AxoGen Inc (AXGN) 2021 Q3 法說會逐字稿

Greetings. Welcome to AxoGen Reports Third Quarter 2021 Financial Results Call. (Operator Instructions) Please note, this conference is being recorded.

問候。歡迎參加 AxoGen 報告 2021 年第三季財務業績電話會議。 （操作員說明）請注意，本次會議正在錄製中。

At this time, I will now turn the call over to Peter Mariani, Executive Vice President and CFO. Mr. Mariani, you may now begin.

此時，我將把電話轉給執行副總裁兼財務長 Peter Mariani。馬裡亞尼先生，您現在可以開始了。

Thank you, Rob. Good afternoon, everyone.

謝謝你，羅布。大家下午好。

Joining me on today's call is Karen Zaderej, AxoGen's Chairman, Chief Executive Officer and President. Karen will begin today's call with an overview of our third quarter performance, an update on our operational highlights and a review of our revised financial guidance. I will then provide an analysis of our financial performance, followed by closing remarks from Karen and a question-and-answer session.

參加今天電話會議的是 AxoGen 董事長、執行長兼總裁 Karen Zaderej。凱倫將在今天的電話會議中概述我們第三季度的業績、更新我們的營運亮點以及審查我們修訂後的財務指引。然後，我將提供我們的財務績效分析，然後是凱倫的閉幕詞和問答環節。

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

今天的電話會議透過網路直播進行現場直播，可在 AxoGen 網站的投資者部分查看。現場電話會議結束後一小時內，公司網站 www.axogeninc.com 的投資者部分將提供重播。

Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC, including, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, statements related to the expected impact of COVID-19 on our business, statements regarding our growth, our 2021 financial guidance, product development, product potential, regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth and product adoption.

在我們開始之前，我想提醒您，在這次電話會議中，公司將對未來事件做出預測和前瞻性陳述。我們鼓勵您查看公司過去和未來向 SEC 提交的文件，包括但不限於公司的 10-K 和 10-Q 表格，其中確定了可能導致實際結果或事件與中描述的內容有重大差異的具體因素。這些前瞻性陳述。這些因素可能包括但不限於與COVID-19 對我們業務的預期影響相關的聲明、有關我們成長的聲明、我們的2021 年財務指導、產品開發、產品潛力、監管流程和批准、APC 改造時間和費用、財務業績、銷售成長及產品採用率。

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

說到這裡，我想把電話轉給凱倫。凱倫？

Thank you, Pete, and good afternoon, everyone.

謝謝你，皮特，大家下午好。

Our total revenue for the third quarter was $31.2 million, representing a 7% decline versus the prior year period. Excluding the impact of revenue from Avive Soft Tissue Membrane and deferred procedures in the prior year period, revenue growth for the quarter was approximately 9% year-over-year.

我們第三季的總營收為 3,120 萬美元，比去年同期下降 7%。排除去年同期 Avive 軟組織膜收入和延期手術的影響，本季營收年增約 9%。

We're encouraged by the underlying growth in our business in light of the difficult operating environment across our industry during the third quarter. Although we believe the incidence of trauma increased during the third quarter compared to both the prior year and prior quarter, surgical schedules and procedure volumes were negatively impacted by the surge in COVID-19 cases and hospital staffing shortages. These challenges caused some procedures to be deferred, most significantly in the month of August. We saw volumes begin to improve in September and remain consistent in October as hospitals continued to adapt to these challenges.

鑑於第三季整個產業艱難的營運環境，我們業務的潛在成長令我們感到鼓舞。儘管我們認為第三季的創傷發生率比去年和上一季度有所增加，但手術時間表和手術量受到了 COVID-19 病例激增和醫院人員短缺的負面影響。這些挑戰導致一些程序被推遲，最明顯的是在八月。隨著醫院繼續適應這些挑戰，我們看到 9 月的數量開始增加，並在 10 月保持穩定。

We view the negative impact to our procedure volumes as transitory in nature, although the timing of recovery is difficult to predict in light of the ongoing staffing shortages being experienced by many of our customers, the continued uncertainty of COVID-19 and ongoing product shipping and transportation challenges. Nevertheless, we remain highly confident in our commercial execution, the underlying demand for our products and the ability of our customers to overcome the present challenges to deliver important health care to patients, including the surgical repair of nerve injuries. We expect to see improvement in our procedure volumes as pressure on hospital operating schedules continues to abate.

我們認為對我們的手術量的負面影響本質上是暫時的，儘管鑑於我們的許多客戶持續面臨人員短缺、COVID-19 的持續不確定性以及持續的產品運輸和運輸，恢復時間很難預測。挑戰。儘管如此，我們對我們的商業執行、對我們產品的潛在需求以及我們的客戶克服當前挑戰為患者提供重要醫療保健（包括神經損傷的手術修復）的能力仍然充滿信心。隨著醫院運作時間表的壓力持續減輕，我們預計手術量將會改善。

The impact of the Delta variant and staffing shortages on the quarter varied across nerve repair applications, similar to our experience during previous surges in COVID-19 cases and hospitalizations. Our breast, OMF and surgical treatment of pain applications were impacted more significantly due to the elective nature of these procedures. While we believe the incidence of trauma increased in the quarter, our trauma business was impacted by ER and surgical capacity constraints, resulting in deferrals of nerve repair for traumatic injuries. As we experienced last year, we would expect many of the deferred nerve repair procedures will ultimately be completed as surgical schedules improve. However, unfortunately for patients, there will be also a portion of injuries that are ultimately not repaired. As a reminder, while optimal outcomes are achieved by repairing the nerve in a very timely manner, nerve repair can result in positive outcomes months after the nerve is injured.

