Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary
June 15, 2022
Earnings Call Speaker Segments
Chris Shibutani
analystOkay. Good morning, everybody. This is the place to be, obviously, with Pfizer and now with Bristol. Thank you for staying with us during our Goldman Sachs Healthcare Conference. Excuse me for that. My name is Chris Shibutani. I'm a member of the research team, cover pharmaceuticals and biotechnology. We are thrilled to have Bristol-Myers join us as well. When we launched our coverage there, by recommendation and the stock has been amongst the most resilient in this environment. Lot of exciting fundamentals. Very pleased that we could have with us a point person who I think can really give voice to many of the things that will move the needle here, and it's an exciting time for Bristol, Adam Lenkowsky. Adam, you are, I think by title, General Manager of U.S. Commercial?
Adam Lenkowsky
executiveCorrect.
Chris Shibutani
analystRight? You look like you graduated from college last year, but in fact, you have been at Bristol for 20-plus years?
Adam Lenkowsky
executive25 years. Thank you for that. I'm glad this is being recorded.
Chris Shibutani
analystAbsolutely. Not video but the transcript will still serve you well.
Chris Shibutani
analystTell us about your journey, what areas you've been to help the audience understand how and why I'll be sort of like trying to extract the information that I will from you and things that I won't be talking about as well.
Adam Lenkowsky
executiveSure. Happy to do that, Chris. And first, thanks so much for having me here. It's a pleasure to be here. So as I said, I've been with Bristol-Myers Squibb now for 25 years. I lead our U.S. commercial organization, which is oncology, immunology and cardiovascular disease. It's such an incredible time for our organization, as you think about the number of launches that we've had over the last 2 years. Just thinking about this year alone, the launch of Opdualag in metastatic melanoma, our third I/O checkpoint inhibitor. We're just a little over a month past our Camzyos approval, which was our eighth approval in just over 2 years. And we're readying for deucravacitinib approval in the September time frame. We've also had a host of other activities, positive study CheckMate 816 and approval so making Opdivo the first and only product that is approved in the neoadjuvant setting. And right before ASCO, and I know many of us have just come back from great ASCO, great to be live, just like it's great to be live here at this conference, we had announced an important transaction to acquire Turning Point Pharmaceuticals for their lead asset, repotrectinib. So incredible time for the company and certainly the most exciting time in my 25 years and looking forward to going deeper in, I'm sure, all these areas.
Chris Shibutani
analystOkay, awesome. So maybe let's set the tone. Oncology's very much where you've been sort of living and breathing. Maybe just with the commercial franchise, Opdivo, clearly, right, we're coming through transitions during COVID, a post-COVID-ish world, new normal. What are you seeing in terms of tone of markets, volumes of patients, et cetera, within oncology and perhaps even more granular than that within lung or some of the other indications? And again, you have purview broadly with cardiovascular. So contextualize what Bristol is seeing in your team.
Adam Lenkowsky
executiveSure. So with Opdivo and with immuno-oncology, I'm very, very pleased with the Opdivo performance. As you saw, we delivered strong double-digit growth in Q1, and that was largely driven by a host of indications that were approved last year and into this year. So not just first-line lung cancer but first-line gastric where we have now a share of about 40% to 45%. Adjuvant bladder, our share is roughly similar. We complemented our Opdivo + Yervoy indication RCC with our Opdivo + cabozatinib indication. We have a leading share in that market as well. And then as I mentioned, 816, which is the first neoadjuvant approval. So that's been the catalyst for our growth in the first quarter and will continue to strengthen throughout the year. As far as what we're seeing from COVID, we did see a significant COVID impact last year, around 10% of the market declined. What we saw as we started to enter into this year, the market was rebounding until we saw the Omicron variant hit in the first quarter. And so we are seeing continue to suppress markets around 5% so it's moderately suppressed. And you're right, it does differ by tumor type. So lung cancer, for example, we see down around 7%, RCC down around 8% contrasted to like melanoma down only around 3%. This is looking at first quarter. But despite the COVID headwinds, we still feel very good about the growth for Opdivo or I/O franchise throughout this year and into next year. And if you do contrast that to cardiovascular, for example, we do see pretty significant differences in markets coming back a little bit faster than they had in the oncology space.
