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TransMedics Group - Q2 2023

August 3, 2023

Transcript

Operator (participant)

Good afternoon, and welcome to TransMedics' Second Quarter 2023 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 replay purposes. I'd now like to turn the call over to Brian Johnston from the Gilmartin Group for a few introductory comments.

Brian Johnston (Managing Director)

Thank you. Earlier today, TransMedics released financial results for the quarter ended June 30th, 2023. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call, including during this 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, our examination of operating trends, the potential commercial opportunity for our products, and our future financial expectations, which include expectations for growth in our organization and guidance on our expectations for revenue, gross margins, and operating expenses in 2023, 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. Additional information regarding these risks and uncertainties appears under the heading Risk Factors on our Form 10-K, filed with the Securities and Exchange Commission on February 27th, 2023, 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, August 3, 2023.

With that, I will now turn the call over to Waleed Hassanein, President and Chief Executive Officer.

Waleed Hassanein (President and CEO)

Thank you, Brian. Good afternoon, everyone, and welcome to TransMedics' second quarter 2023 earnings call. As always, joining me today is Stephen Gordon, our Chief Financial Officer. The first half of 2023 was an important period for TransMedics, as we successfully executed on several operational and strategic growth initiatives. Our efforts have culminated in 2Q being our highest revenue quarter to date. We also buttressed our balance sheet with a successful convertible debt offering, and earlier this week, we entered into agreements for two acquisitions that will propel us further on our growth trajectory, both short and long term. In 2Q, we demonstrated significant commercial momentum and accelerated clinical adoption through NOP across all three organs. Operationally, we opened our new clean room on schedule and secured a second large sterilization partnership, further enhancing our production and throughput capacity.

This will better position us to meet the high and growing demand for OCS. Let me cover the specifics of our 2Q performance. In the second quarter, we achieved total revenue of $52.5 million, representing 156% year-over-year growth and 26% growth over 1Q 2023. U.S. sales represented $49 million in revenue, growing 170% year-over-year, with OUS sales up 48% to $3.5 million. We also demonstrated continued improvement down the P&L as we benefit from increasing operating leverage. Stephen will cover the detail in his section of today's call. Importantly, we buttressed our balance sheet by issuing convertible debt at highly favorable terms, which provided a net of approximately $393 million to enable us to invest in standing up the TransMedics Aviation and Logistics network.

2Q also represented another new high-water mark for case volume, driven by growth across all three organs for the first quarter in many quarters. We saw growth in Liver, Heart, and Lungs. Liver and Heart increased sequentially for the sixth consecutive quarter. Meanwhile, Lung volume was the highest we've achieved in the past eight quarters. We are planning to continue to build on this early Lung momentum and hope to see continued growth going forward. In line with our outlined growth strategy, we also grew the number of Liver, Heart, and Lung transplant programs using OCS and NOP. In 2Q, 35 Liver programs used OCS and NOP, 20 of which were active users. For Heart, there were 40 programs that used the OCS and NOP, 12 of which were active users. There were 13 Lung programs that used the OCS and NOP, five of which were repeat users.

We're encouraged by the early signs of recovery of our Lung program. However, we remain focused on continuing to grow Lung segment of our business over the next 12-18 months. In terms of NOP contribution, approximately 93% of our total U.S. case volume came from NOP. On a per organ basis, approximately 98% of Liver, 81% of Heart, and 97% of Lung cases were from NOP. As we stated before, we expect the NOP to continue to drive the lion's share of our revenue in the U.S. going forward. In 2Q, we initiated production in our new clean room right on schedule, adding more capacity to meet demand for OCS. We are currently building up and training the first and second shifts for the new clean room space.

We expect to produce over 10,000 OCS perfusion modules per year in this new clean room once it's fully staffed. In 2Q, we are able to add significant sterilization capacity by qualifying a second large sterilization partner. This will further enhance our throughput capacity going forward. Our 2Q results have once again demonstrated the growth trajectory of our business. As we described in our 1Q call, our experience operating the NOP model in the United States over the past 18 months, have shown us how inefficient and unscalable the current industry model for organ transportation logistics is. TransMedics is committed to developing a more efficient national model for organ transplantation in the U.S., by launching TransMedics Aviation as the first national transplant-dedicated logistics network.

