Q3 2019 Earnings Call

Good morning, ladies and gentlemen, and welcome to the Axelopran third quarter 2019 earnings Conference call. At this time, all participants are in listen only mode.

Later, we will have another question answer session instructions will be given at that time [laughter]. As a reminder, just have told us they reported I'll now like to hand, the call over to Mr. at choice director of Investor Relations at a seller on please go ahead.

Thanks, and welcome everyone to our third quarter 2019 earnings call. The press release supporting our financial results and ask clinical Abstracts. In addition to the foundation for today's webcast are available on the investors and media page of our corporate website at Www Dot Acceleron pharma Dot com.

Joining me for the call today are a beep doubling our CEO , Kevin Mclaughlin, our Chief Financial Officer, John was all our Chief business Officer, CJ Tango, our Chief commercial Officer, and Todd James Vice President Investor Relations at corporate Communications.

As a reminder, we'll be making forward looking statements regarding our financial outlook. In addition to regulatory for 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 at our most recent Form 10-K on file with the FTC.

I would like to now turn the call over to be Dudley.

I feel.

Great. Thank you Ed good morning, everyone and thank you for joining us today.

Fred you can see Acceleron has deep expertise across the TGF beta superfamily with significant development in the three disease areas.

This is really an exciting time for us with a number of near term clinical and regulatory updates across our entire pipeline in the coming weeks and months I'm extremely proud of the tremendous progress of all of our disease area teams.

Beginning with list Patterson up the U.S. EBITDA in the European Medicines Agency are currently reviewing the B.L.A.M.A. filings, respectively for the treatment of anemia in adult patients with beta thalassemia, who require regular red blood cell transfusions and for the treatment of anemia in adult patients with Myelodysplastic syndromes, where our us now.

Good.

Where our S position and Rs positive and require red blood cell transfusions.

F.D.A. granted priority review for the beta thalassemia indication.

Not far away from the potential of our first approval of an Acceleron discovered medicine with the PDUFA target action date of December 4th 2019 for the M.D.S. indication. The F.D.A. has set a target action date of April 4th 2020.

Our commercial organization has worked hard preparing for this milestone and I'm pleased to report that we'll be ready upon FDA approval to begin making was kind of stepped available to patients.

In addition, regulators in that you are expected to deliver their decision on applications for both indications in the second half of 2020.

We'll continue to work closely with both agencies to advance this therapy toward approval, we believe that Luspatercept did bring significant benefit to patients with these blood disorders, but potentially eliminating or decreasing the red blood cell transfusion burden.

This is a huge achievement for Acceleron and our collaboration partner Celgene and another step forward in delivering this innovative therapy to patients.

We are looking forward to another important and productive ash annual meeting.

A total of six clinical abstracts on the status of had been accepted in and out publicly available on asses website.

Key presentations include new an updated analyses from the pivotal medalist and believe phase three trials in Mds and beta thalassemia, respectively, as well as interim results from our ongoing phase two myelofibrosis trial.

I'll now summarize some of the important data points included in these abstracts, beginning with medalist, which enrolled patients with lower risk who are Rs positive the updated analyses with treatment through the January 2019 data that showed that 47.1% of pay.

Patients treated with Luspatercept achieved red blood cell transfusion independence relative to the 37.9% response rate at week 24 seen in the top line data cut in May 2018.

So this abstract based on the more recent data cut we calculated median duration of clinical benefit.

Which is defined as red blood cell transfusion independence for at least eight weeks and or modified hi, Ie response for patients responding to Luspatercept. The median duration of clinical benefit was 83.6 weeks or approximately 21 months.

It is also important to note that most patients in the trial, achieving transfusion independence and or a retro I'd response with this type of stuff in the medalist study had multiple periods of response with cumulative clinical benefit durability superior to that of patients receiving placebo.

Okay.

Moving to the key believe trial abstract.

