Good day, and welcome to the Bristol-Myers Squibb 2019 Fourth Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. John Elicker, Senior Vice President Public Affairs and Investor Relations. Please go ahead sir..

Good morning, Anna, and thanks everybody for joining us today as we talk about our quarter, and importantly the outlook for 2020 and beyond. I'll take care of the legal requirements, before I turn it over to Giovanni. Both Giovanni and David Elkins, our CFO will have prepared remarks.

And then joining us for Q&A, as well are Samit Hirawat, our Chief Medical Officer and Head of Development; Chris Boerner, Chief Commercialization Officer; and Nadim Ahmed, our President of the Hematology business. During the call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements.

Actual results may differ materially from those indicated by these forward-looking statements, as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date.

We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We will also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available at our website.

And just to remind everybody in case you haven't seen them there are slides to go along with today's call. And with that, I'll turn it over to Giovanni..

Thank you, John, and good morning, everyone. Welcome to our fourth quarter and full year 2019 earnings call. I am pleased to be here today to discuss the earning results of our new company for the first time. On slide 4, let me start by reminding you who the new Bristol-Myers Squibb is today. Our mission hasn't changed.

We are focused on discovering, developing and delivering innovative medicines that help patients living with serious diseases. We aspire to be the leading biopharma company in the industry. Our strategic foundation remains centered on combining the scale and resources of a pharma company with the agility and speed of a biotech.

I am proud of the strength and talent of our people, who are focused on transforming patients lives through science. Moving to slide 5, I am more encouraged about our company's potential today than I was a year ago. The strength of our performance in 2019 has positioned us very well for the future.

As I look at 2019, we've delivered strong in-line performance across our businesses and geographies, and we've made important progress on our late-stage pipeline..

Thank you, Giovanni, and good morning, everyone. Having benefited from working in this industry for over 20 years, I could not be more excited about the growth potential and earnings power of bringing these two companies together. I've been very impressed by the employees of the combined company.

I'm encouraged by the breadth of opportunities we have ahead and our ability to deliver important new medicines to patients. Now let's turn our focus to the performance in 2019. To start, the business continued to deliver strong performance in the fourth quarter with 6% revenue growth on a pro forma basis.

This performance serves as a strong foundation for the future outlook of the company, which we will cover in a moment. Giovanni gave you some brand insights, but let me provide you with additional color on the underlying performance of the business.

Beginning with Opdivo on slide 11, we had continued strong commercial excellence in the quarter where our teams continue to operate very well in increasingly competitive markets. Let me provide you with a perspective on how we see the business at the moment. From a U.S.

demand perspective, we are seeing sequential low single-digit decline driven by the headwinds we've described in the past. Note that demand trends are more steady than reported sales, which were incrementally impacted by buying patterns both in the government channel and from wholesalers.

Now with respect to some key indications, we expect steady performance in our melanoma business driven by our leadership in both metastatic and adjuvant setting. In non-small cell lung cancer, the size of the eligible pool of second-line patients is leveling off at roughly one-third.

In first-line RCC space, we continue to perform well where Opdivo-Yervoy remains the standard of care in intermediate and poor-risk patients and we've seen stabilization in this indication as well. Internationally, we've seen very strong commercial execution in all our key markets, resulting in encouraging growth in the brand.

We expect further growth as we continue to secure reimbursement in first-line RCC. With respect to first-line lung, we look forward to the opportunity to launch 9LA in the same setting and making Opdivo available for patients in these markets. So stepping back, we continue to see 2020 as a transition year for Opdivo, with demand pressures in the U.S.

and growth in our international business. More importantly, as we move into 2021, we believe we have a strong foundation for growth fueled by potential new indications including first-line lung..

Thanks, David, and I think we're ready to go to the Q&A session..

Thank you. We take our first question from Chris Schott from JPMorgan. Please go ahead..

