Good morning, everybody. I'm Chris Schott at J.P. Morgan. It's great to see everyone back in person again at the conference. It's my pleasure today to be introducing Bristol Myers Squibb to again kick off the J.P. Morgan Conference. From the company, we have Chris Boerner, the Chief Commercial Officer. Unfortunately, Giovanni was unable to be with us today as he's recovering from COVID. Before I turn it over to Chris, I did wanna remind people that we've moved away from the breakout session format this year at the conference. We're gonna be doing Q&A from the stage after the presentation. If anybody has any questions, you can use the app to send those to me, and I'll work them into the conversation. With that, Chris, happy to be here.
Thanks for joining us and look forward to the presentation.
Thank you, Chris. Good morning, everyone. It's great to be back live with all of you and to help kick off this year's J.P. Morgan. It is such an exciting time and interesting time to be in the industry. I know we're certainly looking forward to a productive week here in San Francisco. From our perspective, it's also a great opportunity to give you an update on our performance and to talk a bit about why we see such an exciting future at Bristol Myers Squibb. Let's dive into it. This is obviously our disclosure slide. Let me start by reminding you of the strategic foundation of the company.
We have been executing on a very consistent strategy at Bristol Myers Squibb for well over a decade. That strategy centers on us as an innovation-driven company, developing medicines in areas of high unmet need. This is a strategy that has served us very well. It's a strategy that has enabled us to deliver profoundly important drugs to patients across a host of therapeutic areas. It is one that has led to a significant transformation of the company. The output of that transformation is what you see on this slide. When you look at Bristol Myers Squibb today, we are in a very strong position. Importantly, we have multiple waves of innovation that support long-term growth.
When you look across the therapeutic areas that we focus on, the therapeutic areas that you see on the top of this slide, we continue to build breadth and depth, including having important, and in many cases, leading in line assets, an exciting portfolio of new products that have significant long-term opportunity and key mid to late stage assets in our pipeline. All of these support our ability to renew and grow our business. Of course, we have more catalysts coming this year that will continue to evolve this picture. Clearly, you get here as a result of very strong execution. On this slide, let me show you a little bit about how we got here.
When we were last together in 2020, we talked a bit about what we needed to accomplish from a financial standpoint, as well as with respect to progressing our portfolio. As we look across these metrics, we see a very strong track record of execution. Financially, as promised, we've grown our company. We've grown with respect to revenue as well as EPS. We've reduced our debt, and in fact, we have over-delivered on our synergy expectations, and we've generated significant cash flow. That's important, obviously, as an enabler of our ability to continue to invest in the business, but also, and we'll talk more about this, to continue to focus extensively on business development. We've also delivered on our portfolio. We've launched nine new medicines, including three medicines, all of which were first-in-class last year. Similarly, we've continued to execute on business development.
As a result of this, we are well-positioned to renew our portfolio and deliver long-term growth over multiple waves. Those waves of innovation are graphically depicted here. I like this framework because it highlights the progress that we are making in securing near-term growth, as well as articulating multiple paths and optionality for growth in the latter half of the decade. It starts with the nine new products that I referenced earlier. The growth from those products has been bolstered by a second wave of innovation coming from six registrational assets, collectively which have substantial growth. If you combine the early execution of our pipeline along with our continued disciplined business development, we now have visibility into a third wave of growth that will become increasingly important in the latter part of the decade.
I'll dive into each of these waves of innovation in more detail on subsequent slides, but let me first tell you a bit about what it means for us from a financial standpoint, as well as with respect to our portfolio. The net effect of the progress that we have made is to solidify our confidence in our growth trajectory as a company. If you combine the performance of our base business as well as the potential that we see from our new product portfolio, we continue to have confidence in the growth prospects that we have in the short term to grow through the exposure we have from REVLIMID's LOE and deliver on the commitments that you see on the left-hand side of this slide.
Thus, the focus shifts to the paths for growth in the latter part of the decade, and here too, we see multiple paths for growth stemming from the waves of innovation that I referenced earlier. Of course, as we pursue these paths for growth, we continue to diversify and build a much more resilient portfolio. That diversification you see on this slide. As the decade progresses, we transition from a company that was concentrated with a few relatively large products spread across our therapeutic areas to a company that is a much more diversified portfolio with multiple large and important medicines within each of our therapeutic areas, as well as a portfolio that is earlier in its life cycle. We see this making us a much more resilient company, especially as we think about navigating the increasingly complex external environment that was referenced earlier.