Our goal is to control the entire end-to-end process of donor to recipient logistics, to directly manage all NOP transplant volume in the U.S. by the second half of 2024. This will help remove a critical bottleneck to our growth and to the U.S. transplant volumes broadly. We are making this investment because we are seeing NOP volumes starting to outpace the capacity, the availability, and importantly, the limited flight radius of the fragmented, older transplant air charter that is being used today. To that end, I'm delighted that we recently signed a definitive agreement to acquire Summit Aviation, one of the premier U.S. flight charter operators. This acquisition represent a cornerstone element of our strategy, designed to create a dedicated national transplant logistics network to expand the NOP reach and capacity.

Please allow me to provide more color on this important acquisition, and how we envision the next steps to getting our Aviation service operational over the next several months. From a timing perspective or a timeline perspective, this acquisition is expected to close in Q3, 2023. Subject to fulfillment of satisfactory closing conditions, we intend for Ben Walton, the current president of Summit and a veteran of the, assume the role of VP of TransMedics Aviation services. We also intend to maintain and transition the entire operations team and the majority of the pilots from Summit to TransMedics. The TransMedics Logistics team here in Andover, is currently establishing a national digital command and dispatch center that will be located in Andover, Massachusetts.

This center will efficiently deploy the TransMedics Aviation fleet from approximately eight dedicated aviation hubs, capable of covering 100% of the continental, continental U.S. We will use a data-driven approach to continue to refine the national TransMedics transplant logistical network, to maximize coverage and efficiency of the operations. We have also begun the process of acquiring several additional aircraft to expand the TransMedics fleet, to reach our target goal of initially having 10-15 operational airplanes by first half of 2024. Subject to the closing, we intend to maintain Summit's existing flight school operations for the foreseeable future, to ensure future supply of trained pilots to support the TransMedics fleet. We strongly believe this is an important strategic advantage for our long-term success.

As part of our agreement with Summit, we will have a short transition period, during which we intend to wind down all private charter and aircraft management operations to transition to a 100% TransMedics Aviation transplant-focused operation. Finally, we intend to maintain the dispatch operations in Bozeman, Montana, to complement our Andover National Transplant Dispatch and Command Center. As we are continuing to grow the NOP footprint and reach in the U.S., we must also continue to invest in expanding the NOP infrastructure to meet the significant growth in front of us. Especially or specifically, we intend to grow our surgical and field clinical staffing throughout the next 18-24 months to meet the growing demand for our NOP clinical services across the U.S.

Meanwhile, our Logistics team is working on revamping and scaling the NOP workflow and Logistics dispatch to maximize coverage and efficiency of the process. As I've stated publicly before, we at TransMedics are focusing on growing our NOP transplant volume to reach 10,000 transplants per year over the next five years. To achieve this goal, we devised a multifaceted strategy which goes as follows: First, maintain technological leadership in the field by developing a next-gen OCS platform that is optimized for NOP workflow and clinical management. This will enable scalability of the clinical case volume. Second, expand our clinical indications for the OCS platform. Finally, expand the overall TransMedics product offering. To execute on the above strategy, we recently acquired assets and IP related to two perfusion technologies from Bridge to Life.

The first was warm perfusion EVOSS technology for lung and heart transplant, and the second was cold perfusion LifeCradle for heart transplant. We plan to use unique elements of these technologies to supplement our OCS platform to accelerate the OCS next gen product development, expand our OCS Heart clinical indications to cover standard criteria Hearts that are currently preserved today using merely cold static storage. We believe that there may be a better advantage to using cold perfusion technology. Support our broad long-term effort to reignite the momentum for machine perfusion for lung transplant in the U.S. and worldwide. Then finally, expand the breadth and value of our intellectual property portfolio. We hope to have more to share about these technology development programs in the near future.

Our commercial performance over the past six quarters have demonstrated the significant and growing demand for OCS and NOP. We have successfully demonstrated our ability to significantly grow our annual transplant volume and revenue in 2022, and we are on track to deliver similar results again in 2023. It is important to note that we strongly believe that this is only the beginning. We are determined to reach our goal of 10,000 transplants over the next five years. We must, however, take the time to scale and buttress our NOP infrastructure and allow the time for integration of the Aviation and Logistics operation to grow our NOP capacity to the next level.

