Good day, and welcome to the Bristol-Myers Squibb 2020 Second Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead sir..

Thanks, Rolando , and good morning everyone. Thanks for joining us today for our second quarter 2020 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer.

Also participating in today's call are Chris Boerner, our Chief Commercialization Officer; Nadim Ahmed, President Hematology and Samit Hirawat our Chief Medical Officer and Head of Global Drug Development..

Thank you, Tim, and good morning everyone. I hope that everyone is remaining healthy and safe. As we continue to navigate the impact of the pandemic, I want to thank our colleagues around the world whose commitment to our mission and dedication to our patients has enabled us to continue delivering our medicines to those who are relying on us.

Before starting the call, let me briefly comment on yesterday's news on Eliquis. We believe the IP for these medicine reflects the innovation we have brought to help patients with AF and VTE. In this regard we are very pleased by the Court's decision to rule in our favor on both patents. Let's turn to slide four.

We have delivered another very strong quarter with solid commercial performance including a promising start with multiple launches. Strong financial performance and the achievement of important clinical and pipeline milestones that reinforced our long-term potential. Our ability to advance the business was enabled in part by our integration efforts.

Our teams are working well across the organization. Our systems are coming together and we are on track to deliver $2.5 billion in synergies by the end of 2022. With a strong foundation, a broad and deep portfolio and pipeline and significant financial flexibility, I have never been more confident in the future of Bristol-Myers Squibb.

Before I discuss our results I would take a moment to talk about how our teams are coming back to the workplace and into the field..

Thank you, Giovanni. Hello, everyone. And thank you again for joining our call today. As Giovanni mentioned, I continue to be very impressed by the execution of our teams in the wake of COVID-19..

Okay. Thanks, David.

Rolando, could we go to our first question, please?.

Absolutely. And we’ll take our first question from Geoff Meacham with Bank of America..

Hey guys. Good morning, and thanks for the question. Just had a few quick ones. On Opdivo based on demand trends you've seen so far in lung does that change your view of growth looking to 2021.

Maybe just be helpful to get a little bit more detail of a commercial view looking to what happened in 2Q from lung? And then just with respect to the pipeline, TYK2 will be obviously a big growth driver in a category you have some experience with.

When you look to that brand, maybe just help us with the opportunities that you see for TYK2 for differentiation? And what investments commercially that you'd have to make to really maximize the value there? Thank you..

Thank you, Geoff. So, two important questions. And as I mentioned in my remarks, we feel good about both with the opportunity for Opdivo. And the remarks we've made of first-line launch so far and TYK2 particularly as we've now seen a second Phase 2 study in psoriatic arthritis.

But let me just ask, Chris, to give you more color on both Opdivo and TYK2..

Sure. So thanks for the question, Geoff. Let me start with first-line lung, because I think that's probably on a number of folks' mind. The lung launches are going very well and in fact are tracking at or maybe even a bit ahead of our expectations. Let me highlight just a few things.

From a share standpoint, it's still very early days, but share is currently in the mid-single digits and we've seen very good momentum in the uptake here. Importantly, we've seen uptake across all PD-L1 segment, as well as across histology. And the uptake has been particularly good I would say in the PD-L1, one to 49 segment.

As expected, given the timing of approval and the relative immaturity of the data, the uptake of the 9LA regimen has 227. However, in recent weeks, we've even seen an uptake in the use of dual IO with chemo. And again, this appears to be across subgroups. So, good momentum on utilization.

Execution has been particularly good, especially given the dynamics of COVID. Most of the engagements remain virtual. But we're seeing very good engagement between the sales force even in a remote environment with key customers.

Physician reaction has largely been aligned with expectations in our previous conversations with depth and durability of response of these agents with a manageable safety profile being the primary message. So what I would say is it's still early days, but we're very happy with the utilization that we're seeing.

We've got good execution, physician reaction continues to be positive. And we're very pleased that in spite of entering first-line lung as the third company to market our shares. Now after eight weeks are putting us as having the second most widely used regimens in the space.

