Well, good morning, once again, and welcome to TD Cowen's 46th Annual Healthcare Conference. We are absolutely delighted to have Bristol Myers Squibb here again with us this year, representing the company, Adam Lenkowsky, who is Executive Vice President and Chief Commercial Officer. Adam, thank you so much for being here.
Thanks for having me, Steve.
Let's start out with a bit of a big picture. Can you remind us of any notable pushes and pulls throughout the year in terms of both revenue and OpEx we should be considering?
Yes, happy to do that. You know, when I take a step back and think about 2025 performance, we delivered strong performance and execution as we had good momentum coming into 2026, particularly with our growth portfolio. Products like REVLIMID, Breyanzi, CAMZYOS all performed well. We expect that to continue this year. We are now in year two for launches like COBENFY and Opdivo Qvantig that will also contribute to the growth of the company. That said, there are also some headwinds. As you know, you know, we have now full generics in the market for both REVLIMID and POMALYST as part of our legacy portfolio. I should say, and I talked about on the call, although not part of our growth portfolio, you know, that will be offset by significant growth of ELIQUIS this year.
We expect to see double-digit growth. There are some notable quarterly dynamics that, you know, David touched on on the call. I think we saw a significant inventory build in Q4, particularly in our U.S. oncology business, so our IO franchise, Opdivo, Yervoy, Opdualag, and to a lesser extent, REVLIMID. We're seeing that happen now in the first quarter. You know, we're seeing that inventory burn that should normalize by the end of the quarter, and we don't expect any significant deviations for the year. As far as operating expense, we've been very disciplined in our overall operating expense. Recall last year, you know, we did have higher OpEx in the second half versus the first half. That was largely due to some of the deals that we made.
Our partnership with BioNTech, as well as the acquisition of Orbital had, you know, increased the percent of R&D spend in the second half of the year. We expect that to normalize this year. You know, taken together, when I think about the performance of the growth portfolio, the financial discipline, I know we'll talk about the unprecedented number of phase III readouts that we'll have this year. We feel like, you know, we're in a really good position to execute on our strategy of driving long-term sustainable growth.
Great. Let's dig into some of those commercialized products first, and then we'll go more to the products that are on the way. Let's start with CAMZYOS. How is CAMZYOS performing versus what the plan was? You have new competition, how can you beat the competition?
Steve, CAMZYOS continues to perform very well. As you know, it annualized last year at north of $1 billion. We saw consistent and sustained increases in new patients. These are patients who will be on treatment for, you know, many, many years, and we continue to see that, you know, happening this quarter as well. Secondly, you know, what we're seeing is even though we're four years out almost from the launch, every single week, we're continuing to add new prescribers into CAMZYOS treatment, and that's happening at the community practices as well as some of the smaller institutions. It's a very positive sign as we're looking to broaden the business outside of the, you know, COEs and the roughly 500 Centers of Excellence. As it relates to the competition, we've been expecting competition in this space for quite some time.
What we had heard from physicians, you know, for over a year that they did not believe there was any meaningful differences between CAMZYOS and aficamten. I think when you see the label and the approval that they've had, now coming to market in January, that continues to be reaffirmed by our customer base. They don't see any meaningful differences. You know, we remain steadfast that we're going to be the leader in this space for the foreseeable future.
Great. By the way, if you have a question and you're in the audience, just raise your hand and we'll do our best to get the question answered. Let's go to another approved product, that being, Opdivo SubQ. Are you on track to achieve the 30%-40% conversion of Opdivo with the SubQ by 2028? What obstacles, if any, are the payers putting in the way of adoption of that drug?
Yeah. We feel good about the performance of Opdivo Qvantig in its first full year on the market. Remember what we talked about last year was receiving our permanent J-code on July first, we saw a nice inflection of per-sales performance in the back end of the year, largely due to continuing to build confidence in reimbursement with the community. What we're seeing with Opdivo Qvantig is the use across broad number of tumor types in the community. We're seeing use in monotherapy. We're seeing use in combinations, whether it's in GI, RCC, metastatic melanoma. We hear consistently from our community oncology base that, you know, Opdivo Qvantig improves practice efficiency, it improves the economics of the practice.
