Q2 2024 Bristol Myers Squibb Co Earnings Call

July 26, 2024

Operator: Good day and welcome to the Bristol Myers Squibb Q2 2024 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Star key followed by zero.

Good day, and welcome to the Bristol Myers Squibb Second Quarter 2024 Earnings Conference Call.

Operator: --for the 2024 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. Please note, today's event is being recorded. I would now like to turn the conference over to Tim Power, Vice President, Head of Investor Relations. Please go ahead.

Speaker Change: All participants will be in listen-only mode.

Speaker Change: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Tim Power, Vice President, Head of Investor Relations. Please go ahead.

After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Tim Power, Vice President, Head of Investor Relations. Please go ahead.

Speaker Change: After today's presentation, there will be an opportunity to ask questions.

Speaker Change: To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2.

Operator: To withdraw your question, please press star then 2. Please note, today's event is being recorded. I would now like to turn the conference over to Tim Power, Vice President, Head of Investor Relations. Please go ahead.

Speaker Change: Please note, today's event is being recorded.

Tim Power: I would now like to turn the conference over to Tim Power, Vice President, Head of Investor Relations. Please go ahead. Thank you and good morning everyone. Thanks for joining us this morning for our second quarter 2024 earnings call.

Tim Power: Thank you, and good morning, everyone. Thanks for joining us this morning for our second-quarter 2024 earnings call. Joining me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Lenkowsky, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to bms.com that you can use to follow along with for Chris and David's remarks. Before we get started, I'll read our forward-looking statement. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in these SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. And with that, I'll hand it over to Chris.

Tim Power: Thank you and good morning everyone. Thanks for joining us this morning for our second quarter 2024 earnings call. Joining me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Lenkowsky, our Chief Commercialization Officer, and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to BMS.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll read our forward-looking statement. During this call, we make statements about the Company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors including those discussed in the company's SEC filings.

Speaker Change: Joining me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer.

Speaker Change: Also participating in today's call are Adam Lenkowsky, our Chief Commercialisation Officer, and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development.

Speaker Change: As you'll note, we've posted slides to bms.com that you can use to follow along with Chris and David's remarks.

Tim Power: Before we get started, I'll read our forward-looking statement. During this call, we make statements about the company's future plans and prospects that are forward-looking statements. Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements, even if our estimates do not match. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.org. And with that, I'll hand it over to Chris.

Speaker Change: Before we get started, I'll read our forward-looking statement.

Speaker Change: During this call we make statements about the company's future plans and prospects to constitute forward-looking statements.

Speaker Change: Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the Company's SEC filings. These forward-looking statements represent our estimates as of today, and should not be relied upon as representing our estimates as of any future date.

Tim Power: These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com, and with that I'll hand it over to Chris.

These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com, and with that I'll hand it over to Chris.

Speaker Change: We specifically disclaim any obligation to update forward-looking statements even if our estimates change.

Tim Power: We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.org. And with that, I'll hand it over to Chris. Thanks, Tim, and thanks, everyone, for joining us this morning. Starting on slide four, our second quarter results reflect continued progress against our strategy to position BMS for long-term sustainable growth. In Q2, we continued to strengthen commercial performance with uptake accelerating across a number of our marketing products. Growth portfolio revenues increased 18% year-over-year, or 21% excluding the impact of foreign exchange.

We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.org. And with that, I'll hand it over to Chris.

Chris Boerner: We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at BMS.com. And with that, I'll hand it over to Chris.

Chris Boerner: Thanks Tim and thanks everyone for joining us this morning. Starting on slide 4, our second quarter results reflect continued progress against our strategy to position BMS for long-term sustainable growth. In Q2, we continued to strengthen commercial performance with uptake accelerating across a number of our marketed products. Growth portfolio revenues increased 18% year over year or 21% excluding the impact of foreign exchange. This portfolio is on track to be a larger component of our overall mix. Moving forward, we also advanced our pipeline demonstrating the strength of our portfolio and the development of our first- or best-in-class assets. This includes US Regulatory approvals for Breyanzi, Camzyos, and Augtyro.

Chris Boerner: Thanks, Tim, and thanks, everyone, for joining us this morning. Starting on slide four, our second quarter results reflect continued progress against our strategy to position BMS for long-term sustainable growth. In Q2, we continued to strengthen commercial performance with uptake accelerating across a number of our marketing products. Growth portfolio revenues increased 18% year-over-year, or 21% excluding the impact of foreign exchange. This portfolio is on track to be a larger component of our overall mix moving forward. We also advanced our pipeline, demonstrating the strength of our portfolio and the development of our first or best-in-class assets, including U.S. regulatory approvals for BREYANZI, KRAZATI, and AUGTYRO. We also achieved a number of milestones this quarter for our I.O. franchise, including European approval for first-line bladder cancer, presented data at ASCO in first-line liver cancer, and are progressing to a more convenient subcutaneous formulation of nivolumab, where we now have a PDUFA date from the U.S. FDA of December 29th. The EMA is also reviewing our sub-Q application. Before we get into more details around quarterly performance, on slide five, I'd like to step back and take stock of where we are as a company and where we are headed. As discussed previously, we are focusing on reshaping BMS to achieve sustained, top-tier growth and maximize long-term value. We're doing this by focusing on three key objectives.

Chris Boerner: Thanks, Tim, and thanks, everyone, for joining us this morning.

Chris Boerner: Starting on slide four, our second quarter results reflect continued progress against our strategy to position BMS for long-term sustainable growth. In Q2, we continue to strengthen commercial performance with uptake accelerating across a number of our marketed products.

Chris Boerner: Growth portfolio revenues increased 18% year over year, or 21% excluding the impact of foreign exchange. This portfolio is on track to be a larger component of our overall mix moving forward.

Chris Boerner: This portfolio is on track to be a larger component of our overall mix moving forward. We also advanced our pipeline, demonstrating the strength of our portfolio and the development of our first or best-in-class assets, including U.S. regulatory approvals for Brianzi, Crisati, and Octyro. We also achieved a number of milestones this quarter for our I.O. franchise, including European approval for first-line bladder cancer, presented data at ASCO for first-line liver cancer, and are progressing to a more convenient subcutaneous formulation of Novolumab, where we now have a PDUFA date from the U.S. FDA of December 29th. The EMA is also reviewing our sub-Q application. Before we get into more details around quarterly performance on slide five, I'd like to step back and take stock of where we are as a company and where we are headed. As discussed previously, we are focusing on reshaping BMS to achieve sustained top-tier growth and maximize long-term value. We're doing this by focusing on three key objectives.

Chris Boerner: We also advanced our pipeline, demonstrating the strength of our portfolio and the development of our first or best-in-class assets.

Chris Boerner: This includes U.S. regulatory approvals for Brianzi, Crisanti, and Octiro.

Chris Boerner: We also achieved a number of milestones this quarter for our IO franchise, including European approval in first line bladder cancer, presented data at ASCO in first line liver cancer, and are progressing to a more convenient subcutaneous formulation of Nivolumab where we now have a PDUFA date from the US FDA of 29 December. The EMA is also reviewing our Sub Q application. Before we get into more details around quarterly performance on Slide 5, I'd like to step back and take stock of where we are as a company and where we are headed. As discussed previously, we are focusing on reshaping BMS to achieve sustained top-tier growth and maximize long-term value. We're doing this by focusing on three key objectives. First, we are focusing our portfolio on transformational medicines where we have a competitive advantage.

We also achieved a number of milestones this quarter for our IO franchise, including European approval in first line bladder cancer, presented data at ASCO in first line liver cancer, and are progressing to a more convenient subcutaneous formulation of Nivolumab where we now have a PDUFA date from the US FDA of 29 December. The EMA is also reviewing our Sub Q application. Before we get into more details around quarterly performance on Slide 5, I'd like to step back and take stock of where we are as a company and where we are headed. As discussed previously, we are focusing on reshaping BMS to achieve sustained top-tier growth and maximize long-term value. We're doing this by focusing on three key objectives. First, we are focusing our portfolio on transformational medicines where we have a competitive advantage.

Chris Boerner: We also achieved a number of milestones this quarter for our I.O. franchise, including European approval for first-line bladder cancer, presented data at ASCO for first-line liver cancer, and are progressing to a more convenient subcutaneous formulation of Novolumab, where we now have a PDUFA date from the U.S. FDA of December 29th. The EMA is also reviewing our sub-Q application. Before we get into more details around quarterly performance on slide five, I'd like to step back and take stock of where we are as a company and where we are headed. As discussed previously, we are focusing on reshaping BMS to achieve sustained top-tier growth and maximize long-term value. We're doing this by focusing on three key objectives.

Chris Boerner: We also achieved a number of milestones this quarter for our IO franchise, including European approval in first-line bladder cancer, presented data at ASCO in first-line liver cancer, and are progressing to a more convenient subcutaneous formulation of Novolumab, where we now have a PDUFA date from the U.S. FDA of December 29th.

Chris Boerner: The EMA is also reviewing our SubQ application.

Chris Boerner: Before we get into more details around quarterly performance, on slide 5 I'd like to step back and take stock of where we are as a company and where we are headed.

Chris Boerner: As discussed previously, we are focusing on reshaping BMS to achieve sustained, top-tier growth and maximize long-term value. We're doing this by focusing on three key objectives.

Chris Boerner: First, we are focusing our portfolio on transformational medicines where we have a competitive advantage. This means advancing and, where possible, accelerating first or best-in-class treatments across our therapeutic areas, prioritizing pipeline assets with meaningful growth potential, and discontinuing programs that no longer meet our threshold for return on investment. Through these actions, we are ensuring our R&D efforts are focused on programs where BMS has a right to win, and where we can deliver compelling ROI to shareholders. Second, we are actively driving greater operational excellence throughout the organization. This includes streamlining our operations and focusing the organization on what matters most, becoming more efficient in how we operate, improving R&D productivity, and driving a culture that emphasizes speed and accountability. We're executing on our cost-reduction efforts and are on track to achieve the $1.5 billion in cost savings we announced in Q1. Third, we are strategically allocating capital for long-term growth and returns. We remain focused on ensuring we are investing behind our growth portfolio and most critical pipeline assets. Business development and partnerships remain important for us, and we continued to strengthen our balance sheet while maintaining our commitment to returning cash to shareholders. Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution where needed, and accelerating our ability to deliver important medicines to patients. On that note, turning to slide 6, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline. In hematology-oncology, we're driving leadership by extending our I.O. business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals. In cardiovascular, we are leveraging decades of expertise to deliver new treatment options for thrombosis, heart failure, and cardiomyopathy. In immunology, we're focusing our R&D efforts on therapies that reset the immune system, with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with CAR-XT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance nicely.

Chris Boerner: This means advancing and, where possible, accelerating first- or best-in-class treatments across our therapeutic areas, prioritizing pipeline assets with meaningful growth potential, and discontinuing programs that no longer meet our threshold for return on investment. Through these actions, we are ensuring our R&D efforts are focused on programs where BMS has a right to win and where we can deliver compelling ROI to shareholders. Second, we are actively driving greater operational excellence throughout the organization. This includes streamlining our operations and focusing the organization on what matters most, becoming more efficient in how we operate, improving R&D productivity, and driving a culture that emphasizes speed and accountability. We're executing on our cost reduction efforts and are on track to achieve the $1.5 billion in cost savings we announced in Q1. Third, we are strategically allocating capital for long-term growth and returns.

This means advancing and, where possible, accelerating first- or best-in-class treatments across our therapeutic areas, prioritizing pipeline assets with meaningful growth potential, and discontinuing programs that no longer meet our threshold for return on investment. Through these actions, we are ensuring our R&D efforts are focused on programs where BMS has a right to win and where we can deliver compelling ROI to shareholders. Second, we are actively driving greater operational excellence throughout the organization. This includes streamlining our operations and focusing the organization on what matters most, becoming more efficient in how we operate, improving R&D productivity, and driving a culture that emphasizes speed and accountability. We're executing on our cost reduction efforts and are on track to achieve the $1.5 billion in cost savings we announced in Q1. Third, we are strategically allocating capital for long-term growth and returns.

Chris Boerner: and discontinuing programs that no longer meet our threshold for return on investment.

Chris Boerner: Through these actions, we are ensuring our R&D efforts are focused on programs where BMS has a right to win, and where we can deliver compelling ROI to shareholders.

Chris Boerner: Second, we are actively driving greater operational excellence throughout the organization. This includes streamlining our operations and focusing the organization on what matters most, becoming more efficient in how we operate, improving R&D productivity, and driving a culture that emphasizes speed and accountability. We're executing on our cost-reduction efforts and are on track to achieve the $1.5 billion in cost savings we announced in Q1. Third, we are strategically allocating capital for long-term growth and returns. We remain focused on ensuring we are investing behind our growth portfolio and most critical pipeline assets. Business development and partnerships remain important for us, and we continued to strengthen our balance sheet while maintaining our commitment to returning cash-to-share funds. Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution where needed, and accelerating our ability to deliver important medicines to patients. On that note, turning to slide 6, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline. In hematology-oncology, we're driving leadership by extending our I.O. business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals, and cardiovascular. We are leveraging decades of expertise to deliver new treatment options for thrombosis, heart failure, and cardiomyopathy. In immunology, we're focusing our R&D efforts on therapies that reset the immune system, with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with CAR-XT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance.

Chris Boerner: Second, we are actively driving greater operational excellence throughout the organization.

Chris Boerner: This includes streamlining our operations and focusing the organization on what matters most.

Chris Boerner: Becoming more efficient in how we operate, improving R&D productivity, and driving a culture that emphasizes speed and accountability. We're executing on our cost reduction efforts and are on track to achieve the $1.5 billion in cost savings we announced in Q1.

Chris Boerner: We're executing on our cost-reduction efforts and are on track to achieve the $1.5 billion in cost savings we announced in Q1. Third, we are strategically allocating capital for long-term growth and returns. We remain focused on ensuring we are investing behind our growth portfolio and most critical pipeline assets. Business development and partnerships remain important for us, and we continued to strengthen our balance sheet while maintaining our commitment to returning cash-to-share funds. Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution where needed, and accelerating our ability to deliver important medicines to patients. On that note, turning to slide 6, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline. In hematology-oncology, we're driving leadership by extending our I.O. business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals, and cardiovascular. We are leveraging decades of expertise to deliver new treatment options for thrombosis, heart failure, and cardiomyopathy. In immunology, we're focusing our R&D efforts on therapies that reset the immune system, with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with CAR-XT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance.

Chris Boerner: Third, we are strategically allocating capital for long-term growth and returns.

Chris Boerner: We remain focused on ensuring we are investing behind our growth portfolio and most critical pipeline assets. Business development and partnerships remain important for us, and we continued to strengthen our balance sheet while maintaining our commitment to returning cash to shareholders. Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution where needed, and accelerating our ability to deliver important medicines to patients. On that note, turning to Slide 6, our objective of generating top tier growth requires us to deliver on the potential of our pipeline. In hematology, oncology, we're driving leadership by extending our IO business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals. In cardiovascular, we are leveraging decades of expertise to deliver new treatment options in thrombosis, heart failure, and cardiomyopathies. In immunology.

We remain focused on ensuring we are investing behind our growth portfolio and most critical pipeline assets. Business development and partnerships remain important for us, and we continued to strengthen our balance sheet while maintaining our commitment to returning cash to shareholders. Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution where needed, and accelerating our ability to deliver important medicines to patients. On that note, turning to Slide 6, our objective of generating top tier growth requires us to deliver on the potential of our pipeline. In hematology, oncology, we're driving leadership by extending our IO business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals. In cardiovascular, we are leveraging decades of expertise to deliver new treatment options in thrombosis, heart failure, and cardiomyopathies. In immunology.

Chris Boerner: Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution where needed, and accelerating our ability to deliver important medicines to patients. On that note, turning to slide 6, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline. In hematology-oncology, we're driving leadership by extending our I.O. business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals, and cardiovascular. We are leveraging decades of expertise to deliver new treatment options for thrombosis, heart failure, and cardiomyopathy. In immunology, we're focusing our R&D efforts on therapies that reset the immune system, with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with CAR-XT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance.

Chris Boerner: Taken together, these actions are ensuring we're focused on the highest value activities across the organization, tightening our execution where needed, and accelerating our ability to deliver important medicines to patients. On that note, turning to slide 6, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline. In hematology-oncology, we're driving leadership by extending our I.O. business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals. In cardiovascular, we are leveraging decades of expertise to deliver new treatment options for thrombosis, heart failure, and cardiomyopathy. In immunology, we're focusing our R&D efforts on therapies that reset the immune system, with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with KarXT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance nicely.

Chris Boerner: On that note, turning to slide 6, our objective of generating top-tier growth requires us to deliver on the potential of our pipeline. In hematology-oncology, we're driving leadership by extending our I.O. business and broadening our focus to include cell therapies and protein degraders.

Chris Boerner: business and broadening our focus to include cell therapies and protein degraders. We have also expanded into ADCs and radiopharmaceuticals, and cardiovascular. We are leveraging decades of expertise to deliver new treatment options for thrombosis, heart failure, and cardiomyopathy. In immunology, we're focusing our R&D efforts on therapies that reset the immune system, with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with CAR-XT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance.

Chris Boerner: We have also expanded into ADCs and radiopharmaceuticals.

Chris Boerner: In cardiovascular, we are leveraging decades of expertise to deliver new treatment options in thrombosis, heart failure, and cardiomyopathies.

Chris Boerner: We're focusing our R&D efforts on therapies that reset the immune system with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with KarXT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration which continues to advance nicely on Slide 7. Let me update you on our progress with KarXT. Specifically, we have two main objectives, preparing for the upcoming launch and executing against a robust clinical program to expand this important therapy into multiple indications. We are rapidly building out the necessary infrastructure ahead of KarXT's anticipated FDA approval in late September. We're excited about the commercial potential for this product. Adam can speak more about our launch prep in Q&A.

We're focusing our R&D efforts on therapies that reset the immune system with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with KarXT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration which continues to advance nicely on Slide 7. Let me update you on our progress with KarXT. Specifically, we have two main objectives, preparing for the upcoming launch and executing against a robust clinical program to expand this important therapy into multiple indications. We are rapidly building out the necessary infrastructure ahead of KarXT's anticipated FDA approval in late September. We're excited about the commercial potential for this product. Adam can speak more about our launch prep in Q&A.

Chris Boerner: In immunology, we're focusing our R&D efforts on therapies that reset the immune system.

Chris Boerner: with a potentially transformational program in cell therapy. And finally, we are reestablishing our presence in neuroscience, starting with CAR-XT in neuropsychiatry, followed by an exciting pipeline in neurodegeneration, which continues to advance nicely.

Chris Boerner: On slide 7, let me update you on our progress with KarXT specifically. We have two main objectives. Preparing for the upcoming launch, and executing against a robust clinical program to expand this important therapy into multiple indications. We are rapidly building out the necessary infrastructure ahead of KarXT anticipated FDA approval in late September. We're excited about the commercial potential for this project. Adam can speak more about our launch prep in Q&A. As previously discussed, we are also expanding KarXT to additional indications, with data expected in adjunctive schizophrenia in 2025, and Alzheimer's disease psychosis in 2026. Our plans to start trials in both Alzheimer's agitation and bipolar disorder are on track. Finally, we have also initiated planning for two new indications for this product, in autism spectrum disorders and Alzheimer's cognition. On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In hematology-oncology, we're expanding our I.O. franchise with nivolumab sub-q and lung data for OPDUALAG. With the anticipated launch of the subcutaneous formulation of nivolumab at the end of this year, we continue to estimate that at least 30% to 40% of U.S. patients being treated with IV will convert to the more convenient, subcutaneous administration across multiple indications. This ultimately allows patients to benefit from the standard of care cancer medicine into the next decade. With OPDUALAG, we plan to share Phase II proof-of-concept data soon, which supports initiation of a Phase III study in a subset of patients with first-line, non-small-cell lung cancer later this year. In immunology, we expect to see data this year for CD19 next. By resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications.

Chris Boerner: On slide 7, let me update you on our progress with CAR XT specifically.

Chris Boerner: We have two main objectives, preparing for the upcoming launch and executing against a robust clinical program to expand this important therapy into multiple indications.

Chris Boerner: We are rapidly building out the necessary infrastructure ahead of CAR XT's anticipated FDA approval in late September . We're excited about the commercial potential for this product. Adam can speak more about our launch prep in Q&A.

Chris Boerner: As previously discussed, we are also expanding KarXT to additional indications with data expected in adjunctive schizophrenia in 2025 and Alzheimer's disease psychosis in 2026. Our plans to start trials in both Alzheimer's agitation and bipolar disorder are on track. Finally, we have also initiated planning for two new indications for this product in autism spectrum disorders and Alzheimer's cognition. On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In Hematology Oncology, we're extending our IO franchise with Nivolumab sub Q and lung data for Opdualag. With the anticipated launch of the subcutaneous formulation of Nivolumab at the end of this year, we continue to estimate that at least 30% to 40% of US patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications.

As previously discussed, we are also expanding KarXT to additional indications with data expected in adjunctive schizophrenia in 2025 and Alzheimer's disease psychosis in 2026. Our plans to start trials in both Alzheimer's agitation and bipolar disorder are on track. Finally, we have also initiated planning for two new indications for this product in autism spectrum disorders and Alzheimer's cognition. On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In Hematology Oncology, we're extending our IO franchise with Nivolumab sub Q and lung data for Opdualag. With the anticipated launch of the subcutaneous formulation of Nivolumab at the end of this year, we continue to estimate that at least 30% to 40% of US patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications.

Chris Boerner: As discussed, we are also expanding CAR XT to additional indications, with data expected in adjunctive schizophrenia in 2025 and Alzheimer's disease psychosis in 2026. Our plans to start trials in both Alzheimer's agitation and bipolar disorder are on track. Finally, we have also initiated planning for two new indications for this product in autism spectrum disorders and Alzheimer's cognition. On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In hematology-oncology, we're expanding our I.O. franchise with Novolumab Sub-Q and lung data for Optio. With the anticipated launch of the subcutaneous formulation of nivolumab at the end of this year, we continue to estimate that at least 30 to 40 percent of U.S. patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications. This ultimately allows patients to benefit from the standard of care cancer medicine into the next generation. With OptiLag, we plan to share Phase 2 proof-of-concept data soon, which supports initiating a Phase III study in a subset of patients with first-line, non-small-cell lung cancer later this year. In immunology, we expect to see data this year for CD19 next. By resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications.

Adam Lenkowsky: As previously discussed, we are also expanding CAR-XT to additional indications, with data expected in adjunctive schizophrenia in 2025 and Alzheimer's disease psychosis in 2026. Our plans to start trials in both Alzheimer's agitation and bipolar disorder are on track.

Chris Boerner: Finally, we have also initiated planning for two new indications for this product in autism spectrum disorders and Alzheimer's cognition. On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In hematology-oncology, we're expanding our I.O. franchise with Novolumab Sub-Q and lung data for Optio. With the anticipated launch of the subcutaneous formulation of nivolumab at the end of this year, we continue to estimate that at least 30 to 40 percent of U.S. patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications. This ultimately allows patients to benefit from the standard of care cancer medicine into the next generation. With OptiLag, we plan to share Phase 2 proof-of-concept data soon, which supports initiating a Phase III study in a subset of patients with first-line, non-small-cell lung cancer later this year. In immunology, we expect to see data this year for CD19 next. By resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications.

Adam Lenkowsky: Finally, we have also initiated planning for two new indications for this product in autism spectrum disorders and Alzheimer's cognition.

Speaker Change: On slide 8, I want to highlight a few important pipeline milestones across our therapeutic areas this year. In hematology-oncology, we're extending our I.O. franchise with Novolumab Sub-Q and lung data for OptiLag.

Chris Boerner: With the anticipated launch of the subcutaneous formulation of nivolumab at the end of this year, we continue to estimate that at least 30 to 40 percent of U.S. patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications. This ultimately allows patients to benefit from the standard of care cancer medicine into the next generation. With OptiLag, we plan to share Phase 2 proof-of-concept data soon, which supports initiating a Phase III study in a subset of patients with first-line, non-small-cell lung cancer later this year. In immunology, we expect to see data this year for CD19 next. By resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications.

Speaker Change: With the anticipated launch of the subcutaneous formulation of Novolumab at the end of this year, we continue to estimate that at least 30 to 40 percent of U.S. patients being treated with IV will convert to the more convenient subcutaneous administration across multiple indications.

Chris Boerner: This ultimately allows patients to benefit from the standard of care cancer medicine into the next decade. With Opdualag, we plan to share phase 2 proof of concept data soon. This supports initiation of a phase 3 study in a subset of patients with first-line non-small cell lung cancer later this year. In immunology, we expect to see data this year for CD19. Next, by resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications. We have also completed enrollment of our two phase 3 trials for Sotyktu in psoriatic arthritis, and now expect to see data later this year. Looking ahead on slide nine, we will begin to see important data readouts for our pipeline in the second half of this year, with momentum building through 2026. A few to focus on include LPA1 in pulmonary fibrosis.

This ultimately allows patients to benefit from the standard of care cancer medicine into the next decade. With Opdualag, we plan to share phase 2 proof of concept data soon. This supports initiation of a phase 3 study in a subset of patients with first-line non-small cell lung cancer later this year. In immunology, we expect to see data this year for CD19. Next, by resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications. We have also completed enrollment of our two phase 3 trials for Sotyktu in psoriatic arthritis, and now expect to see data later this year. Looking ahead on slide nine, we will begin to see important data readouts for our pipeline in the second half of this year, with momentum building through 2026. A few to focus on include LPA1 in pulmonary fibrosis.

Speaker Change: This ultimately allows patients to benefit from the standard of care cancer medicine into the next decade.

Speaker Change: With OptiLAG, we plan to share Phase 2 proof-of-concept data soon. This supports initiation of a Phase 3 study in a subset of patients with first-line non-small-cell lung cancer later this year. In immunology, we expect to see data this year for CD19NXT.

Speaker Change: By resetting the immune system, we believe this therapy can deliver meaningful benefits for patients across multiple indications.

Chris Boerner: We've also completed enrollment of our two phase three trials for SOTYKTU in psoriatic arthritis and now expect to see data later this year. Looking ahead, on slide 9, we will begin to see important data readouts for our pipeline in the second half of this year, with momentum building through 2026. A few to focus on include LPA-1 and pulmonary fibrosis, our Registrational Multiple Myeloma Pipeline, including GPRC-5D Cell Therapy and our cell mods, iberdomide and mezigdomide. And, of course, MILVEXIAN, which has the potential to be the only oral factor 11A inhibitor in atrial fibrillation. All have the potential to deliver significant benefits for patients and form a large commercial opportunity for the company. With increasing pipeline momentum, we are confident in our ability to further strengthen our growth profile. Let me close with our outlook on slide two. Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver top-line growth at the upper end of our guidance range. We are also raising our guidance range for full-year EPS. David will discuss these updates in more detail. Let me summarize by noting that in Q2, we took notable steps forward on our journey to drive sustained long-term growth. While there is more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst-rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster. Let me now hand it over to David.

Speaker Change: We have also completed enrollment of our two Phase 3 trials for SOTIC2 in psoriatic arthritis and now expect to see data later this year.

Speaker Change: Looking ahead, on slide 9, we will begin to see important data readouts for our pipeline in the second half of this year with momentum building through 2026.

Speaker Change: A few to focus on include LPA-1 and pulmonary fibrosis.

Chris Boerner: Our registrational multiple myeloma pipeline including GPRC5D cell therapy and our CELMoDs Iberdomide and Mezigdomide, and of course Milvexian which has the potential to be the only oral Factor XIa inhibitor in atrial fibrillation, all have the potential to deliver significant benefits for patients and form a large commercial opportunity for the company. With increasing pipeline momentum, we are confident in our ability to further strengthen our growth profile. Let me close with our outlook on slide 10. Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver top line growth at the upper end of our guidance range. We are also raising our guidance range for full-year EPS. David will discuss these updates in more detail shortly.

Our registrational multiple myeloma pipeline including GPRC5D cell therapy and our CELMoDs Iberdomide and Mezigdomide, and of course Milvexian which has the potential to be the only oral Factor XIa inhibitor in atrial fibrillation, all have the potential to deliver significant benefits for patients and form a large commercial opportunity for the company. With increasing pipeline momentum, we are confident in our ability to further strengthen our growth profile. Let me close with our outlook on slide 10. Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver top line growth at the upper end of our guidance range. We are also raising our guidance range for full-year EPS. David will discuss these updates in more detail shortly.

Chris Boerner: Our Registrational Multiple Myeloma Pipeline, including GPRC-5D Cell Therapy and our cell mods, Ivernamide and Mazignamide. And, of course, Novexian, which has the potential to be the only oral factor 11A inhibitor in atrial fibrillation. All have the potential to deliver significant benefits for patients and form a large commercial opportunity for the company. With increasing pipeline momentum, we are confident in our ability to further strengthen our growth. Let me close with our outlook on slide two. Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver top-line growth at the upper end of our guidance range. We are also raising our guidance range for full-year EPS. David will discuss these updates in more detail, but let me summarize by noting that in Q2, we took notable steps forward on our journey to drive sustained long-term growth. While there is more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst-rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster. Let me now hand it over to Dave.

Speaker Change: Our Registrational Multiple Myeloma Pipeline, including GPRC-5D cell therapy, and our cell mods Ibromide and Mazignamide, and of course, Milvexian, which has the potential to be the only oral factor 11a inhibitor in atrial fibrillation.

Speaker Change: All have the potential to deliver significant benefits for patients and form a large commercial opportunity for the company. With increasing pipeline momentum, we are confident in our ability to further strengthen our growth profile.

Chris Boerner: Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver top-line growth at the upper end of our guidance range. We are also raising our guidance range for full-year EPS. David will discuss these updates in more detail, but let me summarize by noting that in Q2, we took notable steps forward on our journey to drive sustained long-term growth. While there is more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst-rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster. Let me now hand it over to Dave.

Speaker Change: Let me close with our outlook on slide 10.

Speaker Change: Given the strength of our Q2 results and the confidence we have in the remainder of the year, we now expect to deliver top-line growth at the upper end of our guidance range. We are also raising our guidance range for full-year EPS.

Chris Boerner: David will discuss these updates in more detail, but let me summarize by noting that in Q2, we took notable steps forward on our journey to drive sustained long-term growth. While there is more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst-rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster. Let me now hand it over to Dave.

Chris Boerner: Let me summarize by noting that in Q2 we took notable steps forward on our journey to drive sustained long term growth. While there is more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster. Let me now hand it over to David.

Let me summarize by noting that in Q2 we took notable steps forward on our journey to drive sustained long term growth. While there is more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility. I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster. Let me now hand it over to David.

Speaker Change: David will discuss these updates in more detail shortly. Let me summarize by noting that in Q2 we took notable steps forward on our journey to drive sustained long-term growth.

David V. Elkins: While there is more work to do, we are strengthening the foundation for that growth by progressing what is a catalyst-rich pipeline, growing our commercial portfolio, and maintaining a strong balance sheet that provides strategic flexibility.

Speaker Change: I want to thank the employees of BMS for their contributions in the quarter and their commitment to delivering breakthrough medicines to more patients even faster.

David Elkins: Thank you Chris and good morning everyone. I'll begin with the highlights of our quarterly sales results on slide 12. Let me start with a brief reminder that unless otherwise stated, all comparisons are made from the same period in 2023 and sales growth rates will be discussed on an underlying basis which excludes the impact of foreign exchange. All references to our P&L are on a non-GAAP basis. Our performance during the second quarter reflects focused execution across the business including a 21% increase in our growth portfolio and a 3% growth in our legacy portfolio. The growth portfolio continued to increase as a portfolio portion of our total sales and now represents about 46% of the business.

David V. Elkins: Thank you, Chris, and good morning, everyone. I'll begin with the highlights of our quarterly sales results on slide 12. Let me start with a brief reminder that, unless otherwise stated, all comparisons are made from the same period in 2023, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. All references to our P&L are on a non-GAAP basis. Our performance during the second quarter reflects focused execution across the business, including a 21% increase in our growth portfolio, and a 3% growth in our legacy portfolio. The growth portfolio continued to increase as a proportion of total sales and now represents about 46% of the business. Spends restored in the quarter came more favorable than expected, reflecting our focus on driving operational excellence, and timing spent, resulting in a slightly higher operating margin of roughly 40%. These results support our positive outlook for 2024 and our updated financial guidance. Second quarter sales performance across our key therapeutic areas reflect continued momentum for several important products, including REBLOZYL, CAMZYOS, and BREYANZI and OPDUALAG. While we saw growth across our immunology business, we recognize there is still more work to do, particularly with SOTUKTU in this highly competitive category. There were also some inventory and gross-to-net favorability across several growth brands this quarter, which will be important to take into consideration when phasing sales in the second half of the year. Let's take a closer look at key brand performance, starting with our oncology franchise on slide 13. OpDevo remains an important product within our immuno-oncology portfolio.

Speaker Change: Let me now hand it over to David.

David V. Elkins: Thank you, Chris, and good morning, everyone. I will begin with the highlights of our quarterly sales results on slide 12. Let me start with a brief reminder that unless otherwise stated, all comparisons are made from the same period in 2023, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange.

David V. Elkins: Our performance during the second quarter reflects focused execution across the business, including a 21% increase in our growth portfolio and a 3% growth in our legacy. The growth portfolio continued to increase as a proportion of total sales and now represents about 46% of the business. Sponsored by the U.S. Department of Labor, These results support our positive outlook for 2024 and our updated financial guidance. Second quarter sales performance across our key therapeutic areas reflect continued momentum for several important products, including Rebozel, Kem Zayas, and Brianzi. While we saw growth across our immunology business, we recognize there is still more work, particularly with Sir Tick Toe in this highly competitive market. There were also some inventory and gross-to-net favorability across several growth brands this quarter, which will be important to take into consideration when phasing sales in the second half of the year. Let's take a closer look at key brand performance, starting with our oncology franchise. Devo remains an important product within our immuno-oncology portfolio.

