Hội nghị công bố kết quả kinh doanh quý 3/2026 của Vericel (VCEL): Doanh thu tăng 26%, nâng định hướng

Điểm nhấn chính

• Vericel Corporation công bố doanh thu quý 3/2026 đạt mức kỷ lục 85,4 triệu USD, tăng 26% so với cùng kỳ năm trước, nhờ đà tăng trưởng ở cả mảng MACI lẫn chăm sóc vết bỏng.
• Doanh thu từ MACI tăng 21% lên 67,4 triệu USD. Ban lãnh đạo nhấn mạnh số ca sinh thiết, số ca cấy ghép và số lượng bác sĩ phẫu thuật tham gia trong quý 3 đều đạt mức kỷ lục, cùng với tỷ lệ ứng dụng MACI Arthro ngày càng tăng.
• Doanh thu mảng chăm sóc vết bỏng tăng 52% lên mức kỷ lục 18,0 triệu USD. Trong đó, Epicel đóng góp 12,7 triệu USD, còn doanh thu thương mại của NexoBrid đạt 2,3 triệu USD.
• Lợi nhuận ròng theo GAAP tăng 179% lên 14,2 triệu USD, tương đương 0,27 USD trên mỗi cổ phiếu pha loãng. EBITDA điều chỉnh tăng 48% lên 25,2 triệu USD, tương ứng biên lợi nhuận 30%.
• Vericel đã nâng dự báo doanh thu cả năm lên khoảng 344 triệu - 346 triệu USD và dự báo biên EBITDA điều chỉnh lên khoảng 28%.
• Doanh nghiệp kết thúc quý với 236 triệu USD tiền mặt và các khoản đầu tư, không có nợ vay, đồng thời còn 191 triệu USD trong hạn mức ủy quyền mua lại cổ phiếu.

Kết quả tài chính cốt lõi

Vericel đã mua lại khoảng 221.000 cổ phiếu với giá 8,8 triệu USD trong quý. Trong 9 tháng đầu năm 2026, doanh thu tăng 26%, trong khi EBITDA điều chỉnh tăng gần 50% lên 50 triệu USD.

Hiệu quả kinh doanh và hoạt động

MACI

MACI ghi nhận quý thứ sáu liên tiếp có mức tăng trưởng doanh thu đạt ít nhất 20%. Ban lãnh đạo cho rằng kết quả này đến từ năng lực triển khai của đội ngũ bán hàng, mức độ thâm nhập sâu hơn vào mạng lưới bác sĩ phẫu thuật, việc ứng dụng MACI Arthro và các sáng kiến thương mại mở rộng.

Tăng trưởng số ca sinh thiết tăng tốc qua từng quý của năm 2026, và tháng 10 là tháng đạt số ca sinh thiết cao nhất của MACI kể từ khi ra mắt. Ban lãnh đạo cho biết lượng sinh thiết tăng cao đang chuyển hóa thành tăng trưởng số ca cấy ghép đúng như kỳ vọng, đặc biệt là trong quý 4.

Các khu vực bán hàng mới ghi nhận mức tăng trưởng sinh thiết cao nhất trong số các nhóm khu vực của công ty trong 9 tháng đầu năm. Vericel kỳ vọng số ca sinh thiết này sẽ hỗ trợ tăng trưởng cấy ghép trong quý 4/2026 và bước sang năm 2027. Ban lãnh đạo cũng lưu ý rằng các đại diện bán hàng thường đạt năng suất cao hơn trong năm thứ hai và thứ ba làm việc.

Số ca phẫu thuật MACI Arthro đạt kỷ lục theo quý và chiếm tỷ trọng cao nhất trong tổng số ca phẫu thuật MACI kể từ khi ra mắt. Hơn 25% số ca phẫu thuật MACI đối với các tổn thương lồi cầu nhỏ hơn 4 cm vuông được thực hiện thông qua MACI Arthro. Công ty đang phát triển các dụng cụ thế hệ tiếp theo nhằm đơn giản hóa quy trình, rút ngắn thời gian phẫu thuật và cải thiện khả năng tiếp cận các vùng đầu gối khác, bao gồm cả các tổn thương xương bánh chè.

Vericel tiếp tục kích hoạt các điểm nghiên cứu và tuyển chọn bệnh nhân tham gia thử nghiệm MACI Ankle MASCOT. Ban lãnh đạo ước tính chỉ định điều trị mắt cá chân tiềm năng có thể phục vụ gần 20.000 bệnh nhân mỗi năm, mở ra cơ hội thị trường vượt mức 1 tỷ USD.

Công ty vẫn đang bám sát tiến độ cho kế hoạch ra mắt tiềm năng tại Anh vào nửa cuối năm 2027. Vericel đã nộp đơn xin Cấp phép Tiếp thị tại Anh vào quý 2/2026, MHRA đã thanh tra cơ sở sản xuất mới của công ty trong quý 3, và Viện Y tế và Chất lượng Điều trị Quốc gia Anh (NICE) đã chấp thuận đưa MACI vào quy trình thẩm định công nghệ đơn lẻ. Ban lãnh đạo ước tính quy mô thị trường có thể tiếp cận tại Anh đạt khoảng 15.000 bệnh nhân mỗi năm.

Mảng chăm sóc vết bỏng

Mảng chăm sóc vết bỏng ghi nhận doanh thu theo quý kỷ lục cho cả Epicel và NexoBrid. Epicel hưởng lợi từ hoạt động sinh thiết gia tăng, số lượng trung tâm thực hiện sinh thiết nhiều hơn, tái định vị thương mại, tăng cường gắn kết chuyên môn giữa các đồng nghiệp và hoạt động bán chéo từ tổ chức bán hàng mảng bỏng hợp nhất.

NexoBrid ghi nhận số lượng trung tâm điều trị bỏng đặt hàng và đơn đặt hàng từ bệnh viện cao nhất từ trước đến nay. Đã có hơn 80 trung tâm đặt hàng và khoảng 70 trung tâm tiếp tục đặt lại. Trong 9 tháng đầu năm 2026, Vericel đã thu hút thêm nhiều trung tâm đặt mua NexoBrid mới hơn cả năm 2025.

