Vericel Q3 2025 Earnings Report

Vericel EPS Results

• Actual EPS: $0.10
• Consensus EPS: -$0.02
• Beat/Miss: Beat by +$0.12
• One Year Ago EPS: -$0.02

Vericel Revenue Results

• Actual Revenue: $67.50 million
• Expected Revenue: $64.57 million
• Beat/Miss: Beat by +$2.94 million
• YoY Revenue Growth: +16.60%

Vericel Announcement Details

• Quarter: Q3 2025
• Date: 11/6/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, November 6, 2025
• Conference Call Time: 8:30AM ET

Vericel (NASDAQ:VCEL) is a biotechnology company specializing in the development, manufacturing and commercialization of cell-based therapies for patients with severe diseases and conditions. The company’s expertise lies in regenerative medicine, where it harnesses the power of autologous cell processing to create products designed to restore function and promote healing in damaged tissues.

Vericel currently markets two FDA-approved therapies. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is indicated for the repair of symptomatic cartilage defects of the knee in adult patients. EPICEL® (cultured epidermal autograft) is approved for use in pediatric burn patients with deep partial-thickness or full-thickness burns covering at least 30% of total body surface area. Vericel manages the entire manufacturing process—from cell collection and expansion to final product release—at its state-of-the-art cell processing facilities in the United States.

The company distributes its products across the U.S. market and has established licensing and distribution partnerships to serve patients in select international regions, including Europe, Canada and Australia. Beyond its commercial portfolio, Vericel maintains a pipeline of investigational therapies targeting tendon repair and other musculoskeletal injuries. Its research and development efforts leverage proprietary cell culture platforms and delivery technologies aimed at addressing significant unmet medical needs in regenerative medicine.

Vericel Q3 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Vericel reported a record Q3 with $67.5M total revenue (MACI $55.7M, +25% y/y), GAAP net income of $5.1M, adjusted EBITDA of $17M (25% margin), record operating cash flow of $22.1M, and $185M in cash and investments, while reaffirming full‑year revenue guidance of approximately $272–$276M.
• Positive Sentiment: MACI Arthro adoption is accelerating — >800 surgeons trained, record biopsy levels (October highs), Arthro‑trained surgeons show materially higher implant conversion rates, and early case data suggest reduced post‑surgical pain and faster rehab timelines.
• Positive Sentiment: Commercial and development initiatives remain on track: salesforce expansion finishing in Q4, Phase 3 MACI Ankle study to start this quarter, commercial manufacturing planned in the new facility next year, and staged OUS expansion targeting a UK submission mid‑2026 with potential H1‑2027 launch.
• Negative Sentiment: Burn‑care showed sequential improvement (EPICEL Q3 = $10.4M, NexoBrid = $1.5M), but EPICEL remains variable and management excluded any potential BARDA‑related NexoBrid revenue from guidance due to government procurement uncertainty, leaving upside/near‑term risk to burn‑care results.

Presentation

[Operator]

Good day and welcome to the Vericel Corporation Third Quarter 2025 earnings call. Today's conference is being recorded. At this time, I would like to turn the conference over to Eric Burns, Vericel's Vice President of Finance and Investor Relations. Please go ahead.

[Eric Burns, VP of Finance and Investor Relations at Vericel Corporation]

Thank you, Operator, and good morning, everyone. Joining me on today's call are Vericel's President and Chief Executive Officer, Nick Colangelo, and our Chief Financial Officer, Joe Mara. Before we begin, let me remind you that on today's call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with 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 Third 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.

[Nick Colangelo, President and CEO at Vericel Corporation]

Thank you, Eric, and good morning, everyone. The company delivered outstanding financial and business results in the third quarter, with strong top-line revenue growth and even higher profit growth, a significant inflection in operating cash flow, and continued progress across a number of key business initiatives. The company generated record third-quarter total revenue, which exceeded our guidance for the quarter, record third-quarter MACI revenue, which increased 25% over last year, and the highest quarterly burn care revenue of the year, as Epicel had one of its highest revenue quarters to date, and NexoBrid had its highest quarterly revenue since launch. The strong revenue performance translated into significant profit growth and cash generation, as the company delivered GAAP net income of more than $5 million and Adjusted EBITDA margin of 25% for the quarter, as well as record third-quarter operating cash flow of more than $22 million.

[Nick Colangelo, President and CEO at Vericel Corporation]

MACI's third-quarter performance was driven by strong underlying business fundamentals, as we continue to expand the MACI surgeon base and derive growth in biopsies with the launch of MACI Arthro. As anticipated, the strong MACI biopsy growth in the first half of the year, which outpaced implant growth to that point, drove an acceleration of implant and revenue growth in the third quarter. MACI also had another quarter of double-digit biopsy growth, with record third-quarter highs in both MACI biopsies and the number of surgeons taking biopsies. This momentum continued into the fourth quarter, as we had the highest number of MACI biopsies and surgeons taking biopsies in any month since launch in October. In addition to the strength of the core MACI fundamentals, the early launch indicators remain very strong for MACI Arthro, which clearly is contributing to MACI's overall biopsy and implant growth.

[Nick Colangelo, President and CEO at Vericel Corporation]

We now have more than 800 MACI Arthro-trained surgeons through the end of October, and the biopsy and implant growth rates continue to increase substantially for trained surgeons and remain significantly higher than the growth rates for surgeons that have not yet been trained. In addition, early data indicates that the cohort of surgeons that have completed a MACI Arthro case to date have a markedly higher implant growth rate than biopsy growth rate, suggesting a higher overall conversion rate for MACI Arthro implanting surgeons. We believe that this dynamic may be driven by the fact that MACI Arthro is a less invasive procedure with the potential for improved patient outcomes. To that end, we remain focused on generating clinical data to demonstrate these potential patient benefits, including a shorter rehab period with MACI Arthro administration.

