AxoGen Inc (AXGN) 2025 Q3 法說會逐字稿

Good morning. Joining me on today's call is Michael Dale, AxoGen 's Chief Executive Officer and Board Director and Lindsey Hartley, Chief Financial Officer. Michael will discuss 3rd Quarter of 2025 financial results and corporate highlights. Lindsay will then provide details on financial performance, guidance, and overall outlook for the year. This will be followed by a question-and-answer session. Today's call and presentation is being webcast live via webcast which is available on the investors section of Axoen's website. Following the end of the live call, a replay will be available in the investors section of the company's website at www.AxoGeninc.com.

早安.今天與我一起參加電話會議的有 AxoGen 的執行長兼董事 Michael Dale 和財務長 Lindsey Hartley。Michael 將討論 2025 年第三季的財務表現和公司亮點。隨後，林賽將詳細介紹全年的財務表現、業績指引和整體展望。接下來將進行問答環節。今天的電話會議和演示將透過網路直播，您可以在 Axoen 網站的投資者關係部分觀看直播。現場電話會議結束後，可在公司網站 www.AxoGeninc.com 的投資者關係部分收聽回放。

Before we get started, I'd like to remind you that during the conference call, the company will make projections and forward-looking statements. Forward-looking statements include but are not limited to statements relating to financial guidance, market development priorities, estimated market opportunities, timing for future product and application launches. And the company's expectations for approval of the biologics license application for Avance Nerve Graft in December 2025, including the anticipated timing of approval and the assumption that advanced nerve graft will be designated as a reference product for any future biosimilar nerve graft and that such designation will provide marketplace exclusivity.

在會議開始之前，我想提醒各位，在本次電話會議期間，公司將做出預測和前瞻性聲明。前瞻性陳述包括但不限於與財務指導、市場發展重點、預計市場機會、未來產品和應用發佈時間相關的陳述。該公司預計 Avance Nerve Graft 的生物製品許可申請將於 2025 年 12 月獲得批准，包括預計的批准時間，以及假設先進的神經移植產品將被指定為未來任何生物類似神經移植產品的參考產品，並且這種指定將提供市場獨佔權。

Forward-looking statements are based on current beliefs and assumptions and are not guarantees of future performance and are subject to risks and uncertainties, including without limitation, the risks and uncertainties reflected in the company's SEC filings, including its most recent Form 10K.

前瞻性陳述基於當前的信念和假設，並非對未來業績的保證，並且受到風險和不確定性的影響，包括但不限於公司向美國證券交易委員會提交的文件（包括其最新的 10-K 表格）中反映的風險和不確定性。

The forward-looking statements are represented only as of the date they are made, and except as required by applicable law, the company assumes no responsibility to publicly update or revise any forward-looking statements.

前瞻性陳述僅代表其作出之日的情況，除適用法律要求外，本公司不承擔公開更新或修訂任何前瞻性陳述的責任。

In addition, for a reconciliation of non-GAAP measures, please refer to today's press release, presentation with highlights from today's call, and the corporate presentation on the investment section of the company's website. I'll now turn the call over to Michael.

此外，有關非GAAP指標的調整，請參閱今天的新聞稿、今天電話會議的重點簡報以及公司網站投資部分的簡報。現在我將把電話交給麥可。

Thank you, operator, and welcome to everyone joining us this morning as we discuss our 3rd Quarter 2025 financial results. I will begin today's call with a financial and corporate overview highlighting our progress through the 3rd Quarter and year-to-date implementing our strategic plan, followed by an update on the Biologics License Application or BLA for our Avance Nerve Graft. I will then pass the call to Lindsay to review the quarter's financials and outlook for the remainder of 2025, and then we will open the lines for question-and-answer session.

謝謝接線員，也歡迎各位今天上午加入我們，一起討論我們2025年第三季的財務表現。今天，我將首先概述公司財務和營運情況，重點介紹我們在第三季度和今年迄今為止實施戰略計劃的進展，然後更新我們Avance神經移植的生物製品許可申請（BLA）的最新情況。然後我將把電話轉給 Lindsay，讓她回顧本季的財務狀況和 2025 年剩餘時間的展望，之後我們將開放問答環節。

As remarked in this morning's earnings release, we are delighted with our 3rd Quarter performance and progress year-to-date for the business. Our strong revenue growth and notable milestone achievements during the quarter further validate our strategic plan objectives and market development strategies, and importantly, AxoGen's ability to operationally execute our plans. Indeed, I am proud of our executive team in each of the respective operating functions at AxoGen for the performance year-to-date that is at or above plan.

正如今天早上發布的收益報告中所述，我們對第三季的業績以及今年迄今的業務進展感到非常滿意。本季強勁的營收成長和顯著的里程碑成就進一步驗證了我們的策略計畫目標和市場發展策略，更重要的是，驗證了 AxoGen 在營運上執行我們計畫的能力。事實上，我為AxoGen各個營運職能部門的執行團隊感到自豪，他們今年迄今的業績都達到了或超過了計畫目標。

Looking ahead, we will continue to optimize our business models based on experience and have confidence in our ability to continue delivering growth consistent with the guidance we have provided for our strategic plan in both the near and longer-term. Regarding the quarter, Q3 sales increased to $60.1 million growing 23.5% compared to the same period last year. This performance reflects double-digit growth across all of our nerve repair target markets, including extremities, oral maxillofacial, and head, neck, and breast. Consistent with prior quarters, our growth is driven by expanding adoption of nerve care using AxoGen's nerve algorithm for the treatment of all types of peripheral nerve injuries, including traumatic, iatrogenic, and chronic nerve injuries. The advanced nerve graft is the primary growth driver often complemented based on the clinical situation by one or more of our nerve repair connection protection or termination products. In extremities, we continue to execute our high potential account strategy with solid growth in both traumatic and chronic nerve injury procedures in the quarter. In OMF and head and neck, search and adoption of the action algorithm during the quarter was strong across all products, excuse me, all procedures, but particularly in mandible reconstruction procedures. And likewise in breast, we continue to see strong adoption of our breast-resensation techniques supported by new surgeon activation, increased procedure volume and implant-based reconstruction cases, and the expansion of our commercial infrastructure.

展望未來，我們將繼續根據經驗優化我們的商業模式，並有信心在近期和長期內繼續實現與我們策略計畫指導方針一致的成長。本季方面，第三季銷售額增至 6,010 萬美元，比去年同期成長 23.5%。這項表現反映了我們所有神經修復目標市場（包括四肢、口腔顎面、頭部、頸部和乳房）的兩位數成長。與前幾季一致，我們的成長得益於 AxoGen 的神經演算法在神經護理領域的應用日益廣泛，該演算法可用於治療各種類型的周邊神經損傷，包括創傷性、醫源性和慢性神經損傷。先進的神經移植是主要的生長驅動因素，通常會根據臨床情況輔以一種或多種神經修復連接來保護或終止產品。在四肢方面，我們繼續執行高潛力客戶策略，本季創傷性和慢性神經損傷手術均實現了穩健成長。在 OMF 和頭頸部領域，本季所有產品（抱歉，是所有程式）對行動演算法的搜尋和採用都很強勁，尤其是在下顎重建程序方面。同樣，在乳房方面，我們繼續看到乳房重建技術得到廣泛應用，這得益於新外科醫生的積極參與、手術量和植入物重建病例的增加，以及我們商業基礎設施的擴展。

In summary, we are encouraged by the broad-based adoption of our nerve care portfolio and momentum across each of our three target markets. To assess our progress, we continue to monitor key metrics tied to our plan in 2025 strategic priorities, including high potential accounts, commercial expansion, professional education, new product development, clinical research, and prostate market development.

