Full Transcript: Bristol-Myers Squibb Q1 2026 Earnings Call

On Thursday, Bristol-Myers Squibb (NYSE:BMY) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. View the webcast at https://event.choruscall.com/mediaframe/webcast.html?webcastid=6fViSl8L Summary Bristol-Myers Squibb Company reported a 1% year-over-year increase in total revenue to approximately $11.5 billion for Q1 2026, with solid growth in their Growth Portfolio, which saw a 9% increase to $6.2 billion. The company highlighted regulatory and clinical milestones, including the FDA's acceptance of the Iberdomide filing for relapsed or refractory multiple myeloma and positive phase 3 interim data for mosigdamide. Bristol-Myers Squibb reaffirmed its full-year financial guidance, expecting performance towards the upper end of their established revenue and EPS ranges, supported by strong execution and financial discipline. Management emphasized their commitment to R&D productivity, leveraging AI to streamline clinical operations, and their focus on delivering over 10 new medicines and expanding their mid-stage pipeline. The company continues to prioritize business development, focusing on strategic areas where they can add clinical and commercial value while maintaining financial flexibility for potential deals. Full Transcript OPERATOR Welcome to the Bristol-Myers Squibb Co 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. After today's presentation there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press Star then two. Please note 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. Chuck Triano (Senior Vice President and Head of Investor Relations) 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, Board Chair and Chief Executive Officer, our Board Chair and Chief Executive Officer and David Elkins, our Chief Financial Officer. Also participating in today's call is Adam Lenkowsky, Chief Commercialization Officer, our Chief Commercialization Officer and Cristian Massacesi, Chief Medical Officer and Head of Development, 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. 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@bms.com finally, unless otherwise stated, all comparisons are made from the same period in 2025 and sales growth rates will be discussed on an underlying basis which excludes the impact of foreign exchange. All references to our P and L are on a non GAAP basis and with that I'll hand it over to Chris. Chris Berner (Board Chair and Chief Executive Officer) 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. Our strategy remains grounded in three 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, Qvantel and Cabenuva. 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 celmods Iberdomide and Mosigdamide. Our Iberdamide filing for relapse or refractory multiple myeloma was accepted by the FDA with Breakthrough Therapy designation and priority review with a PDUFA date of August 17th. This is an important step for our protein degradation platform, potentially enabling us to bring the first Celmod to market for mosigdamide. 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 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 for our ADC Isobran. 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 Zeposia in previously treated esophageal squamous cell carcinoma at asco. 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. We also reported positive phase 4 switch data for Cobinfi, positive phase 3 data for ChemXios in adolescents with obstructive HCM and positive phase 2 data for reblazilin 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 three readouts expected late in the year are Milvexian and atrial fibrillation and secondary stroke prevention, Cobenthy and Alzheimer's, psychosis, admilparent and IPF and Iberdamide PFS data. 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 and 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 mid stage pipeline. Underpinning these efforts are investments we are making in core R and D infrastructure, including broadening the use of AI tools together with laboratory automation and people trained in the right ways of working in research and early development. Target selection and molecule design can have an outsized impact on long term value. We have 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 and D are top priorities for 2026. 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. 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 mid stage portfolio to support growth into the2030s. In summary, based on our performance, we see the business currently tracking towards the upper end of the 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 Elkins (Chief Financial Officer) David 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 and 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 first quarter results and then discuss our financial outlook for the remainder of the year. Starting with Slide 8, total revenue in the first quarter 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. 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. We continue to monitor whether these levels will normalize over the balance of the year. In addition, we saw continued conversion to qvantic where the launch continues to progress well with revenues of $163 million. With Optilag 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, Reblozyl delivered 15% growth with performance continuing to reflect solid uptake across first and second line MDs associated anemia in cell therapy. Breyanzi'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. 