All right, everybody. We're going to get going here with our next company presenter at the Bank of America Annual Healthcare Conference. My name is Jason Gerberry. I cover pharma and biotech, and I'm pleased to be introducing our next company presenter, Bristol Myers Squibb, and Adam Lenkowsky, Executive VP and Chief Commercial Officer. Adam, thanks for joining us.
Thanks for having me, Jason.
Yeah, great. Look, there's a lot to talk about. I think Bristol's at an important inflection point as a company. You're rolling through some older franchises, but you've got a lot of pipeline on the come and, you know, some products that are early in their launch process. I think we have a lot to talk about. Maybe coming out of, you know, 1Q, and as you kind of think about, you know, the growth portfolio specifically, maybe just talk about some of the puts and takes with that versus the legacy portfolio and how things are coming along just in the base business.
Yeah, thanks for the question. We've got very good momentum in our growth portfolio. As you saw in Q1, you know, we delivered 12% growth year-over-year in the growth portfolio. As you said, it's a very young and diversified portfolio. Products like CAMZYOS and BREYANZI delivered strong growth, annualizing both at well over $1 billion. REBLOZYL is annualizing now north of $2 billion. You know, some of our newer launches, Opdivo-Qvantig, you know, we're seeing really strong conversion rates from the IV formulation. Of course, Cobenfy. Cobenfy is delivering steady growth, and we've got a number of catalysts to look forward to over the next 12-24 months, including things like, you know, Alzheimer's disease psychosis readout, bipolar readout, Alzheimer's agitation.
You know, taken together, we feel very good about this portfolio, which will drive strong growth through the end of the decade. We're also seeing continued growth for Eliquis, you know, giving us really nice cash flow with our Pfizer counterparts. We expect to see double-digit growth this year for Eliquis. That's offsetting our legacy portfolio products like Revlimid and Pomalyst, which has now full generic entry. Our growth portfolio coupled with truly an unprecedented number of data readouts, we have the potential to launch 10 new medicines and 30 meaningful lifecycle management indications by the end of the, you know, the end of this decade by 2030. We feel really well-positioned to be one of the fastest-growing companies exiting 2030.
Okay, great. Let's start with CAMZYOS then. I think you've highlighted that you got about 25,000 patients, I think, treated today, with additional diagnosis as a driver of this market. It's kind of a key toggle in the market model. How should we think about the pace of diagnosis expansion and like, the ability of these Centers of Excellence to scale capacity from here?
Again, as I said, we're delivering really good performance with Camzyos. Strong execution from the commercialization teams. I think we're seeing, you know, a couple of things happening. Number 1, steady growth of new patients as well as long persistency, long durations of treatment. Our focus is twofold for Camzyos. Number 1, there's still Jason about 100,000 patients today that are diagnosed with OHCM. That's our, you know, first business opportunity to source as many of those patients. This is a market that we've also created, you know, now 4 years down the road. What we see every single week, which is remarkable for a product that's 4 years on the market, is new prescribers largely in the community. That's another proof point around growing diagnosis rates. We also have partnered with a company called Viz.ai.
It's an AI-based company that they are in about 120 of these Centers of Excellence. What we've been able to see, they have now screened over 3 million echoes. With that, they've been able to increase the diagnosis rates, and we expect that to continue. That coupled with new competition in the market, we believe this is a really good opportunity to continue to grow the market while sourcing the diagnosed patients that are out there today.
Okay. With respect to new competition, you mentioned there, any observations, early changes in the market, if any, that you're seeing? Or is it just too early to say how that competitive dynamic plays out in the area you have indication overlap?
Well, we've been planning for competition for quite some time. We continue to hear from physicians that, you know, there really isn't any meaningful differences between the 2 products. You're right, it's still early. What we see is from the COEs that they've prescribed maybe 1 or 2 patients. What we hear back from our physicians is that they're utilizing the CAMZYOS workflow. The fact that CAMZYOS has been out, it's very predictable dosing, Q4 weeks. They're leveraging that Q4 week dosing for the competition as well. We think this is really significant for CAMZYOS because most of the patients are on either 5 or 10 milligrams, and so patients are gonna feel better almost immediately versus what we've seen with the competition. You really need to titrate that up to the highest 2 doses. Again, it's early, but we, you know, remain steadfast that we're going to continue to lead in this market and, you know, in the near term and in the future.
