of adverse events in these patients with high unmet need.

Speaker Change: Based on these results, we are engaging with regulators to expand the use of YesCarda to include these patients.

Merdad V. Parsey: Additionally, we reported that treatment with TECARTUS resulted in a 40% four-year overall survival rate and median overall survival of almost 26 months in the Pivotal ZUMA-3 trial in relapsed or refractory adult B-cell acute lymphoblastic leukemia. At EHA, we shared preliminary analysis from the Phase 2 ZUMA-24 trial, further supporting outpatient use of YESCARTA in relapsed or refractory large B-cell lymphoma with the use of prophylactic steroids and other early intervention strategies. Real-world manufacturing experience of YESCARTA for second and third-line large B-cell lymphoma reinforces our strong manufacturing success rate of 96%. Further, on slide 22, I will highlight our promising clinical development program for Anito-Cel, a potential best-in-class BCMA CAR-T that we are developing in partnership with ARCELLX. Notably, we shared our study design for our Phase III iMMagine III trial that will include a broader set of earlier-line relapsed or refractory multiple myeloma patients, we expect to have the first patient in for this trial in the second half of this year. We're pleased to note that the tech transfer and transfer of the US IND of an Edo cell to KITE are now complete.

Speaker Change: Additionally, we reported that treatment with Ticardis resulted in a 40% four-year overall survival rate and median overall survival of almost 26 months in the Pivotal Zuma 3 trial in relapsed or refractory adult B-cell acute lymphoblastic leukemia.

Merdad: At EHA, we shared preliminary analysis from the Phase 2 Zuma 24 trial, further supporting outpatient use of Yaskarta in relapsed or refractory large B-cell lymphoma with the use of prophylactic steroids and other early intervention strategies. Real-world manufacturing experience of Yaskarta for second and third-line large B-cell lymphoma reinforces our strong manufacturing success rate of 96%.

Speaker Change: At EHA, we shared preliminary analysis from the Phase 2 Zuma 24 trial, further supporting outpatient use of Yaskarta in relapsed or refractory large B cell lymphoma with the use of prophylactic steroids and other early intervention strategies.

Speaker Change: Real World Manufacturing Experience of Yaskarta, for second and third line large B cell lymphoma, reinforces our strong manufacturing success rate of 96%.

Merdad V. Parsey: Further, on slide 22, I will highlight our promising clinical development program for Anito-Cel, a potential best-in-class BCMA CAR-T that we are developing in partnership with ARCELLX. Notably, we shared our study design for our Phase III iMMagine III trial that will include a broader set of earlier-line relapsed or refractory multiple myeloma patients, we expect to have the first patient in for this trial in the second half of this year. We're pleased to note that the tech transfer and transfer of the US IND of Anito-Cel to Kite are now complete, the Kite manufactured product will be used in the IMAGINE 3 trial, and we anticipate the turnaround time for Anito-Cel to be on par with Kite's commercially available products. Wrapping up with our key 2024 milestones on slide 23, we completed all of our first half milestones and are pleased with our program execution overall. We're off to a good start for the second half, with the readout of PURPOSE-1 occurring ahead of our committed timeline.

Merdad: Further, on slide 22, I will highlight our promising clinical development program for InedoCell, a potential best-in-class BCMA CAR-T that we are developing in partnership with our sellers. Additionally, we shared our study design for our Phase III Imagine III trial that will include a broader set of earlier-line relapsed or refractory multiple myeloma patients. We expect to have the first patient in for this trial in the second half of this. We're pleased to note that the tech transfer and transfer of the US IND of an Edo cell to KITE are now complete.

Speaker Change: Further on Slide 22, I will highlight our promising clinical development program for Anita Sal, a potential best in class BCMA CART that we are developing in partnership with our cellix.

Speaker Change: Notably, we shared our study design for our Phase 3 Imagine 3 trial that will include a broader set of earlier-line relapsed or refractory multiple myeloma patients.

Merdad V. Parsey: We're pleased to note that the tech transfer and transfer of the US IND of Anito-Cel to Kite are now complete, the Kite manufactured product will be used in the IMAGINE 3 trial, and we anticipate the turnaround time for Anito-Cel to be on par with Kite's commercially available products. Wrapping up with our key 2024 milestones on slide 23, we completed all of our first half milestones and are pleased with our program execution overall. We're off to a good start for the second half, with the readout of PURPOSE-1 occurring ahead of our committed timeline.

Speaker Change: We expect to have first patient in for this trial in the second half of this year.

Speaker Change: We're pleased to note that the tech transfer and transfer of the U.S. IND of Anita Cell to Cite are now complete. The Cite Manufacture product will be used in Imagine 3 trial, and we anticipate the turnaround time for Anita Cell to be on par with Cites commercially available products.

Merdad: The KITE manufactured product will be used in the IMAGINE 3 trial, and we anticipate the turnaround time for an Edo cell to be on par with KITE's commercially available product. Wrapping up with our key 2024 milestones on slide 23. We completed all of our first half milestones and are pleased with our program execution overall. We're off to a good start for the second half, with the readout of Purpose One occurring ahead of our committed timeline.

Merdad V. Parsey: Wrapping up with our key 2024 milestones on slide 23, we completed all of our first half milestones and are pleased with our program execution overall. We're off to a good start for the second half, with the readout of PURPOSE-1 occurring ahead of our committed timeline.

Speaker Change: Rapping up with our key 2024 milestones on slide 23.

Speaker Change: We completed all of our first half milestones and are pleased with our program execution overall. We're off to a good start for the second half with the readout of Purpose 1 occurring ahead of our committed timeline.

Merdad V. Parsey: We look forward to the FDA decision next week for SELADELPAR in PBC, as well as an update from the Pivotal Phase II iMMagine 1 trial and later line relapsed or refractory multiple myeloma, in addition to an update on the Pivotal Phase III ASCENT-03 study and first line PD-L1 negative metastatic triple negative breast cancer. Along with these updates, we have a maturing inflammation pipeline that includes several Phase II programs, such as a once-daily oral alpha-4-beta-7 integrin inhibitor and an oral TIPL-2 inhibitor for inflammatory bowel disease. And now, I'll hand the call over to Andy.

Speaker Change: We look forward to the FDA decision next week for Seladelpar and PVC, as well as an update from the Pivotal Phase II Imagine 1 trial and later line relapsed or refractory multiple myeloma.

Speaker Change: In addition to an update on the Pivotal Phase III Ascento 3 study and first-line PD-L1-negative metastatic triple-negative breast cancer.

Speaker Change: Along with these updates, we have a maturing inflammation pipeline that includes several Phase II programs, such as a once-daily oral alpha-4-beta-7 integrin inhibitor and an oral TIPL-2 inhibitor for inflammatory bowel disease.

Andrew D. Dickinson: Thank you, Merdad, and good afternoon, everyone. Starting on slide 25, the team delivered an excellent quarter with our base business up 6% year over year to $6.7 billion dollars. Product sales growth across HIV, liver disease, and oncology more than offset the expected decline in VEKLURY, with total product sales up 5% year over year. Moving to our non-GAAP results on slide 26, product gross margin was 86%, down 84 basis points from last year. R&D expenses were down 3% year-over-year, primarily due to the wind-down of certain MAGROLIMAB, OBELDESIVIR, and TRODELVY atudies following recent data and regulatory updates. Sequentially, R&D was down 5% primarily due to the timing of clinical and manufacturing activities partially offset by the initiation of new studies, these savings reflect disciplined management of R&D resources toward the most meaningful opportunities

Speaker Change: and now I'll hand the call over to Andy.

Andy: Thank you, Merdad, and good afternoon, everyone. Starting on slide 25, the team delivered an excellent quarter with our base business up 6% year-over-year to $6.7 billion.

Andy: Product sales growth across HIV, liver disease, and oncology more than offset the expected decline in VEC-LURE with total product sales up 5% year-over-year.

Speaker Change: Moving to our non-GAAP results on slide 26.

Speaker Change: product gross margin was 86% down 84 basis points from last year.

Andy: R&D expenses were down 3% year-over-year, primarily due to the wind-down of certain megrolamab, obaldesivir, and Tredelvi studies following recent data and regulatory updates. Additionally, sequentially, R&D was down 5% primarily due to the timing of clinical and manufacturing activities partially offset by the initiation of new studies. These savings reflect disciplined management of R&D resources toward the most meaningful opportunities

Speaker Change: R&D expenses were down 3% year-over-year, primarily due to the wind-down of certain megrolamab, obaldesivir, and Tredelvi studies following recent data and regulatory updates.

Andrew D. Dickinson: Sequentially, R&D was down 5% primarily due to the timing of clinical and manufacturing activities partially offset by the initiation of new studies, these savings reflect disciplined management of R&D resources towards the most meaningful opportunities The acquired IPR&D was $38 million, reflecting new and ongoing collaboration payments in the second quarter. SG&A was down 27% year over year, primarily due to the $525 million dollars legal settlement in 2023 that did not repeat in 2024. Excluding this payment, SG&A was up 2% year over year and includes commercial investments ahead of the launch of SELADELPAR. Operating margin for the second quarter was 47%, our strongest operating margin since the third quarter of 2022, highlighting the leverage we have in our business model. Turning to tax, our effective tax rate was approximately 18%, reflecting settlement with a tax authority in the second quarter.

Speaker Change: Sequentially, R&D was down 5% primarily due to the timing of clinical and manufacturing activities, partially offset by the initiation of new studies. These savings reflect disciplined management of R&D resources towards the most meaningful opportunities.

Andy: The acquired IPR&D was $38 million, reflecting new and ongoing collaboration payments in the second quarter. SG&A was down 27% year over year, primarily due to the $525 million legal settlement in 2023 that did not repeat in 2020. Excluding this payment, SG&A was up 2% year over year and included commercial investments ahead of the launch of Celladelpar. Operating margin for the second quarter was 47%. Our strongest operating margin since the third quarter of 2022, highlighting the leverage we have in our business model. Turning to tax, our effective tax rate was approximately 18%, reflecting settlement with a tax authority in the second quarter.

Speaker Change: Acquired IPR&D was $38 million, reflecting new and ongoing collaboration payments in the second quarter.

Speaker Change: SG&A was down 27% year-over-year primarily due to the 525 million dollar legal settlement in 2023 that did not repeat in 2024.

Andrew D. Dickinson: Excluding this payment, SG&A was up 2% year over year and includes commercial investments ahead of the launch of SELADELPAR. Operating margin for the second quarter was 47%, our strongest operating margin since the third quarter of 2022, highlighting the leverage we have in our business model. Turning to tax, our effective tax rate was approximately 18%, reflecting settlement with a tax authority in the second quarter. On a reported basis, our non-GAP diluted EPS grew 50% year over year from $1.34 to $2.01 per share. As mentioned earlier, we had a 525 million dollar legal settlement representing 32 cents per share in the second quarter of 2023 that did not repeat in the second quarter of 2024. Excluding this settlement, EPS grew 21% year over year, reflecting higher product sales and lower expenses, including acquired IP R&D expenses. As highlighted on slide 27, we had a strong first half of the year with solid performance in each of our core franchises across virology and oncology, driving base business growth of 6% year-over-year, which is at the upper end of our full-year guidance of 4 to 6%.

Speaker Change: Excluding this payment, SG&A was up 2% year-over-year and includes commercial investments ahead of the launch of Celladelpar. Operating margin for the second quarter was 47%, our strongest operating margin since the third quarter of 2022, highlighting the leverage we have in our business model.

Andrew D. Dickinson: Turning to tax, our effective tax rate was approximately 18%, reflecting settlement with a tax authority in the second quarter.

Speaker Change: Turning to tax, our effective tax rate was approximately 18%, reflecting settlement with a tax authority in the second quarter.

Andy: On a reported basis, our non-GAP diluted EPS grew 50% year over year from $1.34 to $2.01 per share. As mentioned earlier, we had a 525 million dollar legal settlement representing 32 cents per share in the second quarter of 2023 that did not repeat in the second quarter of 2024. Excluding this settlement, EPS grew 21% year over year, reflecting higher product sales and lower expenses, including acquired IPR and DXP. As highlighted on slide 27, we had a strong first half of the year with solid performance in each of our core franchises across virology and oncology, driving base business growth of 6% year-over-year, which is at the upper end of our full-year guidance of 4 to 6%.

Speaker Change: On a reported basis, our non-gap diluted EPS grew 50% year over year from $1.34 to $2.1 cent per share.

