Q1 2021 Transmedics Group Inc Earnings Call
Yeah.
[music].
Yes.
Hello, everyone. This is the operator todays conference call is due to begin shortly until such time there of language on me on music hold. Please continue this time by you. Thank you for your patience.
Once again to the conference call is just the begin sharkey until such time. Your line will mean on music hold. Please continue at this time by rethinking of our ERP.
Okay.
Sure.
Yes.
Yeah.
Okay.
Okay.
Okay.
Okay.
The <unk>.
[music], Inc.
Yeah.
Okay.
Yes.
Okay.
On a year.
Yes.
Hi.
No.
On.
From Goldman.
And on.
Given the guidance.
Okay.
Right.
Yes.
Hum.
Okay.
Okay.
Good morning.
Sure.
On.
[music] line.
Moving on.
True.
Okay.
Yes.
Yes.
On the.
Moving on.
[music] assets.
On that.
[music].
Okay.
[music] zone.
The unit.
The <unk>.
Moving on.
All of them.
Okay.
As of June.
Okay.
[music].
Okay.
Yes.
Okay.
Yes.
Okay.
True.
[music].
Your line.
Okay.
Okay.
The man.
Sure.
Thank you.
Okay.
The priority.
Okay.
Okay.
Yeah.
[music] range.
Thank you.
Okay.
Okay.
The UCB.
[music] on.
Yes.
Thank you.
Moving on.
[music], Inc.
Okay.
Yes.
[music].
Thank you Damian.
Yes.
[music].
Thank you.
Sure.
Okay.
[music] cash flow.
Okay.
Moving on.
Okay.
In the range.
Okay.
Net.
[music].
Thank you.
Based on them.
[music].
Yes.
[music] index.
Okay.
Yes.
Okay.
[music] cash.
Okay.
Good day.
Yes.
[music].
Good afternoon, and welcome to the tranche Mavericks first quarter 2021 earnings conference call.
At this time all participants are in a listen only mode.
We will be facilitating a question and answer session towards the end of today's call.
This call is being recorded for replay purposes.
I'd now like to turn the call over to Lynn Lewis from the Gilmartin group for a few introductory comments.
Thank you earlier today transmit ex released financial results for the quarter ended March 31, 2021 copy of the press release is available on the company's website before we begin I'd like to remind you that management will make statements. During this call. The include forward looking statements of the meaning of the federal Securities laws, which are made pursuant to the safe Harbor.
The private Securities Litigation Reform Act of 1095 any statements contained in this call that relate to expectations or predictions of future events results or performance are forward looking statements.
All forward looking statements, including without limitation, our examination of operating trends the potential commercial opportunity for our products and the future financial expectations, which include expectations for growth on our organization regulatory approvals and reimbursement and guidance and our expectations for revenue growth margins and operating expenses in 2021 are based upon our current.
Estimates on various assumptions. These statements involve material risks and uncertainties that could cause actual results or events can materially differ from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements for a list and description of the risks and uncertainties associated with our business. Please refer to the risk factors section of our annual report.
Port on form 10-K filed with Securities and Exchange Commission on March 11, 2021 transmitter.
Synthetics disclaims any intention or obligation, except as required by law to update or revise any financial projections of forward looking statements, whether because of the new information future events or otherwise. This conference call contains time sensitive information and is accurate only as of the Lifelock have today may four 2021 on of that I'll now turn the call over to Waleed Hassanein.
President and Chief Executive Officer.
Thank you very much Lynne and sorry, everyone for the technical difficulties early on.
Good afternoon, everyone and welcome to the transmit ex 2021 first quarter earnings call.
Joining me today is Stephen Gordon, our Chief Financial Officer.
As we stated on our last call. We are expecting several catalysts in 2021, which we believe will set a strong foundation for long term growth for transplant.
The positive FDA panel vote to approve our current DVD PMA indication was the first catalyst to be achieved this year and we're looking forward to many more drought this important year.
Today, I will be covering the following five major topics on our call.
First a summary of our financial results for the quarter.
Second the progress achieved across our key strategic initiatives.
Third.
The commentary on our Ocs heart panel meeting results.
The status update on the upcoming catalysts in 2021 and their potential impact on our business and then finally I will discuss expectations for the remainder of 2021.