David V. Elkins: All references to our P&L are on a non-GAP basis.

David Elkins: Expenses during the quarter came in more favorable than expected, reflecting our focus on driving operational excellence and timing of spend, resulting in a slightly higher operating margin of roughly 40%. These results support our positive outlook for 2024 and our updated financial guidance. Second quarter sales performance across our key therapeutic areas reflect continued momentum for several important growth brands, including Reblozyl, Camzyos, Breyanzi, and Opdualag. While we saw growth across our immunology business, we recognize there is still more work to do, particularly with Sotyktu in this highly competitive category. There are also some inventory and gross-to-net favorability across several growth brands this quarter, which will be important to take into consideration when phasing sales in the second half of the year. Let's take a closer look at our key brand performance starting with our oncology franchise on slide 13.

Expenses during the quarter came in more favorable than expected, reflecting our focus on driving operational excellence and timing of spend, resulting in a slightly higher operating margin of roughly 40%. These results support our positive outlook for 2024 and our updated financial guidance. Second quarter sales performance across our key therapeutic areas reflect continued momentum for several important growth brands, including Reblozyl, Camzyos, Breyanzi, and Opdualag. While we saw growth across our immunology business, we recognize there is still more work to do, particularly with Sotyktu in this highly competitive category. There are also some inventory and gross-to-net favorability across several growth brands this quarter, which will be important to take into consideration when phasing sales in the second half of the year. Let's take a closer look at our key brand performance starting with our oncology franchise on slide 13.

David V. Elkins: Expenses during the quarter came in more favorable than expected, reflecting our focus on driving operational excellence and timing of spend, resulting in a slightly higher operating margin of roughly 40%. These results support our positive outlook for 2024 and our updated financial guidance.

David V. Elkins: Second quarter sales performance across our key therapeutic areas reflect continued momentum for several important growth brands, including Reblozell, Chemzaios, Brianzi, and OptiLite. While we saw growth across our immunology business, we recognize there is still more work to do, particularly with Serticto in this highly competitive category.

David V. Elkins: While we saw growth across our immunology business, we recognize there is still more work, particularly with Sir Tick Toe in this highly competitive market. There were also some inventory and gross-to-net favorability across several growth brands this quarter, which will be important to take into consideration when phasing sales in the second half of the year. Let's take a closer look at key brand performance, starting with our oncology franchise. Devo remains an important product within our immuno-oncology portfolio.

David V. Elkins: There are also some inventory and gross-to-net favorability across several growth brands this quarter, which will be important to take into consideration when phasing sales in the second half of the year. Let's take a closer look at a key brand performance, starting with our oncology franchise on slide 13.

David Elkins: Opdivo remains an important product within our immuno-oncology business. Sequentially, global sales were up driven by demand and an estimated benefit of $65 million related to customer buying patterns in the US. We expect growth this year to be in the mid-single-digit range as core indications mature and we await additional regulatory actions, including FDA approval in the peri-adjuvant lung expected in October. In our IO franchise is further strengthened with Opdualag, which delivered another quarter of double-digit growth driven primarily by higher demand. Outside the US we see encouraging trends across several newly launched markets and remain focused on securing reimbursement. As we said previously, we are pursuing further development of Opdualag in a segment of first-line lung cancer, and we remain on track to initiate our Phase 3 registrational program later this year.

Opdivo remains an important product within our immuno-oncology business. Sequentially, global sales were up driven by demand and an estimated benefit of $65 million related to customer buying patterns in the US. We expect growth this year to be in the mid-single-digit range as core indications mature and we await additional regulatory actions, including FDA approval in the peri-adjuvant lung expected in October. In our IO franchise is further strengthened with Opdualag, which delivered another quarter of double-digit growth driven primarily by higher demand. Outside the US we see encouraging trends across several newly launched markets and remain focused on securing reimbursement. As we said previously, we are pursuing further development of Opdualag in a segment of first-line lung cancer, and we remain on track to initiate our Phase 3 registrational program later this year.

David V. Elkins: OPDIVO remains an important product within our immuno-oncology business. Sequentially, global sales were up, driven by demand and an estimated benefit of $65 million related to customer buying patterns in the U.S. We expect growth this year to be in the mid-single-digit range as core indications mature, and we await additional regulatory actions, including FDA approval in the Peri-adjuvant Lung in October. In our I.O. franchise, it's further strengthened with OPDUALAG, which delivered another quarter of double-digit growth, driven primarily by higher demand. Outside the U.S., we see encouraging trends across several newly launched markets and remain focused on securing reimbursements. As we said previously, we are pursuing further development of OPDUALAG in a segment of Firstline Lung Care, and we remain on track to initiate our Phase III registrational program later this year. These expansion opportunities, coupled with the pending approval of the nivolumab, sub-q, further support extension of our IO franchise into the next decade. In cardiovascular, on slide 14, ELIQUIS remains the market leader anticoagulant worldwide with global sales of more than $3 billion. In the U.S., sales are primarily driven by higher demand and market share gains. Sequentially, as is typical in the second quarter, U.S. sales reflect an unfavorable gross-to-net impact, as patients begin to enter medicare coverage gap. As a reminder, these dynamics are more acute in the second half of the year, resulting in lower sales versus the first half. Turning to CAMZYOS, second quarter sales more than tripled compared to the prior year. Sequencially, U.S. sales were driven mainly by demand. U.S. demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drugs.

David V. Elkins: sequentially, global sales were up, driven by demand and an estimated benefit of $65 million related to customer buying patterns in the U.S. We expect growth this year to be in the mid-single-digits. Core indications mature, and we await additional regulatory approval, including FDA approval in the Peri-adjuvant Lung. In our I.O. franchise, it's further strengthened with... Delivered Another Quarter of Double-Digit Growth Driven Primarily by Higher Diversity Outside the U.S., we see encouraging trends across several newly launched markets and remain focused on securing reimbursements. As we said previously, we are pursuing further development of OptiLag in a segment of Firstline Lung Care, and we remain on track to initiate our Phase 3 registrational program later this year. These expansion opportunities, coupled with the pending approval of the Evolumab SubQ, further support extension of our IO franchise into the next decade. Eloquist remains the market leader anticoagulant worldwide with global sales of more than $3 billion. In the U.S., sales are primarily driven by higher demand and market share gains. However, sequentially, as is typical in the second quarter, U.S. sales reflect an unfavorable gross-to-net impact. As Patients Begin to Enter Medicare Coverage As a reminder, these dynamics are more acute in the second half of the year, resulting in lower sales versus the first half. Turning to Kim Zayas, second quarter sales more than tripled compared to the. U.S. demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drugs.

David V. Elkins: Optiva remains an important product within our immuno-oncology business.

David V. Elkins: Sequentially, global sales were up, driven by demand, and an estimated benefit of $65 million related to customer buying patterns in the U.S.

David V. Elkins: We expect growth this year to be in the mid-single-digit range as core indications mature and we await additional regulatory actions, including FDA approval in the periadjuvant lung expected in October .

David V. Elkins: and our I.O. franchise is further strengthened with OptiLine.

David V. Elkins: which delivered another quarter of double-digit growth driven primarily by higher demand.

David V. Elkins: Outside the U.S. we see encouraging trends across several newly launched markets and remain focused on securing reimbursement.

David V. Elkins: As we said previously, we are pursuing further development of OptiLag in a segment of Firstline Lung Care, and we remain on track to initiate our Phase 3 registrational program later this year. These expansion opportunities, coupled with the pending approval of the Evolumab SubQ, further support extension of our IO franchise into the next decade. Eloquist remains the market leader anticoagulant worldwide with global sales of more than $3 billion. In the U.S., sales are primarily driven by higher demand and market share gains. However, sequentially, as is typical in the second quarter, U.S. sales reflect an unfavorable gross-to-net impact. As Patients Begin to Enter Medicare Coverage As a reminder, these dynamics are more acute in the second half of the year, resulting in lower sales versus the first half. Turning to Kim Zayas, second quarter sales more than tripled compared to the. U.S. demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drugs.

David V. Elkins: As we said previously, we are pursuing further development of OptiLag in a segment of first-line lung cancer, and we remain on track to initiate our Phase III Registrational Program later this year. These expansion opportunities, coupled with the pending approval of nivolumab,

David Elkins: These expansion opportunities, coupled with the pending approval to Nivolumab subq, further support extension of our IO franchise into the next decade. In cardiovascular on slide 14, Eliquis remains the market leader anticoagulant worldwide with global sales of more than $3 billion. In the US, sales were primarily driven by higher demand and market share gains. Sequentially, as is typical in Q2, US sales reflect an unfavorable gross-to-net impact as patients begin to enter Medicare coverage gap. As a reminder, these dynamics are more acute in the second half of the year resulting in lower sales versus the first half. Turning to Camzyos, Q2 sales more than tripled compared to the prior year. Sequentially, US sales were driven mainly by demand.

These expansion opportunities, coupled with the pending approval to Nivolumab subq, further support extension of our IO franchise into the next decade. In cardiovascular on slide 14, Eliquis remains the market leader anticoagulant worldwide with global sales of more than $3 billion. In the US, sales were primarily driven by higher demand and market share gains. Sequentially, as is typical in Q2, US sales reflect an unfavorable gross-to-net impact as patients begin to enter Medicare coverage gap. As a reminder, these dynamics are more acute in the second half of the year resulting in lower sales versus the first half. Turning to Camzyos, Q2 sales more than tripled compared to the prior year. Sequentially, US sales were driven mainly by demand.

David V. Elkins: SubQ further support extension of our I.O. franchise into the next decade. In cardiovascular on slide 14, Eloquist remains the market leader anticoagulant worldwide with global sales of more than three billion dollars.

David V. Elkins: Eloquist remains the market leader anticoagulant worldwide with global sales of more than $3 billion. In the U.S., sales are primarily driven by higher demand and market share gains. However, sequentially, as is typical in the second quarter, U.S. sales reflect an unfavorable gross-to-net impact. As Patients Begin to Enter Medicare Coverage As a reminder, these dynamics are more acute in the second half of the year, resulting in lower sales versus the first half. Turning to Kim Zayas, second quarter sales more than tripled compared to the. U.S. demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drugs.

David V. Elkins: In the U.S., sales are primarily driven by higher demand and market share gains. Sequentially, as is typical in the second quarter, U.S. sales reflect an unfavorable gross-to-net impact as patients begin to enter a Medicare coverage gap.

David V. Elkins: As Patients Begin to Enter Medicare Coverage As a reminder, these dynamics are more acute in the second half of the year, resulting in lower sales versus the first half. Turning to Kim Zayas, second quarter sales more than tripled compared to the. U.S. demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drugs.

Kim Zayas: As a reminder, these dynamics are more acute in the second half of the year, resulting in lower sales versus the first half. Turning to Kim Zayas, second quarter sales more than tripled compared to the prior year.

David Elkins: US demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drug. This growth demonstrates steady and consistent adoption outside the US. Sales growth reflects the timing of reimbursement in approved markets, and globally we see significant room for future growth. Let's turn to hematology on slide 15. Sales of Reblozyl in the quarter grew 82% with growth in both US and international markets. In the US, sales benefited from higher demand driven by first-line MDS-associated anemia and some favorable inventory in gross-to-net. Outside the US, the brand is approved in approximately 40 countries including recent broad label introductions in Europe and Japan. We look forward to seeing the first-line indication reimbursed across the globe in cell therapy.

US demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drug. This growth demonstrates steady and consistent adoption outside the US. Sales growth reflects the timing of reimbursement in approved markets, and globally we see significant room for future growth. Let's turn to hematology on slide 15. Sales of Reblozyl in the quarter grew 82% with growth in both US and international markets. In the US, sales benefited from higher demand driven by first-line MDS-associated anemia and some favorable inventory in gross-to-net. Outside the US, the brand is approved in approximately 40 countries including recent broad label introductions in Europe and Japan. We look forward to seeing the first-line indication reimbursed across the globe in cell therapy.

Kim Zayas: Sequentially, U.S. sales were driven mainly by demand. U.S. demand in the second quarter was led by an increase of approximately 1,300 commercially dispensed patients since Q1, bringing the total to almost 6,900 patients on commercial drug.

David V. Elkins: This growth demonstrates steady and consistent adoption. Outside the U.S., sales growth reflect the timing in reimbursement in approved markets, and globally we see significant room for future growth. Let's turn to hematology on slide 15. Sales of REBLOZYL a quarter grew 82%, with growth in both U.S. and international markets. In the U.S., sales benefited from higher demand driven by first-line MDS-associated anemia and some favorable inventory and gross to net. Outside the U.S., the brand is approved in approximately 40 countries, including recent broad label introductions in Europe and Japan. We look forward to seeing the first line indication reimbursed across the globe. In cell therapy, we saw quarter over quarter sales growth with ABECMA, driven largely by ex-U.S. We continue to work through the competitive dynamics in multiple myeloma by discussing our CARMA 3 data with customers. BREYANZI grew 55% in a quarter, which was driven by growth across multiple indications and expanded manufacturing capacity. International sales growth reflected strong demand in markets such as Germany, France, and Japan. Now moving to immunology on slide 16, performance of SOTYKTU continued to be impacted by the competitive environment and the quality of commercial access in the U.S. At the same time, during Q2, we achieved improved commercial access across multiple large PBMs with zero step-bets. Starting earlier this month, we added another large PBM, as we discussed last quarter. We now have greater than 60% of covered lives of favorable access. As a result, in the near term, we anticipate modest incremental gross-to-net pressure on revenue growth, which will be offset by demand growth over time. Turning to slide 17, I will highlight some components of the P&L.

Kim Zayas: This growth demonstrates steady and consistent adoption.

Kim Zayas: Outside the U.S., sales growth reflects the timing of reimbursement in improved markets, and globally we see significant room for future growth.

Kim Zayas: Let's turn to hematology on slide 15. Sales of ribosome in the quarter grew 82% with growth in both U.S. and international markets.

Kim Zayas: In the U.S., sales benefited from higher demand driven by first-line MDS-associated anemia and some favorable inventory and gross Donets.

Kim Zayas: Outside the U.S., the brand is approved in approximately 40 countries, including recent broad label introductions in Europe and Japan.

David V. Elkins: We look forward to seeing the First Line Indication reimbursed across the globe. In cell therapy, we saw quarter over quarter sales growth with Becma, driven largely by XUS. We continue to work through the competitive dynamics in multiple myeloma by discussing our CARMA 3 data with customers. Brianzi grew 55% in a quarter, which was driven by growth across multiple indications and expanded manufacturing capacity. International sales growth reflected strong demand in markets such as Germany, France, Now moving to immunology on slide 16, performance of CYCT2 continued to be impacted by the competitive environment and the quality of commercial access in the U.S. At the same time, during Q2, we achieved improved commercial access across multiple large PVMs with zero step-bets. Starting earlier this month, we added another large PBM, as we discussed last quarter. We now have greater than 60% of covered lives that are favorable. As a result, in the near term, we anticipate modest incremental gross-to-net pressure on revenue growth, which will be offset by demand growth over time. Turning to slide 17, I will highlight some components of the PNC.

Kim Zayas: We look forward to seeing the First Line Indication reimbursed across the globe.

David Elkins: We saw quarter over quarter sales growth with Abecma driven largely by ex-US. We continue to work through the competitive dynamics in multiple myeloma by discussing our KarMMa-3 data with customers. Breyanzi grew 55% in the quarter, which was driven by growth across multiple indications and expanded manufacturing capacity. International sales growth reflected strong demand in markets such as Germany, France, and Japan. Now moving to immunology on slide 16, performance of Sotyktu continued to be impacted by the competitive environment and the quality of commercial access in the US. At the same time, during Q2 we achieved improved commercial access across multiple large PBMs with zero step edits, and starting earlier this month we added another large PBM. As we discussed last quarter, we now have greater than 60% of covered lives with favorable access.

We saw quarter over quarter sales growth with Abecma driven largely by ex-US. We continue to work through the competitive dynamics in multiple myeloma by discussing our KarMMa-3 data with customers. Breyanzi grew 55% in the quarter, which was driven by growth across multiple indications and expanded manufacturing capacity. International sales growth reflected strong demand in markets such as Germany, France, and Japan. Now moving to immunology on slide 16, performance of Sotyktu continued to be impacted by the competitive environment and the quality of commercial access in the US. At the same time, during Q2 we achieved improved commercial access across multiple large PBMs with zero step edits, and starting earlier this month we added another large PBM. As we discussed last quarter, we now have greater than 60% of covered lives with favorable access.

Kim Zayas: In cell therapy, we saw quarter-over-quarter sales growth with the BECMA, driven largely by XUS. We continue to work through the competitive dynamics in multiple myeloma by discussing our CARMA 3 data with customers.

Kim Zayas: Brianzi grew 55% in a quarter, which was driven by growth across multiple indications and expanded manufacturing capacity.

David V. Elkins: International sales growth reflected strong demand in markets such as Germany, France, Now moving to immunology on slide 16, performance of CYCT2 continued to be impacted by the competitive environment and the quality of commercial access in the U.S. At the same time, during Q2, we achieved improved commercial access across multiple large PVMs with zero step-bets. Starting earlier this month, we added another large PBM, as we discussed last quarter. We now have greater than 60% of covered lives that are favorable. As a result, in the near term, we anticipate modest incremental gross-to-net pressure on revenue growth, which will be offset by demand growth over time. Turning to slide 17, I will highlight some components of the PNC.

Kim Zayas: International sales growth reflected strong demand in markets such as Germany, France, and Japan. Now moving to immunology on slide 16, performance of CYCT2 continued to be impacted by a competitive environment and the quality of commercial access in the U.S.

Kim Zayas: At the same time, during Q2, we achieved improved commercial access across multiple large PBMs, with zero step edits. And starting earlier this month, we added another large PBM, as we discussed last quarter. We now have greater than 60% of covered lives with favorable access.

David Elkins: As a result, in the near term we anticipate modest incremental gross-to-net pressure on revenue growth, which will be offset by demand growth over time. Now turning to Slide 17, I will highlight some components of the P&L. In addition to solid commercial execution, our second quarter performance reflects a focus on financial discipline and steady progress against our $1.5 billion cost savings program we discussed on last quarter's call. As a reminder, we plan to reinvest the cost savings into higher growth opportunities to drive greater patient impact and accelerate our sales growth in the second half of the decade. Gross margin came in favorable this quarter, driven primarily by product mix. Operating expenses excluding in-process R&D were impacted by higher deal-related spend, partially offset by cost savings related to our efficiency initiatives and the timing of planned expenditures.

As a result, in the near term we anticipate modest incremental gross-to-net pressure on revenue growth, which will be offset by demand growth over time. Now turning to Slide 17, I will highlight some components of the P&L. In addition to solid commercial execution, our second quarter performance reflects a focus on financial discipline and steady progress against our $1.5 billion cost savings program we discussed on last quarter's call. As a reminder, we plan to reinvest the cost savings into higher growth opportunities to drive greater patient impact and accelerate our sales growth in the second half of the decade. Gross margin came in favorable this quarter, driven primarily by product mix. Operating expenses excluding in-process R&D were impacted by higher deal-related spend, partially offset by cost savings related to our efficiency initiatives and the timing of planned expenditures.

Kim Zayas: As a result, in the near term, we anticipate modest incremental gross net pressure on revenue growth, which will be offset by demand growth over time. Now, turning to slide 17, I will highlight some components of the P&L.

David V. Elkins: In addition to solid commercial execution, our second quarter performance reflects a focus on financial discipline and steady progress against our $1.5 billion cost savings program we discussed on last quarter's call. As a reminder, we plan to reinvest the cost savings into higher growth opportunities to drive greater patient impact and accelerate our sales growth in the second half of the decade. Gross margin came in favorable this quarter, driven primarily by product mix. Operating expenses, excluding in-process R&D, were impacted by higher deal-related spend, partially offset by cost savings related to our efficiency initiatives, and the timing of planned expenditures. On a sequential basis, expenses came in lower than anticipated due to the timing of planned investment spend that shifted to the third quarter. Our tax rate in the quarter changed from 16.9% in the prior year to 14.1%, primarily due to a release of income tax reserve. Overall, Earnings Per Share was $2.07; now moving to the balance sheet and capital allocation highlights on slide 18. Both our growth and legacy portfolios delivered solid revenue growth during the quarter. With legacy continue to contribute to our robust operating cash flow of approximately $2.3 billion. And we closed the quarter on June 30th, we had approximately $7 billion in cash, cash equivalents, and marketable debt securities on hand. During the second quarter, we reduced our total debt position by $3.1 billion.

Kim Zayas: In addition to solid commercial execution, our second quarter performance reflects a focus on financial discipline and steady progress against our $1.5 billion cost savings program we discussed on last quarter's call.

Kim Zayas: As a reminder, we plan to reinvest the cost savings into higher growth opportunities to drive greater patient impact and accelerate our sales growth in the second half of the decade.

David V. Elkins: Operating expenses, excluding in-process R&D, were impacted by higher deal-related spend, partially offset by cost savings related to our efficiency initiatives and the timing of planned expenditures. On a sequential basis, expenses came in lower than anticipated due to the timing of planned investment spend that shifted to the third quarter. The tax rate in the quarter changed from 16.9% in the prior year to 14.1%, primarily due to a release of income tax. Overall, Earnings Per Share was $2.07; now moving to the balance sheet and capital allocation highlights on slide 18. Both our growth and legacy portfolios delivered solid revenue growth during the course. Let the legacy continue to contribute to our robust operating cash flow of approximately $2.3 billion. And we closed the quarter on June 30th. We had approximately $7 billion in cash, cash equivalents, and marketable debt securities on hand. During the second quarter, we reduced our total debt position by $3.1 billion.

Kim Zayas: Gross margin came in favorable this quarter, driven primarily by product mix. Operating expenses, excluding in-process R&D, were impacted by higher deal-related spend, partially offset by cost savings related to our efficiency initiatives, and the timing of planned expenditures.

David Elkins: On a sequential basis. Expenses came in lower than anticipated due to timing of planned investment spend that shifted to Q3. Our tax rate in the quarter changed from 16.9% in the prior year to 14.1%, primarily due to a release of income tax reserve. Overall earnings per share was $2.07 in the quarter. Now moving to the balance sheet and capital allocation highlights on Slide 18. Both our growth and legacy portfolios delivered solid revenue growth in the quarter, with legacy continuing to contribute to our robust operating cash flow of approximately $2.3 billion, and we closed the quarter on 30 June. We had approximately $7 billion in cash, cash equivalents, and marketable debt securities on hand. During Q2, we reduced our total debt position by $3.1 billion, including roughly $2.7 billion of commercial paper and $400 million of long-term debt.

On a sequential basis. Expenses came in lower than anticipated due to timing of planned investment spend that shifted to Q3. Our tax rate in the quarter changed from 16.9% in the prior year to 14.1%, primarily due to a release of income tax reserve. Overall earnings per share was $2.07 in the quarter. Now moving to the balance sheet and capital allocation highlights on Slide 18. Both our growth and legacy portfolios delivered solid revenue growth in the quarter, with legacy continuing to contribute to our robust operating cash flow of approximately $2.3 billion, and we closed the quarter on 30 June. We had approximately $7 billion in cash, cash equivalents, and marketable debt securities on hand. During Q2, we reduced our total debt position by $3.1 billion, including roughly $2.7 billion of commercial paper and $400 million of long-term debt.

Kim Zayas: On a sequential basis, expenses came in lower than anticipated due to timing of planned investment spend that shifted to the third quarter.

Kim Zayas: Our tax rate in the quarter changed from 16.9% in the prior year to 14.1%, primarily due to a release of income tax reserve.

David V. Elkins: Overall, Earnings Per Share was $2.07; now moving to the balance sheet and capital allocation highlights on slide 18. Both our growth and legacy portfolios delivered solid revenue growth during the course. Let the legacy continue to contribute to our robust operating cash flow of approximately $2.3 billion. And we closed the quarter on June 30th. We had approximately $7 billion in cash, cash equivalents, and marketable debt securities on hand. During the second quarter, we reduced our total debt position by $3.1 billion.

Kim Zayas: Overall, earnings per share was $2.07 in the quarter.

Kim Zayas: Now moving to the balance sheet and capital allocation highlights on slide 18, both our growth and legacy portfolios delivered solid revenue growth in the quarter.

Kim Zayas: With legacy continue to contribute to a robust operating cash flow of approximately 2.3 billion dollars.

Kim Zayas: And we closed the quarter on June 30th. We had approximately $7 billion in cash, cash equivalents, and marketable debt securities on hand. During the second quarter, we reduced our total debt position by $3.1 billion.

David V. Elkins: Including roughly $2.7 billion of commercial paper and $400 million of long-term debt. These actions are consistent with our plan to pay down approximately $10 billion of debt over the next two years. In terms of capital allocation, we are prioritizing opportunities that will further strengthen our long-term growth outlook while remaining committed to our dividend. Please turn to slide 19 to walk through the details of our guidance. On Q2 performance, focused execution across the business generated top-line growth and driving operational excellence. These results provide support for updating a full year guidance. As is our practice, we provide revenue guidance on a reported basis, as well as on an underlying basis, which assumes currency remains consistent with the prior year. Our guidance for the full year revenue is now low single-digit growth, which we now expect to come in at the upper end of the range. This is due to the continued performance of our growth portfolio and better than expected sales of revenue. With respect to gross margin, we are raising our guidance to reflect the impact of sales mix. Excluding acquired and process R&D, we continue to expect our total operating expenses to be at the upper end of low single-digit percentage increase range. This reflects incremental costs associated with the recent acquisitions, partially offset by the realization of savings due to our productivity initiative. Given the delay in the timing of anticipated expenses in Q2, we now expect a step-up in Q3. Overall, our previous operating margin target of at least 37% for the full year remains unchanged. For OI&E, we now expect annual expenses of approximately $50 million due to higher-than-anticipated estimated royalties and favorable net interest expense. The annual tax rate would be affected by one-time non-deductible expenses of acquired in-process R&D charges, which impacted our non-GAAP net income in the first quarter. Excluding this impact, the estimated underlying tax rate for the full year is still expected to be about 18%. As a result of these changes, we are raising the range of our 2024 non-GAAP EPS guidance to between $0.60 and $0.90. Now, let's walk through the phasing of our sales for the full year. Year-to-date, our growth portfolio has grown approximately 16%, and we anticipate a similar rate of growth in the second half. In relation to phasing of product sales in the back half of the year, keep in mind the typical product seasonality we expect to see in the business in the third quarter. Also, we had roughly $150 million in stocking in the second quarter, and we anticipate reversing that in Q3. Normalization of these dynamics next quarter will likely temper sequential growth. However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in the fourth quarter. And from REVLIMID, while we continue to monitor variability from generics and other dynamics, we now expect full-year sales to be at the higher end of our $4.5 to $5 billion range.

Kim Zayas: Including roughly $2.7 billion of commercial paper and $400 million of long-term debt. These actions are consistent with our plan to pay down approximately $10 billion of debt over the next two years. In terms of capital allocation, we are prioritizing opportunities that will further strengthen our long-term growth outlook while remaining committed to our dividend.

David Elkins: These actions are consistent with our plan to pay down approximately $10 billion of debt over the next two years. In terms of capital allocation, we are prioritizing opportunities that will further strengthen our long-term growth outlook while remaining committed to our dividend. Please turn to Slide 19 to walk through the details of our guidance on Q2 performance. Focused execution across the business generated top-line growth and driving operational excellence. These results provided support for updated full-year guidance. As is our practice, we provide revenue guidance on a reported basis as well as on an underlying basis, which assumes currency remains consistent with prior year. Our guidance for the full-year revenue is now low single-digit growth, which we now expect to come in at the upper end of the range.

These actions are consistent with our plan to pay down approximately $10 billion of debt over the next two years. In terms of capital allocation, we are prioritizing opportunities that will further strengthen our long-term growth outlook while remaining committed to our dividend. Please turn to Slide 19 to walk through the details of our guidance on Q2 performance. Focused execution across the business generated top-line growth and driving operational excellence. These results provided support for updated full-year guidance. As is our practice, we provide revenue guidance on a reported basis as well as on an underlying basis, which assumes currency remains consistent with prior year. Our guidance for the full-year revenue is now low single-digit growth, which we now expect to come in at the upper end of the range.

Kim Zayas: Please turn to slide 19 to walk through the details of our guidance.

Kim Zayas: on Q2 Performance.

Kim Zayas: Focused execution across the business generated top-line growth and driving operational excellence. These results provided support for updated full-year guidance.

Kim Zayas: As is our practice, we provide revenue guidance on a reported basis, as well as on an underlying basis, which assumes currency remains consistent with prior year.

David V. Elkins: Our guidance for the full year revenue is now low single-digit growth, which we now expect to come in at the upper end of the range. This is due to the continued performance of our growth portfolio and better than expected sales of revenue. With respect to gross margin, we are raising our guidance to reflect the impact of sales. Excluding Acquired and Process R&D, we continue to expect our total operating expenses to be at the upper end of low single-digit percentage increases. This reflects incremental costs associated with the recent acquisitions, partially offset by the realization of savings due to our productivity. Given the delay in the timing of anticipated expenses in Q2, we now expect a step-up in Q3. Overall, our previous operating margin target of at least 37% for the full year remains unchanged. For OI&E, we now expect annual expenses of approximately $50 million due to higher-than-anticipated estimated royalties and favorable net interest expense.

Kim Zayas: Our guidance for the full year revenue is now low single-digit growth, which we now expect to come in at the upper end of the range.

David Elkins: This is due to continued performance of our growth portfolio and better than expected sales of Revlimid. With respect to gross margin, we are raising our guidance to reflect the impact of sales mix excluding acquired in-process R&D. We continue to expect our total operating expenses to be at the upper end of low single-digit percentage increase range. This reflects incremental costs associated with the recent acquisitions partially offset by the realization of savings due to our productivity initiative. Given a delay in timing of anticipated expenses in Q2, we now expect a step up in Q3. Overall, our previous operating margin target of at least 37% for the full year remains unchanged for OIE. We now expect annual expenses of approximately $50 million due to higher than anticipated estimated royalties and favorable net interest expense.

This is due to continued performance of our growth portfolio and better than expected sales of Revlimid. With respect to gross margin, we are raising our guidance to reflect the impact of sales mix excluding acquired in-process R&D. We continue to expect our total operating expenses to be at the upper end of low single-digit percentage increase range. This reflects incremental costs associated with the recent acquisitions partially offset by the realization of savings due to our productivity initiative. Given a delay in timing of anticipated expenses in Q2, we now expect a step up in Q3. Overall, our previous operating margin target of at least 37% for the full year remains unchanged for OIE. We now expect annual expenses of approximately $50 million due to higher than anticipated estimated royalties and favorable net interest expense.

Kim Zayas: This is due to the continued performance of our growth portfolio and better than expected sales of Revlimid.

Kim Zayas: With respect to gross margin, we are raising our guidance to reflect the impact of sales mix.

Kim Zayas: Excluding acquired and process R&D, we continue to expect our total operating expenses to be at the upper end of low single-digit percentage increase range. This reflects incremental costs associated with the recent acquisitions, partially offset by the realization of savings due to our productivity initiative.

David V. Elkins: This reflects incremental costs associated with the recent acquisitions, partially offset by the realization of savings due to our productivity. Given the delay in the timing of anticipated expenses in Q2, we now expect a step-up in Q3. Overall, our previous operating margin target of at least 37% for the full year remains unchanged. For OI&E, we now expect annual expenses of approximately $50 million due to higher-than-anticipated estimated royalties and favorable net interest expense.

Kim Zayas: Given the delay in timing of anticipated expenses in Q2, we now expect a step up in Q3. Overall, our previous operating margin, target of at least 37% for the full year, remains unchanged.

Kim Zayas: For OI&E, we now expect annual expenses of approximately $50 million due to higher than anticipated estimated royalties and favorable net interest expense.

David Elkins: The annual tax rate will be affected by one-time non-deductible expenses of Karuna-acquired in-process R&D charge, which impacted our non-GAAP net income in the first quarter. Excluding this impact, the estimated underlying tax rate for the full year is still expected to be about 18%. As a result of these changes, we are raising the range of our 2024 non-GAAP EPS guidance to between $0.60 and $0.90. Let's walk through the phasing of our sales for the full year. Year to date, our growth portfolio has grown approximately 16%, and we anticipate a similar rate of growth in the second half in relation to phasing of product sales in the back half of the year. Keep in mind the typical product seasonality we expect to see in the business in the third quarter.

The annual tax rate will be affected by one-time non-deductible expenses of Karuna-acquired in-process R&D charge, which impacted our non-GAAP net income in the first quarter. Excluding this impact, the estimated underlying tax rate for the full year is still expected to be about 18%. As a result of these changes, we are raising the range of our 2024 non-GAAP EPS guidance to between $0.60 and $0.90. Let's walk through the phasing of our sales for the full year. Year to date, our growth portfolio has grown approximately 16%, and we anticipate a similar rate of growth in the second half in relation to phasing of product sales in the back half of the year. Keep in mind the typical product seasonality we expect to see in the business in the third quarter.

David V. Elkins: The annual tax rate would be affected by one-time non-deductible expenses of acquired in-process R&D charges, which impacted our non-GAAP net income in the first quarter. Excluding this impact, the estimated underlying tax rate for the full year is still expected to be about 18%. As a result of these changes, we are raising the range of our 2024 non-GAAP EPS guidance to between $0.60 and $0.90. Now, let's walk through the phasing of our sales for the full year. Year-to-date, our growth portfolio has grown approximately 16%, and we anticipate a similar rate of growth in the second half. In relation to phasing of product sales in the back half of the year, keep in mind the typical product seasonality we expect to see in the business in the third quarter. Also, we had roughly $150 million in stocking in the second quarter, and we anticipate reversing that in Q3. Normalization of these dynamics next quarter will likely temper sequential growth. However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in the fourth quarter. And from REVLIMID, while we continue to monitor variability from generics and other dynamics, we now expect full-year sales to be at the higher end of our $4.5 to $5 billion range. In closing, we have entered the second half of 2024 with sales momentum building and key brands and financial discipline driving a leaner and more agile organization.

