Q1 2026 Gilead Sciences Inc Earnings Call
Speaker #1: Good afternoon, everyone, and welcome to GILEAD's first quarter 2026 earnings conference call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks followed by our Q&A session.
Operator: Good afternoon, everyone, and welcome to Gilead's Q1 2026 Earnings Conference Call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks, followed by our Q&A session. Please note that the process for queuing questions has changed this quarter. To ask a question, press star 1, and to withdraw your question, press star 1 again. Now, I'll hand the call over to Jacquie Ross, Senior Vice President, Treasurer, and Head of Investor Relations.
Operator: Good afternoon, everyone, and welcome to Gilead's Q1 2026 Earnings Conference Call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks, followed by our Q&A session. Please note that the process for queuing questions has changed this quarter. To ask a question, press star one, and to withdraw your question, press star one again. Now, I'll hand the call over to Jacquie Ross, Senior Vice President, Treasurer, and Head of Investor Relations.
Speaker #1: Please note that the process for queuing questions has changed this quarter. To ask a question, press *1, and to withdraw your question, press *1 again.
Speaker #1: Now, I'll hand the call over to Jacquie Ross, Senior Vice President, Treasurer, and Head of Investor Relations.
Speaker #2: Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the first quarter of 2026. The press release slides and supplementary data are available on the Investors section of our website, at gilead.com.
Jacquie Ross: Thank you, Rebecca. Just after market close today, we issued a press release with earnings results for Q1 2026. The press release, slides, and supplementary data are available on the investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial and Corporate Affairs Officer, Johanna Mercier, our Chief Medical Officer, Dietmar Berger, and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A, where the team will be joined by Cindy Perettie, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements. Please refer to slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.
Jacquie Ross: Thank you, Rebecca. Just after market close today, we issued a press release with earnings results for Q1 2026. The press release, slides, and supplementary data are available on the investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial and Corporate Affairs Officer, Johanna Mercier, our Chief Medical Officer, Dietmar Berger, and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A, where the team will be joined by Cindy Perettie, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements. Please refer to slide two regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.
Speaker #2: The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day; our Chief Commercial and Corporate Affairs Officer, Johanna Mercier; our Chief Medical Officer, Dietmar Berger; and our Chief Financial Officer, Andrew Dickinson.
Speaker #2: After that, we'll open the call to Q&A, where the team will be joined by Cindy Peretti, the Executive Vice President of Kite. Let me remind you that we will be making forward-looking statements.
Speaker #2: Please refer to slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.
Speaker #3: Thank you, Jacquie, and good afternoon, everyone. I'm pleased to share highlights from GILEAD's first quarter, which has extended our consistent track record of commercial, clinical, and financial execution.
Daniel O'Day: Thank you, Jacquie, and good afternoon, everyone. I'm pleased to share highlights from Gilead's first quarter, which has extended our consistent track record of commercial, clinical, and financial execution. Our strong financial performance and increase in sales guidance reflects the depth and quality of our portfolio, the numerous launches underway, and our continued focus on financial discipline. As we execute on the strongest pipeline in our history, Gilead is also taking steps to further strengthen the company's position for the future. We are looking forward to sharing much more on our Arcellx, Oro, and Tubulis in the coming quarters. Our HIV business grew 10% year over year, reflecting 7% growth for BIKTARVY and an impressive 87% growth for our US PrEP business. The ongoing success of the YEZTUGO launch is a key driver of this growth in HIV prevention, with Q1 sales growing 72% sequentially.
Daniel O'Day: Thank you, Jacquie, and good afternoon, everyone. I'm pleased to share highlights from Gilead's Q1, which has extended our consistent track record of commercial, clinical and financial execution. Our strong financial performance and increase in sales guidance reflects the depth and quality of our portfolio, the numerous launches underway and our continued focus on financial discipline. As we execute on the strongest pipeline in our history, Gilead is also taking steps to further strengthen the company's position for the future. We are looking forward to sharing much more on our Arcellx, Oro, and Tubulis in the coming quarters. Our HIV business grew 10% year over year, reflecting 7% growth for BIKTARVY and an impressive 87% growth for our US PrEP business. The ongoing success of the YEZTUGO launch is a key driver of this growth in HIV prevention, with Q1 sales growing 72% sequentially.
Speaker #3: Our strong financial performance and increase in sales guidance reflects the depth and quality of our portfolio, the numerous launches underway, and our continued focus on financial discipline.
Speaker #3: As we execute on the strongest pipeline in our history, GILEAD is also taking steps to further strengthen the company's position for the future. We are looking forward to sharing much more on our CELEX, ORO, and TUBULUS in the coming quarters.
Speaker #3: Our HIV business grew 10% year over year, reflecting 7% growth for Biktarvy and an impressive 87% growth for our U.S. prep business. The ongoing success of the S2GO launch is a key driver of this growth in HIV prevention, with first-quarter sales growing 72% sequentially.
Speaker #3: Looking forward, with no major LOEs until 2036, GILEAD's HIV business is poised for strong durable growth, supported by up to 7 potential new HIV product launches by 2033.
Daniel O'Day: Looking forward, with no major LOEs until 2036, Gilead's HIV business is poised for strong, durable growth, supported by up to seven potential new HIV product launches by 2033. The first of these potential launches is bictegravir plus lenacapavir, an investigational once-daily oral regimen for virally suppressed people with HIV. This is now under priority review, and we expect an FDA decision in August. Other upcoming HIV milestones include phase III updates later this quarter from the ISLAND 1 and 2 studies evaluating a potential first once-weekly oral for virally suppressed people with HIV. We shared encouraging phase I data at CROI in February for a long-acting integration inhibitor, GS-3242. Later this year, we plan to share additional data that could support the combination of GS-3242 with lenacapavir as a potential twice-yearly injectable treatment regimen.
Daniel O'Day: Looking forward, with no major LOEs until 2036, Gilead's HIV business is poised for strong, durable growth, supported by up to seven potential new HIV product launches by 2033. The first of these potential launches is bictegravir plus lenacapavir, an investigational once-daily oral regimen for virally suppressed people with HIV. This is now under priority review, and we expect an FDA decision in August. Other upcoming HIV milestones include phase III updates later this quarter from the ISLAND 1 and 2 studies evaluating a potential first once-weekly oral for virally suppressed people with HIV. We shared encouraging phase I data at CROI in February for a long-acting integration inhibitor, GS-3242. Later this year, we plan to share additional data that could support the combination of GS-3242 with lenacapavir as a potential twice-yearly injectable treatment regimen.
Speaker #3: The first of these potential launches is bictegravir plus lenacapavir, an investigational once-daily oral regimen for virally suppressed people with HIV. This is now under priority review, and we expect an FDA decision in August.
Speaker #3: Other upcoming HIV milestones include phase 3 updates later this quarter, from the island 1 and 2 studies, evaluating a potential first once-weekly oral for virally suppressed people with HIV.
Speaker #3: We shared encouraging phase 1 data at CROY in February, for a long-acting integration inhibitor, GS3242. Later this year, we plan to share additional data that could support the combination of GS3242 with Lenacapavir as a potential twice-yearly injectable treatment regimen.
Speaker #3: The time frame for potential launch is between 2031 and 2033. In oncology, first-quarter Trodelvy sales were up 37% year over year, reflecting growing demand for Trodelvy.
Daniel O'Day: The timeframe for potential launch is between 2031 and 2033. In oncology, Q1 TRODELVY sales were up 37% year over year, reflecting growing demand for TRODELVY. We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in H2 of this year. Ahead of these decisions, TRODELVY has already received NCCN Category 1 recommendations across the first line and is the leading ADC in second-line metastatic TNBC treatment. We are also expecting phase III updates from the EVOKE-03 trial in first-line metastatic non-small cell lung cancer and the ASCENT-GYN trial in second-line plus metastatic endometrial cancer in H2 of this year. The pending acquisition of Tubulis is another significant milestone in building Gilead's oncology franchise.
Daniel O'Day: The timeframe for potential launch is between 2031 and 2033. In oncology, Q1 TRODELVY sales were up 37% year over year, reflecting growing demand for TRODELVY. We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in H2 of this year. Ahead of these decisions, TRODELVY has already received NCCN Category 1 recommendations across the first line and is the leading ADC in second-line metastatic TNBC treatment. We are also expecting phase III updates from the EVOKE-03 trial in first-line metastatic non-small cell lung cancer and the ASCENT-GYN trial in second-line plus metastatic endometrial cancer in H2 of this year. The pending acquisition of Tubulis is another significant milestone in building Gilead's oncology franchise.
Speaker #3: We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in the second half of this year. Ahead of these decisions, Trodelvy has already received NCCN Category 1 recommendations across the first line and is the leading ADC and second-line metastatic TNBC treatment.
Speaker #3: We are also expecting phase 3 updates from the Evoco3 trial in first-line metastatic non-small cell lung cancer and the ASCENT Guine trial in second-line plus metastatic endometrial cancer in the second half of this year.
Speaker #3: The pending acquisition of Tubulus is another significant milestone in building Gilead's oncology franchise. The company brings a clinical-stage candidate, TUB40, which we believe has the potential to be a leading ADC in ovarian cancer and a next-generation ADC platform with a promising early pipeline.
Daniel O'Day: The company brings a clinical-stage candidate, TUB-040, which we believe has the potential to be a leading ADC in ovarian cancer and a next-generation ADC platform with a promising early pipeline. At the upcoming ASCO meeting, we look forward to additional phase I data on TUB-040 in platinum-resistant ovarian cancer. Additionally, we are expecting a regulatory decision on anito-cel, our potential best-in-disease BCMA CAR T in December 2024. Our acquisition of Arcellx, which closed on 28 April, reflects our conviction in the potential of anito-cel as a differentiated option for patients with multiple myeloma. Given the significant opportunity in 4th line as well as earlier lines of therapy, we believe anito-cel could become a foundational therapy for multiple myeloma, driving growth in our cell therapy business in 2027 and beyond.
Daniel O'Day: The company brings a clinical-stage candidate, TUB-040, which we believe has the potential to be a leading ADC in ovarian cancer and a next-generation ADC platform with a promising early pipeline. At the upcoming ASCO meeting, we look forward to additional phase I data on TUB-040 in platinum-resistant ovarian cancer. Additionally, we are expecting a regulatory decision on anito-cel, our potential best-in-disease BCMA CAR T in December 2024. Our acquisition of Arcellx, which closed on 28 April, reflects our conviction in the potential of anito-cel as a differentiated option for patients with multiple myeloma. Given the significant opportunity in 4th line as well as earlier lines of therapy, we believe anito-cel could become a foundational therapy for multiple myeloma, driving growth in our cell therapy business in 2027 and beyond.
Speaker #3: At the upcoming ASCO meeting, we look forward to additional phase 1 data on TUB40 in platinum-resistant ovarian cancer. Additionally, we are expecting a regulatory decision on Anitosel, our potential best-in-disease BCMA CAR-T in December of this year.
Speaker #3: Our acquisition of Arcelix, which closed on April 28th, reflects our conviction in the potential of Anitosel as a differentiated option for patients with multiple myeloma.
Speaker #3: Given the significant opportunity in fourth line, as well as earlier lines of therapy, we believe Anitosel could become a foundational therapy for multiple myeloma, driving growth in our cell therapy business in 2027 and beyond.
Speaker #3: The Arcelix platform will leverage Kite's industry-leading manufacturing capabilities and could further strengthen our future in oncology and inflammation. In liver disease, Labdelvy revenue for second-line primary biliary cholangitis more than tripled year over year.
Daniel O'Day: The Arcellx platform will leverage Kite's industry-leading manufacturing capabilities and could further strengthen our future in oncology and inflammation. In liver disease, Livdelzy revenue for second-line primary biliary cholangitis more than tripled year over year. We are expecting an update from our phase III IDEAL study for Livdelzy in the H2 of this year. If positive, the IDEAL study could support a label update and expand the second-line PBC addressable population. Additionally, we expect a regulatory decision and potential US launch of Hepcludex for chronic hepatitis delta virus infection later this quarter. In inflammation, the potential acquisition of Ouro Medicines will add to our portfolio with gamgertamig, a BCMA CD3 T-cell engager in multiple B-cell-driven autoimmune diseases. We will also share phase II updates for our oral IRAK4 inhibitor and oral alpha-4 beta-7 small molecule this year.
Daniel O'Day: The Arcellx platform will leverage Kite's industry-leading manufacturing capabilities and could further strengthen our future in oncology and inflammation. In liver disease, Livdelzy revenue for second-line primary biliary cholangitis more than tripled year over year. We are expecting an update from our phase III IDEAL study for Livdelzy in the H2 of this year. If positive, the IDEAL study could support a label update and expand the second-line PBC addressable population. Additionally, we expect a regulatory decision and potential US launch of Hepcludex for chronic hepatitis delta virus infection later this quarter. In inflammation, the potential acquisition of Ouro Medicines will add to our portfolio with gamgertamig, a BCMA CD3 T-cell engager in multiple B-cell-driven autoimmune diseases. We will also share phase II updates for our oral IRAK4 inhibitor and oral alpha-4 beta-7 small molecule this year.
Speaker #3: We are expecting an update from our phase 3 ideal study for Labdelvy in the second half of this year. If positive, the ideal study could support a label update and expand the second-line PBC-addressable population.
Speaker #3: Additionally, we expect a regulatory decision and potential U.S. launch of Hepcudex for chronic hepatitis delta virus infection later this quarter. In inflammation, the potential acquisition of oral medicines will add to our portfolio, with Gamgirtimig, a BCMA CD3 T-cell engager in multiple B-cell-driven autoimmune diseases.
Speaker #3: We will also share phase 2 updates for our oral ARAC4 inhibitor and oral alpha-4 beta-7 small molecule this year. These commercial and clinical updates demonstrate the strength of our execution today underpinned by our continued commitment to financial discipline.
Daniel O'Day: These commercial and clinical updates demonstrate the strength of our execution today, underpinned by our continued commitment to financial discipline. As we look to the remainder of 2026, we see many exciting opportunities to further expand our impact on the patients and communities we aim to serve. With that, I'll hand it over to Johanna.
Daniel O'Day: These commercial and clinical updates demonstrate the strength of our execution today, underpinned by our continued commitment to financial discipline. As we look to the remainder of 2026, we see many exciting opportunities to further expand our impact on the patients and communities we aim to serve. With that, I'll hand it over to Johanna.
Speaker #3: As we look to the remainder of 2026, we see many exciting opportunities to further expand our impact on the patients and communities we aim to serve.
Speaker #3: With that, I'll hand it over to Joanna.
Speaker #1: Thanks, Dan, and good afternoon, everyone. It has been a remarkable start to the year from a commercial perspective, reflecting the innovative nature of our portfolio and our strong execution.
Johanna Mercier: Thanks, Dan. Good afternoon, everyone. It has been a remarkable start to the year from a commercial perspective, reflecting the innovative nature of our portfolio and our strong execution. Beginning on slide 7, Q1 total product sales, excluding VEKLURY, were $6.8 billion, up 8% year over year, driven by continued growth across our key products in HIV, breast cancer, and PBC, partially offset by HCV and cell therapy. Including VEKLURY, Q1 total product sales were $6.9 billion, up 5% year over year. Sequentially, sales were down 12%, in line with normal Q1 seasonality. Moving to slide 8, our HIV commercial teams drove Q1 sales of $5 billion, up an impressive 10% year over year. This growth was driven by strong demand across BIKTARVY, YEZTUGO, and DESCOVY, as well as pricing favorability.
Johanna Mercier: Thanks, Dan. Good afternoon, everyone. It has been a remarkable start to the year from a commercial perspective, reflecting the innovative nature of our portfolio and our strong execution. Beginning on slide 7, Q1 total product sales, excluding VEKLURY, were $6.8 billion, up 8% year over year, driven by continued growth across our key products in HIV, breast cancer, and PBC, partially offset by HCV and cell therapy. Including VEKLURY, Q1 total product sales were $6.9 billion, up 5% year over year. Sequentially, sales were down 12%, in line with normal Q1 seasonality. Moving to slide 8, our HIV commercial teams drove Q1 sales of $5 billion, up an impressive 10% year over year. This growth was driven by strong demand across BIKTARVY, YEZTUGO, and DESCOVY, as well as pricing favorability.
Speaker #1: Beginning on slide 7, first-quarter total product sales excluding Veclary were $6.8 billion, up 8% year over year, driven by continued growth across our key products in HIV, breast cancer, and PBC, partially offset by HCV and cell therapy.
Speaker #1: Including Veclary, first-quarter total product sales were $6.9 billion, up 5% year over year. Sequentially, sales were down 12% in line with normal first-quarter seasonality.
Speaker #1: Moving to slide 8, our HIV commercial teams drove first-quarter sales of $5 billion, up an impressive 10% year over year. This growth was driven by strong demand across Biktarvy, YesTugo, and Descovy, as well as pricing favorability.
Speaker #1: Sequentially, HIV sales were down 13%, primarily driven by Q1 seasonality, in line with our expectations. These typical first-quarter factors included inventory drawdown following a year-end build in the prior quarter and lower average realized price due to channel mix.
Johanna Mercier: Sequentially, HIV sales were down 13%, primarily driven by Q1 seasonality in line with our expectations. These typical Q1 factors included inventory drawdown following a year-end build in the prior quarter and lower average realized price due to channel mix. Looking at HIV treatment in more detail on slide 9, BIKTARVY sales of $3.4 billion were up 7% year over year, driven by higher demand and average realized price, partially offset by inventory drawdown. Sequentially, sales were down 15%, reflecting the Q1 seasonality that I just discussed. BIKTARVY continues to lead as the regimen of choice for both naive and switch patients across major markets. In the US, BIKTARVY's share was once again more than 52%, continuing its record of year-over-year gains in every quarter since launch. This market leadership is a testament to BIKTARVY's differentiation and continued physician confidence.
Johanna Mercier: Sequentially, HIV sales were down 13%, primarily driven by Q1 seasonality in line with our expectations. These typical Q1 factors included inventory drawdown following a year-end build in the prior quarter and lower average realized price due to channel mix. Looking at HIV treatment in more detail on slide 9, BIKTARVY sales of $3.4 billion were up 7% year over year, driven by higher demand and average realized price, partially offset by inventory drawdown. Sequentially, sales were down 15%, reflecting the Q1 seasonality that I just discussed. BIKTARVY continues to lead as the regimen of choice for both naive and switch patients across major markets. In the US, BIKTARVY's share was once again more than 52%, continuing its record of year-over-year gains in every quarter since launch. This market leadership is a testament to BIKTARVY's differentiation and continued physician confidence.