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%. We continued to see strong demand and given our U.S. price reduction that took effect at the beginning of the year, we also saw some wholesaler inventory build in the first quarter. We anticipate this build to reverse in the second quarter. Turning to Camzyos, revenue in the first quarter nearly doubled to $314 million, benefiting from continued demand growth globally. Now moving to Immunology, Global revenue of Satik 2 grew 20%. The recent approval on psoriatic arthritis represents a continued presence in rheumatology. While we await our phase three readouts in Lupus and Sjogren's disease, I will wrap up our product performance on slide 12 with neuroscience where Cabenuva revenue in the first quarter was $56 million representing continued steady growth. Now let's move to the P and 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 excluding in process R and 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 Pamicogam, Qvantel and Kobenphi 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 the quarter was 18.3% reflecting jurisdictional earnings mix. 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 and D and licensing income. 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 31 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. 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, 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. And to reiterate Chris's comment, our strategy remains grounded in three 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. And with that I'll now turn the call back over to Chuck for Q and A. OPERATOR 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 touchtone phone. 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 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. 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 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 Milvex and the Benfi, Adept trials? Just any quantitative bars for success and then 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? And where do you see opportunity as you scan the landscape ahead of these readouts and any framing on potential size of the BD aperture would be helpful. Thank you. Chris Berner (Board Chair and Chief Executive Officer) Thanks for the question Azad. Christian, you want to start and then I'll take the VD question. Cristian Massacesi Thank you. Thank you Azad for the question. Let me start with the fact that we have a very data rich 20, 26 and even probably more 27 and let me start with what we already achieved because in him I think we had a positive MRD with Iberdomide in Excalibur 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 August 17th. We got a breakthrough designation Priority Review so it's progressing at pace. We achieved the mesigdomide this year with assessor to oral presentation at asco. Really looking forward to show you guys the data in IM we will have a readout also with our arlocel that is a GPRC 5D car T that is happening later this year. Moving cardiovascular Malbecin as you were mentioning are important in both Afib and SSP are continue to be expected by the end of the year. We are recruiting the events as an event driven and of course we remain blinded. 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 recommending to continue the studies as so BMS will be the only factor 11 company with factor 11 inhibitor in afib of course with the presence also in SSP this can allow us to continue to lead in the thrombotic space. Confidence remains absolutely unchanged for Maldexion in this space. In neuroscience we continue to expect the ADP studies adapt 1, 2 and 4 by redoubts 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 two studies probably for an approval. This is the base case but for a finding. But we will see how the evolution in this space is happening. The confidence remains unchanged also for Cobenphy study designs. Trial conduction is now completely under control and of course the reason to believe in Covenfi in this space are very clear prior data. The data that we have seen in schizophrenia and of course the open label in adept one where patient before being randomized received cobenfi for for 12 weeks. Give us confidence in potentially bringing this drug in patients with Alzheimer's disease and psychosis. Last but not least to me critical readout this year is Amiparanta 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 patients 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. IPF is guided by the end of the year. PPF will be just a few months later, probably beginning 27 very solid phase two data. I'm very pleased on the execution of the phase three 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 a bms. Chris Berner (Board Chair and Chief Executive Officer) 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. 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. 