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Edited Transcript of TMDX.OQ earnings conference call or presentation 2-Mar-20 9:30pm GMT

Q4 2019 Transmedics Group Inc Earnings Call

Mar 25, 2020 (Thomson StreetEvents) -- Edited Transcript of Transmedics Group Inc earnings conference call or presentation Monday, March 2, 2020 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Stephen Gordon

TransMedics Group, Inc. - CFO. Treasurer & Secretary

* Waleed H. Hassanein

TransMedics Group, Inc. - Founder, CEO, President & Director

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Conference Call Participants

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* David Ryan Lewis

Morgan Stanley, Research Division - MD

* Jason Richard Mills

Canaccord Genuity Corp., Research Division - MD of Research & Analyst

* K. Gong

JP Morgan Chase & Co, Research Division - Analyst

* Brian Johnston;Gilmartin Group;Vice President, Investor Relations

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Presentation

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Operator [1]

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Good day, ladies and gentlemen. And welcome to the TransMedics Fourth Quarter and Full Year 2019 Earnings Conference Call. (Operator Instructions)

As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Brian Johnston from Gilmartin Group.

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Brian Johnston;Gilmartin Group;Vice President, Investor Relations, [2]

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Thank you. Earlier today, TransMedics released financial results for the quarter and year ended December 28, 2019. A copy of the press release is available on the company's website.

Before we begin, I would like to remind you that management will make statements during this call that 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 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 our future financial expectations, which includes expectations for growth in our organization, regulatory approvals and reimbursement, guidance for revenue, gross margins and operating expenses in 2020 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 risks and uncertainties associated with our business, please refer to the Risk Factors section of the final prospectus relating to our initial public offering that we have filed with the Securities and Exchange Commission and in our quarterly report on Form 10-Q for the quarter ended September 28, 2019, which are available on the SEC's website at www.sec.gov. Additional information will be made available by our annual and quarterly reports and other filings that we make from time to time with the SEC. TransMedics 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 is accurate only as of the live broadcast today, March 2, 2020.

And with that, I'll now turn the call over to Waleed Hassanein, President and Chief Executive Officer.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [3]

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Thank you, Brian. Good afternoon, everyone, and welcome to TransMedics' Fourth Quarter and Full Year 2019 Earnings Call. Joining me today is Stephen Gordon, our Chief Financial Officer.

2019 was a momentum-building year for TransMedics in which we built a solid foundation for growth and made meaningful progress across all 3 of our OCS products for heart, lung and liver transplants. We leveraged the strength of our multi-organ, multi-region commercial presence to achieve revenue of $23.6 million for the year, which was up 81% versus 2018. I would like to share a few key highlights across our 3 OCS products and then turn our attention to 2020.

Starting with the OCS Lung product. Lung revenue in Q4 was $3 million, representing 51% growth over last year. We ended the year with 18 OCS Lung commercial centers in the U.S. Our plan is to drive deeper adoption across these centers while we're gradually opening up new accounts.

Finally, as stated during our Q3 call, that TransMedics has been working on a fundamental new initiative to help accelerate adoption of the OCS Lung technology and minimize the center-specific logistical challenges on utilization. I'm delighted to report that in Q4, we initiated the first of several OCS service model collaborations with major U.S. organ procurement organizations, or OPO, and a few transplant centers. The aim of this initiative is to maximize the use of OCS technology, to increase donor organ utilization for lung transplant and overcome center-specific logistical challenges to adopting the OCS Lung System. This collaboration is to augment and complement our existing commercial relationship with transplant centers across the U.S.

Next, on to our OCS Heart product. We're pleased that the FDA has formally communicated to TransMedics the date of our OCS Heart advisory panel meeting to be on April 16. We're maintaining an open, active dialogue with the agency, and we are looking forward to hopefully achieving a positive endorsement of the panel to support the OCS Heart PMA approval.

Clinically, we continue to drive clinical momentum on our heart program with the first ever U.S. adult heart transplant procedures using donors from -- donor hearts from donor after circulatory death or DCD hearts. These DCD hearts were resuscitated, optimized and assessed on our OCS Heart system. This is an entirely new category of heart transplant procedure that was enabled exclusively by the use of our OCS Heart system. Importantly, this new procedure will significantly help end-stage heart failure patients to access the curative therapy of heart transplant.

The first case of DCD adult heart transplant was done in early December. We ended 2019 with 7 DCD heart transplants in the U.S. And today, we are at 20 DCD heart transplants. We ended the year 2019 with 15 OCS Heart trial centers in the U.S.