Delta 變異和人員短缺對本季神經修復應用的影響各不相同，這與我們先前在 COVID-19 病例和住院治療激增期間的經歷類似。由於這些手術的選擇性性質，我們的乳房、OMF 和疼痛手術治療受到了更顯著的影響。雖然我們認為本季創傷發生率有所增加，但我們的創傷業務受到急診室和手術能力限制的影響，導致創傷性神經修復的延遲。正如我們去年經歷的那樣，我們預計隨著手術時間表的改善，許多推遲的神經修復手術最終將完成。然而，對患者來說不幸的是，也會有部分損傷最終無法修復。提醒一下，雖然透過及時修復神經可以實現最佳結果，但神經修復可以在神經受傷幾個月後產生積極的結果。

Turning now to commercial execution. We ended the quarter with 109 direct sales representatives in the U.S. compared to 110 one year ago. We expect to end the year with approximately 115 direct sales representatives as we strategically expand our sales team to support growth in 2022 and beyond. Our direct sales channel continues to be supplemented by independent sales agencies that represented approximately 10% of our total revenue for the third quarter. Our commercial team remains focused on our strategy of driving deeper penetration within customer accounts as a key driver of revenue growth and we are well positioned to continue to drive growth as procedure volumes recover.

現在轉向商業執行。截至本季末，我們在美國的直銷代表數量為 109 名，而一年前為 110 名。隨著我們策略性地擴大銷售團隊以支持 2022 年及以後的成長，我們預計到今年年底將擁有約 115 名直銷代表。我們的直銷管道繼續得到獨立銷售機構的補充，該機構約占我們第三季總收入的 10%。我們的商業團隊仍專注於推動客戶帳戶更深層滲透的策略，將其視為收入成長的關鍵驅動力，隨著手術量的恢復，我們已準備好繼續推動成長。

Another aspect of our strategy is to increase the number of accounts performing nerve procedures using the AxoGen algorithm. Earlier this year, we introduced a new account metric that we believe demonstrates the strength of this strategy, which tracks those accounts that have developed more consistent use of AxoGen products in their nerve repair algorithm. We refer to these as core accounts, defined as accounts that have purchased at least $100,000 in the last 12 months.

我們策略的另一個方面是增加使用 AxoGen 演算法執行神經手術的帳戶數量。今年早些時候，我們推出了一個新的帳戶指標，我們相信該指標展示了該策略的優勢，該指標追蹤那些在其神經修復演算法中更一致地使用 AxoGen 產品的帳戶。我們將這些帳戶稱為核心帳戶，定義為在過去 12 個月內購買至少 10 萬美元的帳戶。

Our core accounts typically contain at least one surgeon who has adapted -- who has adopted the AxoGen nerve repair algorithm for the majority of his or her nerve injury patients and other surgeons who are at earlier stages of AxoGen product adoption. In the third quarter, we had 292 core accounts, an increase of 18% from 248 one year ago and down from 306 in the previous quarter. Core accounts continue to represent approximately 60% of our revenue. We continue to see significant opportunity to drive increased revenue as more accounts reach this level of adoption and as surgeons within these accounts increase their adoption across their nerve repair applications, including extremities trauma, pain, breast and OMF. The year-over-year growth of core accounts reflects our strategy to develop long-term users of the AxoGen portfolio, while the sequential decrease is consistent with the procedural impact in the third quarter.

我們的核心帳戶通常包含至少一位已經適應的外科醫生，他已為大多數神經損傷患者採用了 AxoGen 神經修復演算法，以及其他處於 AxoGen 產品採用早期階段的外科醫生。第三季度，我們擁有 292 個核心帳戶，比一年前的 248 個增加了 18%，比上一季的 306 個有所下降。核心客戶繼續占我們收入的約 60%。隨著越來越多的帳戶達到這一採用水平，以及這些帳戶內的外科醫生在神經修復應用（包括四肢創傷、疼痛、乳房和OMF）中的採用增加，我們繼續看到推動收入成長的重大機會。核心帳戶的同比增長反映了我們開發 AxoGen 產品組合長期用戶的策略，而環比下降與第三季度的程序影響一致。

We have also historically reported our number of active accounts among the estimated 5,100 health care facilities that treat nerve injuries in the U.S. These accounts have a lower adoption threshold of at least 6 orders in the past 12 months. In the third quarter, our active accounts increased to 954, representing a 9% increase compared to 873 one year ago. Active accounts have consistently represented approximately 85% of our total revenue with the top 10% of our active accounts representing approximately 35% of our revenue each quarter.

我們也歷史記錄了美國約 5,100 個治療神經損傷的醫療保健機構中的活躍帳戶數量。第三季度，我們的活躍帳戶增加至 954 個，比一年前的 873 個成長 9%。活躍帳戶一直占我們總收入的約 85%，其中前 10% 的活躍帳戶占我們每季收入的約 35%。

Turning now to our continued focus on building market awareness. During the third quarter, we participated in 2 clinical conferences: the 76th Annual American Society for Surgery of the Hand and the 103rd Annual American Association of Oral Maxillofacial Surgeons. We were pleased with the opportunity to engage with customers in person at these conferences and with the numerous sessions on nerve injury, nerve repair and neuroma pain. AxoGen's nerve repair portfolio was featured in clinical and scientific sessions at each conference, and we hosted an educational symposium at the Hand Society Conference, titled Innovations in Nerve Surgery That Transformed My Practice.

現在轉向我們繼續專注於建立市場意識。第三季度，我們參加了 2 場臨床會議：第 76 屆美國手外科學會年會和第 103 屆美國口腔顎面外科醫師協會年會。我們很高興有機會在這些會議上與客戶面對面交流，並參加許多有關神經損傷、神經修復和神經瘤疼痛的會議。 AxoGen 的神經修復產品組合在每次會議的臨床和科學會議上都有特色，我們還在手學會會議上舉辦了一次教育研討會，題為「神經外科創新改變了我的實踐」。

We also continue to build awareness among patients of the important benefits of nerve repair. In October, we supported Breast Cancer Awareness Month with several activities highlighting ReSensation, a surgical technique designed to restore sensation to the reconstructed breast post-mastectomy. To raise awareness of the surgical treatment of pain, we are partnering with the U.S. Pain Foundation. Each November, the foundation runs a campaign called KNOWvember where they explore and educate on a unique area of pain management through events, social media content and more. This year, the foundation is focusing its campaign to raise awareness of peripheral nerve pain and its treatment options.

