Good afternoon, and welcome to TransMedics Third Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Brian Johnston from Gilmartin Group for a few introductory comments.

Thank you, operator. Earlier today, TransMedics released financial results for the quarter ended September 30, 2022. 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, including during the question-and-answer section that include forward-looking statements within the meaning of federal securities laws. 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, are examination of operating trends, the potential commercial opportunity for our products and our future financial expectations, which include expectations for growth in our organization, regulatory approvals and reimbursement and guidance and/or expectations for revenue, gross margins, and operating expenses in 2022 are based upon 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. Additional information regarding these risks and uncertainties appears under the heading Risk Factors on our Form 10-Q filed with the Securities and Exchange Commission on August 3, 2022, and our subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov and on our website at www.transmedics.com. 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, November 3, 2022. And with that, I'll now turn the call over to Waleed Hassanein, President and Chief Executive Officer.

Thank you, Brian. Good afternoon, everyone, and welcome to TransMedics Third Quarter 2022 Earnings Call. As always, joining me today is Stephen Gordon, our Chief Financial Officer. Throughout 3Q, our commercial momentum continued to accelerate as NOP clinical transplant activity grew across liver and heart procedures in the US. The continued strength in demand for OCS further validates our growth trajectory and enabled us to deliver strong results once again as we posted the fourth sequential period of record year-over-year growth. Total net revenue in 3Q was $25.7 million. This includes new product revenue of $24.3 million and a $1.4 million favorable adjustment in the estimate of accrued clinical trial contra revenue, which Stephen will detail later on this call. New product revenue alone represents 349% growth year-over-year and 18% sequentially. Year-to-date 2022, we have achieved $62.1 million in revenue or $60.7 million, excluding contra revenue adjustment. This represents more than 100% year-over-year growth over the full year of 2021, and we still have Q4 remaining in '22. Notably, NOP revenue accounted for approximately 90% of the total US revenue in the third quarter, and we expect this to continue to grow. Stephen will cover the detail and organ split in his section of this call. Now let me provide some more granular highlights. For the third sequential quarter, liver and heart NOP clinical activities accelerated quarter-over-quarter. Lung activities were relatively muted in 3Q. However, as we've indicated before, we are working on a long-term initiative to revive the lung market throughout 2023. Approximately, 88% of our total US case volume came from NOP. On a per organ basis, approximately 95% of liver, approximately 81% of heart and approximately 67% of lung cases came from NOP. As we move forward, we expect to see NOP contribution to remain high and…

Thank you. [Operator Instructions]

Excuse me. The call got interrupted with some music. We're not done.

I apologize. Please continue.

To date, we have unequivocally demonstrated the strength of our NOP program to accelerate commercial growth and OCS adoption. We are confident in our go-forward strategy and scalability initiatives we discussed above. We fully expect to leverage these initiatives to further capitalize on our unparalleled foothold in the market and drive to the next level of our growth in 2023 and beyond. As mentioned, 3Q results continue to outpace our forecasted demand plans and challenge our finished goods inventory. We are fully cognizant that as we are aggressively expanding our production capacity and infrastructure, we may experience some temporary shortage in supply of finished OCS products in the immediate term. Importantly, we need to allow the proper time to ensure that we are growing our production with the highest quality staff, training and products. During this ramp-up process, we may find ourselves in another backorder situation in 4Q. [Technical Difficulty]

Please standby whilst we try and reconnect with today's speaker. Thank you for your patience. Today's call will continue once we have reconnected with today's speaker. Waleed, you're now in the conference. You may continue.