Okay. Then just quickly on the KRYSTAL-12 results. How attractive do you see the non-obstructive HCM space now and your ability to play catch up there? I know there's an expressed interest to revisit another trial there.
We announced on our earnings call that we're starting a new non-obstructive HCM, phase III study based on the learnings from the ODYSSEY study that we had. You know, we obviously need to see the full data results from Acacia, but I think largely it confirms what we saw in ODYSSEY. You know, numerically, the data that has been put out there, the data looks very similar in KCCQ and, you know, pVO2. Now in fairness, they hit stat sig, we did not. I think there are a lot of learnings that, you know, we were able to apply from ODYSSEY. We'll need to see their dataset. This is 30% of the market, and we want to make sure that we're competing in the entirety of the market, not just the 70%. Our focus really is trying to source those 100,000 patients, which gives us, you know, growth way well into the foreseeable future for TM bios.
Yeah. Okay. Maybe shifting to Opdivo-Qvantig, and you've got roughly about 10% conversion, and I think if you continue on this pace, you'd be at that 30%-40% target at the time frame that you've talked about. One of my question is, just the key factors that could determine whether there's an acceleration to that conversion profile.
Yeah. Teams also they're actually doing really well with OPDIVO. As you said, we're now, you know, north of 10% conversion rates. We're tracking against our objective, which is that 30%-40% peak conversion share over the next 2 years. You know, we're seeing use for OPDIVO across a multitude of tumor types, seeing it in monotherapy, in our adjuvant settings, but also in combination such as in RCC, GI, melanoma. This is what we would expect. I would expect a very similar pace of uptake over the next 1 year or so, and then we get the results of CheckMate-1533. CheckMate-1533 is a study that's looking at the CheckMate -9LA regimen, which is our metastatic first-line lung regimen using the SubQ formulation.
You may recall that's not in our label today, and that represents about 20% of the total IV business that we're unable to tap into right now. We'll get those results. They will likely, you know, be added into NCCN guidelines into the label, in sometime in 2028. That will serve, I think, as that next catalyst of growth for the product. I do see an opportunity to, you know, further accelerate the OPDIVO performance.
In lung.
In lung and continuing the pace across the rest of our, you know, indications.
How, I guess, how are you thinking about the plenary at ASCO with the bispec and the potential impact of, you know, shift away to maybe a PD-1 monotherapy backbone and how that impacts the subcuts in the lung setting?
Thanks for that question. First let me just say we are really excited about this ASCO coming up. We've got some, you know, important data on pumitamig in lung cancer. We've got really exciting and promising data for iza-bren in breast cancer, which is the product that we are partnering with SystImmune. Of course, the results of our phase III study with givastomig, which is our, you know, second CELMoD that will come to market. I think the timing, you know, really lines up perfectly because, you know, by the time that biosimilars start to come to market, you know, we'll start to see data readouts for pumitamig in, you know, the 2028, 2029 time frame.
You know, the vision really is to be able to get the product to market in lung, in breast, in gastric and a host of other tumors. As you know, we've got 7 phase III studies that we're actively, you know, recruiting for today, and that gives us the opportunity to not just maintain, but to grow our IO franchise into the future.
Okay, maybe just come back to oncology, but the treatment of these SubQ combinations, IRA, are you expecting anything this year, visibility in whether or not the SubQs will get rolled into the treatment of IV PD-1?
Well, what you saw is for IV that the, you know, MFP effectuation was pushed 1 year into 2029. We have not received any new information around sub Q. We had expected that last year. That was deferred. We're continuing to monitor that. You know, we are strongly opposed to having sub Q included into the IRA negotiations in the same time of IV. This is a very novel mechanism. It's very different. We're using the Halozyme technology, as you know. You know, we've been working with policymakers to reinforce how this technology is truly differentiated from the IV.
