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

November 17, 2021

New York Stock Exchange US Health Care Pharmaceuticals conference_presentation 42 min

Earnings Call Speaker Segments

Timothy Anderson

analyst
#1

Okay. Well, good morning and thank you to everyone for joining us to our Wolfe health care conference that runs today and tomorrow. We have a host of companies from my coverage, from Justin Lake's coverage, from Andrew Galler's coverage. And most of these sessions will be fireside chats. And we're going to kick things off this morning with Giovanni Caforio. He's the Chairman and CEO of Bristol-Myers Squibb. He has been with the company for quite some time, I think since 2000. And in case you missed it yesterday, the company held a very comprehensive Analyst Day, running through many aspects of the business, pipeline, key marketed products, future patent expiries, what Bristol is trying to do to stay [ relevant ]. And there was a lot of content. So why don't we start with some general questions, Giovanni?

Timothy Anderson

analyst
#2

So 2021 is coming to an end, just 6 weeks left. How is the setup for 2022 looking for Bristol? An intentionally very open-ended question.

Giovanni Caforio

executive
#3

Sure. Thank you, Tim, and thanks for having me. And good morning, everyone. So this is a really important time for us at Bristol-Myers Squibb. Yesterday, we had our meeting, getting close to the end of 2021 because we are at the 2-year anniversary of closing the acquisition of Celgene, which has really transformed the company. And we've made great, I would say, extraordinary progress with bringing the two companies together. Execution has been very, very strong in the company. And so where we are today is that our in-line business and the most important brands there are Eliquis and Opdivo. They're both doing extremely well in the marketplace. Eliquis continues to grow. It's a market leader in its field. And Opdivo has returned to growth, thanks to a number of really important catalysts that I'm sure we'll discuss and that will continue in the foreseeable future. So the foundation of the in-line business is very strong. We are launching nine medicines, which is an unprecedented number, over a short period of time. Six of them have been approved already. And we're looking for three potential, really important approvals next year: mavacamten, the combination Opdivo and relatlimab in melanoma, and the third one is deucravacitinib, where we -- yesterday we announced that the submission has been filed by the FDA, and we expect a PDUFA date in September of next year. So that's a very, very important new product portfolio which we believe has great potential. Of course, as we look at 2022, it's the beginning of generic entries for Revlimid, which is an important moment for the company. And so yesterday, we had an opportunity to reiterate our perspective that the combination of the growth of our in-line brands and the launch portfolio will more than offset the loss of exclusivity of Revlimid between now and 2025. And in fact, we expect to grow during this period. We communicated a target for the launch portfolio to have sales of between $10 billion and $13 billion in 2025. So a lot of the discussion really is on our ability to navigate this first exclusivity loss, and we're pretty confident we have an opportunity to do that.

Timothy Anderson

analyst
#4

So if you're -- if we're looking at 2022 pushes and pulls, right, you've got some new approvals coming through, some new launches underway and then, obviously, the loss of a major product starting to begin. So kind of how are you seeing that net out? I mean would you describe 2022 as a transitional year from a financial standpoint relative to 2021 where the growth has been clean?

Giovanni Caforio

executive
#5

Well, first of all, let me say we see 2022 as a year in which we are able to grow revenue and earnings. The -- there will be, as you said, different dynamics across the portfolio. The loss of exclusivity of Revlimid is driven by two factors. First of all, there is a straightforward LOE that happens internationally at the beginning of the year in Europe and in the middle of the year in Japan. And in the U.S., beginning in the second quarter of 2022, there is a sort of phased volume-limited entry of generics into the U.S. marketplace. So the impact on Revlimid is substantial. At the same time -- and we've said before that we see that as being somewhat more significant than what's reflected in consensus. Now when you look at the rest of the portfolio, I see the growth of Eliquis continuing. The growth of Opdivo can accelerate, in fact, because we started growing in the first -- in second half of this year, and that momentum will continue. And for the launch portfolio, the ones that have already launched, as of the third quarter, they were already annualizing at about $1.5 billion in sales. But obviously, that's a rapidly growing portfolio. And as I said earlier, there will be three more products to launch next year. So net-net, I see that as a year of growth in the top and bottom line. It is the beginning of a period that goes between '22 and '25, where sort of over time, Revlimid in the U.S. loses exclusivity in a way that is gradual every year.

