BMYMP - Bristol-Myers Squibb Company (BMY) Management presents at Goldman Sachs Healthcare C-Suite Unscripted Conference (Transcript)
2024-01-04 18:48:11 ET
Bristol-Myers Squibb Company (BMY)
Goldman Sachs Healthcare C-Suite Unscripted Conference
January 04, 2024, 11:00 AM ET
Company Participants
Adam Lenkowsky - CCO
Conference Call Participants
Chris Shibutani - Goldman Sachs
Presentation
Operator
Hey, it’s the start of the year. Welcome to 2024. Anyway, my name is Chris Shibutani. I'm a member of the Goldman Sachs healthcare team. We are deeply grateful for the teams that were able to join us for this conference this very early date this year, and obviously, the point is to try and give voice and an opportunity to talk about some of the most interesting and intriguing stories across the healthcare landscape ahead of next week's confab. I am especially pleased to once again be able to be joined on stage by Adam Lenkowsky who recently got a promotion to Chief Commercialization Officer from your role previously. So, Adam, thank you very much for joining us.
Adam Lenkowsky
Thank you, Chris. Happy New Year.
Chris Shibutani
Yes, indeed. And especially appreciative to the IR team as well, Tim Power and the newest member, Janet Barth, which a lot of you veterans may remember. So some experienced soldiers in the field here for Bristol. And I would say that I appreciate you starting this year and ending your vacations, except Bristol, nobody in the C-suite or support seem to probably have a holiday vacation, you kept us all pretty busy here, and we'll talk about that with all the deal activity. So it's been kind of a continuous process. So as I always like to do, I always like to start these conversations to sort of level set and let people in the audience know who the conversation is with. So maybe just a little bit of encapsulation of who you are, your background, your journey to this point so that we understand the voice that you bring to the responses to these many questions that I will ask.
Adam Lenkowsky
Great. Thank you, Chris, and good morning, everybody. I'm Adam Lenkowsky. I'm the Chief Commercialization Officer at Bristol-Myers Squibb. I've been with BMS now for over two decades in a number of roles, leading our US business, leading our international business. And over the last seven months, was assigned as the Chief Commercialization Officer for the company, and I lead our commercial work worldwide. And so I just want to say to start, what an important time it is for Bristol-Myers Squibb as we embark on this exciting next chapter for BMS. As you alluded to, 2023 was an important year, particularly at the end of the year, tail end of the year. And we've made a lot of progress setting a strong foundation for this year, including continuing to drive commercial execution across our new product portfolio, accelerating what I think is the best pipeline we've ever had as a company. And then finally, with the three transactions that we made towards the end of the year really sets us up for a very strong 2024.
Question-and-Answer Session
Q - Chris Shibutani
I think that's a perfect setup here. I think for investors, when you look across the pharmaceutical landscape, there has been kind of this phenomenon of obesity and everybody else. And everybody else is addressing a lot of the common challenges well known to the industry, tremendous success with franchise products, a lot of good strategic decisions, commercialization, innovation that has changed healthcare. But inevitably, you have the loss of exclusivity. And those exposure in the portfolio weighs heavily on Bristol and we think about that journey through this decade, particularly, there's been kind of two measuring sticks if you think about what the dialogue has been management to the Street, thinking about how do we get from kind of the early part of the decade to the mid part of the decade, and then longer term, from ‘25 to ‘30. So if I think about the team and what we've learned about, particularly as we've had this transition with Chris Boerner now as the CEO and you in your current role, one of the initial sort of markers or footprints that was set up by you guys was to make an adjustment to your view on the timeline for the intermediate term. The ‘25 pushed out to ‘26 when you felt as if some of the revenue ambitions that you have line of sight to we're just in a different time frame. Talk about that decision, one, that I think makes a lot of sense, but then it also seems to invite questions about whether it implies that there's an acceleration later maybe frame for us the thinking behind that reset in essence.
Adam Lenkowsky
Yeah, happy to do that, Chris. Let me tell you what I'm excited about. As you know, we have launched nine new products, now 10 new products with Augtyro launched right before the Christmas holidays at the back end of the year last year. So we have that coupled with six products that have gone into Phase III studies last year and another six that are moving into Phase III studies this year. And adding on to that includes deals like SystImmune, and Mirati, Karuna and Rayze, all of which are going to continue to add to the growth. So when I take a step back and I think about the midterm and the short-term guidance, at Q3, we had stated that we would push out by 12 months our near-term revenue targets for just these nine products. And those -- we moved that from 2025 to 2026 with delivering greater than $10 billion in sales. We also reaffirmed a $25 billion target for the 2030 time frame. This is non risk-adjusted. So -- but when you look at that, we're talking about just nine products. Adding on top, these six new products that are in Phase III, six that are coming in and the exciting opportunities with these new business development deals, we're going to be a very different company in 2030 with significant gross prospects well beyond these nine products.