Chris Shibutani
analystGot it. No, that's interesting. Tim, thank you for having Adam here. We love the granular tidbits with single-digit kind of percentage things, data points that we don't typically get. So very helpful. Let's talk about the first-line lung opportunity here. Some updates, longer-term data, which is very important from the CheckMate 227, 5-year; CheckMate 9LA, 3-year data, et cetera. Bristol has typically commented about perhaps the competitive share, incremental opportunity, particularly in the low expresser population, how are you feeling about that impact of that data? How should we read that when you think about commercialization going forward?
Adam Lenkowsky
executiveYes, I guess it was an important ASCO for the company because 5 years ago, it'd be hard to imagine that we could say that the 5-year survival rate, now 1 in every 4 patients are alive. And what we're seeing -- and that's what we're seeing with Opdivo + Yervoy in CheckMate 227, the 5-year data, and we're seeing the hallmark of I/O which is the plateauing of the curve and long-term survival. We're also pleased with what we saw in the CheckMate 9LA 3-year data, particularly in the non-expresser patient population. And this is a population that is least penetrated by I/O. So when you look at in the PD-L1 positives, whether it's the 1 to 49 or greater than 50, probably 95% I/-O penetration in those 2 segments. But when you look at the non-expressers, there's some skepticism by physicians. And so there's still about 1/3, 30% to 1/3 of the non-expressor market that they're still using platinum double chemotherapy first. And based on the data that we presented at ASCO with 9LA, in particular, this is a tougher-to-treat patient population. So using 2 doses of chemo plus Opdivo + Yervoy, we think we have an opportunity to grow in that non-expressor segment.
Chris Shibutani
analystGot it. Adjuvant, moving earlier adjuvant, neoadjuvant, very important as we think about this kind of mid-decade period for these franchises, yours as well as KEYTRUDA to really thrive here. Sort of the benchmarking of what kind of overall survival data extent and caliber of that do you feel that the physicians need to see in order for that earlier-line usage to really gain traction momentum, et cetera?
Adam Lenkowsky
executiveYes. It's a great question because we've seen a big change over the last couple of years where looking at some of these endpoints like RFS or DFS or even just with 816, EFS and PCR are becoming well accepted endpoints in the adjuvant or the neoadjuvant space. And that's just -- an example of this would be in adjuvant melanoma, which essentially was our first adjuvant indication. And with an RFS endpoint, we're seeing a share there of north of 40%, 45% high I/O penetration. Same thing with adjuvant esophageal and bladder, where we don't have overall survival as an endpoint there. I think physicians now understand that the bar is high and it takes a long period of time. And it's different than what they're expecting in the metastatic melanoma setting where overall is the gold standard.
Chris Shibutani
analystGot it, okay. Opdualag, congratulations. New product, first-line melanoma. What are you seeing?
Adam Lenkowsky
executiveFirst, we're really pleased with Opdualag. First, the fact that it's the third approved I/O checkpoint agent after Yervoy, Opdivo and now Opdualag. Very, very pleased with the early performance of the team and the execution. So we describe the market, as you know, really in thirds. 1/3 of the market is Opdivo + Yervoy, 1/3 in PD-1 monotherapy, 1/3 in BRAF MEK inhibitors. And our strategy and how this is playing out in the market today, we're seeing really strong uptake in the PD-1 model therapy. We're sourcing business fairly equally between Opdivo and KEYTRUDA monotherapy. We're also starting to see some erosion of Opdivo + Yervoy into Opdualag, which is okay because we know that the patent life for Yervoy expires in 2025. So that conversion is very, very healthy. And so we'll continue to expand not just in the monotherapy but we'll look to expand in the Opdivo + Yervoy segment as well as in the BRAF mutant segment. And we've also announced that we've started 2 Phase III studies, one in adjuvant melanoma, another in second-line MSS CRC. So we think this could be a really significant asset for cancer patients that meets a great unmet need. It's the efficacy profile, specifically the 10-month PFS in metastatic melanoma, coupled with the safety profile that is more consistent with monotherapy PD-1 that has been most attractive to physicians at this point.
