AxoGen Inc (AXGN) 2021 Q4 法說會逐字稿

Greetings. Welcome to the AxoGen, Inc. Fourth Quarter 2021 Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ed Joyce, AxoGen's Director of Investor Relations. Please begin, Mr. Joyce.

問候。歡迎參加 AxoGen, Inc. 2021 年第四季電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。現在我想將會議交給東道主 Ed Joyce，他是 AxoGen 的投資者關係總監。請開始，喬伊斯先生。

Thank you, Hillary, and good afternoon, everyone. Joining me on today's call is Karen Zaderej, AxoGen's Chairman, Chief Executive Officer and President; and Peter Mariani, Executive Vice President and Chief Financial Officer. Karen will begin today's call with an overview of our fourth quarter and update on our operational highlights and our guidance for the year. Pete will then provide an analysis of our financial performance, followed by closing remarks from Karen and a question-and-answer session.

謝謝希拉里，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；執行副總裁兼財務長 Peter Mariani。凱倫將在今天的電話會議中概述我們第四季度的情況，並更新我們的營運亮點和今年的指導。然後，皮特將對我們的財務業績進行分析，然後由凱倫進行總結發言並進行問答環節。

Today's call is being broadcast live via webcast, which is available on the Investors section of AxoGen website. Within an hour of the end of this call, a replay will be available on the Investors 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 be making 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 which may cause actual results or events to differ materially from those described in the 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。本次電話會議結束後一小時內，將在本公司網站 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，在這次電話會議期間，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。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 process and approvals, APC renovation timing and expense, financial performance, sales growth, product adoption, market awareness and our products, data validation, our assessment of our internal controls over financial reporting, our visibility and sponsorship of conferences and educational events and other matters not within our control. And with that, I'd like to turn the call over to Karen. Karen?

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的聲明、監管流程和批准、APC 改造時間和費用、財務表現、銷售成長、產品採用、市場意識和我們的產品、數據驗證、我們對財務報告內部控制的評估、我們對會議和教育活動的可見性和贊助以及其他不屬於我們範圍內的事項控制。說到這裡，我想把電話轉給凱倫。凱倫？

Thank you, Ed, and good afternoon, everyone. Our total revenue for the fourth quarter was $31.5 million, representing a 3% decline versus the prior year period. Excluding the impact of revenues from Avive Soft Tissue Membrane in both years, revenue for the quarter was approximately flat year-over-year. Although we saw a sequential improvement in revenue in November, the Omicron variant negatively impacted procedure volumes and hospital staffing in December, which negatively impacted our revenues for the quarter.

謝謝你，艾德，大家下午好。我們第四季的總營收為 3,150 萬美元，比去年同期下降 3%。剔除 Avive 軟組織膜兩年營收的影響，本季營收與去年同期基本持平。儘管我們看到 11 月份的收入連續改善，但 Omicron 變體對 12 月份的手術量和醫院人員配備產生了負面影響，從而對我們本季度的收入產生了負面影響。

For the year, we achieved revenue of $127.4 million, an increase of 13% over the last year. Excluding the impact of Avive, revenue increased 15% year-over-year. I'm proud of the growth we were able to achieve despite the ongoing challenges of COVID and hospital staffing shortages, and we believe more surgeons and accounts recognize the value AxoGen provides. We had an excellent year engaging and educating surgeons using a combination of in-person and virtual programs, and we again met our annual goal of training more than 75% of hand and microsurgery fellows.

今年，我們營收 1.274 億美元，比去年成長 13%。剔除Avive的影響，營收年增15%。儘管面臨新冠疫情和醫院人員短缺的持續挑戰，我對我們能夠實現的成長感到自豪，我們相信更多的外科醫生和客戶認識到 AxoGen 提供的價值。我們透過面對面和虛擬計畫相結合的方式吸引和教育外科醫生，度過了美好的一年，我們再次實現了培訓超過 75% 的手部和顯微外科醫師的年度目標。

We are confident that we've built the right organization and a solid foundation of clinical evidence that will allow us to deliver sustainable long-term growth as the impact of COVID wanes and hospital operating environments improve. The Omicron-related challenges we faced late in the fourth quarter continued through the early part of Q1. Like all of you, we're encouraged by reports of declining COVID rates in the recent weeks. However, we believe it will take longer for hospital staffing challenges to improve and for surgical schedules to normalize.

我們相信，我們已經建立了正確的組織和堅實的臨床證據基礎，這將使我們能夠隨著新冠肺炎影響的減弱和醫院運營環境的改善而實現可持續的長期增長。我們在第四季末面臨的與 Omicron 相關的挑戰一直持續到第一季初期。和大家一樣，我們對最近幾週新冠感染率下降的報導感到鼓舞。然而，我們認為醫院人員配備的挑戰需要更長的時間才能改善，手術時間表才能正常化。

As a result, we are measured in our outlook of the pace of procedure volume improvement in the first half of the year compared to 2021 and anticipate a return to more normalized growth rates in the second half. Commercially, we remain focused on driving deeper penetration into customer accounts while also continuing to add new accounts. We've achieved success with this strategy as demonstrated by the growth in our active and core accounts, which helps us frame and monitor our growth.

