Okay, good afternoon, everybody. Thanks for joining us for today's fireside chat discussion with Bristol Myers Squibb. I'm Seamus Fernandez, Guggenheim's Global Biopharmaceuticals Analyst. We are here at our 5th Annual Oncology Conference. To my right is Chris Boerner, Chief Commercialization Officer of Bristol Myers Squibb. I've asked Chris to share a few slides on where Bristol is in its transformation journey. After that, we're gonna jump right into Q&A.
Thanks, Seamus. It's great to be here with you and great to see everybody. We did think it would be helpful to kick off this fireside by just reiterating how we think about the growth profile of the company. It really sort of starts on this slide. You know, as we look at BMS today, BMS is in a very strong position. We've spent the last few years really transforming the company from one that is a business that is heavily concentrated in a handful of large but important products to a portfolio that is a younger portfolio. It's a much more diverse portfolio, and it's diversified across therapeutic areas, across modalities, and of course, across payer types.
It's really that portfolio, along with the continued strength that we have coming out of R&D as well as business development, which gives us the building blocks for we think really good growth, not only in the early part of this decade, but really as we get into the latter half as well. As we think about that in specifics, it's really outlined on this slide. We have now launched nine new medicines. Three first-in-class medicines were launched last year. Given the momentum we have with those products as well as the strength of our base business, we feel confident about our ability to deliver on our financial goals for the middle of the decade, and thus the focus really does shift to the latter half of the decade.
There, we see multiple paths to growth, as you can see on the right-hand side of this slide. Specifically, we see additional growth from that new product portfolio that I just referenced. We also have an exciting next wave of assets coming from R&D, and then continued optionality from research and development as well as our ability to continue to do targeted business development. Let's maybe just quickly jump through each of those specific areas, starting with the new product portfolio. As I mentioned, we launched nine new medicines over the last two and a half years or so, including the three I referenced last year. The momentum, even though those products are still very early in their life cycle, the momentum we see coming out of those, gives us confidence in that midterm revenue estimate that you see on the left-hand side.
Importantly, as you see in the middle of this slide, the long-term potential of these assets has been significantly de-risked. As you can also see, we have continued near-term 1-2 years. We feel good about the ability of this new product portfolio to drive growth really throughout the decade. Buoying those products is a next wave of mid-stage assets. I had presented this slide last month. We decided to provide a bit more perspective on what we see as the revenue opportunity with these products. What you can hopefully see on this slide is that in addition to potentially providing meaningful therapeutic benefit for patients across multiple disease areas, each of these products individually and certainly collectively, have the potential to contribute significant growth to the company in the second half of the decade.
Finally, we have a very rich portfolio of phase I and phase II products. Many of those products have the potential to advance to late-stage development over the next 18 - 24 months. Included in this group of products are two exciting CELMoDs. One is targeting lymphoma, the other is in solid tumors targeting prostate cancer. We have a BCMA-targeted T-cell engager in that mix that will likely move forward into late-stage development, as well as our next generation cell therapy asset, GPRC5D, which had very interesting data presented at ASH last December. Of course, supplementing all of this is, I think, a very well-demonstrated ability to do business development.
If you add it all up, hopefully you get a sense of how we're thinking about the growth trajectory of the company, not only in the midterm as well as the long term, why we have so much confidence in that, and it hopefully gives you a framework for how to think about it. With that, maybe I'll turn it back to you.
Great. Thanks, Chris. You know, I think one of the things is that 2023, you know, 2022 has sort of started off, as kind of a key execution year. I think 2023, all eyes are on Bristol Myers in terms of the execution on the product launches. Can you just, you know, give us a sense of, you know, what you're most focused on and what you would encourage investors to think about, as kind of the gauges of these various launches?
Yeah. Absolutely. 2023 is a critically important year from an execution standpoint. I'd say it's an important year to execute really across the board. From a commercial standpoint, the 9 products that I mentioned are critically important. I would say the things I would say most focused on are, first and foremost, the success of those three products from last year. Those are very early on in their in their life cycle. We're, we're very focused, obviously, on continuing to drive the uptick of SOTYKTU in psoriasis. We're off to a great start coming out of the fourth quarter. Obviously, we've got to continue to build a strong foundation for CAMZYOS and obstructive HCM. Again, a product that's picked up momentum over the course of last year, we anticipate continued growth with that product this year.
