Q1 2026 Bristol Myers Squibb Co Earnings Call

April 30, 2026

Speaker #1: Welcome to the Bristol Myers Squibb First Quarter 2026 Earnings Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Operator: Welcome to the Bristol Myers Squibb Q1 2026 Earnings Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then 0. 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 this event is being recorded. I would now like to turn the conference over to Chuck Triano, Senior Vice President and Head of Investor Relations. Please go ahead.

Speaker #1: 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.

Speaker #1: To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Chuck Triano.

Speaker #1: Senior Vice President and Head of Investor Relations. Please go ahead.

Speaker #2: Thank you and good morning, everyone. We appreciate you joining our first quarter 2026 earnings call. With me this morning with prepared remarks are Chris Berner, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer.

Chuck Triano: Thank you. Good morning, everyone. We appreciate you joining our Q1 2026 earnings call. With 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 is Adam Lenkowsky, our Chief Commercialization Officer, and Cristian Massacesi, our Chief Medical Officer and Head of Global Drug Development. Earlier this morning, we posted our quarterly slide presentation to bms.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll remind everybody that during this call, we will 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 #2: Also participating in today's call is Adam Lenkowski, our Chief Commercialization Officer, and Christian Masaccesi, our Chief Medical Officer and Head of Global Drug Development.

Speaker #2: Earlier this morning, we posted our quarterly slide presentation to bms.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll remind everybody that during this call, we will make statements about the company's future plans and prospects that constitute forward-looking statements.

Speaker #2: 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 #2: 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 and we specifically disclaim any obligation to update forward-looking statements, even if our estimates change.

Chuck Triano: 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, and 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. Reconciliation of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. Finally, unless otherwise stated, all comparisons are made from the same period in 2025, 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. With that, I'll hand it over to Chris.

Speaker #2: We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliation of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com.

Speaker #2: Finally, unless otherwise stated, all comparisons are made to the same period in 2025, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange.

Speaker #2: All references to our P&L are on a non-GAAP basis. And with that, I'll hand it over to Chris.

Speaker #3: Thanks, Chuck. Welcome and thank you for joining our first quarter earnings call. We delivered a solid Q1 and continue to improve our say-to-do ratio, with disciplined execution across the business as we continue to best position the company for long-term sustainable growth.

Chris Boerner: Thanks, Chuck. Welcome and thank you for joining our Q1 earnings call. We delivered a solid Q1 and continue to improve our say-to-do ratio with disciplined execution across the business as we continue to best position the company for long-term sustainable growth. Our strategy remains grounded in three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined, shareholder-friendly capital allocation. We saw progress across all three in the quarter. Let me start by highlighting our performance on Slide 4. We started off the year with solid results across our key marketed products. In the quarter, growth portfolio sales were up 9% year over year, with contributions from a broad range of assets, including Reblozyl, Breyanzi, CAMZYOS, Opdualag, AUGTYRO, and KRAZATI.

Speaker #3: Our strategy remains grounded in three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined, shareholder-friendly capital allocation.

Speaker #3: We saw progress across all three in the quarter. Let me start by highlighting our performance on slide four. We started off the year with solid results across our key marketed products.

Speaker #3: In the quarter, growth portfolio sales were up 9% year over year, with contributions from a broad range of assets including Reblizil, Brionzi, Kemziyas, Optolag, Cuvantic, and Cobenvi.

Speaker #3: These are differentiated, durable assets that treat serious diseases and remain early in their life cycles. And they continue to strengthen our foundation for long-term growth.

Chris Boerner: These are differentiated, durable assets that treat serious diseases and remain early in their life cycles, and they continue to strengthen our foundation for long-term growth. Overall, our growth portfolio performed in line with our expectations for this quarter. Outside of the growth portfolio, Eliquis performed well and grew in line with the range we provided on our Q4 call. David will provide more details on the financials shortly. Turning to our recent regulatory and clinical milestones. In Q1, we made progress advancing our broad and diversified pipeline. Regarding our CELMoD, iberdomide, and mezigdomide, our iberdomide filing for relapse or refractory multiple myeloma was accepted by the FDA with breakthrough therapy designation and priority review, with a PDUFA date of 17 August. This is an important step for our protein degradation platform, potentially enabling us to bring the first CELMoD to market.

Speaker #3: Overall, our growth portfolio performed in line with our expectations for this quarter. Outside of the growth portfolio, Eliquis performed well and grew in line with the range we provided on our Q4 call.

Speaker #3: David will provide more details on the financials shortly. Turning to our recent regulatory and clinical milestones. In Q1, we made progress advancing our broad and diversified pipeline.

Speaker #3: Regarding our cell mods, Iberdamide and Mazygnamide, our Iberdamide filing for relapse or refractory multiple myeloma was accepted by the FDA, with breakthrough therapy designation and priority review.

Speaker #3: With a PDUFA date of August 17th. This is an important step for our protein degradation platform potentially enabling us to bring the first cell mod to market.

Speaker #3: For Mazygnamide, we reported positive phase three interim data from the successor two study, demonstrating a meaningful improvement in progression-free survival in patients with relapse or refractory multiple myeloma.

Chris Boerner: For mezigdomide, we reported positive Phase 3 interim data from the SUCCESSOR-2 study, demonstrating a meaningful improvement in progression-free survival in patients with relapsed or refractory multiple myeloma. This marks the second positive pivotal readout from our oral CELMoD program and further strengthens our conviction in the platform. We will also present the full data at ASCO and are actively planning regulatory submissions based upon the data. For our ADC iza-bren, we shared positive Phase 3 interim top-line results in patients with previously treated triple-negative breast cancer based on a study conducted in China. We will present these exciting data, along with the positive Phase 3 China study results for iza-bren in previously treated esophageal squamous cell carcinoma at ASCO. At the same time, we continue to broaden the reach of our end market portfolio through life cycle expansion.

Speaker #3: This marks the second positive pivotal readout from our oral Cell Mod program and further strengthens our conviction in the platform. We will also present the full data at ASCO and are actively planning regulatory submissions based upon the data.

Speaker #3: For our ADC Isomren, we shared positive phase three interim top-line results in patients with previously treated triple-negative breast cancer based on a study conducted in China.

Speaker #3: We will present these exciting data, along with the positive Phase III China study results for Isomren in previously treated esophageal squamous cell carcinoma, at ASCO.

Speaker #3: At the same time, we continue to broaden the reach of our in-market portfolio through lifecycle expansion. We received approvals for SOTIC2 and psoriatic arthritis, and Opdivo for two new classical Hodgkin lymphoma indications.

Chris Boerner: We received approvals for SOTYKTU in psoriatic arthritis and OPDIVO for 2 new classical Hodgkin lymphoma indications. We also reported positive Phase 4 switch data for KRAZATI, positive Phase 3 data for CAMZYOS in adolescents with obstructive HCM, and positive Phase 2 data for Reblozyl in alpha thalassemia. Stepping back, these updates reflect the diversity and breadth of our pipeline, both in terms of therapeutic areas and modalities, as well as continued execution across the business. Moving to Slide 5. As we've said, the latter part of 2026 is shaping up to include an increasing cadence of pivotal readouts that are expected to further define and de-risk our long-term growth profile. Among the Phase 3 readouts expected late in the year are MILVEXIAN in atrial fibrillation and secondary stroke prevention, KRAZATI in Alzheimer's psychosis, admilparant in IPF, and iberdomide PFS data.

Speaker #3: We also reported positive phase four switch data for Cobenvi, positive phase three data for Kemziyas in adolescents with obstructive HCM, and positive phase two data for Reblizil and Alpha thalassemia.

Speaker #3: Stepping back, these updates reflect the diversity and breadth of our pipeline both in terms of therapeutic areas and modalities as well as continued execution across the business.

Speaker #3: Moving to slide five. As we've said, the latter part of 2026 is shaping up to include an increasing cadence of pivotal readouts that are expected to further define and de-risk our long-term growth profile.

Speaker #3: Among the phase three readouts expected late in the year, our Milvexian and atrial fibrillation and secondary stroke prevention, Cobenvi and Alzheimer's psychosis, Admilparin and IPF, and Iberdamide PFS data.

Speaker #3: We anticipate these readouts will help us further diversify and broaden our portfolio and are part of our efforts to deliver more than 10 new medicines and 30 meaningful lifecycle management opportunities by the end of the decade.

Chris Boerner: We anticipate these readouts will help us further diversify and broaden our portfolio and are part of our efforts to deliver more than 10 new medicines and 30 meaningful life cycle management opportunities by the end of the decade. Turning to Slide 6. Central to delivering on these opportunities and enabling sustained long-term growth are our efforts to drive top-tier R&D productivity. In our development organization, we continue to improve execution across drug development by upgrading talent, streamlining decision-making, and instituting tighter management of core clinical activities. We are also focused on enhancing the quality and depth of our early to midstage pipeline. Underpinning these efforts are investments we are making in core R&D infrastructure, including broadening the use of AI tools together with laboratory automation and people trained in the right ways of working.

Speaker #3: Turning to slide six. Central to delivering on these opportunities and enabling sustained, long-term growth are our efforts to drive top-tier R&D productivity. In our development organization, we continue to improve execution across drug development by upgrading talent, streamlining decision-making, and instituting tighter management of core clinical activities.

Speaker #3: We are also focused on enhancing the quality and depth of our early to mid-stage pipeline. Underpinning these efforts are investments we are making in core R&D infrastructure, including broadening the use of AI tools together with laboratory automation and people trained in the right ways of working.

Speaker #3: In research and early development, target selection and molecule design can have an outsized impact on long-term value. We've set a target to reach lead molecule identification approximately 50% faster while applying greater rigor, so that only the most differentiated molecules advance.

Chris Boerner: In research and early development, target selection and molecule design can have an outsized impact on long-term value. We've set a target to reach lead molecule identification approximately 50% faster while applying greater rigor so that only the most differentiated molecules advance. In late development, we're using AI to streamline clinical operations, compress development timelines, and enhance quality oversight. Over time, we expect these efforts to deliver a 30% reduction in cycle times versus just a few years ago. Among others, we have ongoing partnerships with Faro, enabling us to design trials more efficiently and Evinova's cost optimizer tool. These ongoing efforts across R&D are top priorities for 2026. The organization's continued focus on financial discipline enables us to make these and other important investments.

Speaker #3: In late development, we're using AI to streamline clinical operations, compress development timelines, and enhance quality oversight. Over time, we expect these efforts to deliver a 30% reduction in cycle times versus just a few years ago.

Speaker #3: Among others, we have ongoing partnerships with Pharaoh, enabling us to design trials more efficiently, and Evanova's cost-optimizer tool. These ongoing efforts across R&D are top priorities for 2026.

Speaker #3: The organization's continued focus on financial discipline, enables us to make these and other important investments. We remain on track to deliver the remainder of our $2 billion in cost savings from our strategic productivity initiative by the end of 2027.

Chris Boerner: We remain on track to deliver the remainder of our $2 billion in cost savings from our strategic productivity initiative by the end of 2027. With respect to capital allocation, business development remains an important focus. As always, we will continue to index on opportunities where we add strategic value and where we can deliver attractive returns. As our post-LOE growth profile becomes clearer, we'll naturally place greater emphasis on expanding our early and midstage portfolio to support growth into the 2030s. In summary, based on our performance, we see the business currently tracking towards the upper end of our guidance ranges. Looking forward, we have continued momentum in our growth portfolio, broad potential in our pipeline, and the ability to invest in our business while becoming more focused and efficient in how we operate. With that, I'll turn it over to David.

Speaker #3: With respect to capital allocation, business development remains an important focus. As always, we will continue to index on opportunities where we add strategic value and where we can deliver attractive returns.

Speaker #3: As our post-LOE growth profile becomes clearer, we'll naturally place greater emphasis on expanding our early- and mid-stage portfolio to support growth into the 2030s.