因此，與 2021 年相比，我們對上半年手術量的改善速度進行了展望，並預計下半年將恢復到更正常化的成長率。在商業上，我們仍然專注於推動對客戶帳戶的更深入滲透，同時繼續增加新帳戶。我們透過這項策略取得了成功，我們的活躍客戶和核心客戶的成長證明了這一點，這有助於我們制定和監控我們的成長。

As a reminder, active accounts have ordered at least 6 times 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 greater than $100,000 in revenue in the trailing 12 months. We ended the year with 951 active accounts, up 6% over the last year and 294 core accounts, up 9% over the last year. Active accounts typically represent about 85% of our total revenue, with the top 10% contributing about 35% of revenue.

提醒一下，活躍帳戶在過去 12 個月內至少訂購過 6 次，並且可能仍處於採用的早期階段。核心帳戶代表滲透率較高的帳戶，定義為過去 12 個月收入超過 10 萬美元的帳戶。截至年底，我們的活躍帳戶數為 951 個，比去年增長 6%；核心帳戶數為 294 個，比去年增長 9%。活躍帳戶通常占我們總收入的 85% 左右，其中前 10% 的帳戶貢獻了約 35% 的收入。

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 going deeper with that first surgeon and gaining adoption by additional surgeons. We have significant opportunity for growth 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.

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，我們專注於與第一位外科醫生進行更深入的合作，並獲得更多外科醫生的採用。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，我們的核心客戶擁有巨大的成長機會。

We ended the year with 115 direct sales representatives, an increase of 6% during the quarter and up from 111 a year ago. We believe we have an established and well-trained sales footprint and expect that our growth can be delivered primarily by improving sales rep productivity. At the same time, we will continue to monitor and evaluate our sales territories for capacity and growth opportunities and anticipate increasing our sales team by 5 to 10 sales reps this year. Our direct sales force continues to be supplemented by independent sales agencies that represented approximately 10% of our total revenue in the fourth quarter.

截至年底，我們有 115 名直銷代表，本季增加了 6%，比去年同期的 111 名增加了 6%。我們相信我們擁有成熟且訓練有素的銷售足跡，並期望我們的成長主要透過提高銷售代表的生產力來實現。同時，我們將繼續監控和評估我們銷售區域的產能和成長機會，並預計今年將我們的銷售團隊增加 5 至 10 名銷售代表。我們的直銷隊伍繼續得到獨立銷售機構的補充，這些機構約占我們第四季總收入的 10%。

We continue to build market awareness through numerous initiatives across our applications. For example, we're employing direct-to-patient educational campaigns to increase awareness of the potential for nerve repair procedures to improve outcomes for patients with breast cancer and those suffering from chronic neuropathic pain. Over the last few years, we've been very successful growing the number of patients visiting our re-sensation website to learn more about the problem of breast numbness, post-mastectomy and the potential for nerve repair to restore sensation.

我們繼續透過應用程式中的眾多舉措來建立市場意識。例如，我們正在進行直接面向患者的教育活動，以提高人們對神經修復手術的潛力的認識，從而改善乳癌患者和慢性神經性疼痛患者的治療結果。在過去的幾年裡，我們非常成功地增加了訪問我們的感覺恢復網站的患者數量，以了解更多有關乳房麻木問題、乳房切除術後以及神經修復恢復感覺的潛力的信息。

In the fourth quarter, we launched an educational animation to help illustrate the problem with post-mastectomy numbness and its impact on quality of life as well as how re-sensation may be a potential solution. Through these awareness efforts, surgeons report that an increasing number of their patients are expressing interest in returning sensation for a more complete breast reconstruction. Leveraging our success with direct-to-patient educational campaigns for re-sensation we're following a similar strategy to increase visitors to our re-think pain website to raise awareness of the surgical treatment of pain as a potential solution for patients suffering from chronic neuropathic pain.

在第四季度，我們推出了一部教育動畫，以幫助說明乳房切除術後麻木的問題及其對生活品質的影響，以及重新感覺如何成為潛在的解決方案。透過這些宣傳工作，外科醫生報告說，越來越多的患者表示有興趣恢復感覺以進行更完整的乳房重建。利用我們透過直接面向患者的重新感覺教育活動所取得的成功，我們正在遵循類似的策略來增加我們重新思考疼痛網站的訪問者，以提高對疼痛手術治療作為慢性疼痛患者的潛在解決方案的認識神經性疼痛。

In 2021, we initiated a partnership with the U.S. Pain Foundation. Each November, the foundation runs a campaign called November to explore and educate on a unique area of pain management through webinars, social media content and more. In November of 2021, the foundation focused its campaign to raise awareness of neuropathic pain and its treatment options resulting in a significant community response. Direct-to-patient educational campaigns will continue to be important in our market development efforts for the breast and pain applications.

2021 年，我們與美國疼痛基金會建立了合作關係。每年 11 月，基金會都會舉辦一場名為「11 月」的活動，透過網路研討會、社群媒體內容等方式探索和教育疼痛管理的獨特領域。 2021 年 11 月，基金會的活動重點是提高人們對神經性疼痛及其治療方案的認識，從而引起了社區的強烈反響。直接面向患者的教育活動將繼續在我們的乳房和疼痛應用市場開發工作中發揮重要作用。

In terms of our progress with our clinical endeavors, we continue to expect top line results of our RECON study in the second quarter. RECON is our Phase III pivotal study supporting our Biologics License Application, or BLA, which will transition our Avance Nerve Graft from a Section 361 tissue product to a Section 351 biological product. We look forward to the readout of our RECON topline results. The study was designed to test for noninferiority of the primary endpoint, static 2-point discrimination as compared to conduit nerve repairs.

