AxoGen Inc (AXGN) 2022 Q4 法說會逐字稿

Welcome to the AxoGen Fourth Quarter 2022 Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

歡迎參加 AxoGen 2022 年第四季度電話會議。 （操作員說明）提醒一下，正在錄製此會議。

I would now like to turn the conference over to your host, Ed Joyce, AxoGen's Director of Investor Relations. Please begin, Mr. Joyce.

我現在想把會議轉交給你的主持人埃德喬伊斯，他是 AxoGen 的投資者關係總監。請開始，喬伊斯先生。

Thank you, Rob, and 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, followed by a question-and-answer session.

謝謝羅布，大家早上好。 AxoGen 董事長、首席執行官兼總裁 Karen Zaderej 和我一起參加今天的電話會議；執行副總裁兼首席財務官 Pete Mariani。 Karen 將討論本季度和我們今年的展望，Pete 將提供我們的財務業績分析，然後是問答環節。

Today's call is being broadcast live via webcast, which is available on the Investors section of the AxoGen website. Following the end of the live call, a replay will be available on the Investors section of the company's website at www.axogeninc.com.

今天的電話會議通過網絡直播進行現場直播，可在 AxoGen 網站的投資者部分訪問。現場通話結束後，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 the conference call, the company will make projections and forward-looking statements regarding future events, including the 2023 financial outlook, timing of the BLA submission and growth trajectory of the company.

在我們開始之前，我想提醒您，在電話會議期間，公司將對未來事件做出預測和前瞻性陳述，包括 2023 年財務展望、提交 BLA 的時間和公司的增長軌跡。

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 annual and periodic reports.

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。

Actual results or events could differ materially from those described in any forward-looking statement as a result of various factors, including, without limitation, the continued impact of COVID-19 on our business, global supply chain issues, record inflation, the impacts of the failure of Silicon Valley Bank and the recent turmoil in the banking industry, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth, surgeon and product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruption caused by Russia's invasion of Ukraine and related sanctions, as well as those risk factors described under Part 1, Item 1A., "Risk Factors," of our Annual Report on Form 10-K for the most recently ended fiscal year.

由於各種因素，包括但不限於 COVID-19 對我們業務的持續影響、全球供應鏈問題、創紀錄的通貨膨脹、矽谷銀行的倒閉和最近銀行業的動盪、醫院人員配備問題、產品開發、產品潛力、預期的臨床入組時間和結果、監管流程和批准、APC 翻新時間和費用、財務業績、銷售增長、外科醫生和產品採用、我們產品的市場意識、數據驗證、我們在會議和教育活動中的知名度和讚助、俄羅斯入侵烏克蘭和相關製裁造成的全球業務中斷，以及第 1 部分第 1A 項中描述的那些風險因素., “風險因素”，我們在最近結束的財政年度的 10-K 表格年度報告中。

Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. 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.

前瞻性陳述並不能保證未來的業績，實際結果可能與預測結果存在重大差異。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。

In addition, for a reconciliation of the non-GAAP measures, revenue as reported to revenue, excluding the impact of Avive as well as adjusted core and active account numbers, excluding the impact of Avive purchases, please reference today's earnings release and materials on the Investors section of the company's website.

此外，對於非 GAAP 措施的對賬，收入報告的收入，不包括 Avive 的影響以及調整後的核心和活躍賬戶數量，不包括 Avive 購買的影響，請參考今天的收益發布和材料公司網站的投資者部分。

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

有了這個，我想把電話轉給凱倫。卡倫？

Thanks, Ed, and thank you, everyone, for joining us this morning. I'll share the call today with an overview of our fourth quarter and our full year achievements and review our outlook for 2023. Pete will then provide more detail on our financial performance before we open the line for questions.

謝謝 Ed，也謝謝大家今天早上加入我們。我將在今天的電話會議上概述我們的第四季度和我們全年的成就，並回顧我們對 2023 年的展望。在我們開始提問之前，Pete 將提供有關我們財務業績的更多詳細信息。

2022 was a solid year of key accomplishments and milestones. We delivered high teens revenue growth during the back half of 2022 and drove improved operating efficiencies across the business. In May, we announced our pivotal Recon study successfully achieved its primary endpoint as well as important secondary endpoints.

2022 年是關鍵成就和里程碑豐碩的一年。我們在 2022 年下半年實現了十幾歲的收入增長，並提高了整個企業的運營效率。 5 月，我們宣布關鍵 Recon 研究成功實現了主要終點和重要的次要終點。

Late in the year, we also saw the publication of an independent landmark meta-analysis of peripheral nerve repair. This publication provides the strongest clinical evidence to date of the performance of Avance Nerve Graft across all gap links and nerve types compared to autografts and conduits.

今年年底，我們還看到了一項具有里程碑意義的獨立的周圍神經修復薈萃分析的發表。該出版物提供了迄今為止最有力的臨床證據，證明與自體移植物和導管相比，Avance 神經移植物在所有間隙連接和神經類型上的性能。

Additionally, construction of our new processing facility in Dayton, Ohio was completed, and the validation and transition is in process. This new facility will support our BLA for Avance Nerve Graft and provide for our long-term processing capacity. We remain on track for submission of our BLA for Avance by the end of 2023 and anticipate our approval in 2024.

此外，我們在俄亥俄州代頓的新加工設施建設已經完成，驗證和過渡正在進行中。這個新設施將支持我們的 Avance 神經移植 BLA，並提供我們的長期處理能力。我們仍有望在 2023 年底之前為 Avance 提交 BLA，預計我們將在 2024 年獲得批准。

A BLA approval will complete the regulatory transition of Avance Nerve Graft from a 361 tissue-based product to a 351 biological product. And importantly, Avance will then be designated as reference product, which would, in turn, provide 12 years of data exclusivity with regard to potential biosimilars.

BLA 的批准將完成 Avance Nerve Graft 從 361 組織產品到 351 生物產品的監管轉變。重要的是，Avance 隨後將被指定為參考產品，這反過來將提供與潛在生物仿製藥相關的 12 年數據獨占權。

With over 75,000 Avance Nerve Grafts implanted since launch, we are well positioned to continue to lead and innovate in this large and developing peripheral nerve repair market. I'm proud of our team and I look forward to continuing our mission of revolutionizing the science of nerve repair.

自推出以來，我們已經植入了超過 75,000 個 Avance 神經移植物，我們有能力在這個龐大且不斷發展的周圍神經修復市場中繼續引領和創新。我為我們的團隊感到自豪，我期待著繼續我們革新神經修復科學的使命。

Now turning to fourth quarter performance. Revenue increased 17% to $36.2 million compared to last year. Excluding the impact of revenue from Avive Soft Tissue Membrane in the fourth quarter of 2021. For the full year, we achieved revenue of $138.6 million, a 12% increase over the last year, excluding Avive revenue in 2021. As I noted earlier, we were pleased to see our sequential quarterly improvement with high-teens growth in the second half of 2022 versus single digits in the first half.

現在轉向第四季度的表現。與去年相比，收入增長了 17%，達到 3620 萬美元。不包括 2021 年第四季度 Avive 軟組織膜收入的影響。全年，我們實現了 1.386 億美元的收入，比去年增長 12%，不包括 2021 年的 Avive 收入。正如我之前提到的，我們很高興看到我們在 2022 年下半年實現了連續的季度增長，與上半年的個位數增長相比。

This improvement reflects improved hospital staffing and surgical capacity in the second half of the year as well as our ability to execute on our strategy and gain surgeon adoption. Giving more surgeon adopters in our core and active accounts is a key driver of our growth. As a reminder, active accounts were those that awarded at least 6x in the last 12 months and may still be in the early stages of adoption. Core accounts represent more penetrated accounts, defined as those that have had greater than $100,000 in revenue in the trailing 12 months.

