Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary

December 4, 2025

US Health Care Pharmaceuticals Company Conference Presentations 40 min

Earnings Call Speaker Segments

Geoffrey Meacham

Analysts
#1

Geoff Meacham. I'm the senior biopharma analyst. And we're thrilled today to have Bristol-Myers with us on stage. We have CFO, David Elkins. We also have Adam Lenkowsky, Head of Commercial. So guys, welcome.

Unknown Executive

Executives
#2

Good to be here. Thanks for having us.

Geoffrey Meacham

Analysts
#3

Well, we have a number of questions to go over, partly finance, partly commercial. But maybe for you guys, let's just talk about yesterday's news with respect to the Cobenfy study. That's probably the more topical thing to give us some context for kind of the trial amendments.

Adam Lenkowsky

Executives
#4

Yes, happy to do that, Geoff. So as you're aware, yesterday, we announced that the ADEPT-2 study would continue, and we would enroll additional patients into the study. If we take a step back, if you remember, on our Q2 earnings call, we talked about conducting clinical trial site reviews across a number of our near-term priority studies. And as a result of those clinical trial reviews, we did find some irregularities as it relates to the ADEPT-2 study. So we then immediately reported that to the data monitoring committee as well as to the FDA. And in consultation with the FDA and the DMC, the decision was made then to exclude a number of sites and all of those respective patients from the study. The second area was, again, an agreement with FDA and the DMC was to conduct an interim analysis looking at both efficacy and safety. The DMC then met and told us to continue the study as planned. We remain blinded to the data. So this is all done prior to the database lock. And the recommendation was to increase the enrollment back to the original sample size of approximately 400 patients. So again, that study will continue. We now project that study to read out sometime in the back end of next year, right around some of our other data readouts for ADEPT, ADEPT-1 and ADEPT-4. And taken together, remember, we need 2 positive studies to hit, and we've got 4 studies now in flight, ADEPT 1, 2, 4 and now ADEPT-5 as well. And so we feel good about the probability of success for our ADEPT program and the broader Cobenfy development program.

Geoffrey Meacham

Analysts
#5

Yes. Maybe we'll focus first on that on Cobenfy as a franchise. So in the schizophrenia setting, the -- maybe talk a little bit, Adam, about the success so far as you wins along the way on things like formulary on adoption, awareness, then we can get into maybe the investments that you're making in future studies for sure.

Adam Lenkowsky

Executives
#6

So we just passed around a year on the market, and we feel good about where we are at this point in time. We had very early on, achieved strong access position, both in Medicaid and Medicare. And now we have a strong access position in the commercial setting as well. This is a space that's dominated, as you know, by government payers, Medicaid and Medicare. One of the things that we're really pleased about is we're looking at now surpassing 2,700 TRxs on a weekly basis. And so we're approaching 3,000 TRxs, which now far exceeds any other schizophrenia launch in the recent years. And so what I look at is how are we doing adding new prescribers, what's happening with TRxs and NBRxs. And we talked about our acceleration plan, which we've added a number of new salespeople on the ground to improve our reach and frequency as well as entering into the hospital setting where a number of prescriptions are initiated, roughly 20% to 25% of prescriptions are there and we've launched DTC. And since we've done that, you could see a nice acceleration in both NBRx and TRx growth as we end the year. And so we feel good about the momentum that we have coming out of 2025 and into '26. And as we've said, we think this is going to be a big product in schizophrenia. And certainly, when we get additional indications, this will be a very big product for the company.

Geoffrey Meacham

Analysts
#7

What's been the education cycle for -- given the novel mechanism, right, the muscarinic -- is there -- are there some neurologists, some physicians overall that still need a bit of an education of how the drug works. There hasn't been a lot of innovation, I guess, in many years. And so you have to sort of prime the pump, so to speak. Are you still doing that, I guess, are you...

