AxoGen Inc (AXGN) 2021 Q2 法說會逐字稿

Greetings, and welcome to the AxoGen, Inc. Reports Second Quarter 2021 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 AxoGen, Inc. 2021 年第二季財務業績電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

I would now like to turn the conference over to your host, Pete Mariani, Executive Vice President and Chief Financial Officer. Go ahead, sir.

現在我想將會議交給東道主執行副總裁兼財務長 Pete Mariani。繼續吧，先生。

Thank you, Maria, and good afternoon, everyone. 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 second quarter performance, an update on our operational highlights and a review of our financial guidance. I will then provide an analysis of our financial performance, followed by closing remarks from Karen and a question-and-answer session. 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 website at www.axogeninc.com.

謝謝瑪麗亞，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。凱倫將在今天的電話會議中概述我們第二季度的業績、更新我們的營運亮點以及回顧我們的財務指導。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。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 limitations, 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 processes and approvals, APC, renovation, timing and expense, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of internal controls over financial reporting.

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。我們鼓勵您查看該公司過去和未來向SEC 提交的文件，包括但不限於該公司的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所述的結果或事件存在重大差異的具體因素。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 年財務指引、產品開發、產品潛力、監管流程和批准、APC、翻新、時間安排與費用、財務績效、銷售成長、產品採用、產品的市場認知、數據驗證、我們對財務報告內部控制的評估。

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

說到這裡，我想把電話轉給凱倫。

Thank you, Pete, and good afternoon, everyone. Our total revenue for the second quarter was $33.6 million, representing growth of 52% compared to the prior year. I'm pleased with our Q2 results as our team continued to execute well in a dynamic health care market. In the second quarter we achieved growth across our business, led by our overall growth in the repair of traumatic nerve injuries and in the use of advanced nerve graft across applications, with more than 50,000 advanced implants since launch and 145 peer-reviewed clinical publications featuring Avance.

謝謝你，皮特，大家下午好。我們第二季的總營收為 3,360 萬美元，比去年同期成長 52%。我對第二季的業績感到滿意，因為我們的團隊在充滿活力的醫療保健市場中繼續表現出色。第二季度，我們的業務實現了成長，這得益於我們在創傷性神經損傷修復和先進神經移植跨應用領域的整體成長，自推出以來已推出超過50,000 個先進植入物，並發表了145份經過同儕審查的臨床出版品前進。

Adoption of our flagship product continue to grow as surgeons adopted the AxoGen algorithm across our full portfolio of nerve repair products. Our commercial team remains focused on our strategy of driving deeper penetration of our customer accounts. We believe that these efforts have positioned the business for improving growth as the incidence of trauma and the volume of electric procedures returned to normal levels. We're pleased with the continued growth in our second quarter of our application for the surgical treatment of pain. The removal of painful neuromas and the use of Avance to repair the resulting gap is an elective procedure often performed by the same surgeons who repair nerve injuries in our core extremity trauma business, providing an opportunity for these surgeons to expand their nerve repair practice.

隨著外科醫生在我們整個神經修復產品組合中採用 AxoGen 演算法，我們旗艦產品的採用率不斷增長。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。我們相信，隨著創傷發生率和電手術量恢復到正常水平，這些努力使該業務能夠改善成長。我們對第二季度疼痛外科治療申請的持續成長感到高興。切除疼痛性神經瘤並使用Avance 修復由此產生的間隙是一項選擇性手術，通常由我們核心四肢創傷業務中修復神經損傷的外科醫生進行，這為這些外科醫生擴大其神經修復實踐提供了機會。

Our breast neurotization business continued to demonstrate growth as awareness of the problem of numb breast following mastectomy continues to increase among patients and health care providers. Using the ReSensation technique, surgeons can use Avance to reconnect the nerves with the goal of restoring feeling to the reconstructed breast. During the quarter, hospitals continued to open surgical schedules for this elective procedure.

隨著患者和醫療保健提供者對乳房切除術後乳房麻木問題的認識不斷提高，我們的乳房神經化業務持續成長。使用 ReSensation 技術，外科醫生可以使用 Avance 重新連接神經，以恢復重建乳房的感覺。本季度，醫院繼續開放這種擇期手術的手術時間表。

And our oral maxillofacial nerve repair business remained steady during the quarter. The success and benefits of oral max nerve repair are well documented in clinical studies and textbooks. And we expect improved growth for the elective procedures in the second half of the year.

我們的口腔顎面神經修復業務在本季保持穩定。口腔最大神經修復的成功和好處在臨床研究和教科書中都有詳細記錄。我們預計下半年擇期手術的成長將有所改善。

Turning now to commercial execution in our sales team. We ended the quarter with 109 direct sales representatives in the U.S. compared to 106 at the end of the first quarter and 112 1 year ago. We expect to end the year with 115 to 120 direct sales representatives as we plan to strategically expand our sales team during the second half of the year to support growth in 2022 and beyond. Our direct sales channel continues to be supplemented by independent sales agencies who represented approximately 12% of our total revenue in the second quarter compared to approximately 15% 1 year ago. In the second quarter, our sales rep productivity continued to improve and continues to be the primary driver of our revenue growth as we both drive deeper penetration of our existing accounts and add new accounts.