Opdualag is off to a phenomenal start in first-line melanoma. There's additional opportunity to drive growth with that product this year. The other two I would highlight would be the two cell therapy assets. Good growth for both assets in the fourth quarter. This year, it's all gonna be about continuing to see an uptake in supply. The profiles for both of those drugs look very good. I'd say in general, our focus is on continuing to drive the base business. We have important drugs like Eliquis and OPDIVO we can't take the eye off the ball on. It's those new products. Of course, we gotta continue to execute on the pipeline as well.
Right. You know, the recent guidance, I think, sort of surprised folks a little bit just because of the magnitude of the decline that is projected with REVLIMID. Can you just explain what's happening?
Sure.
With REVLIMID? I think your guidance was more conservative or seemed more conservative last year. You guys kinda crushed that number.
Mm-hmm.
To some degree. Are we just talking about a very conservative view of REVLIMID this year, or are we talking about, you know, a well-reasoned sort of brackets for that product?
Yeah. I think the guidance we've given is really the way we see this playing out. Last year, we had anticipated REVLIMID sales of about $9.5 billion. We ended up with $10 billion. We fully expect that additional $500 million to flow out this year. That really reflects the guidance that we gave for REVLIMID this year, which was $6.5 billion, which would be roughly a $3.5 billion dollar drop-down. We still believe, as you flash forward and think about 2024 and 2025, an average to think about is about $2.5 billion per annum in terms of the decline for REVLIMID in each of those two years. Remember we don't have really much of an optic on how wholesalers are gonna manage their inventory of REVLIMID.
We certainly have no influence on it. It's something the erosion of this product is one we just have to stay focused on, and we'll continue to provide updates as appropriate.
Okay, great. You know, as we sort of look at the P&L, one of the questions that we get is on OpEx management.
Yeah.
To some degree. You guys are doing a phenomenal job there. There's also the sort of follow-up question that we get, which is, you know, how are you doing it, and are you fully optimizing the spend behind the new product launches? Is there a point where you say, "Okay, maybe we do need to deploy more resources in that regard"?
Well, let me start by saying that we're absolutely optimizing the investment across these launches. These launches are critical to the growth of the company, as I highlighted just a few minutes ago. I feel very comfortable that we continue to not only put resources, the appropriate resources against those launches today, but we're constantly looking for opportunities to either exceed our internal expectations or pull forward the opportunity we have with these products. Not concerned about investment in those, in those launches. In terms of what we see the OpEx playing out, what we guided to was low single-digit decline in operating expense for this year. The way that gets executed, I think, is different across functions within the company.
From an MS&A standpoint, we're pretty efficient already today, but that doesn't mean that we can't find additional opportunities to divert resources, particularly as we think about moving resources from more established products, later lifecycle products, over to support these launches, and also find opportunities to potentially reduce resources. I'll give you an example of that. Coming out of the pandemic, clearly, digitization is a much more important factor in terms of how we engage with physicians. That's given us an ability to optimize spend. That's on the MS&A side. Routinely, as we go through the portfolio, we're looking at every single one of our investments on, is there scientific rationale to continue this? Does it give us the right return on investment so there are opportunities there as well? That's how generally we think about optimizing spend.
Great. you know, as we sort of move beyond that, we can probably just jump right into oncology because this is an oncology conference.
Yeah.
You know, as we just sort of think about the opportunities, where in oncology are you seeing better than expected performance from the portfolio, and where would you actually like to see a little bit of a catch up? I kinda feel like OPDIVO has been doing well, but perhaps it was delayed by the pandemic or something along those lines. I feel like OPDIVO could be doing a little bit better.
Yeah. I mean, I think what we've seen with OPDIVO is we had promised that we would grow that business in 2022. We delivered double-digit growth with OPDIVO last year. I would say there's continued opportunity to grow OPDIVO. The areas that we think are probably most prime for growth this year are, we've got continued opportunity in GI cancers. We've got the sort of broadest label of anyone in the metastatic space. We have about 45% - 50% share in the metastatic space, depending upon the patient population. Similar share, actually, in the adjuvant setting as well, but there's still room to grow that business. We're heavily focused there. We've seen good uptake in 816 in the neoadjuvant lung space.
Mm-hmm.