這一改善反映了今年下半年醫院人員配備和手術能力的改善，以及我們執行戰略和獲得外科醫生採用的能力。在我們的核心和活躍賬戶中提供更多的外科醫生採用者是我們增長的關鍵驅動力。提醒一下，活躍賬戶是指在過去 12 個月內獎勵至少 6 倍並且可能仍處於早期採用階段的賬戶。核心賬戶代表滲透率更高的賬戶，定義為過去 12 個月收入超過 100,000 美元的賬戶。

The number of our core accounts increased to 332 in the quarter, representing growth of 1% sequentially and 18% over a prior year adjusted level of 282, excluding the impact of Avive purchases in 2021. This represents the impact of our growth strategy to drive deeper penetration into our core and active accounts.

本季度我們的核心客戶數量增加到 332 個，環比增長 1%，比上年調整後的 282 個水平增長 18%，不包括 2021 年購買 Avive 的影響。這代表了我們增長戰略的影響，以推動更深入地滲透到我們的核心和活躍賬戶中。

Core accounts represent about 60% of our revenue and typically contain at least 1 surgeon who's adopted the AxoGen nerve repair algorithm for a significant portion of his or her nerve injury patients.

核心客戶約占我們收入的 60%，通常至少有一名外科醫生採用 AxoGen 神經修復算法來治療他或她的大部分神經損傷患者。

Leveraging this surgeon's success with our products, we focus on gaining more cases with that first surgeon and gaining use by additional surgeons, including middle adopters in that account. Again, we believe our best opportunity for growth is driving deeper penetration in core accounts across all of our nerve repair applications, including trauma, breast, OMS and the surgical treatment of pain.

利用這位外科醫生在我們產品上的成功，我們專注於通過第一位外科醫生獲得更多案例，並獲得更多外科醫生的使用，包括該帳戶中的中間採用者。同樣，我們相信我們最好的增長機會是推動我們所有神經修復應用的核心客戶更深入地滲透，包括外傷、乳房、OMS 和疼痛的外科治療。

The number of our active accounts increased to 968 in the quarter, representing growth of 2% sequentially and 3% over an adjusted prior year level of 941. Active accounts represent about 85% of our total revenue, with the top 10% contributing about 35% of revenue.

我們的活躍賬戶數量在本季度增加到 968 個，環比增長 2%，比調整後的上年同期水平 941 個增長 3%。活躍賬戶約占我們總收入的 85%，其中前 10% 貢獻了約 35 個收入的百分比。

We ended the year with 115 direct sales representatives, up from 111 at the end of the third quarter. We believe our revenue growth can be primarily supported by increases in our sales rep productivity, and we will modestly add additional sales reps as their territories approach targeted levels. Our direct sales force is also supplemented by independent sales agencies that represent approximately 10% of our total revenue.

我們在年底擁有 115 名直接銷售代表，高於第三季度末的 111 名。我們相信我們的收入增長主要可以通過提高銷售代表的生產力來支持，並且我們將適度增加額外的銷售代表，因為他們的區域接近目標水平。我們的直銷隊伍還得到獨立銷售代理的補充，這些代理占我們總收入的大約 10%。

We strive to build market awareness of nerve repair with health care providers through our direct-to-patient initiatives, particularly for breast and pain applications. We utilize our marketing initiatives to drive patient engagement to our Resensation and Rethink Pain websites. These sites are aimed at increasing patient awareness and education of the potential for nerve repair procedures to improve outcomes for those undergoing mastectomy and reconstruction and also for those suffering from chronic neuropathic pain.

我們努力通過我們直接面向患者的舉措，特別是針對乳房和疼痛應用，與醫療保健提供者建立神經修復的市場意識。我們利用我們的營銷計劃來推動患者參與我們的 Resensation 和 Rethink Pain 網站。這些網站旨在提高患者對神經修復程序潛力的認識和教育，以改善接受乳房切除術和重建的患者以及患有慢性神經性疼痛的患者的結果。

Our surgeon education programs remain a top priority for AxoGen and continue to generate interest in the surgical community. Once again, in 2022, we achieved our annual goal of training more than 75% of the most recent class of hand and microsurgery fellows. We have high engagement from the fellowship training institutions, and we're well on our way towards achieving the target with the 2023 class.

我們的外科醫生教育計劃仍然是 AxoGen 的首要任務，並繼續引起外科界的興趣。 2022 年，我們再次實現了培訓超過 75% 的最新手部和顯微外科研究員的年度目標。我們得到了獎學金培訓機構的高度參與，我們正在朝著實現 2023 年班級的目標邁進。

We remain committed to developing the clinical evidence to demonstrate the safety, performance and utility of our nerve repair solutions to support surgeon adoption of the AxoGen algorithm across our full portfolio of nerve repair products. We added 8 new peer-reviewed publications this quarter, now with a total of 215 across extremity trauma, breast, OMS and pain. We believe that this portfolio of high-quality clinical evidence is the most comprehensive in the area of peripheral nerve repair and a key part of gaining surgeon adoption.

我們仍然致力於開發臨床證據來證明我們的神經修復解決方案的安全性、性能和實用性，以支持外科醫生在我們的整個神經修復產品組合中採用 AxoGen 算法。本季度我們增加了 8 篇新的同行評審出版物，目前共有 215 篇涉及四肢創傷、乳房、OMS 和疼痛。我們相信，這一高質量臨床證據組合在周圍神經修復領域是最全面的，也是獲得外科醫生採用的關鍵部分。

Late in Q4, we saw the publication of the most comprehensive peer-reviewed analysis on peripheral nerve repair outcomes entitled a systematic review and meta-analysis of nerve gap repair. The office compared the meaningful recovery rates between allograft, autograft and conduit across 35 high-quality peer-reviewed studies. The studies were screened for nerve injury type and similar outcome measurements, culminating with an evaluation of over 1,500 nerve repairs included in this analysis.

在第四季度末，我們看到了關於周圍神經修復結果的最全面的同行評審分析的發表，題為神經間隙修復的系統回顧和薈萃分析。該辦公室在 35 項高質量的同行評審研究中比較了同種異體移植物、自體移植物和導管之間有意義的恢復率。對這些研究進行了神經損傷類型和類似結果測量的篩選，最終評估了該分析中包含的 1,500 多個神經修復。

The authors concluded that meaningful recovery rates for allograft and autograft repairs were comparable across all gap links up to 70 millimeters and that there were no statistical differences between allograft and autograft outcomes in both sensory and motor nerve repairs. Additionally, allograft and autograft repairs delivered significantly better rates of meaningful recovery in short gaps up to 30 millimeters as compared to conduit repairs.

作者得出結論，同種異體移植物和自體移植物修復的有意義的恢復率在所有高達 70 毫米的間隙連接中具有可比性，並且同種異體移植物和自體移植物在感覺和運動神經修復方面的結果沒有統計學差異。此外，與導管修復相比，同種異體移植物和自體移植物修復在長達 30 毫米的短間隙中提供了顯著更高的有意義恢復率。

Lastly, an additional part of this meta-analysis was an examination of the acute procedure-related costs comparing autograft procedures to allograft. And the study found the costs were comparable in both the inpatient and outpatient setting.

最後，該薈萃分析的另一部分是對自體移植手術與同種異體移植手術的急性手術相關成本進行檢查。研究發現，住院和門診的費用相當。

I would also like to highlight a couple of recent publications in the Oral Maxillofacial segment. One study found that despite potential concerns the cancer treatment could negatively impact nerve regeneration, the oral cancer patients in the study with allograft nerve repair reported meaningful sensory recovery rate similar to those previously published for benign reconstruction. In addition to that study, another recent publication highlighted the cost effectiveness of allograft nerve repair compared to non-surgical therapy.

