Vericel Corp (VCEL) 2025 Q2 法說會逐字稿

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

大家好，歡迎參加 Vericel Corporation 2025 年第二季財報電話會議。今天的會議正在錄製中。現在，我想將會議交給 Vericel 財務和投資者關係副總裁 Eric Burns。請繼續。

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.

謝謝接線員，大家早安。參加今天電話會議的還有 Vericel 總裁兼執行長 Nick Colangelo 和我們的財務長 Joe Mara。在我們開始之前，請允許我提醒您，在今天的電話會議上，我們將根據 1995 年《私人證券訴訟改革法案》做出前瞻性陳述。這些聲明可能涉及風險和不確定性，可能導致實際結果與預期有重大差異，我們向美國證券交易委員會提交的文件中對此進行了更詳細的描述。

In addition, all forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. Please note that a copy of our second quarter financial results press release and a short presentation with highlights from today's call are available in the Investor Relations section of our website.

此外，所有前瞻性陳述僅代表我們截至今天的觀點，不應被視為代表我們在任何後續日期的觀點。請注意，我們第二季度財務業績新聞稿的副本以及今天電話會議的精彩內容的簡短介紹可在我們網站的投資者關係部分找到。

I will now turn the call over to Nick.

我現在將電話轉給尼克。

Thank you, Eric, and good morning, everyone. Company delivered solid financial and business results in the second quarter with significant revenue growth and margin expansion and substantially higher profitability growth. Total revenue increased 20% in the quarter, while gross margin expanded more than 400 basis points to 74% and adjusted EBITDA increased 112% versus the prior year to over $13 million. We also saw continued strength in the MACI growth drivers and key performance indicators for the MACI Arthro launch and significantly better performance for the Burn Care franchise.

謝謝你，艾瑞克，大家早安。公司第二季的財務和業務表現穩健，營收大幅成長，利潤率擴大，獲利能力大幅提升。本季總營收成長 20%，毛利率擴大超過 400 個基點至 74%，調整後 EBITDA 較前一年成長 112%，超過 1,300 萬美元。我們也看到 MACI 成長動力和 MACI Arthro 發布的關鍵績效指標持續強勁，燒傷護理特許經營的表現也顯著改善。

Importantly, we've had a very good start to the third quarter for MACI and the Burn Care products, and the company remains well positioned for a strong second half of the year. MACI generated record second quarter revenue of nearly $54 million, representing 21% growth versus the prior year and 15% sequential growth versus the prior quarter. MACI's performance was driven by strong underlying business fundamentals as we continue to expand the MACI surgeon base and drive growth in biopsies with the launch of MACI Arthro.

重要的是，MACI 和燒傷護理產品在第三季度取得了非常好的開局，並且該公司仍為今年下半年的強勁表現做好了準備。MACI 第二季營收創歷史新高，接近 5,400 萬美元，較上年同期成長 21%，較上一季較上季成長 15%。隨著我們繼續擴大 MACI 外科醫生基礎並隨著 MACI Arthro 的推出推動活檢的成長，MACI 的業績受到強勁的基礎業務的推動。

In the second quarter, we generated the second highest number of MACI biopsies in the quarter since launch, essentially matching our highest biopsy quarter-to-date in the seasonally high fourth quarter of last year. MACI Arthro surgeon training, a key priority for our commercial team in 2025, continues to outpace our initial expectations in the original MACI launch as we've now trained approximately 600 surgeons through the end of July. Both the biopsy and implant growth rates for MACI Arthro trained surgeons continue to be significantly higher than the growth rates for surgeons that have not yet been trained.

在第二季度，我們進行了自推出以來第二高的 MACI 活檢數量，基本上與去年第四季度季節性高峰時本季度迄今為止的最高活檢數量持平。MACI 關節外科醫生培訓是我們商業團隊在 2025 年的一項重要任務，該培訓繼續超出我們在 MACI 最初啟動時的預期，截至 7 月底，我們已培訓了大約 600 名外科醫生。接受過 MACI Arthro 培訓的外科醫生的活檢和植入物生長率仍然明顯高於尚未接受培訓的外科醫生的生長率。

Given the substantial increase in the number of MACI Arthro trained surgeons, overall MACI biopsy growth outpaced implant growth through the first half of the year. Based on historical performance, we expect the implant growth rate to converge with the biopsy growth rate as we move into the second half of the year and beyond, which we believe will sustain strong MACI revenue growth in the quarters ahead. To that end, MACI is off to a strong start to the third quarter with both biopsy and implant volume growth in July accelerating versus the first half of the year.

鑑於 MACI Arthro 培訓外科醫生數量的大幅增加，今年上半年 MACI 活檢的整體成長速度超過了植入物的成長速度。根據歷史表現，我們預計隨著進入下半年及以後，植入物成長率將與活檢成長率趨於一致，我們相信這將在未來幾季維持強勁的 MACI 收入成長。為此，MACI 第三季開局強勁，7 月活檢和植入量的成長均比上半年加快。

While the treatment of patella defects remains the key driver for overall MACI growth, the treatment of small femoral condyle defects, which are the defects that MACI Arthro instruments are designed to treat increased 40% in the second quarter over the prior year. This is a strong indicator that this segment, which represents approximately a third of the over $3 billion addressable market for MACI, has the potential to become MACI's highest volume growth segment over time with the MACI Arthro delivery option.

雖然髕骨缺損的治療仍然是 MACI 整體成長的主要驅動力，但 MACI Arthro 器械旨在治療的股骨小髁缺損的治療在第二季度比上年增加了 40%。這是一個強有力的指標，表明該細分市場約佔 MACI 超過 30 億美元目標市場的三分之一，並且隨著 MACI Arthro 交付選項的推出，有可能隨著時間的推移成為 MACI 銷量增長最快的細分市場。

In addition, as we discussed on our last call, MACI Arthro is being used to treat a meaningful number of patients with trochlea defects, and this segment has now accounted for nearly 20% of MACI Arthro implants to date. The trochlea defect segment is similar in size to the patella segment with approximately 10,000 patients per year and has the potential to become a significant source of business and a meaningful driver of upside MACI growth beyond the treatment of condyle defects.

此外，正如我們在上次電話會議上討論的那樣，MACI Arthro 正被用於治療大量患有滑車缺損的患者，迄今為止，這一部分已佔 MACI Arthro 植入物的近 20%。滑車缺損部位的規模與髕骨部位相似，每年約有 10,000 名患者，並且有可能成為重要的業務來源，並成為除髁狀缺損治療之外的 MACI 增長的重要驅動力。

Finally, we've generated over 100 biopsies from our new arthroscopic-only surgeon segment, another positive indicator that an arthroscopic delivery option for MACI can drive additional utilization from surgeons that previously did not use the product. Based on the strong MACI Arthro launch indicators to date and our expectation for significant MACI implant volume growth in the second half of this year and into 2026, we're implementing our full MACI sales force expansion this year.

最後，我們從新的僅使用關節鏡的外科醫生部門獲得了超過 100 個活檢樣本，這是另一個積極的指標，表明 MACI 的關節鏡輸送選項可以推動以前未使用該產品的外科醫生的更多利用。基於迄今為止 MACI Arthro 強勁的發布指標以及我們對今年下半年和 2026 年 MACI 植入物數量大幅增長的預期，我們將在今年全面擴大 MACI 銷售隊伍。

We'll be increasing our MACI sales force from 76 territories to approximately 100 territories with our new sales reps supporting current territories during our seasonally highest fourth quarter this year and then moving into their new territories at the start of next year. We believe that having the entire expanded sales force in place this year will help support our significant fourth quarter volume and position MACI for continued strong performance for the full year in 2026 and then beyond.

我們將把 MACI 銷售隊伍從 76 個地區擴大到大約 100 個地區，我們的新銷售代表將在今年季節性最高的第四季度為現有地區提供支持，然後在明年年初進入他們的新地區。我們相信，今年整個擴大的銷售隊伍將有助於支持我們第四季度的顯著銷量，並使 MACI 在 2026 年全年及以後繼續保持強勁表現。

Turning to Burn Care. As expected, Epicel performance rebounded in the second quarter with a substantial increase in biopsies, grafts and revenue, which was more in line with its run rate coming into the year. Biopsies in the second quarter were the highest in any quarter since 2023, with an increase of nearly 40% over last year, and we ended the quarter with the highest monthly biopsies on record in June. Given the strength of second quarter biopsies, Epicel is also off to a strong start in the third quarter with July graft volume higher than any other month to date this year, positioning Epicel for another solid quarter.

