Q1 2021 Acceleron Pharma Inc Earnings Call
Year end earnings call.
Brazil had a strong first year of commercial sales and we remain pleased with the launch and the uptake of new patient starts during the beginning of 2021.
For the first quarter BMS reported approximately $112 million and net sales of red blood cells, resulting in approximately $22 4 million in royalties for accelerant.
By comparison net sales were approximately $115 million in the fourth quarter with royalties of approximately $23 million.
We continue to transition from the initial bolus patient group from earlier in the launch to underlying new patient demand.
Which was the largest contributing factor to the slight decline in quarter over quarter sales.
Right.
Additionally, there has been an overall decrease in new patient volume in hematology as compared to pre COVID-19 levels.
Outside of the United States for launch is going well with Austria, and Germany, where our partner Bristol Myers Squibb launch Reblock on the third quarter of last year.
BMS expense for expects launches in multiple new countries across the globe. This year following reimbursement coverage.
We believe there is significant opportunity to grow the brand within its existing indications through further penetration into the long term underlying demand a patient.
Earlier in the Mds treatment journey in the United States.
Additional launches in regions outside of the U S and an increase in reopening activities, including overall physician visits following continued progress and COVID-19 vaccination rates.
We expect that this will lead to a return to growth for <unk>. Following the summer months in the second half of this year.
Alongside BNS, the approval and launch of <unk>, Brazil, and multiple diseases and global markets has been our biggest achievement to date and we continue to be important development work to bring this medicine to additional patient populations, who may benefit.
From rebels a novel mechanism of action, we look forward to presenting results from the beyond phase II trial in adult patients with anemia associated with non transfusion dependent beta thalassemia by the end of June and two phase III trials are underway to evaluate in this pattern in patients with first line lower risk Mds and myelofibrosis.
BMS recently initiated the independent phase III trial in patients with myelofibrosis for.
On a JAK inhibitor and require red blood cell transfusion and we expect top line results from the commands phase III trial on MBS by the end of 2022 or later.
Assuming success in current and future potential indications associated with anemia.
We continue to estimate annual peak sales of around Brazil of more than $4 billion.
Finally, I am very much looking forward to providing updates on our numerous ongoing and planned trials across a rare pulmonary disease pipeline at our upcoming research and development day, which will take place virtually on June 22nd.
We have a robust program plan with contributions from several leading pulmonary physicians and members of the Accelerant Senior management team.
We wish that it could be in person, but are nevertheless, looking forward to connecting with many of you in a virtual setting. Please look for a more detailed information on the event soon.
And with that I would like to hand over the call to Kevin Mclaughlin, our CFO to review the financials and then we'll be available to take your questions Kevin.
Thanks Habib good afternoon, everyone.
I'd like to refer you to our press release issued earlier today for a summary of our financial results for the first quarter of 2021 and take this opportunity to briefly review a few items.
We ended the first quarter with approximately $795 $4 million on cash cash equivalents and investments.
Revenue for the first quarter of 2021 was $24 $8 million, which includes $2 4 million of cost share revenue and $22 4 million of royalty revenue from net sales of <unk> zone. All revenue was derived from the company's partnership with Bristol Myers Squibb.
On a GAAP basis total costs and expenses for the first quarter of 2021.
For $88 $4 million non-GAAP total costs and expenses were $71 $7 million.
On a GAAP basis, the company's net loss for the first quarter of 2021 was $63 $5 million non-GAAP adjusted net loss for the first quarter was $46 $8 million.
With that I'd like to open the call to questions operator.
Okay.
As a reminder to ask a question you will need to press star one on your telephone and for the dry question press the pound key places on firewall the compile the Q&A roster.
Your first question comes from the line that you had on the Weber we have Goldman Your line is open yes.
Hi, Thanks, so much for taking my questions, maybe Habib couple of questions for you in Europe, specifically target, Austria, and Germany launched.
How fast do you expect some of the other countries to come online and give any visibility into the cadence of which funds are going to come online faster than others and then secondly, just curious it sounds like you're expecting more of a rebound in the U S.