Speaker #3: In summary, based on our performance, we see the business currently tracking towards the upper end of our guidance ranges. Looking forward, we have continued momentum in our growth portfolio, broad potential in our pipeline, and the ability to invest in our business while becoming more focused and efficient in how we operate.

Speaker #3: With that, I'll turn it over to David.

Speaker #4: Thank you, Chris, and good morning, everyone. Our performance in 2026 is off to a strong start, as highlighted by our first quarter results. We delivered solid R&D, commercial, and financial performance while continuing to manage our cost structure.

David Elkins: Thank you, Chris, and good morning, everyone. Our performance in 2026 is off to a strong start, as highlighted by our Q1 results. We delivered solid R&D, commercial, and financial performance while continuing to manage our cost structure. Our persistent focus on execution has further strengthened our foundation as we position the company for long-term sustainable growth. I will begin with a review of our Q1 results and then discuss our financial outlook for the remainder of the year. Starting with slide 8, total revenue in the Q1 was up 1% year-over-year at approximately $11.5 billion. Our growth portfolio continued to perform well, with global revenue increasing 9% to $6.2 billion.

Speaker #4: Our persistent focus on execution has further strengthened our foundation as we position the company for long-term sustainable growth. I will begin with a review of our first quarter results and then discuss our financial outlook for the remainder of the year, starting with slide eight, total revenue in the first quarter was up 1% year over year at approximately $11.5 billion.

Speaker #4: Our growth portfolio continued to perform well, with global revenue increasing 9% to $6.2 billion. As Chris mentioned, several products that are still early in their lifecycles are driving growth.

David Elkins: As Chris mentioned, several products that are still early in their life cycles are driving growth as we intentionally expand our business across a wider range of key assets. Within the legacy portfolio, we saw solid growth from Eliquis, which was offset by the continued impact of increased generic entry across several other brands. All in, we are very pleased with our results in the quarter as we build upon our objective to reshape and redefine BMS as one of the fastest-growing pharmaceutical companies into the next decade. Turning to product performance on slide 9, starting with oncology. Opdivo revenue decreased 8% to approximately $2.1 billion, with most of this decline coming from the US. This was primarily driven by an Opdivo inventory drawdown at the wholesaler level, where inventories are at the low end of the typical range.

Speaker #4: As we intentionally expand our business across a wider range of key assets, within the legacy portfolio, we saw solid growth from Eliquis, which was offset by the continued impact of increased generic entry across several other brands.

Speaker #4: All in, we are very pleased with our results in the quarter as we build upon our objective to reshape and redefine BMS as one of the fastest-growing pharmaceutical companies into the next decade.

Speaker #4: Turning to product performance on slide nine, starting with oncology. Opdivo revenue decreased 8% to approximately $2.1 billion. With most of this decline coming from the US, this is primarily driven by an Opdivo inventory drawdown at the wholesaler level, where inventories are at the low end of the typical range.

Speaker #4: We continue to monitor whether these levels will normalize over the balance of the year. In addition, we saw continued conversion to Convantiq, where the launch continues to progress well with revenues of $163 million.

David Elkins: We continue to monitor whether these levels will normalize over the balance of the year. We saw continued conversion to Kyvanti, where the launch continues to progress well with revenues of $163 million. With Opdualag, we delivered another quarter of strong double-digit growth driven by demand globally, where it remains a standard of care in first-line melanoma. Turning to slide 10, Reblozyl delivered 15% growth, with performance continuing to reflect solid uptake across first and second line MDS-associated anemia. In cell therapy, Breyanzi's Q1 growth of 53% reflects its best-in-class profile and continued strong demand across its approved indications in both the US and international markets. We remain encouraged by Breyanzi's continued momentum and growth prospects. Moving to cardiovascular and immunology on slide 11, Eliquis revenue was approximately $4.1 billion in the quarter, an increase of 13%.

Speaker #4: With Opdilag, we delivered another quarter of strong double-digit growth driven by demand globally, where it remains a standard of care and first-line melanoma. Turning to slide 10, Rebazel delivered 15% growth with performance continuing to reflect solid uptake across first and second-line MDS-associated anemia, and cell therapy Brianze's first quarter growth of 53% reflects its best-in-class profile and continued strong demand across its approved indications in both the US and international markets.

Speaker #4: We remain encouraged by Brianze's continued momentum and growth prospects. Moving to cardiovascular and immunology on slide 11, Eliquis revenue was approximately $4.1 billion in a quarter, an increase of 13%.

Speaker #4: We continue to see strong demand and, given our US price reduction that took effect at the beginning of the year, we also saw some wholesaler inventory build in the first quarter.

David Elkins: We continued to see strong demand, given our US price reduction that took effect at the beginning of the year, we also saw some wholesaler inventory build in Q1. We anticipate this build to reverse in Q2. Turning to CAMZYOS, revenue in Q1 nearly doubled to $314 million, benefiting from continued demand growth globally. Moving to immunology, global revenue of Sotyktu grew 20%. The recent approval in psoriatic arthritis represents a continued presence in rheumatology while we await our phase 3 readouts in lupus and Sjögren's disease. I will wrap up our product performance on slide 12 with neuroscience, where Cobenfy revenue in Q1 was $56 million, representing continued steady growth. Let's move to the P&L on slide 13.

Speaker #4: We anticipate this build to reverse in the second quarter. Turning to Camzias, revenue in the first quarter nearly doubled to $314 million. Benefiting from continued demand growth globally.

Speaker #4: Now moving to immunology, global revenue of Sitiktu grew 20%. The recent approval on psoriatic arthritis represents a continued presence in rheumatology, while we await our phase three readouts in lupus and Sjögren's disease.

Speaker #4: I will wrap up our product performance on slide 12 with Neuroscience, where Kabenfi revenue in the first quarter was $56 million representing continued steady growth.

Speaker #4: Now let's move to the P&L on slide 13. As expected, gross margin declined 280 basis points in the first quarter to 70.3%, which was primarily driven by product mix.

David Elkins: As expected, gross margin declined 280 basis points in Q1 to 70.3%, which was primarily driven by product mix. Excluding in-process R&D, operating expenses for Q1 were $3.9 billion, slightly above the same period last year. As compared to a year ago, the incremental investment related to Pamidomig, Kyvanti, and Cobenfy was largely offset by savings from our strategic productivity initiative. This continues to provide additional flexibility to invest behind these growth-oriented opportunities. Our effective tax rate in Q1 was 18.3%, reflecting jurisdictional earnings mix. Overall, diluted earnings per share was $1.58 for Q1, which includes a net charge of $0.03 a share related to in-process R&D and licensing income.

Speaker #4: Excluding in-process R&D, operating expenses for the first quarter were $3.9 billion. Slightly above the same period last year. As compared to a year ago, the incremental investment related to pemidimib, Kabenfiq, and Kabenfi was largely offset by savings from our strategic productivity initiative.

Speaker #4: This continues to provide additional flexibility to invest behind these growth-oriented opportunities. Our effective tax rate in the quarter was 18.3%, reflecting jurisdictional earnings mix.

Speaker #4: Overall, diluted earnings per share was $1.58 for the quarter, which includes a net charge of $0.03 a share related to in-process R&D and licensing income.

Speaker #4: Turning to the balance sheet and capital allocation highlights on slide 14, our financial position remained strong, with approximately $11 billion in cash equivalents and marketable securities as of March 31st.

David Elkins: Turning to the balance sheet and capital allocation highlights on slide 14, our financial position remains strong with approximately $11 billion in cash equivalents and marketable securities as of March 31st. In Q1, we generated approximately $1.1 billion in operating cash flow. This quarter's cash flow reflects roughly $1.2 billion in lower net cash collections due to Eliquis list price reductions. We expect this to be more than offset later in the year through lower rebate payments. In terms of capital allocation, we continue to take strategic and a balanced approach to deploying our strong cash flows. Business development remains a priority, and we are regularly evaluating opportunities in the therapeutic areas we know best, while continuing to return cash to shareholders through our commitment to the dividend. Now moving to guidance on slide 15.

Speaker #4: In the first quarter, we generated approximately $1.1 billion in operating cash flow. This quarter's cash flow reflects roughly $1.2 billion and lower net cash collections due to Eliquis list price reductions.

Speaker #4: We expect this to be more than offset later in the year through lower rebate payments. In terms of capital allocation, we continue to take strategic and balanced approach to deploying our strong cash flows.

Speaker #4: Business development remains a priority, and we are regularly evaluating opportunities in the therapeutic areas we know best while continuing to return cash to shareholders through our commitment to the dividend.

Speaker #4: Now moving to guidance on slide 15, we are reaffirming our financial guidance for the full year of 2026. Based upon the first quarter results and our current projections, we see our financial performance tracking towards the upper end of our established revenue and EPS guidance ranges.

David Elkins: We are reaffirming our financial guidance for the full year of 2026. Based upon the first quarter results and our current projections, we see our financial performance tracking towards the upper end of our established revenue and EPS guidance ranges. We will continue to provide updates as the year progresses. In closing, our strong performance in the quarter reinforces our confidence in our ability to deliver long-term value for our patients and shareholders. To reiterate Chris's comment, our strategy remains grounded in three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined, shareholder-friendly capital allocation. With that, I'll now turn the call back over to Chuck for Q&A.

Speaker #4: We will continue to provide updates as the year progresses. In closing, our strong performance in the quarter reinforces our confidence in our ability to deliver long-term value for our patients and shareholders.

Speaker #4: And to reiterate Chris's comment, our strategy remains grounded in three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio, and maintaining disciplined, shareholder-friendly capital allocation.

Speaker #4: And with that, I'll now turn the call back over to Chuck for Q&A.

Speaker #1: We will now begin. We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone.

Operator: We will now begin.

David Elkins: Operator, please.

Chuck Triano: Operator, please.

Operator: The first question today comes from Asad Haider with Goldman Sachs. Please go ahead.

Speaker #1: If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed or you would like to withdraw your question, please press star then two.

Speaker #1: We ask that you limit yourself to one question. At this time, we will pause momentarily to assemble our roster. The first question today comes from Asad Haider with Goldman Sachs.

Speaker #1: Please go ahead.

Asad Haider: Great. Thanks, thanks for taking the question. Just maybe just to open, just given how consequential the clinical readouts at the end of this year are gonna be for the company. Cristian, just starting with you, can you just level set us on your confidence in the key programs, specifically, for milvexian AF and the Cobenfi ADEPT trials? Just any quantitative bars for success. Related for Chris, you know, how do the timing of these readouts impact the company's BD strategy, as you think about the different outcomes that could unfold with the results of each of these readouts? Where do you see opportunity as you scan the landscape ahead of these readouts? Any framing on potential size of the BD aperture would be helpful. Thank you.

Speaker #3: Great. Thanks, thanks for taking the question. just maybe just to open, just given how consequential the clinical readouts at the end of this year are going to be for the company, Christian, just starting with you, can you just level set us on your confidence in the key programs, specifically for Mulvexia and AF and the Kabenfi Adept trials?

Speaker #3: Just any quantitative bars for success. And then related for Chris, y-you know, how do the timing of these readouts impact the company's BD strategy?

Speaker #3: as you think about the different outcomes that could unfold with the, the results of each of these readouts, and where do you see opportunity as you scan the landscape ahead of these readouts?

Speaker #3: And any framing on potential size of the BD aperture would be helpful. Thank you.

Speaker #4: Thanks for the question, Asad. Christian, you want to start, and then I'll take the BD question.

Chris Boerner: Thanks for the question, Asad. Cristian, you wanna start, and then I'll take the BD question.

Speaker #3: Thank you. Thank you, Asad, for the question. Let me start, with the fact that we have a very data-rich 2026. and even probably more '27.

