Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary

Well, good afternoon once again. Welcome to TD Cowen's 45th Annual Healthcare Conference. We're delighted to have Bristol-Myers Squibb with us again this year. Representing the company is Adam Lenkowsky, who is Executive Vice President and Chief Commercial Officer. So Adam, thank you so much for making the effort to be with us.

Thanks for having me.

Let's start out maybe with -- I think you were going to start out with kind of some brief opening remarks and maybe include in that some of the pushes and pulls of the Medicare Part D redesign as part of the answer.

Yes, happy to do that, Steve. So it's great to be here with everyone. 2024 was an important year for our company. It was the first step in our journey to transform the organization. We delivered strong performance and execution across our growth portfolio with products like Breyanzi, products like Camzyos, Opdualag, all of which performed exceptionally well. I think some of the signature milestones of last year was the approval and then the subsequent launch of Cobenfy. I'm sure we'll talk more about Cobenfy, the first new mechanism of action approved in schizophrenia in decades as well as at the tail end of the year, the approval of Opdivo Qvantig. And so when you look at the growth portfolio, coupled with products like Cobenfy and Opdivo Qvantig and the number of data readouts that we have as a company, and I've been with the company for over 2 decades and over the next several years, we have the opportunity to launch at least 10 new products and over 30 indications from now until the end of the decade. So taken together, you're starting to see what the company is going to look like by the end of this decade and our vision to really drive sustainable long-term growth for the organization. As we move into 2025, it's another important year, and there are pushes and pulls. Of course, we're going to continue to deliver strong double-digit growth across our growth portfolio. I failed to mention products like Reblozyl, which will also continue to drive strong growth for the product. We also have the opportunities with data readouts, for example, the ARISE data readout in adjunctive schizophrenia, the ODYSSEY readout in the first half of the year, which will expand potentially the opportunity for Camzyos in non-obstructive HCM. And then at the end of the year, our R&D organization has been able to accelerate a very important study, which is the ADEPT-2 study, which is a study of Cobenfy in Alzheimer's disease psychosis. So these are some of the, I think, really significant opportunities that we have this year to drive meaningful growth across our growth portfolio. That said, as we described in our earnings call, we have a number of headwinds, including a step down in Revlimid as we look to guide that around $2 billion to $2.5 billion this year. We have coming off the loss of exclusivity of Pomalyst in Europe as well as the LOE of Sprycel in the U.S., all are headwinds to our business. The last thing I'll mention around Part D since you asked, what we have described is Medicare Part D reform is roughly neutral across the portfolio. So there's an opportunity for a product like Eliquis based on the removal of the coverage gap. But it's also a headwind for products like Revlimid, Pomalyst as well as for products like Camzyos and Orencia subcu, where we're now responsible for 10% in the initiation phase and 20%, and that's the case for Camzyos and for the other products we have in our portfolio in the catastrophic phase. We would expect to see robust growth for Camzyos this year, but those are essentially the pushes and pulls for Medicare Part D. But again, taken together, it's going to be another important year for the company as we look to accelerate our growth portfolio and see a number of important data readouts.

And one more question on this topic and that is talk about the phasing in 2025. So how does this redesign impact the sequence of the year?

Yes. The way that we've described this has been, you think Medicare Part D redesign, coupled with a significant inventory build that we saw in Q4 for products, for example, like Opdivo or Eliquis. And you'll see that burn coming in Q1. We would expect growth quarter-over-quarter for a product like Eliquis, but that growth is going to moderate. We said roughly the mid-single-digit growth for a product like Eliquis come Q4 to Q1. And what you historically have seen from Eliquis has been really strong quarters in Q1 and Q2, and then softer quarters in the second half of the year based on patients entering the coverage gap or with the coverage gap elimination, you'll actually see the first quarter being the lowest quarter for Eliquis and that will increase quarter-over-quarter. So again, you will see a sequential decline quarter-over-quarter due to some of the factors I talked about. But net-net, we expect to see robust growth across our key growth drivers.

Just so I can kind of figure this out my own head. So let's say, Eliquis U.S. does for sake of argument, $10 billion this year. Is a starting point, $2.5 billion per quarter? Is that the way to look at it? Or how would you alter those numbers?

The way that we've described Eliquis in the U.S. has been, although you'll see a quarter -- a slight quarter-on-quarter increase from Q4 to Q1. Overall, when you look at the global performance of Eliquis, we would expect to see low double-digit growth year-over-year for Eliquis, so this is still a very important growth product for the company.