Excuse me in the second half is that are you just thinking thats when COVID-19 resolves from the summer is over or what drives the second half. Thank you.
Great. Thanks, Thanks for your questions your own.
So with respect to the first question in terms of Europe and the visibility.
You heard from our partners just last week on the conference call. The ex U S launch has been pretty much driven by two countries, Austria, and Germany, and we've been very very pleased with the initial uptake in those two markets.
I think what you can expect is that in the second half of this year youre going to start to see reimbursements on a staggered basis starting to kick in.
Typically in Europe, a 12 to 18 months post approval is going to start seeing full reimbursement from some of the main markets countries.
Countries that you can expect to start coming on board your own in the second half of the year. In addition to Austria, and Germany are countries like Belgium, Netherlands, France.
Italy, and some of the Nordic countries and that's really.
Consistent with the guidance that our partners at BMS have been providing as well and so from that point of view, we're very much looking forward to those countries.
It's starting to contribute to the overall except for the launch.
And that obviously segways nicely into the into the second part of your question in terms of what is it that we believe is going to be driving.
The inflection point in the second half for the year.
And again a lot of that has to do with what's happening with the ex U S launch of course, and as new countries come on that obviously, you're going to start contributing to the global <unk>.
Except for the brand.
On the U S. Specifically, there's a couple of things that I believe will be contributing significantly and quite frankly.
Starting to see some of these elements starting to play in and really a lot of that is being driven by the continued increase in the vaccination rates.
Different markets start opening up.
Sales representatives are having more face to face access and then secondly on patients.
More of an ability to come in to see their physicians.
On a more frequent basis you may have heard last week your own our partners at BMS.
Actually noted.
That and the Mds population, specifically that they've seen.
A 10% to 20% decrease in new patient visits in the Mds space for.
On pre COVID-19 levels to where they are now and so we're really hoping that Ed vaccination rates continue and hopefully Ed.
<unk>.
Virus transmission subside on that we're going to see a return to growth.
A return to growth, but also a return to normal metrics when it comes to new patient visits.
The MBS to date.
And then finally and most importantly, you're on.
What is going to be a significant driver of this growth in the second half.
Really in the patient mix.
In Q4, we had approximately 40% of our patients that were being treated in Mds patient population.
It really is heavily transfused patients that bolus of patients that were just waiting for something heavily treated.
High transfusion burden and quite frankly, even in the medalist study. These are the patients that did not do so well and dropped out for the persistency levels.
We're definitely nothing close to what we would expect for the on target population in <unk>.
Q1, and you saw that number dropped almost in half to about 20% to 25% and so we believe over the next quarter or so.
That will be pretty much at the tail end of that bolus and that the majority if not all of the population within the Mds grouping on run Brazil are going to be on target and that will really be a surrogate and driving the basis for long term growth. So at the end of the day when you put all that together.
We're very very confident and as I said, we're starting to see signs now of this progress and that we believe the second half is going to have some contribute to some very significant growth and then obviously, we still remain very bullish on our long term prospects of this.
On being a $4 billion plus.
John with the again, if indeed, the lifecycle management opportunities that seem to be successful.
Thank you.
Thank you and our next nine.
Your next question comes from the line of our cash to Ari with Wolfe Research. Your line is open.
Hey, guys. Thanks, so much.
Congrats on the update Ultra day that was interesting to see kind of an additional improvement to week 48 net that.
One concern we had I think looking at the placebo crossover why do you think there was a market reduction in the average 600 bucket versus the initial treatment day is this a sign that maybe the true improvement Act.
On treatment versus Satish is really more on the kind of 30 to 40 meter range and not on the 50 to 60 day range. Additionally was there any imbalance of patients starting on background treatment within three to six months between treatment and for the placebo arm and pulsar. Thank you.
Yes. Thanks for your question of cash I'm going to hand that over to our head of research and development Dr. Jay Backstrom.
Yes. Thank you for the question so with respect to the change in medications note that didnt occur in the trial per protocol. So they would have been on the same medicine that they came in on.