I can best describe it as the following: on the path to a very high TransMedics growth summit, we must stage or pace ourselves to allow for acclimatization and integration to ensure achieving our long-term growth targets. We see the next four to six months as the critical time needed to be ready for our next growth stage or wave in 2024 and beyond. Giving our strong 2Q and H1 2023 results balanced with potential scalability challenges, we are increasing our annual revenue guidance for the full year 2023 to be between $180 million and $190 million, up from our previously communicated guidance of $160 million-$170 million, and representing a 93%-103% growth over full year 2022 total revenue.

With that, let me turn the call to Stephen Gordon to cover the detailed financial results for the quarter.

Stephen Gordon (CFO)

Thank you, Waleed. I will now provide some additional details on the second quarter results and other financial information for the quarter. For the second quarter of 2023, our total revenue was $52.5 million. This is an increase of 156% from the second quarter of 2022, and a 26% sequential increase from last quarter. In the U.S., revenue was $49 million, an increase of 170% from Q2 2022 and 31% sequentially from last quarter. The organ breakdown on U.S. revenue is the following: $32.7 million of OCS Liver, $13.5 million of OCS Heart, and $2.8 million of OCS Lung. Let me repeat that. $32.7 million Liver, $13.5 million Heart, and $2.8 million Lung.

OUS revenue was $3.5 million, a 48% increase from Q2 2022. The breakdown there was $3.1 million of Heart and $0.4 million of Lung. Regarding the breakout of product and service revenue for the quarter, as a reminder, the service revenue is the added amounts we charge for the surgical procurement and organ management as part of the NOP. In Q2, product revenue was $42.5 million and service revenue was $10 million. Service revenue was 19% of the total. The gross margin for Q2 2023 was 70%. This is flat from a year ago, Q2 2022, up from 69% in Q1 2023. The margin on product revenue was 80% in Q2 2023.

That's up from 77% in Q2 of 2022, it's up from 79% in the first quarter of 2023. The margin on service was 28% in Q2 2023. That's up from 20% in Q2 2022 and up from 27% last quarter. The modest sequential improvement in margin is a result of the higher revenue in the quarter. Total operating expenses for the quarter were $37.6 million. That's 56% above Q2 2022 operating expense. We have continued to make critical investments in the company to ensure scalability to support growth. In R&D, we are developing next generation technologies and digital tools to improve OCS capabilities in the NOP process. In SG&A, we're adding resources to both our NOP as well as the company's overall infrastructure.

Operating loss for, for the quarter was $0.9 million in the second quarter of 2023. That's compared to $9.7 million loss in the second quarter of 2022, and improved from a $2.1 million loss last quarter. Our net loss for the second quarter of 2023 was $1 million even, and that compares to $11.5 million in the second quarter of 2022. Total cash on the balance sheet is $582.2 million as of June 30th, June 30th, 2023, which includes the proceeds of the convertible note that we issued in May, which provided a net cash of $393 million to TransMedics after the cost of the capped call related to the debt. Our weighted average common shares outstanding for the quarter was 32.5 million.

As Waleed mentioned earlier this week, we have signed two agreements to support our long-term strategy. First, we signed an agreement and closed to purchase the assets and IP of the EVOSS and LifeCradle technologies from Bridge to Life. Second, we signed an agreement to acquire 100% of the equity of Summit Aviation, which we expect to close in Q3. Finally, as a second step in our aviation strategy, we have purchased two aircraft in early Q3. Overall, our financial results in Q2 2023 reflected the growth and adoption and utilization of our OCS technologies and our NOP service solution. In Q3, we have made several investments to enhance, enhance both our product and services and allow us to continue to grow our business in the long run.

As a concluding statement, I'll just repeat our updated revenue guidance of $180 million-$190 million for the year, which represents 93%-103% growth over 2022. Now I'll turn the call back over to Waleed for closing comments.

Waleed Hassanein (President and CEO)

Thank you, Stephen. We are motivated and humbled by our commercial traction and execution throughout the first half of 2023. That said, and as I said before, we strongly believe that we are in the early innings of a long runway of sustained growth for TransMedics. We must now allow for the time needed to scale our NOP infrastructure, integrate our new national logistic network that will enable us to fully capitalize on our unique NOP market opportunity. Our TransMedics NOP and the broader TransMedics team are working diligently and tirelessly to deliver the best clinical support and technology for our clinical transplant programs globally. I want to take this moment to recognize their efforts and contribution. Importantly, I want to take this moment to welcome the Summit team, the entire Summit team, operations, pilots, and leadership to the TransMedics family.

