AxoGen Inc (AXGN) 2025 Q2 法說會逐字稿

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Joining me on today's call is Michael Dale, Axogen's Chief Executive Officer and Director; and Lindsey Hartley, Chief Financial Officer. Michael will discuss second quarter 2025 financial results and corporate highlights. Lindsey will then provide details on financial performance, guidance, and overall outlook for the year. This will be followed by a question-and-answer session.

參加今天電話會議的還有 Axogen 執行長兼董事 Michael Dale 和財務長 Lindsey Hartley。麥可將討論 2025 年第二季的財務表現和公司亮點。隨後，林賽將提供有關今年財務業績、指導和整體前景的詳細資訊。接下來是問答環節。

Today's call is being broadcast live via webcast, which is available on the Investors section of Axogen's website. 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，您可以在 Axogen 網站的「投資者」部分觀看。現場通話結束後，可在本公司網站 www.axogeninc.com 的投資者專區觀看重播。

Before we get started, I'd like to remind you that during the conference call, the company will make projections and forward-looking statements. Forward-looking statements, which are usually identified by the use of words such as objectives, targets, will, believe, expect, estimate, should, guidance, intend, projects, or other similar phrases, include, but are not limited to statements relating to financial guidance, including revenue, margins, cash flow, future profitability, expectations for growth, market development priorities, estimated market opportunities, timing for future product and application launches and the company's expectations for approval of the Biologics License Application for Avance Nerve Graft, including the anticipated timing of approval and the assumption that Avance Nerve Graft will be designated as a reference product for any future biosimilar nerve graft and that such designation will provide marketplace exclusivity.

在我們開始之前，我想提醒您，在電話會議期間，公司將做出預測和前瞻性陳述。前瞻性陳述通常使用目標、指標、將、相信、預期、估計、應該、指導、打算、項目或其他類似措辭來表示，包括但不限於與財務指導有關的陳述，包括收入、利潤率、現金流、未來盈利能力、增長預期、市場發展重點、預計的市場機會、未來產品和應用推出的時間以及公司對 Avance 神經移植生物製品神經移植將被指定為任何未來生物相似藥神經移植的參考產品的假設，並且這種指定將提供市場獨佔權。

Forward-looking statements are based on current beliefs and assumptions and are not guarantees of future performance and are subject to risks and uncertainties, including, without limitation, the risks and uncertainties reflected in the company's SEC filings, including its Form 10-K and 10-Q. The forward-looking statements are representative only as of the date that they are made, and except as required by applicable law, the company assumes no responsibility to publicly update or revise any forward-looking statements.

前瞻性陳述基於當前的信念和假設，並不保證未來的業績，並受風險和不確定性的影響，包括但不限於公司向美國證券交易委員會提交的文件中反映的風險和不確定性，包括其 10-K 和 10-Q 表格。前瞻性陳述僅在其作出之日具有代表性，除適用法律要求外，本公司不承擔公開更新或修改任何前瞻性陳述的責任。

In addition, for a reconciliation of non-GAAP measures, please refer to today's press release and the corporate presentation on the Investors section of the company's website. Now I'll turn the call over to Michael.

此外，有關非公認會計準則指標的調節，請參閱今天的新聞稿和公司網站投資者部分的公司介紹。現在我將把電話轉給麥可。

Thank you, operator, and welcome to everyone joining us this morning as we discuss our 2025 second quarter financial results. I'll begin today's call with a financial and corporate overview, highlighting our progress through the second quarter and year-to-date implementing our strategic plan, followed by an update on the Biologics License Application, or BLA, for our Avance Nerve Graft. I will then pass the call to Lindsey to review second quarter's financials and outlook for the remainder of 2025, and then we will open the lines for a question-and-answer session.

謝謝接線員，歡迎大家今天早上加入我們，一起討論 2025 年第二季的財務表現。我將在今天的電話會議上首先介紹財務和公司概況，重點介紹我們在第二季度和今年迄今為止實施戰略計劃的進展，然後介紹我們的 Avance 神經移植的生物製品許可申請（BLA）的最新情況。然後，我將把電話轉給 Lindsey，讓他回顧第二季度的財務狀況和 2025 年剩餘時間的展望，然後我們將開始問答環節。

As remarked in this morning's earnings release, we are delighted with our second quarter performance and progress year-to-date for the business. We believe our strong revenue growth and related business milestone achievements reflects the soundness of both our market development strategies and commercial execution capabilities. I have mentioned publicly on various occasions that I felt our performance through midyear would be an important measure of our progress optimizing our business model.

正如今天上午的收益報告中所述，我們對第二季度的業績和今年迄今為止的業務進展感到非常滿意。我們相信，強勁的收入成長和相關業務里程碑的成就反映了我們市場發展策略和商業執行能力的穩健性。我曾多次公開表示，我認為我們到年中的表現將是我們優化商業模式進展的重要衡量標準。

While there will always be opportunity for further optimization, as a leadership team, we believe based on the measures we use for our customer creation business models, we are managing our market opportunities the way we had planned and have high confidence in our ability to grow the business consistent with the guidance we have previously provided for our strategic plan.

雖然總是會有進一步優化的機會，但作為領導團隊，我們相信，基於我們用於客戶創造業務模式的措施，我們正在按照計劃的方式管理我們的市場機會，並且對我們根據之前為我們的戰略計劃提供的指導發展業務的能力充滿信心。

Regarding the quarter, Q2 sales increased to $56.7 million, growing 18.3% compared to the same period last year. This performance reflects double-digit growth across all of our nerve repair target markets, including extremities, oral maxillofacial and head and neck and breast.

本季度，第二季銷售額增至 5,670 萬美元，比去年同期成長 18.3%。這項業績反映了我們所有神經修復目標市場（包括四肢、口腔顎面、頭頸部和乳房）的兩位數成長。

Consistent with prior quarters, our growth is driven by expanding adoption of nerve care using Axogen's nerve algorithm for the treatment of all types of peripheral nerve injuries, including traumatic, iatrogenic and chronic nerve injuries. The Avance Nerve Graft is the primary growth driver, often complemented based on the clinical situation by one or more of our nerve repair connection, protection or termination products.

與前幾季一致，我們的成長得益於使用 Axogen 的神經演算法治療所有類型的周邊神經損傷（包括創傷性、醫源性和慢性神經損傷）的神經護理的不斷擴大。Avance 神經移植是主要的成長動力，通常根據臨床情況輔以一種或多種我們的神經修復連接、保護或終止產品。

In extremities, we continue to execute our high-potential account strategy with solid growth in both traumatic and chronic nerve injury procedures in the quarter. In oral maxillofacial and head and neck, surgeon adoption of the Axogen algorithm during the quarter was strong across all procedures, but particularly in mandible reconstruction procedures.

在四肢方面，我們持續執行高潛力客戶策略，本季創傷和慢性神經損傷手術均可穩健成長。在口腔顎面和頭頸部領域，本季度外科醫生對所有手術都大量採用了 Axogen 演算法，尤其是在下顎骨重建手術中。

And likewise, in breast, we continue to see strong adoption of our breast resensation techniques, supported by new surgeon activation, increased procedure volume and implant-based reconstruction cases and the expansion of our commercial infrastructure. In summary, we are encouraged by the broad-based adoption of our nerve care portfolio and momentum across each of our three target markets.

