AngioDynamics Inc (ANGO) 2025 Q4 法說會逐字稿

Good morning, and welcome to the AngioDynamics fiscal year 2025 fourth-quarter earnings call. (Operator Instructions) As a reminder, this conference call is being recorded.

早安，歡迎參加 AngioDynamics 2025 財年第四季財報電話會議。（操作員指示）提醒一下，本次電話會議正在錄音。

The news release detailing AngioDynamics fiscal 2025 fourth quarter and full year results crossed the wire earlier this morning and is available on the company's website. This conference call is also being broadcast live over the Internet at the Investors section of the company's site at www.angiodynamics.com. A webcast replay of the call will be available at the same site approximately one hour after the end of today's call.

有關 AngioDynamics 2025 財年第四季和全年業績的新聞稿已於今天早上發布，可在公司網站上查閱。本次電話會議也將透過公司網站 www.angiodynamics.com 的「投資者」板塊進行網路直播。會議結束後約一小時，同一網站將提供本次電話會議的網路回放。

Before we begin, I'd like to caution listeners that during the course of this conference call, the company will make projections or forward-looking statements regarding future events, including statements about expected revenue, adjusted earnings and gross margins for fiscal year 2026 as well as trends that may continue. Management encourages you to review the company's past and future filings with the SEC, including, without limitation, the company's Forms 10-Q and 10-K which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements.

在我們開始之前，我想提醒聽眾，在本次電話會議期間，公司將對未來事件做出預測或前瞻性陳述，包括有關 2026 財年的預期收入、調整後收益和毛利率以及可能持續的趨勢的陳述。管理層鼓勵您查看公司過去和未來向美國證券交易委員會提交的文件，包括但不限於公司的 10-Q 表和 10-K 表，這些文件確定了可能導致實際結果或事件與前瞻性陳述中描述的結果或事件存在重大差異的具體因素。

The company will also discuss certain non-GAAP and pro forma financial measures during this call. Management uses these measures to establish operational goals and review operational performance and believes that these measures may assist investors in analyzing the underlying trends in the company's business over time.

該公司還將在本次電話會議中討論某些非公認會計準則和備考財務指標。管理層使用這些指標來制定營運目標和審查營運績效，並相信這些指標可以幫助投資者分析公司業務隨時間推移的潛在趨勢。

Investors should consider these non-GAAP and pro forma measures in addition to, not as a substitute for or as superior to financial reporting measures prepared in accordance with GAAP. A slide package offering insight into the company's financial results is also available in the Investor Relations section of the company's website under Events and Presentations. This presentation should be read in conjunction with the press release discussing the company's operating results and financial performance during this morning's conference call.

投資人應將這些非 GAAP 和考試指標視為依照 GAAP 編製的財務報告指標的補充，而非替代或優於這些指標。在公司網站的「活動和簡報」下的「投資者關係」部分中，還可以找到提供公司財務表現洞察的幻燈片包。本簡報應與今天上午電話會議上討論公司經營業績和財務表現的新聞稿一起閱讀。

Now I'd like to turn the call over to Jim Clemmer, AngioDynamics President and Chief Executive Officer. Mr. Clemmer?

現在我想將電話轉給 AngioDynamics 總裁兼執行長 Jim Clemmer。克萊默先生？

Thank you, operator. Good morning, everyone, and thank you for joining us for AngioDynamics fiscal 2025 fourth-quarter and full-year earnings call. Joining me today is Steve Trowbridge, AngioDynamics Executive Vice President and Chief Financial Officer. Unless otherwise noted, all financial metrics and growth rates provided during the call today are on a pro forma basis, which excludes the impact of our divested dialysis, BioSentry, PICC and midline businesses and our discontinued radio frequency and Cintrex support catheter products.

謝謝您，接線生。大家早安，感謝您參加 AngioDynamics 2025 財年第四季和全年財報電話會議。今天與我一起出席的是 AngioDynamics 執行副總裁兼財務長史蒂夫·特羅布里奇 (Steve Trowbridge)。除非另有說明，今天電話會議中提供的所有財務指標和增長率均為備考基礎，不包括我們剝離的透析、BioSentry、PICC 和中線業務以及我們已停產的射頻和 Cintrex 支持導管產品的影響。

We capped off a tremendous 2025 with a very strong fourth quarter. Total revenue was $80.2 million representing growth of over 12% year over year, led by Med Tech growth of over 20% and Med Device growth of more than 6%. Beyond the topline performance, we drove solid gross margins, positive adjusted EBITDA and strong free cash flow, all as expected.

我們以非常強勁的第四季為輝煌的 2025 年畫上了圓滿的句號。總收入為 8,020 萬美元，年成長超過 12%，其中醫療技術成長超過 20%，醫療設備成長超過 6%。除了營收表現之外，我們還實現了穩健的毛利率、正的調整後 EBITDA 和強勁的自由現金流，所有這些都符合預期。

As we've talked about in the past, we have been navigating a long-term strategic transformation over the past several years to simplify our business, and moving to large, high-growth, high-margin Med Tech markets. Our performance in the quarter and throughout fiscal 2025 validates that strategy and reflects our ability to drive execution.