Speaker #1: Looking at HIV treatment in more detail on slide 9, Biktarvy sales of $3.4 billion, were up 7% year over year, driven by higher demand and average realized price, partially offset by inventory drawdown.
Speaker #1: Sequentially, sales were down 15%, reflecting the first-quarter seasonality that I just discussed. Biktarvy continues to lead as the regimen of choice for both naïve and switch patients across major markets.
Speaker #1: In the U.S., Biktarvy's share was once again more than 52%, continuing its record of year-over-year gains in every quarter since launch. This market leadership is a testament to Biktarvy's differentiation and continued physician confidence.
Speaker #1: We also continue to innovate with Biktecavir, plus Lenacapavir, or Biklen, our once-daily single-tablet regimen. We are targeting a potential launch in late August for people with virally suppressed HIV, including those on complex regimens.
Johanna Mercier: We also continue to innovate with bictegravir plus lenacapavir, or BIC/LEN, our once daily single tablet regimen. We are targeting a potential launch in late August for people with virally suppressed HIV, including those on complex regimens. Building on our long-standing track record of delivering highly effective, differentiated therapies for people with HIV, we believe that BIC/LEN is an exciting addition to our HIV treatment portfolio and has the potential to further expand Gilead's leadership in the switch market. Moving to slide 10, our US HIV prevention or PrEP business grew 87% year over year, comprised of the market-leading branded daily oral DESCOVY and the first and only twice-yearly injectable YEZTUGO. This performance was driven primarily by commercial execution and the strong product profiles of DESCOVY and YEZTUGO.
Johanna Mercier: We also continue to innovate with bictegravir plus lenacapavir, or BIC/LEN, our once daily single tablet regimen. We are targeting a potential launch in late August for people with virally suppressed HIV, including those on complex regimens. Building on our long-standing track record of delivering highly effective, differentiated therapies for people with HIV, we believe that BIC/LEN is an exciting addition to our HIV treatment portfolio and has the potential to further expand Gilead's leadership in the switch market. Moving to slide 10, our US HIV prevention or PrEP business grew 87% year over year, comprised of the market-leading branded daily oral DESCOVY and the first and only twice-yearly injectable YEZTUGO. This performance was driven primarily by commercial execution and the strong product profiles of DESCOVY and YEZTUGO.
Speaker #1: Building on our longstanding track record of delivering highly effective differentiated therapies for people with HIV, we believe that Biklen is an exciting addition to our HIV treatment portfolio and has the potential to further expand GILEAD's leadership in the switch market.
Speaker #1: Moving to slide 10, our U.S. HIV prevention, or PrEP, business grew 87% year over year, comprised of the market-leading branded daily oral Descovy and the first and only twice-yearly injectable YesTugo.
Speaker #1: This performance was driven primarily by commercial execution and the strong product profiles of Descovy and YesTugo. We believe we have the most compelling portfolio of PrEP products on the market and expect to retain and grow our leadership in the rapidly expanding PrEP market in both the near and long term.
Johanna Mercier: We believe we have the most compelling portfolio of PrEP products on the market and expect to retain and grow our leadership in the rapidly expanding PrEP market in both the near and long term. In Q1, the US PrEP market grew approximately 14% year over year, we look forward to further growth as we expand the reach of HIV prevention over time. DESCOVY Q1 sales of $807 million were up 38% year over year, driven by higher average realized price and demand growth. Sequentially, DESCOVY sales were down 1% due to typical Q1 seasonality and partially offset by favorable channel mix. Specifically within PrEP, which accounts for about 80% of DESCOVY's business, Q1 US sales were up approximately 50% year over year.
Johanna Mercier: We believe we have the most compelling portfolio of PrEP products on the market and expect to retain and grow our leadership in the rapidly expanding PrEP market in both the near and long term. In Q1, the US PrEP market grew approximately 14% year over year, we look forward to further growth as we expand the reach of HIV prevention over time. DESCOVY Q1 sales of $807 million were up 38% year over year, driven by higher average realized price and demand growth. Sequentially, DESCOVY sales were down 1% due to typical Q1 seasonality and partially offset by favorable channel mix. Specifically within PrEP, which accounts for about 80% of DESCOVY's business, Q1 US sales were up approximately 50% year over year.
Speaker #1: In the first quarter, the U.S. PrEP market grew approximately 14% year over year and we look forward to further growth as we expand the reach of HIV prevention over time.
Speaker #1: Descovy first-quarter sales of $807 million were up 38% year over year, driven by higher average realized price and demand growth. Sequentially, Descovy sales were down 1% due to typical first-quarter seasonality, and partially offset by favorable channel mix.
Speaker #1: Specifically, within PrEP, which accounts for about 80% of Descovy's business, first-quarter U.S. sales were up approximately 50% year over year. YesTugo continues to show an unprecedented launch trajectory for a new long-acting PrEP product.
Johanna Mercier: YEZTUGO continues to show an unprecedented launch trajectory for a new long-acting PrEP product. Q1 sales of $166 million were up 72% sequentially, exceeding our expectations. I am pleased to share we continue to see strong performance across our key YEZTUGO launch metrics. This includes access, where now approximately 95% of individuals are covered in the US, of which 95% can access YEZTUGO with $0 copay. Market share, where we are now the leading long-acting injectable in switch, we continue to see a higher than expected number of naive PrEP users initiating on YEZTUGO with early signs of growing momentum in this segment. Persistency, where our initial experience of return users is encouraging. Although it is still early, we expect YEZTUGO persistency to be the highest in the HIV prevention category.
Johanna Mercier: YEZTUGO continues to show an unprecedented launch trajectory for a new long-acting PrEP product. Q1 sales of $166 million were up 72% sequentially, exceeding our expectations. I am pleased to share we continue to see strong performance across our key YEZTUGO launch metrics. This includes access, where now approximately 95% of individuals are covered in the US, of which 95% can access YEZTUGO with $0 copay. Market share, where we are now the leading long-acting injectable in switch, we continue to see a higher than expected number of naive PrEP users initiating on YEZTUGO with early signs of growing momentum in this segment. Persistency, where our initial experience of return users is encouraging. Although it is still early, we expect YEZTUGO persistency to be the highest in the HIV prevention category.
Speaker #1: First-quarter sales of $166 million were up 72% sequentially, exceeding our expectations. I am pleased to share we continue to see strong performance across our key YesTugo launch metrics.
Speaker #1: This includes access, where now approximately 95% of individuals are covered in the U.S. of which 95% can access YesTugo with $0 copay. Market share?
Speaker #1: Where we are now the leading long-acting injectable in switch and we continue to see a higher-than-expected number of naive PrEP users initiating on YesTugo with early signs of growing momentum in this segment.
Speaker #1: Persistency? Where our initial experience of return users is encouraging. Although it's still early, we expect YesTugo persistency to be the highest in the HIV prevention category.
Speaker #1: And the impact of our direct-to-consumer campaign, where we are creating strong brand awareness and interest in YesTugo through our omnichannel approach focusing on communities and geographies with the highest needs.
Johanna Mercier: The impact of our direct-to-consumer campaign, where we are creating strong brand awareness and interest in YEZTUGO through our omni-channel approach, focusing on communities and geographies with the highest needs. Given the outperformance of YEZTUGO in Q1 and our growing confidence in the trends we're seeing, we're increasing our 2026 YEZTUGO guidance to $1 billion, potentially achieving blockbuster status in its first full year. Beyond 2026, we continue to expect a steady and durable build in sales over many years as we work to eliminate stigma associated with HIV PrEP and broaden adoption to all communities and individuals who can benefit. Both YEZTUGO and DESCOVY for PrEP sales are expected to meaningfully grow in 2026.
Johanna Mercier: The impact of our direct-to-consumer campaign, where we are creating strong brand awareness and interest in YEZTUGO through our omni-channel approach, focusing on communities and geographies with the highest needs. Given the outperformance of YEZTUGO in Q1 and our growing confidence in the trends we're seeing, we're increasing our 2026 YEZTUGO guidance to $1 billion, potentially achieving blockbuster status in its first full year. Beyond 2026, we continue to expect a steady and durable build in sales over many years as we work to eliminate stigma associated with HIV PrEP and broaden adoption to all communities and individuals who can benefit. Both YEZTUGO and DESCOVY for PrEP sales are expected to meaningfully grow in 2026.
Speaker #1: Given the outperformance of YesTugo in the first quarter and our growing confidence in the trends we're seeing, we're increasing our 2026 YesTugo guidance to $1 billion.
Speaker #1: Potentially achieving blockbuster status in its first full year. Beyond 2026, we continue to expect a steady and durable build in sales over many years as we work to eliminate stigma associated with HIV PrEP and broaden adoption to all communities and individuals who can benefit.
Speaker #1: Both YesTugo and Descovy for PrEP sales are expected to meaningfully grow in 2026. Reflecting this increase to our YesTugo guidance, in addition to first-quarter strength across HIV, we are now expecting 2026 total HIV sales including both treatment and prevention to grow approximately 8% year over year, compared to the 6% previously shared in our February guidance.
Johanna Mercier: Reflecting this increase to our YEZTUGO guidance, in addition to first quarter strength across HIV, we are now expecting 2026 total HIV sales, including both treatment and prevention, to grow approximately 8% year over year compared to the 6% previously shared in our February guidance. This is inclusive of headwinds of approximately 2% associated with the drug pricing agreement with the US government to lower Medicaid pricing for some of our products and proposed changes to the Affordable Care Act. Turning to slide 11, Livdelzi sales of $133 million more than tripled year over year as the launch continues to generate strong and growing demand in the US as well as across Europe. Demand growth continues to be driven by expansion in prescriber adoption, confidence in Livdelzi clinical profile, and broader utilization among appropriate second-line PBC patients.
Johanna Mercier: Reflecting this increase to our YEZTUGO guidance, in addition to first quarter strength across HIV, we are now expecting 2026 total HIV sales, including both treatment and prevention, to grow approximately 8% year over year compared to the 6% previously shared in our February guidance. This is inclusive of headwinds of approximately 2% associated with the drug pricing agreement with the US government to lower Medicaid pricing for some of our products and proposed changes to the Affordable Care Act. Turning to slide 11, Livdelzi sales of $133 million more than tripled year over year as the launch continues to generate strong and growing demand in the US as well as across Europe. Demand growth continues to be driven by expansion in prescriber adoption, confidence in Livdelzi clinical profile, and broader utilization among appropriate second-line PBC patients.
Speaker #1: This is inclusive of headwinds of approximately 2% associated with the drug pricing agreement with the U.S. government to lower Medicaid pricing for some of our products, and proposed changes to the Affordable Care Act.
Speaker #1: Turning to slide 11, Livdelphy sales of $133 million more than tripled year over year, as the launch continues to generate strong and growing demand in the U.S.
Speaker #1: as well as across Europe. Demand growth continues to be driven by expansion in prescriber adoption, confidence in Livdelphy clinical profile, and broader utilization among appropriate second-line PBC patients.
Speaker #1: Sequentially, sales declined 11%, largely driven by inventory drawdown. As we previously highlighted, fourth-quarter sales included a bolus of switches associated with a discontinuation of a competing product, which has normalized in the first quarter.
Johanna Mercier: Sequentially, sales declined 11%, largely driven by inventory drawdown. As we previously highlighted, Q4 sales included a bolus of switches associated with the discontinuation of a competing product, which has normalized in Q1. As we enter Q2, Livdelzy's rapid market capture continues to impress, maintaining its position as market leader with more than 50% share of the US 2nd-line PBC market. More broadly in liver disease, Q1 sales of $767 million were up 1% year over year, primarily reflecting the continued launch of Livdelzy, partially offset by inventory drawdown across the portfolio and lower HCV patient starts. Sequentially, sales were down 9%, reflecting seasonality, partially offset by higher average realized price for HCV products.
Johanna Mercier: Sequentially, sales declined 11%, largely driven by inventory drawdown. As we previously highlighted, Q4 sales included a bolus of switches associated with the discontinuation of a competing product, which has normalized in Q1. As we enter Q2, Livdelzy's rapid market capture continues to impress, maintaining its position as market leader with more than 50% share of the US 2nd-line PBC market. More broadly in liver disease, Q1 sales of $767 million were up 1% year over year, primarily reflecting the continued launch of Livdelzy, partially offset by inventory drawdown across the portfolio and lower HCV patient starts. Sequentially, sales were down 9%, reflecting seasonality, partially offset by higher average realized price for HCV products.
Speaker #1: As we enter the second quarter, Livdelphy's rapid market capture continues to impress, maintaining its position as market leader with more than 50% share of the U.S.
Speaker #1: second-line PBC market. More broadly, in liver disease, first-quarter sales of $767 million were up 1% year over year, primarily reflecting the continued launch of Livdelphy, partially offset by inventory drawdown across the portfolio and lower HCD patient starts.
Speaker #1: Sequentially, sales were down 9%, reflecting seasonality, partially offset by higher average realized price for HCD products. Moving to Tradelvy on slide 12, sales of $402 million were up 37% year over year, and 5% sequentially, with growing demand across breast cancer indications in all regions.
Johanna Mercier: Moving to Trodelvy on slide 12, sales of $402 million were up 37% year over year and 5% sequentially, with growing demand across breast cancer indications in all regions. Trodelvy is already approved in over 60 countries and has been firmly established as the leading regimen in second-line metastatic TNBC across major markets. Turning to the first-line metastatic setting, in the Phase III ASCENT-03 and ASCENT-04 trials, Trodelvy demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival over the standard of care, both as a monotherapy in PD-L1 negative patients and in combination with pembrolizumab in PD-L1 positive patients.
Johanna Mercier: Moving to Trodelvy on slide 12, sales of $402 million were up 37% year over year and 5% sequentially, with growing demand across breast cancer indications in all regions. Trodelvy is already approved in over 60 countries and has been firmly established as the leading regimen in second-line metastatic TNBC across major markets. Turning to the first-line metastatic setting, in the Phase III ASCENT-03 and ASCENT-04 trials, Trodelvy demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival over the standard of care, both as a monotherapy in PD-L1 negative patients and in combination with pembrolizumab in PD-L1 positive patients.
Speaker #1: Trodelvy is already approved in over 60 countries and has been firmly established as the leading regimen in second-line metastatic TNBC across major markets. Turning to the first-line metastatic setting, in the Phase 3 ASCENT-03 and ASCENT-04 trials, Trodelvy demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival over the standard of care, both as a monotherapy in PD-L1 negative patients and in combination with pembrolizumab in PD-L1 positive patients.
Speaker #1: Ahead of potential FDA decisions, the NCCN updated their guidelines with category 1 recommendations across first-line metastatic TNBC, which reinforces the strength of the data in first line with a potential launch in the U.S.
Johanna Mercier: Ahead of potential FDA decisions, the NCCN updated their guidelines with Category 1 recommendations across first line metastatic TNBC, which reinforces the strength of the data in first line with a potential launch in the US in H2 2026. Moving to cell therapy on Slide 13, on behalf of Cindy and the Kite team, Q1 cell therapy sales were $407 million, down 12% year over year and down 11% sequentially, reflecting the expected ongoing in and out of class competition across regions. We continue to pursue expanding access and global reach of our cell therapies. For example, in April, Tecartus received full FDA approval in adult relapsed or refractory mantle cell lymphoma, adding data on patients who are BTK inhibitor naive.
Johanna Mercier: Ahead of potential FDA decisions, the NCCN updated their guidelines with Category 1 recommendations across first line metastatic TNBC, which reinforces the strength of the data in first line with a potential launch in the US in H2 2026. Moving to cell therapy on Slide 13, on behalf of Cindy and the Kite team, Q1 cell therapy sales were $407 million, down 12% year over year and down 11% sequentially, reflecting the expected ongoing in and out of class competition across regions. We continue to pursue expanding access and global reach of our cell therapies. For example, in April, Tecartus received full FDA approval in adult relapsed or refractory mantle cell lymphoma, adding data on patients who are BTK inhibitor naive.
Speaker #1: in the second half of 2026. Moving to cell therapy on slide 13, and on behalf of Cindy and the KITE team, first-quarter cell therapy sales were $407 million down 12% year over year, and down 11% sequentially, reflecting the expected ongoing in-and-out-of-class competition across regions.
Speaker #1: We continue to pursue expanding access and global reach of our cell therapies. For example, in April, Takardis received full FDA approval in adult relapsed or refractory mantle cell lymphoma, adding data on patients who are BTK inhibitor naive.
Speaker #1: This important work of increasing awareness and physician comfort with CAR-T helped set the stage for the potential launch of our next-generation products. Turning to needle cell and with the close of the Arcelix acquisition last week, we are ramping up our detailed launch preparations for what we believe could be a best-in-disease multiple myeloma therapy.
Johanna Mercier: This important work of increasing awareness and physician comfort with CAR T helped set the stage for the potential launch of our next generation products. Turning to anito-cel, with the close of the Arcellx acquisition last week, we are ramping up our detailed launch preparations for what we believe could be a best-in-disease multiple myeloma therapy. Adding Kite's end-to-end expertise in cell therapy to anito-cel's demonstrated deep durable efficacy and differentiated safety profile positions anito-cel to maximize its potential in the $3.5 billion 4th-line plus CAR T market. With a late December PDUFA date and factoring in the time needed for site activation, we expect revenue from anito-cel to begin in early 2027.
Johanna Mercier: This important work of increasing awareness and physician comfort with CAR T helped set the stage for the potential launch of our next generation products. Turning to anito-cel, with the close of the Arcellx acquisition last week, we are ramping up our detailed launch preparations for what we believe could be a best-in-disease multiple myeloma therapy. Adding Kite's end-to-end expertise in cell therapy to anito-cel's demonstrated deep durable efficacy and differentiated safety profile positions anito-cel to maximize its potential in the $3.5 billion 4th-line plus CAR T market. With a late December PDUFA date and factoring in the time needed for site activation, we expect revenue from anito-cel to begin in early 2027.
Speaker #1: Adding KITE's end-to-end expertise in cell therapy, to needle cell's demonstrated deep, durable efficacy in differentiated safety profile, positions a needle cell to maximize its potential in the 3.5 billion fourth-line plus CAR-T market.