總而言之，我們的神經護理產品組合得到了廣泛的採用，並且在我們三個目標市場都取得了良好的發展勢頭，這令我們倍感鼓舞。為了評估我們的進展，我們將繼續監測與 2025 年策略重點計畫相關的關鍵指標，包括高潛力客戶、商業擴張、專業教育、新產品開發、臨床研究和前列腺市場開發。

I'll begin with an update on our performance and growth in high potential accounts. We continue to focus on expanding our presence in these accounts to drive more consistent customer creation, algorithm adoption, and improvements in Salesforce productivity. Our goal for 2025 is to generate at least 66% of total revenue growth from high potential accounts and average count productivity of 21%.

首先，我將報告我們在高潛力客戶方面的業績和成長。我們將繼續專注於擴大在這些客戶中的影響力，以推動更穩定的客戶開發、演算法採用和 Salesforce 生產力的提升。我們 2025 年的目標是，至少 66% 的總營收成長來自高潛力客戶，平均計數效率達到 21%。

Through the first three quarters, approximately 64% of revenue growth was driven by high potential accounts based on an average account productivity of 19%. These results are slightly below our planned target, but notably the result of the fact that we are also seeing double-digit revenue growth and account productivity growth year-to-date in our non-high potential designated accounts as well. Growth in all account types was amplified in the quarter by the discontinuation of our case stock sales program for advanced nerve graft in preparation for the anticipated BLA approval. These sales program previously allowed for advanced nerve grafts to be shipped for a case for an unused product to be returned to AxoGen.

前三個季度，約 64% 的營收成長是由高潛力客戶推動的，這些客戶的平均表現為 19%。這些結果略低於我們計劃的目標，但值得注意的是，這是因為我們今年迄今在非高潛力指定客戶中也看到了兩位數的收入成長和客戶生產力成長。本季度所有帳戶類型的成長都因我們停止了針對先進神經移植的病例庫存銷售計劃而得到加強，該計劃旨在為預期的 BLA 批准做準備。該銷售計劃以前允許將先進的神經移植片運送給 AxoGen，以便將未使用的產品退回給 AxoGen。

With the discontinuation of the K-stock program, previous K-stock customers are transitioning to either order by direct sale or consignment. This shift in purchasing behavior contributed to our top-line performance and reduced revenue growth from high potential accounts by an estimated 4%. To be clear, high potential account growth was actually quite strong on an absolute basis. While it appears lower than last quarter, it's really just a function of the denominator getting larger because of the nice high potential base is performing better as well. The underlying fundamentals in all account types remains very positive, and after accounting for the case stock impact in the 3rd Quarter, we continue to realize that our focus on high potential accounts is enabling broader, more enduring adoption of nerve care and as such, more predictable growth.

隨著 K 庫存計劃的終止，先前的 K 庫存客戶正在過渡到直接銷售或寄售訂購。購買行為的這種轉變對我們的營收業績產生了影響，並導致高潛力客戶的收入成長減少了約 4%。需要說明的是，高潛力帳戶的成長其實非常強勁，絕對值相當可觀。雖然看起來比上一季低，但這實際上只是因為高潛力基數表現更好，導致分母變大所致。所有帳戶類型的基本面仍然非常積極，在考慮了第三季度的病例庫存影響後，我們繼續認識到，我們對高潛力帳戶的關注正在使神經護理得到更廣泛、更持久的採用，從而帶來更可預測的增長。

During the first three quarters of 2025, there were 668 active high potential accounts of the approximately, 780 accounts that meet our high potential criteria, which represents an increase of 8 accounts or 1.2% as compared to the first three quarters of 2024.

2025 年前三個季度，在約 780 個符合高潛力標準的帳戶中，有 668 個活躍的高潛力帳戶，與 2024 年前三個季度相比，增加了 8 個帳戶，增幅為 1.2%。

Regarding our 2025 commercial infrastructure expansion goals, as of the end of the third quarter, we are now at or ahead of our high-end plan for each target market. And breast, we ended the quarter with 22 breast re-sensation sales specialists and two regional sales directors. We have met our goal to double the breast sales force in 2025 by the end of the year. To support broader adoption in non-breast markets, we ended the quarter with 125 sales professionals, including 15 regional sales directors.

關於我們 2025 年的商業基礎設施擴張目標，截至第三季末，我們目前已達到或超過每個目標市場的高端計劃。乳房方面，本季末我們有 22 位乳房再感覺銷售專家和兩位區域銷售總監。我們已經實現了在 2025 年底將乳房銷售團隊規模擴大一倍的目標。為了支持在非乳癌市場更廣泛地採用該產品，我們本季末擁有 125 名銷售專業人員，其中包括 15 名區域銷售總監。

In OMF and head and neck, we ended the quarter with 4 field-based market development managers. Surgeon training remains a core component of our customer creation and nerve repair algorithm adoption. Execution of our 2025 professional education programs are on track, and we fully expect to meet our 2025 surgeon training targets.

在口腔顎面外科和頭頸部外科領域，我們本季末擁有 4 位駐地市場開發經理。外科醫生培訓仍然是我們客戶開發和神經修復演算法應用的核心組成部分。我們的 2025 年專業教育計畫正在按計畫執行，我們完全有信心實現 2025 年外科醫生培訓目標。

In breast, we have trained 62 surgeon pairs year-to-date with one program planned in the 4th quarter. We are confident we will meet our 2025 target of 75 surgeon pairs trained. Active breast re-sensation programs increased 7% in the third quarter of 2024, from 113 to 121. We estimate 281 surgeons performed a breast re-sensation procedure in the 3rd Quarter, which represents a 20% increase versus the 3rd Quarter of 2024.

今年迄今為止，我們在乳房外科領域培訓了 62 對外科醫生，並計劃在第四季度開展一項培訓計劃。我們有信心實現2025年培訓75對外科醫師的目標。2024 年第三季度，活躍的乳房再感覺治療計畫增加了 7%，從 113 個增加到 121 個。我們估計，第三季有 281 位外科醫生進行了乳房感覺恢復手術，比 2024 年第三季增加了 20%。

In extremities, we have trained 97 surgeons year-to-date, of which 30 were trained in the 3rd Quarter with 3 additional programs planned in the 4th quarter. We expect to meet our 2025 target of 105 surgeons trained.

今年迄今，我們在四肢外科領域已培訓了 97 名外科醫生，其中 30 名是在第三季度接受培訓的，第四季度還計劃開展 3 個額外的培訓項目。我們預計到 2025 年將實現培訓 105 名外科醫生的目標。

In OMF and head and neck, we have trained 57 surgeons year-to-date, up 16 from second quarter 2025, exceeding our 2025 target of 45 surgeons trained.

在口腔顎面外科和頭頸外科領域，我們今年迄今已培訓了 57 名外科醫生，比 2025 年第二季度增加了 16 名，超過了我們 2025 年培訓 45 名外科醫生的目標。

Next, I will provide an update on our clinical research priorities. We continue to advance our 2025 initiatives and are on track to complete a level 1 study protocol for implant-based neurotization, a clinical evidence plan for advanced versus autographed and mixed motor nerves, and a clinical evidence plan for oral maxillofacial and head neck.

接下來，我將介紹我們臨床研究的重點工作進展。我們繼續推進 2025 年計劃，並有望完成一項基於植入物的神經移植 1 級研究方案、一項高級與自體和混合運動神經的臨床證據計劃，以及一項口腔頜面和頭頸部的臨床證據計劃。

Regarding research and development, as we have outlined in our strategic plan, innovation remains critical to our long-term growth through the 3 quarters of the 1st 3 quarters of the year, we continue to progress and advance our innovation platform across three pillars. Those include therapeutic reconstruction, ease of cooptation, and protection expansion.