轉向燒傷護理。正如預期的那樣，Epicel 的業績在第二季度反彈，活檢、移植和收入均大幅增加，這與今年的運行率更加一致。第二季的活檢數量是自 2023 年以來任何一個季度中最高的，比去年增加了近 40%，並且我們在 6 月以有記錄以來最高的月度活檢數量結束了本季度。鑑於第二季度活檢的強勁表現，Epicel 在第三季度也迎來了強勁開局，7 月份的移植量高於今年迄今為止的任何其他月份，為 Epicel 的又一個穩健季度奠定了基礎。

NexoBrid also had a strong close to the quarter with the highest number of ordering centers and hospital units ordered in any month since launch. This momentum has carried into the third quarter as July hospital orders exceeded the record number of units ordered in June. Of note, the Category III temporary CPT code for NexoBrid also went into effect as of July 1, which we believe can help drive increased utilization and further enhance NexoBrid uptake over the long term.

NexoBrid 本季也表現強勁，其訂購中心和醫院單位數量是自推出以來任何一個月中最多的。這一勢頭一直延續到第三季度，7 月醫院訂單超過了 6 月創紀錄的訂單單位數量。值得注意的是，NexoBrid 的 III 類臨時 CPT 代碼也於 7 月 1 日生效，我們相信這有助於提高利用率並進一步提高 NexoBrid 的長期吸收率。

Overall, the company delivered significantly stronger revenue and profitability results in the second quarter. We have started the third quarter with a great deal of momentum for both MACI and the Burn Care products. In terms of our longer-term growth initiatives, we received FDA clearance of the IND for the Phase III MACI ankle clinical study in the second quarter and remain on track to initiate the study in the second half of this year. A potential MACI ankle indication represents a substantial longer-term growth driver for MACI and would enable the company to potentially expand into other orthopedic markets. Finally, we also remain on track to initiate commercial manufacturing for MACI in our new facility next year.

總體而言，該公司第二季的營收和獲利業績顯著增強。第三季開始，MACI 和燒傷護理產品都呈現出強勁的發展勢頭。就我們的長期成長計畫而言，我們在第二季度獲得了 FDA 對 III 期 MACI 踝關節臨床研究 IND 的批准，並有望在今年下半年啟動研究。潛在的 MACI 踝關節適應症代表 MACI 的長期成長動力，並將使公司有可能擴展到其他骨科市場。最後，我們也將按計劃於明年在新工廠啟動 MACI 的商業化生產。

I'll now turn the call over to Joe to provide a more detailed review of our financial results and guidance for 2025.

現在我將把電話轉給喬，讓他更詳細地回顧我們的 2025 年財務表現和指導。

Thanks, Nick, and good morning, everyone. Starting with our Q2 results. As Nick noted, we had a very strong revenue and profitability growth in the second quarter. The company achieved record total net revenue for the quarter of $63.2 million with $53.5 million of MACI revenue, $8.6 million of Epicel revenue and $1.2 million of NexoBrid revenue. MACI had a strong second quarter with 21% revenue growth over the prior year and 15% sequential growth versus the first quarter as growth accelerated in the second quarter. MACI also had another quarter of strong double-digit biopsy growth, which outpaced implant growth. And as Nick mentioned, implant and biopsy growth accelerated in July, and we expect that implant growth will converge with biopsy growth over the coming quarters.

謝謝，尼克，大家早安。從我們的第二季業績開始。正如尼克所說，我們第二季度的營收和獲利成長非常強勁。該公司本季的總淨收入達到創紀錄的 6,320 萬美元，其中 MACI 收入為 5,350 萬美元，Epicel 收入為 860 萬美元，NexoBrid 收入為 120 萬美元。由於第二季成長加速，MACI 第二季表現強勁，營收較上年同期成長 21%，較第一季較第一季成長 15%。MACI 在另一個季度也實現了強勁的兩位數活檢成長，超過了植入物的成長。正如尼克所提到的，植入物和活檢的成長在 7 月加速，我們預計植入物的成長將在未來幾季與活檢的成長趨同。

Burn Care also had a much stronger second quarter with revenue of $9.8 million, relatively in line with the lower end of our guidance range for the quarter. Epicel, in particular, had a much stronger second quarter with $8.6 million of revenue, representing 11% growth versus the prior year. The underlying metrics on Epicel were also very strong with Q2 biopsy growth of nearly 40% versus the prior year. This also included our highest Epicel biopsy month to date in June.

Burn Care 第二季的業績也更為強勁，營收達到 980 萬美元，與我們本季預期範圍的下限基本一致。尤其是 Epicel，第二季表現更為強勁，營收達 860 萬美元，較上年成長 11%。Epicel 的基本指標也非常強勁，第二季的活檢量與去年相比成長了近 40%。這也包括我們迄今為止 6 月份 Epicel 活檢量最高的月份。

Although Epicel revenue increased significantly during the second quarter, we continue to see a somewhat higher ratio of canceled cases due to patient health-related issues, which impacted our revenue for the quarter. NexoBrid revenue of $1.2 million represented 52% growth versus the prior year with solid growth in both hospital unit orders and ordering centers. Although the underlying NexoBrid fundamentals continue to progress in Q2, orders placed by specialty distributors were slightly lower than the prior quarter, which impacts the revenue comparison to the first quarter.

儘管 Epicel 收入在第二季度大幅增長，但我們仍然看到由於患者健康相關問題而取消的病例比例有所上升，這影響了我們本季的收入。NexoBrid 的收入為 120 萬美元，比上一年增長了 52%，醫院單位訂單和訂購中心均實現了穩健增長。儘管 NexoBrid 的基本面在第二季度繼續取得進展，但專業分銷商的訂單略低於上一季度，這影響了與第一季的營收比較。

As Nick mentioned, we ended Q2 in June with our highest month-to-date for NexoBrid hospital orders and then surpassed these June orders in July. The company's substantial revenue growth translated into significant margin expansion with gross profit of $46.6 million or 74% of revenue, an increase of more than 400 basis points compared to 2024. This also represents a record quarterly gross margin outside of our seasonally highest fourth quarter.

正如尼克所提到的，我們在 6 月第二季結束時，NexoBrid 醫院訂單量創下了月度最高紀錄，並在 7 月超過了 6 月的訂單量。該公司營收的大幅成長轉化為利潤率的大幅擴大，毛利達到 4,660 萬美元，佔營收的 74%，與 2024 年相比成長了 400 多個基點。這也代表了我們除季節性最高的第四季之外創下的新季度毛利率紀錄。

Total operating expenses for the quarter were $48.6 million compared to $42.6 million for the same period in 2024. The increase in operating expenses was primarily due to increased head count and related employee expenses and additional costs related to the company's new facility, including depreciation and MACI tech transfer-related activities. Moving forward, we expect relatively similar quarterly operating expenses for the balance of the year.

本季總營運費用為 4,860 萬美元，而 2024 年同期為 4,260 萬美元。營業費用的增加主要是由於員工人數增加和相關員工費用以及與公司新工廠相關的額外成本，包括折舊和 MACI 技術轉移相關活動。展望未來，我們預計今年餘下的季度營運費用將相對相似。

Net loss for the quarter narrowed to $0.6 million or $0.01 per share compared to $4.7 million or $0.10 per share in the prior year, which was an improvement of more than $4 million versus 2024. Adjusted EBITDA more than doubled during the quarter with an increase of 112% to $13.4 million or 21% of revenue, an increase of more than 900 basis points versus the prior year as we continue to drive very strong bottom line growth.

本季淨虧損收窄至 60 萬美元或每股 0.01 美元，而去年同期為 470 萬美元或每股 0.10 美元，與 2024 年相比改善了 400 千萬美元。本季調整後的 EBITDA 成長了一倍多，成長了 112%，達到 1,340 萬美元，佔營收的 21%，比上年增長了 900 多個基點，因為我們繼續推動非常強勁的底線成長。

Finally, the company generated $8.2 million of operating cash flow and ended the second quarter with approximately $164 million in cash and investments and no debt. With the investment for the company's new facility completed in the second quarter, we expect cash generation to inflect moving forward, further enhancing the company's strong balance sheet and financial profile.

最後，該公司產生了 820 萬美元的營運現金流，第二季結束時現金和投資約為 1.64 億美元，沒有債務。隨著公司新工廠的投資於第二季完成，我們預計現金產生將在未來發揮作用，進一步增強公司強勁的資產負債表和財務狀況。

Turning to our financial guidance. We are maintaining our MACI revenue guidance and expect MACI full year revenue growth in the low 20% range with third quarter revenue growth in the low 20% range as well or approximately $54 million to $55 million for the quarter. For Burn Care, while we are very encouraged by Epicel's improved performance in the second quarter and the meaningful increase in biopsies in the first half of the year, we are updating our second half quarterly Burn Care revenue guidance to be more in line with recent run rates of approximately $10 million per quarter, consistent with our second quarter revenue and our average quarterly run rate in 2024.