For example, as you think about the policy changes in the U.S. embedded in IRA, as we get to the middle of the decade, BMS is a company that not only has a younger portfolio, but a portfolio that is also increasingly diversified. Diversified across therapeutic areas, diversified across modalities, and diversified across payer types. We think that's gonna be critical to our success and our ability to continue to navigate this uncertainty. I promised that we would double-click on each of those waves of innovation, so let's start doing that now, starting with our new product portfolio. You see on this slide the progress that we're making in terms of renewing our inline business. We've now launched nine new products in the U.S. Those products have good momentum collectively, and in fact are annualizing at over $2 billion.
Importantly, we see these new products as having significant growth potential. Growth potential in the short term from existing indications, as well as in the longer term from multiple line extensions. As many of you may know, we launched three of the more important of these medicines last year, all of which were first-in-class medicines. Let me give you an update on each of those now. I'll start with CAMZYOS. CAMZYOS was approved last April, and it is the first and only myosin inhibitor targeted for the treatment of obstructive hypertrophic cardiomyopathy, and in fact it's the only product approved that really gets to the underlying causes of HCM. Since approval, our focus has been on establishing the foundation for the long-term success of this product, and we're very pleased with how things are going.
You can see on the right side of this slide some of the progress that we've made recently. During the last quarter, we've increased the breadth of prescribing for this product. We've increased the number of customers who are certified to prescribe CAMZYOS. We've made nice progress in increasing the number of patients being treated, as well as very good progress in converting those treated patient scripts into commercial dispense. All of that gives us very good momentum coming out of 2022 into this year where we'll continue to drive growth for this very important product for patients. The newest product that we've launched is Sotyktu. Sotyktu is the first and only TYK2 inhibitor on the market. It was approved in psoriasis last September.
Many of you may recall, we were successfully able to negotiate a very clean label for this product, and that label reflects both the science that went into the development of the drug, as well as all of the data that we've seen coming out of our phase II and phase III clinical programs. This launch is going very well. We're building volume quickly, which is the focus that we have commercially for this product. We already have over 2,000 scripts, and importantly, in just the first month and a half post-approval, over a quarter of all new oral scripts in psoriasis are going to Sotyktu. We're sourcing patients evenly across naive patients, as well as those patients who are experienced on Otezla or a biologic, which confirms physicians' willingness to use Sotyktu across multiple patient types, and that's important.
We've seen good momentum in terms of new volume month-over-month. All of this gives us confidence that the profile of Sotyktu is resonating with both physicians and with patients. Importantly, as we continue to build volume quickly, this puts us in a much better position to be able to negotiate a better market access position as we get later into this year, and certainly as we get into 2024. Let me briefly touch on Opdualag, which is our third IO checkpoint inhibitor in melanoma. This launch continues to perform very well. We have share now in the high teens in firstline melanoma, and we still have room to grow this product given the fact that PD-1 monotherapy, where we expect that the majority of patients will come from, that share in firstline melanoma is still between 15% and 20%.
As we get more clinical data with this program, Opdualag has the potential to extend our IO franchise well into the next decade. What does this mean for us when you put it all together? A few things are clear. First, if you combine the performance of our base business as well as the new product portfolio performance, we remain confident in the $10 billion-$13 billion of risk-adjusted revenue that we expect from the new products in 2025, and that's gonna be important to delivering near term growth for the company. Second, with the line extensions for this new product portfolio that have already read out, we have significantly de-risked the $25+ billion in non-risk adjusted long-term potential that we see for this portfolio.
Finally, as you see in the middle of this slide, we have additional de-risking events that we expect over the next two to three years. Net-net, we feel very good about where we are with this new product portfolio, and we feel very good about the ability of this portfolio to help us compensate for near term LOE exposure, as well as to meaningfully contribute to the long-term growth of the company. As I just told you, we have a lot more to the story than just our new product portfolio. Let me talk for a minute specifically about some key late stage assets. We now have six assets that are in or very close to registrational development, and each of these assets has the potential to significantly benefit patients and support the long-term growth profile of the company.