現在轉向我們銷售團隊的商業執行。截至本季末，我們在美國有 109 名直銷代表，而第一季末為 106 名，一年前為 112 名。我們預計到今年年底將擁有 115 至 120 名直銷代表，因為我們計劃在下半年策略性地擴大我們的銷售團隊，以支援 2022 年及以後的成長。我們的直銷管道繼續得到獨立銷售機構的補充，獨立銷售機構在第二季度占我們總收入的約 12%，而一年前約為 15%。在第二季度，我們的銷售代表生產力持續提高，並繼續成為我們收入成長的主要驅動力，因為我們既推動了現有客戶的更深層滲透並增加了新客戶。

Last quarter we introduced a new account metric that we believe demonstrates the strength of adoption and potential revenue growth in accounts that have developed a 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. Our core accounts typically have at least one surgeon who's adopted the AxoGen nerve repair algorithm for the majority of his or her nerve repair -- nerve injury patients and have other surgeons who are earlier stages of AxoGen product adoption.

上個季度，我們推出了一項新的帳戶指標，我們相信該指標展示了在神經修復演算法中更一致地使用 AxoGen 產品的帳戶的採用強度和潛在收入成長。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 100,000 美元的帳戶。我們的核心客戶通常至少有一名外科醫生在其大部分神經修復中採用了 AxoGen 神經修復演算法（神經損傷患者），並且還有其他處於 AxoGen 產品採用早期階段的外科醫生。

In the second quarter we had 306 core accounts, an increase of 34% from 228 1 year ago. Core accounts represented approximately 60% of our revenue in the quarter. We see significant opportunity to drive increased revenue as more accounts reach this level of adoption and that surgeons within these accounts increase their reduction adoption across their nerve repair applications, including extremities, trauma, pain, breast and OMS.

第二季我們有 306 個核心帳戶，比一年前的 228 個增加了 34%。核心客戶約占我們本季營收的 60%。隨著越來越多的客戶達到這一採用水平，並且這些客戶中的外科醫生在神經修復應用中增加了減少採用，包括四肢、創傷、疼痛、乳房和OMS，我們看到了增加收入的巨大機會。

We've also historically reported a 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 second quarter, our active accounts increased to 959, representing a 22% increase compared to 789 1 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一些活躍帳戶。第二季度，我們的活躍帳戶增加到 959 個，比一年前的 789 個增加了 22%。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. In the second quarter we continued to utilize digital marketing to supplement the efforts of our sales team to deliver important and timely nerve repair news and content to targeted surgeons. We were pleased with the continued high level of surgeon engagement with our e-mail campaigns during the quarter, and our surgeon customers continued to participate in our Nerve Matters online surgeon community, discussing their use of peripheral nerve injury solutions. The community has grown to over 3,400 surgeons as we exited the first half of the year.

現在轉向我們繼續專注於建立市場意識。第二季度，我們繼續利用數位行銷來補充我們銷售團隊的努力，為目標外科醫生提供重要且及時的神經修復新聞和內容。我們很高興看到本季度外科醫生對我們的電子郵件活動的持續高水平參與，並且我們的外科醫生客戶繼續參與我們的 Nerve Matters 在線外科醫生社區，討論他們對周圍神經損傷解決方案的使用。截至今年上半年，該社區已擁有超過 3,400 名外科醫生。

We also continued to increase awareness of nerve repair with patients through our addressed patient marketing campaigns, which were successfully -- which successfully increased visits to our resensation.com and rethink-pain.com website during the first half of 2021. As the leader in nerve repair, we continue to invest in search and education and advocate development. We kicked off our second annual Masterminds program in April, providing a series of virtual education events for emerging leaders in nerve repair. We remain committed to providing education and training for each class of fellows. And as in prior years, we've traded more than 3/4 of the hand and microsurgery fellows in the class of 2021 through a combination of local, in-person hands-on labs and virtual programs.

我們也透過針對患者的行銷活動繼續提高患者對神經修復的認識，這些活動取得了成功，在 2021 年上半年成功增加了我們的 resensation.com 和 rethink-pain.com 網站的訪問量。我們持續投入搜尋和教育，倡導發展。我們於四月啟動了第二屆年度策劃者計劃，為神經修復領域的新興領導者提供一系列虛擬教育活動。我們仍然致力於為每個類別的研究員提供教育和培訓。與往年一樣，透過本地親自動手實驗室和虛擬計畫的結合，我們在 2021 屆畢業生中交換了超過 3/4 的手部和顯微外科研究員。

We're planning a safe return to in-person programs with 5 fellows education events currently scheduled for the second half of 2021. Beyond the surgeon fellowship, we provide support for the transition to practice and are pleased that the majority of the new hand surgery attending from the 2020 class have performed cases using our nerve repair products following completion of their fellowship training. As we carefully return to live programs, we'll be offering a surgeon educational event at the upcoming 76 Annual Meeting of the American Society for Surgery of the Hand Conference in September in San Francisco. Our lab will explore practical solutions for upper extremity trauma through lecture and hands-on cadaveric experiences along with case review and discussion.