Cristian Massacesi: Thank you. Thank you, Asad, for the question. Let me start with the fact that we have a very data-rich 2026, and even probably more 2027. Let me start with what we already achieved because we had a positive MRD with iberdomide in EXCALIBER in 25, and we are expecting the PFS later this year. You know, as Chris mentioned in his opening remarks, the PDUFA date for this filing is 17 August. We got the breakthrough designation priority review, it's progressing at pace. We achieved the mezigdomide this year with success, 2 oral presentation at ASCO. Really looking forward to show you guys the data.

Speaker #3: A-and let me start with what we already achieved, because in IM, I think, we had a positive MRD, with, Iberdromaid in Excalibur in '25, and we are expecting, the PFS later this year.

Speaker #3: You know, as, Chris mentioned in his opening remarks, the PDUFA date for this, filing is August 17. We got breakthrough designation, priority review. So it's progressing, at pace.

Speaker #3: We achieved the mysigdomide, this year with successor to oral representation at ASCO, really looking forward to, to, to show you guys the data. in, in IM, we will have, a readout also with our, ArloCell that is a GPRC, 5D, CAR-T that is happening, later this year.

Cristian Massacesi: In IM, we will have a readout also with our arlo-cel, that is a GPRC5D CAR T that is happening later this year. Moving cardiovascular, milvexian, as you were mentioning, are important readouts. Both AFib and SSP continue to be expected by the end of the year. We are recruiting the events as an event-driven. Of course, we remain blinded. We are recruiting the events as planned, and we're the DMC that regularly is reviewing the data. Even in the most recent meeting, they recommended to continue the studies as planned. BMS will be the only Factor XI company with Factor XI inhibitor in AFib.

Speaker #3: Moving cardiovascular, Mulvexia, as it was mentioning, are important readouts, both AFib and be expected by the end of the year. we have, rec we are recruiting the events as an event-driven and, of course, we remain blinded.

Speaker #3: We are recruiting the events as planned. And we have the DMC that regularly is reviewing the data, and even in the most recent meeting, they recommended to continue the studies.

Speaker #3: as planned. So BMS will be the only, factory level company with factory level inhibitor in AFib, of course, with, the presence also in SSP.

Cristian Massacesi: Of course, with the presence also in SSP, this can allow us to continue to lead in the thrombotic space. Confidence remain absolutely unchanged for milvexian in this space. In neuroscience, we continue to expect the ADP studies, ADEPT-1, 2, and 4 readouts by the end of the year. This is based on very, we are managing the studies and moving the studies more or less at the same with the same timelines, so they are lining up quite nicely. We need 2 studies probably for an approval. This is the base case, for a filing, we will see how the evolution in this space is happening. The confidence remain unchanged also for Cobenfy.

Speaker #3: This can allow us to continue to lead in the thrombotic space. Confidence remains absolutely unchanged, for Mulvexia in this space. In, neuroscience, we continue to expect, the ADP studies Adept 1, 2, and 4 by, readouts by the end of the year.

Speaker #3: this is, based on, very, we are managing the studies and moving the studies, more or less at the same, with the same timelines. So they are lining up, quite nicely.

Speaker #3: We need two studies probably, for, an approval. This is the base case. But, for a filing. But, we will see how the, the, the, the evolution in this space is happening.

Speaker #3: The confidence remains unchanged also for, Kabenfi. Study designs, trial conduction, is, now And, of course, the, the reason to believe in Kabenfi in this space are very clear.

Cristian Massacesi: Study designs, trial conduction is now completely under control. Of course, the reason to believe in Cobenfy in this space are very clear. Prior data, the data that we have seen in schizophrenia and of course, the open label in ADEPT-1, where patient before being randomized received Cobenfy for 12 weeks, give us confidence in potentially bringing this drug in patient with Alzheimer's Disease and psychosis. Last but not least, to me critical readout this year is admilparant in immunology in IPF and PPF. You know, this is a novel mechanism, LPA1. This is an inhibitor that can bring a novel mechanism to patient with this very, very difficult to treat disease. Is a first-in-class asset with a very differentiated profile, not only on efficacy side, but also on the safety side.

Speaker #3: prior data, the data that we have seen in schizophrenia, and of course, the open label in, in Adept 1, where patient before being randomized received Kabenfi for, for 12 weeks.

Speaker #3: Give us, confidence in potentially bringing this drug in patient with Alzheimer's disease and psychosis. Last but not least, to me, critical readout this year is, Amilparant in immunology in, IPF and PPF.

Speaker #3: You know, this is a novel mechanism, LPA-1. This is an inhibitor that can bring a novel mechanism to patients with this very, very difficult-to-treat disease.

Speaker #3: It's a first-in-class asset with a very differentiated profile, not only on efficacy side but also on the safety side. IPF is guided, by the end of the year, PPF will be just a few months later, probably beginning '27.

Cristian Massacesi: IPF is guided by the end of the year. PPF will be just a few months later, probably beginning 2027. A very solid phase 2 data. We, I'm very pleased on the execution of the phase 3 programs, so this is another important therapeutic option. As Chris mentioned, there is much more this year, next year. I have to say it's an exciting time to be at BMS.

Speaker #3: very solid phase two data. We, I'm, I'm very pleased, on the execution of the phase three programs. So this is another, important therapeutic option.

Speaker #3: as Chris mentioned, there is much more. this year, next year, I have to say, it's an exciting time to be a BMS.

Speaker #4: Thanks, Christian. And then, Asad, just on your BD question, look, BD continues to be a top capital allocation priority for us. It's not impacted by the end-of-year readouts.

Chris Boerner: Thanks, Cristian. Asad, just on your BD question. Look, BD continues to be a top capital allocation priority for us. It's not impacted by the end of year readouts. We have a very strong late-stage pipeline. We certainly don't need to chase deals, but as we've said consistently, if there are opportunities that make sense for us to enhance near term growth, we have the financial flexibility to be in the mix. At the same time, we're building for the long term, and we're going to continue to add to our early and mid-stage pipeline as well. Of course, given the size of those deals, we can certainly do both.

Speaker #4: We have a very strong late-stage pipeline. We certainly don't need to chase deals. But as we've said consistently, if there are opportunities that make sense, for us to enhance near-term growth, we have the financial flexibility to be in the mix.

Speaker #4: At the same time, we're building, for the long term, and we're going to continue to add to our early and mid-stage pipeline as well.

Speaker #4: And of course, given the size of those deals, we can certainly do both. irrespective of phase of development, though, the opportunities we're looking for are in areas we know well scientifically where we can add clinical and commercial value and ultimately, we can deliver, value to patients and to our shareholders.

Chris Boerner: Irrespective of phase of development though, the opportunities we're looking for in areas we know well scientifically where we can add clinical and commercial value and ultimately, we can deliver value to patients and to our shareholders. We're size agnostic as we've been. We certainly have the financial horsepower to go after multiple size deals.

Speaker #4: We're size agnostic, as we've been, and we certainly have the financial horsepower to go after multiple size deals.

Speaker #3: Thanks, Chris. Let's take our next question, please, operator.

Chuck Triano: Thanks, Chris. Let's take our next question, please, operator.

Speaker #5: The next question comes from Jeff Meacham with Citi. Please go ahead.

Operator: The next question comes from Geoff Meacham with Citi. Please go ahead.

Geoff Meacham: Great. Morning, everyone. Thanks for the question. Cristian, on pemetrexed, I wanted to check on the cadence of data in say the next 6 to 12 months, would you wait for more mature data on PFS before you really, you know, expand the number of trials, or are you ready to go right now? Then real quick for Adam, just to talk through the Kyvanti, you know, dynamics versus Opdivo and, you know, where you're seeing the biggest demand. Thanks.

Speaker #6: All right. morning, everyone. thanks for the question. Chris and I on Pamina Meg, I wanted to check on the cadence of data and, and say the next 6 to 12 months.

Speaker #6: And, and would you wait for more mature data on PFS before you really, you know, expand the number of trials? Or are you ready to go right now?

Speaker #6: And then real quick on, for Adam, just to talk through the, Cuvantic, you know, dynamics of versus, versus, Opdivo and, you know, where you're seeing the, the biggest demand.

Speaker #6: Thanks.

Speaker #4: Thanks, Jeff, Christian, then Adam.

Chris Boerner: Thanks, Geoff. Cristian, then Adam.

Speaker #1: Thank you, Jeff, for the question on Pamina Meg. Let me start with ASCO. ASCO will be an important meeting this year for PD-1/VEGF inhibitors.

Cristian Massacesi: Thank you, Geoff, for the question on pemetrexed. Let me start with ASCO. ASCO will be an important meeting this year for PD-1 VEGF inhibitors. You know, there are some competitor data in plenary that of course increase the confidence in the class, and we are presenting as a normal our Phase 2 data in non-small cell lung cancer in front-line, as a global data set after the China, the China data we presented previously in other indications. In few days, the abstract will be released. Our strategy with pemetrexed is replace and expand. We wanna replace PD-1 inhibitors, and we wanna expand beyond that. We announce and we deliver seven pivotal studies across indications.

Speaker #1: you know, there are, there are some, competitor data, in plenary that, of course, increase the confidence in the class. And we are presenting, as an oral, our phase two data in anosmocellular cancer in front line, as a global dataset after the China, the China data we presented previously in other indications.

Speaker #1: in a few days, the abstract will be released. Our strategy, with Pamina Meg, is, replace and expand. We want to replace PD-1, PD-1 inhibitors, and we want to expand beyond them.

Speaker #1: y we, announced and we deliver seven pivotal studies, across indications. All of them are ongoing and all of them are recruiting actively. N what, i-is, very important, in my view, is also what we are doing beyond the first wave of trials.

Cristian Massacesi: All of them are ongoing, and all of them are recruiting actively. What is very important in my view is also what we are doing beyond the first wave of trials. The confidence in my view is becoming more and more tangible in terms of level of activity, a combinability that you have with PD-1 VEGF inhibitors bispecifics. In my view, this is potentially translatable across indications. Now, the next step, at least in our strategy, is novel combinations. You know BMS has a very rich oncology portfolio. BioNTech has also an important portfolio of oncology assets.

Speaker #1: The confidence, in my view, is becoming more and more tangible in terms of a level of activity and combinability that you have with PD-1/VEGF, PD-1/VEGF inhibitors by specifics.

Speaker #1: and in my view, this is, potentially, translatable across indications. Now, the next step, at least in our strategy, is novel, novel combinations. and you know, BMS has, a very rich oncology portfolio.

Speaker #1: BioNTech, has also an, an, an important, portfolio of, oncology assets. And what we are doing, we are combining now with started the combination of Pamina Meg with, this, other drugs that represent an enabler for novel regimens.

Cristian Massacesi: What we are doing, we are combining now. We started the combination of pemetrexed with these other drugs that represent an enabler for novel regimens, also using some combination with external partners. On our internal side, we started the combination with our iza-bren ADC, which is an EGFR HER3 ADC. You will see data, as Chris was mentioning, at ASCO in esophageal, in triple-negative. It's a very active ADC, and I think with pemetrexed it can represent a very powerful regimen. We started a combination with our PRMT5 inhibitor, a very dual-type drug. In summary, I have to say that the partnership with BioNTech is moving very well because we are progressing the development of this drug with speed.

Speaker #1: Also, using some combination with external partners. On our internal side, we started the combination with our Isabren ADC, which is an EGFR, R3 ADC.

Speaker #1: You will see data, as Chris was mentioning, at ASCO in esophageal, in triple negative. It's a very active ADC. And I think with Pamina-Meg, it can represent a very powerful regimen.

Speaker #1: We started a combination with our PRMT5 inhibitor, our, non-nodular metastat, a very, du-type drug. So in, in summary, I have to say that the partnership with BioNTech, is moving very well because we are progressing the, the development of this drug with speed.

Speaker #1: We think we are very well positioned to make this, drug as a potential new backbone in immune oncology. And generating the next regimens, very powerful cancer patients across indications.

Cristian Massacesi: We think we are very well-positioned to make this drug as a potential new backbone in immune oncology and generating the next regimens, very powerful cancer patients across indications.

