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spk11: Good afternoon and welcome to TransMedic's third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for repay purposes. I will now like to turn the call over to Brian Jensen from Gilmartin Group for a few introductory comments.
spk00: 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 under 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, followed 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 3rd, 2022. And with that, I'll now turn the call over to Waleed Hassaneen, President and Chief Executive Officer.
spk09: 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 U.S. The continued strength and 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 control revenue, which Steven 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 2022. Notably, NOP revenue accounted for approximately 90% of the total U.S. 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 NLP clinical activities accelerated quarter over quarter. Lung activities were relatively muted in 3Q. However, as we've indicated before, we're working on a long-term initiative to revive the lung market throughout 2023. Approximately 88% of our total U.S. 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 growing to the mid-90s. as a percent of total U.S. organ cases and revenue. We are also very encouraged by the growing number of transplant centers that utilize our Transmedics NLP in 3Q. For heart, there were 26 centers that utilized NLP for heart transplants, of which 11 are frequent users, and the remainder were new users. For liver, 12 centers used NLP and all 12 were frequent users throughout the quarter. For lung, there were nine centers that used NLP, of which four were repeat users throughout the quarter. This progress, in terms of new center openings, as well as early center activity, validates a critical area of our growth strategy, as it proves that NLP is becoming more widely accepted within the U.S. transplant community. These centers are relying on transmedics to operate their transplant programs. This is huge from a competitive positioning standpoint. Again, NOP is becoming an integral part of many U.S. transplant programs' workflow, and we plan to leverage this for our future growth. It is notable that we have achieved these strong results despite being in a back-order situation for a few weeks during 3Q. as the growth and demands of the OCS accelerated beyond our immediate capacity. Our team did a phenomenal job to minimize the impact of the supply constraint by mobilizing inventory from NOP launch points to meet the clinical demands across the US. Overall, we're very encouraged by our performance, the acceleration in demand for OCS and our achievements of 100% year over year revenue growth in 22 compared to the full year 2021. a full quarter ahead of schedule. Now let me discuss our strategies to build on this momentum for the remainder of 22 and into 23 and beyond. First, we are well underway to expand our manufacturing and production capacity. As of today, we're on track to add new clean room production space that is three times the size of our existing clean room by year end. We are now focusing on staffing, training, and securing FDA certification of the new clean room space. In the meantime, we have already instituted a second shift in the original clean room space to expand our production capacity to a level that will enable us to meet the current demands. We have expanded our sterilization capacity, and we are well underway to add more capacity in early 2023. In addition, we're continuing to expand our raw material inventory to meet the growing demand and mitigate against supply chain risks. Currently, we have adequate supply of raw material to meet the demand in the near term. Second, we're working to expand our NOP infrastructure. We're expanding our surgical capabilities and clinical support staff across the board and opening new launch points to expand our geographical reach and coverage in the U.S. Third, we are focused on reviving OCS lung transplant volumes post-COVID era. We have initiated a national program with a goal to doubling lung transplant volumes in the US over the next few years. To do this, we are collaborating with leading transplant programs and as well as partnered OPOs in the US. We hope to benefit from this initiative over the course of 2023. We plan to continue to gradually increase the number of transplant centers using NLP for each organ throughout 2023. Finally, we are partnering with transplant logistics experts to create a dedicated air and ground logistical network across the U.S. to support the growing NLP transplant activities. We're actively engaged with several potential partners to create this dedicated network and have it operational sometime in 2023. Today, we have unequivocally demonstrated the strength of our NOP program to accelerate commercial growth and OCS adoption. We're 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 the next level of growth in 2023 and beyond.
spk04: Hello?
spk11: Thank you. If you would like to ask a question, please press start, flip by one on your telephone.
spk09: Excuse me, excuse me. The call got interrupted with some music. We're not done.
spk11: I apologize. Please continue.
spk09: To date, we have unequivocally demonstrated the strength of our NLP 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're 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 backwater situation in 4Q.
spk04: Please stand by. Mostly trying reconnect with today's speaker. Thank you for your patience. Today's call will continue once we have reconnected with today's speaker. Walid, you're now in the conference. You may continue.
spk09: 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 product in immediate terms. 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 back order 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 80 to 85 million for up from 67 to 75 million for the same period. This represents a phenomenal 164 to 181% growth over 2021. The guidance phrase excludes the $1.4 million adjustment based on the change in estimate of the contract revenue this quarter. Again, I want to stress that the guidance phrase 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.