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. We're size agnostic as we've been and we certainly have the financial horsepower to go after multiple size deals. Thanks, Chris. Let's take our next question please. OPERATOR Operator the next question comes from Jeff Meacham with Citi. Please go ahead. Jeff Meacham Great morning everyone. Thanks for the question. Christian on Pemitameg I wanted to check on the cadence of data in say the next six to 12 months and would you wait for more mature data on PSS before you really expand the number of trials or are you ready to go right now? And then real quick for Adam just to talk through the qvantic Dynamics versus Opdivo and where you're seeing the biggest demand. Thanks. Thanks Jeff. Cristian Massacesi Christian and Adam, thank you Jeff for the question on Pamitinib, let me start with ASCO. ASCO will be an important meeting this year for PD1BGF inhibitors. You know 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 Nosemart Cancer in Frontline as a global data set after the China data we presented previously in other indications. In few days the abstract will be released. Our strategy with Pamicogam is replace and expand. We want to replace PD1 PD L1 inhibitors and we want to expand beyond them. We announce and we deliver seven pivotal studies across indications. 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 and in terms of level of activity, a combinability that you have with PD1VGF, PD L1VGF inhibitors by specifics 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. BioNTech has also an important portfolio of oncology assets. And what we are doing, we are combining now we started the combination of pomitamig 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 Zeposia ADC that is an EGFR ERR3 ADC. You will see data as Chris was mentioning at Asco in esophageal in triple negative is a very active adc. And I think with Palmitamig can represent a very powerful regimen. We started a combination with our PIRA MNT5 inhibitor, our Navlimetostat, a very dutile drug. So 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. We think we are very well positioned to make this drug as a potential new backbone in immuno oncology and generating the next regimens very powerful cancer patients across indications. Adam Lenkowsky Yep. Jeff, thanks for the question. As it relates to qvanti, we're pleased with the qvanti launch performance our teams are executing. 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 Qvantig improves practice efficiency with a three minute in office injection and that patients prefer Qvantig when offered the opportunity versus the IV formulations. So we've now delivered over 10% conversion from IV to Qvantig 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 two years. Chris Berner (Board Chair and Chief Executive Officer) Thanks, Adam. Great. Can we move to our next question please? Operator? OPERATOR The next question comes from Alexandra Hammond with Wolf Research. Please go ahead. Alexandra Hammond Hey guys, thanks for taking the question on Nalvexian. 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? And to the extent that the top line doesn't meet that primary endpoint, is there a path where a specific patient population still supports a meaningful commercial opportunity. Thank you. Chris Berner (Board Chair and Chief Executive Officer) I'll have Christian take that and then Adam, you can add any color commentary as you need to. Cristian Massacesi I mean, Alex, let me start 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 event driven. We remain blinded, as said that the DMC continues the oversight to both studies. We are at a point in which this gives us confidence that we are progressing on the right way with both efficacy and safety. Everything is continuous plan, you know, in afib the study will test non inferiority testosteropixaban and then we will have superiority testing for bleedings 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 Lenkowsky Yeah, Alex. As it relates to commercial opportunity, no vaccine represents a significant opportunity commercially. There is a need for a medicine with low bleeding risk both in AFIB and in ssp. And we think there's a significant advantage to having both indications. We would expect broad adoption. As we talked about previously, fear of bleeding continues to be the main reason why physicians hold back from utilizing factor X in more patients. And despite the highly effective DOACs like Eliquis, roughly 40% of patients who should be anticoagulated are either untreated, underdosed or they discontinue treatment. 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. So we believe this profile is going to drive significant demand 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 and we think this has true blockbuster potential. Chris Berner (Board Chair and Chief Executive Officer) Thanks, Ann. Let's move to the next question please. OPERATOR The next question comes from Chris Schott with JP Morgan. Please go ahead. Chris Schott Great. Thanks so much for the question. Just two for me maybe. First, can you just talk about Chem Zios dynamics, post your competitor approval, just what are you seeing in the market and just how you're thinking about that evolving. And the second one for me was coming back to the cell mods. That was the. Some of this initial clinical data is read out. Can you just elaborate a little bit more? The role in the market you see for those Products based on these initial data sets. And how much of your excitement here is based more on the future readouts versus what we're seeing initially here. Thanks so much. Thanks for the question, Chris. Adam, I think you can take both. Adam Lenkowsky Yeah, thanks, Chris. So Camzidis 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 Camdios in the US with thousands more