Ban lãnh đạo cho biết kết quả khả quan gần đây của Epicel chủ yếu được thúc đẩy bởi năng lực triển khai thương mại thay vì sự thay đổi đáng kể của thị trường điều trị bỏng. Tháng 10 cũng ghi nhận số ca sinh thiết Epicel theo tháng cao nhất trong năm 2026.

Kế hoạch định hướng của ban lãnh đạo

Ban lãnh đạo dự kiến doanh thu MACI quý 4 đạt khoảng 102 triệu USD ở mức trung vị, tương ứng mức tăng trưởng 21% so với cùng kỳ năm trước. Công ty cho biết số lượng ca phẫu thuật duy trì ổn định đến hết tháng 12 có thể tạo ra tiềm năng tăng trưởng vượt mức dự báo này.

Doanh thu mảng chăm sóc vết bỏng quý 4 dự kiến đạt tổng cộng 12 triệu USD, bao gồm 9 triệu USD từ Epicel và doanh thu thương mại NexoBrid cùng 3 triệu USD từ hoạt động mua sắm NexoBrid của BARDA.

Đối với năm 2027, ban lãnh đạo chưa đưa ra dự báo chính thức. Công ty cho biết kỳ vọng nội bộ vẫn rất tích cực nhưng cho thấy ý định duy trì khung dự báo ban đầu thận trọng. Ban lãnh đạo kỳ vọng biên EBITDA điều chỉnh sẽ tiếp tục mở rộng trong khi vẫn cấp vốn cho công tác chuẩn bị ra mắt tại Anh, phát triển MACI Ankle và mở rộng thị trường quốc tế.

Rủi ro và các yếu tố cần theo dõi

• Nhu cầu đối với Epicel có thể biến động do Vericel không thể kiểm soát tỷ lệ xảy ra các ca bỏng nghiêm trọng hoặc số lượng bệnh nhân sống sót để tiếp nhận điều trị.
• Tăng trưởng số ca sinh thiết MACI là một chỉ báo sớm, nhưng quá trình chuyển đổi thành các ca cấy ghép cần có thời gian và vẫn phụ thuộc vào thời điểm thực hiện phẫu thuật.
• Kế hoạch ra mắt tiềm năng tại Anh vẫn phụ thuộc vào các quy trình pháp lý, thanh toán bảo hiểm và định giá, bao gồm cả quá trình thẩm định của NICE.
• Vericel đang vận hành hai cơ sở sản xuất và tiếp tục đầu tư vào việc mở rộng ra quốc tế cùng dự án MACI Ankle, điều này có thể ảnh hưởng đến tốc độ mở rộng biên lợi nhuận.
• Hoạt động mua sắm của BARDA vượt mức 4 triệu USD dự kiến trong quý 1/2027 sẽ phụ thuộc vào thời điểm và quy mô của các đợt mua sắm trong tương lai.

Điểm nhấn phiên hỏi đáp với chuyên gia phân tích

• Mục tiêu dài hạn: Ban lãnh đạo cho biết Vericel dường như đang vượt tiến độ trên lộ trình hướng tới mức doanh thu khoảng 500 triệu USD vào cuối thập kỷ này, nhưng hiện tại chưa cập nhật kế hoạch dài hạn.
• Năng suất của đội ngũ bán hàng: Các khu vực mới của MACI dẫn đầu mức tăng trưởng số ca sinh thiết trong 9 tháng đầu năm. Ban lãnh đạo kỳ vọng các đại diện bán hàng sẽ đóng góp đáng kể hơn khi bước vào năm làm việc thứ hai và thứ ba.
• Mức độ thâm nhập mạng lưới bác sĩ phẫu thuật: Tăng trưởng của MACI ngày càng cân bằng giữa việc tiếp cận thêm bác sĩ phẫu thuật mới và việc tạo ra nhiều ca sinh thiết hơn trên mỗi bác sĩ phẫu thuật hiện có.
• Xu hướng chuyển đổi của MACI: Ban lãnh đạo cho biết mức tăng trưởng sinh thiết mạnh mẽ đang chuyển hóa thành các ca cấy ghép như dự kiến, và tiến độ chuyển đổi vẫn đang diễn ra đúng kế hoạch đến cuối năm.
• Quỹ đạo biên lợi nhuận: Vericel kỳ vọng biên EBITDA điều chỉnh sẽ tiếp tục mở rộng trong năm 2027 nhờ tăng trưởng doanh thu và đòn bẩy hoạt động, trong khi biên lợi nhuận gộp dự kiến sẽ duy trì quanh vùng giữa 70%.
• Phân bổ vốn: Ban lãnh đạo cho biết dòng tiền tăng trưởng cho phép Vericel đồng thời theo đuổi hoạt động mua lại cổ phiếu và các cơ hội phát triển kinh doanh tiềm năng. Hoạt động mua lại cổ phiếu sẽ tiếp tục được thực hiện tùy theo cơ hội thị trường.

Toàn văn nội dung cuộc họp công bố kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Ladies and gentlemen, please stand by. We are about to begin. Good day and welcome to the Vericel Corporation third quarter 2026 earnings call. Today's conference is being recorded. [Operator Instructions] Now at this time, I would like to turn the conference over to Eric Burns, Vericel VP of Finance and Investor Relations. Please go ahead, sir.

Eric Burns

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, I would like to remind you that the discussions during this conference call will include forward-looking statements. Factors that could cause actual results to differ materially from expectations are discussed more fully in the company's most recent filings with the SEC.

Also, the discussions today will include certain non-GAAP financial measures. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release, which is included as an exhibit to Vericel's current report on Form 8-K, filed today with the SEC. A short presentation with highlights from today's call is also available in the Investor Relations section of our website. I will now turn the call over to Nick.