關於研發，正如我們在策略計畫中所概述的那樣，創新對於我們今年前三個季度的長期成長仍然至關重要，我們將繼續在三大支柱領域推進和發展我們的創新平台。這些包括治療性重建、易於整合和保護性擴展。

Consistent with our clinical research objectives to build evidence in support of nerve care, in the 3rd Quarter, we received meaningful external validation of Axogen differentiated technologies and leadership in peripheral nerve repair. 10 new peer reviewed publications cited clinical uses for discussion of our products, bringing our total nerve repair related literature body to 339 publications.

為實現我們旨在為神經護理提供循證依據的臨床研究目標，第三季度，Axogen 的差異化技術和在周圍神經修復領域的領先地位獲得了重要的外部驗證。 10 篇新的同行評審論文引用了我們產品的臨床應用，使我們與神經修復相關的文獻總數達到 339 篇。

This growing body of evidence underscores the clinical relevance and impact of our solutions. Notably, there has been a 70% increase in the number of nerve repair publications in the last 5 years, reflecting in part the growing experience and interest in nerve repair. For those interested, all peer reviewed studies are available on our website.

越來越多的證據凸顯了我們解決方案的臨床相關性和影響力。值得注意的是，在過去 5 年中，神經修復的出版物數量增加了 70%，這在一定程度上反映了人們對神經修復的經驗和興趣的不斷增長。有興趣的讀者可以在我們的網站上查閱所有經過同行評審的研究報告。

During the 3rd Quarter, we also saw significant validation from medical societies. Both the American Association of Hand Surgery and the American Society for Reconstructive Microsurgery released official position statements recognizing nerve allograft as a non-experimental and medically necessary standard medical practice option for the treatment of peripheral nerve defects.

第三季度，我們也獲得了醫學會的大力認可。美國手外科協會和美國重建顯微外科協會都發表了官方立場聲明，承認神經同種異體移植是治療週邊神經缺損的非實驗性且醫學上必要的標準醫療實踐選擇。

These position statements add to the previously released clinical practice guidelines from the American Association of Oral and maxillofacial Surgeons. Together, these endorsements mark a critical step towards establishing peripheral nerve repair with allograft as a recognized standard of care, and we believe this support will be helpful in our efforts to expand coverage.

這些立場聲明是對美國口腔顎面外科醫師協會先前發布的臨床實踐指南的補充。這些認可共同標誌著在將同種異體移植修復週邊神經作為公認的治療標準方面邁出了關鍵一步，我們相信這種支持將有助於我們擴大覆蓋範圍。

On the coverage and reimbursement front, we continue to see non-coverage policies removed within the Blue Cross Blue Shield network and within Medicare Advantage for nerve care, resulting in an estimated 1.1 million newly covered lives in the third quarter.

在承保範圍和報銷方面，我們繼續看到藍十字藍盾網路和聯邦醫療保險優勢計劃中針對神經護理的非承保政策被取消，預計第三季將新增 110 萬承保人。

Year-to-date, we estimate 18.1 million additional lives are now covered for nerve repair for peripheral nerve injuries using synthetic conduits or allografts. This expansion brings coverage amongst commercial payers to more than 64%, reflecting continued momentum and expanding access.

今年迄今為止，我們估計已有 1,810 萬人因週邊神經損傷而接受神經修復，採用的是合成導管或同種異體移植。此次擴大覆蓋範圍，使商業支付方的覆蓋率超過 64%，反映出持續的成長動能和不斷擴大的覆蓋範圍。

And finally, I will provide an update on our prostate clinical and market development plan. We remain enthusiastic about the opportunity to improve nerve function outcomes in robotic assisted radical prostatectomy and are actively collaborating with key opinion leaders to advance surgical technique development.

最後，我將介紹我們前列腺臨床和市場開發計劃的最新進展。我們仍然對改善機器人輔助根治性前列腺切除術中的神經功能結果充滿熱情，並積極與關鍵意見領袖合作，推動外科技術的發展。

During the 3rd Quarter, our clinical development team provided field-based support to surgeons and clinical sites incorporating nerve repair into the robotic assisted prostatectomy cases. We added 4 new clinical sites during the 3rd Quarter, bringing our total to 10 active sites meeting our year-end goal. Procedures are ongoing, and we remain on track to complete 100 cases by year end.

在第三季度，我們的臨床開發團隊為外科醫生和臨床中心提供現場支持，將神經修復納入機器人輔助前列腺切除術病例中。我們在第三季新增了 4 個臨床中心，使我們的活躍中心總數達到 10 個，實現了我們的年終目標。相關程序正在進行中，我們仍有望在年底前完成 100 例病例。

Before I hand it over to Lindsay, I would like to address the status of our biologic license application for advanced nerve graft. In August, the FDA extended the PDUFA goal date from September to December 5, 2025. In the communication from the FDA, it stated that a recent submission by AxoGen, a facility and manufacturing information provided in a response to an FDA information request constituted a major amendment to our BLA for the advanced nerve graft submission, which resulted in the 3-month extension.

在將發言權交給林賽之前，我想談談我們先進神經移植生物製品許可證申請的進展。8 月，FDA 將 PDUFA 目標日期從 9 月延長至 2025 年 12 月 5 日。FDA 在通知中指出，AxoGen 最近提交的一份文件（其中包含對 FDA 資訊請求的回應中的設施和生產資訊）構成了對我們先進神經移植產品生物製品許可申請的重大修改，因此導致申請期限延長了 3 個月。

Since our last public update, interactions with FDA have expanded to all elements of the BLA application. Based on these interactions, we remain confident we will successfully complete the application process, consistent with the new December 5 PDUFA date. The BLA approval will secure 12 years of market exclusivity from biosimilar nerve allografts and establish advanced nerve graft as the only implantable biologic indicated for the repair of functional deficits in peripheral nerves. With this, I will now turn it over to Lindsay.

自我們上次公開更新以來，與 FDA 的互動已擴展到 BLA 申請的所有方面。基於這些互動，我們仍然有信心成功完成申請流程，並與新的 12 月 5 日 PDUFA 日期保持一致。生物製品許可申請的批准將確保生物類似神經同種異體移植產品 12 年的市場獨佔權，並將先進的神經移植產品確立為唯一可用於修復週邊神經功能缺陷的植入式生物製品。接下來，我將把麥克風交給琳賽。

Thanks, Mike. I'm pleased to report our third quarter results. We reported strong growth with revenue of $60.1million, reflecting a 23.5% growth compared to the third quarter of 2024, and a 6% sequential increase over the second quarter of 2025. Revenue growth continues to be fueled by strong sales of advanced nerve graft and the adoption of our comprehensive product algorithm across our target market, with unit volume and mix serving as the primary driver of our performance revenue performance.

謝謝你，麥克。我很高興地向大家報告我們第三季的業績。我們報告稱，營收強勁成長，達到 6,010 萬美元，與 2024 年第三季相比成長 23.5%，與 2025 年第二季相比較上季成長 6%。收入成長持續得益於先進神經移植產品的強勁銷售以及目標市場對我們綜合產品演算法的採用，而單位銷售和產品組合是我們業績收入的主要驅動因素。

As Mike noted during our 3rd Quarter, we successfully ended our pay stock sales program for advanced nerve graft in preparation of the anticipated BLA approval. We estimate our revenue for the 3rd Quarter was positively impacted by 1.6 million, or 3% as the result of customers transitioning away from purchasing advance through the case stock program and ordering through direct sales.

正如 Mike 在第三季指出的那樣，我們已成功結束了針對先進神經移植的股票銷售計劃，為預期的 BLA 批准做準備。我們估計，由於客戶不再透過整箱庫存計畫提前購買，而是透過直接銷售訂購，我們第三季的收入受到了 160 萬英鎊（或 3%）的正面影響。

Our gross profit for the quarter came in at $46 million, up from 36.4 million in the third quarter of 2024 and $42 million in the second quarter of 2025. This represents a gross margin of 76.6%, up from 74.9% in the same period last year, and up from 74.2% in the second quarter of 2025. The year over year increase and sequential increase from second quarter were primarily driven by lower inventory write-offs and reduced shipping costs on products sold. These gains were partially offset by modestly higher product costs, which had a minimal impact of less than 0.5% point on gross margin compared to those periods.