And as it relates to the growth, as Giovanni mentioned, we still see Opdivo as a growth brand going forward. The fundamentals of the business today continue to be relatively strong. We've got relatively stable base of business in the U.S. The second-line lung dynamics continue to play out as we had expected both in the U.S. and ex U.S.

The early launch and lung is performing well. And we've got good fundamentals ex U.S. And then if you think about 2021, with the strong 9ER data that we talked about in the last quarter, we feel really good about the growth opportunities that we see for Opdivo starting in 2021.

With respect to TYK, very excited, obviously about the data that we have already presented with Phase 2 and psoriasis, psoriatic arthritis, Phase 2 data is we think if it plays out in the Phase 3 going to be compelling.

Remember, this is a disease area that's large, over 2 million people are diagnosed in the U.S., EU5 in Japan with psoriatic arthritis. And there's still significant unmet need here. Two-thirds of the patients, for example, who are stable on DMARDs, continue to have disease activity.

And there's considerable dissatisfaction with existing oral agents when you look at the totality of the profile, both efficacy and safety. So, obviously, early days, but we're excited about what we're seeing there..

And we'll move on to our next question from Terence Flynn with Goldman Sachs..

Great. Thanks for taking the questions. Maybe just two for me as well. Just was wondering if you can give us an update on the timing of some of your Opdivo adjuvant studies, I know 816 for new adjuvant lung and 274 for bladder were potentially expected later this year.

So just wondering, any update on timing and how you're thinking about those opportunities? And then the second I had is, I didn't see any mention of 2021 guidance in the release. Just wanted to confirm that there were no changes on that front? Thank you..

Thank you, Terence. Let me just briefly comment on guidance. And then, I'll ask Samit to give you a perspective on the adjuvant readout. So based on where we stand today, we are reaffirming the guidance for 2021. There is really nothing that has changed. The assumptions for COVID are playing out as we thought. The business is strong.

We've given you some comments on early positive indicators. Of course, there is a number of considerations that we discussed the last quarter. They remain very valid today. We've made a number of assumptions regarding COVID, particularly at the end of the year and into next year, I think we'll have to see how those play out.

And obviously, as you know, there is significant variability there. And at this point, we've not really included any impact from U.S. Healthcare Reform in our assumptions, because there again, it's early days and difficult to understand what an impact may be.

So -- but when you look at our assumptions and the strength of our business, we're reaffirming the guidance for 2021 at this point.

Samit?.

Yep. Thank you, Giovanni. And thanks, Terence for the question. For Adjuvant, certainly, many opportunities in front of us beyond the -- still available opportunities in metastatic setting. We're looking forward to a few readouts within the overall holistic program that we have across several tumor types.

The ones that we're looking forward to in 2020 would be melanoma, Checkmate 915 potentially reading out towards the end of this year. And then of course, muscle invasive bladder cancer, Checkmate 274 is the other one. And then you already mentioned a potential PCR endpoint readout for non-small cell lung cancer at the end of this year.

And then in 2021, we're looking forward to the readout for esophageal cancer as well, and then others come in 2022 and beyond..

Thanks, Samit.

Orlando, can we go to the next one?.

Absolutely. We'll take our next question from Chris Schott with JPMorgan..

Great. Thanks so much for the questions. I guess first for me was on TKY2. Can you just elaborate a little bit more on the safety profile of the product that you saw in the psoriatic arthritis study.

Is anything new to report relative to what you saw with psoriasis? Or is it a similar kind of profile that you saw there? And then my second question was coming back to Opdivo in first-line lung. Just any comments of where you think you can get to from a share perspective given this strong initial launch? And when we think about the ex-U.S.

opportunity here, can you just compare and contrast how you're thinking about that versus the U.S. given the lack of a 227 label Ex U.S.? Thanks so much..

Thank you, Chris. Samit, why don't you start on TYK2 and Chris can provide some update on Opdivo..

Thanks, Chris, thank you for the question for TKY2, as already alluded to a little bit by Giovanni and then Chris, earlier, really excited for TKY2 overall. And we've seen the profile as you saw in psoriasis in the Phase 2 study.

And we see similar results in terms of trending, in terms of safety and really looking forward to presenting this data in the next medical conferences.