[Nick Colangelo, President and CEO at Vericel Corporation]

Early data from ongoing investigator case series suggests a significant reduction in post-surgical pain, improved range of motion, and a meaningful acceleration in the timeline to achieving full weight-bearing following MACI Arthro treatment. These initial results suggest very positive outcomes, which could also lead to a shorter overall recovery timeline for patients. We expect to see these cases presented at industry meetings in early 2026, as well as in future publications, and we continue to work with additional surgeons as they complete MACI Arthro cases to collect prospective outcomes data in our MACI Clinical Registry.

[Nick Colangelo, President and CEO at Vericel Corporation]

Finally, the MACI Salesforce Expansion is on track to be completed in the fourth quarter, with the new reps supporting current territories this year and moving into their new territories at the start of next year, which will support our significant fourth-quarter volume growth and position MACI for a continued strong performance for the full year in 2026. In terms of our longer-term MACI growth initiatives, we remain on track to initiate the phase III MACI Ankle Clinical Study this quarter, which represents a substantial growth opportunity for MACI and would enable the company to expand into other orthopedic markets. We also remain on track to initiate commercial manufacturing for MACI in our new facility next year, which is designed to meet both U.S. and global manufacturing requirements and will allow the company to potentially commercialize MACI outside the United States.

[Nick Colangelo, President and CEO at Vericel Corporation]

To that end, we're initiating a staged approach to our MACI OUS expansion, with the first phase targeting a planned MACI launch in the U.K. This is an ideal first step for OUS expansion in that the U.K., has an international mutual recognition procedure that allows for accelerated approval and market access. There's a high level of awareness and surgeon advocacy for MACI, given that the product was previously marketed in the U.K. There's an established reimbursement pathway for this technology, given a prior positive NICE opinion for MACI, and there are concentrated points of care with a dozen or so centers of excellence for the treatment of cartilage injuries in the U.K.

[Nick Colangelo, President and CEO at Vericel Corporation]

We'd expect to submit a marketing application in the middle of next year and potentially launch MACI in the U.K. in the first half of 2027, as we seek to expand the long-term growth and value creation opportunities for the company. In summary, MACI remains the clear market leader for knee cartilage repair with a significant competitive moat. Based on the strength of its underlying business fundamentals, we believe that MACI is very well positioned for a strong close to 2025 and continued strong growth in 2026 and beyond. The early launch indicators for MACI Arthro remain very strong and clearly are contributing to the overall biopsy and implant growth for MACI. As we move into 2026, we expect to capitalize on having a full year to engage with the current MACI Arthro trained surgeons and to continue to meaningfully expand the number of trained surgeons next year.

[Nick Colangelo, President and CEO at Vericel Corporation]

In addition to increasing the MACI Salesforce to drive further growth, we're also supporting the expanded MACI sales team with additional investments across our sales operations, marketing, and medical functions to enhance our operational excellence and commercial execution and create additional opportunities for surgeons to engage with Vericel. We believe that all of these initiatives will reinforce MACI's leadership position and drive continued strong revenue and profit growth in 2026 and the years ahead. I'll now turn the call over to Joe.

[Joe Mara, CFO at Vericel Corporation]

Thanks, Nick, and good morning, everyone. The company delivered very strong financial results in the third quarter, with a record total revenue of $67.5 million. MACI had a strong quarter, with revenue growing 25% to $55.7 million, which was above the high end of our guidance range for the quarter. Importantly, year-to-date MACI revenue growth is over 20%, with its growth rate having increased each quarter during the year. Burn care also had a strong third quarter, with revenue of $11.8 million, which increased 21% sequentially over the second quarter. Epicel revenue of $10.4 million was the highest quarter of the year and one of its highest quarters to date, while NexoBrid revenue of $1.5 million represented its highest quarterly revenue since launch, growing 38% vs the prior year and 26% vs the prior quarter.

[Joe Mara, CFO at Vericel Corporation]

The company's substantial revenue growth translated into significant margin expansion, with gross profit of nearly $50 million, or 73.5% of revenue. The company also delivered GAAP net income of $5.1 million, and Adjusted EBITDA increased nearly 70% to $17 million, or 25% of revenue, an increase of nearly 800 basis points vs the prior year, as the company's profit growth continues to outpace our strong revenue growth. Finally, the company generated record third-quarter operating cash flow of $22.1 million, nearly matching the fourth quarter of last year, and with just $2.6 million of CapEx during the quarter, the company achieved record free cash flow of nearly $20 million, ending the quarter with $185 million in cash and investments, as the expected inflection of our cash generation following the completion of our new manufacturing facility is now being realized.

[Joe Mara, CFO at Vericel Corporation]

Turning to our financial guidance, we expect full-year total revenue of approximately $272 million-$276 million. For MACI, we are maintaining our revenue guidance expectations of low 20% growth for the full year and expect full-year MACI revenue of approximately $237.5 million-$239.5 million and fourth-quarter revenue of approximately $82 million-$84 million. Given MACI's strong third-quarter results and expectations for its continued strong performance in Q4, MACI remains on track for a significant acceleration in revenue growth from 18% in the first half of the year to approximately 23% in the second half of the year. For burn care, we expect full-year revenue of approximately $34.5 million-$36.5 million, with fourth-quarter revenue of approximately $6.5 million-$8.5 million, as Epicel trends to date in the fourth quarter are similar to Q4 of last year.

