Bristol-Myers Squibb Company ($BMY)

All right, everybody. We're going to get going here with our next company presenter at the BofA 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. So Adam, thanks for joining us.

Thanks for having me, Jason.

Yes. So great. Look, there's a lot to talk about. I think Bristol is 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 some products that are early in their launch process. So I think we have a lot to talk about. Maybe coming out of 1Q and as you kind of think about 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.

Yes. So we've got very good momentum in our growth portfolio. As you saw in Q1, we delivered 12% growth year-over-year in the growth portfolio. And 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. And then some of our newer launches, OPDIVO Qvantig, we're seeing really strong conversion rates from the IV formulation. And of course, COBENFY. COBENFY is delivering steady growth, and we've got a number of catalysts to look forward to over the next 12 to 24 months, including things like Alzheimer's disease psychosis readout, bipolar readout, Alzheimer's agitation. So 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, giving us really nice cash flow, with our Pfizer counterparts. We expect to see double-digit growth this year for ELIQUIS. And that's offsetting, in our legacy portfolio, products like REVLIMID and POMALYST, which has now full generic entry. So our growth portfolio coupled with truly an unprecedented number of data readouts, we have the potential to launch 10 new medicines in 30 meaningful life cycle management indications by 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've got about 25,000 patients, I think, treated today, with additional diagnosis as a driver of this market. It's kind of the key toggle in the market model. So how should we think about the pace of diagnosis expansion and the ability of these centers of excellence to scale capacity from here?

Yes. So again, as I said, we're delivering really good performance with CAMZYOS, strong execution from the commercialization teams. And I think we're seeing a couple of things happening. Number one, steady growth of new patients, as well as long persistency, long durations of treatment. Our focus is twofold for CAMZYOS. Number one, there's still, Jason, about 100,000 patients today that are diagnosed with oHCM. So that's our first business opportunity, to source as many of those patients. But this is a market that we've also created, now 4 years down the road. And so 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. And 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. And what we've been able to see, they have now screened over 3 million Echos. And 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. And then 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 there really isn't any meaningful differences between the 2 products. You're right, it's still early. But 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. So they're leveraging that Q4 week dosing for the competition as well. We think this is really significant for CAMZYOS because patients -- most of the patients are on either 5 or 10 milligrams. And so patients are going to feel better almost immediately, versus what we've seen with the competition, you really need to titrate that up to the highest 2 doses. So again, it's early, but we remain steadfast that we're going to continue to lead in this market in the near term and into the future.

Okay. And then just quickly on the ACACIA results. How attractive do you see the non-obstructive HCM space now and your ability to play catch-up there? Because I know there's an expressed interest to revisit another trial there.

We announced on our earnings call that we were starting a new non-obstructive HCM Phase III study, based on the learnings from the ODYSSEY study that we had. We obviously need to see the full data results from ACACIA. But I think largely, it confirms what we saw in ODYSSEY, that numerically, with the data that has been put out there, the data looks very similar in KCCQ and pVO2. Now in fairness, they hit stat sig; we did not. But I think there are a lot of learnings that we were able to apply from ODYSSEY. We'll need to see their data set. But 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%. But our focus really is trying to source those 100,000 patients, which gives us growth way well into the foreseeable future for CAMZYOS.

Yes. Okay. Maybe shifting to Qvantig, and you've got roughly about 10% conversion. And I think if you continue on this pace, you'd be at that 30% to 40% target at the time frame that you've talked about. So what my question is, is just the key factors that could determine whether there's an acceleration to that conversion profile?

Yes. The team is also -- they're executing really well with Qvantig. As you said, we're now north of 10% conversion rates. We're tracking against our objective, which is that 30% to 40% peak conversion share over the next 2 years. We're seeing use for Qvantig across a multitude of tumor types, seeing it in monotherapy, in our adjuvant settings, but also in combination such as in RCC, GI, melanoma. Here's what we would expect. I would expect a very similar pace of uptake over the next year or so. And then we get the results of CheckMate 1533. CheckMate 1533 is a study that's looking at the 9LA regimen, which is our metastatic first-line lung regimen, using the subcu 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 be added into NCCN guidelines, into the label sometime in 2028. And that will serve I think as that next catalyst of growth for the product. So I do see an opportunity to further accelerate the Qvantig performance.

