Ladies and gentlemen, thank you for standing by, welcome to Vericel's Second Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. I would also like remind you that this call is being recorded for replay. I will now turn the conference call over to Eric Burns, Vericel's Vice President of Finance and Investor Relations. Please go ahead.

Thank you, operator and good morning everyone. Welcome to Vericel's second quarter 2023 conference call to discuss our financial results and business highlights. Before we begin, let me remind you on today’s call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may evolve risks and uncertainties that could cause actual - results to differ materially from expectations and are described more fully in our filings with the SEC, which are available on our website. In addition, all forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. Please note that a copy of our financial results press release is available in the Investor Relations section of our website. We also have a short presentation with highlights from today’s call that can be viewed directly on the webcast or accessed on our website. I am joined on this call by Vericel’s President and Chief Executive Officer, Nick Colangelo; and our Chief Financial Officer, Joe Mara. I will now turn the call over to Nick.

Thank you, Eric, and good morning everyone. I'll begin today's call by discussing our financial and business highlights for the second quarter as well as our expectations for the rest of the year. Joe will then provide a more detailed review of our second quarter financial performance and our updated financial guidance for 2023 before opening the call to Q&A. The company had an outstanding quarter as we delivered significant revenue growth and record second quarter revenue continued profitability and operating cash flow and strong underlying business results for MACI and Epicel. From a financial perspective, total revenue for the second quarter increased 24% to approximately $46 million with both MACI and Epicel exceeding our second quarter financial guidance. We also continued to generate strong profitability as we delivered our 12th straight quarter of positive adjusted EBITDA which increased by 60% over last year and operating cash flow of over $10 million ending the second quarter with $147 million of cash and investments and no debt. Based on the strength of our performance in the first half of the year, which included combined total revenue growth for MACI and Epicel of 20% we're raising our full year revenue guidance to $190 million to $197 million. As we look beyond this year into 2024, we expect the momentum in our core business to continue with the anticipated commercial launch of arthroscopic MACI and a significant contribution from NexoBrid. We believe that we're well positioned to drive further revenue growth acceleration with total company revenue growth of over 20% in 2024. Our financial results for the second quarter were driven by continued strength and momentum for MACI as we generated record second quarter revenue of $36.3 million representing 27% growth compared to last year. Our sustained MACI revenue growth over the past…

Thanks, Nick and good morning everyone. Starting with the income statement. Total net revenue for the quarter was $45.9 million, an increase of 24% versus the prior year, driven by strong MACI revenue of $36.3 million and $9.6 million of Epicel revenue. For MACI during the first half of the year, we generated revenue of $70.5 million, which represents 29% growth versus the first half of last year. In addition, over the last four quarters, we've now consistently seen strong MACI growth each quarter with 30%, 24%, 32% and now 27% growth versus the prior year. In total, this represents a 28% growth on a trailing 4 quarters basis as MACI has resumed its high growth profile. For Epicel the $9.6 million of revenue in the second quarter was our highest quarterly revenue since Q1 of 2022 and Q2 revenue grew 40% compared to the first quarter and 17% versus the prior year. In addition, our first half Epicel revenue was more than $16 million significantly ahead of our quarterly run rate of approximately $6 million per quarter entering the year. Gross profit for the quarter was $29.9 million or 65% of net revenue, an increase compared to 62% in the second quarter of 2022. Total operating expenses for the quarter was $35.9 million compared to $31.9 million for the same period in 2022, the increase in operating expenses was primarily due to higher sales and marketing expenses in R&D program related costs. Net loss for the quarter was $5 million or $0.11 per share compared to $9 million or $0.19 per share for the second quarter of 2022. Non-GAAP adjusted EBITDA for the quarter was $4.4 million, which grew 60% versus the prior year. And importantly, this now represents the 12th consecutive quarter that we have generated positive adjusted…

Thank you. [Operator Instructions] Our first question comes from the line of Ryan Zimmerman of BTIG. Please go ahead.

Hi guys, good morning and congrats on a nice quarter. I'll start off. Joe, I appreciate all your comments on guidance. And there's a lot of moving components here, I guess I'll start off with MACI given the first half, '23 performance. I guess I'd like you to speak maybe a little bit to end market dynamics patient behavior and interest levels relative to last year. And then on that topic, again your third quarter commentary suggests an acceleration from your prior expectations. But maybe help us understand just broadly, why that couldn't continue to accelerate in the fourth quarter and why not raise it by a bit more given the record biopsies we're seeing?