Timothy Anderson

analyst
#6

On that topic of Revlimid, there's been consternation and uncertainty about the rate of decline. And you guys have talked about it being a slope, I think, to use your terminology, over a 4-year window from 2022 through 2025. And then come 2026, it fully goes off-patent, and this is all just in the U.S. that we're talking about here. We and I think others have pressed you sometimes to kind of quantify that more because that still leaves a lot of room for interpretation. And I think some of the angst around what that rate of erosion could be has been weighing on the stock in the last 3 months. So my question really is, why not kind of give more granularity on how much that rate might be? Or maybe you will, in fact, do that when we get to your 2022 full guidance that presumably comes in January.

Giovanni Caforio

executive
#7

Yes, absolutely, we are expecting we -- we're expecting to provide more granular guidance on '22 when we provide line item guidance in '22. And I can confirm that in fact, we see that as a slope and providing guidance in '22, I would argue, will give some visibility into the shape of that curve and how it continues for the following years. I think it's important to remember also that we are in litigation with still some companies for Revlimid. And so it's always important to think about that in that perspective, not necessarily in terms of how it impacts the slope but in terms of how -- sort of how much we disclose under those circumstances. But to answer your question, yes, we will provide more detailed guidance on '22 key elements at the beginning of next year, and that will include Revlimid.

Timothy Anderson

analyst
#8

Okay. And when you say slope -- I mean, when I think of slope, I think of a graph and a linear -- a line basically. Can we expect that this erosion is, in fact, kind of linear in the U.S. across that 4-year window? Or is it going to have some nonlinear shape?

Giovanni Caforio

executive
#9

So I think it's great that we have an opportunity to discuss it at the beginning of next year, and we'll have much more deal. I think what's important, though, is that the bottom line is that we do expect to grow during this period. And we've had a number of questions about what happens to the profitability of the business as the top line continues to grow. And there, I would say a couple of things. So first of all, obviously, Revlimid, you can imagine, is a very high gross margin medicine because it's a small molecule. It's a large-volume product. At the same time, there are some products -- and so there will be an impact on gross margin over a period of time. At the same time, as the new product launch portfolio ramps up, there are small molecules that are highly profitable in that portfolio as well. I think what's most important is that we see operating margins remain in the low to mid-40s during this period, and that's because I think we've got sort of a demonstrated ability to be very disciplined in terms of our OpEx base. And we've already made some of the investments that enable us to be ready for the launch of mavacamten, for example, which can leverage the infrastructure that exists for Eliquis already; and relatlimab, which really leverages the oncology infrastructure we also already have. So there will be an opportunity to be extremely disciplined from an OpEx perspective and maintain a high level of profitability for the business during the period.

Timothy Anderson

analyst
#10

Last question on Revlimid, and we'll focus on some other more important topics. My guess is there's not a lot of direct cost that you can pull out of Revlimid because it's a specialty product. Of course, limited prescriber base. It's not something, I think, you're running DTC on. And at this point, you're not doing a lot of R&D on it. So am I right to assume that this isn't a franchise where you could take a lot of direct costs out as the product starts to fade away? So that's number one. And then number two is will you actually still be promoting the brand across this 4-year window where it's a phased erosion in the U.S.?

Giovanni Caforio

executive
#11

Yes. No, thank you. First of all, you are right on the profitability of Revlimid. What I would say is that's the reason why our commitment to maintaining high operating margins in that range is important, because it gives you a perspective on the total financials for the company. There are opportunities actually to leverage the Revlimid infrastructure for the launch of new products because within hematology, the teams that are promoting Eliquis are transitioning to the promotion of Breyanzi and they're promoting Reblozyl. There is a large hematology portfolio that is building for the company, obviously Abecma -- that is building for the company that enables us to leverage that infrastructure. I think that to the extent that we continue to have hematology sales teams and medical teams in the marketplace as the rest of the portfolio grows, there could -- will continue to be a sort of focus on supporting the commercialization of Revlimid, because we look at this a little bit like we look at Opdivo, where we have an infrastructure that moves around different indications as we launch and the focus may vary one quarter from the other. So in hematology, we have a fully resourced organization. I think it's fair to expect a lot of the focus will shift from Revlimid to the new brands over time.