Chris Boerner: Adam.

Speaker #3: Adam.

Speaker #6: Yep. Jeff, thanks for the question. As it relates to, Cuvantic, we're, we're pleased with the Cuvantic launch performance. Our teams are executing well. And we're seeing use across multiple tumor types.

Adam Lenkowsky: Yep. Geoff, thanks for the question. As it relates to Kyvanti, we're pleased with the Kyvanti launch performance. Our teams are executing well, and we're seeing use across multiple tumor types. We're seeing uptake in our monotherapy indications as well as in combination treatment, so in RCC, in gastric cancer, and in melanoma. We're continuing to hear positive feedback from community oncologists that Kyvanti improves practice efficiency with a 3-minute in-office injection and that patients prefer Kyvanti when offered the opportunity versus the IV formulation. We've now delivered over 10% conversion from IV to Kyvanti in the US in just over a year on the market, and we're tracking well against our expectations, and we remain confident in our expectation that physicians will convert approximately 30% to 40% of IV business in the next 2 years.

Speaker #6: We're seeing uptake in our monotherapy indications as well as in combination treatments. So in RCC, in gastric cancer, and in melanoma. We're continuing to hear positive feedback from community oncologists that Cuvantic improves practice efficiency.

Speaker #6: With a three-minute in-office injection and that patients prefer Cuvantic when offered the opportunity versus the IV formulation. So we've now delivered over 10% conversion from IV to Cuvantic in the US in just over a year on the market.

Speaker #6: And we're tracking well against our expectations. We remain confident in our expectation that physicians will convert approximately 30% to 40% of IV business in the next two years.

Speaker #4: Thanks, Adam. Can we move to our next question, please, operator?

Chuck Triano: Thanks, Adam.

Chris Boerner: Thanks, Adam.

Chuck Triano: Great. Can we move to our next question, please, operator?

Speaker #5: The next question comes from Alexandra Hammond with Wolf Research. Please go ahead.

Operator: The next question comes from Alexandria Hammond with Wolfe Research. Please go ahead.

Speaker #7: Hey, guys. Thanks for taking the question. On Novexian, given the size and breadth of the Librexia program, it seems like there's probably a rich set of outcomes between a clean win and miss.

Alexandria Hammond: Hey, guys. Thanks for taking the question. On Nulioxin, given the size and breadth of the Librexia program, seems like there's probably a rich set of outcomes between a clean win and miss. Can you help us think through how you'd approach a subgroup analysis, particularly for patients where the risk/reward calculus might be more favorable for Factor XI? To the extent that the top line doesn't meet that primary endpoint cleanly, is there a path where a specific patient population still supports a meaningful commercial opportunity? Thank you.

Speaker #7: Can you help us think through how you'd approach, subgroup analysis, particularly for patients where the risk-reward calculus might be more favorable for factor 11?

Speaker #7: And to the extent that the top line doesn't meet that primary endpoint cleanly, is there a path that supports a meaningful commercial opportunity? Thank you.

Chris Boerner: I'll have Cristian take that, and then Adam, you can add any color commentary as you need to.

Speaker #4: I'll have Christian take that and then Adam, you can add any color commentary as you need to.

Chris Boerner: I'll have Cristian take that, and then Adam, you can add any color commentary as you need to.

Speaker #1: I mean, Alex, let me, let me start with that. to, to tell that we continue to be on track, on track by the end of the year with, with both, AFIB and SSP.

Cristian Massacesi: I mean, Alex, let me start that to tell that we continue to be on track by the end of the year with both AFib and SSP. You know, these trials are remained driven. We remain blinded. As said, the DMC continues the oversight to the both studies. We are at a point in which this give us confidence that we are progressing on the right way with both efficacy and safety. Everything is continuing as planned. You know, in AFib, the study will test non-inferiority versus apixaban, then we will have a superiority testing for bleedings.

Speaker #1: You know, these trials are event-driven. We remain blinded. As said, the DMC continues to oversight. To the, the both studies, we are at a point in which, um, this gives us confidence that we are progressing on the right, on the right way with both efficacy and safety.

Speaker #1: Everything is continuing as planned. You know, in AFIB, in AFIB, the study will test non-inferiority—that's the Sapixaban. And then we will have a superiority testing for bleedings.

Speaker #1: Based on what we have seen, in, other, trials recently, and, and based on the expectation, and how we size and power the study, I think, we are, very much on track with both the endpoints.

Cristian Massacesi: Based on what we have seen in other trials recently and based on the expectation, and how we size and power the study, I think, we are very much on track with both the endpoints to show non-inferiority and superiority in bleedings. Adam?

Speaker #1: To show non-inferiority and, superiority in bleedings.

Speaker #4: Adam.

Chris Boerner: Adam?

Speaker #6: Yeah. Alex, as it relates to commercial opportunity, Novexian represents a significant, opportunity commercially. There's a need for a medicine with, low bleeding risk, SSP.

Adam Lenkowsky: Alex, as it relates to commercial opportunity, milvexian represents a significant opportunity commercially. There is a need for a medicine with low bleeding risk both in AFib and in SSP. We think there is a significant advantage to having both indications. We would expect broad adoption. As we talked about previously, you know, fear of bleeding continues to be the main reason why physicians hold back from utilizing Factor Xa's in more patients. Despite the highly effective DOACs like Eliquis, roughly 40% of patients who should be anticoagulated are either untreated, you know, underdosed, or they discontinue treatment. That is driven largely by concerns around bleeding risk. This leaves a meaningful unmet need across a substantial number of patients. As a reminder, this study in AFib was designed to demonstrate a superior bleeding profile compared to Eliquis with comparable efficacy.

Speaker #6: And we think there's a significant advantage to having both indications we would expect for adoption. As we talked about previously, you know, fear of bleeding continues to be the main reason why physicians hold back from utilizing factor 10As in more patients.

Speaker #6: And despite the highly effective DOACs, like Eliquis, roughly 40% of patients who should be anticoagulated are either untreated, underdosed, or they discontinue treatment.

Speaker #6: And that's driven largely by concerns around bleeding risk. So this leaves a meaningful unmet need across a substantial number of patients. And as a reminder, this study in AFIB was designed to demonstrate a superior bleeding profile compared to Eliquis, with comparable efficacy.

Speaker #6: So we believe this profile is gonna drive significant demands and will be important for both patients and providers. And as Christian said, we're looking forward to the data readout at the end of this year.

Adam Lenkowsky: We believe this profile is gonna drive significant demand and will be important for both patients and providers. As Cristian said, we're looking forward to the data readout at the end of this year, and we think this has true blockbuster potential.

Speaker #6: And we think this has true blockbuster potential.

Speaker #4: Thanks, Adam.

Cristian Massacesi: Thanks, Adam.

Chris Boerner: Thanks, Adam.

Speaker #3: Great. let's move to the next question, please.

Chuck Triano: Great. Let's move to the next question, please.

Speaker #5: The next question comes from Chris Schott with JPMorgan. Please go ahead.

Operator: The next question comes from Chris Schott with J.P. Morgan. Please go ahead.

Chris Schott: Great. Thanks so much for the questions. Just two for me. Maybe first, can you just talk about CAMZYOS dynamics post your competitor approval? Just what are you seeing in the market, and just how are you thinking about that evolving? The second one for me was coming back to the CELMoDs that was, you know, kind of some of this initial clinical data as readout. Can you just elaborate a little bit more the role in the market you see for those products based on these initial datasets, and how much of your excitement here is based more on the future readouts versus what we're seeing initially here? Thanks so much.

Speaker #4: great. thanks so much for the question. Just, just two for me. maybe first, can you just talk about ChemZio's dynamics post your competitor approval?

Speaker #4: Just what, what are you seeing in the market and just how are you thinking about that evolving? A-and the second one for me was coming back to the cell mods that we've s you know, kind of some of this initial, clinical data has read out.

Speaker #4: Can you just elaborate a little bit more the role in the market you see for those products based on these initial data sets? a-and how much of the your excitement here is based more on the, the future readouts versus what we're seeing initially here?

Speaker #4: Thanks so much.

Speaker #6: Thanks, thanks for the question, Chris. Adam, I think you can take both.

Chris Boerner: Thanks for the question, Chris. Adam, I think you can take both.

Speaker #2: Yeah, thanks, Chris. So, ChemZio continues to have very good momentum. Again, our commercial teams are executing very well in the field. We are seeing continued strong new patient starts, coupled with high persistency rates.

Adam Lenkowsky: Yeah. Thanks, Chris. CAMZYOS continues to have very good momentum. Again, our commercial teams are executing very well in the field. We are seeing continued strong new patient starts coupled with high persistency rates. Physician and patient feedback are very favorable, and physicians consistently cite the significant and rapid improvement in symptoms, and we're seeing very low drop-off rates. In fact, you know, we are approaching 25,000 patients now prescribed CAMZYOS in the US, with thousands more prescribed internationally. As far as, you know, what we're seeing in the field, you know, we've been planning for competition for some time. HCP is continuing to reinforce that they see, you know, little differentiation. It's still early. Some physicians have started 1 or 2 patients on the competition, and you know, they are still operationalizing their own REMS program.

Speaker #2: Physician and patient feedback are very favorable, and physicians consistently cite the significant and rapid improvement in symptoms. We're also seeing very low drop-off rates.

Speaker #2: In fact, you know, we are approaching 25,000 patients now prescribed ChemZio's in the US with thousands more prescribed internationally. As far as, you know, what we're seeing in the field, you know, we've been planning for competition for some time.

Speaker #2: ACPs continue to reinforce that they see, you know, little differentiation, it's still early. Some physicians have started one or two patients. On the competition.

Speaker #2: And, you know, they are still operating, operationalizing their own REMS program. But we also hear consistently that the ChemZio's REMS process is very clear and the infrastructure and workflow that have been established now for four years you know, are, you know, very clear.

Adam Lenkowsky: We also hear consistently that the Camzyos REMS process is very clear, and the infrastructure and workflow that have been established now for 4 years, you know, are, you know, very clear. TLs have shared they'll use the Camzyos dosing and echo regimen at 4 weeks. We see this as a positive. Why is that? Roughly 90% of patients on Camzyos are on the 5-milligram starting dose, and it's simply, you know, one dose titration to 10 milligrams. It's 5 or 10 representing 90% of our business, which is effective for the majority of patients. Camzyos patients feel better in a matter of weeks, where we see from the competition requires multiple titration steps to reach an effective dose.

Speaker #2: And thus, TLs have shared they'll, they'll use the ChemZio's dosing and echo regimen at four weeks. So we see this as a positive. And we why is that?

Speaker #2: Because roughly 90% of patients on ChemZio's are on the 5-milligram starting dose. And it's simply you know, one dose titration to 10 milligrams. So it's 5 or 10 representing 90% of our business, which is effective for the majority of patients.

Speaker #2: ChemZio's patients feel better in a matter of weeks, where we see from the competition requires multiple titration steps to reach an effective dose. And so, you know, our teams were well prepared for the launch of Apicamfen.

Adam Lenkowsky: You know, our teams were well prepared for the launch of apixaban, and we remain confident that we'll be the leader in the space longer term. As it relates to, you know, to iberdomide, I think, you know, we're really excited about the launch of iber. I know that Chris and Cristian have talked about this. I think there are a few areas that, you know, I could point to. Number one, you know, with iberdomide, you know, this is an area that we know very well in multiple myeloma.

Speaker #2: And we remain confident that we'll be the leader in the space longer term. So as it relates to, you know, to Iverdemide and, you know, we're really excited about the launch of, of Iver.

Speaker #2: And I know that, Chris and Christian have talked about this. And so I think there are a few areas that, you know, I should point to.

Speaker #2: Number one, you know, with, with Iverdemide, you know, this is an area that, that we know very, very well in multiple myeloma. we, we see that, you know, for multiple myeloma, it's a highly competitive it's a fragmented market.

