Q1 2026 Earnings Call Transcript

Welcome to the Bristol-Myers Squibb First Quarter 2026 Earnings Conference Call. [Operator Instructions] 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. Go ahead.

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 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. 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 and sales growth rates will be discussed on an underlying basis which excludes the impact of foreign exchange. All references to our P&L are on a non-GAAP basis.

And with that, I'll hand it over to Chris.

Thanks, Chuck. Welcome, and thank you for joining our first quarter earnings call. We delivered a solid Q1 and continued 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 3 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 3 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, [indiscernible], Opdualag, Qvantig and Cobenfy. 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 mezignomide, our ibertamide filing for relapsed or refractory multiple myeloma was accepted by the FDA with breakthrough therapy designation and priority review with a PDUFA date of August 17. This is an important step for our protein degradation platform potentially enabling us to bring first [indiscernible] to market. For mozigimide, we reported positive Phase III interim data from the SUCCESSR-II 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 [indiscernible], we shared positive Phase III 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 III China study results Izobran 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 life cycle expansion. We received approvals for SOTC 2 in psoriatic arthritis and Opdivo for 2 new classical Hodgkin lymphoma indications. We also reported positive Phase I switch data for cobi positive Phase III data for KEMZYOS in adolescents with obstructive HCM and positive Phase II 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 derisk our long-term growth profile. Among the Phase III readouts expected late in the year, our Milvexian and atrial fibrillation and secondary stroke prevention, Cobenfy Alzheimer's psychosis at [indiscernible] iberdomide 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. We 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 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.

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 time lines and enhanced 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 Ferro, enabling us to design trials more efficiently and [indiscernible] 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. 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 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.

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. 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 U.S.

This is 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 Cobenfy, 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 first quarter growth of 53% reflects its best-in-class profile and continued strong demand across its approved indications in both the U.S. 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 continue to see strong demand. And given our U.S. price reduction that took effect at the beginning of the year, we also saw some wholesale 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 Sotyktu grew 20%. And recent approval in cirrhotic arthritis represents a continued presence in rheumatology while we await our Phase III readouts in lupus and Sjogren's disease.

I will wrap up our product performance on Slide 12 with neuroscience, where Cobenfy revenue in the first quarter was $56 million, representing continued steady growth. 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. 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 Pumitamig, [indiscernible] 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&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 from us. 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' comment, our strategy remains grounded in 3 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.

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

[Operator Instructions] The first question today comes from Asad Haider with Goldman Sachs.

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 [indiscernible] trials? Just any quantitative base for success. And then related for Chris, 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?

Thanks for the question. Cristian, do you want to start and then I'll take the BD question. .

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. And let me start with what we already achieved because in NIM, I think we had a positive MRD with Iberdomide in caliber in and we are expecting the PFS later this year. As Chris mentioned in his opening remarks, the PDUFA date for this filing is August [indiscernible]. We got breakthrough designation, priority review.

So it's progressing at pace. We achieved the mezigdomide this year with access to oral presentation at ASCO, really looking forward to show you guys the data. In NIM, we will have a readout also with our [indiscernible] that is a GPRC5D CAR-T that is happening later this year. Moving cardiovascular milvexian, as you was mentioning, are importantly doubt, both AFib and SSP are continue to be expected by the end of the year.

We have -- we are recruiting the events is an event driven. And of course, we remain blinded, we are recruiting the events as planned. And we at BMS are regularly is reviewing the data and even in the most recent meeting, they recommend to continue the studies as planned. So BMS will be the only Factor XI company with Factor XI 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 milvexian in this space.

In neuroscience, we continue to expect the ADP studies, a den, 2 and 4 by 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 time lines. So they are lining up quite nicely. We need the 2 studies probably for an approval.