Chris Shibutani
Yeah. No, I think that the moves that the company made, particularly over the last month, have clearly changed the equation in essence. But let's start with the base case, the foundational aspects, the existing business, the franchises, clearly Bristol-Myers, long legacy in oncology, the combination with Celgene that gives you your presence. At the center point is obviously the immuno-oncology franchise. So let's talk a little bit about Opdivo, has been such an important contributor to the healthcare landscape here. 2028 is a marker year in terms of when we lose exclusivity here. And naturally, investors are all trying to contemplate a couple of things. But importantly, what are the strategies that the companies are bringing to bear? What is the outlook of what impact that may have in terms of that revenue trajectory in that post LOE period.
And when I think about what you guys are doing amongst the approaches that make sense, for instance, is coming up with a presentation that is subcutaneous. So let's talk a little bit about that. Give us an update on where you are in terms of development with that formulation and how you envision as the Chief Commercialization dude, how this will play out in terms of revenue mix, et cetera?
Adam Lenkowsky
Sure. Well, starting with the short term, as you mentioned, we're very pleased with the performance of Opdivo as we talked about in Q3, in 2023, we're delivering on track double-digit growth. We're going to continue to demonstrate growth this year as we have a number of important launches, largely in the back end of the year in early lung cancer, in first-line MSI CRC in bladder cancer. And so although I expect to see not as robust growth this year, we do expect to see growth for Opdivo.
Opdualag is also critically important product for us, one of our nine newly-launched products has become a standard of care in metastatic melanoma. Now around the longer term, last year, we also had a positive trial for our subcu formulation. So why is this important? We expect to launch this either towards the end of this year, more likely in the beginning of next year. That's going to allow us to convert business from IV to subcu. And what I've talked about, Chris, is we believe that it's about 65% to 75% of our current Opdivo IV business, so let me just articulate what those patients are. So either they're adjuvant patients or patients treated with monotherapy perhaps in melanoma, RCC, where you get four doses of Yervoy induction and then you move on to maintenance Opdivo monotherapy, those are the patients that are ripe for conversion. And we've stated that we could convert about 50%. So that equates to about 30% to 40% of our business that we believe we can convert. And importantly, this is going to be a sustainable business past our LOE and into the early 2030s.
Chris Shibutani
And when we think about the commercial effort, inevitably it involves some anticipated dialogue with how the payers are going to be viewing this. The context that they're seeing is that this is on the come that there's probably some profile advantages for patients, particularly in the earlier line settings, but amongst the choices of what they have to sign the checks for include options such as the availability of potential biosimilars of the IV version. Help us understand what some of the messaging has been in the dialogue that you've had with payers thus far?
Adam Lenkowsky
Yeah. Well, just a reminder that the subcu formulation of Opdivo is reimbursed as a medical benefit in Part B versus Part D. And so why did we do that? We did that to make sure that we are preserving physician economics, not disrupting the flow Also, we think it's a huge benefit for patients and physicians. For patients, it's a five-minute in-office subcutaneous injection. And for physicians, it allows them to provide the injection while continuing to fill an infusion chair. And so this is really not on the radar screen of payers today.
Chris Shibutani
Got it. And then in terms of, obviously, you made mention of the Part D aspect. Remind us what the implications of a subcu version are in the context of IRA.
Adam Lenkowsky
Yeah. So we believe that because of the unique formulation that is a Halozyme derivative dual moiety that we will have IRA protection with our subcu formulation.
Chris Shibutani
Okay. No, that's very clear. Sticking to the immune-oncology franchise IO-IO combinations, Bristol actually being the only company that has more than one approved for the combination. And certainly, it's been this Herculean effort from a research and clinical development standpoint, quite complicated. But with Opdualag, we're now two years past the approval in first-line melanoma. Market share, maybe give us an update on where the trajectory is. I think a little over a year ago, we were kind of in the mid- to high teens percentage. I think the most recent updates when we think about some prescription trends, is that -- that's continuing to progress perhaps in the low 20%, mid-20% range. Maybe just give some context for how accurate that assessment is? And where do you think the ultimate penetration can go to with Opdualag?
Adam Lenkowsky
Yeah, Opdualag is a really important growth driver for the organization. Our share today is now 25% and roughly in first-line metastatic melanoma. So it is a standard of care. In fact, when you look at the total Bristol-Myers Squibb share in melanoma, if you add Opdualag, Opdivo Yervoy and Opdivo Mono, we have over 60% market share combined in frontline. And we think there's additional opportunity to grow. There is still about 15% of patients that are prescribed with monotherapy, either Opdivo or KEYTRUDA. And also, we've been making really good progress since NCCN guidelines have been updated to include Opdualag around a Category 1 status in the BRAF mutant population. And so we're seeing some nice uptick there as well. So we think there's some continued growth for sure, for Opdualag into the 2024 and beyond.
Chris Shibutani
In the great sort of verticals, oncology and immunology, the strategy is about these drugs being the gift that keeps on giving in terms of expanding indications. And in oncology, obviously, lung is sort of where the center of gravity is here. If we think about the Phase II data in the first line non-small cell lung setting, you're doing a comparison against the Opdivo monotherapy arm. And typically, when we think about trying to figure out whether this is a work we benchmark against other work that's been done, melanoma comes to mind, RELATIVITY-047 first line. Give us a sense for what your perspective is on whether there's read across and to how much we should believe that this influences our optimism or not in regard to the first-line lung opportunity?