Starting with the first topic.
Net revenue for the first quarter was $7 $1 million, while while our overall revenue declined roughly 6% year over year. It is important to recognize that our U S business grew 11% despite minimal contribution from ocs liver due to the completion of the cap enrollment.
We are encouraged by the growth in our U S business and the continued recovery in the U S transplant activities.
S revenues continued to struggle due to the COVID-19 impact on transplant numbers and the overall disruption throughout the European hospitals.
We are laser focused on our key strategic initiatives, we outlined for 2021 to help drive growth for our business.
Which leads me to the second major topic to discuss.
In the first quarter, we made meaningful progress across all strategic and operational initiatives for transplant.
Let me start by the describing.
The status of the National Ots program.
We continue we're continuing to build of leverage this program as we expand our reach throughout the United States, while increasing awareness about the clinical and financial benefits amongst key national transplant stakeholders in Q1, we expanded and initiate the clinical activities in two new regions in North Carolina.
And Arizona.
Bringing the total to six initiated regions in the U S.
We're actively engaged with several new opioids to meet our stated goal of being active in 10 regions by year end.
We also held three webinars targeting lung transplant programs across the U S to market the National Lgs program.
We will continue to hold each webinars throughout the year to maximize the awareness and address any potential hurdles for broader adoption of this approach.
Meanwhile, we're continuing to build the necessary infrastructure and resources to ensure the long term success of this important program.
We expect this to continue throughout 2021 of into early 2022, as we add additional Oregon, and new service capabilities and new clinical indications.
As we've stated previously.
We strongly believe that the national Ocs program will be an important long term driver for ots, the utilization and revenue growth in the United States.
Moving now to our second initiative, the Ocs liver PMA.
We've been actively engaged with FDA on this important PMA and we look forward to holding our ocs.
Liver advisory panel in mid July.
Given the proximity of the penalty the FDA.
Now of questioning the timing of approving the second tranche of the Ocs liver cap.
Actively discussing this issue with FDA and hope to reach of a solution in Q2.
This is really a bigger suites of situations where in one hand, we are thrilled to have the panel date that soon.
However, it seems to be negatively impacting the cap approval and its associated revenue in Q2.
That said our focus has always been and remains on long term success, which we which will benefit from current panel of timing.
The increases the confidence and the potential approval before year end.
Our third strategic initiative was advancing the Ocs heart DCD indication.
As you know we've completed our 180 patient randomized Ocs DCD heart trial in 2022 and 2020.
With 90 of those 180 patients were transplanted using DCD heart almost yes.
We remain on track for the top line readout of this important program in Q3 2021.
As the end of Q1 that or the typically on April one we have the old 46, new additional DCD heart transplants.
Cases, using the ots system and the DCD Heart continued access protocol.
Finally, our fourth strategic initiative was the Ocs heart DVD PMA.
We finally completed this important milestone with a strong favorable panel vote for approval of the Ocs heart DVD indication.
Now.
We are focused on turning the success into an approval decision in 2021.
Please allow me this opportunity to cover the third major topic and clarify and discuss few observation from the panel meeting.
First the.
The key theme of the panel discussions were fully expected and we're not surprised for transplant ex.
Importantly.
We were prepared to address every major topics raised by FDA.
Second many of the comments the team controversial came from panelists with limited or no heart transplant experience.
So of the ultimate impact may not be as relevant as one would think.
Third range.
Made it to the label, we believe that the data the clinical evidence from expand on cap support an appropriate label for the Ocs heart DVD indications if approved by FDA.
Importantly, we must remember that the ots label language in our PMA are never static.
And they are typically evolve given the fluid nature of our multiple concurrent indications.
In the same Oregon transplant market.
For example, the label language will have to be updated with the DCD heart indication approval in 2021, I'm, sorry in 2022 and.
And with the results of our post approval study for the <unk> indication.
Fourth the post approval study, which we proposed.
In order to continue to build evidence in the real world setting and enabled the potential expansion of our indications to support our leading market position.
We're supported by a leading U S academic heart failure, cardiologists and surgeons to design a robust post approval study.
That is practical.
And easy to implement.
Finally, I'd like to clarify and reiterate that transmit ex conducted an extensive preclinical testing program with tens of animal studies supporting the safety of the ots purchases.