轉向我們的財務指引。我們維持 MACI 收入指引，預計 MACI 全年營收成長率將在 20% 出頭的範圍內，第三季營收成長率也將在 20% 出頭的範圍內，或本季營收約為 5,400 萬至 5,500 萬美元。對於燒傷護理，雖然我們對 Epicel 在第二季度的業績改善和上半年活檢數量的顯著增加感到非常鼓舞，但我們正在更新下半年燒傷護理季度收入指引，以更符合最近每季度約 1000 萬美元的運行率，與我們第二季度的收入和 2024 年的平均季度運行率一致。

Importantly, our internal expectations for Burn Care performance remain higher, and we believe there are still multiple scenarios to achieve our initial guidance range. However, we believe that updating our guidance framework and resetting external expectations for Burn Care revenue in the second half is appropriate at this point in the year, given the difficulty in accurately predicting Epicel quarterly revenue, recognizing that if our team continues to execute well and maintains the current momentum, there remains an opportunity to significantly outperform this updated guidance.

重要的是，我們對燒傷護理表現的內在期望仍然較高，我們相信仍有多種情況可以實現我們最初的指導範圍。然而，我們認為，鑑於準確預測 Epicel 季度收入的難度，在今年這個時候更新我們的指導框架並重新設定下半年燒傷護理收入的外部預期是適當的，我們認識到，如果我們的團隊繼續表現良好並保持目前的勢頭，仍然有機會顯著超越這一更新後的指導。

I would also note at this point, we are not assuming any additional NexoBrid revenue related to the BARDA RFP process that was recently initiated, although there is potential for incremental NexoBrid BARDA revenue in the fourth quarter of this year.

我現在還想指出，我們不會假設與最近啟動的 BARDA RFP 流程相關的任何額外 NexoBrid 收入，儘管今年第四季度 NexoBrid BARDA 收入有可能增加。

In terms of profitability metrics, we expect another quarter of strong financial results in the third quarter with both gross margin and adjusted EBITDA margin in a similar range as the second quarter. For the full year, we have reaffirmed profitability guidance of gross margin of 74% and adjusted EBITDA margin of 26%. Note that this profitability guidance includes the operating expenses in 2025 related to the acceleration of our MACI sales force expansion.

在獲利能力指標方面，我們預計第三季的財務表現將再次強勁，毛利率和調整後的 EBITDA 利潤率都將與第二季持平。對於全年，我們重申了毛利率 74% 和調整後 EBITDA 利潤率 26% 的獲利預期。請注意，該獲利預測包括與加速我們的 MACI 銷售隊伍擴張相關的 2025 年營運費用。

I will now turn the call back over to Nick.

我現在將電話轉回給尼克。

Thanks, Joe. We're very pleased with the pace of MACI Arthro surgeon training and the resulting strength in both the MACI Arthro leading indicators as well as the overall MACI business fundamentals, which provides a strong foundation for MACI implant growth moving forward. The significantly improved trends for Epicel and NexoBrid position the Burn Care franchise for stronger performance as well. So we believe that the company is well positioned to continue to deliver a unique combination of sustained high revenue and profitability growth in the second half of this year and the years ahead.

謝謝，喬。我們對 MACI 關節外科醫師訓練的進度非常滿意，這不僅體現在 MACI 關節領先指標上，也體現在 MACI 整體業務基本面上，為 MACI 植入物未來的成長奠定了堅實的基礎。Epicel 和 NexoBrid 的顯著改善趨勢也為 Burn Care 特許經營帶來了更強勁的表現。因此，我們相信，該公司已做好準備，在今年下半年及未來幾年繼續實現持續的高收入和盈利增長的獨特組合。

With that, we'll open the question -- the conference call for questions.

有了這些，我們就可以開始提問了──電話會議。

(Operator Instructions)

（操作員指示）

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

I want to start with MACI. I appreciate many of the metrics that you provided that point to an uptick in the second half. But if we could unpack the second quarter a little bit. I mean, if I think about the guidance, Joe, 53.8% to 54.6%, that didn't happen. So what do you think is happening here that's impacting that growth, at least right now? And again, I appreciate the confidence, but if you could speak to certainly the uptick in the fourth quarter, especially and the conversion ratio that you're expecting to allow you to either beat or meet that guidance for MACI.

我想從 MACI 開始。我很欣賞您提供的許多表明下半年會出現上升趨勢的指標。但如果我們能夠稍微分析一下第二季的情況。我的意思是，如果我考慮指導，喬，53.8% 到 54.6%，那就沒有發生。那麼，您認為目前發生了什麼事情影響了這種成長？再次感謝您的信任，但如果您能談談第四季度的成長，特別是您預期的轉換率，這將使您能夠超越或達到 MACI 的指導。

Yes. Ryan, thanks for the question. So in terms of MACI, maybe just talk a little bit about the second quarter and the cadence as part of your question. So in terms of the second quarter, I mean, I'd say we're relatively in line at $53.5 million. It was, I'd say, slightly below kind of that range of, call it, approximately $54 million. But first off, I would say, as we talked about on the call and Nick talked about, the underlying indicators remain strong.

是的。Ryan，謝謝你的提問。因此，就 MACI 而言，也許只需稍微談論第二季和節奏作為您問題的一部分。因此就第二季而言，我們的收入相對穩定，為 5,350 萬美元。我想說，它略低於那個範圍，大約是 5400 萬美元。但首先，我想說，正如我們在電話中談到的以及尼克談到的，潛在指標仍然強勁。

The biopsy growth was strong in the second quarter. And we are starting to see an acceleration of both biopsy growth and implant growth as we get into -- of late and into July. So that's certainly encouraging. I would say probably on the margins, there was probably some degree of -- there are probably a few implants from a timing perspective, if you will, where if we looked at what we predicted in the second quarter, perhaps some of the kind of where June ended up, some of those implants probably moved into July relative to our assumptions to start the quarter. I wouldn't say that was all that material. And certainly -- but it's certainly one thing to point out as you think about Q2.

第二季切片成長強勁。隨著我們進入七月，我們開始看到活檢增長和植入物增長的加速。這確實令人鼓舞。我想說，從邊緣來看，可能存在某種程度的——從時間角度來看，可能存在一些植入，如果我們看一下我們在第二季度的預測，也許有些是在 6 月份結束時進行的，相對於我們在本季度開始時的假設，其中一些植入可能會進入 7 月份。我不會說這就是全部內容。當然——但當你考慮第二季時，這肯定是需要指出的一件事。

So I think Q2 generally was in line with our expectations. It was a significant step-up from the first quarter and solid year-over-year growth. And so then as you kind of think about the rest of the year, First off, I would say, as we said in the last call, we're still kind of in that $240 million range that I referenced in the last quarter. And so if you think about the cadence for the second half, the first thing I would point to is before really even getting into Arthro, it's a pretty similar mix when you kind of look at that revenue level from H1 to H2.

所以我認為第二季大致符合我們的預期。與第一季相比，這是一個顯著的成長，並且與去年同期相比也實現了穩健的成長。那麼，當您考慮今年剩餘時間的情況時，首先，我想說，正如我們在上次電話會議中所說的那樣，我們仍然處於我在上個季度提到的 2.4 億美元的範圍內。因此，如果您考慮下半年的節奏，我首先要指出的是，在真正進入 Arthro 之前，當您查看從上半年到下半年的收入水平時，它是一個非常相似的組合。

So that's not all that different. Q3 and Q4, there certainly could be some variability there, which is why we're providing a range sometimes kind of August and September are difficult months to forecast just given kind of out of office and vacations, particularly as you move kind of farther from the COVID dynamics. But generally, again, I think what we're seeing is a lot of strong metrics -- the trained surgeons continue to tick up. We're seeing very strong metrics from that group in particular. So I would say nothing has really changed as we move from where we were last quarter, and we kind of continue to progress throughout the year as you think about MACI on a full year basis.

所以這並沒有什麼不同。第三季和第四季肯定會有一些變化，這就是為什麼我們提供一個範圍的原因，有時 8 月和 9 月很難預測，因為有休假和休假，特別是當你遠離 COVID 動態時。但總的來說，我認為我們看到的是許多強有力的指標——訓練有素的外科醫生的數量不斷增加。我們看到該群體的各項指標都十分強勁。因此，我想說，與上一季相比，情況並沒有什麼變化，而且從全年來看，MACI 的情況也一直在持續進步。

And just to be clear, Joe, or Nick, if you want to answer this, and then I have a follow-up on Epicel. But the 100 Arthro biopsies that you did so far year-to-date, can you comment and obviously give us specifics if you're comfortable, how much of those have converted to MACI at this point?