Kim Zayas: The annual tax rate would be affected by one-time non-deductible expenses of Karuna acquired in-process R&D charge, which impacted our non-GAAP net income in the first quarter.

Kim Zayas: Excluding this impact, the estimated underlying tax rate for the full year is still expected to be about 18%. As a result of these changes, we are raising the range of our 2024 non-GAAP EPS guidance to between $0.60 and $0.90.

David V. Elkins: As a result of these changes, we are raising the range of our 2024 non-GAAP EPS guidance to between $0.60 and $0.90. Now, let's walk through the phasing of our sales for the full year. Year-to-date, our growth portfolio has grown approximately 16%, and we anticipate a similar rate of growth in the second... In relation to phasing of product sales in the back half of the year, keep in mind the typical product seasonality we expect to see in the business in the third quarter. Also, we had roughly $150 million in stockpiles in the second half of the year, and we anticipate reversing that in Q3. Normalization of these dynamics next quarter will likely temper sequential growth. However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in the fourth quarter. And from Revlimid, while we continue to monitor variability from generics and other dynamics, we now expect full-year sales to be at the higher end of our $4.5 to $5 billion range. In closing, we entered the second half of 2024 with sales momentum building and key brands and financial discipline driving a leaner and more agile organization.

Speaker Change: Let's walk through the phasing of our sales for the full year. Year-to-date, our growth portfolio has grown approximately 16%, and we anticipate a similar rate of growth in the second half.

Speaker Change: In relation to phasing of product sales in the back half of the year, keep in mind the typical product seasonality we expect to see in the business in the third quarter.

David Elkins: Also, we had roughly $150 million in stocking in Q2 and we anticipate reversing in Q3. Normalization of these dynamics next quarter will likely temper sequential growth. However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in Q4 and from Revlimid. While we continue to monitor variability from generics and other dynamics. We now expect full year sales to be at the higher end of our $4.5 to 5 billion sales range. In closing, we have entered H2 2024 with sales momentum building in key brands and financial discipline driving a leaner and more agile organization. As Chris said, we're excited about the long-term opportunity ahead of our emerging neuroscience platform.

Also, we had roughly $150 million in stocking in Q2 and we anticipate reversing in Q3. Normalization of these dynamics next quarter will likely temper sequential growth. However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in Q4 and from Revlimid. While we continue to monitor variability from generics and other dynamics. We now expect full year sales to be at the higher end of our $4.5 to 5 billion sales range. In closing, we have entered H2 2024 with sales momentum building in key brands and financial discipline driving a leaner and more agile organization. As Chris said, we're excited about the long-term opportunity ahead of our emerging neuroscience platform.

Speaker Change: Also, we had roughly $150 million in stocking in the second quarter, and we anticipate reversing in the Q3.

David V. Elkins: However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in the fourth quarter. And from Revlimid, while we continue to monitor variability from generics and other dynamics, we now expect full-year sales to be at the higher end of our $4.5 to $5 billion range. In closing, we entered the second half of 2024 with sales momentum building and key brands and financial discipline driving a leaner and more agile organization.

Speaker Change: Normalization of these dynamics next quarter will likely temper sequential growth. However, as a result of these dynamics and the strength of our underlying business, we expect strong growth across the portfolio in the fourth quarter.

Speaker Change: And from Revlimid, while we continue to monitor variability from generics and other dynamics, we now expect full year sales to be at the higher end of our $4.5 to $5 billion sales range.

David V. Elkins: In closing, we have entered the second half of 2024 with sales momentum building and key brands and financial discipline driving a leaner and more agile organization. As Chris said, we're excited about the long-term opportunity ahead of our emerging neuroscience platform, with the anticipated FDA approval of CAR-XT in September. We are committed to investing in high-growth areas where we have competitive advantages to meet the needs of our patients. And with that, I'll now turn the call over to Tim for Q&A. Thanks, David. Raka, could we go to the first question, please?

Speaker Change: In closing, we have entered the second half of 2024 with sales momentum building in key brands and financial discipline driving a leaner and more agile organization.

David V. Elkins: As Chris said, we're excited about the long-term opportunity ahead of our emerging neuroscience with the anticipated FDA approval of CAR XT. We are committed to investing in high-growth areas where we have competitive advantages to meet the needs of our population. And with that, I'll now turn the call over to Tim for Q&A. Thanks, David. Raka, could we go to the first question, please?

Speaker Change: And as Chris said, we're excited about the long-term opportunity ahead of our emerging neuroscience platform.

David Elkins: With the anticipated FDA approval of KarXT in September, we are committed to investing in high growth areas where we have competitive advantages to meet the needs of our patients. And with that, I'll now turn the call over to Tim for Q&A.

With the anticipated FDA approval of KarXT in September, we are committed to investing in high growth areas where we have competitive advantages to meet the needs of our patients. And with that, I'll now turn the call over to Tim for Q&A.

Tim Power: with the anticipated FDA approval of CAR XT in September . We are committed to investing in high growth areas where we have competitive advantages to meet the needs of our patients. And with that, I'll now turn the call over to Tim for Q&A.

Tim Power: And with that, I'll now turn the call over to Tim for Q&A. Thanks, David. Raka, could we go to the first question, please?

Adam Lenkowsky: Thanks. David Rocco, could we go to the first question, please?

Tim Power: Thanks. David Rocco, could we go to the first question, please?

Tim Power: Thanks, David. Rocco, could we go to the first question, please?

Operator: Absolutely. And as a reminder, everyone, if you'd like to ask a question, please press star and then one on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. Today's first question comes from Chris Schott at J.P. Morgan. Please go ahead.

Operator: Absolutely. And as a reminder, everyone, if you'd like to ask a question, please press Star then one on your telephone keypad. If you're using the speakerphone, we ask that you please pick up your handset before pressing the keys. If at any time your question has been addressed and you'd like to withdraw your question, please press star then two. Today's first question comes from Chris Schott at JPMorgan. Please go ahead.

Rocco: Absolutely, and as a reminder everyone, if you'd like to ask a question, please press star then 1 on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys.

Operator: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. Today's first question comes from Chris Schott at J.P. Morgan. Please go ahead. Great. Thanks so much.

If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. Today's first question comes from Chris Schott at J.P. Morgan. Please go ahead.

Tim Power: If at any time your question has been addressed and you would like to withdraw your question, please press star then 2.

Speaker Change: Today's first question comes from Chris Schott at J.P. Morgan. Please go ahead.

Chris Schott: Great. Thanks so much. Just two quick questions here. Maybe the first one is, can you just talk about the immunology portfolio and how we should think about pricing going forward? I know you mentioned that there's some modest incremental price pressure on SOTYKTU given the broader access, but once that rolls out, I guess as we think about the second half of this year, is that a good run rate to think about price for immunology? Or when we consider further access and the competitive environment, is this a business that likely continues to see price erosion over time? The second question I have is just on IRA, I know we're all kind of waiting on the price disclosure for ELIQUIS, but is there any directional color you can share in terms of how negotiations went, any surprises, just how you think about IRA price negotiations more broadly as you think about the portfolio and kind of, market to compete, ect. Is there anything you can share on that front, or [inaudible] disclosure in a month or so, but I appreciate it. Thank you.

Chris Schott: Just two quick questions here. Maybe the first one is, can you just talk about the immunology portfolio and how we should think about pricing going forward? I know you mentioned that there's some modest incremental price pressure on SOTIC2 given the broader access, but once that rolls out, I guess as we think about the second half of this year, is that a good run rate to think about price for immunology? Or when we consider further access and the competitive environment, is this a business that likely continues to see price erosion over time? The second question I have is just on IRA, I know we're all kind of waiting on the price disclosure for Eloquist, but is there any directional color you can share in terms of how negotiations went, any surprises, just how you think about IRA price negotiations more broadly as you think about the portfolio and [inaudible]

[Analyst 3]: Great. Thanks so much. Just two quick questions here. Maybe the first one is can you just talk about the immunology portfolio and how to think about pricing going forward? I know you mentioned that there's some modest incremental price pressure on Sotyktu given the broader access, but once that rolls out, I guess as we think about the second half of this year, is that a good run rate to think about price for immunology? Or when we consider further access competitive environment, is this a business that likely continues to see price erosion over time? The second question I have is just on IRA. I know we're all kind of waiting on the price disclosure on Eliquis, but is there any just directional color you can share of?

Chris Schott: Great. Thanks so much. Just two quick questions here. Maybe the first one is can you just talk about the immunology portfolio and how to think about pricing going forward? I know you mentioned that there's some modest incremental price pressure on Sotyktu given the broader access, but once that rolls out, I guess as we think about the second half of this year, is that a good run rate to think about price for immunology? Or when we consider further access competitive environment, is this a business that likely continues to see price erosion over time? The second question I have is just on IRA. I know we're all kind of waiting on the price disclosure on Eliquis, but is there any just directional color you can share of?

Chris Schott: Thanks so much. Just two quick questions here. Maybe the first one is can you just talk about the immunology portfolio and how to think about pricing going forward? I know you mentioned that there's some modest incremental price pressure on SOTIC-2 given the broader access, but

Speaker Change: Once that rolls out I guess as we think about the second half of this year, is that a good run rate to think about price for immunology or when we consider further access, competitive environment, is this a business that likely continues to see price erosion over time?

Chris Schott: The second question I have is just on IRA, I know we're all kind of waiting on the price disclosure for Eloquist, but is there any directional color you can share in terms of how negotiations went, any surprises, just how you think about IRA price negotiations more broadly as you think about the portfolio and [inaudible] Thanks, Chris. Maybe I'll start with your second question, then I'll flip it over to Adam.

The second question I have is just on IRA, I know we're all kind of waiting on the price disclosure for Eloquist, but is there any directional color you can share in terms of how negotiations went, any surprises, just how you think about IRA price negotiations more broadly as you think about the portfolio and [inaudible]

Speaker Change: The second question I have is just on IRA. I know we're all kind of waiting on the price disclosure on Eloquist, but is there any just directional color you can share of just

[Analyst 3]: Just in terms of how negotiations went, any surprises just how you think about IRA price negotiations more broadly as you're thinking about the portfolio and kind of markets you're competing, et cetera. Just, is there anything you could share on that front or do we just have to wait until that disclosure? I guess in a month or so. But appreciate it, thank you. Thanks, Chris. Maybe I'll start with your second question, then I'll flip it to Adam. So, as expected, we've received the government's final MFP price for Eliquis, and as is consistent with what we've discussed previously, we anticipate CMS is going to publish the MFP price either on or before 1 September and once that happens, we look forward to providing you more color on the impact of MFP on the shape of the Eliquis business.

Just in terms of how negotiations went, any surprises just how you think about IRA price negotiations more broadly as you're thinking about the portfolio and kind of markets you're competing, et cetera. Just, is there anything you could share on that front or do we just have to wait until that disclosure? I guess in a month or so. But appreciate it, thank you.

Speaker Change: In terms of how negotiations went, any surprises, just how you think about...

Speaker Change: IRA price negotiations more broadly as you're thinking about the portfolio and you know markets you're competing etc. Is there anything you'd share on that front or do we have to wait until that disclosure I guess in a month or so? But I appreciate it. Thank you.

Tim Power: Thanks, Chris. Maybe I'll start with your second question, then I'll flip it over to Adam. So, as expected, we've received the government's final MFP price for ELIQUIS. And, as is consistent with what we've discussed previously, we anticipate CMS is going to publish the MFP price either on or before September 1st. And once that happens, we look forward to providing you with more color on the impact of MFP on the shape of the ELIQUIS business. But what I'll say today, now that we have seen the final price, we're increasingly confident in our ability to navigate the impact of IRA on ELIQUIS. ELIQUIS is an important drug for patients, and it's going to continue to be an important drug for the company in the short to medium. If we step back from ELIQUIS, though, I want to continue to emphasize that we firmly oppose government price setting under IRA. We continue to believe that arbitrary price setting by the government on life-saving medicines is not good public policy. So, irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation. But we'll be able to give you more color on ELIQUIS once we get that price published, which we anticipate in the coming weeks and certainly before September 1st. Adam?

[Company Representative]: Thanks, Chris. Maybe I'll start with your second question, then I'll flip it to Adam. So, as expected, we've received the government's final MFP price for Eliquis, and as is consistent with what we've discussed previously, we anticipate CMS is going to publish the MFP price either on or before 1 September and once that happens, we look forward to providing you more color on the impact of MFP on the shape of the Eliquis business.

Chris Schott: So, as expected, we've received the government's final MFP price for Eloquus. And, as we've discussed previously, we anticipate CMS is going to publish the MFP price either on or before September 1st. And once that happens, we look forward to providing you with more color on the impact of MFP on the shape of the Eloquus business. But what I'll say today, now that we have seen the final price, we're increasingly confident in our ability to navigate the impact of IRA on Eloquus. Eloquus is an important drug for patients, and it's going to continue to be an important drug for the company in the short to medium If we step back from Eloquist, though, I want to continue to emphasize that we firmly oppose government price setting under IRA. We continue to believe that arbitrary price setting by the government on life-saving medicines is not good public policy. So, irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation. But we'll be able to give you more color on Eloquist once we get that price published, which we anticipate in the coming weeks and certainly before September 1st. Adam?

Speaker Change: Thanks Chris. Maybe I'll start with your second question then I'll flip it over to Adam. So, as expected, we've received the government's final MFP prize for Eloquus.

Adam: And as is consistent with what we've discussed previously, we anticipate CMS is going to publish the MFP price either on or before September the 1st. And once that happens, we look forward to providing you more color on the impact of MFP on the shape of the Eloquist business.

[Analyst 3]: What I'll say today now that we have seen the final price, we're increasingly confident in our ability to navigate the impact of IRA on Eliquis. Eliquis is an important drug for patients. It's going to continue to be an important drug for the company in the short- to medium-term if we step back from Eliquis. Though, I want to continue to emphasize that we firmly oppose government price setting under IRA. We continue to believe that arbitrary price setting by the government on life-saving medicines is not good public policy. So irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation. But we'll be able to give you more color on Eliquis once we get that price published, which we anticipate in the coming weeks and certainly before September 1st.

What I'll say today now that we have seen the final price, we're increasingly confident in our ability to navigate the impact of IRA on Eliquis. Eliquis is an important drug for patients. It's going to continue to be an important drug for the company in the short- to medium-term if we step back from Eliquis. Though, I want to continue to emphasize that we firmly oppose government price setting under IRA. We continue to believe that arbitrary price setting by the government on life-saving medicines is not good public policy. So irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation. But we'll be able to give you more color on Eliquis once we get that price published, which we anticipate in the coming weeks and certainly before September 1st Adam.

Chris Boerner: And once that happens, we look forward to providing you with more color on the impact of MFP on the shape of the Eloquus business. But what I'll say today, now that we have seen the final price, we're increasingly confident in our ability to navigate the impact of IRA on Eloquus. Eloquus is an important drug for patients, and it's going to continue to be an important drug for the company in the short to medium If we step back from Eloquist, though, I want to continue to emphasize that we firmly oppose government price setting under IRA. We continue to believe that arbitrary price setting by the government on life-saving medicines is not good public policy. So, irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation. But we'll be able to give you more color on Eloquist once we get that price published, which we anticipate in the coming weeks and certainly before September 1st. Adam?

Speaker Change: What I'll say today, now that we have seen the final price, we're increasingly competent in our ability to navigate the impact of IRA on Eliquis. Eliquis is an important drug for patients. It's going to continue to be an important drug for the company in the short to medium term.

Chris Boerner: If we step back from Eloquist, though, I want to continue to emphasize that we firmly oppose government price setting under IRA. We continue to believe that arbitrary price setting by the government on life-saving medicines is not good public policy. So, irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation. But we'll be able to give you more color on Eloquist once we get that price published, which we anticipate in the coming weeks and certainly before September 1st. Adam?

Speaker Change: If we step back from Eloquist, though, I want to continue to emphasize that we firmly oppose government price setting under IRA. We continue to believe that arbitrary price setting by the government on life-saving medicines is not good public policy.

Chris Boerner: So, irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation. But we'll be able to give you more color on Eloquist once we get that price published, which we anticipate in the coming weeks and certainly before September 1st. Adam?

Adam: So irrespective of short-term dynamics, we remain very concerned about the long-term implications of IRA on innovation, but we'll be able to give you more color on Eloquus once we get that price published, which we anticipate in the coming weeks and certainly before September 1st. Adam?

Adam Lenkowsky: Adam, yeah, Chris, thanks for the question. Just more broadly in immunology, we know this is a highly competitive and highly rebated category, and we're making good progress across a number of our key products, as you heard from David and Chris, in our growth portfolio as well as in immunology. Now, I have to acknowledge that Sotyktu performance has been slower than we'd like, but we're focused on improving that. We're executing our plan. A key focus has been on improving our access position. As David mentioned, we're continuing to make significant progress in that area. We came into the year with 25% unrestricted access, and we had that through roughly the first half of the year. As we move into the back half of the year, essentially effective 1 July, we more than doubled that.

Adam Lenkowsky: Yeah, Chris, thanks for the question. Just more broadly in immunology, we know this is a highly competitive and highly rebated category, and we're making good progress across a number of our key products, as you heard from David and Chris, in our growth portfolio as well as in immunology. Now, I have to acknowledge that Sotyktu performance has been slower than we'd like, but we're focused on improving that. We're executing our plan. A key focus has been on improving our access position. As David mentioned, we're continuing to make significant progress in that area. We came into the year with 25% unrestricted access, and we had that through roughly the first half of the year. As we move into the back half of the year, essentially effective 1 July, we more than doubled that.

Adam Lenkowsky: Yeah, Chris, thanks for the question. Just more broadly, in immunology, we know this is a highly competitive and highly rebated category, and we're making good progress across a number of our key products, as you heard from David and Chris, in our growth portfolio as well as in immunology. I have to acknowledge that SOTYKTU performance has been slower than we'd like, but we're focused on improving that. You know, we're executing our plan where a key focus has been on improving our access position. As David mentioned, we're continuing to make significant progress in that area. We came into the year with 25% unrestricted access, and we had that through roughly the first half of the year. As we move into the back half of the year, essentially effective July 1st, we have more than doubled that. We now have approximately 65% access, the majority of which is zero-step edit. And so, that's about over 100 million lives now. And we expect further access improvements in January. So obviously, that's important because we'll see new patients move faster onto commercial product, we'll work to move patients quickly out of our bridge program and onto commercial product, and we'll see much fewer patients atrit at the specialty pharmacy. We'll also see, as David mentioned, a modest increase in gross to net due to the rebates required for improved access offset by increased volume. As a reminder, in Q2, we had a one-time negative impact of about $6 million due to a gross to net true up. So, you know, as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025, and we're committed to making this a big product for the company.

Adam: Yeah, Chris, thanks for the question. Just more broadly, in immunology, we know this is a highly competitive and highly rebated category, and we're making good progress across a number of our key products, as you heard from David and Chris, in our growth portfolio, as well as in immunology. Now,

Speaker Change: I have to acknowledge that SITIC2 performance has been slower than we'd like, but we're focused on improving that. You know, we're executing our plan where a key focus has been on improving our access position.

Adam Lenkowsky: You know, we're executing our plan where a key focus has been on improving our access position. As David mentioned, we're continuing to make significant progress in that area. We came into the year with 25% unrestricted access, and we had that through roughly the first half of the year. As we move into the back half of the year, essentially effective July 1st, we have more than doubled that. We now have approximately 65% access, the majority of which is zero-step edit. And so that's about over 100 million lives now. And we expect further access improvements in January. So obviously, that's important because we'll see new patients move faster onto commercial product, we'll work to move patients quickly out of our bridge program and onto commercial product, and we'll see much fewer patients a trit at the specialty pharmacy. We'll also see, as David mentioned, a modest increase in gross to net due to the rebates required for improved access offset by increased volume. As a reminder, in Q2, we had a one-time negative impact of about $6 million due to a gross to net true up. So, you know, as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025, and we're committed to making this a big product for the company.

Speaker Change: As David mentioned, we're continuing to make significant progress in that area. We came into the year with 25% unrestricted access, and we had that through roughly the first half of the year.

Adam Lenkowsky: As we move into the back half of the year, essentially effective July 1st, we have more than doubled that. We now have approximately 65% access, the majority of which is zero-step edit. And so that's about over 100 million lives now. And we expect further access improvements in January. So obviously, that's important because we'll see new patients move faster onto commercial product, we'll work to move patients quickly out of our bridge program and onto commercial product, and we'll see much fewer patients a trit at the specialty pharmacy. We'll also see, as David mentioned, a modest increase in gross to net due to the rebates required for improved access offset by increased volume. As a reminder, in Q2, we had a one-time negative impact of about $6 million due to a gross to net true up. So, you know, as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025, and we're committed to making this a big product for the company.

Adam Lenkowsky: We now have approximately 65% access, the majority of which is zero step edits. So that's about over 100 million lives now. We expect further access improvements in January. So obviously that's important because we'll see new patients move faster onto commercial product. We'll work to move patients quickly out of our bridge program and onto commercial product, and we'll see much fewer patients attrit at the specialty pharmacy. We'll also see, as David mentioned, a modest increase in gross-to-net due to the rebates required for improved access offset by increased volume. As a reminder, in Q2 we had a one-time negative impact of about $6 million due to a gross true-up.

We now have approximately 65% access, the majority of which is zero step edits. So that's about over 100 million lives now. We expect further access improvements in January. So obviously that's important because we'll see new patients move faster onto commercial product. We'll work to move patients quickly out of our bridge program and onto commercial product, and we'll see much fewer patients attrit at the specialty pharmacy. We'll also see, as David mentioned, a modest increase in gross-to-net due to the rebates required for improved access offset by increased volume. As a reminder, in Q2 we had a one-time negative impact of about $6 million due to a gross true-up.

David V. Elkins: As we move into the back half of the year, essentially effective July 1st, we've more than doubled that. We now have approximately 65% access, the majority of which is zero-step edits.

Adam Lenkowsky: And we expect further access improvements in January. So obviously, that's important because we'll see new patients move faster onto commercial product, we'll work to move patients quickly out of our bridge program and onto commercial product, and we'll see much fewer patients a trit at the specialty pharmacy. We'll also see, as David mentioned, a modest increase in gross to net due to the rebates required for improved access offset by increased volume. As a reminder, in Q2, we had a one-time negative impact of about $6 million due to a gross to net true up. So, you know, as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025, and we're committed to making this a big product for the company.

David V. Elkins: And so that's about over 100 million lives now, and we expect further access improvements in January . So obviously that's important because we'll see.

David V. Elkins: New patients move faster onto commercial product, we'll work to move patients quickly out of our bridge program and onto a commercial product, and we'll see much fewer patients a trit at the specialty pharmacy.

David V. Elkins: We'll also see, as David mentioned, you know, a modest decrease in gross to net due to the rebates required for improved access.

David V. Elkins: All set by increased volume. As a reminder, in Q2 we had a one-time negative impact of about $6 million due to a gross true-up. So, as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year.

Adam Lenkowsky: So, you know, as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025, and we're committed to making this a big product for the company. Thanks, Adam. Rocco, could we go to the next question, please? Yes, sir. Our next question is from Luisa Hector about Barenberg. Please go ahead.

So, you know, as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025, and we're committed to making this a big product for the company.

Adam Lenkowsky: So as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025 and we're committed to making this a big product for the company. Thanks, Adam. Rocco, could we go to the next question, please?

So as we exit the year with our expanded access, we're going to be in a much better position versus where we started this year, which will give us a lot of momentum as we move into 2025 and we're committed to making this a big product for the company.

David V. Elkins: which will give us a lot of momentum as we move into 2025 and we're committed to making this a big product for the company.

Tim Power: Thanks, Adam. Rocco, could we go to the next question, please?

Tim Power: Thanks, Adam. Rocco, could we go to the next question, please? Yes, sir. Our next question is from Luisa Hector about Barenberg. Please go ahead.

Tim Power: Thanks, Adam. Rocco, could we go to the next question, please?

Operator: Yes, sir. Our next question is from Luisa Hector with Berenberg. Please go ahead.

David V. Elkins: Thanks, Adam. Rocco, could we go to the next question, please?

Operator: Yes, sir. Our next question is from Luisa Hector with Berenberg. Please go ahead.

Rocco: Yes, sir. Our next question is from Luisa Hector with Berenberg. Please go ahead.

Luisa Hector: Hello, thank you for taking my questions. I just wondered whether you could describe where the 150 million stocking benefits occurred across which products in Q2. And then, perhaps a question on cendakimab, good to see the positive readout there. Could you tell us how soon you might be able to file, and perhaps how you can position this and some sort of color around the access and the launch ramp, piggybacking on your comments on SOTYKTU, so how should we think about the potential launch there? Thank you. Thanks, Luisa. I'll ask David to start and then Samit and Adam can address the question on Zendaka.

[Analyst 2]: Hello. Thank you for taking my questions. I just wondered whether you could describe where the $150 million stocking benefit occurred across which products in Q2 and then perhaps a question on Cendakimab. So good to see the positive readout there. Could you tell us how soon you might be able to file and perhaps how you can position this and, and some sort of color around the access and the launch ramp, sort of piggybacking on your comments on Sotyktu. So how should we think about the potential launch there? Thank you.

Luisa Hector: Hello. Thank you for taking my questions. I just wondered whether you could describe where the $150 million stocking benefit occurred across which products in Q2 and then perhaps a question on Cendakimab. So good to see the positive readout there. Could you tell us how soon you might be able to file and perhaps how you can position this and, and some sort of color around the access and the launch ramp, sort of piggybacking on your comments on Sotyktu. So how should we think about the potential launch there? Thank you.

Luisa Caroline Hector: Hello, thank you for taking my questions. I just wondered whether you could describe where the $150 million stocking benefit is?

Luisa Caroline Hector: occurred, of course, which products in Q2 and then prep a question on Sendakine maps. So good to see the positive read out there. Could you tell us how soon you might be able to file and perhaps how you can position this and some sort of color around?

Luisa Caroline Hector: Piggybacking on your comments on SITIC2, so how should we think about the potential launch there? Thanks, Luisa. I'll ask David to start and then Samit and Adam can address the question on Zendaka. Yeah, Luisa, thanks for the question. On the inventory, that's really in the I.O.

Piggybacking on your comments on SITIC2, so how should we think about the potential launch there? Thanks, Luisa. I'll ask David to start and then Samit and Adam can address the question on Zendaka.

Speaker Change: the access and the launch ramp, sort of piggybacking on your comments on SITIC2, so how should we think about the potential launch there? Thank you.

[Analyst 3]: Thanks, Luisa. I'll ask David to start and then Samit and Adam can address the question on Cendakimab.

[Company Representative]: Thanks, Luisa. I'll ask David to start and then Samit and Adam can address the question on Cendakimab.

Tim Power: Thanks, Luisa. I'll ask David to start and then Samit and Adam can address the question on cendakimab.

Speaker Change: Thanks Luisa. I'll ask David to start and then Samit and Adam can address the question on Zendaka.

Samit Hirawat: Yeah, Luisa, thanks for the question on the inventory. That's really in the IO franchise across Opdivo and Yervoy, but as well there's some in our immunology franchise at the EULAR symposium. Thanks, David, and thank you for the question for Cendakimab. We have a positive phase 3 study that read out just recently. The trial met both its primary endpoints on dysphagia days as well as the eosinophilic count decrease. It also met the secondary endpoints. But we've just received the data in our hands, so we are doing a deep dive on that. And as we look at the data, we'll of course take into account when the data will be presented at the medical conference, as well as take into account what the landscape is in terms of how patients are treated today.

David Elkins: Yeah, Luisa, thanks for the question on the inventory. That's really in the IO franchise across Opdivo and Yervoy, but as well there's some in our immunology franchise at the EULAR symposium.

David V. Elkins: Yeah, Luisa, thanks for the question. On the inventory, that's really in the I.O. franchise across Optivo and Yervoid, but as well, there's some in our immunology franchise at the RENCI and Symposia.

David V. Elkins: Yeah, Luisa, thanks for the question. On the inventory, that's really in the I.O. franchise across OPDIVO and YERVOY, but there's some in our immunology franchise with the [inaudible]. Thanks, David, and thank you for the question. For Syndacumab, we have a positive phase three study that read out just recently. The trial met both its primary endpoints on dysphagia days as well as the eosinophilic count decrease. It also met the secondary endpoints. But we've just received the data in our hands, so we are doing a deep dive on that. And as we look at the data, we'll, of course, take into account when the data will be presented at the medical conference, as well as take into account what the landscape is in terms of how patients are treated today. And as we plan for the next steps for Syndacumab from a commercial perspective, let me pass it on to Adam, who can then comment on that as well. Yeah, Luisa, thank you for the question. So we're obviously pleased with the positive phase three study for some Daconab. It's early days.

Samit Hirawat: Thanks, David, and thank you for the question for Cendakimab. We have a positive phase 3 study that read out just recently. The trial met both its primary endpoints on dysphagia days as well as the eosinophilic count decrease. It also met the secondary endpoints. But we've just received the data in our hands, so we are doing a deep dive on that. And as we look at the data, we'll of course take into account when the data will be presented at the medical conference, as well as take into account what the landscape is in terms of how patients are treated today.

Samit Hirawat: Thanks, David, and thank you for the question. For cendakimab, we have a positive Phase III study that read out just recently. The trial met both its primary endpoints on dysphagia days as well as the eosinophilic count decrease. It also met the secondary endpoints. But we've just received the data in our hands, so we are doing a deep dive on that. And as we look at the data, we'll, of course, take into account when the data will be presented at the medical conference, as well as take into account what the landscape is in terms of how patients are treated today. And as we plan for the next steps for cendakimab. From a commercial perspective, let me pass it on to Adam, who can then comment on that as well. Yeah, Luisa, thank you for the question. So we're obviously pleased with the positive phase three study for some Daconab. It's early days.

David V. Elkins: franchise across Optivo and Urovoid, but there's some in our immunology franchise with the RENCI and supposed, Thanks, David, and thank you for the question. For Syndacumab, we have a positive phase three study that read out just recently. The trial met both its primary endpoints on dysphagia days as well as the eosinophilic count decrease. It also met the secondary endpoints. But we've just received the data in our hands, so we are doing a deep dive on that. And as we look at the data, we'll, of course, take into account when the data will be presented at the medical conference, as well as take into account what the landscape is in terms of how patients are treated today. And as we plan for the next steps for Syndacumab from a commercial perspective, let me pass it on to Adam, who can then comment on that as well. Yeah, Luisa, thank you for the question. So we're obviously pleased with the positive phase three study for some Daconab. It's early days.

Samit Hirawat: It also met the secondary endpoints. But we've just received the data in our hands, so we are doing a deep dive on that. And as we look at the data, we'll, of course, take into account when the data will be presented at the medical conference, as well as take into account what the landscape is in terms of how patients are treated today. And as we plan for the next steps for Syndacumab from a commercial perspective, let me pass it on to Adam, who can then comment on that as well. Yeah, Luisa, thank you for the question. So we're obviously pleased with the positive phase three study for some Daconab. It's early days.

Samad: Thanks David and thank you for the question. For Syndacuma, we have a positive phase 3 study that read out just recently. The trial met both its primary endpoints on dysphagia days as well as the eosinophilic count decrease.

Speaker Change: I'd also add the secondary endpoints, but we've just received the data in our hands, so we are doing a deep dive on that, and as we look at the data, we'll of course take into account when the data will be presented at the medical conference, as well as take into account what the landscape is in terms of how patients are treated today and as we plan for the next steps.

Samit Hirawat: As we plan for the next steps for Cendakimab from a commercial perspective, let me pass it on to Adam who can then comment on that as well.

As we plan for the next steps for Cendakimab from a commercial perspective, let me pass it on to Adam who can then comment on that as well.

Adam Lenkowsky: Yeah, Luisa, thank you for the question. So, we're obviously pleased with the positive Phase III study for cendakimab. It's early days. And so we look forward to presenting the data. But just roughly, when you look in the U.S., there are about 300,000 treated patients; treatment rates in EOE are pretty low in the United States. In fact, first-line treatment rates are around 4%, and that increases as you go down the line to therapy to third line, where about a third of patients are treated. And the majority of patients are on conventional therapies like PPIs, steroids, and then they're treated with DUPIXENT. And so, as Samit mentioned, you know, this phase of days is important for patients as also the potential for remodeling here. And this is a market where payers are managing about half of the lives in the U.S. So we expect the majority of lives to be positioned behind DUPIXENT. And again, we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting.

Speaker Change: for Syndacumab. From a commercial perspective, let me pass it on to Adam, who can then comment on that as well.

Adam Lenkowsky: Yeah, Luisa, thank you for the question. So we're obviously pleased with the positive phase 3 study for Cendakimab. It's early days, and so we look forward to presenting the data. But just roughly, when you look in the US, there are about 300,000 treated patients. Treatment rates in EOE are pretty low in the United States. In fact, first line treatment rates around 4%, and that increases as you go down lines of therapy to third line, which about 1/3 of patients are treated. And the majority of patients are on conventional therapies like PPIs, steroids, and then they are treated with Dupixent, and so, as Samit mentioned, you know, dysphagia days are important for patients, as also the potential for remodeling here.

Adam Lenkowsky: And so we look forward to presenting the data. But just roughly, when you look in the US, there are about 300,000 treated patients; treatment rates in EOE are pretty low in the United States. In fact, first-line treatment rates are around 4%, and that increases as you go down the line to therapy, to third line, where about a third of patients are treated. And the majority of patients are on conventional therapies like PPIs, and steroids, and then they're treated with Dupixent. And so, as Samit mentioned, you know, this phase of days is important for patients as well as the potential for remodeling here. And this is a market where payers are managing about half of the lives in the US. So we expect the majority of lives to be positioned behind Dupixent. And again, we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting.

