Bristol Myers Squibb Co Q1 FY2026 Earnings Call

Welcome to the Bristol-Myers Squibb First Quarter 2026 Earnings Conference Call. 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 three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio and maintaining disciplined shareholder-friendly capital allocation. We saw progress across all three in the quarter. Let me start by highlighting our performance on Slide 4. We started off the year with solid results across our key marketed products. In the quarter, growth portfolio sales were up 9% year-over-year with contributions from a broad range of assets, including Reblozyl, Breyanzi, Pumitamig, 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 iberdomide 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 the first targeted protein degrader to market. For mezignomide, 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 Izobran, we shared positive Phase III interim topline 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 for 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 Sotyktu in psoriatic arthritis and Opdivo for two new classical Hodgkin lymphoma indications. We also reported positive Phase I switch data for Cobi, positive Phase III data for Camzyos 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 de-risk our long-term growth profile. Among the Phase III readouts expected late in the year, our Milvexian readouts in atrial fibrillation and secondary stroke prevention, Cobenfy Alzheimer's psychosis ADEPT studies and 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. 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 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 Ferro, enabling us to design trials more efficiently and a 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 Qvantig, 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 psoriatic 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 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 in lower net cash collections due to Eliquis list price reductions. We expect this to be more than offset later in the year through lower rebate payments. In terms of capital allocation, we continue to take strategic and a balanced approach to deploying our strong cash flows. Business development remains a priority, and we are regularly evaluating opportunities in the therapeutic areas we know best while continuing to return cash to shareholders through our commitment to the dividend. Now moving to guidance on Slide 15. 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 three priorities: focusing R&D on life-threatening diseases, driving strong execution across the organization to build momentum in our growth portfolio and maintaining disciplined shareholder-friendly capital allocation. And with that, I'll now turn the call back over to Chuck for Q&A.

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 Cristian, just starting with you, can you just level set us on your confidence in the key programs, specifically for the Milvexian 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 in 2027. And let me start with what we already achieved because in myeloma, I think we had a positive MRD with iberdomide in earlier trials and we are expecting the PFS later this year. As Chris mentioned in his opening remarks, the PDUFA date for this filing is August 17. We got breakthrough designation, priority review. So it's progressing at pace. We achieved positive mezignomide results this year with access to an oral presentation at ASCO, really looking forward to show you guys the data. In myeloma, we will have a readout also with our GPRC5D CAR-T program that is happening later this year. Moving to cardiovascular, milvexian, as you were mentioning, importantly both AFib and secondary stroke prevention are continued to be expected by the end of the year. These trials are event-driven. And of course, we remain blinded; we are accruing events as planned. At BMS, the DMC is regularly reviewing the data and in the most recent meeting recommended to continue the studies as planned. So BMS will be the only Factor XI company with a Factor XI inhibitor in AFib, and of course, with presence also in secondary stroke prevention, 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 ADEPT studies, ADEPT-2 and ADEPT-4, readouts by the end of the year. This is based on very good operational execution; we are managing the studies and moving them more or less on the same timelines. So they are lining up quite nicely. We will likely need two studies for an approval; this is the best case, but we will see how the evolution in this space happens. The confidence that remains unchanged also for Cobenfy — study designs and trial conduction are now completely under control. And of course, the reason to believe in Cobenfy in the psychosis space are very clear. Prior data in schizophrenia and, of course, the open-label data in ADEPT-1 where patients were randomized to receive Cobenfy for 12 weeks give us confidence in potentially bringing this drug to patients with Alzheimer's disease psychosis. Last but not least, to me, a critical readout this year is Admilparant in immunology, in IPF and progressive pulmonary fibrosis. This is a novel mechanism — it is an LPA1 inhibitor that can bring a novel mechanism to patients with very difficult-to-treat disease; it is a first-in-class asset with a very differentiated profile, not only on the efficacy side but also on the safety side. IPF readout is guided by the end of the year; PPF readout will be just a few months later, probably beginning of 2027. 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 and 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 Pumitamig 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?