Finally, our OCS 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 readout in May at the American Transplant Congress of this trial. We are on track to submit our PMA for the OCS Liver indication in Q2 2020.

We also received FDA approval for the OCS Liver PROTECT CAP, or continued access protocol, to enable continued clinical momentum and utilization of the OCS Liver system while the PMA is under development and review.

Finally, the FDA approved our OCS DCD IDE trial and its classification as a breakthrough device. This is a first-of-its-kind trial that is aiming to further expand DCD donor liver utilization for transplant using the OCS Liver system. Overall, we expect the combination of the CAP and the DCD liver programs to drive significant clinical momentum of our OCS Liver system while the PMA is under review by FDA. We ended the year 2019 with 17 OCS Liver trial centers in the U.S.

On a macro level, we are very encouraged by 2 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 transplant programs in the U.S. This mandate was designed to encourage transplant centers to be more aggressive in pursuing more donor organs for transplantation.

In addition, CMS and the Department of Health and Human Services also proposed a new ruling to revamp the OPO performance assessment metric in the U.S. These new assessment metrics will focus primarily on rate of donor heart utilization for transplantation at these OPOs.

We believe that these new mandates are supportive and confirmatory of TransMedics' strategy given that the OCS has demonstrated the highest reported rate of donor organ utilization in lung and heart transplants. We expect that over time, transplant centers and OPOs will need to utilize technologies like the Organ Care System to maximize donor organ utilization and meet these new rules.

Looking forward to 2020, we have several major milestones, which we believe will enhance our ability to continue to drive growth of TransMedics's business. These are, for OCS Lung, we expect to continue to expand utilization at transplant center level as well as through OPO commercial service initiatives while minimizing logistical challenges. For OCS Heart, given the panel date of April 16, we expect FDA approval of the OCS Heart indication to be in late Q2 or early Q3 2020. We remain confident in our data and in our ability to address the panel and the agency's questions. We expect continued momentum in our DCD Heart clinical program to drive incremental clinical confidence in the use of the OCS Heart system throughout 2020. This dataset will be the key dataset for future expansion of the indication to include DCD heart transplants. For OCS Liver, we plan to submit our OCS Liver PMA application to FDA in Q2 2020 in parallel to the full trial readout of the PROTECT trial results. We have already initiated the OCS Liver continued access protocol and new OCS Liver DCD breakthrough clinical program to expand our clinical evidence base and continue to drive momentum while the PMA is under review.

For our OCS service model, if successful, we will leverage our OCS service model to further expand our geographical coverage across key organ procurement organizations in the U.S. and transplant centers. Importantly, we will expand it to include OCS Heart once FDA approval is in hand.

Finally, we look forward to continuing to grow our international business by continuing to add new centers and advance reimbursement initiatives in high-volume geographies. That being said, we are concerned about the potential near-term negative impact of the coronavirus pandemic on our ability to grow our international sales, especially in Asia, Italy and the Middle East.

With the above foundation, we're providing a full year 2020 net revenue guidance range of $40 million to $43 million in sales. This represents between 69% and 82% 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 the other.

Before turning the call to Stephen, I want to take the opportunity to highlight that we are monitoring very carefully the impact of the coronavirus pandemic on our business, specifically on our supply chain and our international sales. We're actively taking the necessary precautions to ensure supplies of raw material needed to continue the production of the OCS systems. Near term, we feel confident that we are in good shape from a supply chain standpoint for the next 3 quarters.

With that, I will turn the call over to Stephen Gordon, our CFO, and I will be returning with some closing comments.

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Stephen Gordon, TransMedics Group, Inc. - CFO. Treasurer & Secretary [4]

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Thank you, Waleed. I'll now 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 when sharing revenue results, I will provide both gross revenue, which is the amount we invoice from customers, as well as net revenue, which deduct certain clinical trial and data collection costs that we pay to clinical centers involved in our trials. In Q4 2019, this clinical adjustment only impacted U.S. heart revenue.

So in the fourth quarter of 2019, gross revenue was $6.5 million, a 67% increase over the fourth quarter of 2018. And our Q4 net revenue was $6.1 million, a 71% increase over the fourth quarter of 2018.