正如我們過去所談到的，過去幾年我們一直在進行長期策略轉型，以簡化我們的業務，並轉向大型、高成長、高利潤的醫療技術市場。我們在本季以及整個 2025 財年的表現驗證了該策略，並反映了我們推動執行的能力。

As this is our fiscal year-end call, I wanted to take the opportunity to highlight the products we have made operationally this year as we have achieved great things here at AngioDynamics over the past 12 to 24 months, including key regulatory approvals, international market expansion, new product reductions, clinical data development and critical reimbursement wins, among others, all of which have set us up to deliver profitable growth moving forward.

由於這是我們的財政年度終電話會議，我想藉此機會重點介紹我們今年在營運中生產的產品，因為在過去的 12 到 24 個月中，我們在 AngioDynamics 取得了巨大的成就，包括關鍵的監管批准、國際市場擴張、新產品降價、臨床數據開發和關鍵的報銷勝利等等，所有這些都為我們未來實現了基礎增長。

Starting with our Med Tech portfolio. Auryon has continued to be our largest Med Tech product line. Since its launch in 2020, we've driven over $185 million in cumulative sales, and we are now the third largest product in this space. In the fourth quarter, the platform delivered its 16th consecutive quarter of double-digit increases and for good reason.

從我們的醫療科技產品組合開始。Auryon 一直是我們最大的醫療科技產品線。自 2020 年推出以來，我們的累計銷售額已超過 1.85 億美元，目前已成為該領域的第三大產品。第四季度，該平台連續第 16 個季度實現兩位數成長，這是有充分理由的。

We believe Auryon is the best-in-class peripheral atherectomy platform because of its demonstrated safety profile and versatility.

我們相信，Auryon 是同類最佳的周邊動脈粥狀硬化斑塊切除平台，因為它具有經過驗證的安全性和多功能性。

A big focus of our commercial efforts in 2025 was the hospital setting, a customer base that for us represented a really compelling growth opportunity. As of the end of this year, our hospital customers represented approximately 36% of total Auryon revenue, up from 28% at the beginning of 2025, validating that with a better analogy that provides superior clinical outcomes, we can take meaningful market share from larger competitors regardless of the site of care.

2025 年我們商業努力的重點是醫院環境，對我們來說，這個客戶群代表著一個真正引人注目的成長機會。截至今年年底，我們的醫院客戶約佔 Auryon 總收入的 36%，高於 2025 年初的 28%，這證明，透過提供卓越臨床結果的更好的類比，我們可以從更大的競爭對手那裡奪取有意義的市場份額，無論護理地點在哪裡。

Outside of the US, we have started to see solid traction following Auryon receiving a CE mark approval in September of 2024, which opened up the European PAD market, we began the process of commercializing in that region. In the fourth quarter, we generated over $1 million in revenue from Europe, highlighting the great work done by our commercial team to increase awareness of the platform with driven demand from clinicians within geography.

在美國以外，隨著 Auryon 於 2024 年 9 月獲得 CE 標誌批准，我們開始看到強勁的動力，這打開了歐洲 PAD 市場，我們開始在該地區進行商業化進程。第四季度，我們在歐洲獲得了超過 100 萬美元的收入，這突顯了我們的商業團隊所做的出色工作，透過該地區臨床醫生的需求推動了平台的知名度的提高。

We also have continued to work to develop compelling clinical data in support of its adoption. In January, with the AMBITION BTK trial and registry with the BTK standing for below the knee. This trial will evaluate clinical outcomes in treating patients suffering from critical limb ischemia below their knee using Auryon in combination with standard balloon angioplasty. We believe this rigorous trial, which builds upon our earlier Auryon study, could demonstrate an important advancement and the evidence supporting the benefits of Auryon's laser atherectomy in achieving acute and long-term procedural success in a US market where there is an unmet need, potentially driving increased adoption of Auryon.

我們也將繼續努力開發令人信服的臨床數據來支持其採用。一月份，AMBITION BTK 試驗和註冊，BTK 代表膝蓋以下。該試驗將評估使用 Auryon 結合標準球囊血管成形術治療膝下嚴重肢體缺血患者的臨床結果。我們相信，這項以我們早期的 Auryon 研究為基礎的嚴格試驗可以證明一項重要的進步和證據，證明 Auryon 的雷射旋切術在存在未滿足需求的美國市場實現急性和長期手術成功方面具有優勢，有可能推動 Auryon 的採用率提高。

Beyond PAD, Auryon's unique mechanism of action can lead to great outcomes in coronary interventions. While not currently indicated for urinary applications, we are investing in the R&D and clinical work necessary to potentially unlock this $900 million US market.