Importantly, we need to remember that we have transplanted more than 1100 human hearts across the globe, both from DVD and DCD human dorms with excellent clinical results.
Now, let me move to the fourth major topic that I would like to cover and provides the status update on our five major catalysts for 2021.
Importantly, I want to highlight the potential impact of these catalyst on our overall growth trajectory for the foreseeable future.
The first catalyst we expect.
Is FDA approval of the Ocs heart DVD indication.
We actively engage with the FDA to hopefully drive to a regulatory decision over the next few months.
In parallel we are continuing the preparation for the commercial launch of the Ocs heart.
Pending the FDA approval of course.
Specifically.
Sure.
We are engaged with the.
25 heart transplant centers that are currently active in our DCD cap program, given the clinical experience with the Ocs heart in the DCD program.
Were planning and preparing to leverage our infrastructure to add the Ocs heart of our Nashville Lcs program in the regions, where we're active in once the FDA approval is enhanced.
Finally, we're working with our Kols the design of robust post approval registry that is practical to implement and to scale.
The second potential catalyst is the ocs liver panel meeting and subsequent FDA approval.
We are looking forward to.
True conducting our ocs liver panel meeting in mid July.
Which would position us.
Well for potential approval and launch in Q4 2021.
Similar to the Ocs heart.
The activity engaged with all the liver centers in the U S to prepare for this potential approval later in 2021.
We're planning to add the ocs liver the on naturals, yet the program regions. Once the FDA approval is enhanced.
On another note the full ots protect trial results with one year follow up will be presented at the plenary session on presentation at the upcoming American transplant Congress in early June.
We'll announce the exact date and time once the program the finalized.
The third potential catalyst is the readout of the top line data from Ocs heart DCD and the filing of the PMA supplement.
This has been targeted for Q3 2021.
And we believe that we are on track to achieve this milestone.
This clinical indication would be.
Filed under of breakthrough designation and we are optimistic that it will support at the approval in 2022.
The fourth potential catalyst is the expansion of the Ocs National program could cover at least 10 major regions in the U S and it's been the good coverage for.
For heart and the.
We are on track to meet to meet this milestone.
By year end.
The fifth and final potential catalyst is the publication of the Ocs liver and Ots, DVD and DCD trials data and high impact medical journals.
Again, we're on track to achieve this milestone. These publications will be critical drivers. These publications will be a critical driver for broader clinical adoption of the Ocs technology and the transformation of the clinical standard of care globally.
Now, let me finish with the summary of our expectations and thoughts for the remainder of 2021.
COVID-19 and its new variants domain of threat to transplant activities normalization in the near term.
Day, we see this impact more pronounced internationally and specifically in Europe.
In terms of transplant volume.
So far U S transplant activities continued to recover with lung being the final Oregon to recover from volume perspective, we're still at least in Q1.
The way between 2% to 3% below last year's volumes.
We expect and hope that this recovery would continue barring any new peaks emerging in the United States.
We view the timelines for major FDA regulatory decision on the Ocs heart and Ocs liver.
Pension the limiting our ability to leverage cap programs to grow our revenue in the near term from these programs.
However, we expect approvals to be of major catalysts to drive revenue growth in the U S. In late 2021 and beyond.
Specifically, the FDA hesitation on liver cap second tranche of approval due to the eminent panel date.
Negatively impact our ability to generate revenue from deliver cap in Q2.
We remain laser focused however on our fundamental goal of ending 2021 with all three major transplant indications approved by FDA, which will be a huge driver for revenue growth and streamline our revenue trajectory for the future.
Given the current uncertainties in the imminent FDA clean the key timelines, we will not issue financial guidance for 2021 with the.
I will turn the call because Stephen Gordon, our Chief Financial Officer to review, our detailed financial results for the quarter and the full year.
Thank you Ali.
I will now provide some additional detail on the Q4 results.
Other financial information for the quarter.
For the first quarter of 2021 gross revenue was seven $6 million the <unk>.
Net revenue was $7 1 million.
Net revenue decreased by 6% from the first quarter of 2020.
However in the U S. Our gross revenue was $6 3 million of net revenue of the spots of 8 million of use.
Net revenue increased 11% from the first quarter of 2020.
The Oregon breakdown of U S. Net revenue was $2 3 million of Ocs lung three.