Adam: Yeah, Luisa, thank you for the question.

Adam: So we're obviously pleased with the positive phase 3 study for syndacomab. It's early days and so we look forward to presenting the data.

Speaker Change: But just roughly when you look in the U.S. there are about 300,000 treated patients. Treatment rates in EOE are pretty low in the United States. In fact, first line treatment rates are around 4% and that increases as you go down lines of therapy.

Speaker Change: The majority of patients are on conventional therapies like PPIs, steroids, and then they're treated with Dupixenz.

Adam Lenkowsky: And so, as Samit mentioned, you know, this phase of days is important for patients as well as the potential for remodeling here. And this is a market where payers are managing about half of the lives in the US. So we expect the majority of lives to be positioned behind Dupixent. And again, we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting.

Speaker Change: And so, as Samit mentioned, you know, dysphagia days are important for patients. There's also the potential for remodeling here. And this is a market where payers are managing about half of the lives in the U.S. So we expect...

Adam Lenkowsky: This is a market where payers are managing about half of the lives in the US. We expect in the majority of lives to be positioned behind Dupixent. And again, we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting. Thanks, Adam. Let's go to the next question, please. Rocco.

This is a market where payers are managing about half of the lives in the US. We expect in the majority of lives to be positioned behind Dupixent. And again, we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting.

Speaker Change: In the majority of lives to be positioned behind Dupixent and again we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting.

Tim Power: Thanks, Adam. Let's go to the next question, please. Rocco.

Adam Lenkowsky: And again, we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting. Thanks Adam. Let's go to the next question, please, Rocco.

And again, we look forward to sharing data with regulatory authorities and presenting at an upcoming meeting.

Tim Power: Thanks, Adam. Let's go to the next question, please, Rocco.

Operator: Yes, sir. Our next question comes from Chris Shibutani with Goldman Sachs. Please go ahead.

Operator: Yes, sir. Our next question comes from Chris Shibutani with Goldman Sachs. Please go ahead. Good morning, thank you very much.

Operator: Yes, sir. Our next question comes from Chris Shibutani with Goldman Sachs. Please go ahead.

Speaker Change: Thanks, Adam. Let's go to the next question, please, Rocco.

Rocco: Yes sir, our next question comes from Chris Shibutani with Goldman Sachs. Please go ahead.

Chris Shibutani: Good morning, thank you very much. Chris, you and the team have been much more aggressive on the business development front over the last six to nine months, and you've had to make some really thoughtful decisions about prioritizing programs so that the costs don't overrun. What's your capacity now? And in particular, what's your appetite, noting that historically, Bristol has been in cardiovascular disease, metabolic, and just the requisite question about any interest in the obesity and obesity-related realms. Thank you so much.

[Analyst 3]: Good morning.

Chris Shibutani: Good morning.

Chris Boerner: Chris, you and the team have been much more aggressive on the business development front over the last six to nine months, and you've had to make some really thoughtful decisions about prioritizing programs so that the costs don't overrun. What's your capacity now? And in particular, what's your appetite, noting that historically, Bristol has been in cardiovascular disease, metabolic, and just the requisite question about any interest in the obesity and obesity-related realms. Thank you so much.

Adam Lenkowsky: Thank you very much. Chris, you and the team have been much more aggressive on the business development front over the last six days, nine months, and you've had to make some really thoughtful decisions about prioritizing programs so that the costs don't overrun. What's your capacity now and in particular, what's your appetite? Noting that historically Bristol has been in cardiovascular disease, metabolic, and just the requisite question about any interest in the obesity and obesity adjacent realms. Thank you so much.

Thank you very much. Chris, you and the team have been much more aggressive on the business development front over the last six days, nine months, and you've had to make some really thoughtful decisions about prioritizing programs so that the costs don't overrun. What's your capacity now and in particular, what's your appetite? Noting that historically Bristol has been in cardiovascular disease, metabolic, and just the requisite question about any interest in the obesity and obesity adjacent realms. Thank you so much.

Chris Shibutani: Good morning. Thank you very much. Chris, you and the team have been much more aggressive on the business development front over the last six to nine months, and you've had to make some really thoughtful decisions about prioritizing programs so that the costs don't overrun. What's your capacity now, and in particular, what's your appetite, noting that historically, Bristol has been in cardiovascular disease, metabolic, and just the requisite question about

Speaker Change: Any interest in the obesity and obesity-adjacent realms. Thank you so much.

Samit Hirawat: Sure.

[Company Representative]: Sure.

Chris Boerner: And in particular, what's your appetite, noting that historically, Bristol has been in cardiovascular disease, metabolic, and just the requisite question about any interest in the obesity and obesity-related realms. Thank you so much. Sure. Thanks for the questions, Chris. Maybe I will start, and then I'll turn it over to David, who can speak to the capacity bit.

And in particular, what's your appetite, noting that historically, Bristol has been in cardiovascular disease, metabolic, and just the requisite question about any interest in the obesity and obesity-related realms. Thank you so much.

[Analyst 3]: Thanks for the questions, Chris. Maybe I will start and then I'll turn it over to David, who can speak to the capacity. Well, as expected, we continue to prioritize business development. It's, as you point out, something that we've certainly had as a priority going back to when we did the deals at the end of last year. I would say our priority right now is to execute the deals that we completed seven months ago. Notable among that is we're actively preparing for the KarXT launch, hopefully in September. And certainly Adam can speak to that. As David also mentioned, I would highlight that we're also focused on paying down the debt as a top priority. Beyond that though, business development and partnerships are going to be continue to be important to us in terms of the types of deals that we're interested in.

Thanks for the questions, Chris. Maybe I will start and then I'll turn it over to David, who can speak to the capacity. Well, as expected, we continue to prioritize business development. It's, as you point out, something that we've certainly had as a priority going back to when we did the deals at the end of last year. I would say our priority right now is to execute the deals that we completed seven months ago. Notable among that is we're actively preparing for the KarXT launch, hopefully in September. And certainly Adam can speak to that. As David also mentioned, I would highlight that we're also focused on paying down the debt as a top priority. Beyond that though, business development and partnerships are going to be continue to be important to us in terms of the types of deals that we're interested in.

Chris Boerner: Sure. Thanks for the questions, Chris. Maybe I will start, and then I'll turn it over to David, who can speak to the capacity bit. Well, you know, as expected, we continue to prioritize business development. It's, as you point out, something that we certainly have had as a priority going back to when we did the deals at the end of last year. I would say our priority right now is to execute the deals that we completed seven months ago. Notable among that is, we're actively preparing for the KarXT launch, hopefully in September, and certainly Adam can speak to that. As David also mentioned, I would highlight that we're also focused on paying down the debt as a top priority. Beyond that, though, business development and partnerships are going to continue to be important to us in terms of the types of deals that we're interested in. Obviously, they have to make strategic and financial sense as a first order. We're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and modalities that we're focused on and where we feel we have a right to win. So, those would be primarily the areas of focus for business development. And then the requisite question on obesity, which I'll get to in a second, but there's also a requisite question on the size of the deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to monitor the obesity market, but I would say, with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David?

Speaker Change: Sure. Thanks for the questions, Chris. Maybe I will start, and then I'll turn it over to David, who can speak to the capacity a bit.

Chris Boerner: Well, you know, as expected, we continue to prioritize business development. It's, as you point out, something that we certainly have had as a priority going back to when we did the deals at the end of last year. I would say our priority right now is to execute the deals that we completed seven months ago. Notable among that is we're actively preparing for the KarXT launch, hopefully in September, and certainly Adam can speak to that. As David also mentioned, I would highlight that we're also focused on paying down the debt as a top priority. Beyond that, though, business development and partnerships are going to continue to be important to us in terms of the types of deals that we're interested in. Obviously, they have to make strategic and financial sense as a first order. We're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and modalities that we're focused on and where we feel we have a right to win. So those would be primarily the areas of focus for business development. And then the requisite question on obesity, which I'll get to in a second, but there's also a requisite question on the size of the deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to monitor the obesity market, but I would say, with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David?

Speaker Change: Well, you know, as expected, we continue to prioritize business development. It's, as you point out, something that we've...

David V. Elkins: I would say our priority right now is to execute the deals that we completed seven months ago. Notable among that is the

David V. Elkins: We're actively preparing for the Car XT launch, hopefully in September , and certainly Adam can speak to that.

Chris Boerner: As David also mentioned, I would highlight that we're also focused on paying down the debt as a top priority. Beyond that, though, business development and partnerships are going to continue to be important to us in terms of the types of deals that we're interested in. Obviously, they have to make strategic and financial sense as a first order. We're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and modalities that we're focused on and where we feel we have a right to win. So those would be primarily the areas of focus for business development. And then the requisite question on obesity, which I'll get to in a second, but there's also a requisite question on the size of the deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to monitor the obesity market, but I would say, with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David?

Adam: As David also mentioned, I would highlight that...

Speaker Change: We're also focused on paying down the debt as a top priority. Beyond that though, business development and partnerships are going to continue to be important to us in terms of the types of deals that we're interested in. Obviously they have to make strategic and financial sense as a first order. We're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and modalities that we're focused on and where we feel we have a right to win. So those would be primarily the areas of focus for business development. And then the requisite question on obesity, I'll get to in a second, but there's also a requisite question on size of deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to modify that.

[Analyst 3]: Obviously they have to make strategic and financial sense. As a first order, we're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and modalities that we're focused on and where we feel we have a right to win. So those would be primarily the areas of focus for business development. And then the requisite question on obesity, I'll get to in a second. But there's also a requisite question on size of deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to monitor the obesity market, but I would say with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David, Chris, I think you covered it well.

Obviously they have to make strategic and financial sense. As a first order, we're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and modalities that we're focused on and where we feel we have a right to win. So those would be primarily the areas of focus for business development. And then the requisite question on obesity, I'll get to in a second. But there's also a requisite question on size of deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to monitor the obesity market, but I would say with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David,

Chris Boerner: We're going to continue to be disciplined there. As I mentioned in my prepared remarks, you saw the therapeutic areas and modalities that we're focused on and where we feel we have a right to win. So those would be primarily the areas of focus for business development. And then the requisite question on obesity, which I'll get to in a second, but there's also a requisite question on the size of the deal. I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to monitor the obesity market, but I would say, with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David?

Chris Boerner: I would think about bolt-on deals and partnerships as being the priority for us in the immediate term. And look, we're going to continue to monitor the obesity market, but I would say, with respect to business development for us right now, I would focus on those areas that I highlighted in my prepared remarks. David?

Speaker Change: we wanted to monitor the obesity market but I would say with respect to business development for us right now I would focus on those areas that I highlighted in my prepared remarks

David Elkins: Chris, I think you covered it well.

David V. Elkins: Chris, I think you covered it well. The only thing I'd emphasize as we think about capital allocation overall, besides the debt paydown, is that we remain firmly committed to the dividend, as evidenced by us paying a dividend for the past 90 years and increasing it for the last 15 years. And, as you know, we have one of the lowest payout ratios of our peer groups. So, you know, overall, we remain very financially disciplined from a capital allocation perspective.

Samit Hirawat: The only thing I'd emphasize as we.

The only thing I'd emphasize as we.

[Analyst 3]: Think about capital allocation overall besides the.

Think about capital allocation overall besides the.

David V. Elkins: David? Chris, I think you covered it well. The only thing I'd emphasize as we think about capital allocation overall, besides the debt pay down, is, you know, we remain firmly committed to the dividend as evidenced by us paying a dividend for the past 92 years.

Samit Hirawat: Debt paydown is, you know, we remain firmly committed to the dividend, as evidenced by us paying a dividend for the past 92 years and increasing it the last 15 years. As you know, we have one of the lowest payout ratios of our peer group. You know, overall we remain very.

Debt paydown is, you know, we remain firmly committed to the dividend, as evidenced by us paying a dividend for the past 92 years and increasing it the last 15 years. As you know, we have one of the lowest payout ratios of our peer group. You know, overall we remain very.

Speaker Change: and increasing at the last 15 years and as you know we have one of the lowest payout ratios of our peer groups so you know overall we've been very financially disciplined from a capital allocation perspective.

David V. Elkins: So, you know, overall, we remain very financially disciplined from a capital allocation perspective. Thanks David. Can we go to the next question, please, Rocco? Absolutely. Our next question today comes from Tim Anderson at Wolf Research. Please go ahead. Thank you. Can I go back to the IRA stuff for a moment?

So, you know, overall, we remain very financially disciplined from a capital allocation perspective.

[Analyst 3]: Financially disciplined from a capital allocation perspective.

Financially disciplined from a capital allocation perspective.

Adam Lenkowsky: Great. Thanks, David. Can we go to the next question, please? Rocco. Absolutely.

Tim Power: Great. Thanks, David. Can we go to the next question, please? Rocco. Absolutely.

Thanks David. Can we go to the next question, please, Rocco? Absolutely. Our next question today comes from Tim Anderson at Wolf Research. Please go ahead. Thank you. Can I go back to the IRA stuff for a moment?

Tim Power: Thanks, David. Can we go to the next question, please, Rocco?

Operator: Our next question today comes from Tim Anderson at Wolfe Research. Please go ahead.

Speaker Change: Thanks, David. Can we go to the next question, please, Rocco?

Absolutely. Our next question today comes from Tim Anderson at Wolf Research. Please go ahead. Thank you. Can I go back to the IRA stuff for a moment?

Operator: Absolutely. Our next question today comes from Tim Anderson at Wolf Research. Please go ahead.

Rocco: Absolutely. Our next question today comes from Tim Anderson at Wolf Research. Please go ahead.

Adam Lenkowsky: Thank you. Can I go back to the IRA stuff for a moment? There's no formal gag order preventing drug companies from talking about ongoing price negotiations. I'm told CMS has asked drug companies to keep quiet nonetheless, and all the drug companies have been complying with that, including Bristol. I'm trying to figure out why would drug companies comply with that request and really kind of keep it quiet ahead of the coming announcement. Then second, we might actually be getting that announcement much earlier than people are thinking, possibly in the next week or so ahead of the Congressional recess. If that update does come earlier, can we assume that you'll provide your update, you know, shortly thereafter so, you know, meaning possibly in the next couple of weeks if the news were to come earlier?

[Analyst 1]: Thank you. Can I go back to the IRA stuff for a moment? There's no formal gag order preventing drug companies from talking about ongoing price negotiations. I'm told CMS has asked drug companies to keep quiet nonetheless, and all the drug companies have been complying with that, including Bristol. I'm trying to figure out why would drug companies comply with that request and really kind of keep it quiet ahead of the coming announcement. Then second, we might actually be getting that announcement much earlier than people are thinking, possibly in the next week or so ahead of the Congressional recess. If that update does come earlier, can we assume that you'll provide your update, you know, shortly thereafter so, you know, meaning possibly in the next couple of weeks if the news were to come earlier?

Tim Anderson: Thank you. Can I go back to the IRA stuff for a moment. There's no formal gag order preventing drug companies from talking about ongoing price negotiations.

Tim Anderson: Thank you. Can I go back to the IRA stuff for a moment? There's no formal gag order preventing drug companies from talking about ongoing price negotiations. I'm told CMS has asked drug companies to keep quiet nonetheless, and all the drug companies have been complying with that, including Bristol. I'm trying to figure out why would drug companies comply with that request and really kind of keep it quiet ahead of the coming announcement. And second, we might actually be getting that announcement much earlier than people are thinking, possibly in the next week or so, ahead of the Congressional recess. If that update does come earlier, can we assume that you'll provide your update, you know, shortly thereafter? So, you know, meaning possibly in the next couple of weeks, if the news were to come earlier.

Tim Anderson: I'm told CMS has asked drug companies to keep quiet nonetheless, and all the drug companies have been complying with that, including Bristol. I'm trying to figure out why would drug companies comply with that request and really kind of keep it quiet ahead of the coming announcement. And second, we might actually be getting that announcement much earlier than people are thinking, possibly in the next week or so ahead of the Congressional recess. If that update does come earlier, can we assume that you'll provide your update, you know, shortly thereafter? So, you know, meaning possibly in the next couple of weeks, if the news recedes.

Speaker Change: I'm told CMS has asked drug companies to keep quiet nonetheless.

Speaker Change: And all the drug companies have been complying with that, including Bristol, and I'm trying to figure out why would drug companies comply with that request.

Speaker Change: and really kind of keep it quiet ahead of the coming announcement.

Speaker Change: And then second, we might actually be getting that announcement much earlier than people are thinking.

Speaker Change: Possibly in the next week or so ahead of the congressional recess.

Speaker Change: If that update does come earlier...

Speaker Change: Can we assume that you'll provide your update, you know, shortly thereafter, so, you know, meaning possibly in the next couple of weeks, if the news were to come earlier?

[Analyst 3]: Sure. Thanks for the questions, Tim. So first, we've been consistent that we're going to only speak to the specifics of MFP once we have CMS having published, which we anticipate being on or before 1 September. What I'll say is once that price is disclosed, we're going to be able to provide a very good picture of the shape of the business for Eliquis going forward, inclusive of the impact of IRA. And we very much look forward to being able to provide that clarity. And again, what I would emphasize is based on having seen the price, we're very confident in our ability to navigate the impact of IRA on Eliquis. And so again, we'll provide more details.

[Company Representative]: Sure. Thanks for the questions, Tim. So first, we've been consistent that we're going to only speak to the specifics of MFP once we have CMS having published, which we anticipate being on or before 1 September. What I'll say is once that price is disclosed, we're going to be able to provide a very good picture of the shape of the business for Eliquis going forward, inclusive of the impact of IRA. And we very much look forward to being able to provide that clarity. And again, what I would emphasize is based on having seen the price, we're very confident in our ability to navigate the impact of IRA on Eliquis. And so again, we'll provide more details.

Tim Anderson: If that update does come earlier, can we assume that you'll provide your update, you know, shortly thereafter? So, you know, meaning possibly in the next couple of weeks, if the news recedes. Sure. Thanks for the questions, Tim. First, we've been consistent that we're going to only speak to the specifics of MFP once we have CMS published, which we anticipate being on or before September the 1st.

If that update does come earlier, can we assume that you'll provide your update, you know, shortly thereafter? So, you know, meaning possibly in the next couple of weeks, if the news recedes.

Speaker Change: Sure. Thanks for the questions, Tim. So first, we've been consistent that we're going to only speak to the specifics of MFB once we have

Speaker Change: The, um...

Speaker Change: Once we have CMS having published, which we anticipate being on or before September the 1st.

Chris Boerner: Sure. Thanks for the questions, Tim. First, we've been consistent that we're going to only speak to the specifics of MFP once we have--CMS having published, which we anticipate being on or before September the 1st. What I'll say is, once that price's disclosed, we're gonna be able to provide a very depicture of the shape of the business for ELIQUIS going forward, inclusive of the impact of IRA, and we very much look forward to being able to provide that clarity. And again, what I would emphasize is, based on having seen the price, we're very confident in our ability to navigate the impact of IRA on ELIQUIS. And so, again, we'll provide more details when that price becomes public. And one other point is, we will provide, once that becomes public, as we will announce earlier if CMS comes before September 1st, and we'll put what we anticipate around IRA and its impact on our IR website. And so, that's how we'll be communicating that.

Speaker Change: What I'll say is, once that price is disclosed...

Speaker Change: We're going to be able to provide a very good picture of the shape of the business for Eloquist going forward, inclusive of the impact of IRA, and we very much look forward to being able to provide that clarity, and again, what I would emphasize is, based on having seen the price, we're very confident in our ability to navigate the impact of IRA on Eloquist.

Chris Boerner: And so, again, we'll provide more details when that price becomes public. And one other point is that we will provide, once that becomes public, an announcement earlier if CMS comes before September 1st, and we'll put what we anticipate around IRA and its impact on our IR website. And so that's how we'll be communicating that. Let's go to the next question, please. Yes, sir. Our next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead. Hi guys. Thank you so much for taking my question. Two for me.

And so, again, we'll provide more details when that price becomes public. And one other point is that we will provide, once that becomes public, an announcement earlier if CMS comes before September 1st, and we'll put what we anticipate around IRA and its impact on our IR website. And so that's how we'll be communicating that.

[Analyst 3]: When that price becomes public. One other point is what we will provide once that becomes public is we will announce earlier if CMS comes before 1 September, and we'll put what we anticipate around IRA and its impact on our IR website. And so that's how we'll be communicating that.

When that price becomes public. One other point is what we will provide once that becomes public is we will announce earlier if CMS comes before 1 September, and we'll put what we anticipate around IRA and its impact on our IR website. And so that's how we'll be communicating that.

Speaker Change: And so again, we'll provide more details when that price becomes public.

Speaker Change: And one other point is we will provide, once that becomes public, is we will announce earlier if...

Speaker Change: CMS comes before September the 1st.

Speaker Change: And we'll put what we anticipate around IRA and its impact on our IR website. And so that's how we'll be communicating that.

Let's go to the next question, please. Yes, sir. Our next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead. Hi guys. Thank you so much for taking my question. Two for me.

Tim Power: Let's go to the next question, please.

Yes, sir. Our next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead. Hi guys. Thank you so much for taking my question. Two for me.

Operator: Yes, sir. Our next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead.

Adam Lenkowsky: Great. Let's go to the next question, please.

Tim Power: Great. Let's go to the next question, please.

Operator: Yes, sir. Our next question comes from Evan Segerman with BMO Capital Markets. Please go ahead.

Operator: Yes, sir. Our next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead.

Evan Seigerman: Hi guys. Thank you so much for taking my question. Two for me. So, Adam, can you walk me through some of the key launch preparations you're taking for the launch of KarXT that will help you capitalize on your competitive head start? And then on the IRA/drop earnings, I'm not going to push on the price, but what else do you need to know or need to have in hand to really be able to help us understand kind of when these drop earnings that we've been talking about will be able to provide kind of when that happens? Thank you guys so much.

Speaker Change: Great. Let's go to the next question, please.

Speaker Change: Yes, sir. Our next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead.

[Analyst 3]: Hi guys, thank you so much for taking my question two for me.

Evan David Seigerman: Hi guys, thank you so much for taking my question two for me.

Evan Seigerman: So, Adam, can you walk me through some of the key launch preparations you're taking for the launch of CarXP that will help you capitalize on your competitive head start? And then on the IRA slash drop earnings, I'm not going to push on the price, but what else do you need to know or need to have in hand to really be able to help us understand kind of when these drop earnings that we've been talking about will be able to provide kind of when that happens? Thank you guys so much. Sure. So why don't I let Adam start on CAR-XT, and then I'll take your second question.

So, Adam, can you walk me through some of the key launch preparations you're taking for the launch of CarXP that will help you capitalize on your competitive head start? And then on the IRA slash drop earnings, I'm not going to push on the price, but what else do you need to know or need to have in hand to really be able to help us understand kind of when these drop earnings that we've been talking about will be able to provide kind of when that happens? Thank you guys so much.

Samit Hirawat: So, Adam, can you walk me through?

So, Adam, can you walk me through?

Evan Seigerman: Hi guys, thank you so much for taking my question. Two for me, so Adam, can you walk me through some of the key launch preparations you're taking for the launch of CarXP that will help you capitalize on your competitive head start? And then on the IRA slash drop earnings,

[Analyst 3]: Some of the key launch preparations you're taking for the launch of KarXT that will help you capitalize on your competitive head start and then on the IRA drop earnings. I'm not going to push on the price, but what else do you need to know or need to have in hand to really be able to help us understand kind of when these trough earnings that we've been talking about, when you'll be able to provide kind of when that happens. Thank you guys so much.

Some of the key launch preparations you're taking for the launch of KarXT that will help you capitalize on your competitive head start and then on the IRA drop earnings. I'm not going to push on the price, but what else do you need to know or need to have in hand to really be able to help us understand kind of when these trough earnings that we've been talking about, when you'll be able to provide kind of when that happens. Thank you guys so much.

Evan Seigerman: I'm not going to push on the price, but what else do you need to know or need to have in hand to really be able to help us understand kind of when these trough earnings that we've been talking about and when you'll be able to provide kind of when that happens. Thank you guys so much.

Samit Hirawat: Sure.

[Company Representative]: Sure.

[Analyst 3]: So why don't I let Adam start on KarXT and then I'll take your second question.

So why don't I let Adam start on KarXT and then I'll take your second question.

Chris Boerner: Sure. So why don't I let Adam start on KarXT, and then I'll take your second question.

Adam: Sure, so why don't I let Adam start on CAR-XT and then I'll take your second question. Yeah, Evan, thank you for the question. So we're excited about the launch of CAR-XT, as this is a very important drug with significant commercial potential to be shared.

Adam Lenkowsky: Yeah, Evan, thank you for the question. So we're excited about the launch of KarXT as this is a very important drug with significant commercial potential. As a reminder, given a late September and Q4 launch, we effectively see this as a 2025 launch and KarXT is going to be the first innovative therapy in schizophrenia approved for decades. So let me talk a little bit about how we are preparing for the launch and I'll focus on a few key areas. Number one, we're sourcing a very experienced field sales and strong medical organization to prepare the market for this new mechanism. Secondly, the access team that we have has been out there for months reinforcing the profile with state Medicaid directors and Medicare payers. Just as a reminder, the schizophrenia market is very different in terms of access than markets that are highly PBM driven.

Adam Lenkowsky: Yeah, Evan, thank you for the question. So we're excited about the launch of KarXT, as this is a very important drug with significant commercial potential to be shared. Mind you, given a late September and Q4 launch, we effectively see this as a 2025 launch, and KarXT is going to be the first innovative therapy in schizophrenia approved for decades. So, let me talk a little bit about how we are preparing for the launch, and I'll focus on a few key areas. Number one, we're resourcing a very experienced field sales team and a strong medical organization to prepare the market for this new mechanism. Secondly, you know, the access team that we have been out there for months, reinforcing the profile with state Medicaid directors and Medicare payers. Just as a reminder, the schizophrenia market is very different in terms of access; in markets that are highly PBM driven, government payers will be critical to building access for this product since the patient population is greater than 80% Medicaid and Medicare. We've received very positive feedback from thought leaders and payers in the space that KarXT fills a significant unmet need. And the third area that I'll highlight is, you know, we need to ensure that physicians and patients have a positive first experience. This is a new mechanism with a different profile and ensure that patients stay on treatment. So overall, we're pleased with the launch readiness efforts, and we look forward to launching this important medicine later this year. Yeah, and thank you, Adam. I just want to add a couple of things I haven't summed up here. In addition to looking forward to approval in September, we are also executing on the overall development plan for CAR-XP.

Speaker Change: Mind you, given a late September and Q4 launch, we effectively see this as a 2025 launch, and CARC-C is going to be the first innovative therapy in schizophrenia approved for decades.

Speaker Change: Let me talk a little bit about how we are preparing for the launch, and I'll focus on a few key areas. Number one, we're sourcing a very experienced field sales and strong medical organization to prepare the market for this new mechanism.

Adam Lenkowsky: Number one, we're recruiting a very experienced field sales team and a strong medical organization to prepare the market for this new mechanism. Secondly, you know, the access team that we have been out there for months, reinforcing the profile with state Medicaid directors and Medicare payers. Just as a reminder, the schizophrenia market is very different in terms of access; in markets that are highly PBM driven, government payers will be critical to building access for this product since the patient population is greater than 80% Medicaid and Medicare. We've received very positive feedback from thought leaders and payers in the space. That CAR-XP fills a significant unmet need And the third area that I'll highlight is, you know, we need to ensure that physicians and patients have a positive first experience. This is a new mechanism with a different profile and ensure that patients stay on treatment. So overall, we're pleased with the launch readiness efforts, and we look forward to launching this important medicine later this year. Yeah, and thank you, Adam. I just want to add a couple of things I haven't summed up here. In addition to looking forward to approval in September, we are also executing on the overall development plan for CAR-XP.

Speaker Change: Secondly, the ACCESS team that we have has been out there for months reinforcing the profile with state Medicaid directors and Medicare payers.

Speaker Change: Just as a reminder, you know, the schizophrenia market is very different in terms of access than markets that are highly PBM-driven. Government payers will be critical to building access for this product.

Adam Lenkowsky: Government payers will be critical to building access for this product since the patient population is greater than 80% Medicaid and Medicare. We've received very positive feedback from thought leaders and payers in the space that CAR fills a significant unmet need. The third area that I'll highlight is we need to ensure that physicians and patients have a positive first experience. This is a new mechanism with a different profile and ensuring that patients stay on treatment. Overall we're pleased with the launch readiness efforts and we look forward to launching this important medicine later this year.

Government payers will be critical to building access for this product since the patient population is greater than 80% Medicaid and Medicare. We've received very positive feedback from thought leaders and payers in the space that CAR fills a significant unmet need. The third area that I'll highlight is we need to ensure that physicians and patients have a positive first experience. This is a new mechanism with a different profile and ensuring that patients stay on treatment. Overall we're pleased with the launch readiness efforts and we look forward to launching this important medicine later this year.

Speaker Change: The patient population is greater than 80% Medicaid and Medicare. We've received very positive feedback from thought leaders and payers in the space that CARD-C fills a significant unmet need. And the third area that I'll highlight is, you know, we need to ensure that physicians and patients have a positive first experience.

Adam Lenkowsky: And the third area that I'll highlight is, you know, we need to ensure that physicians and patients have a positive first experience. This is a new mechanism with a different profile and ensure that patients stay on treatment. So overall, we're pleased with the launch readiness efforts, and we look forward to launching this important medicine later this year. Yeah, and thank you, Adam. I just want to add a couple of things I haven't summed up here. In addition to looking forward to approval in September, we are also executing on the overall development plan for CAR-XP.

Samit Hirawat: Yeah, and thank you, Adam. I just want to add a couple of things I haven't summed up here. In addition to looking forward to approval in September, we are also executing on the overall development plan for KarXT. As you know, adjunctive schizophrenia studies, as well as the Alzheimer's disease associated psycho studies, are ongoing, and they're enrolling well. We look forward to data readouts in 2025 and 2026. We anticipate initiation of the Phase III trials in bipolar disorder, as well as Alzheimer's agitation, also in 2025 with a BID dosing. And then also preparing to start the Phase III study, Alzheimer's disease cognition impairment, also in 2025. In addition to that, we are now making preparations for autism studies, which will include children. So we need to do some work on that, but it's really a large program that is being initiated and executed right now. Thanks, Amit. Now, Evan, going back to your question on TROP, I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026. Now, having said that, our focus continues to be on improving the shape of the business over time, and the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets. We saw good growth in the first half, and we expect good growth in the second half. We have new products launching this year, notably CARXT and NEVO SubQ. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026. And as we've discussed over time, these have considerable commercial potential. So those are a number of things that are obviously going to shape how this business looks in the second half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the second half of the decade. Let's go to the next question, please, Robert.

Speaker Change: This is a new mechanism with a different profile.

Speaker Change: and ensuring that patients stay on treatment. So overall.

Speaker Change: We're pleased with the launch readiness efforts and we look forward to launching this important medicine later this year. Thank you. Adam, I just want to add a couple of things, Evan, Samit here. In addition to looking forward to the approval in September ,

Samit Hirawat: Thank you Adam. I just want to add a couple of things, Evan. Samit here. In addition to looking forward to the approval in September, we are also executing on the overall development plan for KarXT. As you know, the adjunctive schizophrenia study as well as the Alzheimer's disease associated psychosis studies are ongoing, and they're enrolling well. We look forward to data readouts in 2025 and 2026. We anticipate initiation of the phase 3 trials in bipolar disorder as well as Alzheimer's agitation also in 2025 with a bid dosing, and then also preparing to start the phase 3 study, Alzheimer's disease cognitive impairment, also in 2025. In addition to that, we are now making the preparations for the autism studies, which will include children. So do we need to do some work on that? But really a large program that is being initiated and executed right now.

Samit Hirawat: As you know, adjunctive schizophrenia studies, as well as the Alzheimer's disease associated psycho studies, are ongoing, and they're enrolling well. We look forward to data readouts in 2025 and 2026. We anticipate initiation of the phase three trials in bipolar disorder, as well as Alzheimer's agitation, also in 2025 with a BID dosing. And then also preparing to start the phase three study, Alzheimer's disease cognition impairment, also in 2025. In addition to that, we are now making preparations for autism studies, which will include children. So we need to do some work on that, but it's really a large program that is being initiated and executed right now. Thanks, Amit. Now, Evan, going back to your question on TROP, I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026. Now, having said that, our focus continues to be on improving the shape of the business over time, and the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets. We saw good growth in the first half, and we expect good growth in the second half. We have new products launching this year, notably CARXT and NEVO SubQ. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026. And as we've discussed over time, these have considerable commercial potential. So those are a number of things that are obviously going to shape how this business looks in the second half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the second half of the decade. Let's go to the next question, please, Robert.

Adam: We are also executing on the overall development plan for CAR-XT, as you know, adjunctive schizophrenia study, as well as the Alzheimer's disease associated psycho studies are ongoing and they're enrolling well. We look forward to data readouts in 2025 and 2026.

Speaker Change: We anticipate initiation of the Phase 3 trials in Bipolar Disorder as well as Alzheimer's Agitation also in 2025 with a BID dosing.

Samit Hirawat: So we need to do some work on that, but it's really a large program that is being initiated and executed right now. Thanks, Amit. Now, Evan, going back to your question on TROP, I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026. Now, having said that, our focus continues to be on improving the shape of the business over time, and the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets. We saw good growth in the first half, and we expect good growth in the second half. We have new products launching this year, notably CARXT and NEVO SubQ. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026. And as we've discussed over time, these have considerable commercial potential. So those are a number of things that are obviously going to shape how this business looks in the second half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the second half of the decade. Let's go to the next question, please, Robert.

