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

Great. Good afternoon, everybody. I'm Terence Flynn, the biopharma analyst at Goldman Sachs, and we're very pleased to welcome Bristol-Myers Squibb today to our virtual conference. Joining us from the company is Nadim Ahmed, who is Executive Vice President and President of Hematology; Chris Boerner, who's Executive Vice President and Head of Commercial -- Chief Commercial Officer. Looking forward to hosting you both today. Thank you for taking time out of your day to join us.

Maybe just to get started, and again, maybe, Chris, this one would be for you. And, then, Nadim, you could add on anything here. We're obviously into June, and some states are starting to reopen now. And just wanted to check in on the operating environment and how that's tracking relative to the expectations that you outlined on your first quarter call, where you said you saw more -- a return to a more stable business environment in the third quarter. And then maybe any commentary across the key end markets that you guys operate in?

Sure. Maybe I'll start, and Nadim can chime in as well. So what I would say, at a high level, is the teams are managing through COVID quite well. The fundamentals of our business remain very strong. And importantly, we're in the process of building what we think is going to be the leading biopharmaceutical company post the acquisition of Celgene, and that importantly remains on track. From a business standpoint, what we said in the first quarter was that we had about a $500 million impact from COVID. The majority of that was Eliquis predominantly in the U.S. As you know, Terence, normally, in the first quarter, we see a drawdown in inventory. This year, mainly in March, we saw a fairly significant increase in wholesale and retail inventory with Eliquis. That began to work its way down in April and May. We expect inventory levels really to normalize by the end of the second quarter. Beyond Eliquis, the impact on the business from COVID in the first quarter was relatively small. Now things are still quite dynamic. And so we're monitoring a number of trends that could affect us in the second quarter and possibly beyond. And I'll just highlight a couple. First, as access to clinics and hospitals has become constrained with COVID, we have seen an impact on patient volume, especially new patient scripts. That's been across therapeutic area, though I would say that the magnitude has been different across therapeutic areas and even within oncology across tumors. So for example, we've seen some choppiness in Opdivo early in the second quarter. What we said on the call is that with respect to this, we expect that to continue in the second quarter, hit its nadir, begin to recover in Q3 and then normalize in the fourth quarter. So that's sort of one big thing that we're following. The second trend I'd highlight is that we are looking to see whether there's any preference that physicians have for dosing schedules or modalities that might limit the amount that patients are going into the clinic. We did see some shift, for example, on Orencia, from the IV formulation to subcu in the first quarter, so we're going to pay attention to that. Nadim can comment on whether there's any potential preference for oral therapies in light of the COVID situation. But those are probably the 2 big trends that we're following. In terms of across markets, I think we're starting to see some European and Asian markets open up. It's a little too early to see whether or not the dynamics there are evolving differently than, say, in the U.S. But I would leave you with maybe a couple of things. First, the situation remains pretty dynamic. It's too early to really give any predictions for the second quarter or the year. But we are starting to see some stabilization, particularly around patient visits and new patient starts. We're continuing to monitor it carefully, but the underlying dynamics of the business and the fundamentals remain very strong and largely in line with expectations. Nadim, anything to add?

Sure. No, I'd add a couple of things. Thanks, Chris. And so I would delve back to [indiscernible] broad shape of the curve is in line with what we said in our earnings, with the peak of the impact in Q2 and becoming more stable in Q3 and returning to normal in Q4. [ I remember ] for Q1, I think about the myeloma business ex U.S. [indiscernible] was about $50 million to $100 million based on stocking. And I think as we think about patient visits and the impact, I think what I would say is that, for both Revlimid and for Pomalyst, a little less of an impact just because they're oral therapies and patients don't have to come to the clinic or the hospital to receive their infusion. So a little bit less of an impact there, but broadly in line with what we said during our [ Q1 call. ]

Great. Great. Well, thanks for all the details on that front. I guess, Chris, again, just moving back to you here, congrats on the ZEPOSIA MS launch and the recent UC data. I was just wondering if you can recap the release for ulcerative colitis and maybe any additional commentary you could give there on if the drug met your target profile?