Adam Lenkowsky
Yeah. Well, you're right. Lung is important overall. And I'll talk a little bit about that in a minute because we're making really good progress with Opdivo Yervoy and our CheckMate -9LA study in growing in frontline. But as it relates to Opdualag, just a reminder, as we said we should get the data sometime early this year. And this is a Phase II proof-of-concept study. So really trying to understand the safety and efficacy of Opdualag in combination with chemotherapy. And we will get the data, hopefully, shortly, we will interrogate the data to understand does that -- does the data that we receive reach the bar which is high with KEYNOTE-189 or are there biomarker-specific patient populations that might be more suitable for Opdualag or Opdualag chemo in lung cancer. So we'll get that data very, very soon and make those decisions. We'll share the data publicly. And just importantly, as we talked about the $25 billion in nonrisk-adjusted sales in 2030, when we look at that number, we could hit the $25 billion of nonrisk-adjusted sales without even having a lung cancer approval for Opdualag. But I guess more holistically, when I think about the lung cancer approach at Bristol-Myers Squibb, when you take what we have today, with Opdivo Yervoy and 9LA, the potential for Opdualag, coupled with the recent approval of AUGTYRO, the acquisition of Mirati and potential for RayzeBio as well gives us a lot of opportunity to penetrate segments of lung cancer, which, as you know, it's just not one disease, it's many diseases together. So we feel like we're in a very strong position to continue to drive leadership in the lung cancer space into the next decade.
Chris Shibutani
Got it. Okay. And then you're threading through nicely in terms of how the portfolio is building. I may try and maintain being a bit of a [bullion] (ph) and thing about the base business here, but we'll definitely get to Mirati and Rayze, et cetera, because that's very exciting, but then to finish up on Opdualag, thinking about the other indication is in liver cancer, hepatocellular first-line data. When you think about Phase III structure, do you think -- when you think about that market opportunity and again defining a profile that could be commercially convincing, would you believe that you need to do a head-to-head study versus TECENTRIQ in combination with Avastin as opposed to doing a head-to-head with Opdualag with Avastin.
Adam Lenkowsky
We'll also see that data as well when we look at Opdualag plus Avastin. And I think what we've seen over the last few years is Avastin is an important component in order to demonstrate a survival benefit in liver cancer. But there's still a significant opportunity for our product to move into the ACC space. This is another Phase II exploratory study. We'll get the data. We'll see what it says. We had an earlier study that did not meet statistical significance looking at Opdualag monotherapy in second-line HCC. As I said, using bevacizumab has shown the ability to demonstrate a survival benefit. And then we'll have to assess what makes the most sense, how do we move forward, how robust the data looks. And similarly, are there segments of the opportunity that we want to break into.
Chris Shibutani
Okay. Let's transition over to CAR-T here. Tremendous sort of innovation, the technical challenges of the logistics of commercialization, however, has been a bumpy journey across the board. We're seeing signs of improvement. Frame for us where we are in terms of particularly for Abecma in the multiple myeloma dynamic here.
Adam Lenkowsky
We've learned a lot over the last three years with both Abecma and Breyanzi. And I think many of our competitors would say the same, particularly as related to supply. But we are in a much better supply position for both. In fact, coming into 2024, we have a relatively unconstrained supply opportunity for both Abecma and we're in a much better supply position for Breyanzi. When I take a step back and I think about the journey for Abecma in particular, it was great, a three chapter story, if you would. We launched, as you remember, in 2021, Abecma, and it was the first BCMA CAR-T coming to the marketplace. And quite frankly, there was just more demand than we could supply. And there was a bolus of patients. Chapter 2 was the emergence of T-cell engagers and products that had come in, that are off-the-shelf, easy to use and physicians, when they couldn't get access to CAR-T, they would just simply just use a T-cell engager. And then Chapter 3 came, we started to improve our supply position. We were in a very good supply position last year, but so was Carvykti and J&J made a lot of improvements as well as we did. And so we saw Carvykti start to accelerate for the treatment of later line multiple myeloma. And really, there were a big reason for that, number one, was around the perception of efficacy differences from Carvykti to -- versus Abecma. And we started to lose some business there. We would expect to see our sales in Q4 of last year that are actually lower than what we reported in Q3. This is an important focus for our commercialization organization is really getting more competitive in this space. So we're doing a number of things, Chris, to accelerate our performance for Abecma.
Firstly, we are expanding our footprint, both in the US. We're in 100 accounts today, we'll be in 180 accounts by mid this year. The second focus is we've got to continue to educate around the appropriate sequencing of T-cell engagers and CAR-T and cell therapy. But I think most importantly is really closing that gap efficacy between Carvykti and Abecma. And when you look at the data that's been presented, both real-world data as well as bridging data for Abecma, the efficacy is actually more similar than it is different. Clearly, physicians understand that the safety profile for Abecma is superior to that of Carvykti, but we need to go out there and that's our focus as a team about to be more competitive and demonstrate the efficacy of Abecma in patients with later-line multiple myeloma.
