Earnings Call Transcript - BMY Q2 2020

Operator, Operator

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.

Tim Power, Vice President, Investor Relations

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.

Giovanni Caforio, CEO

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 this 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 reinforce 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.

David Elkins, CFO

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.

Tim Power, Vice President, Investor Relations

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

Operator, Operator

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

Geoff Meacham, Analyst

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.

Giovanni Caforio, CEO

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.

Chris Boerner, Chief Commercialization Officer

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' minds. 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 segments, 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 been 227. However, in recent weeks, we've even seen an uptick 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 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 a 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 in 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 TYK2, very excited, obviously about the data that we have already presented with Phase 2 and psoriasis, psoriatic arthritis, Phase 2 data. 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, and Japan with psoriatic arthritis. And there's still significant unmet need here. Two-thirds of 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.

Operator, Operator

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

Terence Flynn, Analyst

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.

Giovanni Caforio, CEO

Thank you, Terence. I want to briefly address our guidance, and then I'll ask Samit to share insights on the adjuvant readout. At this time, we are reaffirming our guidance for 2021, as nothing has changed. Our assumptions regarding COVID are aligning with our expectations, and our business remains strong, as indicated by several early positive signs. We have discussed various considerations in the previous quarter, and they are still relevant now. We have made several assumptions about COVID, particularly looking ahead to the end of the year and into next year, though we will need to monitor how these unfold, given the significant variability involved. Additionally, we have not factored in any effects from U.S. Healthcare Reform in our assumptions, as it is still too early to determine any potential impact. With all this in mind, considering the strength of our business, we are reaffirming our guidance for 2021 at this time. Samit?

Samit Hirawat, Chief Medical Officer

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.

Tim Power, Vice President, Investor Relations

Thanks, Samit. Orlando, can we go to the next one?

Operator, Operator

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

Chris Schott, Analyst

Great. Thanks so much for the questions. I guess first for me was on TYK2. Can you just elaborate a little bit more on the safety profile of the product that you saw in the psoriatic arthritis study? Is there 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 on 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.

Giovanni Caforio, CEO

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

Samit Hirawat, Chief Medical Officer

Thanks, Chris, thank you for the question for TYK2, as already alluded to a little bit by Giovanni and then Chris, earlier, we're really excited for TYK2 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?

Chris Boerner, Chief Commercialization Officer

Thanks for the question, Chris. We are pleased with the early dynamics in the U.S. suggesting that physicians are not limiting the dual IO regimen to a specific patient type. We are seeing good uptake of the 227 regimen across various segments and PD-L1 expression levels, as well as different histologies. The patients on therapy so far, particularly in the one to 49 age range, are generally those seeking non-chemo options or those who are frail and cannot tolerate chemotherapy. There is some usage in the greater than 50% population for patients looking for a more aggressive option than single-agent PD-1. With the 9LA regimen, we are observing young, fit patients with severe disease who are motivated for a more aggressive option. As we look ahead, we believe there are significant opportunities to expand dual IO therapy across all patient subtypes. We haven’t seen much utilization yet among the PD-L1 negative, unknown, or untested segment, which is generally underpenetrated, but this presents an opportunity for the 9LA regimen. We believe there are multiple avenues to drive utilization across different patient segments in the U.S. While we won’t have 227 on label outside the U.S., the data will be publicly available, and our medical teams will engage as appropriate. The 9LA data will continue to mature by the time of our launch, providing an entry point into the PD-L1 negative segment. We will keep you updated as we approach the timing of that approval.

Chris Schott, Analyst

Okay. Thanks Chris.

Tim Power, Vice President, Investor Relations

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

Operator, Operator

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

Tim Anderson, Analyst

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 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, besides this just being a different mechanism?

Giovanni Caforio, CEO

Thank you, Tim. Let me start on Eliquis, and then Samit will provide some comments and True North. 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 patents has been confirmed yesterday.

Samit Hirawat, Chief Medical Officer

Zeposia, as you've seen from the MS label, has 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 not only met the primary endpoint, but we see very important, very significant results in the secondary endpoints as well, including 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 an 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?

Chris Boerner, Chief Commercialization Officer

Sure. The only thing I would add to what you said, Samit, is that remembering in 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 evolve 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 inhibitors. 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 is actually important given the chronic nature of this disease, and it offers a better benefit-risk profile potentially than existing agents.

Giovanni Caforio, CEO

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

Operator, Operator

And we'll go to Steve Scala with Cowen.

Steve Scala, Analyst

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 of 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-month review cycle or have they not said that one way or the other? Thank you.

Giovanni Caforio, CEO

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 growth. But we feel really good about where we are based on the strength of the current business and what Chris has 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.

Samit Hirawat, Chief Medical Officer

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.

Giovanni Caforio, CEO

Chris, anything to add on Opdivo?

Chris Boerner, Chief Commercialization Officer

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.

Giovanni Caforio, CEO

Great. Can we go to next one, please?

Operator, Operator

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

Khushal Patel, Analyst

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.

Giovanni Caforio, CEO

Thank you. David?