Median duration of clinical benefit defined as the time of first response of greater than or equal to 33% reduction in red blood cell transfusion units over any 24 weeks to discontinuation due to any causing that episode for this pattern separate bonders was 53.5 weeks as of the.

2018 data cut.

47, or 21% of patients receiving was status that had no loss of response within the entire study period. The average number of Red blood cell units saved over any 24 weeks and all the status that responders was 6.55 units and was 8.16.

It's for patients with a baseline transfusion burden of more than 15 units over 24 weeks.

Lastly, the interim results included in the Ash abstract for ongoing study in patients with anemia associated with myelofibrosis suggest clinically meaningful activity of luspatercept, including those patients receiving concomitant ruxolitinib.

Notably in the cohorts, including treatment with Ruxolitinib in combination with was pattern cohort three a.

Eight or 57% of the non transfusion dependent patients achieved a mean hemoglobin increase of at least 1.5 grams per deciliter.

In the transfusion dependent group cohort three b.

Six patients or 32% achieve transfusion independence over and you consider it consecutive 12 weeks.

Also within this cohort 10, or 53% patients achieved a 50% or better reduction in red blood cell transfusion burden compared to baseline.

Moving to the cohorts for patients receiving treatment with Luspatercept alone.

In trial cohort, one three or 15% of non transfusion dependent patients achieved the mean hemoglobin increase of at least 1.5 grams per deciliter.

In trial cohort, two two or 10% of transfusion dependent patients achieve transfusion independence over any consecutive 12 weeks.

Looking at safety results showed that a minority of eight ease were grade three to four in severity, which is consistent with previous studies in Mds and beta thalassemia.

With that I'd like to move to our pulmonary program with focus on our pulsar phase two trial with Sotatercept, which received orphan drug designation from the FDA and ph in September .

Pollstar is a randomized double blind placebo controlled study designed to evaluate the efficacy and safety of Sotatercept in ph patients. A total of 106 patients had been randomized to receive placebo 0.3 milligrams per kilogram of Sotatercept 4.7 milligrams per kilogram of Sotatercept.

And in combination with standard of care therapies.

Following the six month primary treatment period participants in the trial will be eligible to continue in the 18 month extension period. The primary endpoint of the trial is the change in baseline in pulmonary vascular resistance a key secondary endpoint is change from baseline six minute walk distance.

We look forward to reporting topline results from the pulse our trial in the first quarter of 2020 and preliminary results from our spectra phase two exploratory trial in 2020.

I'll now turn to our neuromuscular program with updates from our 83 trial and charcoal married to disease or CMT.

Although rare CMT is the most commonly inherited neurological disorder with a U.S. prevalent.

Exceeding 100000 patients there are no ft, a treatments for CMT.

We're currently conducting part two of our phase two CMT trial, which was designed to assess the efficacy and safety of 83 versus placebo in a total of 40 patients randomized one to one over a six month treatment period, followed by a six month open label study.

The primary endpoint is the percent change in total most of volume in fat fraction as measured via MRI with secondary endpoints, including motor function tests, such as timed walking tests will also be evaluating these specific patient reported outcomes. We anticipate reporting topline results from part two of the study in the first quarter of 2020.

And with that I'd like to hand over the call to Kevin Mclaughlin, our CFO to review the financials.

To be good morning, everyone.

Our cash cash equivalents and investments as of September 32019 were $468.3 million compared to December 31st 2018, cash cash equivalents and investments of $291.3 million.

Based on our current operating plan and projections, we believe the current cash cash equivalents and investments will be sufficient to fund projected operating requirements until such time as we expect to receive significant royalty revenue from the status of sales.

Collaboration revenue for the third quarter was $4.2 million. The revenue was all from the company's partnership with Celgene and is related to expenses incurred by the company in support of Luspatercept.

Total costs and expenses for the third quarter were $53.1 million. This includes R&D expenses of $37.6 million and seeing a expenses of $15.5 million.

The company posted a net loss for the third quarter ended September 32019 $45.4 million.

I will now turn the presentation back over the B for final remarks.