Yes. Well, what I would say is that we're very encouraged by the opportunity that we have with ZEPOSIA. And I'd actually level it up to, say, in inflammatory bowel disease, generally. Both ulcerative colitis and Crohn's disease, as I think you know, are chronic conditions. They require multiple treatments to manage. And really across both diseases, there's an opportunity, we think, to improve the therapeutic window. Now with respect to ulcerative colitis, specifically, there, there's a real need for oral options with efficacy that's comparable to biologics but with a better safety profile than you see either with existing biologic agents or JAK inhibitors. Today, there are really 2 broad approaches to managing moderate to severe UC. You have JAK inhibitors, and then you have a fairly broad category of biologics that includes TNFs and biosimilars as well as some of the IL-12 and IL-23 inhibitors. What we hear consistently from customers is that they are looking for oral agents with efficacy that is at least in line with JAKs and biologics but have a better safety profile and, specifically, a profile where you don't see the sort of serious infections and thrombosis and subsequent malignancies that have led a number of existing TNFs and JAKs to end up with black box warnings. And in that respect, if you look across the totality of what we've seen, we think we're going to have a role to play. ZEPOSIA is an oral agent. It's a unique mechanism of action, and we think it's going to offer a better benefit/risk profile for patients than existing therapies. Now obviously, we have to wait and see the full data set presented, but we're quite encouraged with what we've seen in UC.

Great. And then maybe on the market opportunity side, I guess, I'm just trying to think about the size of the eligible patient population, maybe in U.S. and Europe. I mean, I think XELJANZ right now is doing around $500 million, $600 million. I would assume that you guys think you can have a better safety profile there. So are those some of the metrics that we should think about as we think about the market opportunity on the UC side?

Yes. So UC is a fairly sizable opportunity. I mean we have about 1.6 million people in the U.S. who are diagnosed with ulcerative colitis. About 50% to 60% of that is moderate to severe. Roughly similar populations when you look at Crohn's disease. And so I think that as we look at it, there's a real opportunity here. And in some ways, we've -- you've heard us talk about this with respect to the TYK program. There's a full spectrum of therapies that are available in the space that range from corticosteroids and immunosuppressant agents that are typically used for more mild patients, all the way to biologics at the other end of the spectrum. And we think the sweet spot for a product like ZEPOSIA is going to be really in those moderate to severe patients who need a safer, more convenient option that delivers biologic-like efficacy but has a more tolerable safety profile. But we anticipate playing in that full space of moderate to severe UC.

Okay. Great. And I guess on the MS front, any more details you can share now on the early launch and maybe your commercial strategy and footprint?

Sure. We are very excited to finally launch ZEPOSIA. As you know, we made the decision when we were approved in late March to delay that launch. We actually formally launched the product on June 1, so a little over a week ago. That launch has mainly, because of COVID, stayed a remote launch, although we expect to transition to more of an in-person promotion as conditions warrant across the country. Given we've only been on the market with the product for a little over a week, it's a little too early to provide details on the launch. But what I would say is that the feedback that we have received from customers has been very, very good. Specifically, what customers continue to highlight is that we have efficacy that is on par with existing oral therapies along traditional physical endpoints, which is really what most of the other S1Ps are promoting, too. We are the only product to study prospectively and demonstrate improvement on novel brain endpoints, so for example, whole brain loss, cortical gray and thalamic volume. And the safety profile, in particular, is important because what we see is a very clean label from a safety standpoint. We have no first-dose cardiac monitoring, no requirement for broad-based ocular testing and really a favorable profile on lymphocyte count. Parenthetically, that safety profile is particularly attractive in light of COVID because it actually can facilitate patients getting onto therapy. So the feedback that we've gotten around the profile of the product is very strong. We've got a very good team from a commercial and medical standpoint that's been ready to launch for a number of months. They've got deep expertise in both neurology and MS, specifically. They were chomping at the bit to get on the market, and we're very excited to make the product available.

Okay. Great. Well, best of luck on that front in the coming months. Maybe now we'll shift over to Opdivo + Yervoy for a little bit before going into Nadim. But just wondering, obviously, there are a couple of important new data sets for 2 tumor types, kidney and lung. Maybe first, we'll start out with CheckMate -9ER on the kidney front. Just wondering how that data shapes, how you think about kind of the medium-term outlook for that franchise.

