Q4 2020 Transmedics Group Inc Earnings Call
Okay.
Ladies and gentlemen, thank you for standing by and welcome to the trends metrics Q4, 2020 earnings conference.
All participants are in listen only mode.
Yeah.
After the speaker's presentation, there will be a question and answer the question Sheila.
To ask a question. During this time you on each press star and the number one on your telephone keypad.
Please be advised the todays call.
It's being recorded any sort of a quiet any further assistance. Please press star zero I would now like to hand, the conference over to your Speaker today Ms. Lynn Lewis. Please go ahead ma'am.
Thank you.
Today, the transmit ex released financial results for the quarter and full year ended December 31, 2020, a copy of the press release is available on the company's website.
We begin I'd like to remind you that management will make statements. During this call may include forward looking statements within the meaning of the federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.
Shipments contained on this call the 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 our future financial expectations, which include expectations for gross in our organization regulatory approvals and reimbursement and guidance and our expectations for revenue gross margin and operating expenses in 2021 are based upon our current.
Estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to 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 uncertainties associated with our business. Please refer to the risk factors section of our annual.
The report on form 10-K filed with Securities and Exchange Commission on March 17th 2020, as supplemented by our other SEC filings, including our quarterly report on form 10-Q for the third quarter of 2020 turns medics disclaims any intention or obligation except as required by law the update.
Is any for any financial projections or forward looking statements, whether because of new information future events or otherwise. This conference call contains time sensitive information is accurate only as of the lifestyle cash today March 2nd 'twenty 'twenty, one and the fact, the country of the call of virtual Waleed, Hassanein, President and Chief Executive Officer.
Thank you so much Lynne.
Good afternoon, everyone and welcome to transmit <unk> fourth quarter and full year 2020 earnings call.
Joining me today is Stephen Gordon, our Chief Financial Officer.
I think we can all agree the 'twenty 'twenty was one of the most challenging year on many fronts and many of US were very delighted to see at the end.
Despite the significant challenges we faced in 2020 due to the global Covid pandemic.
<unk> made significant progress on many of our key strategic initiatives and.
And we ended the year in a strong position to capitalize on several of the upcoming catalysts in 2021.
I would like to cover the the the following four major topics on our call today.
First I will review, our financial results for the quarter and the full year.
Second I will review the progress achieved on our key strategic initiatives in 2020.
Third I'll preview of the upcoming catalyst in 'twenty, 'twenty, one and their potential impact on our business.
Fourth and finally, I would like to provide an overview of our strategy for 2021.
Yeah.
Let me start by summarizing our financial results for <unk> in FY 'twenty 'twenty.
Stephen will cover the detailed financial performance in his section of this call.
Our <unk> net revenue was $7 $6 million, which outperformed expectations and.
And represents 26%.
Year over year gross.
For the full year 2020, our net revenue was $25 $6 million, representing 9% growth over 2019 revenue.
Our overall growth was driven by approximately 18% growth in our U S business, primarily attributable to having all of our three ocs platforms contributing to our or you our U S revenue throughout the year.
Specifically, we had ocs DCD heart and Ocs liver programs active throughout 2020, as well as a recovery of our ocs lung commercial activities in the fourth quarter of 2020.
Overall, we are encouraged that despite COVID-19 related challenges throughout the year and the significant slowing of the transplant procedures in Q2 and early Q.
In the early Q3, our lung business largely recovered in Q4, and we ended the year on an encouraging trajectory.
We are now focused on leveraging the group foundation that we've established in 2020.
And pairing that with the upcoming 2021 catalyst to accelerate our future growth.
The 22 and beyond.
Let me turn to the second topic and provide a summary of the progress achieved in our 'twenty 'twenty.
Five key strategic operational initiatives that we believe represent a solid foundation for future growth.
First the National Ocs program.
In 2020, we launched and expanded our National Ocs program, which is designed to help transmit ex realize our vision to be the national exclusive provider for all ocs related organ retrieval and clinical management activities for transplant centers in the U S.
We started with the ocs lungs, and expanding it into heart and liver once FDA approvals are achieved.
We started 2020 with one active region in the Chicago area.
And we ended 2020 with four active regions across the U S.
Adding new England, Atlanta, and Dallas to the two of the initial Chicago region.
