Acceleron Pharma Inc.
Q2 2020 Earnings Call Transcript

Published: 8 Aug 2020

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the Acceleron Second Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to hand the call over to Ms. Jamie Bernard, Associate Director of Investor Relations at Acceleron. Please go ahead.

[Jamie Bernard:]

Thanks, and welcome, everyone, to our second quarter 2020 earnings call. I hope everyone is healthy and continues to remain safe during these times. The press release reporting Acceleron’s results in addition to the presentation for today’s webcast are available on the Investors & Media page of our corporate website at www.acceleronpharma.com. Joining me on the call this afternoon are Habib Dable, our Chief Executive Officer; Kevin McLaughlin, our Chief Financial Officer; Dr. Jay Backstrom, our Head of Research and Development; Sujay Kango, our Chief Commercial Officer; and Todd James, our Senior Vice President of Corporate Affairs and Investor Relations. As a reminder, we will be making forward-looking statements regarding our financial outlook in addition to regulatory, product development and commercialization plans and research activities. These statements are subject to risks and uncertainties that may cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-Q and 10-K on file with the SEC. With that, I would now like to turn the call over to Habib Dable, our CEO.

[Habib Dable:]

Thank you, Jamie. Good afternoon, everyone, and thank you for joining us today. Months into the COVID-19 pandemic, it is clear that this continues to be an immensely challenging time. Thousands of essential workers, most notably those on the front lines in the health care and emergency services, have risked their lives to support and protect our communities and contain the spread of the virus. And we are extremely grateful for their collective efforts. While we are eager to get back into our offices in Cambridge, for the time being, we have extended our work-from-home policy and are encouraging our employees to do their part by closely following health authority guidelines. Despite many necessary adjustments, I am very proud of our team’s resilience throughout this period. Overall, we are fortunate to have experienced minimal effects on our business and operations. Indeed, we had a highly productive second quarter, marked by strong execution on the clinical, regulatory and commercial fronts. In June, the European Commission-approved REBLOZYL, the Acceleron-discovered medicine, also known as luspatercept for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS or beta-thalassemia. REBLOZYL is the first and only erythroid maturation agent to be approved in Europe, representing an important new class of therapy for these patients. As a result of this approval, Acceleron recognized a $25 million regulatory-based milestone from our collaboration partner, Bristol-Myers Squibb. As you’ll recall, late last year, REBLOZYL received its first approval in the United States for the treatment of anemia in patients with beta-thalassemia who require red blood cell transfusion, followed by the FDA approval in the MDS indication at the beginning of April this year. We are now eight months into the U.S. commercial launch with the ability to promote for the larger lower-risk MDS indication for nearly the entire second quarter. We continue to be encouraged by the product’s uptake and the insights we and our partner at Bristol-Myers Squibb are collecting in the field. I’ll be providing more detail on the launch in a moment. And Sujay Kango, our Chief Commercial Officer, will be able to take your questions toward the end of the call. But first, I want to recognize our entire joint REBLOZYL team for their tremendous efforts in securing these important approvals and for their unwavering focus on the U.S. launch. The recent approval in Europe will expand the market opportunity outside of the U.S., providing potential access to the thousands of patients who have been waiting for a new option to treat their anemia. Since the FDA approvals, our field teams have been targeting health care providers and centers of excellence throughout the United States. Given the public health concerns around the pandemic, the joint field teams have been executing through a virtual sales model, utilizing digital promotion and education materials via e-mail, telephone and video conference with U.S. health care professionals. Though we realize this is not ideal, it has not slowed our progress to date. In the second quarter, we recognized approximately $11.1 million in royalty revenue on net REBLOZYL sales of approximately $55 million. And most recently, the Centers for Medicare & Medicaid Services established a unique REBLOZYL-specific permanent J code, which became effective on July 1, 2020. While we are very encouraged by the early U.S. launch metrics, it is still early, and the next few quarters will provide important additional data point for the first full calendar year and beyond for U.S. sales trends in MDS and beta-thalassemia. Further, we’ll be monitoring for any potential effects COVID-19 may have on sales, particularly in regions that are experiencing growth in cases and hospitalization. As I mentioned, the opportunity to reach more patients has grown with the recent approvals in Europe. We estimate that REBLOZYL will be available in certain European countries soon, leading to the start of additional revenue contributions over the