Yes. So we're excited about the data that we saw with CheckMate -9ER. It's a potential for a third approval for Opdivo in renal cancer and, we think, really strengthens our leading position in that space. As we think about the opportunity for -9ER, that really starts with where we are with Opdivo and Yervoy. As I think we talked about in the first quarter call, market share for Opdivo + Yervoy in first-line renal is around 30% to 35% overall. It's on the higher end of that range, closer to 35% for our labeled indication of intermediate, poor patients in the U.S. It's about 15% actually in the favorable patient population, which is off-label for us at the moment. But we've seen real strength in that business. In fact, we saw share increase over the first quarter. And you'll recall, actually, if you go back a year, there was a lot of consternation about the role that Opdivo plus Yervoy would play in first line given the data that was coming out from competitors on I-O plus TKI. And I think the depth and durability that you see of the responses with Opdivo plus Yervoy has really helped us maintain a strong position and keep Opdivo + Yervoy a standard of care there. In fact, we just presented earlier this year data at ASCO GU which showed 42-month OS with the dual I-O regimen of about 56%. So we're excited about the role -- the continued role that Opdivo + Yervoy is going to play. And what we think -9ER does is enable us to bring what we believe based on the data we've seen, both from an efficacy and safety standpoint, a leading, if not best-in-class, I-O plus TKI option to the market. Now it's very early days. We got to wait and see the full data presented. But we're excited about the opportunity here. We think we have the opportunity to take share from existing I-O/TKI options that are available. We think that this really does open for us in a more meaningful way the favorable patient population, which, as I mentioned earlier, is not in the Opdivo, Yervoy label. And in fact, the majority of the business that has been sourced by I-O/TKI has been in that favorable patient population thus far. And you still see quite a bit of TKI monotherapy there. So you add it all up, we think we've got a real opportunity with Opdivo and CABO. We think it's going to be a best-in-class regimen for us, and we're excited to continue through the regulatory process and ultimately make that available. The last thing I would say on that is we will be the only company to offer multiple I-O modalities in this space, which I think is going to be important.

Great. And maybe just one follow-up there. As you think about that 30% to 35% market share, I mean, it seems like that should be kind of our baseline now. It sounds like you expect that to go higher as you take share from either TKI monotherapy or TKI plus other I-O regimens. I mean, again, I know you're not going to give guidance exactly where that goes. But is it fair to assume that 30% to 35% is a starting point and you guys can work higher from there?

We've been very impressed with the durability of our share with Opdivo and Yervoy in first-line renal. And our ambition is to make sure that Opdivo plus Yervoy continues to be a standard of care in the first-line setting. And as I mentioned, we think that -9ER offers us an opportunity to penetrate a part of this market, either from taking share from existing I-O/TKI options given the profile we have or tapping into the favorable patient population that really quite frankly has been off limits to us from at least a promotional standpoint thus far.

Okay. Great. And now maybe just transitioning over to lung. Obviously, a lot of debate coming out of ASCO this year on the role of Opdivo + Yervoy in frontline lung given the -227 data, the -9LA data and approvals. But then there's also been some competitive data, too, from Roche on their anti-TIGIT with TECENTRIQ. So would just be curious, again, from your seat, Chris, on the commercial side, what are kind of the key messages here that you're coming out of ASCO with to your customers? What are you hearing from the field? And how do you think about that market share over the medium term?