Speaker #1: With the late December PDUSA date and factoring in the time needed for site activation, we expect revenue from a needle cell to begin in early 2027.
Speaker #1: As we wrap up the first quarter and look forward to up to four additional launches this year, shown on slide 14, I want to recognize our commercialization team's for their exceptional execution in driving another strong quarter in Q1, and thank them for their commitment to growing patient impact in the second quarter and beyond.
Johanna Mercier: As we wrap up Q1 and look forward to up to four additional launches this year, shown on slide 14, I wanna recognize our commercialization teams for their exceptional execution in driving another strong quarter in Q1, and thank them for their commitment to growing patient impact in Q2 and beyond. With that, I'll hand the call over to Dietmar Berger.
Johanna Mercier: As we wrap up Q1 and look forward to up to four additional launches this year, shown on slide 14, I wanna recognize our commercialization teams for their exceptional execution in driving another strong quarter in Q1, and thank them for their commitment to growing patient impact in Q2 and beyond. With that, I'll hand the call over to Dietmar Berger.
Speaker #1: And with that, I'll hand the call over to Dietmar.
Speaker #2: Thank you, Joanna. And good afternoon, everyone. I'm pleased to share that the strong momentum across our research and clinical programs has accelerated since our full-year earnings in February.
Dietmar Berger: Thank you, Johanna, and good afternoon, everyone. I am pleased to share that the strong momentum across our research and clinical programs has accelerated since our full year earnings in February. This is supported by disciplined portfolio prioritization and strong execution. With the close of the Arcellx acquisition, our pipeline now consists of 47 clinical programs spanning our portfolio of first in class or best in class assets. The completed acquisition of Arcellx and pending acquisitions of Ouro Medicines and Tubulis add potential best in class CAR Ts, T-cell engagers, and antibody-drug conjugates, as well as capability expanding technologies through the novel D domain binder and next generation ADC conjugation platforms. Starting with HIV on slide 16, we shared 60 abstracts at CROI in February, continuing our track record of showcasing our comprehensive and innovative HIV pipeline at this flagship conference.
Dietmar Berger: Thank you, Johanna, and good afternoon, everyone. I am pleased to share that the strong momentum across our research and clinical programs has accelerated since our full year earnings in February. This is supported by disciplined portfolio prioritization and strong execution. With the close of the Arcellx acquisition, our pipeline now consists of 47 clinical programs spanning our portfolio of first in class or best in class assets. The completed acquisition of Arcellx and pending acquisitions of Ouro Medicines and Tubulis add potential best in class CAR Ts, T-cell engagers, and antibody-drug conjugates, as well as capability expanding technologies through the novel D domain binder and next generation ADC conjugation platforms. Starting with HIV on slide 16, we shared 60 abstracts at CROI in February, continuing our track record of showcasing our comprehensive and innovative HIV pipeline at this flagship conference.
Speaker #2: This is supported by discipline portfolio prioritization and strong execution. With the close of the Arcelix acquisition, our pipeline now consists of 47 clinical programs spanning our portfolio of first-in-class or best-in-class assets.
Speaker #2: The completed acquisition of Arcelix and pending acquisitions of oral medicines and tubulus add potential best-in-class CAR-Ts, T-cell engagers, and antibody-drug conjugates as well as capability-expanding technologies through the novel D-domain binder and next-generation ADC conjugation platforms.
Speaker #2: Starting with HIV on slide 16, we shared 60 abstracts at Crohn February continuing our track record of showcasing our comprehensive and innovative HIV pipeline at this flagship conference.
Speaker #2: This year, we highlighted new data across our suite of LANAC capivir-based regimens for treatment and prevention, as well as our other investigational programs for HIV treatment.
Dietmar Berger: This year, we highlighted new data across our suite of lenacapavir-based regimens for treatment and prevention, as well as our other investigational programs for HIV treatment. Updates across our HIV portfolio include our once daily oral bictegravir plus lenacapavir, or BIC/LEN, for treatment of virally suppressed people with HIV has been filed with FDA, and we expect a regulatory decision based on priority review in August. At CROI, we highlighted that BIC/LEN demonstrated viral suppression in people switching from a multi-tablet regimen in ARTISTRY-1 or from BIKTARVY in ARTISTRY-2 with no clinically meaningful emergent resistance. Moving to our once weekly oral programs, we continue to target updates from the phase III ISLAND One and Two trials in collaboration with Merck later this quarter.
Dietmar Berger: This year, we highlighted new data across our suite of lenacapavir-based regimens for treatment and prevention, as well as our other investigational programs for HIV treatment. Updates across our HIV portfolio include our once daily oral bictegravir plus lenacapavir, or BIC/LEN, for treatment of virally suppressed people with HIV has been filed with FDA, and we expect a regulatory decision based on priority review in August. At CROI, we highlighted that BIC/LEN demonstrated viral suppression in people switching from a multi-tablet regimen in ARTISTRY-1 or from BIKTARVY in ARTISTRY-2 with no clinically meaningful emergent resistance. Moving to our once weekly oral programs, we continue to target updates from the phase III ISLAND One and Two trials in collaboration with Merck later this quarter.
Speaker #2: Updates across our HIV portfolio include our once-daily oral BIGTAGRAVIR plus LANAC capivir, or BIGLAN, for treatment of virally suppressed people with HIV, has been filed with the FDA, and we expect the regulatory decision based on priority review in August.
Speaker #2: At Crohn, we highlighted that BIGLAN demonstrated viral suppression in people switching from a multi-tablet regimen in artistry 1 or from BIGTARVI in artistry 2, with no clinically meaningful emergent resistance.
Speaker #2: Moving to our once-weekly oral programs, we continue to target updates from the Phase 3 Island 1 and 2 trials in collaboration with Merck, later this quarter.
Speaker #2: These trials are evaluating isletravir plus LANAC capivir for virally suppressed people with HIV and, if successful, this could result in the first-ever long-acting oral treatment regimen.
Dietmar Berger: These trials are evaluating islatravir plus lenacapavir for virally suppressed people with HIV, and if successful, this could result in the first ever long-acting oral treatment regimen. We also continue to develop a wholly owned weekly oral treatment regimen, combining a capsid inhibitor with an integrase inhibitor for treatment of people with HIV. With multiple alternative molecules in our portfolio, we are finalizing the selection of the capsid inhibitor and integrase inhibitor for the new combination and look forward to updating you in due course. Moving to even longer acting options, we're excited to be initiating a phase II trial combining our investigational integrase inhibitor, GS-3242, with lenacapavir in H2 of this year. This follows phase I data shared at CROI that showed potential for injectable dosing every four months. The higher dose phase I cohorts with potential for twice yearly dosing are ongoing.
Dietmar Berger: These trials are evaluating islatravir plus lenacapavir for virally suppressed people with HIV, and if successful, this could result in the first ever long-acting oral treatment regimen. We also continue to develop a wholly owned weekly oral treatment regimen, combining a capsid inhibitor with an integrase inhibitor for treatment of people with HIV. With multiple alternative molecules in our portfolio, we are finalizing the selection of the capsid inhibitor and integrase inhibitor for the new combination and look forward to updating you in due course. Moving to even longer acting options, we're excited to be initiating a phase II trial combining our investigational integrase inhibitor, GS-3242, with lenacapavir in H2 of this year. This follows phase I data shared at CROI that showed potential for injectable dosing every four months. The higher dose phase I cohorts with potential for twice yearly dosing are ongoing.
Speaker #2: We also continue to develop a wholly owned weekly oral treatment regimen combining a capsid inhibitor with an integrase inhibitor for treatment of people with HIV.
Speaker #2: With multiple alternative molecules in our portfolio, we are finalizing the selection of the capsid inhibitor and integrase inhibitor for the new combination and look forward to updating you in due course.
Speaker #2: Moving to even longer-acting options, we're excited to be initiating a Phase 2 trial combining our investigational integrase inhibitor, GS3242, with LANAC capivir in the second half of this year.
Speaker #2: This follows Phase 1 data shared at Crohn that showed potential for injectable dosing every four months. The higher dose Phase 1 cohorts with potential for twice-yearly dosing are ongoing.
Speaker #2: In HIV prevention, we continue to drive innovation building on the exceptional clinical profile of YES2GO, and I'm pleased to share that enrollment in our Phase 3 purpose 365 study evaluating once-yearly intramuscular LANAC capivir is complete.
Dietmar Berger: In HIV prevention, we continue to drive innovation building on the exceptional clinical profile of DESCOVY. I'm pleased to share that enrollment in our phase III PURPOSE 365 study evaluating once yearly intramuscular lenacapavir is complete. This registrational study is testing PK, safety, and tolerability across a diverse set of participants indicated for PrEP. We expect these data, along with the unprecedented efficacy and safety results from PURPOSE 1 and 2, to form the basis of regulatory submission with target US approval in 2028. Transitioning to oncology and starting on slide 17, we have announced several strategic investments over the last few months that we believe further strengthen our ADC and cell therapy capabilities and portfolios.
Dietmar Berger: In HIV prevention, we continue to drive innovation building on the exceptional clinical profile of DESCOVY. I'm pleased to share that enrollment in our phase III PURPOSE 365 study evaluating once yearly intramuscular lenacapavir is complete. This registrational study is testing PK, safety, and tolerability across a diverse set of participants indicated for PrEP. We expect these data, along with the unprecedented efficacy and safety results from PURPOSE 1 and 2, to form the basis of regulatory submission with target US approval in 2028. Transitioning to oncology and starting on slide 17, we have announced several strategic investments over the last few months that we believe further strengthen our ADC and cell therapy capabilities and portfolios.
Speaker #2: This registrational study is testing PK, safety, and tolerability across a diverse set of participants indicated for PrEP. We expect these data, along with the unprecedented efficacy and safety results from purpose 1 and 2, to form the basis of regulatory submission with target US approval in 2028.
Speaker #2: Transitioning to oncology and starting on slide 17, we have announced several strategic investments over the last few months that we believe further strengthen our ADC and cell therapy capabilities and portfolios.
Speaker #2: ADCs are one of the most promising modalities in cancer today as highlighted by the incredible impact Trodelvy has demonstrated for patients with second-line metastatic triple-negative breast cancer and pre-treated hormone receptor-positive HER2 negative metastatic breast cancer.
Dietmar Berger: ADCs are one of the most promising modalities in cancer today, as highlighted by the incredible impact TRODELVY has demonstrated for patients with second-line metastatic triple-negative breast cancer and pretreated hormone receptor-positive, HER2-negative metastatic breast cancer. We continue to expect regulatory decisions from FDA for first-line metastatic TNBC in H2 2026. We now also anticipate European Commission decisions later this year. Further, we continue to expect phase III updates from EVOKE-03 in first-line PD-L1-high metastatic non-small cell lung cancer and ASCENT-GYN-01 in second-line+ metastatic endometrial cancer in H2 this year. Given our foundational ADC experience with TRODELVY, we're excited to expand our portfolio and capabilities with the acquisition of Tubulis.
Dietmar Berger: ADCs are one of the most promising modalities in cancer today, as highlighted by the incredible impact TRODELVY has demonstrated for patients with second-line metastatic triple-negative breast cancer and pretreated hormone receptor-positive, HER2-negative metastatic breast cancer. We continue to expect regulatory decisions from FDA for first-line metastatic TNBC in H2 2026. We now also anticipate European Commission decisions later this year. Further, we continue to expect phase III updates from EVOKE-03 in first-line PD-L1-high metastatic non-small cell lung cancer and ASCENT-GYN-01 in second-line+ metastatic endometrial cancer in H2 this year. Given our foundational ADC experience with TRODELVY, we're excited to expand our portfolio and capabilities with the acquisition of Tubulis.
Speaker #2: We continue to expect regulatory decisions from FDA for first-line metastatic TNBC in the second half of 2026. And we now also anticipate European Commission decisions later this year.
Speaker #2: Further, we continue to expect Phase 3 updates from EVOKE-03 in first-line PD-L1 high metastatic non-small cell lung cancer, and ASCEND-GYNE in second-line plus metastatic endometrial cancer, in the second half of this year.
Speaker #2: Given our foundational ADC experience with Trodelvy, we're excited to expand our portfolio and capabilities with the acquisition of tubulus. The lead asset, TOP40, is a potential first-in-class NAPI2B directed ADC that we believe has transformative potential in platinum-resistant ovarian cancer a challenging and aggressive condition with a poor prognosis for many women.
Dietmar Berger: The lead asset, TUB-040, is a potential first in class NaPi2b-directed ADC that we believe has transformative potential in platinum-resistant ovarian cancer, a challenging and aggressive condition with a poor prognosis for many women. At the ESMO conference last year, TUB-040 phase I data showed early treatment responses that deepened over time in a broad ovarian cancer population without any biomarker selection. This is potentially meaningful differentiation from other approved ADCs. Also, in the shared data, TUB-040 was generally well-tolerated across a wide therapeutic index with no clinically relevant bleeding, pneumonitis, ocular toxicity, stomatitis, or neuropathy observed. In the immediate future, we look forward to more mature phase I data on TUB-040 in ovarian cancer at this year's ASCO meeting in June, and expect to enter registrational phase III studies for platinum-resistant ovarian cancer in 2027.
Dietmar Berger: The lead asset, TUB-040, is a potential first in class NaPi2b-directed ADC that we believe has transformative potential in platinum-resistant ovarian cancer, a challenging and aggressive condition with a poor prognosis for many women. At the ESMO conference last year, TUB-040 phase I data showed early treatment responses that deepened over time in a broad ovarian cancer population without any biomarker selection. This is potentially meaningful differentiation from other approved ADCs. Also, in the shared data, TUB-040 was generally well-tolerated across a wide therapeutic index with no clinically relevant bleeding, pneumonitis, ocular toxicity, stomatitis, or neuropathy observed. In the immediate future, we look forward to more mature phase I data on TUB-040 in ovarian cancer at this year's ASCO meeting in June, and expect to enter registrational phase III studies for platinum-resistant ovarian cancer in 2027.
Speaker #2: At the ESMO conference last year, TOP40 Phase 1 data showed early treatment responses that deepened over time in a broad ovarian cancer population without any biomarker selection.
Speaker #2: This is a potentially meaningful differentiation from other approved ADCs. Also, in the shared data, TOP40 was generally well-tolerated across a wide therapeutic index with no clinically relevant bleeding, pneumonitis, ocular toxicity, stomatitis, or neuropathy observed.
Speaker #2: In the immediate future, we look forward to more mature Phase 1 data on TOP40 in ovarian cancer at this year's ASCO meeting in June, and expect to enter registrational Phase 3 studies for platinum-resistant ovarian cancer in 2027.
Speaker #2: Looking longer term, tubulus pipeline includes TOP30, a potential first-in-class ADC targeting 5T4, being evaluated in a Phase 1 basket trial in multiple solid tumors including head and neck cancer and non-small cell lung cancer.
Dietmar Berger: Looking longer term, Tubulis pipeline includes TUB-030, a potential first-in-class ADC targeting 5T4, being evaluated in a phase I basket trial in multiple solid tumors, including head and neck cancer and non-small cell lung cancer. Tubulis has multiple preclinical assets that utilize its next-generation ADC platform. We're excited by the potential to develop ADCs that incorporate novel payloads, including ones developed by Gilead's industry-leading medicinal chemistry group. Moving to cell therapy on slide 18, and on behalf of Cindy and the Kite team, we are pleased to have closed our acquisition of Arcellx at the end of April, which formally brings anito-cel's entire program and the broader D domain binder portfolio into our R&D organization.
Dietmar Berger: Looking longer term, Tubulis pipeline includes TUB-030, a potential first-in-class ADC targeting 5T4, being evaluated in a phase I basket trial in multiple solid tumors, including head and neck cancer and non-small cell lung cancer. Tubulis has multiple preclinical assets that utilize its next-generation ADC platform. We're excited by the potential to develop ADCs that incorporate novel payloads, including ones developed by Gilead's industry-leading medicinal chemistry group. Moving to cell therapy on slide 18, and on behalf of Cindy and the Kite team, we are pleased to have closed our acquisition of Arcellx at the end of April, which formally brings anito-cel's entire program and the broader D domain binder portfolio into our R&D organization.
Speaker #2: Further, tubulus has multiple preclinical assets that utilize its next-generation ADC platform. We're excited by the potential to develop ADCs that incorporate novel payloads including ones developed by GILIAD's industry-leading medicinal chemistry group.
Speaker #2: Moving to cell therapy on slide 18 and on behalf of CINDI and the KITE team, we are pleased to have closed our acquisition of our CELLIX at the end of April, which formally brings a needle cells entire program and the broader D-domain binder portfolio into our R&D organization.
Speaker #2: We have long believed a needle cell has a potential best in disease profile in multiple myeloma, and this is supported by clinically meaningful, deep, and durable efficacy as well as a differentiated safety profile.
Dietmar Berger: We have long believed anito-cel has a potential best-in-disease profile in multiple myeloma, and this is supported by clinically meaningful, deep, and durable efficacy as well as a differentiated safety profile. This includes no delayed or non-ICANS neurotoxicities and enterocolitis in our clinical program. Given our confidence in anito-cel's clinical profile, we are evaluating anito-cel in earlier treatment lines, including 2nd to 4th line relapse or refractory multiple myeloma in the phase III iMMagine-3 trial. This trial is recruiting ahead of expectations with enrollment completion expected in Q2. We are also planning to develop anito-cel in newly diagnosed multiple myeloma.
Dietmar Berger: We have long believed anito-cel has a potential best-in-disease profile in multiple myeloma, and this is supported by clinically meaningful, deep, and durable efficacy as well as a differentiated safety profile. This includes no delayed or non-ICANS neurotoxicities and enterocolitis in our clinical program. Given our confidence in anito-cel's clinical profile, we are evaluating anito-cel in earlier treatment lines, including 2nd to 4th line relapse or refractory multiple myeloma in the phase III iMMagine-3 trial. This trial is recruiting ahead of expectations with enrollment completion expected in Q2. We are also planning to develop anito-cel in newly diagnosed multiple myeloma.
Speaker #2: This includes no delayed or non-ICANS neurotoxicities and enterocolitis in our clinical program. Given our confidence in a needle cells clinical profile, we are evaluating a needle cell in earlier treatment lines including second to fourth line relapse or refractory multiple myeloma, in the Phase 3 IMAGEN-3 trial.