Yeah. Well, let's shift to pipeline because that's a huge area of focus for investors in Milvexian. You have a lot of know-how in this space given Eliquis. You know, one argument that you may hear from physicians was, hey, warfarin was a just a rough drug to use, had a lot of burden on the system, right? That was a maybe an easier drug for Eliquis to displace. As we think about scenarios, are there scenarios where Milvexian, data-wise, could replace Eliquis in full?
Well, clearly that's our belief. Our belief is that the study was designed to show a superiority benefit in bleeding, and we know that bleeding is the most significant unmet need out there, even with products like ELIQUIS, and a comparable efficacy profile. This is a meaningful opportunity for patients, you know, particularly payers, where there would be a clinical and a pharmacoeconomic benefit and prescribers. Prescribers tell us they want a drug that they can be confident that they can use across a very broad patient population, you know, with minimal bleeding. You've heard us, Jason, talk about that 40% of patients who are either untreated, undertreated or discontinued treatment.
I would also say that, you know, if you and I were sitting here, about 10 years ago, you would have asked me the question, "Well, why is there so much stickiness in, you know, in warfarin?" Because at the time, you know, a few years post the launch of ELIQUIS, warfarin still has, you know, a 30% or 40% market share.
Yeah.
We were talking about COUMADIN clinics. It takes time. We can fast-forward now over, you know, 14 years. ELIQUIS is not just the leading NOAC, but also has about a 75% share. It's gonna continue to take time, but we feel very confident about, you know, the profile that milvexian will bring to patients, payers and prescribers, and the fact that this could become, you know, a true standard of care.
Okay. When I think about data that you may be able to get and market around milvexian, if you're able to show a neutral impact on stroke, right? That's table stakes. It seems like perhaps the sliding scale is the degree of superiority that you show on bleeding. You know, if that absolute delta is bigger, in this, like the NNT is compared to the number needed to treat. Am I thinking about the right toggles that may scale the size of this commercial opportunity beyond just, I guess, the lower-hanging fruit, which is those who can't take ELIQUIS 'cause of bleeding risk or suboptimally dose, which I think you've defined as 40% of the epi, or is that 40% of ELIQUIS population?
No, it's the 40% roughly of the 10 million patients in the U.S.
Yeah.
-who are diagnosed every year. You know, the way we think about it is how you articulated that. As I said, that's our base case, which is delivering a stat sig improvement in bleeding. That could be significant in terms of the percent that we believe that milvexian can show a bleeding improvement over that of ELIQUIS. You know, we're very familiar in literally millions of patients through real-world data what the bleeding profile is. We've seen that data also in, you know, in clinical trials, in real-world data. You know, we do believe that this is gonna be a significant benefit in bleeds, you know, over a standard of care ELIQUIS. The question then becomes, you know, what is the efficacy difference in events, in stroke?
I think that's really, you know, what we are anticipating is to see a comparable effect to, you know, to ELIQUIS. With that profile, we think that's the, you know, very significant opportunity that, you know, we believe we have in the market.
Yeah.
If that didn't manifest, for example, you know, if you saw a slightly higher hazard ratio in efficacy, then we would need to look at populations that have, for example, you know, higher risk of bleeds, such as elderly patients, frail patients with renal disorder, PAD and/or CAD, which is still a very significant population. As I said, that's not our base case. Our base case is a hazard ratio that is, you know, close to 1 and a stat sig efficacy profile.
I think what you're describing, though, just so I understand it correctly, is like the point estimate is 1.2. You know, doctors are starting to kind of say to themselves, "Hey, what are my trade-offs on stroke?" Is it still approvable 'cause it falls within the technical criteria on non-inferiority, then docs look to the subgroups, and commercially then they may skew utilization to some of these high-risk subgroups, depending on how the force plot looks.
That's right. I think, look, we're not expecting, you know, a 1.2 hazard ratio.
It's hypothetical.
Right. You know, I don't think it probably makes sense to hypothesize, you know, certainly, as I said, if that was the case, we'd have to look at subpopulations looking within the study. Our base case and how we continue to model Eliquis versus milvexian in a blinded fashion gives us a lot of confidence that the profile will read the way that, you know, we've articulated, which is comparable efficacy and superior bleed profile.