With respect to what to expect with the total change on six minute walk distance.
Again, if you take a look across from change from baseline for just about everybody at 50 meters. If you look at some of the updated data that we're going to present later for spectrum on that cohort. It's in that 50 to 60 meter range and I think we've talked about before I do think that we have the opportunity to.
Add on top of net 30 meter plus range and if you look across the programs that have been conducted frankly, even in the very upfront setting where patients are on no therapy change from baseline and a 50 meter range. So I think overall, our six minute walk distance data on a really very strong against the background of double triple.
Therapy, and really think sets us up nicely for the stellar studies.
Thank you. Our next question comes from the line of Carter Gould with Barclays. Your line is open great. Good afternoon, guys and thanks for all the color on the market dynamics I guess two questions for me maybe following on.
On the prior question I guess, what additional metrics can we expect in the Ats presentation of pulse or are we going to get the results also broken out by background therapy.
Yes.
Changes also in multicomponent improvement any additional color on that front would be appreciated and then just I guess a.
Clarifying question in terms of the timeline for commands we noticed that.
The primary completion got updated I think believe June 2022, you're talking still about for the year end read out in 2022, just wanted some clarity there I appreciate it thank you.
Yes, I think thanks for the question quite frankly on the commands on right now and then on into the rest of it for Jay to continue.
So with respect to commands what I can tell you is that the guidance.
<unk> has remained the same.
<unk> 22 or later.
It's definitely our goal is to be able to to get it in the late 'twenty two first half of 'twenty three.
But that number on our guidance has changed on that Carter.
Yes, the quarters for the update here is up to week 48. The trial is still going on so effectively you can see just more granularity around the six mineral mark empty pro BNP <unk> functional class improvement that will be the focus on the presentation as well as because we have additional safety data update on the safety.
And you'll see that broken out by dose so that that will be the focus here again, it's still an ongoing trial and we will have an opportunity to then.
Present complete results, but that'll be a future event not a course, Inc. Yes.
Thank you for your next question comes from the line a bit on your Bill with Raymond James Your line is open.
Hey, guys. Thanks, Thanks, so much for the question.
I mean, I've had some conversations recently with investors.
Talking about your primary end client and collecting six minute walk at six months.
Primarily in context of seeing the 48 week data and how the magnitude of benefit seems to improve over time can you just maybe comment on why you're confident in the trial design and the primary endpoint selection at six months and then as a follow up.
Do you have any updated thoughts on maybe extending.
The primary endpoint assessed and other high Purion XE net out to 12 months. Thank you.
Yes, Thanks for your question Danielle and.
Maybe I'll start off by outlining.
How pleased we are that at week 48, we continued to see.
Improvement not.
Not only with six minute walk by the way, but also.
<unk> Pro BNP.
As well as in.
And who functional class.
Just to kind of remind everyone. When we were looking at the primary endpoint of six months, we had you know.
Proximately, 25% of patients who had a functional.
Functional class improvement for.
At 48 week for that number is now at 41% and so youre right in a progressive disease to continue to see improvement across our concordance for endpoint.
We are very very pleased and so.
I'll hand, it over to Jay in terms of some of the thinking behind our confidence on why we chose those endpoints from the timing of them, but as you rightfully note in a progressive disease to continue to see improvement. This is something that we're going to continue to watch and we're obviously very very.
Cited above.
Yes, maybe I'll, let me just start there I mean I think as we were you know we've talked about before what would we expect to see on the open label extension what would we be looking for and you know as Habib said in a disease defined by progression stable maintain or improve and frankly, if you look at the abstract and new comes and listened to the Ats presentation.
So that's what you'll see now with respect to your question about the confidence from the endpoint.
We ran a randomized phase II study with a 24 week end point and when you look at both doses combined and we're going into are not doing a three arm trial, we're doing.
Titration approach to treating both doses combined and a very small 106 patient study we had significance on six minute walk distance as a 24 week endpoint to try it again or.
Program with a very efficient and you know heard me say that word before way to get a registration program with efficient endpoint 24 weeks as.
