Q4 2019 Earnings Call

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Ladies and gentlemen, and welcome to the trends genetics fourth quarter and full year 2019 earnings conference call. At this time all participants are in listen only mode. Later, we'll conduct a question and answer session and instructions will follow at that time as a reminder earnings conference call is being required.

Good.

Oh, no wants to turn the conference over to your host Mr., Brian Johnson from Goldman Group.

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Earlier today trends Medix released financial results for the quarter and year ended December 28, 29 team.

The press releases available in the company's website.

But again I would like to remind you that management will make statements. During this call and include forward looking statements within the meaning of federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Any statements contained in this call, but really to expectations or predictions of future events or 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 included which includes expectations for growth and organization regulatory approvals and reimbursement guidance for revenue gross margins and operating expenses in 2020 are based upon or.

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 statement.

Accordingly, you should not place undue reliance on these statements for a list and description of risks and uncertainties associated with our business. Please refer to the risk factor section of the fund final prospectus relating to our initial public offering.

We have filed with Securities Exchange Commission and in our quarterly report on form 10-Q for the quarter ended September 28, 2019, which are available on the Fccs website at www dot at DC Dot com.

Additional information will be made available by our annual and quarterly reports and other filings that we make from time to time with the FCC.

Friends, Medix disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise. This conference call contains time sensitive information and it's accurate only as of the life broadcast today March 2nd 2020.

And with that I know.

Well, we have seen president and Chief Executive Officer.

Thank you Brian Good afternoon, everyone and welcome to transmit Inc.'s fourth quarter and full year 2019 earnings call.

Joining me today Stevens Chief Financial Officer.

29 came to the momentum building year for pets, Phenix in which we build a solid foundation for growth and made meaningful progress across all three of our old yes, sorry.

For heart lung and liver transplant.

We leverage that's trends of our multi organ multi region commercial presence to achieved revenue of 23.6 million for the year, which was up 81% versus 22.

I would like to shape share a few key highlights across our field test products, and then turn our attention to 2020.

Starting with those yes lung Clark.

Lung ramping in Q4 was $3 million presenting 51% growth over last year.

We ended the year with 18, well see edslan commercial centers anyway.

Our plan is to drive deeper adoption across these centers why we're gradually opening up new accounts.

Finally.

I stated during our Q3 calls that Transmix has been working on a fundamental new initiative to help accelerate adoption of those he has long technology.

And minimize dissenters Pacific logistical challenges on utilization.

I'm delighted to report that in Q4, we initiated the first off several well see a service model collaborations with major U.S. organ procurement organizations or appeal.

And a few transplant centers.

The aim of this initiative is to maximize they use civil she has technology to increase donor organs utilization for lung transplant and overcome center specific logistical challenges thought adopting the Lcs lungs.

This collaboration is to off of men and complements our existing commercial relationship.

With trying to send centers across the U.S.

Next.

Onto our old yes, part part.

We're pleased that the if he has formally communicated to transmitting the date of our associates Heart Advisory panel meeting to be in April 16th.

While maintaining an open active dialogue with the agency and we're looking forward to hopefully achieving a positive endorsement of the panel to support the Lcs Carpathia may approval.

Clinically we continue to drive clinical momentum on our harp program with the first ever U.S. adult heart transplant procedures using donors.

From thought that donor parts from donor after circulatory death or BCD Hearts.

These DCD Hearts, what are your suffocated optimized and assessed on our OTSR system.

This is an entirely new category of heart transplant procedure that was enables exclusively by the use of our OTSR system.

Importantly, this new procedure, we significantly help and stage heart failure patients to access the curative therapy of heart transplant.

The first case of BCD hard about heart transplant was done in early December.

We ended 2019 with seven DCD heart transplants in the West and today, we're at 20 DCD heart transplant.

We ended the year 2019, with 15, Lcs hard trial centers in the U.S.

Finally, our Lcs liver product.

As we discussed in our third quarter call, we completed enrollment in our 300 patient protect trial earlier than expected.