Yes, good morning, Ryan, and thanks for the question, so I'll probably take that in pieces and talk a little bit about where we were in the second quarter kind of your point on the third quarter and then round that out as you think about the full year of course touch on Q4. So first off, I would say in the second quarter as we talked about, just another really strong quarter for MACI 27% growth ahead of our guidance. I think the team is doing an excellent job. From an execution perspective. I really just a continuation of the trends we've seen with a number of quarters now and kind of mid '20s, 30% plus and you're looking back, you basically had 29% relative to the first half of last year. So, really strong growth and I think to that point. And to your question, really the strength has been driven by the underlying metrics and really the top of the funnel. So biopsies have been extremely strong and that continued in Q2 where we nearly matched our Q4 number. The growth in surgeons is continued very strongly at three straight record quarters. So, those are really kind of the key drivers. I would say, of our results to-date this year and as we look forward. So from a Q3 perspective as we touched on in the prepared remarks it's off to another strong start and I think we expect another high growth quarter of 20%, which is approximately $37 million for the quarter. And that does importantly imply a step up from Q2 to Q3, which we don't always see. So, I think that's certainly a sign of continued momentum. And then the other piece I would say is, and this will apply to Q4 as well.…

Yes. No, that's great. Joe and I appreciate all your color and thoughts there. And then, Nick, on the NexoBrid launch timing, I think it's the prudent thing was to pull it out of numbers for the back half of the year, but I just want to understand, and I think investors would want to understand. So, is there a potential and kind of what is your view of potential of the FDA allowing these lots to potentially be on the market this year? And what would they need to see I guess to allow that that maybe reestablish The NexoBrid launch in the second half of this year. So this is, I mean this I think is the second delay we've had on NexoBrid since doing the deal with MediWound?

Yes, Ryan. You're right, it is the second delay. We've had obviously the product was not approved on the first go around. We stepped in got the product over the goal line, obviously we're frustrated and disappointed that we're seven months beyond the approval. And we still don't have product from NexoBrid, NexoBrid or MediWound that we can put into the commercial market. So, I think that's a fair comment. And again, we're trying to step in here. Now again engage with the FDA and be able to use these batches of intermediate drug substance to supply the U.S. market. So, I can't go into all the details of our discussions with the FDA as we included in our 10-Q. We have done a detailed risk assessments and we don't believe there's any incremental risk to product quality or patient safety. And obviously, those are the discussions we're having with the FDA. So this is, there were a number of manufacturers, we talked about before, a number of manufacturing updates that were required to be implemented. Following approval, as we talked about previously we were engaged with MediWound in the inspections last fall of their Israeli facility the drug substance facility with CBC in Taiwan those inspections obviously went well and the product was approved. But we had some of these updates or MediWound had updates that needed to be completed, they completed the ones related to their own facility and those were successfully completed again this third-party testing lab is basically testing the microbial - it's a microbial test of in antioxidant solution that sprayed on the pineapple stems in one of the first processing steps. There are a number of other microbial controls that have been added this one, the FDA did not approve this testing site. We were not involved with that obviously MediWound is our contract manufacturer who is responsible for that and they didn't execute. And so, we're going in and working with the FDA to try to be able to use this material. At the end of the day, again, we don't think that there's an incremental risk to using this. It's the same process that was used for all prior NexoBrid manufacturing. So all material that was used in clinical trials All material that was used to treat over 10,000 patients globally the BARDA stockpile all of that product was manufactured without this upstream in process control test. So, we think there is a good case to be able to move forward with it, but I think as you mentioned, it's prudent not to have that in our second half numbers until and unless we get the green light from the FDA.

Okay. And just to follow-up to find finer point on that one. The BARDA revenue that's being recognized in the back half of the year. Are those the same loss that are being held off currently?

Yes.

And then conceivably when would you get an update from FDA. If you get one in the second half of the year, if you can share with us?

