Bristol-Myers Squibb Company (NYSE:BMY) Q1 2024 Earnings Call Transcript

We’ll be executing that. As soon as we have that ready, you will be hearing about it. In addition to that, Opdualag has, of course, other opportunities. As you know, we are already waiting for the data for the adjuvant melanoma trial and we are looking forward to the data evolution towards the back end of this year in first-line hepatocellular carcinoma as well.

Tim Power: Thanks very much Samit. Rocco, can we go to the next question please?

Operator: Our next question comes from Terence Flynn with Morgan Stanley. Please go ahead.

Terence Flynn: Great. Thanks for taking the question. Maybe a two-part from me on the CAR T franchise. David, I think you mentioned something about Abecma ex-US pricing dynamics, some change there to help boost access. Can you just provide a little bit more detail if that was a one-off in a specific country or what’s going on there? And then, on Breyanzi, Gilead has talked more recently about moving in the US out to some of these secondary community hospitals as they think about expanding, particularly on the second-line label indication. And so, is that something that you guys are considering as well or do you feel pretty good about your current footprint for Breyanzi at the primary academic hospitals? Thank you.

Chris Boerner: Thanks, Terence. I’ll let Adam take both of those.

Adam Lenkowsky: Yeah. Hi, Terence. Thanks. So, as it relates to Breyanzi, what we saw in the quarter was we were able to stabilize the decline in the US. Sales were roughly flat versus last quarter. What you’re referring to internationally is we did see strong demand growth, which we expect to continue, but that demand growth was offset by negative price and secure reimbursement, mainly in Germany. So that’s where that took place. And now with KarMMa-3, it gives us the opportunity to have a different conversation with our customers about our data in a larger patient population. And, you know, our objective is to return Abecma to growth over time as we move into this larger patient population. Now, for Breyanzi, you know, we’re very excited about this product.

In Q1, we increased sales over 50% versus the prior year. We anticipate robust growth this year because not only just in accelerated growth in LBCL, as Breyanzi is increasingly recognized as the best-in-class CD19, we also expect to see expanded indications. We just received approval in the US for CLL and with additional approvals anticipated next month in follicular lymphoma and mantle cell lymphoma. And this is going to roughly double the addressable market for Breyanzi. We’re also very encouraged by our expanded manufacturing capacity and now in a much stronger position to meet demand. We’re seeing about 20% outpatient use today for Breyanzi and we expect that to continue based on the differentiated safety profile. So, taken together, we’re very excited about the growth profile of Breyanzi.

Tim Power: Can we go to the next question, please?

Operator: Absolutely. Our next question comes from Tim Anderson at Wolfe Research. Please go ahead.

Adam Jolly: Hi, thanks. This is Adam on for Tim at Wolfe Research. So, just on Sotyktu, can you give us some updated market-share metrics, things like new-to-brand share or versus Otezla in the oral category, percent use in first-line versus later lines, that sort of thing? And also, any details on when the free drug program might begin to wind-down? Thanks.

Chris Boerner: Adam?

Adam Lenkowsky: Sure. I’ll take that, Adam. Thanks for the question. So, we’re continuing to make progress with Sotyktu and we are executing our plan. We delivered in the quarter what we said we would do, and that’s reaching approximately 10,000 paid prescriptions as that’s what we shared in January, and we expect to roughly double that to 20,000 paid prescriptions in Q4. So, that’s what we’re focused on driving today. Remember, we also said there would be an increase in gross-to-net due to broader rebating needed to secure improved access and this impacted sales in Q1, but the volume that we’ll see will more than offset that throughout the year. So, we talked about improving our access position. And aside from the wins that we announced last year in CVS and Cigna ESI, we saw access improvement with Sotyktu, which was added to Optum.

And as David mentioned, we do expect to announce additional improved formulary access, including a large PBM with approximately 30 million lives. So, we remain focused on securing zero steps by 2025. And when you have that better access position, the need for a bridge becomes less and less important. And so, basically, when you look at , you know, when you have better access, patients are — move faster into commercial product because they go directly to the specialty pharmacy. As far as market share, this is a highly competitive market. We look at launch analogs at the top of the funnel or written prescriptions and Sotyktu performance is ahead of products like Tremfya, Cosentyx, at the same time of their launch. We are laser-focused on share growth versus Otezla, which is a critical area of focus and becoming the oral standard-of-care in the market over time.

Tim Power: Thanks, Adam. Rocco, could we go to the next question please?

Operator: Yes, sir. Our next question comes from Dave Risinger with Leerink Partners. Please go ahead.

David Risinger: Thanks very much, and thanks for all of the detailed perspectives that you’re sharing. So, I’m hoping that you can help with other income prospects in the future, including the outlook for AstraZeneca other incomes run-rate and then the anticipated step-down in coming years. Thanks very much.

Chris Boerner: Thanks, Dave. David?

David Elkins: Yeah. So, you know, this year was the big step-down in the PD-1 rate. And then the other thing impacting that is the diabetes that will step-down next year as well. The other thing to keep in mind, as I said in the prepared remarks, is, you know, on the interest for the additional debt that we just did. That was the big change in the guidance that we just provided for this year going from $250 million of OI&E income down to $250 million of expense, and the bulk of that is related to the additional interest cost, which is around $13 billion with a 5.3% interest rate and that’s slightly offset by the royalty income.