Speaker Change: And then also preparing to start the phase 3 study, Alzheimer's disease cognition impairment, also in 2025.

Speaker Change: In addition to that, we are now making the preparations.

Speaker Change: For the autism studies, which will include children, so we need to do some work on that, but really a large program that is being initiated and executed right now.

Chris Boerner: Thanks, Samit. Now, Evan, going back to your question on TROP, I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026. Now, having said that, our focus continues to be on improving the shape of the business over time, and the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets, we saw good growth in the first half, and we expect good growth in the second half. We have new products launching this year, notably KarXT and nivo-sub-q this year. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026. And as we've discussed over time, these have considerable commercial potential. We have some very intersting early programs, so we're gonna start seeing proof of concept, starting this year notably, CD19XT, and of course, as David has mentioned already today, we have a very good balance sheet and the capacity to do smart partnerships and business development. So those are a number of things that are obviously going to shape how this business looks in the back half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the back half of the decade. Let's go to the next question, please, Robert.

[Analyst 3]: Thanks, Samit. Now Evan, going back to your question on trough, I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026. Now having said that, our focus continues to be on improving the shape of the business over time, and the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets. We saw good growth in the first half and we expect good growth in the back half. We have new products launching, notably KarXT and Nivo Sub Q this year. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026.

[Company Representative]: Thanks, Samit. Now Evan, going back to your question on trough, I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026. Now having said that, our focus continues to be on improving the shape of the business over time, and the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets. We saw good growth in the first half and we expect good growth in the back half. We have new products launching, notably KarXT and Nivo Sub Q this year. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026.

Evan: Thanks, Samit. Now, Evan, going back to your question on TROP, I'll redirect you back to the comments that I made at the beginning of the year. We've talked about navigating a period that starts in 2026.

Chris Boerner: We've talked about navigating a period that starts in 2026. Now, having said that, our focus continues to be on improving the shape of the business over time, and the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets. We saw good growth in the first half, and we expect good growth in the second half. We have new products launching this year, notably CARXT and NEVO SubQ. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026. And as we've discussed over time, these have considerable commercial potential. So those are a number of things that are obviously going to shape how this business looks in the second half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the second half of the decade. Let's go to the next question, please, Robert.

Speaker Change: Now, having said that, our focus continues to be on improving the shape of the business over time. And the good news is we have a lot of strategic levers to pull. We have a growing portfolio of young assets. We saw good growth in the first half, and we expect good growth in the back half.

Speaker Change: We have new products launching notably Car XT and Nevo Sub-Q this year. Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026. And as we've discussed over time, these have considerable commercial potential.

Chris Boerner: Those are going to be important in terms of describing the shape of our business longer term. We have late-stage pipeline assets that are reading out starting this year and accelerating through next year and into 2026. And as we've discussed over time, these have considerable commercial potential. So those are a number of things that are obviously going to shape how this business looks in the second half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the second half of the decade. Let's go to the next question, please, Robert.

[Analyst 3]: As we've discussed over time, these have considerable commercial potential with some very interesting early programs. We're going to start seeing proof of concept starting this year, notably CD19 NEX-T. And of course, as David has mentioned already today, we have a very good balance sheet and the capacity to do smart partnerships in business development. So those are a number of the things that are obviously going to shape how this business looks like in the back half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the back half of the decade.

As we've discussed over time, these have considerable commercial potential with some very interesting early programs. We're going to start seeing proof of concept starting this year, notably CD19 NEX-T. And of course, as David has mentioned already today, we have a very good balance sheet and the capacity to do smart partnerships in business development. So those are a number of the things that are obviously going to shape how this business looks like in the back half of the decade. And we're fixated on delivering across the business in the short term as well as pulling the strategic levers I just mentioned that are going to be needed to accelerate the timing and pace of growth for the company in the back half of the decade.

Speaker Change: We have some very interesting early programs. We're going to start seeing proof-of-concept starting this year, notably CD19XT, and of course, as David has mentioned already today, we have a very good balance sheet in the capacity to do

Speaker Change: Smart Partnerships and Business Development. So those are a number of the things that are obviously going to shape how this business looks in the back half of the decade. And we're fixated on delivering across the business in the short term, as well as pulling the strategic levers I just mentioned.

Speaker Change: that are going to be needed to accelerate the timing and pace of growth for the company in the back half of the decade.

Adam Lenkowsky: Let's go to the next question please. Rocco.

Tim Power: Let's go to the next question please. Rocco.

Tim Power: Let's go to the next question, please, Rocco.

Chris Boerner: Let's go to the next question, please, Robert. Absolutely. Our next question today comes from Carter Gould with Barclays. Please go ahead. Good morning. Thanks for taking the questions. Maybe one for Adam. You had a really nice quarter in Brianzi.

Let's go to the next question, please, Robert.

Operator: Absolutely. Our next question today comes from Carter Gould with Barclays. Please go ahead.

Speaker Change: Let's go to the next question, please, Rocco.

Operator: Absolutely. Our next question today comes from Carter Gould with Barclays. Please go ahead. Good morning. Thanks for taking the questions. Maybe one for Adam. You had a really nice quarter in Brianzi.

Operator: Absolutely. Our next question today comes from Carter Gould with Barclays. Please go ahead.

Carter Gould: Good morning. Thanks for taking the questions. Maybe one for Adam. You had a really nice quarter in BREYANZI. You highlighted some of the drivers there. Can you maybe, you know, compartmentalize that a bit and help us think about the second half of the year as we think about both those new indications but also the step up in supply? Just again, given sort of the reset in 2Q, additional color would be pretty helpful. Adam

Rocco: Absolutely. Our next question today comes from Carter Gould with Barclays. Please go ahead.

Carter Gould: You highlighted some of the drivers there. Can you maybe, you know, compartmentalize that a bit and help us think about the second half of the year as we think about both those new indications but also the step up in supply? Just again, given sort of the reset in, Additional color. Adam

[Analyst 1]: Good morning. Thanks for taking the questions. Maybe one for Adam. You had a really nice quarter in Breyanzi. You highlighted some of the drivers there. Can you maybe.

[Analyst 2]: Good morning. Thanks for taking the questions. Maybe one for Adam. You had a really nice quarter in Breyanzi. You highlighted some of the drivers there. Can you maybe.

Carter Gould: Good morning. Thanks for taking the questions. Maybe one for Adam. You had a really nice quarter in Branby. You highlighted some of the drivers there. Can you maybe

[Analyst 1]: Compartmentalize that a bit and help us think about, then, the second half of the year as we think about both those new indications, but also the step up in supply, just again, given sort of the reset in Q2? Additional color here would be pretty helpful.

Compartmentalize that a bit and help us think about, then, the second half of the year as we think about both those new indications, but also the step up in supply, just again, given sort of the reset in Q2? Additional color here would be pretty helpful.

Carter Gould: You know, compartmentalize that a bit and help us think about then the second half of the year as we think about both those new indications but also the step up in supply. Just, again, given sort of the reset in 2Q, additional color here would be pretty helpful.

Chris Boerner: Adam?

Adam Lenkowsky: Yeah, Carter, thank you for the question. You know, we're pleased with BREYANZI's performance in the quarter. Remember, in Q1, we said we expected significant improved manufacturing capacity and also a tailwind from our new indications. So, in the second quarter, you know, as David shared, sales increased over 50% versus the prior year, and we anticipate that to continue through the remainder of the year. And we expect continued strong growth to be driven first by our lead indication in LBCL, as BREYANZI is increasingly recognized as the best in class CD19, as well as by our expanded indications, which are off to a very good start. We're also pleased--and I want to acknowledge and thank our GPS organization--with our expanded manufacturing capacity, we're now in a much stronger position to meet demand in the market. So, taking together our recent approvals, our expanded manufacturing capacity, and best in class, will enable us to compete much more effectively to win in this market.

[Analyst 3]: Adam?

[Company Representative]: Adam?

Adam Lenkowsky: Yeah, Carter, thank you for the question. We're pleased with Breyanzi performance in the quarter. Remember in Q1, we said we expected significant improved manufacturing capacity and also a tailwind from our new indications. So in the second quarter, as David shared, sales increased over 50% versus prior year, and we anticipate that to continue through the remainder of the year. We expect continued strong growth to be driven first by our lead indication in LBCL, as Breyanzi is increasingly recognized as the best-in-class CD19, as well as by our expanded indications, which are off to a very good start. We're also pleased, and I want to acknowledge and thank our GPS organization. With our exceptional expanded manufacturing capacity, we're now in a much stronger position to meet demand in the market.

Carter Gould: Adam. Yeah, Carter, thank you for the question. You know, we're pleased with Brionzi performance in the quarter. Remember, in Q1, we said we expected significant improved manufacturing capacity and also a tailwind from our new indications,

Carter Gould: So in the second quarter, as David shared, sales increased over 50% versus prior year, and we anticipate that to continue through the remainder of the year.

Speaker Change: We expect continued strong growth to be driven first by our lead indication in LBCL, as Briondi is increasingly recognized as the best-in-class CD19, as well as by our expanded indications, which are off to a very good start.

Adam Lenkowsky: We're also pleased, and I want to acknowledge and thank our GPS organization. With our expanded manufacturing capacity, we're now in a much stronger position to meet demand in the market. So, taking together our recent approvals, our expanded manufacturing capacity, and best in class, will enable us to compete much more effectively to win in this market. Thanks, Adam.

We're also pleased, and I want to acknowledge and thank our GPS organization. With our expanded manufacturing capacity, we're now in a much stronger position to meet demand in the market. So, taking together our recent approvals, our expanded manufacturing capacity, and best in class, will enable us to compete much more effectively to win in this market.

Speaker Change: We're also pleased, and I want to acknowledge and thank our GPS organization, with our expanded manufacturing capacity. We're now in a much stronger position to meet demand in the market, and so taking together our recent approvals, our expanded manufacturing capacity, and best-in-class...

Adam Lenkowsky: Taken together, our recent approvals, our expanded manufacturing capacity, and best in class will enable us to compete much more effectively to win in this market.

Taken together, our recent approvals, our expanded manufacturing capacity, and best in class will enable us to compete much more effectively to win in this market.

Speaker Change: will enable us to compete much more effectively to win in this market.

[Analyst 3]: Thanks, Adam.

[Analyst 2]: Thanks, Adam.

Adam Lenkowsky: Let's go to the next question please. Rocco.

Tim Power: Let's go to the next question please. Rocco.

Chris Boerner: Thanks, Adam. Let's go to the next question, please, Rocco.

Chris Boerner: Thanks, Adam.

Tim Power: Let's go to the next question, please, Rocco.

Adam: Thanks, Adam.

Operator: Yes, sir. Our next question comes from Seamus Fernandez with Guggenheim Securities. Please go.

Operator: Yes, sir. Our next question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead.

Adam: Let's go to the next question, please, Rocco.

Speaker Change: Yes, sir. Our next question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead. Great. Thanks for the question. So, a couple of quick ones. Samit, you know, you have a number of...

Seamus Fernandez: Great. Thanks for the question. So, a couple of quick ones. Samit, you know, you have a number of clinical readouts coming in multiple myeloma with your [inaudible] portfolio in 2026. Just hoping you could help us understand how you see those products potentially commercially--or maybe not commercially, but clinically positioned relative to the very increasingly crowded landscape that we see today. And then the second question actually harkens back a little bit to IRA, but more so to Part D redesign. Can you guys help us understand how the Part D redesign dynamics that are likely to materially impact the substantial payout that you make on ELIQUIS is likely to be offset negatively by the impact of the catastrophic cap that comes in in 2025? At what point will you seek to educate the market on those pushes and pulls in 2025? Will that fall with the IRA negotiation effects, or will it fall simply with 2025 guidance? Thanks.

[Analyst 1]: Great.

Seamus Fernandez: Great.

Samit Hirawat: Thanks for the question.

Thanks for the question.

Adam Lenkowsky: So, a couple of quick ones. You know, you have a number of clinical readouts coming in multiple myeloma with your CELMoD portfolio in 2026. Just hoping you could help us understand how you see those products potentially commercially, or maybe not commercially, but clinically positioned relative to the very increasingly crowded landscape that we see today. And then the second actually harkens back.

So, a couple of quick ones. You know, you have a number of clinical readouts coming in multiple myeloma with your CELMoD portfolio in 2026. Just hoping you could help us understand how you see those products potentially commercially, or maybe not commercially, but clinically positioned relative to the very increasingly crowded landscape that we see today. And then the second actually harkens back.

Samit Hirawat: Samit, you know, you have a number of clinical readouts coming in multiple myeloma with your Selmod portfolio in 2026. Just hoping you could help us understand how you see those products potentially commercially or maybe not commercially, but clinically positioned relative to the very increasingly crowded landscape that we see today. And then the second question actually harkens back a little bit to IRA, but more so to Part D redesign. Can you guys help us understand how the Part D redesign dynamics that are likely to materially impact the substantial payout that you make on Eloquus are likely to be offset negatively by the impact of the catastrophic cap that comes in in 2025? At what point will you seek to educate the market on those pushes and pulls in 2025? Will that fall with the IRA negotiation effects, or will it fall simply with 2025 guidance? Thanks. Samit, then Adam.

Samit, you know, you have a number of clinical readouts coming in multiple myeloma with your Selmod portfolio in 2026. Just hoping you could help us understand how you see those products potentially commercially or maybe not commercially, but clinically positioned relative to the very increasingly crowded landscape that we see today. And then the second question actually harkens back a little bit to IRA, but more so to Part D redesign. Can you guys help us understand how the Part D redesign dynamics that are likely to materially impact the substantial payout that you make on Eloquus are likely to be offset negatively by the impact of the catastrophic cap that comes in in 2025? At what point will you seek to educate the market on those pushes and pulls in 2025? Will that fall with the IRA negotiation effects, or will it fall simply with 2025 guidance?

Donna: Clinical readouts coming in multiple myeloma with your Selmod portfolio in 2026.

Seamus Fernandez: Just hoping you could help us understand how you see those products potentially commercially, or maybe not commercially, but clinically

Seamus Fernandez: positioned relative to the very increasingly crowded landscape that we see.

[Analyst 1]: A little bit to IRA, but more.

A little bit to IRA, but more.

Speaker Change: Thank you for joining us today. And then the second question actually harkens back a little bit to IRA but more so to Part D redesign. Can you guys help us understand how the Part D redesign dynamics that are likely to materially impact the substantial

Adam Lenkowsky: To Part D redesign. Can you guys help us understand how the Part D redesign dynamics that are likely to materially impact the substantial payout that you make on.

To Part D redesign. Can you guys help us understand how the Part D redesign dynamics that are likely to materially impact the substantial payout that you make on.

[Analyst 1]: Eliquis is likely.

Eliquis is likely.

Speaker Change: payout that you make on.

Adam Lenkowsky: To be offset negatively by the impact of the catastrophic cap that comes in in 2025? At what point will you seek to educate the market on those pushes and pulls in 2025? Will that fall with the IRA negotiation effects or will it fall, you know.

To be offset negatively by the impact of the catastrophic cap that comes in in 2025? At what point will you seek to educate the market on those pushes and pulls in 2025? Will that fall with the IRA negotiation effects or will it fall, you know.

Speaker Change: Eloquus

Speaker Change: is likely to be offset.

Speaker Change: negatively by the impact of the catastrophic cap.

Speaker Change: That comes in in 2025. And at what point will you seek to educate the market on those pushes and pulls in 2025? Will that fall with the IRA negotiation effects? Or will it fall, you know, simply with 2025 guidance? Thanks.

[Analyst 3]: Simply with 2025 guidance? Thanks.

Simply with 2025 guidance? Thanks.

[Analyst 3]: Samit, then, Adam.

[Company Representative]: Samit, then, Adam.

Chris Boerner: Samit, then Adam.

Samit Hirawat: Thank you, Seamus, for the question. As we think about multiple myeloma, it is a disease which has really been benefiting from multiple therapies that have been approved over the years and certainly has had transformational outcomes for these patients, including small molecules as well as large molecules. And now with cell therapies and bispecifics coming into the play, as we think about cell mods, as we think about Iberdomide and Mezigdomide, both in development across the four phase 3 clinical trials, with the readouts coming in 2026, the way we think about it is multidrug regimens will be required for these patients because ultimately right now we don't have a cure for the disease. And that's the way we have designed the studies with Mezigdomide going head to head versus pomalidomide.

Adam Lenkowsky: Thank you, Seamus, for the question. As we think about multiple myeloma, it is a disease which has really been benefiting from multiple therapies that have been approved over the years and certainly has had transformational outcomes for these patients, including small molecules as well as large molecules. And now with cell therapies and bispecifics coming into the play, as we think about cell mods, as we think about Iberdomide and Mezigdomide, both in development across the four phase 3 clinical trials, with the readouts coming in 2026, the way we think about it is multidrug regimens will be required for these patients because ultimately right now we don't have a cure for the disease. And that's the way we have designed the studies with Mezigdomide going head to head versus pomalidomide.

Samit Hirawat: Thank you, Seamus, for the question. As we think about multiple myeloma, it is a disease that has really been benefiting from multiple therapies that have been approved over the years and certainly have had transformational outcomes for these patients, including small molecules as well as large molecules, and now with cell therapies and biospecifics coming into the play. As we think about cell mods, as we think about iberdomide and mezigdomide, both in development and across four Phase III clinical trials with the readouts coming in 2026, the way we think about it is, multi-drug regimens will be required for these patients because, ultimately, right now, we don't have a cure for this disease. And that's the way we have designed the studies with mezigdomide going head-to-head versus pomalidomide, whereas if we think about iberdomide, we're looking at combinations to really change outcomes when we combine it with valkane and dexamethasone, or move into a maintenance setting after transplant going head-to-head versus REVLIMID. So we believe that there are patients who are not going to be eligible to receive cell therapies where these therapies will play a role. Also, we need manageable toxicities, which don't have the same outcomes of CRS, et cetera, that are associated with biospecific therapies right now. So placement of these therapies will become important, and we'll continue to generate more data through many other trials so that we ultimately give more tools to physicians to prescribe to the right patients for better outcomes in multiple myeloma.

Speaker Change: Samit, then Adam.

Speaker Change: Thank you, Seamus, for the question. As we think about multiple myeloma, it is a disease which has really been benefiting from multiple therapies that have been approved over the years and certainly has had transformational outcomes for these patients, including small molecules as well as large molecules, and now with cell therapies and biospecifics coming into the play. As we think about cell mods,

Speaker Change: As we think about ibridamide and mesigdamide, both in development across the four phase three clinical trials with readouts coming in 2026.

Speaker Change: The way we think about it is multi-drug regimens will be required for these patients because ultimately right now we don't have a cure for the disease.

Samit Hirawat: And that's the way we have designed the studies with mesigdamide going head-to-head versus pomalidomide, whereas if we think about ibridamide, we're looking at combinations to really change outcomes when we combine it with valkane and dexamethasone or move into a maintenance setting after transplant going head-to-head versus Revlimid. So we believe that there are patients who are not going to be eligible to receive cell therapies where these therapies will play a role. Also, we need manageable toxicities that don't have the same outcomes of CRS, et cetera, that are associated with biospecific therapies right now. So placement of these therapies will become important, and we'll continue to generate more data through many other trials so that we ultimately give more tools to physicians to prescribe to the right patients for better outcomes in multiple myeloma.

Speaker Change: And that's the way we have designed the studies with mesigdamide going head-to-head versus pomalidomide. Whereas if we think about ibertamide, we're looking at combinations to really change the outcomes when we combine them with valkane and dexamethasone, or moving into a maintenance setting after transplant going head-to-head versus Revlimid. So we believe that there are patients who are not going to be eligible to receive cell therapies where these therapies will play a role.

Samit Hirawat: Whereas if we think about Iberdomide, we're looking at combinations to really change the outcomes when we combine them with Velcade and dexamethasone, or moving into a maintenance setting after transplant going head to head versus Revlimid. So we believe that there are patients who are not going to be eligible to receive cell therapies where these therapies will play a role. Also, we need manageable toxicities which don't have the same outcomes of CRS, etc., that are associated with bispecific therapies right now. So placement of these therapies will become important and we'll continue to generate more data through many other trials so that we ultimately give more armamentarium to physicians to prescribe to the right patients for better outcomes in multiple myeloma.

Whereas if we think about Iberdomide, we're looking at combinations to really change the outcomes when we combine them with Velcade and dexamethasone, or moving into a maintenance setting after transplant going head to head versus Revlimid. So we believe that there are patients who are not going to be eligible to receive cell therapies where these therapies will play a role. Also, we need manageable toxicities which don't have the same outcomes of CRS, etc., that are associated with bispecific therapies right now. So placement of these therapies will become important and we'll continue to generate more data through many other trials so that we ultimately give more armamentarium to physicians to prescribe to the right patients for better outcomes in multiple myeloma.

Samit Hirawat: So we believe that there are patients who are not going to be eligible to receive cell therapies where these therapies will play a role. Also, we need manageable toxicities that don't have the same outcomes of CRS, et cetera, that are associated with biospecific therapies right now. So placement of these therapies will become important, and we'll continue to generate more data through many other trials so that we ultimately give more tools to physicians to prescribe to the right patients for better outcomes in multiple myeloma.

Speaker Change: Also we need manageable toxicities which don't have the same outcomes of CRS etc. that are associated by specific therapies right now.

Speaker Change: So placement of these therapies will become important and we'll continue to generate more data through many other trials so that we ultimately give more armamentarium to physicians to prescribe to the right patients for better outcomes in multiple myeloma.

[Analyst 3]: Thanks, Samit. Seamus, before I turn it over to Adam to walk through the redesign specifically, I'll just say that when we give the color on MFP, that will be inclusive of all aspects of IRA, including the Part D redesign. And that, whenever we talk about the final MFP price. But Adam.

[Company Representative]: Thanks, Samit. Seamus, before I turn it over to Adam to walk through the redesign specifically, I'll just say that when we give the color on MFP, that will be inclusive of all aspects of IRA, including the Part D redesign. And that, whenever we talk about the final MFP price. But Adam.

Chris Boerner: Thanks, Samit. Seamus, before I turn it over to Adam to walk through the redesign specifically, I'll just say that when we give the color on MFP, that will be inclusive of all aspects of IRA, including the Part D redesigns, that whenever we talk about the final MFP price. But Adam?

Speaker Change: Thanks Samit. Seamus, before I turn it over to Adam to walk through the redesign of that specifically, I'll just say that when we give the color

Adam: On MFP, that will be inclusive of all aspects of IRA, including the Part D redesigns, get that whenever we talk about the final MFP price, but Adam.

Adam Lenkowsky: Yeah, Seamus, you know, as you alluded to, you know, products are impacted differently by the Medicare redesign. We carefully evaluate each of the individual dynamics, both now as well as into the future, to determine the potential impacts. We will see favorability with Eliquis next year due to the Part D redesign, notably with the elimination of the coverage gap that will partially be offset by rev and Pomalyst having responsibility now in the catastrophic phase. So we're monitoring this very closely to understand what the impact is on out of pocket caps as well and other shifts that are happening in the landscape.

Adam Lenkowsky: Yeah, Seamus. As you alluded to, products are impacted differently by the Medicare redesign. We carefully evaluate each of the individual dynamics, both now as well as into the future, to determine the potential impacts. We will see favorability with ELIQUIS next year due to the Part D redesign, notably with the elimination of the coverage gap. That will partially be offset by Rev and POMALYST having responsibility now in the catastrophic phase. So, we're monitoring this very closely to understand what the impact is, at the pocket cap as well, and other shifts that are happening in the landscape. Yeah, and just to close on that, what I would say, when we look at Part D redesign across the entire portfolio, we actually think that it balances and will be largely new. Great. Thanks, Chris.

Adam: Yeah, Seamus, you know, as you alluded to, you know, products are impacted differently by the Medicare redesign.

Adam: We carefully evaluate each of the individual dynamics both now as well as into the future to determine the potential impacts. We will see favorability with Eloquist next year due to the Part D redesign, notably with the elimination of the coverage gap.

Adam: That will partially be offset by Rev and Pommelist having responsibility now in the catastrophic phase. So we're monitoring this very closely to understand what the impact is on out-of-pocket caps as well and other shifts that are happening in the landscape.

Adam Lenkowsky: Yeah, and just to close on that, what I would say, when we look at Part D redesign across the entire portfolio, we actually think that it balances and will be largely new. Great. Thanks, Chris.

Chris Boerner: Yeah, and just to close on that, what I would say, when we look at Part D redesign across the entire portfolio, we actually think that it offsets will be largely meaningful.

[Analyst 3]: Yeah, and just to close off on that, what I would say when we look at Part D redesign across the entire portfolio, we actually think that it offsets and will be largely neutral.

[Company Representative]: Yeah, and just to close off on that, what I would say when we look at Part D redesign across the entire portfolio, we actually think that it offsets and will be largely neutral.

Speaker Change: Yeah, and just to close off on that, what I would say, when we look at Part D redesign across the entire portfolio, we actually think that it offsets and will be largely neutral.

Adam Lenkowsky: Great. Thanks, Chris. Could we go to the next question, please?

Tim Power: Great. Thanks, Chris. Could we go to the next question, please?

Tim Power: Great. Thanks, Chris. Can we go to the next question, please?

Chris Boerner: Can we go to the next question, please? Absolutely. Our next question today comes from Terence Flynn at Morgan Stanley. Please go ahead.

Can we go to the next question, please?

Operator: Absolutely. Our next question today comes from Terence Flynn at Morgan Stanley. Please go ahead.

Speaker Change: Great. Thanks, Chris. Can we go to the next question, please?

Operator: Absolutely. Our next question today comes from Terence Flynn at Morgan Stanley. Please go ahead.

Speaker Change: Absolutely. Our next question today comes from Terence Flynn at Morgan Stanley . Please go ahead.

Samit Hirawat: Great. Thanks so much for taking the question, Dave. I was just wondering if you can provide any early commentary on how we should think about 2025 operating margins. Maybe just walking us through some of the puts and takes, and then separately was wondering if you guys can disclose the Winrevair royalty from Merck. Thank you, David. Yeah, thanks, James. And look, we remain committed to our greater than 37% operating margin. And as you saw, we saw strength in our gross margins with a mix of our business, and we feel really good about the operational efficiency programs that we're executing against now, which gives us a lot of flexibility in maintaining those operating margins above 37%.

Terence Flynn: Great. Thanks so much for taking the question, Dave. I was just wondering if you can provide any early commentary on how we should think about 2025 operating margins. Maybe just walking us through some of the puts and takes, and then separately was wondering if you guys can disclose the Winrevair royalty from Merck. Thank you,

Terence C. Flynn: Great. Thanks so much for taking the question. Dave, just wondering if you can provide any early commentary on how we should think about 2025 operating margins. Maybe just walk us through some of the puts and takes. And then separately, I was wondering if you guys can disclose the WINREVAIR royalty from Merck? Thank you. David?

Taryn Swinn: Great, thanks so much for taking the question. Dave, I was just wondering if you can provide any early commentary on how we should think about 2025 operating margins, maybe just walking us through some of the puts and takes.

Speaker Change: And then separately was wondering if you guys can disclose the Winn-Revere royalty from Merck. Thank you.

[Company Representative]: David.

David Elkins: Yeah, thanks, James. And look, we remain committed to our greater than 37% operating margin. And as you saw, we saw strength in our gross margins with a mix of our business, and we feel really good about the operational efficiency programs that we're executing against now, which gives us a lot of flexibility in maintaining those operating margins above 37%.

Chris Boerner: David?

David V. Elkins: Yeah, thanks, James. And look, we remain committed to our greater than 37% operating margin. And, you know, as you saw, we saw strength in our gross margins across our business. And we feel really good about the operational efficiency programs that we're executing against now, which gives us a lot of flexibility in maintaining those operating margins above 37%. Thanks, Terence. I'm sorry about Wynn-Revier, David? Oh, and Wynn-Revier, that we recognize 22% of global sales of Wynn-Revier. That comes through our other growth revenue that comes through there. And you'll hear about those sales from Merck when they come through, but obviously an important growth driver for us at that 22% royalty rate.

David V. Elkins: Yes. Thanks, Terence. And look, we remain committed to our greater 37% operating margin. And as you saw, we saw strength in our gross margins with a mix of our business. And we feel really good about the operational efficiency programs that we're executing against now, which gives us a lot of flexibility in maintaining those operating margins above 37%.

Speaker Change: David? Yeah. Thanks, James. And look, we remain committed to our greater 37% operating margin, and, you know, as you saw, we saw strength in our gross margins with a mix of our business.

Speaker Change: And we feel really good about the operational efficiency programs that we're executing against now, which gives us a lot of flexibility in maintaining those operating margins above 37%. Thanks, Terence.

[Analyst 3]: Thanks Terrence.

Thanks Terrence.

Adam Lenkowsky: Answer about Winrevair, David.

Terence Flynn: Answer about Winrevair, David.

David V. Elkins: Thanks, Terence. I'm sorry about Wynn-Revier, David? Oh, and Wynn-Revier, that we recognize 22% of global sales of Wynn-Revier. That comes through our other growth revenue that comes through there. And you'll hear about those sales from Merck when they come through, but obviously an important growth driver for us at that 22% royalty rate.

Chris Boerner: Thanks, Terence.

Samit Hirawat: Oh, and Winrevair. That. So we recognize 22% of global sales of Winrevair that comes through our other growth revenue that comes through there. And you'll hear about those sales from Merck when they come through. But obviously an important growth driver for us at that 22% royalty rate.

David Elkins: Oh, and Winrevair. That. So we recognize 22% of global sales of Winrevair that comes through our other growth revenue that comes through there. And you'll hear about those sales from Merck when they come through. But obviously an important growth driver for us at that 22% royalty rate.

ter: I'm sorry about Wynn-Revier, David? Oh, and Wynn-Revier, that we recognize 22% of global sales of Wynn-Revier. That comes through our other growth revenue that comes through there. And you'll hear about those sales from Merck when they come through, but obviously an important growth driver for us at that 22% royalty rate.

Tim Power: Answer about WINREVAIR, David?

David V. Elkins: And WINREVAIR, that--so we recognize 22% of global sales of WINREVAIR that comes through our other growth revenue that comes through there. And you'll hear about those sales from Merck when they come through. But obviously, an important growth driver for us at that 22% royalty rate.

Speaker Change: answer about Wynn Revere, David? Oh and Wynn Revere that so we recognize 22% of global sales of Wynn Revere that comes through our other growth revenue that comes through there and you'll hear about those sales from Merck when they come through.

Speaker Change: But obviously an important growth driver for us at that 22% royalty rate.

Adam Lenkowsky: Great, thanks very much, David. Can we go to the next one, please, Rocco?

Tim Power: Great, thanks very much, David. Can we go to the next one, please, Rocco?

David V. Elkins: And you'll hear about those sales from Merck when they come through, but obviously an important growth driver for us at that 22% royalty rate. Thanks very much, David. Could we go to the next one, please, Rocco?

And you'll hear about those sales from Merck when they come through, but obviously an important growth driver for us at that 22% royalty rate.

Tim Power: Thanks very much, David. Could we go to the next one, please, Rocco?

Operator: Yes sir. Our next question today comes from Mohit Bansal with Wells Fargo. Please go ahead.

Operator: Yes, sir. Our next question today comes from Mohit Bansal with Wells Fargo. Please go ahead.

Speaker Change: Thanks very much, David. Can we go to the next one, please, Rocco?

Rocco: Yes sir, our next question today comes from Mohit Bansal with Wells Fargo. Please go ahead.

Adam Lenkowsky: Great. Thank you very much for taking my question, and maybe one question I want to ask is, like, with new launches, there are spaces you have done really well, like oncology and cardiology, now with Camzyos picking up. But immunology seems to be a challenge, and even before Sotyktu, there was Zeposia. So just want to understand what are the access dynamics that you are finding challenging versus your expectations going in. I'm asking because with some of those IL-23s and all, they have found better access than what we are seeing with Sotyktu. So could you please help us understand that? Thank you.

Mohit Bansal: Great. Thank you very much for taking my question, and maybe one question I want to ask is, like, with new launches, there are spaces you have done really well, like oncology and cardiology, now with Camzyos picking up. But immunology seems to be a challenge, and even before Sotyktu, there was Zeposia. So just want to understand what are the access dynamics that you are finding challenging versus your expectations going in. I'm asking because with some of those IL-23s and all, they have found better access than what we are seeing with Sotyktu. So could you please help us understand that? Thank you.

Mohit Bansal: Great, thank you very much for taking my question. And maybe one question I want to ask is that with new launches, there are spaces you have done really well like oncology and cardiology now with CAMZYOS picking up. But the immunology seems to be a challenge. And even before SOTYKTU there was ZEPOSIA. So just want to understand what are the access dynamics that you are finding challenging versus your expectations going in? I'm asking because with some of those IL-23s and all, they have found better access than what we are seeing with SOTYKTU. So could you please help us understand that? Thank you.

Mohit Bansal: Great. Thank you very much for taking my question.

Adam Lenkowsky: So could you please help us understand that? Thank you. Thanks, Mohit. Good question.

So could you please help us understand that? Thank you.

Mohit Bansal: One question I want to ask is that, with new launches, there are spaces you have done really well, like oncology and cardiology now, with themselves picking up, but immunology seems to be a challenge, and even before SOTIC2 there was the POSIA, so I just want to understand,

Mohit Bansal: What are the access dynamics that you are finding challenging versus your expectations going in? I'm asking because with some of those IL-23s and all, they have found better access than what we are seeing with SOTIC-2, so could you please help us understand that? Thank you.

Chris Boerner: Thanks, Mohit. Good question. And Adam, you'll take it.

[Analyst 3]: Thanks, Mohit. Good question. And Adam, you'll take it?

[Company Representative]: Thanks, Mohit. Good question. And Adam, you'll take it?