next six to 12 months. As a reminder, Bristol-Myers Squibb has sole promotional responsibility outside of North America. In addition, the REBLOZYL approval and launch, we continue to collect meaningful data from the Phase III MEDALIST and BELIEVE trials. At the American Society of Clinical Oncology 2020 Virtual Scientific Program and the 25th Annual European Hematology Association Virtual Congress, we reported new long-term analyses highlighting REBLOZYL’s durable long-term clinical benefit and additional valuable insights from these pivotal studies. These positive long-term results further support our belief that REBLOZYL’s mechanism of late-stage erythroid maturation could enable it to become a potential platform treatment for anemia associated with a broad range of hematologic diseases. Bristol is in currently conducting two additional trials and preparing for a third called the INDEPENDENCE trial for the treatment of anemia in patients with myelofibrosis. We are gearing up for several productive years ahead as we build the luspatercept franchise and look forward to reporting top line results from the BEYOND study in non-transfusion-dependent beta-thalassemia and the COMMANDS study in front line, lower-risk MDS. We are also actively evaluating additional disease areas in which patients with anemia could potentially benefit from our erythroid maturation agent. In addition to our many recent achievements for the REBLOZYL program, we have been absolutely thrilled with our recent progress and updates for sotatercept in patients with pulmonary arterial hypertension or PAH. As you may recall, during the second quarter, sotatercept was granted Breakthrough Therapy designation by the FDA and Priority Medicines or PRIME designation by the EMA. Not only is this a first for an Acceleron-discovered medicine, but sotatercept is now the first and only therapeutic candidate in PAH to receive these designations. This is a meaningful step in the products candidate development as the designations allow for more regular interactions with the two agencies, additional access to senior division members to facilitate and accelerate drug development programs and expedited application filing and application review period for following submission of the regulatory applications for marketing approval. In June, we provided a detailed presentation of the top line Phase II PULSAR data during a Breaking News session at ATS 2020 Virtual. Additionally, many of you joined us during a separate investor webcast that included two of the world’s top experts in PAH. In summary, we were able to achieve impressive outcomes for sotatercept-treated patients in the PULSAR trial with the concordance of results seen across multiple primary and secondary end points at both dose levels and in patients receiving mono, double or even triplet background therapy. Again, we reported a 33.9% mean improvement in PVR at the 0.7 mg per kg dose, a more than 50-meter mean improvement in six-minute walk distance, and sotatercept was generally well tolerated in patients with PAH. Based on the positive PULSAR results and its novel mechanism of action, we believe that sotatercept to become the backbone therapy in the future treatment paradigm of PAH. With an estimated 70,000 patients suffering from PAH in the United States and Europe, sotatercept has blockbuster potential. Thus, we intend to invest accordingly in our clinical development efforts to achieve this long-term vision for sotatercept. We are pleased that sotatercept continues to be recognized by the medical and scientific communities. In May, previously presented preclinical research describing the underlying biology behind sotatercept’s effects in models of PAH was published in the journal, Science Translational Medicine, and adding to the body of evidence supporting sotatercept’s potential in this life-threatening disease. Looking ahead, we plan to host an investor and analyst webinar in October to outline the design of what will be known as STELLAR, our first Phase III trial in patients with PAH. We will provide timing and registration details closer to the event. I hope you will be able to join us on the call. We remain on track to initiate the STELLAR trial at the end of this year. At this time, I would like to hand the call over to Kevin McLaughlin, our CFO, to review the financials, and then we’ll be able to take your questions.

[Kevin McLaughlin:]

Thanks, Habib, and good afternoon, everyone. I would like to refer to our press release issued earlier today for a summary of our financial results for the second quarter 2020 and to take this opportunity to review a few items. We ended the second quarter with approximately $389.8 million in cash, cash equivalents and investments. In July, we closed a follow-on public offering of common stock, including the full exercise of the underwriters’ option to purchase additional shares for net proceeds of $492.5 million. Revenue for the second quarter was $39.8 million, which includes $3.7 million of cost share revenue. As Habib mentioned earlier, approximately $11.1 million of royalty revenue from net U.S. sales of REBLOZYL of approximately $55 million and the recognition of a $25 million regulatory-based milestone for the approval of REBLOZYL in Europe. All revenue was derived from the company’s partnership with Bristol-Myers Squibb. The company’s net loss for the second quarter was $18.5 million. With that, I would like to open the call to questions. Operator?