我還想強調一下最近在口腔頜面部分發表的幾篇文章。一項研究發現，儘管存在癌症治療可能對神經再生產生負面影響的潛在擔憂，但在同種異體移植神經修復研究中，口腔癌患者報告了有意義的感覺恢復率，與之前發表的良性重建相似。除該研究外，最近的另一份出版物強調了與非手術治療相比，同種異體移植神經修復的成本效益。

Patients with persistent trigeminal neuropathy or nerve damage affecting sensation in their face, tongue or jaw are commonly afflicted with high rates of depression, loss of work and decreased quality of life. This patient compared the total cost of ongoing non-surgical therapies compared to surgical repair with allograft reconstruction and found that nerve reconstruction was more effective and had lower long-term costs and represents a significant improvement to the patient.

患有持續性三叉神經病變或影響面部、舌頭或下巴感覺的神經損傷的患者通常患有抑鬱症、失業和生活質量下降的高發率。該患者將正在進行的非手術治療的總成本與採用同種異體移植重建的手術修復進行了比較，發現神經重建更有效，長期成本更低，對患者來說有顯著改善。

For our AxoGen sponsored research programs, we are pleased to see our RECON study discussed in the most recent annual combined hand, nerve and microsurgery meeting. Our RANGER and MATCH registries continue to enroll. And this data is an important part in informing surgeons in their clinical decision-making.

對於我們的 AxoGen 贊助的研究項目，我們很高興看到我們的 RECON 研究在最近的年度手、神經和顯微外科聯合會議上得到討論。我們的 RANGER 和 MATCH 註冊表繼續註冊。這些數據是通知外科醫生進行臨床決策的重要部分。

Lastly, we anticipate top line data readout from our REPOSE Axoguard Nerve Cap study in the fourth quarter of this year. Continuous innovation of products and applications is a key strategic pillar for our long-term growth, and we are mission-driven to provide leading innovative treatments for patients with peripheral nerve injuries. Our Avance Nerve Graft has revolutionized peripheral nerve repair, and we're excited to see this technology expand into new clinical applications.

最後，我們預計將在今年第四季度從我們的 REPOSE Axoguard Nerve Cap 研究中讀出一線數據。產品和應用的持續創新是我們長期發展的關鍵戰略支柱，我們的使命是為周圍神經損傷患者提供領先的創新治療。我們的 Avance 神經移植徹底改變了周圍神經修復，我們很高興看到這項技術擴展到新的臨床應用。

I'd like to highlight one of these exciting initiatives for breast reconstruction patients. Restore of sensation as a part of breast reconstruction is an important quality of life attribute for many women. Our Resensation technique was developed to provide sensation for patients receiving an autologous flap reconstruction which represents roughly 20% of the overall breast reconstruction procedures. The remaining 80% of breast reconstruction procedures are implant-based.

我想強調其中一項針對乳房重建患者的激動人心的舉措。恢復感覺作為乳房重建的一部分是許多女性生活質量的重要屬性。我們的 Resensation 技術旨在為接受自體皮瓣重建的患者提供感覺，這大約佔整個乳房重建手術的 20%。其餘 80% 的乳房重建手術是基於植入物的。

To support patients undergoing implant-based reconstruction, we have collaborated with pioneering surgeons to develop a procedure to provide neurotization to a subset of this patient population. We believe this new approach can be applied to an incremental 10% to 15% of breast reconstruction patients. Leading surgeons have seen promising results and we expect to train 20 breast construction surgical teams in this new procedure in 2023.

為了支持接受基於植入物的重建的患者，我們與先驅外科醫生合作開發了一種程序，為該患者群體的一部分提供神經質化。我們相信這種新方法可以應用於增加 10% 至 15% 的乳房重建患者。領先的外科醫生已經看到了可喜的結果，我們預計在 2023 年將在這個新程序中培訓 20 個乳房構造手術團隊。

I'd now like to spend a moment discussing our outlook for this year. We expect the full year 2023 revenue will be in the range of $154 million to $159 million, which represents about a 11% to 15% growth over 2022.

我現在想花點時間討論一下我們今年的展望。我們預計 2023 年全年收入將在 1.54 億美元至 1.59 億美元之間，比 2022 年增長約 11% 至 15%。

Our growth in the second half of 2022 reflects our ability to execute in an environment of improved hospital staffing and surgical capacity. We're confident in our ability to gain adoption and being measured on the pace of continued improvements as hospitals continue to work through these challenges and return to more normalized operating schedules.

我們在 2022 年下半年的增長反映了我們在醫院人員配備和手術能力得到改善的環境中的執行能力。隨著醫院繼續應對這些挑戰並恢復更正常的運營時間表，我們有信心獲得採用並衡量持續改進的步伐。

Additionally, we expect 2023 gross margin will be reduced in the first half of the year with the transition to our new processing facility, and we expect gross margins will return to approximately 80% by the fourth quarter of 2023.

此外，我們預計 2023 年上半年的毛利率將隨著向新加工設施的過渡而降低，我們預計到 2023 年第四季度毛利率將恢復到約 80%。

We view AxoGen as a growth company and are confident in our ability to continue our long track record of a surgeon adoption and growth supported with patient focus in innovative products and applications, high-quality clinical data, surgeon education programs, and our commercial execution. We're pleased with our performance and accomplishments in 2022, which include high-teens growth in the second half of the year, through reporting of meaningful clinical data and our progress towards our new processing center and filing the BLA for Avance. We look forward to extending these accomplishments in 2023.

我們將 AxoGen 視為一家成長型公司，並相信我們有能力繼續我們在外科醫生採用和成長方面的長期記錄，並在創新產品和應用、高質量臨床數據、外科醫生教育計劃和我們的商業執行方面以患者為中心。我們對我們在 2022 年的表現和成就感到滿意，其中包括通過報告有意義的臨床數據以及我們在新處理中心和為 Avance 提交 BLA 方面取得的進展，在下半年實現了十幾歲的增長。我們期待在 2023 年擴大這些成就。

By continuing to move into middle adopters, gaining surgeon conversion and bringing new innovation to peripheral nerve repair, we can further solidify our position as the leader in peripheral nerve repair and drive long-term sustainable growth.

通過繼續進入中間採用者、獲得外科醫生轉換並為周圍神經修復帶來新的創新，我們可以進一步鞏固我們作為周圍神經修復領導者的地位並推動長期可持續增長。

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

現在我會把電話轉給皮特，讓他回顧一下財務亮點。皮特？

Thank you, Karen. Before I get into the details of our financial performance, I want to comment on the recent disclosures regarding Silicon Valley Bank. We have approximately $8 million of cash with SVB, which is our sole depository bank. The majority of our cash, cash equivalents and investments, which consist of a variety of short-term and high credit treasury bonds and other liquid investments are held in custodial accounts with U.S. Bank for which SVB Asset Management is the adviser. We are opening new accounts with JPMorgan and have begun the process of moving the cash investments to those new accounts.

謝謝你，凱倫。在詳細介紹我們的財務業績之前，我想談談最近有關矽谷銀行的披露。我們在 SVB 有大約 800 萬美元的現金，這是我們唯一的存款銀行。我們的大部分現金、現金等價物和投資，包括各種短期和高信用國債和其他流動性投資，都存放在美國銀行的託管賬戶中，SVB 資產管理公司是該銀行的顧問。我們正在摩根大通開設新賬戶，並已開始將現金投資轉移到這些新賬戶。

And now turning to our results. Fourth quarter revenue was $36.2 million, a 17% increase over the fourth quarter of 2021, excluding Avive revenue in the fourth quarter of 2021. Growth was driven by increases in unit volume of 11% as well as increases in price and product mix of 4% and 3%, respectively.