我們正計劃安全地回歸面對面項目，目前計劃於 2021 年下半年舉辦 5 場研究員教育活動。 2020 年的學員在完成進修訓練後使用我們的神經修復產品進行了案例。當我們小心翼翼地返回現場節目時，我們將在即將於 9 月在舊金山舉行的美國手外科學會第 76 屆年會上提供外科醫生教育活動。我們的實驗室將透過講座和屍體實踐經驗以及病例回顧和討論，探索上肢創傷的實用解決方案。

We continued 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 2,400 nerve repairs now enrolled in RANGER. In 2020, analysis of the MATCH registry, which is a comparative population of conduit and autograph subjects for RANGER, demonstrated that advanced nerve graft outcomes were statistically better than conduit and were similar 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 註冊中心繼續註冊，目前 RANGER 中註冊了超過 2,400 例神經修復患者。 2020 年，對 MATCH 登記（RANGER 導管和親筆簽名受試者的比較群體）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 will transition our Avance Nerve Graft from a Section 361 tissue product to a Section 351 biological product. The study is progressing well, and we now anticipate the final follow-up visit to occur in the coming weeks. A top line study data readout is expected in the second quarter of 2022 and will be followed by filing of our BLA in 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。研究將使我們的Avance 神經移植物從第361 節組織產品轉變351 節生物製品。該研究進展順利，我們現在預計最終的追蹤將在未來幾週內進行。預計將於 2022 年第二季公佈頂線研究數據，隨後將於 2023 年提交 BLA。

Enrollment in the comparative phase of REPOSE, our study of AxoGuard Nerve Cap compared the standard treatment for symptomatic neuroma is well underway, and we expect enrollment to be completed in Q1 2022 and a study data readout in Q2 of 2023. Two recent publications resulting from a collaboration between Washington Nerve Institute and Washington University bring to life the significant negative impact of chronic nerve pain on patient quality of life and the economic burden associated with managing these injuries. Both of these manuscripts address the role of peripheral nerve surgery in the treatment of chronic nerve pain.

REPOSE 比較階段的入組工作正在順利進行，我們對AxoGuard Nerve Cap 的研究比較了症狀性神經瘤的標準治療，我們預計入組工作將於2022 年第一季完成，研究數據將於2023 年第二季度讀出。這兩篇手稿都闡述了周邊神經手術在治療慢性神經疼痛中的作用。

Finding that surgical intervention can significantly improve patient quality of life and that timely surgical referrals are associated with the reduction in the overall economic burden, especially compared to conventional nonsurgical management of the pain. This data helps to inform surgeons and referring clinicians on the growing role of the surgical treatment for chronic nerve pain. As we advance the science of nerve repair we remain committed to investing the time and resources necessary to provide meaningful and impactful clinical events on the utility of our nerve repair portfolio. Nerves regenerate slowly, which often necessitates long follow-up times to assess treatment effect and gather the meaningful clinical data that surgeons, payers and regulators have come to expect when making clinical care decisions.

發現手術介入可以顯著改善患者的生活質量，並且及時的手術轉診與總體經濟負擔的減輕有關，特別是與傳統的非手術疼痛治療相比。這些數據有助於外科醫生和轉診臨床醫生了解手術治療慢性神經疼痛的日益重要的作用。隨著我們推進神經修復科學，我們仍然致力於投入必要的時間和資源，為我們的神經修復產品組合的效用提供有意義和有影響力的臨床事件。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。

Our RECON and RANGER studies highlight the significant amount of time, effort and expertise required to conduct clinical research in peripheral nerve. The RECON study began enrollment approximate 6 years ago. And the RANGER registry began enrollment more than 10 years ago. In RANGER, many of the nerve injuries have follow-up assessment periods of up to 36 months to fully appreciate the impact of the repair. We're fortunate to have an established body of clinical evidence supporting advanced nerve graft. And we remain committed to obtaining the clinical evidence to demonstrate the safety, performance and utility of our nerve repair solutions.

我們的 RECON 和 RANGER 研究強調了進行週邊神經臨床研究所需的大量時間、精力和專業知識。 RECON 研究大約在 6 年前開始招募。 RANGER 註冊中心在 10 多年前就開始註冊。在 RANGER 中，許多神經損傷都有長達 36 個月的追蹤評估期，以充分了解修復的影響。我們很幸運擁有大量支持先進神經移植的臨床證據。我們仍然致力於獲取臨床證據，以證明我們的神經修復解決方案的安全性、性能和實用性。

I'd like to take a moment to comment on the proposed changes in CMS reimbursement rates for nerve repair in the outpatient setting for 2022. While the proposed increases for 2022 are modest at approximately 3% across most nerve repair procedures, we continue to be pleased with the significant increase over the last 3 years for repairs utilizing an implant. While Medicare patients represent a relatively small percentage of trauma cases, commercial payers often follow the lead of CMS. These reimbursement changes make simple nerve repairs economically feasible in the ambulatory surgery center setting, and we believe we are well-positioned with our full portfolio of products to support nerve repair in all surgical sites of care.

