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Bristol-Myers Squibb Company (BMY) Presents at Goldman Sachs 12th Annual Healthcare CEOs Unscripted Conference (Transcript)

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Bristol-Myers Squibb Company (NYSE:BMY) Goldman Sachs 12th Annual Healthcare CEOs Unscripted Conference January 9, 2020 10:25 AM ET

Company Participant

Giovanni Caforio - Chairman and CEO

Conference Call Participant

Terence Flynn - Goldman Sachs

Terence Flynn

Okay, great. Well, thanks for joining us everybody. I'm Terence Flynn, the bio-pharma analyst here at Goldman Sachs, and I'm very pleased to have Bristol-Myers Squibb with us this morning. Participating from the company we have Giovanni Caforio, who is Chairman and CEO. Giovanni, thank you very much for being here this morning, really appreciate the time.

Giovanni Caforio

Thank you, Terence. Thanks. Good morning, everyone.

Terence Flynn

So maybe to kick off, as everyone knows, this is about the one year anniversary of when you announced the Celgene deal, would love for you to maybe recap the progress that's been made here since the announcement? And looking ahead what are really the key drivers that we shall be focused on as we think about you guys generating a return from the acquisition?

Giovanni Caforio

Sure. Thank you, Terence, and good morning, everyone. Let me just say, first of all, I feel better about Bristol-Myers Squibb today than I felt when we announced the acquisition of Celgene. I feel better in terms of the potential the acquisition provides for us to have committed be the leading biopharma company and the opportunities that we have ahead of us. And so let me just give you a couple of perspectives to why, I think, things are going as well or better than planned. First of all, we have a number of businesses that have continued to have really strong performance in 2019 when you look at our hematology franchise with REVLIMID and POMALYST that has continued to be a good driver of growth. OPDIVO has performed very well in the indications when it's approved. ELIQUIS continues to be a driver of growth for the company, and pretty much everywhere you look the commercial performance of the business has been strong.

The second thing that I want to say is that we are working on eight exciting launches over a period of two years and that has been significant clinical and regulatory process with many of those launch opportunities. I would say, on the clinical side, we had two positive studies for OPDIVO in combination with YERVOY first-line lung cancer last year. We also had the pivotal trial data from -- for JCAR017 and lymphoma, which was presented at ASH. And at the end of last year -- and that data, really confirmed our perspective with respect to the differentiated profile of JCAR017 and lymphoma. We had, in house, the data for bb2121, the BCMA CAR T, in partnership with Bluebird, and that's an important asset as well. And finally, we presented some really interesting data on CC-486, which is an oral agent that can really be established potentially as a maintenance standard for patients with AML, and, so significant clinical progress with the late-stage pipelines. On the regulatory front, we were able to submit the file for ozanimod. We received approval for Inrebic. We did receive approval for Reblozyl in beta-thal. And we have important PDUFA coming -- PDUFA dates coming for ozanimod in March, and multiple sclerosis, Reblozyl and MDS in April. We also filed the -- submitted the file for JCAR017 and lymphoma at the end of the year. And so when you really think about the volume of activity from a clinical and regulatory perspective, we're very much on-track for eight potential launches over a period of approximately two years, which is unprecedented for us, and in many ways, I think, in our sector as well. You may remember that at the beginning of last year, I spoke about six potential launches. I’m now speaking about eight potential launches, because, obviously, the data in first-line lung cancer came later and 486 in AML came later. So that's an indicator of the third reason why I'm excited about the potential of the company, which is really the depth and breadth of the early pipeline and the multiple opportunities that we have ahead of us.

So for example, I think, we had a really good ASH in December. At ASH we presented many of the data that I referenced. We also presented some data on our BCMA T-cell engager, which was early data. From the early pipeline that data is early. It's a small number of patients, but it's very compelling as well. And again, speaks to the strength of the early pipeline of Bristol-Myers Squibb going forward. So I would say -- I feel really good about where we are. There is a lot that is going to be happening to us in 2020, but we're in a very good position as a company as we start 2020.