I think there's additional opportunity to grow there. In first line, you know, our business is in the mid-teens, but we're actually seeing a bit of momentum in the PD-L1 negative, so that's gonna be a continued area of focus for us. The big thing that we've been paying a lot of attention to in this IO business generally is the sort of flow of new patient starts into oncology post the pandemic. We saw a little bit of improvement in that at the end of last year. Obviously, we'd love to see that continue. But we feel good about the growth for OPDIVO in 2023. Then as you think about the next few years, we've got a number of additional opportunities there with peri-adjuvant lung cancer data.
We've got the opportunity in the early stage in unresected lung cancer with 73L, peri-adjuvant bladder cancer, adjuvant HCC, first-line HCC. A number of studies that are gonna read out over the next couple of years that give us opportunities to continue to grow that franchise. The last thing I would say is we still have ample opportunity to grow Opdualag in the first-line setting.
Yeah.
Of melanoma. That's gonna be a clear area of focus for us as well.
Remind us where the share is today on Opdualag and what the sort of next opportunity in melanoma is. I guess one of the areas that I've always been excited about is to see that move into the adjuvant setting.
Yeah.
There's also the lung cancer and liver cancer opportunity. Just love to, you know, see how you see this brand, I guess, a combination brand, evolving going forward?
Well, I mean, obviously, the first thing we're focused on is the opportunity sitting right in front of us, that's in first-line melanoma shares in the upper teens today. The way we thought about the growth for this product has been the lowest hanging fruit is PD-1 monotherapy. That's where the data are strongest for this asset. That's where we've been targeting our commercial efforts. About 50%-60% of the use today is in that population. Remember, there's still about 15%-20% share of PD-1 monotherapy, roughly evenly split between OPDIVO and KEYTRUDA, in first line still to be taken. We think that's the lowest hanging fruit for this product. We are seeing about 40%-50% of use coming from OPDIVO + YERVOY.
Frankly, from a financial standpoint, we're ambivalent as to whether it comes from OPDIVO + YERVOY or Opdualag. The reason we haven't targeted that population initially at launch is just the strength of OPDIVO + YERVOY survival data in first-line melanoma. We are seeing a number of physicians choose to use Opdualag in lieu of that combination. Certainly, there's opportunity there as well. As you mentioned, I think the next space you would look at from a proof of concept standpoint would be the adjuvant space. That trial is gonna take a bit longer to play out, so we would expect that in the next couple of years. We'll have lung cancer proof of concept data, hopefully later this year that will inform next steps with that program.
We'll have additional data readout over the next couple of years in HCC as well as in CRC. We think this is a product that has a lot of legs, not only in its existing indications, but potentially in other tumors as well.
Great. You know, I think we've probably now moved past the depth of skepticism that the market had about cell therapy.
Yeah.
I think we're pretty comfortably beyond that. What, you know, where do you see cell therapy really going, whether it be in the multiple myeloma setting or with the CD19 setting, you know, for Breyanzi and ABECMA, and obviously very competitive areas, but what are you learning about the landscape and the interest from physicians today?
Yeah. Well, having been in cell therapy for a long time, even going back before Bristol, I can tell you, I think you're right with your first comment that the skepticism generally about this class of medicines has decreased significantly. When we acquired Celgene, most of the conversations we were having was, can you get access for this product? You know, what will be the uptake? I think what we've seen, certainly with ABECMA and Breyanzi, but I think in general with this class, is that physicians are getting comfortable with utilizing these products. In some cases, they're utilizing a product like Breyanzi in the outpatient setting. Certainly, the market access environment has improved for these products.
As you continue to see studies play out, you see additional opportunities to use these products not only in different patients in the later line setting, but we're starting to now see those products move into earlier lines of therapy.
Yeah.
As we look at our two products, a few things. First, from a competitive standpoint, we are very happy with the profile of these two drugs. You know, and for ABECMA in multiple myeloma, obviously, it's a competitive space with J&J, but what we're seeing physicians play back to us is they like the profile in terms of its efficacy and in particular, its safety. They like the fact that they're seeing real-world data that mimics what they saw in the clinical setting and actually in a more advanced and sicker patient population. That real-world data is absolutely being played back to us. On Breyanzi, we still are perceived to have the best-in-class profile relative to competitive products. That's based on the strength of efficacy and safety.