prescribed internationally. As far as, you know, what we're seeing in the field, we've been planning for competition for some time. HCP has continued to reinforce that they see little differentiation. It's still early. Some physicians have started one or two patients on the competition and they are still operationalizing their own REMS program. But we also hear consistently that the camzios REMS process is very clear and the infrastructure and workflow that have been established now for four years are very clear. And thus TLS have shared. They'll use the camzios dosing and echo regimen at four weeks. So we see this as a positive. And why is that? Because roughly 90% of patients on Camzios are on the 5 milligram starting dose and it's simply 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. Kim Xios 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 at the campten and we remain confident that we'll be the leader in the space longer term. So as it relates to, you know, to Iberdamide, you know, we're really excited about the launch of iber and I know that Chris and Christian have talked about this. And so I think there are a few areas that, you know, I could point to. Number one, you know, with iberdomide, this is an area that we know very, very well in multiple myeloma. 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, 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. And we're confident that iberdomide will provide a balance of high potency manageable toxicity combinability with Daratumumab with the convenience of an ordinary treatment that amplifies the efficacy of IMID based regimen. So our goal is to make both IBER and MEZI foundational in multiple myeloma replacing Revlimid and Pomalis in second line over time in the community longer term serving as partners for T cell redirecting therapies and cell therapy. So we know the work that we need to do to establish both IBER and MESI in the market and we are very excited to bring both of these important medicines patients because we believe this is a real attractive commercial opportunity. Cristian Massacesi Adam, allow me to step in. Chris, I want to use the opportunity. You mentioned the question on Camzayos because 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 non obstruction is different than an obstructive because the heterogeneity of patients and diseases is much higher. That said, we have learned a lot from Odyssey Study. We know better who are the patients which diseases they are affected by that can benefit most from a myosin inhibitor like enzymes. So I want to announce that we are planning now to run a new more focused study in non obstructive SEM. And then of course the detail of it will be highlighted in clinical red where we are progressing this work. Chris Berner (Board Chair and Chief Executive Officer) Thank you Christian, Next question please. OPERATOR Operator, next question comes from Evan Siebersbergen with BMO Capital Markets. Please go ahead. Evan Siebersbergen Hi guys, thank you so much for taking my question. And another one for Christian. So you really inherited the design and kind of the milvexine trials. And can you walk me through the aspects of the trial design, patient selection that increased your confidence in a potentially successful readout later this year? Cristian Massacesi Christian thank you Ivan for the question In I think your question is referring to AFIB specifically imagine because SAP. So in afib let me tell you that first of all the data are solidly based on phase two studies that we run in total knee replacement. That is a very good surrogate for antithrobotic drugs. We learned a lot from Eliquis in that space and we know the predictivity value of that kind of population for antithrobotic agents. I think the very elegant and 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 milligrams twice a day. That is a much higher dose for instance that we are using in ssp, but is a dose that gave us the confidence based on all the work that has been done, the modeling and the work and then that we were able to bring in the phase two part give us confidence to have at least a same level of efficacy than 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 a Pixaban in head to head comparison. In a very well sized study we recruited 20,500 patients. So very well powered for an inferiority margin. So we disclose these margins, of course they go from 0.8 to 1.3 and we will then when an inferiority will be met, test the superiority for bleedings. We test with split alpha for measured bleeding and non measured clinical. Relevant because I want to link what Adam was telling. This is a major 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. So 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. Chris Berner (Board Chair and Chief Executive Officer) Thanks Christian. Thanks Evan, for the question. Let's move to our next question please. Operator. OPERATOR The next question comes from Michael Yee with ubs. Please go ahead. Michael Yee Thank you. Following up on the design of the Malvexian 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. 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. Thank you Christian. Cristian Massacesi Okay, thank you Michael, for the question. we cannot disclose baseline characteristics and which kind of events we are recruiting. By the way, where am I blinded? 