Great. Thanks so very much for the question. Maybe just two here on Opdivo. First, I know, Giovanni, you touched on it a little bit in the prepared remarks, but can you just elaborate on the first-line lung strategy in Europe post the last week's 227 update? And then when we think about first-line lung in the U.S.

is Opdivo+Yervoy and the 227 data the primary focus? Or do you feel that the 9LA regimen of chemo Opdivo+Yervoy will be the bigger focus? I'm trying to figure out how you're balancing those, I guess, two data sets. And then my second question was, another one, just as we think about 2020 for Opdivo.

When you look at where the Street is shaking out here, which, I think, is about a 5% erosion for Opdivo this year versus 2019, do you feel like consensus properly captures the balance of the second-line lung erosion relative to the growth you're seeing in some of these other indications? Thanks so much..

Yes. Thank you, Chris. So first of all, let me just say, as I mentioned in my remarks, our focus in Europe for first-line lung cancer, obviously, has shifted to 9LA, which we believe has -- and we've said before, is an important study.

Let me just ask Chris Boerner to give you a perspective on our overall strategy for first-line lung cancer in the U.S., as we think about the two trials. And then, Chris can provide some perspective on Opdivo performance and the various components of that in 2020 as well..

it's second-line lung cancer, where we've talked about the dynamics there; and it's small cell; and head and neck. And in those two tumors it's a very similar dynamic to lung cancer, where you've seen competitive approvals in the first-line impacting eligibility in the second line.

But I would say importantly, our assumption for this year is that our shares in the second-line setting across those tumors remain stable. It's just stable within a smaller pool of patients..

And again as I – we said earlier in the remarks Chris, while we're not commenting exactly on guidance for the growth of Opdivo this year. We remain confident with growth growing into 2021. And that's our focus, particularly as it relates to preparation for launches and commercial execution..

Can we go to the next question please, Anna.

We take our next question from Seamus Fernandez from Guggenheim. Please go ahead..

Thanks very much. So actually I'd love to ask you guys about the Celgene portfolio a little bit and rather than focusing on the Bristol portfolio. One of the products that we learned about at ASH was the oral the data opportunity.

I was just hoping, you might be able to help put that in context for us to help us understand what may be an underappreciated opportunity in the Bristol story. And particularly something that falls outside of the CVR maybe this is a bit of a surprise upside.

And then also would you update us on the CELMoD development opportunity, maybe just put in context where you see the CELMoD portfolio delivering the most upside? As we talk to physicians, some of the feedback that we get is that this is a pretty straightforward opportunity for physicians to treat patients that have progressed on both Revlimid and Pomalyst.

So just love to get your thoughts on both of those opportunities. Thanks..

Thank you, Seamus. Let me ask Samit to start and give you a perspective both on CC-486 and then CELMoD and Nadim will make some comments from a commercial perspective..

Thank you, Seamus for the question. I think you already teed up the overall portfolio from a, what comes from the Celgene side of things in terms of hematology, where certainly beyond the ones that we've already talked about from CC-486 certainly adds on to that.

CC-486 study in patients with acute myeloid leukemia was certainly a very important data set that we presented at ASH, looking at patients with AML, who have received induction with or without consolidation chemotherapy and then achieve a complete response with or without complete recovery of the bone marrow.

And what we saw over there is of course the overall survival improvement as well as an improvement in the relapse-free survival. And this is an oral agent, so convenience of delivery for these patients becomes very, very important. And this is the first and only treatment that has shown a survival benefit in the maintenance setting.

So we remain excited about that and we're looking forward towards discussions with the health authority and the filings going forward. Of course, here we also continue to think about the overall life-cycle management plan with our portfolio and the combinations that could be available in the future.

As it comes to the CELMoDs and then I will pass it on to Nadim to comment more on I think CELMoDs are certainly a very, very exciting addition to the overall portfolio and in the armamentarium that we look forward to developing in multiple myeloma. We see this as absolute necessary opportunity.