我想花點時間評論 2022 年門診神經修復 CMS 報銷率的建議變化。的顯著增加感到滿足。雖然醫療保險患者在創傷病例中所佔比例相對較小，但商業付款人通常會效仿 CMS 的做法。這些報銷變化使得簡單的神經修復在門診手術中心環境中在經濟上可行，我們相信我們擁有完整的產品組合，可以支持所有手術護理部位的神經修復。

Before I turn the call over to Pete, I'd like to spend a moment discussing our outlook for 2021, including our updated financial guidance. 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.

在將電話轉給 Pete 之前，我想花點時間討論一下我們對 2021 年的展望，包括我們更新的財務指引。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。

On the strength of our first half results, we're increasing our financial guidance for the year. We now expect that full year 2021 revenue will be in the range of $134.5 million to $137.5 million versus the prior range of $133 million to $136 million. And we continue to expect full year gross margin to remain above 80%. This guidance reflects our optimism in the business as we continue to monitor the impact of COVID variants on procedure volumes and surgical capacity. 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%. I'll now turn the call over to Pete for a few -- for a review of the financial highlights. Pete?

根據上半年的業績，我們正在提高今年的財務指引。我們現在預計 2021 年全年營收將在 1.345 億美元至 1.375 億美元之間，而之前的範圍為 1.33 億美元至 1.36 億美元。我們繼續預計全年毛利率將維持在 80% 以上。該指南反映了我們對業務的樂觀態度，因為我們將繼續監測新冠病毒變異對手術量和手術能力的影響。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。現在我將把電話轉給皮特，讓他回顧一下財務要點。皮特？

Thank you, Karen. First quarter revenue increased 52% to $33.6 million. Our revenue increase for the quarter was a result of a 40% increase in unit volume, an 8% benefit from changes in product mix and a 4% increase in price. The growth in unit volume and mix is primarily attributed to growth in our core and active accounts and reflects the initial impact of COVID-19 pandemic, which negatively impacted procedure volumes and revenue in the second quarter of 2020.

謝謝你，凱倫。第一季營收成長 52%，達到 3,360 萬美元。我們本季的營收成長是由於單位銷售增加了 40%、產品組合變化帶來的 8% 收益以及價格上漲 4%。單位數量和組合的增長主要歸因於我們的核心和活躍帳戶的增長，並反映了 COVID-19 大流行的初步影響，這對 2020 年第二季度的手術量和收入產生了負面影響。

On May 17 we announced that we would suspend market availability of our Avive Soft Tissue Membrane effective June 1, 2021, pending ongoing discussions with the FDA regarding the regulatory classification of Avive. In the second quarter, Avive revenue was approximately $1.8 million, representing 5% of total revenue. Gross profit in the second quarter increased 60% to $26.5 million compared to $16.5 million in Q2 of 2020. Gross margin was 78.9% for Q2 compared to 74.7% in the prior year. Gross margin would have been approximately 83.1%, excluding the impact of a onetime charge of $1.4 million reflecting the write-down of inventory and production costs related to the previously disclosed suspension of market availability of Avive.

5 月 17 日，我們宣布，我們將暫停 Avive 軟組織膜的市場供應，自 2021 年 6 月 1 日起生效，等待與 FDA 就 Avive 監管分類進行持續討論。第二季度，Avive營收約180萬美元，佔總營收的5%。第二季的毛利成長了 60%，達到 2,650 萬美元，而 2020 年第二季的毛利為 1,650 萬美元。毛利率約為 83.1%，不包括一次性費用 140 萬美元的影響，該費用反映了與先前披露的 Avive 暫停上市相關的庫存和生產成本的減記。

Prior year gross margin was negatively impacted by lower revenue and a $1.6 million charge for increased inventory reserves and suspension of production in response to the market impact of COVID-19. Total operating expense in the second quarter increased 36% to $33.6 million compared to $24.8 million in the prior year. Total operating expenses in the second quarter included $3.8 million in noncash stock compensation compared to $2.2 million in the prior year. The increase in total operating expenses, including stock compensation, reflects a return 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.

上一年的毛利率受到收入下降以及為應對 COVID-19 市場影響而增加庫存儲備和暫停生產而收取的 160 萬美元費用的負面影響。第二季總營運費用成長 36%，達到 3,360 萬美元，而上年同期為 2,480 萬美元。第二季的總營運支出包括 380 萬美元的非現金股票補償，而去年同期為 220 萬美元。包括股票薪酬在內的總營運支出的增加反映出，由於公司在疫情爆發之初實施了成本削減舉措，導致 2020 年第二季度支出大幅減少，過去幾個季度支出已恢復到更加正常化的水平。

Sales and marketing expense in the second quarter increased 35% to $19.3 million compared to $14.3 million in the prior year. As a percent of total revenue, sales and marketing expenses decreased to 57% for the 3 months ended June 30, 2021, compared to 65% in the prior year. Research and development spending in the second quarter increased 41% to $5.7 million compared to $4.1 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. Product development expenses represented approximately 64% of total R&D in the first quarter compared to 50% in the prior year. While clinical expenses represented the remaining 36% in Q2 of '21 compared to 50% in the prior year.