Thank you Kevin.

This is a very exciting time and acceleron with multiple near term clinical updates in all three of our disease areas with respect to Luspatercept, we and our partner Celgene are preparing for a potential first approval and commercial launch in the U.S. Further we look forward to presenting six clinical abstracts related to it will set us up at the Ash meeting in December .

And with that I'd like to open the call to questions operator.

As a reminder to ask a question you need to press star one or your telephone withdraw your question press the pound key please standby compiled the county roster.

Our first question comes from you on wherever with Cowen Your line is open.

Great. Thanks for taking the question and I was going to maybe start by focusing on the phase two myelofibrosis data.

A hobby and give us a little bit of a sense. So it looks like the combination with rock sort of as expected look look pretty good are you are seeing between 32 and 57% in cohort Hey, you have a mean duration of response of 12 weeks in court be in three be you're looking at 32 weeks, So maybe give us.

I will give an explanation maybe if you can what conifer's the difference in the durability of response between the two of them and then the second question. It looks like file Luspatercept Mano did not do quite as well as combo our patients on the model arm would they naturally more advanced wood.

I have failed rock so in the past I'm trying to understand why that data doesn't look as good in the context of the prior sotatercept data. Thank you.

Yes. Thanks. Thanks. Thanks for your question you're on so as you can imagine rent, where we're pretty excited about this a this data.

And you're right in the important rux cohorts.

We did see efficacy rates of 32% and 53%.

That said.

I do very much look forward to sharing with you more of the details in terms of the why and what some of our suspicions are.

At Ash, but I'm sure you can appreciate that beyond this right now beyond the you know that what's in the press release, we really can't share a lot more details and we do very much look forward to doing that in a few weeks.

Cash presentation, but I can tell you.

From this data based on some of the I guess hurdle rates, we had provided ourselves in the past.

We and our collaboration partners are very excited about this and very much looking forward to sharing with you our plans moving forwards and a few weeks.

Okay and can you maybe give us a little bit of a sense is the data at ash going to be more mature because you're continuing to enroll patients or is it going to be based on this initial 74 patients.

Hey around it's Todd, yes, so most likely the same a similar number of patients.

So not much more mature, but as you can imagine across an oral presentation versus.

Pre defined amount of words, they can put an abstract there'll be additional details in the presentation on Monday at Ash.

And maybe a final question with respect to an f. come forward Luspatercept for beta thalassemia.

Any any new thoughts as to whether you've heard from ft relating to a panel and whether you are still potentially expecting one.

Yeah, Hey around it's Todd again, yes. So.

What we've said historically is that given the new mechanism of action.

With less Patterson ups as I've read right maturation agent.

That is always a high potential for an outcome here, we haven't gotten into specific details on whether it would be one or both indications. So the teams continue to plan as if there could be one but until the FDA would put something on the federal registry as being 100.

Percent happening there is that the company can comment further.

Okay got it thank you.

Thanks, Karen.

Our next question comes from Daniel.

Your line is open.

Hi, guys. Thanks, a question so I'm not sure if I get much of an answer here, but I'm just curious.

You mentioned, the 25% to 30% response rates across right, yes by moving forward how should we think about the opportunity now should we should we be modeling 60%.

Patients background right.

Any color you can provide would be helpful.

Yes, so I I understand I understand your question Danielle and thanks. Thanks for that I think right now and I guess you did preface your question, but it's really tough to say much more than we are today I I will just simply repeat in this cohort with the rux combination.

Which we've always deem to be the most important cohort for multiple factors.

We are very very pleased with these results.

We will continue to.

Share with you more information on how these results will translate in a little bit more color behind these results.

In a few weeks and very much looking forward with sharing your our plans in terms of moving forward in myelofibrosis Witless Patterson.

Okay. Thanks, and then I guess.

You indicated that treatment durations that likely be shorter orientation not on back.

Well it a little worse prognosis.

Not providing detailed on data, but how you're thinking.