Chris Shibutani
analystRight. Okay. So there's always clinical data. Then there's positioning of that clinical data by the commercial team, then there's physician receptivity and perception of that. With that sort of cycle and feedback loop, has it modified anything about your commercialization strategy? And when I think about the data that we saw for the combination with LAG-3 was certainly relative to the Yervoy combination, perhaps a slightly better accountability profile. Does that seem to be acknowledged at the physician clinical and commercial interface as well?
Adam Lenkowsky
executiveAbsolutely. It's certainly being acknowledged. And as I mentioned, it means the efficacy profile, and similarly, we've heard just tremendous stories after just a few doses of Opdualag, patients' tumor shrinking significantly. Some patients' tumors completely gone. And so the product is living up to what we saw in our Phase III studies. The safety profile is probably something that is most attractive to physicians because the management of that is very akin to monotherapy. So we certainly are seeing that very positive receptivity to our efficacy and safety profile. We're seeing use almost equally in the community and the academic setting. And I think melanoma, as we know, it's a bit of a different disease in terms of where it's treated, unlike lung cancer or renal cancer, where you see about 70%, 80% of the treatment in the community. Melanoma skews a little bit more heavily towards the academic medical center. It's about 60% community, 40% academic. And so our business right now is about 50-50, and we expect that to normalize over the coming months to -- at 60-40.
Chris Shibutani
analystAnd then at 1/3 the BRAF segment, the data package and what we know so far, is that going to be enough to equip you to perhaps get some penetration into there? Or do we need some longer duration of follow-up? Your thoughts?
Adam Lenkowsky
executiveIt's a really important point. I mean to date, we have not seen IO-IO or even monotherapy penetrate significantly into the BRAF mutant marketplace. In total, BRAF MEK combination has about an 80% share in that -- about 40% of the market. But there was some important data that was presented at ASCO, and I was talking about this earlier in some roundtable discussions, and it was by Mike Atkins and it was called Dream Seek. And that study looked at what's the best sequence because it's talking about what -- using one over the other, it's about sequencing. And what Dr. Atkins found was that by using dual immunotherapy, in this case, Opdivo + Yervoy first, and then using -- when a patient progresses the BRAF MEK, you have a 20% greater chance of survival than if you do the other way around, starting with BRAF MEK and then going to IO therapy. So we're working with our academic thought leaders. Our medical teams are out there with this important data. And hopefully, that will start to change the tide because this is really about raising the survival curve and giving patients with melanoma the best opportunity for long-term survival.
Chris Shibutani
analystYes. No, and I think this audience is familiar with a lot of the KOLs in the melanoma space. Dr. Atkins has always been a little bit of a MEK/BRAF kind of skeptic. And from that standpoint, that sequencing is relevant to that opportunities. Just to pinpoint sharpen our pencils, next for Opdualag would be adjuvant melanoma, very logical. What would we learn and when and sort of like any sort of milestones from a catalyst table beginning a Phase X when...
Adam Lenkowsky
executiveWe've started the Phase III study for adjuvant melanoma. We've started the -- we'll be starting the Phase III study in second-line CRC. This is microsatellite stable. And then we're investigating through Phase II studies, data in lung cancer in combination with chemotherapy and Opdualag as well as in HCC. And so we're not ready yet to progress that into Phase III.
Chris Shibutani
analystOkay. Great. More to come, obviously. Let's do another exciting launch here. Camzyos, I'm pronouncing that correctly, right?
Adam Lenkowsky
executiveYou are.
Chris Shibutani
analystHow is the initial uptake going? That's kind of a nice debate. It's just like, oh, my god, all these seems like to go through REMS. Don't tell me about it. So how is the initial uptake going? Talk to us there.