第二季的銷售和行銷費用成長了 35%，達到 1,930 萬美元，而去年同期為 1,430 萬美元。截至 2021 年 6 月 30 日的三個月，銷售和行銷費用佔總收入的百分比下降至 57%，而前一年為 65%。第二季的研發支出成長了 41%，達到 570 萬美元，而去年同期為 410 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。第一季產品開發費用約佔研發總額的 64%，去年同期為 50%。 21 年第二季度，臨床費用佔剩餘的 36%，而去年這一比例為 50%。

The increase in product development expenses reflect increased spending in specific programs, including the BLA for Avance Nerve Graft and next-generation Avance products. Additionally, pandemic-related restrictions lowered spending on certain clinical study programs beginning in March of 2020. As a percentage of total revenue, research and development expenses were 17% in Q2 compared to 18% in the prior year. General and administrative expenses in the first quarter increased 35% to $8.7 million or 26% of revenue compared to $6.4 million or 29% of revenue in the prior year.

產品開發費用的增加反映了特定項目支出的增加，包括 Avance 神經移植和下一代 Avance 產品的 BLA。此外，從 2020 年 3 月開始，與疫情相關的限制減少了某些臨床研究項目的支出。第一季的一般和管理費用增加了 35%，達到 870 萬美元，佔收入的 26%，而前一年為 640 萬美元，佔收入的 29%。

Adjusted net loss and net loss per share in Q2 of 2021 was $3.7 million and $0.09 per share compared to adjusted net loss and loss per share in the prior year of $5.9 million and $0.15 per share. Adjusted EBITDA loss in the quarter was $2.4 million compared to an adjusted EBITDA loss of $5.7 million in the prior year. A reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and on our website.

2021 年第二季調整後淨虧損和每股淨虧損分別為 370 萬美元和每股 0.09 美元，而前一年調整後淨虧損和每股虧損分別為 590 萬美元和每股 0.15 美元。本季調整後 EBITDA 虧損為 240 萬美元，而前一年調整後 EBITDA 虧損為 570 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 June 30, 2021, was $106.2 million compared to a balance of $97.2 million at the end of Q1. The $9.7 million increase includes $15 million of additional debt proceeds drawn from the company's debt facility with Oberland Capital on June 30, and net operating cash flow in the quarter of $1.2 million, partially offset by facilities capital expenditures of $7.2 million, primarily for our new Biologics processing center in Dayton, Ohio. And we continue to expect completion of the Dayton facility later this year, followed by a 1-year validation process and expect to begin production in the new center in late 2022.

截至 2021 年 6 月 30 日，現金、現金等價物和投資餘額為 1.062 億美元，而第一季末的餘額為 9,720 萬美元。 970 萬美元的增加包括6 月30 日從公司與Oberland Capital 的債務融資中提取的1,500 萬美元額外債務收益，以及本季120 萬美元的淨營運現金流，部分被720 萬美元的融資資本支出所抵消，主要用於我們的新業務位於俄亥俄州代頓的生物製品加工中心。我們繼續預計代頓工廠將於今年稍後竣工，隨後進行為期 1 年的驗證過程，並預計於 2022 年底在新中心開始生產。

Year-to-date, we've spent approximately $9.1 million on this facility and continue to anticipate total capital expenditures of approximately $26 million for this facility in 2021. Additionally, we expect to continue ramping investment in clinical trials, product development programs, marketing and administrative initiatives, all of which are key to driving our long-term growth. As a result, we anticipate that operating expenses will increase sequentially and that we will continue to see moderate operating cash burn in 2021.

今年迄今為止，我們已在該設施上花費了約910 萬美元，並繼續預計2021 年該設施的總資本支出約為2600 萬美元。行銷的投資和行政舉措，所有這些都是推動我們長期成長的關鍵。因此，我們預計營運費用將連續增加，並且 2021 年將繼續看到適度的營運現金消耗。

Turning to guidance. As Karen noted earlier, we are increasing our revenue guidance and now expect full year 2021 revenue to be in the range of $134.5 to $137.5 million, an increase from our previous range of $133 million to $136 million. Additionally, we continue to expect full year gross margin to remain above 80%. This guidance reflects our optimism in the business as we continue to monitor the impact of COVID-19 variance on procedure volumes and surgical capacity. This guidance also assumes that Avive is not commercially available for the remainder of the year. As we look toward 2022 and beyond, we believe the strength of our strategic plans, 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 Karen 先前指出的那樣，我們正在提高收入指導，現在預計 2021 年全年收入將在 134.5 美元至 1.375 億美元之間，高於之前的 1.33 億美元至 1.36 億美元。此外，我們繼續預計全年毛利率將維持在 80% 以上。這項指引反映了我們對業務的樂觀態度，因為我們將繼續監測 COVID-19 差異對手術量和手術能力的影響。本指南也假設 Avive 在今年剩餘時間內不會上市。展望 2022 年及以後，我們相信，我們的戰略計劃的力量以及在這個服務不足的醫療保健市場的執行將使我們能夠繼續成為一家長期增長的公司，實現從高到低的可持續年化收入增長20%。

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

我想把電話轉回給凱倫。

Thanks, Pete. I'm proud of the achievements of the entire AxoGen team in the second quarter and first half of the year. We remain committed to delivering our innovative nerve repair solutions to patients, surgeons and hospitals, and I believe we're well positioned for success in 2021 and beyond. At this point, I'd like to open up the line for questions. Maria?