[Operator:]

[Operator Instructions] Our first question comes from Yaron Werber with Cowen. Your line is now open.

[Gabe Daoud:]

Hey, this is Gabe on for Yaron. My question has to do with REBLOZYL. And this morning on the Bristol-Myers call, they mentioned that it’s possible that the high physician awareness prior to the launch, for example, the New England Journal article in January may have led to some pent-up demand going into the launch. What are your thoughts on this? And do you think that perhaps upcoming quarters could show some flattening as that demand kind of work its way through and we get to a more normalized scenario?

[Habib Dable:]

Yes. Gabe, this is Habib. Thanks for your question. Maybe I’ll kick it off. And then maybe add, Sujay, our Chief Commercial Officer, to add a little bit of color. I think we benefited on a number of fronts in terms of high physician awareness. I’ll go back to even ASH of a couple of years ago, where you might recall, we had over 7,000 submissions, and they picked six for the plenary session. And we had the opportunity to have the MEDALIST study presented in a plenary session, which was attended by, I believe, over 10,000 people, one. We also had the opportunity to benefit from the Best of ASH, which gave us a number of opportunities for both the BELIEVE and the MEDALIST study to be communicated in various forums after the main Congress. And then as you cited, to have not one, but two New England Journal publication for our lead program really puts us in a place where I think offers us the best opportunity at the Congress. And if you think of all of the opportunities to be presented in a journal, the New England Journal, is really one of the most premier journals we could ask for. Now with that said, I think we benefited from a tremendous amount of awareness going into the launch. I think at the same time, let’s not forget, this is the first time in over a decade that something has been approved for these patients in this space, specifically in MDS and for the first time to treat the anemia for beta-thalassemia patients. So I don’t think it would be wrong to assume that there’s a tremendous amount of pent-up demand out there. So I think the combination of having high awareness as well as being a unique and novel therapy for a patient group that’s been looking for a solution for many, many years now, I think it is – I think we truly are witnessing some pent-up demand. That said, when we continue to look at new account growth persistent in terms of patients getting the second and third doses, looking at repeat orders from the same account, we continue to be very, very encouraged. And at the same time, I don’t think any of us had anticipated launching a drug like this in the virtual environment. And with that, with this – with the tragedy of coronavirus, for our launch, we had to pivot, and I’m thrilled the team was able to pivot so well with our partners at Bristol. And I think with that came some challenges, but also came some opportunities as you would have heard. There also – it’s been some challenges in terms of patients getting – coming into the clinics and getting access to treatment. But at the same time, the blood supply is seeing a shortage, an unprecedented shortage, which allows for solutions like REBLOZYL to perhaps play a role as an unintended consequence. So I guess what I could tell you is that we’re thrilled with the uptake and the awareness to date. I think one quarter is too early to draw any conclusions in terms of long-term demand. But at the same time, I can only tell you that we are very, very encouraged with the uptake to date. Sujay, I don’t know if you want to add any color or even any qualitative feedback in terms of the launch so far.

[Sujay Kango:]

No. Thanks, Habib, for your response. I mean you covered it pretty extensively. So the only one aspect that we can sort of say is the first quarter seems very good. We are very enthused, right? And the only color I can give is now coming into this next quarter, we have the permanent J code, so we’re going to look and see how that plays out moving forward. And the caveat is, having said all of that, we do know that it’s a COVID-19 environment. So we’re trying to sort of evaluate all of those components, and hopefully, that we still are able to bring a lot of positive momentum in a balanced way. That’s what our outlook looks like.

[Gabe Daoud:]

Great. Thank you, guys.

[Operator:]

Our next question comes from Geoffrey Porges with SVB Leerink. Your line is now open.

[Charles Song:]

Hi. This is Charles Song for Geoff. Maybe two questions, one for REBLOZYL. Could you share the revenue breakdown between MDS and beta-thal? I assume the majority will come from the MDS indication. And the second, I know you will share more data or insights on the Phase III design for sotatercept. I was just wondering, given the expected 300-patient size for the pivotal trial, which is somewhat smaller than the other trials, do you expect your trials can enroll patients faster? What is your – our expectations on patient enrollment?