Dominick C. Colangelo

Thank you, Eric, and good morning, everyone. The company had an outstanding third quarter, which was the strongest quarter of the year on a number of measures for the company, MACI, and our burn care business, as we generated top-tier revenue growth across the portfolio, an inflection in profitability, and significant free cash flow. We delivered record third quarter total revenue of more than $85 million, which increased 26% over last year and significantly exceeded our guidance for the quarter.

Based on our third quarter outperformance and the strong momentum that has continued into the fourth quarter, we're raising our full year total revenue guidance to $344 million to $346 million, which represents 25% revenue growth for the year at the midpoint, and an increase in revenue guidance of nearly $25 million since the start of the year. We also had another excellent quarter from a profitability perspective, as net income nearly tripled, adjusted EBITDA grew nearly 50% to more than $25 million, and adjusted EBITDA margin increased to 30%, which was significantly higher than our guidance for the quarter. Based on this outperformance on profitability measures, we're also raising our adjusted EBITDA margin guidance for the year.

MACI had another great quarter with record third quarter revenue of more than $67 million, which exceeded our guidance for the quarter and increased 21% versus the prior year, marking the sixth consecutive quarter with MACI revenue growth of 20% or more, which was notable given the significant acceleration in MACI's revenue growth, MACI implant, and revenue growth in the third quarter of last year. Beyond MACI's strong revenue performance, we continue to see significant momentum in the underlying business fundamentals that support sustained MACI growth.

We achieved record third quarter MACI biopsies, implants, and biopsy and implanting surgeons. Importantly, MACI's biopsy growth rate has increased each quarter this year, and we started the fourth quarter with the strongest biopsy month since launch in October, reflecting the strong demand that has translated into the robust implant procedure volume that supports our increased fourth quarter revenue guidance. With continued momentum across our key growth indicators and a strong start to the fourth quarter, we believe that MACI is exceptionally well positioned to deliver a strong finish to the year and sustain its growth trajectory in 2027 and beyond. MACI's strong performance has been driven by the consistent high level of execution of our expanded MACI sales force, as well as the impact of the MACI Arthro launch and our commercial excellence initiatives.

The primary objective of our sales force expansion and commercial initiatives is to drive deeper penetration within MACI surgeon practices. And during the third quarter, we saw continued strength in biopsies per surgeon, a clear indicator that this initiative is beginning to unlock another key growth driver for MACI. In addition, the cohort of expansion territories has the highest biopsy growth rate for the first 3 quarters of the year, which we expect will lead to accelerating implant growth in our new territories in the fourth quarter and into 2027.

MACI Arthro adoption also continues to gain momentum. We completed a record number of MACI Arthro procedures in the third quarter, which represented the highest percentage of total MACI procedures in any quarter since launch. We also had a record high number of surgeons perform a MACI Arthro procedure in the quarter, and more than 25% of MACI procedures to treat condyle defects under 4 square centimeters were administered via MACI Arthro, another strong indicator of increasing adoption. While the patella defect segment continues to be our highest volume and growth segment, we've also seen higher growth and activity in other defect locations, which we believe is a result of the focus MACI Arthro has created for these other defect segments.

We expect that expanding MACI Arthro adoption and utilization will be further supported by a growing body of positive clinical evidence. Of note, a recent publication evaluating patients treated arthroscopically outside the United States reported durable clinical outcomes and a higher rate of patient satisfaction at a mean follow-up of 13.6 years, reinforcing the potential long-term clinical benefits with the arthroscopic delivery of MACI. In addition, the first MACI Arthro publication, which was published in August, highlighted several surgical and early patient outcome advantages of the MACI Arthro procedure, including minimal surgical disruption to the joint, the ability to treat multiple cartilage defects in different compartments of the knee, a more desirable cosmetic appearance, and improved early postoperative recovery. These initial results suggest positive patient outcomes that could also lead to shorter overall rehab and recovery timelines for MACI Arthro patients.

Looking ahead, we expect our MACI Clinical Outcomes Registry to expand to even more sites in 2027, leading to additional data for future publications that can further enhance MACI's strong clinical profile. Surgeon engagement with MACI also continues to significantly expand as the number of peer-to-peer programs and training labs through the third quarter have more than tripled compared to last year. As we move into 2027, we expect an even greater impact from the expanded MACI sales force, MACI Arthro adoption, and our commercial excellence initiatives, which together with continued overall trends towards restorative cartilage repair procedures, positions MACI for sustained strong growth in 2027 and beyond.

In terms of our longer-term MACI growth drivers, we continue to activate sites and enroll patients in the MACI Ankle MASCOT study. As a reminder, a potential MACI Ankle indication represents a substantial commercial opportunity for the company, with an estimated annual addressable market of nearly 20,000 patients, representing more than a $1 billion market opportunity. We also remain on track for the potential launch of MACI in the U.K. in the second half of 2027, which represents another meaningful market opportunity.

Based on procedural data available from the U.K. National Health Service, we estimate an addressable market of approximately 15,000 patients annually, representing a potential market opportunity of several hundred million dollars. As we noted on our last call, we submitted a MACI Marketing Authorization application to the U.K. in the second quarter. The MHRA completed its inspection of our new manufacturing facility in the third quarter, and earlier this month, NICE accepted MACI for a single technology appraisal, which will establish reimbursement and pricing as well as a specific MACI funding guidance for the NHS. In parallel, we've begun initial market development work to assess additional MACI OUS expansion opportunities in Canada and Europe.

Finally, we're continuing to develop the next generation of MACI Arthro instruments as we remain focused on continuous innovation to further simplify and reduce surgical time for the MACI Arthro procedure and providing greater access for all areas of the knee, including for patella defects, which we expect will support sustained increases in surgeon engagement and MACI utilization.

The company also delivered an exceptional quarter for the burn care business as we built on the momentum from the first half of the year and generated the highest quarterly revenue to date for both Epicel and NexoBrid, with record quarterly burn care revenue of $18 million, representing more than 50% growth versus both the prior year and the prior quarter. Epicel's record quarterly revenue is driven by continued strength in biopsies and new biopsying centers as the burn care commercial team's cross-selling efforts continue to expand Epicel adoption and utilization.