Okay. By the way, if there's questions anywhere along the line, please just raise your hand and we'll pose your question. So let's go to Cobenfy, one of the most exciting rollouts in the industry in 2025. Do you think Cobenfy can reach blockbuster status within 2 to 3 years post launch?

So we're certainly pleased with what we're seeing. These are still early days. We're about 4 months into the launch. Recall, this is the first new mechanism of action in schizophrenia in decades. And so we're looking at TRxs today on a weekly basis, around 2,000 (sic) [ 1,200 ] on a weekly basis. That's what we've seen just over the last few weeks. When I think about some of those drivers for Cobenfy this year, number 1 is access. You touched on it, where we're really pleased with how we've exceeded our expectations on access. We're now well over 90% access for Medicaid and over 80% access in Medicare and making good progress commercially. What that's going to do that's going to help patients get on treatment earlier. The second area that I look at, or the second important KPI, in fact, that's even more important than the TRxs on a weekly basis because the TRxs are a lagging indicator for what we're doing. So very pleased with what we're seeing in adding a number of prescribers week over week and not just increasing the breadth of prescribing and they're about 30,000 psychiatrists in the United States, but also death. And so they are repeat prescribers. The final area is really how is the product performing in the real world. And sometimes with studies in psychiatry, you never really know because the studies that are in Phase III are done on a patient who's been washed out of therapy, then rapidly titrated. And the feedback that we're hearing from both physicians and patients has been phenomenal. The efficacy of the product, both positive symptoms, negative symptoms, but also the cognition that we had hoped to see with unique mechanism of Cobenfy is really coming through. Patients are being engaging with their families again, able to eat at the dinner table or looking for work or thinking about going back to school for the first time. And they're not seeing the weight gain, the sedation, the EPS that's associated with the older D2s. The last piece, I would say, regarding Cobenfy in the real world is, we're seeing positions start slower than we did in the clinical trial. So the doses that we're seeing being used to start around 50 milligrams for a week or 2 and then titrating up to 100 milligrams. In the studies that we conducted, patients were already on the high dose, 125 milligrams by day 8. And so what this is doing, and we're seeing efficacy early on even at the lowest doses, but we're not seeing those GI toxicities as significantly as we saw in the studies, the nausea and the vomiting and that's being managed by positions going slower and titrating slower than we did in the clinical trial. So very excited about where we are today as well as the number of data readouts that we have for Cobenfy. We have a new data readout potentially every year from now to the end of the decade.

You've mentioned the a better-than-expected access or access is ahead of expectations. But what has driven that? Is it the inherent profile of the drug and payers realize they have to cover or is it that Bristol-Myers Squibb is giving terms that just make it attractive or some combination?

No. I think there are very 2 key factors for this. Number one, we had sent our field access teams out early on to reinforce the profile with payers to help them understand the clinical profile of the product, the efficacy of the product with unsurpassed efficacy against positive symptoms, the improvement in cognition and the negative symptoms as well. We know this is a market where patients switch very rapidly every 6 months, 50% of patients already switching. That's number one. So payers are recognizing the value that they're seeing. I think that the second piece is the execution around our field access team has been exceptional right after the approval, they were out there again, reinforcing the benefits of the product. But in terms of economics, although we don't share the gross to net, you know the gross to net mandated rebates at 23.1% in Medicaid. And we provided very modest rebates across the board. And so we feel great about where we are with -- from an access standpoint and maintaining very disciplined in gross to net expenses.

What is the biggest hurdle for Cobenfy in the marketplace? Is it step-through of generic antipsychotics? Or is it competition from branded products? Or is it something else?

That's a great question, Steve. I think -- so the answer really, frankly, is neither the step through or the newer atypicals. I would say, number one, we, of course, expected to have our access at one step edit post a generic D2, which is exactly where we are today. And number two, when you look at some of the newer "atypicals" that are in the marketplace, Steven, they also have been out for several years, and their launch trajectories has long been set in schizophrenia. Their focus is much more on adjunctive treatment in MDD, for example, or bipolar depression being another. The #1 barrier that we face with Cobenfy is really this treatment inertia, which is really how do we break this ingrained prescribing behavior that's been there for now over 3 decades and make sure that Cobenfy is that #1 top-of-mind product that physicians are going to prescribe once the patient moves off of an atypical. That's a key focus for our teams, reinforcing the unique efficacy and safety profile of the product, and we expect to see continued strong and sustained uptake.