同樣，在乳房方面，我們繼續看到乳房重建技術的廣泛採用，這得益於新外科醫生的活躍、手術量和基於植入物的重建病例的增加以及商業基礎設施的擴展。總而言之，我們對我們的神經護理產品組合的廣泛採用以及我們三個目標市場的發展勢頭感到鼓舞。

To assess our progress, we continue to monitor key metrics tied to our plan and 2025 strategic priorities, including high-potential accounts, commercial expansion, professional education, new product development, clinical research and prostate market development. I'll begin with an update on our performance and growth in high-potential accounts.

為了評估我們的進展，我們繼續監控與我們的計劃和 2025 年策略重點相關的關鍵指標，包括高潛力客戶、商業擴張、專業教育、新產品開發、臨床研究和前列腺市場開發。我將首先介紹我們在高潛力客戶方面的業績和成長情況。

We continue to focus on expanding our presence in these accounts to drive more consistent customer creation, algorithm adoption and improvements in sales force productivity. Our goal for 2025 is to generate at least 66% of revenue from high-potential accounts. Through the first half of the year, we continue to exceed our target with approximately 70% of revenue growth driven by high-potential accounts. Furthermore, through the first half of the year, average high-potential account productivity is up 21% year-over-year, tracking in line with our full year target. These results reinforce our belief that our focus on high-potential accounts is enabling broader and more enduring adoption of nerve care, and as such, more predictable growth.

我們將繼續致力於擴大我們在這些帳戶中的影響力，以推動更一致的客戶創造、演算法採用和銷售隊伍生產力的提高。我們 2025 年的目標是從高潛力帳戶中創造至少 66% 的收入。今年上半年，我們繼續超額完成目標，約 70% 的營收成長由高潛力客戶推動。此外，今年上半年，高潛力帳戶的平均生產力年增 21%，與我們的全年目標一致。這些結果強化了我們的信念，即我們對高潛力客戶的關注將使神經護理得到更廣泛、更持久的採用，從而實現更可預測的成長。

During the first half of 2025, there were 641 active high-potential accounts, all of the approximately –- of the approximately 780 accounts that meet our high-potential criteria, which represents an increase of 19 accounts or 3% as compared to the first half of 2024. Regarding our 2025 commercial infrastructure expansion goals, as of end of second quarter, we are now at or ahead of our hiring plan for each target market. In breast, we ended the quarter with 19 breast resensation sales specialists and 1 regional sales director. We are on track to double the breast sales force in 2025 by the end of the year, targeting 22 reps and 2 regional sales directors.

2025 年上半年，活躍的高潛力帳戶有 641 個，約 780 個帳戶全部符合我們的高潛力標準，與 2024 年上半年相比增加了 19 個帳戶，增幅為 3%。關於我們的 2025 年商業基礎設施擴張目標，截至第二季末，我們目前已達到或超過了每個目標市場的招募計畫。在乳房方面，本季末我們有 19 位乳房修復銷售專家和 1 位區域銷售總監。我們計劃在 2025 年底前將乳房銷售隊伍規模擴大一倍，目標是擁有 22 名銷售代表和 2 名區域銷售總監。

To support broader adoption in non-breast markets, we added 5 additional sales representatives in high-potential territories in the second quarter, ending with 124 sales professionals, including 12 regional sales directors. In oral maxillofacial and head and neck, consistent with our plan, we added 5 field-based market development managers year-to-date. Surgeon training remains a core component of our customer creation and nerve repair algorithm adoption. Execution of our 2025 professional education programs are on track and we fully expect to meet our 2025 surgeon training targets. In breast, we have trained 35 surgeon pairs year-to-date, and with 3 programs planned in the second half of the year, we are confident we will meet our 2025 target of 75 surgeon pairs trained.

為了支持非母乳市場更廣泛的應用，我們在第二季度在高潛力地區增加了 5 名銷售代表，最終擁有 124 名銷售專業人員，其中包括 12 名區域銷售總監。在口腔顎面和頭頸部領域，按照我們的計劃，我們今年迄今增加了 5 位現場市場開發經理。外科醫生培訓仍然是我們客戶創造和神經修復演算法採用的核心組成部分。我們的 2025 年專業教育計畫正在按計畫實施，我們完全有望實現 2025 年外科醫生培訓目標。在乳房外科領域，我們今年迄今已培訓了 35 對外科醫生，併計劃在下半年開展 3 個項目，我們有信心實現 2025 年培訓 75 對外科醫生的目標。

Active breast resensation programs increased 9% from the second quarter of 2024 from 116 to 126. We estimate 280 surgeons performed a breast resensation procedure in the second quarter, which represents a 17% increase versus the second quarter of 2024. In extremities, we have trained 67 surgeons year-to-date, up 37 from first quarter 2025, with six additional programs planned in the second half of the year. We expect to meet our 2025 target of 105 surgeons trained. In oral maxillofacial and head and neck, we have trained 41 surgeons year-to-date, up 15 from first quarter 2025. We are on track to meet our 2025 target of 45 surgeons trained. Next, I will provide an update on our clinical research priorities. We continue to advance our 2025 initiatives and are on track to complete a level 1 study protocol for implant-based neurotization, a level 1 clinical evidence plan for Avance versus autograft in mixed and motor nerves and a clinical evidence plan for oral maxillofacial and head and neck.

2024 年第二季度，活躍的乳房修復計畫從 116 個增加到 126 個，成長了 9%。我們估計第二季有 280 名外科醫生進行了乳房復位手術，與 2024 年第二季相比增加了 17%。在四肢領域，我們今年迄今已培訓了 67 名外科醫生，比 2025 年第一季度增加了 37 名，併計劃在下半年再開展 6 個項目。我們預計到 2025 年將實現培訓 105 名外科醫生的目標。在口腔顎面和頭頸領域，我們今年迄今已培訓了 41 名外科醫生，比 2025 年第一季增加了 15 名。我們預計將實現到 2025 年培訓 45 名外科醫生的目標。接下來，我將介紹我們的臨床研究重點的最新情況。我們將繼續推進我們的 2025 年計劃，並有望完成基於植入物的神經化一級研究方案、Avance 與混合神經和運動神經自體移植的一級臨床證據計劃以及口腔頜面和頭頸部的臨床證據計劃。

Regarding research and development, as we have outlined in our strategic plan, innovation is critical to our long-term growth. Through midyear, we continue to progress and advance our innovation platform across 3 core pillars: therapeutic reconstruction, ease of coaptation and protection expansion. Regarding coverage and payment, during the quarter, multiple noncoverage policies were removed within the Blue Cross Blue Shield network for nerve care, adding an estimated 10 million additional covered lives.

關於研發，正如我們在策略計畫中所概述的，創新對我們的長期成長至關重要。到年中，我們將繼續在三大核心支柱上推廣和改進我們的創新平台：治療重建、易於接合和保護擴展。在保險範圍和支付方面，本季度，藍十字藍盾網路內的多項神經護理非保險政策被取消，預計新增受保人數將達到 1,000 萬人。

Year-to-date, we estimate 17 million additional lives are now covered for nerve repair for peripheral nerve injuries using synthetic conduits or allografts, which brings coverage amongst commercial payers to more than 55%. Adding to our progress during the second quarter, we enjoyed significant external validation of Axogen's differentiated technologies and leadership in peripheral nerve repair, with 17 new peer-reviewed publications citing clinical use or discussion of our products. For those interested, these peer-reviewed studies are available on our website.