就我們的臨床工作進展而言，我們繼續期待第二季 RECON 研究的頂線結果。 RECON 是我們的 III 期關鍵研究，支持我們的生物製劑許可申請 (BLA)，這將使我們的 Avance 神經移植物從第 361 節組織產品轉變為第 351 節生物產品。我們期待 RECON 的主要結果的公佈。研究旨在測試主要終點的非劣效性，即與導管神經修復相比的靜態 2 點辨別力。

In addition to the RECON data, our teams are continuing to work on other BLA, CMC, and documentation requirements for our facilities, operations, quality systems and validation as a part of our preparations for a successful application. We expect to submit our BLA to the FDA in 2023. Our RANGER and MATCH registries continue to enroll now with over 2,600 nerve repairs enrolled in RANGER. MATCH is a subset of the RANGER registry, which is the comparative population of conduits and autograft subjects for RANGER.

除了 RECON 數據之外，我們的團隊還在繼續滿足我們的設施、營運、品質體系和驗證的其他 BLA、CMC 和文件要求，作為我們成功應用的準備工作的一部分。我們預計於 2023 年向 FDA 提交 BLA。 MATCH 是 RANGER 註冊表的一個子集，它是 RANGER 的導管和自體移植受試者的比較群體。

Readouts from this data have demonstrated that advanced nerve graft outcomes were statistically significantly better than conduit and were similar to those for autograft. Data from these 2 clinical registries continues to play an important role informing 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. Surgery delays have led to slower-than-expected enrollment, and we're now anticipating completing enrollment in Q2 of this year, with a topline data readout from the comparative phase in Q3 of 2023.

此數據的讀數表明，先進的神經移植結果在統計上顯著優於導管，並且與自體移植的結果相似。這兩個臨床登記處的數據繼續在外科醫生的臨床決策過程中發揮重要作用。 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。手術延遲導致入組速度慢於預期，我們現在預計在今年第二季完成入組，並在 2023 年第三季公佈比較階段的主要數據。

We've always made clinical evidence generation, an important priority and believe that our collection of meaningful data publications is the most comprehensive in the area of peripheral nerve repairs. This unparalleled amount of evidence in nerve repair is expected by our surgeons and payers when making clinical care decisions. As of the end of the year, we have 181 peer-reviewed papers, including growing numbers among all of our nerve repair applications, namely trauma, breast, OMF, and the surgical treatment of pain.

我們始終將臨床證據生成作為重要的優先事項，並相信我們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。我們的外科醫生和付款人在做出臨床護理決策時期望獲得如此多的神經修復證據。截至今年年底，我們有 181 篇同行評審論文，其中包括越來越多的神經修復應用領域的論文，即創傷、乳房、OMF 和疼痛的外科治療。

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. I'd now like to spend a moment discussing our outlook for this year. We expect that full year revenue in 2022 will be in the range of $135 million to $142 million. This revenue guidance represents about 10% to 15% growth over 2021, excluding the $4.1 million of Avive revenue from last year.

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。現在我想花點時間討論我們今年的展望。我們預計 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 年成長約 10% 至 15%，不包括 Avive 去年 410 萬美元的營收。

Full year gross margin is expected to be above 80%. As I noted earlier, we're being measured in our outlook for procedure volume improvement 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. 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 COVID pandemic wanes and hospital operating environments improve.

全年毛利率預計在80%以上。正如我之前指出的，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。我們相信，我們已經建立了具有堅實臨床證據基礎的正確組織，隨著新冠疫情大流行的影響減弱和醫院運營環境改善，我們能夠實現可持續的長期增長。

We continue to view AxoGen as a long-term growth company, delivering sustainable annual revenue growth in the high teens to low 20% range. Now I'll turn the call over to Pete for a review of financial highlights. Pete?

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。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. Fourth-quarter revenue was $31.5 million, a 3% decrease compared to Q4 of 2021. Fourth-quarter revenue was negatively impacted by COVID and related hospital staffing challenges, particularly in the final weeks of the quarter. Fourth-quarter revenue includes $500,000 from the reversal of a sales return reserve recorded in the second quarter of 2021 for Avive soft tissue membrane for which we voluntarily suspended from market availability on June 1, 2021. Avive revenue in the fourth quarter of 2020 was $1.6 million.

謝謝你，凱倫。第四季營收為 3,150 萬美元，比 2021 年第四季下降 3%。第四季營收包括2021 年第二季記錄的Avive 軟組織膜銷售退貨準備金沖銷帶來的50 萬美元，我們於2021 年6 月1 日自願暫停該膜的市場供應。收入為1.6 美元百萬。

Gross profit for the fourth quarter was $26.1 million compared to $27 million in Q4 of 2020. Gross margin was 82.8% for Q4 compared to 83.2% in the prior year fourth quarter. Total operating expense in the fourth quarter decreased 3% to $31.5 million compared to $32.4 million in the prior year. The decrease is primarily due to a reduction in employee compensation where decreases in incentive and stock compensation, bonus and commissions were partially offset by increases in salaries.