This is the best case, but for refining, but we will see how the evolution in this space is happening. The confidence that remain unchanged also for Cobenfy study designs, trial conduction is now completely under control. And of course, the reason to believe in Cobenfy the space are very clear. Prior data the data that we are seeing in schizophrenia and of course, the open label in Adept 1 were patients before being randomized to receive Cobenfy 12 weeks give us confidence in potentially bringing this drug in patients with [indiscernible] disease in psychosis.

Last but not least, to me, critical readout this year is Admilparant in immunology, in IPF and PPF. This is a novel mechanism -- this is an inhibitor that can bring a novel mechanism to patients with is 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. IPPF is guided by the end of the year. PPF will be just a few months later, probably beginning '27, Very solid Phase II data.

I'm very pleased on the execution of the Phase III 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.

Thanks, Cristian. And then 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 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 sized deals.

The next question comes from Jeff Meacham with Citi. .

Great Morning, everyone. Thanks for the question. Cristian, on Pumitamig, I wanted to check on the cadence of data in, say, the next 6 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 Qvantig dynamics versus Opdivo and where you're seeing the biggest demand? .

Thanks, Jeff. Cristian and Adam.

Jeff, for the question on Comite. Let me start with ASCO. ASCO will be an important meeting this year for PD-1 BGF inhibitors. 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 II data in [indiscernible] cell lung cancer in front line as a global data set after the China data we presented previously in other indication in a few days, the abstract will be released. Our strategy with Pumitamig is replace and expand. We want to replace PD-1, PD1 inhibitors, and we want to expand beyond them. We announced and we deliver it 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 in terms of level of activity, a combine ability that you have with PD-1, PD-L1, GF inhibitors by specifics. And in my view, this is potentially translatable across indications.

Now the next step at reading our strategy is novel novel combinations. And BMS has a very rich oncology portfolio, Biotech has also an important portfolio of oncology assets. And what we are doing we are combining now -- we started the combination of Pumitamig with these other drugs that represent an enabler for other regimens, also using some combination with the standard partners. On our internal side, we started the combination with our Iza-bren ADC, which is an EGFR [indiscernible].

You will see that as Chris was mentioning at ASCO, In esophageal real negative is a very active ADC. And I think we mitigant represent a very powerful regimen. We start the combination with our [indiscernible] inhibitor, our meta very do tight drug. So in summary, I have to say that the partnership with biotech 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.

Yes. Jeff, thanks for the question. As it relates to Cobenfy, we're pleased with the Cobenfy 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 Qvantig improves practice efficiency with a 3-minute in-auto injection and that patients prefer gigantic when offered the opportunity versus the IV formulation.

So we've now delivered over 10% conversion from IV to Qvantig in the U.S. in just over a year in the market, and we're tracking well against our expectations, and we remain confident in our expectations that physicians will convert approximately 30% to 40% of IV business in the next 2 years.

The next question comes from Alexandria Hammond with Wolfe Research.

On [indiscernible], given the size and breadth of the [indiscernible] program, seems like there's probably a rich set of outcomes between the clean wind and mix. Can you help us think through how you'd approach a subgroup analysis, particularly for patients where the risk for or calculate might be more favorable for Factor XI. And to the extent that the top line doesn't meet that primary endpoint cleanly. Is there a path where the this patient population still supports a meaningful commercial opportunity?

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

I mean Alex, let me start with that to tell that we continue to be on track by the end of the year with both AFib and SSP. These trials are remain driven. We remain blinded. As said, the DMC continues the oversight to [indiscernible].

We are at a point in which we give us confidence that we are progressing on the right way with both efficacy and safety. Everything is continued as planned. In AFib, the study will test noninferiority versus apixaban, and then we will have a 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? .

Yes. Alex, as it relates to commercial opportunity, to vaccine represents a significant opportunity commercially. There is a need for a medicine with low bleeding risk, both in a Ib and in SSP, and we think there's a significant advantage to having both indications, we would expect gone adoption. As we talked about premium Europe-leading continues to be the main reason why physicians hold back from utilizing Factor Xa in more patients.

