Bristol-Myers Squibb Co Q1 2025 Earnings Call Transcript

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

Question: Christopher Schott - J.P. Morgan Securities LLC - Analyst : Maybe just two ones for me. Just first bigger picture, I think about tariffs and the 232 stuff that's going on right now, can you just provide any color on the company's US manufacturing footprint ability to shift manufacturing to the US over time just in general your ability to navigate this dynamic. I know the details are lacking right now, but just maybe just help frame out how you're thinking about this. And then the second question for me was on COBENFY just in light of the adjunctive results we saw. Just talk a little bit about what this does for your outlook on COBENFY, and just how you think about kind of use in adjunctive given the negative trial results we saw. Thanks so much. Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team So thanks for the questions, Chris. I will start with your tariff question and I'll turn it over to Adam to address COBENFY. So first, let me just say at the outset that we certainly appreciate the administration's efforts to enhance US manufacturing as we think about the pharma sector though, obviously that needs to be done in a very thoughtful and deliberate way. And as you can appreciate, there's a lot that we don't know here. We don't have specifics on the outcome of this investigation, but our hope is that wherever this lands, we ultimately end up enhancing the competitiveness of US companies like BMS. We are a significantly US-based company today. We have been up investing in core infrastructure in the US for many years, so we need to ensure that ultimately our trade policies enhance the sector and support efforts like the ones we've been making in terms of our exposure again what we've said is the tariffs that have gone into place, namely around China, have been reflected in the guidance that we've provided today. It really is simply too early to provide a lot more on pharma-specific sectors, so we'll have to wait for the specifics there, and once we have them, obviously we'll continue to update you.

Question: Mohit Bansal - Wells Fargo Securities, LLC - Analyst : So Chris, a big picture question for you. I mean, given that -- I mean, there has been a lot of cost rationalization over a period of last couple of years. How are you thinking about R&D here? I mean, again there have been a couple of setbacks here with melanoma and all, but as going forward, I mean when you think about taking bets, I mean is there a change in the thought process and how are you thinking about the future pipeline and [riskiness socket].

Question: Luisa Hector - Berenberg - Analyst : Maybe, just another question on COBENFY. I'm just wondering how the readout from ARISE impacts your levels of confidence in Alzheimer's psychosis readout, and perhaps any additional trials that you may be planning.

Question: Geoffrey Meacham - Citi - Analyst : Chris, just got a couple for you, another one on tariffs. Maybe if you could just talk about it at a high level in the flexibility of transfer price assumptions either maybe from an IP or tax or site of manufacturing. I wasn't sure also about your ability to step up inventory as a potential strategy as well. And then second on BD, just given recent deals for Chinese assets, but also how low valuations are across US SMid biotech, how do these factor in your strategy, or your urgency, et cetera.

Question: Evan Seigerman - BMO Capital Markets - Analyst : I wanted to touch on the rumblings we're hearing about the potential implementation of most favored nations' pricing potentially with regard to drug price negotiation, the IRA. I guess what are you hearing and more importantly, what's your stance on how that could impact negotiations for IRA on drug prices going forward? And then secondary I'd love to touch on the potential impact, positive impact of the relaxed cardiac monitoring for CAMZYOS and how this could help accelerate sales with that franchise?

Question: Terence Flynn - Morgan Stanley - Analyst : I guess maybe two for me. First on the COBENFY launch, Adam, I was just wondering if you could elaborate a little bit on what you're seeing with the prescriber base right now in terms of kind of breadth and depth. And then, I know the slides also mentioned some one-time gross to net impact in the first quarter, so just wonder if you could elaborate on that and how we should think about the cadence of gross to net over the course of the year. And then David, I was just, well I know you're not going to give 2026 guidance yet at this point, but again, heard you reiterate the 37% op margin for 2025. But just, directionally, how should we think about 2026 as it seems like there are still a number of moving pieces as we think about next year.