We plan to continue growing our regional coverage of debt of of the U S. Throughout 2021.
In addition to the regional expansion last year. We also successfully established a scalable foundation to help operationalize and scale the National Ocs program.
Let me share a few examples.
First we developed a new process for standardizing screening potential donors for suitability for Ocs lung perfusion of management.
We have established of 24 by seven digital screening ecosystem supported by clinical expertise to screen every potential donor for transplantation in the regions that we're currently active in.
This process enables us to be involved early and hopefully facilitate clinical decision, making downstream the other.
Ultimate goal is to maximize donor lung utilization for transplantation using the ocs platform.
Second we established a national network of surgical expertise that are contracted directly.
The <unk>.
Thereby supplementing our team surgical capabilities.
This is this was done to ensure adequate coverage of every potential donor lungs retrieval on the ots platform, while standardizing the quality of care and the Ocs surgical management.
Third in 2020, we also launched a broad awareness campaign.
Focused on educating every stakeholder within the U S transplant community.
Specifically.
We've targeted transplant programs, both clinical and administrative leadership.
Organ procurement organization administration and clinical leadership.
Payers, both commercial payers and CMS.
And finally, the organ procurement and transplant network or <unk>.
<unk> is the federal contract.
The entity that manages the overall administration of organ transplantation in the U S.
We believe the day National Ocs program is going to be a significant driver of our U S growth going forward.
The second major initiative is the ocs liver PMA.
As a reminder, we completed the data analysis and filed our liver PMA back in Q2 2020.
We have since addressed and submitted all of our responses to the fda's questions.
And as I'll discuss shortly we're currently working with FDA to schedule. The advisory panel meeting for the liver PMA, which will hopefully happen in the next several months.
Building on the clinical momentum of the liver ocs liver protect trial, we have completed the first tranche of Ocs liver cap late in Q4 2020.
And we are now in active discussions with FDA to initiate the second tranche of the Ocs liver cap, which hopefully will start in Q2 2021.
Our third key 2020 initiative was advancing the ots.
Heart DCD indication.
We completed 180 patient Ocs DCD trial in 2020.
We are now awaiting the completion of the follow up period for the primary effectiveness endpoint of six months patient and graft survival post transplant.
We expect the top line readout of this important program in Q3 2021.
As I mentioned earlier to continue to drive clinical momentum in this important program, we secured FDA approval for our cap program in 'twenty five.
Major transplant centers in the third quarter.
<unk> formally initiated the DCD cap enrollment in December of 2020 currently disc cap is actively enrolling and ongoing.
Our fourth initiative was the Ocs heart DVD PMA.
This is the initiative that suffered critical delays due to COVID-19 pandemic.
I am pleased and relieved to finally report that the FDA has completed the review process of the cap data and.
And the Ocs Heart panel meeting is now scheduled on April six 2021.
We're excited and anxiously awaiting this important date and remain confident in our results.
In our trial data.
And the our ability to articulate the clinical value of the Ocs heart system.
Importantly, we're extremely confident in our ability to address any fda's question.
<unk> or to the panelists.
Lastly, our fifth and final key initiative for 2020 was to maintain.
Laser focus on the ocs product quality and supply in the midst of a global pandemic.
Despite the unprecedented challenges due to the Covid pandemic the transplant X team did a phenomenal job true throughout the year and continuing to build and supply ocs life sustaining products across the world.
Importantly, we passed all quality system management, and international regulatory audits and maintained our certifications without any major issues.
This is a true testament to the quality of our team and their laser focus on supporting our ocs product quality to help patients and clinical users worldwide.
Now, let me turn on it let me turn to 2021 and the five major catalysts in front of US this year.
Importantly, I want to highlight the potential impact of these catalysts on our overall growth trajectory over the long term.
There's no doubt the 2021 is a defining year to lay a strong foundation for transmit X to have an accelerated growth trajectory.
<unk> for the foreseeable future.
The first expected catalyst is the ocs.
The Ocs heart DVD panel meeting, which is now scheduled on April six 2021.
We're actively preparing for the commercial launch of the Ocs heart pending FDA approval of course.
As a part of this preparation efforts we are engaged with all 25 heart transplant centers that are currently active in our DCD cap program given their clinical experience with the ocs during the the cap program.
Were planning and preparing to leverage our scalable infrastructure of.
