Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary

February 9, 2023

New York Stock Exchange US Health Care Pharmaceuticals conference_presentation 28 min

Earnings Call Speaker Segments

Seamus Fernandez

analyst
#1

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 fifth annual oncology conference. And 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. And after that, we're going to jump right into Q&A.

Christopher Boerner

executive
#2

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 and it really sort of starts on this slide. As we look at BMS today, BMS is in a very strong position. We are -- 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. And 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 where 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. And as we think about that in specifics, it's really outlined on this slide. We have now launched 9 new medicines, 3 first-in-class medicines were launched last year. And 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. And there, we see multiple paths to growth, as you can see on the right-hand side of this slide. Specifically, you 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. So let's maybe just quickly jump through each of those specific areas, starting with the new product portfolio. As I mentioned, we launched 9 new medicines over the last 2.5 years or so, including the 3 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. But importantly, as you see in the middle of this slide, the long-term potential of these assets has been significantly de-risked. And as you can also see, we have continued near-term catalysts that will read out over the next 1 to 2 years. So 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. And 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. And then 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 to 24 months. Included in this group of products are 2 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. And then, of course, supplementing all of this is, I think, a very well-demonstrated ability to do business development. So 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.

Seamus Fernandez

analyst
#3

Great. Thanks, Chris. So I think one of the things is that 2023 -- 2022 has sort of started off as kind of a key execution year. Now I think 2023 all eyes are on Bristol-Myers in terms of the execution on the product launches. Can you just give us a sense of what you're most focused on and what you would encourage investors to think about as kind of the gauges of these various launches?

Christopher Boerner

executive
#4

Yes, 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 stay most focused on are, first and foremost, the success of those 3 products from last year. Those are very early on in their life cycle. But 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. And again, a product that's picked up momentum over the course of last year, and 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. And the other 2 I would highlight would be the 2 cell therapy assets. Good growth for both assets in the fourth quarter. This year, it's all going to be about continuing to see an uptick in supply. The profiles for both of those drugs look very good. So 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 and then it's those new products. And then, of course, we've got to continue to execute on the pipeline as well.

Seamus Fernandez

analyst
#5

Right. And 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 with Revlimid because I think your guidance was more conservative or seem more conservative last year? You guys kind of crushed that number to some degree. So are we just talking about a very conservative view of Revlimid this year? Are we talking about well-reasoned sort of brackets for that product?

Christopher Boerner

executive
#6

Yes, 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, and 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 drop-down. We still believe, as you flash forward and think about '24 and '25, an average to think about is about $2.5 billion per annum in terms of the decline for Revlimid in each of those 2 years. Remember, we don't have really much of an optic on how wholesalers are going to manage their inventory of Revlimid. We certainly have no influence on it. And so 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.

Seamus Fernandez

analyst
#7

Okay. Great. And as we sort of look at the P&L, one of the questions that we get is on OpEx management to some degree. You guys are doing a phenomenal job there. But there's also the sort of follow-up question that we get, which is -- how are you doing it? And are you fully optimizing the spend behind the new product launches? And is there a point where you say, okay, maybe we do need to deploy more resources in that regard?

Christopher Boerner

executive
#8

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. So I feel very comfortable that we continue to not only put resources -- the appropriate resources against those launches today, but we are constantly looking for opportunities to either exceed our internal expectations or pull forward the opportunity we have with these products. So not concerned about investment in those launches. In terms of what we -- how 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 for more established products, later life cycle 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. So that's on the MS&A side. And then routinely as we go through the portfolio, we're looking at every single one of our investments on -- is there a scientific rationale to continue this, does it give us the right return on investment. So there are opportunities there as well. But that's how generally we think about optimizing spend.

Seamus Fernandez

analyst
#9

Great. And then as we sort of move beyond that, we can probably just jump right into oncology because this is an oncology conference. So 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 kind of feel like Opdivo has been doing well, but perhaps it was delayed by the pandemic or something along those lines, but I feel like Opdivo could be doing a little bit better.