Speaker #2: This trial is recruiting ahead of expectations with enrollment completion expected in the second quarter. We are also planning to develop a needle cell in newly diagnosed multiple myeloma.
Speaker #2: Beyond a needle cell, the ARCELLIX acquisition brings an array of promising research assets, and we are particularly excited to explore the broader applications of the unique D-domain binder platform across a variety of targets in oncology and autoimmune diseases and notably for in vivo cell therapies.
Dietmar Berger: Beyond anito-cel, the Arcellx acquisition brings an array of promising research assets, and we are particularly excited to explore the broader applications of the unique D domain binder platform across a variety of targets in oncology and autoimmune diseases, and notably for in vivo cell therapies. With our increasingly differentiated cell therapy pipeline, we look forward to bringing CAR T to even more patients in the years ahead. Moving to slide 19, our inflammation pipeline has nearly doubled since 2019 and now consists of 10 clinical-stage assets spanning small molecules, antibodies, including bispecifics, and cell therapies that enable a diverse array of approaches to address challenging autoimmune diseases. We are excited about the pending acquisition of Ouro Medicines and its lead asset, gamgertamig, a clinical-stage subcutaneously administered BCMAxCD3 bispecific T-cell engager that we expect to develop in collaboration with Galapagos.
Dietmar Berger: Beyond anito-cel, the Arcellx acquisition brings an array of promising research assets, and we are particularly excited to explore the broader applications of the unique D domain binder platform across a variety of targets in oncology and autoimmune diseases, and notably for in vivo cell therapies. With our increasingly differentiated cell therapy pipeline, we look forward to bringing CAR T to even more patients in the years ahead. Moving to slide 19, our inflammation pipeline has nearly doubled since 2019 and now consists of 10 clinical-stage assets spanning small molecules, antibodies, including bispecifics, and cell therapies that enable a diverse array of approaches to address challenging autoimmune diseases. We are excited about the pending acquisition of Ouro Medicines and its lead asset, gamgertamig, a clinical-stage subcutaneously administered BCMAxCD3 bispecific T-cell engager that we expect to develop in collaboration with Galapagos.
Speaker #2: With our increasingly differentiated cell therapy pipeline, we look forward to bringing CAR-T to even more patients in the years ahead. Moving to slide 19, our inflammation pipeline has nearly doubled since 2019 and now consists of 10 clinical stage assets spanning small molecules, antibodies including bispecifics, and cell therapies that enable a diverse array of approaches to address challenging autoimmune diseases.
Speaker #2: We are excited about the pending acquisition of oral medicines and its lead asset, gemgurtamig, a clinical stage subcutaneously administered BCMA CD3 bispecific T-cell engager that we expect to develop in collaboration with Galapagos.
Speaker #2: Together with KITE's portfolio of a needle cell and next-generation bisystronic CAR-Ts, we believe we could achieve durable immune reset shifting some autoimmune diseases from chronic symptom control to a transformative long-term treatment effect.
Dietmar Berger: Together with Kite's portfolio of anito-cel and next generation bispecific CAR Ts, we believe we could achieve durable immune reset, shifting some autoimmune diseases from chronic symptom control to a transformative long-term treatment effect. Each asset offers unique potential advantages that could allow us to target different patient populations. Specifically, gamgertamig has shown rapid, deep, and sustained plasma and B-cell depletion while maintaining low rate and low-grade CRS with no ICANS to date in over 60 patients with immune-mediated diseases. We are focusing first on orphan autoimmune indications with established proof of concept and high unmet need, including autoimmune cytopenias, pemphigus, and idiopathic inflammatory myopathies. We're targeting phase III registrational trials in select autoimmune diseases as early as 2027. Longer term, we believe gamgertamig has potential in more than 20 autoimmune diseases that are driven by pathogenic B and plasma cells.
Dietmar Berger: Together with Kite's portfolio of anito-cel and next generation bispecific CAR Ts, we believe we could achieve durable immune reset, shifting some autoimmune diseases from chronic symptom control to a transformative long-term treatment effect. Each asset offers unique potential advantages that could allow us to target different patient populations. Specifically, gamgertamig has shown rapid, deep, and sustained plasma and B-cell depletion while maintaining low rate and low-grade CRS with no ICANS to date in over 60 patients with immune-mediated diseases. We are focusing first on orphan autoimmune indications with established proof of concept and high unmet need, including autoimmune cytopenias, pemphigus, and idiopathic inflammatory myopathies. We're targeting phase III registrational trials in select autoimmune diseases as early as 2027. Longer term, we believe gamgertamig has potential in more than 20 autoimmune diseases that are driven by pathogenic B and plasma cells.
Speaker #2: Each asset offers unique potential advantages that could allow us to target different patient populations. Specifically, gemgurtamig has shown rapid, deep, and sustained plasma and B-cell rate, and low-grade CRS with no ICANS to date in over 60 patients with immune-mediated diseases.
Speaker #2: We are focusing first on orphan autoimmune indications with established proof of concept and high unmet need including autoimmune cytopenias, pemphigus, and idiopathic inflammatory myopathies.
Speaker #2: We are targeting Phase 3 registrational trials in select autoimmune diseases as early as 2027. Longer term, we believe gemgurtamig has potential in more than 20 autoimmune diseases that are driven by pathogenic B and plasma cells.
Speaker #2: Additionally, this year we plan to share updates from our broader inflammation portfolio including the Phase 3 ideal study evaluating live delta in PBC patients with incomplete response to UDCA, the Phase 2 SWIFT study evaluating GS1427 or MVISTIGRAST, our investigational oral alpha-4 beta 7 inhibitor for inflammatory bowel diseases, and the Phase 2A COSMIC study evaluating IDIS assertive, our investigational IREK4 kinase inhibitor in cutaneous lupus erythematosus.
Dietmar Berger: Additionally, this year we plan to share updates from our broader inflammation portfolio, including the phase III IDEAL study evaluating Livdelzi in PBC patients with incomplete response to UDCA. The phase II SWIFT study evaluating GS-1427 or emvistegrast, our investigational oral alpha-4 beta-7 inhibitor for inflammatory bowel diseases, and the phase IIa COSMIC study evaluating edecesertib, our investigational IRAK4 kinase inhibitor in cutaneous lupus erythematosus. Finally, reviewing our 2026 pipeline milestones on slide 20, we remain on track across all our key deliverables. We expect an FDA regulatory decision for bulevirtide as a treatment for chronic HDV infection later this quarter. Bulevirtide has been approved as Hepcludex in the EU since 2020, and we look forward to making this available to patients in the US.
Dietmar Berger: Additionally, this year we plan to share updates from our broader inflammation portfolio, including the phase III IDEAL study evaluating Livdelzi in PBC patients with incomplete response to UDCA. The phase II SWIFT study evaluating GS-1427 or emvistegrast, our investigational oral alpha-4 beta-7 inhibitor for inflammatory bowel diseases, and the phase IIa COSMIC study evaluating edecesertib, our investigational IRAK4 kinase inhibitor in cutaneous lupus erythematosus. Finally, reviewing our 2026 pipeline milestones on slide 20, we remain on track across all our key deliverables. We expect an FDA regulatory decision for bulevirtide as a treatment for chronic HDV infection later this quarter. Bulevirtide has been approved as Hepcludex in the EU since 2020, and we look forward to making this available to patients in the US.
Speaker #2: Finally, reviewing our 2026 pipeline milestones on slide 20, we remain on track across all our key deliverables. We expect an FDA regulatory decision for bulavitide as a treatment for chronic HDV infection later this quarter.
Speaker #2: Bulavitide has been approved as had Cludex in the EU since 2020, and we look forward to making this available to patients in the US.
Speaker #2: Additionally, we expect FDA regulatory decisions for BIGLEN in August and a needle cell in December of this year as well as Phase 3 updates for island 1 and 2 in the first half of this year and for IVOCO3, ASCEND GAIN, and IDEAL in the second half.
Dietmar Berger: Additionally, we expect FDA regulatory decisions for BIC/LEN in August and anito-cel in December 2024, as well as phase III updates for ISLAND 1 and 2 in H1 2024 and for EVOKE-03, ASCENT-GYN-01, and IDEAL in H2. With that, I'd like to thank our research and development teams and our partners whose continued strong clinical execution are driving the progress we have seen across our pipeline. Now I'll turn over the call to Andy.
Dietmar Berger: Additionally, we expect FDA regulatory decisions for BIC/LEN in August and anito-cel in December 2024, as well as phase III updates for ISLAND 1 and 2 in H1 2024 and for EVOKE-03, ASCENT-GYN-01, and IDEAL in H2. With that, I'd like to thank our research and development teams and our partners whose continued strong clinical execution are driving the progress we have seen across our pipeline. Now I'll turn over the call to Andy.
Speaker #2: With that, I'd like to thank our research and development teams and our partners whose continued strong clinical execution are driving the progress we have seen across our pipeline.
Speaker #2: Now I'll turn over the call to Andy.
Speaker #1: Thank you, Dietmar, and good afternoon, everyone. As you've heard, GILIAD delivered strong first-quarter results with continued commercial outperformance and disciplined operating execution. As shown on slide 22, our base business grew 8% year over year, to 6.8 billion dollars, driven by continued growth in sales for HIV products, TRIDELVI, and live delta, partially offset by lower sales of HCV and cell therapy products.
Andrew Dickinson: Thank you, Dietmar, and good afternoon, everyone. As you've heard, Gilead delivered strong Q1 results with continued commercial outperformance and disciplined operating execution. As shown on slide 22, our base business grew 8% year-over-year to $6.8 billion, driven by continued growth in sales for HIV products, TRODELVY, and Livdelzi, partially offset by lower sales of HCV and cell therapy products. Sequentially, sales were down 12%, reflecting typical seasonal inventory dynamics in line with our expectations. Total product sales of $6.9 billion were up 5% year-over-year, reflecting lower VEKLURY sales due to fewer COVID-19 related hospitalizations. Moving to our non-GAAP Q1 results on slide 23.
Andrew Dickinson: Thank you, Dietmar, and good afternoon, everyone. As you've heard, Gilead delivered strong Q1 results with continued commercial outperformance and disciplined operating execution. As shown on slide 22, our base business grew 8% year-over-year to $6.8 billion, driven by continued growth in sales for HIV products, TRODELVY, and Livdelzi, partially offset by lower sales of HCV and cell therapy products. Sequentially, sales were down 12%, reflecting typical seasonal inventory dynamics in line with our expectations. Total product sales of $6.9 billion were up 5% year-over-year, reflecting lower VEKLURY sales due to fewer COVID-19 related hospitalizations. Moving to our non-GAAP Q1 results on slide 23.
Speaker #1: Sequentially, sales were down 12%, reflecting typical seasonal inventory dynamics in line with our expectations. Total product sales of 6.9 billion dollars were up 5% year over year, reflecting lower VECLURID sales due to fewer COVID-19-related hospitalizations.
Speaker #1: Moving to our non-GAP first-quarter results on slide 23. Product gross margin was 87%, in line with 2 percentage points year over year, due to the expiration of a longstanding TAF-related royalty obligation in addition to product mix.
Andrew Dickinson: Product gross margin was 87%, in line with our full-year guidance and up 2 percentage points year over year due to the expiration of a long-standing TAF-related royalty obligation in addition to product mix. R&D expenses were $1.4 billion, relatively flat year over year, reflecting higher investments in virology clinical manufacturing offset by lower oncology clinical study activity. Acquired IPR&D expenses were $107 million, primarily driven by an upfront payment related to our Genhouse licensing deal. Additionally, we have now closed the acquisition of Arcellx, and the acquisitions of Ouro Medicines and Tubulis are expected to close later this quarter. The upfront payments related to these transactions are expected to be recorded in our Q2 acquired IPR&D and have been reflected in our full-year EPS guidance, which I will discuss shortly. Back to our Q1 results.
Andrew Dickinson: Product gross margin was 87%, in line with our full-year guidance and up 2 percentage points year over year due to the expiration of a long-standing TAF-related royalty obligation in addition to product mix. R&D expenses were $1.4 billion, relatively flat year over year, reflecting higher investments in virology clinical manufacturing offset by lower oncology clinical study activity. Acquired IPR&D expenses were $107 million, primarily driven by an upfront payment related to our Genhouse licensing deal. Additionally, we have now closed the acquisition of Arcellx, and the acquisitions of Ouro Medicines and Tubulis are expected to close later this quarter. The upfront payments related to these transactions are expected to be recorded in our Q2 acquired IPR&D and have been reflected in our full-year EPS guidance, which I will discuss shortly. Back to our Q1 results.
Speaker #1: R&D expenses were 1.4 billion dollars, relatively flat year over year, reflecting higher investments in virology clinical manufacturing, offset by lower oncology clinical study activity.
Speaker #1: Acquired IPR&D expenses were 107 million dollars, primarily driven by an upfront payment related to our GENHouse licensing deal. Additionally, we have now closed the acquisition of Arcelix, and the acquisitions of oral medicines and tubulous are expected to close later this quarter.
Speaker #1: The upfront payments related to these transactions are expected to be recorded in our second-quarter acquired IPR&D and have been reflected in our full-year EPS guidance, which I will discuss shortly.
Speaker #1: Back to our first-quarter results. SGNA expenses were up 12% year over year, primarily reflecting higher selling and marketing expenses related to the YES2GO launch.
Andrew Dickinson: SG&A expenses were up 12% year over year, primarily reflecting higher selling and marketing expenses related to the YEZTUGO launch. Q1 operating margin was 47%, reflecting our continued focus on operating expense discipline and delivering top-quartile margins. The non-GAAP effective tax rate was 18.3% in Q1. Finally, non-GAAP diluted EPS was $2.03, up 12% year over year. This reflected higher product sales and lower IPR&D expenses incurred this quarter, partially offset by higher tax and SG&A expenses. Moving to our full-year guidance. We are pleased to share our updated expectations for 2026, reflecting revenue outperformance in Q1 and expected momentum through the rest of the year. As a result, we are increasing our revenue ranges by $400 million.
Andrew Dickinson: SG&A expenses were up 12% year over year, primarily reflecting higher selling and marketing expenses related to the YEZTUGO launch. Q1 operating margin was 47%, reflecting our continued focus on operating expense discipline and delivering top-quartile margins. The non-GAAP effective tax rate was 18.3% in Q1. Finally, non-GAAP diluted EPS was $2.03, up 12% year over year. This reflected higher product sales and lower IPR&D expenses incurred this quarter, partially offset by higher tax and SG&A expenses. Moving to our full-year guidance. We are pleased to share our updated expectations for 2026, reflecting revenue outperformance in Q1 and expected momentum through the rest of the year. As a result, we are increasing our revenue ranges by $400 million.
Speaker #1: First-quarter operating margin was 47%, reflecting our continued focus on operating expense discipline, and delivering top quartile margins. The non-GAP effective tax rate was 18.3% in the first quarter.
Speaker #1: And finally, non-GAP diluted EPS was $2.03, up 12% year over year. This reflected higher product sales and lower IPR&D expenses incurred this quarter, partially offset by higher tax in SGNA expenses.
Speaker #1: Moving to our full-year guidance, we are pleased to share our updated expectations for 2026, reflecting revenue outperformance in the first quarter, and expected momentum through the rest of the year.
Speaker #1: As a result, we are increasing our revenue ranges by $400 million. With regards to operating expenses in 2026, and as discussed on our transaction call a few weeks ago, we continue the careful prioritization of operational spend, consistent with our track record over the last several years.
Andrew Dickinson: With regards to operating expenses in 2026, and as discussed on our transaction call a few weeks ago, we continue the careful prioritization of operational spend consistent with our track record over the last several years. For R&D, we expect a transaction-related modest and manageable dollar increase compared to our start-of-the-year guidance. In SG&A, we are effectively absorbing incremental expenses associated with the acquisitions in our prior guidance. Upfront IPR&D of $11.5 billion, together with transaction financing expenses, collectively amounting to $9.50 per share, are reflected in our updated EPS guidance. We are pleased to note that excluding these transaction-related costs, we are effectively maintaining our start-of-the-year non-GAAP EPS guidance, highlighting the flexibility in our operating model and our agility as we flex to accommodate the needs of the business.
Andrew Dickinson: With regards to operating expenses in 2026, and as discussed on our transaction call a few weeks ago, we continue the careful prioritization of operational spend consistent with our track record over the last several years. For R&D, we expect a transaction-related modest and manageable dollar increase compared to our start-of-the-year guidance. In SG&A, we are effectively absorbing incremental expenses associated with the acquisitions in our prior guidance. Upfront IPR&D of $11.5 billion, together with transaction financing expenses, collectively amounting to $9.50 per share, are reflected in our updated EPS guidance. We are pleased to note that excluding these transaction-related costs, we are effectively maintaining our start-of-the-year non-GAAP EPS guidance, highlighting the flexibility in our operating model and our agility as we flex to accommodate the needs of the business.
Speaker #1: For R&D, we expect a transaction-related, modest, and manageable dollar increase compared to our start-of-the-year guidance, and an SG&A—we are effectively absorbing incremental expenses associated with the acquisitions in our prior guidance.
Speaker #1: Upfront IPR&D of 11.5 billion dollars, together with transaction financing expenses, collectively amounting to $9.50 per share, are reflected in our updated EPS guidance. We are pleased to note that, excluding these transaction-related costs, we are effectively maintaining our start-of-the-year non-GAP EPS guidance, highlighting the flexibility in our operating model, and our agility as we flex to accommodate the needs of the business.
Speaker #1: Looking at the detail starting on slide 24, reflecting strength across our HIV businesses, we now expect 2026 HIV sales to grow 8% year over year, ahead of our prior guidance of 6% growth.
Andrew Dickinson: Looking at the details starting on slide 24, reflecting strength across our HIV businesses, we now expect 2026 HIV sales to grow 8% year over year, ahead of our prior guidance of 6% growth. Within HIV, we now expect YEZTUGO sales of approximately $1 billion, up from $800 million at the start of the year. As a result, we are increasing our 2026 base business guidance and now expect a range between $29.4 billion and $29.8 billion. This increase of $400 million results in 5% to 6% growth compared to 2025, up from the 4% to 5% growth expectation we shared in February.