Jeff, for the question on Pumitamig, let me start with ASCO. ASCO will be an important meeting this year for PD-1 bispecifics. 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 non-small cell lung cancer in the frontline as a global data set after the China data we presented previously in other indications; the abstract will be released in a few days. Our strategy with Pumitamig is replace and expand. We want to replace PD-1 inhibitors, and we want to expand beyond them. We announced and we delivered 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 and combinability that you have with PD-1/PD-L1; bispecific inhibitors by specifics. In my view, this is potentially translatable across indications. Now the next step in our strategy is novel combinations. And BMS has a very rich oncology portfolio. Biotech also has an important portfolio of oncology assets. What we are doing is combining now — we started the combination of Pumitamig with these other drugs that represent an enabler for other regimens, also using some combinations with standard partners. On our internal side, we started the combination with our Izobran ADC, which is an EGFR-targeting ADC. You will see that as Chris was mentioning at ASCO. In esophageal squamous cell carcinoma it is a very active ADC. And I think Pumitamig represents a very powerful regimen. We started the combination with our MET inhibitor. 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 a potential new backbone in immuno-oncology and generate the next regimens that are very powerful for cancer patients across indications.

Yes. Jeff, thanks for the question. As it relates to Qvantig, we're pleased with the Qvantig 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 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-auto injection and that patients prefer Qvantig 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 two years.

The next question comes from Alexandria Hammond with Wolfe Research.

On Milvexian, given the size and breadth of the Milvexian program, seems like there's probably a rich set of outcomes between the clean win and mix. Can you help us think through how you'd approach a subgroup analysis, particularly for patients where the risk profile might be more favorable for Factor XI. And to the extent that the topline doesn't meet that primary endpoint cleanly, is there a path where 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 by saying that we continue to be on track by the end of the year with both AFib and secondary stroke prevention. These trials remain event-driven. We remain blinded. As I said, the DMC continues oversight of the studies. We are at a point in which we have confidence that we are progressing 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 test for bleeding. Based on what we have seen in other trials recently and based on the expectation and how we sized and powered the study, I think we are very much on track with both the endpoints to show noninferiority and superiority in bleeding. Regarding subgroup analyses, the trials were designed and powered for the primary endpoints, but prespecified subgroup analyses can provide additional insights, especially in populations with different baseline bleeding or thrombotic risks. If topline does not meet the primary endpoint cleanly, regulators and payers will look at the totality of the evidence, including safety and subgroups. There are certainly patient segments where a safer anticoagulant with comparable efficacy could offer meaningful clinical and commercial value. That said, our expectation based on the trial design and the dose selection is that we are well positioned to meet the predefined criteria.

Yes. Alex, as it relates to commercial opportunity, Milvexian represents a significant opportunity commercially. There is a need for a medicine with lower bleeding risk, both in AFib and in secondary stroke prevention, and we think there's a significant advantage to having both indications; we would expect broad adoption. As we talked about, provider concerns around bleeding risk remain the main reason why physicians hold back from utilizing anticoagulation in more patients. Despite highly effective drugs like Eliquis, roughly 40% of patients who should be anticoagulated are either untreated, underdosed or have discontinued treatment. 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, the AFib study 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. 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 two for me. Maybe first, can you just talk about Camzyos' potential post your competitor approval? Just what are you seeing in the market and how you're thinking about that evolving? And the second one for me was coming back to the CELMoDs that 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?

