Vericel Corporation

Ladies and gentlemen, thank you for standing by. Welcome to Veracel's second quarter 2024 conference call. At this time, all participants are in a listen-only mode. I would also like to remind you that this call is being recorded for replay. I will now turn the conference call over to Eric Burns, Veracel's Vice President of Finance and Investor Relations.

Thank you, Operator, and good morning, everyone. Joining me on today's call are Verasol's President and Chief Executive Officer, Nick Colangelo, and our Chief Client Officer, Joe Marra. Before we begin, let me remind you on today's call, we will be making full looking statements covered under the Private Security Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to the expectations and are described more fully in our funds of the SEC. 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 second quarter financial results press release and a short presentation with highlights from today's call are available in the investor relations section of our website. I will now turn the call over to Nick.

Thank you, Eric, and good morning, everyone. I'll begin today's call by discussing the company's financial and business highlights for the second quarter, as well as our expectations for the remainder of the year. Joe will then provide a more detailed review of the company's second quarter financial results and guidance for 2024 before opening the call to Q&A. The company had another strong quarter as we generated record second quarter revenue of nearly $53 million. highlighted by continued high growth for Macy and solid progression in demand for Nexabrid. We also delivered another quarter of significant margin expansion and profit growth, with record second quarter gross margin of 70% and adjusted EBITDA growth of 42% compared to last year, as the company's profit growth continues to outpace our high revenue growth. Through the first half of the year, the company generated 20% growth in total revenue Macy revenue and burn care revenue, expanded gross margin by over 400 basis points and more than doubled adjusted EBITDA compared to the first half of last year. Based on the strength of our first half performance, we're reaffirming our revenue guidance of 20 plus percent growth for the full year and raising our profitability guidance for gross margin to 71% and adjusted EBITDA margin to 21% for the full year. Macy had another excellent quarter with record second quarter revenue of more than $44 million, which increased 21% and exceeded our guidance for the quarter. Macy's second quarter performance was once again driven by strong underlying business fundamentals as we continued to expand the Macy surgeon customer base and drive growth in biopsies. We had the second highest number of Macy biopsies and surgeons taking biopsies in any quarter since launch. as well as the highest number of biopsies any month since launch during the quarter. The strength of these key Macy growth drivers, together with another quarter of significant increases in peer-to-peer programs and attendees at those programs, demonstrates that surge in interest in Macy remains high as we continue to build a strong foundation for sustained Macy growth over the long term. As our expanded surgeon-based gains further experience with MACI, we also expect biopsies per surgeon and biopsy conversion rates to become more significant growth drivers. Notably, we saw a significant increase in biopsies per surgeon during the second quarter, which helped drive an acceleration in biopsy growth in the quarter. We also saw an uptick in the conversion rate versus the prior year, as there's a direct correlation between surgeon experience with Macy in higher conversion rates. Typically, once surgeons perform more than a few implants on average per year, their conversion rate tends to increase into the mid-40% range and even higher at higher average implant volumes per year, which is significantly above our overall conversion rate and demonstrates the clear potential for conversion rate to become an important growth driver over time as Macy utilization increases across our surge in customer base. Turning to our Macy lifestyle management initiatives, we're excited about the potential launch of Macy-Arthur later this quarter. Our custom Macy-Arthur instruments have already been registered with the FDA, and plans are in place for the commercial launch of this innovative addition to our portfolio upon FDA approval to expand Macy's label to include arthroscopic delivery. As part of the planned launch, we're expanding our target surgeon base from 5,000 to 7,000 surgeons to include surgeons that perform high volumes of cartilage repair surgeries predominantly through arthroscopic procedures. Given that the Macy arthro instruments target smaller cartilage defects that comprise the largest segment of our addressable market, representing approximately 20,000 patients per year, or one-third of the $3 billion addressable market for Macy, we believe that Macy-Arthur will have a meaningful impact on utilization and provides a significant potential upside growth opportunity for the brand and the company in the years ahead. We also remain on track to initiate the Macy-Ankle clinical study in 2025. Cartilage defects in the ankle represent the second largest market opportunity for Macy. We believe that a potential Macy ankle indication with an estimated $1 billion addressable market could be another significant growth driver for Macy in the next decade and beyond. Turning to our burn care franchise, NexaBridge launch momentum continued to build during the second quarter as revenue nearly doubled, and we made further progress with respect to our burn center key performance indicators. Through the end of the second quarter, approximately 70 burn centers had completed P&T committee submissions, more than 40 centers had gained P&T committee approval, and nearly 40 centers had placed an initial product order. There also was a meaningful increase in hospital orders and patients treated in the quarter, as more burn centers incorporate Nexibrid into their regular clinical practices. We also expect FDA approval of a pediatric indication for Nexibrid in the coming weeks, which would provide an important treatment option for pediatric patients with severe thermal burns. There are approximately 20 pediatric burn centers in the U.S. that will be added to our target customer base following approval, which we believe will have a meaningful impact on overall MexiBird uptake over time. Turning to Efecel, while we had a similar number of biopsies in the second quarter as in the first quarter of this year and the second quarter of last year, which resulted in revenue in the $10 million range for both of those quarters, EPICEL revenue in the second quarter of this year was closer to its quarterly run rate entering the year of approximately $8 million. After a strong start to the quarter in April, the number of patients treated with EPICEL was lower in May and June due to a number of factors, including patient health issues and the timing of patient treatments. While there can be variability in EPICEL quarterly results giving the relatively small patient population, and the critical nature of their injuries, demand for EpiCell remains strong. Over the first half of the year, the quarterly run rate for EpiCell has increased as expected to more than $9 million per quarter, with double-digit growth for the first half of the year versus last year. We're also off to a very good start in the third quarter based on the strength in EpiCell biopsies, patients treated, and graft volumes to date in the quarter. Overall, the company delivered another strong quarter in the first half of the year, with sustained high revenue and profitability growth, excellent MESI results, solid progression in maximum demand, and meaningful growth for EpiCell in the first half of the year. Based on the strength of our core portfolio and expected contributions from new product launches, we believe that the company is very well positioned for continued high revenue and profit growth in 2024 and beyond. I'll now turn the call over to Joe.