Sure. I apologize about these technical difficulties, everyone. Let me repeat the last paragraph, and we will continue. As mentioned, 3Q results continue to outpace our forecasted demand plans and challenge our finished goods inventory. We're fully cognizant that as we are aggressively expanding our production capacity and infrastructure, we may experience some temporary shortage in supply of finished goods OCS products in the immediate term. Importantly, we need to allow the proper time to ensure that we are growing our production with the highest quality staff, training and products. During this ramp-up process, we may find ourselves in another backorder situation in 4Q. That said, based on our 3Q and year-to-date results and balancing these results with the expected -- with expected finished goods pressures. For the third sequential quarter, we are raising our annual revenue guidance for the full-year 2022 to USD80 million to USD85 million, up from USD67 million to USD75 million for the same period. This represents a phenomenal 164% to 181% growth over 2021. The guidance raise excludes the $1.4 million adjustment based on the change in estimate of the contra revenue this quarter. Again, I want to stress that the guidance raise excludes the $1.4 million adjustment experienced in Q3. With that, let me turn to Stephen Gordon to cover the detailed financial results for the quarter.

Thank you, Waleed. I will now provide some additional detail on the Q3 results and other financial information for the quarter. As Waleed mentioned, we had a favorable $1.4 million change in estimate in Q3 related to contra revenue that was accrued during the clinical trial phase of several programs. And now we've updated our estimates, resulting in a lower amount of clinical trial payments expected to be paid, and therefore, we see a favorable impact to revenue. So for the third quarter of 2022, I want to focus on the commercial or gross revenue, which represents the true commercial revenue for the quarter. Commercial revenue for the quarter was $24.3 million. This was an increase of 349% from the third quarter of 2021. As a reminder, the third quarter of 2021 was the period after our clinical trials had continued enrollment and for the most part before we received our FDA approval, so revenue in that period was fairly low. The reported $24.3 million for Q3 2022 also represents 18% sequential growth over Q2 of 2022, a good indication of the momentum we are experiencing. In the US, the revenue, again, excluding the $1.4 million favorable revenue adjustment, was $21.9 million. This compares to only $3.2 million that was reported in Q3 of 2021 in the US. The US sequential growth was 21% in Q2 2022. So the organ revenue breakdown in the US was as follows. $12.4 million of liver, $8.2 million of heart and $1.3 million of lung. And I'll repeat that again; $12.4 million of liver, $8.2 million of heart and $1.3 million of lung. Outside of the US, our revenue grew 20% on a constant currency basis. However, taking into consideration unfavorable currency movements, our reported revenue was $2.4 million. This is up 6% from…

Thank you, Stephen. In summary, we're very pleased with our 3Q and year-to-date performance and the strong clinical demand we are experiencing for our OCS technology and NOP offering. We strongly believe, however, that we are just at the early stages of capitalizing on the significant greenfield opportunity that we've created in the transplant space. We plan to leverage the solid foundation we established in '22 to drive TransMedics to the next level of growth for our business in 2023. TransMedics' OCS technology and NOP program are becoming an integral part of performing organ transplants in the US. Now, our goal is to leverage this structure to ensure that we are managing the vast majority of heart, liver and lung transplants, while we are growing the annual transplant volumes in the US. We're thrilled for the future of TransMedics, and look forward to further capitalizing on our global leading position in transplant therapy. With that, I will now turn the call to the operator for Q&A. Operator?

[Operator Instructions] The first question we have comes from the phone line of Allen Gong of J.P. Morgan.

Congrats on a great quarter, and thanks for the question. So I guess, the first question I have is, we clearly saw that even with a little bit of backlog in third quarter, you came in pretty high above expectations and based on the guidance raise, you essentially raised fourth quarter expectations by around the same amount. So how much of that is really influenced by just the trends you've seen so far in October and I guess, like to have those continued from the strength you obviously saw in the third quarter?

Really, the trends we're seeing in October has no influence whatsoever on the guidance. To the contrary, we're seeing acceleration in October. But we're cognizant of the -- we are concerned about the supply chain related to finished goods inventory. So, we wanted to be prudent in our estimation for Q4. So, we were not -- if we are not in this growth phase of ramping up our production capacity, it maybe -- the guidance would have been different. But this is why the guidance is what it is, because we wanted to apply some level of conservatism given where we are in the ramp-up phase.