今年迄今為止，我們估計已有 1700 萬人透過合成導管或同種異體移植修復週邊神經損傷，涵蓋商業支付者的神經修復覆蓋率達到 55% 以上。除了第二季度的進展之外，Axogen 在周圍神經修復領域的差異化技術和領導地位也得到了外部的廣泛認可，其中有 17 篇新的同行評審出版物引用了我們產品的臨床使用或討論。對於有興趣的人，這些經過同行評審的研究可以在我們的網站上找到。

And finally, I will provide an update on our prostate clinical and market development plan. We are excited about the opportunity to improve nerve function outcomes in robotic-assisted radical prostatectomy and continue to work closely with key opinion leaders to advance surgical technique development. During the second quarter, we completed the hiring of our clinical development team, which will provide field-based support to surgeons and pilot sites incorporating nerve repair into their robotic-assisted prostatectomy cases. We added three additional clinical pilot sites and now have 6 active sites. We expect to meet the goal of having 10 pilot sites running by year-end. Procedures are ongoing, and we aim to complete 100 cases by year-end.

最後，我將介紹我們的前列腺臨床和市場發展計劃的最新情況。我們很高興有機會改善機器人輔助根治性攝護腺切除術的神經功能結果，並將繼續與關鍵意見領袖密切合作，推動手術技術的發展。在第二季度，我們完成了臨床開發團隊的招聘，該團隊將為外科醫生和試點站點提供現場支持，將神經修復納入機器人輔助前列腺切除術病例中。我們增加了三個臨床試點站點，目前共有 6 個活躍站點。我們預計到年底將實現 10 個試點站點投入運作的目標。程序正在進行中，我們的目標是到年底完成 100 起案件。

Before I hand it over to Lindsey, I would like to address the status of the Biologics License Application, or BLA, for Avance Nerve Graft. The BLA remains on track and continues to progress as planned. During the second quarter, we completed several key regulatory milestones to support our anticipated approval in September of 2025, the late cycle meeting with the FDA, pre-licensing inspection and sponsor inspection under the FDA's Bioresearch Monitoring Program.

在將其交給 Lindsey 之前，我想先介紹一下 Avance 神經移植的生物製品許可申請 (BLA) 的狀態。BLA 仍在按計劃進行並繼續取得進展。在第二季度，我們完成了幾個關鍵的監管里程碑，以支持我們預計在 2025 年 9 月獲得的批准、與 FDA 的後期週期會議、FDA 生物研究監測計劃下的許可前檢查和贊助商檢查。

These milestones follow the successful clinical trial inspections we spoke about on our last call, further reinforcing our confidence in the strength and completeness of our Biological (sic – Biologics) License Application submission for Avance Nerve Graft. We reiterate prior guidance that we expect BLA approval in September. The BLA approval will secure 12 years of market exclusivity from biosimilar nerve allografts and establish Avance Nerve Graft as the only implantable biologic indicated for the repair of functional deficits in peripheral nerves. With that, I will turn it over to Lindsey, who is off to a great start as Chief Financial Officer and is adding a great deal of clarity to our operating performance.

這些里程碑是繼我們上次通話中談到的成功臨床試驗檢查之後取得的，進一步增強了我們對 Avance 神經移植生物製品（原文如此 - 生物製劑）許可申請的強度和完整性的信心。我們重申先前的指導意見，預計 BLA 將於 9 月獲得批准。BLA 的批准將確保生物相似藥神經同種異體移植的 12 年市場獨佔權，並使 Avance Nerve Graft 成為唯一用於修復週邊神經功能缺陷的可植入生物製劑。接下來，我將把權力移交給林賽 (Lindsey)，她擔任財務長以來，取得了良好的開端，為我們的經營業績帶來了極大的清晰度。

Thanks, Mike. I'm pleased to report our second quarter results. We reported revenue of $56.7 million, reflecting an 18.3% growth compared to the second quarter of 2024 and a 16.7% sequential increase over the first quarter of 2025. The year-over-year performance was driven by an increase of approximately 3% in price and 15% in unit, volume and mix. Our gross profit for the quarter came in at $42 million, up from $35.3 million in the second quarter of 2025 and $34.9 million in the first quarter of 2025.

謝謝，麥克。我很高興地報告我們第二季的業績。我們報告的營收為 5,670 萬美元，與 2024 年第二季相比成長 18.3%，與 2025 年第一季相比較上季成長 16.7%。與去年同期相比，業績成長主要得益於價格上漲約 3% 以及單位、數量和組合上漲 15%。本季我們的毛利為 4,200 萬美元，高於 2025 年第二季的 3,530 萬美元和 2025 年第一季的 3,490 萬美元。

This represents a gross margin of 74.2%, up from 73.8% in the same period last year and up from 71.9% in the first quarter of 2025. The year-over-year increase is primarily due to lower inventory write-offs and shipping costs on products sold, partially offset by slightly higher product costs. Gross margin for the first half of 2025 was 73.1%, 3% less than the first half of 2024. The decrease of gross margin for the first half of 2025 was driven by a 2.8% increase in year-over-year product cost. Product costs increased as a result of the transition of processing Avance Nerve Graft to our Axogen processing center and costs related to the additional steps and tests required as we approach the transition to processing as a biologic in September.

這意味著毛利率為 74.2%，高於去年同期的 73.8%，也高於 2025 年第一季的 71.9%。年比成長主要由於庫存註銷和銷售產品的運輸成本降低，但產品成本略有上升，部分抵消了這一增長。2025年上半年毛利率為73.1%，較2024年上半年下降3%。2025年上半年毛利率下降的原因是產品成本年增2.8%。由於將 Avance 神經移植片的加工轉移到我們的 Axogen 加工中心，以及我們在 9 月接近向生物製劑加工過渡時所需的額外步驟和測試相關的成本，產品成本有所增加。

We expect the cost of our Avance product to decrease over time as we gain economies of scale at the Axogen processing center, and once the BLA is approved, we can begin implementing a continuous improvement program. Our operating expenses increased to $40.3 million, up from $35.8 million in the second quarter of 2024, and as a percentage of revenue, decreased 3.5%, highlighting our ability to increase our operating leverage. Sales and marketing expenses as a percentage of total revenue were up less than 1 percentage point to 42% from 43.1% in the second quarter of 2024. Research and development expenses increased 2.9% to $6.8 million from $6.7 million in the second quarter of 2024.

我們預計，隨著 Axogen 加工中心獲得規模經濟，我們的 Avance 產品的成本將隨著時間的推移而降低，一旦 BLA 獲得批准，我們就可以開始實施持續改進計劃。我們的營運費用從 2024 年第二季的 3,580 萬美元增加到 4,030 萬美元，佔營收的百分比下降了 3.5%，突顯了我們提高營運槓桿的能力。銷售和行銷費用佔總收入的百分比從 2024 年第二季的 43.1% 上升不到 1 個百分點至 42%。研發費用從 2024 年第二季的 670 萬美元增加 2.9% 至 680 萬美元。

As a percentage of total revenue, research and development expenses were down 1.8% to 12.1% from 13.9% in the second quarter of 2024. General and administrative expenses increased 2.9% to $9.7 million from $9.4 million in the second quarter of 2024. As a percentage of total revenues, general and administrative expenses were down 2.6% to 17.1% from 19.7% in the second quarter of 2024.