需要明確的是，喬或尼克，如果你們想回答這個問題，那麼我會對 Epicel 進行跟進。但是，對於您今年迄今為止所做的 100 次關節活檢，如果您願意的話，您能否發表評論並向我們提供具體細節，其中有多少已經轉化為 MACI？

Yes. So we don't talk about sort of how those biopsies have converted. I mean there's -- we haven't seen any difference in sort of how the Arthro segments and just the segments generally have converted versus normal rates. So it's really just a timing issue of when those biopsies convert. And so I would just say kind of as we discussed, whether you're talking about MACI Arthro opening up different surgeon segments or kind of different locations in the knee, all of those trends are in line with kind of what we had hoped for or expected.

是的。所以我們不討論這些活檢是如何轉化的。我的意思是——我們還沒有看到 Arthro 部分和一般部分與正常比率的轉換方式有任何差異。因此這實際上只是活檢轉化的時間問題。因此，我想說，正如我們所討論的，無論您談論的是 MACI Arthro 開闢不同的外科醫生部分還是膝蓋的不同位置，所有這些趨勢都符合我們所希望或預期的。

And the dynamic that Joe was referring to that we saw when MACI was originally launched that biopsies increased first over time, implants tend to catch up with those biopsies. It's kind of all unfolding as we had expected and as we discussed on our last conference call.

喬提到的動態是，當 MACI 最初推出時，我們看到活檢數量隨著時間的推移而增加，植入物往往會趕上活檢數量。一切都按照我們的預期和上次電話會議上討論的那樣發展。

Yes. And Ryan, just one thing to add to the 100 biopsies, that was just one data point from our kind of new Arthro-only segment. It wasn't meant to represent all of Arthro, just to make sure that was clear in our prepared remarks.

是的。瑞安，除了 100 次活檢之外，還有一件事需要補充，那就是這只是我們新推出的僅限關節領域的一個數據點。它並不意味著代表 Arthro 的全部，只是為了確保我們準備好的發言中清楚地表達這一點。

No, that's -- I appreciate the clarification there, Joe. And then just turning to Epicel. So the biopsies were, I think, up 38% in the first half. You do have a price benefit as well. So you alluded to this a little bit, Joe, that the patients are experiencing health issues, whether that's expiration or some point. But trying to reconcile the lower guidance on the burn business overall with that biopsy dynamic, this seems to be kind of sustaining despite what would have been maybe a blip, right, with some of these health issues. So just what's the new reality there that you're factoring in the guidance in terms of patient expiration for these severely burned patients in the back half of the year? Thanks for taking my question.

不，那是——我很感謝你的澄清，喬。然後轉向 Epicel。因此我認為上半年的活檢數量增加了 38%。您確實也享有價格優勢。喬，你稍微提到了這一點，即患者正在經歷健康問題，無論是到期還是其他情況。但是，試圖將燒傷業務整體的較低指導與活檢動態相協調，儘管可能只是曇花一現，但對於其中一些健康問題來說，這似乎是可以持續的。那麼，您在製定下半年這些嚴重燒傷患者的生存期指導時，究竟考慮了哪些新的現實情況？感謝您回答我的問題。

Yes. Yes, Ryan, I'm going to start and then Joe can take that. So what we said on the call was that biopsies were up 38% in the second quarter. But for the first half of the year, biopsies were actually up 20% over last year. So one would expect that you might see some volume growth on grafts as well, even with kind of the regular patient health issues that we face. So that, I think, based on the analytics we've had over time, would have suggested kind of the uptick that we had sort of started guiding to earlier in the year.

是的。是的，瑞安，我要開始了，然後喬可以接手。因此，我們在電話會議上說，第二季的活檢量增加了 38%。但今年上半年，活檢數量實際上比去年增加了 20%。因此，即使我們面臨的是常見的患者健康問題，我們也可能會看到移植物的體積增加。因此，我認為，根據我們長期以來的分析，這應該會預示著我們在今年早些時候開始引導的某種上升趨勢。

Obviously, as we said, June was the strongest month we've ever had for Epicel biopsies. So while they didn't convert into revenue, in full in the second quarter. Obviously, that's what supports our third quarter commentary that we're off to a strong start with Epicel. So there's a bit of that -- the patient health issues we referred to where we didn't see quite -- and again, part of this started from Q4 last year into Q1, where, again, it was a sort of unproductive cohort of biopsies that impacted Q1.

顯然，正如我們所說，六月是我們 Epicel 活檢業務最強勁的一個月。因此，雖然它們沒有轉化為收入，但在第二季卻全部轉化為收入。顯然，這支持了我們對第三季度的評論，即 Epicel 取得了良好的開端。所以有一點——我們提到的患者健康問題我們並沒有完全注意到——而且，部分問題從去年第四季度開始，一直持續到第一季度，同樣，是一批無效的活檢影響了第一季度。

So we don't -- we expect these things normalize over time. There's nothing different in the underlying dynamics. We do track all of the metrics you might expect, the TBSA of biopsies we received, the TBSA of patients that are treated. And there's really no change in any of those underlying patient demographics or otherwise. So it really -- we think there's no reason it won't normalize as usually happens.

所以我們不期望這些事情會隨著時間的推移而正常化。其基本動態並沒有什麼不同。我們確實會追蹤您可能期望的所有指標，我們收到的活檢的 TBSA，接受治療的患者的 TBSA。而且，患者的基本人口統計或其他方面實際上都沒有發生任何變化。所以，我們認為它沒有理由不會像通常那樣正常化。

Yes. And just to maybe talk a little bit about the Epicel and sort of the Burn Care kind of change in our approach, Ryan, which I think is important, and we had some of this in the prepared remarks. But again, I think what we're seeing on the Burn Care side, as Nick said, we had a stronger second quarter of around $10 million. Obviously, Epicel's biopsies were very strong. Strong start -- really strong start for both brands to start the third quarter. So at this point, our metrics are pointing to a higher Q3. But I think what we're talking about or what we're doing here is we're essentially making a change to our approach for the second half of the year.

是的。也許我可以稍微談談 Epicel 和 Burn Care 在我們方法上的一些變化，Ryan，我認為這很重要，我們在準備好的發言中也提到了一些這方面的內容。但同樣，我認為我們在燒傷護理方面看到的情況是，正如尼克所說，我們第二季度的業績表現更強勁，約為 1000 萬美元。顯然，Epicel 的活檢結果非常有力。強勁開局—兩個品牌在第三季都取得了強勁開局。因此，目前我們的指標顯示第三季業績將會提升。但我認為，我們在這裡談論的或正在做的事情實際上是在改變我們下半年的做法。

And so as we've often talked about, precisely forecasting Epicel is very difficult because of these unpredictable patient health dynamics. And just the reality is over the last two to three quarters, in particular, our underlying trends to go into the quarter, our forecast has supported higher volumes. And so for whatever reason, which we've seen a higher ratio of canceled patients and whatnot, we've either been on the low end or below -- a little bit below our Epicel forecasted range. And just to be clear, this is not where we want our guidance to be.

正如我們經常談論的那樣，由於患者健康狀況的不可預測性，準確預測 Epicel 非常困難。事實是，在過去兩到三個季度，特別是進入本季度，我們的預測支持了更高的銷售量。因此，無論出於什麼原因，我們看到取消就診的患者比例更高等等，我們要么處於低端，要么低於 - 略低於我們的 Epicel 預測範圍。需要明確的是，這不是我們想要的指導。

And so as Nick said, the first half of the year, we've actually generated strong biopsies that hasn't correlated to the revenue we expected yet. And so from a guidance perspective, to better account for this, we're essentially shifting to more of a run rate concept versus kind of thinking about our forecast and how we start the quarter. So as we talked about, the average quarterly revenue last year was $10 million. That's what Q2 was. That's going to be our guidance for Q3 and Q4 right now.

正如尼克所說，今年上半年，我們實際上已經產生了強勁的活檢，但這與我們預期的收入還沒有關聯。因此，從指導的角度來看，為了更好地解釋這一點，我們基本上轉向了更多的運行率概念，而不是思考我們的預測以及我們如何開始這個季度。正如我們所說的，去年的平均季度收入為 1000 萬美元。這就是 Q2 的情況。這將是我們目前對第三季和第四季的指導。

I would also say, to some of your question around the stronger start in Q3, importantly, this is not our forecast for Burn Care. And our metrics to date are pointing to something higher. Our expectations are higher. Our team's commercial goals are higher than this. So certainly, we think it's an opportunity to outperform this guidance, and that's what we're focused on. But again, where just a couple of patients could be the difference between $1 million in a quarter, we think just being a bit more conservative with the guidance is appropriate as we close out the year on the Epicel and the Burn Care side.