Chris Shibutani
And so with these steps, is there any way of maybe giving a sense for what the timeline for an inflection, we've actually seen sequential quarterly declines in the sales here. What's a reasonable expectation for when we might be able to see stabilization and a potential positive inflection?
Adam Lenkowsky
Well, I think the inflection would come with a positive approval for KarMMa-3. And as you know, the FDA has shared that we were going to have an ODAC, they have not given us any information around the ODAC thing as of yet. But the inflection really is the ability to move up earlier lines in treatment, and that's where I would see growth coming from Abecma.
Chris Shibutani
And are there strategies around sort of upside downside scenarios as an outcome of the anticipated AdCom?
Adam Lenkowsky
Well, certainly, we plan for a positive and a negative result. But certainly, the upside opportunity would be important. We believe that the data that we have shared with the FDA, we presented at ASH, we had a very robust KarMMA-3 primary endpoint outcome in PFS and this was highly statistically significant. But what we also saw was the secondary endpoint was not a positive endpoint because the study was confounded by significant crossover. And so we look forward to continuing to share data with FDA, talking to advisers at the ODAC because we strongly believe that this is a product with a very good benefit risk profile and one that should be used in a triple refractory exposed patient population.
Chris Shibutani
Now let's transition and talk about some of the new members of the portfolio here. And we're keeping it on oncology here because, obviously, that's been very much a core franchise. You mentioned there was Mirati. Obviously, let's start there. What does that add? How does Mirati in Bristol's hands benefit and maybe function differently than as an independent entity. KRAS was always one of the holy grails for a long time in the late teens, fascinated investors. The commercial trajectory is a little bit tougher. Durability of data has been not as optimistic as originally hoped for. Frame for us, what can you guys do with Mirati and what will that mean?
Adam Lenkowsky
We are -- from a business development standpoint, our focus in -- you've seen this now. We're looking for first-in-class, best-in-class assets. And I think we have the same level of focus in our R&D portfolio as well. And so what we're excited about Mirati is we think this is clearly a best-in-class KRAS G12C asset. Why is that? Number one, the combined ability with PD-1 therapy. We saw that Lumakras cannot do that. So we have started a Mirati, rather had started a study Phase III study looking at combination PD-1 Lumakras -- to PD-1 adagrasib in this Phase III patient population for first-line lung cancer. Secondly, we'll get some data in the middle of this year seeing can we explore the use in the less than 50% for combination therapy and potentially even triple therapy using chemotherapy combined with adagrasib and PD-1. That's number one. Secondly, we have -- also we see the commercial performance today in the market is done -- the team has done very well. The CNS penetration has clearly been seen as a differentiator versus Lumakras in the marketplace. And we have a host of other indications in earlier lines that the Mirati team and we will be exploring together. The second thing that we really liked about the Mirati deal, and you saw this through the CVR agreement, was PRMT5. PRMT5, we think, could be a game changer in treating patients. It's prevalent in around 10% to 15% of all cancer patients, and we'll be getting some data this year that we're presenting at a medical conference later this year. So another really significant opportunity, coupled with the G12D opportunity that presents itself, which is pretty -- very prevalent in pancreatic cancer, and you know that's a very difficult cancer to penetrate. So what Mirati does as well as Rayze and SystImmune, it helps diversify our leading IO portfolio beyond IO and give us additional platforms in oncology to grow.
Chris Shibutani
And in particular, with the PRMT5, this is an area that's certainly captured investor retention. We've seen that. We cover a number of large and small companies who are in that space. Ultimately, what is the profile that you think will be defining of being a potential best-in-class? What should we be watching for when this data starts to play out more in the clinic?
Adam Lenkowsky
Well, I think it's really important, number one, to look at the safety profile of these assets. What you've seen with earlier PRMT5, the safety profile was just too toxic for patients to handle. That's what we really like about Mirati's asset and why we think that is -- could be a potentially differentiated asset. So looking at the safety profile, coupled with robust efficacy and response rates over a host of cancer types, and that's what we'll be sharing at a medical conference later this year.
Chris Shibutani
And then to be pragmatic when you think about the opportunity, for instance, in lung cancer with combinations, given the relative share distribution with pembro has become the dominant use in lung cancer, are you expecting that the ultimate commercial offering will be in combination there? And what can you do to better leverage what is existing within the Bristol House product?
Adam Lenkowsky
For these studies, yes, we have -- Mirati has started the Phase III studies with pembrolizumab. It is the standard of care in the United States and Europe for the treatment of first line lung cancer. So the combinations will be with pembrolizumab. There are other opportunities with PRMT5 and as well as with the KRAS G12C agent to potentially combine with Opdivo and other tumors where Opdivo maintains significant share. So we'll get to explore different potential opportunities to have a mix of PD-1 usage.