Andrew Dickinson: Looking at the details starting on slide 24, reflecting strength across our HIV businesses, we now expect 2026 HIV sales to grow 8% year over year, ahead of our prior guidance of 6% growth. Within HIV, we now expect YEZTUGO sales of approximately $1 billion, up from $800 million at the start of the year. As a result, we are increasing our 2026 base business guidance and now expect a range between $29.4 billion and $29.8 billion. This increase of $400 million results in 5% to 6% growth compared to 2025, up from the 4% to 5% growth expectation we shared in February.
Speaker #1: Within HIV, we now expect YES2GO sales of approximately $1 billion, up from $800 million at the start of the year. As a result, we are increasing our 2026 base business guidance, and now expect a range between 29.4 billion dollars and 29.8 billion dollars.
Speaker #1: This increase of $400 million results in 5 to 6 percent growth compared to 2025, up from the 4 to 5 percent growth expectation we shared in February.
Speaker #1: As we highlighted last quarter, our guidance includes a roughly 2% growth headwind from policy-related changes this year, primarily related to the drug pricing agreement announced in December 2025 and the Affordable Care Act.
Andrew Dickinson: As we highlighted last quarter, our guidance includes a roughly 2% growth headwind from policy-related changes this year, primarily related to the drug pricing agreement announced in 2025 and the Affordable Care Act. Absent this headwind, base business growth would be expected to be 7% to 8%. Our full-year VEKLURY guidance remains unchanged at approximately $600 million, contributing to expected 2026 total product sales between $30 billion and $30.4 billion, an increase of $400 million. Moving to the non-GAAP P&L for the full year 2026, we are adjusting our guidance to reflect the Arcellx, Ouro Medicines, and Tubulis acquisitions. Specifically, we expect R&D expenses to increase a mid-single-digit percentage from 2025, slightly higher than the low single-digit percentage increase shared in our February guidance.
Andrew Dickinson: As we highlighted last quarter, our guidance includes a roughly 2% growth headwind from policy-related changes this year, primarily related to the drug pricing agreement announced in 2025 and the Affordable Care Act. Absent this headwind, base business growth would be expected to be 7% to 8%. Our full-year VEKLURY guidance remains unchanged at approximately $600 million, contributing to expected 2026 total product sales between $30 billion and $30.4 billion, an increase of $400 million. Moving to the non-GAAP P&L for the full year 2026, we are adjusting our guidance to reflect the Arcellx, Ouro Medicines, and Tubulis acquisitions. Specifically, we expect R&D expenses to increase a mid-single-digit percentage from 2025, slightly higher than the low single-digit percentage increase shared in our February guidance.
Speaker #1: Absent this headwind, base business growth would be expected to be 7 to 8 percent. Our full-year VECLURID guidance remains unchanged at approximately $600 million, contributing to expected 2026 total product sales between $30 billion and $30.4 billion, an increase of $400 million.
Speaker #1: Moving to the non-GAP P&L for the full year 2026, we are adjusting our guidance to reflect the Arcelix, oral medicines, and tubulous acquisitions. Specifically, we expect R&D expenses to increase a mid-single-digit percentage from 2025, slightly higher than the low single-digit percentage increase shared in our February guidance.
Speaker #1: This is primarily driven by our investment in clinical programs related to the announced acquisitions of tubulous and Arcelix. Overall, we expect R&D expense as a percentage of total product sales to be less than 20% in 2026.
Andrew Dickinson: This is primarily driven by our investment in clinical programs related to the announced acquisitions of Tubulis and Arcellx. Overall, we expect R&D expense as a percentage of total product sales to be less than 20% in 2026. We expect acquired IPR&D investments of approximately $11.8 billion for the year, which includes the upfront payments associated with our recently announced acquisitions. We expect SG&A expenses to remain in line with our February guidance of a mid-single-digit percentage increase compared to 2025. We expect full-year 2026 operating income of $2.4 billion to $2.9 billion. Full-year 2026 effective tax rate is expected to be between 140% and 190%, reflecting the nondeductible expenses from the Arcellx, Ouro Medicines, and Tubulis transactions.
Andrew Dickinson: This is primarily driven by our investment in clinical programs related to the announced acquisitions of Tubulis and Arcellx. Overall, we expect R&D expense as a percentage of total product sales to be less than 20% in 2026. We expect acquired IPR&D investments of approximately $11.8 billion for the year, which includes the upfront payments associated with our recently announced acquisitions. We expect SG&A expenses to remain in line with our February guidance of a mid-single-digit percentage increase compared to 2025. We expect full-year 2026 operating income of $2.4 billion to $2.9 billion. Full-year 2026 effective tax rate is expected to be between 140% and 190%, reflecting the nondeductible expenses from the Arcellx, Ouro Medicines, and Tubulis transactions.
Speaker #1: We expect acquired IPR&D investments of approximately $11.8 billion for the year, which includes the upfront payments associated with our recently announced acquisitions. We expect SGNA expenses to remain in line with our February guidance of a mid-single-digit percentage increase compared to 2025.
Speaker #1: And we expect full-year 2026 operating income of $2.4 billion to $2.9 billion. Full-year 2026 effective tax rate is expected to be between 140% and 190%, reflecting the non-deductible expenses from the Arcelix, oral medicines, and tubulous transactions.
Speaker #1: Excluding the $11.5 billion in upfront payments related to these recent transactions, operating income would be between $14 billion and $14.5 billion, or $200 million higher than our February guidance.
Andrew Dickinson: Excluding the $11.5 billion in upfront payments related to these recent transactions, operating income would be between $14 billion and $14.5 billion or $200 million higher than our February guidance. On slide 25, you can see that we now expect full-year 2026 non-GAAP loss per share in the range of $1.05 to $0.65 per share. This includes an expense of approximately $9.50 per share relating to the upfront payments and financing costs associated with the Arcellx, Ouro, and Tubulis transactions. Excluding this impact, our non-GAAP diluted EPS would be $8.45 to $8.85 or in line with the non-GAAP EPS guidance we shared back in February.
Andrew Dickinson: Excluding the $11.5 billion in upfront payments related to these recent transactions, operating income would be between $14 billion and $14.5 billion or $200 million higher than our February guidance. On slide 25, you can see that we now expect full-year 2026 non-GAAP loss per share in the range of $1.05 to $0.65 per share. This includes an expense of approximately $9.50 per share relating to the upfront payments and financing costs associated with the Arcellx, Ouro, and Tubulis transactions. Excluding this impact, our non-GAAP diluted EPS would be $8.45 to $8.85 or in line with the non-GAAP EPS guidance we shared back in February.
Speaker #1: On slide 25, you can see that we now expect full-year 2026 non-GAP loss per share in the range of $1.05 to $0.65 per share.
Speaker #1: This includes an expense of approximately $9.50 per share relating to the upfront payments and financing costs associated with the Arcelix, oral, and tubulous transactions.
Speaker #1: Excluding this impact, our non-GAP diluted EPS would be $8.45 to $8.85, or in line with the non-GAP EPS guidance we shared back in February.
Speaker #1: We are pleased to note that the strength in our commercial business reflected in the $400 million increase in product sales, is effectively offsetting the impact primarily R&D of the three deals on an EPS basis.
Andrew Dickinson: We are pleased to note that the strength in our commercial business, reflected in the $400 million increase in product sales, is effectively offsetting the impact, primarily R&D, of the three deals on an EPS basis. On slide 26, we returned greater than $1.4 billion to shareholders in Q1 2026, including over $400 million of share repurchases. Combined with our dividend, we returned approximately 60% of our free cash flow to shareholders in Q1 2026. Looking ahead, given the pace of our activity in the first 4 months of 2026, our business development focus in the near term will be closing and successfully integrating these programs and maintaining strong clinical momentum. At the same time, we will continue to pursue ordinary course business development transactions.
Andrew Dickinson: We are pleased to note that the strength in our commercial business, reflected in the $400 million increase in product sales, is effectively offsetting the impact, primarily R&D, of the three deals on an EPS basis. On slide 26, we returned greater than $1.4 billion to shareholders in Q1 2026, including over $400 million of share repurchases. Combined with our dividend, we returned approximately 60% of our free cash flow to shareholders in Q1 2026. Looking ahead, given the pace of our activity in the first 4 months of 2026, our business development focus in the near term will be closing and successfully integrating these programs and maintaining strong clinical momentum. At the same time, we will continue to pursue ordinary course business development transactions.
Speaker #1: On slide 26, we return greater than 1.4 billion dollars to shareholders in the first quarter of 2026, including over $400 million of share repurchases.
Speaker #1: Combined with our dividend, we returned approximately 60% of our free cash flow to shareholders in the first quarter of 2026. Looking ahead, given the pace of our activity in the first four months of 2026, our business development focus in the near term will be closing and successfully integrating these programs and maintaining strong clinical momentum.
Speaker #1: At the same time, we will continue to pursue ordinary course business development transactions. It is less likely that we will pursue more sizable M&A this year, although we will always leave the door open to consider strategic acquisitions if a compelling opportunity emerges.
Andrew Dickinson: It is less likely that we will pursue more sizable M&A this year, although we will always leave the door open to consider strategic acquisitions if a compelling opportunity emerges. Overall, we are pleased with Gilead's consistent strong performance, highlighted by solid clinical and commercial execution and supported by our disciplined operating model. We continue to be very well-positioned for both near-term and long-term growth and fully focused on executing our strategic commitments. With that, I will invite Rebecca to begin the Q&A.
Andrew Dickinson: It is less likely that we will pursue more sizable M&A this year, although we will always leave the door open to consider strategic acquisitions if a compelling opportunity emerges. Overall, we are pleased with Gilead's consistent strong performance, highlighted by solid clinical and commercial execution and supported by our disciplined operating model. We continue to be very well-positioned for both near-term and long-term growth and fully focused on executing our strategic commitments. With that, I will invite Rebecca to begin the Q&A.
Speaker #1: Overall, we are pleased with GILEAD's consistent, strong performance, highlighted by solid clinical and commercial execution, and supported by our disciplined operating model. We continue to be very well positioned for both near-term and long-term growth, and fully focused on executing our strategic commitments.
Speaker #1: With that, I'll invite Rebecca to begin the Q&A.
Speaker #2: Thank you, Andy. At this time, we'll invite your questions. Please be courteous and limit yourself to one question so we can get to as many analysts as possible during today's call.
Operator: Thank you, Andy. At this time, we'll invite your questions. Please be courteous and limit yourself to one question so we can get to as many analysts as possible during today's call. Again, to ask a question, press star one, and to withdraw your question, press star one again. First question comes from Akash Tewari at Jefferies.
Operator: Thank you, Andy. At this time, we'll invite your questions. Please be courteous and limit yourself to one question so we can get to as many analysts as possible during today's call. Again, to ask a question, press star one, and to withdraw your question, press star one again. First question comes from Akash Tewari at Jefferies.
Speaker #2: Again, to ask a question, press star one, and to withdraw your question, press star one again.
Speaker #3: Question comes from Akash Tawari at Jefferies. Go ahead. Your line is open.
Speaker #4: Hey, thanks so much. Can you talk a bit more about the tubulous deal? How much of that NPV was driven by ovarian and the signal you're seeing there for O4O versus the potential to take this into lung given the amount of NAPI2B expression there?
Akash Tewari: Hey, thanks so much. Can you talk a bit more about the Tubulis deal? How much of that NPV was driven by ovarian and the signal you're seeing there for TUB-040 versus the potential to take this into lung, given the amount of NaPi2b expression there? We're kinda seeing 2 steps forward, 1 step back with the PD-1 bispecifics. You guys haven't been in that class so far. What additional validation would you need to see from the class at ASCO to look forward towards combination approaches with your ADC platform? Thank you.
Akash Tewari: Hey, thanks so much. Can you talk a bit more about the Tubulis deal? How much of that NPV was driven by ovarian and the signal you're seeing there for TUB-040 versus the potential to take this into lung, given the amount of NaPi2b expression there? We're kinda seeing 2 steps forward, 1 step back with the PD-1 bispecifics. You guys haven't been in that class so far. What additional validation would you need to see from the class at ASCO to look forward towards combination approaches with your ADC platform? Thank you.
Speaker #4: And additionally, we're kind of seeing two steps forward, one step back with the PD-1 by Jeff's. You guys haven't been in that class so far.
Speaker #4: What additional validation would you need to see from the class at ASCO to look forward towards combination approaches with your ADC platform? Thank you.
Speaker #5: Yeah, thanks for the question, Akish. I'll invite some of my colleagues to comment as well. Let me just frame this and the other transactions.
Daniel O'Day: Yeah, thanks for the question, Akash. I'll invite some of my colleagues to comment as well. Let me just frame this and the other transactions. You know, as I've said before, we have one of the strongest portfolios ever in Gilead's history, in fact, the strongest before these acquisitions. Each of these kind of contribute to different aspects of strengthening our business. Tubulis, in particular, and we'll get to that, you know, is not only TUB-040, as you've heard in the prepared remarks, and TUB-030, but also the strength of the platform overall. I'll invite Dietmar to comment a little bit further on how he sees the uniqueness of this platform. Andy, if you have any additional comments, please, I welcome them as well. Dietmar, over to you first.
Daniel O'Day: Yeah, thanks for the question, Akash. I'll invite some of my colleagues to comment as well. Let me just frame this and the other transactions. You know, as I've said before, we have one of the strongest portfolios ever in Gilead's history, in fact, the strongest before these acquisitions. Each of these kind of contribute to different aspects of strengthening our business. Tubulis, in particular, and we'll get to that, you know, is not only TUB-040, as you've heard in the prepared remarks, and TUB-030, but also the strength of the platform overall. I'll invite Dietmar to comment a little bit further on how he sees the uniqueness of this platform. Andy, if you have any additional comments, please, I welcome them as well. Dietmar, over to you first.
Speaker #5: As I've said before, we have one of the strongest portfolios ever in GILEAD's history. In fact, the strongest. Before these acquisitions. And each of these kind of contributed to different aspects of strengthening our business.
Speaker #5: Tubulous, in particular, and we'll get to that, is not only Tub40, as you've heard in the prepared remarks, and Tub30, but also the strength of the platform overall.
Speaker #5: And I'll invite Deep Mar to comment a little bit further on how he sees the uniqueness of this platform, and then, Andy, if you have any additional comments, please welcome them as well.
Speaker #5: But Deep Mar, over to you first.
Speaker #6: Yeah. Thanks, Akash, for the question. The tubulous platform to just expand a bit on what Dan has said, right? We see the value of the front-runner molecule, which was what we think is unprecedented data in ovarian cancer.
Dietmar Berger: Yeah. Thanks, Akash, for the question. To just expand a bit on what Dan has said, we see the value of the Tubulis platform's frontrunner molecule, which was what we think is unprecedented data in ovarian cancer. When you look at the data they presented at ESMO in platinum-resistant ovarian cancer, the objective response rates, the durability of the response, and also the tolerability in the patients treated, we think that really stands out. On top of that, this is not in a biomarker-selected population, so we really see a lot of value there. Obviously, also with the objective to take this into earlier lines of therapy, especially into platinum-sensitive ovarian cancer.
Dietmar Berger: Yeah. Thanks, Akash, for the question. To just expand a bit on what Dan has said, we see the value of the Tubulis platform's frontrunner molecule, which was what we think is unprecedented data in ovarian cancer. When you look at the data they presented at ESMO in platinum-resistant ovarian cancer, the objective response rates, the durability of the response, and also the tolerability in the patients treated, we think that really stands out. On top of that, this is not in a biomarker-selected population, so we really see a lot of value there. Obviously, also with the objective to take this into earlier lines of therapy, especially into platinum-sensitive ovarian cancer.
Speaker #6: When you look at the data, they're presented at ASMO. In platinum-resistant ovarian cancer, the objective response, right? The durability of the response and also the tolerability in the patients treated.
Speaker #6: We think that really stands out. And on top of that, this is not in a biomarker-selected population. So we really see a lot of value there.
Speaker #6: Obviously, also with the objective to take this into earlier lines of therapy, especially into platinum-sensitive ovarian cancer. Then there's a second clinical program with the 5T4 targeted Tub30 program with broader potential in different tumor types.
Dietmar Berger: There's a second clinical program with a 5T4 targeted TUB-030 program with broader potential in different tumor types, currently in dose escalation, but already with encouraging findings when you look at expression of 5T4 in some of the early data. Talking about the platform, these are really two technologies we're especially excited about. One is the P5 technology that is a linker technology that from a chemical perspective is entirely new, allows for very stable linkage and allows for delivery of the payload directly at the tumor site with limited general toxicity and the toxicity profile that we see with the molecule, at this point in time, no lung toxicity, no ocular toxicity, et cetera, really underpins that biological story.
Dietmar Berger: There's a second clinical program with a 5T4 targeted TUB-030 program with broader potential in different tumor types, currently in dose escalation, but already with encouraging findings when you look at expression of 5T4 in some of the early data. Talking about the platform, these are really two technologies we're especially excited about. One is the P5 technology that is a linker technology that from a chemical perspective is entirely new, allows for very stable linkage and allows for delivery of the payload directly at the tumor site with limited general toxicity and the toxicity profile that we see with the molecule, at this point in time, no lung toxicity, no ocular toxicity, et cetera, really underpins that biological story.
Speaker #6: Currently, in those escalation, but already with encouraging findings when you look at expression of 5T4 and some of the early data. And then talking about the platform, these are really two technologies we're especially excited about.
Speaker #6: One is the P5 technology that is a linker technology that, from a chemical perspective, is entirely new. It allows for very stable linkage and allows for delivery of the payload directly at the tumor site with limited general toxicity and the toxicity profile that we see with the molecule, with, at this point in time, no lung toxicity, no ocular toxicity, etc., really underpins that biological story.
Speaker #6: And then the second part of the platform being the ALCO5 platform, which allows to link different types of payloads and this is also where the synergy between tubulous and GILEAD comes in.
Dietmar Berger: The second part of the platform being the Alco5 platform, which allows to link different types of payloads. This is also where the synergy between Tubulis and Gilead comes in, developing novel payloads, both from a Tubulis perspective, but also from a Gilead perspective using our medicinal chemistry capabilities. We have been scouring the world for developed and really attractive ADC technologies. We have good experience, obviously, with TRODELVY, we wanted to add to that and expand beyond that. The Tubulis technology is really the first that convinced us to add that to our portfolio because it's just so transformational and has so much opportunity. Regarding your second question with the VEGF PD-1, obviously, this is an interesting mechanism that we follow closely.