spk02: Thank you, Ali. I will now provide some additional detail on the future 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 control 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 a period after our clinical trials had completed 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 but with Q2 of 2022, a good indication of the momentum we are experiencing. In the U.S., 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 U.S. The U.S. sequential growth was 21% in Q2 of 2022. So the Oregon revenue breakdown in the U.S. 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 U.S., our revenue grew 20% on a constant currency basis. However, taking into consideration unfavorable currency movement, our reported revenue was 2.4 million. This is up 6% from Q3 of 2021. And that includes 2.2 million of heart and 0.2 million of lung, which is fairly consistent with what we did last quarter. The key driver of Q3 revenue performance was, again, the growing adoption of the National OCS Program in a U.S. liver and heart. The success of this program is evident in the strong revenue performance. Gross margin for the third quarter of 2022 was 71%, compared to 70% in the third quarter of 2021. and excluding the favorable revenue adjustments, the gross margin would have been 69%. This is slightly lower than last quarter and reflects the larger NOP component. Over time, we do expect margins to gradually improve as we improve our NOP efficiency. Total operating expenses were $23.7 million in Q3 2022, a 53% increase over Q3 2021 operating expense, and a slight decrease from the $24.1 million reported in Q2 of 2022. A significant increase in expenses compared to Q3 2021 was primarily due to our commercialization effort in the U.S. and our NOP in particular, as well as R&D investment in our next-generation platform. The fairly flat sequential spending shows that we have leveled off somewhat from the pace of growth we were seeing over the last several quarters as we were ramping up our NOP teams. We do expect to continue to see growth in expenses, but at a slower pace than in the last few quarters. Operating loss was $5.5 million in the third quarter of 2022 compared to $11.7 million in the third quarter of 2021, primarily a result of the growing revenue in the business. Our net loss for the third quarter of 2022 was $7.4 million compared to $13 million in the third quarter of 2021. Cash and cash equivalents were $204.5 million as of September 30, 2022, and the increase as a result of our debt and equity financing activity in Q3 of 2022. In July, we refinanced our debt with a new $60 million term loan, which netted about $23 million of cash to the balance sheet. And in August, we completed an equity raise, which provided approximately $140 million in net proceeds. This puts Transmedics in a very strong position to continue to execute our strategy and increase OCS utilization throughout the organ transplant field. Weighted average common shares outstanding for the quarter were 30.23 million shares. And finally, I will confirm that our guidance which excludes the impact of the favorable revenue adjustment of 1.4 million is 80 to 85 million. This represents a range of 164 to 181% growth over 2021. With that, I'll turn the call back to our lead for closing comments.
spk09: Thank you, Steven. In summary, We're very pleased with our 3Q and years-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 NLP 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?
spk04: Thank you.
spk11: Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you change your mind at any time, please press star two. Please stand by whilst we order today's Q&A voice chat. The first question we have comes from the phone line of Alan Gong of JP Morgan. Your line is open.
spk01: Hi team, congrats on the 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 how have those continued from the strength you obviously saw in third quarter?
spk09: Alan, thank you for the question. 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 are cognizant of the, we're concerned about the supply chain related to finished goods inventory. So we want it to be proven in our estimation for Q4. So if we are not in this growth phase of ramping up our production capacity, 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.
spk04: Got it.
spk01: And, you know, I think given you're being a little, you know, you seem to be a 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 know, you've previously talked about your ambitions to essentially, you know, double revenues again in 2023 and maybe even 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?
spk09: From a high-level goal, Alan, 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 expectation 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 U.S. and the NLP and the acceleration of our adoption in the U.S. across the three 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.
spk01: If I could sneak a final quick one in, you know, you're talking about the next gen OCS system. We've also heard you mention ambitions and other organs like kidney. Should we expect to get, you know, more concrete, additional concrete updates next year? And do you have any preliminary expectations around timelines for both of those product updates? Thank you so much for the question.
spk09: Thank you, Alan. 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.
spk04: Next question, please, operator. Operator?
spk11: Thank you. We now have Cecilia Furlong of Morgan Stanley. Your line is now open.
spk05: Great. Good afternoon and thank you for taking the questions and congrats on the quarter. I wanted to start just with the guidance and how you're thinking about 4Q. You had 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.
spk09: Great. Thank you, Cecilia. We don't expect air transport to be at all an influence, negative influence in Q4 or even in early 2023. You know, 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, that we will start witnessing that in, you know, 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.
