Q1 2020 Earnings Call
Dotcom.
Joining me on the call this afternoon or be doubling our chief Executive officer.
Mcglaughlin, our Chief Financial Officer, Dr., Jay Backstrom, our head of research and development and CJ can go our chief commercial officer.
As a reminder, we'll 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 SEC with that I would now like to turn the call over to have the Dudley our CEO.
Thank you Todd good afternoon, everyone and thank you for joining us today.
Before we get started I wanted to take a moment to address the cobot 19 pandemic getting affecting all of us today.
First and foremost our hearts go to everyone indirectly impacted.
Due to healthcare and other workers, who are on the front line.
We thank you for yourself witness to help keep us all space.
As it situation continues to evolve we had been moving quickly to protect and support our employee indications that we serve.
In early March we implemented a work from home policy and successfully transitioned to virtual external stakeholder engagement.
We continue to again business critical laboratory manufacturing and related support activity as a responsible essential business, while taking the appropriate measures to minimize risk and ensure the safety of the limited number of employees, who are still coming into our facility.
Although it's too early to tell how impactful, but endemic will ultimately be at present, we had been fortunate to experience minimal effect on our business an operation.
This isn't a large part due to the foresight commitment and flexibility if the entire acceleron team.
Over the coming weeks and months, we will continue to monitor the situation carefully and follow guidance from local and federal Health Authority.
Despite some adjustments to our day to day operations necessitated by the current environment, we continue to make strong progress on the clinical and regulatory front.
But one month ago. The FDA approved rebels, though also known as with tighter step for its second indication the treatment of in EMEA scaling and richer points. This stimulating agent requiring two or more red blood cell units over eight week in adult patients with very low to intermediate risk Myelodysplastic syndrome with ring Sideroblast.
Or myelodysplastic myeloproliferative neoplasms with ring Sideroblasts and thrombocytopenic.
Rebel deal with first approved in November for the treatment of anemia in adult patients the beta thalassemia, who require red blood cell transfusion, becoming the first and only approved a retrade maturation agent.
Acceleron discovered replica of just over a decade ago and as you can imagine these approvals mark a proud moment for our team and our long time partnership with Celgene and now Bristol Myers Squibb.
More important they are huge victories thousands of patients with Mds and beta thalassemia, who until now had been waiting for new option to treat during the year.
Outside of the U.S. Committee for medicinal products for human use of the European Medicines Agency recently issued a positive opinion on red blood cell recommending its approval for the treatment of transfusion dependent in EMEA in adult patients with lower risk Mds and beta thalassemia.
We expect the made decision on the marketing authorization application for rapid though in the second happened this year.
I'd like to recognize jumped the joint development team that Acceleron and Bristol Myers Squibb under continued achievement.
In the first quarter results from both the pivotal phase three metal it and believe trials were published in the New England Journal of Medicine.
These publications, where acceleron first and this prestigious peer reviewed journal.
Moving to rubbers not commercial launch our field team is hard at work alongside our partner Bristol Myers Squibb targeting the top health care providers and centers of excellence thrill to you at the first five months of commercial sales have been encouraging we recognize approximately $1.5 million in royalty revenue revenue on net rebels they'll sales.
Of approximately $8 million for the first quarter of 2020.
Importantly, we are experiencing new and repeat orders from medical centers across the country, which has continued with the recent launch in the MBS indication today.
The current public health environment does introduce certain challenges that we continue to monitor including patients and their potential caregivers ability to manage the regular physician appointments and our field team transition to a virtual sales model as of mid March.
As we look toward our long term vision for rebels, though.
We believe its novel mechanism of late stage with Troy maturation could enable it to become a possible platform treatment for thousands of patients suffering from India caused by a variety of hematologic diseases.
That ends in partnership with BMS, we're presently conducting two additional trials and preparing for a third called independence trial.
This pivotal phase three trial will evaluate tightest up for the treatment of in EMEA in patients with myelofibrosis core on a jaktwo inhibitor and require red blood cell transfusion.
Between now and the end of 2022, we anticipate a steady flow of topline results from the beyond study in non transfusion dependent beta thalassemia and the command study in the frontline lower risk Mds and we also continue to evaluate additional disease areas in support of our vision for the status as a true platform treatment.