Andrew D. Dickinson: As mentioned earlier, we had a 525 million dollar legal settlement representing 32 cents per share in the second quarter of 2023 that did not repeat in the second quarter of 2024. Excluding this settlement, EPS grew 21% year over year, reflecting higher product sales and lower expenses, including acquired IP R&D expenses. As highlighted on slide 27, we had a strong first half of the year with solid performance in each of our core franchises across virology and oncology, driving base business growth of 6% year-over-year, which is at the upper end of our full-year guidance of 4% to 6%. Switching to our expectations for 2024, on slide 28. We continue to expect total product sales in the range of $27.1 to $27.5 billion dollars, and total product sales, excluding VEKLURY, in the range of $25.8 to $26.2 billion dollars. Given the inherent variability experienced historically, and as stated previously, we are not updating our VEKLURY guidance at this time. As we think about the second half of the year, here are some of the factors that we are continuing to monitor.

Speaker Change: As mentioned earlier, we had a $525 million legal settlement representing $0.32 per share in the second quarter of 2023 that did not repeat in the second quarter of 2024.

Andrew D. Dickinson: Excluding this settlement, EPS grew 21% year over year, reflecting higher product sales and lower expenses, including acquired IP R&D expenses. As highlighted on slide 27, we had a strong first half of the year with solid performance in each of our core franchises across virology and oncology, driving base business growth of 6% year-over-year, which is at the upper end of our full-year guidance of 4 to 6%.

Speaker Change: Excluding this settlement, EPS grew 21% year-over-year reflecting higher product sales and lower expenses including acquired IPRD expenses.

Speaker Change: As highlighted on slide 27, we had a strong first half of the year with solid performance in each of our core franchises across virology and oncology, driving base business growth of 6% year over year, which is at the upper end of our full year guidance of 4 to 6%.

Andrew D. Dickinson: Switching to our expectations for 2024, on slide 28. We continue to expect total product sales in the range of $27.1 to $27.5 billion dollars, and total product sales, excluding VEKLURY, in the range of $25.8 to $26.2 billion dollars. Given the inherent variability experienced historically, and as stated previously, we are not updating our VEKLURY guidance at this time. As we think about the second half of the year, here are some of the factors that we are continuing to monitor. First, we continue to expect normal quarter-to-quarter variability in our HIV business that we have always experienced relative to average realized price associated with channel mix. Second, we expect quarterly variability in cell therapy due to continued in-class and out-of-class competition. Third, there is some uncertainty associated with Tredelvi bladder revenue following Tropic Soap 4. As a reminder, bladder represents less than 10% of total Tredelvi sales today.

Andy: Switching to our expectations for 2024, on slide 28, we continue to expect total product sales in the range of $27.1 to $27.5 billion and total product sales, excluding Vecluri, in the range of $25.8 to $26.2 billion. Given the inherent variability experienced historically, and as stated previously, we are not updating our VEC-LORI guidance at this time. However, as we think about the second half of the year, here are some of the factors that we are continuing to monitor.

Speaker Change: Switching to our expectations for 2024 on slide 28, we continue to expect total product sales in the range of $27.1 to $27.5 billion dollars and total product sales, excluding Vecluri, in the range of $25.8 to $26.2 billion dollars.

Speaker Change: Given the inherent variability experienced historically, and as stated previously, we are not updating our VEC-LORI guidance at this time.

Speaker Change: As we think about the second half of the year, here are some of the factors that we are continuing to monitor.

Andy: First, we continue to expect normal quarter-to-quarter variability in our HIV business that we have always experienced relative to average realized price associated with channel. Second, we expect quarterly variability in cell therapy due to continued in-class and out-of-class competition. Third, there is some uncertainty associated with Tredelvi bladder revenue following Tropic Soap 4. As a reminder, bladder represents less than 10% of total Tredelvi sales today.

Speaker Change: First, we continue to expect a normal quarter to quarter variability in our HIV business that we have always experienced relative to average realized price associated with channel mix.

Andrew D. Dickinson: Second, we expect quarterly variability in cell therapy due to continued in-class and out-of-class competition. Third, there is some uncertainty associated with TRODELVY bladder revenue following TROPiCS-04,as a reminder, bladder represents less than 10% of total TRODELVY sales today, and finally, there is a possibility of incremental FX headwinds in the second half of the year. For the rest of 2024, we continue to expect to deliver strong volume growth across all therapeutic areas and, assuming approval, SELADELPARas an incremental contributor to revenue growth. Continued HIV volume and revenue growth consistent with our full year expectation to grow HIV product sales by approximately 4% and continued focus on disciplined operating expense management. Moving to the non-GAAP guidance, there was no change to our non-GAAP gross margin range of 85% to 86%. For R&D, we now expect total R&D expense to increase by a low to mid-single-digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024 despite absorbing the late-stage SELADELPAR program. For SG&A, there is no change to our prior guidance pointing to a mid-single-digit decline compared to 2023. Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the CymaBay transaction.

Speaker Change: Second, we expect quarterly variability in cell therapy due to continued in-class and out-of-class competition.

Speaker Change: Third, there is some uncertainty associated with Trudovie bladder revenue following tropics so far, as a reminder bladder represents less than 10% of total Trudovie cells today. And finally, there is a possibility of incremental FX headwinds in the second half of the year.

Andy: And finally, there is a possibility of incremental FX headwinds in the second half of the year. For the rest of 2024, we continue to expect to deliver strong volume growth across all therapeutic areas and, assuming approval, sell Adelpar as an incremental contributor to revenue growth. Continued HIV volume and revenue growth consistent with our full year expectation to grow HIV product sales by approximately 4% and continued focus on disciplined operating expense management.

Speaker Change: For the rest of 2024, we continue to expect to deliver strong volume growth across all therapeutic areas and, assuming approval, sell Adelpar as an incremental contributor to revenue growth.

Andrew D. Dickinson: Continued HIV volume and revenue growth consistent with our full year expectation to grow HIV product sales by approximately 4% and continued focus on disciplined operating expense management. Moving to the non-GAAP guidance, there was no change to our non-GAAP gross margin range of 85% to 86%. For R&D, we now expect total R&D expense to increase by a low to mid-single-digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024 despite absorbing the late-stage SELADELPAR program. For SG&A, there is no change to our prior guidance pointing to a mid-single-digit decline compared to 2023. Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the CymaBay transaction.

Speaker Change: Continued HIV volume and revenue growth consistent with our full year expectation to grow HIV product sales by approximately 4% and continued focus on disciplined operating expense management.

Andrew D. Dickinson: Moving to the non-GAAP guidance, there was no change to our non-GAAP gross margin range of 85% to 86%. For R&D, we now expect total R&D expense to increase by a low to mid-single-digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024 despite absorbing the late-stage SELADELPAR program. For SG&A, there is no change to our prior guidance pointing to a mid-single-digit decline compared to 2023. Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the CymaBay transaction. For acquired IPR&D, we now expect full-year expenses of $4.7 billion, up from $4.4 billion last quarter, to reflect a $320 million transaction with Janssen to buy out the global Celadel Park royalty. This expense will be included in our third quarter results. Finally, with the strong operational expense control demonstrated in both the first and second quarters and despite this new $320 million acquired IPR&D expense, we are increasing our operating income guidance to $7.2 to $7.6 billion and increasing our non-GAAP diluted EPS guidance to $3.60 to $3.90.

Andy: Moving to the non-GAAP guidance, there was no change to our non-GAAP gross margin range of 85 to 86%. For R&D, we now expect total R&D expense to increase by a low to mid-single-digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024 despite absorbing the late-stage CELA-DELPAR program. For SG&A, there is no change to our prior guidance pointing to a mid-single-digit decline compared to 2023. Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the Sima Bay transaction.

Speaker Change: Moving to the non-GAAP guidance.

Speaker Change: There is no change to our non-gap growth margin range of 85 to 86%.

Andrew D. Dickinson: For R&D, we now expect total R&D expense to increase by a low to mid-single-digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024 despite absorbing the late-stage SELADELPAR program. For SG&A, there is no change to our prior guidance pointing to a mid-single-digit decline compared to 2023. Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the CymaBay transaction.

Speaker Change: For R&D, we now expect total R&D expense to increase by a low to mid-single-digit percentage compared to 2023, reflecting lower than previously expected R&D expenses in 2024, despite absorbing the late-stage CELA-DELPAR program.

Speaker Change: For SGNA, there is no change to our prior guidance, pointing to a mid-single digit decline compared to 2023.

Speaker Change: Consistent with our expectations last quarter, we have been able to absorb the incremental expenses associated with the Sima Bay transaction.

Andy: For acquired IPR&D, we now expect full-year expenses of $4.7 billion, up from $4.4 billion last quarter, to reflect a $320 million transaction with Janssen to buy out the global Celadel Park royalty. This expense will be included in our third quarter results. Finally, with the strong operational expense control demonstrated in both the first and second quarters and despite this new $320 million acquired IPR&D expense, we are increasing our operating income guidance to $7.2 to $7.6 billion and increasing our non-GAAP diluted EPS guidance to $3.60 to $3.90.

Andrew D. Dickinson: For acquired IPR&D, we now expect full-year expenses of $4.7 billion, up from $4.4 billion last quarter, to reflect a $320 million dollars transaction with Janssen to buy out the global SELADELPAR royalties, this expense will be included in our third quarter results. Finally, with the strong operational expense control demonstrated in both the first and second quarters and despite this new $320 million dollars acquired IPR&D expense, we are increasing our operating income guidance to $7.2 to $7.6 billion and increasing our non-GAAP diluted EPS guidance to $3.60 to $3.90. Slide 29 highlights that the increase to our EPS guidance fully absorbs the $320 million dollars, or approximately $0.20 per share, expense associated with the buyout of the SELADELPAR royalty from Janssen. This transaction removes Gilead's royalty obligation to pay 8% of SELADELPAR sales, excluding this transaction, our EPS guidance increase would have been even more significant today, up 30 cents or 8% at the midpoint, again highlighting the financial discipline that is translated into operating leverage. Moving to slide 30, we continue to have sufficient flexibility in our balance sheet to execute on our capital allocation priorities, in the second quarter, we returned $1.1 billion to shareholders, repaid $1.75 billion of senior notes, and paid $1.2 billion as part of the federal transition tax associated with the Tax Cuts and Jobs Act of 2017. The remaining transition tax payment of $1.3 billion is scheduled for April of 2025.

Speaker Change: For acquired IPR&D, we now expect full-year expenses of $4.7 billion, up from $4.4 billion last quarter, to reflect a $320 million transaction with Janssen to buy out the global Celadon Par Royalty.

Speaker Change: This expense will be included in our third quarter results.

Speaker Change: Finally, with the strong operational expense control demonstrated in both the first and second quarters,

Speaker Change: and despite this new $320 million acquired IPR&D expense.

Speaker Change: We are increasing our operating income guidance to $7.2 to $7.6 billion and increasing our non-GAAP diluted EPS guidance to $3.60 to $3.90.

Andrew D. Dickinson: Slide 29 highlights that the increase to our EPS guidance fully absorbs the $320 million dollars, or approximately $0.20 per share, expense associated with the buyout of the SELADELPAR royalty from Janssen. This transaction removes Gilead's royalty obligation to pay 8% of SELADELPAR sales, excluding this transaction, our EPS guidance increase would have been even more significant today, up 30 cents or 8% at the midpoint, again highlighting the financial discipline that is translated into operating leverage. Moving to slide 30, we continue to have sufficient flexibility in our balance sheet to execute on our capital allocation priorities, in the second quarter, we returned $1.1 billion to shareholders, repaid $1.75 billion of senior notes, and paid $1.2 billion as part of the federal transition tax associated with the Tax Cuts and Jobs Act of 2017. The remaining transition tax payment of $1.3 billion is scheduled for April of 2025.

Andy: Slide 29 highlights that the increase to our EPS guidance fully absorbs the $320 million, or approximately $0.20 per share, expense associated with the buyout of the Sela del Par royalty from Yonsei. This transaction removes Gilead's royalty obligation to pay 8% of Celadon Parcells.

Speaker Change: Slide 29 highlights that the increase to our EPS guidance fully absorbs the $320 million, or approximately $0.20 per share, expense associated with the buyout of the Cella Del Par royalty from Janssen.

Speaker Change: This transaction removes Gilead's royalty obligation to pay 8% of Celladelpar's sales.

Andy: Excluding this transaction, our EPS guidance increase would have been even more significant today, up 30 cents or 8% at the midpoint, again highlighting the financial discipline that is translated into operating leverage. Moving to slide 30, we continue to have sufficient flexibility in our balance sheet to execute on our capital allocation priorities. In the second quarter, we returned $1.1 billion to shareholders, repaid $1.75 billion of senior notes, and paid $1.2 billion as part of the federal transition tax associated with the Tax Cuts and Jobs Act of 2017. The remaining transition tax payment of $1.3 billion is scheduled for April of 2025.