Thanks, Nick, and good morning, everyone. Starting with our second quarter results, total net revenue for the quarter was $52.7 million, with Macy revenue of $44.1 million and total burn care revenue of $8.5 million, which was made up of EpiCell revenue of $7.8 million and Nexabrid revenue of $0.8 million. In the second quarter, Macy revenue grew 21% versus the prior year and 10% versus the prior quarter, while Nexabrid increased 76% versus the prior quarter. In addition, through the first half of the year, both of our franchises delivered 20% revenue growth versus the prior year. Growth profit for the quarter was $36.6 million, or 70% of net revenue, an increase 430 basis points versus the prior year, which was the company's highest second quarter gross margin to date. Total operating expenses for the quarter were $42.6 million compared to $35.9 million for the same period in 2023. The increase in operating expenses was primarily due to development and pre-launch activities for Macy Arthro, increased headcount and related employee expense, and lease expense associated with the company's new facility that is under construction. Net loss for the quarter was $4.7 million, or 10 cents per share, compared to $5 million, or 11 cents per share, for the second quarter of 2023. In addition, the company has now generated positive GAAP net income on a rolling 12-month basis as we continue to enhance our strong profitability profile. Non-GAAP adjusted EBITDA for the quarter increased 42% to $6.3 million, or 12% of net revenue, compared to $4.4 million, or 10% of net revenue, in 2023, as adjusted EBITDA growth continued to significantly outpace our high revenue growth. For the first half of the year, adjusted EBITDA more than doubled to $13.5 million, and adjusted EBITDA margin increased approximately 600 basis points. demonstrating continued strong leverage across our P&L. Finally, the company generated $18.5 million of operating cash flow in the quarter and ended the second quarter with $154 million in cash, restricted cash and investments, and no debt. Turning to our financial guidance. For the full year, after a very strong first half of the year, we are reaffirming our total company revenue guidance 238 million to 242 million or 20 to 23% total revenue growth. Within our guidance framework, based on a strong first half results for Macy and the continued strength and its key leading indicators, we have increased our expectations for Macy for the full year. We now expect Macy revenue growth of approximately 20% for the full year an increase versus our prior expectation of high teens growth to start the year with the balance of revenue coming from our burn care franchise. In addition, based on the company's strong overall financial performance, we are increasing gross margin guidance to 71% and adjusted EBITDA margin guidance to 21% for the full year compared to the previous guidance of 70% and 20% respectively. Importantly, we also expect to be GAAP profitable in 2024 on a four-year basis. For the third quarter, we expect sequential growth in both Macy and Burn Care revenue with total company revenue of approximately $55 million, representing growth of more than 20% versus the prior year. For Macy, we expect another strong quarter with year-over-year growth in a similar range as the first two quarters of the year and revenue of approximately $44.5 million. For burn care, we also expect a strong third quarter with total burn care revenue of approximately $10.5 million. Finally, we expect gross and adjusted EBITDA margins in the third quarter to be similar to second quarter margins. This concludes our prepared remarks. We will now open up the call to your questions.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. Our first question comes from Ryan Zimmerman from BTIG. Your line is now open.