Yes. We continue to be very excited about the opportunity for Opdivo and Yervoy in first-line lung cancer. From a commercial standpoint, we're obviously extremely excited to be promoting in the first-line setting. The feedback that we've gotten really since approval and certainly since ASCO has largely been consistent with what customers have been saying to us all along. There's a broad recognition, obviously, that this is a space with an entrenched competitor. But consistent with what we've said previously, this is still an area of significant unmet need. The majority of patients treated with standard I-O plus chemotherapy are going to relapse within a year. Certainly coming out of ASCO, there are still questions about the durability of the benefit we see with existing first-line lung options. Similar to the discussion we just had in renal, customers continue to be very impressed with the depth of durability of benefit with dual I-O. Recall that what we presented with -227 at ASCO was that -- among other data, that patients who achieved a complete or a partial remission at 6 months, 70% were still alive at 3 years. That's very impressive depth and durability in this space. Now while the -9LA data that we presented at ASCO are still relatively immature, you did see a nice separation of those curves early on. You see a consistent benefit across PD-L1 expressions as well as histology. And I think many customers we've spoken to since ASCO are really excited to see how those Kaplan-Meier curves continue to mature over time. And that's important because -- and again, this will tie back to the discussion we just had in renal. Remember that the majority of first-line lung cancer is treated in a community setting, where a great many of those physicians who are treating in lung cancer, in fact, 70% to 80% of them, also treat other tumors, specifically melanoma and renal. In fact, half of the first-line lung cancer treaters have experience with Opdivo and Yervoy in 1 of those other 2 tumors. So the fact that you've got physicians who have experience with the dual I-O regimen in these other tumors, they've seen the benefit that it can provide. It's an important familiarity that we think is going to be important as physicians interpret -227, as they think about the potential with -9LA in the longer term. And these physicians account for about 2/3 of patients who are treated in the first-line setting. So again, I think the feedback we've gotten is consistent. We have a very strong team here. They know how to execute. They know this space, and they know these customers very well. And we're very excited to finally have the opportunity to launch in first line.

Great. And maybe the follow-up is just on the anti-TIGIT combo. I know that's another I-O/I-O combo here. Again, it looked like there's efficacy signal in the high expressors and generally benign safety profile when you add the TIGIT on. But just from kind of your commercial seat, any perspective you can share there? I understand they still have to do a Phase III trial.

Yes. I mean, I think the data that we've seen so far, it's Phase II. It's still pretty early. Certainly, they've seen an impressive production in progression-free survival. The benefit seems to be driven, as you note, in the high PD-1 expressors. Obviously, that's a space, if you look at just the market dynamics today, that's dominated by I-O monotherapy, this was data that was in combination with atezo. So we'll have to see how the Phase III data play out, but clearly, there's a fairly high hurdle when you look at a monotherapy in that patient population versus potentially a combination therapy, both from an efficacy and safety standpoint. But again, it's early days, and we'll see how the data play out over time.

Okay, great. And maybe just the last question for you, Chris, before we go to Nadim is just we're expecting the first Phase III Opdivo adjuvant data potentially later this year, I think, from either 816 or -274. Just wondering how you think about the likelihood of success here? And then what impact could this have on the outer-year growth trajectory as we think about the adjuvant opportunity?

Yes. So adjuvant, as we've discussed, is exciting, not just for us but, we think, for I-O therapy, generally. This is a space where I-O therapy should work. You, typically, in the earlier lines of therapy and certainly in the adjuvant space, you have an immune system that hasn't been beaten up by multiple cycles of chemotherapy. The early data and, certainly, our own experience in adjuvant melanoma with Opdivo and Yervoy has been encouraging. We've seen some early data in -- with Opdivo in neoadjuvant lung. And this is, quite frankly, exciting for no other reason, it's the biggest impact that we can have on patients since the goal here is cure. What we've said consistently is that the adjuvant program is going to be an important potential driver of growth for us. As you know, we do start to see some additional adjuvant programs read out in the coming years. And along with the data that we have seen in first-line lung cancer as well as some of the evolution of our metastatic esophageal and gastric program, we think that sets us up for a nice foundation for continued growth with the Opdivo franchise starting in 2021 and beyond. Now the shape of that curve of growth is going to be fundamentally shaped by the specific readouts that are coming forward. But adjuvant is certainly an important component of what we think is going to be the future for Opdivo and Opdivo + Yervoy.

Okay. Great. Well, thanks for all the comments, Chris. Maybe Nadim, if we turn to hematology now. I think, front and center, a lot of focus on bb2121 and your plans to refile there the BLA. Can you just confirm that those plans are on track for the end of July? And then the kind of corollary question is just how should we interpret the EMA validation of the marketing authorization for bb2121 that occurred last month.

Sure. Terence, can you hear me okay first? I heard I was breaking up a bit before.

Yes, much better now.