現在轉向我們的結果。第四季度收入為 3620 萬美元，比 2021 年第四季度增長 17%，不包括 2021 年第四季度的 Avive 收入。增長的推動因素是單位銷量增長 11% 以及價格和產品組合的增長 4 % 和 3%。

Gross profit in the quarter was $30 million as compared to $26 million in the fourth quarter of 2021. Gross margin was 83% compared to 83.2% in last year's fourth quarter. Total operating expense in the fourth quarter increased 13% to $35.6 million compared to $31.5 million in the prior year. The increase in total operating expenses was primarily the result of compensation costs of $4.1 million, including $2.6 million in stock compensation.

本季度的毛利潤為 3000 萬美元，而 2021 年第四季度為 2600 萬美元。毛利率為 83%，而去年第四季度為 83.2%。與去年同期的 3150 萬美元相比，第四季度的總運營費用增加了 13%，達到 3560 萬美元。總運營費用的增加主要是由於 410 萬美元的補償成本，包括 260 萬美元的股票補償。

Sales and marketing expense in the fourth quarter increased 12% to $19.9 million compared to $17.7 million in the prior year. The increase was primarily due to compensation costs. As a percentage of total revenue, sales and marketing expense was 66% compared to 68% in the fourth quarter of 2021.

與去年同期的 1770 萬美元相比，第四季度的銷售和營銷費用增加了 12%，達到 1990 萬美元。增加的主要原因是補償費用。銷售和營銷費用佔總收入的百分比為 66%，而 2021 年第四季度為 68%。

Fourth quarter research and development expense increased 8% to $6.8 million compared to $6.3 million in the prior year. Product development expenses represented approximately 56% of total R&D in the quarter compared to 73% last year and includes spending in a number of innovation programs across our portfolio, including the next-generation Avance product.

第四季度研發費用增長 8% 至 680 萬美元，而去年同期為 630 萬美元。產品開發費用約佔本季度總研發費用的 56%，而去年這一比例為 73%，其中包括我們產品組合中許多創新項目的支出，包括下一代 Avance 產品。

Clinical expenses represented approximately 44% of total R&D in the quarter compared to 27% last year. As a percentage of total revenues, research and development expense was 19% in Q4 compared to 20% in the prior year.

臨床費用約佔本季度研發總額的 44%，而去年為 27%。第四季度研發費用佔總收入的百分比為 19%，而去年同期為 20%。

General and administrative expense increased 20% to $8.9 million in the fourth quarter as compared to $7.4 million in the prior year. The increase was primarily due to higher net compensation expenses, and G&A as a percent of revenue was 30% in the quarter compared to 28% in the prior year.

與去年同期的 740 萬美元相比，第四季度的一般和行政費用增加了 20%，達到 890 萬美元。這一增長主要是由於淨薪酬支出增加，本季度 G&A 佔收入的百分比為 30%，而去年同期為 28%。

Net loss in the quarter was $5.4 million or $0.13 per share compared to a net loss of $5.3 million or $0.13 per share in the fourth quarter of the prior year. Adjusted net loss was $1.1 million or approximately $0.03 per share in the fourth quarter compared to a loss of $3.3 million or $0.08 per share last year.

本季度淨虧損為 540 萬美元或每股 0.13 美元，而去年第四季度淨虧損為 530 萬美元或每股 0.13 美元。第四季度調整後的淨虧損為 110 萬美元或每股約 0.03 美元，而去年同期為虧損 330 萬美元或每股 0.08 美元。

Adjusted EBITDA loss in the quarter was $700,000 compared to an adjusted EBITDA loss of $2.5 million in the prior year. The balance of our cash, cash equivalents and investments on December 31, 2022, was $55 million compared to a balance of $59.4 million at the end of Q3. The net change includes capital expenditures of $5.5 million related to the construction of our new processing facility in Dayton, Ohio, partially offset by $1.1 million of positive cash flow in the quarter.

本季度調整後的 EBITDA 虧損為 700,000 美元，而去年調整後的 EBITDA 虧損為 250 萬美元。截至 2022 年 12 月 31 日，我們的現金、現金等價物和投資餘額為 5500 萬美元，而第三季度末的餘額為 5940 萬美元。淨變化包括與我們在俄亥俄州代頓建設新加工廠相關的 550 萬美元資本支出，部分被本季度 110 萬美元的正現金流量所抵消。

As Karen mentioned, our full year revenue guidance of $154 million to $159 million represents 11% to 15% growth. Additionally, we expect gross margin will be reduced in the first half of the year with the transition of our new processing facility, we anticipate improvement in the second half of the year with gross margins of approximately 80% in the fourth quarter.

正如 Karen 提到的，我們的全年收入指引為 1.54 億美元至 1.59 億美元，代表著 11% 至 15% 的增長。此外，我們預計上半年毛利率將隨著我們新加工設施的轉型而下降，我們預計下半年將有所改善，第四季度毛利率約為 80%。

Completion of our Dayton processing facility will include approximately $4 million to $5 million of remaining capital spend in the first half of the year. Additionally, we expect first quarter cash burn to be impacted by additional payments that are unique to the first quarter, including payment of our annual bonus, sales meetings and awards and insurance payments.

我們代頓加工廠的完工將包括今年上半年約 400 萬至 500 萬美元的剩餘資本支出。此外，我們預計第一季度的現金消耗將受到第一季度特有的額外付款的影響，包括支付我們的年度獎金、銷售會議和獎勵以及保險金。

We're confident that our balance sheet will continue to provide sufficient liquidity, supported by revenue leverage on our fixed cost infrastructure and thoughtful expense management. With a return to more normalized capital expenditures, we expect our operating cash to continue trending towards cash flow breakeven as we continue our path to profitability.

我們相信，我們的資產負債表將繼續提供充足的流動性，這得益於我們固定成本基礎設施的收入槓桿和周到的費用管理。隨著資本支出恢復正常化，我們預計我們的經營現金將繼續趨向於現金流收支平衡，因為我們繼續走上盈利之路。

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

在這一點上，我想打開問題熱線。

(Operator Instructions) And our first question comes from the line of Mike Sarcone with Jefferies.

（操作員說明）我們的第一個問題來自 Mike Sarcone 與 Jefferies 的合作。

So just the first one for you, Pete. A clarification on the $8 million of cash at Silicon Valley. Is that basically free and clear, and you're just working through the process of transferring that? Can you just talk a little bit more about the accessibility?

因此，皮特，這是給你的第一個。對矽谷800萬美元現金的澄清。這基本上是免費和明確的嗎，您只是在完成傳輸過程嗎？您能多談談可訪問性嗎？

Yes, it is. And it is free and clear. We've seen -- in fact, we've seen cash receipts were received into that account even yesterday and our ability to move money out of that account is something that we can do. So we're making -- we're taking steps to continue to make those transitions.

是的。而且它是免費和清晰的。我們已經看到 - 事實上，即使在昨天，我們也已經看到該賬戶收到了現金收據，我們可以將資金從該賬戶中轉出。所以我們正在 - 我們正在採取措施繼續進行這些過渡。

Got it. Okay. And then just wanted to get an update. Could you parse out what you're seeing across trauma, OMF and breast RECON so far through the year? And then what's baked into your assumptions for 2023 at the low and high ends of guidance?

知道了。好的。然後只是想獲得更新。你能分析一下今年到目前為止你在創傷、OMF 和乳房 RECON 中看到的情況嗎？然後，您對 2023 年指導低端和高端的假設是什麼？

Yes. Well, let me start off with the guidance. I mean our top end of our guidance really takes into consideration the continued predictability and consistency of hospital staffing and surgical schedules, although we recognize that, that's not -- it's still not at capacity. And so we've seen improvement over the last half of the year. And we would expect to see just that continued stability and not a lot of improvement is in our top end of our guidance. And the bottom end of our guidance really assumes that there is some disruption to the improvements that we've seen over the back half of the year.