Timothy Anderson

analyst
#12

All right, I want to layer in one more question, and it's based on a comment that you made. Initially, when you guys did the Celgene deal January of 2019, you were very clear you were taking a more conservative erosion assumption than The Street. You just made a comment earlier that suggested you still are, but I just want to clarify. Is Bristol's assumption for Revlimid erosion, I mean, relative to what you see in consensus? I'm guessing consensus has come down a lot from January of 2019, from where it was. And do you feel that it's being appropriately modeled? Or is there anything you can say on that front?

Giovanni Caforio

executive
#13

Yes, I think it's important that it is -- from our perspective, nothing had changed. So our assumptions with respect to how the loss of exclusivity of Revlimid happens are consistent with what they were in 2019 broadly. Obviously, the performance of the brand has continued to evolve during this first period, and so the starting point has evolved over time but not significantly. I think what's coming to more focus for the investment community, it's my understanding, is more -- a better understanding of the international erosion. That hasn't changed for us either. But obviously, that is happening next year. And so depending on the model you look at, there are differences there, of course. But as far as the U.S. is concerned, there is really no change in our perspective.

Timothy Anderson

analyst
#14

Yes. Okay. So let's talk about what the stock has been doing. It was actually doing okay this year up until about 3 months ago. And then it began a short selloff in mid-August, going from a high of the year of around $70 to mid-50s. And it's just a touch above those levels now. Even before that happened, even when the stock was $70, Bristol and AbbVie have been the two companies tied for the lowest valuations. And they, of course, share this common element of having some big patent expiries ahead of them. So the recent declines, it reflects some nervousness about expiries not only near term but certainly longer term. And I think coupled with nervousness about how certain pipeline products might now be moved through 2022. And when you sum it together, it's this multiyear question about can Bristol effectively backfill things that are going away. And that's really -- it's a tug of war that a lot of companies face when you take this multiyear view of the industry. Because when you look out to 2030, what company doesn't have big products going away? The frustrating thing for investors, I think, has been that for the last 2 years, ever since you guys announced the Celgene transaction, you've really hit on the vast majority of things you could have hit positively on, positive datasets on things like TYK2 and LAG-3, indication expansion, Opdivo returning to growth, Eliquis winning in the courts and kind of taking that risk away, yet the stock just hasn't really seen multiple expansion. So my question to you is, you talk to investors frequently, what has the -- what's been the conversation over the last 2 years as you're trying to tell that story? Where do you get pushback? And then what are the concerns most recently that you're hearing in the last 3 months that suddenly seemed to kind of topple what the stock had been doing?

Giovanni Caforio

executive
#15

Sure. Well, let me step back and sort of answer your question in two ways. First of all, what is our strategy to address those losses of exclusivity? And then what are the areas of focus? In terms of what is our strategy, we've always said that we feel our objective is -- our primary objective is to actually have a company that is well positioned to navigate through the losses of exclusivity of Opdivo and Eliquis in the second half of the decade. And the acquisition of Celgene has been a really important part of that strategy because when you look at what we communicated yesterday, we see a very diversified company in 2025, where we have a launch portfolio of new medicines, 9 new medicines that have tremendous potential to grow from $10 billion to $13 billion in 2025 to over $25 billion in 2029 across multiple therapeutic areas, multiple modalities. A very diversified portfolio. So obviously, the focus on the Revlimid loss of exclusivity during '20 to '25 is important, but we've already spoken about that this morning. And I'm really confident we can navigate through that effectively. So the strategy, I think, is clear. You are right, there is wide recognition that our execution has been very strong. Yesterday, we presented our scorecard, which you've seen many times, for 2021, and that's a very, very good picture of what we have accomplished. Similarly, there are a large number of catalysts for 2022 and 2023 with new readouts, new approvals, continued progress with our pipeline. So what our focus is, and what we discuss with investors, is that the new launch portfolio needs to continue to do what it's been doing so far and become a more and more relevant part of our business mix. I mentioned $1.5 billion in annualized sales as of the third quarter. I see that continuing to be a bigger and bigger part of our business. And obviously, we have three important approvals next year. We feel comfortable about those. And I'm sure we'll talk about mavacamten and relatlimab and deucravacitinib. Those are an important part of the story which happen between now and September of next year. And I personally believe that as Revlimid begins to lose exclusivity next year, our ability to replace it will become more and more clear. So there is no fundamental strategic discussion that we're having for -- with investors. I think the focus is on execution and the strategy playing out over the course of this year for sure. And I expect that to continue to be the case and, in fact, to accelerate next year.