本季毛利為 4,600 萬美元，高於 2024 年第三季的 3,640 萬美元和 2025 年第二季的 4,200 萬美元。這意味著毛利率為 76.6%，高於去年同期的 74.9%，也高於 2025 年第二季的 74.2%。年比和環比成長主要得益於庫存減損減少和已售產品運輸成本降低。這些收益部分被略微上漲的產品成本所抵消，與同期相比，產品成本上漲對毛利率的影響微乎其微，不到 0.5 個百分點。

Gross margin for the first three quarters of 2025 was 74.4%, 1.3% less than the first three quarters of 2024. The decrease of gross margin for the first three quarters of 2025 was driven by a 1.9% increase in year over year product cost. Product cost increased as a result of the transition of processing advanced nerve graft to our Axogen processing center and costs related to additional steps and tests required as we approach the transition to processing as a biologic anticipated in December.

2025 年前三個季度的毛利率為 74.4%，比 2024 年前三個季度下降了 1.3%。2025 年前三個季度毛利率下降的原因是產品成本年增 1.9%。由於將高級神經移植物的加工轉移到我們的 Axogen 加工中心，產品成本增加；此外，隨著我們預計在 12 月將加工方式改為生物製品，還需要進行額外的步驟和測試，因此也增加了成本。

We expect the cost of our advanced product to decrease over time as we gain economies of scale at the Axogen processing center, and once the BLA is approved, we can begin implementing more significant continuous improvement programs. Our operating expenses increased to 44.1 million, up from 36.8 million in the third quarter of 2024, and as a percentage of revenue decreased 2.2 million%, highlighting our ability to increase our operating leverage.

我們預計，隨著我們在 Axogen 加工中心獲得規模經濟效益，我們先進產品的成本將隨著時間的推移而降低；一旦 BLA 獲得批准，我們就可以開始實施更重要的持續改進計劃。我們的營運費用從 2024 年第三季的 3,680 萬增至 4,410 萬，佔營收的百分比下降了 220 萬，這凸顯了我們提高營運槓桿的能力。

Sales and marketing expenses as a percentage of total revenue were up nearly 4% to 42.7% from 38.9% in the third quarter of 2024.

銷售和行銷費用佔總收入的比例從 2024 年第三季的 38.9% 上升了近 4%，達到 42.7%。

Research and development expenses increased 8.1% to 7.6 million from 7 million in the third quarter of 2024. As a percentage of total revenue, research and development expenses were down 1.8% to 12.6% from 14.4% in the third quarter of 2024.

2024 年第三季研發費用成長 8.1%，從 700 萬美元增至 760 萬美元。研發費用佔總收入的比例從 2024 年第三季的 14.4% 下降 1.8% 至 12.6%。

General and administrative expenses remained flat, quarter over quarter at 10.8 million. As a percentage of total revenues, general and administrative expenses were down 4.2% to 18.1% from 22.3% in the third quarter of 2024.

一般及行政費用較上月持平，為1080萬。佔總收入的百分比，一般及行政費用從 2024 年第三季的 22.3% 下降 4.2% 至 18.1%。

Net income for the quarter was 0.7 million or $0.01 per share compared to a net loss of $1.9 million or $0.04 per share in the third quarter of 2024.

本季淨收入為 70 萬美元，即每股 0.01 美元，而 2024 年第三季淨虧損為 190 萬美元，即每股 0.04 美元。

Adjusted net income for the quarter was $6.1 million or $0.12 per share compared to an adjusted net income of $3.1 million or $0.07 per share in the third quarter of 2024.

本季調整後淨收入為 610 萬美元，即每股 0.12 美元，而 2024 年第三季調整後淨收入為 310 萬美元，即每股 0.07 美元。

Adjusted EBITDA for the quarter was 9.2 million compared to an adjusted EBITDA of 6.5 million in the same period last year. Adjusted EBITDA margin improved 210 basis points to 15.4% from 13.3% in the same period last year, driven by revenue growth and increased operating leverage.

本季調整後 EBITDA 為 920 萬美元，而去年同期調整後 EBITDA 為 650 萬美元。受營收成長和經營槓桿提高的推動，調整後 EBITDA 利潤率從去年同期的 13.3% 提高 210 個基點至 15.4%。

As of September 30th, our balance of cash equivalents, restricted cash and investments increased 3.9 million to 39.8 million from 35.9 million at the end of the second quarter of 2025. I am pleased to report that for the first three quarters of 2025, our balance of cash equivalents, restricted cash, and investments increased 0.3 million from a balance of 39.5 million on December 31 of 2024, demonstrating our ability to be free cash flow positive for the year.

截至 9 月 30 日，我們的現金等價物、受限現金和投資餘額從 2025 年第二季末的 3,590 萬美元增加到 3,980 萬美元。我很高興地報告，截至 2025 年前三個季度，我們的現金等價物、受限現金和投資餘額較 2024 年 12 月 31 日的 3950 萬美元增加了 30 萬美元，這表明我們有能力實現全年的自由現金流為正。

Now turning to our full year financial guidance for 2025.

現在來看看我們對2025年的全年財務預期。

We are raising our revenue growth guidance to at least 19%, or revenue of at least 222.8 million. We reiterate our gross margin in the range of 73% to 75%, inclusive of one-time costs related to the BLA approval for advanced nerve grafts, which we are expecting to impact growth margin by approximately 1% or $2 million.

我們將營收成長預期上調至至少 19%，即營收至少達到 2.228 億美元。我們重申毛利率在 73% 至 75% 之間，其中包括與先進神經移植的 BLA 批准相關的一次性成本，我們預計這將對成長利潤率產生約 1% 或 200 萬美元的影響。

As a reminder, these costs will be incurred around the anticipated BLA approval date, currently expected in December. Also, we estimate that 2/3 of these costs relate to the vesting of our BLA milestone-related stock compensation awards and our non-cash.

再次提醒，這些費用將在預計的 BLA 批准日期前後產生，目前預計在 12 月。此外，我們估計這些成本中有 2/3 與我們的 BLA 里程碑相關的股票補償獎勵的歸屬以及我們的非現金獎勵有關。

We continue to expect to be net cash flow positive for the year. In summary, we are very pleased with our 3rd Quarter performance and the progress we have made. We remain focused on executing our strategy, investing in innovation, optimizing our resource allocation, and driving towards profitability. With that, we will now open the line for questions, operator.

我們仍預期今年淨現金流為正。總而言之，我們對第三季的業績和取得的進展感到非常滿意。我們將繼續專注於執行我們的策略，投資創新，優化資源配置，並努力實現盈利。話筒，現在我們將開通提問熱線。

Thank you.

謝謝。

[Operator instructions].

[操作說明]。

First question comes from the line of Chris...

第一個問題來自克里斯那一排…

Congrats on the next quarter.

恭喜你們下個季度取得佳績。

If I look back at the last few years, your fourth quarter revenue tends to be up slightly compared to 3. I know guidance is for at least 19% growth, so you're leaving the door open for something better than that. But at 19%, it would imply a 4% sequential decline. So, I want to make sure we understand how to think about this case stock program transition and whether that 1.6 million. Was in effect kind of pulled forward from 4Q into 3Q. And then there's anything else about the dynamics this year that we should be keeping in mind as we're updating our models, especially related to the BLA decision date would love to sort of.

回顧過去幾年，你們第四季的營收往往比第三季略有成長。我知道公司預期至少成長 19%，所以你這表示成長還有可能更高。但19%意味著季減4%。所以，我想確保我們了解如何考慮這個案例庫存計劃的過渡，以及這 160 萬是否合適。實際上，比賽是從第四季提前到第三季進行的。此外，今年在更新模型時，我們還應該注意其他一些動態因素，特別是與 BLA 決定日期相關的因素，我很想了解一下。

Thanks, Chris. For our 4th quarter, we are expecting our typical seasonality, but in giving our guidance, we have been prudent as, because of the case stock program.