We are looking forward to their contribution to transforming the field of organ transplant logistics under the TransMedics Aviation umbrella. From where I stand, I see a very bright future for TransMedics. We just need the time to continue to execute so we can reach our TransMedics global goal and summit of revenue growth. With that, I will now turn the call to the operator for Q&A. Operator?

Operator (participant)

Yes. Thank you. At this time, we will begin the question-and-answer session. To ask a question, you may press star, then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble the roster. Today's first question comes from Bill Plovanic with Canaccord.

Bill Plovanic (Managing Director and Equity Research Medical Technology Analyst)

Hey, great. Thanks. Good evening, and thanks for taking my questions. I'm gonna skip over guidance here and go right to one, just looking at the U.S. Heart number, you know, you were up, you know, $13 million and then $13.5 million. The sequential increase was maybe a little less than what investors were looking for. Yeah, that I'm sure there's some guidance translation, but I, I was wondering if you could help us understand kind of what are the challenges you're facing in terms of the scale, which you referenced in your prepared comments and the NOP, and then also, you know, have we worked through the manufacturing supply challenges?

Kinda where are you unable to meet demand, and have you missed any cases in the quarter because of, you didn't have supply? Thanks.

Waleed Hassanein (President and CEO)

Thank you, Bill. Let me start with the second part of the question. We missed cases in the quarter, mainly Lung, not because of supply chain issues, but because of logistical issues. We could not find planes to get us to where we need to be to achieve our missions. We've done the same. We lost few missions as well for Heart and Liver, as well in Q3 because of lack of logistical support and capacity in the system. Let me, as far as the other capacity constraint, it's really, we, we are, we are not satisfied by the growth we're achieving now.

We, we see even bigger growth ahead of us, Bill. With the NOP cases now are transitioning from your traditional eight to 12-hour case to 20-30-hour case, given that many of the transplant programs across the U.S. are now more comfortable allowing the organ to be managed overnight and doing the transplant procedure in the morning, to do a, you know, to have better quality and better support. That's. We need to beef up our team to be able to withstand that demand and that growth. We need to beef up our surgical capacity, but most importantly, we need to get the TransMedics Aviation and TransMedics Logistics, the, you know, the broad logistics network up and running to be able to not to lose any case going forward.

As far as specifics to the Heart, I don't see this as a, I see this as a, you know, a little bit of a blip. We're not concerned about it one bit. It's, it's part of the, the, the normal ebbs and flows that happens in transplant. We're not concerned about it and, you know, we're, we're obviously tracking all that, and we, we hope to see this recover, in Q3 and Q4.

Bill Plovanic (Managing Director and Equity Research Medical Technology Analyst)

Okay, if I could circle back to guidance. You know, the revenue guidance contemplates $86 million-$96 million in the back half of the year, and you've already done $94 million. You're essentially saying the business is going down. Can you help us understand kind of what's driving that down in the back half of the year? Or just any more granularity on the thought process behind guidance? Thanks for taking my questions.

Waleed Hassanein (President and CEO)

Sure. Thank you, Bill. Thee things. One, the second half of the year is have summer vacations, some holidays at the end of the year, that always we are concerned about and what their potential impact on the overall transplant volumes. Two, we, we need time to integrate and stand up the logistical network in the second half of the year. That's gonna require attention and, and, and we may have additional cases in the second half of the year that goes uncovered because we don't have access to third-party aircrafts until we have our own network up and operational. Three, just conservatism.

We need to be conservative, given that, you know, given the, the huge growth that we're experiencing, that we, you know, we're already on the path to doubling our revenue from last year. I don't think investors should be concerned about where we are. We, we have a bigger growth wave ahead of us, and right now it is prudent for our TransMedics team to focus on what's coming in 2024 and beyond, given where, what we've done already in 2023. I, I, I don't want, I don't want this to be misinterpreted in any way other than, we are growing, with a neck-breaking speed, and we need to take that time to acclimatize and integrate, on our way to the, to the top of the summit. We're not anywhere close yet.