Adam Lenkowsky: We see that, you know, for multiple myeloma, it's a highly competitive, it's a fragmented market, but there remains a need for more effective and safe options that can address the majority of patients, particularly those patients who are treated in the community setting, and that's 70% to 80% of patients. When we hear from physicians, they're excited about oral, low-burdensome regimens that can provide a better experience for their patients. We're confident that iberdomide will provide a balance of high potency, manageable toxicity, combinability with daratumumab, with the convenience of an oral treatment that amplifies the efficacy of IMiD-based regimens. Our goal is to make both iber and medzi foundational in multiple myeloma, replacing Revlimid and Pomalyst in second line over time in the community, longer-term serving as partners for T-cell redirecting therapies and cell therapy.

Speaker #2: But there remains a need for more effective and safe options that can address the majority of patients, particularly those patients who are treated in the community setting.

Speaker #2: And that's 70 to 80 percent of patients. What we hear from physicians, they're excited about oral, low burdensome regimens that can provide a better experience for their patients.

Speaker #2: And we're confident that Iverdemide will provide a balance of high potency, manageable toxicity, combinability with daratumumab, with the convenience of an oral treatment that amplifies the efficacy of image-based regimens.

Speaker #2: So our goal is to make both Iver and Mezzi foundational in multiple myeloma, replacing Revlimid and Pomalyst in second line over time in the community.

Speaker #2: Longer term, serving as partners for T-cell redirecting therapies and cell therapy. So, you know, we know the work that we need to do to establish both Iver and Mezzi in the market.

Adam Lenkowsky: You know, we know the work that we need to do to establish both iber and medzi in the market, and we're very excited to bring both of these important medicines to patients because we believe this is a real attractive commercial opportunity.

Speaker #2: And we're very excited to bring both of these important medicines to patients because we believe this is a, a real attractive commercial opportunity.

Cristian Massacesi: Adam, allow me to step in. Chris, I wanna use the opportunity you mentioned in the question on CAMZYOS because I received, we received often the question about the non-obstructive HCM plans. I think, first of all, let me start that the level of benefit expected in a non-obstructive is different than an obstructive because of the heterogeneity of patients and diseases is much higher. That said, we have learned a lot from ODYSSEY-HCM. We know better where the patients and which diseases they are affected by that can benefit most from a myosin inhibitor like CAMZYOS. I wanna announce that we are planning now to run a new, more focused study in non-obstructive HCM.

Speaker #1: And Adam, allow me, to, to step in. Chris, I wanna use, the opportunity you mentioned, in the question on ChemZio's. Because, I received we received often, the question about the non-obstructive, HCM plans.

Speaker #1: I think, first of all, let me s let me start that the level of benefit expected in, in non-obstructive is different than in obstructive.

Speaker #1: because of the heterogeneity, of patients and diseases, is much higher. That said, we have learned a lot from Odyssey. we know better where the patients, and which with diseases they are affected by that can benefit most from MIs in inhibitor like ChemZio's.

Speaker #1: So, I, I, I wanna announce that we are planning now to run, a new more focused study in non-obstructive HCM and, then, of course, the detail of it, will be highlighted in clinicaltrade.org where we are progressing this work.

Cristian Massacesi: Then, of course, the detail of it will be highlighted in clinical trial to go along with our progress in this work.

Speaker #4: Thank you, Christian.

Chris Schott: Thank you, Cristian.

Chris Boerner: Thank you, Cristian.

Speaker #6: Next question, please, operator.

Chuck Triano: Next question please, operator.

Speaker #5: Next question comes from Evansley Bergen with BMO Capital Markets. Please go ahead.

Operator: Next question comes from Evan Seigerman with BMO Capital Markets. Please go ahead.

Speaker #7: Okay. Thank you so much for taking my question. And another one for Christian. So you really inherited the design and kind of, the Milvexian trials.

Evan Seigerman: Hi, guys. Thank you so much for taking my question and another one for Cristian. You really inherited the design and kind of the milvexian trials. Can you walk me through the aspects of the trial design, patient selection that, you know, increased your confidence in a potentially successful readout later this year?

Evan Seigerman (BMO Capita: Hi, guys. Thank you so much for taking my question and another one for Cristian. You really inherited the design and kind of the milvexian trials. Can you walk me through the aspects of the trial design, patient selection that, you know, increased your confidence in a potentially successful readout later this year?

Speaker #7: Can you walk me through the aspects of the trial design, patient selection, that, you know, increased your confidence in a potentially successful readout later this year?

Speaker #4: Christian.

Chris Boerner: Cristian?

Speaker #2: Thank you, Evan, for, for the question. in, I, I think, your question is referring to a FIBA specifically, I imagine. because SFP.

Cristian Massacesi: Thank you, Evan, for the question. I think your question is referring to AFib specifically, I imagine.

Evan Seigerman: Yeah

Evan Seigerman (BMO Capita: Yeah

Cristian Massacesi: Yeah. In AFib, let me tell you that first of all, the data are solidly based on a phase 2 studies that we run in total knee replacement. That is a very good surrogate for antithrombotic drugs. We learned a lot from Eliquis in that space, and we know the predictivity value of that kind of population for antithrombotic agents. I think the very elegant, refined work that has been done with milvexian was in selecting the dose for AFib. That was in that trial. We tested multiple dose levels, and ultimately we landed with 100 mg twice a day. That is a much higher dose, for instance, that we are using in SSP.

Speaker #7: Yes.

Speaker #2: You in, yeah. So in AFIB, let me tell you that, first of all, the data are, solidly based on, a phase two studies that we run, in, totally replacement.

Speaker #2: That is a very good surrogate for, antithrombotic drugs. We learned a lot from Eliquis in that space. And we know the predictability value of that, that, kind of population for antithrombotic agents.

Speaker #2: I think the, the, the very elegant and refined work that has been done with, Milvexian was, in selecting the dose for AFIB. That was, in, in that trial, we tested multiple dose levels.

Speaker #2: And, ultimately, we landed with 100 milligram twice a day. That is a much higher dose, for instance, that we are using in, in SSP.

Speaker #2: But it's a dose that gave us the confidence based on all the work that has been done, the modeling and the, the work and then the, the we, we were able to, to bring in, in, in this, in the phase two part.

Cristian Massacesi: It's a dose that gave us the confidence based on all the work that has been done, the modeling and the work and then we were able to bring in this in the phase 2 part, give us confidence to have at least same level of efficacy than what we expect with apixaban, preserving of course the bleeding value. Going specifically to your question, the design of the study is to be able to show a non-inferiority versus apixaban in a head-to-head comparison in a very well sized study. We recruited 20,500 patients, so very well powered for an inferiority margins. We disclose these margins. Of course, they go from 0.8 to 1.3.

Speaker #2: Give us confidence to have at least, same level of efficacy that what we expected with Apixaban. Preserving, of course, the bleeding value. Going specifically to your question, the design of the study is, to be able to show a non-inferiority versus Apixaban.

Speaker #2: In an end-to-end comparison, in a very well, sized study, we recruited, 20,000 and 500 patients. So very well power for an inferiority margin. So we disclose this margins, of course, they go from 0.8 to 1.3.

Speaker #2: And, we will then, when an inferiority will be met, test superiority for, bleedings. We test we split alpha for measured bleeding and no measured clinical relevant bleedings.

Cristian Massacesi: We will then, when an inferiority will be met, test superiority for bleedings. We test with split alpha for measured bleeding and no measured clinical relevant bleedings. Because I wanna link what Adam was telling. This is a measured problem in the clinical setting, and being able to show that the drug provide benefit in terms of decreasing the bleedings will be very important in the marketplace. As said, the study is fully powered, well-designed, and pick, in my view, the right dose to being able to show what the study predefined criteria should meet.

Speaker #2: Because I wanna link what, Adam was telling. This is a measured problem in the clinical setting. And being, able to show that the drug, provide benefit in terms of decreasing the bleedings, would be very important in the marketplace.

Speaker #2: So, as said, the study is fully power, well designed, and, peak, in my view, the right dose, to being able to show what the study, predefined criteria should meet.

Speaker #4: Thanks, Christian. Thanks, Evan, for the question.

Chuck Triano: Thanks, Cristian. Thanks, Evan, for the question.

Chris Boerner: Thanks, Cristian. Thanks, Evan, for the question.

Speaker #6: Let's move to our next question, please, operator.

Chuck Triano: Let's move to our next question, please, operator.

Speaker #5: The next question comes from Michael Yee with UBS. Please go ahead.

Operator: The next question comes from Michael Yee with UBS. Please go ahead.

Speaker #7: Thank you. following up on the design of the Milvexian, study, if you take a look at the recent, AFIB, results, you can see that the stroke rates are quite historically a lot lower than they were back in the original days of Eliquis.

Chuck Triano: Thank you. Following up on the design of the milvexian study. If you take a look at the recent AFib results, you can see that the stroke rates are quite historically a lot lower than they were back in the original days of Eliquis. Just thinking about whether you've taken that into consideration and to what extent you think that impacts the study design and whether you think that there's any chance that the study results will ultimately end up in 2027, which could end up being more positive for you than in 2026. Thank you, Cristian.

Michael Yee: Thank you. Following up on the design of the milvexian study. If you take a look at the recent AFib results, you can see that the stroke rates are quite historically a lot lower than they were back in the original days of Eliquis. Just thinking about whether you've taken that into consideration and to what extent you think that impacts the study design and whether you think that there's any chance that the study results will ultimately end up in 2027, which could end up being more positive for you than in 2026. Thank you.

Speaker #7: So, just thinking about, whether you've taken that into consideration and to what extent you think that impacts, the study design and whether you think that there's any chance that the study results will ultimately end up in 2027, which could end up being more positive for you than in 2026.

Speaker #7: Thank you.

Speaker #4: Christian.

Chris Boerner: Cristian.

Speaker #2: Okay. Thank you, Michael, for the question. you know, I, I, I don't we cannot disclose, baseline characteristics and, which kind of events we are recruiting.

Cristian Massacesi: Thank you, Michael Yee, for the question. You know, we cannot disclose baseline characteristics and which kind of events we are recruiting. By the way, we are blind, of course, to the study. What I can tell you again is that the AFib study, Librexia study, has the right sample size and of course has a predefined number of events. We are recruiting the events as expected. The events predefined number is for efficacy and of course for safety. We are on track by year-end. It's event-driven. We are in April. We will see later in the year if this event rate will change or not. For the moment, we are on track for any year-end readout.

Speaker #2: By the way, we remain blind. It, of course, to the study. what I can tell you, again, is that the AFIB, study, Librexia study, has the right sample size and, of course, has a predefined number of events.

Speaker #2: we are recruiting the events, as expected. and, the, the events, predefined number is for efficacy and, of course, for safety. So we, we are on track by year-end.

Speaker #2: it's event-driven. We are in April. we will see later in the year if these event rate will change or not. For the moment, we are, we are on track for an year-end readout.

Speaker #4: Thanks, Christian.

Chuck Triano: Thanks, Cristian.

Chris Boerner: Thanks, Cristian.

Speaker #6: All right. Thank you, Christian. next question, please, operator.

Chuck Triano: Great. Thank you, Cristian. Next question, please, operator.

Speaker #5: The next question comes from Akash Tawari with Jefferies. Please go ahead.

Operator: The next question comes from Akash Tewari with Jefferies. Please go ahead.

Speaker #8: Hey. Thanks so much. so for your Cobenfi, Alzheimer's psychosis studies, you have several trials. But I know Adept4 requires patients to have a confirmed Alzheimer's diagnosis using both imaging and blood-based biomarkers.