我們也持續提高患者對神經修復重要益處的認識。 10 月份，我們透過多項活動來支持乳癌宣傳月，重點介紹 ReSensation，這是一種旨在恢復乳房切除術後重建乳房感覺的手術技術。為了提高人們對疼痛手術治療的認識，我們正在與美國疼痛基金會合作。每年 11 月，基金會都會舉辦一項名為「KNOWvember」的活動，透過活動、社群媒體內容等方式探索和教育疼痛管理的獨特領域。今年，該基金會的活動重點是提高人們對週邊神經疼痛及其治療方案的認識。

As the leader in nerve repair, we continue to invest in surgeon education and advocate development and are excited to have returned to hosting in-person national surgeon education programs in the second half of 2021. We remain committed to providing education and training for each class of fellows, and as in prior years, we trained more than 3/4 of the hand and microsurgery fellows in the recently graduated class of 2021. For the current class of 2022, we held 3 in-person national programs in the last 2 months and are holding 2 more programs in November. This fall, we are similarly returning to in-person national programs for surgeons of all experience levels to learn best practices in nerve repair from our expert faculty.

作為神經修復領域的領導者，我們繼續投資於外科醫生教育和倡導者發展，並很高興能夠在 2021 年下半年重新主辦現場全國外科醫生教育計畫。的研究員，與往年一樣，我們在2021 年剛畢業的班級中培訓了超過3/4 的手部和顯微外科研究員。面對面的國家計畫並於 11 月舉辦另外 2 個計畫。今年秋天，我們同樣將重返所有經驗水平的外科醫生面對面的國家計劃，以向我們的專家教授學習神經修復的最佳實踐。

We continue to expand our body of clinical evidence in support of our product portfolio and increasing surgeon adoption. Our RANGER and MATCH registries continue to enroll with over 2,500 nerve repairs now enrolled in RANGER. In 2020, analysis of the MATCH registry data, which is a comparative population of conduit and autograft subjects for RANGER, demonstrated that advanced nerve graft outcomes were statistically better than conduit and were similar for those -- to those for autograft. Data from these 2 clinical programs continues to play an important role in informing surgeons' clinical decision-making.

我們繼續擴大臨床證據，以支持我們的產品組合併提高外科醫生的採用率。我們的 RANGER 和 MATCH 登記處繼續註冊，目前 RANGER 中已註冊超過 2,500 名神經修復患者。 2020 年，對 MATCH 註冊數據（RANGER 的導管和自體移植受試者的比較群體）的分析表明，先進的神經移植結果在統計上優於導管，並且與自體移植的結果相似。這兩個臨床項目的數據繼續在為外科醫生的臨床決策提供資訊方面發揮著重要作用。

Our RECON study remains on schedule after completing enrollment of 220 subjects in July of 2020. As a reminder, RECON is our Phase III pivotal study supporting our Biologics License Application, or BLA, which, upon approval, will transition our Avance Nerve Graft from a Section 361 tissue product to a Section 351 biological product. We have completed final subject follow-up and we anticipate a top line study data readout in the second quarter of 2022, followed by filing of our BLA in 2023. Enrollment in the comparative phase of REPOSE, our study of AxoGuard Nerve Cap, compared to standard treatment for symptomatic neuroma is well underway, and we expect enrollment to be completed in Q1 of 2022 with the preliminary study data readout in Q2 of 2023.

在2020 年7 月完成220 名受試者的入組後，我們的RECON 研究仍在按計劃進行。獲得批准，我們的Avance 神經移植將從第 361 條組織產品改為第 351 條生物產品。我們已經完成了最終的受試者隨訪，預計在 2022 年第二季度讀出頂線研究數據，然後在 2023 年提交 BLA。有症狀神經瘤的標準治療正在進行中，我們預計入組將於2022 年第一季完成，初步研究數據將於2023 年第二季讀出。

I'd like to share a few highlights from our recent RANGER publication and some data presentations from this year's ASSH Conference. We are excited to see a new publication from the RANGER investigators on the role of Avance Nerve Graft in nerve reconstruction fall on the resection of painful neuromas. The study evaluated 25 subjects with painful neuromas who elected to undergo surgery for their neuroma pain. The study found that 80% of subjects who had their neuromas resected and had the resulting gap reconstructed with Avance reported an improvement in their pain. Furthermore, 88% of the subjects reported meaningful return of sensory function. Reconstruction with Avance enabled the return of function following the removal of the painful neuroma, an outcome that is typically not achievable with standard neuroma resection and termination techniques.

我想分享我們最近的 RANGER 出版物的一些亮點以及今年 ASSH 會議的一些數據演示。我們很高興看到 RANGER 研究人員發表了一篇關於 Avance 神經移植在神經重建中的作用的新出版物，涉及疼痛性神經瘤的切除。該研究評估了 25 名患有疼痛性神經瘤的受試者，他們選擇接受手術治療神經瘤疼痛。研究發現，80% 的接受神經瘤切除並使用 Avance 重建間隙的受試者表示，他們的疼痛有所改善。此外，88% 的受試者報告感覺功能明顯恢復。使用 Avance 進行重建可以在切除疼痛的神經瘤後恢復功能，而這是標準神經瘤切除和終止技術通常無法實現的結果。

Additionally, a group of investigators presented on the patients' perspective of nerve autograft harvest, the traditional nerve repair technique. The study surveyed a group of patients who had undergone nerve repair with autograft and assessed multiple factors related to the donor site, function and pain. Critical findings from this study included 88% of patients reported pain at the autograft harvest site. 75% reported persistent and (inaudible) loss of sensation distal to the harvest site. And 50% of the subjects reported cold intolerance and thermal sensitivity in the harvest site limb. The findings highlight the compromise that patients and surgeons commonly face when choosing to repair nerve injuries with autograft. We believe that with the growing body of clinical evidence on the performance of Avance Nerve Graft, the increasing understanding of the true morbidity and functional loss of nerve autograft harvest and the benefits of early referral for nerve surgery, surgeons will continue to adopt Avance Nerve Graft as their standard of care for managing nerve gap repairs.