Chris Shibutani
Got it. Let's talk about Rayze. That there's been a couple of things in the second half of the year that have sort of broken the sound down barrier antibody-drug conjugates, ADCs being one of them, and we'll talk a little bit about and a preliminary deal. But first, I want to get to Rayze radiopharmaceuticals. It's almost reaching back into a really old school toolkit, right, but bringing it into the 21st century in terms of targeted delivery. Tell us a little bit about what you think really gets you excited from the potential commercial standpoint. And again, particularly within the toolkit that you guys have on your existing oncology business.
Adam Lenkowsky
So we've been looking at radiopharmaceuticals for a long time and Rayze came to the top of the list because when I think about what Rayze provides really three things, I think, are critical. Number one, it provides a platform for an IND engine. So you can see new products coming one after another in the back end of this decade and well into the next decade based on the technology that Rayze has and Rayze offers, which is differentiated. The second thing that is critically important when you think about radiopharmaceuticals is having a state-of-the-art manufacturing capability and Rayze also offers that for their organization. They've built a tremendous manufacturing facility in Indianapolis. And third, differentiated from some other companies is that they actually have a Phase III-ready asset with RYZ101 after in a post-Lutathera environment. So those three things taken together, we think, is a great opportunity for continued diversification for IO and a platform for growth into the long term. And if you had a chance to walk through the labs like I did and see the results that these platforms are delivering in patients is phenomenal. It's absolutely outstanding and some of the results are comparable to what I've seen with immuno-oncology in some of the toughest to treat cancers.
Chris Shibutani
And I think when the objective is to deliver some therapeutic for oncology, you're willing to go through a fair amount of effort. But nonetheless, the best pharmaceutical products, the best healthcare -- best products, in general, are KISS, keep it simple, stupid, right? And I can go back to 20 years ago, even like when people were just doing catheterizations and doing balloon angioplasty. And there's a little company called Novos that had radiation delivered through those tips. And all of a sudden, the complexity, the logistics of getting the radiation and then the lead blocking and then having two doctors was like having cats in the squad fighting of managing the clinic not straightforward was problematic, never saw the light from a commercialization standpoint. You think about the predecessor here that's demonstrated really finally some momentum from a commercial standpoint, Pluvicto with Novartis and why unintended, this area seems to be hot now. You made it number 2 in terms of the manufacturing, but I think I would love to have you make very clear what the strategy is on this delivery of the product itself. This commercial execution because there are some really concrete nuts and bolts things. We're not baking crackers and off they go. We're making souffles here basically, right? Talk to us about the confidence that you have because, again, we're in a potential dynamic where the efficacy profiles could be so compelling that the demand could outstrip the ability to supply. So how do you prepare for that? What's the secret sauce in your playbook?
Adam Lenkowsky
Remember, radioligand therapy is different than, let's say, cell therapy manufacturing. It's complex, but not nearly as complex as what we've seen with cell therapy. And so the -- as you mentioned, Novartis has really paved the way for many companies, set the playbook on how to effectively commercialize this. We expect to see RYZ101 approved sometime in the 2027 time frame and our approach in the meantime is to keep Rayze as an independent company. As it relates to commercialization, though, it just -- you're looking at the same centers that we're in today, some of the top academic medical centers that are treating patients across a host of different cancers. Our first indication is, as I said, is going to be a post Novartis or post-Lutathera patient population. So we know that you're looking at about 250 sites in the US, about 400 sites worldwide. So it's a pretty limited footprint. And then there's just different -- some different targets. You've got to get to nuclear medicine to talk to them about the delivery mechanism and of course, the medical oncologist. So we certainly know what it's going to take to -- get to develop such an important platform like RYZ101 and the importance of effective commercialization, and we were excited to start to build towards that.
Chris Shibutani
Let me leave oncology a little bit and transition to another not so straightforward commercialization activity, which is with Camzyos. Hypertrophic cardiomyopathy. I personally have tremendous respect from decades ago as a clinician of thinking about this patient population and the absurdity of these barbell types of treatment options, which were both inadequate and the innovation that's involved, but it's been a bit of a pain in the butt to try and get patients processed and through in the REMS, et cetera. Camzyos has been a product that has been essentially hacking the weeds through these fields. Now you have a potential competitor coming up in the rearview mirror with Cytokinetics there. Talk about the dynamics there. Is there something that can be done to somehow skip the path through somehow a little bit and whether you see a bullish or barrier scenario with having a competitor in this space? Is it more voices, share of voice? Or is it potential risk in terms of the winner taking all?