Speaker Change: Excluding this transaction, our EPS guidance increase would have been even more significant today, up 30 cents or 8% at the midpoint, again highlighting the financial discipline that is translated into operating leverage.

Andrew D. Dickinson: Moving to slide 30, we continue to have sufficient flexibility in our balance sheet to execute on our capital allocation priorities, in the second quarter, we returned $1.1 billion to shareholders, repaid $1.75 billion of senior notes, and paid $1.2 billion as part of the federal transition tax associated with the Tax Cuts and Jobs Act of 2017. The remaining transition tax payment of $1.3 billion is scheduled for April of 2025.

Speaker Change: Moving to slide 30, we continue to have sufficient flexibility in our balance sheet to execute on our capital allocation priorities.

Speaker Change: In the second quarter, we returned $1.1 billion to shareholders.

Speaker Change: Repaid $1.75 billion of senior notes, and paid $1.2 billion as part of the federal transition tax associated with the Tax Cuts and Jobs Act of 2017.

Speaker Change: The remaining transition tax payment of $1.3 billion is scheduled for April of 2025.

Andy: Overall, we believe that Gilead is well positioned for near and long-term growth, and we continue to be focused on commercial execution, expense management discipline, and delivering on our strategic commitment. And now, I'll invite Rebecca to begin the Q&A. Thank you, Andy. At this time, we'll open up the call.

Andrew D. Dickinson: Overall, we believe that Gilead is well positioned for near and long-term growth, and we continue to be focused on commercial execution, expense management discipline, and delivering on our strategic commitment. And now, I'll invite Rebecca to begin the Q&A.

Speaker Change: Overall, we believe that Gilead is well-positioned for near and long-term growth, and we continue to be focused on commercial execution, expense management discipline, and to delivering on our strategic commitments.

Thank you, Andy. At this time, we'll open up the call.

Operator: Thank you, Andy, at this time, we'll open up the call for questions. We ask you to 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. Go ahead. Your line is open. Hi there this is Evan Seigerman from BMO Capital Markets. I wanted to touch on TIGIT, there's been a lot of updates in the TIGIT space, you know after ASCO, we had the Roche update, and most recently Merck discontinued a key vibe study in small cell-lung cancer. So Merdad maybe you could just walk us through how do you think about the opportunity for TIGIT? And good would look like for you in terms of both safety and efficacy with the start of 121 program? Thank you very much.

Speaker Change: And now, I'll invite Rebecca to begin the Q&A.

Rebecca: Thank you, Andy. At this time we'll open up the call for questions. We ask you to be courteous and limit yourself to one question so that we can get to as many analysts as possible during today's call.

Evan Seigerman: Hi there this is Evan Seigerman from BMO Capital Markets. I wanted to touch on TIGIT, there's been a lot of updates in the TIGIT space, you know after ASCO, we had the Roche update, and most recently Merck discontinued a key vibe study in small cell-lung cancer. So Merdad maybe you could just walk us through how do you think about the opportunity for TIGIT? And good would look like for you in terms of both safety and efficacy with the start of 121 program? Thank you very much.

Speaker Change: i

Rebecca: Go ahead, your line is open.

Speaker Change: Hi there, this is Evan Seigerman from BMO Capital Markets.

Evan Seigerman: Um, I wanted to touch on digits. There's been a lot of updates in the digits space, and now after ASCII we had the rush update, and most recently, Merck discontinued their keybibes study and small cell lung cancer. So Merdad, didn't you could just walk us through how you think about the opportunity for Tidjid, and what looks good, what good would look like for you in terms of both safety and efficacy, but the star one to one program. Thank you so much.

Speaker: Thanks, Evan, for the question. Yeah, I think, as you noted, there have been a lot of updates on TIGIT over the past six months or so, and I think that gets to our approach, which I think is somewhat differentiated from our competition in that. As we've said all along, we have a differentiated molecule first off, and that is that we have an FC silent molecule relative to an FC active molecule that the competition has. And I would note that this is demonstrating a difference in terms of the adverse event profile, including the data that were highlighted today. Additionally, I think we've tried to stay focused on areas where we believe that there is the best chance of activity.

Merdad V. Parsey: Thanks, Evan, for the question. Yeah, I think, as you noted, there have been a lot of updates on TIGIT over the past six months or so, and I think that gets to our approach, which I think is somewhat differentiated from our competition in that. As we've said all along, we have a differentiated molecule first off, and that is that we have an FC silent molecule relative to an FC active molecule that the competition has. And I would note that this is demonstrating a difference in terms of the adverse event profile, including the data that were highlighted today.

Speaker Change: but

Merdad Parsey: Thanks, Evan, for the question.

Merdad Parsey: Yeah, I think, as you know, as you noted, there have been a lot of updates on TIGIT over the past six months or so, and I think that gets to our approach, which I think is somewhat differentiated from our competition in that

As we've said along, we have a differentiated molecule first off, and that is that we have an FC silent molecule relative to an FC active molecule that the competition has. And we know that that is...

Speaker: And I would note that this is demonstrating a difference in terms of the adverse event profile, including the data that were highlighted today. Additionally, I think we've tried to stay focused on areas where we believe that there is the best chance of activity.

Speaker Change: demonstrating a difference in terms of the adverse event profile including the data that were highlighted today.

Merdad V. Parsey: Additionally, I think we've tried to stay focused on areas where we believe that there is the best chance of activity, and so, for example, we have not initiated any trials with small cells. We look forward to capitalizing on the data we have seen so far, both in non-small cell lung cancer and gastric cancer. As you know, we provided an update on the EDGE gastric study at ASCO, and as I noted in the call, we have completed enrollment in the Phase III trial of that. So we continue to be cautiously optimistic about TIGIT and are doing it in a data-driven way based on the data we've generated in our trials so far.

Additionally, I think we've...

We try to stay focused in areas where we believe that there is the best chance of activity. And so, for example, we have not initiated any trials with small cell. We look forward to...

Speaker: And so, for example, we have not initiated any trials with small cells. We look forward to capitalizing on the data we have seen so far, both in non-small cell lung cancer and gastric cancer. As you know, we provided an update on the EDGE gastric study at ASCO, and as I noted in the call, we have completed enrollment in the Phase III trial of that. So we continue to be cautiously optimistic about Digit and are doing it in a data-driven way based on the data we've generated in our trials so far.

capitalizing on the data we have seen so far, both in non-small cell lung cancer and gastric cancer. As you know, we provided an update on the EDGE gastric study at ASCO.

and as I noted in the call, we have completed an online event of the Phase 3 trial of that. So we continue to be cautiously optimistic about digit and are doing it in a data driven way based on the data we have generated in our trials so far.

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

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

Terence Flynn: Great. Thanks for taking that question, a two-part for me. Just, Merdad, wondering if you can help frame expectations for the PURPOSE 2 trial, just given this is a slightly different population relative to PURPOSE 1. So just as we think about level setting ahead of that data, and then the second part is for Johanna. So, you know, obviously, you guys noted that you've seen growth in the prep market recently, which is encouraging, but what other steps can you as a company take to maybe help alleviate some of the payer roadblocks that are really still in the way of branded prep use, given the still high level of generic Truvada use? Thank you.

Great. Thanks for taking the question. Two-part for me. Just, Merdad, wondering if you can help frame expectations for the Purpose 2 trial, just given this is a slightly different population relative to Purpose 1, so just as we think about level setting there ahead of that data. And then the second part is for Johanna.

Terence Flynn: So, you know, obviously, you guys noted that you've seen growth in the prep market recently, which is encouraging, but what other steps can you as a company take to maybe help alleviate some of the payer roadblocks that are really still in the way of branded prep use, given the still high level of generic Truvada use? Thank you.

You know, obviously, you guys noted that you've seen growth in the prep market recently, which is encouraging, but what other steps can you as a company take to maybe

You know, help alleviate some of the payer roadblocks that are really still in the way of branded prep use, given the still high level of generic Truvada use. Thank you.

Speaker: That's two-part for me. Just, Merdad, wondering if you can help frame expectations for the Purpose 2 trial, just given this is a slightly different population relative to Purpose 1. So just as we think about level setting ahead of that data, and then the second part is for Johanna. So, you know, obviously, you guys noted that you've seen growth in the prep market recently, which is encouraging, but what other steps can you as a company take to maybe help alleviate some of the payer roadblocks that are really still in the way of branded prep use, given the still high level of generic Truvada use? Thank you.

Thanks, Terence, I'll start and then I'll hand it off with Johanna.

Merdad V. Parsey: Thanks, Terence. I'll start and then I'll hand it off to Johanna, as you said. It's a great question and a good thing for us to make sure that everyone remembers. PURPOSE-1 was the trial that was in cisgender women, and as I noted, PURPOSE-2 is our ongoing study in cisgender gay men, transgender women and men, and gender non-binary people. Now, that study is ongoing, it is the second trial that's necessary for filing, and like PURPOSE-1, PURPOSE-2 is designed to evaluate the superiority of LENACAPAVIR against background HIV rates. That's the primary endpoint, and the secondary endpoint will be similar to PURPOSE-1, and it will be superior to Truvada as a secondary endpoint. So once and if we, hopefully, demonstrate a positive result in PURPOSE-2, we would combine those data with PURPOSE-1 and move as quickly as possible to filing those data to LENACAPAVIR 4 for PrEP.

As you said, um...

It's a great question and a good thing for us to make sure that everyone remembers. Purpose 1 was the trial that was in cisgender women, and as I noted, Purpose 2 is our ongoing study in the cisgender community.

Speaker: It's a great question and a good thing for us to make sure that everyone remembers. Purpose 1 was the trial that was in cisgender women, and as I noted, Purpose 2 is our ongoing study in cisgender gay men, transgender women and men, and gender non-binary people. Now, that study is ongoing. It is the second trial that's necessary for filing, and like Purpose 1, Purpose 2 is designed to evaluate the superiority of Lenacavivir against background HIV rates.

Gay Men, Transgender Women and Men, and Gender Non-Binary People. Now, that study is ongoing. It is the second trial that's necessary for...

Speaker: That's the primary endpoint, and the secondary endpoint will be similar to Purpose 1, and it will be superior to Truvada as a secondary endpoint. So once we, hopefully, demonstrate a positive result in Purpose 2, we would combine those data with Purpose 1 and move as quickly as possible to file those data for Lenacavivir 4 for PrEP.

for filing. And like Purpose One, Purpose Two is designed to evaluate the superiority of Lenacapavir against background HIV rates.

Merdad V. Parsey: That's the primary endpoint, and the secondary endpoint will be similar to PURPOSE-1, and it will be superior to Truvada as a secondary endpoint. So once and if we, hopefully, demonstrate a positive result in PURPOSE-2, we would combine those data with PURPOSE-1 and move as quickly as possible to filing those data to LENACAPAVIR 4 for PrEP.

That's the primary endpoint, and the secondary endpoint would be similar to purpose.

One will be Superior Trubada as a secondary endpoint.

So, once we, if, hopefully, we demonstrate a positive result in Purpose 2, we would combine those data with Purpose 1 and move as quickly as possible to filing those data to Lenin-Kapovir 4 for PrEP.

Johanna Mercier: So maybe just to complete the second part of that question around the growth in PrEP and what the opportunities lie ahead, despite some of the payroll blocks that you were referring to. Just a couple of points on that, one is today the market for PrEP is growing at about 12% or so year on year, so, nice, consistent growth that we've seen over the last couple of years. DESCOVY's coverage is over 90% of all lives are covered from an access standpoint, so today the daily orals do not have any concerns from an access standpoint. I think maybe what you're referring to is, potentially, as we think about medical benefits versus a pharmacy benefit, that might create a little bit more access headwinds from a payer standpoint, and we've seen that already with some of our competitors. As we think about LENACAPAVIR, in light of not only the data, just most recently with PURPOSE-1, but also just the profile that it offers with a twice-yearly sub-Q, I think it really allows us to redefine the prep market as a whole. And as much as we're seeing today, maybe over 400,000 users in the US, we really see three major growth opportunities, one is around market size growth, the other one is around market share growth, and the third one is on adherence, so I will just break those down a little bit.

three

So maybe just to complete the second part of that question around the growth in PrEP and what the opportunity lies ahead.

Despite some of the payroll blocks that you were referring to, just a couple of points on that. One is today the market for PrEP is growing at about 12% or so year-on-year, so nice consistent growth that we've seen over the last couple of years. Discobee's coverage

Johanna: One is today the market for PrEP is growing at about 12% or so year on year. So, nice, consistent growth that we've seen over the last couple of years. DSCOBY's coverage.