此外，一組研究人員也介紹了患者對自體神經移植收穫（傳統神經修復技術）的看法。該研究調查了一組接受自體移植神經修復的患者，並評估了與捐贈部位、功能和疼痛相關的多種因素。這項研究的重要發現包括 88% 的患者報告自體移植收穫部位疼痛。 75% 的患者報告採集部位遠端持續且（聽不清楚）感覺喪失。 50% 的受試者報告收穫部位肢體有冷不耐受性和熱敏感性。研究結果強調了患者和外科醫生在選擇用自體移植物修復神經損傷時通常面臨的妥協。我們相信，隨著關於Avance 神經移植表現的臨床證據越來越多，對自體神經移植物的真實發病率和功能喪失的了解不斷加深，以及早期轉診神經手術的好處，外科醫生將繼續採用Avance神經移植作為他們管理神經間隙修復的護理標準。

Collecting clinical data in peripheral nerve repair takes a significant amount of time, effort and expertise. AxoGen has made it a priority to build and develop the knowledge, systems, capabilities and capacity to deliver high-quality, impactful and relevant clinical evidence in peripheral nerve repair. Nerves regenerate slowly, which often necessitates long follow-up times to assess treatment effects and gather the meaningful clinical data that surgeons, payers and regulators have come to expect when making clinical care decisions.

收集週邊神經修復的臨床數據需要大量的時間、精力和專業知識。 AxoGen 將建立和開發知識、系統、能力和能力作為首要任務，以提供高品質、有影響力和相關的周邊神經修復臨床證據。神經再生緩慢，這通常需要很長的追蹤時間來評估治療效果並收集外科醫生、付款人和監管機構在做出臨床護理決策時所期望的有意義的臨床數據。

We are fortunate to have an established body of clinical evidence supporting Avance Nerve Graft, including 145 peer-reviewed clinical publications, along with more than 50,000 Avance implants since launch. We remain committed to obtaining 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.

我們很幸運擁有大量支持 Avance 神經移植的臨床證據，包括 145 篇經過同行評審的臨床出版物，以及自推出以來超過 50,000 個 Avance 植入物。我們仍然致力於獲取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，以支持在我們的整個神經修復產品組合中繼續採用 AxoGen 演算法。

Before I turn the call over to Pete, I'd like to spend a moment discussing our outlook for the remainder of 2021, including our revised financial guidance. We now expect that full year 2021 revenue will be in the range of $127 million to $129 million versus the prior range of $134.5 million to $137.5 million. And we continue to expect full year gross margins to remain above 80%. Our revised guidance reflects the extended period of impact from the Delta variant and ongoing hospital staffing challenges, which continue to pressure nerve repair procedure volumes.

在將電話轉給 Pete 之前，我想花點時間討論一下我們對 2021 年剩餘時間的展望，包括我們修訂後的財務指引。我們現在預計 2021 年全年收入將在 1.27 億美元至 1.29 億美元之間，而之前的範圍為 1.345 億美元至 1.375 億美元。我們繼續預計全年毛利率將維持在 80% 以上。我們修訂後的指南反映了 Delta 變體的長期影響和持續的醫院人員配置挑戰，這繼續給神經修復手術量帶來壓力。

We are remaining measured in our expectations for the fourth quarter as hospitals address these challenges. To help provide further context around our updated guidance, we believe that the low end of our range represents a continuation of our current run rate through the end of the quarter, while the upper end represents a modest, steady improvement, as our customers continue to adapt to the challenges they've been facing. We believe that our revised guidance for 2021 has no impact on the longer-term growth outlook for our business. Though we currently anticipate that there will be a more gradual ramp in procedural volumes, we remain confident in the growth prospects for our business.

隨著醫院應對這些挑戰，我們仍然對第四季的預期保持謹慎。為了幫助提供有關我們更新指導的更多背景信息，我們認為範圍的下限代表了我們當前運行率到本季度末的延續，而上限代表了適度、穩定的改善，因為我們的客戶繼續適應他們所面臨的挑戰。我們認為，修訂後的 2021 年指引不會對我們業務的長期成長前景產生影響。儘管我們目前預計程序數量將會逐步增加，但我們對我們業務的成長前景仍然充滿信心。

As we look forward to 2022 and beyond, we continue to view AxoGen as a long-term growth company, delivering sustainable annual revenue growth in the high teens to low 20%. We're confident that our commercial execution, combined with our substantial investments in clinical data over the past decade, will continue to support surgeon adoption and our long-term growth as we continue our mission to revolutionize the science of nerve repair.

展望 2022 年及以後，我們繼續將 AxoGen 視為一家長期成長型公司，年收入可持續成長在 10% 至 20% 之間。我們相信，我們的商業執行力，加上過去十年對臨床數據的大量投資，將繼續支持外科醫生的採用和我們的長期成長，同時我們繼續履行徹底改變神經修復科學的使命。

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

現在我將把電話轉給皮特，讓他回顧一下財務要點。皮特？

Thank you, Karen.

謝謝你，凱倫。

Our third quarter revenue of $31.2 million represents a decrease of 7% versus the prior year. Our lower-than-expected revenue was the result of a 10% decrease in unit volume and a net 3% increase in changes in prices and product mix. Prior year revenue included approximately $3.3 million from procedures deferred from the first half of 2020 as a result of the initial impact of the COVID-19 pandemic and approximately $1.5 million from a live soft tissue membrane for which we voluntarily suspended market availability as of June 1, 2021. Excluding the impact of both of these items, revenue growth for the third quarter would have been approximately 9%.

我們第三季的營收為 3,120 萬美元，比去年同期下降 7%。我們的收入低於預期是由於單位銷售下降 10% 以及價格和產品組合變化淨增加 3%。上一年的收入包括約330 萬美元來自因COVID-19 大流行的初步影響而從2020 年上半年推遲的手術，以及約150 萬美元來自我們自6 月1 日起自願暫停市場供應的活體軟組織膜，2021年。

Gross profit for the third quarter decreased 6% to $26 million compared to $27.7 million in Q3 of 2020 as a result of lower sales. Gross margin was 83.2% for Q3 compared to 83% in the prior year. Total operating expense in the third quarter increased 13% to $32.7 million compared to $28.8 million in the prior year. Total operating expenses in the third quarter included $2.9 million of noncash stock compensation, consistent with the prior year. The increase in total operating expenses reflects higher facilities costs as well as increased compensation, travel and project costs as we have returned to more normalized spending levels over the past few quarters, following the steep reduction in spend in Q2 of 2020 as a result of the company's cost-mitigation initiatives enacted at the beginning of the pandemic. These increases were partially offset by lower bonus, commission and stock compensation charges in the third quarter, primarily due to lower revenue expectations for 2021.