Adam Lenkowsky
executiveI couldn't be more pleased with how the teams are executing with the Camzyos launch right now. We're excited to bring really the first agent that actually treats the disease of HCM at the source. And we look at the launch metrics today. So we're about a month into the launch at this point. And our primary focus is around 500 accounts, these are our centers of excellence. HCM is a highly concentrated marketplace. So we've identified about 75,000 diagnosed oHCM patients. They are sitting in those 500 accounts. Now about 1/3 of these patients are in just about 100 or 150 accounts, and that's where our teams are at right now. Now when we look at the first priority is educating the centers of excellence cardiologists around the efficacy and safety profile of Camzyos, that robust matrix team that's doing that today. But the best leading indicator that I can share with you really is around REMS certification. So to prescribe Camzyos, you need to be a REMS-certified physician or a designated physician. As of today, we're closing on 1,000 physicians who have already been REMS certified in these 500 accounts. When we look at our top 2 tiers, we have over 90% of physicians in these accounts that are REM-certified. To me, that is the most significant leading indicator for prescribing. So that's number one. When we look at securing access, which is also important at the account, accounts right now are loading into their EHR systems, making sure that it's in the workflow. So that's not a barrier to prescribing. And from a payer standpoint, one of the things we've talked about is it's going to take some time, but we've also seen now several patients who have been treated with Camzyos, treated and some of the stories have been just phenomenal already. And from a payer standpoint, they're going through the system through either prior authorization or through medical exception. So feel very good about that. And the REMS program to date, the feedback has been very positive. It fits right into the workflow of our centers of excellence and these physicians. As you know, that there are essentially 2 components of the REMS. Number one is echo-based dosing to [ systolic ] dysfunction; and the second is around drug-drug interactions.
Chris Shibutani
analystAnd how are the -- you've provided us actually with a metric now. We have 1,000 physicians who are REMS certified, and so we'll be bugging you about what kind of progression there. Aspirationally, help us with some numbers in terms of where you think this could go and at what cadence.
Adam Lenkowsky
executiveYes. I mean we think that now we're going to start to see patients starting to come into the hub for treatment, at their centers already. In fact, we've heard stories from a number of the larger centers, like the Cleveland Clinic, the Mayo centers of the world that they're going to start putting mavacamten clinic days in place so they can line up all these patients for treatments. And we know that there are these 75,000 patients that are out there. We know which accounts that they're desiring. They're not going to show up all at once, of course, but getting these patients in for treatment and then getting them their baseline echo and then their echos every 4, 8, 12 and then every 3 months after is going to be really important. And patients are going to start to feel better within the first 2 to 4 weeks. So we will start to see commercial sales materialize in the back end of the year because once they come through the hub, patients are on a 30-, 35-day free trial offer, and then they move into commercial. So we'll start to see that ramp in the back end of the year and then certainly into next year.
Chris Shibutani
analystSure. So there's drug, there's logistics REMS. There's cost of drug, there's cost of some of the REMS logistics, including ECHO there. Talk to us about sort of resources that are available to possibly facilitate this for the patients depending upon whether you're Medicare or commercial with some of the things such as the workup, the period you see with the echocardiograms, et cetera, implications for sort of what that's going to do to gate the revenue trajectory here.
Adam Lenkowsky
executiveSo we have a very significant customer model that surrounds both the patient and the physician. So we have REMS specialists, we have ECHO tech specialists that they're helping to educate the physicians around the products. How do you get REMS-certified making sure that the ECHOs are done correctly, perhaps in centers that are just not as familiar as how you diagnose HCM. And all of our teams are trained on the REMS program. So the REMS today has not been a barrier to uptake. As far as the mix of commercial and Medicare, now we know commercial patients are eligible for the robust services we have. They're able to enter into the My Camzyos Hub, get not just free trial offer, they can get co-pay support, they can get nurse navigation. And so those are patients that we're seeing coming into the hub today. But we've also treated Medicare patients as well. And so when you look at Medicare patients, they're not eligible for co-pay support but they can get free trial offer. There are third-party copay foundations that they can go to, to seek support for out-of-pocket costs if they need it. And also when you look at the Medicare population, about 20% to 25% of that population are low-income subsidy so their out-of-pocket burden is not significant. So that's some of the support that we offer for helping patients with commercial or Medicare with this product.