Adam Lenkowsky

Executives
#8

Absolutely. Look, there's been nothing new in this space for over 3 decades. So when you look at the psychiatrists who are treating schizophrenia, setting appropriate expectations, reinforcing a differentiated profile and really trying to unlock what has been entrenched prescribing behaviors for decades with generic D2s have been critically important. I think most importantly is really around how do you dose the medication? How do you set the appropriate expectations on? What side effects to expect? And when you look at Cobenfy's profile, you truly see unprecedented efficacy with a side effect profile where you don't see the side effects like EPS, prolactin, weight gain, sedation, which have plagued the generic D2s and quite frankly, the entire class. So this will continue into next year, and we'll continue to have more data from Phase IV and from the real world to best inform our psychiatry community.

Geoffrey Meacham

Analysts
#9

Got you. Makes sense. And I know you're -- so let's talk about the future trials to go after. So obviously, Alzheimer's, you have a lot of the multiple depth studies. But talk about the other indications. I know you guys were talking about at one time, bipolar. There's a lot of different other segments where the mechanism may work. Beyond the ones that you've announced, are you thinking about making this another 5 or 6 trials? And maybe what would be on the docket?

Adam Lenkowsky

Executives
#10

Yes. So this is a great question, and we've got a number of these programs already up and running. So obviously, we've talked about our ADEPT program, and that's for Alzheimer's disease psychosis. And when you look at the roughly 6 million patients with Alzheimer's disease, roughly 30% to 50% have hallucinations and delusions. But we also have studies in Alzheimer's agitation and Alzheimer's cognition, which is really what got us excited about this asset, the differentiated property looking at cognitive benefits for this mechanism. We have a bipolar studies that will likely read out towards the end of next year or into early 2027. We have studies that were standing up in autism irritability and now we're looking at additional indications to bring into our development plan.

Geoffrey Meacham

Analysts
#11

Got you. And does the -- are you looking at the ADEPT studies looking to end of next year. As the gating factor, do you want to see more positive Phase IIIs before you decide to invest in future indications?

Adam Lenkowsky

Executives
#12

We've already stood up those studies. So we're going to go forward with those studies. We've got good proof of concept from early data that we've seen. And when you look at the program that we have, in bipolar, we're looking at exploring that in bipolar mania, and you see very similar symptomatology that you would see in schizophrenia with delusions or manic behavior and then the same with psychosis of Alzheimer's disease. So we feel good about the program that we have and confident about how those studies will read out.

Geoffrey Meacham

Analysts
#13

Well, let's take it a little bit higher level. So I know this internal R&D is a big component of the Bristol story and the growing pipeline. Maybe David, can you talk a little bit about kind of the pushes and pulls on the P&L as we look to next year. Obviously, you have the new product portfolio, where there's a big investment in the success there commercially, but I want to get your perspective of kind of some of the puts and takes.