Yes.
While Brazil remains a top priority we're equally excited by the progress we're making in pulmonary disease.
In January we were absolutely thrilled to announce positive topline results from the pop star Phase two trial in pulmonary arterial hypertension or P.H.
We believe these data demonstrates the tightest up stability potentially reshape the treatment paradigm for patients with this devastating disease on top of currently available therapies.
Most recently, how does that was granted breakthrough therapy designation by the FDA in priority medicine designation by the M&A, a first print acceleron discovered medicine and for a therapeutic candidate in ph.
These designation allow for more regular interactions with the agencies and additional access to senior division members, along with expedited application filing an application review period following pivotal phase three trial results.
We look forward to engaging in end of phase two discussions with the global health authorities by the middle of this year as we work to finalize our phase three development plan in the second half.
We currently expect to initiate a pivotal phase three trial globally at the end of this year or early 2021.
Following the cancellation of the in person American Thoracic Society 2020 International conference due to cope with 19 pandemic Ats now planning to host certain sessions virtually.
The web based session, including the detailed presentation of topline results from the pulse our phase two trial is now expected to take place before the end of June.
We will provide more information on timing and how to accept the presentation as soon as it becomes available Acceleron will host a.
Separate webcast presentation for investors and analysts following discussion.
We hope that many of you will be able to join the call and with that Kevin Mclaughlin, Our CFO will review the financial Kevin.
Thanks, Dave Good afternoon, everyone.
I would like to refer to our press release issued earlier today for a summary of our financial results for the first quarter 2020, and take this opportunity to briefly review a few items.
We ended the first quarter with approximately $415.6 million and cash cash equivalents and investment.
Revenue for the first quarter of Twentytwenty was $4.3 million, which includes 2.8 million of costs year revenue and it has a deep mentioned earlier approximately 1.5 million of royalty revenue from net you less sales of Rupel as bill of approximately $8 million.
All revenue was derived from the company's partnerships with Bristol Myers Squibb.
The company's net loss for the first quarter ended March 31st Twentytwenty was $50.9 billion.
And with that I'd like to open the call for questions operator.
As a reminder, ladies and gentlemen to ask a question you wanted to press star one on your telephone to withdraw your question press the pound key please standby well, we compile the Q and a roster.
Our first question comes from the line Martin Oster from Credit Suisse. Your line is now thing.
Hi, everyone. This is mark on for Marty Congratulations on the progress and thanks for taking my question. My current perspective has been has there been any impact on data collection and patient care think didn't occur that night clean and if so how much flexibility as they're built into the protocol.
Okay.
Yeah, Hey, Mark Thanks for your question, maybe I'll pass it over to our head of R&D Jay backing to address.
Yes, hi, so we've been working very carefully with the sites to really allow them to continue to have access to patient dosing.
Both ftn any I may have issued guidance in the context of the pandemic for management under GCP, we're very much compliance and on top of that.
Fortunate to say so far patients have been able to still access medicines without having a risk.
Really being denied treatments so for the dosing that's been fine.
Okay perfect. Thanks, Thanks for taking my question.
Yes, thanks Mark.
Thank you all our next question comes from a line of Yaron Werber from Cowen. Your line is now open.
Yeah, Hi team and a great to see in such a strong number on rebels ill. So my question has to deal with do you have any sense, how much of it as demand and was there any sort of traditional inventory kind of pull and such and such an early stage and the launch and do you have any sense how much of sales.
We're on label versus potentially early adoption into Mds or him after sort of Ah you know for anemia more broadly.
Yes. Thanks. Thanks for your question your own and I can tell you on the acceleration Acceleron end of things. We are also very very pleased with the first quarter sales just to remind everyone that first quarter is was never represented sales for our first indication and adult beta thalassemia patients requiring regular bugs, but some transition into you.
Alone and so we're very much looking forward to building upon that now.
Mds being approved in the in the second quarter, and just again I'll start it off and I'll pass it over to CJ, our chief commercial officer to add some color, but just to remind everyone. The the method of deliveries here is really a drop shipment and so I'm not a lot not a lot in terms of.
But typical inventory build up that you run in terms of the first part of your question, but I'll pass it on number to Sue Jay to add a little bit more color.
Thanks somebody had been yaron. Thanks for that question. So absolute said right. So the way be MSNBC created the distribution model is the order is collected to wholesalers and be directly ship it to the account.
Plus if you recognize that this is more of a bias built Medicare part b product. So the like leases situation in the traditional model, where the wholesalers holder to entry and then they send it out doesn't occur this and within 24 hours to product goes to the account. So we don't anticipate a whole amount.
If any buildup of inventory at the local physician's office or hospital level. The usually ordered as soon as they have a patient in mind descending order through and within 24 hours.
The vials shipped to the Doctor's office of the hospital. So normally speaking there wouldn't be a buildup of inventory. So most of this is almost directly related to a patient that destocking on treatment within the deal or two or so okay.
Thanks, a lot note that question there.
And just a quick follow up on launching in the corporate banking environment is a little bit of a double edged sword that to the certainly a tough environment to sort of pre to start detailing a new product, but this is a product that people have known about and we've also been hearing that goes from supply issues and blood centers. So can you tell me what kind of tell us what feedback you're hearing so.
So far thank you.
So maybe you.
Yeah, you can continue Sir please okay. Perfect. So there are you raised the question whereby there's an opportunity as you're pointing out so we have heard.
From from the purposes of you know the blood supply is a challenge because many a page.
The owners.
Have a challenge going in and the donor supply has has.
Come down a bit so with that there is an opportunity with regards to red blood cell as you've pointed out because we do offer transfusion independence for the right patients with.
Mds, so thats an opportunity because its squarely in line with the benefits that we do co light on the flip side of equation. We do also though based on not assessment that there are.
In a new patients or actual patients for hematology going into the centers that has come down right. So it's a balancing aspect of it was early launch metrics are very good and we're very encouraged we have to wait and see over a period of time.
What is the overall net net effect of this but we're very encouraged with the early startup the product.
To launch as well as virtual detailing because we are we are doing that including speaker programs. We do also how those outright and we've already started to execute those so more to come into the second second quarter as as we monitor this okay.
Yeah you. Ron This is had these end with just a compliment what cgis thing you need to remember.
This is a community who's been.
Had the opportunity to benefit from the publication in the New England Journal of Medicine as I mentioned earlier, we were simply thrilled to be able to be accepted in this publication and so awareness levels on as a result of that significantly increase and and again there hasn't been anything new in the space.
Over a decade, and therefore, the opportunity for us to get our messages out there on to a market that's been waiting for something new provides us with a wonderful opportunity to increased sharply.
Thank you. Our next question comes from the line of Geoffrey Porges from Ed Levy Leerink. Your line is now open.
Hi, just wanted to.
Actions about so Thomas.
Just give us a sense of obviously, the Ts presentation pushed back a little bit.
What's the latest timing on on your meeting with the FDIC.
And.
What's your latest thinking on the possibility of farming directly with this data.
Lastly.
You highlighted the cash balance Kevin.
Do you expect that your cash reserves is sufficient to fund pivotal trials, assuming they're required to sotatercept. Thanks.
Yes, Hey, Jeff This is heavy saying thanks. Thanks for your questions regarding the first question on eight yes, you're right.
The lives Congress would have been happening in a few days and unfortunately like many in all other Congress does actually the it has been canceled and what the it gets is done.
They are.
They've moved to a virtual format. We're currently working with them and we feel very confident that we will be leveraging that Congress for our presentation before the end of June into virtual format. So you can expect that from a data point of view.
With respect to your question regarding the opportunity in terms of filing directly in interactions that we've had with the FDA and other health authority a couple of things one what we said is that by the middle of this year. Our goal is to have.
Those interactions with the health authorities are the various health authorities and be able to get back with you shortly after that.
Q3 timeframe.
Maybe maybe Q4, but mostly on the Q3 timeframe in being able to share with you are thinking based on those conversations in the advice that we receive on what a phase three trial would look like.
Now I'll allow Jay to if he'd like to add a little bit more color on that but in terms of your question just to finish up on the question regarding the ability to file directly.
I'd like to remind everybody.
The pulse our study has been designed and powered the proof of concept study and we're simply thrilled with the fact that we were able to hit statistical significance on the primary endpoint as well as our secondary but at the same time I do want to remind everyone that the primary endpoint was pulmonary vascular resistance and though we all know but that was an import.
Human dynamic endpoint, but at the same times equally important for us.
To be able to identify a.
A key secondary endpoints, such a six minute walk distance, which would be very important for us and you think about designing a registrational studies in terms of having some sort of a functional benefits. For example, so I've heard you know I've heard the conversations in the chatter regarding the ability to file on this data I think if you look at.
Pat precedent that would not be the case I think will be added benefit of having a prime designation as well as breakthrough therapy designation with the FDA.
That gives us a tremendous opportunity to benefit.
From frequent senior level Council as you think about designing our pivotal studies for phase three new you're very much looking forward to engaging with the regulatory bodies in that regard and if and when we have that all of that lined up in the third quarter or perhaps it will be in the fourth quarter will be coming to you without Registrational study design.
As soon as we can.
Regarding the dollar the you know in terms of the ability to fund on it too presumptuous right now to think about what we would.
In terms of needs in cash needs to run our pivotal study I will tell you right now, though our goal is to move forward with global Registrational studies.
Independently and based on the conversations that we will have in the funding requirements for those studies I can I I feel very confident that we're going to raise need to raise more money to be able to fund those phase III studies on our own.
Kevin Jay would you like add anything to that if there's anything of that I Miss.
Hi, This is Jay I think you summed it up really well from the clinical regulatory front. We're certainly on track to stay on time with our interactions with the agency and we said previously were really planting and prepared text kuna phase three study. So we're in that planning process and more to come after we engage.
Page with the Health authority.
Yeah, and this is Kevin and Jeff. Thanks for the question I think that you know we ended the first quarter with about 415 million in cash that's what we've said we're pleased with that but we're always looking forward to the future and what our cash needs will be.
Certainly the focus for us will be continued.
Work in the research Department as well as our focus on the status of program going forward from a from a study standpoint from you know manufactured preparation standpoint, it obviously market development standpoint.
Great. Thanks, very much the answers guys. Appreciate it thanks for your question Chuck.
Thank you. Our next question comes from the line of Carter goal from Barclays. Your line is now open.
Great Good afternoon, and I offer my congrats on the MDF approval I guess, maybe just a follow on on the previous question just in terms of sort of the sensitivities around being able to start the P. Eight study later this year loose give a little bit more detail I mean, obviously, we've got to wait for the design to kind of be relief, but when we think about other additions.
Oh gating steps can you maybe just go into a little bit more color. There I think we believe Kevin just mentioned manufacturing.
You know any any additional color there would be helpful. In terms of where you stand and other kind of getting steps and then maybe I.
I guess my reach question you seem to be kind of characterizing the phase three program as a single study should we think about when that gets the disclosed around a single pivotal study or could we get greater detail on the broader kind of.
Clinical program. Thank you.
Yes. Thanks. Thanks, Thanks for your questions Carter I'll start off with the last question. If it came across as a single study or previewing presumptuous or that's absolutely not the case, we're not ready to say that at all on until we've had those proper conversations with the health authorities, but in terms of our thinking and some of the gating try.
Did you use et cetera, I'll hand over to Jay to to elaborate on how we're thinking about that at that point [noise].
Yes, I think the key thing is actually to engage with authorities and get agreement on the trial designs and I think when have you said earlier, we're really fortunate with breakthrough therapy designation and the prime designation it really affords us the opportunity to effectively engage and that's our plan.
I mentioned earlier you know, we you know studies startup Theres a lot of steps behind that many of these we can take even in advance of the protocol, but.
But essentially really getting that protocol up ready and agreed by health authorities are the protocols put it in parentheses, where we're working on a full development plan as we get that forward. You know I think we're going to be geared to go we've been really fortunate that we brought a multicenter trial with the top experts all of whom are obviously and.
As you asking about the program given the results so were leverage significantly as we think about starting up a phase three on the timing that we had envisioned I think even at the beginning ways to get something ready by the end of the year. So so far I mean, everything is really aligning against that we'll have obviously much more detail when we completed our health authority and.
Our actions and frankly all of US are looking forward to sharing those plans with you, but it'd be premature prior to the health authority feedback.
Thank you. Our next question comes with a line of Eric Joe from JP Morgan. Your line is now open.
Hi, Good afternoon, guys. Thanks for taking the question.
Just a couple on rebels, though and bit Syria. This first is.
If you could just remind us about the split your coverage in.
Moving reimbursement in that.
Segment, and whether you anticipate any change in that mixes as the result of a weakening economy, especially here.
And then secondly, I'm wondering if you could provide us with an update on.
In enrollment updates in the pediatric phase two trial.
What sort of positive data would look like in that study and just generally how should we think about the incremental commercial opportunity in the pediatric selling but relative to the.
Current adults transfusion dependent.
Thanks.
Okay. Thanks for your questions Eric So for the first question regarding the the access would allow us to Jay to address and then maybe you could passed on to Jay to talk a little bit about where we are with the pediatric indication.
Thanks for the question thanks to the.
So in the Buda Palace Senior segment as you ask largely given the age group of visa young adults. Most of these patients are going to be on the commercial pay side of the equation.
So that's going to be on the commercial about 70% or so we believe we're going to be sitting with and we've always anticipated about 30% or sort of patients would be covered under government pay and that could be a combination of Medicare Medicaid et cetera.
So thats, how we see the business for debate as to how the senior side of the equation.
Honestly speaking with you put it into context aircraft, if I could just put one more color over there the mds opportunities lot larger as you know 1002 1500 patients would be to tell the senior versus you know approximately 30 odd thousand inflation to Mds. It. So it's it's a magnitude difference and or what.
There a larger proportion its just the opposite of going to be on Medicare side of the equation much 70% of Mds patients are going to be mostly covered under Medicare side of the business horses, 30% on the commercial pay so gives you a context that net net as the Mds.
The business comes into line the ratios are going to significantly switch over to the Medicare pay versus the commercial bank hopefully that answers your question.
And Jay if you want to cover the pediatric asset.
Question.
Yes, certainly in for the pediatric we're running a pediatric plan, it's an approved Pip business referred to in Europe.
You know and those as is typical those designs those are often cohort design. So you pick an age group and then you go down to earlier and earlier age groups. So it's early days for the pediatric plan.
To be thinking about that.
Where we are with that program very early days.
In terms of the opportunity Eric we estimate that it's about three or four to one adult pediatric in terms of the bid about senior population.
So the majority is in the at all.
The at least.
Developed countries that Weve, where we've got the good data.
Got it got great. Thanks for taking my questions that.
Yeah. Thanks, Eric.
Thank you. Our next question comes from the line have you gone natrium over from Citi. Your line is now open.
Hi, This is Matt Vietnam amateur taking your question.
Our media presentation, how how much need time everything gets to know when the precision timing if anything.
Morning are we going again, one to two weeks advanced higher Q.
You know as an eighth yet despite you announced that the presentation that's happening within that timeframe.
Yes. Thanks, Thanks for your questions, Matt I want to pass it on over to Todd I head of corporate affairs to address that if you would does.
Hi, Samantha yeah. Thanks for your question.
So a little bit out of our control and in the hands of Ats, when they're going to outline the schedule for the session, but we wouldn't expect it to at least the a few weeks in advance of the actual session to give some people some lead time to open up their schedules as you could imagine.
The with the cancel cancelling of the in person event.
The.
The Congress would like to give their stake holders enough time to be able to clear up their schedules to them being able to participate in this and this virtual of them. So you can expect a decent amount of time and advance. Thanks.
Okay, great. Thank you and then it can take a presentation, we'll have a breakout of the data.
Background therapy is yes.
I was happy finishing the patient.
So what we saw over the presentation, we'll have to wait for that but what we said already is that this is a very heavily pretreated population where over 50% of the patients that were recruited into the both our study we're actually on triplet Vigo dilatory.
Therapies, including prostacyclin.
Okay got it and then I guess, just one more on Santander SAP.
Any additional indications.
He or she has actually fallen, especially now that you development of Ace streets, and Unisys pipeline here pretty open for maybe another indication that you talked about and just curious any thoughts you have there.
Yes, that's a really good question. So obviously right now all focuses on the P.H. in group one pulmonary hypertension, obviously as we continue to evolve the tightest appstore there'll be more to come on where else. We can take it I would like to remind you, though that we do have a number.
There, but in the pulmonary space that we're investigating it's an healthy volunteer study a 13 34, we announced that it at the JP Morgan Conference earlier, this year and the more to come on that at that program evolve.
In 2021, you can expect to hear more about that program and where we're taking it so we're feeling.
Really good about our development pipeline in pulmonary and again just finally, we engaged at the end of last year any collaborations with the company in Cambridge, Balkan therapeutic with risk and leveraging their small molecule approach to modulating gene expression.
Thank you. Our next question comes from a line of Leland Gershell from Oppenheimer. Your line is now open.
Hey, good afternoon. Thanks actually my questions have already been asked and answered. Thank you again, congrats on all the great progress.
Yeah, Thanks, Leo and.
Hi.
Thank you Sir our next question comes on the line of Jeff Hong from Morgan Stanley airline is now open.
Okay. Thanks for taking the question I guess now that you have a full quarter sales and perhaps some weeks of sales since the approval in Mds because any updates to your views on how the trajectory will progress over the coming quarters and are you hearing any early feedback in Mds that modifies your views on adoption rates. Thanks.
Yeah, Jeff. Thanks for your question, so first quarter sales.
Approximately $8 million.
It is one that we're very very happy about again, just to repeat that first quarter.
It was really as many U.S. only and would be the detailed indication only in terms of battle and all data telecommunications Kwame regular a bulk transfusion.
And now with the second quarter, having full quarter with MBS approved in the United States looking forward now as you saw also we had a positive CH NP opinion, which gives us tremendous confidence for getting moving forward than anticipated approval in the second half of this year for Europe.
And our enthusiasm for the launch in impaired from CJ previously as well given the number of new accounts the number of repeat.
Account that are prescribing.
That we continue to feel very optimistic about all of the launch metrics you haven't given any official guidance.
But what I can tell you is that as we continue to.
Launched rubble zone is virtual world, we continue to gain more and more confidence on the traction that were game.
Thanks.
Thanks for your question.
Thank you. Our next question comes on the line apart Choi from Goldman Sachs. Your line is now open.
Hi.
Hi, Thanks for taking our questions and congratulations on all the progress. My first question is commercial and specifically with regards to your interactions with doctors I was just wondering if you can maybe comment on whether the number of interactions have has has increased.
Since you have the Mds label mouth, and if in your prior discussions with potential prescribers, what's maybe some of the feedback along the lines out I mentioned said, but not so much for beta thal, but come back to me. When you have NDS I was just wondering if you're maybe just comment on the level of activity directionally or if you could quantify.
You and your partner have seen since the approval.
Yeah. Thanks for your question, Paul and I will hand, it over the CJ, but I can tell you absolutely. The number of interactions has increased because in many cases in the majority of cases. This is a different prescriber base. So the overlap between beta thalassemia prescribers and Mds prescribers, its quite limited, but I will hand it.
Over to CJ add some color to that.
Sure. Thanks for me so clearly as he pointed out our customer base has a lot larger in the M 40, Mds indication. So yes, we have seen more interactions.
No.
Caveat to that is these are all virtual interactions right because it we launched this drug the indication for Mds almost right on top of the covert 19 pandemic starting to occur and shelter in place orders, so with that kind of a situation almost all of our interactions are now works.
Sure.
So that comes with a little bit of challenge with regards to how it's difficult to contrast, this particular aspect with the prior of sort of flattened in person promotion, having said that.
Right off the bat, we see an uptake within large centers are off Mds or we know that there is adoption occurring which is sort of at the end of the day. That's what you want to see and we're starting to see a lot more that and also have also seen interest in even virtual speaker programs. We've.
Good luck also questions about.
You know how.
How quickly we couldn't get the product to them. All of these questions are coming about from these what you'll engagements I've been on several of these engagements and you asked some sort of color that I wonder.
So they are asking those questions with respect to.
You know the.
Patient population labeled indication taxi have and the interest is very strong from these oney interactions that I've had with physicians, which have been with Mike reps as well as Dms reps are doing joint calls with our reps as well. So net net I see is very favorable engage.
Element and interest which represent.
Okay. Thank you for that and that's very helpful. My follow up question, if I could squeeze one more in places just with regard to I know the part is.
His data is still pending here in terms of the presentation, but can you maybe just comment on do you plan any additional data or longer term follow up updates over the course of 2020 and then can you maybe just elaborate on how you're thinking about potentially incorporating that yet.
Data down the road as part of your Registrational strategy. Thank you very much and thanks for taking our questions.
Yes, Thanks, Paul that's actually a really good question and just to remind everyone. A the pulse our study had a six month primary endpoint.
Yet every patient had the opportunity to rollover into an open label extension program for an additional 18 month in the placebo arms that study would get randomized one to one on low dose in high dose sotatercept.
And just to remind everybody once again, when we cut the data and shared the topline results. The pulse towards the end of January there was 97 out of 106 patients who are eligible to roll over into the open label extension with the first patient being eligible.
Around December of 2018.
At the time of cut off.
Every single patient that was eligible to rollover, we're still in the open label extension. So we take a lot of comfort on from that statistic alone for multiple reasons and the answer to your question. Paul Yes, We do plan to continue to analyze the data set and there will be more to come over the course of this year next year.
In terms of sharing beauty updates both from an efficacy and safety point of view. So thank you for your question.
Yes.
Thank you. Our next question comes on the line of Kennen Mackay from RBC capital markets. Your line is now open.
Hi, Thanks for taking the question.
Just a tremendous progress with sotatercept in T.H. and really excited for the Ats data.
You mentioned six minute walk test is that the secondary endpoint you see as the most meaningful.
Secondary to that obviously pitches tremendously exciting.
This does include noted interest in targeting additional indications with Bristol outside of this pulmonary carve out something like idiopathic pulmonary hypertension. Thank you.
Yeah. So thanks for your question, Ken and the reason six minute walk distance is highlighted on it because it was our key secondary endpoint kennen.
We obviously will have the conversations with the regulators in terms of what the appropriate endpoints would look like moving forward for our pivotal study.
But you are what you're seeing is with six minute walk distance being highlighted is just merely the fact that it with our key secondary.
Now with respect to Sotatercept in the versatility of Sotatercept, one thing to remind you again is that our intention with sotatercept.
With respect to pulmonary indications it to be able to to develop and commercialize it on our own that is that is our goal at that point within within pulmonary and pulmonary hypertension anything beyond that.
Obviously, we would disclose if those conversations ever occurred at the appropriate time, but right now the focus is really on group, one pulmonary hypertension, and perhaps opportunities to grow beyond that but we're very very fortunate that we were able to to carve out the opportunity for sotatercept in.
In pulmonary hypertension for Acceleron to develop and commercialize on our own now with respect to idiopathic pulmonary fibrosis on this is actually a really good question, because obviously you're asking.
Because not only perhaps the relationship of the TGF beta superfamily in that particular disease state, but also because of the high unmet need now I did mentioned earlier to an earlier question from one of the analysts regarding Ace 13, 34, 813, 34 target, specifically TGF beta one and TGF beta green.
Again, it has fast track designation, we have not talked about and identified that indication, but you can assume it's going to be an indication that has fibrosis as part of the you know in rare pulmonary disease as being the real contributing factor to the patient unmet need and so within that group obviously is it.
You bet pulmonary fibrosis scleroderma interstitial lung disease I'm. So you make an excellent point, but there could be other solutions that could be targeting that area that we'll be looking at very very closely. So thanks for your question kind of.
No. Thank you.
Thank you at this time I'm showing no further questions I would like to turn the call back order hobby Dudley for closing remarks.
Yes. Thank you. So thanks, everybody for joining the call today as you've heard we've had very strong quarter.
The fundamentals of our company has never been stronger, we're well positioned for a productive and successful year ahead and.
As always if you have any additional questions. Please feel free to reach out to Todd and I am wishing you all a great safe state evening for everybody. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thanks for participating you may now disconnect.
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