Question-and-Answer Session

Q - Terence Flynn

Great. Well, I think that's a great overview to kick us off. And we're going to get into a number of these topic points over the next 40 minutes or so. Maybe one near-term question and a long-term question, near-term, one of the focal points has been in 2020 guidance, you guys gave some preliminary thoughts about that when you announced the deal. Maybe just give us an update in terms of when to expect the new guidance? And then the second question, as you expect to provide both revenue and EPS guidance, I know, historically, you guys just give EPS, but, Celgene, obviously, has given more metrics. So how do you think about guidance over the near-term?

Giovanni Caforio

Yes. I mean, I think, first of all, let me say I understand the importance of articulating the financial profile of a new company, and investors are interested in us providing guidance. We have not communicated externally exactly what the elements of that guidance will be. What I can tell you that we will provide guidance at our fourth quarter earnings call when we communicate the full results of 2019, and the outlook for '20. That's what we usually done as a company and that's what we're going to do this year. And our call is scheduled every February 6th.

Terence Flynn

Okay. And one follow-up is just that I know you guys in late last year reiterated over 40% EPS accretion in the first year. Is that still on for target? I know there are some moving pieces. We are not asking for official guidance but just to think about that target you guys put out there, how should we think about that?

Giovanni Caforio

Yes, I mean, I think the way to think about it is a number of things have been happened since then. First of all, obviously, we've divested OTEZLA. We’ve also divested our UPSA business, which is our consumer medicines business in Europe. And then at the same time all of the things that I’ve just discussed points to real strength in the business. The other thing that I would say we are very much on-track with the synergies. And so as you will remember we committed to $2.5 billion in synergies and about a third during a period of three years, and we are very much on-track with that plan and that has reflected in our outlook for 2020. So when I look at 2020, again, from the perspective of the financial profile of the company, we’re pretty good about where we are.

Terence Flynn

We look forward to that next month. The other question is just a long-term one here that we get frequently, I'm sure you do as well. But just as we think about in the next couple years a big reason you get Celgene was to get access to a late stage pipeline, you have some upcoming LOEs to think about. So how do you manage through that LOE period here? That's one of the longer term focal points, obviously, Celgene is part of that. But what's the other component of the strategy?

Giovanni Caforio

Sure. I think that from my perspective when we start to thinking about the long-term prospects for Bristol-Myers Squibb, and we really thought about the second half of the decade with the losses of exclusivity of ELIQUIS and then OPDIVO, that was a really important for us to begin to prepare for the transition of our portfolio inside. I guess one comment that I had is this is the nature of our business. And we at Bristol-Myers Squibb have renewed our portfolio and our business successfully before when we lost the exclusivity for PLAVIX and ABILIFY, those were very meaningful, and the productivity of our R&D and business development engines enabled us to renew our portfolio. And so when I think about the future I think about it very much the same way. First of all I believe the late stage pipeline of the company today is clearly the broadest it’s ever been. I believe it is one of the most promising in the industry when you look at the number of opportunities we have for launches, and when you look at the fact that every pretty much -- every one of the assets that we have an opportunity to launch have lifecycle management potential opportunities with other indication comings, I think there is significant potential from the late stage pipeline. I believe that one of the core pillars of our strategy of Bristol-Myers Squibb has always been to basically take innovation, both internally and externally, and business development has always been a core pillar of our capital allocation strategy. So I see that continuing in the future. And I believe that as a company now we have significant financial strength and flexibility. Now, obviously, in the next couple of years our commitment is to delever and go back to the -- and go to the 1.5 debt to EBITDA ratio that we have committed to by the end of 2022. I think that the divestiture of OTEZLA enables us in many ways to be getting there faster. And so in the next couple of years, I do expect us to grow. We do smaller deals that are more science than even deals. But I believe the company will continue to have significant flexibility financially, and then in a couple of years the opportunity to do medium size and larger deals as well. And so I think it's a real combination of a broad pipeline and the right expertise to be doing the right type of business development.