Chris Shibutani
analystAnd then if we think about the spectrum of patients themselves by their sort of severity of disease or status, I think you guys have previously commented that the initial likely targets of patients that the physicians would be recommending might be those who are more at the severe end of the spectrum. Is that case and maybe talk a little bit about demographic of age because this is the kind of thing where the existing treatment had been, it's like okay, you actually have some pretty dramatic procedural things, but perhaps that will give you some sustained benefit with the incumbent risks of actually going through that treatment versus the need to be on a chronic medicine. So help us get a sense for who we're seeing upfront and is that what you expected?
Adam Lenkowsky
executiveYes, so what we've seen come into treatment today is a mix of ages. The average age in the EXPLORER study is around 58, 59 years old. And so we're seeing patients who are in their 50s, 40s, 60s all get treated. So really, I think the population that we're looking to treat, is in our label, any patient who's over 18 years old, who is symptomatic, who is an NYH 2 and 3 class. And we expect to see probably more so the patients who are diagnosed and ready for treatment or in that NYHA 3 class, but that tends to be a little bit more subjective, a little more where we're seeing science where you have them. So coming to treated patients regardless of age, we don't expect it to skew older or younger. And the reason for it is exactly what you're saying. I mean, the options here to treat patients are so few and far between, and the surgical procedures are significant. The options are myectomy, which essentially you are going in and doing invasive open heart surgery or septal ablation where you're inducing an MI in these patients. And so when you look at a choice for a patient between Camzyos or these invasive surgeries, the choice is pretty clear. It's going to be using a product like Camzyos. So we feel really good about patients coming into treatment and the impact that this product can bring to such an underserved patient population.
Chris Shibutani
analystGot it. Anticipating that, obviously, the overall market has a competitive dynamic, how important not just procedurally but in the future with the potential another entrant there, how important is first to market in your view?
Adam Lenkowsky
executiveI think it's critically important in this market, in particular, number one, because we have an opportunity to establish our profile well ahead of the competition coming in. But number two is we also have the benefit of these 75,000 patients coming into the marketplace that are there today and our ability to go after those patients because by the time cytokinetics answers the market, these patients will be gone. But competition is healthy. And so we expected them to answer the market at some point in the next couple of years. We have a few year headstart, which is good. But the next -- after taking these 75,000 patient bolus, the next imperative really is to driving the diagnosis rates. And we're doing that now but I think having multiple assets in the market could even accelerate that further.
Chris Shibutani
analystAnd you think diagnosis rates at the moment that we launched, I think you've said about 20%, 25% you mean in Bristol, and that potentially we could double this over time. Give us a sense for maybe where we could be in diagnosis rates a year from now, 25%, just something to sort of gauge your progress on?
Adam Lenkowsky
executiveSo we're -- you're right. Today is around 25% patient diagnosis. We've said that we think we can double that to roughly 50%. It's going to take time. It won't happen overnight. And those efforts have already started. So we started even prelaunch with an unbranded program called HCM. We have very, very significant patient and physician awareness, patient activation activities are ongoing. And one thing that I'm not sure if you're aware of, but when you look at HCM in particular, it's the single-most genetically passed on cardiovascular disease. So for example, if I have HCM, there's a very good chance, over a 50% chance, that my son or my other son has HCM. And so making sure that they are being diagnosed early and treated early is going to be essential. So that's some of the education that we'll be rolling out over the coming months.
Chris Shibutani
analystGot it. So these approvals are obstructive HCM. Non-obstructive HCM, there's a plan for a Phase III study. What can you tell us and granted, from your perspective as a commercial guy, in terms of what kind of information what we learn that could be useful to -- because I believe part of the $4 billion aspirational target for this product includes maybe some risk adjustment opportunity there in the non-obstructive population? So Phase III study, tell us a little bit of what we can expect.