David Elkins

Executives
#14

Yes. Thanks for that. And really, first, if you're talking about it as we think about as we're going forward, think about what we've accomplished this year in 2025. And it's been a strong year from an execution perspective, particularly on the commercial side. You're really seeing the transition of the portfolio to the growth portfolio, which is now more than 50% of the business in the most recent quarter growing 18%. And it's pretty -- that portfolio in itself. We now have 4 products in there that are annualizing over $1 billion. Reblozyl is annualizing over $2 billion. Adam very nicely laid out Cobenfy and the traction we've been making this year on and adding that to the portfolio. But also next year's '26 is a really important year from a catalyst perspective. If you think about the number of NMEs that we have Phase III data readouts, you guys are going to hear more. I'll start with the CELMoD. We have iberdomide and mezigdomide. We're really excited about those 2 products. We see those that could be next-generation Revlimid and Pomalyst, great from an efficacy and a safety perspective. ASH, you'll hear more about that. We also -- LPA1, which is in pulmonary fibrosis and really is a high unmet need. Really excited about that product, adding that to the portfolio, and we'll have Phase III data there. And of course, milvexian. We have 2 important studies reading out next year there with secondary stroke prevention and AFib. So as we think about 2026, there's a lot to be excited about from the portfolio, but as well as continuing the growth of the growth portfolio. So our focus as we head into '26 is continue to drive the growth portfolio, continue to execute against the pipeline. And then obviously, our efficiency programs that we've laid out. Last year, we had an expense base was about $17.8 billion this year. We got it $16.5 billion. So we've made really good progress on those efficiency programs. We said about $1 billion we'd achieved this year. We feel really good about that. We have line of sight for an additional $1 billion of savings that will be achieved in '26 and '27 and that gives us a lot of financial flexibility. Not only does it give us flexibility to invest when we bring in new products through business development, but it also provides cash flow for us. So I think it's a muscle that we, as an organization, we see even further potential to drive efficiencies there. So as we look at '26, we feel good about where we are from a growth trajectory. We feel good about where we are from driving operational efficiencies and what can do from driving earnings. And then we also feel really good about our cash position. We had $17 billion in cash at the end of the third quarter. That's going to enable us to continue to strengthen that portfolio by bringing in more products.

Geoffrey Meacham

Analysts
#15

So David, talk about the cost savings. And I know a lot of companies have deployed things like AI to drive efficiencies. To what degree have you guys go -- gone all in on that? And has that been more surprising or in line with kind of what you thought in terms of the level of cost efficient?

David Elkins

Executives
#16

Yes. It's a great question. I mean, really, AI is -- we're excited about this, and it's not just from an efficiency perspective. From an AI perspective, we see the greatest opportunity and driving shareholder value by helping us accelerate identifying new medicines, accelerating to proof of concept. And then even -- and we're using it even in study design, helping a site selection of drug development side of things. And it's even making us more efficient on the manufacturing side, I think where we're able to predict problems in manufacturing processes before they occur by using AI. Again, all of these things drive efficiency. But more importantly, if we can increase our probability of success in early development that we can speed the time between proof of concept and product approval by using AI, and we got some early test cases there that we believe that's going to enable us to do that. We'll be able to bring more medicines faster to patients, which does where you create the shareholder value. We are getting efficiencies. A couple of examples around that. It's critically important, like simple things that like automating approval processes, even in the finance organization and the procurement organization, simplifying the procurement process for our scientists and our sales force. So we're spending less time doing internal processes and more focused on the external world, whether it's being competitive or more time in the lab, we're using AI in those cases as well. And of course, it helps us drive those efficiencies that we've talked about earlier.

Geoffrey Meacham

Analysts
#17

So the last sort of financial sort of P&L kind of question you mentioned, I mean the good cash, net cash and also cash flow. But I wanted to ask you on capital deployment, and you guys have done a ton of deals over the years, and they've added a lot of exciting new products to the mix. Maybe where does this rank in the priorities now, now that your new growth portfolio has really -- new product portfolio has taken off? And are there spots that you're not in, but maybe what's the level of the threshold for adding in TA or expanding on what you already have?

David Elkins

Executives
#18

Yes. It's another great question. And look, we think we have plenty of substrates within the TAs that we currently have. And as you already said, we feel really good about where we are in that growth portfolio. And what we have, just the number of data readouts and just remind you, we have the potential for 10 new NMEs by the end of the decade and 30 additional indications by the end of the decade. So we do have a lot of substrates. So from a business development perspective, we're going to continue to look for those areas where there's high unmet need, where we think there's really good science from a modality perspective that can address it and where we can add value and bring down cost to the overall health care system. A great example is just look at the deals that we've done this year, whether it's cell therapy, we see as a tremendous potential for us in immunology and doing orbital therapeutics by doing in vivo will really bring down the cost, the potential to bring down the cost of cell therapy to bring it to a large market like in immunology. We had some really interesting early stage studies that we're excited about that. The other thing I would say is that look what we did on radiopharmaceuticals. We don't talk a lot about that. Huge opportunity for us. We see it as an IND engine. We added to that this year with PhiloChem. And then lastly, I would say, look at the BioNTech partnership. There is an area of solid tumor oncology. We have a very strong position. We believe this is -- has the potential to be standard of care and we have a really robust development program that we're working on with BioNTech there. And we see that being able to go into multiple tumor types. So those are the types of deals that you'll continue to see us do. They're going to be in therapeutic areas where we have deep scientific knowledge and have commercial acumen. And we still see plenty of potential there to continue to do, whether it's partnerships or acquisitions in those areas.