Taken together, we believe that this portfolio has well in excess of $10 billion in potential at peak. While peak may be beyond 2030, we think the performance of these drugs once approved, will still have the potential to further our growth profile in the latter half of the decade. Let me give you a quick update on each of these products, and I'll start with Milvexian. Milvexian is an asset that we think has the potential to extend our leading cardiovascular franchise well into the next decade. Based on all of the data we've seen from our monotherapy, as well as our combination studies, we think it has the potential to deliver efficacy at least as good as what we see with Factor Xa, but with a better bleeding profile.
That's why, along with our partner J&J, we're planning a registration program that consists of three indications. The first of which is in secondary stroke prevention, which we anticipate starting soon. You can see on the bottom of this slide some of the specifics around that first study, and of course, we'll continue to update you on the details of the other studies as we flush those out in the coming months. Based on what we've seen with the milvexian data thus far, we think it has the potential to be a very important next generation antithrombotic with an excess of $5 billion of potential across three indications, specifically SSP, AFib, and acute coronary syndrome. Turning to our two cell mods in multiple myeloma, we see a place for these two agents in different segments of multiple myeloma.
We're developing iberdomide to be a potential new backbone therapy in the post-transplant maintenance setting. I think many of you know this is a large opportunity. It has over 10,000 patients in the U.S. mezigdomide, we think has the potential to be an important medicine in the relapsed/refractory setting. Importantly, last year we made good progress. We advanced both of these drugs into registrational development. I think all of you know, multiple myeloma is a very large market well in excess of $20 billion. In spite of a lot of innovation that we've seen in multiple myeloma, there continues to be considerable unmet need, and we think these two drugs have the potential to help address that unmet need. LPA1 is one of our newest opportunities, this one in pulmonary fibrosis.
For those of you who don't know, pulmonary fibrosis is a disease with a very high unmet medical need. It's a roughly $3 billion a year market. Today, there are two medications approved for the treatment of pulmonary fibrosis. Unfortunately, they have limited efficacy and some tolerability disadvantages. We actually know this mechanism has the potential to slow progression and potentially address the underlying fibrosis of the disease based on a first-generation asset. Late last year, we saw data from our phase II program with a second-generation a-asset that showed good efficacy as well as a favorable safety profile. That allows us to move into a phase III, which we will do later this year.
Based on the phase II data, we believe this has the potential to be an important new option for the treatment of patients with lung fibrosis, and it's also a nice illustration of the optionality that comes from having a very deep and broad pipeline. Let me spend a minute on repotrectinib. Repotrectinib is our opportunity in ROS1-positive lung cancer. I think many of you will remember we acquired this asset as a result of the acquisition of Turning Point last year. We think repotrectinib has the potential to be a best-in-class ROS1 inhibitor based on the compelling efficacy data as well as particularly compelling duration of response data. Currently, the ROS1 market is about a $500 million-$600 million annual market.
We believe based on the profile we've seen with repotrectinib, we have the potential to possibly double the size of that market, and we very much look forward to launching this asset soon. Finally, I'll turn quickly to cendakimab. Our focus with cendakimab is as a potentially differentiated IL-13 for the treatment of eosinophilic esophagitis. EoE is a new and evolving market with a large opportunity for new therapies. Today, there is only one drug that is approved, and there remains significant unmet need for this debilitating disease. The phase III for cendakimab is already underway, and we could see data as early as next year. Of course, there's more to the pipeline than just the late-stage assets, so let me transition quickly to speak to the optionality that we see coming from the early-stage pipeline as well as business development.
We have a very strong innovation engine at BMS. If you combine the execution of our internal discovery expertise with the broad external relationships we've established, we have built an exciting pipeline of over 50 phase I and phase II assets. This pipeline sits on top of a platform, multiple platforms that include small molecules, complex biologics, and cell therapy. Of course, we continue to execute against this pipeline. In fact, we expect over 15 proof-of-concept decisions over the next 18 months or so, we'll talk about a couple of the few of the assets that we think will be moving into potentially registrational development or late development on the next slide. In addition, we'll be bringing in over 30 additional assets entering the clinic we expect over the next couple of years.
You can see on this slide a few of the assets with the potential to move to full development in the near term. Alnuctamab is our BCMA bispecific. We presented very encouraging data at ASH just a month or so ago, data that showed good efficacy as well as favorable safety. From our protein homeostasis platform, we're advancing another CELMoD in hematology, this one in lymphoma. We think CC-282 has the potential to combine with both standard of care as well as novel agents, and we expect proof of concept data for this asset later this year, which of course will inform our phase III. We also have an opportunity to expand this platform into solid tumors with a small molecule that's targeting prostate cancer. The proof of concept and dose optimization study for this asset is already underway.