And one of the data sets that we presented in ASCO 2019 were for CC-220, where we saw that patients who had received prior treatment with IMiD, proteasome inhibitors, daratumumab they still went on to have a response rate of 31%. And these are durable responses that we saw in this late-line setting.

So we have additional plans for not only CC-220 but CC-480, which is another CELMoD looking at multiple myeloma setting.

And there are a multitude of opportunities with our overall portfolio of cell therapies as well as the T-cell engagers, where we will continue to think about how to do treatments for further improvement in the outcome of these patients where cure still does not exist. So we'll be sharing those plans in the coming months as we look forward.

But let me pass it on to Nadim to talk a little bit more from the commercial perspective..

Thanks, Samit. And then thank you for the question, Seamus. So if you think about frontline or newly diagnosed AML across EU5 and the U.S. about 33,000 patients. And about two-thirds of those patients are eligible for intensive chemotherapy and that's the patient group that we studied. And the unmet need even in newly diagnosed AML is very high.

So with the elderly patients, you have a five-year survival of only about 15% and 80% of these patients will relapse within 18 months. So to have a treatment that adds 10 months of overall survival and doubles the relapse-free survival is going to be really important. So we're very excited about the opportunity in AML.

And I'll also remind you that this gives us another opportunity to once again establish the maintenance treatment paradigm in another disease after we did the same in multiple myeloma. So we're very excited about the opportunity. So that's CC-486.

In terms of 220 and Samit covered it very well as well as 480, we are hearing the exact same thing from clinicians who have been using the drug on study. So certainly, we're seeing the CELMoDs work after our IMiD our in-line portfolio.

But I think the additional opportunity as Samit alluded to is some of our life-cycle management opportunities where we then have the chance to move these treatments up earlier in the treatment sequence to displace the IMiD. So we're very excited about that opportunity also..

Thanks, Seamus for the questions.

Can we go to the next question please, Ana?.

Thank you. The next question comes from Geoff Meacham from Bank of America. Please go ahead..

Good morning everyone. Thanks for the question. Just have a couple.

For David or for Giovanni, for 2021 guidance, I know you guys don't want to give details, but generally should we assume that earnings growth will be mostly from the return to growth for I-O and maybe new launches? Or is it more from the operational synergy side of things? And then for Nadim, what is the credit field for BCMA-targeted therapies? Just curious about the status of moving bb2121 up to second-line myeloma and when you guys think about the BCMA modalities in your pipeline, how do you all reconcile bi-specifics with CAR-Ts and others? Thank you..

Yes. Thank you, Geoff. Let me start. Obviously, when you look at 2121 as we've said, we have an opportunity to return to growth for Opdivo. We have a number of really exciting launch opportunities and I've mentioned several of those. And so there is real momentum in the business, which is driven by the portfolio and how new launches come into play.

That's the reason why I feel really good about the fact that the guidance we provided from -- for 2021 is driven by dynamics in the portfolio that are very encouraging for us. Of course, we will be disciplined with respect to continuing to execute on the synergies.

And as you know, we've updated that we feel comfortable with the $2.5 billion about one-third will come this year and we expect about one-third to come next year. But I think the growth of next year, we're really excited about the portfolio opportunities playing out. Let me just ask Samit and Nadim to ask you -- to answer your second question..

Thank you, Giovanni, and thanks Geoff for the question on the BCMA portfolio. So from a BCMA CAR T-cell perspective from ide-cel perspective, we've already shared some of the data last year at ASH looking at ide-cel in the fourth-line plus patient population where we saw a CR rate of 31% overall.

And we're certainly excited towards continuing to expand that portfolio and towards filing of that data set itself. There are three additional studies that are currently ongoing as you can see on ClinicalTrials.gov. KarMMa-2 is the study I think that sort of answers your question that we are beginning to look at the second-line setting.

So we're looking at using ide-cel in the second-line patient population. KarMMa-2 is a randomized Phase III study looking at ide-cel versus a triplet therapy for patients in the third-line plus setting. And then KarMMa-4 was just initiated at the end of last year looking at the first-line patient population in a Phase I/II study.

