Bristol-Myers Squibb Company (NYSE:BMY) Goldman Sachs 43rd Annual Global Healthcare Conference June 15, 2022 12:20 PM ET
CorporateParticipants
Adam Lenkowsky – Senior Vice President and General Manager, U.S. Commercialization
ConferenceCall Participants
Chris Shibutani – Goldman Sachs
Chris Shibutani
Okay, 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 am 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, a 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 my title General Manager of U.S. Commercial, right?
Adam Lenkowsky
Correct.
Chris Shibutani
You look like he graduated from college last year. But in fact, you have been at Bristol for 20 plus years.
Adam Lenkowsky
25 years. Thank you for that. I’m glad this is being recorded.
Chris Shibutani
Absolutely not video, but the transcript will still serve you well. Tell us about your journey and 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 we won’t be talking about as well.
Adam Lenkowsky
Sure 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 head 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 two years. Just thinking about this year alone, the launch of Opdualag in metastatic melanoma, third IO checkpoint inhibitor, just a little over a month past our Camzyos approval, which was our eighth approval in just over two years. And we’re waiting for deucravacitinib approval in the September timeframe.
We’ve also had a host of other activities, positive study in CheckMate-816 in approval. So making Opdivo, the first and only product that is approved in the neoadjuvant setting, and right for ASCO and I know many of us just come back from great ASCO, great to be live just like great to be live here at this conference. We had announced an important transaction to acquire Turning Point Pharmaceuticals, for their lead assay repotrectinib. So incredible time for the company, certainly most exciting time in my 25 years and looking forward to going deeper and sure all these areas.
Chris Shibutani
Okay, awesome. So maybe let’s set the tone oncology is very much where you’ve been sort of living and breathing, maybe just within 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 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 and your team?
Adam Lenkowsky
Sure. 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 about 40% to 45% adjuvant bladder, our share is roughly similar. We complemented our Opdivo Yervoy indication to RCC with our Opdivo cabozantinib indication we’re leading share in that market as well. And then as I mentioned, 816, which is the first new adjuvant approval.
So that’s been a catalyst for our growth in 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 decline. 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 IO 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 have in the oncology space.
Chris Shibutani
Got it. No, that’s interesting. Tim, thank you for having Adam here. I love the granular tidbits with single-digit kind of percentage things data points that we don’t typically get. So there very helpful. Let’s talk about the first-line opportunity here, some updates longer term data, which is very important from CheckMate-227, five-year CheckMate-9LA three year data, et cetera. Bristol has typically commented about perhaps, the competitive share incremental opportunity, particularly the low expression 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
Yes. As I said, it was an important ASCO for the company, because five years ago, it’d be hard to imagine that we could say that the five-year survival rate now one in every four patients are alive. And what we’re seeing, and that’s what we’re seeing with Opdivo Yervoy in CheckMate-227, the five-year data. And we’re seeing the hallmark of IO-IO, which is the plateauing of the curve, and long-term survival.
We’re also pleased with what we saw in the CheckMate-9LA three-year data, particularly in the non-expressor patient population. And this is a population that is least penetrated by IO. So when you look at in the Pdl, one positives, whether it’s the 1 to 49, or greater than 50, probably 95%, IO penetration in those two segments. But when you look at the non-suppressors, there’s some skepticism by physicians. So there’s still about a third — 30% to a third of the non-expressor market that is 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 populations. So using two doses of chemo plus, Opdivo Yervoy, we think we have an opportunity to grow in that non-expressor segment.
Chris Shibutani
Got 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 most 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
Yes, it’s a great question, because we’ve seen a big change over the last couple of years, were looking at some of these endpoints like RFS or DFS, where 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 endpoints, we’re seeing a share there of north of 40%, 45%, high IO 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 survival is the gold standard.
Chris Shibutani
Got it. Okay. Opdualag congratulations, new product, first-line melanoma, what do you see?
Adam Lenkowsky
We’re really pleased with Opdualag, first, the fact that it’s the third approved IO 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 really in thirds, a third of the market is Opdivo Yervoy, a third in Pd1 monotherapy, a third 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 Pd1 monotherapy and resourcing 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, I think, very, very healthy. And so we will continue to expand not just in the monotherapy but we look to expand in the Opdivo Yervoy segment, as well as in the BRAF mutant segment. We’ve also announced that we’ve started 2 phase 3 studies, one in adjuvant melanoma, other 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 to Pd1 that has been most attractive to physicians at this point.