Dietmar Berger: The second part of the platform being the Alco5 platform, which allows to link different types of payloads. This is also where the synergy between Tubulis and Gilead comes in, developing novel payloads, both from a Tubulis perspective, but also from a Gilead perspective using our medicinal chemistry capabilities. We have been scouring the world for developed and really attractive ADC technologies. We have good experience, obviously, with TRODELVY, we wanted to add to that and expand beyond that. The Tubulis technology is really the first that convinced us to add that to our portfolio because it's just so transformational and has so much opportunity. Regarding your second question with the VEGF PD-1, obviously, this is an interesting mechanism that we follow closely.
Speaker #6: Developing novel payloads both from a tubulous perspective, but also from a GILEAD perspective using our medicinal chemistry capabilities. We have been scouring the world for developed and really attractive ADC technologies.
Speaker #6: We have good experience, obviously, with Trodelvy and we wanted to add to that and expand beyond that. And the tubulous technology is really the first that convinced us to add that to our portfolio because it's just so transformational and has so much opportunity.
Speaker #6: Regarding your second question with the VAG-EF PD-1, obviously, this is an interesting mechanism that we follow closely. The combinations need to be in my mind, very targeted to the individual tumor type.
Dietmar Berger: The combinations need to be, in my mind, you know, very targeted to the individual tumor type. You need to really evaluate, does the PD-1 mechanism play a role? Does the VEGF mechanism play a role? We're also obviously looking at the data that is coming out with these different molecules currently in development across different tumor types.
Dietmar Berger: The combinations need to be, in my mind, you know, very targeted to the individual tumor type. You need to really evaluate, does the PD-1 mechanism play a role? Does the VEGF mechanism play a role? We're also obviously looking at the data that is coming out with these different molecules currently in development across different tumor types.
Speaker #6: So you need to really evaluate the PD-1 mechanism play role; does the VAG-EF mechanism play a role? And we're also, obviously, looking at the data that is coming out with these different molecules currently in development across different tumor types.
Speaker #5: And Akash, it's Andy. Maybe I would just add, following what you heard from Deep Mar and Dan, they're clearly numerous sources of value in the acquisition that we're excited about.
Andrew Dickinson: Akash, it's Andy. Maybe I would just add following what you heard from Dietmar Berger and Daniel O'Day, there are clearly numerous sources of value in the acquisition that we're excited about. I think I said on our call a couple of weeks ago, the ovarian opportunity alone is very large. The data is really encouraging. You know, the financial return for our company and the shareholders on ovarian cancer alone can justify the transaction price. You're absolutely right. There is upside in lung cancer, potentially. We'll see as the data develops. All of these products have the potential to be a pipeline and a product, but just the ovarian cancer opportunity alone is very exciting. We'll leave it at that for now.
Andrew Dickinson: Akash, it's Andy. Maybe I would just add following what you heard from Dietmar Berger and Daniel O'Day, there are clearly numerous sources of value in the acquisition that we're excited about. I think I said on our call a couple of weeks ago, the ovarian opportunity alone is very large. The data is really encouraging. You know, the financial return for our company and the shareholders on ovarian cancer alone can justify the transaction price. You're absolutely right. There is upside in lung cancer, potentially. We'll see as the data develops. All of these products have the potential to be a pipeline and a product, but just the ovarian cancer opportunity alone is very exciting. We'll leave it at that for now.
Speaker #5: I think I said on our call a couple of weeks ago, the ovarian opportunity alone is very large. The data is really encouraging. And the financial return for our company and the shareholders on ovarian cancer alone can justify the transaction price.
Speaker #5: You're absolutely right. There is upside in lung cancer potentially. We'll see as the data develops. And all of these products have the potential to be a pipeline and a product, but just the ovarian cancer opportunity alone is very exciting.
Speaker #5: So leave it at that for now.
Speaker #3: As a reminder, we ask that you please limit yourself to one question so we can get to as many analysts as possible on today's call.
Operator: As a reminder, we ask that you please limit yourself to 1 question so we can get to as many analysts as possible on today's call. Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead. Your line is open.
Operator: As a reminder, we ask that you please limit yourself to 1 question so we can get to as many analysts as possible on today's call. Our next question comes from Terence Flynn at Morgan Stanley. Terence, go ahead. Your line is open.
Speaker #3: Our next question comes from Terrence Flynn at Morgan Stanley. Terrence, go ahead. Your line is open.
Speaker #7: Great. Thanks so much. And congrats on all the progress. This is a question for Joanna, and it's one question, I promise. Just on the Yes2Go launch, can you provide the latest mix of switch versus naive buy-and-bill?
Terence Flynn: Great. Thanks so much, and congrats on all the progress. This is a question for Johanna, and it's one question, I promise. Just on the YEZTUGO launch, can you provide the latest mix of switch versus naive buy and bill? Anything new on the adherence its assumption that's embedded in the $1 billion guidance? Thank you.
Terence Flynn: Great. Thanks so much, and congrats on all the progress. This is a question for Johanna, and it's one question, I promise. Just on the YEZTUGO launch, can you provide the latest mix of switch versus naive buy and bill? Anything new on the adherence its assumption that's embedded in the $1 billion guidance? Thank you.
Speaker #7: And then anything new on the adherence? It's assumption that's embedded in the $1 billion guidance. Thank you.
Speaker #3: Thanks for the question. Yeah, we're really excited about what we're seeing with the strong performance in the first quarter. And that's really across all of the launch metrics that you were referring to.
Johanna Mercier: Thanks for the question. Yeah, we're really excited about what we're seeing with the strong performance in the first quarter, and that's really across all of the launch metrics that you were referring to. I would start with just growing confidence with healthcare professionals as the access pathways are getting a lot easier, the logistics, the experience is growing, and we're really seeing that pick up, as well as new prescribers of YEZTUGO also adding every single week. From an access standpoint, we're now at about 95% of coverage with the 95% of those have $0 copay.
Johanna Mercier: Thanks for the question. Yeah, we're really excited about what we're seeing with the strong performance in the first quarter, and that's really across all of the launch metrics that you were referring to. I would start with just growing confidence with healthcare professionals as the access pathways are getting a lot easier, the logistics, the experience is growing, and we're really seeing that pick up, as well as new prescribers of YEZTUGO also adding every single week. From an access standpoint, we're now at about 95% of coverage with the 95% of those have $0 copay.
Speaker #3: I would start with just growing confidence with healthcare professionals as the access pathways are getting a lot easier, the logistics, the experience is growing.
Speaker #3: And we're really seeing that pick up, as well as new prescribers of Yes2Go also adding every single week. From an access standpoint, we're now at about 95% coverage.
Speaker #3: With 95% of those have $0 copay. So we're in a really good situation, which I think is what you're seeing kind of that growth post the January 1st play because of the updates in the prescriber fees, schedules for J-code, and everything else just kind of coming into play.
Johanna Mercier: We're in a really good situation, which I think is what you're seeing kind of that growth post the 1 January play because of the updates in the prescriber fees scheduled for J-code and everything else just kind of coming into play. On the market share front that you were referring to, we're obviously tracking both the naive and switch share. Switch share is obviously greater than the naive, but naive is coming along really quite nicely, and we're seeing strong momentum there as well. We see in the switch share, we see a bit of a split across a third, a third, a third, basically across LA, other LAI injectable, the TRUVADA generics, as well as DESCOVY. We're seeing a little bit of a play there.
Johanna Mercier: We're in a really good situation, which I think is what you're seeing kind of that growth post the 1 January play because of the updates in the prescriber fees scheduled for J-code and everything else just kind of coming into play. On the market share front that you were referring to, we're obviously tracking both the naive and switch share. Switch share is obviously greater than the naive, but naive is coming along really quite nicely, and we're seeing strong momentum there as well. We see in the switch share, we see a bit of a split across a third, a third, a third, basically across LA, other LAI injectable, the TRUVADA generics, as well as DESCOVY. We're seeing a little bit of a play there.
Speaker #3: On the market share front that you were referring to, we're obviously tracking both the naive and switch share. Switch share is obviously greater than the naive, but naive is coming along really quite nicely, and we're seeing strong momentum there as well.
Speaker #3: We see in the switch share, we see a bit of a split. Across a third, a third, a third, basically across LA, other LAI injectable, the Truvada generics, as well as Discovy.
Speaker #3: So we're seeing a little bit of a play there. And then we're seeing really strong market growth at about 14%. That is driving not just Yes2Go.
Johanna Mercier: We're seeing really strong market growth at about 14%. That is driving not just YEZTUGO, that's obviously helping DESCOVY as well. Your last comment was around persistency. Still early days, right? If you think about the volume, only really started in Q4. What we are seeing, we're really pleased with, very encouraging. I think HCPs are starting the second injection and thinking it's a lot easier, access is easier, as well as the experience, the confidence in the injection and the experience for the people getting the injection is also better, as well as what we're hearing anecdotally. We do expect YEZTUGO's persistency to keep growing over time and to be the highest in the overall HIV prevention market. Basically, that sums up our Q1 for YEZTUGO.
Johanna Mercier: We're seeing really strong market growth at about 14%. That is driving not just YEZTUGO, that's obviously helping DESCOVY as well. Your last comment was around persistency. Still early days, right? If you think about the volume, only really started in Q4. What we are seeing, we're really pleased with, very encouraging. I think HCPs are starting the second injection and thinking it's a lot easier, access is easier, as well as the experience, the confidence in the injection and the experience for the people getting the injection is also better, as well as what we're hearing anecdotally. We do expect YEZTUGO's persistency to keep growing over time and to be the highest in the overall HIV prevention market. Basically, that sums up our Q1 for YEZTUGO.
Speaker #3: That's obviously helping Discovy as well. And then your last comment was around persistency. Still early days, right? As you think about the volume, only really started in Q4.
Speaker #3: But what we are seeing, we're really pleased with, very encouraging, I think HCPs are starting the second injection and thinking it's a lot easier.
Speaker #3: Access is easier. As well as the experience, the confidence in the injection and the experience for the people getting the injection is also better as well as what we're hearing anecdotally.
Speaker #3: We do expect Yes2Go's persistency to keep growing. Over time and to be the highest in the overall HIV prevention market. Yeah, so basically that sums up our first quarter for Yes2Go.
Speaker #3: Incredibly strong performance and explains why we've updated our guidance to the billion-dollar opportunity for 2026. Our next question comes from Salveen Richter at Goldman Sachs.
Johanna Mercier: Incredibly strong performance and explains why we've updated our guidance to the billion-dollar opportunity for 2026.
Johanna Mercier: Incredibly strong performance and explains why we've updated our guidance to the billion-dollar opportunity for 2026.
Operator: Our next question comes from Salveen Richter at Goldman Sachs. Go ahead. Your line is open.
Operator: Our next question comes from Salveen Richter at Goldman Sachs. Go ahead. Your line is open.
Speaker #3: Go ahead. Your line is open.
Speaker #8: My question. With regard to users who haven't yet returned for second dose, do you have a sense of what's driving this? How it breaks down between users who are stopping PrEP versus switching to another option or just delayed in coming back from the second dose?
Salveen Richter: My question, with regard to users who haven't yet returned for a second dose, do you have a sense of what's driving this? You know, how it breaks down between users who are stopping PrEP versus switching to another option or just delayed in coming back from the second dose? Maybe just speak to the DTC efforts as well. Thank you.
Salveen Richter: My question, with regard to users who haven't yet returned for a second dose, do you have a sense of what's driving this? You know, how it breaks down between users who are stopping PrEP versus switching to another option or just delayed in coming back from the second dose? Maybe just speak to the DTC efforts as well. Thank you.
Speaker #8: And maybe just speak to the DTC efforts as well. Thank you.
Speaker #3: Sure. Thanks, Salveen. I think what we're doing is we're tracking the claims data, pretty closely. It's not perfect data, I'll be honest with you.
Johanna Mercier: Sure. Thanks, Salveen. I think what we're doing is we're tracking the claims data pretty closely. It's not perfect data, I'll be honest with you. I don't have the level of detail that you're referring to. What we are seeing, however, is really good comeback on the second dose and within a certain timeframe. As long as you give it a couple of weeks ±. I think what we're seeing is really positive and encouraging. What we're hearing as well, right? As we do a lot of market research with our healthcare professionals as well. The DTC only adds to that. We have a lot of efforts going on with persistency.
Johanna Mercier: Sure. Thanks, Salveen. I think what we're doing is we're tracking the claims data pretty closely. It's not perfect data, I'll be honest with you. I don't have the level of detail that you're referring to. What we are seeing, however, is really good comeback on the second dose and within a certain timeframe. As long as you give it a couple of weeks ±. I think what we're seeing is really positive and encouraging. What we're hearing as well, right? As we do a lot of market research with our healthcare professionals as well. The DTC only adds to that. We have a lot of efforts going on with persistency.
Speaker #3: So I don't have the level of detail that you're referring to. What we are seeing, however, is really good comeback on the second dose.
Speaker #3: And within a certain timeframe. So as long as you give it a couple of weeks, plus or minus, I think what we're seeing is really positive and encouraging.
Speaker #3: And what we're hearing as well, right, as you as we do a lot of market research with our healthcare professionals as well, the DTC only adds to that.
Speaker #3: We have a lot of efforts going on with persistency. We really leverage our specialty pharmacies to make sure that they call and remind them to make their appointments well ahead of time.
Johanna Mercier: We really leverage our specialty pharmacies to make sure that they call and remind them to make their appointments well ahead of time. The DTC helps that as well. Our DTC started late February, and what we've been seeing is a huge increase in brand awareness and visibility for YEZTUGO, but it really also helps remind people to come back for their injection as well. All those pieces are coming together, let alone additional work that we're doing to kind of accelerate that and support the DTC campaign. As for actual results on DTC, it is still really early. We just launched late February. We are seeing social media awareness really ramp up because of those efforts, but it takes 6 to 12 months before we really see kind of the outputs of the DTC.
Johanna Mercier: We really leverage our specialty pharmacies to make sure that they call and remind them to make their appointments well ahead of time. The DTC helps that as well. Our DTC started late February, and what we've been seeing is a huge increase in brand awareness and visibility for YEZTUGO, but it really also helps remind people to come back for their injection as well. All those pieces are coming together, let alone additional work that we're doing to kind of accelerate that and support the DTC campaign. As for actual results on DTC, it is still really early. We just launched late February. We are seeing social media awareness really ramp up because of those efforts, but it takes 6 to 12 months before we really see kind of the outputs of the DTC.
Speaker #3: But DTC helps that as well. Our DTC started late February. And what we've been seeing is a huge increase in brand awareness and visibility for Yes2Go.
Speaker #3: But it really also helps remind people to come back for their injection as well. So all those pieces are coming together, let alone additional work that we're doing to kind of accelerate that and support the DTC campaign.
Speaker #3: As for actual results on DTC, it's still really early. We just launched late February. We're seeing social media awareness really ramp up because of those efforts.
Speaker #3: But it takes 6 to 12 months before we really see kind of the outputs of the DTC. Our next question comes from Mohit Bansal at Wells Fargo.
Operator: Our next question comes from Mohit Bansal at Wells Fargo. Go ahead, your line is open.
Operator: Our next question comes from Mohit Bansal at Wells Fargo. Go ahead, your line is open.
Speaker #3: Go ahead. Your line is open.
Speaker #9: Hi. Thank you very much for taking my question. Hope you're really team got some rest off from the crazy first quarter. So my question is regarding the attractiveness of vehicle and treatment here.
Mohit Bansal: Hi. Thank you very much for taking my question. Hope your BD team got some rest after the crazy first quarter. My question is regarding the attractiveness of BIC/LEN treatment here, with as you are about to launch. 5% to 6% of the HIV market could still be a sizable opportunity. Could you please help us understand the opportunity here, and how big this product could be even in the switch market? Thank you.
Mohit Bansal: Hi. Thank you very much for taking my question. Hope your BD team got some rest after the crazy first quarter. My question is regarding the attractiveness of BIC/LEN treatment here, with as you are about to launch. 5% to 6% of the HIV market could still be a sizable opportunity. Could you please help us understand the opportunity here, and how big this product could be even in the switch market? Thank you.
Speaker #9: As you are about to launch, so five to six percent of the HIV market could still be a sizable opportunity. So could you please help us understand the opportunity here and how big this product could be even in the switch market?
Speaker #9: Thank you.
Speaker #3: Thanks, Mohit. It's Joanna. I'll take that one. So yeah, we're really excited about BIC-LEN with the Purdue-Fedate around the corner, right? Late August. And the way we're thinking about BIC-LEN is really two opportunities within it.
Johanna Mercier: Thanks, Mohit. It's Johanna. I'll take that one. Yeah, we're really excited about BIC/LEN with the PDUFA date around the corner, right, late August. The way we're thinking about BIC/LEN is really two opportunities within it. One is what you referred to, which is with ARTISTRY-1 showing with virologically suppressed complex regimen, there are still about 5% to 6% people living with HIV that are on multiple pills, 5, 6, 7, 8 pills, on a daily basis. This is an opportunity to simplify their regimen and move to 1 pill once a day. That is something that we will be very focused on at launch.
Johanna Mercier: Thanks, Mohit. It's Johanna. I'll take that one. Yeah, we're really excited about BIC/LEN with the PDUFA date around the corner, right, late August. The way we're thinking about BIC/LEN is really two opportunities within it. One is what you referred to, which is with ARTISTRY-1 showing with virologically suppressed complex regimen, there are still about 5% to 6% people living with HIV that are on multiple pills, 5, 6, 7, 8 pills, on a daily basis. This is an opportunity to simplify their regimen and move to 1 pill once a day. That is something that we will be very focused on at launch.
Speaker #3: One is what you referred to, which is with Artistry One, showing with virologically suppressed complex regimen, there are still about five to six percent people living with HIV that are on multiple pills, five, six, seven, eight pills on a daily basis.
Speaker #3: And this is an opportunity to simplify their regimen, and move to one pill once a day. And so that is something that we will be very focused on at launch.
Speaker #3: In addition to that opportunity, we also believe that in the switch market, which is the dynamic market for people living with HIV, there's about 20% or so that switch.
Johanna Mercier: In addition to that opportunity, we also believe that in the switch market, which is the dynamic market for people living with HIV, there's about 20% or so that switch, and that has to do with the innovation life cycle that we've seen over the years. People want to switch to the next thing that comes on the market. That does happen in our marketplace. We see that as an opportunity for BIC/LEN. As you think about BIKTARVY, and obviously BIKTARVY, we believe, will continue to remain the standard of care for many years to come with an LOE out to 2036. We do believe, though, that some people do switch off BIKTARVY, and right now they're switching off to competitor products.