Johanna: Over 90% of all lives are covered from an access standpoint, so today the daily orals do not have any concerns from an access standpoint. I think maybe what you're referring to is, potentially, as we think about medical benefits versus a pharmacy benefit, that might create a little bit more access headwinds from a payer standpoint, and we've seen that already with some of our competitors. As we think about Lenacapavir, in light of not only the data, just most recently with Purpose One, but also just the profile that it offers with a twice-yearly sub-Q, I think it really allows us to redefine the prep market as a whole, and as much as we're seeing today, maybe over 400,000 users in the U.S., we really see three major growth opportunities. One is around market size growth, the other one So I will just break those down a little bit.

These over 90% of all lives are covered from an access standpoint, so today the daily orals do not have.

Johanna Mercier: I think maybe what you're referring to is, potentially, as we think about medical benefits versus a pharmacy benefit, that might create a little bit more access headwinds from a payer standpoint, and we've seen that already with some of our competitors. As we think about LENACAPAVIR, in light of not only the data, just most recently with PURPOSE-1, but also just the profile that it offers with a twice-yearly sub-Q, I think it really allows us to redefine the prep market as a whole. And as much as we're seeing today, maybe over 400,000 users in the US, we really see three major growth opportunities, one is around market size growth, the other one is around market share growth, and the third one is on adherence, so I will just break those down a little bit.

Any concerns from an access standpoint? I think maybe what you're referring to is potentially, as we think about medical benefits.

Versus a pharmacy benefit that might create a little bit more

access headwinds from a payer standpoint, and we've seen that already with some of our competitors.

As we think about Lenacapivir, in light of not only the data, just most recently with Purpose One, but also just the profile that it offers with a twice-yearly sub-Q,

Johanna Mercier: And as much as we're seeing today, maybe over 400,000 users in the US, we really see three major growth opportunities, one is around market size growth, the other one is around market share growth, and the third one is on adherence, so I will just break those down a little bit. The market size growth is around reaching more users, so well beyond just white MSMs, thinking about cisgender women, transgender men and women, Latinos, and black individuals, as well as young adults. Reaching more prescribers in different settings than we are today, and over time, reaching more countries, right? Because right now, PrEP revenues are really coming primarily from the United States. From a market share growth standpoint, DESCOVY is the number one branded daily oral today with over 40% share, and we believe LENACAPAVIR will be number one from a law-enacting standpoint.

I think it really allows us to redefine the prep market as a whole, and as much as we're seeing today maybe over 400,000 users in the U.S., we really see three major growth opportunities.

Johanna: The market size growth is around reaching more users, so well beyond just white MSMs, thinking about cisgender women, transgender men and women, Latinos, and black individuals, as well as young adults. Reaching more prescribers in different settings than we are today, and over time, reaching more countries, right? Because right now, PrEP revenues are really coming primarily from the United States. From a market share growth standpoint, Dyscovy is the number one branded daily oral today with over 40% share. And we believe Lenacapsbria will be number one from a law-enacting standpoint.

One is around market size growth, the other one's around market share growth, and the third one is on endurance. So if I just break those down a little bit.

The market size growth is around reaching more users, so well beyond just white MSM's, thinking about cisgender women, transgender men and women, Latino, black individuals, as well as young adults.

Reaching more prescribers in different settings than we are today and over time reaching more countries right because right now PrEP revenues are really coming primarily out of the United States.

Johanna Mercier: From a market share growth standpoint, DESCOVY is the number one branded daily oral today with over 40% share, and we believe LENACAPAVIR will be number one from a law-enacting standpoint. And between the two together, we believe the Gilead presence in HIV prevention will also be leading and greater than where we are today. And last but not least is higher adherence, and that just has to do with frequency of administration, when you think about a twice-yearly sub-q has much higher adherence than a daily oral and obviously better outcomes. So all those pieces together is what we are focused on as an opportunity for the future of prevention with not only DESCOVY but obviously with LENACAPAVIR around the corner, potentially. And from an access standpoint, we are thinking ahead as we think about even the work that CMS is doing when they think about making it a Part B drug for medical benefit in PrEP to ensure greater access. But we're also thinking through how this is gonna impact from both prescribers' standpoints and how we support that reimbursement, challenges that I think others have been facing and how we basically do a very high-touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice.

From a market share growth standpoint, Discovery has been number one brand daily oral today, with over 40% share, and we believe Lenna Capspire will be number one from a law-enacting standpoint, and between the two together, we believe the Gillian presence in HIV prevention will also be leading and greater than where we are today.

Johanna: And between the two together, we believe the Gilead presence in HIV prevention will also be leading and greater than where we are today. And last but not least, higher adherence. And that just has to do with frequency of administration.

And lock the knot Lisa's higher gear in, and that just has to do with a domesticated...

Johanna: When you think about a twice-yearly subcue has much higher adherence than a daily oral and obviously better outcomes, so all those pieces together are what we are focused on as an opportunity for the future of prevention with not only Dyscovee but obviously with Lenacapivir around the corner, potentially. And from an access standpoint, we are thinking ahead as we think about even the work that CMS is doing when they think about making it a Part B drug for medical benefit in PrEP to ensure greater access.

Johanna Mercier: So all those pieces together is what we are focused on as an opportunity for the future of prevention with not only DESCOVY but obviously with LENACAPAVIR around the corner, potentially. And from an access standpoint, we are thinking ahead as we think about even the work that CMS is doing when they think about making it a Part B drug for medical benefit in PrEP to ensure greater access. But we're also thinking through how this is gonna impact from both prescribers' standpoints and how we support that reimbursement, challenges that I think others have been facing and how we basically do a very high-touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice.

The preconceived administration, when you think about a twice nearly subq had much higher adherence.

Then a daily oral, and obviously got our outcomes. So all those pieces together is what we are focused on as an opportunity for the future of prevention with...

Not only Discovery, but obviously with Lena Kappavier around the corner potentially. And from an access standpoint, we are thinking ahead as we think about even the work that CMS is doing when they think about

Johanna Mercier: But we're also thinking through how this is gonna impact from both prescribers' standpoints and how we support that reimbursement, challenges that I think others have been facing and how we basically do a very high-touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice.

You know, making it a Part B drug for medical benefit in PrEP to ensure greater access, but we're also thinking through how is this going to impact from both from a prescriber's standpoint and how do we support that reimbursement.

Johanna: But we're also thinking through how this is gonna impact from both prescribers' standpoints and how we support that reimbursement, challenges that I think others have been facing and how we basically do a very high-touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice. As a reminder, please limit yourself to one question so we can get to as many analysts as possible today. Our next question comes from Daina Graybosch of Lee Ring Partners. Go ahead. Your line is open. Hi, thanks for the question. I want to ask on Anita's cell phone.

But we're also thinking through how this is gonna impact from both prescribers' standpoints and how we support that reimbursement, challenges that I think others have been facing and how we basically do a very high-touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice.

As a reminder, please limit yourself to one question so we can get to as many analysts as possible today. Our next question comes from Daina Graybosch of Leerink Partners. Go ahead. Your line is open. Hi, thanks for the question. I want to ask on Anita's cell phone.

challenges that I think others have been facing and how we basically do a very high-touch approach here to make sure everyone who needs or wants PrEP gets access to their drug of choice.

Speaker: As a reminder, please limit yourself to one question so we can get to as many analysts as possible today. Our next question comes from Daina Graybosch with Leerink Partners. Go ahead, your line is open. Hi, thanks for the question. I want to ask on Anito-Cel, a two part. One is just a process factual, I wonder if you can confirm whether you have completed enrollment in iMMagine-1? And that's what kind of follow-up time we can expect from the data, should it be accepted at ash? And then a deepet question on iMMagine-3, I wonder what your approach is in iMMagine-3 [inaudible] therapy to ask to avoid the higher risk of death that was observed in the competitor trials soon after enrollment? Thank you.

As a reminder, please limit yourself to one question so we can get to as many analysts as possible today. Our next question comes from Daina Graybosch with Leerink Partners. Go ahead, your line is open. Hi, thanks for the question. I want to ask on Anito-Cel, a two part. One is just a process factual, I wonder if you can confirm whether you have completed enrollment in iMMagine-1? And that's what kind of follow-up time we can expect from the data, should it be accepted at ash? And

Operator: As a reminder, please limit yourself to one question so we can get to as many analysts as possible today. Our next question comes from Daina Graybosch with Leerink Partners. Go ahead, your line is open.

As a reminder, please limit yourself to one question so we can get to as many analysts as possible today.

Our next question comes from the rereading partners. Go ahead, your line is open. Aye.

Daina Graybosch: Hi, thanks for the question. I want to ask on Anito-Cel, a two part. One is just a process factual, I wonder if you can confirm whether you have completed enrollment in iMMagine-1? And that's what kind of follow-up time we can expect from the data, should it be accepted at ash? And then a deepet question on iMMagine-3, I wonder what your approach is in iMMagine-3 bridging therapy to ask to avoid the higher risk of death that was observed in the competitor trials soon after enrollment? Thank you.

Hi, thanks for the question. I want to ask on a needle cell, a two part. One is just a process factual. I wonder if you can confirm whether you have completed enrollment, and imagine one, and that's what kind of follow-up time we can expect in the data, should it be accepted at ash.

then a deepet question on iMMagine-3, I wonder what your approach is in iMMagine-3 [inaudible] therapy to ask to avoid the higher risk of death that was observed in the competitor trials soon after enrollment? Thank you.

and then a deeper question on Imagine 3. I wonder what your approach is in Imagine 3 to bridging therapy, so as to avoid the higher risk of death that was observed in the competitor trials soon after enrollment. Thank you.

Speaker: Thanks Daina, so we've got Cindy Perettie here, we'll turn it over to her to answer that. Thanks for the question.

Thanks, Dan. So, we've got Cindy Perettie here. We'll turn it over to her to answer that. Thank you for the question.

Cindy Perettie: Thanks Daina, you know, we continue to be really excited about the potential of the Anito-cel with its best-in-class profile, and our enrollment target for iMMagine-1 has been met. I think the second question you asked is what type of follow-up we would expect to see at ASH, and I think we're in the process of, we did an initial cut, obviously, for the abstract, we'll do a second cut for the final sharing of the data, so I don't have the exact follow-up time, but we can certainly look to follow up with you once we have that. Your second question was about iMMagine-3 and bridging therapy. Right now, we will be moving, so we were able to complete the tech transfer, as you heard from Dan, into our Maryland production facility. So we will be supplying therapy out of our Maryland facility, and we expect to apply a lot of the learnings that we have with our existing products on the market today and be able to get a Anita-cell back to those patients in iMMagine-3, as it relates to having time up front to do bridging therapy. However, with the protocol design today, we do have the option to do bridging therapy if necessary for patients.

Thanks, Daina. You know, we continue to be really excited about the potential with Anita Salveen with its best-in-class profile, and our enrollment target for Imagine One has been met.

I think the second question you asked is what type of follow-up would we expect to see at ash and I think if we're in the process of we did an initial cut obviously for the abstract we'll do a second cut.

Cindy Perettie: So I don't have the exact follow-up time, but we can certainly look to follow up with you once we have that. Your second question was about Imagine Three and bridging therapy. Right now, we will be moving, so we were able to complete the tech transfer, as you heard from Dan, into our Maryland production facility. So we will be supplying therapy out of our Maryland facility, and we expect to apply a lot of the learnings that we have with our existing products on the market today and be able to get a NIDA cell back to those patients in Imagine Three, as it relates to the NIDA cell, having time up front to do bridging therapy.

for the final sharing of the data. So I don't have the exact all the way up time, but we can certainly...

look to follow up with you once we have that.

Cindy Perettie: Your second question was about iMMagine-3 and bridging therapy. Right now, we will be moving, so we were able to complete the tech transfer, as you heard from Dan, into our Maryland production facility. So we will be supplying therapy out of our Maryland facility, and we expect to apply a lot of the learnings that we have with our existing products on the market today and be able to get a Anita-cell back to those patients in iMMagine-3, as it relates to having time up front to do bridging therapy. However, with the protocol design today, we do have the option to do bridging therapy if necessary for patients.

Your second question was around Imagine 3 and bridging therapy. Right now, we will be moving, so we were able to complete the tech transfer, as you heard from Dan, into our Maryland production facility, so we will be supplying therapy out of our Maryland facility, and we expect

to apply a lot of the learnings that we have with our existing products on the market today and be able to get AnitaCell back to those patients in Imagine 3 as it relates to

Cindy Perettie: However, with the protocol design today, we do have the option to do bridging therapy if necessary for patients. Next question comes from Umer Raffat. Report. Go ahead, your line is open. Hi guys, thanks for taking my question. I'm very intrigued about your...