Terence Flynn

And do you have goals in terms of how much internal versus external you think about in terms of the right mix of the pipeline? Or is it more science opportunities driven?

Giovanni Caforio

We've never looked at it that way. I think what we - the way we look at it is we look at deals that number one makes sense strategically. And what I mean by that is they need to be in areas where we have deep internal expertise that makes us believe that we will be able to deliver value from those assets. The second thing is it needs to be breakthrough science. And the third one is it must make sense financially. And in fact, if you really think about it, those three lenses would also the drivers of the acquisition of Celgene. And what I'm encouraged with is the fact that when I look at our research organizations: number one, we have real expertise in some of the most attractive and interesting areas of science right now; number two, we have research sites that are embedded in the best hubs of innovations in the United States; and number three, in every one of those units we've created an integrated unit that goes from discovery to translational medicine, early development, business development, they're all focused on their specific area of expertise. They have a real opportunity to interact with outside sources of innovations and be able to recognize promising science that we want to bring into the company.

Terence Flynn

Okay, great. Maybe one of the other reasons that you got excited for the Celgene deal is diversifying the revenue base in terms of your mix of both Medicare Part B and Part D. Obviously, you have unique perspective here from your Senior Chairman of pharma. What changes, if any, would you expect to see on the drug pricing front this year? I know last year, that was a big focal point for the industry, things seem to have stalled out at least from my perspective someone that would be curious from your seat what you see for this year on the horizon?

Giovanni Caforio

Sure. I think that -- first of all, what I have to say is it's really difficult to predict what policy changes may be implemented. And I think that's difficult forecast for all of us no matter where we. I think what's important is that summary for me, because the centres in our system are not aligned to making medicine affordable for patients. When you look at even the latest data that is available on drug spending in 2018 – drug spending in 2018 grew about 2.5%, of that less than 1% was price. And the growth of pharmaceutical spend in '18 was aligned or lowered with respect to the growth of the other parts of healthcare, and I expect that to continue. But then when you look at facial exposure, over the last few years, patient out of pocket exposure has grown by 50% disproportionately versus the total spend for pharmaceuticals. And right now when you look at our market in the U.S., almost 50% of the spent for pharmaceuticals goes to the supply chain, and only about 54% goes to innovative companies that develop breakthrough pharmaceutical innovation. And so there is a real need for reform, and I think that the reform that is focused on improving the affordability for patients is one that the industry supports. So what may happen in the short-term I think is very difficult to assess. What I can tell you is that you are right, we are better positioned today than we were before. We have a more diversified business, and we have a more balanced mix between parts of the commercial versus Medicare and different parts of the market from a portfolio perspective as quick. So during the period of time of change, I think, we are better positioned today than we were before to be able to continue to invest and be successful during the period of policy change.

Terence Flynn

I know you don’t want to hazard the guess in terms of the senate bill and probability that it moves forward this year, but as you think about that bill, what are the areas that are the industry supportive other than what are the areas that you think could be maybe adaptive somewhat?

Giovanni Caforio

Listen there are many areas the industry supportive of. So establishing out of pocket caps for seniors, I think that’s a priority for the -- I think that is very, very important. Reducing the contribution of patients through the expense during the coverage gap, I think that’s very important. Spreading the costs that patients incurred during the year – throughout the year from what happens today where its concentrated in the first month of the year to a mould of what it is more evenly distributed throughout the year. I think that's a measure that the industry is really supportive of. Anything that enables sort of increased penetration of generics biosimilars in the market innovation companies like ours are always going to be supportive. Price controls that stifle innovation without really improving affordability for patients, I think, these are things we are not supportive of. But I would say there are many elements of that build that are supportive of patients’ affordability that we believe are really valuable. There are parts we don’t believe with support innovative medicines and won't help patients.