Adam Lenkowsky
Well, as a company, I will tell you, we're so proud of being able to acquire MyoKardia integrate Camzyos, launch that and really pioneer in this space where there's been nothing to treat the underlying disease of hypertrophic cardiomyopathy. The feedback that we received from both physicians and patients has been nothing short of outstanding, patients within four weeks are getting off the couch there for the first time in a decade, they're back to work. They're back to playing with their grandchildren. But taking a step back and I think about the launch in the early part of 2022, when we launched that, it was also pioneering the -- really one of the first REMS program as well in the cardiovascular space. So we had to do two things. Educate on new profile other than treating with beta blockers or calcium channel blockers, the benefit risk there and also getting physicians comfortable with what the REMS program looks like, getting them signed up for the REMS program, how do you do the echocardiograms. And so that took some time to do that. And where we're at today is kind of in Phase II. We have seen significant growth for product like Camzyos. In fact, we are averaging approximately 1,000 patients on a quarterly basis as we've seen steady and consistent growth. And Phase III of this launch now beyond just tapping into these about 70,000 diagnosed patients. We've now taken a step forward to say, how do we bring more patients into treatment. And so we have launched and we're investing even further behind this important product. We launched both unbranded and branded direct-to-consumer advertising and most companies probably wouldn't have done that this early. We thought it was so important to do it in parallel to getting those patients who are diagnosed, bring patients into treatment who are diagnosed or perhaps feeling symptomatic, and we've seen a nice inflection for Camzyos since we launched that in the back part of the year.
As far as Cytokinetics is concerned, one of the things I've said and I continue to believe this, we saw the data just like you did, we don't believe that there's any clinically meaningful differences in the data that Cytokinetics had presented on aficamten. We have to see the totality of the data. They only presented around three endpoints. So we'll take a look at that. But we've expected the product to come to market to launch. And I think having two products or more in this marketplace. When we look at market that has only 25% of patients diagnosed, certainly going to drive more patients into treatment, and I'm very confident with the momentum that we have with Camzyos that Camzyos will continue to take the lion's share of the business of obstructive HCM.
Chris Shibutani
And then sticking to cardiovascular briefly to touch upon milvexian, obviously, still in the Phase III process here, some updates relative to competitor programs that it has some disappointments. But then some other more recent data that's come from an IV formulation that actually seemed to sort of ratify a little bit of the potential safety differentiation. What's your view in terms of the mindset of how people should be thinking about the outlook for milvexian? I know it's early, but...
Adam Lenkowsky
No. I think, number one, I talked about the 20 years plus I've been with the company. And one of the things I'm most proud of is the strong heritage that we've had as leaders in the cardiovascular space with Plavix, Eliquis, Camzyos and hopefully, with milvexian. We remain very confident in the three studies. As you know, that we have running in parallel in atrial fibrillation, in secondary stroke prevention and in ACS. And we took a really disciplined and methodical approach to looking at what was the right dose in atrial fibrillation with our partners at J&J. We had a very similar approach that we use for Eliquis back prelaunch. And we -- as you know, we presented data from our TKR study. We explored a wide range of doses and ultimately found that the higher dose, which we put into our AFib clinical trials, demonstrated efficacy that was comparable when you're looking at cross-trial comparisons to Eliquis with a superior bleeding profile. So we remain very confident in the hypothesis that we have put forward in a -- higher dose will yield significant benefit for AFib patients.
Chris Shibutani
Got it. Talking about dose is a good segue to talk about the TYK2 space. It's been novel, certainly the oral therapeutics for advanced immune treatment SOTYKTU obviously has been out there. Again, kind of a little bit bumpy path, success with psoriasis, IBD clinical development challenges. Talk to us about sort of the commercial outlook and the revenue trajectory here because there's a lot as we're at this inflection in the early '24, thinking about insurance coverage and when we see the benefits of that.
Adam Lenkowsky
Yes. Thanks. Obviously, SOTYKTU is a key growth driver for the company in the short term as well as into the long term. The two things that I talked about were critically important for this brand was number one, making sure that we are driving demand. And that means improving our depth and breadth of prescribers. And I think we've made some good progress there with SOTYKTU. The second, in such a highly competitive category like SOTYKTU, you're going to see some market share fluctuations from quarter-to-quarter. We've seen some of that with SOTYKTU already. However, access and reimbursement is critical. And I'm pleased to share with you really for the first time as we come into this new year that we were able to secure ESI in a one-step edit position, and that's about 30 million lives are now under ESI. So when you take CDS, which we were able to secure last year, coupled with ESI, we now have over 55 million lives that are covered under zero or one-step edit. Now there's one more PBM of course the three PBMs represent about 80% of the lives in the United States. We are working feverishly to try to secure access there as well over the next several months. And we are hopeful to have a positive result that will allow patients to get on treatment easier and also be able to push patients out of the hub more readily than we have. So we continue to see strong growth opportunities with SOTYKTU in the short term. And in the longer term, opportunities with SLE, opportunities with PSA, all those are coming in the middle of the decade, assuming positive studies.
Chris Shibutani
And in 2024, actually, we're going to get some PSA data, right?
Adam Lenkowsky
We should get data in the 2024, 2025 time frame for PSA. And what's important there, not just the opportunity alone in PSA, but they're about 30% of patients in PSO that have comorbid joint involvement. So that will also help to solidify the SOTYKTU perception when patients are being treated in derm offices who may have comorbid or concomitant joint involvement.