Adam Lenkowsky
executiveYes. So the $4 billion is a non-risk-adjusted number. Now when you look at the market today, about 70% to 75% of that $4 billion or of the HCM market is in the obstructive. It's where we're indicating today. And about 30% is the non-obstructive. And so we haven't -- we'll be starting the Phase III non-obstructive study in the back end of this year.
Chris Shibutani
analystOkay, got it. Let's shift over to deucravacritinib, the I&I franchise. So another $4 billion sales number out of the head. Tremendous opportunities for a lot of these assets. The key debate really is sort of what is the base case assumption in terms of what the FDA is going to do in terms of the label. I think Bristol has been very consistent in terms of commenting on the data that you've seen across various indications, clearly, sometimes different patient populations, but nonetheless, and what you have embedded. Remind us what you think is your base case and how that's incorporated in your thinking about how you're preparing because that PDUFA is coming up in September, just a couple of months away.
Adam Lenkowsky
executiveYes, September 10 is the PDUFA, as you know. And we're really excited about the potential launch of deucravacritinib as really a best-in-class oral. And our excitement continues to build based on the strengthening of the profile. So we presented long-term [ poetic ] data from our studies that have demonstrated superiority versus OTEZLA in 2 studies. As you know, we also came back from EULAR and we presented our data from Phase II in lupus in SLE, which corroborates the safety profile that we believe and we have strong conviction in that is very different than what is in the JAK 1, 2 or 3. We've seen that in all of our studies. We're not seeing that the hepatic toxicity in the cardiovascular toxicities, the VTE. From a launch preparation standpoint in the label, we will prepare for, like any launch, multiple scenarios. That's what the team is preparing for today and we'll be ready regardless of the scenario. Our teams are rapidly preparing for the launch. We'll have our sales force in place by July 1. And in fact, our medical teams, our marketing teams have been in place now for just about 2 years. So there's a lot of excitement. As I remember coming back from the American Academy of Dermatology, so enthusiastic based on the conversations we've had with thought leaders, with community dermatologists about the profile and the potential of deucravacritinib, not just to be the best-in-class oral but the potential to push back the biologics, the IL-23s, the IL-17s.
Chris Shibutani
analystRight. And so that speaks to this. I mean, on the street, we love-hate binaries and this whole notion of black box versus not black box, et cetera. Talk to us about sort of what you believe the spectrum of outcomes and the implications on sort of the numbers and really on the positioning of where this drug would be in relation to some of the other therapies because as you said, the poetic data is very strong but inevitably, there's a sense of like one of the rules of the road is defined by the label and then how does that manifest commercially?
Adam Lenkowsky
executiveYes. I mean, you're right, it's not binary. It's not black box or not black box. That's why we're preparing for a myriad of scenarios here. But what we have in hand really is the 2 superiority data versus OTEZLA and that's what we'll promote. We'll be ready with the different scenarios as we need it. But really, that's the opportunity that we see is the ability to become the best-in-class agent and source that business from OTEZLA based on the data that we've seen now time and time again from PSO studies and corroborated in just another study, which is the SLE study.
Chris Shibutani
analystOkay. And then you did mention lupus. EULAR was unfortunately competing for sort of like bandwidth for attention with ASCO as well as the ADA meeting. Couple that with the fact that people think of SLE often as one of these like high-risk challenges, virtually a graveyard in terms of any efforts to progress there. Phase II data was quite intriguing. And talk to us about what could that commercial -- what could that opportunity look like?
Adam Lenkowsky
executiveYes. So from a commercial standpoint, very significant. I'd describe it the same way. From a drug development, it's been the graveyard of drug development. And so we were really excited at what we saw ahead of our large Phase II study from an efficacy and a safety standpoint. Commercially, though, number one, this is a very large and significant market with an unmet need. And we believe that we could be potentially the first oral to enter this market, so we could take a commanding leadership position in a market that really is screaming out for more treatment options and effective treatment options.
