Bristol-Myers Squibb Co Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Evan Seigerman - BMO Capital Markets - Analyst : Guys, thank you so much for taking the question, and congrats on the progress this quarter. So one for Adam, now that you have Cobenfy approved, can you walk us through what the next year looks like when it comes to access? I know there's a lot of puts and takes when it comes to Medicaid and commercial. But maybe give us some color as to how we should think about it. Thank you so much.

Question: Evan Seigerman - BMO Capital Markets - Analyst : (multiple speakers)

Question: Chris Shibutani - Goldman Sachs - Analyst : Great. Thank you very much. Certainly, you've been doing a lot to focus the operating expense profile here. And at the same time, you're seeing improving top line. Where are you in that trajectory in terms of what we should expect 2025? Any early commentary on the shape of 2025 top-line dynamics as a function of operating expense would be helpful. Thank you.

Question: Chris Schott - JPMorgan - Analyst : Great. Thanks. Just maybe a two-parter on Cobenfy. Thank you for all the details on the reimbursement piece. Once reimbursement is in place, can you just talk about how you're thinking about the ramp of the drug from there? I guess, historically, I think we've seen more gradual launches in schizophrenia, but these are largely assets with similar mechanisms to existing products. I'm just wondering in this case, are you anticipating this could be a faster ramp than we've historically seen, given the unmet need and your unique mechanism of action? And then just my second part on the same product is just, when you think about the additional line extensions here, what's your confidence in the bipolar I opportunity? It's obviously a very large market and [live] data you've seen in schizophrenia. Do you view that as a high probability of success study as you start to ramp that one? Thank you.

Question: Luisa Hector - Berenberg - Analyst : Hello. Thank you for taking my question. On Sotyktu, you mentioned the price impact in Q4. But could you add a little more color on the outlook for next year, and the access and pricing as we roll into next year? And then, perhaps, just a reminder of the profile that you're looking for in the psoriatic arthritis trial. Thank you.

Question: Geoff Meacham - Citi - Analyst : Morning, everyone. Thanks so much for the question. For Chris or Samit on the milvexian program, I know you guys did talk about the use of -- the potential to upsize the trial previously. But what would you say is the cause for the lower event rate? Does this change the risk profile? We know that GLP-1s have an impact, for example, in cardiometabolic trials. You think changes there commercially could have changed the event rate in your study? Thank you very much. Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer Thanks, Geoff. I'll start, and then I'll turn it over to Samit. Let me just say at the outset, Geoff, that we're encouraged by what we're seeing with this program. Just a reminder, we're developing milvexian because there remains high unmet need for patients in anti-coagulation. That's particularly true in atrial fibrillation, where as I think you know, this is an area where 40 million individuals worldwide have atrial fibrillation and that despite the success of Factor Xa like Eliquis, about 40% of those patients remain on or undertreated due to the risk of bleeding. And we believe milvexian has the potential to improve the outcome for these patients. The update that we provided today is really intended to give some context to the decision to increase the sample size given the encouraging blended event rates that we're seeing at this point in the study. This is a potentially important medicine. We want to do everything we can to ensure that the program continues to read out in 2027. But before I turn it over to Samit, I want to leave you with, we're encouraged by what we're seeing here. And we look forward to seeing this study come to its outcome in 2027. Samit? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Carter Gould - Barclays Capital Inc. - Analyst : Great. Thanks for taking the questions in solid print this morning. Maybe I don't mean to hammer on this again, but just wanted to follow up on the prior question for Samit there. With the increased patient enrollment, will there be any shift in the criteria or enrichment of patients away from the (technical difficulty) our proximal segments. I mean, I appreciate your commentary on what happened to your competitor (technical difficulty). But at the same conversation at ESC, there was talk about the challenges in those populations given especially what seems to be going on here at the event rate. Any color would be appreciated. Thank you. Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team Yeah. Thank you, Carter. There are no plans to change any of these criteria. We will continue to observe them, and the study will continue as is, except for the change in the sample size.

Question: Chun Chung - UBS - Analyst : Morning, guys. Thanks for taking my question. Just one on the recent PRMT5 data. We saw an ORR of 21% across a bunch of solid tumors. Can you, perhaps, talk about efficacy as regard to durability that you're seeing here with the product? And what tumor types are you going to be prioritizing? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Steve Scala - TD Cowen - Analyst : Thank you so much. I have two points, and there are really -- two questions. They're just really clarifications. But if 1 percentage point of Bristol revenue growth is about $500 million, and that's the amount that Bristol is increasing its guidance, that's roughly equivalent to what Revlimid beat by. So is the increase solely attributed to Revlimid? And then, secondly -- and I apologize for going back to asundexian -- but the AFib trial had a lower-than-expected event rate and failed. Why is a lower-than-expected event rate in the milvexian trial encouraging? It as easily could be a risk, I would think. I understand the DSMB point. So any clarity would be appreciated. Thank you.

Question: Courtney Breen - Bernstein - Analyst : Thank you so much for the question. Another question just on the Cobenfy launch. What I wanted to make sure we were able to understand is some of the practicalities around kind of a patient receiving a script and kind of the doctor choosing that patient to prescribe to. Can you share some of the context on the warnings and precautions in the label, particularly around liver, and how many patients you practically expect to be managed through these challenges? I do note that, obviously, there isn't the box label warning. But there are some warnings that require extra physician attention. And so can you just speak to some of those challenges?