There, I think the opportunities are to continue to advance that product into earlier lines of therapy and potentially into a broader set of patients. Overall, we're happy with what we're seeing with cell therapy. The key constraint, obviously, has been manufacturing, and we're working diligently to improve upon that. We were able to move forward some of the capacity for Breyanzi that we had anticipated not being able to deliver until this year into Q4 of last year. We see steady growth in capacity for both of those products over the course of the year.
Great. you know, as we think about the magnitude of the supply increases, you know, as you look at yields improving, should we think about that as, you know, you know, highly scalable over time, you know, such that the reach into the earlier line settings is also going to scale?
Yeah.
Right alongside manufacturing, or is it sort of a steady Eddie as she goes, improvement?
It's very much a relevant question 'cause even if you look at Breyanzi performance last quarter, about half of the apheresis that we were seeing were coming from the second line setting.
Mm-hmm.
There is a strong desire to not only use these products in late line, but to move them up as appropriate. Manufacturing becomes critical there. I think the way we've thought about manufacturing capacity is really on two dimensions. First, you have a vector supply challenge that has to be addressed.
Yeah.
We've managed that by trying to increase the number of suites, working more closely with external suppliers. Where you're ultimately gonna get success, we think in vector supply, is moving to the next generation, which will be suspension vector, and that will happen hopefully over the next couple of years. Until then, we've got to make sure we're continuing to drive vector capacity, and I think we've been successful doing that. As we look at the increase, we see a steady increase in vector supply over the next couple of years that will sustain our ability to drive into earlier lines of therapy. The second thing you look at is then drug supply and drug capacity. There, it's a matter of having the availability of capacity internally and getting the FDA approval to scale up.
We've had good success in scaling up with our existing facilities, and we've now announced that we're gonna be opening a state-of-the-art facility in Devens, focused on Devens, Massachusetts, focused on cell therapy as well as in the Netherlands, in Leiden. There, we're also well in the way to increasing capacity.
Great. you know, We had to talk a little bit about the pipeline and sort of the optionality in the pipeline, which in multiple myeloma is predominantly small molecule drugs. As we just sort of think about some of the pushes and pulls that you have to wrestle with.
Yep.
Importantly, IRA kinda layers into that.
Absolutely.
How do you think about the what impact has that had on your strategic thinking from a longer term perspective and even for these brands that, you know, could have come to market sooner, I think, but perhaps, you know?
Yep.
Maybe it's better for them to not come to market sooner.
Well, IRA poses a number of strategic challenges that I think we're all going to have to work through. I think in reality, we're gonna learn a lot this year because as much as we know about IRA today, there's a lot more we don't know. I think as the framework gets filled out for exactly what this is gonna look like over the course of this year, we'll be better able to understand exactly what this means. Clearly, we have some concerns about the ability, for example, in oncology to move into the adjuvant setting because of just historically how you have walked into that patient population starting in late line, working your way up to larger and larger studies, and then eventually getting into the adjuvant setting.
I referenced the fact that a number of our OPDIVO adjuvant and peri-adjuvant studies are just now reading out many, many years after the first approval. Those kinds of questions are questions we're gonna have to be wrestling with. Small molecules, also we'll have to wrestle with what are the implications of that. Where we sit today, I think the way we look at it is we're gonna continue to invest in good science. We're gonna continue to invest in products that have value to not only patients, but the healthcare system. We're going to evaluate on a case-by-case basis once we know more about exactly how IRA plays out.
Great. T-cell engagers, other, you know, sort of, opportunities and even competitive bispecifics that are starting to be introduced today.
Yep.
How are you thinking about that, in terms of the access points to earlier lines of therapy relative to cell therapy and is that kind of a balancing act that Bristol is kind of playing in its own research?
Yeah. Well, the nice thing is we have multiple modalities that we're targeting to multiple myeloma. I'd say our approach to multiple myeloma has two or three key components to it. First, we have a novel set of CELMoDs that really have been potentially very exciting. We've got iberdomide and mezigdomide that are heading into late stage development now. Iberdomide will be initiating a phase III against REVLIMID in post-transplant maintenance. We think mezigdomide could play in the relapse and remitting setting of multiple myeloma. I think that's one component. The second component are novel agents targeting BCMA. Obviously, we have cell therapy, T-cell engineered antibodies coming as well.