Yes. Thanks, Chris. So Camzyos continues to have very good momentum. Again, our commercial teams are executing very well in the field. We are seeing continued strong new patient starts, coupled with high persistency rates. Physician and patient feedback are very favorable and physicians consistently report significant and rapid improvement in symptoms, and we're seeing very low dropout 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. Competitors have continued to reinforce that they see little differentiation. It's still early. Some physicians have started one or two patients on the competitor, 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 four years are well understood. Physicians have shared they'll use the Camzyos dosing and echo regimen at four weeks. So we think it's a positive. We believe that roughly 90% of patients on Camzyos are on the 5-milligram starting dose. And it's simply one dose titration to 10 milligrams. So that 5- or 10-milligram regimen is effective for the majority of patients. Camzyos patients feel better in a matter of weeks whereas we see the competition requires multiple titration steps to reach an effective dose. So our teams were well prepared for the launch of the competitor, and we remain confident that we'll be the leader in the space longer term. As it relates to iberdomide and the CELMoDs, I think we're really excited about the potential. There are a few areas where Iberdomide can add value. Number one, in multiple myeloma this remains a highly competitive but fragmented market, and there remains a need for more effective and safe options that can address patients treated in the community setting, which is 70% to 80% of patients. When we hear from physicians, they're excited about oral, low-burden regimens that can offer a better experience for their patients. We're confident that Iberdomide will provide a balance of high potency, manageable toxicity and combinability, for example with daratumumab, along with the convenience of an oral treatment to amplify the efficacy of IMiD-based regimens. So our goal is to make both iberdomide and mezignomide foundational in multiple myeloma, replacing Revlimid and Pomalyst in second line over time in the community, and longer term serving as partners for T-cell redirecting therapies and cell therapy. We know the work that we need to do to establish both iberdomide and mezignomide in the market, and we're very glad 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 receive often questions about nonobstructive HCM patients. First of all, the level of benefit expected in nonobstructive is different than obstructive because of the heterogeneity of patients and disease is much higher. That said, we have learned a lot from the obstructive program. We know which patients and which disease features are affected and can benefit most from an inhibitor like Camzyos. So I want to announce that we are planning now to run a new, more focused study in non-obstructive HCM. The details of it will be highlighted in subsequent clinical communications as it progresses.

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

And another one for Cristian. 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?

Thank you, Evan, for the question. I think your question is referring to the AFib studies specifically. In AFib, first of all, the data are solidly based on a Phase II study that we ran in total knee replacement which is a very good surrogate for antithrombotic drug activity. We learned a lot from Eliquis in that space, and we know the predictive value of that kind of population for antithrombotic agents. The very elegant and refined work that has been done with Milvexian was in selecting the dose for Phase III. We tested multiple dose levels in Phase II and ultimately landed on 100 milligrams twice a day; that is a dose that gave us confidence based on modeling and the Phase II data to expect at least the same level of efficacy as apixaban while preserving the bleeding advantage. Going specifically to your question, the design of the study is to be able to show noninferiority versus apixaban with a very well-sized study. We recruited about 20,500 patients, so very well powered for the noninferiority margin. We disclosed the margins cover relative hazard ratios in a range that we carefully selected during study design and which we believe are clinically appropriate. When noninferiority is met, we will test superiority for bleeding. We split alpha to allow for testing both efficacy and clinically relevant bleeding endpoints. Being able to show that the drug provides benefit in terms of decreasing bleeding will be very important in the marketplace. So as I said, the study is fully powered, well-designed and we picked what I believe is the right dose to meet the predefined criteria.

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.

Okay, Michael. We cannot disclose baseline characteristics because we remain blinded to treatment assignment. What I can tell you is that the AFib study has the right sample size and, of course, a predefined number of events. We are recruiting events as expected. The event-driven nature of the trial means that if event rates change it can impact timing, but at the moment we are on track for a year-end readout. We'll monitor event rates over time and will disclose timing updates if they change materially, but for the moment we are on track.

The next question comes from Akash Tewari with Jefferies.

So for your Cobenfy ADEPT studies, you have several trials that I know ADEPT-4 requires patients to have a confirmed Alzheimer's diagnosis using 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 Successor1 study, which goes against POMALYST showing a clinically meaningful effect size based on the results you saw in Successor2?

Thank you, Akash. The decision to go into a biomarker-selected population for ADEPT-4 was to decrease heterogeneity in the patient population. As you know, ADEPT-2 was a study that was already ongoing at the moment we acquired Cobenfy. We wanted to have a more predefined patient population to be recruited into an Alzheimer's disease psychosis setting. This is why we took this approach of biomarker positivity, which can be done through plasma or imaging. I think this increases the confidence that the right patients are treated in the trial even if it increases operational complexity because screening failures are a bit higher. This doesn't reduce our confidence in potential benefit in a trial like ADEPT-2, where we do not have a biomarker-selected population, because ultimately you treat symptoms, but biomarker selection increases the probability that these patients have Alzheimer's pathology. This is the main reason. We are not the only company taking this approach. Going back to your second question on Successor2, I think Successor2 was very encouraging not only because it was positive but also because it came earlier than expected. Hitting an interim PFS barrier that is higher than the original study assumption is meaningful. For Successor1, which is a replacement strategy against Pomalyst, the bar is higher because it is not an add-on; it's a replacement approach. That said, mezignomide appears to be a very potent CELMoD — more potent than iberdomide in our assessments — and it can be well combined with standard-of-care regimens. The level of efficacy we have seen and the study designs lead us to believe this drug can be better than Revlimid and Pomalyst in certain settings. So our confidence in Successor1 is high, although it's a higher bar.