Timothy Anderson

analyst
#16

I have to imagine that when a company's stock is not performing well, management slowly comes under pressure to try to do something to make shareholders happy, to increase shareholder value. And some companies oblige on this more than others. But in reality, there's only so many strings that you can pull as a management team. You can decide to buy more things, you can sell off certain parts of the business. You can't necessarily control how the pipeline is going to play out. But how does this kind of impact how you think about trying to deliver shareholder value? I mean does it -- it seems like it does kind of force companies into higher levels of disclosure, for example. I go back to yesterday's analyst meeting. Again, thought you guys did a great job laying out a very comprehensive case. Lots of excitement, things going on. And the stock is left. We've put out a note. I think the title was something like a 3-hour analyst meeting in 4 pages. We summarized it in 4 pages. And someone kind of quipped back, 3 hours and 4 words. Hurry up and wait. So there's this kind of wait-and-see element on the stock. And is that just going to be how it is with Bristol, where it's just going to take tangible execution on the pipeline, for example, for the stock to start performing? What can Bristol do differently than -- at this point beyond what you already do?

Giovanni Caforio

executive
#17

Yes. No, thank you. First of all, let me say there's tremendous enthusiasm among the management team and in the company because of everything that is happening with the pipeline. And we are confident that we're building a company that is extremely diversified, with very innovative medicines and a real opportunity to grow this next -- this year, next year and over the course of the decade. So the best thing we can do is to say focused on execution and ensure that the scorecard for 2022 is actually as good as the scorecard for 2021 in terms of our execution. We are very disciplined with respect to the way we think about our business, the way we communicate the value drivers in the company. And we're very disciplined in terms of how we allocate resources and capital. Obviously, our priority is innovation because that's who we are as a company. We continue to invest in a disciplined way in internal R&D behind our key opportunities. And we also will continue to be disciplined in business development because business development can play an important role in complementing our own pipeline internal opportunities. At the same time, we've got a lot to develop in the pipeline, and you've seen that yesterday. We've also remained very balanced and disciplined in terms of returning capital to shareholders. We've grown the dividend double digit for the last 2 years that builds on 13 years of consecutive dividend increases. We're executing share repurchases opportunistically over time, and we've done about $12 billion of share repurchases since the acquisition of Celgene over the last couple of years. And I see us continuing to execute a plan that when you look at sort of our performance of the business and the progress of the pipeline, it's playing out as we planned or better than we had expected.

Timothy Anderson

analyst
#18

I want to kind of shift towards a quick question on M&A. But before I do that, I want to revisit the decision by Bristol to acquire Celgene. So it was met with controversy at the time of the deal. We certainly didn't expect it. It made the company much bigger and almost by definition harder to grow when you're bigger. It introduced more LOEs, more -- approximately like Revlimid, as well as intermediate-term LOEs like Pomalyst. And at least looking back in retrospect, I almost wonder whether Bristol's share price would have been higher today had you not done so. And the reason I say that is you've hit on your internal pipeline: TYK2, LAG-3, Opdivo's return to growth, Eliquis has become derisked. So I'm just wondering if you look back at all and maybe second-guess that decision or if you're just absolutely steadfast in your belief that you did the right thing with Celgene.