第四季的毛利為 2,610 萬美元，而 2020 年第四季的毛利為 2,700 萬美元。第四季總營運費用下降 3%，至 3,150 萬美元，而上年同期為 3,240 萬美元。減少的主要原因是員工薪酬的減少，其中激勵和股票薪酬、獎金和佣金的減少被工資的增加部分抵消。

The net decrease in operating expense was partially offset by increases in professional and consulting fees, marketing programs and travel, and research and development projects. Sales and marketing expense in the fourth quarter decreased 11% to $17.7 million compared to $19.8 million in the prior year. The decrease is primarily related to lower employee compensation, partially offset by an increase in marketing programs and travel. As a percent of total revenue, sales and marketing expenses decreased to 56% for the 3 months ended December 31 compared to 61% in the prior year.

營運費用的淨減少被專業和諮詢費用、行銷計劃和差旅以及研發項目的增加部分抵消。第四季銷售和行銷費用為 1,770 萬美元，較上年同期的 1,980 萬美元下降 11%。這一下降主要與員工薪酬下降有關，但行銷計劃和旅行的增加部分抵消了這一下降。截至 12 月 31 日的三個月，銷售和行銷費用佔總收入的百分比下降至 56%，而去年同期為 61%。

Research and development expenses increased 28% to $6.3 million compared to $4.9 million in the prior year. Product development expenses represented approximately 73% of total research and development expenses for the current quarter as compared to 55% in the prior year. The increase in product development expense reflects increased spending and specific programs, including our efforts related to the BLA for Avance nerve graft and a next-generation Avance product.

研發費用增加 28%，達到 630 萬美元，而前一年為 490 萬美元。產品開發費用約佔本季研發費用總額的 73%，去年同期為 55%。產品開發費用的增加反映了支出和具體計劃的增加，包括我們與 Avance 神經移植 BLA 和下一代 Avance 產品相關的努力。

Clinical trial expenses represented approximately 27% of research and development expenses in the fourth quarter compared to 45% in the prior year. As a percentage of total revenue, Research and development expenses were 20% in Q4 compared to 15% in the prior year. General and administrative expense in the fourth quarter decreased 3% to $7.4 million compared to $7.7 million in the prior year. G&A as a percent of revenue was 24% in both periods.

第四季臨床試驗費用約佔研發費用的 27%，去年同期為 45%。第四季研發費用佔總收入的比例為 20%，去年同期為 15%。第四季一般及管理費用下降 3%，至 740 萬美元，而去年同期為 770 萬美元。兩個時期的 G&A 佔收入的百分比均為 24%。

The net decrease is due primarily to decreases in employee compensation, partially offset by increased professional and consulting fees. Adjusted net loss and net loss per share was 3.3 and $0.08 per share in both fourth quarters of 2021 and 2020. Adjusted net loss in the quarter was $1.7 million compared to an adjusted EBITDA loss of $1.3 million in the prior year. The company has updated its definition of EBITDA and adjusted EBITDA to now include amortization of the right-of-use assets and debt discount and deferred financing fees. The reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and on our website.

淨減少主要是由於員工薪酬的減少，部分被專業和諮詢費用的增加所抵消。 2021 年和 2020 年第四季的調整後淨虧損和每股淨虧損分別為 3.3 美元和 0.08 美元。該公司更新了 EBITDA 的定義，並將 EBITDA 調整為現在包括使用權資產攤提、債務折扣和遞延融資費用。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。

The balance of all cash, cash equivalents and investments on December 31, 2021, was $90.3 million compared to a balance of $98.1 million on September 30 of '21. The net change includes capital expenditures of $5.8 million related to the construction of our new processing facility in Dayton, Ohio and $1.9 million of operating cash burn in the quarter. we typically see elevated operating cash burn in the first half of the year, and we expect this to be the case again in 2022.

截至 2021 年 12 月 31 日，所有現金、現金等價物和投資的餘額為 9,030 萬美元，而 2021 年 9 月 30 日的餘額為 9,810 萬美元。淨變化包括與俄亥俄州代頓新加工設施建設相關的 580 萬美元資本支出以及本季營運現金消耗 190 萬美元。我們通常會在上半年看到營運現金消耗增加，並且預計 2022 年將再次發生這種情況。

We expect this to improve in the second half of the year. Additionally, we anticipate capital expense to be up to $14 million over the course of the year for the physical completion equipment and validation of the Dayton facility, along with up to $6 million in capitalized interest through the end of the year, and we expect to convert production to the new facility in early 2023. With $90 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.

我們預計這一情況將在下半年得到改善。此外，我們預計今年用於實體完井設備和代頓設施驗證的資本支出將高達 1,400 萬美元，以及到年底資本化利息高達 600 萬美元，我們預計我們將於2023 年初將生產轉移到新工廠。我們擁有9,000 萬美元現金，資產負債表強勁，預計到年底我們將處於有利地位，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。

As Karen mentioned, our guidance for full year 2022 will be in the range of $135 million to $142 million. and this represents about 10% growth year-over-year, excluding the impact of $4.1 million of Avive revenue from 2021. We're being measured in our outlook for procedure volume improvement 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. And as a matter of corporate housekeeping, we will be providing an update to our expiring shelf registration along with the filing of our 10-K in the coming days. And with that, I'd like to hand the call back over to Karen.