謝謝，皮特。我為整個 AxoGen 團隊在第二季和上半年的成就感到自豪。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，我相信我們已做好準備，在 2021 年及以後取得成功。此刻，我想開通提問專線。瑪麗亞？

(Operator Instructions) Our first question is from Brandon Folkes with Cantor Fitzgerald.

（操作員說明）我們的第一個問題來自布蘭登·福克斯和坎托·菲茨傑拉德。

Congratulations on a very good quarter. Firstly, maybe on the full year guidance range. Just any pushes and pulls in terms of assumptions in that full year range? And then secondly, on the quarterly cadence in the back half of the year, I think we've seen trauma being a little bit less elective. And then you haven't relied historically on this heavy 4Q. Is that the same thinking for 2021? Just any color just given the uniqueness of the times? And then is the 3Q summer activity that you saw in July, is that in line with prior years? And given that, is it fair to think that 3Q may be the best quarter just due to that increased activity?

恭喜您度過了一個非常好的季度。首先，也許是全年指導範圍。就全年範圍內的假設而言，是否有任何推動和拉動？其次，從今年下半年的季度節奏來看，我認為我們已經看到創傷的選擇性減少。從歷史上看，你並沒有依賴這個沉重的第四季。 2021 年也是同樣的想法嗎？只是賦予時代獨特性的任何顏色嗎？那麼您在7月看到的第三季夏季活動是否與往年一致？有鑑於此，僅僅因為活動增加就認為第三季可能是最好的季度是否公平？

Thanks, Brandon. Thanks for the question. Yes. Look, first of all, we're just -- we're pleased with the overall execution of the business. We're continuing to make very good progress in this market within our accounts, and we're happy with the growth that we had here through the first half, and we believe we'll continue to see growth -- nice growth in the second half of the year as well. As far as puts and takes goes, I mean I think we've -- I highlighted in my prepared remarks that we have $1.8 million of Avive revenue in the second quarter. And we've always expected that that -- that we would not have Avive revenue in the back half. That's always been part of our assumption. So as you're thinking about your model, there is that put and take to think about. But overall, in the market, I think we saw good progress through the second quarter. I think our experience in the second quarter is very much like everyone else has seen. And we do think that the recovery is continuing. It's not as if -- and this is consistent with what you're hearing from everybody else. It's not as if there was this full recovery in Q2. It's still happening. And we'll see that extend into Q3 and likely into Q4 as well.

謝謝，布蘭登。謝謝你的提問。是的。首先，我們對業務的整體執行感到滿意。我們的帳戶繼續在這個市場取得非常好的進展，我們對上半年的成長感到滿意，我們相信我們將繼續看到成長——下半年的成長很好也有半年。就投入和產出而言，我的意思是，我認為我們已經——我在準備好的發言中強調，我們第二季的 Avive 收入為 180 萬美元。我們一直預計下半年不會有 Avive 收入。這一直是我們假設的一部分。因此，當您考慮模型時，您需要考慮 put 和 take 的問題。但總的來說，在市場上，我認為我們在第二季度看到了良好的進展。我認為我們第二季度的經歷與其他人所看到的非常相似。我們確實認為復甦正在持續。這並不是說——這與你從其他人那裡聽到的一致。第二季並沒有完全復甦。它仍然在發生。我們將看到這種情況延伸到第三季度，也可能延伸到第四季。

Our next question is from Anthony Petrone with Jefferies.

我們的下一個問題來自 Jefferies 的 Anthony Petrone。

Congratulations. Maybe just, Pete, on the follow-up to the initial question. Just when you look at trauma cases, and obviously, that's being tracked, and it looks like it was sort of mixed in the quarter from competitive calls we've been on in the past week or so. Where do you think U.S. trauma cases are versus pre-pandemic levels? Are we even yet overall in trauma cases? Or do you think we're still at some discount? When do you think we'll get to even? So just to clean that up a bit. And then on the core account sort of update, when we think about those accounts now doing $100,000 in trailing 12-month revenue, just curious as to where do you think the average overall core account contribution can go as this new strategy of going deeper is into place?