Yes. So they would be the same lots, right, because all of the current intermediate drug substance lots were tested by this lab from both the 2021 and 2022 harvest seasons. And then in terms of the timing of the FDA discussions, we'd expect it to be relatively soon. Obviously, you need to be - we collectively needed determination on this in pretty short order. So, I think we'll know, but again the operating assumption is unless we hear otherwise. We're just going to assume, that we have to wait for the next pineapple harvest season. And that would result in new batches of both intermediate drug substance and NexoBrid finished product in the first quarter of 2024.

Okay. A lot of good pineapple going in the way. But I appreciate the updates.

Thank you. One moment please for our next question. Our next question comes from the line of Sam Brodovsky of Truist Securities. Your line is now open.

Hi, thanks for taking the question. First a quick one, and just started to touch on this a little bit before on the sequential for MACI. Should we expect 2Q to 3Q increase as sort of normal going forward or are there some market dynamics, still a little unusual behind your confidence in being able to grow sequentially this year?

Hi, good morning. And you're trailing off a bit at the end, but I think you're asking about should we kind of expect this quarterly cadence going forward.

Yes, sorry. Is anything unusual behind the sequential increase from 2Q to 3Q, or is that a more normal seasonality going forward?

Yes. And I would say, I think, I think the way we're thinking about it is obviously we've kind of got off to a good start with strong results in both Q1 and Q2. And I think we're off to another good start in Q3. So, if you look historically to kind of your point, they can certainly bounce around a little bit. We certainly have seen some years where there is Q3 kind of stepped down from Q2. But I think, kind of where we are now is certainly could change a little bit going forward. But I think what you're seeing come together this year three pretty strong quarters sequentially Q1, Q2 and Q3, which I think is kind of, driven by this - the momentum within the field and kind of driving biopsies in new surgeons et cetera which is great. So I think it's, I think it's just continued execution and that's playing through in terms of the cadence of the numbers and you see pretty strong quarters. The step-up in Q4, because of that may not be quite as high as it's seen in the past, but that's kind of how this year is playing out and I think that's probably how we would be thinking about it going forward. But I would say it could still vary a little bit within quarters, but we actually think it's certainly a good sign to see the continued momentum throughout the year.

Yes, that's great color. And then switching to arthroscopic and thanks for the market commentary that was really great. How should we think about the scale of that launch progressing through '24, should we think about second half being sort of and full market release or is that going to be safe through the year?

Yes, hi, Sam. It's Nick. In terms of the launch itself, once the label is updated for arthroscopic MACI delivery will be out there. Obviously in sort of full launch mode. I think the dynamic - will wait to see exactly how it rolls out. I think experienced MACI users who do a lot of MACI cases having an opportunity to do it arthroscopically. They wanted sort of be trained and it's not obviously very complicated, but they'll probably pick it up a little quicker. The segment surgeons that are non-MACI users, they may wait to sort of kind of tend to peer-to-peer programs so they may they may come sooner, they may come a little later. So, I think - we'll wait to see sort of how it plays out exactly, and it will differ by obviously the differing surgeons. But in terms of our efforts in rolling it out and making it available when we launch, we launch.

Thanks for taking the questions.

Thank you.

Thank you. One moment please for our next question. Our next question comes from the line of Jeffrey Cohen of Ladenburg. Your line is now open.

Hi Nick and Joe, thanks for taking our questions.

Good morning.

Just a pull from our end. Firstly, Nick it sounded like you commented about BARDA in the back half of the year being a few million dollars. And Joe was talking about just a Q4 impact of approximately $1 million for forecasting purposes. What should we think about on BARDA for the back half of this year?

Yes. So just to clarify that. So what Nick was talking about was that BARDA will be replenishing part of their stockpile which in total is about a $3 million replenishment from BARDA perspective, but then it's some economics that play into that and we would share that with MediWound. So essentially what I said, which is I think the right number to think about from our revenue as we would expect something over $1 million of our portion of that $3 million. So over $1 million, but to $1 million and $1.5 million and that would be - our expectation would be that in the fourth quarter.

Okay. So for modeling purposes don't think about anything for the third quarter?

Exactly.

Okay. I got it. And could you talk a little bit about the NexoBrid commercial expansion. It seems like it seems like most of your organization was in place - was expanded over the past few quarters. How does that look now and how might that look going forward specific to NexoBrid?

