AxoGen Inc (AXGN) 2023 Q3 法說會逐字稿

Greetings. Welcome to Axogen reports third-quarter 2023 financial results. (Operator Instructions) Please note, this conference is being recorded. I will now turn the conference over to Adanna Alexander, Investor Relations Consultant. Adanna, you may now begin.

問候。歡迎閱讀 Axogen 報告 2023 年第三季財務表現。 （操作員說明）請注意，本次會議正在錄製中。我現在將會議交給投資人關係顧問 Adanna Alexander。阿達娜，你現在可以開始了。

Thanks, Rob. Good morning, everyone. Joining me on today's call is Karen Zaderej, Axogen's Chairman, Chief Executive Officer, and President; and Pete Mariani, Executive Vice President and Chief Financial Officer. Karen will discuss the quarter and our outlook for the year, and Pete will provide an analysis of our financial performance and guidance, followed by a question-and-answer session.

謝謝，羅布。大家，早安。參加今天電話會議的是 Axogen 董事長、執行長兼總裁 Karen Zaderej；執行副總裁兼財務長 Pete Mariani。凱倫將討論本季和我們對今年的展望，皮特將對我們的財務表現和指導進行分析，然後進行問答環節。

Today's call is being broadcast live via webcast, which is available on the Investors section of Axogen'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.

今天的電話會議透過網路直播進行現場直播，可在 Axogen 網站的投資者部分觀看。現場電話會議結束後，公司網站 www.axogeninc.com 的投資者部分將提供重播。

Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements, including our expectations regarding our ability to expand our footprint and expand core accounts; anticipated growth for revenue categories; penetration of core accounts; marketing opportunities with nerve applications associated with immersion, trauma, breast, OMF, and surgical treatment of pain; and new products.

在我們開始之前，我想提醒您，在這次電話會議中，公司將做出預測和前瞻性陳述，包括我們對擴大業務範圍和擴大核心客戶的能力的期望；收入類別的預期成長；核心帳戶的滲透率；與沉浸、創傷、乳房、OMF 和疼痛手術治療相關的神經應用的營銷機會；和新產品。

Our expectations regarding the timing of our launch for Avive+; our expectations regarding our ability to make a rolling biologics license application submission for Avance nerve graft, and the timing of the BLA submission for approval; our belief that our balance sheet will continue to be sufficient to bridge through to cash flow breakeven and longer-term profitability.

我們對 Avive+ 發佈時間的期望；我們對我們為 Avance 神經移植提交滾動生物製品許可申請的能力的期望，以及 BLA 提交批准的時間；我們相信，我們的資產負債表將繼續足以實現現金流量收支平衡和長期獲利能力。

Our expectation that we will continue trending towards cash flow breakeven and our belief that trends towards operating leverage will allow us to maintain a strong balance sheet position and provide ample support as we work towards profitability; our 2023 financial guidance, including revenue range and gross margin and optimism associated with the adoption of our new products, key strategic pillars, and our balance sheet.

我們預期我們將繼續實現現金流損益平衡，並相信經營槓桿的趨勢將使我們能夠保持強勁的資產負債表狀況，並在我們努力實現盈利的過程中提供充足的支持；我們的 2023 年財務指導，包括收入範圍和毛利率以及與採用我們的新產品、關鍵策略支柱和資產負債表相關的樂觀情緒。

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 but not without limitation, the risks and uncertainties reflected in the company's annual and periodic reports such as hospital staffing issues, regulatory process and approvals, surgery and product adoption, and market awareness of our products.

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，並受到風險和不確定性的影響，包括但不限於公司年度和定期報告中反映的風險和不確定性，例如醫院人員配置問題、監管流程和批准、手術和產品採用以及我們產品的市場認知度。

The forward-looking statements are representative only as of the date they are made, and except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements. In addition, for a reconciliation of non-GAAP measures, please reference today's press release and our corporate presentation on the Investors section of the company's website.

前瞻性陳述僅在作出之日具有代表性，除非適用法律要求，否則我們不承擔公開更新或修改任何前瞻性陳述的責任。此外，有關非公認會計準則措施的調節，請參考今天的新聞稿以及我們在公司網站投資者部分的公司介紹。

Now I would like to turn the call over to Karen. Karen?

現在我想把電話轉給凱倫。凱倫？

Thank you, Adanna, and thank you all for joining us today as we discuss our third-quarter 2023 financial results. We're pleased with the quarter led by revenue of $41.3 million, representing 12% growth year over year. Our performance reflects improvement in emergent trauma as well as continued strength in scheduled procedures. This improvement was the result of stabilization in the hospital operating environment and improved commercial execution.

謝謝阿丹娜，也謝謝大家今天加入我們討論 2023 年第三季財務業績。我們對本季的營收 4,130 萬美元感到滿意，年增 12%。我們的表現反映了緊急創傷的改善以及預定手術的持續實力。這項改善是醫院營運環境穩定和商業執行力提高的結果。

As you may recall, last quarter, we began reporting estimated revenue and growth across two primary procedure categories: emergent trauma and scheduled procedures. These estimates are based on available data received from hospitals and sales reps and assumptions regarding specific surgeon practice and account information, and as such are subject to the limitations of the data received and our assumptions.

您可能還記得，上個季度，我們開始報告兩個主要手術類別的預期收入和成長：緊急創傷和預定手術。這些估計是基於從醫院和銷售代表收到的可用數據以及有關特定外科醫生實踐和帳戶資訊的假設，因此受到收到的數據和我們的假設的限制。

During the quarter, we estimate that emergent trauma procedures represented approximately 50% of revenue and grew in the mid-single-digit percent range versus the prior year. As a reminder, emergent trauma generally results from injuries that initially present in an ER. These procedures are typically referred to and are completed by a specialist either immediately or within a few days following the initial injury.

在本季度，我們估計緊急創傷手術約佔收入的 50%，並且與前一年相比以中個位數百分比成長。提醒一下，緊急創傷通常是由最初出現在急診室的傷害引起的。這些程序通常由專家立即或在初次受傷後幾天內完成。

During the quarter, we began to see stabilization of staffing and procedure scheduling in hospital compared to the first half of 2023. Although we continue to see growth of certain routine procedures and lower-cost settings such as ASCs, access to these procedures within hospitals also improved in the third quarter compared to the first half of the year.

在本季度，與2023 年上半年相比，我們開始看到醫院的人員配置和手術安排趨於穩定。儘管我們繼續看到某些常規手術和ASC 等低成本設施的成長，但在醫院內使用這些手術的機會也增加第三季較上半年改善。

Scheduled procedures also represent approximately half of total revenue. During the quarter, we estimate that this category grew approximately 20% versus the prior year.

預定程序也約佔總收入的一半。在本季度，我們估計該類別比上一年增長了約 20%。

As a reminder, scheduled procedures are generally characterized as procedures where a patient is seeking relief of a nerve condition caused by a nerve defect or surgical procedure. These include breast reconstruction following a mastectomy, nerve reconstruction following the surgical removal of a painful neuroma, and oral and maxillofacial procedures such as a mandible reconstruction and nerve decompression.

提醒一下，預定手術通常是指患者尋求緩解神經缺陷或外科手術引起的神經狀況的手術。這些包括乳房切除術後的乳房重建、手術切除疼痛性神經瘤後的神經重建，以及下顎骨重建和神經減壓等口腔顎面手術。

The growth in this category is reflective of the opportunity to provide improved quality-of-life outcomes for patients. We have built the success with compelling solutions backed by clinical data and supported by surgeon education and effective patient activation programs that educate patients and connect them with trained surgeons.

此類別的成長反映了為患者提供改善生活品質的機會。我們透過令人信服的解決方案取得了成功，這些解決方案以臨床數據為後盾，並得到外科醫生教育和有效的患者激活計劃的支持，這些計劃可以教育患者並將他們與訓練有素的外科醫生聯繫起來。

Our growth strategy continues to be focused on going deeper into core accounts where we believe there's tremendous opportunity to expand our footprint. Core accounts are defined as those with greater than $100,000 in revenue in the trailing 12 months.

我們的成長策略持續專注於深入核心客戶，我們相信這些客戶有巨大的機會來擴大我們的足跡。核心帳戶被定義為過去 12 個月收入超過 10 萬美元的帳戶。

During the quarter, core accounts totaled 372, an increase of 12% over the prior year of 331 and an increase of 7% sequentially. Revenues from core accounts now represent approximately 65% of total revenues, up from 60% in prior quarters, demonstrating the strength of our commercial execution and ability to gain deeper surgeon adoption and expanded use cases of our products.

本季核心帳戶總數為 372 個，比上年同期的 331 個成長 12%，比上一季成長 7%。來自核心客戶的收入目前約佔總收入的 65%，高於前幾個季度的 60%，這證明了我們商業執行的實力以及獲得外科醫生更深入採用和擴大我們產品用例的能力。

We ended the third quarter with 116 direct sales representatives, up one from the end of the second quarter and five from a year ago. We believe our revenue growth can continue to be driven primarily by increased productivity of our sales force, and we will evaluate and add additional sales reps as their territories approach targeted levels.

截至第三季末，我們有 116 名直銷代表，比第二季末增加 1 名，比去年同期增加 5 名。我們相信，我們的收入成長將繼續主要由銷售人員生產力的提高所推動，當銷售代表的區域接近目標水準時，我們將評估並增加更多的銷售代表。

Our direct sales force is supplemented by independent sales agencies that represent approximately 10% of our total revenue. Earlier in the year, we were pleased to provide an update on our key strategic pillar of product and procedure innovation, and we expect this will continue to be a driver of long-term growth.

我們的直銷隊伍得到了獨立銷售機構的補充，這些機構約占我們總收入的 10%。今年早些時候，我們很高興提供有關產品和流程創新的關鍵戰略支柱的最新信息，我們預計這將繼續成為長期增長的驅動力。

As a summary, we announced three specific innovations across our offering, including an expansion of our Resensation technique for women who choose an implant-based reconstruction, which we believe could apply to an additional 10% to 15% of all breast reconstruction patients. We had initially set a goal of training 20 additional surgical teams by year end, but now expect to have more than 30 new teams trained and performing procedures, and we will continue to train additional teams in early 2024.

總而言之，我們宣布了我們產品中的三項具體創新，包括針對選擇基於植入物的重建的女性擴展了我們的Resensation 技術，我們相信這可以適用於所有乳房重建患者中另外10% 至15% 的患者。我們最初設定的目標是在年底前培訓 20 個額外的手術團隊，但現在預計將有 30 多個新團隊接受培訓並執行手術，我們將在 2024 年初繼續培訓更多團隊。

We also announced innovation in our nerve protection portfolio. The category of nerve protection represents approximately $800 million of the overall nerve repair market and covers a wide range of injuries and defects, including carpal and cubital tunnel syndromes, crush injuries, and other non-transected traumatic nerve injuries.

我們也宣布了神經保護產品組合的創新。神經保護類別約佔整個神經修復市場的 8 億美元，涵蓋廣泛的損傷和缺陷，包括腕管和肘管綜合症、擠壓傷和其他非橫斷面創傷性神經損傷。

We believe that the diversity of these injury types and their anatomical locations present some unique challenges. Optimizing outcomes for these patients requires a targeted portfolio of solutions to adequately address the specific aspects of both the injury and healing process.

我們認為，這些損傷類型及其解剖位置的多樣性帶來了一些獨特的挑戰。優化這些患者的治療結果需要有針對性的解決方案組合，以充分解決損傷和癒合過程的特定問題。

Following a successful pilot release, we're happy to announce that in August, we had a national launch for the first of these new products, Axoguard HA+ Nerve Protector. We're very pleased with the initial surge in engagement and feedback as they began to integrate Axoguard HA+ into their nerve protection algorithm. We're confident that Axoguard HA+ will expand the adoption of nerve protection products and will help more patients with nerve injuries.

在成功試點發布之後，我們很高興地宣布，8 月份，我們在全國範圍內推出了首款新產品 Axoguard HA+ 神經保護器。當他們開始將 Axoguard HA+ 整合到他們的神經保護演算法中時，我們對最初的參與度和回饋激增感到非常滿意。我們相信 Axoguard HA+ 將擴大神經保護產品的採用，並幫助更多神經損傷患者。

Additionally, we're continuing the development of a resorbable nerve protection product that functions as a barrier, providing temporary protection and tissue separation during the critical phase appealing to nerve injuries. This new product will be branded Avive+ Soft Tissue Matrix and will be regulated as the Section 361 tissue product. We expect Avive+ will further strengthen our position in nerve protection, supporting emergent trauma and the surgical treatment of pain. We remain on track to launch this product in Q1 2024.

此外，我們正在繼續開發可吸收的神經保護產品，該產品可作為屏障，在神經損傷的關鍵階段提供臨時保護和組織分離。該新產品將命名為 Avive+ Soft Tissue Matrix，並將作為第 361 條組織產品進行監管。我們預計 Avive+ 將進一步加強我們在神經保護、支持緊急創傷和疼痛手術治療方面的地位。我們仍有望在 2024 年第一季推出該產品。

Moving on to updates in our growing body of clinical evidence, over the years, we've made significant investments to develop quality clinical evidence to demonstrate the safety, performance, economics, and utility of our nerve repair solution. Our active clinical programs are progressing as expected.

接下來是不斷更新的臨床證據，多年來，我們投入了大量資金來開發高品質的臨床證據，以證明我們的神經修復解決方案的安全性、性能、經濟性和實用性。我們積極的臨床項目正在按預期進展。

As of the end of the quarter, we have over 200 peer-reviewed publications across trauma, breast, OMF, and pain. In the quarter, the RECON study was published online in the Journal of Hand Surgery and was recently presented in the 78th Annual American Society for Surgery of the Hand Conference. Both events included the author's analysis of the results, which found that advanced return to greater degree of functional recoveries and conduits and superiority was demonstrated as gap lengths increased.

截至本季末，我們擁有 200 多篇涉及創傷、乳房、OMF 和疼痛領域的同行評審出版物。本季度，RECON 研究在線發表在《手外科雜誌》上，並於最近在第 78 屆美國手外科學會年度會議上發表。這兩個事件都包括作者對結果的分析，結果發現，隨著間隙長度的增加，提前恢復到更大程度的功能恢復和管道以及優越性。

We are excited to see the addition of this Level 1 evidence supporting the efficacy of Avance nerve graft in published literature and being discussed by surgeons. This data was supplemented by the findings in the meta-analysis and premier all-payer publications. These publications demonstrated that allograft and autograft sensory and motor outcomes as well as procedure costs were comparable.

我們很高興看到在已發表的文獻中添加了支持 Avance 神經移植功效的 1 級證據，並得到了外科醫生的討論。這些數據得到了薈萃分析和主要付費出版物中的發現的補充。這些出版物表明，同種異體移植和自體移植的感覺和運動結果以及手術成本具有可比性。

Notably, the allograft group reduced OR time and reduced patient morbidity as compared to autograft. We believe that these publications will continue to play an important role in surgeon clinical decision making, especially with middle-adopter surgeons.

值得注意的是，與自體移植相比，同種異體移植組減少了手術時間並降低了患者發病率。我們相信這些出版物將繼續在外科醫生的臨床決策中發揮重要作用，特別是對於中等採用者的外科醫生。

Turning to our new production facility and our BLA for Avance nerve graft, during the third quarter, we began processing tissue in the new state-of-the-art APC facility, which provides for up to three times our current capacity and was designed for long-term growth and expansion. This represents a key milestone in preparation for our BLA submission.

談到我們的新生產設施和 Avance 神經移植 BLA，在第三季度，我們開始在最先進的新 APC 設施中處理組織，該設施的產能高達我們當前產能的三倍，專為長期增長和擴張。這是準備提交 BLA 的一個重要里程碑。

We continue to anticipate a pre-BLA meeting with the FDA in early first-quarter 2024, where we will request utilization of a rolling submission process. We plan to begin filing the modules in the first quarter and complete the submission in the second quarter. We believe this process will support BLA approval in the first half of 2025.

我們預計將在 2024 年第一季初與 FDA 舉行 BLA 前會議，屆時我們將要求採用滾動提交流程。我們計劃在第一季開始提交模組，並在第二季完成提交。我們相信這項流程將支持 BLA 在 2025 年上半年獲得批准。

As a reminder, a BLA approval will complete the regulatory transition of Avance nerve graft from a 361 tissue-based product with 351 biological products. And importantly, we believe that Avance would be designated as the reference product for potential biosimilars providing 12 years of market exclusivity.

提醒一下，BLA 的批准將完成 Avance 神經移植從 361 種組織產品到 351 種生物製品的監管轉變。重要的是，我們相信 Avance 將被指定為潛在生物相似藥的參考產品，提供 12 年的市場獨佔權。

Looking ahead, we remain focused on executing our strategic initiatives, anchored in the strength of our clinical data, innovation, market development, and commercial execution to continue to drive surgeon adoption and growth. Importantly, we're also delivering operating leverage across the business and believe our balance sheet will continue to be sufficient as we bridge through to cash flow breakeven and longer-term profitability.

展望未來，我們仍然專注於執行我們的策略舉措，以我們的臨床數據、創新、市場開發和商業執行的實力為基礎，繼續推動外科醫生的採用和成長。重要的是，我們還在整個業務中提供營運槓桿，並相信我們的資產負債表將繼續充足，以實現現金流收支平衡和長期盈利能力。

Now I will turn the call over to Pete to provide a review of our financial highlights and guidance. Pete?

現在我將把電話轉給皮特，以回顧我們的財務亮點和指導。皮特？

Thank you, Karen. Revenue for the quarter was $41.3 million, representing a 12% increase compared to the third quarter of 2022. Growth was primarily driven by an increase in unit volume of 8% and a 3.5% increase in price. We estimate the revenue from emergent trauma represented about half our total revenue and grew in the mid-single-digit range versus last year, while scheduled procedures also represented about half of total revenue and grew approximately 20% year over year.

謝謝你，凱倫。該季度營收為 4,130 萬美元，較 2022 年第三季成長 12%。成長主要是由單位數量成長 8% 和價格成長 3.5% 推動的。我們估計，來自緊急創傷的收入約佔我們總收入的一半，並且與去年相比呈中等個位數增長，而預定手術也約佔總收入的一半，同比增長約 20%。

Gross profit for the quarter was approximately $33.2 million compared to gross profit of approximately $30.8 million for the third quarter of '22. Gross margin for the quarter was 80.5%, down from 83.3% year over year, reflecting the initiation of tissue processing in our new newly opened Axogen processing center in the quarter.

該季度的毛利約為 3,320 萬美元，而 2022 年第三季的毛利約為 3,080 萬美元。本季毛利率為 80.5%，低於去年同期的 83.3%，反映出本季我們新開幕的 Axogen 加工中心開始進行組織加工。

Total operating expenses for the quarter increased 5% to $37.3 million compared to $35.6 million in Q3 of 2022. The net increase was primarily the result of increased marketing programs, compensation, and professional services.

本季的總營運費用成長 5%，達到 3,730 萬美元，而 2022 年第三季為 3,560 萬美元。淨成長主要是由於行銷計畫、薪資和專業服務的增加。

Sales and marketing expense in the third quarter increased 8% to $21.4 million compared to $19.8 million in the prior year. The increase was primarily due to compensation, marketing programs, and travel. As a percentage of total revenue, sales and marketing expense decreased to 52% compared to 54% in the third quarter of 2022.

第三季銷售和行銷費用成長 8%，達到 2,140 萬美元，而去年同期為 1,980 萬美元。成長主要歸因於薪酬、行銷計劃和旅行。銷售和行銷費用佔總收入的百分比從 2022 年第三季的 54% 下降至 52%。

Research and development expenses was $7 million, remained flat year over year. Product development expenses represented approximately 62% of total R&D compared to 50% in the prior year and included costs for a number of specific development programs, along with the non-clinical spend on the BLA for Avance nerve graft.

研發費用為 700 萬美元，與去年同期持平。產品開發費用約佔總研發費用的 62%，而前一年為 50%，其中包括許多特定開發項目的費用，以及 Avance 神經移植 BLA 的非臨床費用。

Clinical expenses represented approximately 38% of total R&D compared to 50% in the prior year. And as a percentage of total revenues, research and development expense decreased to 17% compared to 19% in the third quarter of last year. General administrative expense was $8.8 million in the third quarter, remaining flat as compared to the prior year.

臨床費用約佔研發總額的 38%，而前一年為 50%。研發費用佔總收入的比例從去年第三季的 19% 下降至 17%。第三季一般管理費用為 880 萬美元，與去年同期持平。

Our net loss in the quarter was $4.1 million, or $0.10 per share compared to a net loss of $4.3 million or $0.10 per share in the third quarter of 2022. We reported adjusted net income in the quarter of $700,000 or approximately $0.01 per share compared to an adjusted net loss of $400,000 or $0.01 per share last year. We also recorded positive adjusted EBITDA in the quarter of $2.4 million compared to positive adjusted EBITDA of $400,000 in the prior year.

我們本季的淨虧損為410 萬美元，即每股0.10 美元，而2022 年第三季的淨虧損為430 萬美元，即每股0.10 美元。我們報告本季調整後的淨利為70 萬美元，即每股約0.01 美元。去年調整後淨虧損為 40 萬美元，即每股虧損 0.01 美元。我們也在本季錄得 240 萬美元的正調整 EBITDA，而前一年的正向調整 EBITDA 為 40 萬美元。

The balance of all cash, cash equivalents, and investments on September 30 was $38.6 million compared to a balance of $40.8 million at the end of the second quarter. The net change of $2.2 million includes interest and other charges capitalized into the company's new processing facility in Dayton, Ohio, which was placed into service during the quarter and provides for up to three times our current capacity and is designed for long-term growth and expansion.

截至 9 月 30 日，所有現金、現金等價物和投資的餘額為 3,860 萬美元，而第二季末的餘額為 4,080 萬美元。 220 萬美元的淨變化包括資本化到公司位於俄亥俄州代頓的新加工設施的利息和其他費用，該設施在本季度投入使用，產能高達我們當前產能的三倍，旨在實現長期增長和擴張。

Capitalization of interest charges continued through mid-August when the facility was placed into service. Subsequently, all interest charges are recorded as interest expense and other income and loss on our P&L. We are pleased with the operating leverage demonstrated through 2023, and we expect to continue trending towards cash flow breakeven, driven by leverage over our fixed-cost infrastructure and our focus on thoughtful operating expense management.

利息費用資本化一直持續到 8 月中旬該設施投入使用時。隨後，所有利息費用均在我們的損益表中記錄為利息費用和其他收入和損失。我們對 2023 年表現出的營運槓桿感到滿意，並且在我們固定成本基礎設施的槓桿作用以及我們對深思熟慮的營運費用管理的關注的推動下，我們預計將繼續趨向現金流盈虧平衡。

Additionally, the license fees that we pay on advance revenue will come to an end in the fourth quarter of this year and provide annual cash savings of approximately $3.5 million in 2024. We believe our operating leverage, combined with normalized capital expenditures, will allow us to maintain our strong balance sheet position and provide ample support as we continue our path to profitability.

此外，我們為預收收入支付的許可費將於今年第四季結束，到 2024 年每年可節省約 350 萬美元的現金。我們相信，我們的營運槓桿加上正常化的資本支出將使我們能夠維持我們強勁的資產負債表狀況，並在我們繼續獲利的道路上提供充足的支援。

Now turning to guidance in today's press release, we are maintaining our full-year guidance with 2023 revenue in the range of $154 million to $159 million, which represents annual growth of 11% to 15%. Additionally, we anticipate the gross margins will be reduced with the continued transition to the new processing facility in the fourth quarter and continue to expect that gross margin for the full year of 2023 will be approximately 80%.

現在轉向今天新聞稿中的指引，我們維持全年指引，2023 年收入在 1.54 億美元至 1.59 億美元之間，年增長率為 11% 至 15%。此外，我們預計隨著第四季繼續向新加工設施過渡，毛利率將會下降，並繼續預計 2023 年全年毛利率將約為 80%。

In summary, we're pleased with our third-quarter performance. We will continue to execute our strategies, invest in innovation, and drive toward cash flow breakeven and profitability. And at this time, we'd like to open the line for questions. Rob?

總而言之，我們對第三季的業績感到滿意。我們將繼續執行我們的策略，投資於創新，並推動現金流損益平衡和獲利。此時，我們想開通提問專線。搶？

(Operator Instructions) Mike Sarcone, Jefferies.

（操作員說明）Mike Sarcone，Jefferies。

Good morning, Karen and Pete. Thanks for taking the questions.

早上好，凱倫和皮特。感謝您提出問題。

Good morning.

早安.

Good Morning.

早安.

So just the first one on the guidance, if I look what's implied for 4Q, that's kind of $38 million to $43 million, which is 5% to 19% year-over-year growth at the low and high end of the range. I was wondering if you could just talk about what are your assumptions that are baked in both ends of the range. And just any more color there would be great to start.

因此，僅是指導中的第一個，如果我看看第四季度的暗示，那就是 3800 萬至 4300 萬美元，在該範圍的低端和高端，同比增長 5% 至 19%。我想知道您是否可以談談您在範圍兩端的假設是什麼。只要有更多的顏色就可以很好地開始。

Yes, Mike. I think for our guidance, we're trending in the middle of the range. We just didn't feel like, in this current environment, trying to mess with the range at the end of the year would be appropriate. We're comfortable with the range that this is implying. And I think that this makes sense for the company.

是的，麥克。我認為就我們的指導而言，我們的趨勢處於該範圍的中間。我們只是覺得，在目前的環境下，試圖在年底改變範圍是不合適的。我們對這所暗示的範圍感到滿意。我認為這對公司來說是有意義的。

Okay, got it. And then, do you think you can just give us some more color on the ASC dynamic and hospitals moving some of those simple procedures to the ASC? In 2Q, you called out an economic impact. I'd just love to get some more granularity on how that situation is playing out.

好，知道了。然後，您認為您可以給我們更多關於 ASC 動態以及醫院將一些簡單程序轉移到 ASC 的資訊嗎？在第二季度，您提到了經濟影響。我只是想更詳細地了解這種情況的進展。

Sure. We saw actually two things happen. We started to see good execution in ASCs as we see some simple procedures transitioning to ASCs, but we also saw stabilization in the hospital environment where hospitals were able in some cases to restabilize their staffing and allow procedures to be there. And in other cases, they've made their changes to procedures and moved ASCs. But as I said, we're starting to be able to move into those.

當然。我們實際上看到發生了兩件事。我們開始看到ASC 的良好執行力，因為我們看到一些簡單的程序過渡到ASC，但我們也看到醫院環境的穩定，在某些情況下，醫院能夠重新穩定其人員配置並允許程序在那裡進行。在其他情況下，他們對程式進行了更改並移動了 ASC。但正如我所說，我們開始能夠進入這些領域。

So all the way around, we saw an increase in what we would call simple trauma. So these are lacerations that can be repaired with a connector or could be repaired with [a short Avance], and we saw those stabilize and start to grow again.

因此，一路走來，我們看到所謂的簡單創傷增加。因此，這些撕裂傷可以用連接器修復，也可以用[短的 Avance] 修復，我們看到這些撕裂傷穩定下來並開始再次生長。

Okay. Thank you.

好的。謝謝。

Mike Kratky, Leerink Partners.

麥克‧克拉基 (Mike Kratky)，Leerink 合夥人。

Hi, everyone. Thanks for taking my questions. I guess just in first of the upcoming BLA approval, I mean, is your expectation that that is going to help drive meaningfully higher utilization from surgeons? What have you heard from your industry contacts? And then just as a follow up, has that pre-BLA meeting been scheduled for 1Q. already? Or is there any other kind of gating factors ahead of that that you need to provide?

大家好。感謝您回答我的問題。我想在即將到來的 BLA 批准之初，您是否期望這將有助於顯著提高外科醫生的使用率？您從行業聯繫人那裡聽到了什麼？作為後續行動，BLA 前會議是否安排在第一季舉行。已經？或者在此之前您需要提供任何其他類型的門控因素嗎？

Yes. So first, on the schedule, no, we don't have a date yet for the pre-BLA meeting. It's not scheduled, but we are on track to have it scheduled to be in the early part of Q1. And in terms of gating factors, yes, there's certain documents that you provide to the FDA. They go through some logistics internally to then come up with a schedule. So those initiatives have to happen yet. But again, we're on schedule to do what we expect to get it scheduled in the early part of Q1.

是的。首先，在日程安排上，我們還沒有確定 BLA 前會議的日期。尚未安排，但我們預計將其安排在第一季初期。就限制因素而言，是的，您需要向 FDA 提供某些文件。他們在內部進行一些後勤工作，然後制定時間表。因此，這些措施也必須實施。但同樣，我們正按計劃完成我們期望在第一季初期完成的工作。

In terms of the impact of the BLA, we think the BLA will be helpful for middle adopters to be comfortable in that data that Avance nerve graft has that shows that it is certainly a superior option to conduits, and that combined with the meta-analysis is going to provide a better opportunity for their patients without the morbidity of an autograft.

就 BLA 的影響而言，我們認為 BLA 將有助於中間採用者感到滿意，因為 Avance 神經移植物擁有的數據表明它肯定是優於導管的選擇，並且與薈萃分析相結合將為他們的患者提供更好的機會，而不會出現自體移植的發生率。

And as I mentioned in the script, it's also faster for those hospitals that are trying to get their ORs turned over more quickly. And so we think that we've got a good opportunity to continue to build this business as we transition into a BLA with the stamp of being a biological product.

正如我在劇本中提到的，對於那些試圖更快地移交手術室的醫院來說，它也更快。因此，我們認為，當我們過渡到帶有生物產品標誌的 BLA 時，我們有一個很好的機會繼續發展這項業務。

Super helpful. Thanks very much.

超有幫助。非常感謝。

Caitlin Cronin, Canaccord Genuity.

凱特琳·克羅寧，Canaccord Genuity。

Hi, everyone. Good morning. Congrats on a great quarter. Just maybe to start, touching on core accounts, it became a larger portion of your business this quarter. Historically, it has only been 60%. Now, it's 65%. Do you expect this to keep growing? And has this really been the result of middle adopter growth or penetration of different types of surgeons within an account? Thank you.

大家好。早安.恭喜您度過了一個出色的季度。也許從核心客戶開始，它已成為本季您業務的更大一部分。從歷史上看，這一比例僅為60%。現在，是 65%。您預計這種情況會持續成長嗎？這真的是中間採用者成長或帳戶內不同類型外科醫生滲透的結果嗎？謝謝。

Yes, thank you. We're very excited that we're seeing faster growth in both emergent and scheduled procedures in our core accounts, and that's been our strategy. We think there's a significant opportunity to grow that business in those core accounts. That's where we've got a lot of upside potential, and it is all of those.

是的，謝謝。我們非常高興看到我們的核心客戶的緊急程序和預定程序都有更快的成長，這就是我們的策略。我們認為在這些核心客戶中存在著發展業務的重大機會。這就是我們有很大的上升潛力的地方，而且就是所有這些。

Now the majority of our -- the vast majority of our core accounts have both some business in trauma and some business in scheduled cases. But we see opportunity to continue to expand both of those and continue to drive that deeper adoption.

現在，我們的大多數核心客戶既有一些創傷業務，也有一些預定病例業務。但我們看到了繼續擴大這兩個領域並繼續推動更深入採用的機會。

And that deeper adoption, really, by definition means we're moving into those middle adopters and becoming the standard of care in those accounts. That's what our goal is and then continue to grow the number of core accounts where we've become the standard of care. So we think that strategy has been effective, and we're happy to see that percentage increase.

實際上，根據定義，更深入的採用意味著我們正在進入那些中間採用者並成為這些帳戶中的護理標準。這就是我們的目標，然後繼續增加核心客戶的數量，使我們成為護理標準。因此，我們認為該策略是有效的，我們很高興看到這一百分比增加。

Awesome. And then just a quick one on breast. You noted a higher number of surgeons expected to train this year. Are you starting to see revenue contribution from this new opening of procedures in that segment?