正如 Karen 所提到的，我們對 2022 年全年的指導將在 1.35 億美元至 1.42 億美元之間。這意味著同比增長約 10%，不包括 2021 年 Avive 收入 410 萬美元的影響。到更正常化的程度。作為公司內務管理的問題，我們將在未來幾天內提供即將到期的貨架註冊的更新以及 10-K 的備案。說到這裡，我想把電話轉回給凱倫。

Thank you, Pete. I'm proud of our achievements this year and of the entire AxoGen team in the face of pandemic headwinds. We remain committed to delivering our innovative nerve repair solutions to patients, surgeons and hospitals, and I believe we're well positioned for long-term success. At this point, I'd like to open up the line for questions. Hillary?

謝謝你，皮特。我為我們今年的成就以及整個 AxoGen 團隊面對大流行病的逆風感到自豪。我們仍然致力於為患者、外科醫生和醫院提供創新的神經修復解決方案，我相信我們已經做好了長期成功的準備。此刻，我想開通提問專線。希拉蕊？

(Operator Instructions) Our first question is from Dave Turkaly of JMP Securities.

（操作指示）我們的第一個問題來自 JMP 證券的 Dave Turkaly。

Pete, maybe just following up on the commentary on the spend you expect in 2022, if your adjusted EBITDA loss was close to $7 million this year, it sounds like you still have some initiatives that you're anticipating spending on. Directionally, I mean, you're almost breakeven and you have plenty of cash, but that EBITDA losses if you were just commenting up or down. Is it up a little bit this year and then when the new facility is on in '23, would you expect it to be -- would you expect to breakeven?

Pete，也許只是跟進您對 2022 年預期支出的評論，如果您今年調整後的 EBITDA 損失接近 700 萬美元，那麼聽起來您仍然有一些預計支出的計劃。我的意思是，從方向上看，你幾乎實現了盈虧平衡，並且擁有大量現金，但如果你只是向上或向下評論，那麼 EBITDA 就會損失。今年是否會上漲一點，然後當新設施在 23 年投入使用時，您是否預計會實現收支平衡？

Look, we're headed in the right direction. I mean, I think your point is right. As we get the building up and running and as we continue to drive revenue growth, I think we're certainly on the path towards breakeven across the line, but I'm not going to call that in in 2022. We're not going to give that type of outlook. But certainly, we're in a good position from a spend perspective. We can -- we've got some initiatives that we're continuing to invest in around the BLA product development and other items. And we think we're in a good position to manage spend well through next year and into '23.

看，我們正朝著正確的方向前進。我的意思是，我認為你的觀點是正確的。隨著我們的建設和運行，以及我們繼續推動收入成長，我認為我們肯定正在全面實現盈虧平衡，但我不會在 2022 年宣布這一點。但當然，從支出角度來看，我們處於有利地位。我們可以——我們已經圍繞 BLA 產品開發和其他項目繼續投資一些舉措。我們認為我們處於有利位置，可以很好地管理明年和 23 年的支出。

Yes. And I don't think anyone would be super surprised about the measured sales outlook as a lot of companies are kind of forecasting that at least in the first half of the year. Could you just remind us, the RECON readout, like what are we anticipating there? I know you said in the second quarter. Is it just -- will it just be a PR? Or are you going to do a call or like what are the plans right now?

是的。我認為沒有人會對測量的銷售前景感到非常驚訝，因為許多公司至少在今年上半年都做出了預測。你能否提醒我們，偵察讀數，例如我們在那裡期待什麼？我知道你在第二季說過。這只是——這只是一個公關嗎？或者你要打個電話或現在有什麼計劃嗎？

Yes, we'll do -- we're going to do a press release and we'll schedule a call. As soon as we have the information available, we'll be excited to talk about that.

是的，我們會做的事——我們將發布新聞稿，並安排電話會議。一旦我們掌握了可用的信息，我們就會很高興地談論這個問題。

Our next question is from Danielle Antalffy of SVB Leerink.

我們的下一個問題來自 SVB Leerink 的 Danielle Antalffy。

This is Erin on for Danielle. I was just hoping you guys could talk about some of the trends that you saw in the fourth quarter related to Omicron and hospital staffing shortages and maybe how that's trended starting heading into the first quarter?

這是丹妮爾的艾琳。我只是希望你們能談談你們在第四季度看到的一些與 Omicron 和醫院人員短缺相關的趨勢，也許從第一季開始趨勢如何？

Sure. I think we're on a pretty good trend of what we measure as daily sales in November and then certainly in December, started to see some substantial drop off of that, especially towards the back end. As Omicron started to ramp up, hospitals had the double whammy of both capacity constraints because of patients in the hospital because of COVID patients testing positive when they were showing they're asymptomatic and showing up for procedures, but not able to have procedures because they were positive with COVID and being sent home and then constraints in terms of staffing. And that continued into January. Now as COVID has -- the incidence rate has come down and to some extent, has come down of hospital beds as well. We start to see things loosening up and getting -- trending much better, and we hope to see that continue to trend.