So let me break this down a little further. For the fourth quarter, U.S. gross revenue was $5.1 million. The $2.8 million was from the OCS Lung and $2.3 million was from OCS Heart. As we mentioned on the last call, we do not expect and we do not have any U.S. OCS Liver revenue since the liver trial had completed enrollment. So then on a net revenue basis, OCS Lung is the same as the gross revenue, which is $2.8 million, and the OCS Heart net revenue was $1.9 million. Outside of the U.S., gross and net are also equivalent, so our Q4 net revenue outside of the U.S. was $1.4 million made up of $0.2 million from lung and $1.2 million from heart. Key drivers of our revenue growth in Q4 was the OCS Lung clinical adoption and early implementation of our new OPO and service initiative that Waleed mentioned earlier, along with the 2 OCS Heart programs currently running, the EXPAND CAP and the DCD Heart trial.

Gross margin for the fourth quarter of 2019 continued to show progress and was 62% compared to 42% in the fourth quarter of 2018, and is also up from 59% in the third quarter of 2019.

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

Operating -- our operating loss was $8.7 million in the fourth quarter of 2019 compared to $6.4 million in the fourth quarter of 2018. Our net loss for the fourth quarter was $9.2 million compared to $7.6 million in the fourth quarter of 2018.

And cash and 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 of 2019.

Weighted average common shares outstanding for the quarter was 21.2 million.

Now let me do a little -- describe detail of the full fiscal year of 2019. For the full year, our gross revenue was $25.8 million, a 76% increase over the prior year. And our full year net revenue was $23.6 million, an 81% increase over the prior year. The detail for the annual revenue is as follows: U.S. gross revenue was $18.5 million and U.S. net revenue was $16.3 million. U.S. net revenue grew by 148% over fiscal 2018 net revenue. And by organ, the U.S. annual gross revenue broke down as $8.3 million to lung, $5.6 million heart, $4.6 million liver. And on a net revenue basis, $8 million, lung; $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. And the $7.4 million included $0.6 million from lung and $6.7 million from heart.

Gross margin for the full year 2019 was 59% compared to 44% in 2018, and total operating expenses were $43.5 million for the full year of 2019 compared to $26 million in 2018.

Operating loss was $29.6 million for the full year compared to $20.2 million in 2018. And net loss was $33.5 million in 2019 compared to $23.8 million in 2018.

Now turning to the outlook for 2020. As Waleed 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 expectations for further OCS Lung adoption driven by progress on our OPO and service initiatives. In addition, we have 2 trials enrolling in both heart and liver compared to only one trial of each in 2019. We expect to continue to experience some lumpiness in the quarterly revenue, as Waleed mentioned, as we progress our 2020 initiatives. And for modeling purposes, while we are not providing quarterly guidance, we expect the first half-second half split in revenues to be roughly 40-60 for the year or 40% in the first half and 60% in the second half.

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

Finally, I also want to mention that we have made a change to our fiscal year in 2020 to match the calendar year and quarters. This will mean Q1 2020 will end on March 31 rather than March 28, which was our old fiscal calendar. And the year-end will be December 31 tied to the calendar quarter. So I hope this will make modeling comparisons a little easier going forward.

And with that, I'll turn the call back over to Waleed for closing comments.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [5]

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Thanks, Stephen. Overall, we're proud of our results and progress in 2019 and are extremely encouraged by our clear path forward in 2020 and beyond. TransMedics is transforming the standard of care in organ transplantation by creating an entirely new clinical practice for extracorporeal perfusion, optimization and assessment of donor organs for transplant.

Transforming the standard of care is never easy, and it takes time. We are confident in our technology, our clinical evidence and our track record to negatively -- to navigate early commercial headwinds and drive towards long-term growth. We're looking forward to a strong 2020 in which we expect to increase utilization of the OCS technology across all 3 of our clinical transplant markets: 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?

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Questions and Answers

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Operator [1]

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(Operator Instructions) For your first question, we have Robbie Marcus from JPMorgan.

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K. Gong, JP Morgan Chase & Co, Research Division - Analyst [2]

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This is Allen on for Robbie. I just want to start off with guidance. I think previously, you had talked about 2020 as being a year where you would be looking to -- I think it was like double your revenue base, and it looks like you're coming in a little below that. So I guess, like, can you walk us through guidance in terms of like what you expect in terms of lung and in terms of heart in terms of like benefits from clinical trial enrollment? Can you just like walk us through the bits and pieces of that and maybe what's falling a little bit short of prior expectations?