Adam Lenkowsky: And, Adam, you'll take it. Sure, Mohit. Thanks for the question. As we talked about, you know, we are focused on continuing to accelerate our growth portfolio. As you saw in the quarter, we're making good progress there. You know, we're delivering strong performance for products like Rebelzill, Kemp's IOs, Brianzi, and OptiLag. You know, as I talked about, certificate performance is slower than we would like, and we are focused on improving both performance and execution.

And, Adam, you'll take it.

Adam Lenkowsky: Sure. Mohit, thanks for the question. So as we talked about, we are focused on continuing to accelerate our growth portfolio. As you saw in the quarter, we're making good progress there. We're delivering strong performance for products like REBLOZYL, CAMZYOS, BEYANZI, and OPDUALAG. As I talked about, SOTYKTU performance is slower than we would like, and we are focused on improving both performance and execution. But ultimately, it's the access there that has taken longer than we expected. Remember, in many of the immunology categories that we compete in, these are highly controlled, highly managed products by the large PBMs. And so it took longer for us to get into a preferred position, based on entrenched contracts. And so, as we're seeing uptake now, we are in a much better position with approximately 65% access with most of that at zero step edit. And that's going to be really important. So we recognize this is a highly competitive market.

Adam Lenkowsky: Sure Mohit, thanks for the question. So as we talked about, we are focused on continuing to accelerate our growth portfolio. As you saw in the quarter, we're making good progress there and we're delivering strong performance for products like Reblozyl, Camzyos, Breyanzi, and Opdualag. You know, as I talked about, Sotyktu performance is slower than we would like and we are focused on improving both performance and execution. But ultimately it's the access there that has taken longer than we expected. Remember in many of the immunology categories that we compete in, these are highly controlled, highly managed products by the large PBMs. And so it took longer for us to get into a preferred position based on entrenched contracts.

Adam: Thanks, Mohit. Good question. And Adam, you'll take it. Sure, Mohit. Thanks for the question. So, you know, as we talked about, you know, we are focused on continuing to accelerate our growth portfolio. As you saw in the quarter, we're making good progress there. You know, we're delivering strong performance for products like RebelVille, Kemp's IOs, Brianzi.

Adam: And OptiLag, you know, as I talked about, so tick-to-performance is slower than we would like, and we are focused on improving both performance and execution, but ultimately, it's the access there that has taken longer than we expect to remember.

Adam Lenkowsky: But ultimately, it's the access there that has taken longer than we expect to remember. In many of the immunology categories that we compete in, these are highly controlled, highly managed products by the large PBMs, and so it took longer for us to get into a preferred position based on entrenched contracts. And so as we're seeing uptake now, we're in a much better position with approximately 65% access, and most of that is at zero step edit, and that can be really important. So we recognize this is a highly competitive market.

Adam Lenkowsky: And so as we're seeing uptake now, we're in a much better position with approximately 65% access, and most of that is at zero step edit, and that can be really important. So we recognize this is a highly competitive market. And, you know, we're continuing to make improvements, and we expect further improvements in access in January. As for Zapposia, Zapposia has really been a tale of two launches; we entered the market for multiple sclerosis.

And so as we're seeing uptake now, we're in a much better position with approximately 65% access, and most of that is at zero step edit, and that can be really important. So we recognize this is a highly competitive market.

Speaker Change: In many of the immunology categories that we compete in, these are highly controlled, highly managed.

Speaker Change: And so it took longer for us to get into a preferred position based on entrenched contracts. And so as we're seeing uptake now, we're in a much better position with approximately 65% access with most of that is at zero step edit. And that's going to be really important.

Adam Lenkowsky: So as we're seeing uptake now, we're in a much better position with approximately 65% access, you know, most of that is at zero step edit and that could be really important. So we recognize this is a highly competitive market and you know, we're continuing to make improvements and we expect further improvements in access in January. As relates to Zeposia, Zeposia has really been a tale of two launches. We entered the market in multiple sclerosis and we've seen good uptake there over time. We're doing that in a market that continues to contract based on the increases in the products like Ocrevus and Kesimpta, but we continue to grow our share in a competitive market. Now UC has been more challenging, it is more managed, it's more managed. Class TNFs have preferred status across virtually all of the PBMs.

So as we're seeing uptake now, we're in a much better position with approximately 65% access, you know, most of that is at zero step edit and that could be really important. So we recognize this is a highly competitive market and you know, we're continuing to make improvements and we expect further improvements in access in January. As relates to Zeposia, Zeposia has really been a tale of two launches. We entered the market in multiple sclerosis and we've seen good uptake there over time. We're doing that in a market that continues to contract based on the increases in the products like Ocrevus and Kesimpta, but we continue to grow our share in a competitive market. Now UC has been more challenging, it is more managed, it's more managed. Class TNFs have preferred status across virtually all of the PBMs.

Adam Lenkowsky: And we're continuing to make improvements, and we expect further improvements in access in January. As it relates to ZEPOSIA, ZEPOSIA has really been a tale of two launches. We entered the market in multiple sclerosis. And we've seen good uptake there over time. And we're doing that in a market that continues to contract based on the increases in the products like OCREVUS and KESIMPTA, but we continue to grow our share in a competitive market. Now UC has been more challenging. It is more managed, it's a more managed class, TNF has preferred status across virtually all of the PBMs, but we're also focused on making progress there as well. So I think it's hard to paint immunology in general with a broad brush. ORENCIA continues to perform well, no biosimilar insight. And finally, as we talked about, we're readying for the launch of KarXT, which has a very different access dynamics than what's in the immunology space today. So we're continuing to make progress in delivering strong performance and execution, and we're confident in our ability to continue to grow our business in the near term and into the longer term.

Speaker Change: So we recognize this is a highly competitive market and we're continuing to make improvements and we expect further improvements and access in January .

Adam Lenkowsky: And, you know, we've seen good uptake there over time. And we're doing that in a market that continues to contract based on the increases in the prices of products like Ocrevus and Cosympta. But we continue to grow our share in a competitive market. Now, UC has been more challenging; it is more managed, it's a more managed class. TNS has preferred status across virtually all of the PBMs, but we're also focused on making progress there as well. So, you know, I think it's hard to paint immunology in general with a broad brush. Orenthia continues to perform well, with no biosimilar in sight. And finally, you know, as we talked about, we're readying for the launch of COREX-T, which has a very different access dynamics than what's in the immunology space today. So we're continuing to make progress in delivering strong performance and execution. And we're confident in our ability to continue to grow our business in the near term and into the longer term.

Speaker Change: As it relates to Zapposia, Zapposia has really been a tale of two launches. We entered the market in multiple sclerosis, and we've seen good uptake there over time. We're doing that in a market that continues to contract based on the growth.

Speaker Change: increases in the, you know, the products like Ocrevus and Kesimpta.

Speaker Change: But we continue to grow our share in a competitive market now.

Adam Lenkowsky: TNS has preferred status across virtually all of the PBMs, but we're also focused on making progress there as well. So, you know, I think it's hard to paint immunology in general with a broad brush. Orenthia continues to perform well, with no biosimilar in sight. And finally, you know, as we talked about, we're readying for the launch of COREX-T, which has a very different access dynamics than what's in the immunology space today. So we're continuing to make progress in delivering strong performance and execution. And we're confident in our ability to continue to grow our business in the near term and into the longer term. Thanks, Adam.

TNS has preferred status across virtually all of the PBMs, but we're also focused on making progress there as well. So, you know, I think it's hard to paint immunology in general with a broad brush. Orenthia continues to perform well, with no biosimilar in sight. And finally, you know, as we talked about, we're readying for the launch of COREX-T, which has a very different access dynamics than what's in the immunology space today. So we're continuing to make progress in delivering strong performance and execution. And we're confident in our ability to continue to grow our business in the near term and into the longer term.

Speaker Change: UC has been more challenging. It is more managed. It's a more managed class.

Speaker Change: TNF have preferred status across virtually all of the the PBMs, but we're also focused on making progress there as well. So, you know, I think

Adam Lenkowsky: We're also focused on making progress there as well. You know, I think it's hard to paint immunology in general with a broad brush. You know, Orencia continues to perform well, no biosimilar in sight. And finally, you know, as we talked about, we're ready for the launch of Sotyktu, which has very different access dynamics than what's in the immunology space today. We are continuing to make progress in delivering strong performance and execution, and we're confident in our ability to continue to grow our business in the near term and into the longer term. Thanks, Adam. Let's go to the next question please.

We're also focused on making progress there as well. You know, I think it's hard to paint immunology in general with a broad brush. You know, Orencia continues to perform well, no biosimilar in sight. And finally, you know, as we talked about, we're ready for the launch of Sotyktu, which has very different access dynamics than what's in the immunology space today. We are continuing to make progress in delivering strong performance and execution, and we're confident in our ability to continue to grow our business in the near term and into the longer term.

Speaker Change: It's hard to paint immunology in general with a broad brush. You know, orenthia continues to perform well, no biosimilar in sight.

Speaker Change: And finally, you know, as we talked about, we're readying for the launch of CoreXP, which has a very different access dynamics than what's in the immunology space today. So, we're continuing to make progress in delivering strong performance and execution, and we're confident in our ability to continue to grow our business in the near term and into the longer term.

Tim Power: Thanks, Adam. Let's go to the next question please.

Tim Power: Thanks, Adam. Let's go to the next question, please.

Adam Lenkowsky: Let's go to the next question, please. Yes, sir. Our next question comes from David Risinger with Leering Partners. Please go ahead. Yes, thanks very much.

Let's go to the next question, please.

Yes, sir. Our next question comes from David Risinger with Leering Partners. Please go ahead. Yes, thanks very much.

Operator: Yes, sir. Our next question comes from David Risinger with Leering Partners. Please go ahead.

Operator: Yes, sir. Our next question comes from David Risinger with Leerink Partners. Please go ahead.

Speaker Change: Thanks, Adam. Let's go to the next question, please.

Speaker Change: Yes, sir. Our next question comes from David Risinger with Leering Partners. Please go ahead.

David R. Risinger: Yes. Thanks very much and congrats on the performance. So two questions, please. First is with respect to IRA, many companies, including Bristol, have suggested it's not too much of a problem. And so I'm just helping--I'm hoping that you could help us understand a little bit how you're thinking about drugs that aren't rebated today like Part B drugs such as OPDIVO and their risk of price pressure when they were negotiated relative to drugs that are heavily rebated today like ELIQUIS. So if you could just comment on that, that would be helpful. And then second, with respect to some of your growth drivers. Obviously, you've kind of commented a lot on SOTYKTU and OPDUALAG, but there are competitors that have shown some pretty encouraging data and competitors claim and in some cases, i.e., with respect to SOTYKTU, they're running head-to-head trials that their drugs are going to show much better efficacy across trial than SOTYKTU and OPDUALAG and launch late decade. So if you could just comment on that and how you're thinking about the future competition. Thanks so much.

Samit Hirawat: Yes, thanks very much, and congrats on the performance. So two questions please. First is with respect to IRA, many companies, including Bristol, have suggested it's not too much of a problem.

David Risinger: Yes, thanks very much, and congrats on the performance. So two questions please. First is with respect to IRA, many companies, including Bristol, have suggested it's not too much of a problem.

David R. Risinger: And congratulations on the performance. So, two questions, please. First, with respect to IRA, many companies, including Bristol, have suggested it's not too much of a problem. And so I'm just hoping that you could help us understand a little bit how you think about drugs that aren't rebated today, like Part B drugs, such as Opdivo, and their risk of price pressure when they're negotiated relative to drugs that are heavily rebated today, like Eliquis. So if you could just comment on that, that would be helpful. And second, with respect to some of your growth drivers, obviously, you've kind of commented a lot on Sotictu and Opdulag, but there are competitors that have shown some pretty encouraging data. And competitors claim, and in some cases, i.e., with respect to Sotictu, they're running head-to-head trials that their drugs are going to show much better efficacy across-trial than Sotictu and Opdulag and launch late in the decade. So if you could just comment on that and how you're thinking about the future competition. Thanks so much.

David R. Risinger: Yes, thanks very much and congrats on the performance.

David R. Risinger: Two questions, please. First is...

Speaker Change: With respect to IRA, many companies, including Bristol, have suggested it's not too much of a problem.

David R. Risinger: And so I'm just hoping that you could help us understand a little bit how you think about drugs that aren't rebated today, like Part B drugs, such as Opdivo, and their risk of price pressure when they're negotiated relative to drugs that are heavily rebated today, like Eliquis. So if you could just comment on that, that would be helpful. And second, with respect to some of your growth drivers, obviously, you've kind of commented a lot on Sotictu and Opdulag, but there are competitors that have shown some pretty encouraging data. And competitors claim, and in some cases, i.e., with respect to Sotictu, they're running head-to-head trials that their drugs are going to show much better efficacy across-trial than Sotictu and Opdulag and launch late in the decade. So if you could just comment on that and how you're thinking about the future competition. Thanks so much.

Samit Hirawat: So I'm just helping. I'm hoping that you could help us understand a little bit how you're thinking about drugs that aren't rebated today, like Part B drugs such as Opdivo, and their risk of price pressure when they're negotiated relative to drugs that are heavily.

So I'm just helping. I'm hoping that you could help us understand a little bit how you're thinking about drugs that aren't rebated today, like Part B drugs such as Opdivo, and their risk of price pressure when they're negotiated relative to drugs that are heavily.

David R. Risinger: And so I'm just helping, I'm hoping that you could help us understand a little bit.

Speaker Change: How you're thinking about drugs that aren't rebated today, like Part B drugs such as Opdivo and their risk of price pressure when they're negotiated relative to drugs that are heavily rebated today like Eliquis.

[Analyst 3]: Rebated today, like Eliquis.

Rebated today, like Eliquis.

Samit Hirawat: So if you could just comment on that, that would be helpful. And then second, with respect to some of your growth drivers, obviously you kind of comment a lot on Sotyktu and Opdualag. But there are competitors that have shown some pretty encouraging data and competitors claim, and in some cases that is with respect to Sotyktu, they're running head to head trials that their drugs are going to show much better efficacy cross trial than Sotyktu and Opdualag and launch late decade. So if you could just comment on that and how you're thinking about the future competition. Thanks so much.

So if you could just comment on that, that would be helpful. And then second, with respect to some of your growth drivers, obviously you kind of comment a lot on Sotyktu and Opdualag. But there are competitors that have shown some pretty encouraging data and competitors claim, and in some cases that is with respect to Sotyktu, they're running head to head trials that their drugs are going to show much better efficacy cross trial than Sotyktu and Opdualag and launch late decade. So if you could just comment on that and how you're thinking about the future competition. Thanks so much.

Speaker Change: So if you could just comment on that, that would be helpful. And then second, with respect to some of your growth drivers,

Speaker Change: Obviously, you've kind of commented a lot on SOTIC2 and OpDualag, but there are competitors that have shown some pretty encouraging data and competitors claim, and in some cases,

David R. Risinger: And competitors claim, and in some cases, i.e., with respect to Sotictu, they're running head-to-head trials that their drugs are going to show much better efficacy across-trial than Sotictu and Opdulag and launch late in the decade. So if you could just comment on that and how you're thinking about the future competition. Thanks so much.

Speaker Change: i.e. with respect to SOTIC-2, they're running head-to-head trials that

Speaker Change: Their drugs are going to show much better efficacy cross-trial than SoTik2 and UpDulag and LaunchLateDecade. So if you could just comment on that and how you're thinking about the future competition. Thanks so much.

Adam Lenkowsky: Thanks, David. I'll let Adam address certainly the first question and, actually, probably the second question as well. But let me just first say we're not going to speculate on the impact of products that have not been or aren't planned to be negotiated. Adam can speak generally about how we manage the different books of business between Medicare and commercial, but Adam. Yeah, I mean, I think we're a long way off from 2028.

Chris Boerner: Thanks, David. I'll let Adam address the--certainly the first question and actually probably the second question as well, but let me just first say, we're not going to speculate on the impact of products that have not been or aren't planned to be negotiated. Adam can speak generally about how we manage the different books of business between Medicare and commercial, but Adam?

[Analyst 3]: Thanks, David. I'll let Adam address certainly the first question and actually, probably the second question as well. But let me just first say we're not going to speculate on the impact.

[Company Representative]: Thanks, David. I'll let Adam address certainly the first question and actually, probably the second question as well. But let me just first say we're not going to speculate on the impact.

Speaker Change: Thanks David. I'll let Adam address the certainly the first question and actually probably the second question as well but let me just first say we're not going to speculate on the impact of

[Analyst 3]: Products that have not been or aren't planned to be negotiated. Adam can speak generally about how we manage the different books of business between Medicare and commercial. But Adam?

Products that have not been or aren't planned to be negotiated. Adam can speak generally about how we manage the different books of business between Medicare and commercial. But Adam?

Speaker Change: products that have not been or aren't planned to be negotiated. Adam can speak generally about how we manage the different books of business between Medicare and commercial, but Adam? Yeah I mean I think we're a long way off to 2028 so I agree I think it's premature to

Adam Lenkowsky: Yes. I mean I think we're a long way off to 2028. So I agree. I think it's premature to discuss if OPDIVO would be eligible for IRA negotiation. Remember, if that people make the list, there could be generics in the market or biosimilars in the market as well. But I think most importantly is what you heard from both David and Chris, is that we announced of PDUFA date for our nivo subcu in late December. So our goal is to convert as much business as we can well prior to the LOE and we expect to convert at least 30% to 40% of the total U.S. business for OPDIVO ahead of the LOE. And we think this is a great opportunity for both physicians and patients, and we look forward to launching this important formulation. Also, with a biosimilar in the market and we don't expect to see OPDIVO completely fall off either. So we also expect to see the sub-q and the IV continue into the next decade as well. As it relates to the competition in immunology or in PSO, I think more specifically, as you're asking, again, we are preparing for competition there. I think SOTYKTU has set a high bar for new orals in the PSO space. This is a very competitive category today. It's only going to become more crowded and more competitive over time. We also plan to have several indications, including PSA by--we'll see some data by the end of this year, which will help both PSO and help accelerate SOTYKTU as well as SLE both of which SLA and PSA will be approved and will read out at that time. So we're going to have to see the results of the study. The oral IL-23 Phase III data would need to be meaningfully different in order to move the needle, but we're continuing to make progress with SOTYKTU and executing our plan, and we focus on growing this important brand.

Adam Lenkowsky: Yeah, I mean, I think we're a long way off to 2028. So I agree. I think it's premature to, you know, to discuss if Opdivo would be eligible even for, you know, for IRA negotiation. Remember, you know, if Opdivo makes the list, you know, there could be generics in the market or biosimilars in the market as well. But I think most importantly is what you heard from both David and Chris is that, you know, we announced a PDUFA date for our Nivo Sub Q in late December. So our goal is to convert as much business as we can well prior to the LOE. And we expect to convert at least 30% to 40% of the total US business for Opdivo ahead of the LOE. And we think this is a great opportunity for both physicians and patients.

Adam Lenkowsky: So I agree. I think it's premature to, (inaudible). We expect to convert as much business as we can well prior to the LOE, and we expect to convert at least 30% to 40% of the total U.S. business for OpDivo ahead of the LOE, and we think this is a great opportunity for both physicians and patients, and we look forward to launching this important formulation. Also, you know, with a biosimilar in the market, again, we don't expect to see OpDivo completely fall off either, so we also expect to see the sub queue and the IV continue into the next decade as well. You know, as it relates to the competition in immunology or in PSO, I think more specifically as you're asking, again, we are preparing for competition there.

Adam: You know, to discuss if, uh...

Optivo: Optivo would be eligible even for

Speaker Change: for IRA negotiation. Remember, if a people makes the list,

Adam: There could be generics in the market or biosimilars in the market as well.

Speaker Change: But I think most importantly is what you heard from both.

Speaker Change: David and Chris is that, you know, we announced

Speaker Change: We will be providing a PDF of the Padupa date for our Nevo SubQ in late December . So our goal is to convert as much business as we can well prior to the LOE.

Speaker Change: We expect to convert at least 30-40% of the total U.S. business for OpDivo ahead of the LOE.

Adam Lenkowsky: We look forward to launching this important formulation also with a biosimilar in the market. We don't expect to see Opdivo completely fall off either. We also expect to see the Sub Q and the IV continue into the next decade as well as it relates to the competition in immunology or in PSO. I think more specifically, as you're asking again, you know, we are preparing for competition there. I think so. Take two has set a high bar for new orals in the PSO space. This is a very competitive category today. It's only going to become more crowded and more competitive over time.

We look forward to launching this important formulation also with a biosimilar in the market. We don't expect to see Opdivo completely fall off either. We also expect to see the Sub Q and the IV continue into the next decade as well as it relates to the competition in immunology or in PSO. I think more specifically, as you're asking again, you know, we are preparing for competition there. I think so. Take two has set a high bar for new orals in the PSO space. This is a very competitive category today. It's only going to become more crowded and more competitive over time.

Speaker Change: And we think this is a great opportunity for both physicians and patients, and we look forward to launching this important formulation.

Speaker Change: Also, you know, with a biosimilar in the market, and we don't expect to see Opdivo completely fall off either, so we also expect to see

Speaker Change: The SUBQ and EIV continue into the next decade.

Adam Lenkowsky: You know, as it relates to the competition in immunology or in PSO, I think more specifically as you're asking, again, we are preparing for competition there. I think Satyakti has set a high bar for new orals in the PSO space. This is a very competitive category today. It's only going to become more crowded and more competitive over time.

You know, as it relates to the competition in immunology or in PSO, I think more specifically as you're asking, again, we are preparing for competition there.

Speaker Change: as well.

Speaker Change: As it relates to the competition in...

Speaker Change: immunology or in in PSO I think more

Adam Lenkowsky: I think SOTYKTU has set a high bar for new orals in the PSO space. This is a very competitive category today. It's only going to become more crowded and more competitive over time. We also plan to have several indications, including PSA by--we'll see some data by the end of this year, which will help both PSO and help accelerate SOTYKTU as well as SLE both of which SLA and PSA will be approved and will read out at that time. So we're going to have to see the results of the study. The oral IL-23 Phase III data would need to be meaningfully different in order to move the needle, but we're continuing to make progress with SOTYKTU and executing our plan, and we focus on growing this important brand.

Speaker Change: specifically as you're asking.

Speaker Change: Again, you know, we are.

Speaker Change: Preparing for competition there. I think Satyakthi has set a high bar for New Orleans in the PSO space. This is a very competitive category today. It's only going to become more crowded and more competitive over time.

Adam Lenkowsky: We also plan to have several indications, including PSA by, you know, we'll see some data by the end of this year which will help both PSO and help accelerate Sotyktu as well as SLE, both of which, you know, SLE and PSA will be approved and will read out at that time. So we're going to have to see the results of the study. The oral IL-23 phase 3 data would need to be meaningfully different in order to move the needle. But we're continuing to make progress with Sotyktu in executing our plan and we focus on growing this important brand.

We also plan to have several indications, including PSA by, you know, we'll see some data by the end of this year which will help both PSO and help accelerate Sotyktu as well as SLE, both of which, you know, SLE and PSA will be approved and will read out at that time. So we're going to have to see the results of the study. The oral IL-23 phase 3 data would need to be meaningfully different in order to move the needle. But we're continuing to make progress with Sotyktu in executing our plan and we focus on growing this important brand.

Adam Lenkowsky: We also plan to have several indications, including PSA by, you know, we'll see some data by the end of this year, which will help both PSO and help accelerate Satyakti, as well as SLE, both of which will be approved and will be weeded out at that time. So we're going to have to see the results of the study. The oral IL-23 Phase III data would need to be meaningfully different in order to move the needle, but we're continuing to make progress with Satyakti and executing our plan, as we focus on growing this important brand.

Speaker Change: We also plan to have several indications, including PSA, by, you know, we'll see some data by the end of this year, which will help both PSO and help accelerate CITIC2, as well as SLE,

Speaker Change: Both of which, you know, SLE and PSA will be approved and we'll read out at that time. So we'll have to see the results of the study, the oral IL-23 phase 3 data with D2B.

Speaker Change: meaningfully different in order to move the needle but we're continuing to make progress with the SITIC-2 and executing our plan.

Samit Hirawat: And I think I'll just add because I think you also mentioned Opdualag, and as far as Opdualag is concerned, once again we are way ahead with melanoma indication already approved in the first line, anticipating the data for the adjuvant melanoma, anticipating also the presentation of the phase 2 data soon, and then initiation of the phase 3 program in the subset of non-small cell lung cancer to continue the progress. Rest of the data that we've seen from the competition is just too small to really interpret anything out of that.

Samit Hirawat: And I think, I'll just add because I think you also mentioned, David, up OPDUALAG and as far as OPDUALAG is concerned, once again, we are way ahead with melanoma indication already approved in the first line, anticipating the data for the adjuvant melanoma anticipating also the presentation of the Phase II data soon and the initiation of the Phase III program in the subset of non-small cell lung cancer to continue the progress. Rest of the data that we've seen from the competition is just too small to really interpret anything out of that. Thanks.

Speaker Change: And we focus on growing this important brand.

Speaker Change: And I think, I'll just add, because I think you also mentioned David Abdullag, and as far as Abdullag is concerned, once again, we're way ahead with melanoma indication already approved in the first line.

Speaker Change: Anticipating the data for the adjuvant melanoma, anticipating also the presentation of the phase 2 data soon, and then initiation of the phase 3 program in the subset of non-small cell lung cancer to continue the progress. The rest of the data that we've seen from the competition is just too small to really interpret anything out of that.

[Analyst 3]: Thanks.

David Risinger: Thanks.

Adam Lenkowsky: Thanks. Can we go to the next question please, Rocco?

Tim Power: Thanks. Can we go to the next question please, Rocco?

Chris Boerner: Thanks.

Steve Scala: Can we go to the next question, please, Rocco? Our next question comes from Steve Scala with TD Cowen. Please go ahead. Oh, thank you very much. Chris, I apologize for being picky, but you said two times on the call that Bristol would give visibility on the contour of Eloquist's business around September 1st, but you didn't say Floor Guidance, And when you were specifically asked about floor guidance, you repeated something from earlier in the call. So is floor guidance no longer in the plan?

Tim Power: Can we go to the next question, please, Rocco?

Speaker Change: Thanks. Thanks a lot. Can we go to the next question, please, Rocco?

Operator: Absolutely. Our next question comes from Steve Scala with TD Cowen. Please go ahead.

Our next question comes from Steve Scala with TD Cowen. Please go ahead. Oh, thank you very much. Chris, I apologize for being picky, but you said two times on the call that Bristol would give visibility on the contour of Eloquist's business around September 1st, but you didn't say Floor Guidance, And when you were specifically asked about floor guidance, you repeated something from earlier in the call. So is floor guidance no longer in the plan?

Operator: Absolutely. Our next question comes from Steve Scala with TD Cowen. Please go ahead.

Rocco: Absolutely. Our next question comes from Steve Scala with TD Cowen. Please go ahead.

Steve Scala: Thank you very much. Chris, I apologize for being picky, but you said two times on the call that Bristol would give visibility on the contour of ELIQUIS business around September 1st, but you didn't say floor guidance. And when you were specifically asked about floor guidance, you repeated something from earlier in the call. So is floor guidance no longer in the plans? And secondly, Samit, on cendakimab in OE. So DUPIXENT showed 60% of patients achieved histologic remission at 24 weeks. Is cendakimab fully competitive with that. You sound very confident. So it sounds like, yes, and historically, your tone in saying things like this has been very predictive. So I'm just curious what to make of it.

[Analyst 1]: Thank you very much. Chris, I apologize for being picky, but you said two times on the call that Bristol would give visibility on the contour of Eliquis business around 1 September, but you didn't say floor guidance. And when you were specifically asked about floor guidance you repeated something from earlier in the call. So is floor guidance no longer in the plans? And secondly, update on cendakimab in EoE. So Dupixent showed 60% of patients achieved histologic remission at 24 weeks. Is cendakimab fully competitive with that? You sound very confident. So it sounds like yes. And historically your tone in saying things like this has been very predictive. So I'm just curious what to make of it. Thank you.

Steve Scala: Thank you very much. Chris, I apologize for being picky, but you said two times on the call that Bristol would give visibility on the contour of Eliquis business around 1 September, but you didn't say floor guidance. And when you were specifically asked about floor guidance you repeated something from earlier in the call. So is floor guidance no longer in the plans? And secondly, update on cendakimab in EoE. So Dupixent showed 60% of patients achieved histologic remission at 24 weeks. Is cendakimab fully competitive with that? You sound very confident. So it sounds like yes. And historically your tone in saying things like this has been very predictive. So I'm just curious what to make of it. Thank you.

Steve Scala: Thank you very much. Chris, I apologize for being picky, but you said two times on the call that Bristol would give visibility on the contour of Eloquist's business around September 1st, but you didn't say floor guidance.

Speaker Change: And when you were specifically asked about floor guidance, you repeated something from earlier in the call. So, is floor guidance no longer in the plans?

Chris Boerner: And secondly, Samit on syndecimab and EOE. Dupixent showed 60% of patients achieved histologic remission at 24 weeks. Is Sendakamab fully competitive with that? You sound very confident, so it sounds like yes. And historically, your tone in saying things like this has been very predictive, so I'm just curious what to make of it. Thank you.

Speaker Change: and secondly Samit on syndecamab and EOE. So Dupixent showed 60% of patients achieved histologic remission at 24 weeks.

Speaker Change: Is Sendakamab fully competitive with that? You sound very confident, so it sounds like yes, and historically your tone in saying things like this has been very predictive, so I'm just curious what to make of it. Thank you.

Samit Hirawat: And historically, your tone in saying things like this has been very predictive, so I'm just curious what to make of it. Thank you. Thanks, Steve. I'll start, and then I'll turn it over to Samit.

And historically, your tone in saying things like this has been very predictive, so I'm just curious what to make of it. Thank you.

Chris Boerner: Thanks, Steve. I'll start, and then I'll turn it over to Samit. So look, we know there's a lot of interest in this topic around floor guidance. As I've said before, in general, we've moved away from providing long-term targets. This actually reflects us going back to the company has done historically. That said, we continue to increase our confidence in the long-term growth profile of this business. We're going to continue to provide updates to you on that business as appropriate, and we'll be transparent about how we see the business evolving. And as for how we do that and when we do that, as I think most of you are aware, our normal practice is to provide forward-looking guidance at the beginning of the year. Normally, when we report our Q4 results and we're going to continue with that process. Samit?

Adam Lenkowsky: Thanks Steve.

[Company Representative]: Thanks Steve.

Chris Boerner: So look, we know there's a lot of interest in this topic around floor guidance. As I've said before, in general, we've moved away from providing long-term targets. This actually reflects us going back to what the company did historically.

[Analyst 3]: I'll start and then I'll turn it over to Samit. So look, we know there's a lot of interest in this topic around floor guidance. As I've said before, in general we've moved away from providing long-term targets. This actually reflects us going back to what the company has done historically. That said, we continue to increase our confidence in the long-term growth profile of this business. We're going to continue to provide updates to you on that business as appropriate, and we'll be transparent about how we see the business evolving. As for how we do that and when we do that, as I think most of you are aware, our normal practice is to provide forward-looking guidance at the beginning of the year, normally when we report our Q4 results, and we're going to continue with that process.

I'll start and then I'll turn it over to Samit. So look, we know there's a lot of interest in this topic around floor guidance. As I've said before, in general we've moved away from providing long-term targets. This actually reflects us going back to what the company has done historically. That said, we continue to increase our confidence in the long-term growth profile of this business. We're going to continue to provide updates to you on that business as appropriate, and we'll be transparent about how we see the business evolving. As for how we do that and when we do that, as I think most of you are aware, our normal practice is to provide forward-looking guidance at the beginning of the year, normally when we report our Q4 results, and we're going to continue with that process. Samit.

Speaker Change: Thanks, Steve. I'll start and then I'll turn it over to Samit. So, look, we know there's a lot of interest in this topic around floor guidance. As I've said before, in general, we've moved away from providing long-term targets. This actually reflects us going back to what the company has done historically.

Samit: That said, we continue to increase our confidence in the long-term growth profile of this business. We're going to continue to provide updates to you on that business as appropriate, and we'll be transparent about how we see the business evolving.

Chris Boerner: That said, we continue to increase our confidence in the long-term growth profile of this business. We're going to continue to provide updates to you on that business as appropriate, and we'll be transparent about how we see the business evolving. And as for how we do that and when we do that, as I think most of you are aware, our normal practice is to provide forward-looking guidance at the beginning of the year, normally when we report our Q4 results, and we're going to continue with that process. Samit?

Samit: And as for how we do that and when we do that, as I think most of you are aware, our normal practice is to provide forward-looking guidance at the beginning of the year, normally when we report our Q4 results, and we're going to continue with that process.

Samit Hirawat: Samit, thank you and thanks for the question. Steve, as always, very pointed one. Look, we did do the study as it relates to comparison versus Dupixent. So it's very hard to start comparing the data. Also remember the way the dysphagia days, which is the more important and most important thing from a symptom relief for the patient, the way we measured it versus what Dupixent did in their study, are very different ways. So we have to keep that in mind. Certainly will not comment on the specificity of the data because we would rather present it at a medical conference or to come on that. Certainly, as mentioned earlier by Adam as well, we look to the data deeply and put it into perspective as we go forward, also in communications with regulators.

Samit Hirawat: Thank you and thanks for the question. Steve, as always, very pointed one. Look, we did do the study as it relates to comparison versus Dupixent. So it's very hard to start comparing the data. Also remember the way the dysphagia days, which is the more important and most important thing from a symptom relief for the patient, the way we measured it versus what Dupixent did in their study, are very different ways. So we have to keep that in mind. Certainly will not comment on the specificity of the data because we would rather present it at a medical conference or to come on that. Certainly, as mentioned earlier by Adam as well, we look to the data deeply and put it into perspective as we go forward, also in communications with regulators.