Okay. Perfect. So I'd say a couple of things. So first, Terence, I would say, we were very pleased with the ASCO data for ide-cel in the KarMMa study. So with longer follow up, we continue to see the depth and durability of response continue to improve. So I think that's really important. And then secondly, to your question in the U.S., we are definitely very committed and plan to hit the target filing date by the end of July. So that was the second part of your question. And then as we think about Europe, of course, we were pleased to see that the EMA validated the MAA for ide-cel, and we look forward to bringing ide-cel in Europe to highly refractory myeloma patients. And a couple of things I'd say about that. One, there were no significant differences in the type or amount of information that was submitted to the FDA and to the EMA. Secondly, though, I wouldn't necessarily read too much into it because each regulator operates differently with their own set of rules. But of course, we were pleased to see the EMA validated and, again, reconfirming that we plan to resubmit by the end of July to the FDA.

Okay. Understood. So just to confirm, so there's basically no big differences, but maybe there are some nuances in terms of what a certain regulator wants at a certain point in terms of the kind of filing process. Is that a fair assumption?

Correct. That's very accurate.

Okay. All right. Great. And I guess the other question that we've been fielding here post ASCO is just thinking about the competitive landscape, particularly first on the CAR-T side before we go over to the bispecific side. But on CAR-T, we obviously saw some data from J&J, Legend. And I think there's a little bit of a debate about the kind of timing of CRS onset and implications for kind of outpatient care, payer dynamics. And so again, would love your perspective on that topic here as -- again, as we shift to kind of a commercialization phase, I think people are going to try to understand where these drugs ultimately fit in the paradigm and then, ultimately, competitive dynamics.

Sure. So maybe I'll start off with the clinical profile, Terence. So I think, as I said, we're very pleased with the ide-cel data and the continued maturity of those results, both in the depth and durability of response. I think that I'd say a couple of things. We have the J&J data, which look very interesting. But we have to remember, it's not a very large sample size. So about 29 patients. So I think that's important. Also for context, when the early ide-cel Phase I data came out with small data sets, the data were not that different to what we're seeing here. So I think there's 2 key things we need to continue to follow. One is, what do the results look like when you have it in a larger group of patients? So for KarMMa, we have over 120 patients. And then what does the durability of response look like? And we don't have those information yet for J&J BCMA CAR-T. Of course, having more therapies per patient is important. And then as I think about your second question, I think, which relate to CRS, again, I would say the same thing I said about the efficacy profile in a relatively small patient set at this stage. I think the same applies to tolerability, too. So we have to see how that pans out. But coming back to the question of CRS, I think one of the important developments that's happened since the last time we spoke is, at least in the draft rule, CMS has come up with a specific DRG for CAR-T, which we didn't have before, which caused some of the access and reimbursement issues in the sites that were giving these treatments in an inpatient setting. So we're very pleased that we do have a new DRG, which assuming it stays the same in the final rule, that really raises the base level of reimbursement much higher than the use of the current DRG for stem cell transplants. So even in the inpatient setting, I think it does make it more viable to administer CAR-T therapies in the inpatient setting because you have a higher level of reimbursement now. So whether you're receiving it in the inpatient setting and you have less or more CRS, and again, I would caution, we're still looking at small data sets, I do think the -- having the DRG has really moved things forward, and I think it's good for the overall field of CAR-T.

Okay. Great. Great. I appreciate the context. I guess one follow-up would be on the DRG. Is that -- do you think now most institutions are going to be essentially flat on kind of the Medicare side? Or do you think that's still going to be -- I know early in the launch, some centers were losing money on Medicare patients. So do you think now it's kind of a cost-neutral environment?

Yes. I think -- so if I were making a broad statement, Terence, generally, it's much better. Two, it's going to vary by institution because I think what institutions will do, they will use the DRG. They may also use the outlier payments. And then, of course, each institution has its own wage index adjustment, too. So it's hard to say how it will be across the country and make a sweeping statement like that. So the only broad statement I would make is that we're in a much better situation now, and then it's going to vary center by center. And I think some centers, especially if you have a situation where you have a significant wage adjustment index, for example, on the coast, I think you're going to be in a good position. But of course, that depends on the individual center. But overall, it's definitely much better for the administration of CAR-T in that setting.