Hey, Danielle Todd, Yes, there's two patient types that would be eligible for monotherapy, let's patter sept, one would be a treatment naive patients of patients that wouldn't see rock. So this is most likely.

A more newly diagnosed patients that patient would as you can imagine have a fairly good prognosis.

And then there's the the patients I think that you are more referencing it's the post trucks patients those patients have a very poor prognosis kind of on the the lines of 18 month survival and as you can imagine that first patient that I was talking about pre rocks.

Good kind of 60 plus percent of those patients will end up on rux, eventually and that's on top of the rocks prevalent patients today.

Those also patients that will be receiving rocks in the future that's what mix the rocks combination.

The more a draft that larger addressable patient population and the unmet medical need in the myelofibrosis kind of patient groups.

Got it and we'll get the breakdown.

Screening rochford.

Sam rocks patients.

Correct.

They will absolutely be additional details within the presentation, but as you can imagine that presentation itself hasn't been fully finalized so it's hard for us to commit to every single detailed that could potentially be in the presentation.

Got it thanks to the question.

Okay. Thanks, Nathan Yeah.

Our next question comes from Martin I'll start with Credit Suisse. Your line is open.

Hi, everyone. This is mark on for Marty. Thanks for taking my question I guess I was hoping to trail more into the response rate to side and thinking about a potential phase three study I was curious.

Do you have a sense for how we should think about how a placebo patient would perform on the transfusion dependent primary endpoint are the hemoglobin primary endpoint. Thanks for taking my question.

Hey markets, Todd, Yes, Theres only one historic reference that you can really look at here and again always impossible to make a cross study references as we could tell with the the references that we're looking at ahead of the medalist data always hard to say.

How it'll play out but within the Celgene Pomalidomide phase three study the placebo RBC CPI in that study from a few years ago was approximately 16% and so thats the best reference point, but again I'm not necessarily.

Necessarily what would occur in and additional phase three study.

And there is no reference or there's no reference for hemoglobin response in a steady as one hasn't.

Been executed, but you can imagine it's.

Very challenging for a patient on placebo to get a random hemoglobin increases just very defined straightforward lab endpoint.

Got it thank you.

Thanks.

Our next question comes from Eric Joseph with JP Morgan Your line is open.

Hi, guys. Thanks for taking my question just a couple on my fibrosis.

I guess can you just remind us how you're thinking about the relative sizing of mother fibrosis anemia is buying severity.

Transfusion dependent versus transfusion dependent and I guess in terms of looking to the next steps do you have a sense of what a registrational endpoint might look like in the transfusion dependent population with highlighting mean going rise here isn't one of the endpoints in the phase two study I guess I thought now sort of what.

I guess, what additional feedback you look to get from either regulators are for this kind of below consensus on whatever editor simply might be in transfusion dependent.

Thanks.

Hey, Eric it's Todd Thanks for your questions, Yes, so the way we generally view the patient breakdown based off of our research is within the within the prevalent pool about 60% of patients are receiving ruxolitinib and whether they have a baseline transfusion burden or not at that.

I'm. They will eventually a majority of them will eventually have a transfusion burden and given the mechanism. It ends up a large majority of them habit, a transfusion burden and a minority of them are anemia only.

And that's.

Likewise with the non RUPS patients at diagnosis.

You'll see maybe a third of patients or have a transfusion burden and just a year after diagnosis, you'll see that I'm getting closer to 50% and given how the disease progresses, you'll see that number increase I'm pretty steadily over the patients disease, which.

General on median survival of kind of five plus years in this patient population.

As far as potential phase three and points. If we would go ahead with the transfusion dependent patient population they'd be fairly similar to what you saw here in the phase two trial, most likely RBC transfusion independence over Eddie consecutive 12 week period over the primary treatment period.

Secondary endpoint that we used in the phase two a proportionate patients that are seeing at least a 50% reduction in transfusions, you know that would be a high probability of another secondary endpoint beyond that you know if we are able to commit to a phase three in the future as of today, we continue to pay.