Of the national.
Ocs program to add Ocs heart to our National Ocs program in the reasons. We're currently active in once the FDA approval is secured.
Finally, we're actively expanding our commercial and regional clinical coverage to accommodate potential increase in clinical uptake with the with the addition of the Ocs heart retrieval.
Overall, we're excited about where we are and hope that the next time. We are on this call. We will be reporting of positive panel of outcome supporting Ocs heart FDA approval.
The second potential catalyst in front of US is the ocs liver panel meeting.
We're looking forward to the Ocs liver panel meeting and assuming a reasonable.
FDA timeline, we're planning for Ocs liver commercial launch in late 2021.
Specifically.
Similar to what we're doing for the heart, we're actively engaged with the ocs liver transplant centers that are involved in the protect and the protect cap programs.
We're also planning to add the ocs liver to our active national Ocs program regions. Once if the approvals is in hand of course.
The third potential catalyst is the readout of the top line data from our Ocs Heart DCD.
The trial and the filing of the PMA supplement.
This is this milestone of this catalyst is targeted for Q3 2021.
This clinical indication will be filed under a breakthrough FDA designation.
And we are optimistic that it will support an FDA approval in 2022.
The fourth potential catalyst is the expansion of the Ocs National program to cover of at least 10 major regions in the U S and expanding it to cover not just the lung Ocs heart and Ocs liver indications once FDA approval of the secure.
Our strategy is to leverage the infrastructure of the National Ocs program, we initiated for the Ocs lung to drive efficient and more streamlined launch of the Ocs heart and liver across the U S.
We have begun the ramp up of the internal and external resources to enable us to capitalize on this strategy.
We plan to maintain maximum flexibility by continuing to drive adoption of the Ocs platform through two major commercial channels first the direct center acquisition and use model in this case the center with purchased the Ocs technology directly from <unk> and day will be.
Responsible for managing donor organ retrieval with the Ocs system.
The second channel is through the National Ocs program. This case, the transplant center would accept the Ocs perfused organs that were retrieved and managed by the transplant process.
Then the center will pay for the cost of the Ocs technology, plus additional service charges to transmit ex directly.
We're extremely enthusiastic about this program as it enables <unk> to be more integrated in the entire process of donor and potentially even the recipient screening to facilitate maximum utilization of donor organs for transplant, while maintaining a very high clinical quality of care.
The fifth and final potential catalyst in 2021 is the publications of Ocs liver Ocs DVD in the Ocs heart DCD trial data in high impact medical journals.
These will be critical drivers for broader clinical adoption of the Ocs technology and the transformation of the clinical standard of care globally.
Now, let me turn to the final topic I would like to cover on this call, which is our plans for 2021.
Based on all of the clinical and scientific facts, we're aware of today.
We remain convinced that COVID-19 and its new variants.
We remain a threat to transplant activity normalization in the near term.
Today, we see that impact being more negative on international and specifically European transplant volume.
We're monitoring the use transplant activities carefully and we expect that.
The debt.
The transplant activities in the U S to continue to recover that's of course barring another major peak on a new variant outbreak in the U S.
Given the timing of initiating the second tranche of our Ocs liver cap, which is now expected in Q2 2021, and the potential commercial launch of Ocs heart and Ocs liver later this year, we expect incrementally improving revenue performance as the year progresses.
We remain confident that we could end 2021 with all of <unk> III Ocs major transplant indications.
E lung heart and liver.
Transplant indications approved by FDA, which will be the primary driver of meaningful revenue growth in 2022 and beyond.
We're enthusiastic about the national Ocs program and its potential.
Two part to position transmit X is of critical.
Trusted national partner to manage all lung heart and liver <unk> and <unk>.
And Ocs clinical management in the U S.
<unk> is uniquely positioned to capitalize on this opportunity to redefining and establishing the new ecosystem of organ transplantation in the U S.
Given the uncertainty about the COVID-19 impact and the many FDA driven catalysts in front of US we will not be issuing financial guidance for 2021 at this time.
With that I will turn the call to Stephen Gordon, Our Chief Financial Officer to review, our detailed financial results for the quarter and the full year Stephen.
Thank you Ali.
I will now provide some additional detail on the Q4 results on other financial information for the quarter and the year.
For the fourth quarter of 2020 gross revenue was $8 $2 million of net revenue was $7 6 million.