I mean, one question that has come up in some of our recent doctor calls is that perhaps the annualized bleed rate of ELIQUIS has come down versus, say, 2010 when the pivotal trials were run then versus, say, OCEANIC-AF, what the annualized bleed rate is. You have a massive trial, right? Presumably it's powered to show some degree of superiority, but if that superiority is small, right, and it's a very large NNT, do you think that that matters commercially?
Doctors have not talked about, you know, number needed to treat as a factor in uptake. I really think if you have a stat sig benefit, it's gonna be incredibly compelling, particularly to payers, where they know that bleeds are a leading, you know, cost for, you know, for payers. They're a leading cost for employers. You know, I also believe that, you know, a product like milvexian is going to show significant pharmacoeconomic benefits. You know, we talk a lot about major bleeds, but these NOACs also come with, you know, with non-major bleeds as well, which are challenging for patients, as you can imagine. That's why you do see such a significant need out there, 'cause patients are discontinuing their treatment prematurely when they see a non-major bleed. That's the I think the significant unmet need out there is a product that has the same, if not probably better efficacy than Eliquis with a superior bleeding profile.
Yeah. Okay. A quick question on SSP. I don't see why you'd have a different outcome than Bayer. I think Cristian has said that the baseline demographics of your study are very similar to the OCEANIC-STROKE trial, so that's all encouraging. Your just thoughts around this opportunity now as you've gotten to see the data and better understand what that can mean from a commercial opportunity. I think in the past I think 8-10 times AF's 8-10 times larger than SSP. Is that ratio still hold in your mind? Anything else you wanna add just on the SSP opportunity?
Well, number 1, I think there's a clear advantage to having both indications, you know, becoming the stroke prevention drug, having secondary stroke prevention and AFib as an indication. You know, as I said, there are about 10 million diagnosed patients in the U.S., this is a much larger opportunity than that of secondary stroke prevention. That said, when I think about what we've seen from our own phase II data, large phase II study looks very similar to, you know, the Bayer study. We had roughly a 30% relative risk reduction in events, very low bleeding. We would expect to see a comparable profile to what, you know, Bayer has shown just based on our own data. It gives us obviously increased confidence in the dataset as, you know, Bayer has presented their phase III. We feel good about both opportunities that we have in front of us. The good news is we don't have to wait that long. We'll see data by the end of the year, and you'll see what the results bring.
Yep. Okay. We'll move to admilparant and IPF. Pulmonary is not a huge area of focus for Bristol currently, but I think there are a lot of clear commercial success stories in the IPF, and there's a lot of clinical attrition stories as well on the development side. I guess the one encouraging thing is that, you know, BI had an oral follow-on. It's been out for about 5 months, it's already annualizing at $1.5 billion. I don't know if you view that as, wow, this is like they're gonna have a first-mover advantage on us that's gonna be hard to displace them. Do you just look at that as like this market was truly undertreated because people couldn't tolerate antifibrotics and there's just a lot of opportunity out there?
Yeah, this is a, you know, an exciting and I think, an opportunity that's probably, you know, underestimated externally. It's one where we've got a lot of enthusiasm about, at least based on the phase II data that we've seen. Another phase III study in IPF will see the results this year and then PPF early next year. I think what we have seen now with the launch of Jakafi just confirms what, you know, we thought, what you were alluding to and, what we know is that this is a market that even if you have modest efficacy and tolerability improvement versus standard of care, which is what, you know, BI has shown, there really is a significant commercial opportunity. It's a $4 billion market today. We think this market can more than double at peak. What is happening and what our colleagues have said is that, you know, with the profile of admilparant, the first LPA1 antagonist into the market that will offer really robust efficacy with minimal GI toxicity, has the opportunity not just to be foundational and first line, but what you're seeing today happen now with the new entrant and what we expect to see with the versatility that admilparant offers the opportunity to be an add-on and/or a switch. That market didn't exist, which is another reason why we expect to see significant growth. We feel really good about, you know, where we are with both our IPF and PPF program. You are right, this is a new area, so there's a lot of work that needs to get done.