Having time up front to do bridging therapy, however, with the protocol design today, we do have the option to do bridging therapy if necessary for patients.

Operator: Our next question comes from Umer Raffat of Evercore. Go ahead; your line is open. Hi guys, thanks for taking my question. I'm very intrigued about your LENACAPAVIR+BICTEGRAVIR trial heading into Phase III, and I'm just trying to understand could this regimen possibly replace BIKTARVY to a meaningful extent? Or would you rather have some sort of low dose [inaudible] in that combination as well as a second alternative? I'm just thinking back to some of the [inaudible] experiences as well. Thank you very much

Operator: Our next question comes from Umer Raffat of Evercore. Go ahead; your line is open.

Our next question comes from Umer Raffat of Ezra Corps. Go ahead, your line is open.

Umer Raffat: Hi guys, thanks for taking my question. I'm very intrigued about your LENACAPAVIR+BICTEGRAVIR trial heading into Phase III, and I'm just trying to understand could this regimen possibly replace BIKTARVY to a meaningful extent? Or would you rather have some sort of low dose [inaudible] in that combination as well as a second alternative? I'm just thinking back to some of the Dovato experiences as well. Thank you very much.

Hi guys, thanks for taking my question. I'm very intrigued about your Lenacaprevir plus Bictegravir trial heading into phase 3, and I'm just trying to understand, could this regimen possibly replace Bictarvy to a meaningful extent?

Or would you rather have some sort of a low-dose nuke in that combination as well as a second alternative? I'm just thinking back to some of the Davado experiences as well. Thank you very much.

Johanna Mercier: So maybe I'll take that one, Umer. So the LEN/BIC combination is a single treatment regimen that really combines a best-in-class integrase inhibitor with a first-in-class capsid. The studies that we are doing, both Phase II and III, are really, first, we looked at the complex regimen, which was kind of the first step, and as we go into phase three, we believe we can get a broader label indication to also include all virologically suppressed. So as we think about that opportunity, we think it's an opportunity for an STR that's optimized, simplified for complex regimens, but also provides optionality in the virologically suppressed switch segment of the marketplace. So as we think about it as a portfolio perspective, we still believe that today, BIKTARVY is the standard of care and will remain the standard of care from a daily oral standpoint, but we also think that's an opportunity in the switch segment. So Naive is a big piece, probably the biggest piece for BIKTARVY's growth and the switch because we have such a large share, obviously, right? So from a switch segment, that offers us another opportunity for us to play in a bigger market space in HIV.

So, maybe I'll take that one out of nowhere. So, the Lendick combination is a single treatment regimen that really combines a best in class integration inhibitor with a first-in-class cockpit. The studies that we are doing those days too.

and three are really, first we looked at the complex regimen, which that was kind of the first step, and as we go into phase three, we believe we can get a broader label indication to also include all virologically suppressed.

Speaker: So as we think about that opportunity, we think it's an opportunity for an STR that's optimized, simplified for complex regimens, but also provides optionality in the virologically suppressed switch segment of the marketplace. So as we think about it from a portfolio perspective, we still believe that today, Big Tarvy is the standard of care and will remain the standard of care from a daily oral standpoint, but we also think that there is an opportunity in the switch segment. So Naive is a big piece, probably the biggest piece for Big Tarvy's growth and the switch because we have such a large share, obviously, right?

So as we think about that opportunity, we think it's an opportunity for an FTR that's optimized, simplified for complex regimen, but also provides optionality in the virologically suppressed switch segment.

Johanna Mercier: So as we think about it as a portfolio perspective, we still believe that today, BIKTARVY is the standard of care and will remain the standard of care from a daily oral standpoint, but we also think that's an opportunity in the switch segment. So Naive is a big piece, probably the biggest piece for BIKTARVY's growth and the switch because we have such a large share, obviously, right? So from a switch segment, that offers us another opportunity for us to play in a bigger market space in HIV.

of the Marketplace.

So what we think about it as a portfolio perspective, we still believe that today Victoria is the standard of care and will remain as a standard of care from a daily oral standpoint, but we also think that's an opportunity in the switch segment. So naive is a big piece, probably the biggest piece for...

Big Tar B's growth, and the switch because we have such a large share, obviously, right. So from a switch segment that offers us another opportunity for us to play in a bigger market space in HIV.

Operator: The next question is from Carter Gould at Barclays. Go ahead, Carter. Your line is open. Great, thank you, good afternoon, thanks for taking the question Maybe another one on Purpose One. So again, yeah, the efficacy was very impressive. However, we did see

Operator: The next question is from Carter Gould at Barclays. Go ahead, Carter. Your line is open.

Carter Gould: Great, thank you, good afternoon, thanks for taking the question, maybe another one on PURPOSE-1. So again, yeah, the efficacy was very impressive, however, we did see north of 20% of patients did have nodules all up to week 52? And I guess for Johanna, as you think about that profile in this setting, recognizing they were only great one but, you know, just sort of the long-term nature of those nodules. How do you see that influencing or impacting profile, it's demand and the potential for those patients to then go back and get retreated after six months? Thank you.

Speaker: So from a switch segment, that offers us another opportunity for us to play in a bigger market space in HIV. Next question is from Carter Gould at Barclays. Go ahead, Carter. Your line is open. Great, thank you. Good afternoon. Thanks for taking the question.

So from a switch segment, that offers us another opportunity for us to play in a bigger market space in HIV.

yeah

Next question is from Carter Gould at Barclays. Go ahead, Carter. Your line is open. Great, thank you. Good afternoon. Thanks for taking the question.

Our next question is from Carter Gould at Barclays. Go ahead, Carter. Your line is open.

Speaker: Maybe another one on Purpose One. So again, yeah, the efficacy was very impressive. However, we did see

Great. Thank you. Good afternoon. Thanks for taking the question. Maybe another one on Purpose 1. So again, yeah, the efficacy was very impressive. However, we did see that north of 20% of patients did have nodules out to Week 52. And I guess for Johanna, as you think about that profile in this setting, recognizing they were only Grade 1, but sort of the long-term nature of those nodules,

How do you see that influence or influencing or impacting the profile, it's demand and the potential for those patients to then go back and get retreated after six months. Thank you.

Johanna Mercier: Sure, and Carter, just to explain a little bit, the nodules are because it's a drug depot, right? So the nodule actually gets smaller over time. What we've seen is actually very little discontinuation in PURPOSE-1 due to that, that's number one, two is that the nodules are sometimes palpable, not all, but sometimes palpable, but not visible, and generally speaking. And so we believe that actually we will have some flexibility as well as to where those injections play out and when, you know, because I think they've been studied in different places, not just in the stomach, in the side, and so I think that'll be an opportunity as well for people to be a little bit more flexible as to where they get their injections. So we're not overly concerned there at all, actually, and really, we're taking it from the data that we're getting from PURPOSE-1, and hopefully we'll have similar data to learn from from PURPOSE-2.

Johanna Mercier: Sure, and Carter, just to explain a little bit, the nodules are because it's a drug depot, right? So the nodule actually gets smaller over time. What we've seen is actually very little discontinuation in PURPOSE-1 due to that, that's number one, two is that the nodules are sometimes palpable, not all, but sometimes palpable, but not visible, and generally speaking. And so we believe that actually we will have some flexibility as well as to where those injections play out and when, you know, because I think they've been studied in different places. Not just in the stomach, in the side, and so I think that'll be an opportunity as well for people to be a little bit more flexible as to where they get their injections.

Sure.

Carter, just to explain a little bit, the nodules are because it's a drug depot, right? So the nodule actually gets smaller over time. What we've seen is actually very little discontinuation in Purpose 1 due to that.

Speaker: Two is that the nodules are sometimes palpable, not all, but sometimes palpable, but not visible, and generally speaking. And so we believe that actually we will have some flexibility as well as to where those injections play out and when, you know, because I think they've been studied in different places, not just in the stomach, on the side. And so I think that'll be an opportunity as well for people to be a little bit more flexible as to where they get their injections.

That's number one. Two is the nodules are sometimes palpable, not all, but sometimes palpable but not visible.

and generally speaking and so we believe that actually...

We will have some flexibility as well as to where those injections play out and when, you know, because I think they've been studied in different places, not just...

Johanna Mercier: Not just in the stomach, in the side, and so I think that'll be an opportunity as well for people to be a little bit more flexible as to where they get their injections. So we're not overly concerned there at all, actually, and really, we're taking it from the data that we're getting from PURPOSE-1, and hopefully we'll have similar data to learn from from PURPOSE-2.

in the stomach, in the side. And so I think that'll be an opportunity as well for people to be a little bit more flexible as to where they get their injections. So we're not overly concerned there at all, actually, and really, we're taking it from the data that we're getting from Purpose One, and hopefully we'll have similar data to learn from from Purpose Two.

Johanna Mercier: So we're not overly concerned there at all, actually, and really, we're taking it from the data that we're getting from PURPOSE-1, and hopefully we'll have similar data to learn from from PURPOSE-2.

Michael Yee: Our next question comes from Mike Yee at Jeffrey. Mike, go ahead; your line is open. Thank you, guys, we have one question on long-acting HIV, specifically the potential for a Q six months, which I think could be a game-changer, I think you have one or two of then on your slide, and they're advancing, can you tell me your confidence level of what you have there, because if you follow HIV development, you know that it's generally [inaudible] more tolerability significant [inaudible] you're on a pretty one spot in phase 1/2. Thank you, let me know.

Operator: Our next question comes from Mike Yee at Jeffrey. Mike, go ahead; your line is open.

Speaker: So we're not overly concerned there at all, actually. And really, we're taking it from the data that we're getting from Purpose 1, and hopefully we'll have similar data to learn from from Purpose 2. This next question comes from Mike Yee at Jeffrey. Go ahead, your line is open. Thank you, guys. We have one question on long-acting HIV specific.

And that question comes from my community at Geoffrey, I go ahead and do a line of open

Michael Yee: Thank you, guys, we have one question on long-acting HIV, specifically the potential for a Q six months, which I think could be a game-changer, I think you have one or two of then on your slide, and they're advancing, can you tell me your confidence level of what you have there, because if you follow HIV development, you know that if it's generally safe [inaudible] more tolerability significant lode reduction, you're on a pretty one spot in Phase I/II. Thank you, let me know.

Thank you guys. We have one question on long-acting HIV specifically.

The potential for a Q6 month, which I think could be a game-changer.

I think you have one or two of them on your slide and they are advancing. Can you tell me your confidence level?

On what you have there, because if you follow HIV development, you know that if it's generally safe and well-tolerative, significant barrel load reduction, you're in a pretty good spot in phase one, too. Thank you. Let me know.

Merdad V. Parsey: Hi Michael, it's Merdad. Thanks, yeah, I think you raised the right question, which is that whenever we're looking at long-acting agents, new long-acting agents, we have to be cautious about the transition from preclinical to clinical. We're not always able to predict the injection site reactions that you might get from the long acting in particular, we were just talking about the nodules for LENACAPAVIR, but other more severe injection site reactions, and then human pharmacokinetics. So I think we need those to play out to allow us to move forward, and that's why you see multiple agents going into phase I. We've generated a number of molecules, we moved them forward, you know, we've been pretty aggressive in moving them forward in order to maintain our leadership in lung-acting HIV treatment, and prophylaxis. So once we start to see those data in phase one, I think that will help us decide both between those molecules and where we want to go forward.

Hi, Michael, it's my dad. Thanks, yeah. I think you raised the right question.

Speaker: Thanks. Yeah, I think you raised the right question, which is that whenever we're looking at long-acting agents, new long-acting agents come out. We have to be cautious about the transition from preclinical to clinical because we're not always able to predict. David Hibb, injection site reactions that you might get from the lung acting agents in particular. We were just talking about the nodules for lenacapavir, but other more severe injection site reactions, and then human pharmacokinetics.

Which is that whenever we're looking at the long acting, new, long acting agents, we have to be cautious about the transition from Greek clinical to clinical. We're not always able to predict the...

Injection site reactions that you might get from the long-acting in particular, we were just talking about the nodules for Lenacabavir, but other more severe injection site reactions, and then the human pharmacokinetics.