Chris Shibutani
And then maybe a little bit of a help with thinking about pricing strategy. We're at an interesting juncture here. So many of the iconic multibillion-dollar franchises in immunology are now seeing biosimilar challenges. We're seeing the emergence of the late-stage development of some advanced oral therapies that like to use vocabulary like biologic-like efficacy. And so theoretically, you could be getting something of a different presentation there. What's the decoder ring for the right pricing strategy if we think about this? And there was one other thing I'll add, which is that as additional indications come on board, we learn that the negotiation process often involves giving a little bit there. So what's the framework to think about immunology pricing as we go into 2024?
Adam Lenkowsky
Well, immunology, as you know, this is a highly competitive and also a highly rebated category. There's no question about it. In order to secure early access, these are -- you're looking at significant rebates to get into an open access or one access deposition. As more competitors come in, as biosimilars come in, I think you'll continue to see downward pressure on pricing. One of the things I talked about when we speak to PBM, they're struggling with how do I treat biosimilars that are in the market today. We know Stelara will come into the market in a biosimilar likely in the early '25 time frame. And it's that push and pull of kind of political pressure to economic pressure that they're facing. And there was just an announcement you may have seen yesterday from CDS on one of their formularies, they decide to put a biosimilar formulation on the same tier as the other branded players. We've seen that in some of the others as well. We haven't seen quite yet other than some downstream employers pushing for this is biosimilar first formularies. But I can see that, and I can envisage that happening over the next few years as you see more biosimilars coming into the marketplace.
Chris Shibutani
And then the role of these advanced orals and the strategy for figuring out how to define the right pricing for the advanced orals [indiscernible]?
Adam Lenkowsky
I can't speculate on the right pricing there. I think the market has already set the pricing and that will continue to erode over time as more competitors and biosimilars come in. That said, from a commercialization standpoint, SOTYKTU has already set a very high bar. And so for another company to come in with an oral product, whether it's an oral IL-23 or oral TYK, it has to show some meaningful difference, we believe, than SOTYKTU demonstrates in the market. And with that by the time that does come into the market, we'll have additional indications like the ones I talked about, like lupus, hopefully like Sjogren's, like PSA, making it more challenging for other stands in the marketplace.
Chris Shibutani
Got it. And maybe remind us when are we getting lupus data.
Adam Lenkowsky
Lupus data is in the post '25 time frame.
Chris Shibutani
Okay. Great. I know that was identified as a clear target there. A couple of more questions, but transitioning over to a product that's launching Reblozyl, MDS and opportunity to get the TAM more broadly defined. How is that launch going? What should we be thinking about?
Adam Lenkowsky
Yeah. We're really pleased with what we're seeing with Reblozyl. Now it's still early days in the launch. We launched at the end of August, but we've seen a nice inflection for Reblozyl since we launched the COMMAND study in the US. We would expect to see approval in first line in Europe in the first half of this year as well. And what we're seeing is uptake -- rapid uptake in the community setting plus both RS positive and negative. Initially, we had heard from academic medical centers that they were taking a more measured approach on uptake in the RS negative until the data was presented final analysis for Reblozyl at ASH. And they saw the durability of response for the RS-negative population, which looked comparable, if not better than the RS positive. So we have seen very nice uptick and expect Reblozyl to be a key driver of growth for the company this year and beyond.
Chris Shibutani
Okay. Great. Let's turn to the -- was it the post -- the day after Christmas, Karuna neuroscience, historically, presence in neurodegenerative disease and then the legacy goes way back to having a presence with neuropsychiatric disease. So this was quite a get. Talk to us about how you're framing the commercial opportunity here?
Adam Lenkowsky
Well, Karuna is incredibly exciting because it really accelerates our reentry into the neuroscience space. As you know, we've been out of neuroscience since we launched Abilify. And so we've been out of neuro for about a decade. But when we looked at the landscape, we thought this was a great fit for Bristol-Myers Squibb because of our focus on neurodegenerative disease and adjacent opportunities. And when we see a product like KarXT, I think about a few things. Number one, you have an asset that essentially is derisked with a PDUFA date coming at the end of September. So we plan to launch sometime in Q4. The second area, this is an opportunity that has multibillion-dollar potential because they have not just one indication that's already said [read out positive] (ph) but multiple indications in Phase III. So it could be the first product that's approved ever in adjunctive schizophrenia. It has a Phase III study in Alzheimer's dementia, psychosis. And harken back to when we launched Abilify now over two decades ago, there has been nothing in this space that has shown any differentiation from products like Zyprexa, Abilify, Risperdal. And when we think about products like KarXT, it brings unsurpassed level of efficacy without that significant baggage that those products bring in schizophrenia and other diseases, mental health diseases such as weight gain, EPS, akathisia, excessive sedation. So this product is really poised, I think, for significant leadership opportunity in schizophrenia and well beyond. And even beyond the Alzheimer's dementia indication, we've talked about opportunities in Alzheimer's agitation in bipolar mania, and we plan to launch a long-acting formulation as well. So this is a pipeline and a product that we think is going to drive significant growth in the back end of the decade and well beyond, and also get us into -- back into neuro as we're starting to bring our kind of our neurodegenerative platform, our anti-Tau into Phase II trial.