Okay. All right. Understood. I guess the last question on the CAR-T side before we go over to the bispecifics is just as it relates to moving bb2121 upstream. I know you guys and blue have partnered to conduct a lot of studies there. Maybe just give us an update on kind of the status of those programs when we might see some data from the earlier-stage settings.

Sure. So I would say a couple of things. So KarMMa-3 is our ongoing Phase III study in patients with 3-plus lines of therapy, so a little bit earlier than the pivotal KarMMa data. So that's ongoing, and the study is enrolling. Then we have 2 Phase II studies. One is KarMMa-2, which is in second-line multiple myeloma patients; and then KarMMa-4, which is a Phase I newly diagnosed myeloma study setting. So for the second- and first-line setting, respectively, I think we're going to wait till we get some Phase II data, but that will give us the opportunity to move it up earlier in the context of Phase III studies.

Okay. And is JCARH125 -- is that still part of the forward plans? I know you had some data at ASCO, but where does that fit into the strategy, if at all?

Sure. So one thing, I'll close out the last question, Terence. Of course, we have our Investor Series meeting coming up, so I think our summit will also be able to provide more info around our development programs. For JCARH125, or orva-cel, I think the data at ASCO are pretty exciting. Again, I'll use the same caveat that it is a pretty small data set, but we did see high rates and durability of responses in pretty heavily pretreated population. But I think we do need to see data in a little bit larger data set and a bit more durability. So with orva-cel, we're going to continue to enroll patients in the study, and then follow up the data before we make forward-looking decisions on that. But early signs are quite encouraging.

Okay. Got it. And now on the bispecific, and again, I mean, I'll keep it more on the commercial side. I guess you obviously are going to have potentially 2 different options here on targeting BCMA as the CAR-T approach you talked about, the bispecific off-the-shelf approach. And so maybe just remind us kind of how you're thinking about positioning these agents. And I guess then the correlated question is just as we think about the fourth-line plus setting here, will, ultimately, every patient receive treatment with a BCMA drug, whether it's a CAR-T or bispecific? And just remind us of how many fourth-line patients are in the U.S. and EU5.

Sure, sure. So I'll say a couple of things. So for our bispecific antibody, CC-93269, our current study, Phase I/II is ongoing. And so from that, we'll have our dose and schedule. So that study continues. But obviously, the early data are very encouraging. But as I think more broadly about the opportunity in inpatient multiple myeloma, I think both the BCMA and novel cell mod approach allows us to bring multiple treatments together to address unmet needs that still remain in multiple myeloma because, unfortunately, patients today will likely still succumb to the disease, and we're not curing large groups of patients. So speaking -- sticking to the BCMA-targeted approach, I think having both a CAR-T as well as a bispecific antibody, I think it will give us an option to gain a greater overall market share versus if we just had one or the other. So I'd say that's one thing. Also, I think within the same line of therapy, there'll be different patients that are more suitable, for example, for a CAR-T therapy versus a bispecific play. So for example, clinicians may choose for a younger, fitter patient, for life reasons, may choose to have a one-and-done treatment. And there, a CAR-T will be a very attractive treatment option. For somebody who's maybe a little bit older, wants to stay close to home, doesn't want to travel to a larger academic institution, then I think having a BCMA antibody offers a great opportunity for that patient. So that's, I would say, in one treatment line overall, you have the opportunity to gain greater market share by having both modalities. And then there's also the opportunity for sequencing as well. So as I said earlier, patients are still relapsing and having multiple lines of therapy. So I think, again, having both a BCMA and a CAR-T allows you the opportunity to sequence these treatments also, in the same way that we've seen we have Revlimid and Pomalyst, actually. And then the third point I would add is, of course, we're going to be studying the combination of BCMA-directed approaches together with novel cell mods. And I think there, we have an opportunity to deliver even more effective treatment options, and that's a unique opportunity that BMS [ has ] a company that has all of those modalities, especially the cell mod space that we know very well available to patients. And then coming to the last point you asked around fourth-line patients, Terence. So the last part of that was around the epi data. So if you think about the U.S. and the EU5, fourth line plus is kind of 15,000-plus patients, but also, you have a little bit of a larger prevalent pool in there. And then as to do all fourth-line-plus patients now get a BCMA therapy moving forward, I think I think there is that opportunity. But the other thing I would point out is that there is going to be a growing pool of patients that are post BCMA. And we think that could be a significant unmet need in the future in late-stage patients, and we're already looking at enrolling some of those patients in some of our ongoing studies.