研發費用佔總收入的百分比從 2024 年第二季的 13.9% 下降 1.8% 至 12.1%。一般及行政開支從 2024 年第二季的 940 萬美元增加 2.9% 至 970 萬美元。作為總收入的百分比，一般及行政開支從 2024 年第二季的 19.7% 下降 2.6% 至 17.1%。

Net income for the quarter was $0.6 million or $0.01 per share compared to a net loss of $1.9 million or $0.04 per share in the second quarter of 2024. Adjusted net income for the quarter was $5.7 million or $0.12 per share compared to an adjusted net income of $2 million or $0.05 per share in the second quarter of 2024. Adjusted EBITDA for the quarter was $9.3 million compared to an adjusted EBITDA of $5.6 million in the same period last year. As of June 30, our balance of cash, cash equivalents and investments increased $7.8 million to $35.9 million from $28.1 million at the end of the first quarter of 2025. Now turning to our full year financial guidance for 2025.

本季淨收入為 60 萬美元，即每股 0.01 美元，而 2024 年第二季淨虧損為 190 萬美元，即每股 0.04 美元。本季調整後淨收入為 570 萬美元，即每股 0.12 美元，而 2024 年第二季調整後淨收入為 200 萬美元，即每股 0.05 美元。本季調整後 EBITDA 為 930 萬美元，而去年同期調整後 EBITDA 為 560 萬美元。截至 6 月 30 日，我們的現金、現金等價物和投資餘額從 2025 年第一季末的 2,810 萬美元增加 780 萬美元至 3,590 萬美元。現在來談談我們 2025 年全年財務指引。

We are raising our revenue growth guidance to at least 17% or revenue of at least $219 million. We reiterate our gross margin guidance in the range of 73% to 75%, inclusive of onetime costs related to the BLA approval for Avance Nerve Graft, which are expected to impact gross margin by approximately 1%. As a reminder, these costs will be incurred around the anticipated BLA approval date, currently expected in September. Also, we estimate that two-thirds of those costs relate to the vesting of our BLA milestone-related stock compensation awards and are noncash. We continue to expect to be net cash flow positive for the year, and we also expect to self-fund our strategic plan with growing cash from operations. In summary, we are pleased with our second quarter performance and the progress we have made. We remain focused on executing strategy, investing in innovation, optimizing our resource allocation and driving towards profitability. With that, we will now open the lines for questions. Operator?

我們將營收成長預期提高至至少 17% 或收入至少 2.19 億美元。我們重申我們的毛利率指導範圍為 73% 至 75%，其中包括與 Avance Nerve Graft 的 BLA 批准相關的一次性成本，預計這將對毛利率產生約 1% 的影響。提醒一下，這些費用將在預計的 BLA 批准日期前後產生，目前預計在 9 月。此外，我們估計這些成本的三分之二與 BLA 里程碑相關的股票薪酬獎勵的歸屬有關，並且是非現金的。我們預計今年的淨現金流將繼續為正，我們也希望利用不斷增長的營運現金來為我們的策略計劃提供資金。總而言之，我們對第二季的業績和所取得的進展感到滿意。我們仍專注於執行策略、投資創新、優化資源配置和實現獲利。現在，我們將開始回答問題。操作員？

(Operator Instructions) Chris Pasquale, Nephron Research LLC.

（操作員指示） Chris Pasquale，Nephron Research LLC。

Congrats on nice results. Mike, I wanted to dig in a little bit more on the progress you've seen in the business through the first six months of the year. The 18% growth this quarter was similar to what you posted in 1Q, but it came against a much tougher comp. So I think arguably, it shows some acceleration in underlying trends. Would just love to know kind of where you think the changes you've implemented are bearing the most fruit here early on? And then maybe juxtapose that with the full year outlook, which does imply a bit of a deceleration in the back half.

恭喜你取得了好成績。麥克，我想更深入地了解今年前六個月你在業務上的進展。本季 18% 的成長率與第一季的成長率相似，但面臨的競爭更為激烈。因此我認為可以說它表明了潛在趨勢有所加速。我很想知道您認為您所實施的變革在哪些方面取得了最大的成果？然後也許將其與全年前景並列，這確實意味著下半年會有所減速。

Certainly. There's -- in terms of the reasons for the growth, it's consistent with what we've described from the very beginning. This is sales management in terms of the application of specific strategies that we think are necessary to grow adoption of nerve care within each of these various clinical application areas. And the basic product value proposition, of course, is Avance, and then -- in conjunction with the products that complement, that make up what we call the algorithm.

當然。就成長的原因而言，它與我們從一開始就描述的一致。這是就特定策略的應用而言的銷售管理，我們認為這些策略對於在各個不同的臨床應用領域中增加神經護理的應用是必要的。當然，基本的產品價值主張是 Avance，然後與補充產品結合，構成了我們所說的演算法。

And just the focus on that in the accounts that have specific -- the greatest potential is the result. So there's really no magic. There's nothing new here. It's exactly what we described, going back to our strategic plan in early March, is, how do you create a customer, and what do you need to manage and measure to ensure that you make your progress? And so we're doing that in each area. There's nothing particularly different from what was previously described. It really boils down to a good solid execution.

並且只專注於具有特定潛力的帳戶——最大的潛力就是結果。所以其實並沒有什麼魔法。這裡沒有什麼新鮮事。這正是我們在 3 月初的策略計畫中所描述的，即如何創造客戶，以及需要管理和衡量什麼以確保進展？因此我們在每個領域都這樣做。與之前描述的並沒有什麼特別的不同。這實際上歸結為良好而紮實的執行。

The bell curve is pretty tight in terms of the performance, and we expect that to continue to come. The opportunity, which we continue to try to manifest to everybody, is that the actual treatment is -- and penetration of nerve care across all various disease and presentation scenarios is very, very low. So as you provide people in front of these physicians who deal with these patients, the opportunities are significant. And what we've simply done is try to organize accordingly. I would say in terms of which area is maybe a pleasant surprise -- I don't -- surprise maybe the wrong word, but exceeding expectations is that we're growing faster in our extremities business than was even part of our original internal plan.

就性能而言，鐘形曲線相當緊密，我們預計這種情況將持續下去。我們繼續努力向每個人展示的機會是，實際治療是——神經護理在各種疾病和表現場景中的滲透率非常非常低。因此，當您為這些治療這些患者的醫生提供人員時，機會是巨大的。我們所做的只是嘗試進行相應的組織。我想說，就哪個領域而言，這可能是一個驚喜——我不認為——驚喜可能用詞不當，但超出預期的是，我們的四肢業務增長速度甚至比我們最初的內部計劃還要快。

All other parts of the business are growing as expected. So bottom line, all parts of the business are growing. And even outside of high-potential accounts, all of our accounts are enjoying significant growth. So the business is moving in the right direction. Our job is obviously to keep it in that direction. But I hope that answers your question.