And despite the highly effective drug like Eliquis roughly 40% of patients who should be anticoagulated are either untreated underdosed or the discontinued treatment. And that's driven largely by concerns around bleeding risk. So this leaves a meaningful unmet need across a substantial number of patients. As a reminder, this study 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 it 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.

The next question comes from Chris Schott with JPMorgan. .

Just 2 for me. Maybe first, can you just talk about Camzyos potential post your competitor approval? Just what are you seeing in the market and just how you're thinking about that evolving? And the second 1 for me was coming back to the CELMoDs that we kind of some of this initial clinical data has 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 for the question, Chris. Adam, I think you can take both.

Yes. Thanks, Chris. So Canada 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 fight the significant and rapid improvement in symptoms, and we're seeing very low drop up rates. In fact, we are approaching 25,000 patients now prescribed Camzyos in the U.S. with thousands more prescribed internationally. As far as what we're seeing in the field, we've been planning for competition for some time.

ACP has continued to reinforce that they see little differentiation. It's still early. Some physicians have started 1 or 2 patients on the competition, and they are still operationalizing their own REMS program. But 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 are very clear. and thus, PLs have shared, they'll use the Camzyos dosing and echo regimen at 4 weeks.

So we think it's a positive. And we lived that because roughly 90% of patients on Camzyos are on the 5-milligram starting dose. And it's simply 1 dose titration to 10 milligrams. So it's 5 or 10 representing [ 9% ] 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.

And so our teams were well prepared for the launch of [ apacamten ], and we remain confident that we'll be the leader in the space longer term. So as it relates to iberdomide, I think we're really excited about the launch of iber. I know that Chris and Christian have talked about this. And so I think there are a few areas that is going to.

Number one, with Iberdomide, this is an area that we know very, very well in the multiple myeloma. We see that for multiple myeloma, it's 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 burden some regimens that can find a better experience for their patients.

And we're confident that Iberdomide will provide a balance of high potency manageable toxicity combined ability with daratumumab with the convenience of an oral treatment to amplify the efficacy of IMiD-based regimen. So our goal is to make both iber and mezi foundational in multi 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. So we know the work that we need to do to establish both iber and mezi in the market, and we're very sad to bring both of these important medicines to patients because we believe this is a real attractive commercial opportunity.

And Adam allow me to step in. Chris, I want to use the opportunity you mentioned in the question on Camzyos because I received received often the question about the nonobstructive HCM plants. I think, first of all, let me start that the level of benefit expected in nonobstructive is different than an obstructive because of the terogenity of patients and diseases is much higher. That said, we have learned a lot from [indiscernible].

We know that we are the patients and which we diseases that are affected by that can benefit most from is inhibitor like Camzyos. So I want to 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 clinical [indiscernible] progressing.

The next question comes from Evan Seigerman with BMO Capital Markets. .

And another 1 for Christian. So you really inherited design in kind of the Milvexian trials. 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?

Thank you, Evan, for the question. In -- I think your question is referring to [indiscernible] specifically, imagine because [indiscernible]. So in AFib, let me tell you that, first of all, the data are solidly based on a Phase II studies that we run in total new replacement. That is a very good surrogate for [indiscernible] drug.

So we learned a lot from Eliquis in that space, and we know the productivity value of that kind of population for antithrobotic agents. I think the very elegant, the refined work that has been done with Milvexian was in selecting the dose for FI. That was -- in that why 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. but it's a dose that gave us the confidence based on all the work that has been done, the modeling and the work that we were able to to bring in this -- in the Phase II part, give us confidence to have at least same level of efficacy that we expected with apixaban, preserving of course of the bleeding value.

Going specifically to your question, the design of the study is to be able to show a noninferiority apixaban in net to add comparison in a very well sized study, we recruited 20,500 patients. So very well powered for inferiority margin. We disclose these margins cost 0.8% to 1.3%. And we will then, when an inferiority will be met, to test the superiority for bleedings.