Giovanni Caforio

executive
#19

Well, Tim, when I look at the acquisition of Celgene, the strategic rationale I've mentioned a few minutes ago, I think it was very clear, it actually has played out better than our base case was. And when I look at our company today, it has tremendous potential. It is a more diversified business across four therapeutic areas. All of them have strong businesses. We are launching products in every one of our four therapeutic areas. We have a mid-stage pipeline that is maturing across the board. The loss of exclusivity of Revlimid is playing out as we had planned and is providing us tremendous financial flexibility with free cash flows of $45 billion to $50 billion in the next 3 years alone. And so the premise of the acquisition of the strategy, of the -- of Celgene was to create a diversified company that would have the breadth and depth of opportunities and resources to compete in the marketplace. I think that's playing out. So I don't spend sort of a lot of time thinking about what would have happened under different circumstances. Of course, that's an important exercise sometimes. But when I look at the premise for the acquisition of Celgene, it actually has played out very, very well. I know you've said it in some of your notes and some of the discussions that we've had.

Timothy Anderson

analyst
#20

So on that topic, what have been the unexpected positives for Celgene, things that have gone better? And then also, I mean, I'm sure there are some things that haven't gone as planned. So what have been the unexpected negatives or challenges for Celgene?

Giovanni Caforio

executive
#21

Sure. I mean let me just say first of all obviously we weren't expecting to have to divest Otezla. We didn't think that, that was necessary. The FTC asked us to do that. And while I think we're happy with the way that was divested and the value we received for it, obviously we would have loved to have that asset for our portfolio as well because we thought it was very complementary to deucravacitinib. I think that in terms of what has gone well, there are a number of things that are going as well or better. You will remember there was some concern as to whether, as an example, the cell therapy platform would result in products with a meaningful sales potential. Because when we acquired Celgene, the uptake of the existing CAR T therapies in the marketplace had been very low. We saw that the reimbursement situation for cell therapy has improved significantly. And actually, the demand that we've seen for Breyanzi and Abecma has exceeded our expectations. Now yesterday, we had an opportunity to discuss the TRANSFORM data, which is the second-line data for Breyanzi in B-cell lymphoma. Compared to standard of care, it's extraordinary data. I think it'll change the standard of care that has been there for 20 years. And now we see Breyanzi as one of the key growth drivers for the company with over $3 billion in revenue potential. There are multiple examples of other pipeline assets that have developed faster and better than we were expecting. And the last thing that I would say is that there has always been great concern for the integration between two large companies. And in our case, a lot of the integration actually happened during the pandemic. But I must say that as you look at how the company has continued to execute effectively during the integration, I'm really impressed with the fact that our business hasn't really lost momentum during that period and we've been able to retain key talent, integrate the teams and continue to advance the pipeline, I would say, at the same speed, if not a higher speed, than we would have under normal circumstances. So these are just examples of things that have gone better. When I look at the pipeline we have today, which we discussed over 3 hours in detail yesterday, it's the best pipeline BMS has ever had. It's about double the size across all lines of development or phases of development that we've ever had and we had in 2019.

Timothy Anderson

analyst
#22

So additional M&A from here. You had described yesterday what I think the prior messaging has been: small deals, midsized bolt-ons. I think you referenced MyoKardia as an example of a midsized bolt-on. That was a $13 billion deal. I have to imagine that the sort of thing is fluid. It depends on how the pipeline delivers. So it could be that if you end up having problems in delivering the pipeline, then obviously you reassess that. But I think, again, when we look at and others look at the magnitude of the expiries ahead, not just Revlimid, not just Pomalyst but Eliquis and Opdivo, it kind of says, well, you really got to kill it on the pipeline and probably still do lots of M&A. So the guidance right now is small to midsized deals. Are we going to see a lot of small to midsized deals?