是的。好吧，讓我從指導開始。我的意思是，我們指南的最高端確實考慮到了醫院人員配備和手術時間表的持續可預測性和一致性，儘管我們認識到，那不是——它仍然沒有達到最大容量。因此，我們在今年下半年看到了改善。我們希望看到我們指導的最高端只是持續穩定而不是很多改進。我們指導的底端確實假設我們在今年下半年看到的改進存在一些中斷。

And I'd say, as we're starting into the year, we've seen some nice stability in those procedures, but we're going to continue to be measured in our outlook for how we see the rest of the year go.

我要說的是，隨著我們進入今年，我們已經看到這些程序有一些很好的穩定性，但我們將繼續衡量我們對今年剩餘時間的展望。

Yes. And if I look at what we've seen, hospitals are still understaffed and they're not able to run all of their operating rooms to full capacity, but it has become predictable. And so we see surgeons in breast, in OMF and in pain where the procedures are scheduled to be able to at least schedule their procedures so they understand what their cadence will be of surgery. The breast surgeons are still working off of a long backlog, and that will take a while, as we've talked about before. But they are able to work through the cases on a regular cadence.

是的。如果我看看我們所看到的情況，醫院仍然人手不足，他們無法讓所有手術室滿負荷運轉，但這已經可以預見了。因此，我們看到外科醫生在乳房、OMF 和疼痛中看到手術計劃至少能夠安排他們的手術，以便他們了解他們的手術節奏。乳房外科醫生仍在處理長期積壓的工作，這需要一段時間，正如我們之前談到的那樣。但他們能夠以規律的節奏處理案件。

In trauma, there has been through last year and into this year some disruption in the ability to take a patient immediately from the emergency department into an OR just because of the lack of flexibility of resources. That has stabilized. They're not always able to do that, but they can refer them and get them into an OR, either at that site of care or an alternate site of care, they may delay it a day, but they are able to do that. And so that's what we mean by predictability, is that we're seeing that the surgeons and the hospitals are creating workaround so that patients can get care and that seems to be holding through the beginning of the year here.

在創傷方面，由於資源缺乏靈活性，從去年到今年，將患者從急診室立即送往手術室的能力出現了一些中斷。那已經穩定了。他們並不總是能夠做到這一點，但他們可以將他們轉介並讓他們進入手術室，無論是在那個護理地點還是在另一個護理地點，他們可能會推遲一天，但他們能夠做到這一點。因此，這就是我們所說的可預測性，我們看到外科醫生和醫院正在製定變通辦法，以便患者能夠得到護理，而且這似乎一直持續到今年年初。

Our next question is from the line of Chris Pasquale with Nephron.

我們的下一個問題來自 Chris Pasquale 與 Nephron 的合作。

Given the fact that mid-March I was hoping that you could provide some thoughts on first quarter. Historically, you get about 22% of full year revenue in the first quarter of the year. Do you expect a similar seasonality in '23? And any other considerations we should take into account in terms of how the year is going to come together?

鑑於 3 月中旬，我希望您能就第一季度提供一些想法。從歷史上看，您在今年第一季度獲得了全年收入的 22% 左右。您預計 23 年會有類似的季節性嗎？關於今年將如何走到一起，我們應該考慮的任何其他因素？

Yes, I think we are returning to typical seasonality. We have these overlays in the past of COVID and hospitals being shut down and then staffing challenges. But we are seeing, again, in this pattern, while they're still constrained in OR capacity, we're seeing a return to what I think are more predictable patterns.

是的，我認為我們正在回歸典型的季節性。在過去的 COVID 和醫院被關閉以及隨後的人員配置挑戰中，我們有這些重疊。但我們再次看到，在這種模式下，雖然它們仍然受到 OR 能力的限制，但我們正在看到回歸到我認為更可預測的模式。

And so we would expect our big step-up in revenue to be during the times of more activity where people unfortunately have more injuries, which is our summer months. So we'd see a step-up in second quarter, another step-up in third quarter as our bigger growth periods with things being more level in Q1 and Q2. So I don't want to give guidance for the Q1 so far, but I think our patterns are certainly more predictable.

因此，我們預計我們的收入會大幅增加，發生在活動較多的時候，不幸的是，人們受傷的次數更多，也就是我們的夏季月份。因此，我們會看到第二季度的增長，第三季度的另一個增長，因為我們的增長期更大，第一季度和第二季度的情況更加平穩。所以到目前為止，我不想為第一季度提供指導，但我認為我們的模式肯定更可預測。

How do you think about the revenue potential for the nerve gap product and whether you could get some incremental commercial momentum post the REPOSE results?

您如何看待神經間隙產品的收入潛力，以及您是否可以在 REPOSE 結果後獲得一些增量商業動力？

Yes. I think we published the pilot results from the nerve gap product, and we're quite pleased with the pilot data that we saw. And again, it's a smaller uncontrolled series. We're completing the randomized portion of that study now. But I think what we've seen is that this concept of surgically managing neuroma is something that has a significant impact to patients.

是的。我認為我們發布了神經間隙產品的試驗結果，我們對我們看到的試驗數據非常滿意。再一次，這是一個較小的不受控制的系列。我們現在正在完成該研究的隨機部分。但我認為我們所看到的是，這種通過手術治療神經瘤的概念對患者有重大影響。

And so we're working through really educating surgeons on the ability to use nerve gap in a variety of applications. And those would include things from amputations of digits, fingers, toes through some surgical procedures in the orthopedic space where you need to cut nerves to access the joint or the surgery that you're trying to get to, but sometimes those patients end up in chronic pain. And we think we have applications to all of those, and now there will be an opportunity to educate surgeons on the benefit they can provide their patients with that surgery.

因此，我們正在努力通過真正教育外科醫生在各種應用中使用神經間隙的能力。這些包括從數字、手指、腳趾截肢到骨科手術中的一些手術，在那裡你需要切斷神經以進入關節或你試圖進行的手術，但有時這些患者最終會慢性疼痛。我們認為我們對所有這些都有應用，現在將有機會教育外科醫生他們可以為患者提供手術的好處。

Our next question comes from the line of Kyle Rose with Canaccord Genuity.

我們的下一個問題來自 Kyle Rose 與 Canaccord Genuity 的合作。

Great. Just wanted to -- as we think about guidance in 2023, how should we be thinking about the growth of the underlying new -- or active accounts and core account growth? And I guess, put in other way, how much of the growth in '23 comes from volume versus price and mix? And if you could just break out those dynamics, that would be helpful.

偉大的。只是想——當我們考慮 2023 年的指導時，我們應該如何考慮潛在新賬戶或活躍賬戶和核心賬戶增長的增長？我想，換句話說，23 年的增長有多少來自數量與價格和組合？如果你能打破這些動力，那會很有幫助。

Yes. If you apply revenue guidance of 11% to 15%, I think we've been successful at taking price over the last several years, and we would continue to expect as we sort of low single-digit price again in 2023. We've also had some mix impact in revenue here in the fourth quarter and in some previous quarters. The way we think about the mix impact is more flattish in the coming years.

是的。如果你應用 11% 到 15% 的收入指導，我認為我們在過去幾年中已經成功地接受了價格，並且我們將繼續期望在 2023 年再次出現低個位數的價格。我們已經第四季度和前幾個季度的收入也有一些混合影響。在未來幾年，我們對混合影響的看法會更加平淡。

So the rest of that -- based on where you put your model, the rest of that would be in units. And I think that's -- we've had 11% unit growth in this quarter and similar Q3. So, I think that's the way we kind of think about it from a unit and price perspective. What was the first part?

所以剩下的——根據你放置模型的位置，其餘的將以單位為單位。我認為那是——我們在本季度和類似的第三季度實現了 11% 的單位增長。所以，我認為這就是我們從單位和價格的角度考慮它的方式。第一部分是什麼？

Core and active.

核心和活躍。

And it's more -- its driving (inaudible) gaps in current accounts.