spk05: Okay, great. And 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 a ceiling? 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 too on NOP expansion in HEARTS specifically, how you're thinking about further expansion in 4Q with NOP in HEARTS and really where you're seeing utilization either DBD or GCD, and thank you for taking the questions.
spk09: Thank you, Cecilia. So on the first part of the question, I'm sorry, Cecilia, can you repeat the first part of the question, please? Oh, on the guidance? Is there an upside to the guidance? Yes. Yeah. Yeah, 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 three weeks of vacation holiday time between Thanksgiving and Christmas and New Year's. And we're dealing with this potential risk of another week or two of back order situation. This is why we want it 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 want it to be realistic with the expectations. The second part, 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 I think the big lesson and the big metric that we learned from 22 is small number of centers, there's 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.
spk05: Great. Thank you for taking the questions. Again, congrats on the quarter. Thank you.
spk08: Thank you. Thank you, Cecilia. Operator, can we go to the next question, please?
spk11: Thank you. We now have Mr. Stuart Jennings of Cowen. Please go ahead when you're ready.
spk12: Hi. Good afternoon. Thanks for taking the questions. Another strong quarter. Wanted to ask Waleed and Steven just about the market growth. One of those databases suggests that transplant vines are growing which is a low double-digit range, at least in 3Q, and 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 OP are affording? 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 U.S. transplant network. There's evidence now that the OCS is growing the market as you stated in the earlier scroll, but any way to quantify it and can that have an impact?
spk09: Thank you, Josh. Yeah, we are definitely playing a big role in the growth in the transplant volumes in the U.S. The source of growth is really multifactorial, Josh. The source of growth is coming from DCD. It's coming from DBD. It's also coming from more centers are comfortable with NOP. And you asked me, how is that going to grow the volume? I 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 OR, doing either transplant or doing another surgical procedure, and they get a donor offer, historically, they would turn down that donor offer because they're 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 their time allows to do the transplant procedure. And I've heard this from several institutions across the three organs, not just in one 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 DVD organs, either that are long distance, older age, or that normally would not be utilized. And through the logistical piece of historical data 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, you know, these big, you know, federal organizations, they're focusing on just you know, 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.
spk12: You definitely did. Thanks. I just want to follow up on, you know, we've talked to some surgeons that are, I think there was a paper published by, I think, National Academy of Sciences earlier this year with some recommendations on how to going to restructure the U.S. transplant network. And one of the proposals was a donor organ unit. And some surgeons expressed interest in establishing those, but also setting up perfusion units as well in this combination. Can you just help us understand that setup better and maybe any thoughts on the prospects of that coming to fruition? Thanks for taking the questions.
spk09: Thank you, Josh. And 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 structure where they can salvage Oregon 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 increase in 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 constraint of the transplant systems in the U.S., working through that same workflow and the same individual center 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 um um you know where it was sitting for several hours um you know so that you know again that's that's our vision that's our view on this particular paper. I think that the paper is trying to, was trying to come up with a creative solutions before the NOP was a mainstream. Now the NOP is mainstream and we continue to, we believe it will continue to grow in the US throughout next year.
spk12: Thanks for helping us think through that. Appreciate it.
spk11: Thank you. Thank you. We now have the next question from Bill. Please go ahead when you're ready.
spk06: Great. Thanks. Good evening. I'd just like to dig into the supply constraint challenges a little more. Help us understand, you know, is this a raw materials? Is it in the capital side, the disposable side, the solution side? Is it organ specific? You know, what exactly is it? Or is it you just need to run more shifts, you can't get products 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 know, you have a champagne problem that demands exceeding supply. And so kind of, you know, and is this a near term problem you're facing that will get resolved sooner rather than later? Or is this something that, you know, will linger on and won't won't be resolved until you have increased capacity, as you noted, which is end of this year, next year, depending on FDA clearance or approval of the site. Thanks.
spk09: Thank you, Bill. 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're, we don't have any issues with solutions. Zero, none. We have inventory of solutions to last us for at least 18 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're working on expanding the footprint of a new clean room that is three times the size of the old clean room. So now, what are the risks? we see the risks as really near term over the next one or two 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 one or two quarters maximum. As far as the the certification of the clean room. We are in active dialogue with the FDA and we have very fair degree of confidence that this is going to be a 30 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 us, when you say a superfusion module... The actual cassette, 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 a 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 a mid- and long-term, even further increase in that capacity, you know, because we did not want to solve for the production piece and forget about sterilization. So we're on it. And we've already achieved some efficiencies for the near-term. Now it's just cranking. cranking the gears and building more of these disposables.