謝謝你，克里斯。對於第四季度，我們預計會受到季節性因素的影響，但由於庫存計劃，我們在給出業績指引時一直比較謹慎。

During the third quarter, we saw an increase of 1.6 million related to these customers transitioning mostly to direct sales. We could discontinue that program September 1st, so we're just 1 month in. So, we're still trying to get a grasp on what that full potential impact could be and if that was a one-time pick up as a result of a shift to direct sales. So, when modeling, I would exclude the 1.6 million that we saw from the KSO program in Q3.

第三季度，由於這些客戶大多轉向直銷，我們看到客戶數量增加了 160 萬人。我們可以在9月1日終止該項目，所以我們才進行了一個月。所以，我們仍在努力了解這可能造成的全部潛在影響，以及這是否是由於轉向直銷而導致的一次性成長。因此，在建模時，我會排除我們在第三季從 KSO 專案中看到的 160 萬人。

Okay, that's helpful. And then, looking ahead to 2026, consensus is right now betting about 16% revenue growth. You've actually done better than that now, three quarters in a row, but that's obviously going to create some tougher comps as well. I know you guys will give formal guidance in February, but just curious if there's any directional comments, you'd like to make now about how you're thinking about next year and maybe some of the key puts and takes, across the business.

好的，這很有幫助。展望 2026 年，目前普遍預期營收將成長 16%。實際上，你們現在的表現比之前更好，已經連續三個季度都取得了不錯的成績，但這顯然也會帶來一些更嚴峻的競爭。我知道你們會在二月份給出正式的指導意見，但我很好奇，你們現在是否有什麼方向性的評論，關於你們對明年的想法，以及公司在各個方面可能做出的一些關鍵調整和取捨。

Hi, Chris. We're not prepared at this point to give any color in 2026 beyond the general statement that we remain very positive about the business and have full confidence in the strategic plan. I realize you guys are looking for more granularity in that, but not ready to provide that.

嗨，克里斯。目前我們不準備對 2026 年做出任何具體說明，只能籠統地表示我們對業務仍然非常樂觀，並且對戰略計劃充滿信心。我知道你們希望獲得更細緻的信息，但我目前還無法提供。

All right, thanks.

好的，謝謝。

Thank you. Our next question comes from the line of Michael Sharone.

謝謝。我們的下一個問題來自邁克爾·沙龍。

Hey, good morning and thanks for taking the questions. I guess just to start on the BLA, thanks for all the color, Mike. In the press release you had put out in late August, you mentioned the FDA was targeting November to maybe start talks around around the label. Is this still the expectation? And then I guess just the follow-up I'll throw out there just on the labeling front. Can you comment on, how you're thinking about, the label in terms of, being broad versus narrow, and you've made some good progress with the medical societies. Does the FDA, take that into account when kind of thinking about the label? Thanks.

嗨，早上好，謝謝你回答這些問題。我想先從BLA開始，謝謝你提供的所有信息，麥克。您在 8 月下旬發布的新聞稿中提到，FDA 計劃在 11 月開始圍繞標籤問題展開討論。這仍然是大家的預期嗎？然後，我想就標籤方面再補充一點。您能否就標籤的廣泛性與狹義性發表一下看法？您在與醫學協會的合作中取得了一些不錯的進展。美國食品藥物管理局（FDA）在考慮標籤時是否會將這一點考慮在內？謝謝。

Sure, with regards to the last part of your question, we do not know, explicitly whether or not the FDA takes that information into account, so I can't comment definitively. With regards to label, as I mentioned in my comments a moment ago, we have expanded already into all parts of the BL application to include a scope of label. And hence, why I was able to provide some color that based upon those interactions we believe that we will continue to serve the full scope of patient indications that we have been serving historically, so no diminution of our ability to provide support service for mixed and motor nerve. Patients, as we have historically.

當然，關於你問題的最後一部分，我們並不清楚FDA是否會考慮這些訊息，所以我無法給出明確的評論。關於標籤，正如我剛才在評論中提到的，我們已經將標籤範圍擴展到 BL 應用程式的所有部分。因此，我可以提供一些信息，基於這些互動，我們相信我們將繼續為我們一直以來服務的所有患者適應症提供服務，因此我們為混合性神經和運動神經提供支持服務的能力不會減弱。患者，就像我們一直以來所做的那樣。

Great, thanks, Mike.

太好了，謝謝你，麥克。

Our next question comes in the line of Caitlin Roberts with Canaccord Genuity.

我們的下一個問題來自 Canaccord Genuity 的 Caitlin Roberts。

Congrats on the quarter and thanks for taking the questions. I guess just to start off, yeah, hi, I guess just to start off in terms of the commercial coverage, I mean, pretty impressive move up from last quarter, I mean, do you see this plateauing at a certain point prior to the BLA or can you give any more color in terms of the trajectory going forward?

恭喜你本季取得好成績，謝謝你回答問題。我想先問一下，是的，你好，我想先就商業覆蓋率而言，我的意思是，與上個季度相比，這是一個相當令人印象深刻的增長，我的意思是，你認為在生物製品許可申請 (BLA) 之前，這種增長會在某個點趨於平穩嗎？或者你能就未來的發展軌跡提供更多細節嗎？

Well, I think it's... I I'll tell you what, I'll let Rick answer that question.

嗯，我覺得是…這樣吧，我讓瑞克來回答這個問題。

All right, hey Caitlin. Great question. So, the increase in our percentage of commercially covered lives primarily reflects the refinement in our data. So, we acquired a data set that tracks health plan enrollment by state and metro area, and so that that is the main driver of the uplift from 55% coverage to 64% coverage.

好的，嗨，凱特琳。問得好。因此，商業保險覆蓋人群比例的增加主要反映了我們數據的改善。因此，我們獲得了一個按州和都市區追蹤健康計畫註冊情況的資料集，而這正是覆蓋率從 55% 提升到 64% 的主要驅動因素。

We're really excited with the progress we've made and we're a few weeks away from engaging the national payers. There are 3 big national payers that currently list this investigational experimental and so that work is ongoing. I've been here 7 months, and I would say we're probably 5 or 6 months ahead of the initial plans on when we would engage them, so the society supports helpful.

我們對所取得的進展感到非常興奮，再過幾週我們就可以與國家支付方接洽了。目前有 3 家大型全國性醫療保險公司將此項研究性試驗列入名單，因此相關工作仍在進行中。我在這裡已經7個月了，我認為我們比最初的計劃提前了5到6個月就與他們接洽，所以社會的支持很有幫助。

We're not going to speculate on when those payers will flip policy to cover us, but we're marching forward in our pursuit of making nerve repair and expected standard of care, and we're happy with the progress. The way we look at it in our strategic plan over time, Caitlin, is to use that phrase I often use like little engine that could. It's going to become fits and starts, but it's going to keep going up into the right simply because factually and objectively we have the information to justify these asks. What was what's happening over the last 12 months and going forward is that we are methodically engaging with the payers with regards to the information they need. And processes they utilize so that we can make these asks and when you do, when you have the high ground objectively to make the ask, most of the time you're going to win and so that that's really what's underway in the effort that Rick and his team is leading and all we can say is so far so good.

