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

Thanks, everybody. Good afternoon. Thanks for joining us for a fireside chat session with Bristol-Myers Squibb. I'm Seamus Fernandez, Guggenheim's global biopharma analyst. We're joined today by Chris Boerner, Chief Commercialization Officer of Bristol-Myers Squibb. And obviously, we have a brief [indiscernible] time here. I do apologize we're starting a touch late just because my Internet connection was unstable. So we're using the support of the global network at this point. So...

Welcome to the world we live in.

Exactly. So thanks again, everybody, for joining us. We do have a short time. So Bristol's breadth in oncology is obviously quite substantial. And we also have a lot going on in other parts of the company, Chris, and lots of interest in deucravacitinib, your TYK2. So maybe if you could just give us a big picture your -- what you're focused on this year, mostly in particular in oncology but also across the overall registrational trials and the overall portfolio of Bristol.

Sure. Yes. Seamus, first, thanks for having us. Yes, it's an absolutely exciting time to be at BMS certainly from a commercial standpoint given everything going on. The way I think about the next 18 to 24 months is maybe let's start by talking about launches, and then we can talk about some of the data readouts that we would expect. Certainly, we're going to be paying very close attention from a commercial standpoint to the launches that we have that are ongoing today. I suspect that we'll have a chance to talk during the course of this discussion about what's going on with Opdivo + Yervoy in lung cancer. That launch is going quite well. We continue to see sort of month-over-month increases in share. We knew this was going to be a competitive environment, but that's a launch that we're going to continue to stay focused on. And we think there's continued opportunity to grow both in the U.S. and ex U.S. Outside of oncology, it's still very early days for ZEPOSIA in MS, but we're very happy with the receptivity that we've been getting from physicians in that space. As you know, we reported out Phase III data in UC last year. We expect to launch in the coming months in the UC space. So that's going to be an important one to pay attention to this year. And then obviously, in hematology, we've got to continue to grow the launches that we executed at the end of last year. Notably, with Reblozyl and Onureg, early days for those launches. Things are going well, but we've got to continue to push on those. With Reblozyl, it's all about maximizing the opportunity that we have in MDS. And then with Onureg, remember, that's a place where we're building a market. So it's going to be establishing that profile and getting physicians to treat in this maintenance setting. And then we've got a number of new launches we'll be looking to. Mavacamten will be coming up later in the year. That was acquired as part of the MyoKardia acquisition. Breyanzi, which we're very excited about, was approved last Friday. And then we've obviously got the data with deucravacitinib, so we'll be marching towards launches in PSO there. In terms of trials that we want to stay focused on, obviously, CheckMate-648 in first-line esophageal is going to be one to watch. We have launches based on CheckMate-649 in first-line metastatic as well as in the adjuvant setting that we would expect later this year. But 648 gives us access to the squamous population, so that's one to pay attention to. If we're going to maximize the opportunity with Reblozyl, we need to see the COMMANDS study play out, so that's going to be one to watch. And then we're going to see continued proof-of-concept data across a number of areas of the portfolio. Deucravacitinib, we'll have additional data on. ZEPOSIA in Crohn's disease, which expands our presence in IBD. And then obviously, Factor XIa early Phase II data, we expect later this year as well. So a lot going on across the portfolio, but those are maybe some of the highlights.

Great. That's not much going on at all. Just kidding. And I think you got a good breadth [indiscernible] Breyanzi. So can you just walk us through what are the sort of key dynamics of launching a product in cell therapy for Bristol-Myers, and really kind of edging into that space? I think we've started to see more of a pickup in terms of utilization of cell therapy in the approved indications for some of the other products that are already approved. So what are the drivers of that [indiscernible] Breyanzi kind of movement in the space?

Yes. Certainly, the macro environment for cell therapy has continued to improve over time. These are logistically complicated products. I think customers over time, as they've gotten experience, have gotten more used to using these products. The access environment, which was a big constraint early on, has improved certainly on the Medicare side. So I think in general, we're launching at a good time, and we're obviously excited about Breyanzi. What I would say is that, first of all, the team is exceptionally well prepared to launch this asset. We've got the infrastructure entirely in place. And what I mean by that is we've got the initial launch centers that have been identified. We'll be launching with a footprint that is actually larger than the current players launched with and is actually in the ballpark of what they have today. Our manufacturing is certainly already in place. And we've got the key patient and customer support services that are in place today, which is great. Most importantly, we have a product that we believe has a best-in-class profile. We've got efficacy on par with the existing agents, and we believe we've got a better safety profile. So all of that core infrastructure is in place. Now that we have the approval, our focus really shifts to 3 or 4 things. First, we have to activate these sites. So we've got to get them REMS trained, and then they, in turn, have to train their staff. So that's priority #1. As we get closer to the first patients being infused, we need to make sure that those infusions go off without a hitch. Customer and patient experience is going to be very important here, we think, in terms of differentiating which product gets used. So we're putting a lot of time and energy on that. Third, we obviously have to sell the profile of Breyanzi because this is a competitive market. We, again, believe we have a best-in-class profile, so the team is going to be focused on that. And then the final thing I would say is the focus then shifts to expanding the CAR-T market, which has been a big constraint heretofore. But there, I think we've got a number of opportunities, first, begin pushing referrals into these centers. We've got a very well-established presence in hematology, so those referral networks are going to be very important. We'll begin to prepare the next wave of sites to be ready to administer Breyanzi. And then important, ultimately, because we like the profile we have, we think we can move this into the outpatient setting. And if you add all of that up, that's going to hopefully expand not only the sites where you can administer these products but also the pool of patients that would potentially be eligible for them. But suffice it to say, we're excited about the opportunity moving into the space. And of course, it's the first of 2 products hopefully that we'll have in the coming months.