Yes. So you're right, Jeff. We've kind of we mentioned that we are adding half a dozen reps for that would be NexoBrid only reps under our original and current plan. And that we've executed on that pretty successfully - if we get the green light from the FDA shortly. Then of course we'll kind of deploy them as NexoBrid only account managers as originally intended. And then sometime down the line, they will be trained up on Epicel and eventually all reps would sell both products. If we have to wait to achieve one launch, then we'll accelerate that Epicel training, get them up to speed there as well. And in the meantime, we have, as I mentioned in the call, we started to see the impact of our NexoBrid reps in terms of, as they call on the NexoBrid accounts that they're actually getting some Epicel pull through now. And we've had cases from those dormant burn centers as well, which is exactly what we are hoping to see when we expanded the sales force

Okay, got it. That's helpful. Nick. And then lastly for us any recent commentary to discuss about the ankle indication as far as the progress or news or what we may expect in the back half of the year?

Yes, obviously our focus, as we've talked about over the past year is that arthroscopic MACI was kind of the nearer term and larger opportunity. And that's been kind of a heavy focus for the team for MACI ankle that continues to progress. There is some upfront work that needs to be done on other preclinical nature and that's progressing. And once we kind of get to the point where we're ready to start talking about our clinical plan. We'll provide more guidance on that either later this year or into early next year.

Okay, got it. Thanks for taking our questions. Congrats on the strong quarter.

Thanks Jeff.

Thank you. One moment please for our next question. Our next question comes from the line of Swayampakula Ramakanth of HCW. Your line is now open.

Thank you. Good morning, Nick and Joe, I'm trying to triangulate your comments on continued increase in biopsies and at the same time trying to be careful regarding fourth quarter MACI numbers. So it is how has the conversion rate been for the biopsies to use of MACI and with adding additional surgeons has that conversion rate stayed the same or is it trending to get into a higher number?

Hi RK, it's Nick. So, as Joe mentioned, really the outperformance for the year so far has been driven principally by significant increase in the number of biopsy surgeons. Obviously three straight quarters of a record number of biopsy surgeons. They of course are driving an increase in biopsy, which is really kind of the top of the funnel and that's principally driving again the outperformance. We did mentioned in the first quarter that there was kind of an uptick in the conversion rate and that sort of maintained into Q2, but I'd say that's kind of secondary to the prior two drivers that I mentioned in terms of new surgeons and their increasing biopsies. I'd say we're kind of in the situation that we've been in the past, even kind of pre-COVID where as you adding a substantial number of new surgeons you're experienced surgeon. They're surgeons segments of those surgeons their conversion rates are going up new surgeon typically have a lower conversion rate as they come on board. And we're kind of seeing that same dynamic now. So, I think that's the explanation. Overall, in terms of the drivers for MACI.

Thank you for that. Nick. And then on, on the MACI arthroscopic product do you need to change anything in the manufacturing of the product itself, or is it the same product, but having a new indication?

Yes, no it's the exact same product, there's no changes to the drug substance or drug product. And that's why we were able to move forward from a regulatory standpoint and in an accelerated manner with the human factor study versus having to do any additional clinical work. So, it's really the instrument kit that has been the development work and that will kind of form the basis around the human factor study.

Okay. And then with the new supplier of Matricel from Germany. Is that going to be making any changes or is that just trying to make sure that you have additional supply, because you're going to be adding additional indications through '24 and '25?

Yes, so Matricel is not a new supplier, they're actually our existing supplier for the membrane. So what we mentioned is that we executed a long-term extension that will take us well into 2030s into the 2030s in terms of our supply agreement and that's important, because it's an exclusive agreement. So that they can sell these membranes to anybody else who might be interested in sort of following down this path. So it's an important part of our sort of long-term market protection strategy for MACI.

Okay, one last question from me Nick. So, traditionally, you've been careful about talking through Epicel and giving guidance on Epicel sales, but I'm glad that you're doing that now, does that mean you are becoming more and more confident about the dynamics of that burn care market or is it more, because you have more feet on the ground for that product?

Well, no, I think it's kind of a stabilization of the market, right. Over the past year and change the incidents of large burns has come down. So you're kind of fighting that dynamic and now that's stabilized more and the team is just out there executing. And I think that's reflected in sort of kind of the stronger first half of this year that we've had compared to the second half of last year. So I think it's just an execution story of market stabilization story. I do think, and again, we're not talking huge numbers of new reps on the ground, right. But having NexoBrid reps in dormant Epicel accounts and then realizing both biopsies and then orders from those accounts that's contributor, right. And that's important. And as I mentioned earlier, it's exactly what that pull through is exactly what we were intending to happen as we expanded the sales force.