當然。我認為我們在 11 月和 12 月的每日銷售額方面處於一個非常好的趨勢，開始看到一些大幅下降，特別是在後端。隨著 Omicron 開始擴張，醫院面臨著容量限制的雙重打擊，因為新冠肺炎患者在醫院中表現出無症狀並前往接受手術，但無法進行手術，因為他們在醫院接受治療。回家，然後人員配備受到限制。這種情況一直持續到一月份。現在，隨著新冠肺炎的發生，發生率下降了，在某種程度上，醫院的病床也下降了。我們開始看到事情正在放鬆並變得更好，我們希望看到這種趨勢繼續下去。

Okay. Great. And then if you could just -- regarding the 2022 guidance, just if you could walk us through kind of some of the assumptions baked in regarding COVID and hospital staffing shortages and kind of what we would expect to see maybe at the upper and the lower end of the range.

好的。偉大的。然後，如果您能——關於 2022 年的指導意見，如果您能引導我們了解一些有關新冠肺炎和醫院人員短缺的假設，以及我們期望在上層和下層看到的情況範圍的末端。

Yes. I think our observation is that even though COVID is certainly coming down -- COVID is coming down, hospitals are still dealing with a census that includes a lot of COVID patients, and we expect that to improve. But what we also are recognizing is that the hospitals still have challenges with staffing. And we think that will take some additional time for them to work through.

是的。我認為我們的觀察是，儘管新冠病毒肯定會下降——新冠病毒正在下降，但醫院仍在進行包括大量新冠患者在內的人口普查，我們預計情況會有所改善。但我們也意​​識到，醫院在人員配置方面仍面臨挑戰。我們認為他們需要一些額外的時間來解決這個問題。

Look, we see hospitals as being very resilient. They will figure this out. We think that in time, this will move back towards what we all hope to be a more normalized situation where surgical schedules are keeping up with the current pace. But I think in our outlook, we wanted to just be fairly measured in assuming when that's going to happen and not get out in front of it. We'll see how things go over the rest of this quarter. And we certainly think that back half of the year, this is back to more normalized growth rates for us.

看，我們認為醫院非常有彈性。他們會解決這個問題的。我們認為，隨著時間的推移，這將回到我們都希望的更正常化的情況，即手術時間表跟上當前的步伐。但我認為，在我們的前景中，我們只是想公平地估計這種情況何時會發生，而不是提前採取行動。我們將看看本季剩餘時間狀況如何。我們當然認為，今年下半年，我們將恢復到更正常化的成長率。

Our next question is from Frank Pinal of Jefferies.

我們的下一個問題來自 Jefferies 的 Frank Pinal。

Hope everyone is doing well. A bit of a follow-up to the last question. I was hoping you can maybe provide some color on rep access sort of exiting last year and so far, what you're seeing this year? And I have a follow-up to that.

希望每個人都做得很好。對最後一個問題的一些後續。我希望您能提供一些有關去年退出的代表訪問權限的信息，到目前為止，您今年看到了什麼？我對此有後續行動。

Well, through the year, we've seen rep access actually get better. Obviously, when things were shut down completely, it went down completely as we've seen hospitals become more comfortable with operating in a COVID environment, they've allowed rep access to occur. It does go up and down depending on what's happening with the hospital in terms of their COVID constraints at a moment if they move into crisis management, then where their extreme capacity, they don't want reps in there. But they're also limited in the number of procedures that they can do.

嗯，這一年來，我們看到代表訪問實際上得到了改善。顯然，當事情完全關閉時，它就完全停止了，因為我們看到醫院在新冠病毒環境下變得更加適應運營，他們允許代表進行訪問。它確實會上下波動，這取決於醫院在新冠肺炎限制方面所發生的情況，如果他們進入危機管理階段，那麼他們的極限能力，他們不希望代表在那裡。但他們可以執行的程式數量也受到限制。

Having said that, I think that some of the tools that we learned in remote case coverage during the COVID pandemic will continue to be important to us, it both helps our productivity as these are unscheduled cases. And many hospitals have put in place restrictions that I think are going to be durable post all of this and that they don't want -- they will ask reps in for a specific case, but not allow reps to just visit the OR on a daily basis and check out the Board. And I think those changes are going to be more durable for the long term. So we've been very successful with the resources that we provide to surgeons to be able to have the access that we need in most cases. And where we can't do that, we can do the remote case coverage.

話雖如此，我認為我們在新冠病毒大流行期間在遠程病例報道中學到的一些工具對我們來說仍然很重要，它有助於我們的生產力，因為這些都是計劃外病例。許多醫院已經實施了限制，我認為這些限制在所有這一切之後將是持久的，但他們不希望這樣做——他們會要求代表來處理特定的病例，但不允許代表只在特定情況下訪問手術室。我認為從長遠來看，這些變化將更加持久。因此，我們非常成功地為外科醫生提供了在大多數情況下所需的資源。如果我們無法做到這一點，我們可以進行遠端病例報告。

Great. I guess, a follow-up to a prior question as well on RECON. What sort of the significance in your view, how are you thinking about the significance of a positive top line readout? I'm sure you're expecting that at this point, but I guess, really on growth penetration. And will the BLA -- will BLA approval in 2023 allow you to charge a premium for Avance? I guess, in addition to what seems like already favorable CMS reimbursement trends that you discussed at least on the JPM presentation.