In lung?

In lung, and continuing the pace across the rest of our indications.

I guess, how are you thinking about the plenary at ASCO with the bispec and the potential impact of a shift away to maybe a PD-1 monotherapy backbone and how that impacts these subcuts in the lung setting?

Yes. So first, let me just say, we are really excited about the ASCO coming up. We've got some 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. And then, of course, the results of our Phase III study with mezigdomide, which is our second CELMoD that will come to market. I think the timing really lines up perfectly, because by the time that biosimilars start to come to market, we'll start to see data readouts for pumitamig in the '28, '29 time frame. And so 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 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 subcut combinations, IRA, are you expecting anything this year, visibility in whether or not the subcuts rolled into the treatment of IV PD-1?

Well, what you saw is for IV that the MFP effectuation was pushed 1 year into 2029. We have not received any new information around subcu. We had expected that last year. That was deferred. We're continuing to monitor that. We are strongly opposed to having subcu included into the IRA negotiations in the same time of IV. This is a very novel mechanism that's very different. We're using the Halozyme technology, as you know. And so we've been working with policymakers to reinforce how this technology is truly differentiated from the IV.

Yes. Well, let's shift to the pipeline because that's a huge area of focus for investors, and milvexian. You have a lot of know-how in this space given ELIQUIS. And so one argument that you may hear from physicians was, hey, warfarin was just a rough drug to use, had a lot of burden on the system, right, so that was 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, particularly payers where there would be a clinical and a pharmaco-economic benefit, and prescribers, because prescribers tell us they want a drug that they can be confident that they can use across a very broad patient population with minimal bleeding. We talk a lot about, and you've heard us, Jason, talk about that 40% of patients who are either untreated, under-treated or discontinued treatment. I would also say that 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 warfarin?" Because at that time, a few years post the launch of ELIQUIS, warfarin still had a 30% or 40% market share. We were talking about Coumadin clinics and it takes time. We're getting fast-forward now over 14 years, and ELIQUIS is not just the leading NOAC, but also has about a 75% share. So it's going to take -- continue to take time, but we feel very confident about the profile that milvexian will bring to patients, payers and prescribers, and the fact that this could become a true standard of care.

Okay. So when I think about data that you may be able to get and market for around milvexian, if you're able to show a neutral impact on stroke, right, that's table stakes. And then it seems like perhaps the sliding scale is the degree of superiority that you show on bleeding. And that absolute delta is bigger, and thus, like the NNT is competitive, 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 because of bleeding risk or suboptimally dose, which I think you defined as 40% of the api or is that 40% of ELIQUIS population?

No, it's 40% roughly of the 10 million patients in the U.S. that are diagnosed every year. The way we think about it is how you actually think of it, that's our base case, which is delivering a stat sig improvement in bleeding. And that could be significant in terms of the percent that we believe that milvexian can show a bleeding improvement over that of ELIQUIS. We know very -- 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 study, in clinical trials, in real-world data. And so we do believe that this is going to be a significant benefit in bleeds over standard of care ELIQUIS. The question then becomes, what is the efficacy difference in events, in stroke? And I think that's really -- what we are anticipating is to see a comparable effect to ELIQUIS. And with that profile, we think that's the very significant opportunity that we believe we have in the market. If that didn't manifest, for example, if you saw a slightly higher hazard ratio in efficacy, then we would need to look at populations that have, for example, higher risk of bleeds, such as the elderly patients, frail patients, patients with renal disorder, PAD and/or CAD, which is still a very significant population. But as I said, that's not our base case. Our base case is a hazard ratio that is close to 1 and a stat sig efficacy profile.

So I think what you're describing though, just so I'm understanding correctly, like the point estimate is 1.2, and doctors are starting to kind of say to themselves, "Hey, what are my trade-offs on stroke?" But it's still approvable because 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 higher-risk subgroups, depending on how the forest plot looks.

That's right. And I think, look, we're not expecting a 1.2 hazard ratio.

It's hypothetical, but, yes.

So I don't think it probably makes sense to hypothesize, but certainly, as I said, if that was the case, we'd have to look at subpopulations looking within the study. But our base case and how we've continued to model ELIQUIS versus milvexian in a blinded fashion gives us a lot of confidence that the profile will read the way that we've articulated, which is comparable efficacy and superior bleed profile.