Plan will be able to give more of those details once we finalize the protocol.

Got it I did say transfusion dependent I meant to say non transfusion dependent if youre. If you were to move forward in the non trend with a big three protocol and the non transfusion dependent population.

How should we think about registration and point there.

Yes, so we would.

Need to talk to a health authorities to to finalize what that would be given they are not on transfusions, obviously, some kind of transfusion endpoint would not be appropriate so it probably be either potentially hemoglobin increase alone or hemoglobin press.

Patient reported outcome measure.

Kind of though a combination endpoint.

Great. Thanks for taking my questions good.

Thanks, Eric.

Thank you. Our next question comes from Jefferies.

The rank your line is open.

Thank you very much and appreciate taking a couple of questions.

First could you can from when the data cut off will be for the updated data because math because something you said my 10th.

During the abstract and then could you just talk a little bit more about the population the 40 patients I think here.

Who are not on toward competent rocks.

I think you're.

Be I'm willing to dispose the proportion that were pretty rocks and post trucks, but.

As you probably you might see will have an opportunity in the pretty rocks patients, but doesn't look like.

Those trucks and then could we talk could you talk a little bit about the uptake.

From from the Mds pivotal trial.

It looks as though so maybe in terms of rush of clinical benefit of 84 weeks, but that's in the responders.

So can you give us a.

Sense of the turtle duration or the medium term duration of treatment across all the patients in that study because clearly it's just the subpopulation who've got to about 21 months. Thanks.

Hey, Jeff It's Todd, yes, so we're not given that the data cut off date for what will be provided in the presentation isn't included in the abstract.

Just like everything else that will be presented it remains under embargo and so we're not able to provide that detail likewise with the breakdown of.

Patient baseline characteristics with in the monotherapy that remains under embargo until the presentation as for duration of all patients receiving outlets Patterson phase three I believe that's also included in the abstract and.

I just got through it here for you.

So median treatment.

Duration for all patients was 50.9 months <unk>.

Weeks sorry.

Right and then for the clinical benefit for responders, which when most people model. They mostly model. The responders. It's the 83.6 weeks' worth of approximately 21 months. So that's a nice update relative to what we presented at Ash last year.

Okay. Thanks for wait for the presentation.

Thanks, Jeff.

Our next question comes from your call I'm, not calling of its with Citigroup. Your line is open.

Yeah, Hi, guys. Thank you very much for taking my questions. If we could move to a talk little bit about status happened. The polysar phase two trial I had a question there in terms of your assumptions for treatment effect, obviously, you're you're studying sotatercept in combination with standard of care, which usually include the combination of background therapy, you are a 25 prostacyclin.

I, usually two or three a background therapy.

And you've shown some very nice preclinical work in the surgeon hypoxia model. That's just how intercept does a better job on pulmonary arterial pressure reduction as well as a reduction in and right heart failure in comparison for the single agent. So you are a PD five prostacyclin, but I'm wondering if you've done any additional work I'm looking at how satisfied.

I would perform in addition in addition to.

Sorry in addition to a those mechanisms in a common in a combination setting because we're just looking.

Comparing to single agent, so that would maybe more reflective of the real world experience.

Experience. So if you could just comment on that aspect and how you and how you developed confidence in the in the design of the phase two study. Thanks.

Yeah, Hey, this is John Quizzle.

So I think the second half of your question was relating to.

Preclinical efforts to look at combination therapy, if I, if I heard that correctly right right and you you correctly said, we presented data showing.

Side by side and combination.

With Sotatercept versus so then to fill or sometimes that's on top of supply the Phil and as you summarized for data Sotatercept.

Reproducibly outperforms, the Delta Sildenafil very convincingly.

And then we can see combination benefit on top of so the other Phil.

We have not presented data looking at you know double or triple combinations in the preclinical setting.

And as you also correctly stated those are patients in the trial. So the trial those allow enrollment of patients who are on a single visit dilator Doe tool visa dilator or even triple.