Perfect. Great quarter. As always, and looking forward to talking to you soon. Thanks.

Okay. Thanks RK.

Thanks RK.

Thank you. All right. One moment please for our last question. Our last question comes from the line of George Sellers of Stephens Incorporated. Your line is now open.

Hi, good morning. Congrats on the quarter and thanks for taking my question. I guess my first one sticking with arthroscopic delivery option in that dynamic. I'm just curious, how does, that option changed the sales strategy, if at all in terms of would you be expanding that sales force. Given the increased target market or with the current sales force. Maybe just shift their focus or how do you expect that launch to impact your sales operations?

Yes. So I think as we talked about in the past when we did our sales force sizing exercise back in 2019. Now we have data on the 12,000 orthopedic surgeons. And we could obviously draw intersection of surgeons that did high volumes of cartilage repair and open procedures and that sort of form the basis for our initial 5,000 targets. There was also a group of those surgeons that did high volumes cartilage repair. But we did not have open procedure data on them. And so, the presumption is that those are kind of arthroscopic only surgeons are predominantly arthroscopic procedure surgeons. And so our intention is to kind of refresh that data and to the extent there are additional targets that will focus on in that ladder bucket, which I expect there will be. That would drive whether we feel like we need to increase the sales force or not. In terms of the sales process the MACI clinical data speaks for itself. And it's obviously very strong basically now this just gives surgeons and option to in appropriate cases delivered the product arthroscopically, which again we think and they think - there is potential meaningful benefits and advantages to do that - to doing that. And so it won't fundamentally change kind of how we sell. I expect we'll add some targets and then again if it requires us to expand the sales force, we'll do that. I would not envision any sort of wholesale restructuring of our sales force if we add 1,000 or two targets you'd add maybe a dozen reps. But, we'll think about that as we get closer to launch.

Okay. That's really helpful. And then I believe you mentioned in your prepared remarks that arthroscopic delivery has the potential to double MACI in the coming years. And I'm just curious, what are some of the key assumptions that would go into that, is it simply sort of what's going on now that more surgeons taking biopsies and more biopsies is going to drive that revenue growth? Or is there any change in your expectations for biopsy conversion rates associated with arthroscopic delivery.

Yes, well, I'll just start and Joe can kind of go into the sort of the math of that comment. But what we basically said was that over the coming years we could essentially double our current business. If we had the same share of those smaller femoral condyles defects as we do in the patella. So you don't MACI's a go-to-product and patella cases. There's about 10,000 patients in the addressable market with patella defects. There is double that in this segment of femoral condyles defects that are two to four square centimeters in sizes, triple that if you added all femoral condyles defects below four centimeters. So it's a big market opportunity and the point is, if we get to the same share, because now you have a delivery advantage in those smaller defects you could basically double the size of our current business.

Yes, just to add, I think, Nick kind of hit it. This is Joe. But I would also point out, we have a slide in our earnings deck that I think it's helpful where we kind of double-click a bit on the TAM that digitally shows this. But again, I think what we're saying there is again, the patella is about $500 million opportunity and kind of north of into double-digits on that and again from a, that competitive and potentially could be so in this two to four square centimeter segment. That could be significant, which is where you don't kind of potentially effectively doubling the business kind of plays in. So I think the point one to make. And again if the slides helpful. This is a pretty big opportunity when we think arthroscopic MACI would potentially make us much more competitive in that space.

Okay, okay, that makes a lot of sense. Thank you for that color. And thank you for the time. I'll leave it there.

Thank you.

Thank you. At this point. I would now like to turn the conference back to CEO, Nick Colangelo for closing remarks.

Okay. Thank you, operator. And thanks everyone for your questions and your continued interest in Vericel obviously the company had a very strong financial and business results in the second quarter. And we expect that momentum to continue in the second half of the year and beyond. So we look forward to providing further updates on our next call. And with that, thanks again and have a great day.

This concludes today's conference call. Thank you for participating. You may now disconnect.