NexoBrid's record quarterly commercial revenue was driven by the highest number of ordering burn centers and hospital orders in any quarter to date. Notably, we've added more new NexoBrid ordering centers through the third quarter of this year than during all of last year, continuing to expand the number of consistent users, an important driver of further uptake. To date, more than 80 centers have placed NexoBrid orders, with approximately 70 centers having placed repeat orders, as we continue to focus on driving more centers to become consistent users.

Building on the success with MACI, we've also recently implemented several commercial and operational excellence initiatives across burn care that we believe are beginning to have a meaningful impact on performance. For Epicel, we began the year with a full commercial rebranding that refreshed the product's positioning around the critical importance of achieving wound closure, significantly increased our peer-to-peer activity, and sharpened our focus on supporting our surgeon customers with a multidisciplinary approach to drive the best clinical outcomes for patients.

At NexoBrid, we've implemented similar account planning as well as stakeholder mapping initiatives that are leading to broader standardization of treatment algorithms across burn centers in more consistent adoption and utilization of NexoBrid. As we move into 2027, we believe that these commercial initiatives and our enhanced execution can drive continued strong results for the burn care franchise.

Overall, we're on track to deliver a strong close to the year and another great year for the company. Our recent financial results and increased guidance demonstrate the company's unique combination of sustained high revenue growth, profitability, and cash generation. We believe that the durable growth of our portfolio positions the company to sustain strong revenue and profit growth in 2027 and the years ahead as we remain on track to achieve our mid-term revenue and profitability targets. I'll now turn the call over to Joe to discuss our third quarter results and updated 2026 guidance in more detail.

Joseph Mara

Thanks, Nick, and good morning, everyone. Total revenue in the third quarter increased 26% to $85.4 million, significantly above our guidance range, driven by strength across both commercial franchises. MACI revenue was $67.4 million, representing 21% growth, and burn care revenue was $18 million, representing 52% growth, with both franchises continuing to deliver top-tier revenue growth. Within burn care, Epicel revenue increased 23% to $12.7 million, its highest quarterly revenue since launch. Commercial NexoBrid revenue was $2.3 million, also a quarterly record, increasing 54% versus the prior year and 46% versus the prior quarter as utilization continues to increase. We also recognized $3 million of NexoBrid procurement revenue under our BARDA agreement.

The company also delivered very strong profitability, with gross margin of more than 73% and adjusted EBITDA margin of 30%, both well above our guidance for the quarter. GAAP net income increased 179% to $14.2 million, or $0.27 per diluted share, and adjusted EBITDA increased 48% to $25.2 million, expanding over 400 basis points versus the prior year. The company generated approximately $18 million of operating cash flow and $16 million of free cash flow, ending the quarter with $236 million in cash and investments and no debt. We repurchased approximately 221,000 shares of common stock for $8.8 million in the third quarter, with $191 million remaining under our repurchase authorization as of the end of the quarter.

Through the first 9 months of the year, the company has generated exceptional financial results with revenue growth of 26%, adjusted EBITDA growth of nearly 50% to $50 million, and more than $45 million of free cash flow, further demonstrating our top-tier financial profile.

Turning to guidance. Based on the strong results to date, the clear momentum in the business, and a strong start to the fourth quarter for both franchises, and particularly for MACI, we are increasing full-year total revenue guidance to $344 million to $346 million from $330 million to $340 million, an increase of $10 million at the midpoint of our guidance range. This is the third consecutive quarter that we have raised revenue guidance, and our full year guidance is now $24 million above our starting point for the year. We are increasing full-year MACI revenue guidance to $290 million to $292 million from $284 million to $290 million.

Importantly, we are also raising fourth quarter MACI guidance and now expect 21% growth or approximately $102 million of revenue in the fourth quarter at the midpoint of our guidance. Our increased fourth quarter MACI guidance reflects the strong MACI procedure trends to start the quarter, and if these recent trends continue into December, this would result in upside to our fourth quarter MACI guidance. We are also raising full-year burn care revenue guidance to approximately $54 million from $46 million to $50 million. This implies $12 million of total fourth quarter burn care revenue, with $9 million of Epicel and commercial NexoBrid revenue and $3 million of NexoBrid BARDA procurement revenue.

Moving down the P&L, we continue to expect full-year gross margin of approximately 75%, and we are increasing full-year adjusted EBITDA margin guidance to approximately 28% from 27%, reflecting this higher revenue outlook and continued expense discipline. This concludes our prepared remarks. We will now open the call to your questions.

Operator

[Operator Instructions]

We will go first to Joshua Jennings with TD Cowen.

Phần hỏi đáp

Joshua Jennings

Congratulations on the strong third quarter results. Great to see the momentum continuing. I wanted to just talk about the LRP targets that you have in play with the significant outperformance to date in 2026. You have to have even more confidence in the run there to achieve those and hit those marks. Maybe just talk about any thoughts on potential updates to LRP targets as we move into 2027 and get closer to the year where you set those, what seems to be not as ambitious targets after the first 9 months of '26.

Joseph Mara

Yes, good morning, Josh, and thanks for the questions. This is Joe. I'll take that one. So yes, I mean, I would say, I appreciate the question in the sense that at this point we're probably kind of outpacing our expectations to kind of hit those targets, particularly on a top-line level, where it's kind of getting that half a billion by the end of the decade. Obviously the updated guidance for this year kind of gets us into the mid-$340s, which is a pretty substantial number for the company. So I think we feel like we're very much on track, particularly from a top-line perspective. And then I would say if you look at kind of the bottom-line metrics, I think what really stands out is, number one, we're already performing well on the gross margin side. We talked about getting into the high 70s on a full-year basis.