[Habib Dable:]

Yes. So I can answer the first question really easily in terms of the breakdown. So we haven’t given any breakdown in terms of the sales per indication, but I think your assumption is a good one. As you know, in the United States, the beta-thalassemia population is fractional compared to the MDS population. And also, when you look at the uptake, the significant uptake occurred after the approval of the MDS indication. So I think your assumption is a good one that the majority – the vast majority of this growth is associated with the MDS indication. Regarding Phase III, I’m going to hand that over to Jay Backstrom, our Head of R&D.

[Jay Backstrom:]

Good question. So we will go through the details of the STELLAR study in the fall and review time lines, et cetera, at that point. Although I think it’s fair to answer the question. If you take a look at how successful we were with PULSAR recruiting, the 300-patient trial, I do believe considering Breakthrough Therapy designation, and the attention that we had at ATS, we’re looking forward to recruiting that relatively quickly. But I’ll review all those details when we get to our conference in the fall.

[Charles Song:]

Thank you very much.

[Habib Dable:]

Yes. Thanks for your question.

[Operator:]

Thank you. Our next question comes from Marty Auster with Crédit Suisse. Your line is now open.

[Marty Auster:]

Great, thanks for taking my question. I had a question just on sotatercept. I was curious if you can provide any update on kind of when and where the PULSAR OLE data and/or any initial update on SPECTRA might be presented later on this year. And then also from PULSAR OLE, what sort of kind of incrementals beyond the kind of base data we got on the ATS top line release? Or we can expect to see?

[Habib Dable:]

Yes. Thanks for your question, Marty. So with respect to incremental presentations, both on the open-label extension as well as the exploratory study in SPECTRA, you can expect that we’re going to bring more data forward and leverage congresses probably in the first half of next year in terms of further data dissemination. But I’ll hand it over to Jay if you want to add any more color on that response as well as the second part of your question.

[Jay Backstrom:]

Yes. So that’s what we have planned right now. So first half of next year, and you can imagine a conference we would be interested in, in presenting both SPECTRA and the open-label extension. And I made a comment to this on a previous call, I mean the beauty of the open-label extension is that we’re continuing to follow not just for safety, which is important in this context, but also on following efficacy end points. So we continue to look at functional class improvement. We also, as you know, have placebo patients that crossed over. So there are also some interesting data in the crossover data. So it should be a nice opportunity to give an update. Again, we’re looking forward to do that in the first half of next year.

[Marty Auster:]

Thanks for the update.

[Jay Backstrom:]

Thank you, Marty.

[Operator:]

Our next question comes from Carter Gould with Barclays. Your line is now open.

[Carter Gould:]

Good afternoon, guys. Thanks for taking the question and congrats on the launch. I guess maybe to start for Jay. Just based on the strength of PULSAR data you’ve seen so far, just sort of wondering how aggressive you’re going to be in rolling out some of the Phase II work across either chronic bone disease or the group four diseases. Is that something we should view as sort of like a longer-term objective or something that might be done sort of concomitantly alongside STELLAR? And then just to make sure I’m clear on SPECTRA, the delay here, that’s just related to COVID, there is no additional patients enrolled in that study?

[Jay Backstrom:]

Yes. So I’ll take the second question first with respect to SPECTRA. I’d mentioned before, yes, that the trial did – our enrollment was a bit affected by that. So hence, we couldn’t necessarily complete that in enough time to share data this year. But that’s back on track, so we look forward again to sharing that first half of next year. And then with respect to looking beyond PAH, and we’re going to – really thrilled that we’re able to move forward with a program. We definitely have an interest. We actually mentioned at the ATS call for looking at other areas within pulmonary hypertension, so we’re frankly actively evaluating that now. So we’ll have more to come on that, but it’s an area we certainly have interest in.

[Carter Gould:]

Thanks, guys.

[Jay Backstrom:]

Thanks, Carter.

[Operator:]

Thank you. Our next question comes from Chris Raymond with Piper Sandler. Your line is now open.

[Chris Raymond:]

Hey, thanks for taking the question. So, just maybe two, I think. I think I remember at ATS, you guys said you were on track to conclude the end-of-Phase two meetings with FDA around the middle of the year. So just curious if that’s been concluded and if you’re maybe waiting in minutes before giving any color on those discussions. And then maybe if you could comment on maybe just directionally if FDA and EMA are aligned with respect to the Phase III.

[Habib Dable:]

Yes. Thanks for your questions, Chris. I guess maybe I’ll hand that over to you, Jay, for both of those.