Geoffrey Meacham

Analysts
#19

Okay. That's helpful. Well, let's talk about some of the assets and new product portfolio. And one of the questions we get a lot is a Subq, Opdivo, the new launch [ kinetic ]. So if you think about the maybe the access and the initial kind of demand. Obviously, the idea for you guys and for Merck too is to roll this out in patients that are maybe pre metastatic, healthier patient. But over time, though, to potentially just let the metastatic kind of end of things, play out with respect to biosimilars. But just talk about how you're setting the stage for that with the Qvantig launch today.

Adam Lenkowsky

Executives
#20

Yes. We're pleased with what we're seeing with the Qvantig launch. Also, we launched right around this time last year, so a year on the market, and we're seeing really good conversion from the IV over to the subcu. One of the things we talked about was once we received our permanent J-code, in July, we see that July 1, we would see that inflection in sales, and that's what we have reported in Q3, a really nice jump in sales, and we expect to see continued strong conversion over time for this formulation. What we're hearing from physicians and patients the convenience of a 3-minute in office, a subcutaneous injection is incredibly patient and provider friendly. About 70% of the use now is in the community where the majority of patients are treated. And we're actually seeing broad utility across a number of tumor types. So it's not just in the monotherapy or adjuvant indications, but we're seeing use in combination where a combination with YERVOY or combination with TKIs or chemotherapy. So we expect to see continued conversion from now to LOE. And as we had shared, we expect to see 30% to 40% of our IV business converted by the 2028 time frame.

Geoffrey Meacham

Analysts
#21

Adam, can you sort of -- I wouldn't say force, but can you drive use in one versus another based on things like the gross to net or discounts or volume or I'm trying to get a sense for how you can maybe further strike point [indiscernible] the paradigm?

Adam Lenkowsky

Executives
#22

Well, clearly, in the community, they are very economically driven, and that's why you see the majority of the use there. I think number one, the advantage of a 3-minute in office injection versus a 30-minute to 1-hour infusion is that you can inject the patient and at the same time, fill another infusion chair or a suite in the community. That's number one. Number 2 is when you look at net cost recovery, there are benefits to using the subcu over the IV formulation. And so that is going to be a determining factor. But the major determining factor really is around the convenience that it offers to patients and the benefits to physicians.

Geoffrey Meacham

Analysts
#23

Okay. That's helpful. Sticking with oncology. So cell therapy overall, you guys are among the largest cell therapy companies out there on the back of the Celgene deal. Talk about maybe, David, where this ranks kind of in your new product portfolio like priorities with the investments that you're making, this isn't a category where you could sort of be passive or you have to invest in infrastructure and manufacturing and consistently. So maybe talk about like the priorities of where this ranks?

David Elkins

Executives
#24

Yes. Look, I mean the good thing is we're blessed with numerous modalities in oncology and hematology. And this is an important franchise for us, and we've really focused that the dedicated team of doing that. I'd say for Breyanzi, just tremendous success in a number of indications that are there, the broadest indications in its class. I think the other thing is that we have a follow on. We have Arlocel, which is do targeting, which we're really excited about. And then as I already talked about, NEX-T, CD19, we see that as the opportunity to go into autoimmune diseases. And then if you throw on top of that, the in vivo that I was talking about with the Orbital acquisition, being able to bring down those manufacturing costs, it makes it a really attractive franchise for us. So it's an important component to the overall growth story. And this is the great thing about us. I think whether it's immuno-oncology, whether it's cell therapy, radiopharmaceuticals, and even with our iza-bren with our ADC, we have a lot of modalities, which is what we've been focused on from a business development perspective but as well as from an internal development perspective, that enables us to go after the most interesting science where there's that high unmet need. And that's why we feel really comfortable about our growth trajectory as we exit this decade because we have a lot of breadth and depth across really important tumor types.