Hey, good morning. Thanks for taking our questions. I want to start first on Macy, and then I have a burn care question, but a two-part question on Macy. So I appreciate the guidance, Joe, both for the year and quarterly. I just want to make sure people are clear about the pacing expectations and kind of the the step-up implied in fourth quarter coupled with the Arthro launch that may be happening over the back half of the year. And then the second part of the question, a little different, but it's around your comments, Nick, on conversion, which is you're seeing more tenure in the user base of conversion, which, as you noted, is going to increase conversion ratios. But at the same time, as you move to smaller cartilage defects, which in absolute value will increase, I would imagine that has some downward pressure on the conversion ratio, just given that there may be less acute injuries, and so maybe there's less likelihood to convert from biopsy to procedure there. And so how would you have us think about conversion against those two factors over time, just given the nature of the injuries treated in the arthral launch? And then I have one follow-up on burn care. Thanks.

yeah so good morning ryan thanks for questions uh you know i'll start on maybe the macy cadence um and then we'll address kind of your conversion question uh second so you know from a macy perspective you know obviously two strong quarters start the year you know as nick said you know extremely strong leading indicators so we do have you know higher expectations on a full year basis you know we started in kind of the mid to high teens now around that 20 range So certainly, you know, increasing expectations on Macy, you know, as it continues to perform well, you know, in terms of the cadence for the rest of the year. So, you know, we did call out to your point, you know, a Q3 estimate of, you know, around 44 and a half million on Macy. And that's pretty similar growth that we've seen over the first couple of quarters is probably, you know, about an average of the two. And then as you think about kind of the seasonality and the step up for Q4, you know, I would generally say, you know, it follows our typical seasonal pattern. So whether you look at kind of the H1 to H2 growth, you kind of look at the step up to Q4, you know, which is in that 50% range, you look at the kind of call it H1, H2 mix, which is, you know, around our 43 to 57% if you look at that guidance. So I'd say it's very similar, you know, to what we've seen in the past, you know, in terms of You know expectations and sort of assumptions around kind of Macy Arthro you know I think we've consistently said. You know our expectation is that's more of a 2025 driver. You know it's really kind of the core performance of Macy you know that's continuing to perform and you know, again, that's the seasonality and mix is very much in line within the guidance to what we've seen last year and what we typically see.

Yeah, thanks. And so, Ryan, to your conversion rate, yeah, you know, as we've talked about for years now, as surgeons gain more experience and our, you know, higher volume surgeons clearly have higher conversion rates, a lot of the dynamics that we point to are that we're adding a lot of new surgeons and we continue to do so, and that's what sort of balances out sort of those higher conversion rates because obviously as they're getting up to speed, they have lower conversion rates. So it's remained relatively stable. In terms of the size of the defect, I'll just tell you that a two to four square centimeters defect on the surface of your knee, that's a pretty big injury. you know, when we look at, for instance, we're targeting Macy Arthro for those two to four square centimeter femoral condyle defects, and we can see sort of how those defects are treated in the patella, which obviously Macy is a go-to product there. And it's a pretty significant piece of our business now. To the best of my knowledge, it's at least at you know, the average conversion rate, if not higher for patellar cases. So, you know, I don't anticipate any impact on conversion rate from, you know, that size and location of the defect. They're getting treated somehow. And we just think Macy will be able to have a greater penetration into those defects on the femoral condyle with the Macy-Arthro instrument kit.