And you've talked about -- or the company, broadly speaking, offered a view of Breyanzi and the opportunity for ide-cel to the tune of $4 billion in peak potential sales. Can you just walk us through a little bit of how you think about the product mix opportunity? Obviously, the liso-cel opportunity, right now, it's obviously here and now, it's a developing market. What is it that really needs to happen particularly with a product like ide-cel to really develop that market in the way that we're starting to see the CD19 market advance?

Yes. Well, I mean, obviously, as you think about the 2 cell therapies that we're going to have, the markets are going to be very different. The products are different. The dynamics of these launches are going to be very different. With liso-cel, we're entering into a competitive market in CD19, but we think we've got a best-in-class profile, as we just talked about. Ide-cel, again, is not going to be competitive day 1 but will shortly thereafter be competitive. And so I think that dynamic is going to be different. But nonetheless, we think we're in a good position because we have a first-in-class asset with ide-cel. In general, though, as you look across both of these products, I think there are some fundamental truths. First, we've got to make sure that you get a very good customer experience out of the gate with these initial launches. That's going to be really important. And I think that, to a certain extent, hamstrung some of the existing cell therapy offerings at launch. That means ease of patient initiation. That means access issues are addressed when they pop up. And it also means that the patient experience themselves is very smooth. Now again, I think some of the macro changes that have taken place over the last number of years with these institutions getting more comfortable with cell therapies are certainly going to help in that regard. But each product has its own set of unique characteristics, so we need to make sure that when we launch ide-cel, physicians know how to use it, they know the unique efficacy and safety profile that we address access issues and certainly stay focused on reimbursement, which is going to be important. Then I think it comes back to what we just talked about, which is if you're going to get the potential of these assets, you've got to expand the pool of patients who are eligible for these therapies. And again, that means, from our perspective, leveraging, in the case of ide-cel, the very extensive footprint that we have in multiple myeloma and the leadership position that we have there to get those referrals into the centers that are administering ide-cel and continue to expand the footprint over time. So that's going to be the real focus for the teams.

And you mentioned Reblozyl [indiscernible] Reblozyl just because I think the launch has surprised relative to expectations. So can you walk us through the -- how the product is being used today and also a little bit of where you believe the product can go? Obviously, you offered a robust market opportunity for that product. What's the sort of next step to expanding the patient population [indiscernible]?

Yes. So we're obviously very happy with the way Reblozyl is playing out so far. We've had a very good launch. The execution on that product has been very good. And we think that Reblozyl has a really important role to play in its initial indication, which, as you know, is MDS and beta thalassemia. And within MDS, the on-label patient population includes those patients who are low-risk, ESA-eligible and RS-positive in the second-line setting. So as you think about the overall opportunity in MDS, it's a relatively small percentage of that overall opportunity. Nonetheless, we think there's considerable opportunity to, first of all, make sure we fully penetrate that market. And that's certainly the focus at launch. We'd also have the opportunity to continue to drive persistency for this product. There's an opportunity based on the MEDALIST data to see quite long persistency of use for Reblozyl and obviously ensuring that patients have the right dose. So as you think about the initial launch within that second-line selected population, it's really going to be about establishing Reblozyl's profile and ensuring that physicians maximize the opportunity we have there, getting the right dose and ensuring that patients stay on therapy. Then as we think about the longer-term opportunity, it really comes down to, as I mentioned earlier, the COMMANDS study. COMMANDS gives us the opportunity to expand that patient population into the RS negatives and also begin to move that into an earlier line of therapy, and that's going to be critical as we think about MDS. And then, of course, beyond MDS, we have opportunities potentially in other disease areas like MF. But as we think about where we sit today, launch is going very well in the U.S. There's been a lot of pent-up demand so far. But as we get into Q1 and certainly into Q2, we think we're going to be tapping into real underlying demand with this product. So that's what we're focused on in the U.S., and it's still very early days for the launch of Reblozyl outside the U.S.

Got it. And in terms of the drivers. I think, when we talk to thought leaders, the thought leader feedback has been relatively muted in their own utilization of the products. It's really the [ topic ] is really being driven in the community more so than the academic centers?

So far, it's been a mix of both. I think initially, we had quite a bit of use in the academic centers. Obviously, COVID has played a bit into that. But I think we've actually seen a mix of both. And I think as we step back, in order for us to ensure that we maximize this opportunity, we're going to have to make sure we cover both community and academic. That's how we size the field teams, for example, and that's been the focus of our commercial organization.

Great. And why don't we shift gears to Opdivo + Yervoy? [indiscernible] in the lung cancer setting. Interested to just know a little bit more about what really are the core drivers and what are the physicians particularly enthusiastic about. I assume that it's the durable efficacy that you're seeing. But I guess we're also wondering in terms of next updates from data, your 9LA program is maturing. How are you feeling about the evolution of those data as they mature as well?

Is this focused mainly in lung cancer, Seamus, or across the portfolio?

Yes, let's start with lung cancer, and we'll go from there.