So we're really excited towards looking into the outcomes of these studies and the data generation.

And when we talk about the overall portfolio from a BCMA perspective, I think all the emerging data tells us that BCMA is absolutely an important target that we need to be able to attack from various modalities, whether it be through the cell therapies that we talked about or the T-cell engager that we have now shared the data from the Phase 1 Study -269 and certainly looking forward to now looking at how to bring that forward as more data matures and accelerate that development plan.

And then, of course, we'll look into our pipeline how to combine these with as we previously discussed with CELMoD et cetera. But let me pass it on to Nadim to give you a little bit more on that..

Sure. Thanks Samit. And so one thing I will remind everyone is that once we had a good idea that BCMA was going to be a very important target for multiple myeloma, we strategically and proactively embarked on a multi-modality approach to treating this disease.

And our thinking there was that you have very different patient segments that can benefit from CAR-T versus a T-cell engager and even ADC, which we have early on in the clinic.

So as you think about the various patient segments, patient profiles and patient preferences, you can envisage where a patient has the opportunity to receive CAR-T with a one-and-done treatment that allows them to have a very long treatment-free interval. So there's an opportunity to do that.

Physicians may choose to refer their younger and fitter patients for CAR-T for example. You may have somebody who prefers to be treated closer to home for whom a T-cell engager will be an ideal treatment. And then both treatments work differently. For a T-cell engager, you need to continue the treatment to stay on top of the disease.

And with the CAR-T therapy it's a once-and-done treatment. So we think there's definitely room for both and even potentially three modalities to coexist one within the same line of therapy, but of course also across multiple lines of therapy in exactly the same way we approach Revlimid and Pomalyst in the multiple myeloma market.

So we feel very confident that we're actually delivering on our strategy and there's the opportunity for multiple-patient segments to benefit from all these types of modalities..

Okay, thanks. And can we go to the next question please..

Next question comes from Tim Anderson from Wolfe Research. Please go ahead..

Thank you. A couple of questions, originally you guys at the time of the deal gave 2022 and 2025 guidance on revenues and net income. That has not been updated since the Otezla divestiture.

And I'm wondering, are you going to update that at some point? Or can you update that today I guess as it will have changed? And then second question is at least for us the black box has been how to model Revlimid erosion.

At the time of the deal, you made it very clear that your internal forecasts were much more conservative and cautious on the rate of erosion of Revlimid from 2022 onwards to the big product. I'm wondering now a year on as you see analyst models, do you think the analyst community is appropriately modeling that erosion? Thank you..

Thank you, Tim. Let me just start on both questions and then David can add more comments. So first of all with respect to guidance I think, as we said from the beginning, we were not going to go back and update the S-4 from last year.

As you know there have been a number of things that have happened since last year; the divestiture of Otezla as you mentioned; the divestiture of our UPSA consumer medicines business; and on the other side continued really strong performance with our in-line business and significant progress with the pipeline, which obviously is a key driver of our performance in the next few years.

So overall as I mentioned also in my remarks, I feel better today about where we are than I felt a year ago when we first announced the deal.

And the strength of our in-line business and the progress made with our pipeline make me feel really good about the future and the key drivers that were behind the confidence we had last year and we have today in the business. Today we provided guidance on 2020 and 2021.

I made some comments about our perspective on 2022 and we feel pretty good about where we are. So now with respect to Revlimid also there, there have been good developments. First of all, I would say the in-line performance of the brand continues to be strong and the teams are doing a great job continuing to support an important franchise.

I think that's important. We had two IPR decisions, which were favorable to Bristol-Myers Squibb. We did reach a settlement with Alvogen, which was aligned with our expectations. And I would say that overall, we continue to see the loss of exclusivity for Revlimid as a slope.

That is driven by sort of all the same assumptions that we've discussed in the past. There has been good development and so nothing has really changed there..