Okay. Very helpful, Nick and Joe. And then just on burn care, You know, the nature of the business is volatile. I've covered you guys long enough to know that. I just want to make sure that there's no structural change in the burn market, you know, from what you saw. It sounds like, you know, you guided early May and then, you know, you saw some volatility in the patient population around EpiCell in later May and June. But again, just want to be clear that you're not seeing any structural change there. with the episode.

No. Yeah, thanks Ryan. Appreciate the question and it's a fair one, but you know our my point of, you know, we had similar biopsies, right? That's the top of the funnel. And if you saw some, you know, sort of structural change in the burn market, you would expect that that's the place you see it. You know, we also mentioned that we had a very strong start in April and then, you know, we just had sort of that that variability that you can see in certain months based on patient health issues and again, the critical nature of their injuries. And right back to a strong start in July, highest biopsies of the year in the month of July. So, you know, we feel pretty good about, you know, EpiCell and the continued growth. First half of the year, up 12%. So, you know, I think we're again feeling pretty good about that. We also have implemented kind of our Salesforce optimization plan where we've added, you know, a few additional territories for the Burn Care Salesforce, so we're up to 17. As of the third quarter, you know, all reps will now be promoting both EpiCell and Nexabrid. And, you know, we've seen a pretty strong pull through for EpiCell from the formerly dormant accounts that were being called on for Nexabrid. We think we're set up nicely for strong burn care growth, and based on the guidance we've given, it's in the 30% range for the year, so pretty robust growth.

All right. Thanks for taking the questions, guys. Thanks, Ryan. Thanks, Ryan.

Thank you.

Please stand by.

Our next question comes from Mike Kratke from Lear Inc. Partners. Your line is now open.

everyone thanks for taking our questions so it looks like macy sales came in a bit higher than the street during the quarter and you also decided seeing the highest number of biopsies in any month since launch so can you just confirm what month of the quarter that record number of biopsies came in and to what extent is that tied to some of your ongoing pre-arthroscopic launch activities that you mentioned well yeah i mean just

it was in May for what that's worth. You know, I think the more important part is we're continuing to see very strong engagement with surgeons in terms of the number of surgeons taking biopsies, you know, continuing to be at sort of very high levels. Obviously that translates to more biopsies, particularly when you see an uptick in biopsies per surgeon, which is great. You know, that's really independent of, arthroscopic prep obviously you know the arthroscopic delivery is not approved yet so it's really independent it's just kind of the strength of the core basic business that we've really been seeing for quite some time now understood and maybe just as a follow-up you know can you give us a sense of you know a regarding the 2000 new target surgeons that you cited basically just how quickly you can start

targeting those surgeons, you know, reaching out to them? And at what point you really expect a Salesforce efficiency to start taking up?

Well, you know, there's really, I mean, obviously we have the target list set and ready to go. So, you know, immediately upon FDA approval, you know, sales reps can start calling on those surgeons. So there's really no limitation on that. So excited to have that. You know, I'd say we probably feel like, you know, We'll see more immediate uptake potentially from Macy's surgeons who are obviously familiar with the product. They also do a lot of arthroscopic procedures as we always remind folks. Anytime they're doing chondroplasties, microfractures, OATs, and the vast majority of cartilage repair procedures are done arthroscopically. So they're used to treating cartilage injuries that way. So I think it's a pretty easy transition for patients with appropriate defects for experienced surgeons to kind of flip to Macy arthroscopic delivery. Similarly, though, as you know, those 2,000 surgeons we'll be adding who really do their high volumes of cartilage repair predominantly through arthroscopic procedures, they too are used to treating cartilage injuries with arthroscopic instruments and doing things like microfracture augmentation where they're also doing implants as part of that. So we think it's a pretty... pretty seamless transition that will continue, you know, it'll occur over time and give us a pretty long runway, we think, for MESI growth as we move forward in the years ahead.