Geoffrey Meacham

Analysts
#25

One of the more exciting mechanisms is your partnership with BioNTech and the VEGF PD-1. Talk a little bit about that in terms of the -- maybe the context for forming that partnership like what was the -- did you -- what was the kind of background for how you're exploring that as a modality? And then going forward, you've invested in a ton of studies and maybe what's more exciting to you as you expand that offering?

David Elkins

Executives
#26

Yes. I'll start at a really high level, and I'll turn it over to Adam. But look, this is a great example of how we think through business development. This is a really exciting area and it's an area that we've been following very closely. There is multiple options to enter into this. But look, we are looking for the best science. We're looking it's very important to be first or second to market because that's where the greatest value is generated in this place, and you can see that in IO today. And then do we have a right to win? Do we have the scientific expertise, do we have the development capabilities and do we have a commercial organization that can add value beyond in the hands of somebody that currently owns it? When we looked at the entire landscape that was out there, we became most excited about biotech and where they are. They're just really strong from a scientific perspective, but our capabilities in development and in commercial really complements their scientific capabilities bringing those two organizations together and being able to do that in a joint partnership, 50-50 partnership, we think that adds the most value for both us and biotech. You want to talk about the programs?

Adam Lenkowsky

Executives
#27

Yes, just adding, we've been leaders in this space now for nearly 2 decades, starting with the launch of YERVOY back in 2010. And then we -- looking at the launch of Opdivo and of course, Opdualag. So we're the only company that's launched and commercialized 3 IO assets. So we think this was a great fit. The partnership is going very well. We've got 5 studies that we have announced, 3, which BioNTech had up and running in first-line non-small cell lung cancer, that is the largest opportunity for the category. The second is small cell lung cancer in first line. And then we'll be presenting data over the next week or so at San Antonio Breast symposium in triple-negative breast cancer, and that's the third study we have. On the earnings call, we also announced studies in first-line gastric cancer. And what's really exciting is the potential to broaden beyond where we've seen PD-1/PD-L1s work. So we had announced the study in first-line MSS CRC. And so that's going to be another important opportunity to expand what today is a $40 billion to $50 billion category even further.

Geoffrey Meacham

Analysts
#28

Are there lessons to be learned from the pace of new Phase IIIs and the development of Opdivo, the lessons to be learned that you can translate here in terms of not be linear or just to more of a basket kind of approach to am I hitting the right?

Adam Lenkowsky

Executives
#29

No, absolutely. There are a lot of learnings to be -- I think when you look at the number of PD-1, PD-L1 VEGF that are being developed today, most of them in China. I think it's -- what we see today in these first-generation PD-1, PD-L1s are going to pay out in comparison to the number of these new assets that are coming to market and coming to the market quickly. So as David said, I think the first learning is being first or second to market is absolutely critical because when you look at Opdivo and KEYTRUDA, together, we command about 80% of the marketplace today. In fact, when I think about where we compete with Opdivo, we are -- have the leading market share in the majority of tumor types today with the exception of lung cancer where we were later to market. That's number one. Number two, I think that the importance of having infrastructure in place in the community, in particular, is essential because that's where the majority of PD-1, PD-L1s are treated. And so that's where we have a stronghold and I think a true competitive advantage in the U.S., but also we've got a global footprint, as you know, with Opdivo and Opdivo Yervoy and then the third, I think the velocity of new indication launches are really important. And as David said, we have that muscle to be able to flex and be agile from one indication to another indication in order to maximize those opportunities. I think those are some of the learnings that we have beyond -- I guess the final one is around the importance of non-registrational data generation because the data that we generate is always going to move faster than label can move. So the non-registrational data is critically important.