Question: Seamus Fernandez - Guggenheim Securities, LLC - Analyst : Thanks very much for the question. So I wanted to just get a sense for your enthusiasm for the upcoming data at ACR for your CD19 asset and how you see the evolution of a potential market for intensive immunologic treatments like this, versus the potential for whether it be T-cell engagers or bispecific products with a similar type target profile, but perhaps less efficacy. And then just the second question is on the 2025 dynamics. Just hoping to get maybe a little bit of a better sense of the sort of pushes and pulls on IRA. I know you've said that you expect it to be largely neutral, but it does seem like there are opportunities to potentially increase volume in that context. And I just wanted to clarify whether or not any volume benefits are incorporated into your assumptions around that neutral assumption. Thanks.

Question: Matt Phipps - William Blair & Company, L.L.C. - Analyst : Good morning. Thanks for taking my question. I was wondering how you all view the market opportunity for the GPRC5D CAR-CT maybe relative to Abecma, given you've now moved the 5D program into a second-line Phase 2 trial. Do you think the profile is strong enough to really challenge

Question: David Risinger - Leerink Partners - Analyst : Yes. Thank you very much. So I'll just keep it to one high-level question, please. So Chris, I think you mentioned a few times on the call that you see Bristol-Myers as a sustainable growth company. Could you just provide some more context on that, your sustainable growth expectations in light of 2026 revenue pressures and the end of the diabetes royalty stream? Thanks very much. Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer Thanks for the question, David. Yeah. Look, as we have said consistently, our North Star, since I took over as CEO in November, has been that we execute in the short term and stay focused on building a company that will deliver long-term sustained growth and shareholder value, particularly as we work our way through the middle of the decade, exiting with a very strong growth profile towards the end of the decade. And as I think about the way that we continue to build confidence in that, I would say, I'd highlight three things. First, we have a young portfolio of growing assets. You've seen that in the quarterly results. And we're squarely focused on continuing to drive performance in this growth profile. We've got products like Cobenfy, which just launched very early in its life cycle. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Akash Tewari - Jefferies LLC - Analyst : Hey, thanks so much. Given that there's been reports of J&J shutting down their cardiometabolic division, is there any potential for your team to renegotiate your partnership with them around milvexian? And on subcu Opdivo, your team doesn't seem to be guiding for branded reps beyond the FDA regulatory protection which is a market contract to what Merck is communicating on subcu KEYTRUDA. Any color on why your team seems to be more conservative here? Thank you. Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer So do you mind repeating the second question?

Question: James Shin - Deutsche Bank - Analyst : Hi, guys. Thanks for taking our question. I just want to go back to milvexian real quick. I really appreciate the update on the stroke and embolism event rates. But was there any separation between the arms? And perhaps, even more importantly, do you have any color on bleed rates. Thank you.

Question: Olivia Brayer - Cantor Fitzgerald - Analyst : Hi, good morning. Thank you for the question. Can you guys talk through what you're looking to see in that adjunctive schizophrenia data set next year? And when you think about uptake in that setting, are you getting any early feedback around potential off-label use from potential early adopters? I mean, how big of a market do you think that could realistically be just given the focus on making monotherapy use a standard of care? Also, I just wanted to ask a quick clarification on milvexian timelines. I know it's still 2027, but should we assume that it's later in the year considering today's update? Thank you. Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer Thanks for the questions, Olivia. Maybe we'll ask Samit and Adam to get those questions between the three of them. Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team Yeah. Thank you. Remember, Olivia, how patients are treated today with the antipsychotics that are available. Without even having an approval in the label, patients are being treated with combinations of D2 agonist in this space. So it was important from our perspective to generate the data to showcase efficacy as well as the safety profile of combining muscarinic agonist with the background therapies that patients are on. And that's the intent of showing the -- from the ARISE program perspective, as an adjunctive therapy, what Cobenfy can deliver on top of the background therapies. That will be important, and that study will read out in 2025. On milvexian side, from a clarification perspective, the 2027 is an event-driven endpoint in the trial. So we can't give you a specific in terms of the timing within 2027. That's why we give you a general guidance for 2027 as before.

Question: Sean McCutcheon - Raymond James - Analyst : Hi, guys. Thanks for taking the question. One more on Cobenfy. Can you speak to your view on the import of the M1 component for Cobenfy as it relates to potentially driving cognitive improvements in schizophrenia in particular? What proportion of the population have cognitive deficits? Do you expect these patients to be kind of parsed out in the monotherapy setting or post atypical or in the adjunctive setting? And what are your comments to those that are looking at the BID regimen and GI adverse effects as potential barriers on ease of use in this patient population, where compliance or lack thereof is a significant variable when thinking about your competitors that are coming up behind you? Thanks. Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer Good morning, Sean. Samit will take the first part and then Adam. Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team Yeah. Thank you. Remember, the differentiating feature for Cobenfy is that it's a dual direct agonist as opposed to some of the other therapies in development that target the M4 to indirect ways because they are allosteric modulators, which require a ligand such as acetylcholine to be present in the brain. And M1 is a very important component because from a biological perspective, that is associated with cognition function in the brain. And so having a direct impact on M1 as well as M4 gives us that opportunity to really impact the cognition. And during the overall life cycle, as we think about the Alzheimer's disease patients as they go through it, cognition does become important in terms of the impact on the patient and patient life and quality of life. So there's a large proportion of patients who will have cognitive impairment and will be eligible if the data reads out positive to be treated with the drug. So overall, that's why we've developed a program in all three parts of AD that impact from a psychosis perspective, agitation perspective, as well as the cognition perspective. Adam? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Kripa Devarakonda - Truist Securities - Analyst : Hey, guys. Thank you so much for taking my question, and congrats on the quarter today. I'll switch gears and not ask a Cobenfy question. I want to ask a question about your HFpEF program. You've recently published data from a Phase 2 with mavacamten. Can you talk about how this translates to 224, which I think is the drug you've indicated as the HFpEF drug? And what percentage -- like, how big of a market do you see? And can you remind us of the timelines for this program? Thank you.