3 million negotiates hard line.
<unk> 4 million of interest liver.
Ex U S revenue was $1 $3 million, let's go out of $1 million from Q1 of 2020 from included 1 million of especially the small and one 2 million for both of his heart.
The key driver of Q1 revenue performance was strong she is low.
So the heart sales in the U S. Reflecting the continued recovery of U S sales productivity.
But the completion of the ocs liver protect up in the lower transport of activity outside of the U S were headwinds for the quarter.
Gross margin for the first quarter of 2021 was 68% compared to 65% from Q1 last year and 63%.
Last quarter.
In line with our state of the expectation of the increasing gross margin.
Total operating expenses for the quarter of 11, 3 million, which was down 12% from Q1 of 2020 and up 6% from the fourth quarter of 2020.
While limited travel and other spending due to COVID-19 or still impact the cash building. We have continued to invest in growing our industrial sales progress.
Our operating loss was $6 $5 million on the first quarter of 2021 compared to $8 million from the first quarter of 2020.
And our net loss for the first quarter of 2021 was $7 9 million compared to the eight point logo of the first quarter of 2012.
Finally cash cash equivalents of marketable securities look of the wall Securities were $118 $1 million as of March 31st total one.
If we could show a reduction of $7 5 million from the balance of the end of FY 'twenty.
The weighted average common shares outstanding for the quarter were $27 4 million.
Just confirming while each comments, though through the current uncertainty we are not providing guidance for 2021 of the chipotle.
Well I would like to turn the call back to all of you propose on coverage.
Okay.
Yeah.
Thank you Steven.
While revenue is expected to continue to be impacted in the near term by the cadence of clinical trials on FDA review timelines, we're optimistic and confident in our long term prospects given our progress across all the growth catalyst in 2020 one.
We are advancing rapidly towards two major regulatory decisions on our Ocs heart and Ocs liver indications that would have significant commercial ramifications on our business and we will fundamentally alter our growth trajectory long term the.
Ultimate goal remains that we end 2021 with three approved transplant market indications in the U S.
And we remain confident that this goal is attainable.
I'm excited about it I'm excited about and confident in the future of our business as we continue to transform the field of organ transplantation globally, using our ocs technology platform with that.
I'll now turn the call to the operator for Q&A operator.
As a reminder to ask the question you will need the press star one on your telephone.
Question plans of the founder of <unk>.
The first question comes from the line of Robbie Marcus from Jpmorgan. Your line is now open.
Hi, Thanks, you've got some of the non here on for Ravi.
So firstly on the heart panel.
Just on your commentary there, but the help me understand a little better.
What's your sense of what needs to happen on what the when you expect the labels the look like.
From the panel the outcome and what you need in terms of addition.
On the trial, you mentioned to potentially get the the extended criteria the selling.
You kind of talk through some of the puts and takes here.
I think our label that will come out of this panel.
Help us cover all of the extended criteria that was studied in the expand trial.
We feel very confident about that.
We don't at this point, we don't expect to do additional trials to be able to get the label for extended criteria.
The trial I was referring to is the post approval registry. That's the part of the post market program that we have proposed to the FDA all along so you know.
I just want to clarify the label we are.
We are thinking of and speed.
Speaking about should be able to cover all of the extended criteria parts that were studied in the expand profit.
Okay, great. Thank you.
Then switching to the lung.
I know you saw on the previous quarter of some pent up demand from backlog to work through.
What are some of the commercial dynamics you've seen.
<unk> for the quarter any noise seem recoveries and broader med tech because of <unk> been seeing in the lung franchise and what day.
You expect.
Going forward from here we.
We expect we expect the lungs. The continued to recover it's still it's still lagging out of the true Oregon's, but it's it's coming close and we expect to see that recovery to continue.
As long as we don't get another COVID-19 peak.
The thing that we've been noticing more.
More of.
Transparently recently is there are more and more patients being transplanted.
After they've been suffering with COVID-19.
Younger younger patient profiles that are coming to the transplant waiting list in the acute.
The situation and getting a lung transplant.
Because they had suffered from COVID-19 on COVID-19 ended up completely destroying the lung function.