Yeah.
From now until approval. You know, we know the work that we need to do to get this product to market, and we expect this to be a significant player in IPF and PPF.
Okay. Maybe to CELMoDs quickly. The space is incredibly fluid, increasingly complex, that being the multiple myeloma space with recent data from TECVAYLI. I think there's open questions around how bispecifics and CAR T-cells will be sequenced. You know, where Maybe it's a little bit difficult to have a full view until some of the readouts like SUCCESSOR-2 come out, right? You have a better sense head-to-head how agents like POM or I should say Mezi compare to POM more directly. Paint the picture because I do, I do hear the feedback that these drugs would generally probably resonate well with community oncologists because of the ease of use profile.
We're very much looking forward to our PDUFA date for iberdomide, which is August 17th of this year based on the MRD endpoint. As I mentioned earlier, you know, we will present the results of mezigdomide, our phase III study at ASCO, which, you know, again, you'll see kind of how, you know, what a, what a significant opportunity Mezi and Iber are, particularly in the community. I mean, that's where 70%-80% of patients are treated. That's where we believe that initially, you know, we will have a stronghold. There is an unmet need in the market for a product that has, you know, increased potency versus REVLIMID and pom, manageable toxicity in oral drug. All those sit really nicely within the workflow of the community oncologist versus what you see with you know, potentially combinations of TCEs. It's why CAR Ts can't be used outside of these Centers of Excellence. When I think about, you know, what the opportunities that we have at hand, you know, number 1, you know, we know that when you look at MRD for CELMoDs, they are significantly better than what we see for IMiDs. These products, CELMoDs, they were engineered to be more potent than Rev and POM, and we're confident in that. We'll also have, you know, 2 studies that will demonstrate head-to-head. One is gonna be in an earlier line of treatment. We have a head-to-head Iber versus Rev study in first line, newly diagnosed patients.
We'll have SUCCESSOR-1 readout, where you'll be able to see, you know, how mezigdomide combination compares to that with a pomalidomide combination. Taken together, you know, this is a market we know well. We're very excited to bring these products to patients and to prescribers. Our goal is over time, to be able to replace REVLIMID and POM in the second-line setting.
Okay. Maybe shifting gears to just oncology and the BD strategy. As we think about the initial wave of trials to replace your PD-1 or OPDIVO, the coming wave of trials are gonna be built on novel combinations, right? iza-bren's one logical, you know, partner there. Thinking about other kinda novel agents, does that imply that Bristol is gonna be active on the BD front here to effectuate the strategy?
Yeah. I think, you know, we feel very good about, you know, a rich and deep oncology pipeline. This is an area that we've been, you know, leaders for quite some time, and we talked about some of the really exciting data that's coming at ASCO. As far as novel, you know, we do believe that's gonna be the case, that novel combinations are gonna replace, you know, what largely used today is, you know, chemo combinations. Yes, we built very deliberately our pipeline to include certain platforms. You know, we think we have a truly differentiated ADC with iza-bren, the first HER3 EGFR ADC. Remember, we also have through our RayzeBio acquisition, you know, a platform in radiopharmaceuticals. You know, we are leaders today in cell therapy.
We continue to add to that important modality. We, you know, have targeted therapies which we haven't talked much about, like PRMT5, which, you know, is in around 10%-15% of all tumor types. These are in MTAP deletions. Many of these are gonna be used in combinations as novel. We have a host of other products in our pipeline that we're working to rapidly bring forward. I think oncology is a really important space for business development because the science continues to move probably the fastest in this space. Just yesterday, we announced a pretty interesting and innovative approach with Hengrui, which is a Chinese biopharmaceutical company for a landmark deal with 13 assets, four of which we get access to that are all oncology-focused.
These are potentially, you know, first-in-class, best-in-class or TCEs, trispecifics, things that we know are going to be really important for kind of future forward combinations. You know, we feel good about how we're positioning ourselves with oncology and to remain leaders in the space in the future. Pliminabate, of course, being the anchor asset there because there's so much room for, you know, for continued growth in immuno-oncology. This is an area that we know so well. We go back almost 2 decades there.