Tim Power: Thanks, David. Could we go to the next question please?

Operator: And our next question comes from Mohit Bansal with Wells Fargo. Please go ahead.

Mohit Bansal: Thank you very much for taking my question. I actually want to probe the trough guidance comment a little bit further. It does seem like that you are considering it. But if that is the case, can you talk a little bit about the puts and takes there regarding the timing of such guidance? I’m asking because it depends on when you think the trough is, if it is ’26 or if it is ’28 because, I mean, you might not want to provide if it is ’28 just now because it is still a little bit uncertain regarding the timing of it. So what are the puts and takes regarding the timing of it when you eventually decide to provide it? Thank you.

Chris Boerner: Yeah. So, maybe I’ll start and then David can chime in if he has any additional — anything else that he would like to provide. I think the way we’re thinking about the trough guidance, and again, it’s something that we have been engaged with investors for the last number of months. I think the way I would think about it is, first and foremost, probably the underlying question on guidance right now is, what is the impact of IRA on Eliquis? We will, as I said earlier, be in a position in September when the price for Eliquis coming out of the IRA process is known in public. At that point to talk about what that price is and the impact of — on Eliquis on both the top-line as well as on EPS. And then, in terms of how we’re thinking about the timing of the trough, again, and we said this back at the beginning of the year, we see the impact starting in 2026 and our plan is to be growing by the end of this decade. David, anything else you would add?

David Elkins: I think you covered it, Chris.

Chris Boerner: Okay. Thanks.

Tim Power: Thanks, Chris. Can we go to the next question please, Rocco?

Operator: Absolutely. Our next question is from Carter Gould with Barclays. Please go ahead.

Carter Gould: Good morning. Thanks for taking the questions and for all the color today. I wanted to dig into Camzyos for a second. You did a data at ACC and sort of the current rates are the one with that seemed, you know, very positive. And just, you know, when you think about that REMS registry data and the potential to potentially get the REMS modified down the road, should we be reading into that data? Any level of confidence or anything on that front you want to message? And, I guess, along those lines as well, just, I believe, housekeeping on, did I hear a $20 million inventory impact in the quarter? I know something was called on the slides, but I’m not sure that was quantified. Any help there would be great too. Thank you.

Chris Boerner: Yeah. Thanks, Carter. Maybe Samit can start and then Adam.

Samit Hirawat: Yeah. Thank you, Carter, for the question. So for Camzyos, we remain obviously very confident in the overall profile of Camzyos. It has been a very transformational therapy for patients. And as you mentioned, the data at ACC clearly showed from the patients that have been treated in the real world that there is transformational outcome. And from a safety perspective, with 80% of the patients being treated at the 2.5 milligram and the 5 milligram dose, the overall outcomes remain really, really positive as well as the impact on the ejection fraction is minimal at best. So, certainly, it gives us an opportunity to collate that data and find the conversations continuing with the FDA at appropriate times. Remember, we’ve also got the nonobstructive hypertrophic cardiomyopathy study that will be reading out early next year.

So that will provide another opportunity for us to also engage deeper into conversations for the REMS program as a whole and how we can bring this therapy to more patients as well as decrease the burden on the patients. With that, let me pass it on to Adam to comment more.

Adam Lenkowsky: Yeah. Carter, thanks for the question. We’re pleased with Camzyos’ performance in the quarter. You know, we saw a nice acceleration of new patient starts. We saw about a 25% increase in patients added to commercial dispense, but that was offset, as you mentioned, by approximately $25 million inventory work-down from Q4 to Q1. And, you know, we saw a slight gross-to-net impact as well from co-pay restart that happened at the beginning of the year. What we see from Camzyos is consistent positive feedback from physicians and patients. It’s very positive. We also are making very good progress in the launch internationally as we work to secure reimbursement. So, we’re seeing good momentum for Camzyos, and we feel good about the performance of this important product from, you know, now until the end of the year for sure.

Tim Power: Great. Let’s go to the next question.

Operator: And our next question comes from Steve Scala with TD Cowen. Please go ahead.

Steve Scala: Thank you so much. This is a different version of earlier questions, but there are a number of potential obstacles in Bristol’s future, Eliquis IRA price and patent expiration, Opdivo patent expiration, other patent expirations, et cetera. But based on your replies to those earlier questions, it sounds like the — that Bristol views the IRA price of Eliquis as the single biggest obstacle to profits in the next decade. Is that the conclusion that you’d like us to draw? And then, the second question is that, it was noted Revlimid free drug was lower in Q1. Just to confirm, is that consistent with prior Revlimid guidance? And what is the reason it is lower? Was there just fewer patients requesting free drug or did Bristol change the terms? Thank you.

Chris Boerner: So, Steve, I’ll start and then I’ll ask [Technical Difficulty] Take the last part of your question. We’ve highlighted the issue around the Eliquis price and the negotiations because that is an important consideration in the mid-term as we think about this sort of transition period that we’re going through that we’ve talked about in the middle of the decade. And so we’ll have greater insight into what that impact is later this year and we’ll be able to provide more of an estimate for the impact both on top line and on EPS as we get into the back half of the decade at that time. What I would say, though, as I step back, I mean, clearly, you’ve articulated that the importance of Eliquis, and as we’ve discussed in the past, we have a number of LOEs that we face during the course of the decade.