We test we split alpha for measure bleeding and nonmajor clinical relevant bleedings because I want to link what Adam was telling. This is a measure of probably 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 picked in my view, the right dose to being able to show what the study predefined criteria should meet.

The next question comes from Michael Yee with UBS.

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. 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. Cristian?

Okay. Michael, for the question. I don't -- we cannot disclose baseline characteristics and which kind of events that we are recruiting by we remain blinded, of course, to the study. What I can tell you, again, is that the AFIB study, the [indiscernible] 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. It's 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 year-end readout. .

The next question comes from Akash Tewari with Jefferies.

So for your Cobenfy [indiscernible] studies, you have several trials that I know [indiscernible] requires patients to have a confirmed Alzheimer's diagnosis using to 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 II trial conduct? And then just on CELMoDs, can you talk about your confidence on the successor on study, which goes against POMALYST showing a clinically meaningful effect size based on the results you saw in Successor2?

Cristian?

Thank you, Akash. The Cobenfy ADPET-4 decision to go into a biomarker-selected population, was based in try to decrease teragenity in the patient population. As you know, ADEPT-2 was a study that was already ongoing in the moment we acquired Cobenfy. And we wanted to have a more predefined patient population to be recruited into an Alzheimer 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 tria even if increase a little bit at the -- 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 you can see also maybe in a trial like ADEPT2, 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. Going back to your second question on [indiscernible].

I think a Successor2 was a very good news not only because it -- and as you mentioned, Successor2 is an add-on study on top KD, but because it came earlier than expected. We hit you will see the task, but you already know that when you eat an interim PFS means that you eat a bar that is higher according to the study, what the study was designed for. This is answering your question on Successor1. We believe Mezigdomide is a very potent sermon is more potent than Iberdomide, for instance, is a drug that can be very well combined with the standard of care regimens that we will see, little bit less with anti-38. This is why Iberdomide 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 or Successor1 is high and of course, is higher bar because it's not an add-on is a replacement strategy, but I think [indiscernible] high.

Thanks, Christian. And let me just also say that I'm glad to hear so many questions on CELMoDs. The CELMoD program, we're quite excited about. You're going to see exciting data at ASCO on iber and mezi.

We shouldn't forget you'll also see data on good 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, BCL-6 LDD, AR LDD and this program in this platform is quite deep. 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.

The next question comes from Louise Chen with Scotiabank.

I wanted to ask you, in addition to your ADP study for Cobenfy, I know you have several additional potential indications for Cobenfy, 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. And how do you see these all coming together to give Bristol a more comprehensive hold on the market?

Cristian and then Adam, to provide color and the commentary.

So ADP, because we believe this is a huge medical need -- and we believe a Cobenfy bring benefit based on what we have seen in schizophrenia. We are focusing our strategy in psychosis specifically assessing hallucination delusions and this is something that we have seen patients really having an improvement in schizophrenia. We wanted to have a multiple shot on goal. This is why we have Adept II and Adept 4 that are similar studies with the difference.

One is biomarker selected population, the other one d1 not. And we have a Adept 1 that is more a study that will assess how Cobenfy to avoid relapses. But we also designed Adept 5. So we have now 4 shots on goal in this program because the best case I was mentioning before is having at least 2 positive things are changing maybe. And we believe this is an important setting.

Cobenfy bring benefit to patients, we want to really have a multiple shows. When talking -- when thinking the other indication, bipolar disorder is the next one in line because we're expecting results in 2027. We are testing Cobenfy, specifically in many on the -- in the context of bipolar disorders. And 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 Cobenfy already providing benefit.

So the confidence is high also for this. Education is coming in 2028, like cognition, AD cognition. And cognition is probably different mechanism. Psychosis is probably mediated a muscarinic receptor 4. Cognition probably by muscling receptor 1. Cobenfy is working on both.