Then finally, you know, from a patient standpoint, you know, it's really patient-friendly when they're offered an opportunity to go on the IV or on the SubQ, the 3-minute in-office subcutaneous injection is clearly preferable. You know, we are on track to deliver against our roughly 30%-40% conversion commitment. You know, we're really pleased with what we're seeing from this launch.
Okay, similar question this time about Cobenfy. How's it tracking against plan and what is the outlook?
Yeah. Cobenfy in its first full year on the market, we made good progress. What we're seeing in a highly entrenched market is we're increasing the number of prescribers each week. We're focused on driving both depth and breadth of adoption. What's a positive sign of those physicians who have a positive experience with Cobenfy, they have an increased proclivity to increase their depth of prescribing. This year is an important year as we look to bring new datasets into the market. In fact, by the end of this month at a conference called SIRS, which is the Schizophrenia International Research Society, we will have our switch study, which is a phase IV study that was conducted.
That is the number one question that we get from psychiatrists: how do I switch my patients that will not help, you know, decompensate those patients from positive symptoms and also minimize adverse events? We'll be sharing those data at the end of this month, and we'll be able to disseminate that data broadly across the psychiatry community. We've also increased our focus in peer-to-peer. We'll have real-world data we feel good about the progress that we're making. Again, this is an important year too, we still expect to see steady and consistent growth from this important asset.
Great. Let's stick to the switching study for a second. How long do you think it'll take physicians to embrace that data in the clinic?
This is one where it's gonna take time. We'll have the data presented at the end of the month. We'll publish the data mid-year. We will work with our teams to disseminate the data very broadly. Unlike what you see, though, in areas like cardiovascular, or in oncology where you have NCCN guidelines, you know, APA guidelines have not been updated since 2020. We wouldn't expect these guidelines to be updated. It's gonna take some time, but we're gonna work tirelessly to get this in front of as many physicians as we can so they can treat patients and have, you know, the best possible experience and be able to start with and stay on Cobenfy long term.
You've done a great job securing coverage, commercial coverage, government payer coverage for this asset, and Q1 2026 should be the time where that's in full play. Is this the quarter where we can get the best picture of the potential of this drug?
You know, we were really pleased with our ability to achieve access, particularly Medicare and Medicaid access, very early on in the launch, within the first, you know, three to four months. As we said, when you look at this drug, I mean, you could see, you know, a nice steady increase in TRXs. We'd expect that to continue. The way that we've described it is steady and consistent growth in schizophrenia. You know, we would not expect an inflection. We have not seen that inflection in other products. The inflection, though, comes where you add new indications to Cobenfy. We'll have data readouts in the back end of this year in Alzheimer's disease psychosis. That'll be a great opportunity to inflect the drug. It's a meaningful commercial opportunity. We'll have bipolar, our studies reading out early next year.
Really it's going to be these next indications that will inflect the product. All of the leading indicators that we're seeing, you know, really point to a direction of this is gonna be a big drug in schizophrenia and a multi-billion dollar drug longer term with a suite of new indications.
Are there any updates on the Alzheimer's disease psychosis trial, ADEPT-2? Is it on track to read out at the end of this year, and how has it gone with the addition of the new patients and so forth?
Yeah. you know, we are tracking towards the end of the year. Reminder, we have, not just one study, but we have three studies in Alzheimer's disease psychosis that will read out at the end of the year. ADEPT 2, ADEPT 1, and ADEPT 4 should all read out by the end of the year. We also have ADEPT 5, which is a study that is looking at a BID formulation for Cobenfy in Alzheimer's disease psychosis. We look forward to those data readouts. We've got multiple shots on goal, and, you know, we know this product works just based on what we've seen from the open label phase I study. That said, you know, we know in neuroscience studies it does tend to be high placebo rates as well, and that's why we have multiple studies that are ongoing.
You know, we have confidence in this study and these programs that they should hit, this year.
Okay. I understand why you're saying end of year, that leaves open a lot of days and months. Can you be more specific as to when we might get this data?
Probably by the end of the year.
Okay.
See the studies read out.
Okay. We're talking December then.
I don't know if it's December or November.
Okay. Okay.
Roughly towards the end of the year.
Okay. Okay. Good enough.
We'll let you know. I'm pretty sure you'll know as soon as we do.
Let's move to Milvexian, another very exciting drug. What is the base case assumption within Bristol as to whether this becomes the new standard of care for ELIQUIS and replaces it entirely? Do you more just go into treatment settings where ELIQUIS does not play?