spk06: So it sounds like you've, you know, in your earlier comments, you've pulled all your disposable inventory that wasn't productive in the field. You've been shipping it around and moving it, which is probably why your cogs are higher. You're running OT and you're trying to put out as much as you can. You know, I think you mentioned that your labor TAB, Mark McIntyre:" kind of took a little longer to get up and running the training the folks whatever but they're up now, why wouldn't it be I don't understand like. TAB, Mark McIntyre:" 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 them out at this point i'm just trying to understand. TAB, Mark McIntyre:" Our hand, are you concerned that. TAB, Mark McIntyre:" We are hand hiccup down the line yeah.
spk09: TAB, Mark McIntyre:" Exactly, we are we are hand to mouth at this point, though. And we don't like that. And with hand-to-mouth, there's 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. Gotcha.
spk06: Okay, thanks for the granularity. I think that's really helpful for all of us, especially as it related to guidance. And then, you know, if you think about, I'll just ask one more, and that's on the lung, you know, 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 because it's almost like running a full another clinical trial to get all the the patient sign-offs 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 thanks for taking my questions sure sure thank you bill um re-engaging with fda on um on updating the design of the post-approval study is is a part of that um
spk09: 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 get the community focused back again on lung transplant and show them the success of NLP in heart and liver and the amount of growth that these organs have been experiencing in the U.S. 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.
spk06: Thanks for taking my questions.
spk10: Thank you, Bill.
spk11: We now have Another question on the line from Siraj Kalia of Oppenheimer. Your line is now open.
spk07: Good afternoon, Waleed. Stephen, can you hear me all right?
spk09: I can hear you just fine.
spk07: Hi, Siraj. Perfect. Gentlemen, congrats on a nice quarter. So, Waleed, three questions from my side. You know, liver approval, I believe, was in November 21, if memory serves me right. DCD heart was sometime late Q1 22. Well, if we were to map out liver adoption and heart adoption, how are you seeing the slope of the adoption curves of these two organs? What is different? And if so, what is causing it?
spk09: 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 the liver really jumped on the NLP bandwagon quicker, and that resulted in the uplift of the liver. But we said the heart will be shortly thereafter, and we've seen 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.
spk02: 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 trajectories. And I don't know if the approval is as much as the utilization of the NLP, which is really driving the slope of these curves.
spk07: Right. I was just curious if there was anything clinical or, you know, just in terms of the excitement in one organ versus another. It looks like there is, and so fair enough. Well, you mentioned about frequent NOP users. I believe 11 in heart, 12 in liver, so on. So when a transplant site is a frequent NOP user, what would cause them to use NOP plus OCS in one 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, how do you define frequent?
spk09: 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 three to four OCS usage per month for a center to qualify as a frequent user. So, you know, the centers that we call users, but not frequent users, are the centers that use it, you know, early centers, like the heart, the few centers that joined in Q3, they did one, two, maybe, you know, three. So we expect those to ramp up in the same trajectory. We don't expect centers to be onesies, twosies. If they are, they won't last because there are many centers that are, once they try the NLP, once it works, they don't stop. And you don't expect to see these kind of staccato movements that we used to see during the trial. And when that happens, we move on and focus on other centers that are effective. 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 three to four times per month throughout the quarter consistently.
spk07: Okay, that's great, Claire, additional information. Finally, Waleed, from my side, Waleed, you have given a lot of clarity in terms of some of the supply issues, labor, you know, manufacturing, or rather the facility inspections and all that. If I take a step back, Waleed, you know, this is a pretty complex field, right? And I remember from the ThorTech hardware 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 to 2x, 3x, the current levels? Gentlemen, thank you for taking my questions, and congrats again.
spk09: Thank you, Suresh. Suraj, it's what we said. Actually, we are not going to make the same mistakes that others may have done in the past. One of our main reasons for us to be 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 corner 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's a weak link, I don't deserve to be here. So we are making sure that every aspect of our quality chain is addressed taking 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? Yeah, 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.
spk08: Thank you.
spk11: Thank you. We have no further questions on the line, so I'd like to hand it back to Waleed for any final remarks.
spk09: Thank you. Thank you so much for your time, and I apologize about the technical difficulties.
spk10: Have a wonderful evening, everybody.
spk11: Thank you all for joining. This does conclude today's call. You may now disconnect your line.
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