So this is where the confidence day. So I will say the Cobenfy, we believe that can bring benefit in controlling these kind of symptoms in Alzheimer, in the bipolar patients, and this is a noncore asset for our portfolio in our science. We are building -- we really would like you to start to see how we are building our portfolio in Alzheimer with a Phase II asset and multiple Phase I assets that show the commitment that BMS has for this disease because we want to play in this disease.

Yes. Just to add, Christian, did a good job covering much of our life cycle management program. But from a commercialization standpoint, I would say, stepping back, there are approximately 7 million patients diagnosed with Alzheimer's disease. And roughly 30% to 50% have psychosis and that's elucidation of delusions and the vast majority have cognitive impairment.

So this presents a real significant unmet need where there are no approved treatments today. And 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 then often treated and used inappropriately rather than treating the underlying psychiatric diseases, they -- they leave patients with cognitive impairment, falls and fractures and these are all really serious issues in long-term care facilities.

We believe that Covent has potential to play a very important role in treating a number of Alzheimer's disease. Safety becomes increasingly important in an elderly population, where Cobenfy is not associated with EPS sedation doesn't carry a box warning. And in those 2 areas, ADP and Alzheimer's ease cognition, Cobenfy can be the first and only product apron those states.

Let me -- thank you, Adam. Let me go back to your second question on cell therapy. I could discuss about cell therapy strategy in hematology or in a immune disease. I want to focus on that immune disease because probably is newer.

And I think it's is more -- it's important that we explain the strategy that we want to put in place on the development maybe in the commercial side. I believe that BMS has a very powerful platform in this space and with 1 aim resected immune system. And 2 is that immune system. This is the strategy that we want to take.

We decided to have a multimodal approach. This is why we have an autologous, an allogenic and an in vivo platform. And I have to say, this set as a part, compare many other players in the space. If you think of these products, this can be transformative for patients without immune disease because if you can eradicate B cells, you can provide benefit to patients with a severe or moderate stage of the disease.

But the vision can be to use these onetime treatment before the patients start to have the organ damage by the autoimmune diseases. The most advanced program is [indiscernible], our autologous CAR-T. We have 2 ongoing pivotal start, 1 in lupus and 1 is [indiscernible]. We have a multiple later 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 and scalable approach because from one donor, you can manufacturing 100 cells. And so this can broaden up the access, but the real transformative thing can be in vivo. We acquired [indiscernible] an mRNA in vivo platform where you have the patients that are producing, manufacturing the cells itself worse -- so this is really -- can be transformative because they can really broaden up and give scalability in such a broad space like immune disease. So I hope I addressed the strategic -- we want to be a player.

We want to lead in this space. I think we are very well set to doing that.

The next question comes from Terence Flynn with Morgan Stanley. .

I'll keep it to one. Christian, I appreciate the details on the Milvexian AFIB trial in terms of noninferiority 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 if you don't want to answer that question, what you think is a clinically relevant delta versus Eliquis that would drive reimbursement coverage?

Maybe start and then, Adam, you can opine 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 this margin, why I can speak about it. They go from [indiscernible] to 1.3 something.

So we believe in the study and the preclinical and clinical work plan in Phase II is set to show that the noninferiority is meant to have a similar activity on efficacy versus a pixel. It is possible that [indiscernible] can have another ratio less than 1, but it's not needed. Because clinically, very commercially the success required to be similar and having a better bleeding profile in measure bleedings and clinically meaningful bleedings. And this is where the study, I think, is extremely well set and power to show the noninferiority and then superiority on the bleeding rates.

Just from a coverage standpoint, Terence, what payers consistently telling is that bleeding -- and particularly major bleeding is the single largest cost driver associated with oral anticoagulation therapy today. That's why Eliquis has significant share in the market and payer discussions are suggesting that the potential of 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.

The next question comes from Seamus Fernandez with Guggenheim Securities. .