業務的所有其他部分都如預期般增長。因此，總體而言，業務的所有部分都在成長。即使除了高潛力帳戶之外，我們所有的帳戶都實現了顯著的成長。因此，業務正在朝著正確的方向發展。我們的工作顯然是保持這個方向。但我希望這能回答你的問題。

Yes, that's helpful. And then I know the updated guidance calls for at least 17% growth, but anything you'd call out in terms of back half of the year dynamics versus first half?

是的，這很有幫助。然後我知道更新後的指導要求至少成長 17%，但您能否就下半年與上半年的動態做出說明？

Sure. It's part of the BLA process. Until it's final, it's not. And so we're trying to maintain a level of conservatism given that there may be some sort of change in terms of how we employ our logistics in providing our product, and we planned accordingly. But we think it's prudent until that's completely settled and that we understand exactly what the mechanics will be, that we don't get ahead of ourselves.

當然。這是 BLA 流程的一部分。直到最終確定前，都還不是。因此，考慮到我們在提供產品時如何運用物流可能會發生某種變化，我們試圖保持一定程度的保守，並據此制定了計劃。但我們認為，在問題完全解決之前，在我們確切了解機制之前，我們最好不要操之過急。

Michael Sarcone, Jefferies.

薩科內（Michael Sarcone），傑富瑞集團。

I guess just a follow-up there on Chris'. You have this ramping sales rep productivity factor that's playing out through the year. So when we think about kind of historical seasonality or quarterly cadence, do we expect it to be similar to years past? Or we typically see a slight bump in the third quarter? Could that be exacerbated by productivity improvements as you're growing the rep base?

我想這只是對克里斯的後續報導。銷售代表生產力的提升因素全年都在發揮作用。因此，當我們考慮歷史季節性或季度節奏時，我們是否預計它會與過去幾年相似？或者我們通常會在第三季看到小幅上漲？隨著銷售代表基礎的擴大，生產力的提高是否會加劇這種情況？

In general, the prior history would be something that I don't think will change. If we kind of go through our various segments, on the extremities side, we typically see an increase in procedures when weather is good and people are outside and active, which is primarily summer. On the chronic nerve injury side, these are elective procedures and we typically see an increase in those kinds of procedures in the last quarter of the year as patients have maximized their co-pays.

總的來說，我認為先前的歷史是不會改變的。如果我們仔細觀察各個部分，在極端情況下，我們通常會看到，當天氣好、人們在戶外活動時，也就是夏天，手術量會增加。在慢性神經損傷方面，這些都是選擇性手術，我們通常會在每年的最後一個季度看到此類手術的增加，因為患者已經最大限度地提高了共同支付。

On the oral maxillofacial and head and neck, I mean these are malignant pathologies typically, so we don't see much in the way of seasonality. On the breast, we typically see a slowdown in breast reconstructive procedures during the summer as many women are caretakers for the kids, and when they're off from school in the summer, they generally prioritize time with family. And so you mix it all together. And I think just given the expansion of the business, I would say that we're still looking at our own seasonality. But those are the key elements that I would describe by clinical application area.

對於口腔顎面部和頭頸部來說，我的意思是這些通常是惡性病變，所以我們看不到太多的季節性。就乳房而言，我們通常會看到夏季乳房重建手術的數量有所減少，因為許多女性要照顧孩子，而當她們在暑假放假時，她們通常會優先考慮與家人在一起的時間。然後你把它們混合在一起。我認為，考慮到業務的擴展，我們仍在關注自己的季節性。但這些是我根據臨床應用領域來描述的關鍵要素。

Got it. And then just one calling out the commercial coverage wins. It seems like you're making pretty good progress there, and that's prior to the BLA approval. So maybe you could dig in a little and just tell us what's helping to drive that progress now? And then is it fair to assume that, that can -- those coverage expansion wins can accelerate even more post BLA approval?

知道了。然後，只要有人喊出商業報道，就會獲勝。看起來你們在那裡取得了相當不錯的進展，這是在 BLA 批准之前。那麼也許您可以深入一點並告訴我們現在是什麼在推動這一進步？那麼是否可以公平地假設，在 BLA 批准後，這些覆蓋範圍擴大的勝利可以進一步加速？

Yes. To the latter point, I think you can absolutely expect that. But as –- and I'll allow Rick to build on here to my answer. But one of the things that even it took me a while to actually appreciate is that the RECON study, while done some years ago, was only published a little more than two years ago. And so the database, the dossiers, the value dossiers that support our products have only recently been updated and then made available to payers and all the third parties who provide opinion and/or clarification on our product status from an evidence standpoint and regulatory standpoint.

是的。對於後一點，我認為你絕對可以期待。但是——我會允許 Rick 在此基礎上繼續我的回答。但有一件事我花了一段時間才真正意識到，那就是 RECON 研究雖然是幾年前完成的，但發表的時間才兩年多一點。因此，支持我們產品的資料庫、檔案和價值檔案最近才更新，然後提供給付款人和所有第三方，他們從證據和監管的角度對我們的產品狀態提供意見和/或澄清。

And so as this information is digested and as we engage with those payers, you basically are able to make clear to people that this is a therapy that should be covered. And so then it starts to build upon itself. It's kind of like the snowball effect. And so this isn't going to happen overnight. But the long story short, it's why we've basically said that over the period of our strategic plan, we fully expect to get to nearly complete commercial coverage. It won't happen in 1 year, but 5%, 6%, 7%, and it builds on itself. And Rick, do you want to add anything to that?

因此，當我們消化這些資訊並與付款人接觸時，您基本上可以向人們表明這是一種應該得到承保的治療方法。然後它就開始自我建構。這有點像滾雪球效應。所以這不會在一夜之間發生。但長話短說，這就是為什麼我們基本上說在我們的策略計畫期間，我們完全希望實現幾乎完整的商業覆蓋。這不會在一年內發生，但會以 5%、6%、7% 的速度逐漸增加。瑞克，你還有什麼要補充的嗎？

The thing I'd add to what Mike said is that I've been pleasantly surprised in my first four months is the health care climate in the US is changing and I think practitioners acknowledge that they need to stand up and let their voice be heard. So as we've gone out across some of these regional plans and we're developing ways to engage national payers toward the back end of this year and early next year, clinicians are activated. They're willing to sign letters.

我想補充的是，在麥克所說的內容上，我驚訝地發現，在前四個月裡，美國的醫療保健環境正在發生變化，我認為從業者承認他們需要站出來，讓他們的聲音被聽到。因此，當我們推出一些區域計劃並製定方法讓國家付款人在今年年底和明年年初參與進來時，臨床醫生就開始行動了。他們願意簽署信件。

They're willing to reach out to payers and they're willing to advocate for patient access and coverage. And so we expect to see the number of patient appeals and surgeon appeals climb over time. And really, when you break down the coverage landscape in the United States, we report at least 55% of commercially covered lives have access. You guys know this, if three payers flip, that looks pretty good. So we've got really concrete plans in place, and we look forward to moving the mission forward. We think over time, our benefit to risk value prop is there. This is a really good opportunity for the company. And as patient access improves, it's really going to open up one of the main bottlenecks on our business.