Yeah. Similarly, the good news is that, you know, we don't have to wait very long. We'll have both the data readouts in SSP and in AFib by the end of this year reading out with our partner J&J. As far as AFib, now this is obviously a very significant opportunity. It's an area where ELIQUIS dominates in the space. Our, you know, thesis is that ELIQUIS is gonna play across a broad the vaccine is gonna play across a broad patient population, not just those 40% of patients who are untreated or undertreated based on bleeding. You know, if we achieve, you know, what we hope to achieve, which is comparable efficacy with a better bleeding profile, we think this could become a potentially new standard of care in treating atrial fibrillation.
We know that, you know, bleeding is the number one reason why, you know, physicians tend to either underdose or they don't dose. It's also the number one reason why Eliquis dominates in this space over Xarelto, is why, you know, it's because of the, you know, literally millions of real-world data patients that we have in looking at improvement in bleeding profile. We're excited to see these data read out and, you know, we believe that this could be a new standard of care in atrial fibrillation and really become, you know, the stroke drug if we have approvals for both SSP and for AFib.
Okay, great. I should tell the audience, we do have a cardiovascular panel this afternoon, half of which will be devoted to clotting, so hopefully you can participate in that as well. I assume you're having some early conversations, or maybe not, but early conversations with payers on Milvexian. What are they setting the bar to be relative to whether they would embrace it as a new therapy?
Oh, it's a great question. We have had a number of discussions with payers sharing our target product profile compared to what we see with Eliquis. Although they haven't given us, you know, a specific threshold of what they wanna see, they also recognize the value of a product that has comparable efficacy to Eliquis with a lower bleeding profile. They recognize the economic benefits, the significant, you know, cost savings that come with a lower bleeding profile, so don't lead to hospitalizations, increasing morbidity, and it's really the payers and employers that have to bear the brunt of those significant, you know, bleeding events.
you know, they are looking forward to seeing a product that potentially can have a better bleeding profile than ELIQUIS, and we'll continue to have these discussions along the way to ensure that patients can gain access to this important product.
Well-
What is that target product bleeding profile compared to that then? Superior. Obviously, to get on the market, you know, we have to have a superior bleeding profile compared to a standard of care ELIQUIS. You know, we have put together our design paper, you've seen that, and so, you know, we do expect to see improvement in major bleeds versus standard of care ELIQUIS. That's the way we get on the market, and then, you know, we would expect to see a, an event rate, an efficacy rate that is comparable to that of ELIQUIS.
Let's go on to another topic, digging a little bit deeper into drug products that are on the come, but also on some of the products we just talked about. How would you rank the following Bristol readouts in 2026 and 2027 by peak revenue potential? Admilprant, Cobenfy, Iberidone, Ibertamide.
Zongolimab.
Zongolimab, and Milvexin. How would you rank them into their peak potential revenue-wise?
Well, I'm glad you mentioned, you know, five of the products, and because all five, you know, will read out by the end of this year. All five have, you know, very strong, commercial potential. When you look at the, you know, the five assets, you can just see the diversification of those assets from immunology to CV to hematology, and to cardiovascular disease. I'll touch briefly on, you know, on each of the assets, and, you know, we can go as deep as you want, Steve, on them. You know, when I think about, Opdivo Qvantig and ADP, you know, this is obviously a significant opportunity for the brand. I mentioned we've got four studies here.
There's nothing approved in ADP. We think that the profile of Cobenfy can really transform an area that has seen nothing approved, just use of off-label antipsychotics. We just talked about the opportunity with milvexian, particularly in atrial fibrillation, the ability to, you know, to beat ELIQUIS, you know, which is a product that continues to grow steadily after over a decade on the market. That is another significant commercial opportunity for the company, as well as for our partners in J&J. We're looking forward to that data readout. Iber and Mezi, which is our two cell mods, we've got a lot of momentum coming out of ASH, and that's Iber, Mezi, and golcadomide. You also know that, you know, we received recently our PDUFA date in a priority review from the FDA for iberdomide.