[Joe Mara, CFO at Vericel Corporation]

I would also note that we are not assuming any additional NexoBrid revenue related to the BARDA (Biomedical Advanced Research and Development Authority) RFP (Request for Proposals) process initiated in August, although there is potential for incremental NexoBrid BARDA revenue in the fourth quarter. From a profitability perspective, we have reaffirmed our full-year profitability guidance of gross margin of 74% and Adjusted EBITDA margin of 26%. For the fourth quarter, we expect gross margin of approximately 77%. Approximately $50 million of total operating expenses, which includes the investments related to our recent Salesforce expansion, and Adjusted EBITDA margin of approximately 40%. Overall, 2025 is set up to be another positive year for the company, with strong top-line growth as well as significant margin expansion and profit growth.

[Joe Mara, CFO at Vericel Corporation]

As we look ahead to next year and beyond, we believe that the durable growth of our portfolio positions the company to sustain strong top-line growth in the years ahead and supports our midterm profitability targets that we announced earlier this year of gross margin in the high 70% range and Adjusted EBITDA margin in the high 30% range by 2029. This now concludes our prepared remarks. We'll now open the call to your questions.

[Operator]

If you are dialed in via the telephone and would like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment. A voice prompt on the phone line will indicate when your line is open. Please state your name and company before posing your question. Again, you may press star one to ask a question. We'll pause for just a moment to allow everyone an opportunity to signal. We'll move to our first question. Your line is now open.

[Josh Jennings, Managing Director at TD Cowen]

Hi, good morning. This is Josh Jennings from TD Cowen. Am I coming through okay?

[Joe Mara, CFO at Vericel Corporation]

Yes, good morning, Josh. We can hear you fine.

[Josh Jennings, Managing Director at TD Cowen]

I'm sorry about that. I got an operating notice. I didn't hear my name called. Thank you. Maybe just appreciate your comments. Congratulations on the strong Q3 results. Your comments just a moment ago, Joe, on 2026, continued momentum. Sorry for the typical question a little bit too early prior to 2026. Got it. Maybe just for the MACI franchise, just thinking about MACI Arthro contributions in 2026. Additive vs cannibalistic of standard MACI, and how we should be thinking about the MACI growth as we move into the coming quarters next year? One follow-up.

[Joe Mara, CFO at Vericel Corporation]

Yeah, so good morning, Josh, again, and thanks for the question. First off, just a reminder, we haven't given any specific 2026 commentary as of yet, but happy to give kind of our initial thoughts. Of course, we'll kind of give more formal guidance as we move into next year. I would say I'll kind of hit just briefly on both franchises, but certainly cover MACI. I would say across the portfolio, our expectations next year are very high. We have a number of impactful initiatives that we're very excited about across both franchises, particularly MACI. I do think we'll be pretty prudent to start the year from a guidance perspective. Maybe just briefly starting with burn care, I think that one's pretty straightforward. We talked about last quarter, this kind of run rate concept, which we think is appropriate.

[Joe Mara, CFO at Vericel Corporation]

We said we would adjust it kind of as needed on a quarterly basis. But if you look at our run rate over the last several quarters, we've kind of been in that $9 million-$10 million range on burn care. So I think as a starting point for next year, kind of being in that range, call it in the high $30 million on a full-year basis next year is a good place to start. We do have expectations that NexoBrid will continue to increase. Certainly, there remains a possibility of some potential BARDA-related revenue that could materialize. But just given Epicel's variability, we're just going to be prudent on that, and I think that one's pretty straightforward. So. From a MACI perspective, I would say.

[Joe Mara, CFO at Vericel Corporation]

As we think about the guidance and kind of what next year looks like, if you kind of look at where analysts are, I mean, most analysts are kind of right around 20% on a full-year basis ±. We think that's a good starting point. As we think about 2026. If you look at where we were on a full-year basis last year, MACI was 20%. It's 20% on a year-to-date basis this year. We're not going to get ahead of ourselves and plan to start the year guiding above the trends or that 20%. Again, that's a good place to start. You can also look at kind of the incremental revenue on a year-over-year basis. That points to something kind of similar in that $40 million+ range. Again, we don't want to get ahead of ourselves.

[Joe Mara, CFO at Vericel Corporation]

I guess kind of the last point I will make on the Arthro question. I think as we think about 2026 and really moving forward, we're not really thinking about this as kind of Arthro vs non-Arthro. We're thinking about this from a MACI total level. If you kind of step back and think about the progression during the year, I think we're seeing exactly what we wanted to see as we kind of march through the year. First off, great foundation in terms of engagement with surgeons. We're up to 800 trained surgeons. I think the majority of those are either new to MACI or new to smaller defects. That's exactly what we'd want to see. The second point there that we've talked about for a few quarters now is we are seeing higher biopsy and implant growth after surgeons are trained.

[Joe Mara, CFO at Vericel Corporation]

That is obviously exactly what we want to see. We think that could be impactful over time. The last point, early days, but when we look at our Arthro implanters, so the surgeons that have done Arthro implants, we are actually seeing signals of a higher conversion rate. I mean, if you kind of look at that collectively, that is a pretty strong data set and consistent to what we hear externally. Good signals on Arthro, for sure. I would say certainly we are mindful of that, but we are just not going to get ahead of ourselves in terms of a planning assumption or guidance next year, and would rather start the year a bit more prudently, which we think sets us up for success as we move throughout the year.