Terence Flynn

Maybe just one more before we move on to the commercial side in the pipeline. IPI PARP demo that was announced still hasn’t gone through. Just wondering theoretically if it were to be enacted, do you think there could be a legal challenge from the industry to that given some of the questions about how broad that would be covering 50% of population? Just wondering more from a theoretical perspective.

Giovanni Caforio

Yes, I think that’s difficult to answer until all of the details I know. What I can tell you is that some of those policies would be extremely damaging. Actually the delay would reduce the number of new medicines that go to patients. They won't improve the affordability of the medicine unless benefit design change are implemented. So some of the ones you describe are ones the industry is not supportive of. I think we need to make sure that policy to for the recognition of the U.S. pharmaceutical innovation abroad. And I think that should be the priority.

Terence Flynn

Great. You talked about some of this in your opening remarks about the ASH and the lot of the data you have there both in the hallways was this was one of the best ASHs for the Celgene portfolio in a number of years, you have a number of assets in the multiple myeloma, particularly against BCMA, which is one of the newest most exciting targets in the area. It's also very competitive because of how interesting of a target it is. So as you guys think about defending your position in myeloma, how should we think about that? What are the keys that we should be focused on? And how are you positioned now coming out of ASH to protect that franchise?

Giovanni Caforio

Yes. So Terrance, first of all, let me say was a really good ASH, and it was good to be there and it really showed the strength of Bristol-Myers Squibb and hematology going forward. There was a lot of data that was presented and it was all really compelling clinical data that made or exceeded expectations in many areas. I think the multiple myeloma field is an important field for us of course. And I -- as the company that has really transformed the treatment of multiple myeloma from the Celgene legacy, of course, we have deep knowledge and expertise in that area. There has been a lot of progress that has been made in multiple myeloma, but multiple myeloma is not being cured. That is continued to be there are many patients that progress through multiple lines of therapy, and need new treatment option. And so we are very committed and continued to invest in the development of new medicines in multiple myeloma because we believe the unmet medical need remains very high.

And BCMA is one of the most promising targets and I believe it can be the next big target that we discuss in multiple myeloma and in black cancers in general. And one of the things that we were attracted to from the beginning was the fact that we have the ability now to have multiple approaches against BCMA. And what you saw at ASH was two different approaches playing out. There was clear interest in BB2121 as the first-in-class CAT T agent in multiple myeloma, but also there was an early data from our T-cell engager program that was considered to be very compelling from a clinical perspective. And I – and obviously we will advance both programs as well as other ways of attacking BCMA. Ultimately, you're right. This is a very competitive field. I believe we're very well positioned. And I think that the way I think about BCMA is that as often in oncology there will be an initial focus on late-stage patients that have failed multiple lines of therapy, but ultimately the most effective agents will continue to move to the front line, and I think that's what we're planning on doing in the future. I think there is a room for more than one mechanism of action in attacking BCMA. There may be patients that benefit from the efficacy of a CAR T approach, which is one administration. Those may be patients that have proximity to academic institutions; a real ability for a long-term durable response, there may be patients that prefer to be treated with a more conventional approach like a T-cell engager. We don't have to think about BCMA as there's only going to be one modality that wins. I think our portfolio is broad of opportunities in BCMA that may be more than one that eventually plays a really meaningful role in the treatment of multiple myeloma. I think it was started in the late-stage settings, but I do believe it will move to high risk patients in the front -- in the earlier stage. And obviously as very knowledgeable in the field, we're putting all our efforts in that area.

Terence Flynn

Great. For me that's a good segway to my follow-up question, which is one of the other pieces of Celgene deal was the CAR T portfolio. So BB2121, you mentioned JCAR017 is the other -- you mentioned moving to the earlier stage setting. So that's one of the goals for the CAR T therapies, but there have been some hurdles with the initial launches. So maybe at a high level, you can just talk to us about how you as a company are going to move CAR T earlier into the earlier lines of therapy? How do you think about BB2121 playing there and the strategy for JCAR017 given some of the challenges we've seen so far with some of the early entrants?

