Bristol-Myers Squibb Company (BMY) Presents at Goldman Sachs 41st Annual Global Healthcare Conference (Transcript)

Bristol-Myers Squibb Company (NYSE:BMY) Goldman Sachs 41st Annual Global Healthcare Conference June 11, 2020 3:00 PM ET

Company Participants

Nadim Ahmed – EVP and President Hematology

Chris Boerner – EVP, Chief Commercialization Officer

Conference Call Participants

Terence Flynn – Goldman Sachs

Terence Flynn

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 is Executive Vice President and Head Commercial — Chief Commercial Officer. I am looking forward to hosting you both today. Thank you for taking time out of your day to join us.

Question-and-Answer Session

Q – Terence Flynn

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 of a return to a more stable environment in the third quarter? And then maybe any commentary across the key-end markets that you guys operate in?

Chris Boerner

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 remained 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 draw down in inventory. This year, mainly in March, we saw a fairly significant increase in wholesale and retail inventory with Eliquis. That began to work us 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 patients’ 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 normalized 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 shifts, 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 two 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, so little too early to see whether or not the dynamics are evolving differently than say in the U.S.

But I believe you with maybe a couple of things. First, the situation remains pretty dynamic. It’s too early to really give the 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 remains very strong and largely in line with expectations. Nadim, anything to add?

Nadim Ahmed

Sure. Now, 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 Q1 and becoming more stable in Q3 and returning to normal in Q4. And in Q1, I think about the myeloma business ex-U.S. [indiscernible] was based $50 million to $100 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 for their own therapy in patients and to the clinic, or the hospital to receive a little bit less of an impact, but broadly in line with what we said during our [indiscernible].

Terence Flynn

Okay, 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?

Chris Boerner

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 that 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’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 are two broad approaches to managing moderate to severe UC, you see you have JAK inhibitors, and then you have a fairly broad category of biologics 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 JAK 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 TNF and JAK 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 and it 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 dataset presented, but we’re quite encouraged with what we’ve seen in UC.

Terence Flynn

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’re going to 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?

Chris Boerner

Yes. So, UC is a fairly sizable opportunity and you 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 is a real opportunity there.

And in some ways, you’ve heard us talk about this with respect to the TYK program. There is a full spectrum of therapies that are available in this 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.

Terence Flynn

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

Chris Boerner

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 1st, so a little over a week ago. That launches mainly because of COVID state of 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 for 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 to.

We’re the only product to study prospectively and demonstrate improvement or 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 cause cardiac monitoring health 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 on to 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 in MS specifically. They were chomping at the bit to get on the market and we’re very excited to make the product available.

Terence Flynn

Okay, great. Well, best of luck on that front in the coming months. Maybe 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 two 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 the franchise?

Chris Boerner

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 to 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 and Yervoy in first line rental is around 30% to 35% overall, from the higher end of that range, closer to 35% for a labeled indication of intermediate and 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 we go back in 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 to 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 months OS with the dual I-O regimen of about 56%.

So, we’re excited about 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, 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 label.

And in fact, the majority of the business that has been sourced by I-O TKI has been in that favorable location population thus far. I mean, you still see quite a bit of TKI monotherapy there. So, you added all up. We think we’ve got a real opportunity with Opdivo and Cabo. We think it’s going to be 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 the space, which I think is going to be important.

Terence Flynn

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 mild therapy 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 the starting point and you guys seem to work higher from there?

Chris Boerner

So, 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 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 to the profile we have or tapping into the favorable patient population that really quite frankly has been off limits to us at least from a promotional standpoint thus far.

Terence Flynn

Okay, great. And now maybe just transitioning over to lung, obviously, a lot of debates coming out of ASCO this year on the role of Opdivo and Yervoy in frontline lung, given the 227 data and 9LA data and approvals, but then there’s also been some competitive data too from Roche and 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?

Chris Boerner

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 had 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 said previously, this was 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 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 continued to be very impressed with the data 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 in six months, 70% were still alive at three years. That’s very impressive depth and durability in this phase.

Now, while the 9LA data that we presented at ASCO are still relatively mature, 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, but 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 and one of those other two tumors.