Yes. I mean one question that's 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-OF (sic) [ OCEANIC-AF ], what the annualized bleed rate is. And so you have a massive trial, right, so 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 number needed to treat as a factor in uptake. I really think if you have a stat sig benefit, it's going to be incredibly compelling, particularly to payers where they know that bleeds are a leading cost for payers, they're a leading cost for employers. I also believe that a product like milvexian is going to show significant pharmaco-economic benefits. And we talk a lot about major bleeds, but these -- NOACs also come with nonmajor bleeds as well, which are challenging for patients, as you can imagine. So that's why you do see such a significant need out there, because patients are discontinuing their treatment prematurely when they see a nonmajor bleed. And that's the -- I think the significant unmet need out there is a product that has the same, if not slightly better, efficacy than ELIQUIS, with a superior bleeding profile.

Yes. Okay. And then a quick question on SSP. I don't see why you'd have a different outcome than Bayer. I think Christian has said that the baseline demographics of your study are very similar to the OCEANIC SSP trial. So that's all encouraging. So your just thoughts around this opportunity now as you've gotten to see the data and better understand what that could mean from a commercial opportunity. I think in the past, I think 8 to 10x larger than SSP. Does that ratio still hold in your mind? And anything else you want to add just on the SSP opportunity?

Well, number one, I think there's a clear advantage to having both indications, becoming the stroke prevention drug, having secondary stroke prevention and AFib as an indication. As I said, there are about 10 million diagnosed patients in the U.S. So 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, a large Phase II study, looks very similar to the Bayer study. We had roughly a 30% relative risk reduction in events, very low bleeding. So we would expect to see a comparable profile to what Bayer has shown just based on our own data. It gives us obviously increased confidence in the data set, as Bayer has presented their Phase III. But we feel good about both opportunities that we have in front of us. And 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.

Yes. Okay. Maybe we'll move to admilparant in 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. So I guess the one encouraging thing is that BI had an oral follow-on, and it's been around for about 5 months, started already annualizing at $1.5 billion. I don't know if you view that as, "Wow, this is like they're going to have a first mover advantage on us, that's going to be hard to displace them." Or do you just look at that as like this market was truly under-treated because people couldn't tolerate antifibrotics and there's just a lot of opportunity out there?

Yes. This is an exciting and, I think, an opportunity that's probably underestimated externally, but it's one where we've got a lot of enthusiasm about based on the Phase II data that we've seen. Another Phase III study in IPF we'll see the results this year, and then PPF early next year. But I think what we have seen now with the launch of Jascayd just confirms 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 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. And what is happening and what our thought leaders have said is that 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. So we feel really good about 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 from now until approval. But 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 bispecs and CAR-Ts will be sequenced. Maybe it's a little bit difficult to have a full view until some of the readouts like SUCCESSOR-2 come out, right, and you have a better sense head-to-head how agents like pom, or I should say, mezi compare to pom more directly. But paint the picture. Because I do hear the feedback that these drugs would generally probably resonate well with community oncologists because of the ease-of-use profile.

Yes. So we're very much looking forward to our PDUFA date for iberdomide, which is August 17 of this year based on the MRD endpoint. And then as I mentioned earlier, we will present the results of mezigdomide, our Phase III study, at ASCO, which again you'll see kind of how -- what a significant opportunity mezi and iber are, particularly in the community. I mean that's where 70% to 80% of patients are treated. That's where we believe that initially, we will have a stronghold. And there is an unmet need in the market for a product that has increased potency versus Rev and pom, manageable toxicity, an oral drug. All those fit really nicely within the workflow of the community oncologists versus what you see with potentially combinations of TCEs. And it's why CAR-Ts can't be used outside of these centers of excellence. So when I think about the opportunities that we have at hand, number one, we know that when you look at MRD for CELMoDs, they are significantly better than what we see for IMiDs. These products sound like they were engineered to be more potent than Rev and pom, and we're confident in that. We'll also have 2 studies that will demonstrate head-to-head. One is going to be in an earlier line of treatment. So we have a head-to-head iber versus Rev study in first line, newly diagnosed patients. And then we'll have SUCCESSOR-1 readout, where you'll be able to see how mezi combination compares to that with the pomalidomide combination. But taken together, this is a market we know well. We're very excited to bring these products to patients and to prescribers. And our goal is, over time, to be able to replace Rev and pom in the second-line setting.