[Josh Jennings, Managing Director at TD Cowen]

Appreciate that. It's great to see the conversion rate thesis playing out from MACI Arthro. We've anecdotally kind of gotten back from some surgeons that patient demand from MACI Arthro is increasing. More patients are seeking out orthosurgeons that perform MACI Arthro or coming in requesting MACI Arthro. Just wondering if what we're picking up is a trend and whether that's helping kind of drive surgeon adoption rates, surgeons hearing from patients, and then they're getting more interested or also driving volumes. Any you can share on that dynamic would be helpful. Thanks for taking the questions.

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah, hey, Josh, it's Nick. Yeah, I mean, as we've talked about repeatedly, we've heard and seen the anecdotal feedback since the early days with MACI Arthro. There's a lot of social media activity from top MACI Arthro implanters. That certainly can be one contributing factor to sort of patients' awareness of a MACI Arthro option. That makes perfect sense to us. As Joe mentioned, besides the anecdotal kind of feedback we've been getting, which has been very positive, the parameters that Joe mentioned just sort of line up with everything we expected to happen, and it's the progression that we've been talking about for the entire year. Yeah, really kind of pleased with the trends. I think it makes a lot of sense that patients would be interested in a less invasive.

[Nick Colangelo, President and CEO at Vericel Corporation]

Procedure that has potential benefits in terms of faster recovery and potentially overall rehab timelines. Of course, the surgeon interest. We are well ahead of where we expected to be on trained surgeons for the year. That awareness and engagement has been really positive as well.

[Josh Jennings, Managing Director at TD Cowen]

Thanks, Nick.

[Operator]

We'll move to our next question from Richard Newitter with Truist Securities.

[Richard Newitter, Managing Director and Senior Equity Research Analyst at Truist Securities]

Hi. Thanks for taking the question. Congrats on the quarter. I just wanted to get a better understanding of where you're potentially seeing MACI Arthro actually potentially getting used, where the traditional MACI was not. Just the cannibalization vs market expansion, anything anecdotal that you can give us there. I have a follow-up. Thank you.

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah, hey, Richard, it's Nick. I think it's kind of continuing the trends that we've talked about on the past quarters. Again, we don't really. Cannibalization is not sort of how we think about this. We look at increasing MACI utilization and whether a surgeon implants MACI through a mini arthrotomy or a small open incision or arthroscopically. That all contributes to the strong MACI growth that we are seeing. As we talked about before and as Joe alluded to, when you think about it from a surgeon perspective, the trained surgeons and now the biopsying and implanting surgeons come from existing MACI users, but also new users who were former open targets or the new Arthro-only targets that we added. The training kind of breaks down, as we talked about before, roughly a third of sort of the former MACI users who were primarily condyle.

[Nick Colangelo, President and CEO at Vericel Corporation]

Users, and then a third from those that did both condyle and femoral condyles. Then a third new users, whether they were open targets or the new targets. Good distribution of surgeons, all of whom are taking biopsies and obviously doing implants. From a defect location or a patient perspective, we've talked a lot about that we've seen use not only on the femoral condyles but also in areas of the knee like the trochlea and tibia, even a few patella cases here and there. That, I think, will continue, especially as we think about the continued innovation with the MACI Arthro instruments, where we will work with surgeons, design the next version 2.0 of MACI instruments that will allow access to different portions of the knee and so on.

[Nick Colangelo, President and CEO at Vericel Corporation]

I think it's pretty broad-based, as we've been talking about all year, and supports the growth that we've seen in this third quarter.

[Richard Newitter, Managing Director and Senior Equity Research Analyst at Truist Securities]

Okay, that's really encouraging to hear. I'm just curious just given where you are in kind of a new product launch here, as we look to next year. And understanding you might not want to provide official guidance, totally understand that for 2026, but anything that we should be aware of on the cadence. On revenue or on the P&L, just. It's been a little bit counterintuitive for the last two years. And just to preempt any surprises as we all calibrate our models into next year. Thanks.

[Joe Mara, CFO at Vericel Corporation]

Yeah, so thanks, Richard, for the question. This is Joe. I would say as we go into any year, I mean, I think from a MACI perspective, there's always going to be that seasonality. I mean, it can certainly ebb and flow a bit on a quarterly basis. I would say one thing as we're thinking about, we're talking about the full year, but we have tended to see in the last couple of years that the first quarter has tended to be at kind of a lower growth rate for whatever reason coming off Q4. I mean, that, of course, is a dynamic we've seen that I would point out that was present in the last couple of years. That's probably one piece. In general, I would say it typically follows a pattern as we've seen.

[Joe Mara, CFO at Vericel Corporation]

It can vary a bit by quarters, but halves tend to look pretty similar. Nothing I would call out, obviously, on the burn care side, which I do not think you were necessarily getting to, but clearly there can be variability there. We are going to kind of stick with that run rate framework, and we will adjust as needed, as we have done in the fourth quarter here, just based on what we are seeing because we certainly want to make sure we are not going to get ahead of ourselves in any quarter on burn care. That is more of a framework question. I would say maybe just to hit the profitability for next year and kind of the profitability concept, nothing to call out next year quarterly, but I would say as you are thinking about the year and just going forward.

[Joe Mara, CFO at Vericel Corporation]

I'd say first off, I think it's pretty notable if you look back at Q3 that this is, of course, the fourth quarter, just based on the MACI trajectory, is always our highest revenue quarter, highest margin quarter, etc. To be net income positive at a $5 million level, I think, is pretty notable in the third quarter. We achieved 25% Adjusted EBITDA margin in the third quarter, which is also pretty notable. And then just on the cash generation for a moment, I mean, whether you look at free cash flow or operating cash flow, you're kind of around $20 million for the quarter. We talked a few years ago about that P&L inflection that we're starting to really get on the stronger side of. I think we're just starting that kind of inflection on the cash generation piece.