Got it. And I think given you're being a little -- you seem to being little conservative, but it sounds like a lot of these supply challenges, manufacturing work should be done by the time you get into 2023. You've previously talked about your ambitions to essentially double revenues again in 2023 and maybe even in the years after that, similar to what you're on track to do this year. Is that a reasonable target that you're still holding to, given the momentum that you're seeing and the fact that you should be in a much better supply situation come the New Year?

From a high-level goal, Allen, again, we believe that the success we've achieved in '22 and the rapid acceleration is just the tip of the iceberg. That's what we believe. I would not comment yet on our expectations for '23. We will do that in the beginning of the year. And as always, we are going to be prudent and realistic in our estimation. But at a high level, our expectation is TransMedics is in the early innings of a significant growth curve, driven primarily initially from the US NOP and the acceleration of our adoption in the US across the 3 organs we are working with. So that hasn't changed. In fact, the results of '22 validates that. But we'll comment on the guidance for '23 early next year.

If I could sneak a final quick one in. You're talking about the next-gen OCS system. We've also heard you mention ambitions in other organs like kidney. Should we expect to get more concrete -- additional concrete updates next year? And do you have any preliminary expectations around timelines for both of those product updates?

I think next year, we are going to discuss both. That's our expectation, leading with the next generation -- first phase of the next generation. And hopefully towards year end of '23, the kidney might play a role. Next question please, Operator? Operator?

We now have Cecilia Furlong of Morgan Stanley.

Great. Congrats on the quarter. I wanted to start just with the guidance and how you're thinking about 4Q. You talked previously about some air transport constraints. How that situation is playing out? And then, just really what you're thinking or what's contemplated either from lung recovery, what you're seeing in heart recently? Just would love kind of a broader take on organ specific contributions in 4Q

Great. We don't expect air transport to be at all an influence -- negative influence in Q4 or even in the -- in early '23. As far as the heart momentum, we expect that to grow. We expect liver to grow and we expect lung to grow. However, lung, I think it's prudent to assume that lung growth, we will start witnessing that in Q1, Q2 '23 rather than in Q4. But we expect -- again, we see no risks to Q4 revenue from air transport. We expect the heart momentum to continue to accelerate. We expect the liver momentum to continue to accelerate and we're hopeful that the lung will begin the recovery in Q4, but I think tangibly, we will start looking at that in Q1 and Q2 of '23.

Okay. Great. Then if I could follow up as well, just -- as you're thinking about guidance and the supply -- potential supply dynamics, does the high end of your guidance right now really represent the feeling, could we see upside just as we sit here today looking at supply pressures that could potentially arise? And then just wanted to follow up to on NOP expansion in heart specifically. How you're thinking about further expansion in 4Q with NOP in heart and really where you're seeing utilization, either DBD our DCD?

So on the first part of the question -- I'm sorry, Cecilia, can you repeat the first part of the question, please, on the guidance? Is there upside to the guidance?

Yes.

Yes. The only risk we see that made the guidance what it is, is the supply chain issue. We're dealing with two things in Q4. We're dealing with a short quarter because of the approximately 3 weeks of vacation holiday time between Thanksgiving and Christmas and New Year, and we're dealing with this potential risk of another week or two of backorder situation. This is why we wanted to be prudent and conservative. We don't see any other risks in Q4 other than the finished goods inventory production that we were talking about. Is there an upside? We're hopeful, but we wanted to be realistic with the expectations. The second part.

Number of centers.

As far as growing the number of centers and number of hubs, we are growing the number of hubs in Q4, but we are more focused on the growth in the number of centers and making sure that those new centers that came in Q3 become repeat centers in Q4. And that's going to generate its own momentum, and we're adding new centers in the heart and we're doing the same thing for the lung. I think the big lesson and the big metric that we learned from '22 is small number of centers, there is a significant leverage with a small number of centers that are regularly adopting that could generate significant acceleration in revenue. So right now, we are increasing the number of centers. Now we're focusing on driving repeat utilization from NOP. Operator, can we go to the next question, please?

We now have Joshua Jennings of Cowen.