Johanna Mercier: In addition to that opportunity, we also believe that in the switch market, which is the dynamic market for people living with HIV, there's about 20% or so that switch, and that has to do with the innovation life cycle that we've seen over the years. People want to switch to the next thing that comes on the market. That does happen in our marketplace. We see that as an opportunity for BIC/LEN. As you think about BIKTARVY, and obviously BIKTARVY, we believe, will continue to remain the standard of care for many years to come with an LOE out to 2036. We do believe, though, that some people do switch off BIKTARVY, and right now they're switching off to competitor products.
Speaker #3: And that has to do with the innovation lifecycle that we've seen over the years. And so people want to switch to the next thing that comes on the market.
Speaker #3: So that does happen in our marketplace. And so we see that as an opportunity for BIC-LEN. As you think about BIC-TARVI and obviously BIC-TARVI, we believe will continue to remain the standard of care for many years to come with an LOE out to 2036.
Speaker #3: We do believe though that some people do switch off BIC-TARVI and right now they're switching off to competitor products. We believe with BIC-LEN, there's an opportunity to play in that switch market, which we haven't had in the past, and move them from BIC-TARVI if they're going to switch anyway to BIC-LEN.
Johanna Mercier: We believe with BIC/LEN, there's an opportunity to play in that switch market, which we haven't had in the past, and move them from BIKTARVY, if they're gonna switch anyway, to BIC/LEN. As you think about BIC/LEN with bictegravir as the integrase inhibitor standard of care and lenacapavir as a really innovative capsid inhibitor, pulling those two together, that combination of two orthogonal mechanisms with really high resistance and no cross-resistance makes it a really appealing option for patients. That's how we're thinking about the BIC/LEN opportunity. I will say, obviously, with a late launch in 2027 and late August, access will need to ramp up, so it'll be modest revenues in 2026 with a nice ramp in 2027 and beyond.
Johanna Mercier: We believe with BIC/LEN, there's an opportunity to play in that switch market, which we haven't had in the past, and move them from BIKTARVY, if they're gonna switch anyway, to BIC/LEN. As you think about BIC/LEN with bictegravir as the integrase inhibitor standard of care and lenacapavir as a really innovative capsid inhibitor, pulling those two together, that combination of two orthogonal mechanisms with really high resistance and no cross-resistance makes it a really appealing option for patients. That's how we're thinking about the BIC/LEN opportunity. I will say, obviously, with a late launch in 2027 and late August, access will need to ramp up, so it'll be modest revenues in 2026 with a nice ramp in 2027 and beyond.
Speaker #3: And as you think about BIC-LEN, with BIC-TECRAVIR as the integrase inhibitor—standard of care—and lenacapavir as a really innovative capsid inhibitor, pulling those two together, that combination of two orthogonal mechanisms with really high resistance barriers and no cross-resistance makes it a really appealing option for patients.
Speaker #3: And so that's how we're thinking about the BIC-LEN opportunity. I will say obviously with the late launch in 2007 and late August, access will need to ramp up.
Speaker #3: So it'll be modest revenues in 2026 with a nice ramp in 2007 and beyond. Our next question comes from Carter Gold at Cancer Fitzgerald.
Operator: Our next question comes from Carter Gould at Cantor Fitzgerald. Go ahead, your line is open.
Operator: Our next question comes from Carter Gould at Cantor Fitzgerald. Go ahead, your line is open.
Speaker #3: Go ahead. Your line is open.
Speaker #10: Great. Good afternoon. Thanks for taking the question. Another one on Yes2Go adherence. Joanna, I appreciate your framing of adherence as sort of highest in the category.
Carter Gould: Great. Good afternoon. Thanks for taking the question. Another one on YEZTUGO adherence. Johanna Mercier, I appreciate your framing of adherence as sort of highest in the category. Fair to assume those comments are anchoring on aptitude adherence around 50% still? Are there any reasons based, I guess, on the early days that the greater than 80% adherence that you outlined at HIV Day, 18 months ago, is not still in play? Thank you. With the once-yearly offering.
Carter Gould: Great. Good afternoon. Thanks for taking the question. Another one on YEZTUGO adherence. Johanna Mercier, I appreciate your framing of adherence as sort of highest in the category. Fair to assume those comments are anchoring on aptitude adherence around 50% still? Are there any reasons based, I guess, on the early days that the greater than 80% adherence that you outlined at HIV Day, 18 months ago, is not still in play? Thank you. With the once-yearly offering.
Speaker #10: Fair to assume those comments are anchoring on Apertu adherence around 50% still. And are there any reasons based, I guess, on the early days that the greater than 80% adherence that you outlined at HIV Day 18 months ago is not still in play?
Speaker #10: Thank you. With the once yearly.
Speaker #3: Yeah. Thanks, Carter. I think what you're referring to is also the adherence, not the persistency. At 80%. And we still believe, obviously, that adherence is obviously much greater because you're at 100% for six months.
Johanna Mercier: Yeah. Thanks, Carter. I think what you're referring to is also the adherence, not the persistency at 80%. We still believe, obviously, that adherence is obviously much greater because you're at 100% for 6 months. From a persistency level, we do believe, well, we do believe with a Q6 monthly, and what we're seeing in early days is definitely much stronger than what the current competition is seeing in the marketplace. That's what's encouraging to see people coming back for their second injection and obviously potentially even third later this year. That's what we're tracking super closely, and supporting those efforts as well.
Johanna Mercier: Yeah. Thanks, Carter. I think what you're referring to is also the adherence, not the persistency at 80%. We still believe, obviously, that adherence is obviously much greater because you're at 100% for 6 months. From a persistency level, we do believe, well, we do believe with a Q6 monthly, and what we're seeing in early days is definitely much stronger than what the current competition is seeing in the marketplace. That's what's encouraging to see people coming back for their second injection and obviously potentially even third later this year. That's what we're tracking super closely, and supporting those efforts as well.
Speaker #3: From a persistency level, we do believe well, we do believe with a Q6 monthly and what we're seeing in early days is definitely much stronger than what the current competition is seeing in the marketplace.
Speaker #3: And so that's what's encouraging to see people coming back for their second injection. And obviously potentially even third later this year. And so that's what we're tracking super closely.
Speaker #3: And supporting those efforts as well. I think we what we're also very conscious of is just making sure the logistics and the schedule is happening in a timely way and working with clinics and different specialty pharmacies to make sure that happens exactly in line with that.
Johanna Mercier: I think we, you know, what we're also very conscious of is just making sure the logistics and the schedule is happening in a timely way and working with clinics and different specialty pharmacies to make sure that happens exactly in line with that. I do see the opportunity for YEZTUGO to be very persistent moving forward and, of course, understanding that you're in a prevention market, so it's never gonna be 100%. I think it's just that balance is important as well.
Johanna Mercier: I think we, you know, what we're also very conscious of is just making sure the logistics and the schedule is happening in a timely way and working with clinics and different specialty pharmacies to make sure that happens exactly in line with that. I do see the opportunity for YEZTUGO to be very persistent moving forward and, of course, understanding that you're in a prevention market, so it's never gonna be 100%. I think it's just that balance is important as well.
Speaker #3: And so I do see the opportunity for Yes2Go to be very persistent moving forward. And of course, understanding that you're in a prevention market.
Speaker #3: So it's never going to be 100%. But I think it's just that balance is important as well. Our next question comes from Jeff Meacham at Citi.
Operator: Our next question comes from Geoff Meacham at Citi. Go ahead, your line is open.
Operator: Our next question comes from Geoff Meacham at Citi. Go ahead, your line is open.
Speaker #3: Go ahead. Your line is open.
Speaker #10: Hey everyone. Congrats on the quarter. And thanks for the question. One on Anita Cell. As you guys approach the launch and just looking at the development and earlier lines, just want to get your perspective on the safety advantage among CAR-Ts.
Geoff Meacham: Hey, everyone. Congrats on the quarter, thanks for the question. One on anito-cel. As you guys approach the launch and just looking at the development in earlier lines, I just want to get your perspective on the safety advantage among CAR-Ts. You know, would we expect it to narrow or to widen as you treat patients upstream that are maybe perhaps less heavily pretreated? Thank you.
Geoff Meacham: Hey, everyone. Congrats on the quarter, thanks for the question. One on anito-cel. As you guys approach the launch and just looking at the development in earlier lines, I just want to get your perspective on the safety advantage among CAR-Ts. You know, would we expect it to narrow or to widen as you treat patients upstream that are maybe perhaps less heavily pretreated? Thank you.
Speaker #10: Would we expect it to narrow or to widen as you treat patients upstream that are maybe perhaps less heavily pretreated? Thank you.
Speaker #3: Thanks, Jeff. It's Cindy. We actually agree with the statement you just made. We're really excited about the potential for Anita Cell going into earlier lines, whether it's newly diagnosed multiple myeloma or even in smoldering, where patients aren't technically diagnosed with the disease.
Cindy Perettie: Thanks, Geoff. It's Cindy. We actually agree with the statement you just made. We're really excited about the potential for anito-cel going into earlier lines, whether it's newly diagnosed multiple myeloma or even in smoldering where patients aren't technically diagnosed with the disease. Safety really matters at that point. I think it's a combination, though, particularly with our efficacy profile that we've seen to date, coupled with the safety profile, we think it's gonna be a really important option for patients in earlier lines. We're working on right now the trial designs in newly diagnosed multiple myeloma, and we'll be sharing more information on those as available. We think it's gonna be an opportunity based on both the exceptional efficacy that we're observing as well as a differentiated safety profile.
Cindy Perettie: Thanks, Geoff. It's Cindy. We actually agree with the statement you just made. We're really excited about the potential for anito-cel going into earlier lines, whether it's newly diagnosed multiple myeloma or even in smoldering where patients aren't technically diagnosed with the disease. Safety really matters at that point. I think it's a combination, though, particularly with our efficacy profile that we've seen to date, coupled with the safety profile, we think it's gonna be a really important option for patients in earlier lines. We're working on right now the trial designs in newly diagnosed multiple myeloma, and we'll be sharing more information on those as available. We think it's gonna be an opportunity based on both the exceptional efficacy that we're observing as well as a differentiated safety profile.
Speaker #3: So safety really matters at that point. I think it's a combination though, particularly with our efficacy profile that we've seen to date coupled with the safety profile.
Speaker #3: We think it's going to be a really important option for patients in earlier lines. And we're working on right now the trial designs in newly diagnosed multiple myeloma.
Speaker #3: And we'll be sharing more information on those as available. So we think it's going to be an opportunity based on both the exceptional efficacy that we're observing as well as a differentiated safety profile.
Speaker #3: Our next question comes from Alex Hammond at Wolf. Go ahead. Your line is open.
Operator: Our next question comes from Alex Hammond at Wolfe. Go ahead, your line is open.
Operator: Our next question comes from Alex Hammond at Wolfe. Go ahead, your line is open.
Speaker #11: Hey guys. Thanks for taking the question. So obviously this year you guys have had three new acquisition integrations running simultaneously alongside multiple commercial launches.
Alex Hammond: Hey, guys. Thanks for taking the question. Obviously this year, you guys have had three new acquisition integrations running simultaneously alongside multiple commercial launches. I guess, like, how should we think about margins in the near term and the long term? Is there room for continued margin expansion, particularly in that 2027 to 2028 time frame? Thank you.
Alexandria Hammond: Hey, guys. Thanks for taking the question. Obviously this year, you guys have had three new acquisition integrations running simultaneously alongside multiple commercial launches. I guess, like, how should we think about margins in the near term and the long term? Is there room for continued margin expansion, particularly in that 2027 to 2028 time frame? Thank you.
Speaker #11: So I guess how should we think about margins in the near term and the long term? Is there room for continued margin expansion? Particularly in that 2007 to 2008 timeframe.
Speaker #11: Thank you.
Speaker #12: Hey Alex. It's Andy. Thanks for the question. We appreciate it. I mean, look, you see in the first quarter a 47% operating margin, significant strengthening of the margin from last year.
Andrew Dickinson: Hey, Alex, it's Andy. Thanks for the question. We appreciate it. I mean, look, you see in the Q1 a 47% operating margin, significant strengthening of the margin from last year. The business continues to perform really well. You see that in our updated guidance, including the increase in the revenue guidance. You also see the ability to absorb all three of these deals, essentially to offset with the revenue outperformance, the incremental expenses that we expect this year. Of the roughly $400 million in incremental expenses, little over $200 million of those are R&D expenses this year. The remainder of them are the financing expenses.
Andrew Dickinson: Hey, Alex, it's Andy. Thanks for the question. We appreciate it. I mean, look, you see in the Q1 a 47% operating margin, significant strengthening of the margin from last year. The business continues to perform really well. You see that in our updated guidance, including the increase in the revenue guidance. You also see the ability to absorb all three of these deals, essentially to offset with the revenue outperformance, the incremental expenses that we expect this year. Of the roughly $400 million in incremental expenses, little over $200 million of those are R&D expenses this year. The remainder of them are the financing expenses.
Speaker #12: The business continues to perform really well. You see that in our updated guidance, including the increase in the revenue guidance. You also see the ability to absorb all three of these deals essentially into offset with the revenue outperformance.
Speaker #12: The incremental expenses that we expect this year. So of the roughly $400 million in incremental expenses, a little over $200 million of those are R&D expenses this year.
Speaker #12: And then the remainder of them are the financing expenses. But you see our ability with the revenue outperformance and the disciplined expense management to pull those in and offset them when you look when you exclude the IPR&D and kind of look at our EPS expectation on an apples to apples basis.
Andrew Dickinson: You see our ability with the revenue outperformance and the disciplined expense management to pull those in and offset them when you exclude the IPR&D and kind of look at our EPS expectation on an apples-to-apples basis. I will say, you know, we expect in 2027 to find room in our portfolio and our P&L for these as well. We've spent a lot of time planning for this as we were looking at the transaction, so we feel very comfortable about the ability to navigate the incremental expenses. When you look beyond 2027, you know, our expectation was that we were gonna have more room in our portfolio in any event. As you know, we've been, you know, wrapping up a number of phase III trials across our entire portfolio.
Andrew Dickinson: You see our ability with the revenue outperformance and the disciplined expense management to pull those in and offset them when you exclude the IPR&D and kind of look at our EPS expectation on an apples-to-apples basis. I will say, you know, we expect in 2027 to find room in our portfolio and our P&L for these as well. We've spent a lot of time planning for this as we were looking at the transaction, so we feel very comfortable about the ability to navigate the incremental expenses. When you look beyond 2027, you know, our expectation was that we were gonna have more room in our portfolio in any event. As you know, we've been, you know, wrapping up a number of phase III trials across our entire portfolio.
Speaker #12: I will say we expect in 2027 to find room in our portfolio and our P&L for these as well. We've spent a lot of time planning for this as we were looking at the transaction.
Speaker #12: So we feel very comfortable about the ability to navigate the incremental expenses. And then, when you look beyond 2007, our expectation was that we were going to have more room in our portfolio in any event.
Speaker #12: As you know, we've been wrapping up a number of phase three trials across our entire portfolio. So I think 2006 and 2007, these are modest increases.
Andrew Dickinson: I think, 2026 and 2027, these are modest increases. They're manageable. 2028 and beyond, we needed to add to the portfolio in any event, and these are really high-quality assets that we can add, and you should still expect very strong financial performance. We, you know, on the bottom line and the top line, and there is room to strengthen the margin over time. Of course, it, you know, can vary from quarter-to-quarter, but when we look at where we are, we feel like we're in a great spot today and really excited about what lies ahead.
Andrew Dickinson: I think, 2026 and 2027, these are modest increases. They're manageable. 2028 and beyond, we needed to add to the portfolio in any event, and these are really high-quality assets that we can add, and you should still expect very strong financial performance. We, you know, on the bottom line and the top line, and there is room to strengthen the margin over time. Of course, it, you know, can vary from quarter-to-quarter, but when we look at where we are, we feel like we're in a great spot today and really excited about what lies ahead.
Speaker #12: They're manageable. 2008 and beyond, we needed to add to the portfolio in any event. And these are really high-quality assets that we can add.
Speaker #12: And you should still expect very strong financial performance. On the bottom line and the top line. And there is room to strengthen the margin over time.
Speaker #12: Of course, it can vary from quarter to quarter. But when we look at where we are, we feel like we're in a great spot today.
Speaker #12: And really excited about what lies ahead.
Speaker #3: Our next question comes from Umar Rifat at Evercore. Umar, go ahead. Your line is open.
Operator: Our next question comes from Umer Raffat at Evercore. Umer, go ahead. Your line is open.
Operator: Our next question comes from Umer Raffat at Evercore. Umer, go ahead. Your line is open.
Speaker #13: Thank you guys. I was actually really looking forward to a possible update on your phase two ulcerative colitis trial of the oral alpha for beta seven.
Umer Raffat: Thank you, guys. I was actually really looking forward to a possible update on your phase II ulcerative colitis trial of the oral alpha-4 beta-7. I think ClinicalTrials.gov says it wrapped up in March. I guess, how should I interpret lack of any update there? Thank you.
Umer Raffat: Thank you, guys. I was actually really looking forward to a possible update on your phase II ulcerative colitis trial of the oral alpha-4 beta-7. I think ClinicalTrials.gov says it wrapped up in March. I guess, how should I interpret lack of any update there? Thank you.
Speaker #13: I think clean trial says it wrapped up in March. I guess how should I interpret lack of any update there? Thank you.
Speaker #12: Umar, thank you for the question. We're really excited about the oral alpha for beta seven. And we're very much looking forward to updating you in due course, right?
Dietmar Berger: Umer, thank you for the question. We're really excited about the oral alpha-4 beta-7, and we're very much looking forward to updating you in due course, right? Don't read anything into the current timeline, right? We are looking at the data, and we will update you very soon.
Dietmar Berger: Umer, thank you for the question. We're really excited about the oral alpha-4 beta-7, and we're very much looking forward to updating you in due course, right? Don't read anything into the current timeline, right? We are looking at the data, and we will update you very soon.
Speaker #12: Don't read anything into the current timeline, right? We are looking at the data. And we will update you very soon.
Speaker #3: Our next question comes from Tyler Van Buren at TD Cowan. Tyler, go ahead. Your line is open.