Frankly quicker, obviously isn't a 48 week and I think with the size of the study the confidence that we are seeing the consistency of improvement of six minute walk over what I expect is the clearly significant I think for the endpoints is solid we socialize the protocols, both with FDA and in Europe. So we've got volume from the regulatory authorities on this.
Roche and so I think for for stellar we're in a very good place, but again recognize its one study of three programs and if you look at the secondary endpoints included in stellar. We also have a multi component endpoint. We included time to clinical worsening although in this cohort and we may not see the number of events that we would expect in some.
Other studies, and then I'll turn to Hyperion, which is now posted on planned trials Docker would you take a look at that the primary endpoint. There is a morbidity and mortality endpoint, it's not six minute walk distance, it's not measured exactly every 24, it's a it's an event driven trial.
So time will be variable here is we anticipate the potential for tighter step one added upfront to really reduce the probability of those patients having such events.
Thoughtful design of an intermediate and high risk cohort that are at risk for these events and so we think we'll be able to demonstrate that and then similarly.
And the Zenith study, which we haven't talked a lot of basketball will share more of that at the R&D day on the it'll be looking again at a morbidity and mortality endpoint, but also with functional improvements et cetera likely built across the program. So when I put all that together again.
The best way to have a positive phase III study is have a solid positive phase II program and do very little to vary from what you've done there except potentially strengthen it and that's what we've done the stellar with strength in stellar on and I feel we have a very high probability of technical success, given the phase II data.
Got it thank you so much.
And your next question.
Comes from the line of Eric Joseph with Jpmorgan. Your line is open.
Hi, good evening. Thanks for taking the question just a quick one from us on stellar which is really how should we be frame expectations for services.
And timelines disappears.
Good day represented particular challenge is it fair to sort of grasp on the pulse of our experience.
Larger.
Thanks.
Alright again over to you Jay.
Yes on what I'll say, a couple of things were on track as I would've helped us to be as we opened up the trial at the end of the year. So so far so good Erik.
Theres clearly clearly interest in this study and in the program, which is to the good we've got investigators working hard to get the centers up and running so.
I feel like we're at a place where things so far so good of course, you know it's early on the recruitment phase and early in the beginning of the study.
But again I think we were very fortunate with Paul sorry, I think I've said on previous calls that we had completed enrollment before we got into the middle of the pandemic and then as things got better we were able to keep patients on and continue to follow hence the ability to get the open label data.
<unk> presented I feel like we're in a similar place the centers are really interested they want to get patients on trial, they're working hard with us to get the centers open and Sandeep commented on hopefully we're getting to a call on so that we won't even ask if the pandemic is going to influence for our accrual just feedback to the routine business.
So far so good and we'll see how we go but we're on track.
Okay.
We think the pandemic has affected prevalent.
Ed.
Has it affected the prevalence.
Has there been.
The increase mortality.
I guess thats ability really to infection and mortality.
On ph patients.
He might have.
The impact on your answer.
Yeah, obviously, it's a vulnerable group that's for sure what I can tell you from our own experience and without generalizing across.
From our programs for patients on trial.
We havent seen on <unk>.
Patients are fine and not succumbing to the pandemic to COVID-19.
We still have over 90 plus percent who came into open label on open label. So they are able to both the access on medicine and manage through it.
So interesting question as a trusted with vaccination strategies.
Pulmonary and good management, hopefully that can minimize that but Ah interesting question, but we're not seeing that effect on our expense.
Great. Thanks for taking my question.
Thank you Eric.
Your next question comes from the line of <unk> with <unk> Leerink. Your line is open. Thank you very much on cash.
I appreciate taking the questions.
So for keeping on the theme of Stella.
Some of the relatively small study.
280 for patients. So I know you're very confident about the effect that you saw.
On the Pulsar study.
But it is absolutely clear that you won't need any of the experience for patients observations our experience from Hyperion.
For regulatory approval in the U S or Europe.
That's the first question and then I just wanted to follow up on the frontline.
It was part of that study in Mds.
Could you comment on how recruitment is going because you pointed out.