Overall, as we've said, we are excited about the data to be able to now plan the Phase 3 program in psoriatic arthritis, and looking forward to the readout towards the end of the year for the psoriasis program for the first study, and then the second study in the first quarter of next year.

So nothing to report as differentiation at this time from what we've already known from a safety perspective.

So Chris, do you want to take over the Opdivo question?.

Sure. Thanks for the question, Chris. So one of the things that we're most pleased about with respect to what we're seeing in the early dynamics in the U.S. is that, as we had suspected, physicians are not pigeonholing the dual IO regimen to a specific patient type.

In fact, as I mentioned before, we're actually seeing good uptake of the 227 regimen and really across segments across PD-L1 expression levels as well as across histologies.

What I would say with respect to the patients that have gone on therapy thus far, within the one to 49 segments, the patients are generally those who are requesting non-chemo options or they may be frail patients who can't tolerate chemotherapy.

We are seeing some utilization in the greater than 50% population for patients who want or maybe need a more aggressive option than single agent PD-1. And then with a 9LA regimen, we're seeing patients who are young, maybe they're fit patients with severe disease, but they're motivated to have a more aggressive option.

So those are the types of patients that we're seeing right now. Importantly, as I think about the opportunity to continue to grow here, again, I think we're going to continue to emphasize the opportunity for dual IO patient -- dual IO therapy across all patient subtypes.

We have not seen as much utilization yet in the PD-L1 negative, unknown or untested segment, that's an area where IO is generally underpenetrated. So that's obviously an opportunity with a 9LA regimen. So we think we have a number of opportunities where we can continue to drive utilization across patient segment types in the U.S.

Outside of the U.S., obviously, we won't have 227 on label. However, I'd say a couple of things. First of all, that data will be publicly available and obviously as appropriate, our medical teams will be engaging on that. But 9LA data by the time we launch will obviously continue to mature. That data does provide us an entree into the PD-L1 negative.

So those are some of the dynamics that I think will be at play as we get into the ex U.S. market. But, again, I think we'll continue to update you as we get closer to the timing of that approval..

Okay. Thanks Chris..

And we'll move, Rolando for the next one..

Okay. And next we'll hear from Tim Anderson with Wolfe Research..

Thank you. I have a question on the Eliquis patent ruling. Your press release last night, you said, you expect generics sometime after 2026, but before 2031? I think everyone on the analyst side expects generics around mid 2027, I mean, you get pediatric exclusivity.

But I'm wondering that exclusivity could actually extend beyond that based on that press release language. You've done settlements with lots of generic challengers. You've never made any of those terms of public.

So is there a reasonable possibility that generics don't arrive until something like 2028? Or maybe even later? And then on ozanimod and ulcerative colitis from the True North trial, will there be something differentiating in the data relative to the current in market competitors, beside this just being a different mechanism?.

Thank you, Tim. Let me let me start on Eliquis, and then Samit will provide some comments and True North. So first of all, let me say, we've always been confident in the strength of the IP for Eliquis.

And as you alluded to, and just as a background, the IP covering Eliquis is a composition of matter patent, which expires in November of 2016, with a potential pediatric extension to May 27, and a formulation patent, which expires in 2031. And we're very pleased with the outcome when the strength of both patterns has been confirmed yesterday..

.:.

Samit Hirawat:.

Zeposia, as you've seen from the MS label is a best-in-class safety profile with the absence of the first dose monitoring both for the cardiovascular aspect of it and then lack of required broad based ocular testing in this drug.

Now from the Phase 3 UC trial perspective, as we look at Zeposia and obviously, the data will be presented in the future medical meeting, but it is not only met the primary endpoint, but we see very important, very significant results in the secondary endpoints as well, including the improvements in the endoscopic findings, which is very uncommon for many of the drugs out there.

And these are very stringent definitions that have been used in the trial. So overall, what I would say is from a safety perspective, as well as from the efficacy perspective, you will see that this drug, which can be given orally is differentiated. And we are looking forward to the dialogue with the health authorities and agencies for submission.