由於銷售額下降，第三季毛利下降 6%，至 2,600 萬美元，較 2020 年第三季的 2,770 萬美元下降。第三季毛利率為 83.2%，去年同期為 83%。第三季總營運費用成長 13%，達到 3,270 萬美元，而去年同期為 2,880 萬美元。第三季的總營運支出包括 290 萬美元的非現金股票補償，與去年同期一致。總營運支出的增加反映了設施成本的增加以及補償、差旅和項目成本的增加，因為我們在過去幾個季度恢復了更加正常化的支出水平，而 2020 年第二季度支出因公司在大流行開始時制定的成本削減措施。這些成長被第三季獎金、佣金和股票補償費用的下降部分抵消，這主要是由於 2021 年收入預期下降。

Sales and marketing expense in the third quarter increased 4% to $18.4 million compared to $17.7 million in the prior year. As a percent of total revenue, sales and marketing expenses increased to 59% for the 3 months ended September 30 compared to 53% in the prior year. Research and development spending in the third quarter increased 51% to $6.4 million compared to $4.2 million in the prior year. Research and development costs include product development, including the nonclinical expenses in support of our BLA for Avance Nerve Graft and expenses for all clinical research. The increase in R&D expenses reflected increased spending in specific programs, including the BLA for Avance Nerve Graft and a next-generation Avance product. As a percentage of total revenue, research and development expenses were 21% in Q3 compared to 13% in the prior year.

第三季銷售和行銷費用成長 4%，達到 1,840 萬美元，而去年同期為 1,770 萬美元。截至 9 月 30 日的三個月，銷售和行銷費用佔總收入的百分比增加至 59%，而去年同期為 53%。第三季的研發支出成長了 51%，達到 640 萬美元，而去年同期為 420 萬美元。研究和開發成本包括產品開發，包括支援 Avance 神經移植 BLA 的非臨床費用以及所有臨床研究的費用。研發費用的增加反映了特定項目支出的增加，包括 Avance 神經移植的 BLA 和下一代 Avance 產品。第三季研發費用佔總收入的比例為 21%，去年同期為 13%。

General and administrative expenses in the third quarter increased 16% to $7.9 million or 25% of revenue compared to $6.8 million or 20% of revenue in the prior year. Adjusted net loss and net loss per share in Q3 of 2021 was $3.6 million and $0.09 per share compared to adjusted net income and net income per share in the prior year of $1.5 million and $0.04 per share. Adjusted EBITDA loss in the quarter was $2.5 million compared to an adjusted EBITDA of $2.3 million in the prior year. The reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and on our website.

第三季的一般和管理費用增加了 16%，達到 790 萬美元，佔收入的 25%，而前一年為 680 萬美元，佔收入的 20%。 2021 年第三季調整後淨虧損和每股淨虧損分別為 360 萬美元和每股 0.09 美元，而前一年調整後淨收益和每股淨收益分別為 150 萬美元和每股 0.04 美元。本季調整後 EBITDA 虧損為 250 萬美元，而前一年調整後 EBITDA 為 230 萬美元。這些非公認會計原則財務指標與公認會計原則的調節可以在今天的收益報告和我們的網站上找到。

The balance of cash, cash equivalents and investments on September 30 was $98.1 million compared to a balance of $106.2 million at the end of Q2. The decrease includes facilities capital expenditures of $8 million, including $1.2 million of capitalized interest, primarily on our new biologics processing center in Dayton, Ohio; and net operating cash burn in the quarter of $200,000. We expect completion of the Dayton facility early next year, followed by a 1-year validation process and expect to begin production in the new center in early 2023.

截至 9 月 30 日，現金、現金等價物和投資餘額為 9,810 萬美元，而第二季末的餘額為 1.062 億美元。減少額包括 800 萬美元的設施資本支出，其中包括 120 萬美元的資本化利息，主要用於我們位於俄亥俄州代頓的新生物製品加工中心；該季度淨營運現金消耗為 200,000 美元。我們預計代頓工廠將於明年初竣工，隨後進行為期 1 年的驗證過程，並預計於 2023 年初在新中心開始生產。

Turning to guidance. As Karen noted earlier, we are revising our revenue guidance and now expect full year 2021 revenue will be in the range of $127 million to $129 million compared to our previous range of $134.5 million to $137.5 million. Additionally, we continue to expect full year gross margins to remain above 80%. Although we remain measured in our expectations for the fourth quarter as hospitals address capacity constraints and surgical schedules, we are confident that our commercial execution and the underlying demand for our products position us to see improvement as hospitals continue to adapt to these challenges. As we look toward 2022 and beyond, we believe the strength of our strategy and the execution in this underserved health care market will allow us to continue to be a long-term growth company, delivering sustainable annualized revenue growth in the high teens to low 20%.

轉向指導。正如凱倫先前指出的，我們正在修改我們的收入指導，現在預計 2021 年全年收入將在 1.27 億美元至 1.29 億美元之間，而之前的範圍為 1.345 億美元至 1.375 億美元。此外，我們繼續預計全年毛利率將維持在 80% 以上。儘管隨著醫院解決容量限制和手術計劃，我們仍然衡量對第四季度的預期，但我們相信，隨著醫院繼續適應這些挑戰，我們的商業執行和對產品的潛在需求使我們能夠看到進步。展望2022 年及以後，我們相信，在這個服務不足的醫療保健市場中，我們的策略優勢和執行力將使我們能夠繼續成為一家長期成長的公司，實現年化收入在十幾歲到二十歲以下的可持續成長%。

And with that, I'd like to hand the call back over to Karen.

說到這裡，我想把電話轉回給凱倫。

Thank you, Pete.

謝謝你，皮特。

I'm proud of the achievements of the entire AxoGen team in the face of the headwinds during the quarter. We remain committed to delivering our innovative nerve repair solutions to patients, surgeons and hospitals, and I believe we are well positioned for success as we move through the final months of 2021 and beyond.

我為整個 AxoGen 團隊在本季度面對逆風時所取得的成就感到自豪。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，在 2021 年最後幾個月及以後，我們已經做好了成功的準備。

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

此刻，我想開通提問專線。搶？

(Operator Instructions) And our first question comes from the line of Danielle Antalffy with SVB Leerink.