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Stephen Gordon, TransMedics Group, Inc. - CFO. Treasurer & Secretary [3]

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Yes, Allen, this is Stephen Gordon, the CFO. So yes, as far as guidance by organ, we're not going to provide guidance by organ. We talked about the drivers being the -- certainly the lung adoption as well as the 2 trials in heart, 2 trials in liver. And then ultimately, we hope to have the heart approved in the second half of the year. So I think that's as much guidance as we're going to give 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 we feel like 70% to 80% is close to doubling.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [4]

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Yes. And Allen, this is Waleed. I'd like to also shed some more light in addition to what Stephen discussed. I think we feel very comfortable in the guidance we're issuing for 2020. 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 16. We could not influence the date. Now we know what the date is, so we had to factor that 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 and other Asia Pacific region. And we've done -- we discounted a lot of our Middle East revenue that we're expecting in 2020, to which I'm talking specifically about the impact of the coronavirus pandemic. So I think net-net, we have to be realistic. We have to put a guidance that we stand by, and we feel very confident in this guidance and we feel that it would be a significant year ahead of us in 2020. And we will continue to monitor the dynamics that are influencing our business globally.

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K. Gong, JP Morgan Chase & Co, Research Division - Analyst [5]

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Got it. And then when it comes to the OCS Heart approval, when you do get it approved, how should we think about the trajectory for that launch and the translation into sales? Should we think about it being more modest ahead of DCD? Or do you think you can still get some pretty healthy adoption even ahead of that?

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [6]

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Thanks, Allen. For the heart, we expect the heart adoption to be -- I would say it's not linked to DCD. We expect heart adoption to go through a cycle that will be transitioning from clinical to commercial. We know this cycle had some inertia factors in it. We hope that we -- by -- that applying the lessons learned from 2019, dealing with the lung early adoption situation, that we've learned a ton from that, and we kind of put together a ramp 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 lung, but we don't link the DCD to the approval. The approved indication is categorically different. As far as DCD is concerned, I think once the DCD is approved, that will add to a heart trajectory. But we don't look at the DCD as necessarily the main catalyst for the heart growth. We expect to see heart adoption to grow once the FDA is approved. However, we expect to go through the similar steps for transforming trial centers to commercial centers that will include the post-market registry and the like. However, we hope that the service model will address the big portion of the logistics and the infrastructure headwind that we saw with the lung. With centers we're not really ready for the broad -- the breadth of the OCS capabilities in the post-market setting, we hope that, that service model that we've established for the lung will help the heart address that specific area.

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Operator [7]

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For your next question, we have David Lewis from Morgan Stanley.

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David Ryan Lewis, Morgan Stanley, Research Division - MD [8]

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Just a few questions from me. Stephen, I know we're not going to get per organ guidance per your kind of corporate practice. But just given your commentary around coronavirus, I wasn't aware that Asia Pac was a significant contributor in 2020. So can you help us at all with the split between U.S. and ex U.S. revenue? Ex U.S. was about 35% of the business in 2019. We had it closer to 30% in 2020. Should we be assuming flattish ex U.S. trends as it relates to guidance? Up modestly? I mean, any help you can give us between U.S. and ex U.S. in light of your coronavirus commentary would be super helpful and then a couple of quick follow-ups.

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Stephen Gordon, TransMedics Group, Inc. - CFO. Treasurer & Secretary [9]

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Sure, sure. Yes, I would expect x U.S. to be about -- between 20% and 25% of our revenue in 2020. So it will grow, but certainly it will grow modestly.

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David Ryan Lewis, Morgan Stanley, Research Division - MD [10]

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Okay. Understood. And the majority of that disconnect versus kind of our prior model, you believe, is more Asia Pac contribution and just conservatism around coronavirus in Europe?

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Stephen Gordon, TransMedics Group, Inc. - CFO. Treasurer & Secretary [11]

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Well, I think it's a couple of things. I think -- and some of that is impacting it. I think if you look at just the heart, which is our primary franchise outside the U.S., I would expect that to grow probably in high single digits. And maybe that's the disconnect. Maybe we have that as a higher growth rate. But I think lung and potentially liver, those are small numbers. They -- we will see growth there in probably double-digit growth rate, but the numbers are small. So I think that's probably where the disconnect is.

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David Ryan Lewis, Morgan Stanley, Research Division - MD [12]

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Okay. Very helpful, very specific. And then, Waleed, just on heart panel. Have you had any conversations with the agency around the data heading into the panel? So question one. And then related question is just what is assumed in 2020 now? Did you take a very conservative view and just pull heart out of 2020? Or did you assume some meaningful contribution from heart in the second half of the year? And I just had one more quick one on lung.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [13]

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Sure. So relating to the first part, David, 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 FDA, and we feel very confident for -- from where we stand today about addressing any of these questions or any additional questions relating to the data.