Chris, I wonder if you would like to comment as well?.

Sure. The only thing I would add to what you said, Samit, is that remembering UC, the unmet need here is really for oral options with efficacy that's comparable to biologics, but with a better safety profile than you see with existing biologic agents in JAK inhibitors.

There's obviously in this space, a lot of competitive noise and the data are going to evolved and clearly we need to wait for the full True North data set to be presented. But based on what we know today, and the data that we've seen, we feel very good about the Zeposia profile.

And you see the efficacy appears to be in line with biologics, but with better safety and specifically, we're not seeing either here or in the MS profile, the rates of serious infections or thrombosis or malignancies that have led to black box warnings for a number of the TNF inhibitors and JAK.

So, given the chronic nature of this disease, we think Zeposia is going to have a role to play. It's an oral agent. As you noted, Tim, in your question, it has a unique mechanism of action, which actually is important given the chronic nature of this disease, and it offers a better benefit risk profile potentially than existing agents..

Thanks, Chris. I think we're ready for the next, Orlando..

And we'll go to the Steve Scala with Cowen..

Thank you. If I can ask three follow-up questions. First on Eliquis. Are the settlement dates fixed now although undisclosed, or in some way are they dependent on the 2031 patent? Secondly, you've said many times that Opdivo is likely to return to growth in 2021. Can you clarify.

Is that for the full year? The second half of 2021? The fourth quarter 2021? And is it dependent on Adjuvant lung approval? And then lastly on ide-cel. Has the FDA indicated that they still plan to review ide-cel in an eight months review cycle or have they not said that one way or the other? Thank you..

Thank you, Steve. Let me maybe take the three very quickly. So as I mentioned, the details of those settlements which are complete are confidential. And again, as I said, there is clearly potential for some extension beyond 2026. I would say in between 2026 and 2031, depending on the outcome of the appeal.

And I don't think there's anything more than we can say about that. With respect to Opdivo, what we've commented on, is that the brand has an opportunity to grow in 2021. We're not really providing quarterly breakdowns of that -- of the growth.

But we feel really good about where we are based on the strength of the current business and what Chris, as mentioned earlier, about first-line lung and the approval potential in first-line renal based on 9ER. And this would be the main driver. I think the only thing we can say for ide-cel is what we've already communicated.

We have requested a priority review. But it's obviously the agency's decision to make that comment. Samit anything..

Yes. I think in addition to that, we have a breakthrough therapy designation as well. So overall, the agency will take a look at the data itself, which we are really excited about. And then, of course, the overall status of the program that we have..

Chris, anything to add on Opdivo?.

No. I think you've covered Opdivo well. What we've said is that the trajectory of the growth will be determined by the Adjuvant indications that we feel very good about the growth opportunities starting in 2021 based on the dynamics I've mentioned..

Great. Can we go to next one, please..

And we'll hear from Khushal Patel with Guggenheim Securities..

Hi. Thanks so much for participating on behalf of Seamus. So, in terms of the reaffirmation of the 2021 EPS guidance.

I was just wondering in relation to that how the integration efforts and just expense management in the P&L was progressing? And how that might play through in 2021, especially with R&D increasing, as trials ramp up presumably? And just push and pull for I guess, the synergies there.

And then potentially any comments in regard to the elections? And then the second question just with a cash pile building up. Wondering how the team is thinking about deals in the future, maybe bolt-ons. Just any color there would be nice? Thanks..

Thank you.

David?.

Yes. So thank you for the question on the integration and synergies. Look, as Giovanni and I both said on the integration side of things, we're really pleased with how quickly everything has gone.

And we're very fortunate to get the vast majority of people in the roles over 90%, prior to COVID situation hitting us, which was very fortunate, because everybody knew the roles and the reporting relationships. And that really enabled everyone to come together.

I think also just having a crisis like this, everyone's working remotely and getting through it and the way everyone's reacted to focus on meeting patient needs and making sure we're getting product at the door has really -- I think the cultural integration has sped up. And we've seen that through the surveys.