Congratulations on a strong quarter. Wanted to ask Waleed and Stephen just about the market growth. Those databases suggest that transplant volumes are growing in the high single-digit to low double-digit range at least in 3Q [indiscernible], seems like in October as well. OCS is the new technology that's been added to the market. Is there any way to parse out the market growth contribution that OCS and NOP reporting? And the reason I'm asking is I want to know if there's any kind of read-through as CMS and HHS and Congress are working to transform the US transplant network? There's evidence now that the OCS is growing the market as you stated in the earnings call. But any way to quantify it? And can that have an impact?

Yes, we are definitely playing a big role in the growth in the transplant volumes in the US. The source of growth, it's really multifactorial, Josh. The source of growth is coming from DCD, is coming from DBD, it's also coming from more centers are comfortable with NOP. And you ask me how is that going to grow the volume? I'll give you one anecdotal example. Several centers in Q3 commented to us directly that with the NOP, historically, when the center is busy, meaning the surgeons are busy in a OR doing either transplant or doing another surgical procedure and you get a donor offer, historically, they would turn down that donor offer because they are busy. Now with the NOP, they would accept that donor offer, send the NOP team to procure the organ, bring it back, keep it overnight or stagger it when the OR is free and when the time allows to do the transplant procedure. And I've heard this from several institutions across the 3 organs, not just in 1 organ. So yes, we think the OCS and the NOP are playing a key role in growing the transplant volume by accessing more DCD, accessing more DBD organs, either that are long distance, older age or that normally would not be utilized and through the logistical piece of historical logistical challenges that transplant programs are not able to accept organs while they're busy doing another transplant procedure, today, they can do that. Now to address your part about the national initiatives from CMS and HHS. I think we're still in the early innings, Josh. I think these big federal organizations, they're focusing on just keeping up with what's going on. I think over the next year, however, we expect them to be more and more aware as the numbers continue to grow. I hope I addressed your questions.

You definitely did. And just one follow up on -- we've talked to some surgeons that are -- I think there was a paper published by the National Academy of Sciences earlier this year with some recommendations on how to kind of restructure the US transplant networking. One of the proposals was a donor organ unit that some surgeons expressed interest in establishing those, but also setting up perfusion unit as well in combination. Can you just help us understand that setup better and maybe any thoughts on the prospects of that coming to fruition?

Josh, the paper you're referring to, that paper was drafted before NOP became a reality in the United States. So what they were trying to do is without the knowledge of NOP, trying to create something, a pseudo-type structure where they can salvage organ and keep them in a centralized location. That was the extent of their horizon, given their lack of knowledge of the NOP. Today, that concept doesn't make any sense. It adds cost, it adds complexity, it adds time unnecessarily. And frankly, when it was tried, it never really resulted in increasing organ transplants. We believe that the NOP is here to stay. The NOP is the most seamless way of growing the transplant volume, working within the current constraints of the transplant systems in the US, working through that same workflow and the same individual central control over their volume or over their cases as they're doing it today rather than centralizing things and shipping things in the middle of the night without knowing what happened to the organ where it was sitting for several hours. So, again, that's our vision, that's our view on this particular paper. I think the paper is trying to -- was trying to come up with creative solutions before the NOP was the mainstream. Now the NOP is mainstream and we continue to -- we believe it will continue to grow in the US throughout next year.

We now have the next question from Bill Plovanic with Canaccord.

Great. I'd just like to dig into the supply constraint challenges a little more. Help us understand, is this raw materials? Is it in the capital side, the disposable side, the solution side? Is it organ specific? What exactly is it? Or is it you just need to run more shifts? You can't get product sterilized. Help us understand so that we can understand the guidance and kind of what those limitations are and what you're doing to mitigate those risks near term. You have a champagne problem that demand is exceeding supply. And so kind of -- and is this a near-term problem you're facing that will get resolved sooner rather than later? Or is this something that will linger on and won't be resolved until you have increased capacity as you noted, which is end of this year, next year, dependent on FDA clearance or approval of the site?