These are just three illustrations of the optionality that's emerging from our pipeline, and we look forward to continuing to update you on the progress of these programs as well as other programs from the pipeline. Tying things together really across the portfolio, what you see are multiple near-term catalysts. We've used this scorecard format to update you on our performance in recent years. As you can see, this is already a busy slide, and as we continue to execute across our pipeline, we anticipate continuing to fill this slide out. Of course, we're gonna update you on the performance against each of these catalysts as we go forward. Beyond the pipeline optionality, we continue to be in a strong financial position and pursue a balanced capital allocation approach.
This means that we have been able to reduce our leverage, return cash to shareholders through growing the dividend, remain opportunistic around share repurchases, and importantly, remain focused on business development as a top priority. With respect to business development, we'll continue to assess deals based on their strategic alignment, the soundness of the science, as well as the attractiveness of the financials. We're also going to continue to focus on deals that further strengthen the growth profile of the company. Given the importance of business development, let me give you a little bit more color on our efforts. We have a very strong track record, as I think many of you know of converting balance sheet favorability and flexibility to revenue growth. You can see some of the recent transactions that we've executed on the left-hand side of the slide.
These recent deals have brought into the company multiple new products as well as attractive pipeline assets. Significantly, they have strengthened the growth profile of the company. Looking forward, we have developed very deep scientific, financial, and executional skills with respect to business development. That puts us in a very good position to continue to execute disciplined business development going forward. To summarize, we are very well-positioned to renew and continue to grow the business in the long term. We've executed very well across core elements of the business. That puts us in a very strong position today. The new product portfolio is off to a very good start. The long-term potential of this portfolio of assets continues to be significantly de-risked. Coming behind these new products are a late-stage pipeline that continues to advance and an early-stage pipeline with considerable optionality.
We're in a very strong financial position, and that gives us considerable firepower to continue to further strengthen the growth outlook of the company through business development. Hopefully this gives you a flavor of why we are so excited about the future of Bristol Myers Squibb, and with that, I will look forward to answering your questions. I'll turn it back to you, Chris. Thank you.
While you're walking over here, I'd like to start with a big picture question. I think the Street remains very focused on some of your late decade LOEs, and I think you talked about in the slides your $25 billion kind of non-risk adjusted target. If you just maybe elaborate a bit of how confident you're feeling today about Bristol's ability to manage through that patent cycle that we're all kind of looking at, looking out, you know, five, six years.
You know, I think we feel very good about the opportunity and the growth profile that we have for the company throughout the decade. Obviously, you don't get to the outer years of the decade to your question until you get to the middle of the decade. On that front, as I highlighted just now, we feel really good about our ability to grow through the middle of the decade and that initial LOE exposure that we have with REVLIMID. The new product portfolio is off to a good start. It's already annualizing with significant revenue. We have to remember that a number of these products are still very early in the launch cycle, so products like CAMZYOS and Sotyktu. There's additional catalysts that we have as we expand capacity and cell therapy.
All of that, along with the performance of the base business, gives us a lot of confidence in that middle of the decade, which of course establishes a very solid foundation as we think about the back half of the decade. Clearly, as you get further out, there's just by definition, more uncertainty. The way we think about it is wanting to have multiple pathways for growth. There, I think, as I mentioned, we've got multiple ways to continue to grow as a company. One, the new product portfolio not only has a lot of momentum into the mid-term, but it has a lot of potential that has been significantly de-risked already as we think about the long-term opportunity. Second, we've got those registrational products that I highlighted, and embedded in those are potentially very meaningful products. I know milvexian, which has a lot of potential.
The CELMoD programs, obviously, you have to wait and see the data, but those programs have potential. Even though you have smaller opportunities there, like LPA1, collectively, those are potentially very significant contributors to growth in the outer years. Then, of course, we've got optionality and the ability to do business development as well. If we step back from it and look at it in its totality, we feel very good about the prospects we have to grow through the decade as well as those two periods of LOE exposure.
Great. Another big picture one for me is you've obviously de-risked a number of the pipeline assets, but I think that some of the launches, at least relative to Street expectations, have maybe been a bit more gradual.