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 and the events predefined number is for efficacy and of course for safety. So we are on track by year end is 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 a near end result. Thanks Christian. Great. Chris Berner (Board Chair and Chief Executive Officer) Thank you Christian. Next question please. Operator. OPERATOR The next question comes from Akesh Tiwari with Jeffries. Please go ahead. Akesh Tiwari Hey, thanks so much. So for your Kabenfi Alzheimer's psychosis studies you have several trials that 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 and was it based on any issues you saw with the ADEPT two trial conduct and then just on cell mods. Can you talk about your confidence on the successor one study which goes head to head against Pomalyn showing a clinically meaningful effect size based on the results you saw in successor two? Cristian Massacesi Thank you Christian. Yeah, so the. Thank you Akash. The Cobenphy ADEPT four decision to go into a biomarker selected population was based in trying to decrease heterogeneity in the patient population. As you know, Adept 2 was a study that was already ongoing in the moment we acquired Cobenfi and 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 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, even if increase a little bit the operational challenges. Because of course we need a predefined number of patients biomarker positive to run so the screening failures are a little bit higher. This doesn't take out any confidence of the potential benefit that you can see. Also more maybe in a trial like ADEP 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 cell month, I think a successor to was a very good news not only because it and as you mentioned successor 2 is an add on study on top KD, but because came earlier than expected. We eat an interim pfs. You will see the Tarasco. But you already know that when you eat an interim PFS it means that you eat a bar that is higher according to what the study was designed for. This is answering your question on successor one. We believe mesigdomide is a very potent celmods is more potent than iberdomide for instance is a drug that can be very well combined with the standard care regimens that we see a little bit less with anti CD38. This is why Aberdomide is doing that job. But 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. So the confidence of success of one is high and of course is higher bar because it is not an add on, it's a replacement strategy. But I think the PTS is high. Chris Berner (Board Chair and Chief Executive Officer) Thanks Christian. And let me just also say that I'm glad to hear so many questions on cell mods. The Celmod program we're quite excited about. You're going to see exciting data at ASCO on IBER and mesi, we shouldn't forget. You'll also see data on glucotamide 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, BCL6, LDD, ARLD and 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. So it's exciting to see. So stay tuned for that at ASCO and beyond. Thanks Chris. Let's take our next question please. 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 ADP study for Cobenphy, I know you have several additional potential indications for Covent fee and which of those additional indications are you most excited by? And then secondly, you have a lot of different modalities in yourself therapy franchise and pipeline. And how do you see these all coming together to give Bristol a more comprehensive hold on the market? Chris Berner (Board Chair and Chief Executive Officer) Thank you, Christian. And then Adam, you can provide color commentary. Cristian Massacesi So adp, because we believe this is a huge medical need and we believe Cobentin can bring benefit based on what we have seen in schizophrenia. You know, we are focusing our strategy in psychosis, specifically assessing hallucination, delusions. And this is something that we have seen a patient really having an improvement in schizophrenia. We wanted to have multiple shots and goals. This is why we have Adept 2 and Adapt 4 that are similar studies with a difference. One is biomarker selected population, the other one not. And we have Adapt one that is more a study that will assess how Cobenti will avoid relapses. But we also design ADEPT functions. 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 things are changing maybe and we believe this is an important setting. CO benefit can bring benefit to patients. We want to really have a multiple shots on goal when talking, when thinking. The other indication, bipolar disorder is the next one in line because we expecting results into 2027. We are testing Cobenfi specifically in mania in the context of bipolar disorders. 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. We have seen Cobenphy already providing benefit. 