他們願意與付款人聯繫，並願意倡導患者獲得醫療服務並獲得保險。因此，我們預計患者上訴和外科醫生上訴的數量會隨著時間的推移而增加。事實上，當你分析美國的覆蓋範圍時，我們報告說至少有 55% 的商業保險覆蓋人群可以享受保險。你們知道這一點，如果三個付款人翻轉，那看起來就相當不錯了。因此，我們已經制定了非常具體的計劃，並期待著推進任務。我們認為，隨著時間的推移，我們的風險價值主張的利益是存在的。這對公司來說確實是一個好機會。隨著患者就醫條件的改善，這確實會打破我們業務中的一個主要瓶頸。

Caitlin Cronin, Canaccord Genuity.

凱特琳‧克羅寧 (Caitlin Cronin)，Canaccord Genuity。

Congrats on a great quarter. Just to start off, how was the interaction during the late cycle BLA meeting? Any more color on that? And if there were any processes that you've had to implement as you near the expected approval?

恭喜本季取得優異成績。首先，後期 BLA 會議期間的互動如何？還有更多顏色嗎？當您接近預期批准時，您是否必須實施任何流程？

Sure. First of all, as it has been throughout the whole process, it's been professional, cooperative, highly interactive, although it does go in waves. So it might be almost every other day, and sometimes you might go a week at a time between interactions. But unlike, for example, in my experience on Class III devices, you don't have these finite gates that you go through. You go through the same processes, but you don't get a-- you don't receive immediate clarity that, okay, this is now done. And so that all comes together towards the end. So I can't say that we know with certainty exactly yet as part of the process exactly what will be required, other than we fully expect there will be modifications to our quality system in the discussions that we've had with the FDA to date.

當然。首先，整個過程雖然以波浪式進行，但始終是專業化、合作化、互動性強的。因此，可能幾乎每隔一天就會發生一次互動，有時兩次互動之間可能需要間隔一週。但與此不同的是，例如，根據我在 III 類設備上的經驗，你不需要經歷這些有限的門。您經歷了相同的過程，但您沒有得到-您沒有立即得到明確的答复，好的，現在已經完成了。最終一切都會水到渠成。因此，我不能說我們已經確切地知道作為流程的一部分究竟需要什麼，但我們完全預計，在迄今為止與 FDA 進行的討論中，我們的品質體系將會有所修改。

Got it. Okay. And then as you work through your hiring process for the year, any change to kind of the cadence and level of OpEx spend expected in the back half?

知道了。好的。然後，當您完成今年的招募流程時，預計下半年的營運支出節奏和水準會有什麼變化嗎？

No, not yet, although we are looking at what might be possible in terms of incrementally accelerating our hiring plans. It's not that it's a surprise to us, but it's more and more evident that one of the greatest opportunities we have is simply to scale this footprint. There's lots of need for nerve care. And while we have a good-sized sales force in terms of some comparisons in the context of nerve repair, it still remains a pretty small footprint. And so our ability to scale that within the context of our ability to fund our operations is what we're looking to do. So we're very encouraged by the progress that we have with the commercial footprint. And so that's on the table. But at the moment, there's no change in our guidance.

不，還沒有，儘管我們正在研究如何逐步加快我們的招聘計劃。這對我們來說並不意外，但越來越明顯的是，我們面臨的最大機會之一就是擴大這一足跡。神經護理的需求很大。儘管從神經修復領域的一些比較來看，我們的銷售團隊規模相當大，但其影響力仍然很小。因此，我們希望在為我們的營運提供資金的能力範圍內擴大這一規模。因此，我們對商業足跡所取得的進展感到非常鼓舞。這就是我們要討論的問題。但目前，我們的指導方針沒有改變。

Mike Kratky, Leerink Partners.

麥克‧克拉基 (Mike Kratky)，Leerink 合夥人。

This is Sam on for Mike. So again, I just wanted to dig in on the BLA process a little bit more. Are there like any specific major milestones to call out remaining in your back and forth with the FDA prior to the expected approval in September? And then I have one follow-up.

這是 Sam 為 Mike 代言。所以，我只是想更深入地了解 BLA 流程。在預計 9 月獲得批准之前，您與 FDA 之間是否有任何具體的重要里程碑需要指出？然後我還有一個後續問題。

Sure. There's no -- as I've already mentioned, there's no explicit milestones beyond what we've already shared, where you basically get a check box, you have an impression. But the final stages are that we'll work with the FDA upon -- as regards to labeling and then final requirements as part of the quality systems. So those conversations will be ongoing for the next 30 days. And it will be a process that, upon complete, obviously, we will update everybody.

當然。沒有——正如我已經提到的，除了我們已經分享的內容之外，沒有明確的里程碑，你基本上會得到一個複選框，你會有一個印象。但最後階段我們將與 FDA 合作——關於標籤以及作為品質體系一部分的最終要求。因此這些對話將在接下來的 30 天內持續進行。這個過程完成後，我們顯然會向所有人通報最新情況。

Got it. And then just can you provide a little bit more detail on kind of the specific manufacturing improvements that you're planning on implementing following the BLA approval in September? How quickly can you implement these improvements and kind of drive meaningful operating leverage? And whether this is something that we might see a good deal of in 4Q?

知道了。那麼，您能否提供一些更詳細的信息，說明您計劃在 9 月 BLA 批准後實施的具體製造改進措施？您能多快實施這些改進並實現有意義的營運槓桿？我們是否會在第四季看到大量此類現象？

Sure. So much of the improvements that we expect to introduce are classic continuous improvement processes by virtue of, if it takes five steps and you can do it in three, you start to do it in three. And these need to be qualified and verified, but they all basically reduce inefficiencies. And so those are the types of things that we'll be doing.

當然。我們期望引入的許多改進都是經典的持續改進過程，因為如果需要五個步驟，而你可以在三個步驟中完成，那麼你就可以在三個步驟中開始完成。這些都需要經過資格認定和驗證，但它們基本上都減少了低效率。這些就是我們要做的事。

Those will be complemented by electronic systems that we'll be introducing also that, by virtue of those, will reduce a lot of the manual recordkeeping that accompanies the current process. So there's nothing particularly remarkable about what we're going to be doing. It's just that we're going to be doing them once we have one system upon which we can run our day-to-day operations. We continuously refine our processes even as they exist even in the current situation. We enjoy greater yields as a result of that. But there's tremendous opportunity for very basic improvements that we'll ensue upon the completion of the BLA.

我們將引入電子系統作為補充，從而減少目前流程中大量的手動記錄工作。所以我們要做的事情並沒有什麼特別值得注意的地方。一旦我們擁有一個可以運行日常運作的系統，我們就會去做這些事情。即使在當前情況下，我們也會不斷改進我們的流程。因此，我們獲得了更高的利益。但是，在 BLA 完成後，我們將迎來巨大的基礎改進機會。

Jayson Bedford, Raymond James.

傑森貝德福德、雷蒙詹姆斯。

Congrats on the progress. Just a few. I guess maybe start with gross margin. What was the biggest change in the 2Q gross margin versus 1Q?

恭喜你取得進展。就幾個。我想也許從毛利率開始。第二季毛利率與第一季相比最大的變化是什麼？

The biggest change was really just savings from our product cost year-over-year -- I mean, the quarter-over-quarter and the lack of the write-off reduction.

最大的變化實際上就是我們產品成本的同比節省——我的意思是，環比節省，以及沒有減少註銷。

Okay. Helpful. It looked like there was a fairly big sequential jump in high-potential accounts. I think previously you had identified about 780 high-potential accounts. I guess, first, is this still the right number? And second, can you reach the 780 by year end?