Akash Tewari: Hey, thanks so much. So for your Cobenfy, Alzheimer's psychosis studies, you have several trials, but I know ADEPT-4 requires patients to have a confirmed Alzheimer's diagnosis using both imaging and blood-based biomarkers. Can you talk about why you added that criteria for the study? Was it based on any issues you saw with the ADEPT-2 trial conduct? Just on CELMoDs, can you talk about your confidence on the SUCCESSOR-1 study, which goes head to head against Pomalyst, showing a clinically meaningful effect size based on the results you saw in SUCCESSOR-2? Thank you.

Speaker #8: Can you talk about why you added that criteria for the study, and was it based on any issues you saw with the Adept2 trial conduct?

Speaker #8: And then just on CellMods, can you talk about your confidence on the SUCCESSOR-1 study, which goes head-to-head against Pomalyst, showing a clinically meaningful effect size based on the results you saw on SUCCESSOR-2?

Speaker #8: Thank you.

Speaker #4: Christian.

Chuck Triano: Cristian?

Speaker #2: Yes. So, the and thank you, Akash. The, the Cobenfi Adept4 decision to, go into a biomarker-selected population was based in a try to decrease heterogeneity in the in the in the patient population.

Cristian Massacesi: Thank you, Akash. The Cobenfy ADEPT-4 decision to go into a biomarker selected population was based in a try to decrease the heterogeneity in the patient population. As you know, ADEPT-2 was a study that was already ongoing in the moment we acquire Cobenfy. We wanted to have a more predefined patient population to be recruited into an Alzheimer's Disease psychosis setting. This is why we took this approach of biomarker positivity. This can be done through plasma or radiologically. I think, of course, this is increase the confidence that the right patients are treated in the trial.

Speaker #2: As you know, Adept2 was a study that was already ongoing, in the moment, we acquired, Cobenfi. and, we wanted to have, to have a, a, a more, predefined patient population to be recruited into, into an Alzheimer's disease psychosis setting.

Speaker #2: This is why we took these, approach of, biomarker positivity. That can be done through plasma or radiologically. and I think, of course, this is, increase the confidence that the right patients are, treated in the trial.

Speaker #2: even if, increase a little bit at the operational the operational, challenges because, of course, we need a predefined number of patients biomarker positive to run.

Cristian Massacesi: Even if increase a little bit the operational challenges, because of course, we need a predefined number of patients biomarker positive to run. The screening failures are a little bit higher. This doesn't take out any confidence of the potential benefit you can see also maybe in a trial like ADEPT-2, where we do not have a biomarker positive study, because ultimately, you treat symptoms, but give more confidence that you have Alzheimer patients. This is the main reason. We are not the only one doing this, taking this approach in this space. Going back to your second question on CELMoDs, I think SUCCESSOR-2 was a very good news.

Speaker #2: So, the screening failures are a little bit higher. This is, doesn't take out any confidence of the potential benefit you can see also maybe in a trial like Adept2 where we do not have a, a fa a biomarker positive study because ultimately you treat symptoms.

Speaker #2: But give more confidence that you have Alzheimer's patients. This is the main reason. We are not the only one doing this, taking this approach in the in the space.

Speaker #2: Going back to your, second question on, on CellMods, I think a successor to was, a very good, news. not only because, it, and as you mentioned, successor two is an add-on study on top of KD.

Cristian Massacesi: Not only because it and as you mentioned, SUCCESSOR-2 is an add-on study on top KD, but because it came earlier than expected. We hit an interim PFS. You will see the Tarasco, but you already know that when you hit an interim PFS, it means that you hit a bar that is higher according to what the study was pre-designed for. This is answering your question on SUCCESSOR-1. We believe Mezigdomide is a very potent CELMoD. It's more potent than Iberdomide, for instance. It is a drug that can be very well combined with the standard of care regimens that we see. A little bit less with anti-CD38. This is why Iberdomide is doing that job.

Speaker #2: but because it came earlier than expected. We hit an interim PFS. You will see the data RASCO, but you already know that when you hit an interim PFS means that you hit a bar that is higher.

Speaker #2: according to what the study, what the study was, pre designed, for. This is answering your, question on successor one. We believe Mesignomide is a very potent CellMods.

Speaker #2: It's more potent than, Iberdomide, for instance. It's, a drug that can be very well combined, with, the, the, the, the standard care regimens that we, we, we see.

Speaker #2: A little bit less with, anti-CD38. This is why Iberdomide is doing that job. But, I believe that, the level of, efficacy we have seen, and the, the design of the study let us believe that this drug can be better than, Revlimid and, and Pomalidomide.

Cristian Massacesi: I believe that the level of efficacy we have seen and the design of the study let us believe that this drug can be better than Revlimid and pomalidomide. The confidence of SUCCESSOR-1 is high, and of course, is higher bar because it's not an add-on, it's a replacement strategy. I think the PDS is high.

Speaker #2: So the, the confidence of successor one is, high. And, of course, is higher bar because it's not an add-on, it's a replacement strategy. But, I think the PTS is high.

Speaker #4: Thanks, Christian. And let me just also say that I'm glad to hear so many questions on CellMods. This, the CellMod program, we're quite excited about.

Chris Boerner: Thanks, Cristian. Let me just also say that I'm glad to hear so many questions on CELMoD. The CELMoD program we're quite excited about. You're gonna see exciting data at ASCO on IBR and Mezi. We shouldn't forget you'll also see data on golcadomide, which continues, in my view, to be a sleeper in the program just because of the high-quality data that we've seen thus far. You'll see more of that data at ASCO. Of course, behind this, we've got additional degraders, BCLxL DD, AR LDD. This program and this platform is quite deep, and it's nice to see these data maturing as they are across each and every one of these programs. It's exciting to see. Stay tuned for that at ASCO and beyond.

Speaker #4: You're gonna see exciting data at ASCO on IBER and MESI. We shouldn't forget you'll also see data on Golcotamide, which continues, in my view, to be a sleeper in the program just because of the high-quality data that we've seen thus far.

Speaker #4: You'll see more of that data at ASCO, of course, behind this. We've got additional degraders: BCL6LDD, ARLDD, and this program in this platform is quite deep, and it's nice to see this data, maturing as they are across each and every one of these programs.

Speaker #4: So it's exciting to see. So stay tuned for that at ASCO and beyond.

Speaker #6: Thanks, Chris. let's take our next question, please.

Chuck Triano: Thanks, Chris. Let's take our next question, please.

Speaker #5: The next question comes from Luis Chen with Scotiabank. Please go ahead.

Operator: The next question comes from Louise Chen with Scotiabank. Please go ahead.

Louise Chen: Hi. Thanks for taking my questions. I wanted to ask you, in addition to your ADEPT study for Cobenfy, I know you have several additional potential indications for Cobenfy. Which of those additional indications are you most excited by? Secondly, you have a lot of different modalities in your cell therapy franchise and pipeline, and how do you see these all coming together to give Bristol a more comprehensive hold on the market? Thank you.

Speaker #9: Hi. Thanks for taking my questions. I wanted to ask you, in addition to your ADP study for Cobenfi, I know you have several additional potential indications for Cobenfi.

Speaker #9: And which of those additional indications are you most excited by? And then secondly, you have a lot of different modalities in your self-therapy franchise and pipeline.

Speaker #9: And how do you see these all coming together to give, first of all, a more comprehensive hold on the market? Thank you.

Chris Boerner: Cristian, and then Adam can provide color commentary.

Speaker #4: Christian and then Adam, you can provide color commentary.

Cristian Massacesi: ADEPT, because we believe this is a huge medical need, and we believe that Cobenfy can bring benefit based on what we have seen in schizophrenia. You know, we are focusing our strategy in psychosis, specifically assessing hallucination delusion, delusions. This is something that we have seen a patient really having an improvement in schizophrenia. We wanted to have multiple shots on goal. This is why we have ADEPT-2 and ADEPT-4 that are similar studies with the difference one is biomarker selected population, the other one not. We have ADEPT-1 that is more a study that will assess how Cobenfy will avoid relapses. We also design ADEPT-5.

Speaker #2: s-so ADP and because we believe that this is a huge medical need, and we believe that Cobenfi can bring benefit based on what we have seen in, in schizophrenia.

Speaker #2: you know, we are focusing, our, strategy in, psychosis specifically assessing, hallucination and delusion. Delusions. And this is something that we have seen patients really having an improvement in, in schizophrenia.

Speaker #2: the, we wanted to have a multiple shots on goals. This is why we have Adept2 and Adept4 that are similar studies with the difference one is biomarker selected, population; the other one not.

Speaker #2: And we have ADEPT-1 that is more a study that will assess how Cobenfi will avoid relapses. But we also designed ADEPT-5. So we are now four shots on goal in this program, because the base case I was mentioning before is having at least two positive.

Cristian Massacesi: We have now 4 shots on goal in this program because the base case I was mentioning before is having at least two positive. Things are changing maybe. We believe this is an important, an important setting. Cobenfy can bring benefit to patients. We wanna really have a multiple shots on goal. When thinking the other indication, bipolar disorder is the next one in line because we expecting results in 2027. We are testing Cobenfy specifically in mania, on the, in the context of bipolar disorders. You know, if you think this is a very similar in terms of the productive symptoms that we see in AD psychosis. Then we have AD agitation.

Speaker #2: Things are changing maybe. and we believe this is an important, an important setting: Cobenfi can bring benefit to patients. We wanna really have a multiple shots on goal.

Speaker #2: When talking when thinking the other indication, bipolar disorder is the next one in line because we're re expecting results in 2027. we are testing Cobenfi specifically in mania, on the in the context of bipolar disorders.

Speaker #2: And you know, if you think, this is very similar in terms of the productive symptoms that we see in AD psychosis. And then we have AD agitation. AD agitation is very related to psychosis because this is one symptom that we have seen Cobenfi already providing benefit.

Cristian Massacesi: AD agitation is very related to psychosis because this is one symptom that we have seen Cobenfy already providing benefit. The confidence is high also for this. Agitation is coming in 2028, like cognition, AD cognition. Cognition is probably different mechanism. Psychosis is probably mediated by muscarinic receptor 4. Cognition probably by muscarinic receptor 1. Cobenfy is working on both. This is where the confidence stay. I would say the cobenfy we believe can bring a benefit in controlling these kind of symptoms in Alzheimer, in the bipolar patients, and is an anchor asset for our portfolio in neuroscience. We are building.

Speaker #2: So the confidence is high also for this. Agitation is coming, in 2028, like cognition. AD cognition. And cognition, is probably different mechanism. Psychosis is probably mediated by muscarinic receptor 4.

Speaker #2: cognition probably by muscarinic receptor 1. But Cobenfi is working on both. So this is where the confidence stay. So I would say the, the Cobenfi we believe can bring benefit in controlling this kind of symptoms, i-in Alzheimer, in the bipolar patients, and is, an anchor asset for our, portfolio in neuroscience.

Speaker #2: We are building, and we really would like you to start to see how we are building our portfolio in Alzheimer’s with a phase two asset, and multiple phase one assets.

Cristian Massacesi: I really would like you to start to see how we are building our portfolio in Alzheimer with a phase 2 asset and multiple phase 1 assets that show the commitment that BMS has for this disease, because we wanna play in this disease.

Speaker #2: That show the commitment that BMS has for this disease. Because we wanna play in this, in this disease.

Chuck Triano: That's good.

Speaker #4: That's good.

Speaker #3: Yeah. Just to add, Christian, come did a great job covering, you know, much of our life cycle management program. But from a commercialization standpoint, I would say, you know, stepping back, there are approximately 7 million patients diagnosed with Alzheimer's disease and roughly 30 to 50 percent have psychosis.

Adam Lenkowsky: Just to add, Cristian did a great job covering, you know, much of our lifecycle management program. From a commercialization standpoint, I would say, you know, stepping back, there are roughly 7 million patients diagnosed with Alzheimer's disease, and roughly 30% to 50% have psychosis, and that's hallucinations and delusions. The vast majority have cognitive impairment. This presents a real significant unmet need where there are no approved treatments today. You know, we know that antipsychotics have significant safety limitations. They have movement disorders. They carry box warnings that are specific to elderly patients with dementia. They're often treated and used inappropriately rather than treating the underlying psychiatric diseases. You know, they leave patients with cognitive impairment, falls and fractures, and these are all really serious issues in long-term care facilities.