Question: Trung Huynh - UBS - Analyst : Just a couple on CAMZYOS from me. So, one on the Alzheimer's psychosis trial, just what's your expectations for the bar for that study? What's a meaningful reduction in hallucinations and delusions we should be thinking about? And then the second, just a clarification on the CAMZYOS's gross to net question. If you back out the COBENFY numbers, ex-that one off, it looks like gross to net is 35% to 40%. I think you just said that we should be thinking about that increasing, but you've also previously said you should have modest discounts above Medicaid statutory rate, which is like 23%. So are we thinking that gross to net increases from 35% to 40%? Are you having to be more aggressive on rebates for traction?

Question: Courtney Breen - Bernstein SG - Analyst : A couple from me, the first kind of as it relates that relates to tariffs, we've seen a number of companies come out and make statements about kind of their capital investments within the US in manufacturing and R&D kind of both backward looking as well as forward-looking. So I wonder if you could provide some comments on kind of Bristol's perspective there in terms of committed capital expenditure going forward. And then the second question is just as we think about kind of M&A and I know there's been a couple of questions on this so far, you've also got some kind of key data cards to turn over. Milvexian, I think, is one of the big ones as well as some of these kind of subsequent COBENFY trials. And so can you talk a little bit about kind of how you're approaching making those M&A decisions in the context of kind of internal success rates and kind of waiting for sequencing of those data cards to turn over.

Question: Tim Anderson - Bank of America - Analyst : I have a question on long-term guidance. So Chris, when you took over, you, kind of stopped, providing those or you guys kind of withdrew some of the elements that you had given. Can we expect you to revisit this at some point? I know on trough guidance you said end of the decade. I think the key there is, the absolute level of the trough number. So wondering if you can assure us that it won't go lower than $6 a share that's kind of where a lot of analyst numbers thought out. And then the second question is just transfer pricing. So companies commonly have these set up with major brands, not all brands, levels of disclosure, next to nothing, any color you can share in which particular brands Bristol has transfer pricing arrangements in place such that if tariffs come through in Europe that [ensnares] this, we have some idea of which brands might be impacted. Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team Thanks for the questions, Tim. I'll start and then I'll turn it over to David to talk about transfer pricing. We're not going to be giving long-term guidance as a standard course, and this is what we've discussed previously. That's a philosophical point of view. Our focus is as you know and as we've been discussing, is to drive sustained top-tier growth as we exit the decade. We've talked at length over the last 18 months about how we're going to deliver on that. And the way we think about guidance, Tim, is we want to give you guidance that is a clear line of sight to the things that we're going to hold ourselves accountable for and that you can ultimately hold us accountable for and that's what we're going to do with respect to all of the guidance elements that that we've done so we. We really have fixated on going back to what the company has done historically, which is to provide annual guidance. And then of course, as we did today, we update that guidance as the business conditions warrant. With respect to trough, I think that's going to -- how we talk about trough will be very aligned to that philosophy. But rest assured, the way we think about trough is we're going to do everything we can through either accelerating our internal clinical programs, continuing to engage in business development. And just executing across the enterprise to ensure that we do everything we can to shorten the depth of that trough, move it in as close as we can so that we can again return this company to sustained long-term growth and do that certainly by the time we exit this decade. David? do you want to talk about (multiple speakers)--

Question: David Risinger - Leerink Partners - Analyst : Yes, thanks very much and thanks for all the updates. So I have two questions. First is high level and then one is on COBENFY. So the industry is obviously facing three major government threats in the United States. Number one, actions that are harming US biopharma innovation, including HHS cuts and questioning and criticism of esteemed medical scientists. Second, tariff threats. And third, the Trump administration's agenda to take down drug prices more than the Biden administration. So considering what appears to be a lack of appreciation in Washington on the benefits of the biopharma industry to the American public at large, and to the economy in the country, could you comment on how Bristol's leadership team and Board are engaging differently today with Washington to defend the industry and company? And then separately regarding the COBENFY adjunctive trial failure, could you talk about the more disappointing results in the risperidone subgroup and whether the company believes that risperidone DDIs with COBENFY may have impacted the efficacy in that subgroup and how you may potentially evaluate COBENFY in combination with other therapies in the adjunctive setting in the future?