（操作員說明）我們的第一個問題來自 SVB Leerink 的 Danielle Antalffy。

This is Erin on for Danielle. Just one -- or just a couple for me. I was just hoping you could maybe talk about the impact of hospitals' staffing shortages and if there's any steps that you could possibly take to mitigate these impacts? And then also, just as it relates to the mix of procedures by setting, was there an -- was there a certain setting maybe like the ASC that was less impacted by these shortages versus the hospital? And just -- do you expect to see a shift of procedures to the ASC going forward?

這是丹妮爾的艾琳。對我來說只有一個——或者幾個。我只是希望您能談談醫院人員短缺的影響，以及您是否可以採取任何措施來減輕這些影響？然後，正如它與設置的程序組合相關一樣，是否有一個特定的設置可能像 ASC 一樣，與醫院相比，受這些短缺的影響較小？只是——您是否期望看到未來程序向 ASC 轉變？

Sure. That's great question. Definitely, we saw impacts of actually the combination of the COVID-19 Delta variant rise in certain parts of the country and then complicated by the fact that the hospitals have staffing shortages. And so the first thing that we saw impacted were our more elective procedures. So breast reconstruction is a great example in that it's always an inpatient procedure. It takes a lot of OR time. And it is deferrable without significant complication to the patient. And so that's usually, for us, the very first sign that hospitals are starting to push procedures out, but we also saw that in the surgical treatment of pain and oral maxillofacial surgery, all of those being very elective procedures and all of them impacted and delayed as hospitals are trying to manage their flow.

當然。這是一個很好的問題。當然，我們看到了 COVID-19 Delta 變種的影響在該國某些地區增加，然後又因醫院人員短缺而變得更加複雜。因此，我們看到受到影響的第一件事是我們更具選擇性的程序。因此，乳房再造就是一個很好的例子，因為它始終是住院手術。這需要大量的手術時間。並且可以推遲，不會為患者帶來明顯的併發症。因此，對我們來說，這通常是醫院開始推遲手術的第一個跡象，但我們也看到，在疼痛的外科治療和口腔頜面手術中，所有這些都是非常選擇性的手術，並且所有這些都受到影響和影響。

In the -- traumatic injuries is actually not quite as clear because it really depends on the circumstances of the hospital and what they're trying to do on these more emergent procedures. And so the first thing that we see and similar to what we saw last year is that these procedures were moved to alternate sites of care. So in the early days, in some of the areas where you saw Delta variant in particular starting to creep up, we saw an increase in move to either outpatient surgery centers or ambulatory surgery centers, which were less affected, both by the staffing shortages at that stage and Delta variant. But as Delta variant became pretty strong, all of those staffing shortages kind of came to a head, and we saw procedures delayed and deferred even more.

在--創傷性傷害實際上並不那麼清楚，因為這實際上取決於醫院的情況以及他們在這些更緊急的程序中試圖做什麼。因此，我們看到的第一件事與去年類似的是，這些程序已轉移到其他護理地點。因此，在早期，在一些你看到Delta 變種特別開始蔓延的地區，我們看到越來越多的人轉移到門診手術中心或門診手術中心，而這些中心受到的影響較小，都是因為人員短缺那個階段和三角洲變體。但隨著達美航空變體變得相當強大，所有這些人員短缺都達到了緊要關頭，我們看到程序被推遲，甚至推遲得更多。

So this is going on in an ongoing basis. We hear from companies -- well, CEOs of hospital systems that they certainly have today staffing problems, but there could potentially be another wave of staffing issues as Delta variant wanes, but there's more resignations that may come. And so we're just trying to be cognizant of that and try and support the hospitals as they go through this, recognizing that our elective procedures will continue to be more -- will continue to be deferred but, at the same time, trying to bring back those traumatic nerve injuries as soon as possible so that those patients can get the best possible care.

因此，這種情況正在持續發生。我們從公司——嗯，醫院系統的執行長那裡聽到，他們今天確實遇到了人員配備問題，但隨著達美航空變體的減弱，可能會出現另一波人員配備問題，但可能會有更多的辭職。因此，我們只是試圖認識到這一點，並在醫院經歷這一過程時嘗試為他們提供支持，認識到我們的選擇性手術將繼續推遲，但同時，努力盡快帶回那些創傷性神經損傷，以便這些患者能夠得到最好的照護。

Great. And then just on the 2021 outlook, it seems like your updated guidance implies about $32 million in revenue for 4Q, considering that you did about $31 million in 3Q. And it seems like it's -- things are getting better since the lows of August. They've gotten better in September and have continued into October. Just kind of want to understand the puts and the takes that are being contemplated. And then also, just if you could talk about the backlog and if we should think of the -- is that contemplated in the 2020 outlook? Or should we think of any backlog procedures that are made up in 4Q as upside?

偉大的。然後就 2021 年的前景而言，考慮到您在第三季度的收入約為 3,100 萬美元，您更新的指導似乎意味著第四季度的收入約為 3,200 萬美元。自八月低點以來，情況似乎正在好轉。他們在九月有所好轉，並持續到十月。只是想了解正在考慮的賣權和賣出選擇權。另外，如果您能談談積壓的問題，以及我們是否應該考慮 2020 年展望中是否考慮到了這一點？或者我們應該將第四季度彌補的任何積壓程序視為上行空間？

Yes. I think our outlook is really reflective of the fact that we've got a lot of -- we got a lot of confidence in our ability to come in and help hospitals get through these procedures, but they are challenged with how they are going to schedule these procedures. And so where we saw an uptick in September, that September run rate sort of ran consistent for us through October. We didn't see the additional pickup as in the month of October that we would have liked to have seen to have provided a little stronger outlook for the fourth quarter.

是的。我認為我們的前景確實反映了這樣一個事實：我們對自己介入並幫助醫院完成這些程序的能力充滿信心，但他們面臨著如何解決這些問題的挑戰。因此，我們在 9 月看到了上升，而 9 月的運行率在整個 10 月都保持一致。我們沒有看到 10 月的額外回升，我們希望看到這為第四季度提供了更強勁的前景。

So we're trying to put -- the puts and takes, we're looking at our current run rate, and if we maintain that through the end of the year that, that pretty much defines the bottom end of our guidance. And if, as we expect, hospitals are able to get these procedures done and work through some of these challenges that they have with staffing that we'll see a moderate improvement, and that kind of moves us through the top end of the range. So we're not trying to bake in any exceptional growth in Q4. And if we see more procedures coming in more quickly, then that's going to move us up in the range. But we wanted to sort of set the bottom end of this at a current state business.