We've done from an employee engagement perspective. You also know, on the integration side of things we mentioned before that we announced all the major sites around the world and there was a high overlap there. So people know where they're going to be working. So again, that helps from a cultural aspect.

On the synergy side, as I said in my call, things are going very well. We're going to achieve one-third of those next year. I think the team is doing an amazing job.

Within a couple weeks after us closing the deal, we got all of our major suppliers together, and we saw about a billion dollars of the $2.5 billion coming from third-party -- from third parties. And we feel very, very confident in how we're executing against those synergies..

Yes. With respect to capital allocation, you had a question. Nothing really has changed with respect to capital allocation. And what I would say is that as we've said in the past, our priority for capital allocation, the central pillar of that has always been to continue to source externally innovation through business development.

So that's very much a priority for us. And as you know, we look at business development from the perspective of deals that are sort of aligned strategically with therapeutic areas. We know well, where there is a potential for breakthrough science and obviously, we're disciplined from a financial perspective.

So we're very active, looking at potential deals across the board to strengthen our discovery platform, increase the number of collaborations we have and pretty much across the board. So you are right that our financial positions continues to strengthen and business development remains an area of focus for us..

Thanks, Giovanni. Orlando.

Could we go to the next one, please?.

Yes. We'll hear from Andrew Baum with Citi..

Thank you. Couple of questions, please. Firstly, to Giovanni, could you give us the true level of concern in the industry. But also in Bristol regarding the President's executive order on most favored nation's IPI that you referred to in your opening comments.

Extensively, it would seem that the requirements for having favorable CBO score and the HHS being able to validate that is a requirement, which doesn't seem likely given what happened last time. So what is the real risk that that changes, and therefore, this proposal has lags? I'm just trying to understand how real the threat is.

And whether something has changed and we shouldn't be quite as relaxed as we are given the last time round. Second, perhaps Samit could talk to some of the forthcoming data at ESMO.

You have a deep tranche of immuno-oncology agents, CCR-25, IL8 among others, what data will we see at ESMO?. And then finally, just on the COVID impact For Eliquis ex U.S., particularly in Europe, where obviously there's a delay in reimbursement.

How much scope do you see for NOAC market share increases as a function of COVID? And trying to keep patients out of medical centers from getting their INR measures? Thank you..

Sure. So let me let me start on government related issues. Samit will cover ESMO, and Chris maybe can give you some insights into your question on demand. So first of all, let me say, Andrew, I think it's really early to provide any more granular assessment. As you know, we have not seen the IPI executive order yet.

And so with respect to that, there is there is some level of uncertainty with respect to really what is in the order and what a path to implementation may be. I want to say, again, what I said in my opening remarks, we feel very strongly that it is not the right direction for the U.S. to go.

I think our view is shared not just across the industry, but providers and patients associations and other policy stakeholders are aligned with our view. I think the solution to patient affordability issues in the U.S. is to work on patient affordability issues.

It is really not to import models and pricing levels that are not working internationally into the U.S. And quite frankly, the IPI doesn't do as much for patients as we should be doing for patients.

So our industry continues to be really open to discussing different types of solutions with the administration that would help patients more, but also would enable us to continue to invest in innovation. I think it's really important at a time in which everybody understands the importance of our industry, which quite frankly, is primarily a U.S.

industry in fighting disease. The impact of IPI in the version, at least we knew would be extremely significant on our industry and the ability to continue to invest in innovation. And we hope that and we hope that we are able to move into directions that are better for patients in the U.S.

From our perspective, when you think about our portfolio, it's clearly much more differentiated today than it was in the past across multiple segments. And when you look at our sales, it's about 40%. internationally and 60% in the U.S. Part B just as a reference point, it's about 15% of our business.

With respect your question about the rebate rule, I think we would have to see how HHS goes about really thinking about the various sort of implications of a rebate rule and assess what the cost of that would be versus the benefits.

So I'm not sure, I can really speculate on how that would be certified and whether the issues that were raised in the previous version would even be an issue at all at this point. I think that's just much as I know at this point.

Samit?.