Bill Plovanic (Managing Director and Equity Research Medical Technology Analyst)

Great. Thanks for taking my questions, and see you at our conference next week.

Waleed Hassanein (President and CEO)

We're looking forward to it. Thank you.

Operator (participant)

Thank you. The next question comes from Allen Gong with JPMorgan.

Allen Gong (VP)

Hi, team. Congrats on the, you know, the good quarter. You know, I just had one question on Lung. It was kind of encouraging to see that inflect upwards a little bit, given the challenges you've seen. You know, I'm also curious around, you know, the acquisition that you announced with EVOSS. How should we think about, you know, what that platform can kind of bring to OCS and what features from that you're planning to maybe incorporate into OCS to help revitalize that market?

Waleed Hassanein (President and CEO)

Thank you, Allen. We are, we're excited as well about the Lung performance this quarter. By no means we're, we're declaring victory. We're continuing to monitor the situation and continue to invest mind share in, in reviving that. There, there are other initiatives we'll be announcing in the second half of this year to help the Lung. Specifically, around the EVOSS, and OCS and, you know, you know, being fully transparent, we believe the current OCS design is far superior than EVOSS on many fronts. However, EVOSS brings two unique attributes that we think might be of a clinical importance. We need to do the studies to, to prove it or disprove it. One is the negative pressure ventilation, and two, just a better, smaller footprint.

Again, we, we need to lead the first two results of a clinical program, but we, we did not want to lose an opportunity to integrate that into the OCS and have the clinicians have access to both positive and negative pressure ventilation. That, that's, that's what we see as unique there, and we believe it, it, it might add some significant clinical benefit. We need to do the, the trials to prove it.

Allen Gong (VP)

Got it. Then, you know, just a quick follow-up on profitability. I think it was definitely encouraging to see, you know, gross margins for both the product and service piece of your business improve as well as, you know, pretty good expense control on the operating side. When we think about, you know, the, the further investments you might need to make on building out TransMedics, you know, the, the airfreight piece of the business, how should we think about that for, you know, the back half of the year once the Summit Aviation closes, as well as into 2024? Thank you.

Stephen Gordon (CFO)

Yeah. Hey, Allen, this is Stephen. Yeah, definitely, we're seeing some, you know, kind of modest improvement in margin, you know, with volume growth, but we're gonna continue to invest, you know, by incorporating Summit. You know, Summit, I think, is a, you know, a modest increase in the overall spend rate, but we're gonna bolster that with aircraft that we intend to purchase, and so we will see depreciation come onto our books, you know, for, for aircraft over the second half of the year.

Operator (participant)

Next question.

Suraj Kalia (Managing Director)

You could walk us through. That would be question number one. In terms of Bridge to Life integration with the next gen form factor, Waleed, can you give us a little more specifics in terms of how you're thinking about it, the timing of this acquisition of assets, and the incremental clinical improvements that you are thinking about that necessitated this asset acquisition? Finally, Stephen, for you, in terms of Summit Aviation, is this the end of the road, or should we start thinking, you know, 12, 18, 24 months down the line, we would need to buy more planes to complement this fleet? Gentlemen, thank you for taking my questions.

Waleed Hassanein (President and CEO)

Thank you, Suraj. Suraj, the Heart was up in Q2 over Q1. You know, the maybe not at, at, at the same pace that it was in Q1 over Q4, but it's up. It's not down, and it's not flat. You know, factors to that is, again, I- we're not concerned about it one bit. This is the ebbs and flows of organ transplantation. There were a few cases that we lost because we couldn't find planes to meet the, meet the, the, the mission. It's not the, it's not the only reason. It's just the ebbs and flows of, of organ transplant. You know, coming out of ISHLT, there may have been some, you know, confusion, confusing remarks made at ISHLT.

We, we took care of that, and we feel very strongly that the Heart will rebound in the second half of the year and going forward, and we're, we're monitoring this very closely. Net-net, we are not concerned about that dynamic one bit. The Heart is growing, and, you know, you know, we, we, we are tracking it, and we hope to report better, you know, that this issue is, it's not existence in Q3. Remind me again, what's the second half of the second part before we go to the Aviation? There was a, there was a second part.