Mds patients are not seeking medical care, so I'm wondering what's happening for that trial.
Lastly, Jay could you just talk about what proportion of newly diagnosed Mds.
<unk> patients are going to be transfusion free on April.
In the control arm and then what do you have to show in the active to achieve superiority banks policies for other questions.
Okay, well, let's start with six minute walk, yes Shelly.
Yes. Please.
Yeah, So I'll start with the six minute walk distance.
As I mentioned, Jeff we can.
Cook full advantage of being granted breakthrough therapy designation in prime and so we have discussed.
Not only <unk>.
Stellar, but the entire program with the health authorities and we've aligned with them that the.
Primary endpoint, which is a measure of functional benefit six minute walk distance is an acceptable regulatory endpoint. So we've got that alignment.
In addition, we discussed all the other secondary endpoints included in that so that I think as to the good.
Also to recognize you put the totality of the information together that we have when you look at pulsar now with the additional crossover patients. We have spectra. So you were adding a body of evidence within the clinical parameters. In addition to stellar and then when you bring on the other programs of course over time, we will have all of that.
So straight answer, yes, acceptable regulatory endpoints and we serve you socialized.
With commands I think it's you know, it's like anything our BMS partner on running those programs there, they're working to get to completion of the study so far.
Have some effects on the pandemic back in March.
BMS took a decision to close the program for a period of time, but they have since reopened or adding additional centers. So they are pushing a lot to actually get patients on.
It's a fairly narrow patient population and so that has been principally the challenge of accrual.
Nonetheless, there isn't there's clear interest in getting patients on the trial.
Then with respect to your last question about what to expect.
Recall that this for patients that still require transfusions.
We are stratified by Epo levels, and if you look at the publications that were out in the last.
The last two years or so from plots Becker and for now.
For the Msas in settings, where patients start to begin to get transfusions.
And for particularly once they start to get Epo levels above 200.
But it does not work well.
Best you begin to see even in the best of circumstances is something in the 15% to 20% range, but quite honestly once you get over Epo levels of 200 day.
Don't get transfusion independence on on an Esa, it's just not doesn't work well.
So for the trial is really looking at that population and then if you take a look at the data that we have the force patter step even if you take a look at the data that we have on the medalist study where patients who are in that two unit range at the beginning we had over 80% of those patients achieving transfusion independents, which is really quite durable.
So without going into more detail on the stats, Jeff I think those two kind of bookends. If you can give you some sense of what to expect for the probability of success on that spend.
Great. Thank you Jay.
Thanks, Jeff.
Your next question comes from the line of Aegon at some of it with Citigroup. Your line is open.
Alright, thanks, very much for taking the questions I just had one on the on a stretching for any or can you describe what you're hoping to see in the phase one on <unk> data in patients with <unk> that you believe will meet the objectives for the target product profile for this program.
Okay. Thank you for your question you got all I'm going to hand that over to Jay as well.
Yeah. So we designed it is a one day and we haven't really gone into a lot of the details. So that's going to be my teams are to come to R&D day, we will get into further but just to kind of frame it.
I think what's really going to be important for us on that opening setting is to be able to identify our go forward dose. That's the one day portion.
And you know to try to define that in a quicker manner as possible and so there's a number of ways to do that.
It will be rich and clinical pharmacology PK PD parameters biomarker to look for target engagement and I think we do have clinical endpoints in there that'll give us some guidance as to what we anticipate as we go into the phase two.
But really it is trying to get to that place, where we feel good about a dose on it.
Final extrapolate back to what the Clinton farm team did with Patterson and we need to give them the same opportunity with some data to generate it.
This preceded me coming into the company I was very impressed.
With their understanding of what they saw on their PK PD modeling they predicted that 0.3 and seven would be good doses and they respond on both active doses. So we're going to look for that on the one day and then based on that one day.
I always say that you know the.
The most critical step moving forward into any development program is getting the dosing schedule right and once we've established that then we have some latitude as to where to go on how to run and so that will position us nicely for the phase two so we're getting the centers opened at <unk> will be absolutely critical.