Geoffrey Meacham

Analysts
#30

And Adam, you mentioned China and all the competition. Maybe, David, when you think about BD back to that question, we've seen a ton of new products coming out of China and a ton of new deals. And then in the U.S., it's kind of odd. We've seen a lot of CVR kind of deals. So we've seen some new structures emerge that really haven't been like that widespread in the biopharma space over the past couple of years. How does Bristol think about sort of deal structure? Do you -- and maybe give us some context for the emphasis of assets coming from China?

David Elkins

Executives
#31

Yes. Look, I mean, we're agnostic where the asset comes from. It's where is the most important science, where do you have proof of concept and what assets are available and then what value can be created from those. So look, China is critically important. And if you look at the number of INDs that are coming out of China now globally, they're becoming a greater percentage of the total, and they can surpass the U.S. by next year. So you can't just ignore any geographic area, especially if they're producing that much science. Secondly is, from our perspective, we're putting scientists on the ground there. We have business development teams there. We're looking for -- and it's a great way to get products into humans as quickly as possible to get to proof of concept. So it's critically important to the development cycle as well. That being said, look, there's a tremendous amount of science here in the United States and in Europe, and we look across the Board to find the best science for that unmet medical need.

Geoffrey Meacham

Analysts
#32

Makes sense. So going through kind of the rest of the pipeline, so milvexian, you mentioned that. So talk about the recent discontinuation of the study and what gives you confidence in the other two studies with respect to read-through?

Adam Lenkowsky

Executives
#33

Yes, Geoff. So we announced with our partner, J&J, that the ACS study, we had a futility analysis and it did not hit the threshold that was needed. So the IDMC recommended to stop the study because of the low likelihood of hitting the primary endpoint. So as we commissioned that study, we knew that was going to be the highest risk study that we put forward. We haven't seen a lot of work in either Factor X or XIa in that space, but we were opportunistic in that area. We feel very confident about the SSP data readout that will come next year. Our AFib readout will come as well. Recall, we had a very large 2,000-patient SSP study, Phase II that showed really significant relative risk reduction with minimal bleeds. And we did a lot of work to really get the dose right. You've also seen recently the announcement from Bayer. They have a positive study in SSP. And so that gives us more confidence in the mechanism. The biggest opportunity really lies in atrial fibrillation. And a lot of work was done there with our partner, J&J. We took a similar playbook to what we did with Eliquis many years ago. We conducted over 1,000-patient TKR study that showed similar low bleeds, and we were very choiceful in the dose that we brought into that study. So when you look at the dose in SSP, which is 25 milligrams BID, we're actually looking at 100-milligram BID dose in atrial fibrillation. And with now over 20,000 patients enrolled in the study in a blinded fashion, we're not seeing anything remotely close to what Bayer had presented when their study was stopped. So we're excited for both of those data readouts next year.

Geoffrey Meacham

Analysts
#34

Yes. And those are very large market opportunities. Is there -- do you want to turn the card over on those next year before you look at other potential indications? Or is there maybe a few other cardio indications that you can go after with milvexian?

Adam Lenkowsky

Executives
#35

Yes. We are in constant discussions with our J&J partners around what could be next. Obviously, we want to see positive studies in SSP and AFib, but there are a number of potential future indications that we could pursue together.

Geoffrey Meacham

Analysts
#36

Yes, AFib for sure seems like a major, major -- more of an unmet need that really than any other cardio verticals I feel like?

Adam Lenkowsky

Executives
#37

It's exciting. You know we're leaders with Eliquis really over the last decade. The product is phenomenal, continuing to grow linearly just about every month. We're now at about a 75% NBRx share in the U.S. And that said, there's still about 40% of patients that are either untreated or undertreated. And why is that? Because of risk of bleed. And that's what, hopefully, milvexian will bring to these patients and to the broader Afib population, a lower bleeding profile than the standard of care Eliquis with comparable efficacy.