So, the fact that you’ve got physicians, who have experience with a dual I-O regimen or these other tumors, they’ve seen the benefit that they can provide is an important familiarity that we think is really important as physicians interpret 227, as they think about the potential with 9LA and the longer term. And these positions account for about two-thirds 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 the first-line.

Terence Flynn

And maybe the follow-up is just on the anti-TIGIT combo. I know that’s another I-O/I-O combo here again look like there’s efficacy signal in the high expresses. And generally benign safety profile, when you have the TIGIT on. But just some kind of your commercial seats, any perspective, you can ensure their understanding they still have to do a Phase 3 trial?

Chris Boerner

I think the data that we’ve seen so far in Phase 2, it’s still pretty early. Certainly they’ve seen an impressive reduction in progression free survival. The benefit seems to be driven as you know, in the high-PD-L1 expresses, obviously that’s a space you look into the market dynamics today that’s dominated by I-O manotherapy. This was data that was in combination with atezo. So we’ll have to see how the Phase 3 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, its early days and we’ll see how the data play out overtime.

Terence Flynn

Okay, great. And maybe just the last question for you, Chris before we go to Nadim. It’s just we’re expecting the first Phase 3 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 adjuvant opportunity?

Chris Boerner

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 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 is certainly our own experience and adjective melanoma, with Opdivo and Yervoy has been encouraging. We’ve seen some early data in Opdivo and 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 sure. What we say 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 — 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 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 and Yervoy.

Terence Flynn

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 in your plans to re-file there, the BLA. Can you just confirm that those plans are on track for the end of July? And then kind of corollary question is just how should we interpret that EMA validation of the marketing authorization for bb2121 that occurred last month?

Nadim Ahmed

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

Terence Flynn

Yes, it’s much better now.

Nadim Ahmed

Okay, perfect. So I’d say a couple of things. So, first, I would say that 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 continues 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’re pleased to see that the EMA validated the MAA for ide-cel, and we we look forward to bringing ide-cel in Europe for highly refractory myeloma patients. And a couple of things I’d say about that. One, there were most 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 for the FDA.

Terence Flynn

Okay, understood. So just to get persuade 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?

Nadim Ahmed

Correct, that’s very accurate.

Terence Flynn

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 basically first line on the CAR-T side before we go over to the biospecific side. But on CAR-T, we obviously thought some data from J&J legend. And I think there’s a little bit of a debate about the kind of timing of CRF onset and implications for kind of outpatient care, payer dynamics and so again, we’d love your perspective here again as we shift to kind of the commercialization phase, I think people are going to try to understand where these drugs ultimately fit in the paradigm and then ultimately competitive dynamics.

Nadim Ahmed

Sure. So, maybe I’ll start off with clinical profile 10. 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. And I think that, I would say a couple of things, with 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, and so, I think that’s important.

Also for context, when the early ide-cel Phase 1 data came out with small data sets, the dates were not that different from what we’re seeing here. So, I think the two key things we need to continue to follow. One is, what do the results look like when you have it in that 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 — of course having more therapies for patients is important.

And then, as I think about your second question, I think which relates to CRS, again, I would say the same thing I said about the efficacy profile are relatively small patient set at this stage. I think the setting 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 development that’s happened since last we spoke is, at least in the drop CMS has come out with a specific DRG for CAR-T, which we didn’t have before, which caused the access and reimbursement issues in the sites that we’re 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 a base level reimbursement much higher than the use of the current DRG for stem cell. So, even in the inpatient setting, I think it does make it more viable to administer CAT 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 having the DRG has really moved things forward and I think it’s good for the overall field of CAR-T.

Terence Flynn

Okay, great. Great. I appreciate the context. I guess one follow-up would be on the DRG 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 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?

Nadim Ahmed

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 one institution would do that DRG, they may also use the outlier payments and then of course each institution has its own wage index adjustments 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 it that we’re in a much better situation now and then it’s going to vary sensor by sensor. And I think some sensors, 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.

Terence Flynn

I guess the last question on the CAR-T side, before we go over to the vice versa. Just as it relates to moving bb2121 upstream, I know you guys in 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?