Suraj Kalia (Managing Director)

Yeah, Waleed, I was curious about-

Waleed Hassanein (President and CEO)

Oh, the EVOSS.

The EVOSS.

The EVOSS, yes. Suraj, as you know, the next gen program for TransMedics has already started. We're not, you know, it's been, it's been ongoing for the last year. The reason for the timing for the EVOSS acquisition is three things: We think that negative pressure ventilation might add a clinical benefit to combine it with our positive pressure ventilation. We are not going to release a product that has OCS name on it, that, that has one ventilation mode. It will have both ventilation mode. To the form factor, the bottom line is, we, we need to make sure that the final form factor would be the right form factor for the OCS Lung system, that be lighter, smaller than the existing OCS platform.

That's all we can comment on at the, at the moment. Let me turn it on to Stephen to address the specific question about Summit.

Stephen Gordon (CFO)

Yeah, the, the answer, Suraj, about Summit, is this is, this is not the end all. You know, Summit is a, you know, a, a relatively smaller operator, and we need to buttress the fleet by investing in additional planes. We've already started that process, which we, we bought two early in Q3, and we're gonna continue to buy more as we go through the next 12 months. It's definitely not the... it's a beginning. It's, it's definitely not the end.

Suraj Kalia (Managing Director)

Thank you.

Waleed Hassanein (President and CEO)

Thank you, Suraj.

Operator (participant)

Thank you. The next question comes from Ryan Daniels with William Blair.

Ryan Daniels (Group Head of Healthcare Technology and Services)

Yeah, thanks for taking the questions. Congrats on the strong performance. Waleed, one for you. I think you mentioned eight aviation hubs. I'm curious how that'll correlate to the current NOP hub infrastructure, meaning, will you consolidate that a bit and change it now that you actually own the assets and, and can be a little more flexible there, given your internal ownership?

Waleed Hassanein (President and CEO)

Ryan, it's good to have you on, on our call. Thank you for the question. We are, we are exploring all of the above at the moment, Ryan. I hate to give an answer that might send people to think that there's a, there's a definitive direction. The, the definitive direction is we did the math, we based on data and historical performance and national heat map of donors, and we believe that if we put air assets at eight out of our 15 hubs across the United States, will result in nearly 100% coverage of the continental U.S. For for us, that's, that's huge. The workflow part is still underway. For workflow optimization, we might actually open new hubs. Let us do the work.

I, I hate to front run this. I want the, the, the team in TransMedics to take the time to do it right, and definitely once we have it, we will be sharing it, on our upcoming calls.

Ryan Daniels (Group Head of Healthcare Technology and Services)

Okay.

Waleed Hassanein (President and CEO)

For us, the priority is to provide 100% coverage, 100% availability, 100% coverage across the continental U.S. That is the number one priority for the network to get operational.

Ryan Daniels (Group Head of Healthcare Technology and Services)

Yeah, makes sense. Then regarding your comments about, you know, clients getting more comfortable with NOP and, and going to 20-30-hour cases, kind of improving the work-life balance and outcomes by allowing them to be in the morning versus, you know, anytime at night, I'm curious if that's something that's also driving active and repeat users and maybe increasing the overall use of NOP, such that there might be cases that, that before they didn't use it, didn't use OCS, but now just because of that luxury, in order to improve the work-life balance, they're actually moving more of their cases to the platform.

Waleed Hassanein (President and CEO)

Ryan, absolutely correct. It's not just, it's well, well beyond work-life balance at the moment. It's safer. It's safer for the patient, it's safer for the staff. It is less cost intense to have your primary transplant staff operate in the morning and actually could enable them to do multiple cases back-to-back, versus paying, you know, double time in the middle of the night with the emergency or trauma teams that are on call. It may or may not be the right talent assembled to do a safe transplant procedure. The other benefit, in addition to that, is in major academic institution, it provides a better teaching and training opportunity for the fellows that are involved in organ transplantation. It's well beyond just work-life balance for the clinical staff.

It's really, it's a comprehensive benefit, and we've, as, as you know, we've, we've, we've always stated that one of the benefits of NOP is to enable that to happen, and we're, we're, we're really glad to see this happening and taking off that soon. We expected this to be a late transition. We're seeing this transition happening sooner than what we expected. It's, it's great, but we need to make sure that we are staffed up for it and making sure that our team is fresh, safe, and ready to cover these cases for as long as they need to.