Christopher Boerner

executive
#10

Yes. 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% to 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. So we're heavily focused there. We've seen good uptake in 816 in the neoadjuvant lung space. I think there's additional opportunity to grow there. In first line, our business is in the mid-teens, but we're actually seeing a bit of momentum in the PD-1 negative. So that's going to 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. And then as you think about the next few years, we've got a number of additional opportunities there with periadjuvant lung cancer data. We've got the opportunity in the early stage in unresected lung cancer with 73L, periadjuvant bladder cancer, adjuvant HCC, first-line HCC. So a number of studies that are going to 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 of melanoma. And so that's going to be a clear area of focus for us as well.

Seamus Fernandez

analyst
#11

And 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. But there's also the lung cancer and liver cancer opportunity. So I just love to see how you see this brand, I guess, combination brand evolving going forward?

Christopher Boerner

executive
#12

Yes. Well, I mean, obviously, the first thing we're focused on is the opportunity sitting [indiscernible] in front of us, and 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% to 60% of the use today is in that population. And remember, there's still about 15% to 20% share of PD-1 monotherapy, roughly even [ loose split ] between Opdivo and KEYTRUDA in first-line still to be taken. So we think that's the lowest-hanging fruit for this product. We are seeing about 40% to 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. But we are seeing a number of physicians choose to use Opdualag in lieu of that combination. But certainly, there's opportunity there as well. And then 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 going to 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. And then we'll have additional data readout over the next couple of years in HCC as well as in CRC. So 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.

Seamus Fernandez

analyst
#13

Great. And I think we've probably now moved past the depth of skepticism that the market had about cell therapy. I think we're pretty comfortably beyond that. What -- where do you see cell therapy really going, whether it be in the multiple myeloma setting or with the CD19 setting for Breyanzi and Abecma and obviously, very competitive areas. But what are you learning about the landscape and the interest from physicians today?

Christopher Boerner

executive
#14

Yes. 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? How -- what will be the uptake? And 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. And 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. So as we look at our 2 products, a few things. First, from a competitive standpoint, we are very happy with the profile of these 2 drugs. In -- 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, 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. So that real-world data is absolutely being played back to us. And then 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. And 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. But 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. And we see steady growth in capacity for both of those products over the course of the year.

Seamus Fernandez

analyst
#15

Right. And as we think about the magnitude of the supply increases, as you look at yields improving. Should we think about that as highly scalable over time such that the reach into the earlier line settings is also going to scale right alongside manufacturing? Or is it sort of a Steady Eddy as she goes improvement?

Christopher Boerner

executive
#16

It's very much irrelevant question because even if you look at Breyanzi's performance last quarter, about half of the apheresis that we were seeing were coming from the second-line setting. So there is a strong desire to not only use these products in late line, but to move them up as appropriate. So manufacturing becomes critical there. I think the way we've thought about manufacturing capacity is really on 2 dimensions. First, you have a vector supply challenge that has to be addressed. We've manage that by trying to increase the number of suites, working more closely with external suppliers, where you're ultimately going to 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. But until then, we've got to make sure we're continuing to drive vector capacity. And I think we've been successful in doing that. And 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. And 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 going to be opening a state-of-the-art facility in Devens focused on -- Devens, Massachusetts focused on cell therapy as well as in the Netherlands and [ Leighton ]. So there were also well in the way to increasing capacity.

Seamus Fernandez

analyst
#17

Great. 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. And as we just sort of think about some of the pushes and pulls that you have to wrestle with, importantly, IRA kind of layers into that. 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 could have come to market sooner, I think, but perhaps maybe it's better for them to not come to market sooner?