That's something that we are keeping our eyes on because that's the could create another another wave of pent up demand that could stay with us long term, but that's the only thing that's the only new dynamic that we witnessed in Q1 more and more patients younger patients non traditional lung failure patients are coming for four of <unk>.
Non transplant, because they have COVID-19 last year.
Great. Thank you.
Your next question comes from the line of the Cecilia furlong from Morgan Stanley. Your line is now.
Great. Thanks, a lot of.
You didn't see him for taking our questions I guess I just wanted to start with the service model could you talk a little bit more about the traction you've seen in Q1, COVID-19 kind of disruptive to a certain extent pathway. So I guess, just the value proposition right now and the world recovering from COVID-19 of the service model and then as you're thinking about.
The commercialization for heart, just how you rolled that out between your at the centers on the comp versus moving hard into the surface.
Sure.
So sitting here for the question.
So the first the first one relating to the National program.
We are as we stated before we're excited about this program we are we.
We think this program of you're gonna have a significant impact.
Sort of mid and long term on the adoption of our technology.
What we have done in Q1 is.
You know broadly disseminated the value proposition both clinically.
Economically financially.
And even.
No.
The work life balance wise in COVID-19.
Related impact wise too.
To all of the lung transplant programs.
We are seeing the traction starting to build we expect that traction to continue to build into Q2 and Q3 really I'm looking towards the end of this year to really have a palpable momentum that is generated from this program.
As anything.
Given the COVID-19.
Environment, everything is going to take a little bit longer than what we wanted to so.
Q1 was was that.
And early.
For us to see that momentum starting to build we need to be patient and the need to continue to.
Reiterate the value proposition throughout the next two quarters and hopefully by year end, we'll see tangible.
Evidence of that momentum building up and hopefully be reflected in our revenue relating to the heart commercialization Cecilia and trying to even will deliver commercialization. We can of followed the same path. We start with the active programs that have experience with the ots went up through the cap expand or weather or add to the.
On the 25 ETD programs given the fact that yes, we have been active only in the DTD, but now the understand the value proposition of an Ocs heart.
And we focus on those first and then on top of that we lay out the the National program, we envision ourselves to continue to provide flexible.
True flexible.
Mechanisms for adoption of our technology through the direct acquisition and the National program at least throughout 2021 and the into mid 2022, where one or one or both we will declare themselves as we have to continue that way, so where we're staying flexible we're enabling both the Mac.
<unk> to drive adoption.
On one that disrupt the.
The adoption curve early on but we think the this this is going to be different on the lung for all the reasons, we stated several times before.
Thankfully and I guess the changes.
Alex Yes, DCD Hearts of findings in the first quarter can you just talk about I'm trying to decide on.
On COVID-19 headwinds listed on just really what you were saying at the end of the quarter end to end of the April timeframe, just from the cadence standpoint, and then on.
Just on leverage as well on when we could hear of a bit more clarity on if the second tranche of consumers, who just progressed to the panel and thank you sure sure. Thank you Cecilia. So we're very we're very we're very bullish on the DCD Heart program.
The app for two reasons, one the numbers that the pace of enrollment.
<unk> is still at all time high.
Compared to any program, we conducted in the past, but what we've seen in Q1 that gives us even more confidence on more.
Excitement is that now we're not we're no longer limiting or would no longer limited or focused or concentrated the enrollment in the hands of the top three of four leading centers now we're seeing distribution of the enrollment cleaning deep into the 25.
<unk> across the 25 centers, which is very exciting price and we're seeing centers that are sort of medium volume transplant programs really doing quite a quite a number of cases in Q1 two.
That would meaningfully impact their total volume.
And when you look at the.
The macro level, we track this on a quarterly basis in the U S. In Q1 day was approximately $65 or 70, New Hearts were additional heart transplanted compared to last year Q1 of.
Those 45 were in the old yet.
Because they were DCD Hearts. These are new hearts that otherwise would not have been transplanted. So the ocs contributed to approximately 50 or 60% of the growth of heart transplant in Q1.
So thats very exciting for us we expected true.
We hope and we expect this trajectory to continuing to continue.
On the heart from relating to the liver cap I think assets here, yeah, we're really cutting it very close here, we are doing our best trying to convince the FDA that the cap is important but also when you look at it from their perspective.
The panel is scheduled the mid July.
And by the time, we get approval, we'll be probably sort of early June may June so.