Geoffrey Meacham

Analysts
#38

Yes. So sticking with cardio, let's talk about Camzyos for a second. So the -- just with respect to new patient identification, are you past some of the initial investments and awareness? Are you looking more at the kind of access reimbursement type of -- like give us some -- a bit of a status update on the commercial and what's the drivers from here?

Adam Lenkowsky

Executives
#39

Yes. As David mentioned, when you look at Camzyos, it's another one of our key growth drivers that's annualizing now at over $1 billion, and we expect to see continued significant growth from this important product. So we launched the product several years ago. It was a product with the REMS program. It took some time for our centers of excellence to kind of operationalize a new program, understand a new treatment modality. But when you look at the performance of this brand growing at very high double-digit rates with durations of treatment now at almost 4 years, we expect, you're going to see really significant growth. And I still think we're scratching the surface because we've got about 20,000 patients, a little over 20,000 patients on Camzyos today. And we know there are still about 70,000 patients with obstructive HCM that are diagnosed and waiting for Camzyos. And that doesn't even include these hundreds of thousands of patients who are out there who are undiagnosed. And so our focus is continuing to drive growth in the centers of excellence. And what I'm also pleased about is what we're seeing in the community cardiology offices. As now we have more time behind us, we're seeing uptake coming from the community card -- community cardiologists in the U.S., which is also driving nice growth for the brand.

Geoffrey Meacham

Analysts
#40

Is the speed of diagnosis and as docs become more familiar with sort of the symptom the presentation, is that getting better? Is that accelerating? And maybe talk about that in the context of maybe the OUS opportunity?

Adam Lenkowsky

Executives
#41

Yes. So we've definitely seen an increase in diagnosis rates over the last couple of years. I think the direct-to-consumer campaign certainly helps patients. When you look at a disease that is so heavily misdiagnosed or going undiagnosed, there are so many patients out there who are suffering who can look to direct-to-consumer and say, "Hey, that's me. That's something that I may be suffering with. I'm going to go ask your doctor. And that's what we've seen. We've seen that coupled with a shift since we've launched into NYHA Class II, which is a little bit less severe than what we see in Class III and Class IV. And so we're seeing that shift come into the U.S. today. We're now continuing to start outside of the U.S. in launching, getting reimbursement, and we're finding very similar successes in a number of our major markets. So very pleased with what we're seeing with Camzyos, and this is going to be a very big product for the company.

David Elkins

Executives
#42

And that's another area that we were talking about AI earlier. One of the challenges that we had is the cath labs were full. They're back to back with patients and getting patients in to get them properly diagnosed now that there's a treatment option was one of the barriers that we had early on. One of the things that we did is we used AI to go back, working with some of the centers of excellence using AI to review the echocardiograms of these patients and then with about 90% accuracy, identifying those patients that had cardiomyopathies. So with that, that helped the doctors appropriately identify the patients to bring in to provide treatment. So that's just another area where AI is adding value to the health care system.

Geoffrey Meacham

Analysts
#43

Is that something that you have to go through FDA to sort of as a diagnostic tool or is it just sort of analytics that you can put in your thought?

David Elkins

Executives
#44

It's an analytic -- it's a tool that the cardiovascular doctor uses at the end of the day to determine it.

Geoffrey Meacham

Analysts
#45

Okay. Okay. So Sotyktu, another new product launch. So maybe same kind of question there, like give us some of the go forward, what are the pushes and pulls as you look to '26?