Christopher Boerner

executive
#18

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 going to learn a lot this year because as much as we know about IRA today, there's a lot more we don't know. And I think as the framework gets filled out for exactly what this is going to look like over the course of this year, we'll be better able to understand exactly what this means. But 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 periadjuvant studies are just now reading out many, many years after the first approval. So those kinds of questions are questions we're going to have to be wrestling with small molecules. Also we'll have to wrestle with what are the implications of that. But where we sit today, I think the way we look at it is we're going to continue to invest in good science. We're going to continue to invest in products that have value to not only patients but the health care system. And then we're going to evaluate on a case-by-case basis once we know more about exactly how IRA plays out.

Seamus Fernandez

analyst
#19

Great. And T cell engagers, other sort of opportunities and even competitive bispecifics that are starting to be introduced today. 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?

Christopher Boerner

executive
#20

Yes. 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 2 or 3 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 development -- 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. So 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. And then finally, we're looking at additional novel targets like GPRC5D and -- and I mentioned earlier, we have a cell therapy against that target with really interesting data that we showed at ASH. So that's conceptually how we're going at multiple myeloma. The one thing that we see playing out in this space is well -- 2 things maybe. One is there's considerable -- in spite of a lot of innovation there's considerable unmet need here. And 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 going to be targeted to specific patient types and the needs of those specific patients. So you may have cell therapy within the second or third line targeted to a some of patients and then CELMoDs and TC engineered antibodies or bispecifics to others. So 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.

Seamus Fernandez

analyst
#21

Great. So one of the other things is where you're headed in solid tumors from a next-gen perspective beyond Opdualag. How do you -- how are you thinking about your IO/IO strategy? And then also, we just heard a lot of talk about targeted therapy in lung cancer. Maybe you can kind of walk us through how Bristol is thinking about targeted therapies in cancers? And lastly, I know you guys licensed the ADC from Eisai, how are you thinking about some of that space as well?

Christopher Boerner

executive
#22

Yes. I mean, 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. So 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. So that's going to be an important component of that. You mentioned that we've been licensed in ADC. We obviously have our own TIGIT program. And so 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, and that's in a second line plus prostate cancer population. And that could be very exciting. And again, that's a proprietary program that we have where we have the ability to have multiple targets across both solid and liquid tumors.

Seamus Fernandez

analyst
#23

Great. I think we have time for one last question. So I'm going to go to SOTYKTU and because as the Chief Commercial Officer, it's fun to go away from oncology every once in a while I'm sure. As you think about one thing that we talked about on the recent conference call was launch trajectory and the free drug dynamic that's kind of coming into play quite a bit more. As you look at this brand moving through the year, do you see the opportunity for off-cycle additions to formularies that actually will start to realize an improved gross to net? And when might we start to really get visibility on prescription trends in that regard?

Christopher Boerner

executive
#24

Yes. Well, let me answer the last piece of that question first, which is we're going to continue to give updates on the quarterly calls on how we're doing from a prescription standpoint. And 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, very compelling market share already after the first couple of months of launch. And for better or worse, the world we live in, in this particular marketplace is that you've got to break down rebate walls. And 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 have been getting from another product not coming in. And 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. But 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. But it's certainly something that we're very focused on. And 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 0, 1 steps for this very important drug. We've got the profile to do it, and we're seeing good uptake.

Seamus Fernandez

analyst
#25

Great. Well, I think with that, unfortunately, we have run out of time but a really fantastic discussion, Chris, thanks so much for coming and joining us here at our fifth annual oncology conference at Guggenheim.

Christopher Boerner

executive
#26

Pleasure to be here.

Seamus Fernandez

analyst
#27

Thanks so much.

Christopher Boerner

executive
#28

Thank you.

Read the full transcript via the API

You're viewing the first half of this call. Get the complete Bristol-Myers Squibb Company transcript — plus 251,000+ transcripts from 12,000+ companies, speaker segments, AI summaries and full-text search — through the EarningsCalls.dev API.

Get the API View API docs →

For developers and AI pipelines

Programmatic access to Bristol-Myers Squibb Company earnings transcripts and 251,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.