I think it will be very clear and during Q2, whether or not really.
We would have the second tranche from the capital would just kind of drive true through the to the panel just drive it to the approval from there.
So hopefully you will have that visibility within the next 60 days of yourself.
Thank you.
Your next question comes from the line of Josh Jennings from Cowen. Your line is now one of them.
Hi, This is Brian here for Josh. Thank you for taking the question I just wanted to start with the clarification on your comment on the liver cap.
I understand the view that approvals clearly outweigh the capex activity in terms of priority from the company, but what is the rationale you've gotten specifically for non increasing the cap given the data we've seen that.
Very favorable and don't raise any concerns about the safety or efficacy.
Brian that connects one question. Unfortunately.
You know the bad debt.
I can't comment specifically, but at a very very very very good.
High level the feedback we received the we're so close to the panel why don't we just go through of panel and get that get the approval.
So we're going back with some of the arguments you highlighted then.
And we hope that we will prevail and.
We'll wait and see in the next 60 days, but we completely agree with your with your sentiment, but also we see it.
See where they are coming from so but there's nothing there that we're aware of that gives us any pause or concern.
The data is very strong the.
We are as confused by that feedback as you are but also we understand how close we are to cause the timeline for the panel.
Okay. Thank you and maybe changing gears to O U S. Can you just share the month to month progression of the trends you've experienced the recently and just whether you see that getting better or sort of staying the same.
Over the next couple of months.
Hey, Bob interest Steven the yeah. So if you look at the kind of where we are on the April we're definitely seeing some uptick in international.
Business, it's slow and steady.
I don't think it's a trend yet, but we definitely are seeing the come back from where it was early in Q1.
Yeah.
Hello.
True.
Yeah.
Operator.
Okay. Next question comes from the line of sales Slavonic from Canaccord. Your line is now open.
Great. Thank you.
The two questions just first is clarification on the.
The heart approval.
Do you have any FTE audits remaining to gain that approval.
Hi, Bill no we passed.
All of the audits with flying colors, a while back.
Okay, and then in terms of.
In the discussion on the label have you completed the label discussions is that push on for approval and then same question for the post approval study kind of where.
Where are you at right now and those of discussions right.
So build that's the great question no at this point we.
We.
We are focused on are waiting on them, making the final decision and once that is the decision is made the.
Two remaining profit is the P F.
Design and the.
The final label language.
So that's the sort of the two things that were waiting for.
Okay, and then if they.
Provided the timeframe or do you of the timeframe it would you'd expect to get the kind of final decision before you move on to the label even periods.
I think the time frames overall timeframes are the same that we've communicating pre panel, which is three to four months from panel date and I believe the toe to the same timeframes that will hold given our.
The recent discussions with the with the FDA.
Okay.
All right.
And just again it was in your prepared remarks, Merck should confirm that because that can I ask you to go back and do any more animal testing or anything of that nature.
Yes.
The requirement for the approval I don't even know if they can but of the high again, so the bill.
Bill.
There's some I cannot predict what the FDA is going to ask for Mike.
My remarks were in the remarks I made on the panel date.
Is it significant.
Miss characterization here there are tens of animals of data really closing hundreds of animal data that was submitted.
For some reason it was not reflected in the pound discretion, we have access to all the data and all of the results address the question that was raised at the panel date, that's what gives us the confidence. So that's one aspect of the answer is the second aspect of answers as we all know the FDA always prioritize.
Human data of our 80 preclinical testing so we feel very confident that well.
Wherever misunderstanding of mischaracterization of and we can clarify given the data that we have access to.
And.
That's that was really the key.
Comment on the better Mark I was trying to get across that we feel very confident of our position with our preclinical program with our preclinical data.
That would help address any.
Open the remaining questions by FDA and the fact that the.
Statement at the panel date was not accurate or correct given the significant number of animal studies that were presented and submitted in the PMA.
Okay. That's really helpful. Thanks, and then second question.
Just on the <unk> program you provided about the granularity. Thank you.
Yeah.
And any.
Any kind of color around the first site the signed up.
On the first and second sites signed up kind of what Youre seeing in terms of traction I appreciate that youre now up to six but its really speaking of some kind of looking for of those first one or two.