Thank you. Thanks, Andrew for the question on the ESMO. I think the way to look at it is there are several presentations or data that are being presented at ESMO primarily from the Phase 1 studies and some updates. But the most important one to focus on would be Checkmate 9ER for renal cell cancer, because that certainly is a differentiating therapy.

And as Chris mentioned earlier, as well as you heard in the other comments in earlier presentations inclusive of all subtypes are both in and inclusive the favorable risk population, which is currently not covered to our data in the dual IO setting. There will also that update on the dual IO with a four-year follow up for that study.

So those two are going to be key as they provide a better way to look at treatment for patients with renal cell cancer with a dual IO, and then of course, we're looking at potentially getting the 9ER approval later. And so that will certainly provide an additional way to treat these patients for a safe and effective medicine perspective.

There was a third question on….

Yes. Thanks Andrew for the question on Eliquis. So let me just say at the outset that fundamentals for Eliquis remains very strong both in the U.S. and ex U.S. With the number one OAC in 12 markets now globally. We're the number two in five additional markets. And the fundamentals, again are very strong.

With respect to COVID impact, there are really two things that are at play. As David mentioned, there's an inventory work down of the inventory build that we saw in Q1. That's the largest COVID impact that we've seen for the quarter. That's mainly been in the U.S., though not exclusively, but the main impact was in the U.S.

And then there's been a smaller impact on demand and that's reflective of the fact that the OAC market has been impacted by new patient volume that has come down. The negative impact was most significant in April. It's begun to recover. We've really not seen an impact on total patient volumes.

As you note, one of the potential upsides for Eliquis has been -- first of all, that Eliquis has been disproportionately unaffected by COVID relative to other players. And then secondarily, we have seen as you alluded to in a number of markets, the desire to try to keep patients out of hospitals and institution. And that's impacted warfarin share.

So we've seen a decrease in warfarin share from about 16% at the end of the first quarter to about 14% in June. And that's reflective of -- we think new patients initiating on DOACs as opposed to warfarin. As you alluded to unlike warfarin, DOACs don't require extensive monitoring or dose adjustments.

And so as a result, we've seen some IDNs and a number of governments seek to reduce exposure of those patients and Eliquis has disproportionately picked up that share loss. So that's certainly been an opportunity coming out of COVID..

Thanks, Chris. Let's go to the next one..

And we'll hear from Navin Jacob with UBS..

Hi. Thanks for taking my question.

Can you hear me okay?.

Yes, Navin..

Perfect. Thanks. Just a few if I may. On Reblozyl, a strong quarter. Wondering how much inventory build there was relative to demand. And if you could remind us about the timing of the first-line MDS study readout.

Are there any interim analyses that could happen earlier than the final look? And then also the timing of the MS study, please? And then just a question on your early stage pipeline. I think you recently moved your LPA antagonist into Phase 2 for IPF.

Wondering if you could discuss any kind of activity that you may have seen in Phase 1b that moved that decision to move that asset into Phase 2?.

Thank you, Navin. Why don't we ask Nadim to start and then Samit will cover a couple of your pipeline related questions..

Great. Navin, thanks for your question. So one thing I do want to reiterate that you heard earlier. Overall, we're very encouraged by the launch of Reblozyl, and especially the ability of our commercial teams to pivot to a virtual launch.

And we have seen good early adoption so far, especially and I think some key factors here are the significant unmet need in MDS, especially in ESA refractory patients, the unique mechanism of action of Reblozyl of course, our field teams that have very good experience and knowledge of MDS and relationships of MDS prescribers has allowed us to get that access.

And we have we have good access with players, now that we have a permanent J-Code since July. So coming back to a question, Navin. There are some kind of short term dynamics here, partly COVID and the impact of blood shortage. On your specific question about inventory, this is a product that's shipped directly to our customers and sites.

So that isn't really in play here. The one area that is -- could be a little bit in play here is, of course, of a new treatment addressing a significant unmet need, you do get a pent up demand with new oncology agents. So there likely is somewhat of a bolus effect going on. But as I said, we're very pleased with the progress so far.

And the teams focused on both new patient initiation as well as patient persistence and what we're seeing is encouraging. We're seeing new patients continue to initiate and we're seeing most patients go on to receive their second and third treatment. Customer feedback remains very good. Brand awareness is high driven by our field team.