Great. Tim thanks for the questions.

Anna, can we go to the next one please?.

The next question comes from Terence Flynn from Goldman Sachs. Please go ahead..

Hi, good morning. Thanks for taking the questions. I was wondering first on Opdivo, if you can give us your latest thoughts on the opportunity in adjuvant bladder following the Roche data. Just wondering, if there are any notable trial design differences you could point to for your study versus their trial.

And then on bb2121 and JCAR and the commercial ramp on the forward, anything you guys have learned from the competitive CAR T launches that you can leverage? And would you expect to have stronger launches as a result? Thank you..

Thanks Terence. Samit, why don't you start and....

Sure. Thank you for the question, Terence.

And as it relates to the adjuvant setting, first of all, let me start by saying that immuno-oncology products are going to play a major role in the adjuvant setting because, the earlier we can utilize these treatments, it will provide an opportunity to not only shift the level of recurrence, but provide a potential for cure for these patients.

And overall, as we move earlier and earlier from the metastatic setting to the earlier setting, the overall plan that we have in place, we feel very confident about it in non-small cell lung cancer melanoma, RCC, gastric and of course in bladder cancer as well. There -- it's no point trying to do cross-trial comparisons.

At this point, I think we are pretty close to where we will be starting to see the data emerging. I think just to keep in mind that, the overall patient population that we've enrolled seems very similar.

And without getting into the specifics, the one major difference is placebo used in our trial versus observation in the other trial and the treatment duration is different. But I think, we should wait for the data for it to read out, rather than getting into the specifics at this time.

But I think, Chris can give you more color on the commercial side..

Yes. So let me just say something on a macro level with respect to the adjuvant programs and then I'll talk specifically about bladder. Just a reminder, that as you think about the adjuvant setting, you need to think not only about the patients who are treated today, but also the potential for patients to be treated.

So, what we saw when we launched I-O in the adjuvant melanoma space was that you saw treatment rates increase significantly. And then a number of the tumors in which we are pursuing our early-stage program, you see treatment rates in the low to single digits ultimately up to potentially around 40% for some tumors.

But still there's plenty of opportunity for us to not only treat patients who are being treated today, but with improved therapies, improve the treatment rates overall. With respect to bladder cancer specifically, this is a very large patient population. It's highly fragmented.

And we have importantly multiple opportunities in the muscle-invasive space. About 50% of those patients are getting surgery today. We have CheckMate-078 which is in the periadjuvant setting. We're looking at the entire population with CheckMate-274 and we also have a non-muscle invasive bladder program as well. So, it's an important opportunity for us.

We are still very confident in the opportunity for I-O in the adjuvant setting and we very much look forward to seeing the data..

Great. Thanks, Chris. I'll pick up on CAR T. So, I think a couple of things I would mention as you alluded to. So, clearly there have been some headwinds in the marketplace.

And I think about things like reimbursement access environment, complexity of manufacturing, also the safety profile of current agents has led to most of the administration being conducted in the inpatient setting. So, we're addressing all of those near-term headwinds. So a couple of things I would say.

So if I use just liso-cel as an example, the data we showed at ASH of the pivotal data, we're seeing a safety profile where we're seeing significant reduction in the incidence and severity of CRS neurotoxicity, which we think bodes well to be able to give this treatment in the outpatient setting, which will allow us to expand our prescriber base.

So we're excited about that. The other thing that's important to point out from a differentiation of BMS is that, we do have very deep relationships with hematologists and that includes multiple myeloma that includes lymphoma.

So, our footprint out in the community will really help us to drive those referrals into the treatment sites where CAR Ts will be given as well as expand out into the community with assets like liso-cel. So from where we're looking, we think we're addressing the near-term headwinds.

In terms of the access environment, ongoing work continues in terms of addressing the DRG issue. Great news last year that the National Coverage Determination wasn't implemented so that could have impacted site of care. So that's not an issue for us now.