Samit Hirawat: Thank you. And thanks for the question, Steve. As always, very pointed one. Look, we did do the study as it relates to comparison versus DUPIXENT. So it's very hard to start comparing the data. Also remember the way the dysphagia days, which is a more important and most important thing from a symptom relief for the patient. The way we measured it versus what DUPIXENT did in their study are very different ways. So we have to keep that in mind. Certainly will not comment on the specificity of the data because we would rather present it at a medical conference or to come on that. Certainly, as mentioned earlier by Adam as well, we look to the data deeply and put it into perspective as we go forward also in communications with the regulators.

Speaker Change: Samit? Thank you. And thanks for the question, Steve, as always, very pointed one. Look, we did do the study as it relates to comparison versus to PICSET, so it's very hard to start comparing the data.

Speaker Change: Also remember the way that dysphagia days which is a more important and most important thing from a symptom relief for the patient

Speaker Change: The way we measured it versus what Dupikshan did in their study are very different ways.

Adam: So we have to keep that in mind. Certainly we will not comment on the specificity of the data because we would rather present it at a medical conference or to come on that. Certainly as mentioned earlier by Adam as well, we look to the data deeply and put it into perspective as we go forward also in communications with regulators.

Adam Lenkowsky: Let's go to the next question please. Ranka.

Tim Power: Let's go to the next question please. Ranka.

Samit Hirawat: Certainly, we'll not comment on the specificity of the data because we would rather present it at a medical conference or something like that. Certainly, as mentioned earlier by Adam as well, we look at the data deeply and put it into perspective as we go forward in our communications with regulators. Let's go to the next question, please. Absolutely. Our next question today comes from Trung Huynh with UBS. Please go ahead. Morning guys, Trung Huynh from UBS.

Certainly, we'll not comment on the specificity of the data because we would rather present it at a medical conference or something like that. Certainly, as mentioned earlier by Adam as well, we look at the data deeply and put it into perspective as we go forward in our communications with regulators.

Operator: Absolutely. Our next question today comes from Trung Huynh with UBS. Please go ahead.

Adam: Let's go to the next question, please, Raka.

Raka: Absolutely. Our next question today comes from Trung Huynh with UBS. Please go ahead.

Let's go to the next question, please. Absolutely. Our next question today comes from Trung Huynh with UBS. Please go ahead. Morning guys, Trung Huynh from UBS.

Tim Power: Let's go to the next question, please, Rocco.

Operator: Absolutely. Our next question today comes from Trung Huynh with UBS. Please go ahead.

[Analyst 1]: Morning guys. Trung Huynh from UBS. I have a few follow-ups on the Sub Q Opdivo. So today you highlighted again the 30% to 40% conversion. How quickly are you arriving at this 30% to 40% of patients? What's stopping it from being more as we've seen things like Darzalex have quite significant conversion. And then when is the exclusivity expected to last for this Sub Q vs IV? Given the somewhat recent CMS drafts on IRA on Sub Q formulations. I think you mentioned in one of the questions the next decade, but do you have a year? Thank you, Adam.

[Analyst 3]: Morning guys. Trung Huynh from UBS. I have a few follow-ups on the Sub Q Opdivo. So today you highlighted again the 30% to 40% conversion. How quickly are you arriving at this 30% to 40% of patients? What's stopping it from being more as we've seen things like Darzalex have quite significant conversion. And then when is the exclusivity expected to last for this Sub Q vs IV? Given the somewhat recent CMS drafts on IRA on Sub Q formulations. I think you mentioned in one of the questions the next decade, but do you have a year? Thank you,

Trung Huynh: I have a few follow-ups on the sub-Q of Devo. So today you highlighted again the 30-40% conversion. How quickly are you reaching this 30-40% of patients? What's stopping it from being more? As we've seen things like Darzalex have quite significant conversions, And then, when is the exclusivity expected to last for this sub-Q versus IV given the somewhat recent CMS drafts on IRI for sub-Q formulations? I think you mentioned in one of the questions the next decade, but do you have a year? Thank you. Adam?

Trung Huynh: Good morning, guys. Trung Huynh from UBS. I have a few follow-ups on the subcu OPDIVO. So today you highlighted again the 30% to 40% conversion. How quickly are you arriving at this 30% to 40% of patients? What's stopping it from being more as we've seen things like DARZALEX have quite significant conversion? And then, when is the exclusivity expected to last for this sub-q versus IV given the somewhat recent CMS drafts on IRA on sub-q formulations? I think you mentioned in one of the questions the next decade, but do you have a year? Thank you.

Raka: Morning guys, Trung Huynh from UBS. I have a few follow-ups on the sub-q of Devo. So today you highlighted again the 30-40% conversion.

Trung Huynh: How quickly are you arriving at this 30-40% of patients? What's stopping it from being more? We've seen things like Darzalex have quite significant conversion.

Trung Huynh: And then, when is the exclusivity expected to last for this sub-Q versus IV, given the somewhat recent CMS drafts on IRI on sub-Q formulations? I think you mentioned in one of the questions, the next decade, but do you have a year? Thank you.

[Company Representative]: Adam.

Chris Boerner: Adam?

Adam Lenkowsky: Yeah, Trung, thanks for the question. So again, as I said, we are looking forward to the PDUFA date in late December, and our launch planning is, we said, we would convert at least 30% to 40% of the total US Opdivo IV business. We have the good news. We have time because the LOE is not until 2028. So we expect that conversion to come largely from patients who are in the adjuvant setting, use in combination with Yervoy where there's continuing Opdivo treatment. For example, indications in metastatic melanoma, in first line RCC, as well as in Opdivo monotherapy. These indications represent approximately 70% of our overall business. So we talked about the benefits of Sub Q, has the potential to benefit both patients with a less than 5 minute infusion time and physicians who are able to free up chairs, particularly in the community setting.

Adam Lenkowsky: Yeah, Trung, thanks for the question. So again, as I said, we are looking forward to the PDUFA date in late December and our launch planning is continuing to progress. So we said we have converted at least 30% to 40% of the total U.S. OPDIVO IV business. And we have--the good news is we have time because the LOE is not until 2028. So we expect that conversion to come largely from patients who are in the adjuvant setting, use in combination with YERVOY where there is continuing OPDIVO treatment, for example, indications in metastatic melanoma in first-line RCC as well as in OPDIVO monotherapy. These indications represent approximately 70% of our overall business. And so we talked about the benefits of nivo sub-q has the potential to benefit both patients with a less than five-minute infusion time and physicians who are able to free-up chairs, particularly in the community setting. And we do have the potential to benefit patients through the next decade with nivo sub-q based on the fact that we've got a broad patent estate. So we expect to see both nivo sub-q and OPDUALAG continue to persist our leading IO franchise into the early 2030s.

Trung Huynh: Adam? Yeah Trung, thanks for the question. So again, as I said, we are looking forward to...

Speaker Change: The Padova date in late December and our launch planning is continuing to progress all week. We said we would convert at least 30 to 40 percent of the total U.S. OpDivo IV business and we have the good news we have time because the LOE is not until 2028.

Speaker Change: So we expect that conversion to come largely from patients who are, you know, in the adjuvant setting, use in combination with Yervoy where there's continuing Optivo treatment, for example, or indications in metastatic melanoma.

Speaker Change: In first line RCC, as well as in ob-devo monotherapy. These indications represent approximately 70% of our overall business.

Adam Lenkowsky: These indications represent approximately 70% of our overall business, and so we talked about the benefits of Nevo SubQ, which has the potential to benefit both patients with a less than five minute infusion time and physicians who are able to free up chairs, particularly in the community setting. We do have the potential to benefit patients in the next decade with Nevo SubQ based on the fact that we've got a broad patent estate, so we expect to see both Nevo SubQ and OptiLag continue to be our leading I.O. franchise into the early 2030s.

Speaker Change: And so we talked about the benefits of Mevo SubQ, has the potential to benefit both patients with a less than five minute infusion time and physicians who are able to free up chairs, particularly in the community setting.

Adam Lenkowsky: We do have the potential to benefit patients in the next decade with Nivo Subq based on the fact that we've got a broad patent estate. So we expect to see both Nivo Subq and Opdualag continue to persist our leading IO franchise into the early 2030s.

We do have the potential to benefit patients in the next decade with Nivo Subq based on the fact that we've got a broad patent estate. So we expect to see both Nivo Subq and Opdualag continue to persist our leading IO franchise into the early 2030s.

Speaker Change: We do have the potential to benefit patients in the next decade with NEVO SubQ.

Speaker Change: Based on the fact that we've got a broad patent estate, so we expect to see both Nevo SubQ and OptiLag.

Speaker Change: Continue to persist our leading I.O. franchise into the early 2030s.

Adam Lenkowsky: Thanks, Adam. Let's go to the next question, please. Absolutely. Our next question comes from Matthew Phipps with William Blair. Please go ahead. Thanks for doing the questions.

Thanks, Adam. Let's go to the next question, please. Absolutely. Our next question comes from Matthew Phipps with William Blair. Please go ahead.

Tim Power: Thanks, Adam. Let's go to the next question, please.

Adam Lenkowsky: Thanks Adam. Let's go to the next question please.

Tim Power: Thanks Adam. Let's go to the next question please.

Operator: Absolutely. Our next question comes from Matthew Phipps with William Blair. Please go ahead.

Speaker Change: Thanks, Adam. Let's go to the next question, please.

Speaker Change #100: Absolutely. Our next question comes from Matthew Phipps with William Blair. Please go ahead.

Matthew Phipps: Thanks for taking my questions. Two quick ones on Phase III trials. Wondered if recruitment has recommenced in the ACTION-1 trial with RZ101 and Actinium supply is secured there. And then on the successor trials with mezigdomide, it looks like the trials have advanced to Part 2 of the Phase III. Wondering if you can give us any sense of the dose that was taken from Part 1 into Part 2? Thank you.

Matthew Phipps: Two quick ones on Phase 3 trials. I wondered if recruitment has recommenced in the Action 1 trial with RZ-101, and Fectinium supply is secured there. And then on the successor trials with Mavigdamide, it looks like the trials have advanced to Part 2 of the Phase 3. I'm wondering if you can give us any sense of the dose that was taken from Part 1 into Part 2. Thank you. Matt.

[Analyst 3]: Thanks for taking the questions. Two quick ones on phase 3 trials.

Matthew Phipps: Thanks for taking the questions. Two quick ones on phase 3 trials.

Samit Hirawat: What are these?

What are these?

Matthew Phipps: Thanks for doing the questions. Two quick ones on Phase 3 trials. What if recruitment has recommenced in the Action 1 trial with RZ-101?

[Analyst 3]: Recruitment has recommenced in the ACTION-1 trial with RYZ101 and Actinium-225 supply is secured there.

Recruitment has recommenced in the ACTION-1 trial with RYZ101 and Actinium-225 supply is secured there.

Samit Hirawat: On the successor trials with Mezigdomide. It looks like the trials have advanced.

On the successor trials with Mezigdomide. It looks like the trials have advanced.

Matthew Phipps: Fectinium Supply is secured there. And then on the successor trials with Navigdamide, it looks like the trials have advanced to part two of the phase three. I'm wondering if you can give us any sense of the dose that was taken from part one into part two.

[Analyst 3]: To part two of the Phase 3. Wondering if you can give us any sense of the dose that was taken from part one into part two? Thank you, Matt. Thanks, Matt. Amit.

To part two of the Phase 3. Wondering if you can give us any sense of the dose that was taken from part one into part two? Thank you,

[Company Representative]: Matt. Thanks, Matt. Amit.

Matthew Phipps: Thanks, Matt. From it, yeah. Thank you for both the questions. For the Actinium 225 study, as you know, we are the furthest along in terms of the Actinium 225 Phase 3 trial. GapNet is the first indication with very strong data supporting it.

Chris Boerner: Thanks, Matt. Samit?

Samit Hirawat: Yeah. Thank you for both the questions. For the Actinium 225 study, as you know, we are the furthest along in terms of the Actinium 225 Phase 3 trial. GapNet is the first indication with very strong data supporting it.

Samit Hirawat: Yeah, thank you. For both the questions for the Actinium-225 study. As you know, we are the furthest along in terms of Actinium-225 phase 3 trial. GEP-NETs is the first indication with very strong data supporting it. We have reinitiated the recruitment in the trial, and we are still looking forward to the data readout in 2026 along with certainly looking forward to new indications starting with small cell lung cancer phase 1 trial that is already ongoing for Mezigdomide trial. Again, enrollment is continuing. We will not yet declare what the dose we've taken forward, but certainly yes, both trials have moved to the part 2 of the study, and you'll continue to hear about how the trial progresses, and we're looking forward to the readout starting in 2020.

Matthew Phipps: Thanks Matt from it. Thank you for both the questions.

Speaker Change #102: For the Actinium-225 study, as you know, we are the furthest along in terms of the Actinium-225 Phase III trial. GapNet is the first indication, with very strong data supporting it. We have reinitiated the recruitment in the trial, and we are still looking forward to the data readout in 2026.

Samit Hirawat: We have reinitiated recruitment in the trial, and we are still looking forward to the data readout in 2026, along with certainly looking forward to new indications starting with small cell lung cancer Phase 1 trial that is already ongoing. For mesigdamide, again, enrollment is continuing. We will not yet declare the dose we've taken forward, but certainly, yes, both trials have moved to Part 2 of the study, and you'll continue to hear about, you know, how the trial progresses, and we're looking forward to the readout starting in 2020. Thanks, Samit.

We have reinitiated recruitment in the trial, and we are still looking forward to the data readout in 2026, along with certainly looking forward to new indications starting with small cell lung cancer Phase 1 trial that is already ongoing. For mesigdamide, again, enrollment is continuing. We will not yet declare the dose we've taken forward, but certainly, yes, both trials have moved to Part 2 of the study, and you'll continue to hear about, you know, how the trial progresses, and we're looking forward to the readout starting in 2020.

Speaker Change #102: Along with certainly looking forward to new indications starting with small cell lung cancer phase one trial that is already ongoing.

Speaker Change #102: For Mezygdamai trial, again, enrollment is continuing, we will not yet declare what the dose we've taken forward, but certainly, yes, both trials have moved to the part two of the study, and you'll continue to hear about, you know, how the trial progresses, and we're looking forward to the readout starting in 2026.

Adam Lenkowsky: Thanks, Samit. Let's go to the next question, please.

Tim Power: Thanks, Samit. Let's go to the next question, please.

Samit Hirawat: Let's go to the next question, please. Absolutely. Our next question comes from Olivia Brayer with Cancer Fitzgerald. Please go ahead. Hi, good morning, and thank you for the question.

Let's go to the next question, please.

Operator: Absolutely. Our next question comes from Olivia Brayer with Cantor Fitzgerald. Please go ahead.

Speaker Change #103: Thanks Samit. Let's go to the next question please.

Absolutely. Our next question comes from Olivia Brayer with Cancer Fitzgerald. Please go ahead. Hi, good morning, and thank you for the question.

Operator: Absolutely. Our next question comes from Olivia Brayer with Cantor Fitzgerald. Please go ahead.

Olivia Brayer: Hi, good morning, and thank you for the question. I wanted to ask a follow-up on SOTATERCEPT. It looks like you guys changed your other income guidance by about $200 million for the year. So is that essentially entirely from the SOTATERCEPT launch? Obviously, a big number there if you back it out based on a 22--or a 22% royalty rate. And then how are you thinking about SOTATERCEPT's contribution to your P&L going forward just given the strong economics there? And one more, just can you also comment on level of enthusiasm around your PRMT5 program and what we'll see from the Phase I readout in the back half of the year? Thank you.

Speaker Change #104: Absolutely. Our next question comes from Olivia Brayer with Cancer Fitzgerald. Please go ahead.

[Analyst 2]: Hi, good morning, and thank you for the question. I wanted to ask a follow up on sotatercept. It looks like you guys changed your other income guidance by about $200 million for the year. So is that essentially entirely from the sotatercept launch? Obviously a big number there. If you back it out based on a 2022 or a 22% royalty rate. And then how are you thinking about sotatercept's contribution to your P&L going forward just given the strong economics there. And one more, just can you also comment on level of enthusiasm around your PRMT5 program and what we'll see from the phase 1 readout in the back half of the year?

[Analyst 4]: Hi, good morning, and thank you for the question. I wanted to ask a follow up on sotatercept. It looks like you guys changed your other income guidance by about $200 million for the year. So is that essentially entirely from the sotatercept launch? Obviously a big number there. If you back it out based on a 2022 or a 22% royalty rate. And then how are you thinking about sotatercept's contribution to your P&L going forward just given the strong economics there. And one more, just can you also comment on level of enthusiasm around your PRMT5 program and what we'll see from the phase 1 readout in the back half of the year? Thank you.

Olivia Brayer: I want to ask a follow-up question on Sotatercept. It looks like you guys changed your other income guidance by about $200 million for the year. So is that essentially entirely from the Sotatercept launch? Obviously a big number there if you back it out based on a 22% royalty rate. And then how are you thinking about Sotatercept's contribution to your P&L going forward just given the strong economics there? And one more, can you also comment on the level of enthusiasm around your PRMT-5 program and what we'll see from the phase one readout in the back?

Olivia Brayer: Hi, good morning and thank you for the question. I wanted to ask a follow-up on Sotatercept. It looks like you guys changed your other income guidance by about $200 million for the year. So is that essentially entirely from the Sotatercept launch? Obviously a big number there if you back it out based on a 22% royalty rate.

Olivia Brayer: And then how are you thinking about Sotatercept's contribution to your P&L going forward just given the strong economics there? And one more, can you also comment on the level of enthusiasm around your PRMT-5 program and what we'll see from the phase one readout in the back? David, David, and Samit.

And then how are you thinking about Sotatercept's contribution to your P&L going forward just given the strong economics there? And one more, can you also comment on the level of enthusiasm around your PRMT-5 program and what we'll see from the phase one readout in the back?

Speaker Change #106: And then how are you thinking about Satyarthit's contribution to your P&L going forward, just given the strong economics there? And one more, can you also comment on level of enthusiasm around your PRMT-5 program and what we'll see from the phase one readout in the back half of the year? Thank you.

Adam Lenkowsky: Thank you David.

Chris Boerner: David and Samit.

[Company Representative]: David.

Samit Hirawat: Yeah, Olivia, thanks for your question. The 1 increase was mainly driven by two things, as I said earlier in my remarks, which is the diabetes royalties coming in better than we had anticipated, as well as interest expense coming in better than anticipated. What I was saying earlier related to Winrevair, since we still own the intellectual property of that, that 22% of global sales related to the product goes through our other growth revenue line. It comes through sales. Thank you, Olivia, for the question on PRMT5. Certainly, again, very much further along on that one. Phase 1 trial continues on what we will be presenting data is the responses that have been seen across multiple different tumor types.

David Elkins: Yeah, Olivia, thanks for your question. The 1 increase was mainly driven by two things, as I said earlier in my remarks, which is the diabetes royalties coming in better than we had anticipated, as well as interest expense coming in better than anticipated. What I was saying earlier related to Winrevair, since we still own the intellectual property of that, that 22% of global sales related to the product goes through our other growth revenue line. It comes through sales.

David V. Elkins: Yeah, Olivia, thanks for the question. The O&E increase was mainly driven by two things, as I said earlier in my prepared remarks, which is the diabetes royalties coming in better than we had anticipated as well as interest expense coming in better than anticipated. And what I was saying earlier related to WINREVAIR, since we still own the intellectual property of that, that 22% of global sales related to the product goes through our other growth revenue line. So it comes through sales.

David: David then Samit? Yeah, Olivia, thanks for your question. The ONE increase was

Speaker Change #108: Mainly driven by two things, as I said earlier in my prepared remarks, which is...

Speaker Change #108: The Diabetes Royalty is coming in better than we had anticipated, as well as interest expense coming in better than anticipated. And what I was saying earlier related to Wynn Revere, since we still own the intellectual property of that, that 22% of global sales related to the product goes through our other...

Samit Hirawat: Thank you, Olivia, for the question on PRMT5. Certainly, again, very much further along on that one. Phase 1 trial continues on what we will be presenting data is the responses that have been seen across multiple different tumor types.

Samit Hirawat: And thank you, Olivia, for the question on PRMT5. Certainly, again, very much further along on that one. Phase I trial continues on. What we will be presenting data is the responses that have been seen across multiple different tumor types. So really looking forward to presenting that data as we plan to initiate the Phase II studies in a couple of indications, which we will talk about more as we get closer to the initiation of those trials in selected patients, of course, with MTAP deletions.

Speaker Change #108: Growth Revenue Line. So it comes through sales.

Speaker Change #109: And thank you, Olivia, for the question on PRMT-5. Certainly, again, very much further along on that one. Phase 1 trial continues on. What we will be presenting data is the responses that have been seen across multiple different tumor types.

Samit Hirawat: So, really looking forward to presenting that data as we plan to initiate the phase 2 studies and a couple of indications, which we will talk about more as we get closer to the initiation of those trials in selected patients, of course, with MTAP deletions.

So, really looking forward to presenting that data as we plan to initiate the phase 2 studies and a couple of indications, which we will talk about more as we get closer to the initiation of those trials in selected patients, of course, with MTAP deletions.

Speaker Change #109: So we're really looking forward to presenting that data as we plan to initiate the phase 2 studies and a couple of indications which we will talk about more as we get closer to the initiation of those trials.

Adam Lenkowsky: Thanks. Let's go to the next one please. Rocco.

Tim Power: Thanks. Let's go to the next one please. Rocco.

Samit Hirawat: Well, let's go to the next one, please, Roger. Yes sir, our next question comes from Steve Chesney with Redburn Atlantic. Please go ahead. Yeah, great.

Tim Power: Thanks. And let's go to the next one, please, Rocco.

Speaker Change #109: In selected patients, of course, with MTEP deletions.

Operator: Yes, sir. Our next question comes from Steve Chesney with Redburn Atlantic. Please go ahead.

Speaker Change #110: Thanks. Let's go to the next one, please, Rocco.

Rocco: Yes sir, our next question comes from Steve Chesney with Redburn Atlantic. Please go ahead.

[Analyst 1]: Yeah, great, thank you. Maybe just a follow up on radiopharma, please. With regard to the commercial opportunity for RYZ101 and GEP-NETs, I wonder how competitor filings of an ANDA and a 505(b)(2) for Lutathera impacts your thinking on pricing for innovators in the space. And then also on CD19 NEX-T, we've seen a couple competitor data sets over the past month or two that showed relapses at a fairly early time point and somewhat lower than expected response rates. Just wondering how you guys have been thinking about that as it relates to CD19 NEX-T. You know, whether you have more confidence in your construct or are you doing something differently on dosing? Thank you, Adam.

Steve Chesney: Yeah, great, thank you. Maybe just a follow up on radiopharma, please. With regard to the commercial opportunity for RYZ101 and GEP-NETs, I wonder how competitor filings of an ANDA and a 505(b)(2) for Lutathera impacts your thinking on pricing for innovators in the space. And then also on CD19 NEX-T, we've seen a couple competitor data sets over the past month or two that showed relapses at a fairly early time point and somewhat lower than expected response rates. Just wondering how you guys have been thinking about that as it relates to CD19 NEX-T. You know, whether you have more confidence in your construct or are you doing something differently on dosing? Thank you,

Steve Chesney: Thank you. Maybe just to follow up on radiopharmaceuticals, please. With regard to the commercial opportunity for RAYS 101 and GEPNUTS, I wonder how competitor filings of an ANDA and a 505B2 for Lutathera impact your thinking on pricing for innovators in the space. And then also on CARNXT, we've seen a couple competitor datasets over the past month or two that showed relapses at a fairly early time point and somewhat lower than expected response rates. Just wondering how you guys have been thinking about that as it relates to CARNXT, whether you have more confidence in your construct, or are you doing something differently on dosing? Thank you. Adam, then Samit.

Steve Chesney: Yeah, great. Thank you. Maybe just a follow-up on radiopharma, please. With regard to the commercial opportunity for RYZ101 and GEP-NET, I wonder how competitor filings of an ANDA and a 505(b)(2) for LUTATHERA impacts your thinking on pricing for innovators in the space? And then also on KarXT, we've seen a couple of competitor data sets over the past month or two that showed relapses at a fairly early time point and somewhat lower-than-expected response rates. Just wondering how you guys have been thinking about that as it relates to KarXT, whether you have more confidence in your construct or are you doing something differently on dosing? Thank you.

Stephen Michael Scala: Yeah, great. Thank you. Maybe just a follow-up on radiopharma, please. With regard to the commercial opportunity for Rays 101 and GEPNUTS, I wonder how competitor filings of an ANDA and a 505B2 for Lutathera impacts your thinking on pricing for innovators in the space?

Speaker Change #112: And then also on CARNXT, we've seen a couple competitor datasets over the past month or two.

Speaker Change #112: That showed relapses at a fairly early time point.

Speaker Change #112: and somewhat lower than expected response rates. Just wondering how you guys have been thinking about that as it relates to CARNEXT, you know, whether you have more confidence in your construct or are you doing something differently on dosing? Thank you.

Chris Boerner: Adam, then Samit.

Adam Lenkowsky: Yeah, first, let me just talk about our enthusiasm about RayzeBio and the platform that we have here. We believe this is a really exciting platform, one that's going to grow significantly through the back end of the decade. And what particularly excites us about Rayze is the kind of robust IND engine that we'll see over the course of the next decade or plus as well as what we know is a state-of-the-art manufacturing facility that has been forward. Now the lead program in RYZ101 in GEP-NET is, I think, a fairly modest commercial opportunity. However, when you look at this technology, particularly the Actinium-based radiopharmaceutical platform, this has the potential to have efficacy and safety across a host of solid tumor treatments. So as we've talked about, we are looking at this in small-cell lung cancer and potentially many other tumor types. So we look forward to launching the GEP-NET indication that will be the lead asset and well--as well as a number of new INDs coming in the back half of the decade and beyond.

[Analyst 3]: Then summit.

[Company Representative]: Adam Then summit.

Adam Lenkowsky: Yeah, first let me just talk about our enthusiasm about RayzeBio and the platform that we have here. We believe this is a really exciting platform, one that's going to grow significantly through the back end of the decade. And you know, what particularly excites us about RayzeBio is the kind of robust IND engine that we'll see over the course of the next decade or plus, as well as what we know is a state-of-the-art manufacturing facility that has now the lead program in RYZ101 in GEP-NETs is, you know, I think a fairly modest commercial opportunity. However, when you look at this technology, particularly actinium-based radiopharmaceutical platform, this has the potential to have efficacy and safety across a host of solid tumor treatments.

Speaker Change #113: Adam, then Samit. Yeah, first, let me just talk about our enthusiasm about Raise Bio and the platform that we have here. We believe this is a really exciting platform, one that's going to grow significantly.

Speaker Change #114: through the back end of the decade. And, you know, what particularly excites us about RAISE is the kind of robust IND engine that we'll see over the course

Speaker Change #115: of the next decade or plus as well as what we know is a state of the art manufacturing facility that has been forward. Now, the lead program in Raise 101 in GeppNet

Adam Lenkowsky: Now, the lead program in Ray's 101 in GEPNets is, you know, I think a fairly modest commercial opportunity. However, when you look at this technology, particularly the actinium-based radiopharmaceutical platform, this has the potential to have efficacy and safety across a host of solid tumor treatments. So, you know, as we've talked about, we're looking at this in small cell lung cancer and potentially many other tumor types. So, we look forward to launching the GEPNet indication, which will be the lead asset, as well as a number of new INDs coming in the back half of the decade and beyond.

Speaker Change #116: is, you know, I think a fairly modest commercial opportunity. However, when you look at this technology, particularly actinium-based...

Speaker Change #115: Radio Pharmaceutical Platform. This has the potential to have efficacy and safety across a host of solid tumor

Adam Lenkowsky: So you know, as we've talked about, we are looking at this in small cell lung cancer and potentially many other tumor types. So we look forward to launching the GEP-NET indication that will be the lead asset as well as a number of new INDs coming in the back half of the decade and beyond.

So you know, as we've talked about, we are looking at this in small cell lung cancer and potentially many other tumor types. So we look forward to launching the GEP-NET indication that will be the lead asset as well as a number of new INDs coming in the back half of the decade and beyond.

Speaker Change #115: Treatment o, you know, as we've talked about, we're looking at this when small cell lung cancer and potentially many other tumor types. So we look forward to launching the Get-Net indication, the lead asset.

Speaker Change #115: and well, as well as a number of new INDs coming, you know, in the back half of the decade and beyond. Yeah, and thank you, Adam. And just to talk about CD19NextT,

Adam Lenkowsky: So, you know, as we've talked about, we're looking at this in small cell lung cancer and potentially many other tumor types. So, we look forward to launching the GEPNet indication, which will be the lead asset, as well as a number of new INDs coming in the back half of the decade and beyond. Yeah, and thank you, Adam. And just to talk about CD19NextT, there are a couple of things to understand. Number one, we have two ongoing studies. The first study enrolls patients not only with far-advanced systemic lupus erythematosus but also systemic sclerosis as well as myositis.

So, you know, as we've talked about, we're looking at this in small cell lung cancer and potentially many other tumor types. So, we look forward to launching the GEPNet indication, which will be the lead asset, as well as a number of new INDs coming in the back half of the decade and beyond.

Samit Hirawat: Yeah. And thank you, Adam. And just to talk about CD19 NEX-T, there are a couple of things to understand. Number one, we have two studies ongoing. The first study enrolls patients not only with far advanced systemic lupus erythematosus, but also systemic sclerosis as well as myositis. The second study is enrolling patients with multiple sclerosis. Now, it's very important to understand the profile of the patients that are being enrolled. These are patients who have far advanced disease. They're on glucocorticoids, immunosuppressants, immunomodulators, and these patients may also have underlying organ dysfunctions such as renal failure and kidney damage. So as we think about the impact of these single infusion CAR T cell therapies, what are we trying to achieve? We're trying to achieve a remission in the sense that patients can go off of their treatments such as glucocorticoids and immunosuppressants.

Speaker Change #117: There are a couple of things to understand. Number one, we have two studies ongoing. The first study enrolls patients not only with far-advanced systemic lupus erythematosus, but also systemic sclerosis as well as myositis.

Samit Hirawat: Yeah. And thank you, Adam. And just to talk about CD19 NEX-T there are a couple of things to understand. Number one, we have two studies ongoing. The first study enrolls patients not only with far advanced systemic lupus erythematosus, but also systemic sclerosis as well as myositis. The second study is enrolling patients with multiple sclerosis. Now it's very important to understand the profile of the patients that are being enrolled. These are patients who have far advanced disease. They are on glucocorticoids, immunosuppressants, immunomodulators. And these patients may also have underlying organ dysfunction such as renal failure and kidney damage. So as we think about the impact of these single-infusion CAR-cell therapies, what are we trying to achieve? We're trying to achieve a remission in the sense that patients can go off of their treatments such as glucocorticoids and immunosuppressants. What one does not expect at this time at least that we can revert the damaged kidney to a normal state because kidney doesn't grow by itself. So I think we have to keep that in mind as we look at the data and we're looking forward to bring that data as we look to the presentation of these patients that we are treating today.

Samit Hirawat: The second study is enrolling patients with multiple sclerosis. Now, it's very important to understand the profile of the patients that are being enrolled. These are patients who have far-advanced disease. They're on glucocorticoids, immunosuppressants, immunomodulators, and these patients may also have underlying organ dysfunctions such as renal failure and kidney damage.

Speaker Change #117: The second study is enrolling patients with multiple sclerosis. Now, it's very important to understand the profile of the patients that are being enrolled. These are patients who have far-advanced disease. They are on glucocorticoids, immunosuppressants, immunomodulators. And these patients may also have underlying organ dysfunctions such as renal failure and kidney damage.

Samit Hirawat: So, as we think about the impact of these single infusion card cell therapies, what are we trying to achieve? We're trying to achieve remission in the sense that patients can go off of their treatments such as glucocorticoids and immunosuppressants. What one does not expect at this time, at least, is that we can revert the damaged kidney to a normal state because the kidney doesn't grow by itself. So, I think we have to keep that in mind as we look at the data, and we're looking forward to presenting that data as we look at the presentation of these patients that we are treating today.

Speaker Change #117: So as we think about the impact of these single infusion card cell therapies, what are we trying to achieve? We are trying to achieve a remission in the sense that patients can go off of their treatments such as glucocorticoids and immunosuppressants.

Samit Hirawat: What one does not expect at this time, at least, that we can revert the damaged kidney to a normal state because kidney doesn't grow by itself. So, I think we have to keep that in mind as we look at the data, and we're looking forward to bring that data as we look to the presentation of these patients that we are treating today.

What one does not expect at this time, at least, that we can revert the damaged kidney to a normal state because kidney doesn't grow by itself. So, I think we have to keep that in mind as we look at the data, and we're looking forward to bring that data as we look to the presentation of these patients that we are treating today.

Speaker Change #117: What one does not expect at this time, at least, is that we can revert the damaged kidney to a normal state, because kidney doesn't grow by itself. So I think we have to keep that in mind as we look at the data, and we're looking forward to bring that data as we look to the presentation of these patients that we're treating today.

Samit Hirawat: So, I think we have to keep that in mind as we look at the data, and we're looking forward to presenting that data as we look at the presentation of these patients that we are treating today. Thanks so much. Absolutely. Our next question today comes from James Shin with DB. Please go ahead.

So, I think we have to keep that in mind as we look at the data, and we're looking forward to presenting that data as we look at the presentation of these patients that we are treating today.

Thanks so much. Absolutely. Our next question today comes from James Shin with DB. Please go ahead.

Tim Power: Great. Thanks, Samit. Let's go to the next one, please.

Operator: Absolutely. Our next question today comes from James Shin with DB. Please go ahead.

Adam Lenkowsky: Great, thanks Simon. Let's go to the next one please.

Tim Power: Great, thanks Simon. Let's go to the next one please.