[Joe Mara, CFO at Vericel Corporation]

In terms of the fourth quarter, obviously, we'd expect a strong quarter there as well, as I talked about in the remarks. Next year, I would say. As you think about next year, I think we would expect on the margin side, things to continue to tick up on both the gross margin and the Adjusted EBITDA side. Probably want to just be a little bit prudent there to start the year in the sense that the last two or three years have been really strong and probably a bit ahead of our expectations in terms of how quickly the margin has gotten up the curve. I certainly think kind of being up, call it a point in gross margin, maybe a point or two on Adjusted EBITDA is a reasonable starting point.

[Joe Mara, CFO at Vericel Corporation]

We will have to, there will be investments on the Salesforce on a full-year basis, on the ankle trial ramping up. The cost of goods sold will absorb some of the new building. That has to be contemplated next year. Lastly, I would just say, I think from a broader lens, if you kind of look at where the kind of financial trajectory of the company is and our P&L metrics, they are really kind of starting to ramp up pretty significantly. Last year, we had $50 million of Adjusted EBITDA. This year, our guidance is pointing to $70 million. We are already starting to get into that $100 million zone on Adjusted EBITDA level now. If you assume even similar revenue growth over the next few years and.

[Joe Mara, CFO at Vericel Corporation]

A high 30% Adjusted EBITDA, I think it's certainly reasonable to be kind of getting close to that $200 million EBITDA range. By 2029, call it. I think we're pretty excited about, obviously, everything that's going on on the MACI side and across the business, but we're also very focused on that kind of financial trajectory in 2026, but really over the next several years, which could be pretty significant. Again, we think it makes us pretty unique for a company of our size and scale.

[Richard Newitter, Managing Director and Senior Equity Research Analyst at Truist Securities]

Thank you.

[Joe Mara, CFO at Vericel Corporation]

Thanks, Richard.

[Operator]

We'll take our next question from Ryan Zimmerman with BTIG.

[Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG]

Hey, guys. Can you hear me okay?

[Joe Mara, CFO at Vericel Corporation]

Yeah, good morning, Ryan.

[Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG]

Morning. Nice quarter. Thank you. Just given the biopsy trends you saw early in the year, the results this quarter. The MACI guidance was tightened. I'm wondering why fourth quarter wouldn't step up, maybe relative to your prior guidance, given what you're seeing and your commentary about biopsies in the third and into the fourth quarter.

[Joe Mara, CFO at Vericel Corporation]

Yeah, so thanks for the question, Ryan. I'll take that. I mean, I think clearly a very strong third quarter, as we referenced, the biopsies at the start of the year led to that higher implant and revenue growth, which was great to see. To your point, the leading indicators have been strong. I'd say particularly the biopsies, which is, of course, a key leading indicator for us. I think in terms of the guidance, I would say another dimension there is with that strong third quarter, it really de-risks where we need to be in the fourth quarter to achieve our full-year guidance. To your point, we're essentially maintaining the full-year guide at the same level. It kind of points to about $82 million-$84 million in the fourth quarter, which is right in line with kind of where estimates and consensus are.

[Joe Mara, CFO at Vericel Corporation]

I'd also say this kind of points to a pretty strong acceleration still from an H1-H2 perspective. Depending on where you're on the range, it's 18% to, call it, 22%-23%. Pretty significant step up in the second half. Also gives us, I'd say, a pretty achievable step up Q3-Q4. I'd just say broadly, we just want to be prudent here on Q4. We recognize there certainly remains a wider range given some of the leading indicators. We've got a great foundation of biopsies in place, but Q4 is our largest quarter. December is our highest month. There always can be some variability at quarter end, particularly with the year-end holidays. We think this is appropriate. It's an achievable step up. I would say just we do not want to get ahead of ourselves as we close out the year.

[Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG]

Yeah. Okay. Fair enough. The other question, and you kind of talked about this, Nick, which is you're seeing adoption in MACI Arthro, but I guess I'm not clear. I mean, how much MACI Arthro sales were in the third quarter and what are you expecting relative to legacy MACI, if you will, as we convert and move into both the fourth quarter, but then into 2026? I mean, if you were to kind of think about it with broad strokes, I mean, does it entirely convert over this next quarter? Do you convert over the course of 2026? I guess I'm just curious kind of how you think about the rise of MACI Arthro relative to maybe the decline of legacy MACI. Thanks.

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah. So we kind of don't, like we said earlier, think about a decline of legacy MACI. I mean, legacy MACI was principally focused on patella defects and large defects anywhere in the knee. I’d say that patella defects is one of the strongest, if not the strongest, growth drivers for core MACI. That remains the case. There’s not like a decline in the core MACI. Again, you’re never going to have full sort of switch over to MACI Arthro because MACI Arthro instruments are designed for the smaller defects. If it’s above 4 sq cm, you’re doing an open procedure. If it’s a patella case, you’re typically going to do an open procedure. These small defects were the smaller part. We had lower penetration there. That’s the whole thesis for launching the MACI Arthro instruments.

[Nick Colangelo, President and CEO at Vericel Corporation]

As we've seen an increase in biopsies and implants on smaller condyle defects, those are kind of MACI Arthro-attributable cases. Again, we do not think about it as it's got to be blank on the core and then blank on Arthro. You can often start intending to do an Arthro case and flip to open if the defect got bigger since you did a biopsy. I mean, it's almost like a halo effect on the whole brand. That is how we approach it. No doubt, as we've talked about, the trends for trained surgeons and how they're behaving is exactly what you want to see and supports the overall growth for the brand.

[Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG]

Okay. That's very helpful. If I could sneak one last one in, I'll hop back in queue. If you go back, some of the insurance carriers and their policies do not restrict lesion size. Some do. Have you had to work through that? Is there any impact or any gating factor there in terms of lesion size as you launch MACI Arthro? Thanks for taking the question.

[Nick Colangelo, President and CEO at Vericel Corporation]

Yep. The short answer is not at all. As you mentioned, there are some plans that do not have any sort of size restrictions or parameters there. There are some that require that the defect be one, one and a half, or two sq cm or above. That is, again, exactly what the MACI Arthro instruments are designed for. They are two, three, or four sq cm defects. That has not been an issue at all. As we have talked about often, every major medical plan has a policy, a medical policy for MACI. Our prior approval rates are up in the mid-90% range. For the appropriate patients, MACI gets approved.

[Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG]

Yeah. All right. Appreciate it.

[Joe Mara, CFO at Vericel Corporation]

Thanks, Ryan.

[Nick Colangelo, President and CEO at Vericel Corporation]

Thanks.

[Operator]

We'll take our next question from Caitlin Roberts with Canaccord Genuity.

[Caitlin Roberts, Director of Medical Technology Equity Research at Canaccord Genuity]

Hi. Thanks for taking the question. Congrats on the quarter. Just to start with burn care, can you just walk us through the puts and takes here? You said Epicel, you expect similar Q4 dynamics this quarter as last year. And then the BARDA contract, any more color on that and why there could be some BARDA upsides? NexoBrid and also has the new category three code for NexoBrid helped uptake there.

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah. Hey, Caitlin, this is Nick. Just on the Epicel trends coming into the quarter that Joe referenced, I mean, what we said was to start the quarter, and again, we're still relative, we're only a third of the way through the quarter, that the trends to date, which essentially is sort of the biopsies that we have coming into the quarter and in the first weeks of the quarter, were more like Q4 last year. That is what we're going to guide to, as you know. We still have a good amount of the quarter to go. The biopsies for patients we're going to treat in December are not even sort of in-house yet. We just do not have the visibility on that. As Joe mentioned, we want to be very prudent in sort of.

[Nick Colangelo, President and CEO at Vericel Corporation]

Making sure that we don't get ahead of ourselves on Epicel guidance, given its variability. On the BARDA opportunity, as you know, the RFP is public and was intended to sort of begin on October 1. Obviously, we're all aware there's a government shutdown, so things sort of came to a screeching halt. We are hopeful and expect that when the government reopens, that there's an opportunity to move forward on that RFP and the procurement, etc., and advanced development of NexoBrid. More to come on that. Obviously, until that happens, we can't really kind of share much more about it. On the CPT code, I think we have, as we've talked about, had a pretty good number of P&T committee approvals for NexoBrid up in the 70 range, and more than 60 ordering centers.

[Nick Colangelo, President and CEO at Vericel Corporation]

Kind of in the CPT world, I think we feel comfortable. There's pretty widespread utilization. We would expect that next year we'll pursue a permanent code, which would then become effective in 2027. That would be our plan right now. More to come on that as we get into next year.

[Caitlin Roberts, Director of Medical Technology Equity Research at Canaccord Genuity]

That's great. And then just maybe touching on the MACI Salesforce hiring, where are you now? You noted you're on track to be completed in the Q4. Any changes to the amounts that you noted last quarter that you would hire into the year?

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah. No, we said we were going to be adding 25 new territories and three new regions. That is essentially virtually complete. Onesie, twosies left to go on that. We are extremely pleased with the quality and caliber of the talent we've brought in. If you're in the sports medicine business, this is a great place to be with MACI. Zero issues in attracting top talent. Couldn't be more excited to kind of have this expanded team as we, again, to support our Q4 volumes, but also as we move into next year. Really excited about that. That, quite frankly, is just one piece, as I mentioned, of sort of the overall investments and enthusiasm around MACI. Expanding the sales force.

[Nick Colangelo, President and CEO at Vericel Corporation]

We're really proud to have kind of built this franchise from a $30 million product 10 years ago to close to a quarter billion now. We're really focused on the people, the resources, the processes that we have to have in place to take it from a quarter billion to a $500 million product over the next several years. That's what we're focused on. The sales force expansion is one piece of it, as I alluded to in my prepared remarks. We're also focused on additional marketing, sales ops, and other kinds of investments in medical affairs and engagement with our key customers to make sure that we drive and achieve what's clearly right in front of us as we move forward over the next several years.

[Caitlin Roberts, Director of Medical Technology Equity Research at Canaccord Genuity]

Great. Thank you so much.

[Nick Colangelo, President and CEO at Vericel Corporation]

Okay. Thank you.

[Operator]

We'll take our next question from Mike Kratky with Leerink Partners.

[Mike Kratky, Senior Research Analyst at Leerink Partners]

Hi, everyone. Thanks for taking my question and congrats on a nice quarter. You've continued to show great progress on some of the leading indicators like biopsies and surgeons taking biopsies. Can you just clarify how much of your three-quarter growth for MACI is being driven by implant volume vs pricing? Have you seen some of these really positive leading indicators start to materialize in your MACI volume growth? How is that tracked relative to your expectations? Thanks.