So let me dissect that situation. We don't have any issues with raw material for the foreseeable future over the next 18 months. We don't have any issues with -- the big issue that -- we don't have any issues with solutions. Zero, none. We have inventory of solutions to last us for at least 18 months to 24 months, and we have several orders coming throughout next year. The big problem is, or the big issue is the throughput on the production floor in the area of perfusion modules. And this problem peaked its head at end of Q2. We took some aggressive actions to increase the number of heads, double the shift. It took time to get to full double shift and while we are working on expanding the footprint of our new cleanroom that is 3 times the size of the old cleanroom. So now what are the risks? We see the risks as really near term over the next 1 or 2 quarters. We do not expect this to be a lingering effect. We are working very hard to make sure it is not a lingering effect because we can do this once, but we want to get out of this situation within the next 1 or 2 quarters maximum. As far as the certification of the cleanroom, we are in active dialogue with the FDA, and we have very fair degree of confidence that this is going to be a 30-day to 60-day process compared to anything longer than that. But until it's done, it's not done. So that's our situation.

And just for perfusion modules.

The actual [prefect] -- the actual disposable unit that goes with every organ, not the hardware. It's not a hardware issue. It's not a sensor issue. It's not solution issue. It's not a raw material issue. It's really the assembly part of the raw material into an active sterile perfusion module. As far as sterilization capacity is concerned, Bill, we've increased near term our sterilization capacity. We're working on the mid and long term, even further increasing that capacity because we did not want to solve for the production piece and forget about sterilization. So, we're on it and we already achieved some efficiencies for the near term. Now it's just cranking the gears and building more of these disposables.

So, it sounds like you've -- in your earlier comments, you've pulled all your disposable inventory that wasn't productive in the field. You have been shipping it around and moving it, which is probably why your COGS are higher. You run an OT and you're trying to put out as much as you can. I think you mentioned that your labor kind of took a little longer to get up and running, training the folks, whatever, but they're up now. Why wouldn't it be -- I don't understand like why can't you increase sequentially? Or is it just a function, you were just sucking out any inventory in the field and you're kind of hand to mouth at this point? I'm just trying to understand that were you concerned [about a] hiccup down the line?

Yes. Exactly. We are hand to mouth at this point, Bill. And we don't like that. And with hand to mouth, there is always hiccups. So that's why we have to be prudent. And what we're trying to do is over the next couple of quarters start building strategic reserves like we used to have in Q1 and early Q2. Right now it's literally hand to mouth.

Got you. Okay. Thanks for the granularity. I think that's really helpful for all of us, especially as it related to guidance. And then as you think about -- I'll just ask 1 more and that's on the lung. You talked about, that's been a little slower for you. Have you had any luck with the FDA, or any discussions with the FDA in changing the post-approval study? Because from my understanding that was one of the big limitations. It's almost like running a full another clinical trial to get all the patients sign-ups and what have you. And that's been a big barrier to kind of just commercializing that product. So, any update on activity with the FDA and kind of expectations there?

Sure. We're engaging with FDA on updating the design of the post-approval study as a part of that national initiative that we are leading to revive the lung. That being said, that is not the main driver here. It's a key part, but it's not the main driver. The main driver is we need to get the lung transplant community in this country, laser-focused again on lung transplantation in the post-COVID era. COVID caused a lot of the transplant program to be distracted from lung transplantation and it became even further consolidated. So, we need to just to get the community focus back again on lung transplant and show them the success of NOP in heart and liver and the amount of growth that these organs have been experiencing in the US as a proof of concept that if they can apply the same model, they can achieve the same results, which is growing their transplant volume without growing their workload, without growing their staffing needs. And now, we have the tangible proof of that. It's no longer a hypothesis or a vision. It's actually happening. They're seeing it. Some of them are seeing it even in their own institutions. So, these are the two-pronged approach that we are pursuing to revive the lung program.

We now have another question on the line from Suraj Kalia of Oppenheimer.

Waleed, Stephen, can you hear me all right?

We can hear you just fine.

Perfect. Gentlemen, congrats on a nice quarter. So, Waleed, 3 questions from my side. Liver approval, I believe was in November '21 if memory serves me right. DCD heart was sometime late Q1 '22. Waleed, if we just -- if we were to map out liver adoption and heart adoption, how are you seeing the slope of the adoption curves of these 2 organs? What is different? And if so, what is causing it?