我還要說的是，對於您關於第三季開局更強勁的一些問題，重要的是，這不是我們對燒傷護理的預測。到目前為止，我們的指標都指向更高的水平。我們的期望更高。我們團隊的商業目標比這更高。因此，我們當然認為這是一個超越預期的機會，這也是我們關注的重點。但是，僅僅幾名患者就可能在一個季度內造成 100 萬美元的差異，我們認為，在 Epicel 和燒傷護理方面結束今年的財報時，對指導意見採取更保守一些的做法是合適的。

Richard Newitter, Truist Securities.

Truist Securities 的 Richard Newitter。

A couple of questions here. So it's -- I was jumping around some calls, so I apologize. But it sounds like the -- effectively reiterating MACI, even though 2Q wasn't quite at the guide, but just under. And it's really just maybe a slight call down from Epicel for the full year and you hope to exceed that, but just to be prudent. Is that the summary?

這裡有幾個問題。所以——我剛才接了一些電話，所以我很抱歉。但這聽起來像是在有效地重申 MACI，儘管第二季度沒有完全達到指導水平，但略低於指導水平。這可能只是 Epicel 對全年業績的略微下調，你希望能超過這個數字，但只是為了謹慎起見。這就是摘要嗎？

Yes, I think that's fair. Exactly.

是的，我認為這很公平。確切地。

Okay. So two quick follow-ups on that. One, on MACI, -- with respect to the range of outcomes of when your conversion rates could hit, do you feel confident that, that's just a matter of timing within a six-month time frame, a three-month time frame or it could extend beyond because MACI Arthro is a bit of new territory for you. So while the biopsy trends are improving and good, is there anything that's different versus MACI traditional and MACI Arthro in the conversion rate or the time line to conversion that maybe just won't work the same as it has in the past? And I have one follow-up.

好的。因此，對此有兩個快速的跟進。第一，關於 MACI，關於您的轉換率何時能夠達到的結果範圍，您是否有信心，這只是六個月時間範圍內、三個月時間範圍內的時間問題，或者可能會延長，因為 MACI Arthro 對您來說是一個新領域。因此，雖然活檢趨勢正在改善且向好，但與 MACI 傳統和 MACI Arthro 相比，在轉換率或轉換時間線方面是否存在什麼不同，可能無法像過去那樣發揮作用？我還有一個後續問題。

Yes, Rich, so this is Nick. No, we have not seen, as I mentioned previously, any difference in conversion rates for MACI Arthro cases versus MACI open cases. So as we talked about previously with the launch of MACI in 2017, you saw a very steep increase in biopsies and then an increase in implant growth, but that kind of played out over the back half of 2017. And then as we talked about on the last call, you went from 40%-plus biopsy growth in the back half of 2017 to 54% implant growth in 2018.

是的，里奇，這是尼克。不，正如我之前提到的，我們沒有看到 MACI Arthro 病例與 MACI 開放病例的轉換率有任何差異。因此，正如我們之前在 2017 年推出 MACI 時所討論的那樣，您會看到活檢數量急劇增加，然後植入物生長也隨之增加，但這種情況在 2017 年下半年才有所顯現。然後，正如我們在上次電話會議上討論的那樣，您的活檢增長率從 2017 年下半年的 40% 以上上升到 2018 年的 54%。

So it definitely doesn't play out over a quarter. It plays out over multiple quarters. And any time we've seen a sort of biopsy growth outpacing implant growth, it tends to catch up over time. And there's no reason to think that, that won't happen here. And on our prepared remarks, we mentioned that the MACI both -- and this is really encouraging. Obviously, biopsies outpaced implants in the first half of the year, but even biopsy growth is now accelerating and implant growth is accelerating. And I think we've kind of laid the foundation for this kind of dynamic earlier this year, and those are the trends that we're seeing play out now.

所以它肯定不會在一個季度內發揮作用。它會在多個季度內發生。每當我們看到某種活檢組織的生長速度超過植入物的生長速度時，它就會隨著時間的推移而趕上。我們沒有理由認為這種事情不會發生。在我們準備好的演講中，我們提到 MACI 都——這確實令人鼓舞。顯然，今年上半年活檢的成長速度超過了植入物，但現在切片的成長速度正在加速，植入物的成長速度也正在加速。我認為我們在今年早些時候已經為這種動態奠定了基礎，而這些就是我們現在看到的趨勢。

(Operator Instructions)

（操作員指示）

Mike Kratky, Leerink Partners.

麥克‧克拉基 (Mike Kratky)，Leerink 合夥人。

This is Sam on for Mike. Thanks for taking our questions. You mentioned biopsy growth outpaced implant growth in the first half of the year. Are you just seeing a deceleration in biopsy conversion rates around this time of year? And what's ultimately the underlying cause of this? And then kind of appreciate that you saw an acceleration in July, but what really gives you confidence that these biopsy and implant rates can converge in the second half of the year? And then I have a follow-up.

這是 Sam 為 Mike 代言。感謝您回答我們的問題。您提到，今年上半年切片的成長速度超過了植入物的成長速度。您是否發現每年這個時候活檢轉換率都會下降？而這背後的根本原因到底是什麼呢？然後，我很欣賞您在七月看到了加速，但是什麼真正讓您有信心這些活檢和植入率可以在下半年趨於一致？然後我有一個後續問題。

Yes. I mean -- so I think, again, as Nick talked about, we've seen this dynamic before in the MACI launch, which I think is a very important context, which is there's times when biopsy growth can be growing faster than implants. And I would just say, broadly, when we think about kind of conversion, biopsy growth and implants, they tend to kind of move together when the conversion is stable, which is what has been going on for the last few years. That said, there can certainly be points in time or kind of points during a year where one might be kind of moving slightly different than the other.

是的。我的意思是——所以我認為，正如尼克所說的那樣，我們之前在 MACI 發布會上就看到過這種動態，我認為這是一個非常重要的背景，即有時活檢的生長速度可能比植入物更快。我想說的是，廣義上講，當我們考慮轉化類型、活檢生長和植入物時，當轉化穩定時，它們往往會一起移動，這就是過去幾年一直在發生的情況。話雖如此，在一年中的某些時間點或某些時間點，一個事物的走勢可能會與另一個事物略有不同。

So I don't think this is -- it's not atypical that they're not moving -- they're not exactly sort of in sync at any point in time. But I think at this point, what's encouraging is we've seen that strong biopsy growth in the first half of the year. And we think that puts us in a very good position as we think about both the second half of '25, but also into next year as we talked about as well. So again, this is not atypical to see that move in a slightly different pace, and it's what we would have expected with the ARSPA launch.

所以我不認為這是——它們不動並不罕見——它們在任何時候都沒有完全同步。但我認為目前令人鼓舞的是，我們看到今年上半年活檢數量強勁成長。我們認為，這讓我們處於非常有利的位置，因為我們不僅考慮 25 年下半年，也考慮我們談論的明年。因此，再次強調，看到這項措施以略微不同的速度發展並不罕見，這也是我們對 ARSPA 發布的預期。

Got it. That's helpful. And then as a second question, can you just kind of comment on to what degree MACI Arthro surgeons that have been trained to date are surgeons from your existing MACI customer base? Or have you kind of begun to get more meaningful penetration in the incremental 2,000 arthroscopic surgeons that you flagged as being part of your TAM expansion?

知道了。這很有幫助。然後作為第二個問題，您能否評論一下迄今為止接受過培訓的 MACI 關節外科醫生在多大程度上是來自您現有的 MACI 客戶群的外科醫生？或者，您是否已經開始在您標記為 TAM 擴展一部分的增量 2,000 名關節鏡外科醫生中獲得更有意義的滲透？

Yes, that's a great question. Obviously, as we mentioned, we're really pleased to kind of be at 600 trained surgeons through the end of July. And as we talked about sort of the surgeon segments on the last call, you had about 2,500 existing MACI users prior to launch, and those were broken out into surgeons who had typically done patella-only implants previously. And then the other half of those users would do patella and typically smaller or larger, I'm sorry, condyle defects.

是的，這是一個很好的問題。顯然，正如我們所提到的，我們很高興到 7 月底能夠有 600 名訓練有素的外科醫生。正如我們在上次電話會議上討論外科醫生細分時所說，在推出之前，您有大約 2,500 名現有的 MACI 用戶，這些用戶被分為以前通常只進行過髕骨植入的外科醫生。然後另一半使用者會做髕骨手術，通常較小或較大，對不起，是髁突缺損。

So we'd say about a third of our 600 trained surgeons come out of each of those two buckets, the existing MACI users. And then the other third comes out of either the former MACI open targets who had not engaged yet or the new arthro-only surgeons that we added when we launched MACI. So really encouraged to see the trained surgeons, the third coming out of those prior nonusers. And as we mentioned on the call, we've now had 100 biopsies or more than 100 biopsies out of the kind of arthro-only segment as well.