Giovanni Caforio

Sure. I think that from my perspective when you look at the challenges that have happened with some of the early entrants, they've been primarily related to access and reimbursement in Medicare. They've been related to the referral of patients to academic institutions with the experience to treat patients with a technology like CAR T. So I'm going to use the example of JCAR017 and the profile of JCAR017. And I do believe it is a differentiated profile. It is very effective, but it also has a very different profile in terms of – see the side effects and incidents of CRS. And you've seen some data at ASH where the product is being -- it is being used in the outpatient settings. So I think that the move of CAR T from a small number of academic institutions to a larger number of academic institutions and the ability to potentially administer the product in the outpatient settings, these are all drivers of expansion of the market. When I speak about outpatient settings, I’m obviously not speaking about a small practice in the community. I’m speaking about the outpatient setting within hospitals, institutions and very large networks of oncologists. I think there is a real opportunity for JCAR017 there. The data presented cleanly spoke to the possibility of using that product in the outpatient setting. I think there is progress on the access from. There is clearly no problem on the commercial side, on the Medicare side. There is clear progress towards better reimbursement. And obviously, in that setting, the use in the outpatient setting from an access perspective from an investment perspective would be significantly easier as well. The third point that I would say is the referral of patients from the community into those institutions that use CAR T. I think that's where our hematology unit is uniquely positioned. Because of our presence in hematology, because of our knowledge of the field, the ability to ensure the physicians to refer the right patients to the institutions that will use a CAR T approach, I think that's a differentiated capability that we have at Bristol-Myers Squibb. And moving to BB2121 that clearly is the case in multiple myeloma where we have a deep knowledge of the field. We understand patient profiles, who the treaters are and the ability to accelerate appropriately the referral patients to the institutions that will use the BB2121, I think that's one of the areas of focus for us. I must say that I am very pleased with the work that I have seen has been conducted by was once a Celgene team that is now part of our organization in terms of from a medical perspective, in terms of interacting with thought leaders and prescribers and really understanding this marketplace to be ready to execute a successful launch. Now many of the dynamics that I discussed will play out over signed, the uptake is still going to be slower than a more traditional technology, but I think there is a real opportunity to expand that market.

Terence Flynn

It sounds like – still it looks like a slower uptake given some of the novelty on the multiple myeloma sight for BB2121 but is it fair to assume that we should expect a stronger launch than we’ve seen what maybe the CD19 CAR Ts and lymphoma because a lot of these challenges hurdles have already been worked through in the system you guys know what to expect going in?

Giovanni Caforio

I think this is one of the areas where as we’ve said from the beginning the number three is probably an advantage versus having launched during the period in which the market really established itself and remain more sustainable than it was.

Terence Flynn

Great. One of the other questions we get on Celgene is the level of patent litigation, and so now that this is in your hands. Maybe walk us through how your strategy will differ if at all from Celgene strategy? And what are the next milestones that we should focus on here in the forward as we think about that litigation?

Giovanni Caforio

Yes. So first of all what I would say is obviously last year there was also one area where we had some positive developments. There were two IPRs that were not instituted and one of them based on lack of merits. I think that’s important because the starting point is that we believe in the strength of the IP that supports Revlimid. We also were able to reach an additional settlement with the company called Alvogen, and I was aligned with our expectations. As we’ve said all alone we have modelled as most likely scenario the possibility that a number of settlements may happen between now and 2022 and that the erosion of Revlimid will happen over a period of time beginning ‘22 through the end of ‘25 with full generic ends in ‘26. And we're still aligned with that set of assumptions. Now obviously there are number of things that have to happen there. We’ve have discussed our belief that the next step maybe a trial. We do not have a date for a trial yet. There is a free trial hearing that has been scheduled in May. It is possible that the trial starts this year. But that’s very consistent with the timeline that we have communicated from the beginning. Ultimately we believe the most likely scenario is one where multiple settlements can be achieved. That's clearly something that we will continue to work on. So I’m not sure I can point to a real difference in strategy. But what I can tell is we are very focused on executing the strategy we communicated since the beginning of last year. And so far the events that have happened are very consistent with our set of assumptions.

Terence Flynn

Great. Maybe moving out to OPDIVO obviously another area of commercial execution focus for you guys. As we kick off 2020 here, maybe just remind us of the outlook this year and then that return to growth that you guys have talked about in 2021. What are the key inputs in terms of trial readouts, where do we stand? Where is your confidence level now? Obviously you had a couple of readouts in front-line lung, but what are the remaining ones that we should be focused on?

Giovanni Caforio

So first of all, I would say the performance of OPDIVO this year has been strong in every indication in which the product is approved. It's been very much aligned with our expectation. Overall the brand, particularly in the U.S. has been impacted by the shrinking of the opportunity in second-line lung cancer where we maintained a very competitive market share by the pool of patients that are available for IO in second-line has gone down as we were expecting. We've seen sort of a stabilization of that trend towards the end of last year and we expect that trend to stabilize this year with a final sort of size of the second-line market to be about a third of what it was originally. Now speaking to the dynamics you're describing, we do expect the brand to be a growth brand, and I do expect OPDIVO would have real opportunities for growth in 2021. The two positive trials in first-line lung cancer give us increased confidence in that growth because we believe there is an important opportunity there. I continue to see this year as a year of somewhat transition because of the dynamics related to the size of the market opportunity in second-line lung, but I do continue to see meaningful opportunities for growth beginning in 2021. As I said they become more real in terms of first-line lung cancer what are the other data readouts that are important. There are a number of important data readouts this year. So first of all, obviously, one of them in the first half of this year is study 9ER, which is the combination with cabo in first-line renal that's an important study for us. We expect that study again in the first part of this year. But then more broadly this year there are a number of other opportunities for data readouts. Some of the ones that are -- that I will mention in the metastatic setting, the possibility for data readouts in gastric and esophageal, and in the adjuvant setting a number of data readouts, which include the potential for adjuvant studies to readout in melanoma that's the combination of the OPDIVO and YERVOY, potentially bladder adjuvant, and between the end of this year and the beginning of next year, an esophageal adjuvant study as well. So these are all data readouts that are important for OPDIVO. I would say beyond simply OPDIVO, this year, in the second half, we also expect the data readout from the laboratory of OPDIVO combination in first-line melanoma. And then beginning the next year there is a very broad adjuvant program that begins to readout again between 2020 and 2023, which I think is a meaningful opportunity for the brand as we enter into the segment of early stage.

Terence Flynn

Maybe a couple follow-ups there, you mentioned this trend of stability on the lung cancer front maybe about a third of what the original market was. I'm assuming that's in the U.S. but would you expect a similar dynamic in Europe? Or is there something different there in terms of that one third of the original opportunity? How should we think about the European number this year as we go through?

Giovanni Caforio

I would say that I would expect the European dynamics to be very similar. They will happen over different time-frames depending on when first-line therapies were first reimbursed, which is obviously later than the U.S. and the speed of adoption in different markets into the first-line setting. But ultimately, we do expect the same dynamics internationally. We expect that to happen somewhat as different times in various markets.

Terence Flynn

And then on the front-line lung, 227, we've seen the data last year. You recently got a compendia listing there based on that study in first-line lung cancer. Maybe just give us a view on the implications for reimbursement coverage. And then CheckMate-9LA remind us that the filing plans for this as well as CheckMate-227?

Giovanni Caforio

Yes. Sure. So, I mean, first part of your question on compendia listing, obviously, that's a positive event. I think that it speaks to the value of the data across histologies and levels of PD-L1 expression. And from -- as you know very well, when you do have compendia listing, it has chose to prescribe the regimen, I think that would be reimbursed. We obviously don't promote that regimen until it's approved and we don't expect to have sort of a meaningful update until regulatory approved, but it is a positive event. And it's primarily because of the recognition of the strength and value of the data. I'm not going to comment on the regulatory front. Obviously, this is our two important data sets. We've discussed them with regulators right away after the data was presented. And typically what we comment on is acceptance of files when the PDUFA data is established. You had another part of your question. Sorry.

Terence Flynn

Was it as if you think about the filing what maybe first the presentation of CheckMate-9LA. Have you guys decided on the ...

Giovanni Caforio

It will be at a scientific conference this year. We've not communicated which one.

Terence Flynn

Okay. And then as you think about the filings, how do you, again, how do you balance the time to market versus the breadth of the label? Because I think, again, there's an assumption that 9LA offers you again a broader label given the data and PD-L1-positive and negative. And so how do you balance those two things?

Giovanni Caforio

Yes, I think we've, I believe it is a really good question. And I think it is important to look at those two data sets together because with 2 to 7 years, you have a study that is very much worth with $39 million follow-up that really demonstrates the durability of response, the long-term flattening of the curve and the potential for a long-term impact on survival. That's the key differentiating value of an IO regimen. The 9LA data is obviously shorter follow-up because of the study enrolled until the beginning of last year. I think what people would be interested in looking at is really the beginning of the curve and whether the crossing of the curve that you see in study 227 -- we saw in study 227 because of the rabbit progressors can be addressed by using two cycles of chemotherapy. So in order to really understand the value of the therapeutic approach you can look at the data sets together. With respect to regulatory filings, we've not delayed one of the two filings to wait. For the other, we thought it was important to proceed with every one of them.

Terence Flynn

And maybe as we think forward to the end of this year, do you think will walk away with an impression that you guys can throw your lung cancer sales in that 2021 and beyond from where they end at the end of 2020 based on the totality of the data packages here?

Giovanni Caforio

Yes. Listen I think there is a real – I think there is an important opportunity in first-line lung cancer, which is a large market. I recognize that it is a very competitive market there are established standards of care. Obviously the opportunity is different than if we had launched three years ago. But what I'm hearing from physicians is that there is an opportunity for a new differentiated regimen to be established in as one of the options in first-line lung cancer. Remember that over 50% of the physicians that are leaders for lung cancer and experienced with OPDIVO plus YERVOY because of the fact that they use it in melanoma and renal. And there they have adopted it very rapidly. So I do see first-line cancer, obviously, we need to get approval in getting to the launch by contingent upon successful completion of the regulatory process. I think there is a real opportunity to establish a presence in first-line lung cancer, which is a growth opportunity for the brand.

Terence Flynn

And the other trial you mentioned near term is CheckMate 9ER in first-line kidney. Your current share I think is around 30% to 35% in the U.S. on OPDIVO YERVOY. Do you think a positive outcome from 9ER is important to maintain that market share or do you think the data that you have the differentiated IO combo is enough to kind of keep the status quo as it is or as 9ER important to kind of continue to stabilize share and expand further?

Giovanni Caforio

Yes. I think what we've seen -- I think what we’ve seen that the combination with the TKI has initially impacted primarily the use of TKIs, and we were able to maintain a very strong presence in the intermediate and poor risk segments of the market, which is where we have our indication. I think it’s fair to say that we've also seen some impact on our share. And we do maintain a very strong share in both poor and intermediate risk patients, but I do see 9ER as an important study to continue to strengthen our presence in that field. We've seen some impact on our share from the launch of the TKI combo.

Terence Flynn

Okay. All right. Maybe just an interest of time moving on to ozanimod, any update on the regulatory interactions and maybe just give us your latest on confidence in the March approval, obviously, it's another important milestone from the Celgene pipeline side.

Giovanni Caforio

Yea. So I would say the things on track so far for the PDUFA date in March and the teams are up to bidding for launch in the U.S. Again, I think this is another area where we've been very impressed with the quality of the work that had been done in preparation for launch. Ozanimod is a differentiated oral agent with good efficacy and potentially differentiated safety profile. Obviously this is a competitive market, and physicians tend to adopt newer agents when they have had experience with them. So BMS opportunity is one where we do expect uptake to happen overtime as physicians understand the value of ozanimod over time, but I feel confident that we are going to be ready for launch in March. The other important thing about ozanimod is that this year we will see the results of the opportunity Polaris [ph] Phase-III program. And I think that’s an important opportunity for ozanimod, and we look forward to seeing that data.

Terence Flynn

Okay. And maybe one follow-up is just how important is having a differentiated label versus go any as you think about the outcome of the March as you find there has been a focus on the path from the Celgene side, but as you guys think about the commercial opportunity help is that?

Giovanni Caforio

Well, I think it’s important to have a label that really reflects the differentiated safety profile of the agent. What we've seen is that with the approval of a recent agent that I think there is an opportunity that the profile is reflected in the label and that we're not going into a class labelling from the perspective of monitoring, but rather there may be available that really reflects the differentiated profile of the asset. I think that clearly would be both.

Terence Flynn

Okay. And one other in immunology is we're going to see the first Phase III data for your TYK2 in psoriasis, obviously another important asset for you guys in the pipeline side. Could this drug theoretically be bigger than OTEZLA? And if so, what are the opportunities that we should be focused on beyond psoriasis for this drug?

Giovanni Caforio

Yes, I think that this is one of our most exciting programs, quite frankly, because TYK2 is a very specific selective pathway, and our agent is a very selective agent. Remember the Phase II data was very compelling in terms of providing the degree of efficacy that is similar to biologics with a very acceptable safety profile. If that profile is confirmed in Phase III in psoriasis, we believe our asset can be a really important asset. There is an opportunity for expansion into psoriatic arthritis based on Phase II study that will read this year. So that is an incremental opportunity. And then obviously the same pathway has made us decide to initiate a series of Phase II studies in other indications, such as UC and Crohn's. And over time, we will see the results of those trials. I think this is an asset that has the potential to be a pipeline in one asset. It's a really specific molecule that we believe has great progress, but promise, but obviously, we need to look at the data to understand that we will have readout from the first of the psoriasis study towards the end of this year, and then potentially at the beginning of next year in the second trial. And I think these are important data readouts, but we're very excited about the TYK2 actually.

Terence Flynn

Maybe just in the last minute or so, we're asking everyone for thoughts on one potential change that could happen in your specific industry, so in this case, biopharma, in the new decade that may be under appreciated by the investment community?

Giovanni Caforio

Yes. I think that science is moving at a speed which is extraordinary. And so I personally believe that technology and the use of data and analytics has great potential for our industry. I believe we at BMS have taken a very deliberate approach to the use of data and analytics in -- on the commercial side at the beginning, but now very heavily in R&D. When you look at the leading position we've been able to establish for ELIQUIS. We have over 2 million patients of real world data that we follow longitudinally. It's the largest dataset ever in cardiovascular. We've been able to leverage that data extensively from a payer perspective, from an access perspective in discussions with the physicians. When that is possible, I believe that the use of data and advanced analytics can truly accelerate the way we do R&D and bring our products to market demonstrate the value of our products. I'm very confident that we started making significant investments a few years ago in this area. We have some really concrete examples of how we've already brought that to life at Bristol-Myers Squibb, and we are accelerating our efforts in that area.

Terence Flynn

Do you ever think we'll get to a point where you will see kind of virtual clinical trials where you'll be able to replace me the control arm with predictive data?

Giovanni Caforio

I think replacing the control arm is a real possibility. I also believe that really mining large data sets to understand the real world performance of assets outside of clinical trials to demonstrate the value is important. And ultimately I think if we are able to identify signals of activities faster to bring the right assets into late-stage development, that's extraordinarily valuable, and we're working in every one of those areas.

Terence Flynn

Great. Well, thank you so much for your time today.

Giovanni Caforio

Thank you. Thank you very much.

Terence Flynn

Thank you.