We look forward to a full data read out in May at the American transfer in Congress.

This trial.

We are on track to submit our pmeight for the Lcs liver indication in Q2 2020.

We also received FDA approval for the OTI has liver protect cap or continued access protocol to enable continued clinical momentum and utilization of Lcs liver system, while the p. amazed under development and review.

Finally safety approved our OTI has D C D E trial.

And it's classification as a breakthrough device.

This is a first of its kind trial that is aiming to further expand BCD donor deliver utilization for transplant using the lcs ever system.

Overall, we expect the combination of the cap and the DC de lever programs to drive significant clinical momentum of our OTI has liver system, while the P. amaze under review by the FDA.

We ended the year 2019, with 17, Lcs liver trial centers in the U.S.

On a macro level.

We are very encouraged by two major federal mandates and initiatives from CMS and the department of health and human services.

To promote organ transplantation and drive better utilization of donor organs for transplantation.

As a part of these mandates CMS issued a final ruling to remove post transplant clinical outcomes.

As a requirement for CMS certification of Transdigm programs in the U.S.

This mandate was designed to encourage transplant centers to be more aggressive and pursuing more doing the oregons 'cause transplantations.

In addition, CMS and and Palmer of Health and Human services also proposed a new tooling to revamp the opioid performance assessment metric anyway.

New assessment metrics will focus primarily on rate of donor heart utilization for transplantation at these appeals.

We believe that these new mandates are supportive and confirmatory of transmitting strategy given that that we'll see aes has demonstrated the highest reported rate of dona organ utilization in long and heart transplant.

We expect that overtime transplant centers and appeals, we need to utilize technologies like the organ care system to maximize donor or utilization.

And need.

These new rules.

Looking forward to 2020.

Several major milestones, which we believe will enhance our ability to continue to drive growth of Transmix business.

These are.

Well if he has long we expect to continue to expand utilization a transplant center level as well as through opioid commercial service initiatives, while minimizing logistical challenges.

But we'll see as hard given the panel date of April 16th we expect if he approvals, yes heart indication to be in late Q2 or early Q3 2020.

We remain confident in our in our data and in our ability to address the panel and the agencies question.

We expect continued momentum in our D.C.D. harp clinical program to drive incremental clinical confidence in the use of those yes hearts system to our 2020.

This dataset, we need a key datasets for future expansion of the indications to include DCD heart transplant.

But we'll see a sliver plan to submit our OTI has liver PMC application 52 to 2020 in parallel to the full trials readout of the protect trial results.

We have already initiated the LCFS liver continued access critical and new deals yet liver de Bray breakthrough clinical program to expand our clinical evidence based and continue to drive momentum while the P. amaze under review.

For our own she has service model.

If successful.

We will leverage our old she has service model to further expand our geographical coverage across key organ procurement organizations in the U.S. and transplant centers.

Importantly, we will expanded to include Lcs heart once if de approval is enhanced.

Finally, we look forward to continuing to grow our international business by continuing to add new centers and advanced reimbursement initiatives in high volume geography.

That being said we are concerned about the potential near term negative impact of the Corona Vitesse pandemic and our ability to grow our international sales, especially in Asia, Italy, and the Middle East.

With the about with the above foundation, we're providing a full year 2020 net revenue guidance range of 42.

To 43 million.

In sales.

This represents between 69 at 82% percent growth year over year.

We expect to see overall revenue sequential growth. However, the organ specific revenue may be lumpy throughout the year between one quarter to that.

Before turning the call to Steven I want to take the opportunity to highlight that we are monitoring very carefully the impact of the corona biased pandemic on our business.

Typically on our supply chain, our and our international sales.

We are actively taking the necessary precautions to ensure supplies of raw material needed to continue the production of those yet systems.

Near term, we feel confident that we are in good shape from a supply chain standpoint for the next three course.

With that.

Let's turn the call over to Steven.

Even Gordon our CFO and I will be returning to some closing costs.

Thank you Kelly.

No go ahead and provide an overview of the financial results.