Chris Shibutani
Right. 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 hasn’t modified anything about your commercialization strategy. And when I think about the data that we saw for the combination with Opdualag 3 was certainly relative to the Yervoy combination and perhaps a slightly better tolerability profile, does that seem to be acknowledged at the physician clinician commercial interface as well?
Adam Lenkowsky
Absolutely. It’s certainly being acknowledged. And as I mentioned, that means the efficacy profile and similarly we just heard tremendous stories after just a few doses of Opdualag, patients, tumors shrinking significantly, some patient’s tumors completely gone. And so the product is living up to what we saw at our Phase 3 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, is a bit of a different disease in terms of where it’s treated. Unlike lung cancer, or renal cancer, 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 that 60:40.
Chris Shibutani
And then at 1/3rd of the BRAF segment, the data package 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 and follow up your thoughts?
Adam Lenkowsky
It’s really important point, I mean, to-date we have not seen IO-IO or even monotherapy penetrates 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 an important data that was presented at ASCO and I was talking about this earlier and some roundtable discussions. And it was by Mike Atkins and was called Dream Seek. And that study looked at what’s the best sequence because it’s not about what — using one over the other, it’s about sequencing. And what Dr. Hawkins found was that by using dual immunotherapy in this case, Opdivo Yervoy first and then using when a patient progresses, 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 do IO therapy.
So we’re working with our academic thought leaders, or 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
Yes. No, I think this audience is familiar with a lot of the KOLs and 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 for that opportunities. Just to pinpoint sharpen our pencils, next for Opdualag would be adjuvant melanoma, very logical, what would be learned and when and sort of like any sort of milestones from a catalyst stable beginning a Phase X when –
Adam Lenkowsky
We’ve started the Phase 3 study for adjuvant melanoma. We’ve started the — we’ll be starting to back and do Phase 3 study in second-line CRC. This is microsatellite stable. And then we’re investigating through Phase 2 studies, data in lung cancer in combination with chemotherapy and Opdualag as well as in HCC. So we’re not ready yet to progress that into Phase 3.
Chris Shibutani
Okay, great. More to come, obviously. Let’s do another exciting launch here, Camzyos, I’m pronouncing that correctly. Okay. How’s the initial uptake going? That’s kind of the notice of debate is just like, Oh, my God, all these things need to go through REMS, don’t tell me about it. So how’s the initial uptake going — talk was there.
Adam Lenkowsky
I couldn’t be more pleased with how the teams are executing with 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. ACM is a highly concentrated marketplace. So we’ve identified about 75,000 diagnosed OHCM patients. They are sitting in those 500 accounts. Now about a third 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 of robust matrix team that are 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 in on 1000 physicians who have already been REMS certified. And these 500 accounts. When you look at our top two tiers, we have over 90% of physicians in these accounts that are REMS 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 accounts right now we’re loading in to their EHR systems, making sure that it’s in the workflow. So that’s not a barrier to prescribing. 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’ve 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’s fits right into the workflow of our centers of excellence. And these physicians, as you know, that there are essentially two components of the REMS. Number one is, eco base dosing, defensive solids assumption. And the second is around drug-drug interactions.
Chris Shibutani
And how are — you have provided us actually with a metric now, we have 1000 physicians who are REMS certified and so we’ll be bugging you about what kind of progression they’re aspirationally help us with some numbers in terms of where you think this could go, and what cadence?
Adam Lenkowsky
Yes. I mean, we think that now we’re going to start to see patients starting to come into the hub for treatment [indiscernible] already, in fact, we’ve heard six stories from a number of the larger centers like the Cleveland clinic’s, the Mayo centers of the world that they are going to start putting [indiscernible] clinic days in place, so we can line up all these patients for treatments. And we know that there are the 75,000 patients [Technical Difficulty] and 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 echoes every 40, 12 and then every three months after, it’s going to be really important and patients are going to start to feel better within the first two to four 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 it certainly into next year for sure.
Chris Shibutani
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 periodicity with the echocardiograms, et cetera. Implications for sort of what that’s going to do to gate the revenue trajectory here.
Adam Lenkowsky
So we have a very significant customer model that surrounds both the patient and the physician. So we have REMS specialists, we have echo techs specialists that are helping to educate the physicians around the products, how do you get REMS certified, making sure that the echoes are done correctly, perhaps in centers that are just not as familiar with how you diagnose HCM. And all of our teams are trained on the REMS program. So the REMS, [Technical Difficulty] 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 [MyCamps] [ph] IOs hub, get not just free trial offer, they can get copay 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 we look at Medicare patients, they’re not eligible for copay support, but they can get free trial offer. They are a 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, whether commercial or Medicare with this product.