Operator: Our next question comes from Tyler Van Buren at TD Cowen. Tyler, go ahead. Your line is open.
Operator: Our next question comes from Tyler Van Buren at TD Cowen. Tyler, go ahead. Your line is open.
Speaker #14: Hey guys, thanks very much. For Yes2Go, can you discuss what regions in the U.S. you're seeing the greatest uptake so far in the launch, and how you expect that to evolve in the coming months and years?
Tyler Van Buren: Hey, guys. Thanks very much. For you, Sue, can you discuss what regions in the US you're seeing the greatest uptake so far in the launch and how you expect that to evolve in the coming months and years?
Tyler Van Buren: Hey, guys. Thanks very much. For you, Sue, can you discuss what regions in the US you're seeing the greatest uptake so far in the launch and how you expect that to evolve in the coming months and years?
Speaker #3: Sure, Tyler. It's Joanna. I'll take that. Where we are seeing the greatest uptake is actually where we had already penetrated the HIV prep market.
Johanna Mercier: Sure, Tyler. It's Johanna. I'll take that. Where we are seeing the greatest uptake is actually where we had already penetrated the HIV PrEP market. As you think about certain cities across the United States, San Francisco, LA, New York, Florida, et cetera, those are definitely areas where they were more comfortable with PrEP, therefore it's more of a switch market there. What we're also very focused on in parallel to that kind of build has been on the naive market and making sure that we're creating awareness where there is a high unmet medical need, where you see the highest HIV incidence in certain parts, for example, the rural South of the United States. That's obviously, that's gonna be over time, but that's also where we're seeing more of the naive prescriptions coming through as well.
Johanna Mercier: Sure, Tyler. It's Johanna. I'll take that. Where we are seeing the greatest uptake is actually where we had already penetrated the HIV PrEP market. As you think about certain cities across the United States, San Francisco, LA, New York, Florida, et cetera, those are definitely areas where they were more comfortable with PrEP, therefore it's more of a switch market there. What we're also very focused on in parallel to that kind of build has been on the naive market and making sure that we're creating awareness where there is a high unmet medical need, where you see the highest HIV incidence in certain parts, for example, the rural South of the United States. That's obviously, that's gonna be over time, but that's also where we're seeing more of the naive prescriptions coming through as well.
Speaker #3: As you think about certain cities across the United States, San Francisco, LA, New York, Florida, etc. Those are definitely areas where they were more comfortable with prep.
Speaker #3: And so therefore, it's more of a switch market there. What we're also very focused on in parallel to that kind of build has been on the naive market and making sure that we're creating awareness where there's a high unmet medical need where you see the highest HIV incidence in certain parts.
Speaker #3: For example, the rural south of the United States. And that's obviously that's going to be over time. But that's also where we're seeing more of the naive prescription coming through as well.
Speaker #3: Our next question comes from Mike Yee at UBS. Mike, go ahead. Your line is open.
Operator: Our next question comes from Mike Yee at UBS. Mike, go ahead. Your line is open.
Operator: Our next question comes from Mike Yee at UBS. Mike, go ahead. Your line is open.
Speaker #14: Great. Thank you. On GS3242, you had some great data at CROI recently. Your competitor seems to think that they are ahead. I think publicly stating 2030 type time to market.
Mike Yee: Great. Thank you. On GS-3242, you had some great data at CROI recently. Your competitor seems to think that they are ahead, I think publicly stating 2030 type time to market, and you're saying 2031 to 33. Can you talk a little bit about your timing and what drives the difference between 31 and 33 and how you're thinking about that program? Thanks.
Mike Yee: Great. Thank you. On GS-3242, you had some great data at CROI recently. Your competitor seems to think that they are ahead, I think publicly stating 2030 type time to market, and you're saying 2031 to 33. Can you talk a little bit about your timing and what drives the difference between 31 and 33 and how you're thinking about that program? Thanks.
Speaker #14: And you're saying 21 to 2031 to 33. Can you talk a little bit about your timing and what drives the difference between 31 and 33 and how you're thinking about that program?
Speaker #14: Thanks.
Speaker #12: Yeah. Thanks for the question. I mean, obviously, currently and what you've seen at CROI, we're currently in the dose escalation phase. We're looking at the pharmacokinetics for different doses.
Dietmar Berger: Yeah, thanks for the question. I mean, obviously currently and what you've seen at CROI, we're currently in the dose escalation phase. We're looking at the pharmacokinetics for different doses. We are very comfortable with the Q4 month dosing. Obviously, our ambition, and we are really encouraged by the data that we've seen, is to bring this to once every 6 months dosing. I'm confident moving forward there. 31 to 33 is really only a reflection and, I would call it a conservative reflection of, you know, the different trial designs and the different clinical plans that we're currently working on.
Dietmar Berger: Yeah, thanks for the question. I mean, obviously currently and what you've seen at CROI, we're currently in the dose escalation phase. We're looking at the pharmacokinetics for different doses. We are very comfortable with the Q4 month dosing. Obviously, our ambition, and we are really encouraged by the data that we've seen, is to bring this to once every 6 months dosing. I'm confident moving forward there. 31 to 33 is really only a reflection and, I would call it a conservative reflection of, you know, the different trial designs and the different clinical plans that we're currently working on.
Speaker #12: We are very comfortable with the Q4 months dosing. Obviously, our ambition and we're really encouraged by the data that we've seen is to bring this to once every six months dosing.
Speaker #12: So I'm confident moving forward there. And 31 to 33 is really only a reflection and I would call it a conservative reflection of the different trial designs and the different clinical plans that we're currently working on.
Speaker #12: But what I do want to assure you about is, we will try to bring this forward to patients as quickly as possible because we feel a once-every-six-months injectable treatment, on the basis of 30 to 42, will really be able to make a difference for patients.
Daniel O'Day: What I do wanna assure you about is we will try to bring this forward to patients as quickly as possible because we feel a once every 6 month injectable treatment on the basis of GS-3242 will really be able to make a difference for patients.
Dietmar Berger: What I do wanna assure you about is we will try to bring this forward to patients as quickly as possible because we feel a once every 6 month injectable treatment on the basis of GS-3242 will really be able to make a difference for patients.
Speaker #3: Our next question comes from Chris Schott at JPMorgan. Chris, go ahead. Your line is open. Apologies. Our next question comes from Tazeen Ahmad at BofA.
Operator: Our next question comes from Chris Schott at J.P. Morgan. Chris, go ahead. Your line is open. Apologies. Our next question comes from Tazeen Ahmad at BofA. Go ahead. Your line is open.
Operator: Our next question comes from Chris Schott at J.P. Morgan. Chris, go ahead. Your line is open. Apologies. Our next question comes from Tazeen Ahmad at BofA. Go ahead. Your line is open.
Speaker #3: Go ahead. Your line is open.
Speaker #15: Okay. Great. Thanks for taking my question. I wanted to ask your thoughts on how you're thinking about the impact to Trodelvy sales and triple negative in particular in the case that Astra and Ziagi's dapter way is approved.
Tazeen Ahmad: Okay, great. Thanks for taking my question. Wanted to ask your thoughts on how you're thinking about the impact to TRODELVY sales on triple-negative, in particular in the case that Astra and Daiichi's DATROWAY is approved. I think they have a PDUFA in June. You know, they're claiming a superior overall survival benefit relative to chemotherapy in patients that aren't eligible for immunotherapy. Does that change what you think the market opportunity is in this indication for TRODELVY? Thanks.
Tazeen Ahmad: Okay, great. Thanks for taking my question. Wanted to ask your thoughts on how you're thinking about the impact to TRODELVY sales on triple-negative, in particular in the case that Astra and Daiichi's DATROWAY is approved. I think they have a PDUFA in June. You know, they're claiming a superior overall survival benefit relative to chemotherapy in patients that aren't eligible for immunotherapy. Does that change what you think the market opportunity is in this indication for TRODELVY? Thanks.
Speaker #15: I think they have a PDUFA in June. And they're claiming a superior overall survival benefit relative to chemotherapy in patients that aren't eligible for immunotherapy.
Speaker #15: Does that change what you think the market opportunity is in this indication for Trodelvy? Thanks.
Speaker #3: Yeah. Thanks, Tazeen, for the question. Listen, we're really excited about Trodelvy performance. Let me start with Q1, right? With a 37% year-on-year growth and a lot of that growth is really driven by the confidence that is building with physicians with Trodelvy.
Johanna Mercier: Thanks, Tazeen, for the question. Listen, we're really excited about TRODELVY performance. Let me start with Q1, right? With the 37% year-on-year growth, and a lot of that growth is really driven by the confidence that is building with physicians with TRODELVY. We had really been building as a standard of care in second-line setting for metastatic TNBC. What we've seen since the publications and the NCCN guidelines updating us to a Category 1 for both first line PD-L1 negative as well as PD-L1 positive, what we've seen is a really nice uptake in earlier lines, including first line and obviously that spontaneous use that we're seeing. We feel very confident that the offering that TRODELVY is bringing to these patients, to these women, is really gonna make a difference.
Johanna Mercier: Thanks, Tazeen, for the question. Listen, we're really excited about TRODELVY performance. Let me start with Q1, right? With the 37% year-on-year growth, and a lot of that growth is really driven by the confidence that is building with physicians with TRODELVY. We had really been building as a standard of care in second-line setting for metastatic TNBC. What we've seen since the publications and the NCCN guidelines updating us to a Category 1 for both first line PD-L1 negative as well as PD-L1 positive, what we've seen is a really nice uptake in earlier lines, including first line and obviously that spontaneous use that we're seeing. We feel very confident that the offering that TRODELVY is bringing to these patients, to these women, is really gonna make a difference.
Speaker #3: So we had really been building as a standard of care and second line setting for metastatic TNBC. What we've seen since the publication and the NCCN guidelines updating us to a category one for both first line PL1 negative as well as PL1 positive what we've seen is a really nice uptake in earlier lines, including first line and obviously that spontaneous use that we're seeing.
Speaker #3: So we feel very confident that the offering that Trodelvy is bringing to these patients, to these women, is really going to make a difference.
Speaker #3: And I think it's the overall profile of Trodelvy. I think the data speaks for itself. I think it's practice changing as we've been told both at ASCO and at ESMO when both studies were presented.
Johanna Mercier: I think it's the overall profile of TRODELVY. I think the data speaks for itself. I think it's practice-changing, as we've been told both at ASCO and at ESMO when both studies were presented. We're excited about the potential approvals of both first line and second line towards the later, I guess, Q3 of this year. More to come.
Johanna Mercier: I think it's the overall profile of TRODELVY. I think the data speaks for itself. I think it's practice-changing, as we've been told both at ASCO and at ESMO when both studies were presented. We're excited about the potential approvals of both first line and second line towards the later, I guess, Q3 of this year. More to come.
Speaker #3: And we're excited about the potential approvals of both first line and second line towards the later I guess Q3. of this year. So more to come.
Speaker #3: Our last question comes from Chris Shot at JPMorgan. Chris, go ahead. Your line is open.
Operator: Our last question comes from Chris Schott at J.P. Morgan. Chris, go ahead. Your line is open.
Operator: Our last question comes from Chris Schott at J.P. Morgan. Chris, go ahead. Your line is open.
Speaker #14: Great. Sorry. It was muted before. I just wanted to come back to Anita Cell and launch dynamics as we look out to 2027. I guess specifically, do you think you're going to need the second line imagined three data before you can broadly convert over practices?
Chris Schott: Great. Sorry, I was muted before. I just wanted to come back to anito-cel and launch dynamics as we look out to 2027. I guess, specifically, do you think you're gonna need the second line iMMagine-3 data before you can broadly convert over practices? Do you think there's an ability to ramp this product just based on the initial later line approvals? Thank you.
Chris Schott: Great. Sorry, I was muted before. I just wanted to come back to anito-cel and launch dynamics as we look out to 2027. I guess, specifically, do you think you're gonna need the second line iMMagine-3 data before you can broadly convert over practices? Do you think there's an ability to ramp this product just based on the initial later line approvals? Thank you.
Speaker #14: Or do you think there's an ability to ramp this product just based on the initial later line approvals? Thank you.
Speaker #15: Thanks a lot for the question, Chris. This is Cindy. We feel really confident about the Anita Cell launch. We think that it's going to offer the one-and-done treatment that cell therapy has with stellar efficacy, but also with not compromising on safety.
Cindy Perettie: Thanks a lot for the question, Chris Schott. This is Cindy Perettie. You know, we feel really confident about the anito-cel launch. We think that it's gonna offer the one-and-done treatment that Celltraby has with stellar efficacy, but also with not compromising on safety, and that matters in every line. We're excited to bring it forward in fourth line. We're hearing from our KOLs and many of our authorized treatment centers, their excitement, and that pans through in two ways. One is we've seen it in our enrollment for iMMagine-3, which went faster than we expected. The second is that we expect to have a majority of our authorized treatment centers activated within Q1 2027 based on their enthusiasm to bring this on board. We see an opportunity at a patient level.
Cindy Perettie: Thanks a lot for the question, Chris Schott. This is Cindy Perettie. You know, we feel really confident about the anito-cel launch. We think that it's gonna offer the one-and-done treatment that Celltraby has with stellar efficacy, but also with not compromising on safety, and that matters in every line. We're excited to bring it forward in fourth line. We're hearing from our KOLs and many of our authorized treatment centers, their excitement, and that pans through in two ways. One is we've seen it in our enrollment for iMMagine-3, which went faster than we expected. The second is that we expect to have a majority of our authorized treatment centers activated within Q1 2027 based on their enthusiasm to bring this on board. We see an opportunity at a patient level.
Speaker #15: And that matters in every line. We're excited to bring it forward in fourth line. We're hearing from our KOLs and many of our authorized treatment centers their excitement.
Speaker #15: And that pans through in two ways. One is we've seen it in our enrollment for imagined three, which went faster than we expected. And the second is that we expect to have a majority of our authorized treatment centers activated within the first quarter of 2027 based on their enthusiasm to bring this on board.
Speaker #15: So, we see an opportunity at a patient level. We know the market in fourth line plus is $3.5 billion. So there's a substantial opportunity there.
Cindy Perettie: We know the market in fourth line plus is $3.5 billion. There's a substantial opportunity there. We also think that anito-cel offers that differentiated both efficacy and safety profile that patients and physicians are looking for.
Cindy Perettie: We know the market in fourth line plus is $3.5 billion. There's a substantial opportunity there. We also think that anito-cel offers that differentiated both efficacy and safety profile that patients and physicians are looking for.
Speaker #15: We also think that Anita Cell offers that differentiated both efficacy and safety profile that patients and physicians are looking for.
Speaker #3: That completes the time that we have for questions. I'll now invite Dan to share any closing remarks.
Operator: That completes the time that we have for questions. I'll now invite Dan to share any closing remarks.
Operator: That completes the time that we have for questions. I'll now invite Dan to share any closing remarks.
Speaker #16: So thanks, everybody, for joining. I just want to wrap up a very strong quarter with thanking the Gilead teams for another impressive quarter. I think the performance that you're seeing at Gilead today in the second quarter is clearly driven by the quality of our portfolio that's been enhanced also by adding some acquisitions since the beginning of the year.
Daniel O'Day: Thanks, everybody, for joining. I just want to wrap up a very strong quarter with thanking the Gilead teams for another impressive quarter. I think the performance that you're seeing at Gilead today in this Q2 is clearly driven by the quality of our portfolio that's been enhanced also by adding some acquisitions since the beginning of the year, the numerous launches underway, and our continued focus on financial discipline, financial management, which you heard today, and our ability to add to the portfolio and continue to have our focus on disciplined financial management. Underpinning all this is obviously the dedication of our teams that I get to work with every day, the people and communities.
Daniel O'Day: Thanks, everybody, for joining. I just want to wrap up a very strong quarter with thanking the Gilead teams for another impressive quarter. I think the performance that you're seeing at Gilead today in this Q2 is clearly driven by the quality of our portfolio that's been enhanced also by adding some acquisitions since the beginning of the year, the numerous launches underway, and our continued focus on financial discipline, financial management, which you heard today, and our ability to add to the portfolio and continue to have our focus on disciplined financial management. Underpinning all this is obviously the dedication of our teams that I get to work with every day, the people and communities.
Speaker #16: The numerous launches, underway, and our continued focus on financial discipline, financial management, which you heard today and our ability to add to the portfolio and continue to have our focus on discipline, financial management.
Speaker #16: So underpinning all of this is obviously the dedication of our teams that I get to work with every day, the people and communities. And we're going to continue to stay very focused on commercial and clinical execution like you've seen us do in past quarters.
Daniel O'Day: We're gonna continue to stay very focused on commercial and clinical execution like you've seen us do in past quarters. I would just say, you know, closing off as we look for the remainder of 2026, in addition to the 2 really strong launches that are underway right now with YEZTUGO and Livdelzi, we have up to 4 potential upcoming launches before the end of the year and up to 5 phase III updates this year. There's just so many opportunities on the horizon to increase our impact, and we look forward to keeping you informed on the progress throughout the year. As usual, if you have any additional questions that you weren't able to get answered today, please reach out to our investor relations group. We're happy to help you and support you in any way possible.
Daniel O'Day: We're gonna continue to stay very focused on commercial and clinical execution like you've seen us do in past quarters. I would just say, you know, closing off as we look for the remainder of 2026, in addition to the 2 really strong launches that are underway right now with YEZTUGO and Livdelzi, we have up to 4 potential upcoming launches before the end of the year and up to 5 phase III updates this year. There's just so many opportunities on the horizon to increase our impact, and we look forward to keeping you informed on the progress throughout the year. As usual, if you have any additional questions that you weren't able to get answered today, please reach out to our investor relations group. We're happy to help you and support you in any way possible.
Speaker #16: So I would just say closing off as we look for the remainder of 2026, in addition to the two really strong launches that are underway right now with just TUGO and LEVDELZY, we have up to four potential upcoming launches before the end of the year.
Speaker #16: And up to five phase three updates this year. So there's just so many opportunities on the horizon to increase our impact. And we look forward to keeping you informed on the progress throughout the year.
Speaker #16: As usual, if you have any additional questions, that you weren't able to get answered today, please reach out to our investor relations group. We're happy to help you and support you in any way possible.
Daniel O'Day: Thank you for your attention and focus on Gilead today.
Daniel O'Day: Thank you for your attention and focus on Gilead today.