Merdad V. Parsey: So I think we need those to play out to allow us to move forward, and that's why you see multiple agents going into phase I. We've generated a number of molecules, we moved them forward, you know, we've been pretty aggressive in moving them forward in order to maintain our leadership in lung-acting HIV treatment, and prophylaxis. So once we start to see those data in phase one, I think that will help us decide both between those molecules and where we want to go forward. Remember we're also moving our BNAB program forward, which will be our, you know, which is our most advanced lung acting program with LENACAPAVIR+BNABs, and we expect to get phase two data from that study as well. So for those early programs, it's the usual risks, which is why we take multiple shots, and hopefully we'll be able to advance one of them quickly. Our next question comes from Brian Abrams at RBC Capital Markets.

Merdad V. Parsey: So I think we need those to play out to allow us to move forward, and that's why you see multiple agents going into phase I. We've generated a number of molecules, we moved them forward, you know, we've been pretty aggressive in moving them forward in order to maintain our leadership in lung-acting HIV treatment, and prophylaxis. So once we start to see those data in phase one, I think that will help us decide both between those molecules and where we want to go forward. Remember we're also moving our BNAB program forward. Which will be our, you know, which is our most advanced lung acting program with LENACAPAVIR+BNABs, and we expect to get phase two data from that study as well. So for those early programs, it's the usual risks, which is why we take multiple shots, and hopefully we'll be able to advance one of them quickly.

Speaker: So I think we need those to play out to allow us to move forward, and that's why you see multiple agents going into phase I. We've generated a number of molecules. We moved them forward, you know, we've been pretty aggressive in moving them forward in order to maintain our leadership in lung-acting HIV treatment, and so once we start to see those data in phase one, I think that will help us decide both between those molecules and where we want to go forward.

So I think we need those.

to play out to allow us to move forward. And that's why you see multiple agents going into phase one.

We've generated a number of molecules, we moved them forward, you know, we've been pretty aggressive in moving them forward in order to maintain our, our leadership in long acting HIV treatment and, and

Merdad V. Parsey: So once we start to see those data in phase one, I think that will help us decide both between those molecules and where we want to go forward. Remember we're also moving our BNAB program forward. Which will be our, you know, which is our most advanced lung acting program with LENACAPAVIR+BNABs, and we expect to get phase two data from that study as well. So for those early programs, it's the usual risks, which is why we take multiple shots, and hopefully we'll be able to advance one of them quickly.

peripheral axis and

So, once we start to see those data in Phase 1, I think that will help us decide both choosing between those molecules.

Speaker: Remember we're also moving our BNAB program forward, which will be our, you know, which is our most advanced lung acting program with Lenacath and Vir Plus BNABs, and we expect to get phase two data from that study as well. So for those early programs, it's the usual risks, which is why we take multiple shots, and hopefully we'll be able to advance one of them quickly. This question comes from Brian Abrams at RBC Capital Markets.

where we want to go forward.

Remember, we're also moving our BNAB program forward, which will be our, you know, which is our most advanced long-acting program with Lenny Kapp, the beer plus.

BNABs, and we expect to get Phase II data from that study as well. So for those early programs, it's the usual risks, which is why we take multiple shots, and hopefully we'll be able to advance one of them quickly.

Operator: Our next question comes from Brian Abrams at RBC Capital Markets. Brian, go ahead. Your line is open. Hi there. Thanks so much for taking my question. You guys have an oral GLP-1, GS-4751 in your preclinical pipeline, are you planning to moving forward? And as you continue to diversify that portfolio, how are you guys thinking about the obesity landscape and potentially participating or other metabolic areas and [inaudible] that you may be more interested in pursuing? Thanks

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

Speaker: Brian, go ahead. Your line is open. Hi there. Thanks so much for taking my question. You guys have an oral GLP-

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

Brian Abrahams: Hi there. Thanks so much for taking my question. You guys have an oral GLP-1, GS-4751 in your preclinical pipeline, are you planning to moving forward? And as you continue to diversify that portfolio, how are you guys thinking about the obesity landscape and potentially participating or other metabolic areas and adjacencies that you may be more interested in pursuing? Thanks.

Hi there, thanks so much for taking my question. You guys have an oral GLP-1GS-4751 in your preclinical pipeline.

Are you planning to move it forward and as you continue to diversify the portfolio, how are you guys thinking about the obesity landscape and potentially participating, or are there other metabolic areas and adjacencies that you may be more interested in pursuing? Thanks.

Unknown: Thanks, Brian. Yes, we have shared some preclinical data on 4571, as you note, it is an internally developed oral GLP-1 agonist that came out of our initial interest in our NASH program. And based on the data so far, both preclinical and toxi, we are planning a phase one study for that molecule, and that will help us evaluate 4571 for weight management, obesity, and other metabolic diseases. Once we generate those data, we will decide in a data-driven way how best to proceed from there, and, you know, we'll just have to see how that plays out. We want to make sure we develop something that's best-in-class and allows for a best-in-class profile, so we'll update more as the data are generated.

Thanks, Brian. Yes, we have shared some preclinical data on 4571, as you note.

It is an internally developed oral GLP-1, and Agnes which came out of our...

An initial interest in our NASH program. And based on the data so far, both preclinical and the toxic, we are planning a phase one study for that molecule, and that'll help us evaluate 48 by 71 for our weight management, obesity, and other metabolic diseases.

Once we generate those data, we will decide in a data-driven way how best to proceed from there, and we'll just have to see how that plays out. We want to make sure if we develop something that's best-in-class and allows for a best-in-class profile.

Speaker: And, you know, we'll just have to see how that plays out. We want to make sure we develop something that's best-in-class and allows for a best-in-class profile. So we'll update more as the data are generated.

So we'll update more as the data are generated.

Operator: Our next question comes from Chris Schott at J.P. Morgan. Chris, go ahead. Your line is open. Great thanks so much. My questions, or the question was just on the US CAR T franchise, just, wondering your latest view on how should we be thinking about sequential growth from here? And maybe as part of that, can we just get an update on kind of your community physicians engagement with the CAR Ts and any leading indicators that you're seeing there that help maybe guide some of the efforts or when we could start see the impact for some of these efforts in the US? Thank you.

Operator: Our next question comes from Chris Schott at J.P. Morgan. Chris, go ahead. Your line is open.

Our next question comes from Chris Schott at J.P. Morgan. Chris, go ahead, your line is open.

Chris Schott: Great thanks so much. My questions, or the question was just on the US CAR T franchise, just, wondering your latest view on how should we be thinking about sequential growth from here? And maybe as part of that, can we just get an update on kind of your community physicians engagement with the CAR Ts and any leading indicators that you're seeing there that help maybe guide some of the efforts or when we could start see the impact for some of these efforts in the US? Thank you.

Great, thanks so much. My questions were just on the U.S. Cartee franchise. Why is it your latest view on how we should be thinking about...

Sequential Growth from here and maybe as part of that, can we just get an update on your community physician engagement with the car keys and then the leading indicators that you're seeing there that help to move a guide to the efforts, when we can start seeing the impact from some of these efforts in the U.S. Thank you.

Cindy Perettie: Thanks, Chris. You know, we are really pleased with our strong cell therapy growth this quarter, and this is really part and parcel of our U.S. Refresh strategy, so, as a reminder, we restructured our sales team at the end of last year, we got our new sales team in place, trained, and ready to go. And as part of that strategy, we also focused for the next couple of quarters on really within the authorized treatment centers, making sure that referrals occur between the lymphoma specialist and the CAR T specialist. And that's what you're seeing as part of the excellent performance that we had this quarter, and we'll continue to deliver and really focus on the referrals within the HEC. But we're also, in parallel, building up those community practices and spending time educating both the community practices, I'd say regional hospitals, and those institutions about the curative potential of CAR T and why it's important to bring this into the therapies that they're offering to their patients. And we're making really good progress there, including a lot of work with national payers, but despite all of this, as you heard earlier from both Dan and Johanna, we are facing, you know, it's a dynamic market. We're remaining cautious for the second half of this year as we continue to see some competitive headwinds, both in class competition, so we have new indications that came out in the late May, early June timeframe, which are capturing physician mind share initially, and we're also seeing out of class competition with bi-specifics.

Thanks, Chris, you know, we are really pleased with our strong self therapy growth this quarter

And this is really part and parcel to our U.S. Refresh Strategy, so as a reminder, we

We restructured our sales team at the end of last year. We got our new sales team in place and trained and ready to go, and as part of that strategy, we also focused

For the next couple of quarters, on really within the authorized treatment center, making sure those refer on the curve between the lymphoma specialists to the CAR-T specialist. And that's what you're seeing as part of the excellent performance that we had this quarter.

Cindy Perettie: And that's what you're seeing as part of the excellent performance that we had this quarter, and we'll continue to deliver and really focus on the referrals within the HEC. But we're also, in parallel, building up those community practices and spending time educating both the community practices, I'd say regional hospitals, and those institutions about the curative potential of CAR T and why it's important to bring this into the therapies that they're offering to their patients. And we're making really good progress there, including a lot of work with national payers, but despite all of this, as you heard earlier from both Dan and Johanna, we are facing, you know, it's a dynamic market. We're remaining cautious for the second half of this year as we continue to see some competitive headwinds, both in class competition, so we have new indications that came out in the late May, early June timeframe, which are capturing physician mind share initially, and we're also seeing out of class competition with bi-specifics.

Speaker: And we'll continue to deliver and really focus on the referrals within the HEC. But we're also, in parallel, building up those community practices and spending time educating both the community practices, I'd say regional hospitals, and those institutions about the curative potential of CAR T and why it's important to bring this into the therapies that they're offering to their patients. And we're making really good progress there, including a lot of work with national payers.

And we'll continue to deliver and really focus on the referrals within the HEC. We're also in parallel building up.

that those community practices and spending time educating both the community practices, I'd say regional hospitals.

and those institutions about the curative potential of CAR T and why it's important to bring this into the therapies that they're offering to their patients. And we're making really good progress there, including a lot of work with national payers.

Speaker: But despite all of this, as you heard earlier from both Dan and Johanna, we are facing, you know, a dynamic market. We're remaining cautious for the second half of this year as we continue to see some competitive headwinds, both in class competition. So we have new indications that came out in the late May, early June timeframe, which are capturing physician mind share initially, and we're also seeing out of class competition with bi-specifics.

Despite all of this, as you heard earlier from both

Dan and Johanna. We are facing, you know, it's a dynamic market. We are remaining cautious for the second half of this year as we continue to see some competitive headwinds, both in class competitions. So we have new indications that came out at the late May, early June timeframe.

Cindy Perettie: We're remaining cautious for the second half of this year as we continue to see some competitive headwinds, both in class competition, so we have new indications that came out in the late May, early June timeframe, which are capturing physician mind share initially, and we're also seeing out of class competition with bi-specifics. But with all of that said, we are focused on execution and working with our physicians and institutions to raise awareness of the curative potential for CAR T, and we'll continue to do so in the second half of this year. As it relates to community practices, I shared last quarter that it's taking us a little bit longer than we had expected to get them up and fully operating, but we're making great progress as it relates to that, and learning a lot along the way.

which are capturing physician mind share initially and we're also seeing out-of-class competition with the vice-specific but with all of that said.

Speaker: But with all of that said, we are focused on execution and working with our physicians and institutions to raise awareness of the curative potential for CAR T. And we'll continue to do so in the second half of this year. As it relates to community practices, I shared last quarter that it's taking us a little bit longer than we had expected to get them up and fully operating. But we're making great progress as it relates to that and learning a lot along the way.

We are focused on execution and working with our physicians and institutions to raise awareness of the curative potential for CAR T, and we'll continue to do so the second half of this year.

Cindy Perettie: As it relates to community practices, I shared last quarter that it's taking us a little bit longer than we had expected to get them up and fully operating, but we're making great progress as it relates to that, and learning a lot along the way. So we're continuing to refine our blueprint as we onboard new centers.

As it relates to community practices, I shared last quarter that it's taking us a little bit longer than we had expected to get them up and fully operating, but we're making great progress as it relates to that and learning a lot along the way, so we're continuing to refine our blueprint as we onboard new centers.

Speaker: So we're continuing to refine our blueprint as we onboard new centers. Our next question comes from Steven Seathouse at Raymond James. Steve, go ahead. Your line is open. Yes, thank you very much. I've just given you some of the newer tailwinds.

Operator: Our next question comes from Steven Seedhouse at Raymond James. Steve, go ahead. Your line is open. Yes, thank you very much, just given you some of the newer tailwinds outside of Oncology, so LENACAPAVIR obviously which you indicated could redefine the prep market and then SELADELPAR of course as well. When you just combine that with the updated view of oncology pipeline, are you still expecting the 2030 revenue mix to be about a third of oncology or is that more of a moving target? I was hoping you could comment on the long-term outlook. Thank you.