From a manufacturing capacity capability between Summit and Seattle, we feel very good about capacity at launch. And we also have longer-term plans to expand that footprint to make sure we continue to have great capacity. But the other final thing I would add is, we've seen transformational data in very late-stage setting.

But I think the true potential of these therapies is moving them up earlier in the treatment sequence from a long-term potential perspective. And you heard from Samit that we have a very aggressive life-cycle management plan for both of these assets that will allow us to unlock that long-term potential for these transformational therapies..

Thanks, Terence.

Can we go to the next question please, Anna?.

The next question comes from Matt Phipps from William Blair. Please go ahead..

Thanks for taking my question. I was wondering, if you could quantify the impact of buying patterns for Opdivo in the U.S.

for the quarter, or do we just assume it's the difference between the 6% decline in quarter-over-quarter prices versus – I know you mentioned the low single-digit decline in demand?.

Yes, Matt.

Chris?.

Yeah. So let me address that, Matt. So as David mentioned in his prepared remarks, we saw Opdivo decline on the quarter versus same time last year about 2%. And let me just characterize that.

That was entirely driven by the U.S., which was down about 10%, but virtually all of that decline year-over-year as a result of the dynamics we've been talking about quite a bit, which are the dynamics in second-line lung cancer. As you look on a sequential basis the U.S. was down roughly 6%.

About half of that was a result of the inventory work down with the VA. The remaining portion of that was mainly the second-line eligibility issue in lung cancer. We saw a little bit of an impact in eligibility in small-cell lung cancer and head and neck.

But importantly, if you normalize for the VA inventory movements what you see in both Q3 and Q4 from a demand standpoint was Opdivo was down as David mentioned in low single digits around 2% to 3%.

And importantly, as we see both 2020 and 2021, the impacts that you saw in the quarter will have no material impact on what we see for the year as a whole in 2020 and for the growth opportunities for Opdivo as we go into 2021..

Can we go to the next question please Anna?.

The next question comes from Steve Scala from Cowen. Please go ahead..

Thank you. I have two questions both for clarification. First, Giovanni to clarify on what you said about growth in 2022, did you say you see growth into 2022 or through 2022 although moderating? And if into, is there any scenario where earnings would be down in 2022? So that's the first question.

And the second one is on the other income expense guidance for 2020. It appears way better than one would expect given the financing costs. Now you mentioned the step-up in royalties on KEYTRUDA and the AstraZeneca diabetes products in 2020.

But I thought that the KEYTRUDA royalty was flat at 6.5% through 2024 and the AstraZeneca royalties are either flat at or step down in 2020. So are you saying that the royalty rates are the same, but the products will grow or something different? And I don't think there's a lot of optimism about the AstraZeneca diabetes portfolio.

So I'm wondering again, is it the royalty rates are changing or the products' royalties are changing? So please clarify. Thank you..

Thank you, Steve. Let me ask – let me answer the first question. So when I spoke about 2022, I'm speaking about growth in 2022 moderated by in terms of the growth rate by the potential beginning of the entrance of generics for Revlimid in 2022.

So I see at this point our business growing in 2022 as a year with the moderation of the growth rate versus 2021 driven by the dynamic I just discussed.

David?.

Yes. And KEYTRUDA from a volume perspective continues to grow; and AstraZeneca the rate continues to increase. So that is being offset by the higher interest expense, as I talked about in my prepared remarks with the $45 billion of debt and average interest rate of 3.4%..

Hey, can we go to the -- I think we have time maybe for two more questions, Anna..

Thank you. The next question comes from David Risinger from Morgan Stanley. Please go ahead..

Thanks very much, and congrats on the disclosures. So, sorry to go back on this Giovanni, but just a quick question, I think that last year you had said that you expected a sort of growth EPS through 2025. In your prepared remarks, you mentioned continuing growth into 2022.

Could you just provide any comments beyond 2022 please? And then second with respect to CAR T hospitals are obviously losing significant amount of money on patients who are not in clinical trials, which are paid for by manufacturers.