Net revenue increased by 26% from the fourth quarter of 2019.
In the U S. Gross revenue was $6 3 million of net revenue was $5 7 million.
U S net revenue increased 22% from the fourth quarter of COVID-19.
The Oregon breakdown on U S. Net revenue was as follows.
<unk> 5 million was the Ocs low $1 1 million was the Ocs heart and $2 1 million was the ocs liver.
And ex U S revenue was 1.9 billion that's up.
The 39% from Q4 of 2019 and included <unk> 6 million of Ocs lung and $1 3 million of Ocs heart.
A few of the key drivers of Q4 revenue performance where first.
The strong recovery of Ocs lung sales in the U S. After two consecutive quarters that we're very negatively impacted by the Covid pandemic.
The development of our National Ocs program other momentum to this recovery.
Secondly, we had a strong quarter in U S. Ocs liver sales as we completed the first phase of the Ocs protect the cup.
The lung and liver sequential improvements offset the lower Ocs heart revenue due to the stocking orders that we saw in Q3 2020.
Also outside of the U S. We initiate the clinical use of the ocs lung and heart, and Taiwan, which had a favorable impact as well.
Gross margin for the fourth quarter of 2020 was 63% in line with our expectations at this level of revenue.
Total operating expenses for the quarter were $10 7 million, which was 14% below our spending in the fourth quarter of 2019.
This reduction was primarily the result of limitations related to the Covid pandemic.
We did see the sequential increase of operating expenses for low income $6 million. In Q3 2020, we have continued to invest on our national Ocs program commercial initiatives.
Operating loss was $5 9 million in the fourth quarter of 2020 compared to $8 7 million of the fourth quarter of 2019.
Our net loss.
For the fourth quarter of 2020 was $6 3 million compared to $11 2 million in the fourth quarter of 2019.
Finally, cash cash equivalents and marketable securities were $125 6 million as of December 31, 2020, which equates to a reduction of $7 1 million from the balance of the end of Q3 2020.
And the weighted average common shares outstanding for the quarter were $27 2 million.
Let me share some details on the full fiscal year 2020 results.
For the full year net revenue was $25 6 million the <unk>.
9% increase over the prior year the.
Detail for the annual revenue is as follows U S. Net revenue was $19 2 million.
And grew by 18% over fiscal 2019 by.
By Oregon, The U S annual net revenue broke down on those $5 4 million for lung.
The 6 million for heart and $5 2 million for liver.
Outside the U S. Annual revenue was 24 2020 was $6 4 million, which was down 13% from 2019.
Gross margin for the full year of 2020 was <unk> 65 per cent compared to 59% in 2019. The total operating expenses were $43 million for the full year 2020, essentially flat from the 43 of the $5 million in 2019.
Operating loss was $26 4 million for the full year compared to 29 6 million of 2018 the <unk>.
Net loss was $28 7 million in 2020 compared to $33 5 million in 2019.
Overall, while 2020 was an extremely challenging year due primarily to the COVID-19 pandemic of the hub of get caused both in transport activity as well as a regulatory timeline.
We're extremely proud of the manner in which we managed for the year. We are confident on our ability to progress of the business forward.
Looking ahead, we are optimistic about our prospects for meaningful revenue growth.
As a result of the upcoming FDA approvals.
For 2021 as Waleed mentioned, we are not providing formal financial guidance at this time.
We believe that on the current Covid environment, there still exists the high level of uncertainty on the <unk>.
The impact on our business as well as of the timelines. The therefore, we will defer reinstating guidance until some of the uncertainty is mitigated.
I will share however.
So we do expect to continue to increase our spending level throughout 2021 to achieve further critical mass in our national Ocs program commercial infrastructure as well as progress our next generation of sales platform development.
We believe 2021 of the year to accelerate our strategy and we're not going to hold back on these critical investments.
Now I would like to turn the call back to our lead for closing comments.
Thank you Steven.
Despite the unprecedented challenges in 2020, our team made significant progress across many strategic initiatives.
We've build a strong platform and we're well positioned to leverage this foundation for long term success.
To that end, we're focused on executing on the many catalysts, we outlined earlier and for 'twenty 'twenty, one to be of truly transformative year for transplants.
With our Ocs heart panel scheduled.