Regarding the second question or the second part of the question, we did not assume significant contribution of the heart in 2020. We assumed some modest contribution specifically actually around Q4, but we have an ongoing DCD program that is going to contribute some growth this year. We did not do anything that is super aggressive or anything like that because we just kind of wanted to be realistic and ensure that we are learning from the 2019 early adoption and -- or the early rollout of the heart in 2020. So that's, I think, my response to that part. Stephen, would you like to add anything?

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Stephen Gordon, TransMedics Group, Inc. - CFO. Treasurer & Secretary [14]

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No, I would agree. We do have certainly contribution primarily in the fourth quarter from heart. I think we'll leave it at that.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [15]

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Right. And at the end of the day, David, even if the -- for whatever reason, the approval is delayed by a month or 45 days or 60 days, we don't see that as a meaningful impact to our revenue in 2020 nor our guidance in 2020.

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David Ryan Lewis, Morgan Stanley, Research Division - MD [16]

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Perfect. Very clear. And then lastly, Waleed, just lung traction. It actually did pop up here sequentially, which is nice to see. Can you just give us a sense, maybe a deeper dive on these commercial initiatives? Like there's the center-specific dynamic, but there's also the OPO-driven dynamic. I just wondered if this changes how you're thinking about in the future. Are you just more reliant on OPOs? Are you still as reliant on centers? And how many centers do you think you're going to add in 2020? That would be super helpful.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [17]

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Sure, sure. No, no, that's clear. So David, no, we look at the OPO and the center dynamic as complementary and supportive. We don't look at it as one way or the other. The beauty of the OPO initiative, it is not center specific. Now that lung allocation is a national allocation, we can take a lung from anywhere in the U.S. and transplant it anywhere in the U.S., which we -- with the Organ Care System, which we couldn't do before. So that helps. It also eliminates or minimizes the impact of the center-specific logistics and head count and resources that provided some headwind in the early adoption of the OCS Lung system. So providing these service initiatives both for the center and the OPO, we're hoping to see the adoption of the lung start to streamline and the growth that we're expecting start to materialize in the second half of 2020, 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 OPOs throughout 2020, and we expect that this will alleviate this concern about logistics -- center-specific logistics that is causing some headwind to a broader adoption of the OCS Lung System. And we're hoping that if it works, that once we get approval for heart or liver or any other indication, that becomes sort of the platform that we start the commercial discussions from rather than just dealing with it with that center-specific logistics alone.

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Operator [18]

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Last question, sir, we have Jason Mills from Canaccord Genuity.

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Jason Richard Mills, Canaccord Genuity Corp., Research Division - MD of Research & Analyst [19]

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Can you hear me okay?

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [20]

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We can hear you just fine.

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Jason Richard Mills, Canaccord Genuity Corp., Research Division - MD of Research & Analyst [21]

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I'd like to follow up on several of David's points and questions. How ubiquitous is your service model in lung? And can you gauge it in percentage terms relative to the market? Can you gauge it in percentage terms relative to the potential center base or OPO clientele that you would ultimately target? Is there a way to help us understand where you are and where you're going there? And obviously, where you might be going in heart and liver, although that's de minimis at this point given the approval time frames?

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [22]

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Sure. Thanks, Jason, for the question. I think it's early days, but our vision is to end 2020 fully operational in the top 8 to 12 OPOs in the country, high-volume, high-performing OPOs that are located across the United States, across all regions in the U.S. And as I said earlier, the beauty of that 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'm a little bit cautious making any assumptions. It's too early to define that, but that gives you an order of magnitude. We're hoping that by the end of the year, we'll be in -- anywhere between 8 to 12 high-performing, large-volume OPOs across the major geographical area in the United States. We're already in discussion with the vast majority of those. And we hope that throughout -- quarter-over-quarter, we will sign them up, and we'll see this program taking off. Ultimately, these lungs 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 actually started with our broad footprint in major lung transplant centers. And hopefully, once the heart is approved, heart transplant centers in this country, that makes these lungs find a home for transplantation. We're just taking the pressure of logistics and manpower and organization out of the equation.