We've kind of already been in the mid-70s, another strong quarter while we're adding our new manufacturing facility in Q3. And then from a bottom-line perspective, I think it's certainly noteworthy. We've seen fourth quarters with 40%-plus margins, and that gives you a sense of where the company is at scale. But to see a third quarter kind of reach that 30% level, I think is noteworthy. So we've updated our full-year guidance from an adjusted EBITDA perspective. And even with the pretty substantial amount of investments we're making across the business to continue to drive growth, not only in the near term, but in the mid and long term, whether that's kind of ex-U.S., sales force expansion, et cetera. So there's a ton of investment in there and we're still on track to expand our bottom-line margins pretty significantly this year at that 28% level relative to last year. So I think to answer your question, we're not going to update it at this point. We'll certainly be kind of prudent as we get into guidance for next year, but I would say broadly from a kind of long-term perspective, we feel like we're tracking very well to the targets we laid out from an LRP perspective.

Joshua Jennings

Excellent, thanks for that. And then just maybe 1 follow-up, at our visit to Burlington inter-quarter, 1 of the new learnings for me was just for the MACI sales force, historically, there have been meaningful productivity gains for reps as they go from their first year, second year, and even the second year to the third year. But I was hoping to just circle back on that, Nick and Joe, and just get a review on those precedents and just how this sales force expansion has a long tail. Thanks.

Dominick C. Colangelo

Yes, thanks, Josh. I'll take that one. And we talked about it a little bit on our second quarter call as well, that obviously we have a strong track record over the years of when we expand, we've seen increases in rep productivity, and we certainly expect that to be the case again. So we talked about earlier in the year the new territories and new reps got off to a good start in the first quarter, where we saw them pulling through cases that were biopsies that were already existing within their territories. And they had a particularly strong biopsy growth that happened again in the second quarter. And really has continued throughout the year where new territories have sort of led all the cohorts in terms of biopsy growth. And obviously that sets up those new territories for strong growth in Q4 and into 2027, given the timeframes for when those biopsies convert. So we also mentioned that what we have typically seen as we look at sort of new rep adds post-COVID is that in their second and third years, they actually sort of lead on implant growth versus new territories or even the legacy territories that tend to be the higher volume territories. So that's why we're very confident that this is not just a 2026 play, obviously, and that in 2027 and beyond, that these new reps will have an even greater impact on the overall biopsy growth.

Joshua Jennings

Appreciate that.

Operator

[Operator Instructions]

We will go next to Caitlin Roberts with Canaccord Genuity.

Caitlin Roberts

Just with the strong growth in MACI, curious how much of that is being driven by new surgeon engagement. So how far along in the surgeon penetration curve since you expanded your target surgeon base for Arthro are you guys now?

Dominick C. Colangelo

Yes, hey Caitlin, thanks. It's Nick. I'd say that we've talked over the years that sort of the primary driver from a surgeon perspective up until last year was really just adding new surgeons as MACI has become kind of standard of care over its first decade on the market. I'd say last year we made a note that we were starting to see sort of more biopsies per surgeon, and that was contributing to the MACI growth as well in sort of a more balanced way. So now when we look at sort of the growth in the business, whether it's biopsies, which are the leading indicator, or even implants, we see that we are continuing to add new surgeons, but we're also seeing, again, more biopsies per surgeon. So that overall biopsy growth, which leads to the implant growth, is really kind of a balanced growth between new surgeon adds and deeper penetration within their practices.

Caitlin Roberts

Great. And then another cartilage technology has announced a recent launch in Europe, including the U.K. I mean, how are you thinking about just the competitive landscape as you enter the U.K., and then more broadly other regions OUS?

Dominick C. Colangelo

And so, obviously, it's been a topic of conversation during the course of the year. And we kind of start from, I think it's been pretty well settled as these discussions have emerged that, first of all, MACI is the clear market leader in cartilage repair. And as you look at, it's obviously a very large underpenetrated market with a lot of growth left, especially when you look at sort of the restorative therapies that are used in the market. So MACI has got this clear positioning of young active patients with small, moderate, and large defects, no bony involvement, and in addition to the trends of moving to restorative, that's what's been fueling the growth. And so based on the work we've done and sort of we just completed our annual ATU, or awareness, trial, and usage market research that we do each year with 100 surgeons, half are MACI users, half are not. And those sort of product positionings that we've seen over the years were reinforced. And so I don't think anything has changed in terms of our perspective of the MACI growth opportunities and so on.

There are a lot of other cartilage repair products in the market already that are marketed by several of the largest medtech companies in the United States and globally. And obviously, MACI has become the market leader. That's been the case for the 10 years it's been on the market. So nothing from our perspective is changing in that regard. In the U.K., same sort of dynamic where I think it's pretty well understood that autologous chondrocyte implants are sort of the gold standard for treating cartilage injuries. Other options have been around in Europe for a long time. The U.K. in particular has designated, as I've talked about before, approximately a dozen joint preservation centers to treat patients with cartilage injuries using ACI technologies. It's seen as sort of a cutting-edge technology in the U.K., and the patient demographics are going to be the same. Sort of the physician perspectives on appropriate patients to use MACI or any of these other products that have been around for a while are no different. And as I've mentioned, MACI obviously was developed in Europe. Pivotal study was conducted there. The U.K. surgeons came over and trained our U.S. surgeons when we launched the product. So really no kind of difference from our perspective in sort of MACI's positioning as a leader in U.S., presumably soon, global cartilage repair. And so I guess that's our perspective as we move forward.

Caitlin Roberts

Thanks so much for the color.

Operator

We will go next to Richard Newitter with Truist Securities.

Richard Newitter

I just wanted to go back to '27. Thanks for some of the early color there, and it sounds like maybe just starting on the MACI side, in the past during third quarters into the following year, you provided some broad strokes to think about a placeholder for the year ahead. I guess on MACI, is it right to think about maybe a 20% starting point for next year and then all those kind of incremental drivers, U.K., increasing productivity of sales force? Those are things that would bring you above that. Just trying to get a sense so that we can kind of get numbers more or less as a good starting point. So anything there? And then same question for burn. Is it reasonable to kind of think of the algorithm where you're back to your normal kind of run rate of, call it $10 million to $12 million per quarter? Is that a good way to think of the quarterly cadence as a placeholder to start off '27?