Giovanni Caforio

executive
#23

Well, first of all, let me say our view starts from the fact that, as we said yesterday, we see the value of our pipeline as being higher than is currently reflected in consensus for the second half of the decade. And we're focused on the pipeline playing a really important central role in our opportunity to continue to grow the business during that period. We laid out some very clear financial targets, which actually have increased over the last 12 months since I first discussed this at the beginning of the year because the pipeline is actually going better than we had expected. I think it's also important to say that when we forecast the evolution of our business between now and 2029, it is clear that while we focus and have ambitious objectives for the late-stage pipeline that is launching today, there is a lot in the mid-stage pipeline that is heavily risk adjusted. And so the optionality that is in the pipeline is always underrepresented in any long-term view that you have. So I see tremendous optionality, and that's why yesterday, we said multiple paths to growth. Business development plays an important role. When I discussed yesterday, it's primarily science deals that are small deals, and we will look at small to medium-sized bolt-ons. It's primarily because our strategic framework for doing M&A leads us to those types of opportunities. But I can tell you we are size agnostic. We just reflect on the fact that when we apply our lens of generating value for shareholders and being financially disciplined, looking at transformational science and areas that are therapeutic areas that we know well, the majority of the deals we end up looking at are the ones I described. But we are agnostic with respect to size. I really don't see M&A as a reaction to something going wrong. I see M&A as an inherent part of our innovation strategy. We've done a lot of deals in the last 12 to 18 months, at a time in which the pipeline was delivering extremely well, because they were the right thing -- the right deals for us to do. And I see us continuing to do that. The good thing is we have tremendous financial flexibility. But at the same time, I can assure you we'll continue to be disciplined.

Timothy Anderson

analyst
#24

Another, and maybe final general question, is Bristol's footprint in China. So a number of years ago, Bristol exited certain emerging markets and kind of shrunk its overall emerging market footprint as we tried to kind of realign the portfolio. And when I think about what your footprint in China is now, I think it's clearly on the lighter side relative to the peer group. I think you guys still aren't disclosing what yourselves in China are, although maybe that's changed recently. But as you're a bigger company now and as you've got all this pipeline in front of you, to maximize what you have, don't you need to build up that footprint in China?

Giovanni Caforio

executive
#25

Yes. No, thank you. I think you framed it very well, Tim, and I agree with you. So we do have an opportunity to incrementally invest in China and other markets and grow our business internationally. And the reason why -- one of the reasons, I think it's the main reason, why our business in China is a smaller business than maybe other peer companies have is that there has been in the past a long period during which a lot of the growth in China has happened through more primary care assets that looked at diseases in which we didn't have a presence. And the specialty care market with the types of medicines that we are developing is growing in China now, but it has developed later than sort of the more traditional small-molecule primary care businesses. And I think now we are a big company and we have a broader portfolio, and it's a real opportunity for us. And so when you look at some of the indications and some of the medicines that we're focused today, I can tell you, for example, for some of the new indications for Opdivo, we are filing, at the same time, in China and other international markets as the U.S. There has been a real focus for the entire pipeline to include a strategy to address the needs in China, and I expect that market over time to grow faster for us and become a more important opportunity. So that's clearly a growth opportunity that we are pursuing.

Timothy Anderson

analyst
#26

And that's something that would presumably require additional field force and infrastructure build-out within the country. And you would just do that organically over time?

Giovanni Caforio

executive
#27

Yes, we do. We would and we will. And we're doing that already. It builds on an infrastructure which we already have because we've been in China for a long period of time. Some of our medicines like, you may remember several years ago, BARACLUDE, entecavir for Hepatitis C was one of the most successful launches in China for a long period of time. We still have an infrastructure that promotes that brand, and we are transitioning that infrastructure to oncology now. We are ready to pick up new therapeutic areas, and we are ready to incrementally invest in China.