Speaker #3: And that's hallucinations and delusions. And the, the vast majority have cognitive impairment. So this presents a real significant unmet need where there are no approved treatments today.

Speaker #3: And, you know, we know that antipsychotics have significant safety limitations. They have movement disorders. They carry BOPS warnings that are specific to elderly patients with dementia.

Speaker #3: And they often treated, and used inappropriately rather than treating the underlying psychiatric diseases, you know, they, they lead patients with cognitive impairment, falls, and fractures.

Speaker #3: And these are all really serious issues in long-term care, facilities. And we believe that Cobenfi has the potential to play a very important role in treating, a number of Alzheimer's, diseases, safety becomes increasingly important in an elderly population, where Cobenfi is not associated with EPS, sedation, doesn't carry a BOPS warning.

Adam Lenkowsky: We believe that Cobenfy has potential to play a very important role in treating a number of Alzheimer's diseases. Safety becomes increasingly important in an elderly population where Cobenfy is not associated with EPS, sedation, doesn't carry a box warning. In those two areas, ADEPT and Alzheimer's Disease cognition, Cobenfy would be the first and only product approved in those spaces.

Speaker #3: And in those two areas, ADP and Alzheimer's disease cognition, Cobenfi will be the first and only product approved in those spaces.

Speaker #2: Let me thank you, Adam. Luis, let me go back to your second question on cell therapy. you know, I, I could, I could discuss about, cell therapy strategy in hematology or in autoimmune disease.

Cristian Massacesi: Let me... Thank you, Adam. Louise, let me go back to your second question on cell therapy. You know, I could discuss about cell therapy strategy in hematology or in autoimmune disease. I wanna focus on autoimmune disease because probably is newer and I think is more important that we explain the strategy that we wanna put in place on the development, maybe in the commercial side. You know, I believe BMS has a very powerful platform in this space and with one aim, a reset immune system. To reset immune system, this is the strategy that we wanna take, we decided to have a multimodal approach. This is why we have an autologous, an allogenic, and an in vivo platform. I have to say, this set us apart compare many other players in this space.

Speaker #2: I wanna I wanna focus on autoimmune disease because probably is, newer. And I think is, is more, is important that we explain the strategy that we wanna put in place, on the development, maybe in the commercial side.

Speaker #2: You know, I believe that BMS has, a very powerful platform in this space. And with one aim: reset the immune system. And, to reset the immune system, this is the strategy that we wanna take, we decided to have a multimodal approach.

Speaker #2: This is why we have an autologous and allogeneic and an in vivo platform. and I have to say this, set, as a part, com-compare many other, players in this space.

Cristian Massacesi: If you think this product, this can be transformative for patients with autoimmune disease, because if you can eradicate B cells, you can provide benefit to patients with a severe or moderate state of the disease. The vision can be to use this one time treatment before the patient start to have the organs damaged by the autoimmune diseases. The most advanced program is Xolair, our autologous CAR-T. We have two ongoing pivotal studies, one in lupus and one in scleroderma. We have multiple other indications ongoing, and we see a level of activity that is unprecedented. We have in clinic now an allogeneic CAR-T that of course can represent a more accessible and scalable approach because from one donor you can manufacturing 100 cells. This can broaden up the access.

Speaker #2: I-i-if you think this products, this can be transformative with for patients with autoimmune disease because if you can eradicate B cells, you can provide benefit to patients with severe or moderate state of the disease.

Speaker #2: But the vision can be to use, this one-time treatment before the patients start to have the organs damaged by the autoimmune diseases. The most advanced program is, XolaCell.

Speaker #2: Our, our autologous, CAR-T. we have two ongoing pivotal studies. One in lupus and one in scleroderma. We have a multiple other indication o-o-ongoing. And we see a level of activity that is unprecedented.

Speaker #2: And then we, having clinic now in allogeneic, CAR-T, that occurs can represent a more accessible and scalable approach because, from one donor, you can, manufacturing, 100, cells.

Speaker #2: And so this can broaden up the, the, the access. but the real transformative, thing can be, in vivo. We acquire orbital and mRNA in vivo platform where you have the patients that are producing, manufacturing the cells in cell to cell.

Cristian Massacesi: The real transformative thing can be in vivo. We acquire Orbital, an mRNA in vivo platform, where you have the patients that are producing, manufacturing the cells in self vs self. This is really can be transformative because it can really broaden up and give scalability in such a broad space of autoimmune disease. I hope I addressed the strategic. We wanna be a player. We wanna lead in this space. I think we are very well set to doing that.

Speaker #2: So this is really, can be transformative because it can really broaden up and, and give scalability in, such a broad space like autoimmune disease.

Speaker #2: So I hope I, I, I, I addressed the strategic, we wanna be a player. We wanna lead in this space. I think we are very, well set, to doing that.

Speaker #4: Thanks, Christian and Adam. let's move to our next question, please.

Chuck Triano: Thanks, Cristian and Adam. Let's move to our next question, please.

Speaker #5: The next question comes from Terrence Flynn with Morgan Stanley. Please go ahead.

Operator: The next question comes from Terence Flynn with Morgan Stanley. Please go ahead.

Speaker #6: Great. thanks so much for taking the question. I'll keep it to one. you know, Christian appreciate the, details. On the mill vaccine AFib trial in terms of non-inferiority, on the efficacy endpoint.

Terence Flynn: Great. Thanks so much for taking the question. I'll keep it to 1. You know, Cristian, appreciate the details on the milvexian AFib trial in terms of non-inferiority on the efficacy endpoint. Just was wondering if you could elaborate in terms of what differential it's powered for on bleeds for superiority, or if you don't wanna answer that question, what you think is a clinically relevant delta versus Eliquis that would drive reimbursement coverage. Thank you.

Speaker #6: But just was wondering if you could elaborate in terms of what differential its powered for on bleeds for superiority or if you don't wanna answer that question, what you think is clinic a clinically relevant delta versus Eliquis.

Speaker #6: that would drive reimbursement coverage. Thank you.

Cristian Massacesi: Maybe I start, and then Adam, you can step in as you want. Terence, again, the study is designed to show non-inferiority. Non-inferiority as margins that goes, as I was mentioning, we disclose this margin, why I can speak about it. They go from 0.8384 to 1.3 something. We believe in the study and the preclinical and clinical work done in phase 2, is set to show that the non-inferiorities met to have a similar activity and efficacy versus apixaban. It is possible that milvexian can have another ratio less than 1, but is not needed. Because clinically, medicommercially, the success require to be similar and having a better bleeding profile in measure bleedings and clinically meaningful bleedings.

Speaker #2: Maybe I start, and then Adam, you can you can step in, as you want. So Terrence, again, the study is designed to show non-inferiority.

Speaker #2: Non-inferiority as a margins that goes as I was mentioning. We disclose this margin why, I can speak about it. they go from 0.8384 to 1.3 something.

Speaker #2: So w-we believe a-and the study and, and, and the preclinical and clinical work done in phase two, is set to show, that the, the, the non-inferiority is met to have a similar activity and efficacy, versus Apixaban.

Speaker #2: It is possible that, Maldexian can have another ratio less than one, but it's not needed. Because, clinically, maybe commercially, this assess, require to be similar.

Speaker #2: And having a better bleeding, profile, in measured bleedings and clinically meaningful bleedings. And this is where the study, I think, is, extremely well, set in power to show the non-inferiority and then superiority on the bleeding rates.

Cristian Massacesi: This is where the study, I think, is extremely well set in power to show the non-inferiority and then superiority on the bleeding rates.

Speaker #4: Just from a coverage standpoint, Terrence, and where payers consistently tell us is that bleeding and particularly major bleeding is a single largest cost driver associated with oral anticoagulation therapy today.

Adam Lenkowsky: Just from a coverage standpoint, Terence, what payers consistently tell us is that bleeding, and particularly major bleeding, is the single largest cost driver associated with oral anticoagulation therapy today. It's why Eliquis has significant share in the market. Payer discussions are suggesting that the potential of improved benefit risk profile will be a strong value proposition, particularly around economic benefits. Payers aren't necessarily anchored to a specific percentage threshold. What they're looking for is a clinically meaningful and statistically credible reduction in major bleeds that translates into fewer hospitalizations and fewer e-events that are clinically and economically important.

Speaker #4: It's why Eliquis has significant share in the market. And payer discussions are suggesting that the potential of an improved benefit-risk profile will be a strong value proposition.

Speaker #4: Particularly around economic benefits. And payers aren't necessarily anchored to a specific percentage threshold, but what they're looking for is a clinically meaningful and statistically credible reduction in major bleeds that translates into fewer hospitalizations and fewer events that are clinically and economically important.

Speaker #2: Thanks, Adam. Thanks, Christian.

Terence Flynn: Thanks, Adam. Thanks, Cristian.

Chris Boerner: Thanks, Adam. Thanks, Cristian.

Speaker #4: Great. Let's take our next question, please.

Chuck Triano: Great. Let's take our next question, please.

Operator: The next question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead.

Speaker #5: The next question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead.

Speaker #6: Great, thanks for the question. So, if I may, I just wanted to drill in a little bit on milvexian — parent, and the opportunity there. Just from a commercial perspective, you know, we're seeing a very robust potential combination market poised to emerge here.

Seamus Fernandez: Great. Thanks for the question. If I may, just wanted to drill in a little bit on afimetoran and the opportunity there. Just from a commercial perspective, you know, we're seeing a very robust potential combination market poised to emerge here. Obviously the key is success in clinical programs. Just wanted to get, maybe Cristian, a little bit more of your sense of, you know, what are the key risks as we evaluate phase 2 to phase 3, and how do you see the opportunity beyond that? When we look back at the phase 2, it incorporated a Bayesian analysis from a statistical perspective. There weren't that many patients on background therapy.

Speaker #6: but obviously, the key is success in, clinical programs. So just wanted to get, maybe Christian a little bit more of your sense of, you know, what are the key risks as we evaluate phase two to phase three?

Speaker #6: and, and how do you see the opportunity beyond that? And we look back at the phase two, and incorporated a Bayesian analysis, from a statistical perspective.

Speaker #6: there weren't that many patients on background therapy. so just trying to get a better understanding of how you see, you know, the risk-reward heading into the IPF results, and the PPF results.

Seamus Fernandez: So just trying to get a better understanding of how you see, you know, the risk reward heading into the IPF results and the PPF results. Then just for Adam, you know, as you look at the evolution of this market, how are you looking at the impact of the current antifibrotic standard of care and the dropout rate that patients experience and suffer from, versus some of the emerging data sets for other combinations in this setting, like the troponin data? Thanks so much.

Speaker #6: And then just, for Adam, you know, as you look at the evolution of this market, how are you looking at the impact of the current antifibrotic standard of care and the dropout rate that patients experience and suffer from, versus some of the emerging data sets for other combinations?

Speaker #6: in this setting, like the Troposternell data. Thanks so much.

Speaker #2: Christian and Adam.

Chris Boerner: Cristian, then Adam.

Cristian Massacesi: Seamus, let me start with the target. LPA1 inhibition is important because it is working in 3-dimension in the fibrotic process in IPF and PPF. Fibrosis, inflammation, also repair. This is the novelty of the target. I think admilparant is the first-in-class in this space for both IPF and PPF. The goal here is to improve upon efficacy, but also to have a differentiated tolerability. You know, there are drugs that the patient can use today that have some GI issues, some cough issues. Admilparant profile is very different, very differentiated. The conviction on this program is sitting on the phase 2 results in both IPF and PPF.

Speaker #3: Seamus, the, the, let me start with the target. LPA1 inhibition is, important because it's working in three dimension in the fibrotic, process, in, for in, in, in IPF and PPF.