Operator: Our next question comes from Steven Seedhouse at Raymond James. Steve, go ahead. Your line is open.

Our next question comes from Steven Seathouse at Raymond James. Steve, go ahead, your line is open.

Steven Seedhouse: Yes, thank you very much, just given you some of the newer tailwinds outside of Oncology, so LENACAPAVIR obviously which you indicated could redefine the prep market and then SELADELPAR of course as well. When you just combine that with the updated view of oncology pipeline, are you still expecting the 2030 revenue mix to be about a third of oncology or is that more of a moving target? I was hoping you could comment on the long-term outlook. Thank you.

Yes, thank you very much. Just given some of the newer tailwinds outside of oncology, so when a cap of beer obviously which...

You indicated it could redefine the prep market and then sell Delpar, of course, as well.

When you just combine that with the updated view of oncology pipeline, are you still expecting the 2030 revenue mix to be about a third of oncology, or is that more of a moving target? Just hoping you could comment on the long-term outlook. Thank you.

Unknown: Yeah, thanks, Steven, for the question. So one third of sales remains our target, you know, with the portfolio that we have today and which we believe is achievable without additional BD. I'll just remind you, you know, we keep in mind that the indications in that target are probability adjusted, and many of them are around 50%. So, you know, you'd expect to see puts and takes in that pipeline evolution, and we certainly expected that when we set that target, so our target allows for some programs to fail or fall short of initial expectations, and others obviously succeed to support achieving that goal. I would just note that oncology sales today are already more than a third of the way there, in quarter two 2024, there will be about 12% of total product sales growing nicely, so it's highlighting the progress we're making on this, on this, on this overall goal. I think you're right to point out, you know, also the progress in the, as you put it, the tailwinds with our virology business and LENACAPAVIR data as well as SELADELPAR. Obviously as that grows, you know, that puts, you know, even more stretch to our ambition, it's a good problem to have, but I think the ambition we have is very much along the lines of diversifying our business as well as solidifying our base in virology, and we're firmly committed to that strategy.

Yeah, thanks.

Steven for the question. So one third of sales remains our target, you know, with the portfolio that we have today, and what we believe is achievable without additional BD. I'll just remind you, you know, we keep inviting to the indications in that target or probability adjusted, and many of them are around 50%.

So, you know, you'd expect to see puts in tanks in that pipeline evolution and we certainly expected that

Speaker: So our target allows for some programs to fail or fall short of initial expectations, and others obviously succeed to support achieving that goal. I would just note that oncology sales today are already more than a third of the way there. In quarter two 2024, there will be about 12% of total product sales growing nicely. So it's highlighting the progress we're making on this, on this, on this overall goal. I think you're right to point out, you know, also the progress in the, as you put it, the tailwinds with our virology business and my kappa beer data as well as celladelphi are obviously As that grows, you know, that puts, you know, even more stretch to our ambition.

when we set that target. So it allows for some programs to fail or fall short of initial expectations and others obviously succeed to support achieving that goal. I would just note that oncology sales today are already more than a third of the way there.

Unknown: I would just note that oncology sales today are already more than a third of the way there, in quarter two 2024, there will be about 12% of total product sales growing nicely, so it's highlighting the progress we're making on this, on this, on this overall goal. I think you're right to point out, you know, also the progress in the, as you put it, the tailwinds with our virology business and LENACAPAVIR data as well as SELADELPAR. Obviously as that grows, you know, that puts, you know, even more stretch to our ambition, it's a good problem to have, but I think the ambition we have is very much along the lines of diversifying our business as well as solidifying our base in virology, and we're firmly committed to that strategy.

In Q2 2024 there are about 12% of the total product sales.

growing nicely, so it's highlighting the progress we're making on this overall goal.

I think you're right to point out, you know, also the progress, and as you put it, the tailwinds with our virology business and Metacapavir data, as well as Seladelpar, obviously

Unknown: Obviously as that grows, you know, that puts, you know, even more stretch to our ambition, it's a good problem to have, but I think the ambition we have is very much along the lines of diversifying our business as well as solidifying our base in virology, and we're firmly committed to that strategy.

As that grows, you know, that puts, you know, even more, you know, stretch to our ambition. It's a good problem to have, but I think the ambition we have is very much along the lines of diversifying our business.

Speaker: It's a good problem to have, but I think the ambition we have is very much along the lines of diversifying our business as well as solidifying our base in virology, and we're firmly committed to that strategy.

as well as solidifying our base in biology and we're firmly committed to that strategy.

Operator: Our next question comes from Tim Anderson at Wolf Research. Tim, go ahead; your line is open.

Our next question comes from Tim Anderson at Wolf Research. Tim, go ahead, your line is open.

Tim Anderson: Thank you, I have a question about the TROP-2 space. So sometime before or around year-end, we'll get your Phase III first-line triple-negative readout with TRODELVY from the ASCENT-03 trial, and we'll also be getting Astra's TROPION-Breast02. And the design of those trials is quite similar, which will allow probably for the best side-by-side comparison thus far of your drug versus Astra's, and I'm sure you've thought about this a lot. What's your prediction for how those results will likely stack up against each other? I'm guessing you'll show less ILD as one benefit, but how do you think efficacy and other safety metrics will compare?

Speaker: So sometime before or around year-end, we'll get your Phase 3 first-line triple-negative readout with Tredelvy from the Ascent 03 trial, and we'll also be getting Astra's Tropin Breast 02. And the design of those trials is quite similar, which will probably allow for the best side-by-side comparison thus far of your drug versus Astra's, and I'm sure you've thought about this a What's your prediction for how those results will likely stack up against each other? I'm guessing you'll show less ILD as one benefit, but how do you think efficacy and other safety metrics will compare?

Thank you. I have a question on the Trove 2 space. So sometime before or around your end, we'll get your...

Page 3, first line triple negative readout with Trudel V from the Cent O3 trial, and we'll also be getting AstraZtropian Brestow 2, and the design of those trials are quite similar.

which will allow training for the best side-by-side comparison thus far of your drug versus astra. And I'm sure you've thought about this a lot.

What's your prediction for how those results will likely stack up against each other? I'm guessing you'll show less ILD as one benefit, but how do you think efficacy and other safety metrics will compare?

Merdad V. Parsey: Sure, this is Merdad, maybe, look, I think you hit the highlights. We are, TRODELVY has demonstrated great efficacy in the triple negative breast cancer space, and we remain, I think, the only approved TROP to ADC. And that space in triple negative is definitely where TRODELVY is doing very well and has become standard of care for most physicians. So, I think that sets us up nicely, and ASCENT-03, as we update the status of that trial as the end of the year rolls around, I think it will be part of the continuation of that story and our expectation for TRODELVY's success in triple negative breast cancer.

Sure, this is Merdad. Maybe, like, I think you hit the highlights. We are

Ow, Fritz

Trudelby has demonstrated great efficacy in the triple negative breast cancer space and we remain, I think,

The only approved trip to ADC and that space in triple negative is definitely where Tredelphi is doing very well and has become standard of care.

for most positions.

So I think that sets us up nicely, and Ascento 3, as we update the status of that trial as the end of the year rolls around, I think will be part of the continuation of that story and our expectation for Tredelby's success in triple negative breast cancer.

Merdad V. Parsey: We have felt that there are areas where our programs are differentiated, and for TRODELVY, as you mentioned, our adverse event profile has remained largely predictable and very, very manageable on the part of physicians. We certainly, both the ILD you mentioned as well as stomatitis have been very different in their manifestations, and mostly for TRODELVY, it's been neutropenia and diarrhea, which I think clinicians have gotten very comfortable with managing, certainly when we speak to our KOLs. So we'll be looking for that data, and we'll look for our data, and in particular, I think it's a continuation of where we think TRODELVY can go and really solidify our position in triple negative breast.

We have felt that there are areas where our programs are differentiated and for Tridelby, as you mentioned, our adverse event profile has remained

largely predictable and very manageable on the part of physicians. We certainly, both the ILD you mentioned, as well as stomatitis, have been very different in their manifestations, and mostly for Tredelphi it's been neutropenia.

and Diarrhea, which I think clinicians have gotten very comfortable with managing, certainly when we speak to our KOLs.

Merdad: So we'll be looking for that data, and we'll look for our data, and in particular, I think it's a continuation of where we think Tredelvi can go and really solidify our position in triple negative breast cancer.

We'll be looking for those data, and we'll look for our data, and in particular, and I think it's a continuation of where we think Tridelby can go and really solidify our position in triple negative breast. Yeah, I would just reemphasize what Merdad said. I think just the fact that we are the ones on the market today,

Johanna Mercier: Yeah, I would just re-emphasize what Merdad said. I think just the fact that we are the ones on the market today and so well-established as the number one standard of care in triple negative breast cancer second line, I do think that that is a big differentiator as we think about some of these data points.

and so well established as the number one standard of care in triple negative breast cancer second line, I do think that that is a big differentiator as we think about some of these data points.

Speaker: Salveen, go ahead; your line is open. Thank you. Good afternoon, everyone. With regard to the long acting program, could you speak more about

Speaker: Our next question comes from Salveen Richter at Goldman Sachs. Salveen, go ahead. Your line is open. Thank you, good afternoon, everyone, with regard to the long acting program, could you speak more about potential read-through from PURPOSE-1 to PURPOSE-2 and whether there're typically any differences in responses to HIV drugs in these different patient populations? And regarding the strategy to extend the PrEP market, could you speak to specific strategies here and why you haven't been able to reach these patients already? Thank you.

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

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

Salveen Richter: Thank you, good afternoon, everyone, with regard to the long acting program, could you speak more about potential read-through from PURPOSE-1 to PURPOSE-2 and whether there're typically any differences in responses to HIV drugs in these different patient populations? And regarding the strategy to extend the PrEP market, could you speak to specific strategies here and why you haven't been able to reach these patients already? Thank you.

Thank you. Good afternoon, everyone. With regard to the long-acting program, could you speak more about potential read-through from Purpose 1 to Purpose 2 and whether there are typically any differences in responses to HIV drugs in these different patient populations? And regarding the strategy to expand the PrEP market, could you speak to specific

Strategies here and why you haven't been able to reach these patients already, thank you.

Daniel O'Day: Thank you, Salveen, it's kind of a two-part story, so I'll have Merdad start and maybe have Johanna add as well.

Thanks, Salveen. It's kind of a two-part, so I'll have Merdad start and maybe have Joanna add as well. Yeah, Salveen, you're absolutely right that the patient populations are different. This is why we did the Broad Purpose Program, to really get a diversity of patients.

Merdad V. Parsey: Yeah, Salveen, you're absolutely right that the patient populations are different, this is why we did the broad purpose program to really get a diversity of patients early in our program to ensure that we can bring PrEP to a variety of populations early on in our development. The patient populations are different, we're talking about really cisgender women relative to the PURPOSE-2 population, which is a different population. And our expectation is that those populations have different levels of awareness and different levels of compliance in their use of PrEP otherwise, for example, with the oral PrEP agent. And despite that, I think the strength of the Purpose 1 data, and the fact that you have people who are essentially protected for six months with no infections occurring in cisgender women so far, I think give us a lot of confidence that with, I would expect some variability in the background infection rate in the population. If we are able to maintain that degree of protection in Purpose 2, we remain really confident that the outcome will be very powerful.

early in our program to ensure that we can bring PrEP to a variety of populations early on in our in our development.

The patient populations are different. We're talking really cisgender women relative to the Purpose 2 population, which is a different population.

and our expectation is that those populations have different levels of awareness, different levels of compliance.

and their use of prep, otherwise, for example, with the oral prep agents.

Merdad: For example, with the oral PrEP agent. And despite that, I think the strength of the Purpose 1 data, and the fact that you have people who are essentially protected for six months with no infections occurring in cisgender women so far, I think give us a lot of confidence that with, I would expect some variability in the background infection rate in the population. If we are able to maintain that degree of protection in Purpose 2, we remain really confident that the outcome will be very powerful.

Merdad V. Parsey: And despite that, I think the strength of the PURPOSE-1 data, and the fact that you have people who are essentially protected for six months with no infections occurring in the cisgender women so far. I think give us a lot of confidence that with, I would expect some variability in the background infection rate in the population, if we are able to maintain that degree of protection in PURPOSE-2, we remain really confident that the outcome will be very powerful.

And despite that, I think the strength of the purpose one data in the fact that you have people who are essentially protected for six months with no infections occurring in the...

in the cisgender women so far, I think give us a lot of confidence that with

I would expect some variability in the background infection rate in the population. If we are able to maintain that degree of protection in purpose too, we remain really confident that the outcome will be very powerful.