Chris Shibutani
analystOkay, perfect. Let's move on to milvexian. Factor XIa, Phase II, 2 studies. Total knee replacement, we got last fall. Secondary stroke prevention, SSP. Confirm you have the data in-house. You will report the data in the second half of the year. Try to rattle off all sorts of meetings and dates and see when you started to [ twitch ], or is there any more indication? And Tim, don't look at him, that we might be able to get an insight into this data?
Adam Lenkowsky
executiveYes. It's a great question. And I probably would, call a friend, maybe Samit can answer the question around time lines. But rest assured, we'll work with our Janssen partners and present the data likely in the back end of this year and we're excited to do so. But I will say, with the TKR data, now the secondary stroke prevention data, we will be moving forward into Phase III. We'll work with Janssen's R&D organization, with our R&D organization to decide what's the best cadence of indications that can come out of the studies? And what's the right sequence of Phase III studies we want to put forward to the market?
Chris Shibutani
analystRight. And what is specifically the key data from this SSP study that you'll be looking at that we should be attentive to that helps you fan out into the next derivative of like, oh, this is why we should go into these areas? When you think about Eliquis, tremendous product. It has certain indications, has certain realms that [ a dozen ] does not participate in. And again, I think Venn diagrams often get used, but these are pretty chunky pieces of Venn diagram, and you're starting with like 2 letters of the alphabet. Maybe both of them are vowels and somehow you extrapolate a Phase III, help me. What is the data that's coming from this SSP study that we're super anticipating to help your decision-making?
Adam Lenkowsky
executiveWell, you'll have to wait to see it, I guess. But look, obviously, when you're looking at a Phase II study, you want to understand what's the right dose. You want to progress into Phase III so that's something that you'll see. And also, you have to look at what the profile is, the efficacy and the safety profile. So those are the data that you'll see when BMS and J&J roll the data out sometime in the back end of this year.
Chris Shibutani
analystArguably, the vocabulary I would sense with that not efficacy and safety but safety and efficacy? I mean, I think when we talked to the folks over Janssen that they really have this emphasis there. We also got a peak into sort of what the mechanism XIa could do at the earlier meeting in March, the ACC. I think it is from the Bayer data set. What were your takeaways from that?
Adam Lenkowsky
executiveI think the Bayer data, though you can't do cross-comparisons, I think they have a very similar conviction as we do, which is we have a strong belief in this mechanism. We have a strong belief that when you look at the profile with low bleeds, high efficacy, potential for multiple cardiovascular indications, I think those are probably the similarities. From a commercial standpoint, really what excites me about milvexian, in my 25 years with the company, we're going from products like Plavix to Eliquis to now Camzyos to milvexian, we'll continue our leadership well into the back end of the 2030s. So just another great opportunity to help patients and secure our leadership in the long term in CV diseases.
Chris Shibutani
analystRight, in that foundational aspect of the cardiovascular business. And this question came up earlier, which I thought was interesting. When we thought about how the 10As came on, we were coming from kind of the movement of [ wide-eyed ] movement of [indiscernible], et cetera. And that took a while, streets in patient. It was a little bit sort of like these are kind of mediocre launches. And then you look away for a moment, you look back and it's like, holy cow, these are huge products. Now the next stage is going potentially to the XIas from the 10s, the cadence, similar, different, quicker? Are we in a different place?
Adam Lenkowsky
executiveIt's -- I think I remember when we launched Eliquis, and you probably remember this, too, where we started out of the gate and it was slow and steady increase. And there were people who are saying this is a sluggish launch, it was a disappointing launch. Fast forward 10 years and Eliquis is one of the largest products in the world, the largest prescribed product in the U.S. by volume. And so these products do take time. They are chronic so patients are on product for several years of therapy. And now 10 years later, we have about a 60-plus percent share of the new-to-brand Rx in the Afib market, similar in VTE. And our TRx share has continued to grow linearly, hasn't stopped. And so there are very few analogs that I would expect to see the same dynamic as we bring milvexian XIa into the marketplace.