What is the sun for their business have the double what they are doing it tripled or are they just getting going I'm just trying to kind of get a feeling for maybe what this can do once you get this expanded to more players and what the timing for that is.
Sure.
Bill that's of Great question, I think what I can share publicly is the following.
That all of those six.
Thank you.
The the older four alright, I would take four out of the <unk> have seen the valuables, yes with the lead cases that otherwise they would have never transplanted.
And obviously with the various magnitude, meaning one opioid did five cases on other opioid. The two one did wanted just because of the the vintage of them joining the program, but I can assure you of that four out of the sales have seen the value in their own.
Fear.
And the AUM business.
What's the ots can do to get more lungs transplanted.
One of the other two have seen it but it hasn't materialized has seen the value of taken rungs at all she asked but it hasn't materialized yet to transplant because you werent the.
Two are the two new.
Opioids that we're working with and one of these remaining to see the CN a.
The successful case, given given just at the most recent one so.
We expect that to continue and that's why I'm targeting year end, where we hopefully can have a critical mass that we can report to and maybe even begin of trend going forward into 2022 about how are we on attractive.
But right now I need to protect this program allow us the time to mature.
And allow more opioids critical mass of opioids to be involved in so we can really see the.
Aggregation of results.
And track it.
That way by year end.
Okay, great. Okay. Thanks, really appreciate taking the questions.
Your next.
Question comes from the line of <unk> <unk> from Oppenheimer. Your line is now open.
Good afternoon Wahid Steffan can you hear me all right.
Can you just try and trust perfect. So will lead the few questions. Let me start out with the DCD trial volume to remind me. It's the non inferiority trial and there is no hierarchical analysis with speed of you already relative to cold storage right.
Not not.
So it's Raj. This is the DTD trial, so, we're appearing apples and bananas.
Right and.
Meaning.
Cold storage standard criteria of Hearts.
The the design was with always the non inventory already.
Because the our hearts that otherwise would have not been transplanted.
It's highly unlikely.
I would stop here.
So that's the design.
We actually.
Question, the validity of of doing the randomized trial for this for this indication and we wait and see what the result shows but on.
Our expectations is that we.
The design is what it is which is an atmosphere of a trial.
I don't remember Suraj, if we have the testing for superiority of not usually when we have the non inferiority we need.
The non inferiority, we test for superiority, but I don't have the answer for that I need to.
I'll follow up with you offline to get to get you the exact.
And so based on the protocol.
Got it.
So well either in terms of liver.
The has seen the top line data on liver.
And just following up on the on.
The heart panel.
Was wondering if you could you could walk us through is the something of the data on below the top line. The PMA was filed correct me if I'm wrong Q2, 'twenty 'twenty sort of FTE has been low.
Looking at the state of for a long period of time is there something in your view.
Net.
Could again be a hiccup for the FTE on the liver site.
Suraj I cannot predict to what could be a hiccup for EBITDA on.
On the <unk>.
Reputation.
All I can assert is the following our liver data is the peanuts.
And the highest number of statistical superiority endpoints that we've ever achieved in any trial was conducted in the history of transplant ex.
I'm sure the FDA.
Pick on something that the key relevant but from a clinical perspective from an implementation perspective.
We feel very strongly that our liver data.
What I just described ex the <unk>.
Cleanest, it's the highest rate of endpoints achieving statistical superiority in any trial we've conducted.
Got it and it will lead one final question and I'll hop back in queue.
The panel the heart panel on.
I'm just trying to get the practical assessment of the feedback youre getting from the ground post the heart panel, how many new centers to your ex.
Expect.
To add in the U S heart centers in the U S and O U S. Once you'll get the DVD approval.
And heart. Thank you for taking my questions.
Thank you Suraj I think once FDA approval is in hand, I think we're targeting anywhere between.
25 to 30 hard launching.
Sites be sort of a 25 DCD heart.
Sites plus the.
The five that we're involved in and not expand on cap.
On that.
That would be our sort of the low hanging fruit.
Okay, I don't see any questions at this time of obtaining the whole thing back to volume for any closing remarks.
Thank you operator, thank you everybody for joining us on this call and we look forward to our next call have a wonderful afternoon bye bye.
This concludes today's conference call. Thank you for participating you may now disconnect.
Yeah.
Okay.
Okay.
Zero.
Good day.
Yeah.