Adam Lenkowsky

Executives
#46

Yes. So as we came into '25, certainly, we were not where we had hoped we would be. But it was an important year coming in because we finally were able to secure access that was at parity to Otezla. And so we continue to see improvements in new patient starts in TRxs. However, it's just not where we expected we would be when we launched this product. We made the difficult decision to cease promotion in dermatology in the U.S. and in a number of our ex-U.S. markets because really the lack of competitiveness in there. And this is an area that requires significant investment, and we want to make sure that we're leveraging our capital in the best way possible, investing behind what we see our key growth drivers like Cobenfy, like Camzyos and also investing into R&D and/or dropping to the bottom line. What we're excited about, though, is some of our next set of data readouts. We'll have a data readout in SLE for Sotyktu coming into 2026, which is really exciting. As you know, that has been a very, very difficult area to have success with medications. We conducted a Phase II study there, if you recall, and we saw really exciting results, and we're hopeful to see a positive study there. And then that, as you know, are treated by rheumatologists. So with an SLE readout and then in 2027, we'll have a Sjogren's readout, which are areas of really high unmet need and areas where we believe that we can win with Sotyktu.

Geoffrey Meacham

Analysts
#47

Okay. That makes sense. And then maybe in the final few minutes, I know, David, we talked at the beginning of this year, health care policy was a topic du jour. We've had some great insights with Secretary Azar yesterday and then Marty on Tuesday. Talk a little bit about where Bristol is with regard to the rest of the industry on the tariff, MFN. I know you guys have already communicated that you're onshoring a lot of manufacturing and so bringing jobs over here. But maybe talk through kind of where you are in that continuum.

David Elkins

Executives
#48

Yes. Look, we continue to engage with the administration, but as well as policymakers broadly. And a couple of things I'd say around this is, one, we feel we're really good where we are from a tariff perspective. We have a very flexible supply chain, as you highlighted. We're continuing to increase our investments within the U.S. in order to make it very flexible, both in Massachusetts as well as our operations in New Jersey. And we're also doing a number of other things from engaging on an MFN perspective. We can't talk about those discussions, but we believe it's a critically important that access to medicines is given and also that the cost differential between outside the United States and inside the United States gets more normalized over time. So all of those types of things are really good. On the tax policy side of things, that's critically important to incentivize investments here in the United States. And I think the recent changes of the one big beautiful bill, but as well as the top Tax Reduction and Jobs Act that happened earlier are all things that equalize tax policy globally that enabled us to move capital investment here into the United States. So all of those things, we feel really good about, and we're going to continue to engage on that. The last thing I would say is on -- as far as on the FDA side of things, we really haven't seen any impact in our engagement in the products that we have going through the regulatory process. The people at the FDA have just been fantastic, and we're moving at pace as we have been. So we haven't seen any impact there either.

Geoffrey Meacham

Analysts
#49

One element to come out of that is there this year, it does seem like there is a much more consumer-driven kind of model that's coming out of pharma and big cap biotech. Maybe talk about that as a strategy for Bristol. You have a lot of companies that now have portals that you can go right into. But I think it just sort of connects a lot of payers and patients, but some are more than that, right? Some are more of a drop ship kind of element. I don't know, but where does that rank in terms of Bristol's sort of distribution and priority?

Adam Lenkowsky

Executives
#50

This is an area where we are completely aligned with the administration. We think direct-to-patient is very important. The ability to have improved visibility into drug prices, ensuring access and affordability. We were one of the first companies to announce that Eliquis would be available through direct to patient through Eliquis 360 at a price that is a 40% reduction from our list price. So patients who either were cash-paying patients or underinsured patients could go to the pharmacy and get this at a significantly reduced cost. We then follow that up with Sotyktu. And so patients now can go and get Sotyktu at a roughly 80% reduction than they would pay at the pharmacy counter. So we think this is really important, and it's a trend that we know will continue with this administration and I think beyond.

Geoffrey Meacham

Analysts
#51

Awesome. David, Adam, thank you very much.

David Elkins

Executives
#52

Thank you.

Adam Lenkowsky

Executives
#53

Thank you, Geoff.

This call discussed

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