因此，我們可以說，我們 600 名訓練有素的外科醫生中約有三分之一來自這兩個群體，即現有的 MACI 使用者。另外三分之一來自尚未參與的前 MACI 開放目標或我們在推出 MACI 時添加的新的僅從事關節外科手術的外科醫生。看到訓練有素的外科醫生真的令人鼓舞，這是從之前未使用者中走出來的第三位。正如我們在電話中提到的那樣，我們現在已經進行了 100 次活檢，或者說，在僅限關節的部分中也進行了 100 多次活檢。

So exactly what we would want to see for the prior users who were patella only. They are obviously now are increasing both biopsy and implants in terms of their growth rates and expanding into condyle defects. And then what you see out of the prior kind of combo patella and larger femoral condyle defect users, they're migrating down into the smaller MACI Arthro defects. So it's exactly the dynamic that you would want to see in these early launch indicators.

這正是我們希望看到的，對於之前僅有髕骨的用戶來說。顯然，它們現在正在增加活檢和植入物的生長速度，並擴展到髁狀突缺損。然後，您會看到，先前使用髕骨組合和較大股骨髁缺損的患者正在轉向較小的 MACI 關節缺損。因此，這正是您希望在這些早期發布指標中看到的動態。

Joshua Jennings, TD Cowen.

約書亞·詹寧斯 (Joshua Jennings)，TD Cowen。

Hi, this is Eric on for Josh. Thank you guys for taking the questions. On MACI Ankle, congrats on receiving the IND there. It sounds like the clinical study is going to be kicking off in the back half of the year. Are you able to share any detail on what the trial design looks like there? Any thought on patient enrollment and what the timing could be for complete enrollment?

大家好，我是 Eric，代表 Josh 發言。謝謝你們回答這些問題。關於 MACI Ankle，恭喜您在那裡獲得 IND。聽起來臨床研究將會在今年下半年啟動。能否分享一下那裡的試驗設計細節？對於患者入組有什麼想法？什麼時候可以完成入組？

Yes. So obviously, very pleased that we received FDA IND clearance for the MACI ankle study. As I mentioned on the call, it's about $1 billion addressable market for us. So we think it could be a substantial longer-term growth driver for the business over time. It's just not to get into too much detail as it's listed on clinicaltrials.gov, but it is a prospective open-label randomized controlled Phase III study, two-year-endpoint, just like the SUMMIT study for MACI in the knee will be approximately 300 patients that 2:1 ratio between MACI and bone marrow stimulation or microfracture, which is the active comparator.

是的。顯然，我們很高興 MACI 踝關節研究獲得了 FDA IND 批准。正如我在電話中提到的，這對我們來說是一個大約 10 億美元的潛在市場。因此我們認為，從長遠來看，它可能成為業務長期成長的重要動力。由於它已在 clinicaltrials.gov 上列出，因此無需贅述，但它是一項前瞻性開放標籤隨機對照 III 期研究，以兩年為終點，就像針對膝關節 MACI 的 SUMMIT 研究一樣，將有大約 300 名患者參與，MACI 與骨髓刺激或微骨折的比例為 2:1，這是活性對照。

And then it will focus on patients with lesions that are greater than 1.2 square centimeters. So pretty straightforward and then the endpoints are much like the endpoints were in the SUMMIT study, where you're looking at pain and function improvements at two years.

然後它將重點關注病變面積大於 1.2 平方公分的患者。因此非常簡單，終點與 SUMMIT 研究中終點非常相似，您可以觀察兩年後的疼痛和功能改善。

Great. Thank you for your view on that. And then -- just curious to check in on some of the midterm profitability targets that you guys have in play for gross margin and adjusted EBITDA margin by 2029. Are those high 70% and high 30% margin targets, respectively, still in play here?

偉大的。感謝您對此的看法。然後——我只是好奇地想了解你們到 2029 年對毛利率和調整後 EBITDA 利潤率的一些中期盈利目標。這兩個分別高達 70% 和 30% 的利潤率目標現在仍然有效嗎？

Yes. So we had -- from a profitability perspective, the company had a pretty strong second quarter. Our gross margin in the second quarter was kind of in that mid-70% range, consistent with where our full year guidance is that we reaffirmed as well from a profitability perspective. Adjusted EBITDA was strong as well, kind of into the low 20s in the second quarter, which is strong for a middle of the year quarter for us, and we reaffirmed our full year there. So yes, as we think about kind of end of the decade, kind of getting from the mid-70s to the high 70s on the gross margin side, certainly still seeing -- we -- nothing's changed, I would say, in our view on either gross margin or adjusted EBITDA.

是的。因此，從獲利能力的角度來看，公司第二季表現相當強勁。我們第二季的毛利率大約在 70% 左右，與我們從獲利角度重申的全年預期一致。調整後的 EBITDA 也很強勁，第二季達到 20% 出頭，這對於我們年中季度來說已經很強勁了，我們也重申了全年的強勁表現。所以是的，當我們想到這個十年末，毛利率從 70 年代中期到 70 年代後期，當然仍然看到 - 我們 - 我想說，就毛利率或調整後的 EBITDA 而言，什麼都沒有改變。

So again, we're not too far on the gross margin side. We need to keep kind of driving strong revenue growth and kind of manage our spend. But certainly, from an adjusted EBITDA perspective, we very much remain on track there as well. So no change in terms of our kind of midterm targets, I would say, on the profitability side.

所以，我們的毛利率並沒有太高。我們需要繼續推動強勁的收入成長並管理我們的支出。但當然，從調整後的 EBITDA 角度來看，我們的發展仍然保持在正軌上。因此，我想說，就獲利能力而言，我們的中期目標沒有改變。

(Operator Instructions)

（操作員指示）

Caitlin Cronin, Canaccord Genuity.

凱特琳‧克羅寧 (Caitlin Cronin)，Canaccord Genuity。

Hi, thanks so much for taking the questions. I guess just to start off with the Arthro biopsies, you mentioned 100 Arthro naive surgeons with the biopsies. I mean how many total biopsies to date are you seeing across all the surgeon cohorts? And then how many of those have converted already into implants?

你好，非常感謝您回答這些問題。我想先從關節活檢開始，您提到了 100 名不熟悉關節活檢的外科醫生。我的意思是，到目前為止，您在所有外科醫生隊伍中總共進行了多少次活檢？那麼其中有多少已經轉化為植入物呢？

Yes. So the -- it's not really possible. I suppose you could look at the size and location of defect and say this may be a defect that's intended to be treated arthroscopically. But even there, it really depends precisely on the location and so on. So I guess we would just say this, biopsies generally, as we said, increased at a double-digit rate in the first half of the year, and that's accelerating as we move into the second half of the year as we would have expected because we're now up to 600 MACI Arthro trained surgeons, both their implant and biopsy growth rates are significantly higher than the overall averages.

是的。所以——這其實是不可能的。我想您可以查看缺損的大小和位置，然後說這可能是需要關節鏡治療的缺損。但即使如此，這也確實取決於地點等等。所以我想我們只能說，正如我們所說，活檢總體上在上半年以兩位數的速度增長，而且隨著我們進入下半年，這一增長速度正在加速，正如我們預期的那樣，因為我們現在有 600 名 MACI Arthro 培訓的外科醫生，他們的植入物和活檢增長率都明顯高於整體平均水平。

So as we continue to train more surgeons and they take more and more biopsies, that's the dynamic that ends up leading towards this accelerating biopsy growth. And we did mention on the call as well that the small femoral condyle defects increased 40% in the second quarter this year over last year. So good indicator there about the impact that MACI Arthro can have. And as we've talked about with you before, it's the largest part of our addressable market. So when that growth rate is kind of ripping like that, it can have a pretty big impact on our business over time.

因此，隨著我們繼續培訓更多的外科醫生，他們進行越來越多的活檢，這種動態最終將導致活檢加速成長。我們在電話會議上也提到，今年第二季股骨髁小缺損比去年增加了 40%。這是一個很好的指標，表明 MACI Arthro 可以產生影響。正如我們之前與您討論過的，這是我們目標市場中最大的一部分。因此，當成長率達到如此高水準時，隨著時間的推移，它會對我們的業務產生相當大的影響。

Got it. Okay. And then just any more color on the MACI sales force expansion and how many have been hired already? And then just the time line to just add the further members this year?