Nadim Ahmed

So I would say a couple of things. So KarMMa-3 is ongoing Phase 3 study in patients with three plus lines of therapy. So a little bit earlier than the pivotal KarMMa data, so that’s ongoing, and the study is enrolling. And we have two Phase 2 study, one is KarMMa-2, which is in second line multiple myeloma patients. And then KarMMa-4, which is a Phase 1 newly diagnosed myeloma study setting. So for the second and first-line setting, respectively, I think we’re going to wait till we get from Phase 2 data, but that gives us the opportunity to move it up earlier in the concept for Phase 3 study.

Terence Flynn

And it 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?

Nadim Ahmed

So, one thing I’ll close out the last, so first we have our investor series meeting coming up. So I think somewhat we’ll 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 things heavy. That is a pretty small data set. But we did see higher rates and durability of responses in that pre heavily pre treated 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 their forward decisions on early signs are quite encouraging.

Terence Flynn

And now in the biospecific and again, I mean, I’ll keep more on the commercial side. I guess, you obviously are going to have potentially two different options here on the targeting BCMA as the CAR-T approach we talked about the bispecific off the shelf approach. 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. Well, ultimately every patient received 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?

Nadim Ahmed

So I’d say a couple of things. So for our bispecific antibodies CC-93269, our current study Phase 1, 2 is ongoing. And so from that, we’ll have our dose and schedules for that study continues, but obviously, the early days were very encouraging. But as I think more broadly about the opportunity in patient multiple myeloma, I think, both the BCMA and novel cell mode approach allows us to bring multiple treatments together to address unmet needs to remain a multiple myeloma. Because unfortunately, patients today will likely still succumb to the disease. And we’re not curing large groups of patients.

So sticking to the BCMA targeted approach, I think having both CAR-T as well as 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 side. So 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 CAR-T therapy versus a bispecific place. 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 large academic institution. Then and I think having a BCMA antibody offers a great opportunity for that patient.

So that’s why 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 for BCMA and CAR-T allows you the opportunity to sequence these treatments also in the same way that we’re seeing with 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 direct approaches together with noble 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 as a company that has all of those modalities, especially the cell mod space that we know very well available to patient.

And then coming to the last point you asked around for patients parents. 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 prevalence pool in there. And then as to do all four to five patients now get a BMA therapy moving forward, 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 posted 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.

Terence Flynn

Okay, great. Really appreciate the perspective. Maybe in the last five minutes, 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 relative launches and market opportunity. I’ll leave it open to you, Nadim?

Nadim Ahmed

All right, why don’t we — why don’t we speak about — can you hear me okay, Terence?

Terence Flynn

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

Nadim Ahmed

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

Terence Flynn

Okay.

Nadim Ahmed

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 option for patients of MDS who have MDS replace anemia. So, there are a couple of things. Secondly, I would say we have the opportunity here to really leverage our deep relations with this relationship for 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, there are the couple of points I would make is, we’ve had 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 from the 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.

Terence Flynn

Great. Maybe one follow-up is 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?

Nadim Ahmed

Yes. So, I think, a couple of things I would 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 our RS-negative patients into play, and of course it’s an earlier treatment setting that’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 vaccination. Obviously we weren’t promoting 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 indications. But of course, that bodes well for the long-term potential as we see the results of the COMMANDS study for the brand.

Terence Flynn

Okay, great. Then maybe the last one I’ll ask you about is just and againm I know it was Celgene guidance, not Bristol guidance. But I think Celgene has guided to it got opportunity for luspatercept 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 3 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?

Nadim Ahmed

Sure, Terence. So, it’s our policy, we don’t necessary provide product guidance. So maybe I’ll answer your question a little bit different way. So, I think the way we think about the opportunity for Reblozyl is three broad categories. And of course, we have active lifecycle 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 online because it relies on patients being transfusion dependent. So, I would say they are the three core pillars of Reblozyl when we continue to look at other opportunities and indications. And so, that’s what I’d say to that question.

Terence Flynn

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.

Chris Boerner

Thanks Terence.

Nadim Ahmed

Appreciate.

Terence Flynn

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

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