Mm-hmm.
Than we've been expecting. Maybe just hear your perspective. I know you're doing a $2 billion run rate with the new product portfolio. How have these launches gone? Have there been any kind of learnings or, you know, how should we think about that, I guess, over the next few years of these ramps?
Yeah. I think in totality, the launches, we're very happy with the performance. Remember, a number of these products, as I mentioned, are still very early in the cycle. In fact, two of the most important products we launched last year, Sotyktu and CAMZYOS, we're still in the very early days of those launches. We anticipate as we expand cell therapy capacity, we have the ability to ramp those two products. The profile for both of those agents is holding up very well, and we've seen either already executed or have the opportunity to expand the label for both of those products. This is gonna be an important year to continue to drive incremental growth with products like REBLOZYL and with increasing access to ZEPOSIA. Overall, we feel very good about those launches.
Now when you launch nine new assets in a short period of time in the midst of a global pandemic...
Mm-hmm.
Not everything's gonna go exactly to script. I would say that there are a number of things that as we look back on it, that we continue to learn and adjust to, and I'd like highlight maybe a few things. First, obviously, we launched some of these early assets at the beginning of COVID.
Mm-hmm.
That I think was something we all had to adjust to very quickly. Not only did we have to adjust how we had to engage with customers had to engage with how they staffed up and engaged with us. I think that I've been a little surprised at the variability with which some of those markets have come back. We're still seeing, as we've discussed in oncology, a number of indications that are still 15%-20% behind new patient volume that we saw pre-COVID.
Mm-hmm.
That's something that we continue to have to work our way through. Logistics have been very important across these launches, not only our logistics, but for a product like CAMZYOS, we've had to work with customers to make sure they've got the infrastructure set up to prescribe that product. You know, a number of these launches were in areas that we had to build de novo capabilities in, and so as we've thought about building patient support programs for a drug like ZEPOSIA, some things worked very well, some things didn't. We had to adjust quickly and learn not only for that product, but also to incorporate those learnings into the patient support programs we have for Sotyktu and CAMZYOS. That's gone very well, but it sort of emphasizes the need for agility and very quick learning and adaptation.
The good news is really across all of these launches is we have a great team. That team has stuck with us through all of the ups and downs of COVID. I think from a commercial and medical standpoint, we've been able to identify those things that have gone really well and leverage those, and those things that haven't gone as well and learn from them.
It sounds like still a lot of opportunity and the peak sales forecasts are largely intact.
Yep.
-just kinda continuing to execute along. Maybe just pivoting to the individual products and some of the statistics on the Sotyktu are interesting. Just a little bit more about just the experience that you're finding with that initial launch. Are you finding the drug resonating more with community physicians versus KOL? Is there just any more color we can, we can get on that uptick?
Yeah. The launch for Sotyktu is going very well.
Mm-hmm.
We continue to be impressed not only with the resonance of the profile of Sotyktu with academic physicians, most of whom we had been engaging with on discussions around the label going into the approval, but particularly in the community setting. In fact, we've seen significant uptake of Sotyktu in the community where the vast majority of these patients are gonna sit. In that dimension, we feel really good.
Mm-hmm.
The profile continues to resonate, and that's I think reflective of the fact that we have a very clean label, which enables us to articulate a very clear differentiation against Otezla, which, as you know, coming into this launch, was the standard of care for oral psoriasis. In terms of what we've heard back, we've got good uptake in terms of new trialists for this product. We see increasing in trialists and the number of trialists as well as the depth of trialists week over week. The volume coming out of this early launch is also continuing to increase nicely. I referenced that volume becomes important because one of the things we've gotta do is build volume quickly to be able to negotiate a better access position for this product as soon as possible.
A particularly nice statistic for Sotyktu is the fact that we have got over a quarter of new product scripts already going to Sotyktu, that's something that is a particularly impressive number just one month after the approval of the drug. You add it all up, we feel like we're coming out of the first full quarter of the launch of this product feeling great about where we are.
Great. I think you talked more about 2024 as being a time horizon-
Yeah.
Where we'd see broad coverage of the drug, but as you mentioned, the 25% kind of new start share. If you're able to sustain that, is there a possibility some of that coverage gets pulled into 2023?