Joseph Mara

Yes, so I'll start on that one, Rich. So good morning and thanks for the question. This is Joe. So, you know, I would say, I guess the first thing I would kind of say is just per our prepared remarks, as Nick talked about, we're seeing a ton of momentum in the business and on both franchises, we think there are kind of multiple growth drivers that will continue. Obviously the sales force expansion we've talked about, MACI Arthro momentum continues, a number of commercial excellence initiatives that we think are having a meaningful impact. So, we certainly think that's not going to end at the end of 2026 and continue right into 2027. So I would say, we are pretty bullish on kind of what next year could look like, particularly from an internal expectation perspective. I guess from a guidance perspective, just kind of getting there, I'd probably get to a couple of points.

So number 1, probably early in terms of kind of formal guidance, and I know that's not the question, but in terms of what that will look like, we'll obviously refine that as we get into '27. But probably a couple of helpful areas and data points to look at and think about here. So earlier the question was asked around kind of our mid-term targets. And again, we feel like we're at this point likely outpacing that a bit, which is great. But I would say we're not going to get ahead of ourselves in terms of how we start the year from a guidance perspective. So we're certainly mindful of that trajectory, but I think that helps as you think about kind of the path from '27 and beyond.

The second thing I would just point to, which I think is really clear and helpful, is if you really look at where consensus is, that's probably a pretty good starting point, whether you look at total revenue, MACI revenue, and probably burn care to a degree as well. And if you kind of go back to where we started this year, I think we were very clear and probably a bit prudent, I would say, in our guidance philosophy on both franchises, where for MACI, for example, we said, look, we have internal expectations higher, but we're going to start the year probably a bit conservative and point to something with similar year-over-year dollar growth. And so that's how we started this year. That's actually where consensus is next year, if we kind of look at '26 to '27, that's probably a good starting point. Again, we'll refine that and our internal expectations are higher, but that's kind of the direction we went this year. And I think obviously that's worked out well and we've beaten that from a MACI perspective. On the burn care side, you got to kind of think through the pieces there a little bit.

Obviously, NexoBrid we expect to continue to ramp. Epicel is performing much better, but I think we'll certainly kind of use a similar framework where we're thinking about kind of where has the business been and probably start a bit prudent there as well. So, I think it's just a balance where we feel like '27 is set up for a really strong year. But I think the good news is when you look at consensus or you think about how that fits in the mid-term targets, again, that's right in line with kind of how we've been guiding this year. And we think that's an appropriate starting point to start the year. Certainly as we move through the year, our expectations could change.

Richard Newitter

Okay. So if I'm hearing you right, there's probably no reason internally or just with all the momentum drivers you have out in front that there wouldn't be a 20%-plus growth trajectory here, but you'll continue the philosophy of appropriately conservative at the start of the year and then seek to outperform that and kind of think of that around a 20% base. Is that right?

Joseph Mara

Yes, again, I think you kind of hit it, which is probably from a guidance framework perspective, we'll start a little bit more conservatively than that. From an internal kind of planning and progressions throughout the year, obviously we're going to tend to strive for high growth on both franchises, I would say, including MACI. But again, we just don't want to get ahead of ourselves as we're sitting here in November for next year.

Richard Newitter

Okay, really helpful, and congrats on the quarter, guys. Thanks.

Joseph Mara

Thanks, Rich.

Operator

We will take our next question from Ryan Zimmerman with BTIG.

Ryan Zimmerman

I want to spend a moment on 2 things. One, on MACI, maybe, Joe, you could talk about kind of the dynamics between, 1, price and volume, but also conversion from biopsy to procedure. I guess I'm interested in understanding, I mean, the biopsy numbers, the KPIs you're talking about sound very good, and I'm wondering how you're seeing that translate, particularly from a conversion perspective, if there's been any acceleration or step-up, pull forward, and so forth with all the efforts on commercial excellence. Thank you.

Joseph Mara

Yes, and I'll start now. Good morning, Ryan. So, I'd say as we look at the third quarter, in terms of the dynamics, I think we're very pleased with the result, another 20%-plus quarter ahead of our guidance. I would add, just kind of related to your question, if you actually look at MACI kind of on a 2-year stack basis, it's actually our best quarter of the year from a revenue perspective. So I think that sort of helps get at the underlying strength that we're seeing. And maybe just to start with Q4 and I'll kind of work backwards, but I'd say Q3 was strong when we look at it from multiple dimensions, but just to reiterate kind of the start we've gotten off to in Q4, so obviously October's behind us, into November now, and our procedure volume has been very strong. And December, I would say, our early indicators are very strong as well. So we upped the guidance in Q4, and we kind of upped our framework instead of pointing to kind of the high teens, we're pointing to 20%-plus. So I think you can imagine, we're obviously talking about strong biopsy growth accelerating each quarter.

I would say, particularly as we've gotten into Q4, we've seen that start to translate. So I would say the strong biopsy growth that we're seeing is translating as we would anticipate, particularly in Q4 from an implant perspective. So I think conversion remains on track as we move toward year-end.

Ryan Zimmerman

Okay, fair enough. And then the second question, we've had 3 quarters now with Epicel just really outkicking its expectations. And so it's so variable. I think we all know that we've lived through kind of the ups and downs with Epicel quarter to quarter. But at what point do you guys say, as opposed to what's called an $8 million run rate per quarter, collectively it's $10 million to $12 million with NexoBrid. I mean, at what point do you start to say, yes, $9 million is right or $10 million is right on Epicel? What do you need to see to kind of get to that comfort level to kind of bump that a little higher from a quarterly run-rate perspective?

Dominick C. Colangelo

Yes, hey, thanks, Ryan. This is Nick. I think, as Joe mentioned earlier, just kind of whether it's on a company basis, MACI, or burn care, we've kind of taken a pretty disciplined approach to how we guide. I'd say your point is absolutely accurate that Epicel now for a good number of quarters, 5 or 6 quarters, has performed at a much higher level. And we talked a little bit about the reasons for that. Once we restructured the sales force, had all 17 territories or reps promoting both products, we've seen a lot of the benefits of having NexoBrid in the bag. Not only does it hit a different point in terms of its momentum, but also the cross-selling efforts for Epicel.