知道了。好的。那麼，關於 MACI 銷售團隊擴張還有什麼消息嗎？目前已經僱用了多少人？那麼今年增加更多成員的時間表是什麼？

Yes. So these positions were posted last night. So we haven't hired anyone yet, but I expect it will be done in pretty short order. And the whole rationale there, as we mentioned on the call, is that we have some -- we're going to have some very significant volumes in the fourth quarter. And we're already kind of right at the beginning of August. And so you'll have reps who will be hired kind of towards the end of August into September. So we expect a decent number, meaningful number of reps will be in the field supporting our current reps in their existing territories probably by early October.

是的。這些職位是昨晚發布的。所以我們還沒有僱用任何人，但我預計很快就會完成。正如我們在電話中提到的那樣，整個理由是，我們有一些——我們將在第四季度有一些非常可觀的交易量。現在已經是八月初了。因此，您將在 8 月底至 9 月僱用銷售代表。因此，我們預計，大約到 10 月初，將會有相當數量的銷售代表在現場支援我們現有的銷售代表。

And so give them a good chance to again support a very high volume quarter and then realign the territories and all the representatives will be in their new territories starting on January 1. And we believe that is very important. As Joe mentioned on our last call, things don't change when the calendar flips to January 1 and the momentum that we're seeing and expect in the back half of the year, we want to capitalize on that day one in 2026. And that is what led to accelerating the growth based on the leading indicators we're seeing from MACI Arthro and sort of our expectations for implant growth in the back half of the year.

因此，給他們一個很好的機會來再次支持一個非常高銷售量的季度，然後重新調整領土，所有代表將從 1 月 1 日開始在他們的新領土上工作。我們認為這非常重要。正如喬在我們上次電話會議中提到的那樣，當日曆翻到 1 月 1 日時，事情不會改變，而我們看到並預期下半年會出現這樣的勢頭，我們希望在 2026 年的第一天抓住這一機會。根據我們從 MACI Arthro 看到的領先指標以及我們對下半年植入物成長的預期，這就是導致成長加速的原因。

That's great. And then just one more quick one. Any update on if you're continuing to see this kind of dynamic of dormant Epicel accounts becoming active given the NexoBrid engagement in those accounts?

那太棒了。然後再快速地問一次。鑑於 NexoBrid 對這些帳戶的參與，您是否繼續看到這種休眠 Epicel 帳戶變得活躍的動態？

Yes, we've definitely continued this year. We're I'll just roughly say, a handful of centers that hadn't used Epicel recently are sending in biopsies. And so we think as we continue to have a greater presence in a larger number of burn centers, that dynamic will continue.

是的，今年我們肯定會繼續。我只是粗略地說，少數最近沒有使用 Epicel 的中心正在發送活檢樣本。因此，我們認為，隨著我們在越來越多的燒傷中心的影響力不斷擴大，這種活力將會持續下去。

Mason Carrico, Stephens.

梅森·卡里科，史蒂芬斯。

I'll ask my two upfront, if that's all right. You've called out MACI ASP increasing mid- to high single digits annually. I think approval rates have stayed north of 90%. Can you just confirm or speak to your confidence in sustaining that price momentum moving forward without triggering some form of access pushback? And then second, could you just update us on the international expansion opportunity? What are your latest thoughts there on the time line, specific geographies you may plan on targeting?

如果可以的話，我會提前問我的兩個孩子。您曾指出 MACI ASP 每年以中高個位數成長。我認為支持率一直維持在 90% 以上。您能否確認或表達您對維持未來價格動能而不會引發某種形式的准入阻力的信心？其次，您能否向我們介紹國際擴張機會？您對時間表以及計劃針對的具體地區有何最新想法？

Yes. So on pricing, Mason, as we've talked about before, we do an extensive amount of MACI and really for all our products, pricing research to make sure that we can optimize pricing on what are considered by payers, surgeons, patients alike, highly innovative products. And so we have always been thoughtful about how we implement price increases. As we've said, MACI is a biologic product. Payers and hospital administrators expect that you'll be taking sort of mid- to high single-digit prices on an annual basis, and we've done that. And as you know, as you mentioned, our prior approval rate for MACI cases is in the mid-90% range.

是的。因此，關於定價，梅森，正如我們之前談到的，我們對所有產品都進行了大量的 MACI 定價研究，以確保我們能夠根據付款人、外科醫生、患者等高度創新產品的考慮來優化定價。因此，我們一直在深思熟慮如何實施提價。正如我們所說，MACI 是一種生物製品。付款人和醫院管理人員預計您每年將收取中高個位數的價格，而我們已經這樣做了。如您所知，我們對 MACI 案件的先前批准率在 90% 左右。

And so we haven't seen any change in that over the years as we've continued to take price. And so that's an important part of the equation for us, and it's a pretty unique position to be in, in the med tech space. On the OUS side, we continue to progress with our evaluation with our outside sort of global consulting group. And we had planned and expect to have a road map for the OUS opportunity by the end of the year. So it's progressing well. I think we have a clear intent to be able to expand into certain OUS geographies sort of in the next few years.

因此，多年來，隨著我們繼續保持價格不變，我們沒有看到任何變化。所以這對我們來說是一個重要組成部分，而且在醫療技術領域，這是一個非常獨特的地位。在 OUS 方面，我們繼續與外部全球諮詢小組一起推進評估。我們已經制定了計劃，並希望在今年年底之前製定 OUS 機會的路線圖。所以進展順利。我認為我們有明確的意圖，即在未來幾年內將業務擴展到某些 OUS 地區。

We have prioritized Europe and entry into that region first. And there are some interesting pathways that kind of along the mutual recognition front that would allow us to do that in a -- at a relatively fast pace. And so that time frame of potentially launching in certain countries or in the 2027, '28 time frame is still our current thinking.

我們優先考慮歐洲並首先進入該地區。在相互承認方面有一些有趣的途徑，可以讓我們以相對較快的速度做到這一點。因此，我們目前仍考慮在某些國家或 2027 年、2028 年的時間範圍內推出該產品。

[Jeff Cohen], Ladenburg Thalmann.

[傑夫·科恩]，拉登堡·塔爾曼。

Could you talk -- Joe, I guess, could you tease out a little bit the back half SG&A guide and talk about sales expansion and perhaps talk about geographies as well.

可以談談嗎——喬，我想，你能否稍微介紹一下後半部分的銷售、一般和行政費用指南，並談談銷售擴張，也許還可以談談地理位置。

Yes. And so yes, I would say from an operating expense perspective, we've been kind of around $49 million in total in the last couple of quarters. there may be a little bit of a mix shift as we kind of close out the year as we start hiring kind of on the sales side. But I think I said in the prepared remarks, obviously reaffirming our overall guidance from a profitability perspective for both gross margin and adjusted EBITDA. And I think we're assuming essentially kind of flat quarters or around that same number from an OpEx perspective over the next couple of quarters.

是的。是的，我想說，從營運費用的角度來看，過去幾季我們的總費用大約是 4900 萬美元。隨著我們開始在銷售方面招募員工，年底可能會出現一些組合變化。但我認為我在準備好的演講中說過，顯然從盈利角度重申了我們對毛利率和調整後 EBITDA 的總體指導。我認為，從營運支出的角度來看，我們假設未來幾季的營運支出基本上持平或大致相同。

So as we talked about, the hiring will probably sort of -- by the time kind of everyone's hired, it will take some time for that. And so there'll be some impact in the fourth quarter. But really, it's more of an annualized -- if you think about roughly 25 additional sales reps, it's kind of more of a 2026 impact, I would say, from a sales force expansion perspective.

所以正如我們所說的，招聘可能會有點——當每個人都被雇用時，這需要一些時間。因此第四季會產生一些影響。但實際上，它更像是一種年度化——如果你考慮大約 25 名額外的銷售代表，我想從銷售團隊擴張的角度來看，它更像是 2026 年的影響。

Okay. Got it. That's helpful. And then secondly, for us, could you talk about the BARDA RFP as far as the time frame or duration and size of the RFP that's out there?

好的。知道了。這很有幫助。其次，對於我們來說，您能否談談 BARDA RFP 的時間框架或持續時間以及 RFP 的規模？

Yes. So the RFP is in the public domain. And so anybody who's interested can take sort of a deeper look at it. But proposals or responses are due in sort of late August and presumably a decision will be made shortly thereafter. What the RFP covers would be procurement of basically of a stockpile for preparedness. And the details of that are clearly stated that the initial procurement would be for 2,750 units. There would be a management funding for that. There's a second ramp-up procurement that is listed.