而且它更多 - 它在經常賬戶中的驅動（聽不清）差距。

Active and core accounts. Yes, this is mainly about rep productivity. We continue to believe we have a lot of opportunity to drive growth through rep productivity in our accounts, these reps have been in their accounts, most of them have been in accounts for years now. And we've got good connections with surgeons, good connections with the support staff within the hospitals and their ability to continue to drive growth along with the data that we've come out with recently, I think, allows them to continue to drive their own increased productivity and do so within their core accounts. And so we could see a mix of both increase of core accounts as well as revenue per core account across 2023.

活躍和核心賬戶。是的，這主要是關於代表生產力。我們仍然相信，我們有很多機會通過我們客戶的代表生產力來推動增長，這些代表一直在他們的賬戶中，他們中的大多數人已經在賬戶中工作多年了。我們與外科醫生建立了良好的聯繫，與醫院內的支持人員建立了良好的聯繫，並且他們有能力繼續推動增長以及我們最近得出的數據，我認為，這使他們能夠繼續推動他們的發展擁有更高的生產力，並在他們的核心客戶中這樣做。因此，我們可以看到整個 2023 年核心賬戶的增長以及每個核心賬戶的收入的混合。

Okay. And then obviously, the ramp of the manufacturing facility and the submission and eventual regulatory decision on the BLA, those are big milestones for the company. So I'm just wondering, can you frame out any interim, I guess, things that need to happen along the way before your manufacturer is fully certified and running? And then also view similarly on the BLA filing, just making sure that investors understand all the milestones over the course of the next, call it, 2 years?

好的。然後顯然，製造設施的提升以及 BLA 的提交和最終監管決定，這些都是公司的重要里程碑。所以我只是想知道，我想，在您的製造商獲得完全認證和運行之前，您能否制定出任何過渡期間需要發生的事情？然後對 BLA 申請也有類似的看法，只是確保投資者了解下一個過程中的所有里程碑，稱之為 2 年？

Yes. So we are initially transitioning Avance into the new manufacturing facility as a tissue product. So that's the first milestone, and that's the work that we're doing right now. So that transition will be completed here in the first half of the year. We then revalidate as a biological product and I know that sounds like double work, but we did spend a lot of time in conjunction with the FDA trying to figure out the best way to do this validation and decided a 2-stage validation just made it cleaner. So we will revalidate the facility as a biologic.

是的。因此，我們最初將 Avance 作為紙巾產品轉移到新的製造工廠。所以這是第一個里程碑，這就是我們現在正在做的工作。因此，過渡將在今年上半年在這裡完成。然後我們作為生物產品重新驗證，我知道這聽起來像是雙重工作，但我們確實花了很多時間與 FDA 合作，試圖找出進行此驗證的最佳方法，並決定進行兩階段驗證。清潔工。因此，我們將重新驗證該設施作為生物製品。

Again, there's no specific process changes, but the data on how you gather data is different between the 2 validations. That's probably the biggest milestone for filing the BLA -- what is the long lead time item and the biggest milestone for filing the BLA yet this year. We do expect to get the BLA completed by the end of the year and submitted. And then it's into the FDA process. So I'm not sure that there will be milestones that we can really see until they come.

同樣，沒有具體的流程變化，但關於您如何收集數據的數據在 2 次驗證之間有所不同。這可能是提交 BLA 的最大里程碑——什麼是提前期較長的項目，也是今年提交 BLA 的最大里程碑。我們確實希望在年底前完成 BLA 並提交。然後進入 FDA 流程。所以我不確定在它們到來之前我們是否能真正看到里程碑。

Our next question is from the line of Ryan Zimmerman with BTIG.

我們的下一個問題來自 BTIG 的 Ryan Zimmerman。

Just following up on Kyle's question about the BLA. I just want to understand kind of your confidence level in getting the BLA and after it's submitted, is it -- remind me, is it 180 days that they have to respond? How long just as we kind of think about '24 and where that could come in?

只是跟進 Kyle 關於 BLA 的問題。我只是想了解您對獲得 BLA 的信心程度，在提交後，是——提醒我，他們必須在 180 天內做出回應嗎？就在我們考慮 24 年以及它可以發揮作用的時候多久了？

Yes. So confidence is we passed our primary, our endpoint in our pivotal study. So we feel pretty confident in this process. Now there's a lot of information that we are compiling and providing to the FDA, including this manufacturing facility, but we're far enough along in the manufacturing facility. I feel very comfortable that it's -- while it's a big project, it's just making sure we have all the documentation, right? The -- actually, the facility is beautiful. So we think it will be a very effective biologics processing center.

是的。因此，我們有信心在關鍵研究中通過了我們的主要終點。所以我們對這個過程很有信心。現在有很多信息我們正在彙編並提供給 FDA，包括這個製造工廠，但我們在製造工廠方面已經足夠了。我感到很舒服——雖然這是一個大項目，但它只是確保我們擁有所有文檔，對嗎？ -- 實際上，設施很漂亮。所以我們認為這將是一個非常有效的生物製品加工中心。

In terms of the submission time, I'm going to hesitate a bit. We do technically have the RMAT designation, which gives us an accelerated review. I'm not -- I think we have to be flexible on that because I'm not sure all the timings have been as accelerated, but FDA has been catching up. So if we get that, then we should see something with a 6-month clock. If not, it may be a little longer.

在提交時間方面，我會猶豫一下。從技術上講，我們確實擁有 RMAT 稱號，這使我們可以加快審核速度。我不是——我認為我們必須對此保持靈活，因為我不確定所有的時間安排是否都加快了，但 FDA 一直在追趕。所以如果我們明白了，那麼我們應該會看到有 6 個月時鐘的東西。如果沒有，它可能會更長一些。

Okay. That's helpful, Karen. And then couple of other quick questions for me. If I look at account growth, active account growth for the year, so about 17 accounts relative to kind of what you've done historically. How do you think about the pace of account growth -- active account growth and core account growth for that matter as we look ahead to next year? Given that it has slowed down, is it even a good proxy for us to think about -- it's a metric you guys have given out for some time now.

好的。這很有幫助，凱倫。然後問我幾個其他的快速問題。如果我看一下賬戶增長，今年的活躍賬戶增長，那麼大約有 17 個賬戶相對於你過去做過的事情。在我們展望明年時，您如何看待賬戶增長的速度——活躍賬戶增長和核心賬戶增長？鑑於它已經放緩，它甚至是我們考慮的一個很好的代理 - 這是你們已經給出了一段時間的指標。

Yes. I think it's helpful, but our first priority is now driving deeper penetration within those accounts. The accounts we're in, we're by far and away, lightly penetrated. And so that is our lowest-hanging fruit and the way that we think that we can achieve better sales rep productivity. So we will move some active accounts into being core accounts. There'll be some growth just organically in active accounts. That threshold is actually quite low. But I think the number that you want to continue to watch also is the average revenue per account or just think about what's the penetration into those accounts.

是的。我認為這很有幫助，但我們現在的首要任務是在這些客戶中推動更深入的滲透。我們所處的賬戶，我們很遠很遠，被輕輕地滲透了。因此，這是我們最容易實現的目標，也是我們認為可以提高銷售代表生產力的方式。因此，我們會將一些活躍賬戶轉為核心賬戶。活躍賬戶會有一些有機增長。這個門檻其實很低。但我認為你想要繼續關注的數字也是每個賬戶的平均收入，或者想想這些賬戶的滲透率是多少。

That's helpful, Karen. And then squeeze one more in. You mentioned flap reconstruction for breast RECON. Just curious if you could kind of size the market opportunity that you're referring to. I think you said it was around 20% of those cases. And then you guys -- I know you're targeting 20 today, but -- but help us understand, I mean if -- I don't know if there's X breast RECON procedures and 20% of those are at the flap reconstruction, what is that on an annual basis, just in absolute terms?