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, conditioned probably by muscarinic receptor 1. McObenfin is working on both. So this is where the confidence stay. So I would say the Cobenfib we believe can bring a benefit in controlling these kind of symptoms in Alzheimer in bipolar patients and is an anchor asset for our portfolio in neuroscience. We are building. I really would like you to start to see how we are building our portfolio in Alzheimer with a phase two assets and multiple phase one assets that show the commitment that VMS has for this disease. Because we want to play in this disease. Adam Lenkowsky Yeah, Just to add, Christian 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 or 50% have psychosis and that's hallucination delusions. And the vast majority have cognitive impairment. So this presents a real significant unmet need where there are no approved treatments today. And 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 and they 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. We believe that Covenpi 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 Coventi is not associated with eps. Sedation doesn't carry a box warning. And in those two areas, ADP and Alzheimer's disease cognition covempi would be the first and only positive group in those states. Cristian Massacesi Let me thank you Adam. 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 want to focus on autoimmune disease because probably is newer and I think is more is important that we explain the strategy that we want to put in place on the development maybe in the context commercial side. 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 want to take. We decided to add a multimodal approach. This is why we have an autologous, an allogenic and an in vivo platform. And I have to say this set us apart completely compare many other players in this space. If you think of these products, 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. But the vision can be to use these one time treatments before the patient start to have the organs damaged by the autoimmune diseases. The most advanced program is Xolacel, our autologous CAR T. We have two ongoing pivotal studies, one in lupus and one in scleroderma. We have a multipolateral indication ongoing and we see a level of activity that is unprecedented. And then we have in clinic now an allogenic CAR T that of course can represent a more accessible scalable approach. Because from one donor you can manufacturing hundred cells. And so these can broaden up the access. But 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 himself or self. So this is really can be transformative because it can really broaden up and give scalability in such a broad space like autoimmune disease. So I hope I address the strategic. We want to be a player, we want to lead in this space. I think we are very well set to do that. Chris Berner (Board Chair and Chief Executive Officer) Thanks Christian and Adam. Let's move to our next question please. OPERATOR The next question comes from Terrence Flynn with Morgan Stanley. Please go ahead. Terrence Flynn Great. Thanks so much for taking the Question. I'll keep it to one. You know Christian, appreciate the details on the MIL vaccine AFIB trial in terms of non inferiority on the efficacy endpoint, but just was wondering if you could elaborate in terms of what differential it's powered for on bleeds for superiority or what if you don't want to answer that question, what you think is a clinically relevant delta versus Eliquis that would drive reimbursement coverage. Thank you. Cristian Massacesi Maybe I start and then Adam, you can step in as you want. So Terence, again the study is designed to show non inferiority. Non inferiority has margins that goes as I was mentioned, we disclosed margin. Why I can speak about it. They go from 0.8384 to 1.3 something. So we believe in the study and the preclinical and clinical work done in phase two is set to show that the non inferiority is met to have a similar activity on efficacy. That's right. It is possible that Maldexion can have another ratio less than 1, but it's not needed because clinically and maybe commercially the success required to be similar and having a better bleeding profile in measured bleedings and clinically meaningful bleedings. And this is where the study I think is extremely well structured set and power to show the non inferiority and superiority on the bleeding rates just from a coverage standpoint. Adam Lenkowsky Terrence, what payers consistently tell us is that bleeding, 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 and payer discussions are suggesting that the potential of an improved benefit risk profile will be a strong value proposition, particularly around economic benefits. And payers aren't necessarily anchored to a specific percentage threshold. What they're looking for is clinically meaningful and statistically credible reduction in major bleeds that translates into fewer hospitalizations and fewer events that are clinically and economically important. Chris Berner (Board Chair and Chief Executive Officer) Thanks, Adam. Thanks, Christian. Great. Let's take our next question please. OPERATOR The next question comes from Seamus Fernandez with Guggenheim Securities. Please go ahead. Seamus Fernandez Great. Thanks for the question. So if I may just wanted to drill in a little bit on Milparant and the opportunity there. Just from a commercial perspective, you know, we're seeing a very robust potential combination market poised to emerge here. But obviously the key is success in clinical programs. So just wanted to get maybe Christian, a little bit more of your sense of what are the key risks as we evaluate phase two to phase three and how do you see the opportunity beyond that? When we look back at the phase two and incorporated a Bayesian analysis from a statistical perspective. 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. 