Thanks, Cristian. And let me just also say that I'm glad to hear so many questions on CELMoDs. The CELMoD program is quite deep and we're excited about it. You're going to see exciting data at ASCO on iberdomide and mezignomide. We shouldn't forget you'll also see more data on other CELMoD programs which continue to mature. Behind this, we have additional targeted degraders across multiple targets and modalities, and 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 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. Which of those additional indications are you most excited by? And then secondly, you have a lot of different modalities in your cell therapy franchise and pipeline. How do you see these all coming together to give Bristol a more comprehensive hold on the market?

So for ADP, we believe this is a huge medical need and we believe Cobenfy can bring benefit based on what we have seen in schizophrenia. We are focusing our strategy in psychosis specifically assessing hallucinations and delusions, and this is something patients really have an improvement on in schizophrenia. We wanted to have multiple shots on goal. This is why we have ADEPT-1, ADEPT-2 and ADEPT-4 that are similar studies with differences: one is biomarker-selected, another is not. ADEPT-1 is more focused on relapse prevention. We also designed ADEPT-5. So we have now four shots on goal in this program because the best-case scenario is having at least two positive studies. We believe this is an important setting. If Cobenfy brings benefit to these patients, we want multiple chances to demonstrate that benefit. Regarding other indications, bipolar disorder is next in line with results expected in 2027. We are testing Cobenfy specifically in mania in the context of bipolar disorder, which is related to productive psychotic symptoms that overlap with AD psychosis. AD agitation is also related and Cobenfy has already shown signals of benefit there. Education on cognition is coming in 2028 — cognition is a different mechanism; psychosis is likely mediated by muscarinic receptor M4, cognition may involve M1. Cobenfy has activity across both, so confidence is increasing. We believe Cobenfy can provide symptomatic benefit in Alzheimer patients for psychosis, agitation and potentially cognition, and it is an important asset for our portfolio given the unmet need. On cell therapy, I want to focus on the immune disease opportunity because that is relatively newer for many. BMS has a very powerful platform in this space with the aim to reset the immune system or reprogram the immune system. We decided to have a multimodal approach: autologous, allogeneic and in vivo platforms. This sets us apart from many players. Autologous CAR-T is the most advanced; we have two ongoing pivotal starts, one in lupus and another in an autoimmune indication. We are seeing levels of activity that are unprecedented. We also have an allogeneic CAR-T in clinic which can represent a more accessible and scalable approach because one donor can manufacture multiple doses. And the transformative part can be in vivo: we acquired an mRNA in vivo platform where the patient produces the therapeutic cells themselves. That can be scalable because it eliminates complex manufacturing steps and truly broaden access across a broad range of immune diseases. So our strategy is to be a leader in this space and we believe we are well positioned to do that.

Yes. Just to add, Christian did a good job covering much of our life cycle management program. From a commercialization standpoint, stepping back, there are approximately seven million patients diagnosed with Alzheimer's disease, and roughly 30% to 50% experience psychosis — hallucinations or delusions — and the vast majority have cognitive impairment. This presents a significant unmet need where there are no approved treatments today. Antipsychotics have significant safety limitations, including movement disorders and boxed warnings specific to elderly patients with dementia, and they are often used inappropriately rather than treating underlying psychiatric disease. They leave patients with cognitive impairment, increased falls and fractures, which are serious issues in long-term care facilities. We believe that Cobenfy has potential to play an important role in treating a number of Alzheimer's symptoms. Safety becomes increasingly important in an elderly population; Cobenfy is not associated with extrapyramidal symptoms, sedation or a boxed warning. In areas like AD psychosis and Alzheimer's-related cognition, Cobenfy could potentially be the first product approved without the safety limitations of current antipsychotics.