這很有幫助，凱倫。然後再擠一個進去。你提到了乳房 RECON 的皮瓣重建。只是好奇您是否可以衡量您所指的市場機會。我想你說過大約佔這些案例的 20%。然後你們——我知道你們今天的目標是 20 個，但是——但是幫助我們理解，我的意思是如果——我不知道是否有 X 乳房 RECON 程序，其中 20% 是在皮瓣重建中，每年的絕對值是多少？

Sure. So breast reconstruction -- so I'm going to back up a second and just explain a little bit about breast reconstruction. The breast reconstruction for women who have a mastectomy can be done by a variety of techniques, but they fall into predominantly 2 buckets. One is the flap, where they use autologous tissue to reconstruct the breast mount and the second are implant-based procedures.

當然。所以乳房再造——所以我要倒退一秒鐘，只解釋一下關於乳房再造的知識。可以通過多種技術為接受過乳房切除術的女性進行乳房重建，但它們主要分為兩類。一種是皮瓣，他們使用自體組織重建乳房支架，第二種是基於植入物的手術。

And so we have historically been focused only on the flap procedures. Those are about 15,000 to 20,000 procedures a year, just depending on the data, but 15,000 to 20,000 procedures -- or excuse me, patients per year. So we have really been focused in that segment. But as happens when there's a new tool available, some leading surgeons have really been looking at that other portion, the implant based repairs and saying, well, these women have numb breasts as well, and that's a problem. And is there something that we can do to assist these women?

因此，我們歷來只關注皮瓣手術。每年大約有 15,000 到 20,000 次手術，這取決於數據，但是每年有 15,000 到 20,000 次手術——或者對不起，病人。所以我們真的很專注於那個領域。但是當有一種新工具可用時，一些領先的外科醫生真的一直在關注其他部分，即基於植入物的修復，並說，好吧，這些女性也有乳房麻木，這是一個問題。我們可以做些什麼來幫助這些女性？

And obviously, you can't innovate the implant, but they often have a lack of sensation on the skin and the nipple areolar complex. And that's an important part of sensation. And so techniques were developed that would allow some -- a subset of some of those patients. And it really has to do with length and size of the implants and whether we can actually have the sufficient length to reach the target at the nipple and areolar complex.

顯然，您無法創新植入物，但它們通常對皮膚和乳頭乳暈複合體缺乏感覺。這是感覺的重要組成部分。因此開發了一些技術，這些技術可以允許一些——其中一些患者的一個子集。這確實與植入物的長度和大小有關，以及我們是否真的有足夠的長度來到達乳頭和乳暈複合體的目標。

So that's why we're saying as we're seeing this process -- or procedure expand into implant-based procedures, we're estimating that it's going to be for a portion today. Now this is evolving as surgeons are figuring out enhanced surgical techniques to try and reach better, a broader set of patients. But right now, we would estimate that in this implant-based group that we can assist about 15% to 20% of those patients.

所以這就是為什麼我們說，當我們看到這個過程——或程序擴展到基於植入的程序時，我們估計今天會有一部分。現在，隨著外科醫生正在研究改進的手術技術，以嘗試更好地覆蓋更廣泛的患者，這種情況正在發生變化。但現在，我們估計在這個基於植入物的群體中，我們可以幫助大約 15% 到 20% 的患者。

Our next question is from the line of Ross Osborn with Cantor Fitzgerald.

我們的下一個問題來自 Ross Osborn 和 Cantor Fitzgerald。

Congrats on the progress. So starting off with some of your smaller verticals. Have you seen any return of growth on OMF to start off the year with those surgeons that were using Avance before COVID to improve quality of life? And what can you do to accelerate growth in the third?

祝賀進步。因此，從一些較小的垂直領域開始。對於那些在 COVID 之前使用 Avance 來改善生活質量的外科醫生，您是否看到 OMF 在年初開始出現任何增長回報？您可以做些什麼來加速第三個領域的增長？

Yes. Thanks for the question. Yes, we saw all messed at -- depressed during COVID, people became concerned about having surgery in their mouth. And it was -- has just been the neurotization in OMF has been slow to recover. And we're starting to see that in the Q4 time frame, we see that the 2 publications that I mentioned will also be very helpful.

是的。謝謝你的問題。是的，我們看到一切都亂七八糟——在 COVID 期間情緒低落，人們開始擔心要進行口腔手術。它是——剛剛 OMF 的神經質恢復緩慢。我們開始看到，在第 4 季度的時間範圍內，我提到的 2 份出版物也將非常有幫助。

One of the things -- the majority of the work that we've done in OMF has been in benign mandible reconstructions. And then some of the injuries from dental procedures, so wisdom teeth extraction and putting in dental implants.

其中一件事——我們在 OMF 中所做的大部分工作都是在良性下頜骨重建方面。然後是牙科手術造成的一些傷害，所以智齒拔除並植入牙科植入物。

And of the 2 papers that I mentioned, this is the first case series looking at patients with malignant tumors and having a mandible reconstruction. And the concern is then well with the follow-on treatment radiation in particular, that these patients have affect the nerve regeneration and what this paper showed is that these patients actually achieved quite good meaningful recovery rates. And so we think that will be very helpful for surgeons as they're making decisions about the care pathway for these patients and they're really trying to achieve quality of life for patients in both benign and malignant tumor reconstruction.

在我提到的兩篇論文中，這是第一個研究惡性腫瘤患者並進行下頜骨重建的病例係列。並且特別關注後續治療放療，這些患者影響了神經再生，而本文顯示的是這些患者實際上實現了相當不錯的有意義的恢復率。因此，我們認為這對外科醫生非常有幫助，因為他們正在為這些患者制定護理途徑，並且他們真的在努力為良性和惡性腫瘤重建患者實現生活質量。

The second paper had to do with the iatrogenic injuries from dental procedures and just recognizing that these have a lifelong impact to patients when they have numbness in the lips, in the tongue, in the mouth that, that can have impact in both self-esteem as well as sort of practical things in the way that you interact and chew and shave and sort of live your life. And so that will be helpful, I think, as we reengage surgeons.

第二篇論文與牙科手術造成的醫源性傷害有關，只是認識到當患者的嘴唇、舌頭和口腔出現麻木時，這些會對患者產生終生影響，這會對自尊產生影響以及你互動、咀嚼、刮鬍子和過你的生活的方式中的一些實用的東西。因此，我認為，當我們重新聘請外科醫生時，這將有所幫助。

So we're optimistic in what we see. Long answer is we're optimistic with what we see with OMF and expanding into head and neck with mandible reconstructions. We think that will be a nice opportunity to continue to reengage with those surgeons and bring in new surgeons who can adopt this procedure.

所以我們對我們所看到的感到樂觀。長話短說，我們對 OMF 的結果持樂觀態度，並通過下頜骨重建擴展到頭頸部。我們認為這將是一個很好的機會，可以繼續與這些外科醫生重新接觸，並引進可以採用這種手術的新外科醫生。

Okay. Great. And then would you discuss your efforts on accelerating the referral process from patients showing up on your Rethink Pain website?

好的。偉大的。然後你會討論你為加速出現在你的 Rethink Pain 網站上的患者的轉診過程所做的努力嗎？

I'm sorry, it's hard to hear the question. Can you say it again?

對不起，很難聽到這個問題。你能再說一遍嗎？

Sure. would you discuss your efforts on accelerating the referral process from patients showing up on your Rethink Pain website?

當然。您能談談您為加快出現在您的 Rethink Pain 網站上的患者的轉診過程所做的努力嗎？

Sure. Thank you. Yes, we really have learned a lot on activating patients through the work that we've done in Resensation. So helping women in that case, be advocates for their own health care to go in and have be armed with the questions to ask their surgeon and decide if sensation in breast reconstruction is important to you. Then if it is important, then here are questions to ask your surgeon, here's what you can do to take control of your care.