Finally, we're looking at additional novel targets like GPRC5D, and I mentioned earlier we have a cell therapy against that target with really interesting data that we showed at ASH. That's conceptually how we're going at multiple myeloma. The one thing that we see playing out in this space is. Well, two things maybe. One is there's considerable in spite of a lot of innovation, there's considerable unmet need here. Second, historically, this is a disease area where you've thought about drugs by line of therapy. We think given the amount of innovation in this space, you're likely to see that become much more fragmented, where in individual lines of therapy, agents are gonna be targeted to specific patient types and the needs of those specific patients.
You may have cell therapy within the second or third line targeted to some set of patients, and then CELMoDs and TCE-engineered antibodies or bispecifics to others. That's sort of how we see that market playing out, but clearly having more modalities to go after it puts us in a good position.
Great. you know, one of the other things is where you're headed in, solid tumors from a next gen perspective.
Yep.
Beyond Opdualag. How are you thinking about your IO strategy? Also, we just heard a lot of talk about targeted therapy in lung cancer. Maybe you can kinda walk us through how Bristol's thinking about targeted therapies in cancers. Lastly, I know you guys in licensed the ADC from Eisai, you know.
Yep.
How are you thinking about some of that space as well?
I mean, I again, I think I would start with we have obviously a very strong and big business with immuno-oncology in addition to the, I guess, 11 tumors and 25 indications we have with OPDIVO. We've got 15 ongoing registrational studies with some sort of OPDIVO combination. That's still a big business for us, and we'll look for opportunities to combine anything we're doing with those agents. We have repotrectinib, which we'll launch hopefully later this year, which we believe is a best-in-class targeted therapy against ROS1/NTRK. And there we see the opportunity to not only become a best-in-class agent based on the strength of duration of response data that we've seen coming out of the phase II, but also potentially to expand that market. It's about a $500 million market today.
We think we have the potential to possibly double that market. That's gonna be an important component of that. You mentioned that we've in-licensed an ADC. We obviously have our own TIGIT program, the way we thought about solid tumor oncology is to continue to look for additional modalities beyond IO that may be used either synergistically with our immuno-oncology portfolio or separately. One area that we're particularly excited about is the use of CELMoDs in solid tumor. We'll have the first real proof of concept around that coming out with our AR LDD program, which is targeting prostate cancer. We should see data on that program later this year, that's in a second line, plus prostate cancer population. That could be very exciting.
Again, that's a proprietary program that we have, where we have the ability to have multiple targets across both solid and liquid tumors.
Great. I think we have time for one last question, so I'm gonna go to SOTYKTU, and because as the Chief Commercial Officer, it's fun to go away from oncology every once in a while.
Yeah.
I'm sure. You know, as you think about, y ou know, one thing that we talked about on the recent conference call, was, you know, this launch trajectory and the free drug dynamic that's kind of coming.
Yep.
Into play quite a bit more. As you look at, you know, this brand moving through the year, do you see the opportunity for off-cycle additions to formularies that actually will start to realize and improve gross-to-net? You know, when might we start to really get visibility on prescription trends in that regard?
Yeah. Well, let me answer the last piece of that question first, which is we're gonna continue to give updates in the quarterly calls on how we're doing from a prescription standpoint. Then, of course, there will be secondary data sources that you can look to as well. We are incredibly happy with the performance of this product in its first full quarter. We've got great momentum, both in terms of script volume. We've got very compelling market share already after the first couple of months of launch. For better or worse, the world we live in in this particular market, marketplace is that you've got to break down rebate walls.
The way you do that is you build volume, you build volume quickly, ideally, to the point that you're able to demonstrate a trajectory for your drug, and importantly, to the extent possible, that payers begin to see rebates that they would've been getting from another product not coming in.
Yeah.
The nice thing is we're seeing both of those right now. We are engaging with payers, and we'll continue to do that. What we've said is that the base case for improved access is going to be 2024.
Yep.
Clearly, we have every incentive to try to move that forward. We're having good discussions right now. We have about 10% of patients who have open access today. It's certainly something that we're very focused on. We do believe there's a possibility, perhaps not with all plans, but potentially with some, to move into a better position. Remember, our goal ultimately is to get to zero one steps for this very important drug.
Yeah.
We've got the profile to do it, and we're seeing good uptake.
Great. Well, I think with that, unfortunately, we have run out of time, but a really fantastic discussion.
Good. Thank you.
Thanks so much for coming and joining us here, at, our 5th A nnual Oncology Conference.
Pleasure to be here.
Thanks so much.
Thank you.