[Joe Mara, CFO at Vericel Corporation]

Yeah. Good morning, Mike. Thanks for the question. Yeah, I mean, I'd say kind of the acceleration that we're seeing in Q3 in terms of the performance, I mean, that's really volume-driven. As we've talked about, early in the year, we obviously had some strong biopsy growth. The implant growth was not tracking at the same level. What we really saw in the third quarter, which is what we anticipated, was really the volume from an implant perspective really ticked up. Again, as you kind of think going forward, obviously, the most important indicator as we look forward, or one of the most important, of course, is that biopsy growth. That's really something that has continued to be strong. Nick referenced October was really strong as well. I think our highest month ever.

[Joe Mara, CFO at Vericel Corporation]

So that's. It's really kind of been driven by that piece, both in Q3. Then again, you think about those volumes as we start Q4, that's what is going to drive us going forward.

[Mike Kratky, Senior Research Analyst at Leerink Partners]

Understood. Thanks very much.

[Joe Mara, CFO at Vericel Corporation]

Thank you.

[Operator]

We'll take our next question from Mason Carrico with Stephens.

[Ben Mee, Equity Research Associate at Stephens]

Hey, guys. Good morning. This is Ben on for Mason. In terms of the MACI Arthro trained surgeons, you called out that one-third split between surgeon types. Could you compare and contrast Arthro biopsy growth and maybe Arthro procedures across these different groups?

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah. Just to be clear, we talked about the fact that we had former MACI users, about half of whom were condyle-only surgeons or users. Then we had the other half of those prior users that did both femoral condyle and patella cases. Then we have new users. It kind of splits between those two, a third, a third, or three, and a third. To be honest, we've seen kind of biopsy growth across the board. I don't think there's any sort of notable groups that are outperforming the others. Obviously, if they were smaller users and they ramp up even a handful, it's a high biopsy growth rate. Or if you're a new one, it's a really high biopsy growth rate. I think the rates across those segments are relatively similar. As Joe alluded to.

[Nick Colangelo, President and CEO at Vericel Corporation]

It's pretty exciting for us to say. Between the new users, a third of the surgeons being trained, and then another third coming from patella-only. I mean, that's two-thirds of these trained surgeons who probably didn't think about using MACI, or certainly didn't, in smaller condyle defects. And so that's, again, exactly what we would have wanted to see this early in the launch.

[Ben Mee, Equity Research Associate at Stephens]

Great. Thanks for that. Then you've historically called out mid to high single-digit pricing for MACI. Could you speak to the durability of that pricing moving forward, or just the durability of that in light of the current reimbursement environment? Thank you.

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah. So again, just so everybody understands, MACI is reimbursed under a medical benefit. It requires prior approval by each plan before a case can move forward. Obviously, the pricing is known when plans include MACI in their medical benefits. They know the appropriate patients are going to be treated because they have to approve them in advance. That is what leads to these high, sort of mid-90% prior approval rates that we have achieved consistently for the last decade since we launched MACI. Some of the other things, we do not have a big, obviously, Medicare business at all. A lot of the macro-stuff that is circulating out there does not really apply to MACI.

[Nick Colangelo, President and CEO at Vericel Corporation]

In terms of the sort of mid to high single-digit price increases that we've sort of routinely taken, I mean, we do a lot of pricing research with plans and hospital administrators. Again, this is viewed as a very sort of high-tech product where more like a biologic in the pharma space where mid to high single digits are pretty routine. We are pretty comfortable in our pricing practices and our approach.

[Ben Mee, Equity Research Associate at Stephens]

Great. Thanks for taking the questions.

[Nick Colangelo, President and CEO at Vericel Corporation]

Okay. Thank you.

[Operator]

We'll move to our next question from Jeffrey Cohen with Ladenburg Thalmann.

[Jeffrey Cohen, Managing Director and Director of Equity Research at Ladenburg Thalmann]

Hey, Nick and Joe, thanks for taking our questions. Congrats on the quarter. Two specifically. Firstly, Joe, perhaps you could talk about R&D a bit and anticipation for Q4 full year and general commentary there.

[Joe Mara, CFO at Vericel Corporation]

Yeah. I mean, we haven't from a spend perspective, broadly, I mean, we don't typically kind of get into the pieces. I would say, I think we called out, as you're thinking about kind of Q4, we called out about $50 million of total OpEx, which I think kind of gets us back to a similar point on a full-year basis that we've been talking about all year. I think as you think about kind of R&D going forward, it really kind of all the buckets, again, I referenced it earlier, but there's sort of two key incremental investments on the operating expense side, which are the salesforce expansion. Nick talked about we have some related investments around that, which I think will be important, and that'll be incremental next year.

[Joe Mara, CFO at Vericel Corporation]

Then the Ankle Trial, really next year, will become much more operational, where you're going to see more sites and potentially patients kind of ramping up. I would expect that to increase, particularly next year. We'll kind of get to where next year's spend is as we get into next year, probably at a somewhat similar rate in terms of growth this year, perhaps a bit higher just for some of those investments. Again, on Q4, we did specifically call out $50 million, just to be clear of kind of what was expected there.

[Jeffrey Cohen, Managing Director and Director of Equity Research at Ladenburg Thalmann]

Okay. Got it. Then secondly, I know. Nick, you brought up post-surgical pain. Could you talk about that in a little more detail as far as anything that has been noted or you've noted as far as the medical treatment as well as the weight-bearing and some of the times and some of the medications that you've understood so far?

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah. This started way back even in the first quarter when we were talking about the fact that surgeons who had done the initial MACI Arthro cases were posting on social media about sort of these immediate positive benefits in terms of post-surgical pain or range of motion or sort of back to full weight-bearing. Those are kind of the key early indicators. As expected, both by us and surgeons through our market research using the product, when you have a less invasive surgery, you have less arthrofibrosis. The knee is not swollen. You get better range of motion, etc. It just promotes a potentially faster healing process. We have been really focused. We were fortunate to be able to get MACI Arthro instruments on the market quickly through the human factor study pathway, which did not involve a clinical study.