David Elkins, CFO

Thank you for the question about integration and synergies. We are very pleased with the progress we've made in integration thus far. We were fortunate to fill over 90% of the roles before the COVID situation, which helped everyone understand their responsibilities and reporting lines. This clarity allowed for a smoother collaboration. During this crisis, our team's commitment to meeting patient needs and ensuring product delivery has accelerated our cultural integration, as reflected in our employee engagement surveys. As for the integration process, we previously announced the major global sites, which have high overlap and familiarity for our teams, further supporting cultural alignment. Regarding synergies, I mentioned in my earlier comments that we are on track to achieve one-third of our goals next year. The team has performed excellently. Shortly after closing the deal, we brought our main suppliers together and identified about a billion dollars of the projected $2.5 billion from third parties. We feel very confident about our execution on these synergies.

Giovanni Caforio, CEO

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 position continues to strengthen and business development remains an area of focus for us.

Tim Power, Vice President, Investor Relations

Thanks, Giovanni. Orlando. Could we go to the next one, please?

Operator, Operator

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

Andrew Baum, Analyst

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 nations 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.

Giovanni Caforio, CEO

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 some level of uncertainty regarding 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 patient 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 to your question about the rebate rule, I think we would have to see how HHS goes about really thinking about the various 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?

Samit Hirawat, Chief Medical Officer

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 of the favorable risk population, which is currently not covered to our data in the dual IO setting. There will also be an 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…

Chris Boerner, Chief Commercialization Officer

Thank you, Andrew, for your question about Eliquis. I want to emphasize that the fundamentals for Eliquis are very strong, both in the U.S. and internationally. We are the leading oral anticoagulant in 12 markets globally and hold the number two position in five additional markets. Regarding the impact of COVID, there are two key factors to consider. First, as David mentioned, we are experiencing a reduction in inventory due to the buildup observed in Q1. This has primarily affected the U.S., albeit not exclusively. Second, there has been a minor impact on demand, largely due to a decrease in new patient volume within the oral anticoagulant market, with the most significant decline occurring in April. However, we are seeing signs of recovery, and overall patient volumes have not been adversely affected. One potential advantage for Eliquis is that it has been less impacted by COVID compared to other options. Additionally, we’ve noted a trend in several markets towards keeping patients out of hospitals and institutions, which has led to a decline in warfarin use. Warfarin share decreased from about 16% at the end of Q1 to 14% in June, suggesting that new patients are opting for direct oral anticoagulants instead. As you pointed out, DOACs, unlike warfarin, do not require extensive monitoring or dose adjustments, making them more appealing. Consequently, some integrated delivery networks and government entities are looking to minimize patient exposure, which has allowed Eliquis to gain from the loss in warfarin share. This presents a significant opportunity as we emerge from the COVID situation.

Tim Power, Vice President, Investor Relations

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

Operator, Operator

And we'll hear from Navin Jacob with UBS.

Navin Jacob, Analyst

Hi. Thanks for taking my question. Can you hear me okay?

Giovanni Caforio, CEO

Yes, Navin.

Navin Jacob, Analyst

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?

Giovanni Caforio, CEO

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

Nadim Ahmed, President Hematology

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 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 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 team's 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 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?

Samit Hirawat, Chief Medical Officer

Thank you. The COMMANDS study is a Phase 3 trial that includes both RS-negative and RS-positive patients and is currently enrolling participants. We expect to have results by late 2022. The myelofibrosis study has just begun, so it may take some time to progress, and we will provide updated timelines for 2022 and beyond. Regarding interstitial pulmonary fibrosis, we have presented and published our data, which showed interesting results and some side effects related to blood pressure. We are now conducting a Phase 2 study to explore how we can manage these side effects, and this will determine our next steps with the molecule for later trials. We will need to wait for the data to be released.

Tim Power, Vice President, Investor Relations

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

Operator, Operator

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

Matt Phipps, Analyst

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.

Giovanni Caforio, CEO

Thank you, Matt.

Chris Boerner, Chief Commercialization Officer

Starting with renal cell, the current market share remains relatively stable compared to last quarter. Our overall share for first-time renal is between 30 and 35%, with Opdivo and Yervoy in the first-line indication also between 30% and 35%. We recognize that we are under-penetrated in the favorable patient population, which is currently off-label. Regarding 9ER, we are pleased with the data we've observed for overall survival and progression-free survival, and we are encouraged by the safety profile. Although it’s still early and we await complete data presentation, we believe these results present a compelling opportunity against existing IO/TKI options. We see a clear chance to gain market share from current IO/TKI regimens in this area. Additionally, TKI monotherapies account for a significant portion of first-line usage, currently around 30%, primarily among the favorable population, which we also view as an opportunity since 9ER was tested across risk statuses, including that population. Furthermore, we have both monotherapy available in the second-line and Opdivo and Yervoy in first-line renal cell. This positions us uniquely with various treatment modalities. We anticipate a strong position with 9ER, and the first-line opportunity will be crucial for brand growth, particularly starting in 2021 upon approval.

Samit Hirawat, Chief Medical Officer

Thank you, Chris. And when it comes to subcutaneous 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 in concert with our communications with the health agencies.

Matt Phipps, Analyst

Thank you.

Giovanni Caforio, CEO

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 continued 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.

Operator, Operator

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