About three minutes left, maybe we'll just jump to Cobenfy. You know, as we think about sort of the early launch dynamics in schizophrenia and the entrenchment of the D2S, I guess what I wonder is, you know, is there a market analog you can point to that, hey, with time and resources, there can be a later inflection point in the rollout in schizophrenia specifically?
Cobenfy is delivering, you know, steady growth. You saw that in Q1. What we have seen and expect for Cobenfy is to continue to deliver that growth, similar cadence of growth in schizophrenia. The inflections, what we have seen through analogs come from new indications. Right now we're ahead of all recently launched D2S in schizophrenia. There remains a very attractive opportunity to grow our schizophrenia business, you know, into the future. It's those data readouts that are coming, you know, in bipolar, in ADP, in Alzheimer's disease, cognition, agitation, autism, that it's going to accelerate the pace of growth for this product. We feel confident that this is going to continue to be a, you know, multi, you know, billion-dollar asset, you know, over time. We need to add new indications, and we look forward to data readouts coming over the next several months.
Are there any issues that you see in terms of the dosing profile in Alzheimer's? I know it's dosed 3 times a day. Or is the view that a lot of these patients are in long-term care facility nursing homes, and so obviously, the patient doesn't need to remember to dose 3 times a day. That would obviously be problematic if the patient had to do that. But I'm just curious if there's anything inherent in the product profile that we're seeing in maybe the schizophrenia adoption that plays into the ADP opportunity.
Yeah, I think there, you know, there are some parallels that we'll need to make sure we take those learnings from schizophrenia, and we will apply them into future launches. Number 1 is ensuring that we're building confidence in how to dose those patients, how to titrate patients to get the best the maximal benefit and minimize the side effects, particularly the GI side effects. When you're looking at an Alzheimer's patient population, you know, safety becomes of utmost importance. Many patients, as you said, Jason, they are in nursing homes. Side effects and adverse events like, you know, movement disorders, EPS, excessive sedation, these products, every D2 carries a box warning for elderly-related patients with dementia. We know that Cobenfy doesn't have any of those, you know, challenges.
We will have to make sure that physicians are confident in how to use the product, how to titrate the product. You know, the PID dosing started with the Karuna development program, that's why we have ADEPT-5, which is a program that's designed to move PID dosing into BID dosing because we do understand. Although most of these patients are treated in a long-term care facility, you know, PID dosing is not ideal. We wanna make sure that they do have the opportunity for BID.
We're gonna continue to look at data generation like we've just launched with our switch study, as well as our food effect study that helps physicians really be able to use the product in a more real-world setting, how to dose it, how to titrate it to manage any side effects and to maximize the efficacy of the product.
Quick question. I'll ask you to put your CFO hat on. There was commentary on the most recent earnings call just about that this pipeline-rich fourth quarter data flow won't impede the company's the ability to transact and do BD to augment the portfolio. Maybe just give us a little bit of flavor for appetite for BD, some of the parameters around that in terms of what the company's focused on.
Yeah. You know, David has said this well. I mean, we are in a, you know, a very, you know, good position in terms of having the capital to do the types of deals that we wanna do. Now, you know, we're gonna be selective in those deals, making sure that the deals fit nicely into our therapeutic areas. You know, we believe we are the, you know, the best owners, the rightful owners. We have the ability to win, that these, you know, assets are differentiated. BD remains a, you know, a top priority. You know, we're focused on two key areas.
Number 1 is, you know, using capital allocation for business development, continuing to add to the, you know, the profile, not in this part of the decade, but continuing in the next part of the decade so that, you know, we continue to see that long-term sustainable growth. The other area we're focused on is, you know, paying out the dividend and making sure that, you know, we're continuing to return money to shareholders and, you know, we've paid dividend, I think, 93 years now. David would be better, 94 years potentially. I think that's the area that we're gonna continue to do is balance between, you know, smart business development, looking at opportunities that, you know, fit really well within our profile, our therapeutic area footprint, and then returning our, you know, money to shareholders.
All right, great. We're out of time, so thank you so much for joining us.
Thanks so much.