因此，我們正在嘗試放置 - 放置和放置，我們正在考慮當前的運行率，如果我們在今年年底之前保持這種運行率，那麼這幾乎定義了我們指導的底部。如果正如我們所期望的那樣，醫院能夠完成這些程序並解決他們在人員配置方面遇到的一些挑戰，我們將看到適度的改善，這將使我們達到這一範圍的高端。因此，我們並不想在第四季度實現任何異常成長。如果我們看到更多程式更快進入，那麼這將使我們的範圍上升。但我們想在目前的國有企業中確定這一點的底線。

And specifically to your deferred procedure, we think those procedures are going to come in. It's just us trying to figure out what is the pace of getting those scheduled and getting those procedures done. Last year, we saw experiences where those deferred procedures came in very, very quickly. But as Karen pointed out, these staffing shortages are causing us to be a little more measured in the pace at which those procedures might come back.

特別是對於您推遲的程序，我們認為這些程序將會進入。去年，我們看到這些延後的程序來得非常非常快。但正如凱倫指出的那樣，人員短缺導致我們對恢復這些程序的速度更加謹慎。

Our next question is from the line of Anthony Petrone with Jefferies.

我們的下一個問題來自安東尼·佩特龍（Anthony Petrone）和傑弗里斯（Jefferies）的電話。

Great. First question on our end would -- relates first to RECON study, just an update on next steps into year-end and just whether or not you're seeing any notable impact from COVID just in terms of time lines there. And then in terms of just sort of FDA developments during the quarter. Integra had a panel meeting on SurgiMend acellular dermal matrix products for breast reconstruction, obviously, a mixed vote from the panel. When you look at the breast neurotization opportunity for AxoGen, anything from that panel meeting that potentially may be a tailwind for the Avance business or otherwise?

偉大的。我們最後的第一個問題是——首先與 RECON 研究有關，只是到年底的後續步驟的最新情況，以及您是否在時間線方面看到了新冠疫情的任何顯著影響。然後就 FDA 本季的進展而言。 Integra 召開了一次關於用於乳房重建的 SurgiMend 無細胞真皮基質產品的小組會議，顯然，小組的投票結果不一。當您審視 AxoGen 的乳房神經化機會時，該小組會議中的任何內容都可能成為 Avance 業務或其他業務的順風車嗎？

Sure. Thank you. So on the RECON study, again, we completed enrollment and follow-up of all those subjects. And so at this point, there's not an impact in hospital staffing associated with the study as we have this with the CRO to complete the data tables. So no, we don't see any impact on RECON despite the staffing challenges at hospitals, and we still look forward to having the top line data readout in second quarter of next year.

當然。謝謝。因此，在 RECON 研究中，我們再次完成了所有這些受試者的入組和追蹤。因此，在這一點上，與該研究相關的醫院人員配置不會受到影響，因為我們讓 CRO 完成資料表。因此，儘管醫院的人員配備面臨挑戰，但我們認為 RECON 不會受到任何影響，我們仍然期待明年第二季獲得頂線數據讀數。

In terms of the -- looking at this recent panel that happened, I think we've read through it and looked at what was going on there. I think it is important to make sure that in communicating with these panels that it is not just a statistically significant difference but also a clinically relevant and clinically meaningful endpoint is an important measure to put in place. And I think in this particular case, at least as I read the panel, I think there was varying thought processes among the panel members around the presentation on clinically meaningful endpoints.

就最近發生的這個小組而言，我認為我們已經通讀了它並了解了那裡發生的事情。我認為重要的是要確保在與這些專家小組溝通時，這不僅是統計學上的顯著差異，而且是臨床相關和臨床有意義的終點，這是一項重要的措施。我認為在這個特殊情況下，至少在我閱讀小組時，我認為小組成員圍繞著具有臨床意義的終點的演示存在不同的思考過程。

And so I think it's a very good reminder to all of us that when we're doing these trials, we want to make sure that we're showing both of those points. Fortunately, for us, as we've designed RECON, those are both baked into RECON. It's also information that we have, and we are -- would pull data from RANGER and Sensation-NOW to support our broader label claim. And all of that was kept in mind when we set those studies up. So I'm anticipating that we have those -- that information in a form that the panel -- if there is a panel that the panel would be able to understand it.

所以我認為這對我們所有人來說都是一個很好的提醒，當我們進行這些試驗時，我們希望確保我們展示這兩點。幸運的是，對我們來說，正如我們設計的 RECON 一樣，這些都已融入 RECON 中。這也是我們擁有的信息，而且我們正在從 RANGER 和 Sensation-NOW 中提取數據來支持我們更廣泛的標籤主張。當我們進行這些研究時，所有這些都被牢記在心。因此，我預計我們會以專家組能夠理解的形式提供這些資訊。

And if I can, if I could sneak one follow-up in there, which would be on the core business and kind of shifting to the core accounts, that new category announced last quarter. When you think about some of the headwinds you saw in 3Q, Delta and staffing shortages, how did that play in those core accounts? And are they -- is there a portion of those accounts that are more insulated? Or was it evenly dispersed across the entirety of the accounts in the quarter, again, the pressures on Delta and staffing?

如果可以的話，如果我可以偷偷地在那裡跟進一個後續行動，這將是關於核心業務並轉移到核心客戶，這是上個季度宣布的新類別。當您想到第三季、達美航空和人員短缺時看到的一些不利因素時，這些不利因素對這些核心客戶有何影響？這些帳戶中是否有一部分是更加隔離的？或者它是否均勻地分散在本季度的整個帳戶中，再次，達美航空和人員配置的壓力？

Well, Delta definitely had regional differences across the country. So Florida, the Southeast, Tennessee, the Tennessee Valley area, all of those have a greater impact overall on volume and on those core accounts in those regions. But the staffing is much more broadly impacted. If you look at it, we still did show an 18% overall growth year-over-year in this core account. So we see that as still a continuing funnel and fuel for our overall growth, both increasing the number but also increasing the penetration of volume with that account. Remember, the $100,000 is a floor. It's not a ceiling that's just getting into that category, and our largest accounts are over $1 million.