Our PDUFA is now mid-August based on an MRD endpoint, so we'd also expect to see Iber and Mezi partnering with CD38 as well as with Kyprolis in earlier lines of multiple myeloma, also providing a very good commercial opportunities over time. Finally, I think one of the sleeper assets that we don't talk enough about is Admilprant. Admilprant is will be indicated for both IPF and PPF. These are fatal lung diseases, and, you know, when you look at the market today, it's about a $4 billion market. We think the market can grow significantly over time. A product like Admilprant, you know, would not come with some of the baggage that we see with the products today.
High rates of diarrhea, some other products that are coming to market that have high rates of cough or dyspnea, difficulty with, you know, inhalation type of mechanism. LPA1 or Admilprant is an oral agent that has a, you know, potential opportunity to halt the progression of the disease while having minimal adverse events. All of these are exciting opportunities, and we look forward to sharing the readouts at the end of this year, and they will all contribute to the growth at the end of the decade of this company. Our focus is really driving long-term sustainable growth.
We couldn't agree more. The IPF and PPF market does look very large. Could it be over $10 billion?
The way that we see it is it could at least double. you know, today it's a $4 billion market. We think it could be, you know, between $8 billion and $10 billion. How that would happen, when you look at the diagnosis rates and treatment rates in IPF and PPF, particularly in PPF, they're incredibly low. In PPF, the treatment rate's only 30% today. We would expect to see with newer agents coming to the market, increases in both that, both diagnosis and treatment rates. With a product like admilprant, with an improved safety profile, you could see longer duration of treatment as it halts the progression of disease.
We'll also see, you know, coming likely, you know, with the approval of Admilprant, but also when I think about the next several years, you know, into 2035, the potential of combinations in this space, all of which will serve to grow the category. What could be a, you know, what is a relatively modest category today, we think could be a big category by the middle of the, you know, the 2030s.
A competitor, in the LPA1 space, had a failed trial. How is Admilprant different, and how will it not suffer that same fate?
Yeah. You know, we know that Amgen had a failure, you know, in their LPA1 program. Now, reminder, you know, Admilprant has a different mechanism of action. LPA1 is an asset that targets three specific pathways in the treatment of IPF and PPF. Amgen had what was called an LPAR1, which is different mechanistically. I think the second area that gives us confidence in our program is we had a very large phase II program, about 400 patients in this program for IPF and PPF. We saw significant improvement in FVC, which is the primary endpoint of both our IPF and PPF studies, both strong efficacy as well as a, you know, very good tolerability and safety profile.
You know, taken together, we feel like those are really good reasons to believe in the enthusiasm that we have in this asset.
Maybe we can move to Opdivo and in its LOE. The reason why I'm mentioning this is other companies with very large LOEs as well, including in the PD-1 space, have been more vocal with investors about their ability to push out the LOE and gain additional time on the market, and we're talking at least 1 year or much more. Why is Bristol not engaging in this conversation as well? I know you're a conservative company and so forth, but is there anything different about the IP estate at Bristol, say, versus your competitors who are being more vocal?
Here's what I'd say, Steve. Number one, as you just rightly pointed out, like, it's not our style to go out and talk about things that, you know, and potentially get over our skis in some areas, that we are closely monitoring the case laws as it relates to, you know, patent exclusivity. What I will say is this: we will continuously to vigorously defend our IP, whether it's for Opdivo or any other product. We've been successful already in staving off biosimilars that are trying to come to market with Opdivo, we do give 2028, December 2028 as our LOE as a conservative planning date. That's what's in our long-range financial plan.
I believe that's what's modeled in your long-range financial plan and should be the case, and we'll continue to update you as we look to the future. We do have subsequent patents for Opdivo that bring us out into the 2030s, but we are modeling, you know, December 2028 as the loss of exclusivity for Opdivo. We also have, of course, we talked about Opdivo Qvantig, which could extend the franchise into the 2030s, and what's really exciting is that by the time that we start to see the, you know, biosimilars coming into the market in the, let's say, the early 2029 period, we could also start to see some of our pemetrexed data come. With pemetrexed, this gives us a potential opportunity to not just grow, but expand the opportunity we have with IO, with our BioNTech partners.
We have multiple options around, you know, maintaining and growing our IO franchise into the future.
Let's drill on to pemetrexed. Why is the Bristol strategy in developing this asset better than that of competitors?