Joe and I mentioned earlier kind of the rebranding for Epicel, peer-to-peer activity is up, how we approach each biopsy we get from a kind of multidisciplinary functional approach and working with surgeons on sort of the best treatment plans for outcomes for those patients. I just think all of those execution initiatives have really sort of changed the performance level for Epicel. Now, all of that being said, we can't control the number of catastrophic burns that occur or the number of patients that survive to be treated, but we have noted that for those that do, we're performing at a much higher level. So I'd say more to come on how we'll sort of guide for quarters going forward. As we get into next year, obviously that continued performance, we would expect it doesn't end when the calendar flips on January 1st. And we said there we've gotten off again to a strong start in burn care, had the highest number of Epicel biopsies of the year in October. So we think we're set up for sustained higher performance for the reasons I mentioned. But we'll get into, and Joe, you can comment if you want, sort of how we'll approach guiding to burn care as we get into '27.

Ryan Zimmerman

Okay.

Joseph Mara

Yes, no, I mean, nothing to add. I mean, I think it's a fair question. Again, obviously the framework has worked quite well this year and I think we'll kind of adjust as needed as we get into next year. But again, I think that's where we want to just separate kind of our internal expectations and some of the better execution we're seeing from the team, particularly with what we can control on burn care from our guidance framework that we just want to make sure is appropriate, both on a full-year basis and I would say quarter to quarter.

Ryan Zimmerman

Okay, fair enough. Thanks, guys.

Operator

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

Samuil-Hrabar Gatev

This is Sam on for Mike. Margins came in really strong this quarter, and with 2026 EBITDA margin now expected to reach 28%, how should we be thinking about the next step-up in margin, including contributions from manufacturing utilization, sales force leverage, and just incremental spending related to the U.K. launch and then the potential trajectory moving into '27?

Joseph Mara

Yes, so good morning. Thanks for the question. So, Joe, I'll take that. Again, as we talked earlier, I think the margins in the third quarter, particularly I think on the EBITDA line, I mean, we were well ahead on both gross margin and EBITDA, but very strong in the third quarter to be at that 30% level. So if you kind of think about the multi-year trajectory here, you can see with kind of our increase to 28%, last year was in the 25% to 26% EBITDA margin range on a full-year basis. So really some nice expansion this year during what was really our investment year, probably a bit ahead of where we started, which is great.

I think as you move through the next few years, to the question earlier, I feel like we're on track certainly to kind of hit that high 30% range. It's really the leverage, really the top-line growth and then the leverage in the business. I mean, we are in an investment phase here with 2 facilities operating, of course, on the manufacturing side. We will have our sales force expansion in place. So that'll kind of be in the run rate, which will be helpful.

There are other areas we'll probably continue to ramp up in terms of ex-U.S. and as we get closer to a potential U.K. launch and looking at other markets, certainly from an ex-U.S. perspective, that'll continue. And then MACI Ankle will continue to ramp. So there's still spend, certainly, that we're going to continue to invest in. Again, having said that, I think we would still expect some expansion from a bottom-line perspective next year. Gross margin, again, we're kind of already in that mid-70% range, so that's probably around where we're going to be this year and something similar next year. And again, I don't want to get too far ahead in terms of formal guidance, but I do think if you look at where consensus is on both gross margin and adjusted EBITDA, that's probably a good starting point to give you a sense of things continuing to tick toward our mid-term targets, pretty healthy this year and next year.

Samuil-Hrabar Gatev

Got it. Very helpful. And then just on MACI, can you provide a little bit more color on where the strongest areas of incremental growth are coming from today? What is the contribution from larger versus smaller defects, the penetration across those segments, and just comment on MACI Arthro's ability to kind of continue penetrating those smaller defect segments, which historically were not a large part of the business?

Dominick C. Colangelo

Yes, I'll start with that. As I mentioned in my prepared remarks, obviously MACI use in the patella has been our highest volume and highest growth area. Historically, the whole idea behind MACI Arthro is to be able to penetrate those smaller defects in the 2 to 4 square centimeter range. And as we mentioned, everything with MACI kind of unfolds over quarters and years. And we were seeing some very nice momentum there where we had record number of MACI Arthro procedures, the highest percentage of total MACI procedures we've ever seen in a quarter, which is great, highest number of surgeons, and then more than a quarter of those smaller defects being treated via MACI Arthro administration. So it's kind of all the things we would want to see.

Obviously, we've talked about the dynamics of when surgeons become MACI Arthro implanters and particularly when they reach a threshold, you just see the overall sort of utilization by those surgeons increase across kind of defect size and location. And so from that perspective, that's why we expect MACI Arthro to continue to sort of contribute to the overall utilization for MACI. So we're pleased with where it is. And we expect, as we said, not only the sales force or commercial initiatives, but the MACI Arthro adoption to contribute to the sustainable growth rate for MACI. And of course, having continuous innovation really helps keep surgeon engagement high, which we also noted on our call. So we're working on next generation MACI Arthro instruments that again will allow us to make it even simpler and faster with the current sort of focus, and then be focused on the ability to access other parts of the knee as well, like patella, which could be another very important evolution for the brand.

Samuil-Hrabar Gatev

Thank you.

Operator

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

Mason Carrico

Nick, maybe circling back to the prior question that you just answered, could you just update us on the implant mix, what it looks like today by defect type and maybe how that compares to the mix pre-Arthro? And then are you seeing similar conversion rates across defect types or are there any differences there?

Dominick C. Colangelo

Yes, hey Mason. So as I mentioned, for the patella, which is again our biggest part of the business, that's at this point, especially greater than 4 square centimeters, which is a lot of the MACI patella business, that's kind of going to be an open procedure just because of the size of the defect. And even when we develop MACI Arthro patella instruments, that will allow you to treat 2 to 4 square centimeter defects using arthroscopic instrumentation. And so that will help in terms of kind of addressing even more patella defects, which are a very meaningful part of the market. As we talked about, since we've introduced MACI Arthro, we've obviously grown in those smaller defects and not just on the condyles. We've mentioned that we've seen nice growth in biopsies and implants in the trochlea and so on. So it changes by quarter just depending on patients and where their defects are that happen to be treated in that quarter. But I would just say overall growth has been strong, continues to grow strongly, and we're starting to see higher growth in those other smaller defects in various places of the knee.