Chris Shibutani
analystGot it. Racing the clock here, a couple of quick hits and then one other question. ZEPOSIA, access, comment on what kind of progress that we're making, gross to net dynamics there. I know that product was priced for the MS market so that tells what we should know there, where we are.
Adam Lenkowsky
executiveSo with ZEPOSIA, we're focused on 2 areas: number one is driving demand and number two is securing access. So right now, as we're driving demand, most of those patients are ending up into our hub, into our patient support program. And so we're very confident based on the conversations that we've been having with payers, they will have a much improved access position come January 1 of '23. Right now, although we've removed new-to-market blocks, we're still in a double-step added position in over 75% of patient lives out there. So we will expect to significantly improve that come January. And with that, we see improvement in patient volumes over time.
Chris Shibutani
analystOkay. And then I know it's not your domain, CAR-T. The issue there that we're all paying attention to is limitations in vector supply. Commentary from management across the value chain and the suppliers there that we should be able to renormalize and restore in the second half. Still accurate? Any nuance?
Adam Lenkowsky
executiveSo we are really excited about what we're seeing with the commercial demand for CAR-T, whether that's ABECMA or Breyanzi. So starting with ABECMA in multiple myeloma. We have talked about increasing our vector capacity, and we're doing that now in the middle of the year and that's happening. You'll see that start to manifest itself in commercial sales now through the back end of the year. Now for Breyanzi, we're awaiting our second-line approval. We've got our PDUFA coming up this month. And similarly, we're also trying to secure additional slot capacity, additional vector, and that will start to come online more in Q4.
Chris Shibutani
analystGot it, okay. And then lastly, I want to really capitalize on the fact that you are here, and thank you once again for coming. Your title is Head of Commercial. And we think about like the pharma sales model. Everything is always evolving, but particularly, we had the disruption of the pandemic, et cetera, which forced people to do all sorts of exercises and virtual continued medical education, remote sampling and all those things. What's the mix of activities? How is that impacting your headcount and your view on spend?
Adam Lenkowsky
executiveSo when you think about just what's happened over the last couple of years, I think it's forced all of us to rethink our customer model, which was largely an in-person model for so many years and had to shift in order to reach our patients. So we have been building, over time, what we think are best-in-class digital capabilities, remote and virtual capabilities. You mentioned remote sampling being one, medical on demand being another. So just being able to reach our physicians and our patients when they want to be contacted. So that, I think, is really critical. Looking at building up our digital and AI capabilities to best understand customer practices is something that we're working on and we've had in place for quite some time to help with patient identification. So those are some of the things that we've been doing. In terms of the mix, there'll always be a place for in-person promotion. In fact, it's probably our most effective lever. And when you look at some of these areas that we are now in, whether it's moving into dermatology or UC or even with Camzyos in 500 accounts, we're not talking about building massive organizations in the primary care space. So we're in markets with 10,000, 11,000, 8,000 physicians. So we're rightsized, I think, for where we need to be. And the flexibility across our organization is something that's going to continue to be important is to be able to maneuver our field teams to the opportunities that we have. And a great example of that is, and I talked about the Turning Point planned acquisition. So why we think that's such an important acquisition? It fits so nicely strategically because it fits right into our lung team. There's no additional OpEx really required to support that launch. And it's just a good example of the flexibility that we have as a company from an OpEx standpoint in order to maximize the opportunities that we have ahead of us.
Chris Shibutani
analystThank you for the rescue. Tim and [ Eric ] are going to scold me that I didn't bring up the Turning Point. But you're right. I mean, that does make sense. It leverages very well. So thank you very much. Your energy is commensurate to the activities that you have ahead for you with Camzyos and deucravacritinib. And we certainly look forward to keeping in touch. I appreciate all the additional insights.
Adam Lenkowsky
executiveThanks. It was great.
Chris Shibutani
analystThanks so much. Thanks, Tim, for partnering with us.
Timothy Power
executiveThank you, everybody.
For developers and AI pipelines
Programmatic access to Bristol-Myers Squibb Company earnings transcripts and 32,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.