It's a cohort type study and affords us the opportunity as we see things that we can share.
Prior to that but right now we're in that study startup phase so no data to share yet and we're getting the spin ready.
Got it thank you very much Jay.
Thank you Hugo.
Your next question comes from the line of Combing, Ken Kim with Goldman Sachs. Your line is open.
Hi, I was wondering with regard to Hyperion and plane is time to clinical worsening.
The natural history for the population of patients that you are going to be enrolling into that study.
Yeah. Good question, we take a look at that there's been some recent.
For several studies that have looked at this upfront population, we've selected out an intermediate and high risk cohort.
And the way this is defined as net from newly diagnosed patients. If in fact, you can achieve goal, which is really getting them under control until like functional class one if possible on their high risk for such events and between 20, maybe 30% a year on it really depends on the population for higher risk patients companies. So well if you look at the <unk>.
Data out there principally the time to clinical worsening is.
Have a composite endpoint. So that does include all cause mortality.
Fortunately with.
With the number of therapies out early lines of treatment.
Or not the most common event that's fortunate.
But hospitalization because of worsening in some other the other criteria typically be the ones that tend to drive it we've.
Deliberately selected this population because it's enriched for pompe patients that should have such events and quite honestly Theres. Just recent publications out where the field is hungry to get these patients under control. There's a there's a strong desire to do it.
Believe that the pulsar data showing that we can add on top of in spring advantage for patients, particularly if you look at that PDR reduction that is a really good goal for patients upfront to be controlled.
So like the trial, we are working hard to get it open.
That's what to expect so.
Oh, yes about patient care.
They need rescue.
That's helpful. Maybe just one more point of clarification, you mentioned earlier that you had for about 20% of patients and keep for her.
Populations at 25% now is that with respect that total pension.
On the other sale or is that new patients coming on therapy.
Yes, I know that's with respect to the total population on represent with MBS because don't forget we still have a portion of the population that's on beta.
Beta thalassemia in United States as well.
Okay. Thank you.
Your next question comes from the line of Atlanta Shell with Oppenheimer. Your.
Your line is open.
Hey, good afternoon, and thanks for taking my questions and thanks for the color. We appreciate the publication on the Pulsar data on in England Journal I wanted to ask for in terms of the safety profile you can see on hemoglobin increases on the patients want to ask maybe question for James just in the context of the periods for patient population.
If you think about potential for licensing hemoglobin any concerns about the inconsistency of the predictability on any possibly for monitoring requirements that might come in for patients who go on to partnerships with George Thank you.
Yes. So let me just start I think Paul Star Wars was quite instructive for US as you know with Patterson was.
Worked actually on it in 2008, when I was at Celgene for Mds, So that it that it has an effect on hemoglobin is expected as part of its profile. When we take a look at the data that we presented its share in the range of one two to one five grams per deciliter. So the magnitude of that change is not dramatic.
And in fact actually you know a number of therapies DRA have anemia associated with it. So I don't think it'll be something that most patients will be concerned with.
And frankly, it's probably not going to be anything looked at is that is anything but a potential benefit of the patients where we.
Potentially have to think about it is those that are really at the upper end of normal that are running already with high hemoglobin <unk> touch.
Touching that up and getting that up a little bit higher would certainly require some potential monitoring in those patients. What we do know is that this isn't something that continues to rise steadily dose after dose.
Actually with our strategy of $3 seven we attenuate the effect and then usually by the second or third dose you don't see any further increases. So this is just it's present easy to take to look at patients who are already considered being managed for anemia potentially because of some of the other therapies. So.
I think it's kind of can be woven neatly into routine.
Care for patients, which is for kind of what we're replicating on our study.
Thanks, and then just a question in terms of you know for.
Further indication on potential.
What's your pipeline I mean, obviously, a logical do with.
This mechanism and pathway.
On the fibrotic indications and so forth.
Just wondering if maybe you habib.
Allude to any further development plans that you may have somebody can just wait for the LNG to COVID-19.
Sure.