Johanna Mercier: And maybe to pick up on the second part of that, Salveen. So just to take a step back, I think it's important to understand how much we have moved the needle, actually, when you think about the penetration in the prevention market. Just a couple of years ago, you were about 25% penetration when you, you know, if you consider it from a CDC standpoint, estimate, we're now over a third of that, so we have really grown this market and expanded it. I think one of the challenges has definitely been, this is not a typical market that you, you know, it's not HIV treatment, it is a market where these are individuals that are not sick, they have no, you know, asymptomatic, obviously, they have nothing. And so therefore it's very challenging when you think about a daily oral pill, which is today over, you know, 95% of the total market, whether you think about current generics or DESCOVY share, and taking a pill every single day is incredibly challenging. So many use PrEP on demand, and I do think there's, and in that, the biggest population that we see are actually white MSM, so very much a high commercial market here, and we believe that there's a real opportunity to, with something that has the profile of LENACAPAVIR with a twice yearly sub-Q, that we can truly expand the reach of the people, the individuals that could truly benefit from prevention for the future. And so that's kind of a step, so I think it's an ongoing growth that we've been seeing, I think we have to do a step change here as we think about the future of prevention, I think we have to think completely differently about what LENACAPAVIR could offer all of these people, and really make a dent in this HIV epidemic.

And maybe to pick up on the second part of that, Salveen, so just to take a step back, I think it's important to understand how much

We have moved the needle, actually, when you think about the penetration in the prevention market. Just a couple of years ago, you were about 25% penetration when you, you know, if you consider it from a CDC standpoint estimate. We're now over a third of that, so we have really grown this market and expanded it. I think one of the challenges has definitely been this is not a typical market that you, you know, it's not HIV treatment. It is a market where these are individuals.

Johanna: I think one of the challenges has definitely been, this is not a typical market that you, you know, it's not HIV treatment, it is a market where these are individuals that are not sick, they have no, you know, asymptomatic, obviously, they have nothing, and so therefore it's very challenging when you think about a daily oral pill, which is today over, you know, 95% of the total market, whether you think about current generics or Dyscovishare, and taking a pill every single day is incredibly challenging. So many use PrEP on demand, and I do think there's, and in that, the biggest population that we see are actually white MSM, so very much a high commercial market here, and we believe that there's a real opportunity to, with something that has the profile of Lenacapavir with a twice yearly sub-Q, that we can truly expand the reach of the people, the individuals that could truly benefit from prevention for the future, and so that's kind of a step, so I think it's an ongoing growth that we've been seeing, I think we have to do a step change here as we think about the future of prevention, I think we have to think completely differently about what Lenacapavir could offer all of these people, and really make a dent in this HIV epidemic. Our last question comes from

Johanna Mercier: I think one of the challenges has definitely been, this is not a typical market that you, you know, it's not HIV treatment, it is a market where these are individuals that are not sick, they have no, you know, asymptomatic, obviously, they have nothing. And so therefore it's very challenging when you think about a daily oral pill, which is today over, you know, 95% of the total market, whether you think about current generics or DESCOVY share, and taking a pill every single day is incredibly challenging. So many use PrEP on demand, and I do think there's, and in that, the biggest population that we see are actually white MSM, so very much a high commercial market here, and we believe that there's a real opportunity to, with something that has the profile of LENACAPAVIR with a twice yearly sub-Q, that we can truly expand the reach of the people, the individuals that could truly benefit from prevention for the future. And so that's kind of a step, so I think it's an ongoing growth that we've been seeing, I think we have to do a step change here as we think about the future of prevention, I think we have to think completely differently about what LENACAPAVIR could offer all of these people, and really make a dent in this HIV epidemic.

that are not sick, they have no asymptomatic, obviously, they have nothing, and so therefore it's very challenging when you think about a daily oral pill which is today.

Johanna Mercier: And so therefore it's very challenging when you think about a daily oral pill, which is today over, you know, 95% of the total market, whether you think about current generics or DESCOVY share, and taking a pill every single day is incredibly challenging. So many use PrEP on demand, and I do think there's, and in that, the biggest population that we see are actually white MSM, so very much a high commercial market here, and we believe that there's a real opportunity to, with something that has the profile of LENACAPAVIR with a twice yearly sub-Q, that we can truly expand the reach of the people, the individuals that could truly benefit from prevention for the future. And so that's kind of a step, so I think it's an ongoing growth that we've been seeing, I think we have to do a step change here as we think about the future of prevention, I think we have to think completely differently about what LENACAPAVIR could offer all of these people, and really make a dent in this HIV epidemic.

Over 95% of the total market where you think about current genetics or discovery share.

and taking a pill every single day is incredibly challenging. So many use PrEP on demand.

Johanna Mercier: So many use PrEP on demand, and I do think there's, and in that, the biggest population that we see are actually white MSM, so very much a high commercial market here, and we believe that there's a real opportunity to, with something that has the profile of LENACAPAVIR with a twice yearly sub-Q, that we can truly expand the reach of the people, the individuals that could truly benefit from prevention for the future. And so that's kind of a step, so I think it's an ongoing growth that we've been seeing, I think we have to do a step change here as we think about the future of prevention, I think we have to think completely differently about what LENACAPAVIR could offer all of these people, and really make a dent in this HIV epidemic.

and I do think there's, and in that, the biggest population that we see are actually white MSN, so very much a high commercial.

Markett here, and we believe that there's a real opportunity to meet something that has the profile of Lenin Kappa Bear with a twice yearly sub cue that we can truly expand.

Johanna Mercier: And so that's kind of a step, so I think it's an ongoing growth that we've been seeing, I think we have to do a step change here as we think about the future of prevention, I think we have to think completely differently about what LENACAPAVIR could offer all of these people, and really make a dent in this HIV epidemic.

It's about the reach of the people, the individuals that could truly benefit from prevention for the future. And so that's kind of the step. So I think it's an ongoing growth that we've been seeing. I think we have to do a step change here as we think about...

The future of prevention, I think we have to think completely differently about what Lena Cavaver could offer all of these people and really make a dent in this HIV epidemic.

Operator: Our last question comes from Olivia Brayer at Cantor Fitzgerald. Olivia, go ahead; your line is open. Our next question comes from James Shin at Deutsche Bank. James, go ahead. Your line is open.

Operator: Our last question comes from Olivia Brayer at Cantor Fitzgerald. Olivia, go ahead; your line is open.

Our last question comes from Olivia Brayer at Cantor Fitzgerald. Olivia, go ahead, your line is open.

Our next question comes from Jameson at Deutsche Bank, James Gohead, your line of open.

Operator: Our next question comes from James Shin at Deutsche Bank. James, go ahead. Your line is open. Hey, guys, thanks for the question. For PrEP, is the move to Part-B a net possittive to access? And when LEN is eventually proved for PrEP do you expect the markets remain mostly buy and bill? Thank you.

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

Hey guys, thanks for the question. For prep, is the move to party a net positive to access, and when Len is eventually proved for prep, you expect the markets remain mostly a buy and bill. Thank you.

James Shin: Hey, guys, thanks for the question. For PrEP, is the move to Part-B a net positive to access? And when LEN is eventually proved for PrEP do you expect the markets remain mostly buy-in-bill? Thank you.

Johanna Mercier: Sure, I'll take that one. So the move, the NCD for PrEP that CMS is working on, I do think it's positive, I think it's really around providing greater access and, potentially, you know, providing also the services that go with it. So, D2B could actually be a nice move, despite the fact that today, Medicare is a very small piece of the total prevention market. As we think about LENACAPAVIR, I think it'll be both, I think there's probably opportunities for it to be both a pharmacy benefit as well as a medical benefit, and be a buy-in bill. And I think we just need to think very differently, because buy-and-bill, in the current users of prevention, this is not something that they're familiar with. And so this is something we're really thinking about today for tomorrow is setting up that system to make sure they understand how to do this if they want to do it, but that they have an option if they don't want to do it. And I think that's what we're kind of planning for as we think about the future of LENACAPAVIR.

Sure, I'll take that one. So the move, the NCD for PrEP that CMS is working on, I do think it's positive. I think it's really around providing greater access and potentially

You know, providing also the services that go with it. So, it'd need to be could actually be a nice move despite the fact that today, Medicare is a very small piece of the total prevention market.

Speaker: I think there's probably opportunities for it to be both a pharmacy benefit as well as a medical benefit and be a buy-in bill. And I think we just need to think very differently, because for the current users of prevention, this is not something that they're familiar with. And so this is something we're really thinking about today for tomorrow is setting up that system to make sure they understand how to do this if they want to do it, but that they have an option if they don't want to do it. And I think that's what we're kind of planning for as we think about the future of Lenacapavir.

As we think about Lenna Capavir, I think it'll be both. I think there's probably opportunities for it to be both a pharmacy benefit as well as a medical benefit and be a buy-in bill. And I think we just need to think very differently, because buy-in bill in...

Johanna Mercier: And I think we just need to think very differently, because buy-and-bill, in the current users of prevention, this is not something that they're familiar with. And so this is something we're really thinking about today for tomorrow is setting up that system to make sure they understand how to do this if they want to do it, but that they have an option if they don't want to do it. And I think that's what we're kind of planning for as we think about the future of LENACAPAVIR.

Johanna Mercier: And so this is something we're really thinking about today for tomorrow is setting up that system to make sure they understand how to do this if they want to do it, but that they have an option if they don't want to do it. And I think that's what we're kind of planning for as we think about the future of LENACAPAVIR.

In the current users of prevention, this is not something that they're familiar with. And so this is something we're really thinking about today for tomorrow is to setting up that system.

to make sure they understand how to do this, if they want to do it, but that they have an option if they don't want to do it. And I think that's what we're kind of planning for as we think about the future of Lenacapavir.

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

That completes the time that we have for questions. I'll invite Dan.

Daniel O'Day: Thank you, everybody, in closing, you know, we, the team here, would like to summarize the quarter as follows. We had a very strong quarter of revenue growth and impressive bottom-line growth that highlights the leverage in our model. Secondly, we made progress that should enable us to build on that growth in the future, including really remarkable data from the PURPOSE-1 trial and from across the HIV portfolio with the promise to extend our HIV leadership well into the late 2030s and beyond. The imminent launch of SELADELPAR in the US, and continued progress in oncology, and all of this leaves us well-positioned for the second half of 2024, when we will continue to focus on quarter after quarter of strong clinical, commercial, and financial execution. My thanks to the Gilead teams and to all of you for joining us today, I want to hand it over to Jacquie Ross for some final comments.

to share any closing remarks.

Thank you everybody, in closing, you know, we, the team here would like to summarize the corridor as follows, we have a very strong corridor revenue growth and impressive bottom line growth that highlights the leverage in our model.

Secondly, we made progress that should enable us to build on that growth in the future, including really remarkable data from the Purpose One trial and from across the HIV portfolio with the promise to extend our HIV leadership well into the late 2030s and beyond.

Daniel O'Day: The imminent launch of SELADELPAR in the US, and continued progress in oncology, and all of this leaves us well-positioned for the second half of 2024, when we will continue to focus on quarter after quarter of strong clinical, commercial, and financial execution. My thanks to the Gilead teams and to all of you for joining us today, I want to hand it over to Jacquie Ross for some final comments.

The imminent launch of Celadon PAR in the U.S.

Dan: And all of this leaves us well-positioned for the second half of 2024, when we will continue to focus on quarter after quarter of strong clinical, commercial, and financial execution. My thanks to the Gilead teams and to all of you for joining us today. I want to hand it over to Jackie Ross for some final comments.

and continued progress in oncology, and all of this leaves us well positioned for the second half of 2024. When we will continue to focus on quarter after quarter of strong clinical commercial and financial execution. My thanks to the Gillette teams and all of you for joining today, I want to hand it over to Jackie Ross for some final comments.

Jacquie Ross: Thank you, Dan, and thank you all for joining us today, one final housekeeping item. I can share that we are tentatively planning to release our third quarter 2024 earnings results on Thursday, November 7. 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 third quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter.

Thank you Dan and thank you all for joining us today. One final housekeeping item. I can share that we are tentatively planning to release our third quarter 2024 earnings results on Thursday, November 7th.

Jackie Ross: I can share that we are tentatively planning to release our third quarter 2024 earnings results on Thursday, November 7th. 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 third quarter. We appreciate your continued interest in Gilead and look forward to updating you on our progress throughout the quarter.

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 third quarter.

We appreciate your continued interest in going out and looking forward on updating you on our progress throughout the quarter.

E. E. E. E. E. E. E. E. E. E. E.

Q2 2024 Gilead Sciences Inc Earnings Call

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