As we sit here, we don't see a difference. We do not see a difference at all. The difference was early in the year when liver really jumped on the NOP bandwagon quicker and that resulted in the uplift of the liver. But we said, the heart will be shortly thereafter and we're seeing that. We saw that in Q3. So, I think our original statement will prove to be true. Liver and heart will catch up with each other by end of this year or Q1 of next year.

And Suraj, this is Stephen. So just the number sequentially, heart sequentially grew about 40%, liver sequentially grew about 30%. So, they're both on pretty good trajectory. I don't know if it's the approvals as much as the utilization of the NOP, which is really driving the slope of these curves.

Right. I was just curious if there was anything clinical or just in terms of the excitement in 1 organ versus another. Looks like there isn't. So fair enough. Waleed, you mentioned about frequent NOP users, I believe 11 in heart, 12 in liver, so on. So when a transplant side is a frequent NOP user, what would cause them to use NOP plus OCS in 1 organ and maybe not use it the next month? And maybe if you could just kind of clarify or give us a little more granularity in what does -- how do you all define frequent?

Sure. Actually, I was going to answer the question exactly that, Suraj. So, what we define as frequent is actually a center that doesn't stop using the OCS month over month. And we have a minimum of 3 to 4 OCS usage per month for a center to qualify as a frequent user. So the centers that we call users but not frequent users are the centers that use it early centers like the heart, the few centers that joined in Q3. They did want to -- maybe 3, so we expect those to ramp up in the same trajectory. We don't expect centers to be onesie-twosies. If they are, they won't last because there are many centers that are -- once they try the NOP, once it works, they don't stop. And we don't expect to see these kind of staccato movements that we used to see during the trial. And when that happens, we don't -- we move on and focus on other centers that are more engaged. And it's only a matter of time when these centers come back and -- because they're seeing momentum in the region. So, that's the definition of an active user. An active user is a center that -- our definition of an active user are centers that are using the OCS at a very high rate and minimum of 3 times to 4 times per month throughout the quarter consistently.

Okay. That's great additional information. Finally, Waleed, from my side. Waleed, you have given a lot of clarity in terms of some of the supply issues, labor, manufacturing or rather the facility inspections and all that. If I take a step back, Waleed, this is a pretty complex field, right? And I remember from the Thoratec, HeartWare days, right, you start ramping up and then somewhere there might be a quality hiccup, right, which might cause advisory notice. As you look at OCS in the current manufacturing chain, in the production chain, what is the weakest link for quality control that you're like, you know what, we need to keep an eye on this as we ramp up the 2x, 3x, the current levels?

Suraj, it's what we said. Actually, we are not going to make the same mistakes that other may have done in the past. One of our main reason for us to being very prudent is exactly what I stated in my script, that we need to give it the proper time for attracting the right talent, training them adequately and ensuring that we have the highest quality product to leave our floor. We are not going to cut corners in our quality of our product. As we stand here, we do not see a weak link in our quality process. If I'm standing here and I know that there is a weak link, I don't deserve to be here. So, we are making sure that every aspect of our quality chain is addressed, taken care of. We're allowing the time for the team to be ready and we're not demanding them to triple the production capacity overnight. We're doing it in stages. We're making sure that the quality metrics are met. We're really being very prudent and giving them the appropriate time to scale to avoid these issues from happening. Could something happen that we're not aware of? Yes, everything is possible. But again, the key for us is to give it the proper time, proper training, making sure our quality metrics are met before we even release the product to the market. So, we're not going to cut corners to meet the supply demand. We have to make sure that our product quality is of the highest category because that's what's going to sustain this business and help us grow it.

Thank you. We have no further questions on the line. So, I'd like to hand it back to Waleed for any final remarks.

Thank you. Thank you so much for your time. And I apologize about the technical difficulties. Have a wonderful evening, everybody.

Thank you for joining. This does conclude today's call. You may now disconnect your line.