恭喜。皮特，也許只是對最初問題的後續處理。當你查看創傷案例時，顯然，這些案例正在被跟踪，而且看起來本季度的情況與我們在過去一周左右的競爭電話中的情況有些參差不齊。您認為美國的創傷病例與疫情前的水平相比如何？我們在創傷案件中大體上還平衡嗎？或者你認為我們還有折扣嗎？你認為我們什麼時候才能扯平？所以只是要清理一下。然後，關於核心帳戶的更新，當我們考慮這些帳戶現在過去 12 個月的收入為 100,000 美元時，我們只是好奇，隨著這種深入研究的新策略，您認為平均總體核心帳戶貢獻會去向哪裡？到位嗎？

Great. Well, actually, trauma is not back to pre-pandemic levels people's activity while improving and increasing. And then there's a resultant level of trauma associated with that. It has been getting better in terms of activity. So therefore, the trauma cases have increased some. They're not back to what we would consider normal for this time period. One difference that we see compared to, obviously, early last year, is that while some elective procedures and hotspots are being delayed, what we aren't seeing is trauma cases being delayed. Hospitals are looking to continue to prioritize those as long as they have really any kind of surgical capacity. So we have been less effective than elective procedures in our trauma business.

偉大的。嗯，實際上，創傷並沒有回到大流行前的水平，人們的活動同時也得到改善和增加。然後就會產生與此相關的某種程度的創傷。活動方面已經越來越好了。因此，外傷病例增加了一些。他們還沒有回到我們所想的這段時間的正常狀態。顯然，與去年初相比，我們看到的一個區別是，雖然一些選擇性手術和熱點被推遲，但我們沒有看到創傷病例被推遲。只要醫院確實具備任何類型的手術能力，他們就會繼續優先考慮這些問題。因此，在我們的創傷業務中，我們的效率不如選擇性手術。

In terms of the question about core accounts, just a reminder, a core count is a minimum of $100,000 in the trailing 12 months.

關於核心帳戶的問題，提醒一下，過去 12 個月內核心帳戶數量至少為 10 萬美元。

But if you just do some math, so think of it as 60% of our business, you can see that the average is obviously higher than that. Our highest accounts are over $1 million in that category. And we see that we have room even to grow those highest accounts. So we look to continue to drive penetration, that's where we think we get the biggest dollar impact and then continue to add more core accounts as we take -- if you think about a progression of taking active accounts to core accounts, so they move up into that higher region, and we continue to develop new accounts to move them into active. We see this as a total expansion as we drive penetration.

但如果你只是做一些數學計算，那麼將其視為我們業務的 60%，你可以看到平均值明顯高於此。我們在該類別中的最高帳戶超過 100 萬美元。我們發現我們甚至還有空間來增加那些最高的帳戶。因此，我們希望繼續推動滲透率，我們認為這就是我們獲得最大美元影響的地方，然後繼續增加更多核心帳戶——如果你考慮將活躍帳戶轉移到核心帳戶的過程，那麼它們就會上升進入更高的區域，我們繼續開發新帳戶以使它們活躍起來。我們認為這是我們推動滲透率的全面擴張。

Our next question is with Jaime Morgan with SVB Leerink.

我們的下一個問題是 SVB Leerink 的 Jaime Morgan。

So you guys just touched on the trauma market. I'm curious just how the progression of the other markets is going in the second quarter and kind of how to think about the outlook between the surgical treatment of pain breast and OMF in the back half of the year. And if those markets aren't back to normal either yet, which I'm assuming they're not, when can we expect to see more normal levels in those markets?

所以你們剛接觸了創傷市場。我很好奇第二季度其他市場的進展如何，以及如何看待下半年疼痛乳房手術治療和 OMF 之間的前景。如果這些市場還沒有恢復正常（我假設它們還沒有恢復正常），那麼我們什麼時候才能看到這些市場恢復正常水平？

Sure. If we look at each of the segments, breast reconstruction neurotization, we have had what I would call an air pocket of patient flow that occurred because women didn't have mammograms, they didn't have preventive care, so they didn't have diagnosis of a tumor, and they didn't have a mastectomy. And those things were delayed. So there was this air pocket of patient flow. We believe we're through that and see breast reconstruction ramping back up. That is of course tempered as is an elective procedure that takes quite a bit of our time. So in areas that are a hotspot. And that's a very regional determination, but areas that are a hotspot for COVID, we see the cases in those areas going down for a period of time. They're delayed. They're not lost. But those cases are delayed until they have more capacity in the, surgical capacity in the hospital.

當然。如果我們看一下乳房重建神經化的每個部分，我們會發現我所說的病人流氣穴，這是因為女性沒有進行乳房X光檢查，她們沒有預防性護理，所以她們沒有診斷出腫瘤，但他們沒有進行乳房切除手術。而這些事情都被延後了。所以就存在著患者流動的氣穴。我們相信我們已經度過了難關，並且看到乳房重建工作正在回升。這當然是一個緩和的過程，因為這是一個需要花費我們大量時間的選擇性程序。所以在熱點地區。這是一個非常區域性的決定，但在新冠疫情的熱點地區，我們看到這些地區的病例數在一段時間內有所下降。他們遲到了。他們沒有迷路。但這些病例會被推遲，直到醫院具備更多的手術能力。

So what do we think will happen for the rest of the year? Overall, we think we're going to be going through these rolling pockets of impact from COVID, that it will be manageable in the same way that we've managed over the last 12 months, that the overall surgical impact will be less than what we saw over the last year. And in general, these will all -- all of the elective procedures will be increasing through the year. So we think that breast neurotization will be continuing to ramp through the back half of the year. Oral maxillofacial we've seen has been very flat. I think we mentioned before it's been our slowest market to recover with a significant patient reluctance to come in and have surgery in this sort of invasive surgery in the mouth. That we do expect to start to ramp back up in the back half of the year, but it has been relatively flat through the first half of the year.