嗯，達美航空在全國範圍內確實存在地區差異。因此，佛羅裡達州、東南部、田納西州、田納西河谷地區，所有這些地區對這些地區的交易量和核心帳戶都有更大的影響。但人員配置受到的影響要廣泛得多。如果你看一下，我們的核心帳戶仍然顯示出 18% 的整體年成長。因此，我們認為這仍然是我們整體成長的持續漏斗和動力，既增加了該帳戶的數量，又提高了該帳戶的交易量滲透率。請記住，100,000 美元是一個底價。進入這一類別並沒有上限，我們最大的帳戶超過 100 萬美元。

And so while we saw staffing affecting accounts across the board, we still see that distribution of driving penetration. And that's -- as their staffing resolves, we see that -- we believe we'll come back up to continuing to drive on those 2 dimensions, both continuing to increase the number of core accounts taking from our active accounts and moving them to core and increasing the revenue per account.

因此，雖然我們看到人員配置全面影響帳戶，但我們仍然看到推動滲透率的分佈。那就是 - 隨著他們的人員配置解決，我們看到 - 我們相信我們將繼續推動這兩個維度，繼續增加核心帳戶的數量，從我們的活躍帳戶中獲取並將它們轉移到核心並增加每個帳戶的收入。

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

我們的下一個問題來自 Canaccord 的凱爾·羅斯 (Kyle Rose)。

Great. I wondered if we could just get a little more commentary on what you're seeing just with respect to staffing shortages. I mean some of the diligence we've done is suggesting that, yes, there are staffing shortages, but that's more related to the inability to flex for like over time or additional operating hours. But that just -- the queue was full, so it's hard to flex higher as we do see in -- from Q4. Is that what you're seeing? Or are you seeing actual decreases in procedure volumes in the markets you serve?

偉大的。我想知道我們是否可以就您所看到的人員短缺問題獲得更多評論。我的意思是，我們所做的一些努力表明，是的，存在人員短缺，但這更多是與無法靈活應對超時或額外的工作時間有關。但這只是 - 隊列已滿，因此很難像我們所看到的那樣更高 - 從第四季度開始。這就是你所看到的嗎？或者您發現您所服務的市場中的手術量實際上減少了​​？

Yes. I have to give a different answer for different segments. So for those elective procedures that require a hospital stay, we are seeing that the staffing shortages are causing those to be pushed out and either not scheduled at all or scheduled way out into the future because, I would say, more acutely, the staffing shortages are in the hospital floors, not necessarily ORs. Hospitals are trying to keep the ORs moving at as much capacity as they can.

是的。我必須針對不同的細分領域給出不同的答案。因此，對於那些需要住院的選擇性手術，我們看到人員短缺導致這些程序被推遲，要么根本沒有安排，要么安排在未來，因為，我想說，更嚴重的是，人員短缺位於醫院樓層，不一定是手術室。醫院正在努力讓手術室盡可能保持運作。

Now I've talked to some hospital CEOs that have, in their system, hundreds or thousands of backlog procedures that they need to get through. So there are some sizable amounts of backlog and what the shortages are causing in the OR is, as you said, the inability to flex and create more capacity so that they can both deal with the current procedure volume and the backlog at the same time. It doesn't mean they won't get to it. It's just going to be working it off will take a little bit more time.

現在我已經和一些醫院的執行長交談過，他們的系統中有成百上千的積壓程序需要完成。因此，存在大量積壓，正如您所說，手術室的短缺導致無法靈活調整和創造更多容量，以便他們能夠同時處理當前的程序量和積壓。這並不意味著他們不會做到這一點。只是要花更多的時間來解決它。

Okay. That's helpful. And then with respect to guidance, I just want to make sure I understand it appropriately. If you see kind of status quo the exit rate of October for the rest of the quarter, that brings you to the low end. And if you see maybe some gradual improvement, that takes you to the high end. But maybe just talk to us about how October trended on a month-over-month basis relative to September.

好的。這很有幫助。然後關於指導，我只想確保我正確理解它。如果您看到本季剩餘時間 10 月的退出率保持現狀，那麼您就會處於低端。如果你看到一些逐漸的改進，那就會把你帶到高端。但也許只是跟我們談談 10 月相對於 9 月的月度趨勢如何。

Yes. We saw -- so we saw things get better in September, but then going into October, it remained relatively consistent. Slightly better but still, I would say, relatively consistent. So we think that -- and that's why we set the low end of the guidance there is to say, "Let's just assume that because of these headwinds, we remain flat through the quarter." And then, of course, if we can start to get the volume back up to what I would consider a normal through -- flow and/or start to tackle some of the deferred procedures, we would see some increasing through the quarter, which would be the higher end.

是的。我們看到——所以我們看到九月情況有所好轉，但進入十月份，情況仍然相對穩定。稍微好一點，但我想說，仍然相對一致。因此，我們認為，這就是為什麼我們將指引的下限設定為：“讓我們假設，由於這些不利因素，我們整個季度保持平穩。”當然，如果我們能夠開始將交易量恢復到我認為的正常流通量和/或開始解決一些推遲的程序，我們將看到整個季度的交易量有所增加，這將是成為高端。

We've reached the end of the question-and-answer session. I'll now turn the call over to Karen Zaderej for closing remarks.

我們的問答環節已經結束了。現在我將把電話轉給凱倫‧札德雷 (Karen Zaderej) 致閉幕詞。

Thank you, Rob.

謝謝你，羅布。

I want to thank everyone for joining us on today's call. We look forward to speaking with many of you at the Jefferies London Healthcare Conference and at the Canaccord MedTech and Diagnostics Forum later this month. Thank you.

我要感謝大家參加今天的電話會議。我們期待在本月稍後的 Jefferies 倫敦醫療保健會議以及 Canaccord 醫療技術和診斷論壇上與你們中的許多人進行交流。謝謝。

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

謝謝。今天的會議到此結束。此時您可以斷開線路。感謝您的參與。