Timothy Anderson

analyst
#28

Okay. I want to shift to maybe a brand discussion here at least on one product, maybe more. Eliquis launched in 2012, I think. It's been an amazing drug, about $11 billion this year. We've wondered when does it flatten out and just absolutely hasn't. One possible driver of in the not-so-distant future is Xarelto generics, which I think could come in the market in 2024. So I'm wondering if that could start to kind of impact the growth of that product. That's one question. And then the second question is, you've signed generic settlement agreements on Eliquis. You've guided that it will push generic entry to, I think, 2028. We don't really know the substance of those agreements, and I'm wondering if this could be like another Revlimid where we actually get phased generic entry over the period of some number of years that we just haven't learned about yet from the company.

Giovanni Caforio

executive
#29

Yes. No, absolutely. Let me say a couple of things. First of all, starting quickly with generics. We're very pleased that the courts reaffirmed the validity of our patents, including a formulation patent that expires later than 2028. We had signed a number of settlement agreements with generic companies that start in the middle of 2028. They're not volume-limited agreements. So I think you should think about the second half of '28 as a traditional small-molecular erosion curve. From the perspective of what drives growth for Eliquis, we see that Eliquis has become the leading agent in the class with shares that are above 60% across multiple markets. It's clearly the better medicine. It's the most cost-effective medicine as a result of its bleeding profile, and it's being widely recognized as such. And so while we're focused on sort of an entry of a generic later in that period, we feel we are very well positioned from a physician perspective but also from an access perspective to continue to be successful during that period.

Timothy Anderson

analyst
#30

Okay. Opdivo, maybe a question or two. Well, I guess one line of questioning here. Price erosion in Western markets. We have Lilly saying they'll compete on price. They really talked about it in U.S., says -- they haven't really said as much about places like Europe. I could see it possibly gaining more traction in Europe than in the U.S. You have companies like [ Etourette ] that say they'll come in and the value proposition will be price. And obviously, we've seen PD-1 commoditization in China already. So when you're looking at Opdivo and how it's returned to growth, is -- are lower-priced products something that you anticipated would occur? And do you think that will, in fact, impact the growth of Opdivo or that these will just be relegated to the distant margins and basically won't see much uptake or cause much disruption?

Giovanni Caforio

executive
#31

Yes. No, thank you. So first of all, our experience, when you look at very competitive therapeutic classes including in Europe, is that we have really not seen examples of reimbursement that has been granted beyond the indications in the label and the data that exists for individual products, including in some of the most cost-sensitive markets internationally. I would say with the exception of China, we have not seen any of the international markets where governments set very aggressive prices, situations where a product may have been reimbursed for an indication it didn't have, based on data it didn't have. And we definitely don't think that at this point, we've seen any indication of those dynamics existing in the U.S. So while we are looking at the issue of PD-1 commoditization, and it's clearly an area that we continue to follow very closely, at this point, given the volume of prescriptions that we have, the reimbursement dynamics in the U.S., the way we've seen it play out in some of the large international market, we don't see that as a significant dynamic playing out. Of course, it's one that we continue to look at, but that's our assessment. What I can tell you is that our focus is really on continuing to ensure the long-term sustainability of our I-O platform. And that's why we think that the combination of Opdivo and relatlimab, for example, as a fixed-dose combination and as a new product provides us a real opportunity to offer an option to patients that is really valuable in melanoma. And obviously, we have a longer exclusivity period and a very differentiated profile. And we are targeting to continue to expand the use of that strategy to adjuvant melanoma. And as you know, that combo is in clinical trials across a number of tumors, including lung cancer, hepatocellular carcinoma and colorectal cancer. That's one of the examples. We are working on a subcutaneous formulation of Opdivo. We think, from the perspective of the utilization of health care resources, that will be extremely cost effective, and it's part -- one of our strategies, and we'll continue to do that. But that's the way I think about it.

Timothy Anderson

analyst
#32

We're going to wrap up the discussion here. We're intentionally not asking about the pipeline just because you covered it in such detail yesterday at your Analyst Day and you have a great slide deck and we wrote out the summary as well. So Giovanni, I want to thank you for your time today. It's been super helpful. We look forward to seeing how the next year unfolds for the company. Thank you.

Giovanni Caforio

executive
#33

Thank you, Tim. Thank you very much. Thanks, everyone. Appreciate the opportunity.

This call discussed

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