我們不會猜測這些支付方何時會改變保單來承保我們，但我們正在努力使神經修復成為預期護理標準，我們對所取得的進展感到滿意。凱特琳，從長遠來看，我們在策略規劃中看待這個問題的方式，就像我常說的那句話一樣，就像一輛小火車，最終也能成功。過程可能會斷斷續續，但最終會朝著正確的方向發展，因為我們有事實和客觀資訊來證明這些要求的合理性。在過去 12 個月以及未來一段時間內，我們正在有條不紊地與付款方溝通，以了解他們所需的資訊。他們利用各種流程，使我們能夠提出這些要求。當你客觀上佔優勢提出要求時，大多數情況下你都會成功。這就是里克和他的團隊正在領導的這項工作的真正意義所在，我們只能說，到目前為止一切順利。

That's awesome, thanks so much. And then just as a follow-up, Lindsey, I don't think I heard the breakdown in revenue growth this quarter between price and volume and mixed. Do you have that available?

太棒了，非常感謝。林賽，我還有一個後續問題，我好像沒有聽到本季營收成長按價格和銷售以及混合方式細分的具體數據。你有這個嗎？

Yeah, we're seeing about this typical, increase from price, our mix is the same as what we see historically.

是的，我們看到的是典型的價格上漲，我們的產品組合與歷史上的情況相同。

Okay, great. Thank you so much.

好的，太好了。太感謝了。

Thank you. Our next question comes from the line of Jayson Bedford from Raymond James.

謝謝。我們的下一個問題來自 Raymond James 的 Jayson Bedford。

Good morning and congrats on the progress. Maybe just a quick financial. Hey, Mike, the case stock program that was there, I realized it's relatively small, but was there any impact on gross margin either in Q3 or an expected impact in Q4?

早安，祝賀你們的進展。或許只是簡單的財務分析。嘿，麥克，我知道之前那個庫存計劃規模相對較小，但它對第三季的毛利率有影響嗎？或者預計會對第四季產生影響嗎？

From [case] stock specifically?

具體來說，是從[案例]庫存中挑選的嗎？

Yeah, on the on the gross margin line.

是的，在毛利率那一行。

We're not seeing it yet. In the future, we do anticipate some savings just from the nature of that program. It required a lot of additional resources shipping back and forth. With one month in right now, it's hard to say what that total impact is going to be, but we hope to see in the next quarter or two.

我們目前還沒有看到。未來，我們預計僅憑該計劃的性質就能節省一些費用。來回運輸需要耗費大量額外資源。現在才過了一個月，很難說最終會產生多大的影響，但我們希望在接下來的一個或兩個季度看到結果。

But there will be no negative impact. The only question is to what degree, the [case stock] program was not a very efficient program.

但不會產生負面影響。唯一的問題是，[庫存]計劃在多大程度上不是一個非常有效的計劃。

Okay. Internationally, I think historically you've talked about addressing the international market, I'm just wondering what the timing is and is it somewhat dependent on the BLA at all?

好的。從國際層面來看，我認為你們過去曾談到開拓國際市場，我只是想知道具體時間安排，以及這是否在某種程度上取決於生物製品許可申請（BLA）？

Completely hinge connected to the BLA in terms of any formative efforts going forward. So, until we actually have that and then can then re-engage with competent authorities overseas, we're not going to make any significant investment changes.

在未來的任何形成性努力方面，都與BLA完全相關。所以，在我們真正獲得這些條件並且能夠重新與海外主管機關接洽之前，我們不會做出任何重大的投資改變。

Okay, thank you.

好的，謝謝。

So bottom line, at some point during the first half of 2026, we'll come to a conclusion as to what we will do and where we will do it, and then we'll be providing updates at that point.

總而言之，在 2026 年上半年的某個時候，我們將就我們要做什麼以及在哪裡做做出決定，屆時我們將提供最新消息。

Helpful, thank you.

很有幫助，謝謝。

Thank you. Our next question comes from Michael Jacks at Lee Equity Partners.

謝謝。下一個問題來自 Lee Equity Partners 的 Michael Jacks。

Hi, everyone. Congrats on the strong quarter. You provided some really helpful color on the dynamics between high productivity accounts and other accounts. So, what seems to be driving some of the adoption in the non-high productivity accounts, and have you seen any signs of utilization growth in those or how you could convert some of those to high productivity accounts over time? Thanks.

大家好。恭喜你們本季業績出色。你對高產帳戶和其他帳戶之間的動態關係提供了非常有幫助的見解。那麼，是什麼因素推動了非高生產力帳戶的採用？您是否看到這些帳戶的使用率有所成長？或者，您如何隨著時間的推移將其中一些帳戶轉化為高生產力帳戶？謝謝。

Sure, are you on the call still?

當然，你還在通話中嗎？

I am.

我是。

Go ahead.

前進。

So, yeah, so our strategy continues to be really focusing the majority of our efforts in the high potential cohort, which is about 800, accounts. The reason for focusing, in that segment, is because that's where the majority of the nurse repair. Takes place in the hospital segment. Now we do have, of course, a lot of other accounts, and the progress that we've been making and the support that we're getting from societies and the increased awareness of the Axogen nerve repair algorithm also. Basically, means that you have more procedures adopting the exigent algorithm outside of our hyper potential focus. So, in some ways the progress that we're making within these academic institutions also has a spillover effect in the other non-hyperemia accounts.

所以，是的，我們的策略仍然是將大部分精力集中在高潛力群體上，這個群體大約有 800 個帳戶。之所以重點關注這一領域，是因為大多數護理師的維修工作都集中在這一領域。故事發生在醫院場景。當然，我們還有很多其他帳戶，我們取得了進展，也得到了社會各界的支持，人們對 Axogen 神經修復演算法的認識也不斷提高。基本上，這意味著在我們的超強潛力關注範圍之外，您有更多採用嚴格演算法的程式。因此，從某種程度上說，我們在這些學術機構中取得的進展也對其他非充血帳戶產生了外溢效應。

Understood. Thanks very much.

明白了。非常感謝。

Thank you. Our next question comes in line of Ross Osborn from Cantor Fitzgerald.

謝謝。我們的下一個問題來自 Cantor Fitzgerald 公司的 Ross Osborn。

Hi, good morning. Thanks for taking our questions. So, what are the next steps for targeting the prostate market following the completion of your targeted 100 procedures by your end?

您好，早安。謝謝您回答我們的問題。那麼，在您完成目標 100 例手術後，下一步針對攝護腺癌市場應該採取哪些措施？

At the conclusion of the initial clinical trials that we're running and development of the procedure guides, we will follow those patients, and we will evaluate those outcomes.

在我們正在進行的初步臨床試驗和手術指南制定完成後，我們將對這些患者進行隨訪，並評估這些結果。

And based upon those outcomes, that will determine the velocity that we invest thereafter. So we're assuming it will be positive, but we are watching and Realistically, we won't see the clinical feedback on that initial 100 patients that we are enrolling in this trial until sometime towards the middle part of 2026 at the earliest. In the meantime, what we are doing. In terms of work product is we are further characterizing the market, refining the support plans and beginning the process to think through what would be required in terms of a control study, level one type studies. So that's what's underway with prostate.

我們將根據這些結果來決定我們接下來的投資速度。所以我們假設結果是正面的，但我們仍在觀察。實際上，最早也要到 2026 年中，我們才能看到我們最初招募的 100 名患者參與這項試驗的臨床回饋。與此同時，我們正在做什麼。就工作成果而言，我們正在進一步描述市場，完善支援計劃，並開始思考在控制研究、一級研究方面需要做些什麼。這就是前列腺疾病目前的情況。

Perfect. And then outside of prostate, would you provide some more color on where you stand on generating level one evidence across your portfolio?

完美的。除了前列腺癌之外，您能否進一步說明您在建立整個投資組合的一級證據方面所採取的立場？

So, we have protocols in development, with respect to breast, and then, we will have the same, really for each of the segments to be prioritized, we will have one or more studies, that will be looking to kick off formally during 2026.

所以，我們正在製定乳癌方面的方案，然後，對於每個需要優先考慮的細分市場，我們也會制定相同的方案，並進行一項或多項研究，這些研究計劃在 2026 年正式啟動。

Actual dates and timing of that have not been confirmed, but as soon as we do, we will update everyone publicly.