[Nick Colangelo, President and CEO at Vericel Corporation]

Obviously, we didn't have the clinical data supporting a faster post-surgical recovery. That's what we've been focused on. I alluded to in my comments that through case series and through the MACI Clinical Outcomes Registry, we've been gathering that data. We'd expect in early 2026 that that data will be presented at industry conferences, ultimately, hopefully, make its way into publications. We think in the progression of MACI Arthro, when you go from high awareness and training, which obviously we've checked that box, to sort of surgical technique demonstrations, which you see, for instance, at the International Cartilage Repair Society meeting that was recently held in Boston, very effective presentation there, and then you move into these clinical benefits for patients. That's sort of the progression you would expect to see for MACI Arthro.

[Nick Colangelo, President and CEO at Vericel Corporation]

That is kind of exactly what we are seeing and sort of why we made those comments in our prepared remarks.

[Jeffrey Cohen, Managing Director and Director of Equity Research at Ladenburg Thalmann]

Perfect. Thanks for taking our questions.

[Nick Colangelo, President and CEO at Vericel Corporation]

Okay. Thanks, Jeffrey.

[Joe Mara, CFO at Vericel Corporation]

Thanks, Jeffrey.

[Arthur He, Senior Equity Analyst of Biotechnology and Therapeutics at H.C. Wainwright & Co.]

Hey, good morning. Nick and Joe, can you hear me okay?

[Joe Mara, CFO at Vericel Corporation]

Yes. Good morning.

[Arthur He, Senior Equity Analyst of Biotechnology and Therapeutics at H.C. Wainwright & Co.]

Hey, this is Arthur on for RK. I just had a quick question on the MACI side. Maybe for the MACI Arthro, could you give us more color regarding the timing from the surgeons finish the training to they are taking their first biopsy? How does that compare to the initial, the MACI launch? On the conversion-wise, you mentioned there's a high conversion rate in terms of Arthro. How about the average time for the conversion? How that compares to the open surgery?

[Nick Colangelo, President and CEO at Vericel Corporation]

Yeah. Just starting with the training, it's very much like MACI, core MACI when we launched, where training is never really a barrier. You can train online. You can do cadaver labs. We have MACI Arthro synthetic knees they can practice on. Obviously, in the first cases that were done, biopsies were already taken. Then they trained and did the MACI Arthro procedure. There's really no sort of gating item around training. Often, if there's a surgery that a surgeon intends to do arthroscopically, they'll just get trained ahead of the training. There's really not a connection between whether you take a biopsy first, you get trained first and then take a biopsy, etc. Any of those scenarios, MACI Arthro training, we make a lot of different methodologies available to surgeons, and they just kind of do what they feel most comfortable with.

[Nick Colangelo, President and CEO at Vericel Corporation]

In terms of the conversion rate, I think we mentioned on our last call that we have not seen any sort of differences in the MACI Arthro conversion timelines vs regular. Kind of early days on that, but kind of similar at this point.

[Arthur He, Senior Equity Analyst of Biotechnology and Therapeutics at H.C. Wainwright & Co.]

Oh, thanks, Nick. The last one. Could you discuss the timing and scale of the MACI Ankle phase? How should we think about the data readout there?

[Nick Colangelo, President and CEO at Vericel Corporation]

Just in terms of the timing, we said we're set to initiate the study in the fourth quarter of this year. We've kind of built a timeline very much like the pivotal study, the SUMMIT pivotal study for the indication in the knee, which was two years to enroll, two-year follow-up, and then call it 18 months+ on the regulatory pathway. We've always said this is kind of a 20-30+ opportunity. That's a very important part of our sort of long-term strategy for MACI with the core business, obviously, with a ton of momentum, MACI Arthro, then MACI OUS expansion opportunities, and then MACI Ankle following that. Just kind of this sort of long runway of growth opportunities for MACI, particularly with no like competition on the horizon.

[Arthur He, Senior Equity Analyst of Biotechnology and Therapeutics at H.C. Wainwright & Co.]

Thanks, Nick. And Joe, taking my question, congrats on the quarter.

[Nick Colangelo, President and CEO at Vericel Corporation]

Okay. Thanks. Okay. I believe that concludes all of the questions. I just want to thank everyone for joining us this morning. Obviously, we had an outstanding third quarter and are very well positioned for a strong close to the year and to continue to deliver a unique combination of sustained high revenue growth and profitability in 2026 and the years ahead. We look forward to providing further updates on our progress on our next call. Thanks again and have a great day.

[Operator]

This concludes today's call. Thank you again for your participation. You may now disconnect and have a great day.

Participants

Executives

• Joe Mara, CFO
• Eric Burns, VP of Finance and Investor Relations
• Nick Colangelo, President and CEO

Analysts

• Arthur He, Senior Equity Analyst of Biotechnology and Therapeutics at H.C. Wainwright & Co.
• Caitlin Roberts, Director of Medical Technology Equity Research at Canaccord Genuity
• Ben Mee, Equity Research Associate at Stephens
• Josh Jennings, Managing Director at TD Cowen
• Jeffrey Cohen, Managing Director and Director of Equity Research at Ladenburg Thalmann
• Mike Kratky, Senior Research Analyst at Leerink Partners
• Richard Newitter, Managing Director and Senior Equity Research Analyst at Truist Securities
• Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG