AxoGen Inc (AXGN) 2022 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the AxoGen, Inc. Reports First Quarter Earnings Call. (Operator Instructions)

女士們先生們，美好的一天，歡迎參加 AxoGen, Inc. 第一季收益電話會議。 （操作員說明）

At this time, it is my pleasure to turn the floor over to your host, Ed Joyce. Sir, the floor is yours.

現在，我很高興將發言權交給主持人艾德喬伊斯。先生，地板是你的了。

Thank you, Dagmar, and good afternoon, everyone. Joining me on today's call is Karen Zaderej, AxoGen's Chairman, Chief Executive Officer and President; Erick DeVinney, Vice President of Peripheral Nerve Science and Clinical Innovation; and Pete Mariani, Executive Vice President and Chief Financial Officer. Karen will discuss the quarter and our outlook for the year, Erick will discuss the RECON study and top line results, and Pete will provide an analysis of our financial performance, followed by closing remarks from Karen, and a question-and-answer Session.

謝謝達格瑪，大家下午好。參加今天電話會議的是 AxoGen 董事長、執行長兼總裁 Karen Zaderej； Erick DeVinney，週邊神經科學與臨床創新副總裁；執行副總裁兼財務長 Pete Mariani。凱倫(Karen) 將討論本季和我們對今年的展望，埃里克(Erick) 將討論RECON 研究和頂線結果，皮特(Pete) 將提供我們的財務業績分析，然後是凱倫(Karen)的結束語和問答環節。

Today's call is being broadcast live via webcast, which is available on the Investors section of the AxoGen website. Within an hour following the end of the live call, a replay will be available on the Investor section of the company's website at www@axogeninc.com. Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC, including, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements.

今天的電話會議透過網路直播進行現場直播，可在 AxoGen 網站的投資者部分查看。現場電話會議結束後一小時內，將在公司網站 www@axogeninc.com 的投資者部分提供重播。在我們開始之前，我想提醒您，在這次電話會議中，公司將對未來事件做出預測和前瞻性陳述。我們鼓勵您查看公司過去和未來向 SEC 提交的文件，包括但不限於公司的 10-K 和 10-Q 表格，其中確定了可能導致實際結果或事件與中描述的內容有重大差異的具體因素。這些前瞻性陳述。

These factors may include without limitation, statements related to the expected impact of COVID-19 and hospital staffing on our business, statements regarding our growth, our financial guidance, product development, product potential, expected clinical enrollment timing and outcomes, regulatory processes and approval, APC renovation timing and expense, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of internal controls or financial reporting, our visibility ads and sponsorship of conferences and educational events, global business disruptions caused by Russia's invasion of Ukraine and related sanctions and other matters not within our control.

這些因素可能包括但不限於與COVID-19 和醫院人員配置對我們業務的預期影響有關的聲明、有關我們的成長、我們的財務指導、產品開發、產品潛力、預期臨床入組時間和結果、監管流程和批准的聲明、APC 改造時間和費用、財務業績、銷售成長、產品採用、我們產品的市場認知度、數據驗證、我們對內部控製或財務報告的評估、我們的可見性廣告以及會議和教育活動的贊助、由以下原因造成的全球業務中斷俄羅斯入侵烏克蘭及相關制裁等不屬於我們控制範圍的事項。

And with that, I'd like to turn the call over to Karen. Karen?

說到這裡，我想把電話轉給凱倫。凱倫？

Thank you, Ed, and good afternoon, everyone. It's a pleasure to be talking to you today. I am pleased with our first quarter revenue of $31 million, matching last year's first quarter and an increase of 6%, excluding the impact of revenue from Avive Soft Tissue Membrane. We are also thrilled to have announced today that our RECON study successfully achieved its primary endpoint, which is a critical milestone towards transitioning Avance Nerve Graft to a licensed biologic and further supports the expanded adoption of Avance.

謝謝你，艾德，大家下午好。今天很高興與您交談。我對第一季營收 3,100 萬美元感到滿意，與去年第一季持平，成長 6%（不包括 Avive 軟組織膜營收的影響）。我們今天也很高興地宣布，我們的 RECON 研究成功實現了其主要終點，這是將 Avance 神經移植物轉變為許可生物製劑的一個重要里程碑，並進一步支持 Avance 的擴大採用。

Before providing comments on our operational results, we'd like to discuss the RECON top line data readout. The study achieved its primary endpoint of non-inferiority as compared to conduits. The safety profile of the study was consistent with previously published data, and we remain on track to complete the work necessary to submit our BLA in the second half of 2023. I would like to remind you that this study was the culmination of many years of effort and one of the most significant undertakings in our company's history. We are extremely pleased with today's outcome, which is consistent with the results we have seen in our registry data collected over the last decade. Achieving RECON's top line endpoint provides clinical confirmation of the performance of Avance Nerve Graft.

在對我們的營運結果發表評論之前，我們想討論一下 RECON 的頂線數據讀數。該研究達到了與導管相比的非劣效性的主要終點。研究的安全性與先前發布的數據一致，我們仍有望在 2023 年下半年完成提交 BLA 所需的工作。的事業之一。我們對今天的結果非常滿意，這與我們在過去十年收集的註冊數據中看到的結果是一致的。實現 RECON 的最高終點為 Avance 神經移植的性能提供了臨床確認。

The results of this study provide level 1 clinical evidence, the highest quality possible, which significantly bolsters our growing arsenal of data and peer-reviewed papers and provides robust data to support surgeon adoption of Avance as the optimal treatment option for many patients with peripheral nerve injuries.

這項研究的結果提供了1 級臨床證據，即盡可能最高的質量，這顯著增強了我們不斷增長的數據和同行評審論文庫，並提供了可靠的數據來支持外科醫生採用Avance 作為許多周圍神經患者的最佳治療選擇受傷。

We believe the current standard of treatment using autograft is suboptimal and can lead to complications with a second surgical site. Use of Avance Nerve Graft has an established track record and continues to gain traction with surgeons as they adopt the AxoGen algorithm. We still have much work to be done prior to filing the actual BLA submission, which we anticipate will occur in the second half of 2023. We're in the process of compiling the appropriate documentation on this clinical study, our facilities, operations, quality systems and much more, all of which are required for a successful application.

我們認為，目前使用自體移植的治療標準並不理想，可能會導致第二個手術部位出現併發症。 Avance 神經移植的使用已經建立了良好的記錄，並且隨著外科醫生採用 AxoGen 演算法而繼續受到外科醫生的關注。在提交實際的 BLA 提交之前，我們還有很多工作要做，我們預計將在 2023 年下半年提交。這些都是成功應用程式所必需的。

I'd like to now turn the call over to Erick DeVinney, our VP of Peripheral Nerve Science and Clinical Innovation, who will go over the RECON trial and top line results. Erick has been with AxoGen for 15 years and has been instrumental in the design and execution of the RECON study, and we're happy to have him on the call today. Erick?

我現在想將電話轉給我們的周邊神經科學和臨床創新副總裁 Erick DeVinney，他將討論 RECON 試驗和主要結果。 Erick 在 AxoGen 工作 15 年，在 RECON 研究的設計和執行中發揮了重要作用，我們很高興今天邀請他參加電話會議。艾瑞克？

Thank you, Karen. It's a pleasure to be here. I'd like to begin by providing some background on Avance Nerve Graft and the RECON study. Launched in 2007, there are over 50,000 Avance Nerve Grafts that have been implanted to date. Avance had a long successful and safe track record, excuse me. Launched in 2007 with over 50,000 Avance Nerve Graft implants, Avance has had a long and successful track record on the market. Originally, it was classified and regulated as a 361 tissue product, which fell under the FDA human cells, tissues and tissue-based products. In 2010, AxoGen and FDA aligned on transitioning events from a 361 tissue to a 351 biologic. As part of this transition plan, FDA granted AxoGen an enforcement discretion to allow us to continue to market and distribute Avance, while working towards our BLA submission.

謝謝你，凱倫。很高興來到這裡。首先，我想提供一些有關 Avance 神經移植和 RECON 研究的背景知識。 Avance 神經移植物於 2007 年推出，迄今已植入超過 50,000 個神經移植物。抱歉，Avance 有著長期成功且安全的記錄。 Avance 於 2007 年推出，擁有超過 50,000 個 Avance 神經移植植入物，在市場上擁有長期成功的記錄。最初，它被分類為 361 組織產品並受到監管，屬於 FDA 人體細胞、組織和組織基產品的範疇。 2010 年，AxoGen 和 FDA 在從 361 組織到 351 生物製品的過渡事件上達成協議。作為該過渡計劃的一部分，FDA 授予 AxoGen 強制執行裁量權，允許我們繼續行銷和分銷 Avance，同時努力提交 BLA。

Subsequent to our transition plan, FDA released a guidance document on regulatory considerations for tissue products that included classification of peripheral nerve as a nonstructural biologic tissue. In support of our BLA, we underwent a special protocol assessment to gain agreement with the FDA on the robustness of the study design and the analysis plan. Those efforts and discussions led to the creation of the RECON study. RECON is a Phase III pivotal clinical trial designed to compare safety and efficacy of Avance Nerve Graft and conduits for digital nerve injuries in the hand. The study is prospective, randomized, subject and evaluator minded and assessed recovery outcomes in nerve discontinuities between 5 and 25 millimeters in length across the 12-month period. The study was designed to look at sensory outcomes for Avance with the primary endpoint being a test for noninferiority to conduits. Additional analyses were performed to test for superiority between the groups.

在我們的過渡計畫之後，FDA 發布了一份關於組織產品監管注意事項的指導文件，其中包括將週邊神經分類為非結構性生物組織。為了支持我們的 BLA，我們進行了特殊的方案評估，以就研究設計和分析計劃的穩健性與 FDA 達成協議。這些努力和討論促成了 RECON 研究的創建。 RECON 是一項 III 期關鍵臨床試驗，旨在比較 Avance 神經移植物和導管治療手部指神經損傷的安全性和有效性。該研究是前瞻性、隨機性、注重受試者和評估者的研究，評估了 12 個月內長度在 5 至 25 毫米之間的神經中斷的恢復結果。研究旨在觀察 Avance 的感官結果，主要終點是對導管的非劣效性測試。進行了額外的分析以測試各組之間的優越性。

The primary endpoint measure of static 2-point discrimination outcomes. This is the ability of an individual to feel or discriminate between a single point and 2 points in the affected area. In other words, it's a measure of sensory density in the skin. The smaller the distance that can be identified as 2 distinct points, the better the sensation. Static 2-point discrimination is a standard and well-accepted measure for determining sensory recovery in the hand. It defines the highest threshold of sensory recovery and normal sensation in the hand is characterized as static 2-point discrimination of 6 millimeters or less.

靜態 2 點辨別結果的主要終點測量。這是個人感覺或區分受影響區域中的單一點和 2 個點的能力。換句話說，它是皮膚感覺密度的衡量標準。可以辨識為兩個不同點的距離越小，感覺就越好。靜態兩點辨別是確定手部感覺恢復的標準且廣為接受的測量方法。它定義了感覺恢復的最高閾值，手部正常感覺的特徵是 6 毫米或更小的靜態 2 點辨別力。

The study design also included in-depth training for surgeons on [tentative] good nerve repair. We were able to leverage the AxoGen nerve repair training algorithm developed by expert nerve surgeons and the RECON lead investigators to ensure attention was given to the important technical considerations that lead to better nerve repair outcomes. This included training on trimming to healthy nerve ends, achieving intentional as nerve repair and the appropriate surgical techniques to be used during implantation of each of the products. This training and standardization was implemented to ensure that each subject had an opportunity to achieve a good outcome.

研究設計還包括對外科醫生進行關於[暫定]良好神經修復的深入培訓。我們能夠利用由專家神經外科醫生和 RECON 首席研究員開發的 AxoGen 神經修復訓練演算法，確保專注於重要的技術考慮因素，從而獲得更好的神經修復結果。這包括修剪健康神經末梢、實現有意的神經修復以及每種產品植入過程中使用的適當手術技術的培訓。實施這種培訓和標準化是為了確保每個科目都有機會取得良好的成果。

RECON enrolled its first subjects in 2015, and the last subject completed follow-up on August of 2021. Both study groups were found to be well balanced across the demographic variables of age, gender and gap links and of sufficient sample size to support the analysis. As we outlined today in our press release, the RECON study met its primary endpoint. The predefined analysis found that overall gap links, the Avance group met noninferiority testing. This is an important step towards using the evidence from RECON to support our BLA for Avance.

RECON 於2015 年招募了第一批受試者，最後一名受試者於2021 年8 月完成了追蹤。很好的平衡，並且有足夠的樣本量來支持分析。正如我們今天在新聞稿中概述的那樣，RECON 研究達到了主要終點。預定義的分析發現，總體差距鏈接，Avance 組滿足非劣效性檢定。這是利用 RECON 的證據支持我們的 Avance BLA 的重要一步。

In addition to the primary endpoint analysis, we also observed that as nerve gap links increased, Avance performance demonstrated statistical superiority to conduits in the return of static 2-point discrimination and gaps greater than 12 millimeters. In addition to demonstrating superior sensory outcomes, as gap links increased, subjects repaired with Avance Nerve Graft were found to have statistically superior time to recovery in gaps greater than 10 millimeters. These patients were achieving normal static 2-point discrimination up to 3 months earlier than those in the conduit group.

除了主要終點分析之外，我們還觀察到，隨著神經間隙連接的增加，Avance 性能在靜態 2 點辨別和間隙大於 12 毫米的返回方面表現出優於導管的統計優勢。除了表現出卓越的感官效果外，隨著間隙連接的增加，使用 Avance 神經移植修復的受試者被發現在間隙大於 10 毫米的情況下具有統計上更優的恢復時間。這些患者比導管組患者早 3 個月達到正常的靜態 2 點辨別能力。

This follows what we would expect given the mechanistic differences between Avance Nerve Graft and manufactured conduits. The biologically active laminin structure found in Avance provides the organized architecture inherent to peripheral nerve and the guidance SKUs that can provide a direct pathway across the nerve defect. In our preclinical evaluations, Avance process allografts demonstrated superior numbers of axons regenerating across the gap as compared to conduits. We believe this plays a key role in achieving the superior results observed with Avance.

鑑於 Avance 神經移植物和製造的導管之間存在機械差異，這符合我們的預期。 Avance 中發現的生物活性層粘連蛋白結構提供了周圍神經固有的有組織的結構以及可以提供穿過神經缺陷的直接通路的引導 SKU。在我們的臨床前評估中，與導管相比，Avance 過程同種異體移植物顯示出跨間隙再生的軸突數量更多。我們相信，這對於實現 Avance 所觀察到的卓越成果發揮關鍵作用。

The safety profile of the study was similar to previously published studies. Nerve-related pain was the most commonly reported adverse event in RECON. Persistent and unresolved pain was observed in 9 or 8.3% of the conduit group and in 2 subjects or 1.8% of the Avance group. The incidence of pain was observed across all gap lengths.

研究的安全性與先前發表的研究相似。神經相關疼痛是 RECON 中最常見的不良事件。導管組中有 9 名或 8.3% 的受試者觀察到持續且未解決的疼痛，而 Avance 組有 2 名受試者或 1.8% 的受試者觀察到持續且未解決的疼痛。觀察所有間隙長度的疼痛發生率。

We're excited with these top line results, and we are continuing our analysis of the additional data that includes quality of life measures, pain medication, usage and other outcome measures within the study. We look forward to reporting the full analysis of the RECON study results later this year. We're working diligently towards the required tasks and submissions of the BLA, and we anticipate submission of the BLA in the second half of 2023. Thank you for the opportunity to share these exciting findings.

我們對這些最重要的結果感到興奮，我們正在繼續分析其他數據，包括研究中的生活品質指標、止痛藥、使用情況和其他結果指標。我們期待在今年稍後報告 RECON 研究結果的全面分析。我們正在努力完成 BLA 所需的任務和提交，預計將於 2023 年下半年提交 BLA。

Now I'd like to turn the call back over to Karen to discuss our first quarter results. Karen?

現在我想將電話轉回給凱倫，討論我們第一季的業績。凱倫？

Thanks, Erick. We cannot be more excited about this huge achievement, and I want to thank all of our participating subjects, clinical sites and investigators and all of our employees who have contributed to this accomplishment.

謝謝，埃里克。我們對這項巨大成就感到無比興奮，我要感謝所有參與的受試者、臨床中心和研究人員以及為這項成就做出貢獻的所有員工。

Returning to our first quarter results, we were pleased that our revenue increased each month of the quarter and across each of our nerve repair applications of extremities -- extremities trauma, breast, pain and OMF. With COVID-related hospitalizations peaking early in the quarter and then declining, surgical schedules gradually improved across the quarter despite ongoing hospital staffing challenges. For example, after suspending breast reconstruction procedures for several weeks, most of our breast customers had restarted reconstruction procedures by the end of the quarter, providing the opportunity to begin catching up on a growing backlog of patients. We anticipate hospital staffing issues will improve over the course of the year and are optimistic about our growth prospects.

回到我們第一季的業績，我們很高興看到我們的收入在該季度每個月以及我們四肢的每個神經修復應用（四肢創傷、乳房、疼痛和 OMF）上都在增長。儘管醫院人員配備持續面臨挑戰，但隨著新冠肺炎相關的住院治療在本季度初達到頂峰然後下降，整個季度的手術時間表逐漸改善。例如，在暫停乳房重建手術幾週後，我們的大多數乳房客戶在本季結束時重新啟動了重建手術，這為開始處理不斷增加的積壓患者提供了機會。我們預計醫院人員配備問題將在今年得到改善，並對我們的成長前景持樂觀態度。

Our commercial focus remains on driving deeper penetration into customer accounts while also continuing to add new accounts. We continue to expand surgeon adoption of the AxoGen nerve repair algorithm across our accounts, leveraging the numerous clinical publications featuring our products and now supported by the positive top line results of our RECON trial to lead discussions with surgeons. As of the end of the quarter, we had 288 core accounts and 926 active accounts, representing an increase of 5% and 1% versus prior year's first quarter, respectively. As a reminder, active accounts are those that (inaudible) 6 times in the last 12 months and may still be in the early stages of adoption. Active accounts continue to represent about 85% of our total revenue, with the top 10% contributing about 35% of revenue.

我們的商業重點仍然是推動對客戶帳戶的更深入滲透，同時繼續增加新帳戶。我們繼續在我們的客戶中擴大外科醫生對 AxoGen 神經修復演算法的採用，利用大量介紹我們產品的臨床出版物，現在得到我們 RECON 試驗的積極頂線結果的支持，以引導與外科醫生的討論。截至本季末，我們擁有 288 個核心帳戶和 926 個活躍帳戶，分別比去年第一季成長 5% 和 1%。提醒一下，活躍帳戶是指在過去 12 個月內出現過 6 次（聽不清楚）的帳戶，並且可能仍處於採用的早期階段。活躍帳戶繼續占我們總收入的 85% 左右，其中前 10% 的帳戶貢獻了約 35% 的收入。

Core accounts represent more penetrated accounts, defined as those that have had greater than $100,000 in revenue in the trailing 12 months. Our core accounts continue to represent about 60% of our revenue and typically contain at least one surgeon who's adopted the AxoGen nerve repair algorithm for a significant portion of his or her nerve injury patients. Leveraging this surgeon's success with our products, we focus on gaining more cases with that first surgeon and gaining adoption by additional surgeons in that account. We continue to see that our best opportunity for growth is within our core accounts by more deeply penetrating the treatment of traumatic injuries and continuing to expand into other nerve repair applications, including breast, OMF and the surgical treatment of pain.

核心帳戶代表滲透率較高的帳戶，定義為過去 12 個月內收入超過 10 萬美元的帳戶。我們的核心客戶仍然占我們收入的 60% 左右，通常至少有一名外科醫生採用 AxoGen 神經修復演算法來治療他或她的大部分神經損傷患者。利用這位外科醫生在我們產品上的成功，我們專注於獲得第一位外科醫生的更多病例，並獲得該帳戶中其他外科醫生的採用。我們繼續看到，透過更深入滲透外傷治療並繼續擴展到其他神經修復應用，包括乳房、OMF 和疼痛的外科治療，我們的最佳成長機會就在我們的核心客戶中。

We ended the quarter with 116 direct sales representatives, an increase of 1 during the quarter and up from 106 a year ago. As we commented in February, we expect that our growth expectations can be delivered primarily through improvements in sales rep productivity. However, we do anticipate adding 5 to 10 sales representatives this year to increase our number of territories based on growing sales and market opportunities. Our direct sales force continues to be supplemented by independent sales agencies that represent approximately 10% of our total revenue.

截至本季末，我們有 116 名直銷代表，比去年同期的 106 名增加了 1 名。正如我們在二月所評論的那樣，我們預計我們的成長預期可以主要透過銷售代表生產力的提高來實現。然而，我們預計今年將增加 5 到 10 名銷售代表，以根據不斷增長的銷售和市場機會增加我們的地區數量。我們的直銷隊伍繼續得到獨立銷售機構的補充，這些機構約占我們總收入的 10%。

We continue to build market awareness of nerve repair with health care providers and through our direct-to-patient initiatives, particularly in our market development efforts for the breast and pain applications. We continue to see strong traffic at both our re-sensation and rethink pain websites. These educational marketing tools are aimed at increasing awareness of the potential for nerve repair procedures to improve outcomes for patients undergoing mastectomy and reconstruction, and those suffering from chronic neuropathic pain.

我們繼續與醫療保健提供者一起並透過我們的直接面向患者的舉措，特別是在乳房和疼痛應用的市場開發工作中，建立神經修復的市場意識。我們繼續看到我們的重新感知和重新思考疼痛網站的流量強勁。這些教育行銷工具旨在提高人們對神經修復手術的潛力的認識，以改善接受乳房切除和重建的患者以及患有慢性神經性疼痛的患者的結果。

We continue to achieve our goals with our surgeon and with our search and education program, including training more than 75% of the current class of hand and microsurgery fellows. With our return in the fall to in-person education programs that include hands-on nerve repair training, there has been significant educational interest among surgeons, resulting in strong attendance at both our fellows and our best practices program. We will continue these programs throughout the year.

我們繼續與我們的外科醫生以及我們的搜尋和教育計劃一起實現我們的目標，包括培訓目前班級超過 75% 的手部和顯微外科研究員。隨著秋季我們恢復面對面的教育計劃，包括動手神經修復培訓，外科醫生對教育產生了濃厚的興趣，導致我們的研究員和最佳實踐計劃的大量參與。我們將全年繼續這些計劃。

Our RANGER and MATCH registries continue to enroll, now with over 2,600 Avance nerve graft repairs enrolled in RANGER. Data from these 2 clinical registries continue to play an important role, in forming surgeons in their clinical decision process. Enrollment in the comparative phase of REPOSE, our study of AxoGuard Nerve Cap compared to standard treatment for symptomatic neuroma is ongoing, and we anticipate completing enrollment in Q2 of this year with a top line data readout from the comparative phase in Q3 of 2023. The results of the REPOSE pilot phase were published in February in foot and ankle surgery. Results from this study concluded that subjects showed significant and durable improvements in pain over the 12-month follow-up period, which the author stated is indicative of lack of neuroma reoccurrence. Subjects who reported opioid use for pain treatment before surgery had discontinued use by 3 months post surgery. In addition, subjects showed significant and clinically meaningful improvements in quality of life measures. The authors further concluded that while the study population had neuromas in the foot, the procedure has applicability for neuromas in all other areas of the body. Also with our AxoGuard Nerve Cap, we initiated a new study for large diameter nerve caps called REPOSE-XL. This pilot study focuses on a line extension of AxoGuard Nerve Caps with diameters from 5 to 7 millimeters. This study is currently enrolling.

我們的 RANGER 和 MATCH 註冊中心繼續註冊，目前 RANGER 註冊了超過 2,600 例 Avance 神經移植修復患者。來自這兩個臨床登記處的數據在外科醫生的臨床決策過程中繼續發揮著重要作用。 REPOSE 比較階段的入組工作正在進行中，REPOSE 是我們對AxoGuard Nerve Cap 與症狀性神經瘤標準治療進行比較的研究，我們預計在今年第二季度完成入組，並在2023 年第三季度公佈比較階段的頂線資料。這項研究的結果得出結論，在 12 個月的隨訪期間，受試者的疼痛表現出顯著且持久的改善，作者表示這表明神經瘤沒有復發。術前報告使用鴉片類藥物治療疼痛的受試者在術後 3 個月停止使用。此外，受試者的生活品質指標表現出顯著且具有臨床意義的改善。作者進一步得出結論，雖然研究族群的足部患有神經瘤，但該手術也適用於身體所有其他部位的神經瘤。此外，我們也利用 AxoGuard 神經帽啟動了一項名為 REPOSE-XL 的大直徑神經帽新研究。這項試驗研究的重點是直徑 5 至 7 毫米的 AxoGuard 神經帽的產品線延伸。該研究目前正在招募中。

Marketing our products with a solid foundation of clear, high-quality clinical evidence is a priority, and we believe that our growing collection of meaningful data publications is the most comprehensive in the area of peripheral nerve repair. As of the end of the quarter, we now have 188 peer-reviewed papers with growing numbers among all our nerve repair applications, including trauma, breast, OMF and the surgical treatment of pain. We remain committed to developing the clinical evidence to demonstrate the safety, performance and utility of our nerve repair solutions to support the continued adoption of the AxoGen algorithm across our full portfolio of nerve repair products.

以清晰、高品質的臨床證據為堅實基礎來行銷我們的產品是我們的首要任務，我們相信，我們不斷收集的有意義的數據出版物是周圍神經修復領域最全面的。截至本季末，我們現在擁有 188 篇經過同行評審的論文，並且在我們所有的神經修復應用中，包括創傷、乳腺、OMF 和疼痛的外科治療，論文數量不斷增加。我們仍然致力於開發臨床證據，以證明我們的神經修復解決方案的安全性、性能和實用性，以支持在我們的整個神經修復產品組合中繼續採用 AxoGen 演算法。

Moving on to our full year guidance, we continue to expect that full year revenue in 2022 will be in the range of $135 million to $142 million. This revenue guidance represents 10% to 15% growth over 2021, excluding the Avive revenue from last year. Full year gross margin is still expected to be above 80%. As we noted in our February call, we are being measured in our outlook for the procedure volume improvements and revenue growth in the first half of the year compared to 2021, but we anticipate a return to more normalized growth rates in the second half of the year. Our progress this year is meeting our initial expectations, and we're confident that we've built the right organization with a solid foundation of clinical evidence that will allow us to deliver sustainable long-term growth as the impact of the pandemic abate. We continue to view AxoGen as a long-term growth company, delivering sustainable annual revenue growth in the high teens to low 20% range.

展望全年指引，我們繼續預期 2022 年全年營收將在 1.35 億至 1.42 億美元之間。該收入指引預計較 2021 年成長 10% 至 15%（不包括去年 Avive 的營收）。全年毛利率仍預計在80%以上。正如我們在 2 月的電話會議中指出的那樣，與 2021 年相比，我們正在衡量上半年手術量改善和收入成長的前景，但我們預計下半年將恢復到更正常化的成長率。我們今年的進展正在滿足我們最初的期望，我們相信我們已經建立了正確的組織，並擁有堅實的臨床證據基礎，這將使我們能夠在大流行的影響減弱時實現可持續的長期增長。我們仍然將 AxoGen 視為一家長期成長的公司，年收入可持續成長在 10% 到 20% 的範圍內。

Now, I'll turn the call over to Pete for a review of financial highlights. Pete?

現在，我將把電話轉給皮特，讓他回顧一下財務要點。皮特？

Thank you, Karen. First quarter revenue was $31 million, matching the first quarter of 2021 and an increase of 6%, excluding the $1.7 million of Avive revenue in the first quarter of 2021. First quarter revenue was negatively impacted by the Omicron variant and related hospital staffing challenges, particularly in the first half of the quarter. Revenue was negatively impacted by a 4% decrease in unit volume, which is offset by changes in price and product mix. And if you exclude the impact of Avive revenue in the prior year, units increased by 3% and price and mix combined for a similar 3% impact.

謝謝你，凱倫。第一季營收為3,100 萬美元，與2021 年第一季持平，成長6%，不包括2021 年第一季Avive 的170 萬美元營收。負面影響，尤其是在本季的前半段。單位銷售量下降 4% 對收入產生了負面影響，但價格和產品組合的變化抵消了這種影響。如果排除上一年 Avive 收入的影響，單位數量增加了 3%，價格和組合合計也產生了類似的 3% 的影響。

Gross profit for the first quarter was $25.5 million compared to $25.9 million in Q1 of '21. Gross margin was 82.1% for the quarter compared to 83.3% in the prior year. Total operating expense in the first quarter increased 15% to $36.8 million compared to $32.1 million in the prior year. The increase in total operating expenses was primarily due to increased sales and project-related headcount and the return of in-person sales team and physician meetings and education events, travel and increased professional services spending.

第一季的毛利為 2,550 萬美元，而 2021 年第一季的毛利為 2,590 萬美元。本季毛利率為 82.1%，去年同期毛利率為 83.3%。第一季的總營運費用成長了 15%，達到 3,680 萬美元，而去年同期為 3,210 萬美元。總營運費用的增加主要是由於銷售和項目相關人員數量的增加以及面對面銷售團隊和醫生會議和教育活動的回歸、差旅以及專業服務支出的增加。

Sales and marketing expense in the first quarter increased 16% to $20.9 million compared to $18 million in the prior year. The increase was primarily due to marketing development programs, compensation-related and travel-related expenses from increased sales activity with greater hospital access. As a percentage of total revenue, sales and marketing expenses increased to 67% for the 3 months ended March 31st compared to 58% in the prior year.

第一季的銷售和行銷費用成長了 16%，達到 2,090 萬美元，而去年同期為 1,800 萬美元。這一增長主要是由於行銷開發計劃、由於銷售活動增加以及醫院准入增加而產生的與薪酬相關和差旅相關的費用。截至 3 月 31 日的三個月，銷售和行銷費用佔總收入的百分比增加至 67%，而去年同期為 58%。

Research and development expenses increased 9% to $6.3 million compared to $5.7 million in the prior year. The increase in R&D expenses reflects increased spending in specific programs, including our efforts related to the BLA for Avance Nerve Graft and a next-generation Avance product. Product development expenses represented approximately 66% of total research and development spending in the first quarter of both 2022 and 2021. Clinical trial expenses represented approximately 34% in both quarters. As a percentage of total revenue, research and development expenses were 20% in Q1 compared to 19% in the prior year.

研發費用增加 9%，達到 630 萬美元，而前一年為 570 萬美元。研發費用的增加反映了特定專案支出的增加，包括我們與 Avance 神經移植 BLA 和下一代 Avance 產品相關的努力。 2022 年及 2021 年第一季度，產品開發費用約佔研發總支出的 66%。第一季研發費用佔總營收的比例為 20%，去年同期為 19%。

General and administrative expense in the first quarter increased 15% to $9.6 million compared to $8.4 million in the prior year. G&A as a percent of revenue was 31% compared to 27% in the prior year. The net increase was due primarily to increased professional services in the quarter and facilities-related costs.

第一季的一般及管理費用增加了 15%，達到 960 萬美元，而去年同期為 840 萬美元。 G&A 佔收入的百分比為 31%，而前一年為 27%。淨成長主要是由於本季專業服務和設施相關成本的增加。

Adjusted net loss and net loss per share was 8.5 and $0.20 per share in the first quarter of '21 compared to 3.1 and $0.08 per share last year. Adjusted EBITDA loss in the quarter was $7.4 million compared to an adjusted EBITDA loss of $1.9 million in prior year. The reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and on our website. The balance of all cash, cash equivalents and investments on March 31, 2022 was $73.7 million compared to a balance of $90.3 million at year-end. The net change includes capital expenditures of $5 million related to the construction of our new processing facility in Dayton, Ohio, and approximately $7.6 million related to items which typically occur in the first quarter of each year, including payment of our annual bonus, sales meetings and awards and insurance payments.

2021 年第一季調整後淨虧損和每股淨虧損分別為 8.5 美元和 0.20 美元，而去年同期分別為 3.1 美元和 0.08 美元。本季調整後 EBITDA 虧損為 740 萬美元，而上年度調整後 EBITDA 虧損為 190 萬美元。這些非公認會計原則財務指標與公認會計原則的調節可以在今天的收益報告和我們的網站上找到。截至 2022 年 3 月 31 日，所有現金、現金等價物及投資餘額為 7,370 萬美元，而年底餘額為 9,030 萬美元。淨變化包括與我們在俄亥俄州代頓建設新加工設施相關的500 萬美元資本支出，以及與通常在每年第一季發生的項目相關的約760 萬美元資本支出，包括支付我們的年度獎金、銷售會議以及獎勵和保險金。

With $74 million in cash, our balance sheet is strong, and we expect to end the year well positioned to continue funding our growth, while maintaining an appropriate level of cash. Our annual guidance remains unchanged with revenue of $135 million to $142 million, which is about 10% to 15% growth, excluding the $4.1 million of Avive revenue from 2021. The year is progressing well and in line with our initial expectations, and we anticipate to return to more normalized growth rates in the second half of the year, and we continue to expect gross margins to remain above 80%.

我們擁有 7,400 萬美元現金，資產負債表強勁，預計到年底我們將能夠繼續為我們的成長提供資金，同時保持適當的現金水準。我們的年度指引保持不變，營收為 1.35 億至 1.42 億美元，成長約 10% 至 15%，不包括 2021 年 Avive 的 410 萬美元收入。下半年將恢復到更正常的成長率，我們繼續預期毛利率將維持在80%以上。

At this point, I'd like to open the line for questions. Operator?

現在，我想開通提問專線。操作員？

(Operator Instructions) Our first question comes from Danielle Antalffy.

（操作員說明）我們的第一個問題來自 Danielle Antalffy。

Guys, this is Erin on for Danielle. Thanks for taking our questions and congrats on a great quarter and the RECON results. I think just starting off for us with the RECON, I was hoping if you guys could just frame for us the potential impact this will have on revenue and growth. Where do you expect this study to have the most meaningful impact? Would it be within kind of existing surgeons or potentially help penetrate new surgeons and accounts? Thank you so much.

夥計們，這是丹妮爾的艾琳。感謝您回答我們的問題，並祝賀您取得了出色的季度業績和 RECON 結果。我認為，從 RECON 開始，我希望你們能為我們框架這將對收入和成長產生的潛在影響。您認為這項研究將在哪些方面產生最有意義的影響？它是否屬於現有外科醫生的範圍，或者可能有助於滲透新的外科醫生和帳戶？太感謝了。

Sure. Thank you. Yes, we're very happy to have the results and complete this study. It's an exciting milestone for us. So we'll break out the champagne in a little bit. But in terms of the impact, I think I'll put it -- we've talked about in the past about early adopters and middle adopters. And early adopters are usually those surgeons who are willing to try things for themselves, build their own databases and were certainly the early adopters of the AxoGen algorithm. And in many cases are the faculty that teach our nerve programs today. But middle adopters tend to look for more confidence and security of data and that the experts in front of them have already evaluated that data. And so to complete a study like this with the rigor of a Phase III study with the independence of a Phase III study and level 1 evidence I think will bring middle adopters who may have been sitting on the sidelines to begin to think about changing their algorithm.

當然。謝謝。是的，我們很高興得到結果並完成這項研究。這對我們來說是一個令人興奮的里程碑。我們稍後會開香檳。但就影響而言，我想我會這樣說——我們過去討論過早期採用者和中間採用者。早期採用者通常是那些願意親自嘗試、建立自己的資料庫的外科醫生，當然也是 AxoGen 演算法的早期採用者。在許多情況下，今天教授我們神經課程的教師。但中間採用者傾向於尋求更多的數據信心和安全性，並且他們面前的專家已經評估了這些數據。因此，以 III 期研究的嚴謹性、III 期研究的獨立性和 1 級證據來完成這樣的研究，我認為將使那些可能一直處於觀望狀態的中間採用者開始考慮改變他們的演算法。

Now I do want to caution, this is not like a pharmaceutical where everybody changes what their prescribing patterns, and it changes all at once. I still believe these middle adopters will trial. So they'll do a few implants, they'll wait and see their outcomes. They'll see how that progresses in this first segment that they adopt and they'll continue to adopt in this stairstep pattern. But it will help us as we continue to drive penetration in our core -- our active and core accounts to bring in those, not only the second and third surgeon, but many of the other surgeons in those same centers.

現在我確實想警告一下，這不像一種藥物，每個人都改變他們的處方模式，而且它會立即改變。我仍然相信這些中間採用者會嘗試。所以他們會做一些植入，他們會等著看結果。他們將看到他們採用的第一部分的進展情況，並將繼續採用這種階梯模式。但這將幫助我們，因為我們繼續推動我們的核心滲透——我們的活躍和核心帳戶不僅引進了第二和第三位外科醫生，還引進了這些中心的許多其他外科醫生。

Okay, great. Thanks so much. And then I guess just turning to the quarter and revenue, if you guys could just talk sort of about the trend that you've seen in the quarter, how things are looking into April, just maybe by the different areas like trauma, breast, pain? And then just how we should be thinking about the cadence for the rest of the year?

好的，太好了。非常感謝。然後我想談談季度和收入，如果你們能談談你們在本季看到的趨勢，四月份的情況如何，也許只是透過創傷、乳房等不同領域，疼痛？那我們該如何考慮今年剩餘時間的節奏呢？

Sure. Well, I'll start, and Pete will chime in as we sit and talk about the rest of the year. But the quarter definitely had challenges. January was very disruptive to procedures, actually in all of our segments. In fact, if I look at our more elective procedures, we had a near shutdown of those procedures at points in the month of January. That's because these elective procedures like breast and oral maxillofacial are very -- both elective, but also resource intensive.

當然。好吧，我先開始，當我們坐下來談論今年剩下的時間時，皮特會插話。但本季確實面臨挑戰。一月份對程序造成了很大的破壞，實際上是在我們所有的部門。事實上，如果我看看我們更多的選擇性程序，我們在一月份的某些時候幾乎關閉了這些程序。這是因為這些選擇性手術，如乳房和口腔顎面手術，既是選擇性手術，也是資源密集手術。

They're inpatient procedures, they're long OR procedures, and we saw a significant disruption of those. Now I'm happy to say that as the quarter progressed, obviously COVID hospitalizations went to a much, much more manageable levels, but hospitals are also beginning to manage their staffing challenges and were able to open up even these inpatient procedures as well as bring back procedures like some of the trauma procedures that sort of dispersed into community and ambulatory surgery centers to try and allow some of those to even occur, where hospitals didn't have the capacity or the capability to do it. So we saw things improving each month in the quarter and each of our segments got better as we went through the quarter. And again, as we ended the quarter, the breast reconstruction sites were up and starting to do surgery again, the oral maxillofacial program was back to doing surgery again, and we were seeing a rebound in the surgical treatment of pain as well as trauma. And Pete, do you want to talk about going forward?

它們是住院手術，是長時間的手術室手術，我們看到了這些手術的嚴重中斷。現在我很高興地說，隨著本季度的進展，顯然新冠肺炎住院治療已經達到了更易於管理的水平，但醫院也開始應對人員配備方面的挑戰，甚至能夠開放這些住院程序，並帶來背部手術，例如一些創傷手術，分散到社區和門診手術中心，試圖允許其中一些手術進行，而醫院沒有能力或能力這樣做。因此，我們看到本季每個月的情況都在改善，隨著本季的進行，我們的每個細分市場都變得更好。再次，當我們本季結束時，乳房重建部位已經恢復並開始再次進行手術，口腔顎面計劃再次恢復進行手術，我們看到疼痛和創傷的手術治療出現反彈。皮特，你想談談未來嗎？

Yes, no, we're happy with the way things came out for the quarter. We had in our guidance, at year-end we suggested that we thought first half growth would look like low to mid-single digits in the first half and then a return to more normalized growth in the second half of the year. We achieved 6% growth here in the first quarter. We would continue to take that same measured approach here over the second quarter. And we'll just -- we're off to a good start. We've got lots of optimism about where the business is, but continue to be measured here in the near term and then a return to more normalized growth in the back half.

是的，不，我們對本季的情況感到滿意。我們在年底的指導中表示，我們認為上半年的成長將是低至中個位數，然後在下半年恢復到更正常化的成長。第一季我們實現了 6% 的成長。我們將在第二季度繼續採取同樣的謹慎方法。我們將會有一個好的開始。我們對業務狀況非常樂觀，但短期內將繼續進行衡量，然後在下半年恢復更正常化的成長。

Our next question comes from Frank Pinal.

我們的下一個問題來自弗蘭克·皮納爾。

Hi, guys, congrats on the -- on the compelling data on RECON and nice quarter. I hope you're all do well. Just 2 quick ones for me. As a follow-up to the RECON question, I'm wondering if there's an opportunity with the headline data here, early on in the year to sort of use that as part of your marketing plan or if there's an opportunity there to bolster sales for the back half of the year? I guess that's one. And then second -- I'll just ask my second now. And Pete, I think you gave some guidance on the cadence of margins for the balance of the year. The call accidentally dropped on me, if you can restate that, that would be extremely helpful.

嗨，夥計們，恭喜 RECON 上令人信服的數據和美好的季度。我希望你們一切都好。對我來說只有 2 個快速的。作為 RECON 問題的後續行動，我想知道今年年初這裡的標題數據是否有機會將其用作行銷計劃的一部分，或者是否有機會促進銷售下半年？我想那就是其中之一。然後第二個──我現在就問第二個。皮特，我認為您對今年剩餘時間的利潤節奏給出了一些指導。電話不小心掉到了我身上，如果你能重述一下，那就非常有幫助了。

Well, so I'll start with the RECON data. We're very excited about it. In fact, we have a little bit later tonight the rollout with the broader investigators, where the lead investigators will be presenting the data and reviewing it with them, and I think it will create some positive scientific discussion that will happen amongst the investigators and amongst their peers. We fully expect that this will be data that will be compelling and interesting. While I can't guarantee it because it's not within our control.

好吧，我將從 RECON 數據開始。我們對此感到非常興奮。事實上，今晚晚些時候我們將與更廣泛的研究人員一起推出，主要研究人員將展示數據並與他們一起審查，我認為這將在研究人員和其他研究人員之間產生一些積極的科學討論。我們完全期望這將是引人注目且有趣的數據。雖然我不能保證，因為這不在我們的控制範圍內。

I expect it will be discussed and presented at some of the upcoming hand conferences later this year. Again, given the rigor and level of evidence, it's truly unique in this area. And so I know that surgeons are excited to talk about it and hopefully it will be something that will be a major part of their agenda. And then as the paper comes out, which will certainly follow all of this, then the reps will be able to provide that as additional scientific evidence in their discussions. So absolutely, it's something we plan to talk about. We plan to continue to build on. But of course, we're going to do it in the rigors of good clinical evidence.

我預計它將在今年稍後即將舉行的一些手工會議上進行討論和展示。再次強調，鑑於證據的嚴謹性和水平，它在該領域確實是獨一無二的。所以我知道外科醫生很高興談論它，並希望這將成為他們議程的主要部分。然後，隨著論文的發表，這肯定會遵循所有這些，那麼代表們將能夠在他們的討論中提供這些作為額外的科學證據。所以絕對，這是我們計劃討論的事情。我們計劃繼續發展。但當然，我們將在嚴格的良好臨床證據的情況下做到這一點。

Yes, and Frank, what I mentioned was that we just reiterated our guidance that margins will continue to be above 80%.

是的，弗蘭克，我提到的是我們剛剛重申了我們的指導，即利潤率將繼續高於 80%。

Our next question comes from Ross Osborn.

我們的下一個問題來自羅斯·奧斯本。

Congrats on the quarter. So I guess sticking with gross margin quickly, it was obviously still above 80%, but are there any headwinds or tailwinds you would highlight that occurred during the quarter that maybe we should be thinking about through the balance of the year?

恭喜本季。因此，我想盡快堅持毛利率，它顯然仍高於 80%，但您是否會強調本季度發生的任何逆風或順風，也許我們應該在今年的剩餘時間內考慮這些逆風或順風？

No, look, I think we've had -- our margins have been sort of in the low 80s consistently and they've moved around up from quarter-to-quarter just with changes in the pace of manufacturing or processing throughput, just normal ups and downs of the manufacturing process. We're comfortable with margins continuing to be in historical ranges.

不，看，我認為我們的利潤率一直在 80 左右，並且隨著製造或加工吞吐量的變化而逐季度上升，這很正常製造過程的起伏。我們對利潤率繼續保持在歷史範圍內感到滿意。

Okay, great. And then one more on the sales and marketing side of things. Would you just remind us of direct-to-patient educational campaigns you guys have ongoing. And then as a follow-up, could you share any quantitative measures on your resonation or RETHINK PAIN, maybe a website hits? Or have you seen any changes in traffic as the year started.

好的，太好了。然後是銷售和行銷方面的問題。您能提醒我們一下你們正在進行的直接面向患者的教育活動嗎？然後作為後續行動，您能否分享有關您的共鳴或重新思考痛苦（也許是網站點擊率）的任何定量衡量標準？或者您看到年初以來流量發生了任何變化？

So first, the outreach that we have, the education activities, we look at educating both consumers and surgeons. So on the surgeon side, we have always educated 75% of the hand and microsurgery fellows. Of course, during the pandemic, we had to go to virtual education, which was good, but it's never as good as these hands-on programs. In the fall of last year, we were able to return back to in-person education, both for fellows. We also have a separate program, a little different targeting on the level of information provided to attending. In fact, I just came from one of these programs in Atlanta and surgeons are frankly just super excited to get back together and talk about an important topic like nerve repair.

首先，我們的外展活動、教育活動，我們著重於對消費者和外科醫師進行教育。因此，在外科醫生方面，我們一直對 75% 的手部和顯微外科醫師進行了培訓。當然，在大流行期間，我們不得不接受虛擬教育，這很好，但它永遠不如這些實踐項目。去年秋天，我們能夠重新開始對研究員進行面對面的教育。我們還有一個單獨的計劃，在向參加者提供的資訊層面上略有不同。事實上，我剛從亞特蘭大的一個計畫回來，坦白說，外科醫生們非常興奮能回到一起討論像神經修復這樣的重要話題。

We see very good adoption -- well, that's -- we see very good initial trial and then progressed adoption from the surgeons who attend these programs, but it really starts with an education. They're very not promotional. They are very much on the techniques and principles of nerve repair. And when you go through that, you step back and it's logical and clear why we've developed the algorithm and portfolio that we have, is that it answers the needs that surgeons have as they go into these different types of nerve injuries. And so we find that a very helpful and impactful process to help surgeons think about what they're doing, be confident in what they're doing and expand their work. And of course, RECON will help to continue to support that.

我們看到了非常好的採用——嗯，就是這樣——我們看到了非常好的初步試驗，然後參加這些計畫的外科醫生逐漸採用，但這實際上是從教育開始的。他們非常不促銷。他們非常關注神經修復的技術和原理。當你經歷這個過程時，你退後一步，你會發現我們開發演算法和產品組合的原因是合乎邏輯且清晰的，因為它滿足了外科醫生在處理這些不同類型的神經損傷時的需求。因此，我們發現這是一個非常有用和有影響力的過程，可以幫助外科醫生思考他們正在做的事情，對他們正在做的事情充滿信心並擴展他們的工作。當然，RECON 將幫助繼續支持這一點。

On the patient side, much of what we try and do is actually just increase awareness. Patients don't think anything about nerve and they don't know that nerves are a cause of either a problem or a quality of life impact that they have. So what we found with breast reconstruction and we're applying some of that learning now in the surgical treatment of pain. We've been doing the breast reconstruction work with patients for about 4 years, was that patients were unaware that when they had a breast reconstruction that they would likely be numb. And it was just something that wasn't discussed. We found a real gender difference in even the way they talked about it after surgery with their surgeons, and that if they had a female surgeon, it was one of the top things that they would bring up and talk about a numb, is this what's happening here, why don't I feel anything. And they almost never mentioned it to their male surgeons.

在患者方面，我們嘗試和做的很多事情實際上只是提高意識。患者對神經沒有任何想法，他們不知道神經是導致問題或影響生活品質的原因。我們在乳房重建中發現了什麼，我們現在正在將其中的一些知識應用到疼痛的外科治療中。我們為患者做乳房再造工作已經有大約四年了，患者並不知道當他們進行乳房再造時，他們可能會變得麻木。這只是沒有討論的事情。我們發現，甚至在手術後與外科醫生談論此事的方式上，我們也發現了真正的性別差異，如果他們有一位女外科醫生，這是他們麻木地提出和談論的最重要的事情之一，這是什麼？ 發生在這裡，為什麼我沒有任何感覺。他們幾乎從未向男性外科醫生提起過這一點。

And so what we were trying to do in our education program was raise awareness before the surgery to say if sensation is important to you, then ask your surgeon about it upfront and open up that dialogue. And then we also provided them access to tools that explain in a very simple way what nerves are, why it makes a difference. We had patients tell their own story. There's little videos of patients talking about sensation and what it meant to them to be able to hug their baby and feel the baby. That's an important characteristic that women identify with. And what we found it has greatly increased the number of patients.

因此，我們在教育計劃中試圖做的就是在手術前提高人們的認識，讓他們知道感覺對您來說是否重要，然後提前向您的外科醫生詢問並展開對話。然後我們也為他們提供了一些工具，以非常簡單的方式解釋神經是什麼，為什麼它會產生影響。我們讓病人講述他們自己的故事。有一些小影片顯示患者談論感覺以及能夠擁抱嬰兒並感受嬰兒對他們意味著什麼。這是女性認同的重要特徵。我們發現患者數量大大增加了。

I hear this anecdotally. I guess I don't have a good measure for this. But anecdotally, I hear from many surgeons how often now patients walk into their breast reconstruction discussion and say, and sensation is one of the things on their list. They ask, I want to understand what my sensation outcomes could be, do you do sensory reconstruction? And if not, who does. And so we see anecdotally that it's become a much bigger topic. I don't -- if my fingertips have the click-throughs of the number of subjects that we get through the website, but we do have -- if they go on the website, there is a surgeon locator that they can click through and find a surgeon who does the resensation work.

我聽到這個軼事。我想我對此沒有很好的衡量標準。但有趣的是，我從許多外科醫生那裡聽到，現在患者經常參加乳房重建討論並說，感覺是他們清單上的事情之一。他們問，我想了解我的感覺結果可能是什麼，你們做感覺重建嗎？如果沒有，誰會呢？因此，我們有傳聞說它已經成為一個更大的話題。我沒有——如果我的指尖點擊了我們透過網站獲得的受試者數量，但我們確實有——如果他們進入網站，就會有一個外科醫生定位器，他們可以點擊並找一位做感覺工作的外科醫生。

Again, RETHINK PAIN is at a much earlier stage. It's a little more complex because pain is multifactorial and we're trying to help patients identify whether they have nerve pain or something else that they need to see a pain specialist on. I can say initially that we're quite pleased with the initial traffic we're getting on the RETHINK PAIN website, and we hope to continue to learn and expand on that and help refer those patients to a surgeon who can help them with their chronic pain problem. Sounds great. Thanks for taking my questions.

同樣，重新思考痛苦還處於早期階段。這有點複雜，因為疼痛是多因素造成的，我們正在努力幫助患者確定他們是否患有神經疼痛或其他需要去看疼痛專家的疾病。我首先可以說，我們對 RETHINK PAIN 網站上的初始流量感到非常滿意，我們希望繼續學習和擴展這一點，並幫助將這些患者轉介給能夠幫助他們治療慢性疼痛的外科醫生。聽起來很棒。感謝您回答我的問題。

(Operator Instructions) Our next question comes from Dave Turkaly.

（操作員說明）我們的下一個問題來自 Dave Turkaly。

Congrats, and I want to congratulate Ed for coordinating the first quarter results with the top line release, impressive. Karen, can you remind us -- I may have missed this, but how many Avance grafts and conduits or treatment in total were in the RECON study.

恭喜，我要祝賀艾德將第一季業績與頂線發布協調起來，令人印象深刻。凱倫，你能提醒我們嗎——我可能錯過了這一點，但 RECON 研究中總共有多少 Avance 移植物和導管或治療。

So the enrollment with 220 subjects.

因此招生科目有220個。

And so that's the number of nerve repairs that they were as well?

那麼這就是他們的神經修復數量嗎？

Yes, so we evaluated only 1 nerve injury per patient. Some patients might have had more than 1 nerve injury, but the protocol was written to address that. So no patient is included in the study twice. They're only in the study once.

是的，因此我們僅評估每位患者 1 處神經損傷。有些患者可能有超過 1 個神經損傷，但該方案是為了解決這個問題而編寫的。因此，沒有患者被兩次納入研究。他們只參加過一次研究。

Got it. And when you look at the algorithms that surgeons use the conduit, the collagen tubes and the like, are they indicated specifically for certain length of gap, or I mean, where are they most commonly used?

知道了。當你查看外科醫生使用導管、膠原蛋白管等的演算法時，它們是否專門針對一定長度的間隙而指定，或者我的意思是，它們最常用於哪裡？

Yes, great question. So historically, conduits have an indication of up to 30 millimeters, and I say that there's some variation with some brands, but they're typically in the up to 30 millimeters. That is actually still the exam question for surgeons as they come out of their program at the fellow and move into being an attending. One of the questions is, what is the appropriate gap link for our conduit and it still says up to 30 millimeters. We have said from even the prior data that, that was generous to a fault to where they're shown to be effective. And that was the point of this study to help be able to demonstrate that; A, Avance is an appropriate treatment for nerve repair and I think we've clearly demonstrated that with these results. But to also demonstrate that there is the conduit performance decreases as the length increases, and that's what we saw in the study as well.

是的，很好的問題。從歷史上看，導管的指示長度可達 30 毫米，我說某些品牌存在一些差異，但它們通常可達 30 毫米。這實際上仍然是外科醫生的考試問題，因為他們從研究員計畫中畢業並成為主治醫師。問題之一是，對於我們的導管來說，合適的間隙連接是多少，它仍然說最多 30 毫米。我們甚至從先前的數據中就可以看出，對於那些被證明是有效的地方來說，這是慷慨的。這項研究的目的就是要幫助證明這一點；答：Avance 是一種適合神經修復的治療方法，我認為我們已經透過這些結果清楚地證明了這一點。但也要證明導管性能隨著長度的增加而降低，這也是我們在研究中看到的。

Got it. And I guess, clearly you wanted to hit the primary end point. And then when you look at some of the other data, I guess I'd just love your thoughts on -- I mean, we all know they're good, but the return of function, the 12-millimeter, the time to recovery of the 3 months and the 10 and the pain delta, which was the most surprising to you or which do you think is the most powerful in terms of secondary observations? Well, I think those are 2 separate things and I'll look at my friend, Erick, to see if he has any additional comments. But I guess we fully believe and expected that Avance would be superior in these longer lengths. And we were -- we used to see we were able to demonstrate that. I think the thing that was probably more surprising and it's just a finding that helps us solidify things that I've heard surgeons talk about, they give us data within the safety side of looking at the persistent pain and the difference between conduits and Avance. And these are patients that the pain is not letting up for them.

知道了。我想，顯然你想達到主要終點。然後，當你查看其他一些數據時，我想我只是喜歡你的想法 - 我的意思是，我們都知道它們很好，但是功能的恢復，12 毫米，恢復時間3 個月、10 個月和疼痛在增量中，哪一個對您來說是最令人驚訝的，或者您認為哪一個在二次觀察方面最有力？嗯，我認為這是兩件不同的事情，我會看看我的朋友艾瑞克，看看他是否有任何其他評論。但我想我們完全相信並預期 Avance 在這些更長的長度上會更勝一籌。我們曾經看到我們能夠證明這一點。我認為可能更令人驚訝的事情是，它只是一個發現，可以幫助我們鞏固我聽到外科醫生談論的事情，他們為我們提供了安全方面的數據，觀察持續的疼痛以及導管和Avance 之間的差異。這些患者的痛苦並沒有減輕。

It's unresolved, may very likely be something that will result in a revision or this will be an impact on their quality of life going forward. And this is a hard thing to study in something like our registry because it needs a very rigorous and consistent way of asking about the pain and following up on the pain. And then the registry study is just hard to be sure that you have that. So while anecdotally I've heard surgeons talk about this, we are pleased to be able to see this type of data and it's something we'll dig into a little bit more because we really think it's impactful for surgeons to understand that.

它尚未解決，很可能會導致修訂，或者這將影響他們未來的生活品質。在我們的登記處這樣的地方進行研究是一件困難的事情，因為它需要一種非常嚴格和一致的方式來詢問疼痛并跟踪疼痛。然後註冊表研究很難確定你擁有這一點。因此，雖然我聽說外科醫生談論過這一點，但我們很高興能夠看到此類數據，我們將進一步深入研究這一點，因為我們真的認為外科醫生了解這一點是有影響力的。

And then interestingly, the returning normal sensation up to 3 months earlier. I think there's a good scientific explanation as to why it does that, but we have not seen that in some of our previous results. Again, it takes a study of this type of rigor and structure to be able to pick up a trend like that. And 3 months is -- that's pretty meaningful to be able to get back to normal sensation that much earlier. No, I agree. And maybe if I could slip one last one in for your colleague. The pain one, I mean it may be too early to answer this, but is there any sort of reason or -- and obviously we know what Avance is versus what a tube collagen is, but why that would be the case, like initial thoughts on why that would be so?

有趣的是，早在三個月前就恢復正常感覺了。我認為為什麼會這樣做有一個很好的科學解釋，但我們在之前的一些結果中還沒有看到這一點。同樣，需要對這種嚴格性和結構進行研究才能發現這樣的趨勢。三個月－能夠這麼早恢復正常感覺是非常有意義的。不，我同意。也許我可以為你的同事塞下最後一張。痛苦的一個，我的意思是現在回答這個問題可能還為時過早，但是有什麼原因嗎？想法一樣為什麼會這樣呢？

Yes, when you look at the mechanism of how conduit support regeneration, not matter what's on the inside, its reliant upon a vibrant matrix forming and filling that tubular structure. And that doesn't have the organization and the alignment that you see in something like a nerve allograft. Active laminin scaffold in an organization inside Avance Nerve Graft that provides the structure to support regeneration across versus the disorganized regeneration you see inside a tube.

是的，當你觀察管道如何支持再生的機制時，無論內部是什麼，它都依賴於形成和填充管狀結構的充滿活力的基質。而且它沒有你在神經同種異體移植物中看到的組織和排列。 Avance 神經移植物內部組織中的活性層黏連蛋白支架提供了支持跨管再生的結構，而不是您在管內看到的無序再生。

And that disorganized regeneration if it's incomplete or if it's suboptimal, disorganized regeneration results in essentially a neuroma and neuroma like pain. And if that becomes symptomatic, you detect that, and that's an unfortunate impact on the patient's quality of life. So if you look at how these products work and that -- the importance of that active laminin scaffolding that makes a huge difference in how the nerves regenerate. The disorganized regeneration of these manufactured tubes leads to the -- potentially leads to this greater risk of seeing this type of chronic pain.

如果再生不完整或不理想，則混亂的再生會導致本質上的神經瘤和類似神經瘤的疼痛。如果出現症狀，您會發現，這會對患者的生活品質產生不幸的影響。因此，如果你看看這些產品的工作原理，你會發現活性層黏連蛋白支架的重要性，它對神經的再生方式產生了巨大的影響。這些人造管的無序再生會導致—可能會導致這種類型的慢性疼痛的更大風險。

Okay, that was our final question. I'd like to turn the floor back over to Karen Zaderej for closing remarks.

好的，這是我們的最後一個問題。我想請凱倫‧札德雷 (Karen Zaderej) 致閉幕詞。

Thank you. Well, I believe we're off to a solid start this year, and we could not be more excited about our RECON achievement announced today. I am proud of all our members of team AxoGen, who remain committed to our mission of improving nerve function and quality of life for patients with peripheral nerve injuries. I want to thank everyone for joining us on today's call, and we look forward to speaking with you in the near future.

謝謝。嗯，我相信今年我們已經有了一個良好的開端，我們對今天宣布的 RECON 成就感到非常興奮。我為 AxoGen 團隊的所有成員感到自豪，他們仍然致力於改善週邊神經損傷患者的神經功能和生活品質。我要感謝大家參加今天的電話會議，我們期待在不久的將來與您交談。

Thank you. This concludes today's conference call. We thank you for your participation. You may disconnect your lines at this time, and have a great day.

謝謝。今天的電話會議到此結束。我們感謝您的參與。此時您可以斷開線路，祝您有個愉快的一天。