Presuming that the prostacyclin therapy is stable at the time of enrollment.

To summarize the reason why we think Sotatercept is a very distinct mechanism.

Looking at rebalancing that the MPR to signaling pathway, which we believe has the potential to be disease modifying that really changed the way the vascular remodeling happens in those patients.

And our sense is that we don't anticipate a tremendous difference between having multiple layers of visa dilator in combination.

With Sotatercept.

But.

We have not done that were presented that data conference at this point.

Alright, Thank you very much.

Our next question comes from Jeff Hung with Morgan Stanley . Your line is open.

Thanks for taking the question Youve, a pediatric phase two for Luspatercept, a beta thal patients that recently showed up on clinical trials that Gov can talk a little bit more about this study and remind us that are strategy for moving into the pediatric population for different indications.

Hey, Jeff, Yes, it's Todd Yeah, as everybody knows given that beta thalassemia is a hereditary disease.

You know these patients are becoming symptomatic very early in life. Some patients started transfusion burden as early as a two years of age and so what we're doing with this phase two trial along with our partners Celgene is a this is our first I'm studying the teacher pediatric setting and so we're looking.

Across multiple age groups.

Multiple doses across approximately 48 on pediatric subjects, and we'll be able to generate.

Some nice data there so hopefully be able to move forward in the future with additional studies in pediatric Celsion yeah.

Thanks.

Yeah.

Our next question comes from add White with H.C. Wainwright Your line.

Hi, guys. Thanks for taking my question I, just want to ask a quick one on.

A C E 083.

In the C.M.T. patient population I'm just wondering after stopping.

The trial and the development and Fsh day.

You know if you can just briefly explain why you have out you're continuing on or have confidence in the in the.

CMT population and then also do you have any other.

TGF beta protein superfamily drugs in the pipeline.

For muscular or neuromuscular disorders, I see have worn preclinical for.

Pulmonary disease, but just wondering if you have anything else in muscular neuromuscular. Thanks.

Yeah, Hey, Ed This is a beep. Thanks for your question. So it's obviously we were disappointed in September when we shared the FSD results with 83.

Again, I'm asking why would we be continuing with the C and T program or whereas the confidence coming from so I would say a couple of things first of all we were very deliberate in terms of these two studies one being a my obviously one being in neuropathy, such as CMT and I also would run.

Mind, you that you know and even in the Fsh de group, we actually did see double digit increases in muscle mass, but unfortunately that did not translate into a functional benefit which is why we decided not to move forward.

CMP trial has already been fully enrolled and as we've discussed previously it will be reading out in the first quarter of next year. So it's really at the tail end of that study and so we do look forward to Unblinding that study in the first quarter of next year.

And CMT is very much a different disease I think based on the disappointment with Fsh D.

Whatever whatever percentage of success you add on translating muscle mass increases into a functional benefit probably have gone down now for CMT. So I would say, we're cautiously optimistic now but that said CMP is a different diseases being in neuropathy, you do not you have damage nerves I'm leading to the atrophy.

Unlike a a toxic protein which is associated with the atrophy NFS HD and it is also a much more focal and distilled disease, which may lend itself to a a drug which is locally injected into a dominant muscle and so a again looking forward to seeing how that study reads.

The first quarter regarding other products in our pipeline no. We are we're not a investing in any products at this point in our in our in house pipeline in neuromuscular and it will very much be looking forward to the to the CMT data, which I'm sure will help define our path forward a in neuromuscular disease.

You mentioned, they 13 34, just to be clear again that asset is the targets TGF beta one in three and we are looking forward to talking a lot more about that next year as our next pulmonary asset coming that will be coming into the clinic.

Great. Thank you happy.

Yeah. Thanks it.

Once again, ladies gentlemen, if you wish to ask the question at this time. Please press Star then one are you touched on telephone.

Our next question comes from Leland Gershell with Oppenheimer. Your line is open.

Hey, good morning, guys. Thanks for taking my question just back on the myelofibrosis not sure. If you can answer this one either but patients on Ruxolitinib you know certain factors nimble often start to lose efficacy or become effectively a failure population if you could characterize for us.

The population in your phase two or that was combo with products to what extent those patients on on rux. Prior to also being put on the status of had perhaps the weighting of activity or or or approaching failure versus those who had already been who had remained stable in list was.

Was an add on with it with potential increase efficacy. Thank you.

Hey, Leland and start thanks for your question, Yeah. Unfortunately, given that that isn't within the abstract we aren't able to get into that amount of detail not all the we can say is based off of the trial design that patients were on a stable rock status when entering a when entering our trial.

Okay, well have to wait for the last presentation then thank you.

Great. Thanks.

Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Hi, good morning, everyone and thanks for taking your questions, maybe just staying on the topic of math as you think about a potential pivotal trial design I was wondering if you maybe provide some color on on clinician feedback and buying with regard to the one and a half grams per deciliter.

Change as as our clinical benchmark relative to some of the guidance our guidelines in society document like the international working group they have looked for two or.

Or higher and just you know that your thoughts there as a potential input for out for clinical trial design here going forward.

Hey, Paul It's Todd yes, so today. Unfortunately, there's nothing for these these patients and so an agent and given the unmet need with anemia in that almost all patients have some form of anemia.

Throughout the course of the disease and over 50% of them have moderate to severe anemia, and most likely leading to a transfusion burden you know any agent that shows activity here would be very much welcomed by the community and patients when we talk today.

Docs about the unapproved agents that they use in the space they get in the range of ER and they don't exactly define what they consider response they get a teens.

Percentage response with Epo and these patients with Pomalidomide Celgene run studies had a 16% response rate and so these are response rates in the teens and so what we're showing whether it be in hemoglobin response, and then EEMEA only patients or in the true.

Fusion independents response, and those cohorts are fairly significant activity relative to what doctors are using today in the field.

Okay. Thanks for that and maybe just on the commercial side. Since you guys are approaching a product launch here in the not too distant future I was wondering if you could maybe provide a little more color on how you and your partner will be sort of targeting or co promoting out potential accounts.

You know who goes on first how do you share and sort of divide these territories that and accounts that maybe a little more color there would be would be helpful. Thank you.

Yeah sure maybe a C.J. tangoe, our chief commercial officer can add a little bit of color there for you Paul.

Hi, Paul Great question, and thanks to be up as you know we are complementary and Synergizing our efforts with the Copromotion partner Celgene, who has a tremendous leadership in hematology. So they have the threat of covering the entire nation. Then as we have communicated in the part of the have a total of up to.

20 field based people about 16 reps and then leadership show with hot as part of that'd be a focused largely on optimizing the high target.

Within the beat to tell the senior committee, which would be likely first approval. So with that in mind, what we tend to do as we are focused on really sort of going into the higher sort of desktop targets that there's going to be a larger opportunity for the patient population and we are coordinating all our efforts jointly.

Alongside shall I reps have.

Gladly coordinated and knowing the celgene reps out their planning a coal plants together.

Through this kind of collaboration that a grassroots level. We know we can actually do a better job together and addressing the customer needs in an efficient on a timely manner. So we are able to optimize their needs and no patient would be left behind so that's the approach we are taking so.

Sort of targeting them to larger accounts alongside them and then they have the Brett so they can cover the rest of the country as well so we'll be able to go ramp we wouldn't that's necessary.

Okay.

Yes got it thanks for taking your questions.

Great.

Our next question comes from Kennen Mackay with RBC capital markets. Your line is open.

Hi, Thanks for taking my question excuse me in here two questions. One on me Myelofibrosis data and then a separate one on photographer impure.

I've got a I was just wondering if you could discussed within Tropic <unk> or what are you a little bit of things like that might quite apart mm pensions, we're achieving greater than 1.5 grams per deciliter at any time point, but sort of more of a best response offer suspension for sustaining hemoglobin television on offline on that note was wondering if there was just had to be.