Questions from the audience? Maybe we could talk about Camzyos. So we have this April PDUFA date to loosen the REMS program. What should be our expectation for the trajectory of the product once that is crossed and successfully the label has changed. So what will change relative to the product usage?

Yes. Camzyos has performed well. And so when we look at the performance over the last several years, certainly through 2024, we are seeing strong, steady, consistent growth from Camzyos. The feedback on that product has been incredibly positive from patients and from physicians and patients are going to be on Camzyos for many, many years. And the PDUFA that's coming up, and we talked about what we see in the European label that was revised in December time frame. Similarly, in the U.S. with our PDUFA upcoming, we expect to see an easing of the echo requirements from after you move from week 12 instead of every 3 months, the now echo requirements would be once every 6 months. What that would allow physicians to do is treat more patients, particularly in these centers of excellence. So that's one area. Number two is we are also focused on expanding the use of Camzyos in the community cardiology offices about 40% of patients. They presented their community cardiologists, so that's another key area for us to expand the growth of Camzyos in oHCM.

So we should definitely see some sort of an inflection once the REMS is loosened?

The way that we describe it, when you look at cardiovascular analogs there's not really an inflection. I think back to the Eliquis launch, Steve, if you recall that, or we have used analogs like ENTRESTO. And so large blockbuster cardiology products, they grow slow, steady and consistently. That's what we saw from Eliquis, now one of the largest products in the world, and we expect to see the same cadence of growth for a product like Camzyos. So steady uptake. We've been adding over 1,300 patients on a quarter-on-quarter basis. And we -- even with the improved capacity, we'd expect to see us to continue to improve that over time, but I wouldn't say there would be an inflection in the curve for Camzyos, but this is a product that will continue to grow as we add to the large base of patients who are on the product today, and we'll continue to move on to the product into the future.

Got it. Okay. Let's stick with Camzyos. One more question, and that is should it succeed in the non-obstructive HCM the market opportunity, how does it change?

Yes. I mean we look forward to getting that data readout. It's the ODYSSEY study, and we should see that in the first half of this year. And so if that study is positive, then Camzyos would be the first and only product to be approved in both non-obstructive and obstructive hypertrophic cardiomyopathy. There's very little to treat non-obstructive HCM. It adds about 1/3 to the HCM market. 1/3 Patients who are diagnosed with non-obstructive versus obstructive HCM gives physicians additional confidence to prescribe, and we very much look forward to seeing that data readout over the coming months.

Okay. Questions on Camzyos before we go on to another topic? So apologies if you've been asked this question, I think, several times in the last 3 or 4 weeks, and that is Opdivo subcu. We know it's early, and you've said it's early. But is it no longer that early that you could give us some characterization of the types of patient switches what tumors are being prescribed for this and so forth?

Yes. It is early. I mean, we received approval at the end of December. Our teams launched in mid-January. So we've got about, let's say, 1.5 months' worth of launch experience thus far. And what we've seen so far has been positive response from physicians, early feedback and in terms of early usage, number one, largely in the community setting, as you'd expect, physicians play back to us. They really appreciate the 3- to 5-minute in-office subcu injection. The reason for that, particularly in the community being so economically-driven is that they're able to treat another patient in an infusion chair, maybe with a 30- to 60-minute infusion, while treating a patient for just 3 minutes in-office injection. We are seeing that the products being used largely so far in patients who are treated adjuvantly. So in the monotherapy setting, whether it's adjuvant melanoma or adjuvant bladder, or patients who have been on concomitant Opdivo Yervoy, then move on to the maintenance phase of Opdivo, for example, in our first-line RCC indication or first-line metastatic melanoma indication. So the feedback has been positive, feedback from patients so far has also been positive. But it is important to note that we would expect to see that this -- the trend line really start to move and inflect after we get a permanent J-Code July 1, which is very common for any Part B reimbursed oncolytic. And so once that happens, the reimbursement would come far more certain and we'll start to see that growth coming in the back end of the year.

Okay. Would you expect the approval of KEYTRUDA subcu? Any meaningful impact on Opdivo subcu?