偉大的。我想，這也是 RECON 上一個問題的後續。您認為有什麼樣的意義？我確信您現在已經在期待這一點，但我想，真正在成長滲透方面。 BLA 是否會在 2023 年獲得 BLA 批准，允許您對 Avance 收取溢價？我想，除了您至少在摩根大通演講中討論過的看似已經有利的 CMS 報銷趨勢之外。

Sure. Well, I'll start with the pricing piece. Being a BLA, actually, we don't believe we'll adjust the reimbursement of Avance. So we don't see that as impacting our pricing strategy. We think that we've done a good job of looking at this and pricing this to be comparable to autograft so that from an economic standpoint to hospitals, it is a good choice for their patients to switch from autografting to Avance. In terms of the data readout, we're getting very excited about that.

當然。好吧，我將從定價部分開始。事實上，身為 BLA，我們不認為我們會調整 Avance 的報銷。因此，我們認為這不會影響我們的定價策略。我們認為，我們已經很好地研究了這一點，並將其定價為與自體移植相當，因此從經濟角度來看，醫院的患者從自體移植轉向 Avance 是一個不錯的選擇。就數據讀出而言，我們對此感到非常興奮。

I think that there's an opportunity -- there's an opportunity for us to, in fact, showcase this with a lot of surgeons. Our PIs are pretty enthusiastic about getting a chance to announce this information. We will be looking to present it later in some conferences.

我認為這是一個機會——事實上，我們有機會向許多外科醫生展示這一點。我們的 PI 非常熱衷於有機會宣布這一訊息。我們將在稍後的一些會議上介紹它。

Obviously, we'll do the short-term presentation here when we -- when we have the data in second quarter, but we're looking for more extended review with surgeons and some presentations at scientific conferences later this year and think that it's going to create some buzz among our surgeon friends as they continue to think about changing their treatment algorithms. This is important -- really for middle adopters, our early adopters and innovators they were willing to try Avance and actually help us build this data. But middle adopters are looking for this type of level 1 evidence to be confident in changing their treatment algorithms. And we think it will be helpful as we continue to drive penetration in some of our core accounts to help convert those middle adopters.

顯然，當我們在第二季度獲得數據時，我們將在這裡進行短期演示，但我們正在尋求與外科醫生進行更廣泛的審查，並在今年晚些時候的科學會議上進行一些演示，並認為這將會發生當我們的外科醫生朋友繼續考慮改變他們的治療演算法時，他們會引起一些轟動。這很重要——對於中間採用者、我們的早期採用者和創新者來說，他們願意嘗試 Avance 並實際上幫助我們建立這些數據。但中間採用者正在尋找這種類型的 1 級證據，以便有信心改變他們的治療演算法。我們認為，隨著我們繼續推動一些核心客戶的滲透，以幫助轉換那些中間採用者，這將很有幫助。

I do want to go back real quick. One thing I thought I heard you say with BLA approval in 2023, we actually plan to do the submission in 2023. And while we have an expedited review with the FDA, I think we should assume right now that it will be a year approval, just they're running a little slower and [saber] given some of the other things going on. So we're assuming a 2024 approval.

我確實想快點回去。我想我聽到你說 BLA 在 2023 年獲得批准，我們實際上計劃在 2023 年進行提交。的運行速度有點慢並且[軍刀]考慮到其他一些事情正在發生。所以我們假設 2024 年會獲得批准。

(Operator Instructions) Our next question is from Gibran Ahmed of Canaccord. Please proceed with your question.

（操作員說明）我們的下一個問題來自 Canaccord 的 Gibran Ahmed。請繼續你的問題。

This is Gibran on for Kyle. I guess one question from us. In terms of backlog, sort of a follow-up from the Omicron dynamics seen at the end of the Q4. Did the backlog grow this quarter? Maybe has there been any sort of shift in terms of how the 2022 guide is assuming working through that backlog? Obviously, less of a factor on the trauma side of the business, but curious if any sort of dynamics have shifted on that front.

這是紀伯倫為凱爾做的。我猜我們有一個問題。就積壓訂單而言，有點像第四季末 Omicron 動態的後續情況。本季積壓數量有增加嗎？也許 2022 年指引假設如何處理積壓工作有任何變化？顯然，這對業務的創傷方面影響較小，但很好奇這方面是否有任何動態變化。

Yes. Thank you for the question. We do believe that there are some deferred cases in certainly all of our segments. But in trauma, we no longer have visibility to what those are. It really has to do with the staffing issues that they have. In the first round, if you go back to 2020, when hospitals were turned back on, they were able to run with significant overtime and pulled back these nerve repair patients very quickly. And we could see a very clear spike in their business as they worked off all of their deferred patients in about a 2- to 4-week period, they no longer have that flexibility. They can't work them off that quickly.

是的。感謝你的提問。我們確實相信，我們所有的細分市場都存在一些延期案例。但在創傷中，我們不再了解這些是什麼。這確實與他們面臨的人員配備問題有關。第一輪，如果你回到2020年，當醫院重新開放時，他們能夠大量加班，很快就拉回了這些神經修復患者。我們可以看到他們的業務出現了非常明顯的激增，因為他們在大約 2 到 4 週的時間內處理掉了所有延期的患者，他們不再具有這種靈活性。他們不可能這麼快就把它們解決掉。

We do think that they'll be bringing patients back in. And as a reminder, you can do nerve repair. It's always better when it's done sooner in terms of the outcomes expected, but you can still get good meaningful recovery up to a year post the injury. So it isn't something that has to be done in days or weeks. It's better if it's sooner, but we think it's going to be a little bit longer tail for any deferred patients. In our more elective procedures like in particular, breast neurotization we do have a fair number of patients who are -- have been deferred on their breast reconstructions. These deep flat procedures are pretty resource-intensive in the hospital. They're a long surgical procedure, and they're an inpatient stay.