Speaker #3: Fibrosis, inflammation, also repair. So this is the novelty of the target. And, I think, our mill parent is the first in class, in this in this space, for both IPF and PPF.

Speaker #3: The goal here is to improve, upon efficacy, but also to have a different, differentiated, tolerability. You know, there are, drugs that the patient can use today that have some GI issues, some, cough issues.

Speaker #3: So, a mill parent profile is very different, very differentiated. The conviction on this program is sitting on the Phase 2 results. In both IPF and PPF, we are more than 60% improvement versus placebo in the lung function decline with 60 milligrams b.i.d.

Cristian Massacesi: We have more than 60% improvement versus placebo in the lung function decline with 60 milligram BID. You know, we tested different doses, and the dose relationship is very clear. This is another nuance, very important, that we put in the Phase 3 that give me confidence in what we are doing because we are running both studies, IPF and PPF, with two doses, 60 and 120. The dose relationship and the benefit of having higher dose was very clear. Deeper efficacy while the dose is increasing. PMC also for these trials are continuous to monitor and reviewing the conduction of the study, safety, and efficacy, and tell us to continue as planned. We do not see any flag, especially on safety side in terms of hypotension, syncopal events, even in overall in the trial.

Speaker #3: And you know, we tested, different doses. And the dose relationship is very clear. This is another nuanced, very important that we put in the phase three.

Speaker #3: They give me confidence in what we are doing. Because, we in running we are running, both studies, IPF and PPF, with, two doses, 60 and 120.

Speaker #3: The dose relationship and the benefit of having higher dose was very clear—deeper efficacy while the dose is increasing. DMC, also for these trials, are continuously monitoring and reviewing the conduction of the study, safety, and efficacy, and tell us to continue as planned.

Speaker #3: So we do not see any flag, especially on safety side in terms of hypotension, syncopal events, even in, in overall in the trial. So two shots on goal with 60s and 120 in a very well-designed power studies.

Cristian Massacesi: Two shots on goal with 60 to 120 in a very well-designed power studies. The Phase 2 and the Phase 3 population are very similar. We tried and the teams did a very good job in ensuring consistency and in trying to have as much as possible in Phase 3 what we did in Phase 2. In your question on the specific on the design of the trial, in both trials in IPF, we stratify based on prior treatment, pirfenidone and nintedanib or nothing. We can use add-on or in patients that don't receive any treatment. In PPF there is stratification based on usage or not of antifibrotic. The studies will answer that question, and the drug can be used on top of standard care or as a single agent.

Speaker #3: The phase two and the phase three population are very similar, with tried and determined the ver the teams with very good job in ensuring consistency and in trying to have, as much as possible, in phase three, what, we did in phase two.

Speaker #3: in your question on the specifically on the design, of the trial, in both trial in, in, IPF, we stratify, based on prior treatment, perphenidone and indelamide, or nothing.

Speaker #3: so we can use a, add-on or, or, in, in patient that don't receive any treatment. And in PPF, there is stratification based on usage or not of antifibrotics.

Speaker #3: So the studies will answer that question. And the drug can be used, on top of standard care, or, or as a single agent. Very high confidence on how these programs have been delivered on the target, execution, and looking really forward to the results.

Cristian Massacesi: Very high confidence on how this program has been delivered on the target, execution, and looking really forward to the results.

Chris Boerner: Adam.

Speaker #2: Adam.

Chris Boerner: Yeah, just quickly, Seamus, you know, we're excited about this program as well. You know, we believe that admilparant has the potential to play a meaningful role in both IPF and PPF with an improved efficacy and tolerability profile, as Cristian described. There remains a significant need for improved therapies that slow disease progression, that are well-tolerated, and ultimately help patients manage their disease. You know, as you were alluding to, GI tolerability remains a significant barrier, where approximately 50% to 60% of patients on treatment today are discontinuing therapy by 12 months with current standard of care. Even what we're seeing with the newest approved products, the diarrhea rate is roughly 40%.

Adam Lenkowsky: Yeah, just quickly, Seamus, you know, we're excited about this program as well. You know, we believe that admilparant has the potential to play a meaningful role in both IPF and PPF with an improved efficacy and tolerability profile, as Cristian described. There remains a significant need for improved therapies that slow disease progression, that are well-tolerated, and ultimately help patients manage their disease. You know, as you were alluding to, GI tolerability remains a significant barrier, where approximately 50% to 60% of patients on treatment today are discontinuing therapy by 12 months with current standard of care. Even what we're seeing with the newest approved products, the diarrhea rate is roughly 40%.

Speaker #4: Yeah, just, just quickly, Seamus, you know, we're excited about this program as well. You know, we believe that, mill parent has the potential to play a meaningful role in both IPF and PPF with an improved efficacy and tolerability profile, as Christian described.

Speaker #4: There remains a significant need for improved therapies that slow disease progression, that are well-tolerated, and ultimately help patients manage their disease. You know, as you were alluding to, GI tolerability remains a significant barrier, where approximately 50 to 60 percent of patients on treatment today are discontinuing therapy by 12 months with current standard of care.

Speaker #4: And even what we're seeing with the newest approved products, the diarrhea rate is roughly 40%. What we're hearing from our thought leaders is that at mill parent has the potential to be foundational as a first-line option and has the versatility of being used in combination given the expected efficacy and tolerability profile and unmet needs in the marketplace.

Adam Lenkowsky: What we're hearing from our thought leaders is that admilparont has the potential to be foundational as a first-line option and has the versatility of being used in combination given the expected efficacy and tolerability profile and unmet needs in the marketplace. We've got important pre-launch activities that are underway now, and we are very much looking forward to the data readout in the H2 of the year.

Speaker #4: So we've got important pre-launch activities that are underway now. And we are very much looking forward to the data readout in the second half of the year.

Speaker #5: Great. Thanks, Adam. And operator, can we please take our last question?

Chris Boerner: Great. Thanks, Adam. Operator, can we please take our last question?

Chuck Triano: Great. Thanks, Adam. Operator, can we please take our last question?

Speaker #6: The last question today will come from Mohit Bansal with Wells Fargo. Please go ahead.

Operator: The last question today will come from Mohit Bansal with Wells Fargo. Please go ahead.

Speaker #2: Okay. Thank you very much for speaking me in. so I have a question on bumetanide. so your competitor has signaled that, Vagis PD1, compared to an, an IO or a PD1, may be able to show a minimal regression in hazard ratio when you go from PFS to OS.

Mohit Bansal: Great. Thank you very much for squeezing me in. I have a question on pumitamig. Your competitor has signaled that a VEGF PD-1, compared to an IO or a PD-1, may be able to show a minimal regression in hazard ratio when you go from PFS to OS. We saw regression when we compared to chemo, but with the IO combo, it may not be a same situation. How are you thinking about that given that Bristol is probably the only company with two IO combos on the market, and you have seen data for both LAG-3 as well as CTLA-4 on top of PD-1?

Speaker #2: We saw regression when, when we compared it to chemo. But, but, but with the, with, with the IO combo, it may not be a, a same situation.

Speaker #2: How, how are you thinking about that given that Bristol is probably the only company with two IO combos on the market, and you have seen data for both, both, both, both, both leg three as well as CTLA4 account on top of PD1?

Speaker #2: So how are you thinking about this sort of regression from PD1 OS, given in the context of Vagis PD1? It's kind of an important investor debate right now.

Mohit Bansal: How are you thinking about this sort of regression from PFS to OS, given in the context of VEGF PD-1? It is kind of an important investor debate right now. Thank you.

Speaker #2: Thank you.

Speaker #4: Christian?

Chris Boerner: Christian?

Cristian Massacesi: Thank you, Mohit, for the question. Let me start on the way we deliver these two mechanisms. I truly believe bispecifics are a better way to deliver two different mechanism than using two different antibodies because you are much more on target, you are much more selective in delivering them, and potentially you can decrease also the off-target issues like adverse event. There is another important learning that we have had, that we are having every day with these drugs. Our pumitamig is a safe drug. The safety is very predictable. The combinability is very high. We know VEGF is impacting PFS. This is what also you are mentioning. I think that we will see where the data are maturing.

Speaker #3: thank you, Mohit. for the start, on, the way we deliver these two mechanisms. I truly believe by specifics, are, a better way to deliver, two different mechanisms than, using two different antibodies.

Speaker #3: Because you are much more, on target. You are much more selective. in, in delivering them. And, potentially, you can decrease also the off-target, issues like adverse events.

Speaker #3: So there is another important learning that we, have, had that we are having every day with these drugs. PD, PD our, our bumetanide is a safe drug.

Speaker #3: The safety is very predictable. The combinability is very high. So we know VGF is, impacting PFS. This is, what, what also you are mentioning.

Speaker #3: And, I think, that, we will see where the data are maturing. We will see even a few weeks at ASCO what this PFS improvement can translate in terms of OS.

Cristian Massacesi: We will see even in few weeks at ASCO what this PFS improvement can translate in terms of OS. My base case, Mohit, is that if I have a drug that give me a good PFS gain and a statistical significance OS gain, that will be without increasing the safety in a dramatic way, is good enough. Then I can use this as a backbone, and I can improve even further pairing other mechanisms that can continue to increase the PFS gain and potentially translating even in a better OS. I don't think we can simplify so much like in the past, the VEGF inhibitors did not translate in OS because here we have the IO component.

Speaker #3: my base case, Mohit, is that, if I have a drug that, give me, a good PFS gain, and, statistically significant OS gain, that will be without, increasing the safety in, in dramatic way.

Speaker #3: This is good enough. Because then I can use this as a backbone and I can improve even further, pairing other mechanisms. That can, continue to increase the PFS gain and potentially translating even in a better, in a better OS.

Speaker #3: I don't think we can be so, simplif we can simplify so much like, in the past, VGF inhibitors did not translate in, in OS because here we have the IO component.

Speaker #3: And, we still don't know how much the VGF part of the, drug is giving us the upside for the IO. And it's possible, actually, that, this is, give us an uplift also for OS.

Cristian Massacesi: We still don't know how much the VEGF part of the drug is giving us the upside for the IO. It's possible actually that this is give us an uplift also for OS. I'm excited by this bispecific. I'm excited very much about pumitamig and the plan that we are putting in place because I truly believe this can be the backbone for future regimens for cancer patients across indications.

Speaker #3: So I'm, I'm excited by this by specifics. I'm excited very much about bumetanide. And the plan that we are, putting in place because I truly believe this can be the backbone for future regimens for cancer patients, across indications.

Speaker #4: Thanks, Christian. And thanks, everyone, for the questions, in closing. I just want to come back to where we started. we're doing what we said we would do.

Chris Boerner: Thanks, Cristian. Thanks everyone for the questions. In closing, I just wanna come back to where we started. We're doing what we said we would do. We're executing across the business, advancing a really differentiated pipeline that we think is gonna strengthen the growth profile for the company, and operating consistently with financial discipline. Of course, that discipline enables us to have flexibility to invest in growth, to pursue business development where it makes sense, and ultimately deliver long-term value. There's always more work to do, but the foundation we've built and the momentum we're seeing gives us confidence in the trajectory of the business. With that, thanks for joining us today. As always, the team is available for follow-ups. Have a good rest of the day.

Speaker #4: We're executing across the business, advancing, a really differentiated pipeline, that we think is going to strengthen the growth profile, for the company. And operating consistently with financial discipline and, of course, that discipline enables us to have flexibility to invest in growth, to pursue business development where it makes sense, and ultimately deliver, long-term value.

Speaker #4: There's always more work to do, but the foundation, we built and the momentum we're seeing is this confidence, in the trajectory of the business.

Speaker #4: So with that, thanks for joining us today. And as always, the team, is available for follow-ups. Have a good rest of the day.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Q1 2026 Bristol Myers Squibb Co Earnings Call

Request DemoDemo

Bristol Myers Squibb

Earnings