具體日期和時間尚未確定，但一旦確定，我們將立即向大家公開通知。

Thanks for taking our questions and congrats on progress.

感謝您解答我們的問題，並祝賀您的進展。

Thank you.

謝謝。

Thank you. Our next question comes from the line of David Turkaly with Citizens JMP.

謝謝。我們的下一個問題來自 Citizens JMP 的 David Turkaly。

Hey, good morning. Like I know the society updates are, positive and I know you've been working on them for a while, but I was curious if you could just comment on sort of the process there and maybe why you think this happened kind of right in front of the BLA. Is there anything to read into that?

嘿，早安。我知道社團動態都是正面的，也知道你為此努力了一段時間，但我很好奇你是否可以評論一下這個過程，以及你認為為什麼這件事會在英國律師協會（BLA）的眼皮底下發生。這其中有什麼深意嗎？

Well, fortunately, it's serendipitously coincidental, but this is really a process of socialization of clinical evidence and the society's understanding that for nerve care to go forward, they, as the leaders of their membership need to take an effort formally.

幸運的是，這只是一個巧合，但這實際上是臨床證據社會化的過程，也是社會認識到，為了推進神經護理，他們作為其成員的領導者，需要正式地做出努力。

To provide the guidelines and the expectations because that's part of their duties and roles as a society and for any novel therapies until societies do that, it's very difficult for these types of new therapies to be adopted to go forward. And furthermore, it directly impacts coverage and payment as coverage and payment is really driven by medical care and clinical guidelines.

提供指導方針和期望，因為這是他們作為社會成員的職責和角色的一部分；對於任何新的療法，在社會做到這一點之前，這些類型的新療法都很難被採納並向前發展。此外，它還會直接影響醫療保障和支付，因為醫療保障和支付實際上是由醫療保健和臨床指南驅動的。

And then just as a quick follow-up, is there any thoughts on sort of Your other products, maybe the lines and such in terms of the societies may be looking at them and maybe having a policy at some point down the line that may include them or incorporate them as well.

那麼，作為後續問題，您對貴公司的其他產品，例如產品線之類的，有什麼想法嗎？例如，相關機構可能會關注它們，並在未來某個時候制定一項政策，將它們納入其中或加以整合。

There is nothing imminent in that regard and frankly it will be really dependent upon evidence in the future for them to take up the mantle of something like that, and that's work that still has to be done. So, some of these algorithms that are being adopted are things that people believe in based on their clinical practice and experience, but objectively we also need to develop the evidence to support them the way you want to create, to put them into the guidelines. So that's underway, but that won't happen this year and unlikely to actually complete next year either, more like a 2027 event.

在這方面，目前還沒有任何迫在眉睫的跡象，坦白說，他們能否承擔起這樣的責任，真的要取決於未來的證據，而這項工作仍然需要完成。因此，目前採用的一些演算法是基於人們的臨床實踐和經驗而得出的結論，但客觀來說，我們也需要建立證據來支持這些演算法，以便按照你想要的方式製定指南。所以這項工作正在進行中，但今年不會完成，明年也不太可能完成，更像是等到 2027 年才能完成。

Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets.

下一個問題來自 Lake Street Capital Markets 的 Frank Takkinen。

Great thanks for taking the questions. Hey Mike, thanks for taking the questions. Congrats on the next quarter. I was hoping to start with some more guideline commentary as well. How should we think about impacts commercially? Can you do anything differently? Would you maybe pull hiring forward even more? Sounds like you've already been hiring a little faster than anticipated, but with some of these, positive guidelines, do you change strategy and get a little bit more aggressive in any of those areas?

非常感謝您回答這些問題。嗨，麥克，謝謝你回答這些問題。恭喜你們下個季度取得佳績。我也希望能夠先對一些指導原則進行評述。我們應該如何從商業角度考慮影響？你還能做些什麼不同的事嗎？您是否考慮進一步提前招聘？聽起來你們的招募速度已經比預期快了一些，但是有了這些積極的指導方針，你們會改變策略，在這些領域採取更積極的措施嗎？

No, we won't change strategy, although I think maybe to provide open clarity on this, what we have decided is with respect to the strategic plan is we will incrementally hire on a quarterly basis across all target markets. So, we believe that we do not touch every customer and in every opportunity. And that the most important thing we can do for our therapies to ensure that we have coverage in order to develop use of nerve care in all locations of service. So, to that end, and we'll continue to update everybody, but actually will be. Incrementally expanding the sales footprint for several years going forward on an incremental basis, but we will also do that within the constraints we previously described in terms of financials. So, we'll do this with our operating cash flow, and we'll do this only as we can maintain positive leverage.

不，我們不會改變策略，不過為了更清楚地說明這一點，我們已經決定，在戰略計劃方面，我們將按季度在所有目標市場逐步招聘。因此，我們認為我們無法接觸到每一位客戶，也無法把握每一個機會。而我們能為我們的療法做的最重要的事情就是確保我們擁有覆蓋範圍，以便在所有服務地點發展神經護理的使用。所以，為了達到這個目的，我們會繼續向大家通報最新情況，但實際上也會如此。未來幾年，我們將逐步擴大銷售規模，但同時也遵守我們先前在財務方面所規定的限制。所以，我們將利用經營現金流來做到這一點，而且只有在我們能夠保持正槓桿的情況下才會這樣做。

Got it. That's helpful. I know there was previously some street perception that the government shutdown could impact the delay process based on your commentary today that feels like those conversations are going well and potentially ahead of ahead of expectations in some areas. I assume it's fair to think that the government shutdown is not having an impact on any of your FDA interactions at this point.

知道了。那很有幫助。我知道之前坊間普遍認為政府停擺可能會影響延期進程，但根據你今天的評論，感覺這些討論進展順利，在某些方面甚至可能超出了預期。我認為，目前政府停擺應該不會對您與FDA的任何互動產生影響。

That that is fair. So, to date, we've maintained productive discussions and as I've just described, we've already extended our discussions to future labeling and scope and expectations, so these things are not finalized yet, but directionally we're already receiving sites.

這很公平。所以，到目前為止，我們一直保持著富有成效的討論，正如我剛才所描述的，我們已經將討論擴展到未來的標籤、範圍和期望，所以這些事情還沒有最終確定，但方向上我們已經收到了一些網站。

Perfect, I'll stop there. Thanks for taking the questions.

很好，我就說到這裡。謝謝您回答問題。

Thank you.

謝謝。

Thank you. Our next question comes from the line of Anthony Petrone at Mizuho Group.

謝謝。我們的下一個問題來自瑞穗集團的 Anthony Petrone。

Thank you and congrats on the. Hi Mike, how are you?

謝謝，也恭喜你。嗨，麥克，你好嗎？

Congrats on the quote. Apologize to just hopping between earnings calls. So, I had some phone difficulties. It's actually a follow-up question to the one I was just asked just on timing just to get that down a little bit more closely so the the label will, I think the original communication was that label could come before BLA announcement targeted December 5. Is that still the thinking or will those sort of, coincide more in a December time frame and then I'll have a quick follow-up.

恭喜你獲得報價。很抱歉我只是在各個財報電話會議之間來回切換。我的手機出了點問題。實際上，這是我剛才被問到的問題的後續問題，是關於時間安排的，想更精確地確定一下，以便標籤能夠……我認為最初的溝通是，標籤可能會在 BLA 公告發布之前發布，目標日期是 12 月 5 日。還是現在這樣想嗎？或者這些事情會在 12 月更加吻合，到那時我會盡快跟進。

Well, we will I think the way everyone should plan for this is explicit to the guidance previously provided. In other words, the FDA said November would then be labeling, and then the final date would be December 5th. So could it come earlier? Yes, but There's no discussion to that effect, and we have no insight that that will occur. All we know is that the work product that supports labeling and all the rest of the BLA application is continuing to pace and some of it a little bit ahead of the official schedule. So, I think for the sake of planning and assumptions, everyone should still assume because we are that this will go through December 5.