好的。很有幫助。看起來高潛力帳戶的數量出現了相當大的連續增長。我認為您之前已經確定了大約 780 個高潛力帳戶。我想，首先，這仍然是正確的數字嗎？第二，你能在年底達到 780 分嗎？

We don't have a specific goal to do that this year, Jayson. A lot of it -- some of this is footprint related. Probably as we enter into next year, we'll codify more goals specific to how we expand that. So the way it works today is that each individual rep was -- as part of the planning process was required to pick within the survey of high-potential accounts which accounts that they believe they had the greatest opportunity.

傑森，我們今年沒有具體的目標。其中很多——其中一些與足跡有關​​。或許，當我們進入明年時，我們會制定更多有關如何擴展這一目標的具體目標。因此，今天的工作方式是，作為規劃過程的一部分，每個銷售代表都需要在高潛力帳戶調查中挑選出他們認為擁有最大機會的帳戶。

They have also accounts that they manage, which are not high-potential accounts. I want to be clear about that. But a good part of compensation and our focus from both a marketing and a sales management standpoint is on those. And so we did not pick all 780 this year, but we will certainly be working towards expanding that target pie as we look into next year, but not this year.

他們也管理一些帳戶，但這些帳戶並不是高潛力帳戶。我想明確這一點。但從行銷和銷售管理的角度來看，薪酬的很大一部分以及我們的重點都集中在這些方面。因此，我們今年沒有選擇全部 780 個，但我們肯定會在展望明年時努力擴大這個目標範圍，但不是今年。

Okay. Okay. And maybe just lastly, I think in respond -- when you were responding to an earlier question from Chris on the second half cadence, you mentioned leaving some variability for -- I forget the exact language, but some sort of change in logistics and mechanics. Can you just elaborate on that comment? I think it was tied to the BLA.

好的。好的。也許最後，我認為在回應時——當您回答克里斯關於下半場節奏的先前問題時，您提到留下一些變化——我忘記了確切的語言，但在物流和機制上有一些變化。能詳細說明一下這篇評論嗎？我認為它與 BLA 有關。

Sure. It primarily involves a trunk stock. So a product that we would have as a component of supply when an unplanned or unscheduled procedure is available. And so as we look forward to post BLA, it's very unlikely that, that will be part of our repertoire. And so this requires us logistically to look at supplying that product differently for some customers. It's not a majority in any way of our business, but it's also not an insignificant element. And so while we have plans in place for that, we're also -- until that's truly codified and finalized with FDA, we're trying to be prudent to make sure we don't have any disruptions.

當然。它主要涉及後備箱庫存。因此，當有計劃外或非預定程序可用時，我們會將產品作為供應的一部分。因此，當我們期待 BLA 之後，它不太可能成為我們曲目的一部分。因此，這要求我們從物流角度考慮為某些客戶提供不同的產品。在我們的業務中，它無論如何都不是多數，但也不是無關緊要的因素。因此，雖然我們已經制定了計劃，但在該計劃真正編纂成法典並與 FDA 最終確定之前，我們也會謹慎行事，以確保不會出現任何中斷。

Ross Osborn, Cantor Fitzgerald.

羅斯奧斯本、康托費茲傑拉。

Congrats on the quarter. So starting off, I was hoping you could provide some more color on where you're seeing above expectation growth within the extremities business.

恭喜本季取得佳績。因此，首先，我希望您能提供更多細節，說明您在四肢業務中看到的超出預期的成長。

Well, basically, it's broad-based. So we have internal growth targets that we had for the business. And what I can speak to is that we're exceeding those and we have been consistently. So we're very pleased with that. And if you ask, well, why? It's a lot of things. So going back for more than a year now, we've one, stabilized the organization. We've slowly and incrementally added to that. So in terms of tenure, that's deepening even over the last year. And then just the focus of the business, the clarity of purpose that everyone has. They're excited to wake up and go to work. And we have commitments to the future.

嗯，基本上，它是廣泛的。因此，我們為業務設定了內部成長目標。我可以說的是，我們正在超越這些目標，而且一直如此。所以我們對此感到非常高興。如果你問，為什麼？有很多事情。回顧過去一年多的時間，我們已經穩定了組織。我們已經慢慢地、逐步地​​增加了這一點。因此，就任期而言，這種趨勢在過去一年中甚至有所加深。然後就是業務重點，每個人的目標都清晰。他們興奮地醒來並去上班。我們對未來充滿承諾。

And so all this together is adding to a more productive, more focused effort on part of the teams. Also, the focus on high-potential accounts, I can't overemphasize. There's a lot of opportunity in nerve care. But if you want to create enduring repeatable revenue, you need to build nerve care as part of -- as an expectation of care within an individual institution and within the individual physicians who practice in that institution. And so all those things combined are what's leading to the greater overall productivity.

因此，所有這些因素共同作用，使團隊的工作更有效率、更專注。此外，我再怎麼強調對高潛力帳戶的關注也不為過。神經護理領域有很多機會。但是，如果您想創造持久的可重複收入，您需要將神經護理作為單一機構內以及在該機構執業的個別醫生的護理期望的一部分。所有這些因素結合起來就導致了整體生產力的提高。

Got it. That's helpful. And then would you remind us of how we should be thinking about the time from training a new doc to the company to getting to scale?

知道了。這很有幫助。然後，您能否提醒我們，我們應該如何考慮從培訓新醫生到公司擴大規模的時間？

I'll ask Jens to comment on that.

我會請 Jens 對此發表評論。

Yes. So one of the things that we've done this year is really continue to expand our surgeon education and training programs, which is a critical component in activating the surgeons. So once they go through a training -- let's pick a breast training program. It typically takes about three quarters for them to get fully productive after they attend a training program. So there is some ramp-up time.

是的。因此，我們今年所做的事情之一就是繼續擴大我們的外科醫生教育和培訓計劃，這是激勵外科醫生的關鍵組成部分。因此，一旦他們完成了訓練——我們就選擇一個乳房訓練計劃。他們參加培訓計劃後通常需要大約三個季度的時間才能完全發揮生產力。因此需要一些時間。

Dave Turkaly, Citizens.

戴夫·特卡利 (Dave Turkaly)，公民。

Congrats on the results and the clinical progress. Mike, I just want to clarify one thing. I know you've gone through a bunch of inspections. And I just wanted to ask like explicitly, were there any issues raised or any observations from the FDA?

祝賀結果和臨床進展。麥克，我只想澄清一件事。我知道你已經接受過很多檢查。我只是想明確地問一下，FDA 是否提出了任何問題或意見？

No. I mean, one, we don't provide that level of discrete detail. But no. So far so good is the phrase that I utilize. But I think it's important, as I continue to emphasize, is that the BLA process, we believe, is on track, and we'll report out on that once it's concluded. Most of the work involved at this point is revolving around the quality systems, which is fully expected. We're moving from a device regulatory scheme, a quality system to a biologic, and we are the first of its kind. So where the work mostly comes into play is that we're dealing with human tissue, and that quality system needs to be adapted to literally what an injectable drug would utilize. So as you might imagine, it's not a natural change in process. But that said, we've worked together with the agency and we think we've got our hands around it.