Ryan Daniels (Group Head of Healthcare Technology and Services)

Perfect. That's, that's very helpful. Then, one last one, just in regards to the potential CapEx for planes. I don't know if you mentioned this, but should we be thinking of, you know, outright purchases or leases? Then if it's a purchase, is it CapEx, you know, kind of $10 million-$12 million range, is that what we should be thinking per plane? Thanks.

Stephen Gordon (CFO)

Yeah, Ryan, I think in the near term, it is CapEx, it is purchases, and the range is pretty close to what you just described.

Waleed Hassanein (President and CEO)

Ryan, just to add to what Stephen said, the reason why we, we looked at both options, we believe strongly that this is the right initial assumption to have the best cost profile for the operation. Leasing an aircraft adds significant margin to the lessor, that we wanna make that an efficient process so we can pass some of the cost savings and efficiencies to our transplant users.

Ryan Daniels (Group Head of Healthcare Technology and Services)

Great. Thanks again for taking the questions, and congrats on all the strategic momentum.

Waleed Hassanein (President and CEO)

Thank you. Thank you, Ryan.

Operator (participant)

Thank you. The next question comes from Josh Jennings with TD Cowen.

Josh Jennings (Managing Director)

Hi, thanks for taking the questions. Was hoping Waleed to just ask a follow-up on OCS Lung franchise and just the Lung initiative that you guys have in place in, in trying to help double lung transplant volumes in the United States. I know there's been some talk on this call about the technology acquisition, but can you just help us, just remind us of, I guess, the thrust there, both in terms of collaboration with the lung transplant surgeon community and any other societies, and just the cadence of how you see OCS being adopted at a higher clip in 2024 and beyond?

Waleed Hassanein (President and CEO)

Thank you, Josh. I think, Josh, we're in the early stages of, of, of these initiatives. I think the second half of this year, we, we will start ramping up. We wanted to wait until we announced the acquisition because we believe this is gonna be one of the catalysts that will get people's attention. As you may know, in the community, there was a lot of focus on what's coming next, and EVOSS had some attention, you know, focus on it. We, you know, we wanted to get that out of the, you know, get, get that acquisition completed. We'll use that as a, as a potential catalyst, but there are other several catalysts that we're working on with the existing OCS platform.

You know, it's gonna take some time to get the next-gen Lung system integrated with negative pressure ventilation and the new form factor operational, and we, we will probably use that as a second wave of growth, not the first wave of growth. We, we have other ideas and concepts to how to we can get the Lung growing in 2024. Maybe the next-gen Lung system will be sort of late 2024, early 2025-time horizon, but we have others that we are planning to enact and implement in later this year and early next.

Josh Jennings (Managing Director)

Great, I, I apologize if this question was already asked at, at another earnings call as well. Just in terms of the, the roadmap to profitability, and you're adding the Aviation business, tucking that in, but any, any high-level comments, and I think we frequently get asked about just the revenue run rate, where TransMedics could, could hit EBITDA positivity. I don't know if there's any updated thoughts. I know that acquisition isn't closed yet, but anything on roadmap to, to profitability or just any margin impact from the, from a high level from this Summit Aviation acquisition. Thanks for taking the questions.

Stephen Gordon (CFO)

Hey, Josh, it's Stephen. Well, first, I would say we were EBITDA positive this quarter. No, it's a very good question. I would say we're not prepared to say that at this, this call about, you know, where we think it's gonna be once we integrate Aviation. It's probably gonna change. It's gonna change so much, some on the investment side, but it's also we're gonna be adding additional revenue from the Aviation, which we haven't had before. You know, give us some time to, to model that through, and we'll, we'll prepare that for future calls.

Josh Jennings (Managing Director)

Understood. Thanks, Stephen.

Operator (participant)

Thank you. This concludes the question-and-answer session. I would like to return the call to Waleed Hassanein for any closing comments.

Waleed Hassanein (President and CEO)

Thank you. Thank you all for joining us on the Q2 call. We look forward to speaking with you again for Q3. Have a great afternoon, everyone.

Operator (participant)

Thank you. The conference is now concluded. Thank you for attending today's presentation of Medtronic Central Lines.