Chris Shibutani
And everything 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 the 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 could actually have some pretty dramatic procedural things, but perhaps that’ll 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 up front. And is that what you expected?
Adam Lenkowsky
Yes. So what we’ve seen come into treatment today is mixed age, 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 NYHA 2 and 3 class, and we expect to see probably more so of the patients who are diagnosed and ready for treatment are in that NYHA 3 class but that since tends to be a little bit more subjective a little more, where we are seeing science where you have them.
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, we’re acceptable ablation where you’re inducing an MI in these patients. And so 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 underserved patient population.
Chris Shibutani
Got 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
I 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. And that are there today, and our ability to go after those patients because by the time cytokinetics enters the market, these patients will be gone.
But competition is healthy, and sort of expected them to enter the market at some point in the next couple of years. We have a few year, head start, 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
And 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
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 over overnight. And those efforts have already started. So we started even pre-launch with a unbranded program called could it be HCM. We have very, very significant patient and physician awareness, patient activation activities that 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 or a 50% chance that my son or my other son has HCM and so making sure that they’re 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
Got it. So there’s approvals are obstructive HCM non-obstructive HCM, there’s planning for a Phase 3 study, or can you tell us and grant in, from your perspective as a commercial guy in terms of what kind of information will 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 3 study, tell us a little bit of what we can expect.
Adam Lenkowsky
So the $4 billion is a non-risk adjusted number. Now, when you look at the market today, about 70%, 75% of that $4 billion or of the HCM market is in the obstructive, it’s where we’re indicated today. And about 30% is the non-obstructive. And so we haven’t — we will be starting the Phase 3 non-obstructive study in the back end of this year.
Chris Shibutani
Okay, got it. Let’s shift over to the deucravacitinib the I&I franchise. So another $4 billion sales number out ahead, tremendous opportunities for a lot of these assets. The key part of the 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 personal 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 PDUFA is coming up in September just a couple months away.
Adam Lenkowsky
Yes, September 10 is the PDUFA as you know. And we’re really excited about the potential launch of deucravacitinib, as the best-in-class oral. And so and our excitement continues to build based on the strengthening of the profile. So we’ve presented long-term data from our POETYK studies that have demonstrated superiority versus Otezla in two studies. As you know, we also came back from UR and we presented our data from Phase 2 in lupus and SLE, which corroborates the safety profile that we believe we have strong conviction in that is very different than what isn’t a JAK 1, 2 or 3.
We’ve seen that in all of our studies, we’re not seeing that the hepatic toxicity, the cardiovascular toxicities, the mace, the VTE. From a launch preparation standpoint, in the label, we will prepare for 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 two years. So this is a lot of excitement. As you know, I remember coming back from the American Academy of Dermatology, so enthusiastic based on the conversations I’ve had with thought leaders, with community dermatologists about the profile, and the potential of deucravacitinib not just to be the best-in-class, oral, but the potential to push back the biologics, the IL 23, IL 17s.
Chris Shibutani
Right. 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 POETYK data is very strong. But undoubtedly, there’s a sense of like, what are the rules of the road is defined by the label? And then, how does that manifest commercially?
Adam Lenkowsky
Yes. 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 two Superiority data versus Otezla and that’s what will 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
Okay. And then, you did mention lupus, ELR 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 is one of these, like high-risk challenges, virtually a graveyard in terms of any efforts to progress there. Phase 2 data was quite intriguing. And talk to us about what could that opportunity look like?
Adam Lenkowsky
Yes. So from a commercial standpoint, very significant. Yes, I described it the same way from a drug development, it’s been the graveyard of drug development. And so we’re really excited to what we saw ahead of our large Phase 2 study from an efficacy and 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
Okay, perfect. Let’s move on to Milvexian Factor XIA Phase 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. Should I rattle off all sorts of meetings and dates and see when you started twitching? 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
Yes, it’s great question. And it probably would, call a friend maybe someone can answer that question around timelines. But rest assured we’ll work with our dancing partners and present the data likely in the back end of this year. I’m 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 3, will work with Janssen’s R&D organization with our R&D organization decide what’s the best cadence of indications that can come out of the studies and what’s the right sequence of Phase 3 studies we want to put forward to the marketers.