Including a very detailed description of revenue by geography and by organ.

As I have done in the past one showing revenue results I will provide both gross revenue, which was the amount we invoice from customers as well as net revenue.

Which deduct certain clinical trial and data collection costs that we paid the clinical centers.

No trials.

In Q4, 2019, this clinical adjustment only impacted us part revenue.

So with the fourth quarter 2018, gross revenue was 6.5 million, 67% increase over the fourth quarter 20 team and our Q4 net revenue was 6.1 million.

71% increase over the fourth quarter.

So let me break this down a little further for the fourth quarter U.S. gross revenue was $5.1 million.

[music] point 8 million was from the old see us long and $2.3 million was from Lcs heart.

As we mentioned on the last call. We did not expected we do not have any U.S. associates liver revenue since the liver trial has completed enrollment.

So then on a net revenue basis, you'll see us long is the same as the gross revenue, it's 2.8 billion and the Lcs Heart net revenue was $1.9 million.

Outside of the U.S. gross and net also equivalent so our Q4 net revenue outside of U.S. was $1.4 million made up of point 2 million from long.

1.2 million from far.

A key drivers of our revenue growth in Q4 was that we'll see us long clinical adoption and early implementation of our new appeal and service initiative that will lead mentioned earlier, along with the two Lcs harp programs currently running the expand Cup.

BCD heart trial.

Gross margin for the fourth quarter 29 team continued to show progress and was 62% compared to 42% in the fourth quarter 20 feet. I was also up from 59% in the third quarter of 29.

Total operating expenses was $12.4 million in the fourth quarter met grew by 58% compared to 7.9 million in the fourth quarter 2018.

Operating our operating loss was 8.7 million in the fourth quarter of 20, Nike compared to 6.4 million in the fourth quarter. Please see our net loss for the fourth quarter was 9.2 million compared to 7.6 million in the fourth quarter.

And cash cash equivalents and securities were 80.7 million as of December 28, 2019, which equates to a reduction of 7.6 million from the balance at the end of the third quarter from Nike.

A weighted average common shares outstanding for the quarter was 21.2 million.

Now, let me do a little scrub detail of the full fiscal year plenty Nike.

For the full year, our gross revenue was 25.8 million.

76% increase over the prior year and our full year net revenue was 23.6 million.

81% increase over the prior year.

A detailed for the annual revenue is as follows US gross revenue was 18.5 million and U.S. net revenue was 16.3 million.

US net revenue grew by 148% over fiscal 2018.

And by Oregon, The U.S. annual gross revenue broke down as 8.3 million to loan.

5.6 million heart.

4.6 million live.

And on a net revenue basis 8 million loan.

4.7 million heart and 3.5 million liver.

Outside the U.S. annual revenue for 2019 was $7.4 million.

14% growth from 2018.

7.4 million included point 6 million from loan and 6.7 million from park.

Gross margin for the full year 2019 was 59%.

44% 2018, a total operating expenses were $43.5 million for the full year 2019, compared to 26 million internally.

Operating loss was 29.6 million for the full year compared to 20.2 million in 2018, and net loss was 33.5 million 29.

23.8 million.

Now turning to the outlook for 2020 as well even mentioned earlier, we expect net revenue to be in the range of 40 million to $43 million.

The growth in revenue is primarily based on our expectation expectation for further you'll see us little adoption.

And by progress on our appeal and serves initiatives. In addition, we have two trials enrolling in both heart and liver compared to only one trial of each and 20 Nike.

We expect to continue to experience some lumpiness in the quarterly revenue as well he mentioned as we progress our 2020 initiatives.

And for modeling purposes, while we're not providing quarterly guidance. We expect the first half second half split in revenues to be roughly 40 60 for the year, a 40% in the first stuff that 60% or the second though.

In addition, operating expenses are expected to grow at about 25% to 30% for the year.

Finally, I also wanted to mentioned that we have made a change to our fiscal year in 2020 to match the calendar year quarters. This will mean Q1 2020 will end on March 31st.