Five short weeks from now.
The clinical and regulatory timelines related to ocs liver and heart DCD coming to a head in the upcoming months.
And the scalable foundation of the National Ocs program, taking shape.
We believe that transmit makes us uniquely position to become the national partner for all transplants stakeholders and that in few short years. The vast majority of organ transplanted in the U S will be preserved and managed on the Ocs technology platform.
I Am Humbly, Inc.
Extremely excited for the months and years ahead of us with that I will now turn the call to the operator for Q&A operator.
And as a reminder, if you would like to ask a question press star one on your telephone keypad.
Star one.
And your first question comes from David Lewis from Morgan Stanley.
Good afternoon, and thanks for taking the question and nice quarter and of <unk>.
<unk> environment. So a few for me maybe.
Maybe Steven really to just start with you and I appreciate the tough environment, we're not going to give guidance, but I was hoping you could just help us mirror <unk> comment about the business improving performance across the year. If you could maybe just level set us on where to begin sort of the first quarter is it safe to assume revenues can be flat sequentially or sort.
The more in line with sort of the consensus range, which is sort of 6% to seven for the first quarter.
Revenue benchmark us on the first quarter I, just want to confirm that will lead the view as the.
Things should get better sequentially across the quarters.
I got a couple of follow ups.
Yes.
Hello.
Okay.
Operator Hello.
Yes.
I am here I don't know what the lines or not.
While the speaking.
It looks like they may have disconnected hold one moment okay.
The Speakers' lines are having the disconnection problem. Please continue to hold.
Yeah.
Hi, everyone I apologize, we had some technical difficulty so.
David are you still on the call.
Sure.
Can you hear me.
Hi, Ken Hi, Ken Great care of my question should I repeat my quick question about the sequential growth and what we said is the Q1 is going to be a little bit choppy I would expect the potential to have flattish from Q4 to Q1, the see growth starting after that.
Okay.
Thank you can you comment why the Choppiness of the main reason is that this kind of transition of the liver top from the first tranche of the second tranche.
You will see kind of a GAAP out in Q1.
Okay, very very helpful and we can work with that okay, and just a couple of other questions here I guess the will lead. The first question would just be that the lung performance sequentially was.
Was very solid you just sort of walk through some of the commercial dynamics there.
And then I'll ask my second question as well, which is this your heart pedal confidence you cant predict the outcome of the FDA panel, but you sound incrementally more confident about the data with which <unk> submitted to the panel on just kind of help us understand what's underpinning that confidence of just been any dialogue with the agency here during the cap of submission process.
Thanks, so much sure.
Sure. Thank you David So the first question related to the lung recovery I think the.
The good solid recovery in Q4.
Obviously, we were working hard to even accelerate debt recovery, even further I.
I think three things contributed to the long recovery in Q4, one that the transplant volume came back and the pent up demand that we are hoping to see at the ended the year would you actually Derrick. So that's number one number two the awareness campaign that the team has been doing about.
The availability of the National Ocs program.
Resonated and began the process of resonating with some of their institutions that are doing lung transplant, whether or not there are on the original Ocs center and three of course, the momentum that was generated by having four regions active in Q4.
We hope that we can carry that momentum forward on 2021 and continue to build on that momentum continue to expand awareness continue to open up new territories, and hopefully that will get us to where we need to be with the lung business relating to the heart panel meeting as I've said numerous times no one here and certainty I am net.
I never will predict what FDA.
Decisions would be or what the outcome of the kind of on meeting is my comments are primarily focused on our ability.
Our confidence on our data and our confidence in the results and now seeing the FDA comments.
Or at least.
Getting a better feel for the FDA comments, we feel that we have our arms around.
These important questions that the FDA race raises to the panel and we have solid data to support our position, that's where our confidence coming from but we never we never can predict what the outcome is but were very helpful and very confident in our ability to.
To meet those.
Questions and that's what gives us the confidence that we hopefully will be.
The successful in this mission.
Okay very helpful. And then just maybe just last one from me and I'll jump back in queue is just we're not predicting the timing of the approval. Once approved if you are approved for heart. How soon after can we consider full commercial launches that.
The one month three months.
Just help us out with that thanks, So much sure sure. That's an important question David and thank you for asking it I think realistically speaking, it's not going to be a flip of a switch, but we expect it to be significantly more streamlined in the lungs. So the lung.
We took us anywhere between 90 to 120 days to see any uplift in the commercialization in the lung we expect the heart to be somewhere between 30 to 60 days and we attribute that to the one to the effort debt Tamara and his team have been doing in preparing for that.
Launch in the educational campaign that are ongoing but more importantly, the national program as well is going to help streamline that process. So that based on the east we feel that it's going to be on a much more streamlined.
On a process from approval to starting seeing some meaningful impact on our revenue.
Great. Thanks, so much of a nice quarter.
Thank you Dave.
And your next question comes from Robbie Marcus from Jpmorgan.
Oh, great. Thanks for taking the questions.
I was hoping you could spend a minute and just.
Just walk us through some of the learnings you had from the lung launch in and what Youll apply.
On to the the heart and liver.
The transition from a clinical two of commercial setting.
And then second if you could walk us through if you of any metrics on what utilization looks like.
<unk> you put in the.
The program, where you manage to the account versus just selling the ocs system in if theres any early.
Data statistics, you could point to and increased volumes.
Sure. Thank.
Thank you Robyn so on the first question I think the learnings on the lung as we've stated before.
Stating in public you before the I think the biggest learning.
I think negatively impact our lung.
Early commercialization is the hiatus between conducting the pivotal trial and the length of.
FDA review cycle without any continued access protocol to keep the clinical momentum and awareness of the technology benefit going that that was a huge learning and resulted in us really starting from ground zero because it took 14 to 18 months from finishing the last patient in the cloud to getting the first approval.
So that that's something we Ava.
Avoided.
Throughout the heart and the and deliver on our program.
So that's number one the second is really the the.
The active engagement on planning for commercialization.
Resources planning for resources training.
Active business discussion with the administration integration discussion Howard begin of scale, how could we be helpful.
<unk> in the lung we started from scratch after the FDA approval here, we're engaged with the centers given our position given our relationship given our active participation on ongoing programs.
Within the same institutions that gives us huge leverage and then finally and I think frankly the <unk>.
One that could be truly transformative is the foundation that we spent in debt that we develop for the national.
Program that is going to be potentially.
Potentially a huge game changer.
For both heart and liver.
As far as debt. The next part of the question on the second question Ravi.
I want to wait a little bit until we have more.
Data points on the board to try to metric the group.
We certainly saw growth we saw.
The significant awareness and we're monitoring that carefully but I think we're too early to try to metric and extrapolate that we need a couple of more of two or three more quarters under our belt.
To be able to comfortably share that data publicly.
But we're monitoring it very carefully and we're excited about what we're seeing and we hope that by adding the heart and subsequently the liver.
We are going to.
My goal is within the year or so from now that this is going to be a key point that we're highlighting every earnings call.
<unk> point about the the percentage of our revenue coming from the direct acquisition model versus the National program.
Great and then maybe just one last one Steven you mentioned increased spending in 2021, I realized we're not getting revenue guidance, but can you.
Qualitatively or quantitatively help steer us in the direction of increased spending.
Yes, Robin sure I think I would look at Q1 2020 as kind of a base, which I think we were spending close to $13 million in the quarter.
We're going to get back to that level, and we're going to grow sequentially from there. So I would use that as the base.
Kind of be aggressively ramping up this.
Cash flow program.
And youre going to get there in first quarter or at some point in the year.
I think we will get pretty close in the first quarter, okay, great. Thanks for taking the questions.
Thank you Robyn.
And once again as a reminder, if you would like to ask a question press star one on your telephone keypad.
And the next question is from Sarah.
So Raj <unk> from Oppenheimer and company.
Good afternoon Waleed, Stephen can you hear me all right.
We can hear you just fine ice Raj.
So gentlemen, congrats on the quarter, So we'll leave.
Regarding the Ocs heart panel, obviously, the panel is going to make a set of recommendations on the risk reward.
You guys seem to be pretty confident.
Is there anything in the discussions with the FDA. So far that gives you the same level of comfort from a labeling perspective.
Okay.
On.
Raj. Thank you for the question, we never discuss any discussions related to the labeling I think we would be putting the cart before the horse our focus is to get strong positive flow.
We trust the FDA.
Leadership.
To do the right thing on the labeling.
However, I don't see any controversial topic, so far at all relate to labeling I think the key foundation has to go through the panel discussed the issues on hand, and hopefully end up in a positive outcome I believe that the process will be hopefully streamline from there.
Fair enough.
In terms of the National <unk> program I can see how you all are trying to.
Alleviate some of the staff and logistical constraints the transplant centers have.
Agree with the at least approached that of elite trying what are the incremental revenues per case relief debt on a normalized basis Youll see such a program pulled through because in fact, you are helping offset some of the costs of the centers, but how does the math work for you all.
On the normalized basis.
I think I think the only thing we can say at this point Suraj is as I've said numerous times the National program is nothing but a mechanism to streamline the process of adoption of the ocs with the main revenue stream at scale the primarily disposable.
Disposable revenue.
And.
We have the ability to do that.
So far it's again early innings, but it's exactly the vision is maturing in that fashion and definitely from a from a cost benefit to the transplant program is huge on.
Many fronts, it's logistical costs infrastructure costs.
<unk> cost it's life work balance cost.
And.
Again, I don't want to be too.
Two forward on my skis here.
But debt.
We believe in this we think there is of significant it is a significant win win approach for everybody involved and we hope to be able to continue to prove that throughout 2021 on beyond.
Fair enough and will lead final question forgive me if I missed this the 90 patients for the DCD cap heart cap.
<unk> will give a timeline on when you all think that could be enrolled thank you for taking my questions.
Thank you thank you suraj.
I think.
Realistically speaking, we see the 90 patient cap for pretty much wrapping up by the by year end.
However, in our discussions with FDA and given the broad publicity about the success of the Ocs DCD Heart program in the U S and internationally I think the FDA.
It is very is very keen and aware of the patients are positive patient impact. So I am hopeful that collaboratively, we can work with FDA to potentially expand that cap.
If the approval is not in hand by that time.
So I'm not worried about when do we finish it as.
As much as well.
Are more focusing on getting the data getting the PMA.
PMA supplement filed.
On a timely fashion to make sure that we're shortening the time gaps between.
Transitioning from capped into a potential extension to the cap and the like.
And the last question comes from the line of Josh Jennings from Cowen and company.
Hi, This is Brian here for Josh Thanks for taking my questions.
Of two regulatory ones. The first is just on the liver PMA are you planning to supplement the filing with data from the cap program and I guess my question is just has the possibility been discussed with the FDA already and do you feel you now have a definitive stance from the agency on whether the cap data should be added to the filing.
Brian Thank you for the question and.
And every PMA, we file we always supplement data with cap.
And we expect to do so we have done that already shared.
The data with FDA on the first few cases in the cap and we expect as we March towards the panel on the cap will be discussed is it going to play that all of that the cap played on the heart.
Doubt it but.
It's not an option or.
Or nuanced, Inc. Every PMA youll have to the report the latest set of data that you have and we plan to do so and in this case, we've already submitted that data to FDA.
Okay. That's helpful and then on the on DCD Heart I believe you included the DCD Heart U S filing in the three Q of this year. In addition to releasing the data. So can you clarify when in 2022, we could see an approval just given that the <unk>.
Submission I believe as the supplement and you have breakthrough status.
Would you expect the panel as part of this review or just how are you thinking about just the approval timeline for next year.
Yes, that's an excellent question, Brian again, we can predict what FDA.
Decisions will be Inc.
All we can predict is if the data is strong as we hope it is.
That FDA will honor the breakthrough designation and there will be of streamline review process.
If there is any questions in the data or depending on the outcome of the upcoming panel FDA may or may not hold than other panel. The facts are DCD as the first of its kind of indication yes. It has the breakthrough designation.
But.
These are all.
Bridges, we have to cross after we finish the heart panel on the after we see the data.
But roughly speaking.
Not out of the ordinary to assume nine to 12 months.
On a PMA supplement.
No.
So that's what we're assuming.
And I have no further questions at this time of.
Turn the call back over to the speakers for any final remarks.
Thank you operator, thank you everybody for your time this afternoon, and we're looking forward to our.
Our next call. We appreciate your time, thank you very much.
Ladies and.
Gentlemen, This concludes today's conference call. Thank you for participating you may now disconnect.
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Non-GAAP.
Net.
Net.
Yes.
The next.
Good day.
Revenue.