我認為，大家應該按照之前提供的指導方針來製定計劃。換句話說，FDA表示11月將進行標籤標註，最終日期為12月5日。那麼，它會不會提前到來呢？是的，但是目前還沒有這方面的討論，我們也沒有任何跡象表明這種情況會發生。我們只知道，支援標籤製作和所有其他 BLA 申請工作的相關成果正在按計劃推進，其中一些部分甚至比官方計劃略微提前完成。所以，我認為為了方便規劃和假設，大家還是應該假設，因為我們目前的情況是，這種情況會持續到 12 月 5 日。

And then just a higher level one it was kind of asked a couple times here, but you know you did get some medical society positive announcements and also a Blue Cross Blue Shield as well as Medicare Advantage extended number of covered lives and so when you think about what a BLA can do, to Maybe incremental society announcements and or coverage expansion.

然後，還有一個更高層次的問題，這個問題之前也問過幾次，但你知道，我們確實收到了一些醫學協會的積極公告，藍十字藍盾和聯邦醫療保險優勢計劃也擴大了承保人數，所以當你思考BLA能做什麼時，也許會促成一些醫學協會的漸進式公告和/或擴大承保範圍。

Is that just something that we should be expecting in 2026 under a scenario where you do get a positive outcome on the BLA. Thanks again and congrats.

如果 BLA 獲得正面結果，那麼這是否就是我們在 2026 年應該期待的事情？再次感謝，也恭喜你。

Thank you.

謝謝。

So, the PLA will no doubt be a positive support for all of our market development efforts and guidelines development. There are still institutions, there are still certain quarters of the medical community who, based upon the current regulatory status, consider advanced aircraft as experimental. So, with the conclusion of the BLA, that question, will be resolved, and we will have as part of our regulatory status and now codified official benefit risk profile, that we can all refer to in reference, and all of our future data will build off of that. So, strategically, and tactically, it will have an impact. What I want to caution everybody about though is it will not be a light switch effect. So, there's, for many customers, they are barely aware that this process is underway, but there are exceptions. So, it'll be positive, but I don't want anyone to think that this is going to be like a traditional market approval where you're not on the market and then all of a sudden, the floodgates open, that, that's not what will transpire. Yeah. Thanks, Anthony.

因此，PLA無疑將對我們所有的市場開發工作和指導方針制定提供積極的支援。仍然有一些機構，仍然有一些醫學界人士，根據目前的監管狀況，將先進的飛機視為實驗性的。因此，隨著 BLA 的最終批准，這個問題將得到解決，我們將擁有監管地位的一部分，以及現在已經編纂成法的官方收益風險概況，我們所有人都可以參考它，我們未來的所有數據都將以此為基礎。因此，無論從戰略層面或戰術層面來看，這都會產生影響。不過我想提醒大家的是，這不會像關燈一樣立竿見影。因此，對於許多客戶來說，他們幾乎沒有意識到這個過程正在進行中，但也有例外。所以，結果會是正面的，但我不想讓任何人認為這會像傳統的市場審批一樣，你還沒進入市場，然後突然之間，閘門就打開了，事情不會是這樣的。是的。謝謝你，安東尼。

Our final question this morning comes from line of Yi Chen with H.C. Wainwright & Co.

今天早上的最後一個問題來自 Yi Chen 與 H.C. Wainwright & Co. 的聯繫。

Hi, how's it going? I guess to follow-up a little bit on the segment growth, I'm curious about if you're seeing, particular profitability. I know you have different fragmentations of each of these markets and breast and extremity and. And OMF. I'm curious if you see anyone to be more specifically profitable and if that's guiding any of your strategic decisions and investing.

你好，最近怎麼樣？我想就細分市場的成長情況再補充一點，我很想知道您是否看到了具體的獲利能力。我知道你們對這些市場，包括乳房和四肢等，都有不同的市場區隔。我的天哪。我很好奇您是否認為某些公司更有獲利潛力，以及這是否會影響您的策略決策和投資。

Good question. The simple answer is all the segments are from a profitability standpoint, very positive.

問得好。簡單來說，從獲利角度來看，所有業務部門的前景都非常樂觀。

The pri the markets that we have established were part of a process to determine what would be the most. Efficient as well as effective ways to further our business purpose and so in that sense we love all of our children to use that expression. So, they were selected explicitly because we thought they were addressable in different ways. So, I know it's a little bit of a non-answer, but it's because they're all positive in that we make progress and is accretive to the business.

我們所建立的這些市場是確定什麼是最有利的過程的一部分。高效且有效的方式來推進我們的業務目標，因此從這個意義上說，我們愛我們所有的孩子（借用這個表達方式）。因此，我們特意選擇了他們，因為我們認為他們可以透過不同的方式來解決。我知道這有點像是在敷衍了事，但這是因為它們都是正面的，顯示我們取得了進步，並且對業務有益。

Got it. And then just following up, if you could, you mentioned how the BLA would obviously unlock better coverage potentially. I'm curious if you could quantify that. You obviously again have pretty good support within the medical groups and societies and like you mentioned.

知道了。然後，如果可以的話，我想補充一點，您提到 BLA 顯然有可能帶來更好的保險覆蓋範圍。我很想知道你是否能對此進行量化。顯然，你在醫療團體和協會中再次獲得了相當好的支持，正如你所說。

Reimbursement is largely driven by these medical guidelines. I'm curious if you could quantify the impact, of the BLA. You mentioned international markets and kind of focusing, obviously that would be a gate to open up international market discussions, but I guess focusing on, more local in the US.

報銷很大程度上取決於這些醫療指南。我很想知道您是否能夠量化 BLA 的影響。你提到了國際市場和某種程度的關注，顯然這將是開啟國際市場討論的大門，但我認為重點應該更多地放在美國本土。

This is Rick. I'm happy to happy to chime in and answer that. Sorry, in terms of the BLA unlocking incremental coverage and quantifying the impact, I think the way to think about it is that it helps unlock portions of the TAM that may have not been accessible prior rather than thinking about it in terms of a direct impact to revenue in 2026. In the way Mike said it, this isn't a light switch and so that's how I would think about it.

這是里克。我非常樂意插話回答這個問題。抱歉，就 BLA 解鎖增量覆蓋範圍和量化影響而言，我認為應該這樣理解：它有助於解鎖以前可能無法觸及的 TAM 部分，而不是從 2026 年對收入的直接影響來考慮。根據麥克的說法，這不是一個電燈開關，所以我也會這樣看待它。

Got it. Thanks for answering the questions and congrats on the quarter.

知道了。感謝您回答問題，並祝賀您本季取得佳績。

Thanks.

謝謝。

Thank you, ladies and gentlemen, that concludes our question-and-answer session. I'll turn the phone back to Mr. Dale for any final comments.

謝謝各位，我們的問答環節到此結束。我將把電話轉回給戴爾先生，請他作最後的總結發言。

Thank you, operator. On behalf of the Axogen team, I want to thank everyone for their time and interest in our work to fulfill the promise and potential for all stakeholders and our business purpose to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We look forward to updating you on our continued progress and plans for on our earnings call next quarter.

謝謝接線生。我謹代表 Axogen 團隊，感謝大家抽出時間關注我們的工作，並對我們實現所有利益相關者的承諾和潛力以及我們的商業目標——通過使恢復周圍神經功能成為預期護理標準來恢復健康和提高生活質量——表示關注。我們期待在下個季度財報電話會議上向您報告我們的最新進展和計劃。

Thank you.

謝謝。

Thank you. This concludes today's teleconference. You may disconnect your lines at this time.

謝謝。今天的電話會議到此結束。您可以在此時斷開線路。