So we are encouraged. But as you as I said earlier, there is a little bit of a bolus effect too. So we'll see how that dynamic continues to play out through the rest of the year. But very pleased with the progress so far.

Samit?.

Yes. Thank you. From the COMMANDS study perspective, it's a Phase 3 study. As you know, in the first line setting which includes both RS-negative and RS-positive patients and that study is currently enrolling. We're looking at readout coming in 2022 -- late 2022 timeframe. The myelofibrosis study is just starting off.

So that will take a little while to get going and we'll obviously provide the timelines again 2022 and beyond. For the interstitial pulmonary fibrosis side, as you are aware, we had presented the data and publish the data in IPF as well, where we've seen interesting results, where the side effects were there for the blood pressure effects as well.

So we are now investigating the -- in the Phase 2 study looking at seeing what we can do in terms of management of the side effect and the molecule is going to be investigated there, which will then decide how we proceed further with that molecule into a later stage trials. But we have to wait to see the data when it reads out..

Great. I think we have time for maybe one very last quick question, Rolando..

All right. We'll get that question from Matt Phipps with William Blair..

Thanks for taking my questions. Just ahead of the ESMO presentation of 9ER data.

Can you remind us on your positioning of that regiment in RCC? Do you think you can meaningfully grow Opdivo total sales in RCC? Or is it really more going to just shore up Opdivo across the different regimens? And then just a quick second one, with some of the COVID related impacts on infusion center access, have you all thought about accelerating time launch for subcutaneous Opdivo? Looks like you recently started another trial that's combined with subcu Opdivo and Yervoy? Thanks..

Thank you, Matt..

Sorry, Giovanni, maybe I'll start with renal cell. So, just the baseline of where the business is today, Matt, is that market share is roughly unchanged from the last quarter. Our overall share of people you're avoiding first time renal is between 30 and 35% on the upper end of that for Opdivo and Yervoy in first line renal is between 30% and 35%.

On the upper end of that for labeled indication. And then importantly, we are under penetrated as you would expect in the favorable patient population, which is currently off label. And the way we're thinking about 9ER is, first of all, we're very happy with the data that we've seen both on OS and PFS. We're also very encouraged by the safety profile.

And so as we think about positioning this agent, while it's still early days and we need to see the full data set being presented. We think these provide -- these data provide a very compelling opportunity with respect to existing IO/TKI options. So there's a clear opportunity we think to drive share from existing IO/TKI regimens in this space.

Second, TKI monotherapies still a fairly sizable percentage first-line use. It's about 30% in first-line today, mostly in the favorable population. We think that's an opportunity for us as well, because remember, 9ER was conducted across risk status as well as included -- it included the favorable patient population.

So we think there's a real opportunity for us to continue to drive share in that population as well. And so, I think that -- the last thing I would say about the opportunity we have here is to remember our position in renal cell we have both mono therapy in the second-line setting we have Opdivo and Yervoy in first-line.

And this gives us a options with IO plus TKI in fact will be the only company with that many different modalities at play. And so we think we're going to have a very strong position with 9ER and first-line is going to be an important opportunity for us to continue to grow the brand starting in 2021 when it's approved..

Thank you, Chris. And when it comes to subcu development, so we are continuously working on that and making good progress on that and looking forward to the readouts of the Phase 1 study where we're looking at the PK parameters, where we'll be able to then compare it to the IV parameter.

And then concert with our communications with the health agencies..

Thank you..

Thank you. And thanks everyone. Again, thanks for participating in the call. In closing, let me just say again. We had a very successful quarter. I'm very proud of our teams have executed despite the challenges of the pandemic. We advanced our pipeline. We delivered strong commercial execution. We've continue to supply our medicines to patients.

And we are very well positioned for the future. Our pipeline has increased potential to transform patients lives through our science. Thanks everyone for participating in the call. And as always, our team will be available to answer any other questions you may have. Thank you..

And ladies and gentlemen, that does conclude today's call. We thank you for your participation. You may now disconnect..