Question: Carter Gould - Cantor Fitzgerald - Analyst : The BD messaging is coming through clear, and the focus on that endogenous events won't be a stage gate is clear. I guess my question is more on exogenous events and the extent to which uncertainty around tariffs, FDA, drug pricing environment are stage gates to being able to move on drug pricing either a hold-up on your side or on the target side. Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of the Leadership Team I'll take that one, Carter. I think you mean that any of those exogenous factors having an impact on our ability to do business development. Look, I think, we clearly have been focused on putting ourselves in a very strong financial position. We do that by, frankly executing on the business as you saw us do in this quarter that we've been discussing today. But also, as David referenced, by continuing to focus on making the company more efficient and more agile, that enables us to pull costs out of the system and puts us in a stronger position. That financial flexibility gives us the ability to be much more engaged on business development and frankly, that I think is way more important than any of the exogenous factors that you referenced. And so again I would just reiterate business development remains our top priority. We have the financial position to move on business development, but we're also going to be very disciplined. We're going to stay focused on those opportunities where we like the science, where we're the rightful owners, and importantly where we can continue to improve the growth profile of the company. 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 : Two questions, probably both for Samit. Just to be absolutely clear on your prepared remarks and answers to questions, and I know that you need to speak with regulators, but Bristol seems to see a path to positive regulatory action on the existing ARISE data. Is that correct or is there no such path? So that's the first question. Second question is to what extent did the Milvexian Phase 3 trial benefit from the competitor Phase 3 stoppage, for instance? Did enrollment jump 10%, 20%? And given that, why hasn't timing of the primary endpoint changed? Were events, for instance, running behind in the patients previously enrolled before the competitor setback.

Question: Zach Dunn - Guggenheim - Analyst : This is Zach Dunn on for Seamus Fernandez. Thank you for the questions. A few from us on CAMZYOS and your CMI portfolio. Firstly, how defensible is your first-in-class position with CAMZYOS such as your establishment at HCM centers and updated REMs in light of aficamten potentially coming to market this year? And then to non-obstructive HCM and myosin inhibition, what read through, if any, might there be to your development efforts in HFpEF? How would you characterize prospects for success in HFpEF with MYK-224?

Question: Asad Haider - Goldman Sachs - Analyst : Maybe just going back to capital allocation and I know a lot has been answered already, but just if you could just unpack, Chris, what's driving this renewed emphasis on BD, if you could unpack that a little bit more in the context of the lack of visibility on some of the structural challenges that the industry is facing and then any comments on size and what exactly you're looking to solve for as you scan the landscape of external assets. Is

Question: Matt Phipps - William Blair - Analyst : Two quick ones. I know it's early days, but any particular indications or physician settings where you're seeing more adoption or more interest in Qvantig so far? And then independent styles coming up. Just how meaningful is this market opportunity expansion and can you give us any sense of what would be a clinically meaningful benefit and transfusion independence. 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: Sean McCutcheon - Raymond James - Analyst : So for the EXCALIBER study with MRD negativity readout later in the year, do you suspect that you could be able to obtain an approval on that MRD negativity outcome as an intermediate endpoint? And with the movement of CAR-T into second line and later, how do you think this shapes the opportunity, and the bar for utilization of iberdomide in the triplet if it does show benefit over DVD? 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: Srikripa Devarakonda - Truist Securities - Analyst : I have one question on your radio franchise and then maybe a big picture question. Can you talk about expectations from grades 101 in first-line small cell lung cancer that's expected later this year? And then maybe a big picture FDA question, the FDA commissioner has recently made a lot of comments on his vision for changes at the FDA at different levels. Was there anything in particular that you think might have a significant impact on either the timelines or how you do drug development or post-marketing surveillance?

Question: James Shin - Deutsche Bank - Analyst : One for Chris. Sorry to belabor macro, Chris, but totally -- I totally understand the backdrop is still fluid. But is there an initial data point or policy decision that will inform next steps? For example, would having visibility on US corporate tax reform be a starting point or would you need the actual form of tariff rates or any color like that to budget accordingly. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.