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 I'll start and then Adam can opine. Terence, again, the study is designed to show non-inferiority on efficacy. Non-inferiority margins, as I mentioned, are in a predefined and clinically accepted range. The study is set to demonstrate similar efficacy versus apixaban and then test superiority on bleeding. It is certainly possible that the hazard ratio for efficacy could be less than one, but it's not required. Clinically and commercially, the success requirement is being similar in efficacy while having a better bleeding profile in major and clinically relevant bleeding. The study is well set and powered to show non-inferiority and then superiority on bleeding rates.

Just from a coverage standpoint, Terence, payers consistently tell us that bleeding — 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. Payer discussions suggest that the potential of an improved benefit-risk profile will be a strong value proposition, particularly around economic benefits. Payers aren't necessarily anchored to a specific percentage threshold; what they're looking for is a clinically meaningful and statistically credible reduction in major bleeds that translates into fewer hospitalizations and fewer clinically and economically important events.

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 incorporate a subgroup 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.

Seamus, let me start with the target. LPA1 inhibition is important because it works on three dimensions in the fibrotic process: fibrosis, inflammation and repair. This is the rationale for the target. Admilparant is the first-in-class LPA1 inhibitor being evaluated for IPF and progressive pulmonary fibrosis. The goal is to improve efficacy while having a differentiated tolerability profile. There are drugs patients can use today that have GI tolerability issues; Admilparant appears differentiated. Our conviction on this program is supported by Phase II results in both IPF and PPF where we saw meaningful improvements versus placebo in lung function decline at the 60 mg twice-daily dose. We tested different doses and the dose-response relationship was clear. That informed our Phase III dose selection. The DMC continues to monitor these trials and has advised to continue as planned; we do not see safety flags. Both Phase III trials are well-powered and designed to reflect the populations we studied in Phase II. Importantly, in IPF, we stratify based on prior antifibrotic treatment, so the trial will allow us to understand add-on use as well as monotherapy potential. In PPF, we similarly account for background antifibrotic use. So the trials will address the question of use on top of existing antifibrotics and as standalone therapy. We have high confidence in the program's execution and target biology and look forward to the results.

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 improved efficacy and tolerability. There remains a significant need for improved therapies that slow disease progression and are well tolerated. GI tolerability remains a significant barrier with current antifibrotic therapies — roughly 50% to 60% of patients on treatment today discontinue therapy by 12 months with current standards of care, and even with newer approved products the diarrhea rate can be around 40%. What we're hearing from thought leaders is that Admilparant's potential to be both efficacious and better tolerated could make it foundational as a first-line option and also versatile for combinations. We have important prelaunch activities underway, and we look 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.

I have a question: your competitor has signaled that VEGF plus PD-1, compared to an IO or PD-1 alone, may show only a minimal regression in hazard ratio when moving from PFS to OS. We saw a regression when comparing it to chemotherapy, but with an IO combo it may not be the same. How are you thinking about that, given that Bristol is probably the only company with two IO combos on the market and you have seen data for both LAG-3 and CTLA-4 added to PD-1? How are you thinking about this regression from PD-1 PFS to OS in the context of VEGF, which is an important investor debate right now?

Thank you, Mohit, for the question. Let me start on how 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 can be more targeted and selective in delivering them and potentially decrease off-target adverse events. Our Pumitamig is a safe drug with predictable safety and high combinability. VEGF combinations have an established impact on PFS; whether that translates into OS depends on multiple factors including subsequent therapies and the specific disease context. My base case is that if you have a drug that gives you a good, statistically significant PFS gain without dramatically increasing safety concerns, that backbone can be used to add other mechanisms to further increase PFS and potentially improve OS. I don't think the dynamics are as simple as they were in the past when VEGF inhibitors did not translate in OS in certain contexts. The immuno-oncology landscape is evolving, and bispecific approaches like Pumitamig could provide a new backbone that enhances outcomes across indications. I'm excited about Pumitamig and the strategic plan because I believe it can be a backbone for future regimens across cancer 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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