James Shin: Thanks for taking the question. There are a couple more on the pipeline. Just to piggyback on PRMT5 readout later this year, can you shed some light on data size, which data points to expect, and are you thinking this will be disclosed via conference setting and then similar to that about the U19 Next, how will that be read out? And then, I think another question, our previous question talked about some of the negotiation dynamics and immunology. You know, a lot of these CBMs are getting into biosimilars, has Yeah, and I think your question, you're breaking up a bit, James. I think you're asking about disclosure for PRMT-5 and PRMT-9. Yeah, exactly.

James Shin: Good morning, guys. Thanks for taking the questions. A couple more on the pipeline. Just to piggyback on PRMT5 readout later this year, can you shed some light on the data size, which data points to expect? And are you thinking this will be disclosed via conference setting? And then similar to that about CD19 NEX-T, how will that be read out? And then I think another question, our previous question talked about some of the negotiation dynamics in immunology. A lot of these CDMs are getting into biosimilars. Has that changed negotiation dynamics at all in your early interactions? Thank you.

Operator: Absolutely. Our next question today comes from James Shin with DB. Please go ahead.

Speaker Change #117: Thanks so much. Let's go to the next one, please.

Speaker Change #118: Absolutely. Our next question today comes from James Shin with DB. Please go ahead.

[Analyst 3]: Good morning guys. Thanks for taking the question.

James Shin: Good morning guys. Thanks for taking the question.

Adam Lenkowsky: A couple more on the pipeline just to piggyback on PRMT5 readout later this year. Can you shed some light on the.

A couple more on the pipeline just to piggyback on PRMT5 readout later this year. Can you shed some light on the.

James Shin: Good morning, guys. Thanks for taking the question. A couple more on the pipeline. Just to piggyback on PRMT5 readout later this year, can you shed some light on the data size, which data points to expect, and are you thinking this will be disclosed via...

[Analyst 3]: Data size, which data points to expect.

Data size, which data points to expect.

Adam Lenkowsky: Are you thinking this will be disclosed via conference setting and then similar to that about CD19 NEX-T, how will that be rolled out? Then I think another question, a previous question talked about some of the negotiation dynamics and immunology. You know a lot of these PBMs are getting into biosimilars. Has that changed the negotiation dynamics at all in your early interactions? Thank you, Samit.

Are you thinking this will be disclosed via conference setting and then similar to that about CD19 NEX-T, how will that be rolled out? Then I think another question, a previous question talked about some of the negotiation dynamics and immunology. You know a lot of these PBMs are getting into biosimilars. Has that changed the negotiation dynamics at all in your early interactions? Thank you,

Speaker Change #121: conference setting and then similar to that about to be 19 next I will that be read out and then

Speaker Change #120: I think another question, our previous question talked about some of the negotiation dynamics and immunology. You know, a lot of these CBMs are getting into biosimilars. Has that changed the negotiation dynamics at all in your early interactions? Thank you.

Chris Boerner: Samit and Adam. Yeah, and I think your question, you're breaking up a bit, James. I think you're asking about disclosure for PRMT-5 and PRMT-9. Yeah, exactly.

Chris Boerner: Samit and Adam.

Chris Boerner: Yeah, and I think your question, you're breaking up a bit, James. I think you're asking about disclosure for PRMT-5 and PRMT-9. Yeah, exactly.

Tim Power: Yeah. And I think your question, you're breaking up a bit, James. I think you were asking about disclosure for?

Chris Boerner: PRMT-5 and PRMT-9. Yeah, exactly.

Samit Hirawat: PRMT5 and CD19.

James Shin: Yeah, exactly.

Samit Hirawat: Yeah. So both of these molecules, we are looking forward to presenting the data this year, certainly through a medical conference for both of them. For PRMT5, all the patients that have been enrolled, we are looking forward to bring the dose overall safety and where we've seen responses. And certainly, that will be the data that we will be presenting. For KarXT, we're looking forward to presentation of the data for certainly SLE at an upcoming conference as well and then grow from there. We are obviously preparing and planning to have conversations with regulatory authorities as well to plan for later stages of development of this molecule.

[Analyst 3]: Then Adam.

[Company Representative]: Samit Then Adam.

Adam Lenkowsky: Yeah, and I think your question. You're breaking up a bit, James. I think you were asking about disclosure for PRMT5. Exactly.

Speaker Change #120: on that then Adam yeah and I think your question you're breaking up a bit James I think you're asking about disclosure for

Samit Hirawat: So both of these molecules. We are looking forward to presenting the data this year, certainly through a medical conference, for both of them for PRMT5, all the patients that have been enrolled. We're looking forward to bring the dose, overall safety, and where we've seen responses, and certainly that'll be the data that we will be presenting for CAR NEX-T. We're looking forward to presentation of the data for, certainly, SLE at an upcoming conference as well, and then grow from there. We are obviously preparing and planning to have conversations with regulatory authorities as well to plan for later stages of development of this molecule.

Speaker Change #122: PRMT-5 and PRMT-9. So both of these molecules, we are looking forward to presenting the data this year, certainly to a medical conference of both of them. For PRMT-5, all the patients that have been enrolled, we are looking forward to bringing the dose, overall safety, and where we've seen responses.

Speaker Change #122: And certainly that will be the data that we will be presenting. For CAR-NEXT-E, we're looking forward to presentation of the data for certainly SLE at an upcoming conference as well, and then grow from there. We are obviously preparing and planning to have conversations with regulatory authorities as well to plan for later stages of development of this molecule.

Adam Lenkowsky: Yeah, just quickly on the biosimilar question. As I mentioned in UC, yes, biosimilars do have a preferred position in first line. However, in respect to the PSO market, we are continuing to work with payers to understand the dynamics there. But we have not heard or seen PBMs move to a biosimilar first approach. The reason for that largely is the fact in PSO products like Humira and Stelara do not have a dominant position in that space. So we would not expect biosimilars, at least in the near term, to take on a preferred position. Thanks, Adam. Let's go to the next one, please.

Samit Hirawat: We are obviously preparing and planning to have conversations with regulatory authorities as well to plan for later stages of development. Yeah, just quickly on the biosimilar question, as I mentioned, in UC, yes, biosimilars do have a preferred position in first line. However, in respect to the PSO market, we are continuing to work with payers to understand the dynamics there. But, you know, we have not heard or seen PVMs move to a biosimilar first approach.

We are obviously preparing and planning to have conversations with regulatory authorities as well to plan for later stages of development.

Speaker Change #123: Yeah, just quickly on the biosimilar question, as I mentioned, you know, in UC, yes, biosimilars do have a preferred position in first line. However, in

Adam Lenkowsky: Yeah. Just quickly on the biosimilar question, as I mentioned, in UC, yes, biosimilars do have a preferred position in first-line. However, in respect to the PSO market, we are continuing to work with payers to understand the dynamics there. But we have not heard or seen PBMs move to a biosimilar first approach. The reason for that largely is the fact in PSO, products like HUMIRA and STELARA do not have a dominant position in that space. So we would not expect biosimilars, at least in the near term to take on a preferred position.

Speaker Change #123: Respect to the PSO market, we are continuing to work with payers to understand the dynamics there, but

Speaker Change #124: We Have Not Heard or Seen.

Speaker Change #124: PBMs moved to a biosimilar first approach. The reason for that largely is the fact in PSO

Samit Hirawat: The reason for that largely is the fact that in PSO, products like Humira and Stellara do not have a dominant position in that space. So we would not expect biosimilars, at least in the near term, to take on a preferred position.

Speaker Change #124: Products like Humira and Stellara do not have

Speaker Change #124: a dominant position in that space so we would not expect biosimilars at least in the near term to take on a preferred position.

Tim Power: Thanks, Adam. Let's go to the next one, please.

Operator: Absolutely. Our next question today comes from Kripa Devarakonda with Truist Securities. Please go ahead.

Adam Lenkowsky: Thanks Adam, let's go to the next one please. Absolutely. Our next question today comes from Kripa Devarakonda with Truist Securities. Please go ahead. Hey guys, thank you so much for taking my question and congratulations on the quarter performance. I have one question on CanXaOS and maybe a question on IRA.

Tim Power: Thanks, Adam. Let's go to the next one, please.

Speaker Change #124: Thanks, Adam. Let's go to the next one, please.

Absolutely. Our next question today comes from Kripa Devarakonda with Truist Securities. Please go ahead. Hey guys, thank you so much for taking my question and congratulations on the quarter performance. I have one question on CanXaOS and maybe a question on IRA.

Operator: Absolutely. Our next question today comes from Kripa Devarakonda with Truist Securities. Please go ahead.

Speaker Change #125: Absolutely. Our next question today comes from Kripa Devarakonda with Truman Securities. Please go ahead.

Kripa Davarakonda: Hey, guys, thank you so much for taking my question and congrats on the quarter performance. I have one question on CAMZYOS and maybe a question on IRA. CAMZYOS, in terms of patients added per quarter, it seems like we're starting to see a little bit of acceleration. I know last couple of quarters, you said you thought of reaching steady state. Do you think this is just noise or could this be a trend going forward? Are you seeing awareness and understanding of the drug increase uptake? And the other thing on IRA is actually a little bit more futuristic maybe. Do you see any potential impact on IRA implementation depending on result of the November election? Could there be any change? Thank you.

[Analyst 2]: Hey guys, thank you so much for taking my question and congrats on the quarter performance. I have one question on Camzyos and maybe a question on IRA for Camzyos. In terms of patients added per quarter, it seems like we're starting to see a little bit of acceleration. I know last year, couple of quarters you said you started reaching steady state. Do you think this is just noise or could this be a trend going forward? Are you seeing awareness and understanding of the drug increase uptake? And the other thing on IRA is actually a little bit more futuristic maybe. Do you see any potential impact on IRA implementation, depending on result of the November election, could there be any change? Thank you.

Kripa Devarakonda: Hey guys, thank you so much for taking my question and congrats on the quarter performance. I have one question on Camzyos and maybe a question on IRA for Camzyos. In terms of patients added per quarter, it seems like we're starting to see a little bit of acceleration. I know last year, couple of quarters you said you started reaching steady state. Do you think this is just noise or could this be a trend going forward? Are you seeing awareness and understanding of the drug increase uptake? And the other thing on IRA is actually a little bit more futuristic maybe. Do you see any potential impact on IRA implementation, depending on result of the November election, could there be any change? Thank you.

Kripa Devarakonda: Hey guys, thank you so much for taking my question and congrats on the quarter performance.

Kripa Devarakonda: I have one question on Canva, it was maybe a...

Kripa Devarakonda: CanXaOS, in terms of patients added per quarter, it seems like we're starting to see a little bit of acceleration. I know the last couple of quarters you said you started reaching steady state. Do you think this is just noise or could this be a trend going forward? Are you seeing awareness and understanding of the drug increase uptake? And the other thing on IRA is actually a little bit more futuristic, maybe. Do you see any potential impact on IRA implementation depending on the result of the November election? Could there be any change? Thank you.

Kripa Devarakonda: question on IRA. The cancers in terms of patients added per quarter, it seems like we're starting to see a little bit of acceleration. I know last couple of quarters you said you sort of started reaching steady state.

Kripa Devarakonda: Do you think this is just noise or could this be a trend going forward? Are you seeing awareness and understanding of the drug increase uptake?

Speaker Change #127: And the other thing on IRA is actually a little bit more futuristic maybe, do you see any potential impact on IRA implementation depending on result of the November election, could there be any change? Thank you.

Kripa Devarakonda: Do you see any potential impact on IRA implementation depending on the result of the November election? Could there be any change? Thank you. So Adam, and then I'll take your IRA question.

Do you see any potential impact on IRA implementation depending on the result of the November election? Could there be any change? Thank you.

Chris Boerner: So Adam, and then I'll take your IRA question.

[Analyst 3]: So, Adam, and then I'll take your IRA question.

[Company Representative]: So, Adam, and then I'll take your IRA question.

Adam Lenkowsky: Copy. Thanks for the question. We've seen steady and consistent growth from Camzyos, and, as David mentioned, we saw approximately 1,300 patient increase on commercial drug quarter over quarter. We expect that to be steady and consistent growth over time. Physician and patient feedback continue to remain very positive. Our focus is increasing our user base both in the large COEs while also increasing breadth of prescribing in some of the smaller institutions and some of the larger community practices. In fact, we'll be deploying additional community representatives. These are our Eliquis representatives into the community cardiology accounts to drive treatment. So we're seeing good momentum with Camzyos, and we're pleased with the performance of this very important product. I know we're running over, got time maybe for two more here, so maybe go to the next one please.

Adam Lenkowsky: Kripa, yeah, thanks for the question. And we've seen steady and consistent growth from Camzyos. And as David mentioned, we saw approximately 1,300 patient increase on commercial drug quarter-over-quarter. We expect that to be steady and consistent growth over time. Physician and patient feedback continues to remain very positive. Our focus is increasing our user base, both in the large COEs, while also increasing breadth of prescribing in some of the smaller institutions and some of the larger community practices. In fact, we'll be deploying additional community representatives. These are ELIQUIS representatives into the community of cardiology account to drive treatment. So we're seeing good momentum with CAMZYOS and we're pleased with the performance of this very important product.

Speaker Change #128: So Adam, and then I'll take your IRA questions.

Speaker Change #129: Kripa, yeah, thanks for the question. And we have seen steady and consistent growth from Canxiolus, and as David mentioned, we saw approximately 1,300 patient increase on commercial drug quarter over quarter.

Speaker Change #129: We expect that to be...

Speaker Change #129: steady and consistent growth over time.

Adam Lenkowsky: Our focus is increasing our user base, both in the large COEs while also increasing breadth of prescribing in some of the smaller institutions and some of the larger community practices. In fact, we'll be deploying additional community representatives, these are our Eloquist representatives, into the community cardiology accounts to drive treatment. So we're seeing good momentum with CanXylose, and we're pleased with the performance of this very important product. I know we're running late.

Our focus is increasing our user base, both in the large COEs while also increasing breadth of prescribing in some of the smaller institutions and some of the larger community practices. In fact, we'll be deploying additional community representatives, these are our Eloquist representatives, into the community cardiology accounts to drive treatment. So we're seeing good momentum with CanXylose, and we're pleased with the performance of this very important

Speaker Change #130: Physician and patient feedback continues to remain very positive.

Speaker Change #131: Our focus is increasing our user base, both in the large COEs, while also increasing breadth of prescribing in some of the smaller institutions and some of the larger community practices.

Speaker Change #131: We'll be deploying additional community representatives. These are our Eloquist representatives into the community cardiology accounts to drive treatment. So we're seeing good momentum with CAMS-IOS and we're pleased with the performance of this very important product.

Tim Power: And I know we're running over time maybe for two more here. So maybe go to the next one, please.

Tim Power: I know we're running over, got time maybe for two more here, so maybe go to the next one please.

unknown: We've got time for maybe two more here, so maybe we can go to the next one, please. Yes, sir. And our next question today comes from Sean McCutcheon and Raymond James. Please go ahead. So we're going to get the oceanic AF data at ESC in about a month. Obviously, the Brista AF is ongoing, and time will tell if there are any distinctions from the rapid failure we saw for Asundexian, but and, you know, likely insufficient dose finding and specificity is noted. But what are the specifics you're looking for, for a read-through on the mechanism for those data?

We've got time for maybe two more here, so maybe we can go to the next one, please.

Speaker Change #132: And now we're running over. We've got time maybe for two more here. So maybe go to the next one, please.

Operator: Yes sir. And our next question today comes from Sean McCutcheon and Raymond James. Please go ahead.

Yes, sir. And our next question today comes from Sean McCutcheon and Raymond James. Please go ahead. So we're going to get the oceanic AF data at ESC in about a month. Obviously, the Brista AF is ongoing, and time will tell if there are any distinctions from the rapid failure we saw for Asundexian, but and, you know, likely insufficient dose finding and specificity is noted. But what are the specifics you're looking for, for a read-through on the mechanism for those data?

Operator: And yes, sir. And our next question today comes from Sean McCutcheon with Raymond James. Please go ahead.

Speaker Change #133: Yes, sir. And our next question today comes from Sean McCutcheon and Raymond James. Please go ahead.

Adam Lenkowsky: Hey guys, thanks for taking over or staying over to take my question. Maybe one for Samit. So we're going to get the OCEANIC-AF data at ESC in about a month. Obviously the Bayer's AF is ongoing and time will tell if there are any distinctions from the rapid failure we saw for Asundexian and likely insufficient dose finding and PACIFIC is noted. But what are the specifics you're looking for for a read through on the mechanism for those data and do you see any risk to getting data that come in that clearly show sufficient inhibition of Factor XIa activity yet a detriment on stroke prevention?

Sean McCutcheon: Hey guys, thanks for taking over or staying over to take my question. Maybe one for Samit. So we're going to get the OCEANIC-AF data at ESC in about a month. Obviously the Bayer's AF is ongoing and time will tell if there are any distinctions from the rapid failure we saw for Asundexian and likely insufficient dose finding and PACIFIC is noted. But what are the specifics you're looking for for a read through on the mechanism for those data and do you see any risk to getting data that come in that clearly show sufficient inhibition of Factor XIa activity yet a detriment on stroke prevention?

Sean McCutcheon: Hey, guys. Thanks for taking over it--thank you for taking my question. Maybe one for Samit. So we're going to get the Oceanic AF data at ESC in about a month. Obviously, LIBREXIA AF is ongoing and time will tell if there are any distinctions from the rapid failure we saw for ASUNDEXIAN. But and likely insufficient dose-finding in Pacific as noted, but what are the specifics you're looking for read through on the mechanism for those data? And do you see any risk to getting data that come in that clearly shows sufficient inhibition of Factor XIa activity, do you have a detriment on stroke prevention? Thanks.

Sean McCutcheon: Hey guys, thanks for taking over, or staying over to take my question. Maybe one for Samit. So, we're going to get the oceanic AF data at ESC in about a month.

Speaker Change #135: Obviously, the BRCAF is ongoing, and time will tell if there are any distinctions from the rapid failure we saw for asundexian. And, you know, likely insufficient dose finding in specific is noted.

Sean McCutcheon: And do you see any risk to getting data that comes in that clearly shows sufficient inhibition of Factor XI-A activity, yet a detriment to stroke prevention? Thanks. Before Samit answers, I just want to address the second part of Kripa's question very quickly around, based on the prior learnings from the phase two studies. That's why we chose the doses that we chose for a single agent at a higher dose of 100 milligrams BID compared to 25 milligrams BID, where there was a background of anti-platelet agents.

And do you see any risk to getting data that comes in that clearly shows sufficient inhibition of Factor XI-A activity, yet a detriment to stroke prevention? Thanks.

Speaker Change #136: What are the specifics you're looking for, for a read-through on the mechanism for those data, and do you see any risk to getting data that come in that clearly shows sufficient inhibition of Factor XI-A activity, yet a detriment on stroke prevention? Thanks.

[Analyst 3]: Before Samit answers, I just want to address the second part of Kripa's question just very quickly around national, obviously we're going to continue to follow the election in the United States. It's difficult to speculate on how things will change from a policy standpoint with any given administration, just simply because it's not just a presidential election, but it's also, you have to look at the composition of Congress. So I think we're just going to have to continue to pay attention to this over time. But Samit, do you want to address.

[Company Representative]: Before Samit answers, I just want to address the second part of Kripa's question just very quickly around national, obviously we're going to continue to follow the election in the United States. It's difficult to speculate on how things will change from a policy standpoint with any given administration, just simply because it's not just a presidential election, but it's also, you have to look at the composition of Congress. So I think we're just going to have to continue to pay attention to this over time. But Samit, do you want to address.

Speaker Change #136: Before Samit answers, I just want to address the second part of Kripa's question, just very quickly around

Chris Boerner: And before Samit answers, I just want to address the second part of Kripa's question just very quickly around patient. Obviously, we're going to continue to follow the election in the United States, it's difficult to speculate on how things will change from a policy standpoint with any given administration just simply because it's not just a Presidential Election, but it's also you have to look at the composition of Congress. So I think we're just going to have to continue to pay attention to this over time. But Samit, do you want to address? based on the prior learnings from the phase two studies. That's why we chose the doses that we chose for a single agent at a higher dose of 100 milligrams BID compared to 25 milligrams BID, where there was a background of anti-platelet agents.

Samit: Thank you. Thank you for the question as well. Look, I think let's start off with the first fact that when we started the Malvexian program it was based on the prior learnings from the phase 2 studies. That's why we chose the doses that we chose for a single agent at a higher dose of 100 milligrams BID whereas the 25 milligram BID where there was a background of anti-platelet agents.

Samit Hirawat: Thank you. Thank you for the question as well. Look, I think let's start off with the first fact that when we started the Milvexian program, it was based on the prior learnings from the phase 2 studies. That's why we chose the doses that we chose for a single agent at a higher dose of 100 mg bid, whereas the 25 mg bid, where there was a background of antiplatelet agents. Second, independent investigators have now conducted preclinical work to show the differentiation between Asundexian versus Milvexian, showing the inhibition and the time it takes and the doses that are required for real inhibition of Factor XIa. And so that gives us a little bit more confidence in terms of how things are shaping up.

Samit Hirawat: Yeah. Thank you. Thank you for the question as well. Look, I think let's start off with the first fact that when we started the Milvexian program, it was based on the prior learnings from the Phase II studies. That's why we chose the doses that we chose that for a single agent at a higher dose of 100 milligrams BID, whereas the 25 milligram BID where there was a background of antiplatelet agents. Second, independent investigators have now conducted preclinical work to show the differentiation between ASUNDEXIAN versus MILVEXIAN, showing the inhibition and the time it takes and the doses that are required for real inhibition of Factor XIa. And so that gives us a little bit more confidence in terms of how things are going--are shaping up. Third, for AF, secondary stroke prevention as well as ACS, the enrollment continues very well in these three trials and we're looking forward to those readouts. Last thing I would say is when the data are presented, we certainly would like to see the number of events that happened, what time they happened and the impact of the dose that was used that will all be very helpful as we think about MILVEXIAN.

Samit Hirawat: Second, independent investigators have now conducted preclinical work to show the differentiation between asyndexian versus malvixian, showing the inhibition and the time it takes and the doses that are required for real inhibition of factor XI A. And so that gives us a little bit more confidence in terms of how things are shaping up. Third, for AF, secondary stroke prevention, as well as ACS, enrollment continues very well in these three trials, and we're looking forward to those readouts. And the last thing I would say is that when the data are presented, we certainly would like to see the number of events that happened, what time they happened, and the impact of the dose that was used. That will all be very helpful as we think about milking.

Samit: Second, independent investigators have now conducted preclinical work to show the differentiation between Asyndexian versus Malvixian, showing the inhibition and the time it takes and the doses that are required for real inhibition of Factor XI A, and so that gives us a little bit more confidence in terms of how things are shaping up.

Samit Hirawat: Third, for AF secondary stroke prevention as well as ACS, the enrollment continues very well in these three trials, and we're looking forward to those readouts. Last thing I would say is when the data are presented, we certainly would like to see the number of events that happened, what time they happened, and the impact of the dose that was used. That will all be very helpful as we think about Milvexian.

Third, for AF secondary stroke prevention as well as ACS, the enrollment continues very well in these three trials, and we're looking forward to those readouts. Last thing I would say is when the data are presented, we certainly would like to see the number of events that happened, what time they happened, and the impact of the dose that was used. That will all be very helpful as we think about Milvexian.

Samit: Third, for AF, secondary stroke prevention, as well as ACS, the enrollment continues very well in these three trials, and we're looking forward to those readouts. Last thing I would say is, when the data are presented, we certainly would like to see the number of events that happened, what time they happened, and the impact of the dose that was used. That will all be very helpful as we think about Melvixian.

Samit Hirawat: And the last thing I would say is that when the data are presented, we certainly would like to see the number of events that happened, what time they happened, and the impact of the dose that was used. That will all be very helpful as we think about milking. Thanks. And let's go to the last one, please, Rob.

And the last thing I would say is that when the data are presented, we certainly would like to see the number of events that happened, what time they happened, and the impact of the dose that was used. That will all be very helpful as we think about milking.

Adam Lenkowsky: Great, thanks. Let's go to the last one, please, Rocco.

Tim Power: Great, thanks. Let's go to the last one, please, Rocco.

Tim Power: Great. Thanks. And let's go to the last one, please, Rocco.

Operator: Absolutely. Our final question today comes from Alex Hammond of BofA. Please go ahead.

Operator: Absolutely. Our final question today comes from Alex Hammond at B of A. Please go ahead.

Samit: Great, thanks. Let's go to the last one, please, Raka.

Raka: Absolutely. Our final question today comes from Alex Hammond at B of A. Please go ahead.

[Analyst 2]: Hey, guys, thanks for squeezing me in. So following Camzyos's strong performance this quarter and the REMS registry data acc, can you set expectations for potential REMS modification moving forward? And do you think having the results from the Odyssey study reading out early next year will provide a favorable time to reengage with the FDA?

[Analyst 5]: Hey, guys, thanks for squeezing me in. So following Camzyos's strong performance this quarter and the REMS registry data acc, can you set expectations for potential REMS modification moving forward? And do you think having the results from the Odyssey study reading out early next year will provide a favorable time to reengage with the FDA? Thank you.

Alex Hammond: Hey guys, thanks for squeezing me in. So following Hans BioStrong's performance this quarter and the REMS registry data ACC, can you set expectations for potential REMS modification moving forward? And do you think having the results from the ODSU study read out early next year will provide a favorable time to re-engage with the FDA? Thank you for the question. As both David and Adam said earlier, thousands of patients have now been treated with ChemZyos, and certainly, we've learned a lot, and we see the manageable profile here, as well as the transformational outcomes that these patients achieve and stay on treatment for a very long time, with 80% of the patients being treated with 2.5 and 5 milligram doses.

Alex Hammond: Hey, guys. Thanks for squeezing me in. So following CAMZYO's strong performance this quarter and the REMS registry data at ACC. Can you set expectations for potential REMS modification moving forward? And do you think having the results from the ODYSSEY study reading out early next year will provide a favorable time to reengage with the FDA? Thank you. Samit?

Alex Hammond: Hey guys, thanks for squeezing me in. So following Camp DioStrong's performance this quarter and the REMS registry data at ACC, can you set expectations for potential REMS modification moving forward? And do you think having the results from the ODYSSEY study reading out early next year will provide a favorable time to re-engage with the FDA? Thank you.

Chris Boerner: Samit? Thank you for the question. As both David and Adam said earlier, thousands of patients have now been treated with ChemZyos, and certainly, we've learned a lot, and we see the manageable profile here, as well as the transformational outcomes that these patients achieve and stay on treatment for a very long time, with 80% of the patients being treated with 2.5 and 5 milligram doses. We continue our conversations with the FDA. I will not get into the specifics. And certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study, about six months in, with a readout now expected in two queues next year, we will certainly have multiple engagements with the FDA on that front.

Chris Boerner: Samit?

Samit Hirawat: So I think as--thank you for the question, as both David and Adam said earlier, thousands of patients have now been treated with CAMZYOS and certainly, we've learned a lot and we see the manageable profile here as well as the transformational outcomes that these patients have and stay on treatment for a very long time with 80% of the patients being treated with 2.5 and 5 milligram doses. We continue our conversations with the FDA. I will not get into the specifics. And certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study about six months in with a readout now expected in 2Q next year, we will certainly have multiple engagements with the FDA on that front as well.

Alex Hammond: Thank you for the question. As both David and Adam said earlier, thousands of patients have now been treated with ChemZyos, and certainly, we've learned a lot, and we see the manageable profile here, as well as the transformational outcomes that these patients achieve and stay on treatment for a very long time, with 80% of the patients being treated with 2.5 and 5 milligram doses. We continue our conversations with the FDA. I will not get into the specifics. And certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study, about six months in, with a readout now expected in two queues next year, we will certainly have multiple engagements with the FDA on that front.

[Analyst 3]: Thank you, Samit.

[Company Representative]: Samit.

Samit Hirawat: Thank you for the question. As both David and Adam said earlier, thousands of patients have now been treated with Camzyos. And certainly we've learned a lot and we see the manageable profile here as well as the transformational outcomes that these patients have and stay on treatment for a very long time. With 80% of the patients being treated with 2.5mg and 5mg doses, we continue our conversations with the FDA. I will not get into the specifics, and certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study about six months in, with a readout now expected in Q2 next year, we will certainly have multiple engagements with the FDA on that front as well.

Alex Hammond: [inaudible]

Speaker Change #138: So I think, thank you for the question. As both David and Adam said earlier, thousands of patients have now been treated with ChemZyos and certainly we've learned a lot and we see the manageable profile here as well as the transformational outcomes that these patients have and stay on treatment for a very long time with 80% of the patients being treated with 2.5 and 5 milligram doses.

Samit Hirawat: We continue our conversations with the FDA. I will not get into the specifics. And certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study, about six months in, with a readout now expected in two queues next year, we will certainly have multiple engagements with the FDA on that front. Thanks, Samit. So before we close the call, maybe I'll just leave you all with a few things. We are pleased with the performance of the business, and in particular, the growth portfolio performance, where revenues grew nicely in the first half and now represent, as David said earlier, 46% of the total business.

We continue our conversations with the FDA. I will not get into the specifics. And certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study, about six months in, with a readout now expected in two queues next year, we will certainly have multiple engagements with the FDA on that front.

Speaker Change #138: We continue our conversations with the FDA. I will not get into the specifics. And certainly now that we have pulled in the readout of the non-obstructive hypertrophic cardiomyopathy study about six months in, with a readout now expected in two queues next year, we will certainly have multiple engagements with the FDA on that front as well.

Chris Boerner: Thanks, Samit. So before we close the call, maybe I'll just leave you all with a few things. We are pleased with the performance of the business and in particular, the growth portfolio performance where revenues grew nicely in the first half and now represent, as David said earlier, 46% of the total business. At the same time, our pipeline continues to advance with new medicines and we look forward to important catalysts coming up like the KarXT launch and a number of data readouts in the coming months. So overall, I'd say we've executed well in the quarter. We feel good about the full year and are raising our outlook accordingly. It's certainly going to be a busy back half of the year and we're focused as a team and as a company on driving strong execution. So thank you all for your time today and the Investor Relations team is certainly available to answer any follow-up questions that you may have. Have a nice weekend.

[Analyst 3]: Thanks Amit.

[Company Representative]: Thanks Amit.

Samit Hirawat: At the same time, our pipeline continues to advance with new medicines, and we look forward to important catalysts coming up, like the CAR XT launch and a number of data readouts in the coming months. So overall, I'd say we've executed well in the quarter. We feel good about the full year and are raising our outlook accordingly. It's certainly going to be a busy back half of the year, and we're focused as a team and as a company on driving strong execution. So, thank you all for your time today, and the Investor Relations team is certainly available to answer any follow-up questions that you may have. Have a nice weekend.

Adam Lenkowsky: So before we close the call, maybe.

So before we close the call, maybe.

[Analyst 3]: I'll just leave you all with a few things. We are pleased with the performance of the business and, in particular, the growth portfolio performance where revenues grew nicely in the first half and now represent, as David said earlier, 46% of the total business. At the same time, our pipeline continues to advance with new medicines, and we look forward to important catalysts coming up like the KarXT launch and a number of data readouts in the coming months. So overall I'd say we've executed well in the quarter. We feel good about the full year and are raising our outlook accordingly. It's certainly going to be a busy back half of the year, and we're focused as a team and as a company on driving strong execution.

I'll just leave you all with a few things. We are pleased with the performance of the business and, in particular, the growth portfolio performance where revenues grew nicely in the first half and now represent, as David said earlier, 46% of the total business. At the same time, our pipeline continues to advance with new medicines, and we look forward to important catalysts coming up like the KarXT launch and a number of data readouts in the coming months. So overall I'd say we've executed well in the quarter. We feel good about the full year and are raising our outlook accordingly. It's certainly going to be a busy back half of the year, and we're focused as a team and as a company on driving strong execution.

Speaker Change #138: Thanks, Samit.

Speaker Change #139: So, before we close the call, maybe I'll just leave you all with a few things. We are pleased with the performance of the business and, in particular, the growth portfolio performance where revenues grew nicely in the first half and now represent, as David said earlier, 46% of the total business.

Speaker Change #139: At the same time, our pipeline continues to advance with new medicines, and we look forward to important catalysts coming up, like the CAR-XT launch and a number of data readouts in the coming months. So, overall, I'd say...

Speaker Change #140: We've executed well in the quarter. We feel good about the full year and are raising our outlook accordingly. It's certainly going to be a busy back half of the year, and we're focused as a team and as a company on driving strong execution. So thank you all for your time today, and the Investor Relations team is certainly available to answer any follow-up questions that you may have.

Chris Boerner: So, thank you all for your time today, and the Investor Relations team is certainly available to answer any follow-up questions that you may have. Have a nice weekend. Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

So, thank you all for your time today, and the Investor Relations team is certainly available to answer any follow-up questions that you may have. Have a nice weekend.

[Analyst 3]: So, thank you all for your time today, and the investor relations team is certainly available to answer any follow-up questions that you may have. Have a nice weekend.

So, thank you all for your time today, and the investor relations team is certainly available to answer any follow-up questions that you may have. Have a nice weekend.

Operator: Thank you sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

Speaker Change #141: Have a nice weekend.

Speaker Change #142: Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

Operator: Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

Operator: [inaudible] BF-WATCH TV 2021 [inaudible] I love you, love you, love you, love you, love you. BF-WATCH TV 2021, [inaudible] Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. BF-WATCH TV 2021,,,,,,,,,,,,,, [inaudible] music music music music music music music music music music music music, BF-WATCH TV 2021 [inaudible] BF-WATCH TV 2021 BF-WATCH TV 2021

Operator: Sa.

[inaudible]

Christopher S. Boerner: A film by J.S. Boerner Directed by J.S. Boerner Cinematography by J.S. Boerner Music by J.S. Boerner Edited by J.S. Boerner Produced by J.S. Boerner Cinematography by J.S. Boerner Edited by J.S. Boerner Music by J.S. Boerner

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Operator: Sa.

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