我們確實認為他們會把病人帶回來。就預期結果而言，越早完成總是越好，但您仍然可以在受傷後一年內獲得良好且有意義的恢復。因此，這不是必須在幾天或幾週內完成的事情。越早越好，但我們認為對於任何延期的患者來說，尾巴會更長一些。在我們更多的選擇性手術中，特別是乳房神經化手術中，我們確實有相當多的患者被推遲了乳房重建手術。這些深層平坦手術在醫院中是相當資源密集的。這是一個漫長的外科手術，而且是住院治療。

And so from a resource standpoint in a hospital, they are actually some of the first ones we see deferred every time that there's been a hospital constraint. And so at this point, we are having surgeons tell us that they have substantial deferred waiting lists and deferred patients, but they don't have enough block time in the OR to work them off quickly. So they are telling us that it may take them as much as a year or more to work through their deferred patients. So while we thought about that in our guidance, it's also something that's going to trickle in. It's not going to be a big spike.

因此，從醫院資源的角度來看，每當醫院出現限制時，它們實際上是我們首先看到的一些延遲。因此，此時，外科醫生告訴我們，他們有大量的推遲等待名單和推遲的患者，但他們在手術室沒有足夠的空閒時間來快速處理這些問題。因此，他們告訴我們，他們可能需要一年或更長時間才能處理好延期的患者。因此，雖然我們在指導中考慮了這一點，但它也會慢慢滲透進來。

That's helpful. Appreciate the color there, Karen. And then maybe if I could just squeeze a second one in. The active account, core account numbers have held relatively sort of steady now for a couple of quarters in terms of percentages of revenue. I guess what do you need to see to start maybe getting more pull-through from those active accounts into core accounts? Does that direct-to-patient marketing efforts that you alluded to? Does that help sort of drive that? Or maybe what are some other factors to consider there?

這很有幫助。欣賞那裡的顏色，凱倫。然後也許我可以再擠入第二個帳戶。我想您需要看到什麼才能開始將更多的資金從這些活躍帳戶轉移到核心帳戶？您提到的直接面向患者的行銷工作是嗎？這有助於推動這一點嗎？或者也許還有哪些因素需要考慮？

Yes. So first of all, we expect the percent of our revenue to remain approximately the same. Now we expect our revenue to grow up, but to go up -- but for example, approximately 60% of our revenue coming from these core accounts as our revenue goes up, it's going to be primarily driven by increased penetration in core accounts. And so we think that 60% number will hold approximately the same. The drivers of that are really increasing the usage of surgeons within the accounts.

是的。因此，首先，我們預計我們的收入百分比將保持大致相同。現在，我們預計我們的收入會成長，但會成長——但舉例來說，隨著我們收入的成長，我們約60% 的收入來自這些核心客戶，這將主要由核心客戶滲透率的提高所推動。因此我們認為 60% 的數字大致相同。其驅動因素實際上是增加了外科醫生在帳戶中的使用率。

So it is really that first surgeon. I've described this as almost a stair step of adoption. That first surgeon who's kind of our anchor surgeon in the core account has some significant adoption, but it's not fully adopted. We want to continue to drive full adoption with that surgeon so that they become a champion across the full algorithm that we teach and start to move to the second and third surgeon at those accounts.

所以這確實是第一位外科醫生。我將這描述為幾乎是採用的階梯。第一個外科醫生是我們核心帳戶中的主力外科醫生，有一些重要的採用，但還沒有完全採用。我們希望繼續推動該外科醫生的全面採用，以便他們成為我們教授的完整演算法的冠軍，並開始轉向這些帳戶的第二和第三外科醫生。

In addition, at our biggest accounts, we can be bringing in the breast business and the surgical treatment of pain. Those are the segments that are driven more on the patient education segment to help patients start to show up and ask the right questions to say, I think sensation is important to me in my breast reconstruction and I want to understand where I can get that done. And we're more and more seeing patients showing up understanding that, that is a problem and looking to have the repair done in a site that will do the re-sensation technique.

此外，在我們最大的客戶中，我們可以引入乳房業務和疼痛的手術治療。這些部分在患者教育部分受到更多推動，以幫助患者開始出現並提出正確的問題，我認為感覺對我的乳房重建來說很重要，我想了解我可以在哪裡完成這項工作。我們越來越常看到患者意識到這是一個問題，並希望在能夠進行重感覺技術的部位進行修復。

We have reached the end of the question-and-answer session. I will now turn the call back over to Karen Zaderej for closing remarks.

我們的問答環節已經結束。現在，我將把電話轉回給凱倫‧札德雷 (Karen Zaderej)，讓其致閉幕詞。

Thank you, Hillary. I just want to thank everyone for joining us on today's call, and we look forward to speaking with you in the near future.

謝謝你，希拉蕊。我只想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。

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

今天的會議到此結束。此時您可以斷開線路。感謝您的參與，祝您有美好的一天。