[Jay Backstrom:]

Yes. So we’re very much on track as we hoped and plan to be with our health authority interaction. They’ve been very productive. So it’s really been quite good, and we’re taking all of the guidance that we’ve received from both agencies and really applying that to our broad program and plan. With respect to alignment, if you take a look at trials in this space, the regulatory end points tend to be fairly consistent across both regions. So we do believe that as we run STELLAR, it should be able to meet the needs both in U.S. and Europe.

[Chris Raymond:]

Okay. And can you just confirm, so your end-of-Phase two discussions have been concluded, correct?

[Jay Backstrom:]

Well, because we have Breakthrough Therapy and PRIME, that’s the beauty of those designations. It’s basically ongoing dialogue. So we’ve been able to do kind of what we needed to do at this juncture to be prepared to initiate our Phase III, which is why we put it out here today because that’s exactly where we had hoped to be. We’ve been planning to start this trial, actually, frankly, since the PULSAR results were out, but it’s good to engage in the health authorities. So we’re kind of finalizing all those plans, and we’ll really share the details of the STELLAR program in October. So that – those – again, those meetings have really been quite productive.

[Chris Raymond:]

Thank you.

[Operator:]

Thank you. Our next question comes from Yigal Nochomovitz with Citigroup. Your line is now open.

[Yigal Nochomovitz:]

Hi, Habib and team. Thank you for taking the questions. Just with regard to STELLAR, if you could expand a bit on the comments there. I mean is there a specific reason why you’re waiting until October to inform the markets as far as the trial design? Are there still items that need to be nailed down with the regulatory agencies in terms of the trial design? And can you confirm at this point that it will be about a 300-patient trial with functional end points? Or has there been any changes to that high-level guidance?

[Habib Dable:]

Okay. Thanks for your question, Yigal. I guess, Jay, that’s for you as well.

[Jay Backstrom:]

Yes. Certainly. Yes, still 300. As we had signaled before, we’re looking at around a 300-patient study with a functional end point, so no changes there. Putting it into October really just gives us a chance to dot the Is, cross the Ts and put this up at a time at or near the time you can almost expect to see it on clintrials.gov given our timing. So it’s just really kind of getting a balance that we laid out in front of you. Everything’s buttoned up, but that direction of 300 in functional end point hasn’t changed.

[Yigal Nochomovitz:]

Okay. Great. And then in terms of your hypothesis around disease modification and vascular remodeling, are there other trials that you’re going to run or want to run to explore that further beyond SPECTRA? Or would that be potentially included in the STELLAR trial to look at disease modification, specifically beyond the functional end points?

[Jay Backstrom:]

Yes. So I’ll go ahead and continue, Habib, if that’s okay.

[Habib Dable:]

Yes.

[Jay Backstrom:]

I think – yes, so Habib made the comments going back about wanting – thinking about the potential for sotatercept to be back on therapy. We’ve – we’re going to highlight STELLAR. I’m really delighted that we’re going to be able to run a program, so it won’t be a single study. We believe STELLAR will be the kind of trial that we need for registration, for example, in Europe, and I mentioned that earlier. The other two studies that we’re going to look at, I think, will really begin to build the body of evidence that we need to show that we really are affecting significant outcomes. So I look forward to sharing more around those programs, too. Our focus right now today is getting STELLAR out of the gate, and we’re working fast and furious to do that. I can give you more details about that in October, and then looking forward to another future point to really share with you the entire development program that we’re considering.

[Yigal Nochomovitz:]

Thank you.

[Jay Backstrom:]

Thanks, Yigal.

[Operator:]

Thank you. And our next question comes from Jeff Hung with Morgan Stanley. Your line is now open.

[Hannah Latimer:]

Hi, this is Hannah on for Jeff. Just going back to REBLOZYL, can you give us any more incremental feedback from clinicians on MDS? And does it change your views on the adoption rates at all? And then if you could provide an update on the enrollment for COMMANDS and what the impact has been from COVID.

[Habib Dable:]

Yes. Thanks for your questions. So for the first question, maybe I’ll pass that on to you, Sujay, if there is any incremental color that you can share, and then maybe hand it over to Jay with respect to the COMMANDS study, please?