Understood. Thanks very much. Okay. Thanks, Mike. Thank you.

Our next question comes from Josh Jennings from TD Cohen. Your line is now open.

Hi, good morning. Thanks for taking the questions. It's nice to see that Macy Momentum here. Wanted to just follow up on the last question, just around, but in a different angle. Just thinking about the success you've had in terms of getting more surgeons in peer-to-peer events, getting trained, I just wanted to hear from you just what's driving that. I mean, it's clearly... it's you're experiencing momentum, but you do have tenure data out there early in the year. You have Arthro on tap. And I guess for the gist of the question, just trying to figure out, you know, that leading indicator, any just high-level comments on the first half, the drivers of that, and whether this Macy-Arthro approval is driving some of that increased interest this year.

No, I'd say, you know, back to the prior response that, you know, we've just seen a lot of momentum in the core Macy business. you know, exited sort of those COVID impacted years. And since that time, I mean, we've seen, we may see just in total rebound to its, you know, prior high growth profile, you know, as it becomes more and more the standard of care for cartilage repair based on, as you mentioned, not only sort of the two-year data in the pivotal study, the five-year data in the extension study, 10-year data that was published earlier this year, I just think you kind of see this broadening of the customer base that, you know, has just continued for a number of years now. And then as we launch Macy-Arthro, you know, those new targets, again, they're doing high volumes of cartilage repair already. Macy will be a new option for them. But I'm pretty sure they're aware of sort of Macy and its profile from the clinical and efficacy perspective.

Understood. Thanks for that. I also wanted to just get an update on business development initiatives. I think your team is out there on the hunt, you know, the profitability profile inflecting. How would you have investors think about those efforts and M&A opportunities out there to bring even more portfolios under the Verasol roof? Thanks.

Yeah, our corporate development strategy has been quite consistent over the number of years. And, you know, obviously we have a lot ahead of us with new product launches and continued high growth with our core business. But as you said, we have a dedicated effort on the business development front, always looking at opportunities in the sports medicine space that would be synergistic with Macy for our customer base in the burn care space. And then you know, probably relatively less so, but also given our expertise in advanced cell therapy development, manufacturing, commercialization, you know, a lot of folks come to us with different opportunities as well. I'd say, you know, for us, the hurdles are relatively high. You know, you all know, have seen sort of BD deals sort of go awry, even in our space. And so, We're very focused on maintaining the innovation profile of our portfolio. I think we're in a relatively unique position where our products are the only approved products of their kind in our space. And so that's where it all starts. And then we also have a unique financial profile. And so we're very focused on making sure we maintain our high revenue growth rate, our profitability, and so on. You know, I always say that if something transacts, you should be pretty comfortable. We probably looked at it, but we have a pretty high bar. And, you know, we'll add products and portfolios as it makes sense for us. But you're right. We certainly have the financial sort of firepower to be able to do that. And it's all about just making sure it's a right fit for us. Appreciate that.

Thank you. Thank you.

Our next question comes from Jeffrey Cohen from Leidenberg, Salmon and Company. Your line is now open.

Good morning. A couple questions from our own. So, firstly, could you talk about an extra grade in pediatric indication and how that might go on as far as we are trying to bring some of those in addition to the current 70 and what I hear you saying, 75.

commercial folks as well focus on that area yeah I think I had a little bit of a hard time hearing you Jeff but I think I have the gist of the question so yeah upon approval you know obviously we have the 17 territories that I mentioned as we've implemented kind of our Salesforce optimization for the burn care franchise and So, you know, on average, it's about one center per territory, and so it's certainly they're already in the target base for these reps, but until the approval comes, they're obviously not sort of in there promoting the use of Nexavert. We certainly have seen, you know, a few centers using it, these pediatric burn centers. They're free to do that. We just can't promote it, but you know, on day one, we've got a playbook for the reps to go out and sort of promote Nexabrid. And, you know, it'll be, we'll have to go through the same process, right? P&T committee approval and establishing ordering protocols and patient protocols, et cetera. But we do think there'll be a pretty meaningful impact over time. You know, roughly 25 to 30% of hospitalized burn patients are pediatric patients. And so, you know, as I mentioned on the call, we think this will certainly aid in Nexabrid uptake over time.