Okay. So maybe shifting gears to just oncology and the BD strategy. As we think about the initial wave of trials to replace your PDX or OPDIVO, the coming wave of trials are going to be built on novel-novel combinations, right? So iza-bren's one logical partner there. But thinking about other kind of novel agents, does that imply that Bristol is going to be active on the BD front here to effectuate the strategy?

Yes. So I think we feel very good about our rich and deep oncology pipeline. This is an area that we've been leaders for quite some time. And we talked about some of the really exciting data that's coming at ASCO. As far as novel-novel, we do believe that's going to be the case, that novel-novel combinations are going to replace what's largely used today is chemo combinations. So yes, we've built very deliberately our pipeline to include certain platforms. So we think we have a truly differentiated ADC with iza-bren, the first HER3 EGFR ADC. Remember, we also have, through our RayzeBio acquisition, a platform in radiopharmaceuticals. We are leaders today in cell therapy. We continue to add to that important modality. We have targeted therapies, which we haven't talked much about, like PRMT5, which is in around 10% to 15% of all tumor types. These are in MTAP deletions. Many of these are going to be used in combinations as novel-novel. And we have a host of other products in our pipeline that we're working to rapidly bring forward. But 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 I think a pretty interesting and innovative approach with Hengrui, which is a Chinese biopharmaceutical company, for kind of a landmark deal with 13 assets, 4 of which we get access to that are all oncology focused. And these are potentially 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. And we feel good about how we're positioning ourselves with oncology and to remain leaders in this space in the future. Pumitamig, of course, being the anchor asset there because there's so much room for continued growth in immuno-oncology. This is an area that we know so well, we go back almost 2 decades there.

Okay. So about 3 minutes left, so maybe we'll just jump to COBENFY. And as we think about sort of the early launch dynamics in schizophrenia and the entrenchment of the D2s, I guess what I wonder is, 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?

So COBENFY is delivering steady growth. You saw that in Q1. And what we have seen and expect for COBENFY is to continue to deliver that similar cadence of growth in schizophrenia. And the inflections, what we have seen through analogs, come from new indications. And right now, we are ahead of all recently launched D2s in schizophrenia. There remains a very attractive opportunity to grow our schizophrenia business into the future. But it's those data readouts that are coming in bipolar, in ADP, in Alzheimer's disease, cognition, agitation, autism, that is going to accelerate the pace of growth for this product. And we feel confident that this is going to continue to be a multibillion-dollar asset over time. But 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?

I think there are some parallels that we need to make sure we take those learnings from schizophrenia, and we will apply them into future launches. Number one 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, safety becomes of utmost importance. And many of these patients, as you said, Jason, they are in nursing homes. So side effects and adverse events like 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 challenges. Now we will have to make sure that physicians are confident in how to use the product, how to titrate the product. The TID dosing started with the Karuna development program. And so that's why we have ADEPT-5, which is a program that's designed to move TID dosing into BID dosing, because we do understand that although most of these patients are treated in a long-term care facility, TID dosing is not ideal. So we want to make sure that they do have the opportunity for BID. And then we're going to 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.

So a 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. So 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 is focused on.

Yes. So David has said this well, I mean, we are in a very good position in terms of having the capital to do the types of deals that we want to do. Now we're going to be selective in those deals, making sure that the deals fit nicely into our therapeutic areas. We believe we are the best owners, the rightful owners, we have the ability to win, that these assets are differentiated. But BD remains a top priority. So we're focused on 2 key areas. Number one is using capital allocation for business development, continuing to add to the profile, not in this part of the decade, but continuing in the next part of the decade so that we continue to see that long-term sustainable growth. The other area we're focused on is paying out the dividend and making sure that we're continuing to return money to shareholders. And we've paid dividend, I think 93 years now, David would be better, 94 years potentially. And I think that's the area that we're going to continue to do, is balance between smart business development, looking at opportunities that fit really well within our profile, our therapeutic area footprint, and then returning money to the shareholders.

All right. Great. We're out of time. So thank you so much for joining us.

Thanks so much.

All right.