Rather than more 20, Eightth, which was our office fulfillment and the year end will be December 30, Onest tied to the calendar quarters I hope this from a modeling comparisons a little easier going forward.

With that I'll turn the call back over to while Lee for closing comments.

Thanks Steven.

Overall, we're proud of our results from progress in 2019 on are extremely encouraged by our clear path forward and 2020 and beyond.

Transmix is transforming the standard of care in organ transplantation by creating an entirely new clinical practice for extra capacity of profusion optimization and assessment of doing oregons for transfer.

Transforming to standard of care is never easy and it takes time.

We are confident in our technology.

Our clinical evidence in our track record to negatively to.

Navigate early commercial headwinds and drive towards long term growth.

We're looking forward plus strong 2020 in which we expect to increase utilization of those yet technology across all three of our clinical transparent market heart lung and liver.

Again, thank you so much for joining us on this call and now we will open up the line for questions operator.

Ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key audio Touchtone telephone. If your question has been answered all your wish or move yourself from the Q. Please press the town.

For your first question, we have Robbie Marcus from JP Morgan line is open.

Mr. Robbie Marcus your line is open.

Oh, sorry about that honestly the Allen on for Robby I just wanted to start off with guidance I'm. I think previously you had talked about 2020 as being a year, where you would be looking to I think it was double your revenue base.

Got it looks like you're coming in a little below that so I guess like can you walk us through guidance in terms like what you expect in terms of long in terms of heart in terms of like benefits from clinical trial enrollment figures like walks through the bits and pieces of that and maybe whats falling a little bit short of prior expectation.

Hi, This is Stephen Gordon the CFO so.

Yeah as far as far as guidance by working we're not going to provide guidance by or give.

You talked about the drivers being the.

Certainly the long adoption as well as the.

Two trials and hard to trials and liver and then ultimately.

We hope to have the heart approved in the second half the year.

So I think that's as much guide as we're going to get by organ at this point regarding kind of we've often said that we feel like we can close to double the revenue each year and you feel like 70% to 80% as close to Dublin.

And now and this is really I'd like to also shed some more light in addition to us even discussed.

I think we we feel very comfortable in the guidance, we're issuing 420 20.

Many of US expected. The there are several factors that led to the guidance being what it is for example, we expected the heart panel to be a little bit earlier now we know it's on April 16th we we could not influenced the date now we know what the data is so we had to factor that in.

Into into our consideration we're sitting here with.

A situation globally that pretty much resulted in us being very conservative and completely eliminating revenue that we were expecting for 2020 from China, South Korea Hong Kong.

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And other Asia Pacific region, and Weve down.

We discounted a lot of our middle East revenue.

That we're expecting in 2020, what I'm talking specifically about the impact of different buyers pandemic.

So I think net net.

We had to be realistic we had to put a guidance that we stand by and we feel very confident this guidance and we feel that will be a significant year ahead of us in 2020.

And we will continue to monitor the dynamics that are.

Influencing our business globally.

Got it and then when it comes to the O. She has heart approval. When you do get approved how should we think about the trajectory for that launch.

The translation the sales should we think about it being more modest ahead of D. C. D or do you think seems still get some pretty healthy adoption even out of thought thank you guys.

Thanks Alan.

The heart we expect.

We expect the heart adoption to be.

I would say, it's not it's not linked to DCD, we expect heart adoption to go through a cycle on that will be transitioning from clinical to commercial we know this cycle has some inertia factors in it.

We hope that we thought by.

Applying the lessons learned from 2019 and dealing with the lung early adoption situation that we've learned a ton from that and we kind of put together.

Iran that makes sense and we assumed a lot of the key factors and we've addressed some of the key factors for the heart. So we expect the heart to be.

A little bit smoother than the long, but we don't link the DCD to the two that proved approved indication is categorically different.

As far as DCD is concerned I think once the D. C. D is approved that will add too.

Our trajectory, but we don't look at the BTD as necessarily the main catalysts for the heart growth, we expect to see art adoption to grow once the F.D. is approved however, we expect to go through the similar similar steps for transforming trial centers to commercial centers that we include the post market trends history and.

Like however, we hope that they service model, which will address the big portion of the logistics and the infrastructure headwind that we saw with along with centers were not really ready for abroad.

Breadth of the Lcs.

Capabilities in Nab inept post market setting, we hope that that service model.

That we've established for the long we will help the heart addressed that specific area.

The next question.

All right. Thanks for your next question, we have David Lewis from Morgan Stanley.

Ladies open.

Good afternoon.

Just a few questions from me Stephen I know, we're not going to get.

Well, we're in guidance per year kind of corporate practice, but just given your commentary around corner virus I wasn't aware the Asia Pac was a significant contributor in 2020 Suky help us at all but the split between U.S. and actually less revenue actually asked is about 35% of the business in 2019, we had a closer to 30% 2020 should be assuming.

Flattish ex us trends as it relates to guidance up modestly him any help you can give us between you actually next you asked some of your current a virus commentary b.

Super helpful. In a couple of quick follow ups sure sure, Yes, I would expect.

Excuse to be about between 20% to 25% of our revenue.

In 2020, so we'll grow but certainly will grow modestly.

Okay.

Understand the majority of that disconnect versus kind of our prior model. You believe is more Asia Pac contribution and just conservatism around come under Vivus in Europe.

Well I think I think it's a couple of things I think it's some of that is impacting it I think you look at just the heart, which is our primary franchise outside the U.S. I would expect that to grow probably at high single digits and maybe that's the disconnect. Maybe we have that has a higher growth rate.

Big long and potentially liver those are small numbers that you will see growth there in probably double digit growth rate, but the numbers are small so I think thats, probably where the disconnected.

Okay very helpful. Her specific and then will lead to some harpenau actually had any conversations with the agency or around the data.

Heading into the panels sort of question one and then related question is just what is assumed to 2020 now do you take a very conservative view just pull hard at a 2020 or did you assume some meaningful contribution from heart, India and the second half of the year I just had one more quick one on long.

Sure so relating to the first part David.

We we have been having constant communication with the FDA around the data and we feel confident in our ability to address and we've addressed these questions to 58.

And we feel very confident for.

You know from where we stand today about addressing any of these questions or any additional questions relating to date.

Regarding the second question or the second part of the question.

We did not assume significant contribution of the heart in 2020, we assume some modest contribution.

Specifically actually around Q4.

But we have an ongoing DCD program that is.

He is going to contribute some growth this year.

We did not do anything you know.

That is super aggressive or anything like that because we just kind of wanted to be realistic and ensure that we.

We are learning from the 2019.

Early adoption in the early rollout of the heart in 2020, so thats.

My My response to that part Steven would you like to add anything.

We do have certainly contribution from early in the fourth quarter.

From heart.

I think leaves with up right and at the end of the day, David even if the for whatever reason the.

The the approval is delayed by a month or 45 days or 60 days, we don't we don't see that as a meaningful impact to our revenue.

In 2020, nor our guidance in 2020.

Perfect very clear. Thank you for that and then lastly, when they just long traction it actually pop up here sequentially, which was nice to see just give a sense maybe a deeper dive on these commercial initiatives like there is the there was the center specific dynamic, but there's also the o. PEO driven dynamic I just wonder if this changes how you're thinking about in the future you just more reliant I know Peos are you still Ashley.

And on the owners known how many centers do you think you're going to add in 22020 heavy super helpful. Thank you sure none of that that's that's clear.

So David No we look at the appeal and the center dynamic as complementary and supportive we don't look at it as one way over or the other the on the.

The beauty of the opioid initiative. It is not center specific now that lung allocation is a national allocation, we can take along from anywhere in the U.S. and transplanted anywhere in the us.

Which we.

With the organ care system, which we couldn't do before.

To that that helps it also eliminate or minimizes the impact of the center specific logistics and headcount and resources on that provided some headwind in early adoption of the Lcs lung system. So.

Providing these the service initiatives both for the center and the OPO.

We're hoping to see that the adoption of the lungs treat start to streamline and and the growth that we're expecting start to materialize into second half of 2020 as as I've said on the Q3 call, but that's the initiative that I was referring to then and now it's started and we expect to add additional centers additional opioids throughout 2000.

20, and we expect that this.

Well it alleviate this concern about logistics.

Center specific logistics.

And.

That is causing some headwind to a broader adoption of those your phone system.

And we're hoping that if it works.

At once we get approval for heart or liver or any other indication that become sort of the platform that we start the commercial discussions from rather than rather than just dealing with it with that would that center specific logistics alone.

Great very clear thanks, so much.

Thank you.

Last question, Sir we have to someone else from Canaccord Genuity. Your line is open muscle milk.

Thank you only.

Taking the question can you hear me okay.

Can you just fine hi, Jason.

I would like to follow up on several David's 0.2 questions.

How are you back when it is your service model in line.

Can you get in percentage terms relative to the market can you gauge it in percentage terms relative to that potential centered base or OPO kind tell where you would ultimately target.

There are ways to help us understand where you are and where you're going there.

And obviously, where you might be going and art and liver, although that's a de minimis at this point given.

The approval time for.

Sure.

Thanks, Jason for the question I think it's early days, but our vision is to end 2020.

Fully operational in the top.

Eight to 12 opioids in the country.

Hi, volume high performing opium shows that our and located across the United States.

You know across all regions in the U.S.

And as I said earlier that beauty of that on is it enables maximum utilization of the donor pool.

Without tying it down to a center specific.

Dynamic and we're hoping to see that play out in front of us in 2020 again I I.

And a little bit cautious.

Making any assumptions, it's too early to define that but that gives you an order of magnitude we were hoping that by the ended the year, we'll be in anywhere between eight to 12 high performing large volume opioids across the major geographical area and the United States.

We're already in discussion with the vast majority of those and we hope that through up quarter over quarter, we will sign them up and we'll see this this program taking off.

Ultimately these loans will have to be transplanted somewhere so the centers will continue to play a key role.

And the beauty about us offering this service, it's actually started with our broad footprint in major lung transplant centers and hopefully you want the heart is approved heart transplant centers in this country that makes these lungs find a home for transplant patients with just taking the pressure of logistics and manpower and.

One out of vacation.

Great and two follow ups to that so preventative those on the call that don't.

No the extent of opioid network in the United States, how how much would take the top eight to 12.

Hi volume appeals represent in terms of the volume of loans that are transplant today or that might ultimately be satisfied. If we were in an environment that extended criteria along for use more ubiquitous Lee and there was a higher number of long sprint translating this country. That's question. One question too is that you mentioned something.

An important to earlier in your prepared remarks, which which was the the proposal it changed.

The the post transfer outcomes guidelines.

One thing that we discovered as we talk to clinicians are transplant centers is there not willing to.

Sacrifice their level of success with respect to organ transplantation, even if they know that.

The patients won't be getting donor organs that they're older an age or extended criteria recipients sort of.

Sort of patients and so it could you spend a minute on that.

Specific proposal and how you think it might impact.

Your business over the both near and long term ill add one quick follow up after that sure. Thanks, Jason So.

A question number one.

And without getting too granular I think.

That that the top 10 to 12 opioids were talking to engage with property to present, the vast majority of for that.

Vast majority of organ transplants or lung transplants performed in this country or a big big majority of that have that volume.

The impact of this technology as we've seen from our trial I can only speak from.

Data points that was witnessed in our trial the impact of increasing the utilization is it's obviously.

Essential we were talking about potentially.

Tripling.

The higher the number of available lungs for transplant and that that and that's the exciting point.

Relating to the next that the second part of the question, we completely understand that today centers do not want to sacrifice the long short or long term clinical outcomes because they know if they do CMS will disqualify them from trans fat reimbursement.

We don't want that to happen either in fact, our data again I can only speak for our data our data shows that we have the best outcome in lung transplant from lung that otherwise wouldn't have been transplanted with a one year survival hovering about three or four percentage point above the national average of.

A one year survival in lung transplant today in the U.S. So.

We don't see this as compromising the outcome in fact, we believe based on our data that the Lcs is one of the very few if not the only technology that can guarantee a safe increase in the supply of donor lungs, and dorner Hearts and donor livers, because we know you have the highest rate of utilization.

But also our clinical outcomes were not compromise. So I think that was he has provides the answer to that question. However, the national mandates, we're really focusing on giving these transplant centers the license and the comfort zone to say listen transplant is a cost effective it's a it's a it's the people.

Of choice, it's the curative treatment for these patients that are dying at a rate of anywhere between 16, and 25% and the waiting list so to see that coming from CMS and HHS was very encouraging and its confirmatory trial, our position our strategy and our marketplace. So.

That's that's the point I was trying to comment on.

Yes, it seems like an important one at that so thank you for that color and then lastly from me.

David pointing out, but I want to go back to the first quarter since your public.

Offering that we are we saw you deliver.

Growth in U.S. long and frankly, you as hard as well the U.S. long above our expectations and there was up nicely sequentially.

On the other hand, the international business was well below expectations. So I guess a couple of questions here just wondering to make sure we're level setting properly as we head into Guy a modeling our quarterly for 2020.

The the trends in U.S. land finally, given you seem to have some tailwinds I think David asked it one way or asking a different way how much of that you think came from early success.

With the service model how much of it is just overcoming initial inertia post extended criteria approval and then international International only did you see any sort of one time or.

Different trends in the international business that caused it to be down somewhat sequentially was there something in there that was.

Nominally or could you talk a little bit about that and thank you sure sure. Thanks, Jason So on the first part of a question I would say in Q4.

70, 30 split 70% is just on the work that our commercial and clinical team has been putting in the long commercial initiative to overcome that early headwind and about 30% of the success of Q4 came from the early service model.

We are expecting.

We are tracking that percentage and we're looking.

Forward too you know looking what that trend would look like as we mature in that service model and add additional opioids and additional centers throughout 2020.

Relating to the second part of the question I believe that where we are.

So here's how we see our international business specifically in Europe.

I think we 2019 was a year, where a lot of our national reimbursement initiatives, we're maturing and maturing rapidly.

Which unfortunately caused a lot of the.

The centers to kind of hunkered down protect their their operating budgets waiting for the national reimbursement decision as to come out or anticipating that would be positive. So that was a major amnesia I recall that dynamic that we we we've seen in 2000.

19 for 2020, what's taking the same dynamic into the year, we did not want to over EUR estimate <unk> Europe, and we are we're not going to over estimate Europe until we see some major reimbursement initiatives maturing on and we're expecting one.

To mature in the near term here in the UK and we're hoping that another one we will declare itself sometime in the second half of this year.

So that's that's the that's what happened in 2019, we have no.

Fundamental issues or clinical issues for technology issues that were aware off.

That is causing that year over year growth I think our team did a great job in the previous two years and we reached a level of maturity that beyond which to grow we need some form of a national funding. However, as Stephen said, we expect some growth.

Albeit on a smaller scale because the numbers are small we are pushing forward initiatives to start releasing liver and lung commercial product outside of the U.S.

And one of those initiatives was obviously in Europe, but also in Asia Pacific. So again, that's why we're monitoring very carefully what's happening with the corner virus and the good news is in the numbers were sharing in the guidance. We're sharing we've already taken out all the impact of any Asia Pacific.

Sales completely out of equation for 2020, and we hope that changes, but for now that that's where we are.

Got it thank you when we.

I'm showing no further questions at this time I would now like to turn the conference back to Mr., while you're hedging.

Well. Thank you. So much. We appreciate you taking the time to be in our earnings call for Q4, 2019, and full year 2019, we're looking for too.

Our next call.

For Q1 2020, thank you very much and have a wonderful leaving.

Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and have a wonderful day you may all disconnect.

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