We get asked that question a lot. I would say our incentives are completely aligned with everyone who asks me that question. Obviously, our focus is to ensure that this product, which is not only first-in-class, but clearly based on its profile, we believe the best product for the treatment of psoriasis from an oral standpoint, we wanna get that into the hands of patients as quickly as possible. That means making sure that we get access as quickly as possible. The thing that we control in order to do that is to drive volume very, very quickly.
While we've talked about the importance of those negotiations as it relates to the January formulary updates, we're obviously gonna do everything we can to pull that forward, and the way we do that is to take the momentum we have coming out of 2022 and continue to drive that forward in 2023.
Okay. one more on this one. I think from the slide it says about evenly split the volume.
Yep.
So far of naive patients versus Otezla failures. Is that what you would have anticipated? As we think about longer term, where do you see the role for Sotyktu? I mean, do we see Otezla still being kind of like the frontline drug and then you step into Sotyktu? Or do you think the drug can move into kind of a frontline systemic kind of position over time?
Well, our position is that this needs to be the oral of choice, and given the fact that is when you come off of topicals, typically what you will do is you'll start with an oral therapy. We very much envision that that's where Sotyktu is going to play. I think with respect to what we're seeing thus far, it's not terribly surprising just given the fact that when you launch a new product, physicians are gonna find a way to incorporate that into how they're treating their patients. When you have a drug with the profile that Sotyktu has, very clear and compelling efficacy differentiation across relative to the existing oral therapy, physicians are gonna find for the patient sitting in front of them a way to potentially use that product.
In some cases, where access would allow it, they'll go for a naive patient. In many cases, it's gonna be those patients, at least initially, who have experience on a biologic or on nintedanib already. In some ways, that dynamic is playing out as expected.
Okay, great. Maybe just continuing along on the new product launch side, CAR-T capacity, I think
Yep
...a big topic in 2022. just maybe on Breyanzi, just give us an update. Where are we in terms of getting more capacity to be able to really ramp that product?
Yeah. Well, we're very excited about the potential that we have with Breyanzi, given the fact that we've expanded that label. That expansion actually roughly doubles the opportunity that we have with the initial indications when you go from third line into second line. Clearly, capacity becomes important. What we had said last year was that we anticipated being able to ramp capacity coming into 2023 through this year, and we're very much on track to being able to do that. As I step back, as I said, in my prepared remarks, we're very happy with the profile of this drug. It's holding up exceptionally well, and I would say the same is true actually for Abecma.
As I think we discussed on the third quarter call, we were actually able to increase our supply of Abecma in the second half of last year, and we feel very good about the trajectory for capacity with that asset as well.
When I think about that capacity coming on board for Breyanzi, is it a fairly tight kind of window between when you get capacity and when we'd see revenue step up? Or is there promotion efforts and education efforts that need to go into the product that you can't really do until you have the capacity, I guess?
Well, I think it's a little bit of both. I think that initially what you can say really with respect to both of these assets is that in these later lines of therapy, there's probably more demand for these products than the capacity that exists, not just from us, but in many respects in the market. In that regard, as more capacity comes online.
Mm-hmm
that translates into additional patients being treated. I think where promotion becomes particularly important is as you expand the label opportunity for these assets, obviously, you gotta make sure that you're educating customers on the opportunity that you have with cell therapy. Increasingly, it's important to make sure you maintain a very good connection with customers, because where you encounter potential challenges with capacity, you've gotta make sure you're able to keep physicians engaged and customers engaged with the product, and we've done that exceptionally well. I think in general, as you think about the ramp of these, it's more going to be a steady increase as capacity comes online.
Mm-hmm.
Additional patients will be able to be treated.
Okay, great. CAMZYOS continuing on the kind of the big new launch opportunities. You got any surprises from the education process or rollout so far that kind of inform your view of how this could... Where it positions in the market?
I think the biggest surprise that we had, I think there was a positive and a more challenging aspect to it was, we've talked about this previously, is that when we launched, we had a number of accounts that were a little slower in terms of getting their internal logistics set up. Those were some of the larger centers of excellence. We've spent probably the majority of our time in this launch getting those centers up and running. The interesting thing is, while a handful of these larger centers had to work through some of the logistics associated with this product, we had a number of medium and smaller size institutions that got up to speed very quickly and began putting multiple patients on therapy.