Chris Shibutani
Yeah. I mean there's -- the opportunities are there. And when you're thinking about how to slice the difference segment in the market. There's clearly schizophrenia, there's monotherapy, there's combinations, the terminology of cycling through therapies often gets widely used, which, to me, I interpret to mean that we're still having a very difficult time identifying the right patients and that the chronology of individual patient disease is just very unpredictable. But particularly on long-acting formulation, this is something that's always kind of puzzling to me. When you look at existing LAIs, for instance, for Abilify, the percent penetration in schizophrenia is pretty modest. It's -- I think it's maybe teens, 20% or so still higher in Europe. Why is that?
Adam Lenkowsky
Well, it's about a $6 billion market right now, the LAI market, and we see continued growth there. Right now, the Invega family of products tend to have a dominant space there. But in schizophrenia, we believe this is a ripe opportunity. It's just the issue has been the products that have long-acting injectables, they have these significant rate-limiting side effects, as you talked about. And that's why you see 60% to 70% of patients cycling from one product to another because you have these rate-limiting side effects that make patients noncompliant. So we think that, that will improve the compliance rate by moving to...
Chris Shibutani
But the relative penetration of the long acting in the US seems to be relatively modest.
Adam Lenkowsky
Compared to -- certainly compared to oral formulations for sure. But schizophrenia, we think is a really good opportunity but even better potentially in an Alzheimer's patient population, if you think about what that can burn. And by the time that we launched the Alzheimer's indication that we would expect to bring our long-acting formulation into the marketplace.
Chris Shibutani
Got it. So the deal anticipated to close sometime in the first half of '24. PDUFA in September, meaning that the team that's actually on board is the one that's actually doing all of the seventh and eighth inning commercial prep work. As you peer behind the curtain, how are you feeling about the work that they're doing and what will you inject into that process as Bristol?
Adam Lenkowsky
Well, we have enjoyed having multiple meetings with the Karuna team. They've done a really nice job in starting to build a commercialization infrastructure to get ready to launch. They put individuals on their commercial teams, access, medical, marketing, sales that have extensive experience. But we know the work that needs to get done that's in front of us in order to be successful in launching this critically important product. So what we will be doing is, in parallel, we'll be doing the groundwork as well to ensure that we are readying for this important launch.
Chris Shibutani
And then to close, since I love talking about people who are not here. There's an important adjustment that's happened in the C-suite. This is C-suites unscripted. So this wasn't necessarily scripted. But Chris Boerner is our CEO now. And clearly, he's been a very busy guy. I think the Christmas holidays basically did not happen for him. Help us maybe from your perspective of working and you took on his seat as the Chief Commercial Officer, something or things that you think might be underappreciated that we should keep an eye out for. He's still a little bit of an objectively two-dimensional guy for a lot of people. What should we keep an eye out for? What maybe is underappreciated about Chris Boerner?
Adam Lenkowsky
Well, as I said, it's such an exciting next chapter for Bristol-Myers Squibb, particularly with Chris at the helm. I've had the pleasure of working with Chris since he joined the company in 2015. As you said, I succeeded in the CCO role. I think you've already seen Chris put his stamp on the company with the number of deals that we were able to transact in the back end of the year. Chris brings tremendous sense of urgency. He understands our business better than anybody. He understands the importance of kind of how do we navigate through the back end of this decade, the challenges, the opportunities that are in front of us and the focus on bringing value to our shareholders and the importance of focusing on the patients that we serve. I think with Chris, what people probably don't know or appreciate, because Chris has been so present as Chief Commercialization Officer for the last four years, people probably think of Chris as this pharmaceutical legacy person. But in reality, Chris grew up and spent much of his career in the biotech world. And what that brings to us and having him as the leader of our company, is that, number one, he understands the importance of R&D and what I appreciate about Chris, the importance of the commercial R&D partnership, which is more important now than ever with the rapidly changing landscape. And so Chris is, in my opinion, the perfect person to lead Bristol-Myers Squibb over the next decade.
Chris Shibutani
Now certainly, he cut his teeth in the golden age of Genentech, Sue Desmond-Hellmann and many legacy people in oncology. So I think there's a great toolkit there. And I'll actually add that I thought that he takes a very well-appreciated approach or an underappreciated approach, but I asked kind of a mean question during the R&D Day and my team and my associates and I were kind of hiding on afterwards because I thought it was kind of a mean question. And he kind of sought me out afterwards and really wanted to continue to engage. And that ability to be in this listen productive, sleeves rolled up kind of mindset, I think, is one that characterizes him and the C-suite.
Chris Shibutani
So thank you for being a great guy and coming here so early after you basically had your holidays ripped away from you with all the deals, but I think it's an exciting time for the company. We'll be looking forward to a lot of the progress and these deals closing and watching the portfolio to grow in 2024. Adam Lenkowsky, we appreciate it. Thank you.
Adam Lenkowsky
Thanks for having me, Chris.
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Bristol-Myers Squibb Company (BMY) Management presents at Goldman Sachs Healthcare C-Suite Unscripted Conference (Transcript)