Perfect. And then lastly, Costello, I did hear you call out the burn franchise for Q3 on your guide of 10 and a half. Can you give us a or some flavor beneath that on extra good versus Ecclesial, please.

Sorry, Jeff, we're having a hard time in the morning. This is Joe. Are you asking about kind of Q3 revenue composition within the guidance?

Yes, within Burns. Thank you.

Yeah, so I'd say if you kind of look at Burns here and you kind of think about the framework there, Nick talked about this a bit, You know, in the first half of the year, you know, EpiCell obviously can vary a bit by quarter, and we saw that, but, you know, pretty encouraging that it was kind of over the 9 million mark, you know, grew in the double digits from a run rate perspective, also from a year-over-year perspective on total revenue for EpiCell. So, as we think about the back half, and, you know, I think Q3 is certainly part of that equation, you know, we expect EpiCell to kind of be at that higher run rate, calling in that 9 to $10 million range. you know, don't know exactly what it's going to look like across quarters, but I think that's a reasonable assumption. And then in terms of next hybrid, you know, I'd say, as we talked about in the prepared remarks, you know, some strong progression from Q1 to Q2, you know, as we think about the second half of the year and think about the third quarter, you know, that should certainly continue, you know, that progression kind of throughout the year. So, you know, it's difficult to say exactly what the mix will be, but, you know, we certainly expect EpiCell will kind of remain at these higher run rates and have a strong second half of the year. We're seeing, you know, strong indicators there. And, you know, it actually brings the movement in the right direction as well. So I'd say both of those are part of it. And that's how we're thinking about Q3 and the back half.

Perfect. Thanks for taking your questions. Thanks, Jeff.

Thank you.

Thank you.

Our next question comes from Swayam Thakula Ramakant from HCW. Your line is now open.

Thank you. Good morning, Nick and Joe. A quick question on the burn franchise. If I heard everything correctly, when you're talking, Nick, about conversion rates, you were saying something about epi-cells biopsy and conversion there. Did some of that spill over into the third quarter? Because you're also talking about some timing and I'm just trying to have an idea if any of the revenue that you had expected in the second quarter spilt over into the third.

Yeah, thanks, RK. So yeah, as I mentioned, just kind of the top of the funnel again was pretty consistent with prior quarters. And yeah, I did mention that there's always going to be patient health variables that impact timing of treatments. And we certainly did see, particularly late in the quarter, cases that were pushed into or rescheduled into Q3. Again, that happens because these patients have a lot of other injuries or infections that prevent surgeries from taking place. So the short answer is yes, but that, you know, is relatively common.

Okay. And then a quick question on the pediatric indication of Nexaparib. You said you have 70 centers, burn centers already had their PT and approval. If you get the pediatric indication on board, is How many of these centers also do pediatrics and also would you add centers outside of the 70 which are just only for pediatrics? I'm not very good at the burn market.

Yeah, so let me just kind of give a quick overview. So in the launch, there's about 140 burn centers in the U.S. that are accredited by the ABA. We target, we break them up into three tiers and we really focused on the 90 tier one and tier two centers with our initial launch. And that's kind of what we've been reporting on in terms of the 70 submissions, the 40 approvals, et cetera. There's about 20 pediatric burn centers that will now, you know, we will actively promote to. So certainly in some of our existing centers, pediatric patients can be treated. They don't all get treated at the pediatric centers. But again, we can't be in there promoting. So you'll have some that pediatric centers that used the product a few, but many of them were sort of waiting for the pediatric indication. And so, you know, we think, as I mentioned on the call, that, you know, we have a meaningful impact on expert uptake as we get out there and get these centers through the process and they start treating this pediatric burn population.

Thank you. Looking forward to the exciting second half of this new introduction.

Okay. Thanks, Arpit.

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Nick Colangelo for closing remarks.

Well, thank you, everyone, for your questions and continued interest in VeriCell. As we mentioned, the company had a very strong first half of the year. We expect to continue to deliver sustained high revenue and profit growth for the remainder of the year and beyond. And we look forward to providing further updates on our progress on our next call. So thanks again and have a great day.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.