當然。謝謝。是的，通過我們在 Resensation 中所做的工作，我們確實學到了很多關於激活患者的知識。因此，在這種情況下幫助女性，成為她們自己的醫療保健的倡導者，並準備好詢問她們的外科醫生的問題，並決定乳房重建的感覺對你是否重要。然後，如果它很重要，那麼這裡有一些問題要問您的外科醫生，這是您可以採取的措施來控制您的護理。

And we're looking to apply a lot of those same tools into helping patients who suffer from chronic pain, determine do they have potentially a neuroma that is the cause of the pain or was it neuropathic pain? And if it is, how can they find a surgeon who does a surgical treatment of pain or a pain surgeon rather than ending up in a paying clinic as their primary care, which will address the symptoms but not address the cause of the pain.

我們正在尋求應用許多相同的工具來幫助患有慢性疼痛的患者，確定他們是否可能患有導致疼痛的神經瘤或神經性疼痛？如果是的話，他們怎麼能找到一個對疼痛進行手術治療的外科醫生或疼痛外科醫生而不是最終在付費診所作為他們的初級保健，這將解決症狀而不是解決疼痛的原因。

And so we're seeing early success in applying those same tools. We still need to build out more information for patients. In pain, it is more complex than a -- than in the reconstruction. If you're a woman, you have a mastectomy, you know you have a mastectomy and are thinking about reconstruction.

因此，我們看到應用這些相同工具的早期成功。我們仍然需要為患者構建更多信息。在痛苦中，它比重建更複雜。如果您是女性，您接受了乳房切除術，您知道您接受了乳房切除術並且正在考慮重建。

In pain, you know you have pain, but you don't know that it's a neuroma pain. And so we have added some tools to help those patients determine do they have neuroma pain and are they an appropriate potential surgical candidate, with, of course, the final decision always being made by the health care practitioner.

在疼痛中，你知道你有疼痛，但你不知道這是一種神經瘤疼痛。因此，我們添加了一些工具來幫助這些患者確定他們是否患有神經瘤疼痛，以及他們是否是合適的潛在手術候選人，當然，最終決定始終由醫療保健從業者做出。

And so we're going to continue to build out those tools this year, but we think that we can help activate these patients, again, to be good stewards of their own care.

因此，我們今年將繼續構建這些工具，但我們認為我們可以幫助激活這些患者，再次成為他們自己護理的好管家。

Our next question comes from the line of Dave Turkaly with JMP Securities.

我們的下一個問題來自 JMP Securities 的 Dave Turkaly。

Karen, the meta-analysis that you talked about that large review, who actually did that? And where was that published?

凱倫，你談到那個大型評論的元分析，實際上是誰做的？那是在哪裡發表的？

It's published -- it's e-published in PRS. It's a group of independent authors who actually wrote it, but they did this, again, deep review of the data and prepared a very solid analysis of nerve repair across autograft, allograft and conduits. So we're very excited to see the data. And it was e-published at the end of December. It will be in print in one of the coming journals. It's actually not been out in the -- so PRS is Plastic and Reconstructive Surgery.

它已發布——它是在 PRS 中以電子方式發布的。實際上是一群獨立作者寫的，但他們再次這樣做，對數據進行了深入審查，並準備了對自體移植、同種異體移植和導管神經修復的非常可靠的分析。所以我們很高興看到這些數據。它於 12 月底以電子方式出版。它將在即將出版的期刊之一上印刷。它實際上還沒有出現——所以 PRS 是整形和重建手術。

Great. I know people have asked a little bit about the guidance and I was looking at the sort of rep productivity. And I was wondering if you had any color or comments there in terms of kind of where your average folks are today and sort of where you think they can go? Is there still room for that to expand?

偉大的。我知道人們已經問了一些關於指導的問題，而我正在研究代表生產力的類型。我想知道你是否有任何顏色或評論，關於你的普通人今天所處的位置以及你認為他們可以去的地方？還有擴展的空間嗎？

Yes. No, we're seeing that rep productivity has -- it's now over about $1.1 million per rep. And we've always said we've got reps that do $2 million a year and maybe a little bit more. And we -- as a rep is getting close to $2 million, that's when we split those territories and bring additional resources in to cover those hospitals.

是的。不，我們看到代表生產力已經 - 現在每個代表超過 110 萬美元。我們一直說我們有每年 200 萬美元甚至更多的銷售代表。而我們——作為一名代表接近 200 萬美元，那是我們拆分這些地區並引入額外資源來覆蓋這些醫院的時候。

So we think there's plenty of opportunity for rep productivity to go from $1.1 million up to $1.3 million, $1.5 million plus on average as we continue to drive deeper into these accounts. Now that's not all this year, obviously. But over time, we're going to increase rep productivity, we think, fairly solidly. And then as we move up the curve from $1.1 million to $1.2 million to $1.3 million, we'll continue to add more reps, and we'll do so in a way that allows us to not only drive additional rep growth but continue to drive rep productivity growth.

因此，我們認為，隨著我們繼續深入研究這些客戶，代表生產力有很多機會從 110 萬美元上升到 130 萬美元，平均超過 150 萬美元。顯然，今年還不止這些。但隨著時間的推移，我們認為，我們將相當穩固地提高代表生產力。然後隨著我們從 110 萬美元上升到 120 萬美元到 130 萬美元的曲線，我們將繼續增加更多的銷售代表，我們這樣做的方式不僅可以推動額外的銷售代表增長，而且可以繼續推動代表生產力增長。

And so we think we've got a lot of opportunity with rep productivity to be the primary driver of growth. And we certainly believe we're still in the very early stages of growth even in our best core accounts to continue to bring in additional surgeons within those accounts across our applications.

因此，我們認為我們有很多機會讓代表生產力成為增長的主要驅動力。我們當然相信，即使在我們最好的核心客戶中，我們仍處於增長的早期階段，以繼續在我們的應用程序中的這些客戶中引入更多的外科醫生。

And one last one maybe for Karen. The timing of the next-gen advanced product, I think you said is later this year, but I guess, would that be sort of like used across all indications or will be designed more specifically for one? Or I guess any color or thoughts on timing and what might be new about it, if you can elaborate?

最後一個可能是給凱倫的。下一代先進產品的時間，我想你說過是在今年晚些時候，但我想，這會有點像在所有適應症中使用，還是會更專門為一個適應症設計？或者，如果您可以詳細說明，我猜想有什麼顏色或關於時間的想法以及它可能有什麼新內容嗎？

So this is -- you're asking specifically about NextGen Avance?

所以這是——你是在專門詢問 NextGen Avance？

Yes.

是的。

Yes. So we haven't given any updates on a description of the product. I can tell you it won't be available this year. We'll complete the BLA and then be talking with the FDA about the second generation and on Avance. And then we are also working on some concepts for a third-generation Avance with the idea that we would like to have a third-generation Avance 12 years from now.

是的。所以我們沒有對產品的描述進行任何更新。我可以告訴你它今年不會上市。我們將完成 BLA，然後與 FDA 討論第二代和 Avance。然後我們還在研究第三代 Avance 的一些概念，我們希望在 12 年後擁有第三代 Avance。

At this time, we've reached the end of our question-and-answer session. I'll hand the floor back to Karen Zaderej for closing remarks.

至此，我們的問答環節已經結束。我將把發言權交還給 Karen Zaderej，讓他發表閉幕詞。

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

謝謝你，Rob，我還要感謝 AxoGen 團隊，他們仍然非常致力於我們改善周圍神經損傷患者生活質量的使命。我們對今年在實現目標方面取得的進展感到滿意，我們將繼續專注於確保我們的長期成功。我要感謝大家今天早上加入我們。謝謝你，祝你有美好的一天。

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

今天的會議到此結束。感謝您的參與。此時您可以斷開線路。