驚人的。然後快速地在乳房上塗上一層。您注意到今年預計將有更多外科醫生接受培訓。您是否開始看到該細分市場新開放程序帶來的收入貢獻？

Yes, it's been exciting to see the expansion into the implant-based procedures. The opportunity for Resensation as we're ending breast cancer awareness month has been a meaningful topic of conversation among women who have breast cancer.

是的，看到植入手術的擴展令人興奮。隨著乳癌宣傳月即將結束，Resensation 的機會已成為乳癌女性之間一個有意義的話題。

And I think the realization that this is an important outcome for women has continued to spur significant interest in the procedure. We had standing-room-only interest in our training programs before the implant-based procedures, and we think this will continue to be an impactful part of our overall growth in the scheduled procedures.

我認為，認識到這對女性來說是一個重要的結果，繼續激發了人們對該手術的濃厚興趣。在基於植體的手術之前，我們對我們的培訓計劃只有站立室的興趣，我們認為這將繼續成為我們預定手術整體增長的一個有影響力的部分。

Thank you.

謝謝。

(Operator Instructions) Dave Turkaly, JMP Securities.

（操作員指令）Dave Turkaly，JMP 證券。

Hi. Good morning. Karen, maybe the Avive+, the resorbable -- does anybody else have a resorbable product? I'm just curious. Were surgeons asking for this? I am kind of wondering exactly what -- where it will be used specifically.

你好。早安. Karen，也許是 Avive+，可吸收產品——還有其他人有可吸收產品嗎？我只是好奇。外科醫生有這樣的要求嗎？我有點想知道它到底會用在什麼地方。

Yes. Actually, if you remember, we had an absorbable product prior that was very well received by the market, and we voluntarily withdrew that as some FDA changes in classification of products. I didn't tell you that I regularly receive phone calls from surgeons who were saying that they would like a replacement back for that product, that it was an important part of the overall treatment algorithm.

是的。事實上，如果你還記得的話，我們之前有一個可吸收的產品，很受市場歡迎，但隨著FDA對產品分類的一些改變，我們自願撤回了該產品。我沒有告訴你，我經常接到外科醫生的電話，他們說他們想要更換該產品，這是整個治療演算法的重要組成部分。

It's not going to be used -- it's a very niche product. It's not going to be used in all procedures. But in those procedures where there is a trauma that can cause damage to the surrounding tissue of a nerve as well as the nerve, it can be important to have a temporary or resorbable soft tissue matrix that provides protection during the critical healing phase, and surgeons are very interested in having this as a part of their algorithm in addition to the offerings we have with Axoguard. And so we are looking forward to getting this launched in the first quarter.

它不會被使用——它是一個非常小眾的產品。它不會在所有過程中使用。但是，在那些可能對神經周圍組織和神經造成損傷的創傷手術中，擁有臨時或可吸收的軟組織基質在關鍵癒合階段提供保護是很重要的，並且外科醫生除了我們與Axoguard 提供的產品之外，我們非常有興趣將其作為其演算法的一部分。因此，我們期待在第一季推出該產品。

Great. And then maybe one follow up for Pete. Pete, can you give us, from a modeling standpoint, sort of what you think interest expense is going to look like maybe just on a quarterly basis moving ahead, given that capitalization is now rolling off?

偉大的。然後也許是皮特的後續行動。皮特，從建模的角度來看，您能否告訴我們，考慮到資本化現在正在下滑，您認為未來的利息支出可能只是按季度計算？

Yes, I think with the structure of our debt, you'll see anywhere from $1.7 million to maybe $1.9 million a quarter, actually. Yes, that's interest expense, and then we'll see interest income as well off the cash that we have of a few hundred thousand.

是的，我認為根據我們的債務結構，實際上每個季度你會看到 170 萬美元到 190 萬美元之間的債務。是的，這就是利息支出，然後我們也會從我們擁有的幾十萬現金中看到利息收入。

Thank you.

謝謝。

Thanks, Dave.

謝謝，戴夫。

Thanks, Dave.

謝謝，戴夫。

Thank you. At this time, we've reached the end of our question-and-answer session, and I'll turn the call over to Karen Zaderej for closing remarks.

謝謝。此時，我們的問答環節已經結束，我將把電話轉給 Karen Zaderej 進行結束語。

Thank you, Rob. I'd like to thank the Axogen team who remain committed to our mission of improving nerve function and quality of life for patients with peripheral nerve injuries. We're happy with our current progress, and we remain focused on ensuring our long-term success. I want to thank everyone for joining us this morning and have a great day.

謝謝你，羅布。我要感謝 Axogen 團隊，他們始終致力於改善週邊神經損傷患者的神經功能和生活品質。我們對目前的進展感到滿意，並將繼續致力於確保我們的長期成功。我要感謝大家今天早上加入我們並祝您有美好的一天。

This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。