Mason Carrico

Got it. And then in the past, I know you guys have talked about Arthro-trained surgeons growing biopsies and implants faster than non-trained surgeons. It seems like that's obviously still the case given the growth metrics that you guys are calling out. But just to ask directly, does that trend continue to hold?

Dominick C. Colangelo

Yes. And as I mentioned, we also sort of added a little bit of commentary to that by saying just like we did when we looked at conversion rates for MACI open surgeons and once they hit sort of a critical mass of a few implants per year, you see higher conversion rates for them. As I mentioned earlier, when you kind of have a MACI Arthro implanter that's hit a critical mass of MACI Arthro implants, you see not only those trends continue, but also sort of increased utilization across the board, whether it's MACI Open or MACI Arthro cases and kind of regardless of where the defect is in the knee. So exactly the kind of things that you would want to see, and again, believe that the continuous innovation of those instruments will continue to sort of engage surgeons and just keep the brand fresh. And so I think that's a very important contributor to MACI's performance, not only now and in the near term, but over the longer term as we move forward.

Mason Carrico

Got it. Thank you.

Operator

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

Jeffrey Cohen

I wondered if you could talk about the burn franchise a little bit and talk about the wound market. I know that you had called out wounds. Maybe give us a sense of the commercial teams and their focus and awareness specific to wounds and what you're seeing.

Dominick C. Colangelo

Thank you. Yes. So just to be clear, kind of on the burn care side, we're not really sort of on the wound side of things. But obviously we had the highest quarter ever for the burn care business, highest quarter ever for Epicel and NexoBrid on the commercial side as well. So really pleased with what we're seeing there. I think, as I mentioned in my prepared remarks, a lot of it has to do with sort of the cross-selling impacts. If you look at kind of my commentary there, Epicel was driven by high biopsy levels and biopsying centers. NexoBrid was driven by the most orders from centers and hospital orders overall. So you're kind of seeing a larger footprint and the impact it has in sort of driving both pieces of the business. And as I mentioned earlier, we think we're operating at a different level for both of those products. And we think that's going to continue going forward.

Jeffrey Cohen

Got it. And then as follow-up, could you talk about BARDA a little bit? A bit early, but can you give us a sense of contribution going forward throughout '27? I know you've given us a sense already of back half of '26.

Dominick C. Colangelo

Yes, as we look at the 2 pieces, 1 is procurement revenue that began in the third quarter, so $3 million of the NexoBrid procurement. The $5-plus million was related to the BARDA procurement, so that initiated on time and according to plan. We'd expect another $3 million in the fourth quarter and then about $4 million to start the year in the first quarter next year with opportunities for further procurement later in the year. So that's kind of the first piece of it.

Secondly, we're also working on, and that counts as revenue, as I mentioned, or is recognized as revenue. The second piece of it is sort of the development work we're doing on a blast indication and other things, and that sort of has a cost offset or other income component impact on the P&L that began as well in the second half of the year and that will carry through in 2027 as those activities continue to ramp up and potentially other ones on top of that. That depends on sort of the activity level and timing and so on. So we haven't really commented on what that will look like in '27, but that will be incorporated both in the revenue in our guidance at the appropriate time and then sort of in our margin guidance as well.

Jeffrey Cohen

Okay, thank you. Perfect. Thanks for taking our questions.

Operator

We will take our final question from Charles Wallace with H.C. Wainwright.

Swayampakula Ramakanth

This is Charles on for RK. Maybe just 1 more on the burn care franchise and Epicel. So, obviously it's challenging to project and lumpy by nature, but for the third quarter, could you maybe split how much of the beat was due to higher burn incidents versus the commercial initiatives? And how much of the commercial piece, the initiatives that you put in place, do you think will be repeatable in the future? Thank you.

Dominick C. Colangelo

Yes, I'd say in sort of the burn market data that we're able to access, it lags, so you can't really see sort of any market dynamics, but it's been pretty stable. And I'd say really the growth we've seen in Epicel relates to sort of execution, particularly through the first half of the year. The top of the funnel was relatively consistent. That improved a little bit in the third quarter. But the outperformance was definitely driven on the execution side. And again, we've had multiple quarters in a row now since we've implemented these initiatives and actually more are sort of in the early stage. So to the extent we can control things, it's absolutely repeatable and obviously has taken Epicel to a different level.

Swayampakula Ramakanth

Great. That's very clear. And maybe 1 final question, if I could sneak it in. So with your cash flow growing, how are you balancing potential BD against share buyback? And what does the right BD asset look like? Thank you.

Dominick C. Colangelo

Yes, well, obviously we're in a fortunate position to be generating, hitting that cash inflection point. And I think you can see that absolutely as we sort of finished up the CapEx involved with our new facility. So we announced the authorization last quarter, we obviously started the repurchase program in the third quarter. We have nearly a quarter billion in cash and that's growing pretty substantially. So we're not really at a point where we're thinking about it's 1 or the other. We can do both. And so I think that will be opportunistic in the share repurchases, but that doesn't impact sort of our desire or ability to do any business development transactions.

Swayampakula Ramakanth

Great. Thanks for taking my questions, and congratulations on a great quarter. Thank you.

Operator

This concludes our question and answer session. I will now turn the call back over to CEO Nick Colangelo for closing remarks.

Dominick C. Colangelo

Okay, well, just wanted to say thanks to everyone who joined us this morning. Obviously we're very pleased in delivering an outstanding third quarter and strong year-to-date performance, and we look forward to providing updates on our next call. So thanks again, and have a great day.

Operator

Ladies and gentlemen, that does conclude today's call. We thank you for your participation. You may disconnect at this time.

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