Help in that trial, if hemoglobin dude.

Hi, rich or something we team in the.

Prior I after you get MD Anderson have done Weve reported Patterson and then just a quick follow up on sort of how to affect them see age I was just hoping you could discuss a little bit more the decision to start the newer food to spectra trial and from the differences versus pull sorry <unk>.

It seems like broker on top of standard of care, but spectra has become Trump fishing theres escalation.

Seven I'm, just hoping you'd reminder, phone rationale here and rationale for the different primary TV RV.

Sure, Matt Thanks, again, and what's important for him about her gosh.

Hey, Ken and it's Todd I'll start with the your myelofibrosis questions and then I'll hand, it over to John Quizzle. If your question on the difference between Oh, sorry Inspector trials for the the two ways of being able to assess hemoglobin in the phase two trial I can't get into the details into inter patient variability.

The two endpoints are very distinct but both are.

Deemed acceptable from a response rate perspective for you might be a remember in both now see me in Mds or which we had the positive phase three data in a at ash last year that we are using and in the phase two we are using mean hemoglobin a as the at risk.

Area, whether it be grabbing a half or wouldn't gram per deciliter, depending on the patient population. So I'm, just mean hemoglobin, though not as stringent as that every assessment is still a huge benefit to patients.

And then what was the second part excursions so as per the protocol. If a patient has a hemoglobin excursion there is either a dosing down for a dose hold but we're not able to get into what that data actually looks like or if it happened at all at this point because that isn't it.

Included in the abstract today. So thats included in the presentation at Ash will absolutely be able to discuss status at that time.

Okay. Thanks.

Yes, Thanks Todd.

So back to your question on each of the two trials were running.

So yeah. So there are two others, a pulse our trial and the spectrum trial, the pulse or trial is the placebo controlled.

Blinded study that we was designed for under patients were enrolled 106.

And we're testing or placebo, a 0.3 makes perfect dose and is there a 0.7 mix for kick those.

And the primary endpoint is a pulmonary vascular resistance.

With an important secondary endpoint of six minute walk.

So full service designs to put this products on a map of familiar endpoints that have been used for you know the drugs that have come before primarily a visa dilator type agents and give us a strong basis for compared comparing how sotatercept is performing a ones.

Based on top of the standard of care.

Spectra is a trial, we designed to really try to elicits and explore new endpoints and new potential effects.

Sotatercept and the reason for that is because of the potential disease modifying mechanism quite distinct from the visa dilators It came before.

We think that theres potential to see different type of activity in the patients and so we wanted to have a chance to a look at some additional types of affects the drug may have so there.

We're doing Oh I see pets.

Looking at exercise capacity with that's technology and we're also looking at cardiac and Myride to have really the best possible way of visualizing the affects the Sotatercept may have on right heart function and morphology.

If you recall in the some of the animal data we presented we've seen.

Reversal of right hard enlargement.

After four weeks of treatment.

In the animal model.

So spectral in order to accomplish that exploratory goal, we designed to be open label.

Or enrolling roughly it's designed to enroll roughly 20 to 25 patients.

And.

Without the placebo control aspect of it we felt that it would be desirable to have every patient capable of getting up to the 0.7 make perfect dose.

And we felt it would be useful to explore a tearing up to that those my starting 0.3, given moving to 0.7.

Till we get a very nice look at how each patient or just funding it each dose level.

Got to about a super helpful comp extremely appreciate all the recovery bearing <unk> Ford FEMA team at Ash.

Thanks, Ken.

Thank you. This concludes the question answer session I would now let's turn the call back over to have these probably for closing remarks.

Okay, great. So thanks, everybody again for joining our call today I'm wishing you all the great day and very much looking forward to seeing all of you at Ash, where we're looking forward to sharing much more details on our program so with that have a great day.

Ladies and gentlemen, this whole foods today's conference call. Thank you for participating you may now disconnect.