Great. If I may, I just wanted to drill in a little bit on Admilparant and the opportunity there. Just from a commercial perspective, we're seeing a very robust potential combination 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 II to Phase III -- and how do you see the opportunity beyond that?

When we look back at the Phase II and incorporated a [indiscernible] 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 the risk/reward heading into the IPF results and the PPF results? And then just for Adam, 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 [ treprostinil ] data.

Cristian and Adam.

Seamus, the -- let me start with the target. LPA1 inhibition is important because it's working in 3 dimension in the fibrotic process in IPF and PPF, fibrosis, inflammation and also repair. So this is the duty of the target. And I think Admilparant is the first-in-class in this space for both IPS and BPS.

The goal here is to improve on efficacy also to have a differentiated tolerability. You know there are drugs that the patient can use today that have some GI issues, some issues. So Admilparant is very different differentiated. The conviction on this program is sitting on the Phase II results. in both IPF and PPS.

We have more than 60% improvement versus placebo in the lung function decline with 60-milligram BID. And we tested different doses. And the dose relationship is very clear. This is another and one's very important that we put in the Phase III, they give me confidence in what we are doing.

Because we running -- we are running both studies, and PPF with 2 doses, 60 and 120. The dose relationship and the benefit of having I was very clear, deeper efficacy while the dose is increasing. BMC also for these trials are continues to motor and reviewing the conduction 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 in overall in the trial. So 2 shots on goal in a very well-designed power study.

The Phase II and the Phase III population are very similar. We tried and time the teams did a very good job in ensuring consistency and in trying to have as much as possible in Phase III what we did in Phase II. In your question on specific on the design of the trial, in both trials in IPF, we stratify based on prior treatment, [indiscernible] or nothing. So we can use add-on in patients that don't receive any treatment.

And in PPF, there is certification based on usage or not of antifibrotic. So the studies will answer that question, and the drug can be used on top of [indiscernible] as a single agent. Very high confidence on how this program has been delivered on the target, execution and looking forward to the results.

Adam? .

Just quickly, Seamus. We're excited about this program as well. 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 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're 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. And even what we're seeing with the newest approved products, the diarrhea rate is roughly 40%. What we're hearing from our thought here is that a Admilparant 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 on many 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.

Operator, can we please take our last question. .

The last question today will come from Mohit Bansal with Wells Fargo. .

So I have a question on -- so your competitor has signaled that VEGF PD-1 compared to an IO or PD-1, may be able to show a minimal regression in hazard ratio when you go from PFS to OS. We saw a regression when we compare it to chemo, but with IO-combo, it may not be a same situation. How are you thinking about that given that Bristol is probably the only company with 2 IO combos in the market and you have seen data for both the with LAG-3 as well as CTLA-4 count on top of PD-1. So how are you thinking about this sort of regression from PD-1 -- for PFS to OS, given in the context of VEGFs kind of an important investor debate right now?

Cristian?

Thank you, Mohit, for the question. Let me start on the way we deliver these 2 mechanisms. I truly believe bispecifics are a better way to deliver 2 different mechanisms than using 2 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 -- we are having every day with these drugs.

Our Pumitamig is a safe drug. The safety is very predictable, the combinability is very high. So we know VGF is impacting PFS. This is what also you are mentioning.

And I think that we will see where the data are maturing. We see even a 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 gave me a good PFS gain and the statistical significance OS gain that will be without increasing the safety in a dramatic way is good enough. Because then I can use this as a backbone and I can improve even further paring other mechanisms that can continue to increase the PFS gain and potentially translating even in a better OS.

I don't think we can be so simply -- we can simplify so much like in the past, the VEGF inhibitors did not translate in U.S. because here, we have the IO component. And we still don't know how much the DGF part of the drug is giving us the upside for the IO. And it is possible actually that this is give us an uplift also for OS. So I'm excited by this by specifics.

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.

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, 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. 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.

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