Chris Shibutani
Right. And what is specifically the key data from this SSP study that you’ll be looking at. We should be attentive to that helps you fan out into the next derivative of like, oh, and this is why we should go into these areas when you when you think about Eliquis, a tremendous product, it has certain indications, it has certain realms that it doesn’t 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 two letters of the alphabet, maybe both of them are vowels. And scenario, extrapolate a face pretty helped me, what is the data that’s coming from this SSP study that we’re super anticipating to help your decision-making?
Adam Lenkowsky
Well, you have to wait to see it, I guess. But, but obviously, when you’re looking at a Phase 2 study, you want to understand what’s the right dose, you want to progress into Phase 3. So that’s something that you’ll see. And also, you have to look at what the profile is the efficacy and 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
Arguably, the vocabulary I would sense would actually be not efficacy and safety, but safety and efficacy. No, I mean, I think when we talk to the folks over at Janssen, that they really have this emphasis there. We also got a peek into sort of what the mechanism 11A could do at the earlier meeting in March, ACC, I think it is from the buyer data set. What were your takeaways from that?
Adam Lenkowsky
I think the buyer data, although you can’t do cross comparisons, I think they have a very similar condition 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 was 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 and my 25 years with the company, we’re going from products like Plavix, to Eliquis, to now Camzyos; 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
Right. Yes. And 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 Luddite movement of Coumadin and Coumadin Labs, et cetera. And that took a while streets and patient, it was a little bit sort of like, oh, these are kind of mediocre launches, and then you look away from them. And you look back and it’s like, holy cow, these are huge products. Now, the next stage is going potentially to the 11As from the 10s, the cadence similar, different quicker, are we in a different place?
Adam Lenkowsky
No. It’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 increasing. There were people who were saying this was a sluggish launch, was a disappointing launch. Fast forward 10 years and Eliquis is, one of the largest products in the world, the largest prescribe products in the US by volume. And so these products do take time, they’re 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 [Technical Difficulty] in a fit market, similar in VTE and our TRX share has continued to grow linearly hasn’t stopped. And so there are very few analogs, I expect to see the same dynamic as we bring Milvexian Factor XIA into the marketplace.
Chris Shibutani
Got it. Racing the clock here, couple of quick hits. And then one other question is Zeposia comment on what kind of progress that we’re making gross to net dynamics there, I know the product was priced for the MS market. So but tell us what we should know there. And we’re here.
Adam Lenkowsky
So with Zeposia, we’re focused on two areas, because 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’ve seen improvement in patient volumes over time.
Chris Shibutani
Okay. And then I know it’s not your domain CAR T. The issue there that we’re all paying attention to is limitations and better supply, commentary from management’s across the value chain and supplier there that we should be able to renormalize and restore the second half still accurate, any nuance?
Adam Lenkowsky
So we are really excited about what we’re seeing with the commercial demand for CAR T whether that’s a BCMA, or Breyanzi. So starting with the BCMA in multiple myeloma, we have talked about increasing our vector capacity. And we’re doing that now, 10 middle of the year that’s happening, you’ll see that start to manifest itself in commercial sales from now to the back end of the year.
Now for Breyanzi, we’re awaiting our second-line approval. We’ve got a PDUFA coming up this month. And similarly we’re also trying to secure additional slack capacity additional vector and that will start to come online more in Q4.
Chris Shibutani
Got it. Okay. Then lastly, I want to really capitalize 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’s always evolving, but particularly, we had the disruption of the pandemic, et cetera, which forced people to do all sorts of exercises and virtual continuing medical education, remote sampling, and all those things. What’s the mix of activities, how’s that impacting your headcount and your view on spend?
Adam Lenkowsky
So when you think about just what’s happened in the last couple of years, I think it’s forced all of us to rethink our customer model, which was largely in person model for so many years and had to shift in order to reach our patients. So we have been building over time or 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. And so that I think, is really critical, looking at building up our digital and AI capabilities to best understand customer practices, it’s 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 look at some of these areas that we’re 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, 8000 physicians. So we’ve right sized, 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, I talked about the Turning Point planned acquisition. And so why do we think that’s such an important acquisition, it fits so nicely, strategically, because it fits right into our long-term. 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
Thank you for the rescue of Tim and me, and they are going to scold me that I didn’t bring up the Turning Point. But you’re right. I mean, that doesn’t 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 deucravacitinib, and we certainly look forward to keeping in touch. Appreciate all the additional insights. Thank you for partnering with us. Thank you, everybody.
Adam Lenkowsky
Thank you.
Question-and-Answer Session
Q – Chris Shibutani
End of Q&A
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