Look, I'm not sure if it's better than competitors. I mean, number 1, you know, we're very pleased with our partnership with BioNTech. They were very careful in selecting a PD-L1 VEGF, note the mechanism difference. That has not played out, as you know, in the first-gen PD-1, PD-L1s, when you look at adding a VEGF, we do think there's some mechanistic plausibility to an advantage that a PD-L1 VEGF could give. Number 2 is, you know, we've got a lot of experience in this space now, you know, almost two decades starting with, you know, the launch of YERVOY, then to Opdivo, to LAG-3. You know, we've got experience from a scientific standpoint as well as, you know, strength commercially here.
We have eight phase III studies that we have already announced that either started or enrolling or will be initiating. Then with our BioNTech partner, we are excited because, you know, we've structured the deal and both companies have exciting assets in our early pipeline. Looking at novel combinations with ADCs, combinations with targeted therapies. You'll start to see more of that in the phase I stage as we look to accelerate. Our goal is to be first or second in every tumor that we're going to compete in, save for, you know, lung, where we know Summit has a clear lead there. We feel very good about the partnership we have and the speed at which we're moving forward.
Sticking with the pipeline, but overall, not just in combination, with ipilimumab, but what phase I or phase II assets across the Bristol Myers Squibb R&D portfolio are you most keen to get your hands on to commercialize?
Well, as a commercial leader, you know, there's nothing better than launching. As I said, we've got, you know, the opportunity to launch at least, you know, up to 10 new medicines and 30 new lifecycle management indications, you know, by 2030. That's really this, you know, the wave of assets that are in phase III or moving into rapidly into phase III today. The next wave we just talked about pumilimab, you know, in phase III, but also, you know, we'll start to move faster with phase I novel combinations. I think anti-tau is another area. I think when you look into the 2030s, perhaps the neuroscience field could be the next oncology vestige where there's a huge unmet need there in Alzheimer's disease in particular.
our anti-tau, which is in phase II today, you know, we've got a number of really promising assets in neuroscience, but also specifically in Alzheimer's disease, products with brain shuttle technologies, new mechanisms, combinations that we're really excited to bring forward. In the oncology space, very excited to launch a product like PRMT5. Now we have two studies in phase III. As you know, MTAP deletions are prevalent in about 10%-15% of most cancer types. Many of those studies are already in phase I, and they'll be moving into phase III after proof of concept in monotherapy and in combination. I would also say Orbusil. We just announced a study that was done in China in triple-negative breast cancer.
In triple-negative breast cancer, izalontamab brengitecan, which is our HER3-EGFR ADC that we partner with SystImmune in, showed both an overall survival and a PFS benefit in monotherapy. Just think about what that could mean in combination in areas like lung cancer, EGFR-mutant lung cancer or triple-negative breast cancer and a host of other different cancer types. These are just a few examples of assets that we're really excited, and we've got a significant number of assets that are in phase I today or moving into phase I. Orbital being another example where we're possibly looking at curing patients or at least having durable remissions in some of the toughest to treat autoimmune diseases. We've got a real significant number of assets that are coming behind these phase III data readouts.
We try to end all our panels by asking, what do you think the biggest surprise or change will be at Bristol Myers Squibb in the next decade?
Yeah, I love that question, Steve. Thanks for asking. Well, I think the number one surprise for Bristol is not a surprise to the Bristol management team, but I think it's gonna be a surprise to, you know, many of the analysts out there around how, you know, you're modeling growth for the company at the end of the decade. When Chris became CEO in 2023, he set out a clear vision for this company, and that is to be the fastest-growing company at the end of the decade. We wanna see top-tier, long-term sustainable growth.
When you look at the number of assets that we have, we talked about so many of them this morning, whether it's from, you know, Cobenfy to Milvexin, to Admilprant, to Arloscel, which is our GPRC5D, to our cell mod platforms, to products that are, you know, are moving very rapidly into phase III. to our radiopharmaceutical platform. All of these substrate are gonna provide significant growth. I'm looking forward to sitting here, Steve, one year from now.
Mm-hmm.
You'll just see, you know, a good piece of the readouts that we have as a company. We feel really good at Bristol Myers Squibb about, you know, where we will be as a company and the growth trajectory we'll have, you know, from 2029 to, you know, the end of the decade and driving long-term sustainable growth and what that means to the company, to our shareholders, and importantly to patients.
Yep. I have to say it's an impressive amount of momentum in the product story. Sadly with that, we do need to conclude. We are out of time. Adam, thank you so much for making the time to be with us.