Okay. Great. Really appreciate the perspective. Maybe in the last 5 minutes and maybe I'll throw it back to you is, would you prefer to talk about CC-486? Or would you prefer to talk about luspatercept and the relative launches and market opportunity? I'll leave it open to you, Nadim.

All right. Why don't we speak about [Audio Gap] Can you hear me okay, Terence?

Now I can. Sorry, you cut out for a second. Now I hear you.

Okay. So let me start with Reblozyl, and then if you still have questions on CC-486, happy to address those.

Okay.

Okay. So I would say a couple of things about Reblozyl. A reminder that this is the first treatment for MDS in over a decade, and we think it's a really important new option for patients who have MDS who have MDS-related anemia. So there are a couple of things. Secondly, I would say, we have the opportunity here to really leverage our deep relationship with this customer base because Revlimid also is, of course, indicated in del(5q) MDS. So we have a field force that knows the MDS treaters. And our early feedback, very positive from customers in terms of the Reblozyl launch. And then the other couple of points I would make is that we've had both good traction in terms of positive feedback from customers. But our access to customers, even as we switch to our virtual launch model, has been very good. And I think one additional tailwind, especially in a COVID-19 perspective, is the fact that there is a shortage of blood supply out there. So I do think having a treatment that significantly obviates the need for blood transfusions is an important additional offering that Reblozyl brings to the table. So, so far, we're pleased with the feedback we're getting from customers, and we're pleased with the level of access we're having through virtual engagement also.

Great. Maybe one follow-up. It's just I know you guys are conducting a frontline study there to access that patient population. But -- and I know you obviously won't promote it in the frontline setting. But is there the potential for off-label usage? I know there was some earlier data on that front, but just trying to think about use beyond the kind of later-line setting.

Yes. So I think -- a couple of things I'd say. Obviously, we're early in the launch. I suspect most of the use will be in the indicated setting. But as you said, the COMMANDS study, which is the ESA-naive study, we're excited about that for a couple of reasons. One, it brings RS-negative patients into play. And of course, it's an earlier treatment setting because it's ESA-naive patients. So I think our core use at the beginning will be in the indicated population, but it also depends on what gets added to NCCN guidelines as we move forward. So there may be that potential that clinicians -- obviously, we won't promote in this setting. But clinicians may choose to use it in, for example, RS-negative patients, possibly ESA-naive patients, but I expect, at the beginning, will be in our core indication. But of course, that bodes well for the long-term potential as we see the results of the COMMANDS study for the brand.

Okay. Great. And maybe the last one I'll ask about is just in -- and again, it's -- I know it was Celgene guidance, not Bristol guidance, but I think Celgene had guided to a peak opportunity for luspatercept of just over $2 billion. And just wanted to get any thoughts or perspective on that. And then I believe that excluded myelofibrosis, which, again, I know there's a Phase III program that's going to get underway there. So again, any comments you can give on that front in the last minute or so, Nadim?

Sure. Sure, Terence. So it's our policy. We don't necessarily provide product guidance. So maybe I'll answer my question -- I'll answer your question a little bit differently. So I think the way we think about the opportunity for Reblozyl is in 3 broad categories. And of course, we have active life cycle management going on. So clearly, the initial second-line MDS ESA-refractory patient population is the first pillar. And secondly, it's COMMANDS as we move up to the ESA-naive patient population and include RS-negative patients. And then the myelofibrosis opportunity, we are excited about because that would be independent of lines because it relies on patients being transfusion-dependent. So I would say they are the 3 core pillars of Reblozyl, and we continue to look at other opportunities and indications. So that's what I'd say to that question.

Okay. Great. Well, I think we're right up on time. But thank you both very much for being with us today. Really appreciate the perspective. Best of luck over the coming months. And stay safe.

Thanks, Terence.

Appreciate it.

Thank you, guys. Have a good one. Take care.

Bye.