I think the approval of KEYTRUDA's subcu will be pretty much a good tailwind for the market, quite frankly. I think that -- when I think about the market, the market, which is now an IV market for PD-1, PD-L1s will shift than having multiple competitors, multiple agents and Roche is in the market as well, moving the market from IV to subcu. And so our focus is really driving that conversion to subcu to Opdivo Qvantig. And as we have said, we feel confident about our ability to convert roughly 30% to 40% of our Opdivo IV business to Opdivo Qvantig by the LOE, which is in 2028.

Merck thinks they'll get roughly the same conversion in 12 to 18 months. either they're too optimistic or you're too conservative. Can you talk about why your conversion might take much longer than their?

We're going to work to convert patients as quickly as we possibly can. And so we've given a range in terms of what we expect that to happen, 30% to 40%. It's going to take some time. I think one of the differences when you look at our label is we expect patients to convert who are monotherapy patients, who are patients who are coming off can come Opdivo Yervoy or patients who are on, for example, Opdivo with TKIs or on it with chemo. But we are studying right now Opdivo plus Yervoy, so Opdivo subcu or Opdivo Qvantig with Yervoy, and that will add to the label that will likely take place in the '27, early '28, opening up the remainder of our business. So 75% of our business today is eligible for conversion. And so once that study reads out, is label enhancing, we then receive the broader 100% eligibility. I think that's perhaps some of the difference, but we'll have to see how quickly we're able to convert. But for our oncology organization, it's all hands on deck to ensure we're able to maximize the conversion to Opdivo subcu based on the benefits it provides to both physicians and patients.

Sticking with Opdivo, how our launch preparations for Opdivo plus Yervoy in first-line HCC going?

Yes. First-line HCC launch readiness is going very well. The team is -- has been launch ready for some time. We should see the approval of that indication in the first half of this year. It's a good growth opportunity for Yervoy in particular. We've got another launch that's coming in the first half of the year with Opdivo Yervoy in MSI-high CRC. So those are 2 good opportunities for Opdivo. That said, when you look at where Opdivo is in its life cycle, so the Opdivo business is starting to slow. So we expect to see low single-digit growth this year over last year for Opdivo, which again reinforces the importance that we're placing on the conversion from IV to subcu.

Moving to Sotyktu. Does it still have blockbuster potential in your eyes?

Well, this is a really important year for Sotyktu. We come into this year now with parity access to Otezla and to the second generation biologics. Clearly, Steve has taken us longer than we had hoped to gain that access. But what that's going to do, it's going to allow us to open up the opportunity to more patients, make it easier for physicians. However, as you know, this is a very competitive category. It's also a category that is highly rebated. And as such, in the United States, it's going to take time or the rebates that were needed and required to get that early access to get that access this year to wash out. And so we'd expect to see from Q4 to Q1, a decline in net sales. And also, when you look throughout the year, it's going to take time for net sales to grow as we grow volume. So for what I'm looking at this year is -- how is the team performing in share? Are we growing demand? Are we increasing paid prescriptions. We have a PsA positive readout. We'll be presenting those data shortly, which will help both in PSO because about 20% to 30% of patients have comorbid PSO and PsA. We also have data readouts coming next year in SLE, which is a significant opportunity with high unmet need as well as Sjögren's the following year. So taken together, we expect to see the product grow. PSO will remain competitive, and we will be as competitive as we can be to drive this product.

Okay. Questions from the audience? Maybe zooming out a little bit. Has there been any evidence of bleed-through of IRA pricing to the commercial setting as you've gone through the contracting cycle?

So thus far, we haven't seen any of that "spillover" that we're talking about. I mean, there are very few times where we meet with payers. They're not asking for incremental rebates, whether it's on the Part D side or on the commercial side. We know that the MFP price goes into effect January of 2026. And so that date -- that price has been in the public domain now for quite some time. We're going to continue to remain disciplined in gross net with Eliquis. This is a great product, as we said, when you look at the importance of Eliquis to patients, our market share in the United States is now closing on 75% new to brand Rx. So Eliquis is the dominant product in the marketplace. And that's why we expect continued growth, and we'll have to manage the potential spillover for Eliquis in the commercial setting.

And when we look at or we anticipate the Eliquis LOE, what should be our expectation for the erosion curve? Is it going to be a standard small molecule erosion curve? Or might it be more tempered downward slope for whatever reason?