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 in this setting like the trepostinil data. Thanks so much Christian and Adam. Cristian Massacesi Seamus did the. Let me start with the target. LPA1 inhibition is important because it's working in three dimension in the fibrotic process. In IPF and PPF, fibrosis inflammation also repair. So this is the novelty of the target and I think Armipanata is the first in class in this space for both IPS and bps. The goal here is to improve upon efficacy but also to have a differentiated tolerability. You know, there are drugs the patient can use today that have some GI issues, some calf issues. So amiparanta profile is very different, very differentiated. The conviction on this program is, is sitting on the phase two results. In both IPF and PPF we have more than 60% improvement versus placebo in the lung function decline with 60mg BLD. And 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 three 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 condition, introduction of the study safety and efficacy and tell us to continue as planned. So we do not see any flag especially on safety side in terms of hypotension, syncopal events, even overall in the trial. So two shots on goal with 16, 30, 120 in a very well designed power studies. The phase two and the phase three 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 three. What we did in phase two, your question on the specifically on the design of the trial. In both trials in IPS we stratify based on prior treatment pefenidone or nothing. So we can use add on or in patients that don't receive any treatment and in PPF there is stratification based on usage or not of anti fibrotics. So the studies will answer that question and the drug can be used on top of standard care or as a single agent. Very high confidence on how this program has been delivered on the target execution and looking really forward to the results. Adam Lenkowsky Adam, just quickly, Seamus. You know, we're excited about this program as well. We believe that Admiral Peron has the potential to play a meaningful role in both IPF and ppf. With an improved efficacy and tolerability profile. As Christian described, there remains a significant need for improved therapies that slow disease progression that are well tolerated and ultimately help patients manage their disease. As you were alluding to, GI tolerability remains a significant barrier. Where approximately 50 to 60% of patients on treatment today or discontinuing therapy by 12 months with current standard of care. 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 Admilparent has the potential to be foundational as a first line option and has a versatility of being used in combination given the expected efficacy and tolerability profile and and on the needs in the marketplace. So we've got important prelaunch activities that are underway now and we are very much looking forward to the data readout in the second half of the year. Chris Berner (Board Chair and Chief Executive Officer) Great. Thanks Adam and operator. Can we please take our last question? OPERATOR The last question today will come from Mohit Bansal with Wells Fargo. Please go ahead. Mohit Bansal Great. Thank you very much for squeezing me in. So I have a question on Premetameg. So your competitor has signaled that a VEGF PD1 compared to an IO or a PD1 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 the same situation. How are you thinking about that given that Bristol is probably the only company with two I O combos on the market and you have seen data for both, both lag 3 as well as CTLA 4 account on top of PD1? So how are you thinking about this sort of regression from PD1 2 or for PFS to OS given in the context of VEGF PD1? It's kind of an important investor debate right now. Chris Berner (Board Chair and Chief Executive Officer) Thank you, Christian. Cristian Massacesi Thank you Moit 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 mechanisms 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 events. So there is another important learning that we have had that we are adding every day with these drugs. Our pomitomic is a safe drug, the safety is very predictable, the combinability is very high. So we know BGF is impacting pfs. This is what also you are mentioning and I think that we will see where the data are maturing. We will see even 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 statistical significance OS gain that will be without increasing the safety in dramatic way 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. I don't think we can be so simply we can simplify so much. Like in the past the BGF inhibitors did not translate in OS because here we have the IO component and we still don't know how to how much the BGF part of the drug is giving us the upside for the IO. And it's possible actually that this gives us an uplift also for os. So I'm excited by these bispecifics. I'm excited very much about pomitomic and the plan that we are putting in place because I truly believe that this can be the backbone for future regimens for cancer patients across indications. Chris Berner (Board Chair and Chief Executive Officer) 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. 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. There's always more work to do, but the foundation we built and the momentum we're seeing gives us confidence in the trajectory of the business. 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. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.