[Sujay Kango:]

Thanks for that question. So with regards to color on what we’re hearing from physicians, right, they are very much enthused with the responses that they are seeing as well as the benefit that REBLOZYL as erythroid maturation product is offering them. So as of now, what we are hearing is they are excited about the benefit. They are seeing transfusion independence. They are seeing a reasonably quick response to the patient population. And sort of as Habib alluded early on, that is giving us confidence that patients are staying on therapy. So we’ll wait to see, although it’s early quarter, we have to wait and see how consistently is the patient going to be on therapy moving forward. Now the other part of the equation is we are seeing not just the initial physicians that ordered the therapy, we are seeing added number of accounts ordering treatment. So we are adding new accounts into the treatment paradigm as well as existing accounts are repeat ordering the product. So those two elements are giving us good consistency as well as the growth that we are seeing over this period of time. So hopefully, that gives you a good amount of color with regards to how the product is doing in the marketplace. We feel very good about it.

[Jay Backstrom:]

And then with respect – yes, thank you, Sujay. And then with respect to COMMANDS, I just referred to the BMS call this morning where Samit referenced that during the Q&A. BMS had mentioned earlier a lot of their programs were affected by COVID-19. COMMANDS was included in that. They’re back opening those centers, recruitment is continuing and the anticipated readout for the trial is late 2022. So, I think that’s essentially what we were indicating earlier. I think the good news is that the centers are back and recruitment is continuing.

[Hannah Latimer:]

Great, thank you.

[Operator:]

Thank you. And our next question comes from Leland Gershell with Oppenheimer. Your line is now open.

[Leland Gershell:]

Hi, good afternoon, Habib and team. Thanks for taking my question. One question sort of related to Yigal’s earlier. Should we think about SPECTRA as informing or maybe elements of the design is STELLAR? Or is it more just kind of a regulatory, finishing up on the regulatory side and making sure that the design is aligned with their view? And then I have a quick question about REBLOZYL.

[Habib Dable:]

Yes...

[Jay Backstrom:]

Yes. Yes, go ahead. I’m sorry, Habib, please, go ahead. Sorry.

[Habib Dable:]

Thanks for your question, Leland. And I just wanted to kind of reiterate a couple of things that we said previously is one, the PULSAR study stands on its own in terms of giving us the confidence, the conviction to be moving forward with our first registrational study. And STELLAR, as you heard from Jay, is going to be moving forward, and we’re going to be hosting a webinar in October, where we’ll be sharing with you those details. And so we’re chomping at the bit in terms of getting that first study up and running. Now SPECTRA is an exploratory study. And as we said earlier, we do plan to share with you an update in the first half of next year on the learnings from that. And also, I would say that STELLAR is our first program. And as Jay alluded to, we are planning to be moving forward with multiple studies in order to broaden that label. And SPECTRA, as we learn more from that, will only help us as we start thinking about designing further in subsequent studies. But Jay, please add some more around that if you’d like.

[Jay Backstrom:]

Right. You basically said what I was going to say. So SPECTRA is not going to inform STELLAR. It really gives us really interesting data. But STELLAR, we’re good with. Again, what I said earlier is just getting the final buttoned-up details, but nothing hidden behind it. We’ve got a plan. We’ve socialized it with health authorities. We’re moving forward, and we’ll just provide the details to that in October.

[Leland Gershell:]

Okay. Great. That’s helpful. And then just quickly on REBLOZYL, the J code, I don’t know if you’ve commented this earlier, apologies if I missed it. But with the granting of the specific J code, is there any way you could quantify any hurdles or issues that the products have run into earlier on reimbursement that you think will be addressed? Or is it more of a formality given the high adequacy of reimbursement prior to the granting?

[Habib Dable:]

Yes. So I’ll hand that over to Sujay, if you don’t mind answering that, the J code question, please?

[Sujay Kango:]

Sure, absolutely. So the benefit of having the permanent J code is two things, right? One is that the cycle time for the approval of reimbursement and the paperwork that is needed changes. So for certain accounts, that is going to be paramount importance because the reimbursement will be much more faster and the processing that is required could be at a different level. So that’s one benefit. So you could see that in certain sort of smaller practices, et cetera, that may not have all the support network. This could be of benefit to them. The other part of the equation is it so largely gives more confidence with regards to the access. So from our prior data set, it doesn’t suggest that we had any challenges with the access, it’s just the speed of reimbursement is accelerated. So that will benefit certain accounts. Thank you.

[Leland Gershell:]

Great. Thanks very much for taking the questions.

[Sujay Kango:]

Thank you, Leland.