Pulmonary or outside about what can you may be looking at to do once you go for it on the R&D side.
It's a great. It's a great question so.
So I guess, the first thing I would say that.
And everyone that the licensing agreement for <unk> with BMS allows us to develop and commercialize across all areas of pulmonary hypertension. So we've talked quite a bit today about.
Functional classes.
Within.
One pulmonary hypertension or ph.
But we've always just be have a tremendous amount of work that we're going to share.
At R&D day in terms of our findings pre clinically and group two pulmonary hypertension, it's basically ph for the <unk> left heart disease, and you didn't hear about our clinical development plan and where that confidence is coming from in terms of that path forward.
Based on other opportunities within pulmonary hypertension, including group three and beyond.
We're not there yet.
In terms of the robustness of our fleet preclinical work to be able to share make any commitments, but we're obviously exploring that heavily and so yes.
We.
Try and make the R&D day, where you're going to hear a lot more not only about group one but also specifically about group two pulmonary hypertension and for Datacom.
Revenue.
Stay tuned for that thanks for it.
Great.
Your next question comes from the line of Kennan Mackay with RBC capital markets. Your line is open.
Hi, This is Michael Murray on for Kevin. Thanks for taking my questions on the <unk> launch I know commercial is out of your hands, but what are you hearing from the boots on the ground.
Whereas the remaining low hanging fruit so to speak from a sales and marketing perspective.
And then just another quick one how do sales breakdown between current Mds and beta Thal markets on where do you think is the larger near term growth opportunity. Thank you.
Yes, great well.
Let me start off Michael by saying and commercial.
It's not out of our hands it predominantly India NSE fans worldwide, but in the United States and in North America, We do have the opportunity to co promote in the U S. Now with the first launch.
We have 20 commercial people in the field.
That are funded by BNS under the leadership of Jay Kengo, Our Chief commercial officer, and perhaps he can give you some from live color in terms of answering some of the questions that you got to James.
Yeah, absolutely. So if I understood. Your question you were trying to kind of get a sense of stupid low hanging fruit and.
The second question was a little bit with regards to.
The split now maybe I can take the second part for US, we don't really kind of a breakdown the sales as to how much of the revenue today is coming between the two indications that we have which is that transfusion dependent beta thalassemia as well as the risk.
Rs positive Mds patients right. However, what I can tell you is you can almost sort of imagine that largely speaking the cohort of Mds patient population is significantly lower.
I'll say the data tell us female patients and we can resume some of us to the tune of the low risk Mds patient population in totality is about 20000 in the U S.
Buying close to 40000 between U S and Europe, which is the low risk patient population.
If you think about the beta thalassemia patient population in the U S, particularly that is transfusion dependent.
I have about 1500 patients you can almost assume that the majority of the revenue stream at least in the United States, which right now is the bulk of that evolution is going to come from MDI. So hopefully that gives you a generic but a pretty reasonable framework of how to expect now.
Hi, My first question was the low hanging fruit on the commercial where do we see growth is how I kind of assume that's the question.
We do see a lot of growth still continuing in the Mds segment, because we haven't yet.
You know capitalize on all the patients that are earlier in the patient journey as Habib and our peers at BMS have quantified in the prior set of conversations. So we do believe that we can still sort of.
A larger segment of earlier lines of Esa treated patient population similar to what we have created in our phase III Registrational study and that should drive for the growth within within the second half of the year and moving forward. So hopefully that gives you a line of titles from.
Yeah that Ed Thank you.
Great. Thank you Michael.
We have reached the end of the Q&A session I would like to turn the call back Doug Sullivan CEO Habib Dudley for closing remarks.
Thank you operator, thanks, everyone for joining us today I'm very much looking forward to connecting with many of you around Etfs in the next few weeks as well on during the virtual R&D day in June and in the meantime, if you have any questions. Please feel free to reach out to Todd or Jamie.
Meantime, I hope everyone continues to stay safe and healthy and wishing you all a great evening.
This concludes today's conference call. Thank you for participating you may now disconnect.
[music].
Okay.
Yes.
[noise].