Yes. So for Eliquis, our LOE is until April of 2028. Upon LOE that we expect to see at least 8 generics coming on day 1 based on the settlement that had been in place now for a few years. So unlike a typical like small molecule, for example, where you see one generic in the market for 6 months and you start to see that influx of generics coming 6 months later. You'd expect to see a very rapid erosion for Eliquis post-LOE in 2028. And that's why we're excited about not just the growth of Camzyos, but also the data readouts that we have coming for milvexian to readouts coming next year in SSP and ACS as well as the following year in atrial fibrillation. And so there's a significant unmet need in AFib. As you know, Steve, it's a head-to-head study versus Eliquis, non-inferiority and bleeding. And so that would extend our franchise and our leadership position from -- when I been with the company for 8 years from products like Plavix to Eliquis, the Camzyos, and now to milvexian into the next decade.

It is a little bit impressive that the milvexian studies are expected to end on time based on what is now known at least, whereas other major cardiovascular trials get pushed out, and they seem to be getting pushed out on an accelerating basis rate but for some reason, the Bristol studies are right on time. To what do you attribute that?

Well, first, I have to get full credit to our R&D organization, who've done an exceptional job in executing against these incredibly important studies, all 3 of them. I think where we are today in atrial fibrillation, when you look at with Bayer out of the marketplace, certainly allowed us to accelerate the number of patients that are coming into our studies, not patients, obviously, who have been tried at asundexian, but patients who are out there with AFib. We are well past the point where Bayer was in their period where they stopped the study. So we feel optimistic about where we are with that study. And our team has also done an exceptional job in really focusing on recruitment in ACS and SSP. We know these customers. We've been with these customers for quite some time in clinical trials. These are global studies. So the teams prioritize this to ensure that we are able to get these studies read out in time. And now they are event-based, as you know. So that's our best projection, but we do expect to see data readouts next year in the 2 of the 3 of the studies.

Okay. I guess I should have been able to conclude that on my own, but I didn't. So when Bayer left this field, did your recruitment go up a lot?

Yes.

Okay. So there's a lot more events being accumulated more quickly.

It did. We had very rapid recruitment. I should also mention our J&J partners, as well. We've been working closely together to recruit the studies. But when you have only one product recruiting in this area, at least having the head start to recruit in this area, then I think that allows us to see really rapid uptake in our enrollment.

Okay. I know Bristol tends to be conservative and doesn't want to get over at skis, but that might also argue that the study could end early, which I know the company won't speak to. But -- okay. Let's talk about your radioligand therapy. What targets tumors and molecules are you exploring with radioligand therapy?

Yes. This is an important modality. In fact when we acquired Rayze, we thought this was and continue to believe this is a best-in-class technology. It's actinium based, as you know, which offers a very significant advantage, more targeted. And so our first data readout is a Phase III study in GEP-NETs post-Lutathera, and we'll see the data read out next year and potentially for a '27 launch. But beyond that we have said that this is truly an IND engine for the company. We have studies now that we're commissioning in multiple tumors such as small cell lung cancer where are the SSTR positive rate is high, it's around 50%. We are -- have data now in metastatic breast cancer in HCC and some earlier assets that we're also studying in RCC. So -- and I think the platform for radiopharmaceuticals is still fairly nascent, say, for one company, and we expect this to be a real growth opportunity for the company in the 2030s that allows us to diversify our oncology portfolio.

Great. So we're down to mere seconds. One more question, and that is, what product in Bristol's early development that you don't really talk about with investors are you most excited about?

Look, that's a great question, but as you know, it's like picking your favorite child until I might give an answer that Samit or Robert might give differently. But what I'll say is, for me, it's our NEX-T in CD19 we presented the data last year. As you know, this is a cell therapy with a Breyanzi like construct. The data that we presented in lupus was received extremely well. We're looking at resetting the immune system, looking at durable remissions here that just don't exist in immunologic diseases. So -- and what we've shown in SLE, hopefully, we'll be able to show in scleroderma, in myositis, we just presented data about a week ago in multiple sclerosis. So when you think about the opportunities here, and these are in later lines of treatment, and we are resetting the immune system, showing complete B-cell depletion and now the potential for durable responses and potential for cures. I think this is a really exciting asset for the company and importantly, for patients.

Lots of exciting stuff going on at Bristol-Myers Squibb. So thank you for the rundown.

Thank you, Steve. Appreciate it. Great seeing you, and thanks for the questions.