I think we feel very good about having navigated that, but that was probably the biggest surprise in terms of sort of the execution of the launch. I will say a second surprise with this asset has been the consistency with which the feedback on this drug has been overwhelmingly positive. Physicians are seeing the benefit of this product. They're seeing it impact patients very, very quickly, as quickly as one or two cycles into therapy. That not only confirms for us the profile that we were attracted to with CAMZYOS, but how that profile is actually playing out in the real world.
Entering 2023, are we at a point with CAMZYOS where it is more focused on kind of commercial ramp, or are we still in part of that, this education kind of certification process?
Remember, we targeted this initial phase of launch to roughly 500 institutions that account for roughly 60% of the business. There, we've made very good progress in terms of engaging with customers, not only on the initial discussions of getting certified, working through the REMS, but also continuing to update them on the clinical profile and what we're hearing from other customers. That process has gone very well and will continue. I think the focus really is within these institutions to get patients onto therapy. We had always anticipated that patients would come onto therapy as they come in for those routine visits. I think we're starting to see particularly some of these larger institutions try to get patients in more quickly.
That actually creates some of the logistical challenges, 'cause if you're gonna have 100 or 200 patients that could potentially at an institution be treated, how do you manage those patients coming in? How do you get them in? Who's gonna actually work through some of the requirements to get patients initiated? We've worked through that, but I think our focus right now is get as many of those patients into the clinic and on therapy, just given the profile of this drug.
Okay. Maybe turning to the next six assets. I think milvexian's gotten a lot of attention. Just from your perspective, what do you think we need to see from these phase III studies to help, I guess, differentiate from ELIQUIS? I'm kind of thinking most of the life cycle of that drug is gonna be in a world where there's generic ELIQUIS.
Yeah.
Tell me a bit about what, you know, what type of profile you ideally would wanna see to be able to be successful with that.
Yeah. Well, remember, just if we step back, as we think about the milvexian development program, first and foremost, we're gonna be developing this in large part where Factor Xa's don't play.
Okay.
Right now you don't see much use of Factor Xa's in SSP or ACS primarily, this actually speaks to the reason to develop milvexian. You don't see that because it's very difficult to combine Factor Xa with the standard of care dual antiplatelet therapy that's the backbone for treatment of those two diseases, and you can't combine those primarily because of the toxicity and the specifically the bleed rates. There's a big push of the development program we have with this agent that won't be in a space where Factor Xas or even generic Xas would be at play. As we think about AFib, which is really the area where that's relevant.
Mm-hmm.
Our focus is on demonstrating with milvexian the ability to have efficacy, at least as good as what you see with backbone Factor Xas, but with a better bleed profile. What we know from our experience with ELIQUIS is that a large percentage, upwards of 40% of patients, either don't get a Factor Xa or are undertreated primarily because of a concern of bleeding. For those patients, we think there's a clear opportunity with milvexian if the data play out as we expect. Now, as you think about the broader population in AFib, that's where a concern about potentially generic Factor Xas being relevant. There, the reality is it's gonna be data dependent. What I would say is we've thought about the commercial opportunity for milvexian.
We've anticipated that the vast majority of the use that we get in AFib is gonna be in that 40% of patients for whom Factor Xas aren't relevant today.
Okay, that makes sense. Maybe in the last minute or so here, just think about capital deployment and kinda priorities there. Last year, it seems like we had the ASR, we had a couple smaller tuck-in deals. I guess, is that kind of a roadmap to think about Bristol's capital deployment kinda strategies going forward? You know, could we see that skew more towards BD or even more share repel? I guess just, you know, how do you think about this year setting up?
Well, I think that the way we talk about capital allocation is that we start from the, from the fact that we are in a very strong financial position, and what that gives us the ability to do is continue to return cash to shareholders via the dividend and growing that dividend.
Mm-hmm.
We continue to have optionality in terms of share buybacks. Business development remains a top priority for us. The way we think about business development is we're gonna continue to put a significant focus there. We'll continue to be size agnostic. We'll focus on deals that, as I mentioned before, make strategic sense for the company, that have science where we feel that we can contribute and be a leader in. Obviously, the financials have to be important. We're gonna continue also to focus on deals that continue to further strengthen the growth profile of the company and contribute to those multiple ways of how we think about growing the business.
Great. I think we're about out of time. Chris, I really appreciate all the comments.
Thank you, Chris.
Thanks for joining us.
Yep, thanks for the time.
Thank you.
Yep.