[Operator:]

Thank you. Our next question comes from Ed White with H.C. Wainwright. Your line is now open.

[Ed White:]

Thanks for taking my questions. So most of mine have been asked and answered, but maybe we can just get an update on ACE-1334 in pulmonary disease. And then also similar to the previous question on the COMMANDS study and impact of COVID. Just curious on the INDEPENDENCE trial since it’s expected to start later this year or early next year. Does that include any expectations you have for impact from COVID?

[Habib Dable:]

Ed, thanks for your question. So with respect to ACE-1334, really no update on that. But just to remind everyone, this is a healthy volunteer study that we have declared to be a pulmonary program that we plan to move forward with if successful. And again, it targets TGF-beta 1 and 3. So you can imagine that based on the mechanism of action, we’ll be looking at areas within pulmonary that are driven by fibrosis. And hopefully, more to come. And if successful, we’ll hear a lot more about ACE-1334 next year. So with respect to – specifically to the INDEPENDENCE study, I think you also heard from our colleagues at Bristol that the goal is to be able to move this study forward before the end of this year, if not early next year, at the latest, and everything is still on track. Jay, anything on top of that?

[Jay Backstrom:]

No. I was going to say just that. Yes. So things are on track. They’ve been in start-up and planning for INDEPENDENCE. That continues. So as we see it today, on track.

[Ed White:]

Great. Thank you very much.

[Jay Backstrom:]

Yes. Thanks for your question, Ed.

[Operator:]

Thank you. Our next question comes from Kennen MacKay with RBC Capital Markets. Your line is now open.

[Bikramjot Singh:]

Hi, guys. This is Bikram on for Kennen. A couple of questions for us. Could you talk more about the trend you were talking about, the blood transfusions being difficult to access during these times and what you have been hearing from physicians, their preference for REBLOZYL versus blood transfusions? And second, what are the response rates you’re seeing in the real clinical setting with MDS versus what you saw in the Phase III MEDALIST study?

[Habib Dable:]

This is Habib, and thanks for your question. Just to clarify, what I had said earlier is that what we’re seeing is there’s a – or at least what I had hoped that I had said was that you’re seeing right now less patients wanting to spend the time in the transfusion centers and trying to do whatever they can to minimize their time in those settings due to the pandemic. And therefore, if there are opportunities where we can play a role that would significantly reduce the need for red blood cell transfusions or even eliminate them in some cases and to reduce and minimize that time in those settings, then perhaps we could be looked at as a solution during these difficult times. With respect to your other question in terms of response rates, we don’t have anything quantitative that we can tell you at this time. And quite frankly, I think it’s too early. But I remain very encouraged by a number of metrics, and that is with the number of patients that are getting their second, third doses and so on as well as the repeat orders coming out of the same accounts, which to me is a surrogate for some good early experiences. But again, way too early to draw any conclusion.

[Bikramjot Singh:]

Got it. Thank you so much.

[Habib Dable:]

Yes. Thank you for your questions.

[Operator:]

[Operator Instructions] Our next question comes from Paul Choi with Goldman Sachs. Your line is now open.

[Aliza Seidenfeld:]

This is Aliza on for Paul. I guess if you could provide any qualitative information or trends you’ve seen about the cadence of sales and prescription in the second quarter and more in context of COVID hot spots specifically or regional differences you’ve seen.

[Habib Dable:]

Yes. So quite frankly, there’s really nothing more I can add in terms of the prescription trends at this time. And as I said, it’s still very, very early to even try to determine any trends. Again, we haven’t even had a full quarter of sales yet for MDS, and so I’d like to defer answering that to maybe a couple more quarters out.

[Aliza Seidenfeld:]

Okay, sir. Thank you.

[Habib Dable:]

Yes. Thank you.

[Operator:]

Thank you. I’m not showing any further questions at this time. I would now like to turn the call back over to Habib Dable for closing remarks.

[Habib Dable:]

Yes. Thank you. So as you’ve heard, we had another strong quarter. And in reviewing our corporate priorities, we are looking at a busy and productive remainder for the year. It’s obviously exciting time at Acceleron. And before that conclude, I want to recognize our incredible teams, whose work is really making a meaningful difference in the lives of the patients and the families that we’re trying to serve. And I want to thank you all for joining the call, and please feel free to reach out to Jamie or Todd directly if you have any further questions. And I hope you all stay healthy and safe, and have a great evening.

[Operator:]

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.