那我們認為今年剩餘時間會發生什麼事？總體而言，我們認為我們將經歷新冠肺炎帶來的滾滾影響，並且可以像我們過去 12 個月的管理方式一樣進行管理，總體手術影響將小於我們在過去的一年裡看到了。總的來說，所有的選修程序都​​將在這一年增加。因此，我們認為乳房神經化將在今年下半年繼續增加。我們所看到的口腔頜面已經非常平坦了。我想我們之前提到過，這是我們恢復最慢的市場，病人非常不願意進來進行這種口腔侵入性手術。我們確實預計下半年會開始回升，但上半年相對持平。

And the surgical treatment of pain, it's a little hard to say what's normal because that was a new introduction for us, really focusing on it last year. It has continued to grow, but of course off a really small base and that we really launched AxoGuard Nerve Cap and a focus on neuroma management only at the beginning of last year. So while it's a small segment, we continue to be pleased with the adoption and interest from surgeons in expanding into the surgical treatment of pain.

對於疼痛的手術治療，很難說什麼是正常的，因為這對我們來說是一個新的介紹，去年才真正關注它。它一直在持續增長，但當然基礎非常小，而且我們直到去年年初才真正推出了 AxoGuard Nerve Cap 並專注於神經瘤管理。因此，雖然這只是一小部分，但我們仍然對外科醫生對擴展到疼痛外科治療領域的採用和興趣感到高興。

Got it. That's helpful. And then I think you were referring to, alluded to it before with your commentary just on the core accounts, Karen. But is bringing on the new incremental surgeon or new account versus just getting an existing active user to do more cases, more needle-moving in terms of driving the growth and kind of delivering as you're talking about the sustainable high teens to low 20s annualized growth?

知道了。這很有幫助。然後，我認為您之前在對核心帳戶的評論中提到過，凱倫。但是，與僅僅讓現有的活躍用戶做更多的病例相比，引入新的增量外科醫生或新帳戶，在推動增長和交付方面更加針鋒相對，就像你談論可持續的十幾歲到二十幾歲的人一樣年化成長？

Yes. The best opportunity for us is to continue to drive penetration with an existing user and an existing account. Just from a -- continuing to move the needle, that's the thing that is the biggest impact. But obviously we're not only doing that. We continue to focus on the strategy. This does. We need to continue to expand out our footprint so that our users can use our products in all sites of care. We -- nerve repair is done predominantly in hospital-based centers, but is moving to ambulatory surgery centers. And we need to be positioned to be able to support that. And we believe with the product portfolio that we have, we are well-positioned to be their choice, their partner of choice in all of their nerve repair regardless of the site of care. So we continue to work in all of those areas, expanding and adding new accounts at the same time that we're driving penetration with existing users and in existing accounts.

是的。對我們來說，最好的機會是繼續提高現有用戶和現有帳戶的滲透率。僅從 - 繼續推動這一點來看，這就是最大的影響。但顯然我們不只這樣做。我們繼續關注戰略。確實如此。我們需要繼續擴大我們的足跡，以便我們的用戶可以在所有護理場所使用我們的產品。我們—神經修復主要在醫院中心進行，但正在轉移到門診手術中心。我們需要做好準備來支持這一點。我們相信，憑藉我們擁有的產品組合，我們有能力成為他們的選擇，他們在所有神經修復中的首選合作夥伴，無論護理地點如何。因此，我們將繼續在所有這些領域開展工作，擴大和添加新帳戶，同時推動現有用戶和現有帳戶的滲透。

(Operator Instructions) Ladies and gentlemen, we have reached the end of our question-and-answer session. I'd like to call -- turn the call back over to Karen Zaderej for closing remarks.

（操作員說明）女士們先生們，我們的問答環節已經結束。我想打電話給凱倫‧札德雷 (Karen Zaderej)，讓其結束語。

Thank you, Maria. I want to thank everyone for joining us on today's call. We look forward to speaking with many of you virtually at the Guggenheim MedTech Disruptor Summit on August 9, the Canaccord Genuity Annual Growth Conference on August 11, the Morgan Stanley Global Healthcare Conference on September 9, the Cantor Fitzgerald Global Healthcare Conference on September 27, and the Jefferies London Healthcare Conference in November. Thank you.

謝謝你，瑪麗亞。我要感謝大家參加今天的電話會議。我們期待在8 月9 日舉行的古根漢醫療科技顛覆者高峰會、8 月11 日舉行的Canaccord Genuity 年度成長會議、9 月9 日舉行的摩根士丹利全球醫療保健會議、9 月27 日在舉行的Cantor Fitzgerald 全球醫療保健會議上與大家進行虛擬交流。謝謝。

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

今天的會議到此結束。此時您可以斷開線路。感謝您的參與。