是的。因此，此 RFP 屬於公共領域。因此，任何有興趣的人都可以對其進行更深入的了解。但提案或回覆將於 8 月底提交，預計不久後就會做出決定。RFP 涵蓋的內容基本上是採購緊急儲備物資。具體細節明確指出，初始採購量為 2,750 台。將會有管理資金用於此。其中列出了第二次加強採購。

So the first one is between October of this year and end of September next year, the ramp-up procurements for the year after that. And then there's just a number of other items around managing what's essentially a VMI inventory for BARDA, other development projects for room temperature, formulations, different indications and so on. So there's a pretty long list of about a dozen funding opportunities under that RFP. Obviously, at this point, the timing, the negotiations around that have not occurred.

因此，第一個階段是在今年 10 月到明年 9 月底之間，後一年是加強採購。然後還有一些其他事項，涉及管理 BARDA 的 VMI 庫存、其他室溫開發項目、配方、不同適應症等。因此，該 RFP 下有大約十幾個融資機會。顯然，目前，時機和圍繞該問題的談判尚未發生。

So there's -- we can't really speak to a, whether we would assume that BARDA typically, when they fund the program and then they look to stockpile a program that it would be -- NexoBrid will have a very strong opportunity. But in terms of the exact timing and funding amounts, that's left to negotiation after being selected.

因此，我們無法真正談論，我們是否會假設 BARDA 通常情況下，當他們為該專案提供資金，然後他們尋求儲存一個專案時，NexoBrid 將擁有非常好的機會。但具體時間和資金數額，還要等選定後再進行協商。

Swayampakula Ramakanth, H.C. Wainwright.

拉瑪坎特 (Swayampakula Ramakanth)，H.C. 溫賴特。

A couple of quick questions. So in your prepared remarks, Joe, you were talking about there's a potential for the burn franchise to outperform your $10 million per quarter guidance. So what are the pushes and pulls for that to happen?

幾個簡單的問題。因此，喬，在您準備好的發言中，您談到燒錢特許經營權有可能超越您每季度 1000 萬美元的指導。那麼，促使這現象發生的因素有哪些呢？

Yes. I mean -- so I mean, again, I try to lay out, I think it was Ryan's initial question. I just wanted to make sure people understood. From an external guidance perspective, we want to be very clear, which is our external guidance is $10 million a quarter. It's more of a run rate concept. So that's our approach. I would say internally, as we talked about, I'd say the first piece is we've had a pretty strong start to July on both products. So that's always kind of what you want. And so again, our guidance is not meant to be our forecast. But essentially, if NexoBrid can continue on a stronger run rate that we've seen in June and July, for example, that could kind of help it continue to tick up.

是的。我的意思是——所以我再次嘗試闡述，我認為這是瑞安最初的問題。我只是想確保人們理解。從外部指導的角度來看，我們希望非常明確，我們的外部指導是每季 1000 萬美元。它更像是一個運行率概念。這就是我們的方法。我想說，從內部來看，正如我們所討論的，我想說的第一點是，我們在 7 月的兩款產品都有了相當強勁的開局。所以這始終是你想要的。所以，再次強調，我們的指導並不意味著我們的預測。但本質上，如果 NexoBrid 能夠繼續保持我們在 6 月和 7 月看到的更強勁的運行率，那麼這可能會幫助它繼續上漲。

And it's really, at this point, obviously more about Epicel given the scale of the two products. And really, it's about what happens from a conversion of those strong biopsies in the second quarter. It's been a strong start in July, but we need to see how that plays out into August and September. Again, our metrics point to this is a strong start. So it points to it should be a stronger quarter. But again, we just don't want to get ahead of ourselves not knowing exactly what the rest of August looks like, let alone September at this point with Epicel because you can always have cancellations and whatnot.

從目前的情況來看，考慮到這兩款產品的規模，顯然 Epicel 的作用更為突出。事實上，這與第二季度這些強有力的活檢轉化後發生的情況有關。七月開局強勁，但我們需要看看八、九月的表現如何。再次，我們的指標表明這是一個好的開始。因此，這表明本季應該會更加強勁。但是，我們只是不想提前知道八月剩餘時間的具體情況，更不用說九月的情況了，因為 Epicel 總是有取消的情況等等。

But again, strong start. So it would be continuing to drive kind of a high higher conversion rate or call it a more average conversion rate and then not getting those cancellations due to patient health. That's probably what's most variable as we think about the quarter. But again, a strong start.

但再次，開局強勁。因此，它將繼續推動更高的轉換率，或稱為更平均的轉換率，並且不會因為患者的健康狀況而取消治療。這可能是我們對本季最不確定的因素。但再次，這是一個強勁的開始。

And I would just add that, as Joe mentioned in his prepared remarks, at this point, we're not including any potential BARDA revenue that could come in the fourth quarter in our guidance. So there's a commercial piece that could allow us to outperform. And then there's some potential BARDA revenue as well. Again, timing and amount can't determine at this point. But there's multiple paths to kind of exceed the guidance that Joe provided.

我還要補充一點，正如喬在他的準備好的演講中提到的那樣，目前，我們還沒有將第四季度可能出現的任何 BARDA 收入納入我們的預期中。因此，有一個商業部分可以讓我們表現得更佳。此外，BARDA 還可能帶來一些收入。再次強調，目前還無法確定時間和金額。但有許多方法可以超越喬提供的指導。

Nick, you kind of stole my question, but on that BARDA revenue from the fourth quarter potential, in general, is there a range you folks are thinking about on the dollar amount if it happens?

尼克，你有點搶了我的風頭，但就 BARDA 第四季度的潛在收入而言，總的來說，如果發生這種情況，你們考慮的金額範圍是怎樣的？

That's what I said earlier. I mean the RFP clearly states forth or sets forth the sort of procurements that BARDA is interested in. So the 2,750 units from October of this year through September of next and then up to 5,000 in the following year. Obviously, without knowing sort of the pricing on that, you can't really estimate the revenue. And then, of course, there's management contracts to manage that VMI inventory and other things that are stated there. I think they'd like to have access to some commercial inventory and there's funding for that, that would be involved.

這就是我之前所說的。我的意思是，RFP 明確說明或列出了 BARDA 感興趣的採購類型。因此，從今年 10 月到明年 9 月將生產 2,750 台，然後到明年將生產 5,000 台。顯然，如果不知道具體定價，就無法真正估算收入。當然，還有管理合約來管理 VMI 庫存和其中規定的其他事項。我認為他們希望獲得一些商業庫存，並且有資金支持，這將涉及其中。

So there's a lot of pieces, and it's just impossible at this point to kind of quantify from a revenue perspective what that would be or the timing thereof. But one would expect that if BARDA is interested in having an available stockpile through a VMI kind of procedure that they'd want to have it sooner than later. So anyway, more to come on that.

因此，有許多部分，目前不可能從收入角度量化這些部分或時間。但人們可以預料，如果 BARDA 有興趣透過 VMI 之類的程序獲得可用的庫存，那麼他們希望盡快獲得。無論如何，關於這一點，我們還將有更多內容。

And then on the Arthro product, you stated that there are 600 trained at this point. In general, once a surgeon gets trained, how long does it take for them to kind of become comfortable enough to start taking biopsies and start sending them over to you folks?

然後關於 Arthro 產品，您說目前已經有 600 名員工接受了培訓。一般來說，外科醫生接受培訓後，需要多長時間才能熟練地開始進行活檢並將其發送給你們？

Yes, I'd say, actually, it often happens in reverse, where surgeons will take biopsies and then get trained when they're ready to move forward with the procedure. So no time at all to get comfortable taking a biopsy. They do arthroscopic chondroplasties all the time, and that's when they end up taking a biopsy. So that's not -- no impact there at all.

是的，我想說，實際上，它經常以相反的方式發生，外科醫生會進行活檢，然後在準備好進行手術時接受培訓。因此根本沒有時間進行切片檢查。他們經常進行關節鏡軟骨成形術，最後進行活檢。所以根本不會產生影響。

There are no further questions. I'd like to turn the floor back to Nick Colangelo for any additional or closing remarks.

沒有其他問題了。我想把發言權交還給尼克·科朗吉洛，請他發表補充意見或結語。

Okay. Well, we just wanted to say thank you to everyone for your questions and continued interest in Vericel, and we look forward to providing further updates on our progress on our next call. So thanks again, and have a great day.

好的。好吧，我們只是想對大家提出的問題和對 Vericel 的持續關注表示感謝，我們期待在下次電話會議上提供有關我們進展的進一步更新。再次感謝，祝您有美好的一天。

This concludes today's conference. We thank you for your participation. You may disconnect at this time.

今天的會議到此結束。我們感謝您的參與。您現在可以斷開連線。