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Jason Richard Mills, Canaccord Genuity Corp., Research Division - MD of Research & Analyst [23]

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Great. And 2 follow-ups to that. So for the benefit of those on the call that don't know the extent of the OPO network in the United States, how much would you think the top 8 to 12 high-volume OPOs represent in terms of the volume of lungs that are transplanted today or that might ultimately be transplanted if we were in an environment that extended criteria lungs were used more ubiquitously and there was a higher number of lungs transplanted in this country? That's question one. Question two is I thought you mentioned something very important earlier in your prepared remarks, which was the proposal to change the post-transplant outcomes guidelines. One thing that we discovered as we talked to clinicians or transplant centers is they're 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 if they're older in age or extended-criteria recipient sort of patients. And so could you spend a minute on that specific proposal and how you think it might impact your business over both the near and long term? And I had one quick follow-up after that.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [24]

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Sure. Thanks, Jason. So for question number one, again, without getting too granular, I think that the top 10 to 12 OPOs we're talking to and engaged with will probably represent the vast majority of organ transplants or lung transplants performed in this country or a big, big majority of 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 obviously substantial. We're talking about potentially tripling or higher the number of available lungs for transplants. And that's the exciting point.

Relating to the next -- the second part of the question, we completely understand that today, centers do not want to sacrifice their long -- short- or long-term clinical outcomes because they know if they do, CMS will disqualify them from transplant 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 lungs that otherwise wouldn't have been transplanted with a 1-year survival hovering about 3 or 4 percentage points above the national average of 1-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 OCS is one of the very few if not the only technology that can guarantee a safe increase in the supply of donor lungs and donor hearts and donor livers because we know we have the highest rate of utilization but also our clinical outcomes were not compromised. So I think the OCS provides the answer to that question. However, the national mandates were really focusing on giving these transplant centers the license and the comfort zone to say, listen, transplant is a -- cost effective, it's the treatment of choice, it's the curative treatment for these patients that are dying at a rate of anywhere between 16% and 25% on the waiting list. So to see that coming from CMS and HHS was very encouraging, and it's confirmatory to our position and our strategy and our marketplace. So that's the point I was trying to comment on.

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Jason Richard Mills, Canaccord Genuity Corp., Research Division - MD of Research & Analyst [25]

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Yes. It seems like an important one at that. And then lastly for me, David pointed it out, I don't want to go back to it. It was the first quarter since your public offering that we saw you deliver growth in U.S. lung and frankly U.S. heart as well, but U.S. lung, above our expectations, and it was up nicely sequentially. On the other hand, the international business was well below expectations. So I guess a couple of questions here. Just wanting to make sure we're level setting properly as we head into modeling out quarterly for 2020. The trends in U.S. lung, finally, given -- seem to have some tailwinds. I think David asked it one way. I'll ask it a different way. How much of that do 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 internationally, did you see any sort of onetime or some different trends in the international business that caused it to be down somewhat sequentially? Was there something in there that was an anomaly? Or can you talk a little bit about that?

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [26]

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Sure. Sure. Thanks, Jason. So on the first part of the question, I would say in Q4, it's 70-30 split. 70% is just the work that our commercial and clinical team has been putting in the lung commercial initiative to overcome the early headwinds, and about 30% of the success of Q4 came from the early service model. We are expecting -- we're tracking that percentage, and we're looking forward to -- looking what the trend would look like as we mature in that service model and add additional OPOs 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 were maturing and maturing rapidly, which, unfortunately, caused a lot of the centers to kind of hunker down, protect their operating budgets, waiting for the national reimbursement decisions to come out, anticipating that will be positive. So that was a major, how you call that, dynamic that we've seen in 2019. For 2020, we're taking the same dynamic into the year. We did not want to overestimate Europe, and we're not going to overestimate Europe until we see some major reimbursement initiatives maturing. And we are expecting one to mature in the near term here in the U.K., and we're hoping that another one will declare itself sometime in the second half of this year. So that's the -- that's what happened in 2019. We have no fundamental issues or clinical issues or technology issues that we're aware of that is causing the year-over-year growth. I think our team did a great job in the previous 2 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 are monitoring very carefully what's happening with the coronavirus. And the good news is in the numbers we're sharing and the guidance we're sharing, we've already taken out all the impact of any Asia Pacific sales completely out of the equation for 2020. And we hope that changes, but for now that's where we are.

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Operator [27]

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I am showing no further questions at this time. I would now like to turn the conference back to Mr. Waleed Hassanein.

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Waleed H. Hassanein, TransMedics Group, Inc. - Founder, CEO, President & Director [28]

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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 forward to our next call for Q1 2020. Thank you very much, and have a wonderful evening.

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Operator [29]

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