Could you just talk about prospects for changes to Medicare reimbursement and potential changes in DRG codes in the future? Thanks so much..

Sure. David let me start and then Nadim will comment. So let me just say again I feel really good about where we are with our business. We discussed very clearly in Q3 we would not update the S-4 going forward.

And I feel pretty good about having provided visibility into the next three years, which clearly demonstrate the earnings power the growth outlook for the company.

Most importantly, I feel really good about the fundamentals of the business both in terms of the performance of the in-line portfolio and the speed at which the pipeline that will drive the long-term growth of the company is advancing. So I'm not going to make comments beyond 2022.

But I believe I provided my perspective on where we are as a company and the real opportunity we have for the long term.

Nadim?.

Sure. Thanks for the question. So I think part of the issue around the access reimbursement environment has as I said previously has been driven a lot by the fact that many of these treatments have been given in the inpatient setting.

So, one I would say if you have a treatment that has the potential to be utilized in the outpatient setting then you start entering into the Part B environment, which is very different to the inpatient capitated DRG environment. So that's one point I would make especially as it pertains to liso-cel.

I think in the inpatient setting the challenge has exactly been that decapitated treatment. Even having said that though, as things have started to improve, we saw the NTAP improve to 65% last year through CMS. I think there's been lots of talk and we've been working on a potential DRG for CAR T specifically.

Currently, sites are having to use the DRG for stem cell transplant, which under-reimburses the cost of CAR T therapy. So there is work to do, but the two things I would leave you with is outpatient represents a discrete different opportunity which isn't affected by capitated payments.

But at the same time I think CMS is working on the opportunity to come up with a specific DRG potentially for CAR T. And I think that will help reimbursement in the inpatient setting also..

Thanks, Dave.

Can we go to our last question, please Anna?.

We take our next question from Navin Jacob from UBS. Please go ahead..

Hi. This is Prakhar Agrawal on behalf of Navin. So my first question is on the CheckMate oral trial. There were some interesting data at ASCO GI recently in first-line HCC for Opdivo cabo and Opdivo cabo Yervoy triplet regimen. So, any comment on the data presented and the potential for these two regimens in HCC? And second question is on Yervoy.

So Yervoy performed better than expectations this quarter. So the question is, is the impact from the uptake of KEYTRUDA and lighter regimen is in first-line RCC mostly done? And should we expect more tempered erosion in U.S. in 2020? Thank you..

Samit, why don't you start?.

Yes. In the HCC arena, our focus is primarily on the Opdivo-Yervoy combination. So beyond that we're not really looking to any expanded way of looking at it this time. So that's all I can share at this time from HCC perspective. But maybe Chris you have....

Yes. So Yervoy for the quarter was flat relative to the same time last year and we did show sequential growth of around 9% versus the third quarter of 2019. And that growth was driven really by both the U.S. as well as in ex-U.S..

We saw a bit of an uptick in the use of Opdivo+Yervoy, really across multiple tumors and the remainder of the business where we have Opdivo+Yervoy in the market today, as well as the use of Yervoy as a monotherapy in a selected number of indications was relatively stable for the quarter.

So what we're really starting to see is the increased use of Opdivo+Yervoy really spread across multiple tumors and that's happening both in the U.S. and to a lesser extent outside of the U.S..

Thank you. Thank you Chris and thanks everyone. So before we close I would like to thank John Elicker for extraordinary leadership of IR over many, many years. Thank you John. Now in closing, we've had a very successful 2019 and I'm proud of the focus that our teams have had throughout a very, very busy year. We advanced our pipeline.

We delivered strong commercial execution to make a difference in the lives of patients and we are very well positioned as we embark on our next chapter as a new company. Thanks everyone..

Thanks everybody for taking the time. As always if you have any follow-ups give us a call..

Ladies and gentlemen this concludes today's conference call. Thank you for your participation. You may now disconnect..