不。我的意思是，首先，我們沒有提供這種程度的離散細節。但事實並非如此。到目前為止一切都很好是我使用的短語。但我認為重要的是，正如我不斷強調的那樣，我們相信 BLA 進程正在順利進行，一旦進程結束，我們就會報告相關情況。目前所涉及的大部分工作都圍繞著品質體系展開，這是完全可以預料到的。我們正在從設備監管計劃、品質系統轉向生物製劑，我們是此類中的首家。因此，我們主要的工作就是處理人體組織，品質系統需要適應注射藥物的實際用途。所以正如你可能想像到的，這不是一個自然的過程變化。但話雖如此，我們已經與該機構合作，我們認為我們已經掌握了它。

And I just was curious also if you've had any sort of discussions around the labeling. I know -- I think you're expecting a pretty broad label, but have they made any comments about either like injury type or type of nerve or physical location or anything like that, any discussions about anything that might be less broad?

我只是好奇你們是否就標籤問題進行過任何討論。我知道——我認為您期待的是一個相當廣泛的標籤，但他們是否對損傷類型、神經類型或身體位置或諸如此類的事情發表過任何評論，是否對任何可能不太廣泛的內容進行過討論？

Sorry to interrupt you, Dave. We're just engaging in that process. And so we fully expect that, that will ensue over the next 30 days. So we will not be in a position to provide any kind of guidance until this is completed.

很抱歉打擾你，戴夫。我們只是參與這一進程。因此，我們完全預計這將在未來 30 天內發生。因此，在完成之前，我們無法提供任何指導。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Congrats on a good quarter. I was hoping to start with a little bit more color on breast. It sounds like you had a good quarter of hiring. Can you talk about rep ramp up, the quality of the reps you've been able to retain through the hiring process? And then maybe any other underlying trends just in breast in general throughout the quarter would be great to hear.

恭喜本季業績良好。我希望先在胸部添加一些顏色。聽起來您本季的招募情況不錯。能談談銷售代表的提升情況嗎？透過招募流程，您能夠保留哪些銷售代表的品質？那麼，也許整個季度乳房方面的任何其他潛在趨勢都值得了解。

Sure. In terms of the ramp-up, obviously, we got behind the eight ball early in the year, but we've fully caught up and expect to maintain that cadence going forward. In terms of quality, obviously, it's in the eyes of the beholder, but we have no problems attracting talent. We have multitudes of candidates who seek the jobs once we post them across the organization, not just in breast.

當然。就提升而言，顯然，我們在年初處於劣勢，但我們已經完全趕上，並希望在未來保持這種節奏。就品質而言，顯然這取決於旁觀者的看法，但我們在吸引人才方面沒有任何問題。一旦我們在整個組織內發布職位信息，就會有大量候選人前來求職，而不僅僅是在胸部。

So we're very, very pleased. So it's an exciting space right now, and it's very encouraging in that regard. In terms of the ramp-up, we have a multistage program that we bring the reps -- representatives -- each representative through for extremities as well as breast. And in total, it's a program that transpires over about 9 months before the rep is finished with their formal training. They are engaged and working before that period is complete, but it is a process that takes time.

所以我們非常非常高興。所以現在這是一個令人興奮的領域，在這方面非常令人鼓舞。在提升方面，我們有一個多階段計劃，我們讓代表們——每個代表都經歷四肢和乳房的訓練。總的來說，該計劃將持續約 9 個月，直到銷售代表完成正式培訓。他們在該期限結束之前就開始參與並工作，但這是一個需要時間的過程。

Got it. That's helpful. And then just one more...

知道了。這很有幫助。然後再來一個…

In terms of trend -- I'm sorry. Go ahead, Frank.

就趨勢而言——我很抱歉。繼續吧，弗蘭克。

Go ahead. I was just going to ask you the second half of the breast trends question I had.

前進。我正要問您有關乳房趨勢問題的後半部。

Yes. Really nothing new in trends other than as more breast resensation is done, more physicians basically look at it really from an ethical standpoint that they believe they have the obligation to provide this as an option to their patients. And so once you are introduced to it, that becomes the desire and the expectation based upon the fact that the data that's available and the experience that's available clearly suggests that you can add value to those patients. And so that's a dynamic. That's not a new dynamic, but it's just one that continues to grow as our footprint grows and as we train more surgeons and establish more sites.

是的。事實上，趨勢上沒有什麼新東西，只是隨著乳房復原手術的增多，越來越多的醫生從道德的角度看待這個問題，認為他們有義務為病人提供這種選擇。因此，一旦你接觸到它，它就會成為一種願望和期望，因為現有的數據和經驗清楚地表明你可以為這些患者增加價值。這就是一種動態。這並不是什麼新動態，但隨著我們的足跡不斷擴大、培訓更多外科醫生和建立更多站點，這種動態將繼續增長。

Got it. That's helpful. And then maybe just one last one on gross margin. Lindsey, I appreciate the comments of the step down in write-downs quarter-over-quarter that drove that snapback in gross margins in the quarter. I was just curious how you guys are thinking about that dynamic? Are we kind of through write-downs? Or is there any other future cleanup that you think may occur in future quarters related to write-downs?

知道了。這很有幫助。最後再問一下毛利率。林賽，我很欣賞你關於季度環比減值下降的評論，這推動了本季毛利率的回升。我只是好奇你們是如何看待這種動態的？我們是不是已經完成減記了？或者您認為未來幾季可能會發生與減損相關的其他清理工作嗎？

Yes. We are going through a process of identifying process improvements, and as we transition through the BLA, identifying things. And if we identify additional write-offs, we'll take them as we deem necessary. At this moment, we don't -- I don't see any, but you never know what will come up. We are thinking that the -- we will be impacted in Q3 by the BLA, PSUs as we've disclosed. And then in Q4, we expect to return back to a little bit normal and then implement those process changes and hopefully get some upside on that as we move forward in '26.

是的。我們正在經歷一個識別流程改進的過程，並且在我們透過 BLA 進行轉變時識別事物。如果我們發現需要額外註銷，我們會根據需要進行註銷。目前，我們還沒有——我沒有看到任何消息，但你永遠不知道會發生什麼。我們認為——正如我們所披露的，我們將在第三季度受到 BLA、PSU 的影響。然後在第四季度，我們預計將恢復到稍微正常一點的狀態，然後實施這些流程變更，並希望在 26 年前進的過程中獲得一些好處。

There are no further questions at this time. I would now like to turn the floor back over to Mike Dale, CEO, for closing comments.

目前沒有其他問題。現在我想把發言權交還給執行長麥克戴爾 (Mike Dale)，請他發表最後評論。

Thank you, operator. On behalf of the Axogen team, I want to thank everyone for their time and interest in our work, to fulfill the promise and potential for all stakeholders in our business purpose, to restore health and improve quality of life by making restoration peripheral nerve function and expected standard of care. We look forward to updating you on our continued progress and our plans on our earnings call next quarter. Thank you.

謝謝您，接線生。我謹代表 Axogen 團隊感謝大家對我們工作的時間和興趣，以實現我們業務目標中所有利益相關者的承諾和潛力，透過恢復周圍神經功能和預期的護理標準來恢復健康和改善生活品質。我們期待在下個季度的財報電話會議上向您通報我們的持續進度和計劃。謝謝。

You may disconnect your lines at this time. Thank you for your participation.

現在您可以斷開線路。感謝您的參與。