除了周邊動脈疾病 (PAD) 之外，Auryon 獨特的作用機轉還可在冠狀動脈介入治療中取得良好效果。雖然目前尚未指明用於泌尿系統，但我們正在投資必要的研發和臨床工作，以潛在地打開這個價值 9 億美元的美國市場。

We believe the Auryon platform technology with its current market leadership and future opportunities will continue to be a growth driver for AngioDynamics in the short, medium and long term. Auryon is a prime example of how we have been able to take a novel solution and drive to become one of the leading technologies in a competitive, difficult to penetrate market. We know what it takes to win, a great product, high-quality clinical data, highly effective access market programs, and a well-established sales and marketing infrastructure. We are running that playbook with our mechanical thrombectomy portfolio and we are in the early stages of replicating the success we have achieved with Auryon. To that end, our mechanical thrombectomy portfolio made up of AngioVac and AlphaVac has become the fastest-growing part of our Med Tech segment.

我們相信，憑藉目前的市場領導地位和未來機遇，Auryon 平台技術將繼續成為 AngioDynamics 在短期、中期和長期內的成長動力。Auryon 是一個典型的例子，它展示了我們如何能夠採用新穎的解決方案，並努力成為競爭激烈、難以滲透的市場中的領先技術之一。我們知道成功的要素是什麼：優秀的產品、高品質的臨床數據、高效的市場准入計劃以及完善的銷售和行銷基礎設施。我們正在利用機械血栓切除術產品組合來執行這一策略，並且我們正處於複製 Auryon 所取得的成功的早期階段。為此，由 AngioVac 和 AlphaVac 組成的機械血栓切除術產品組合已成為我們醫療技術部門成長最快的部分。

In the quarter, we delivered approximately 45% year-over-year growth. These two technologies are clearly differentiated and much of the work done over the last 18 months has helped spur a solid adoption trajectory. Following AlphaVac's FDA clearance in CE marking during the first half of calendar 2024, this product has delivered five consecutive quarters of sequential revenue growth. This was aided by the strength of our clinical data, in particular, the publication of our APEX trial results in December of 2024, which demonstrated AlphaVac's strong performance in the US showing a 35.5% reduction in clot burden from the baseline compared to a 9.3% reduction for the current market leaders IDE data.

本季度，我們實現了約 45% 的同比增長。這兩種技術有著明顯的區別，過去 18 個月所做的大量工作有助於推動其穩定採用。繼 AlphaVac 在 2024 年上半年獲得 FDA 的 CE 標誌批准後，該產品已連續五個季度實現收入成長。這得益於我們強大的臨床數據，特別是 2024 年 12 月發布的 APEX 試驗結果，該結果證明了 AlphaVac 在美國表現強勁，血栓負擔較基線減少了 35.5%，而目前市場領導者 IDE 數據的減少率為 9.3%。

We also initiated the RECOVER-AV trial in Europe in September of 2024, aimed at further strengthening our clinical evidence base in the European market. While AlphaVac is a fantastic product that was purpose built to mitigate the need for blood return, we continue to believe that its rate of adoption would have been even more rapid if we also offered a version that offers blood return functionality. We now have a fully developed product, and we are working with the FDA to establish a regulatory pathway for a version of AlphaVac that includes blood return, and we believe that by offering two versions of the technology with and without blood return. It will further enhance our competitive positioning and offer a better suite of solutions for all customers.

我們也於 2024 年 9 月在歐洲啟動了 RECOVER-AV 試驗，旨在進一步加強我們在歐洲市場的臨床證據基礎。雖然 AlphaVac 是一款出色的產品，專為減輕回血需求而設計，但我們仍然相信，如果我們也提供具有回血功能的版本，它的採用率會更快。我們現在已經擁有了完全開發的產品，我們正在與 FDA 合作，為包括血液回輸在內的 AlphaVac 版本建立監管途徑，我們相信透過提供帶血液回輸和不帶血液回輸兩種版本的技術，我們可以實現這一目標。它將進一步增強我們的競爭地位，並為所有客戶提供更好的解決方案。

We continue to be very encouraged about the of our other mechanical thrombectomy platform technology and AngioVac which grew nearly 4% during the quarter and just over 25% for the full year. We attribute much of this success to the ongoing synergistic benefits that we have seen as a result of our concerted joint commercialization efforts within the mechanical thrombectomy portfolio.

我們繼續對我們的其他機械血栓切除平台技術和 AngioVac 感到非常鼓舞，它們在本季度增長了近 4%，全年增長了 25% 以上。我們將這一成功很大程度歸功於我們在機械血栓切除術產品組合中共同努力實現商業化所帶來的持續協同效益。

AngioVac and AlphaVac provide AngioDynamics with an unparalleled product portfolio option. And with a fully trained and optimized sales force, we continue to realize commercial adoption synergies between these two product lines. To support the demand, we are seeing in the market for these products. We plan to add additional dedicated reps to this sales force during fiscal 2026.

AngioVac 和 AlphaVac 為 AngioDynamics 提供了無與倫比的產品組合選擇。憑藉著經過全面培訓和優化的銷售隊伍，我們將繼續實現這兩條產品線之間的商業採用協同效應。為了滿足需求，我們正在市場上尋找這些產品。我們計劃在 2026 財年為該銷售團隊增加更多專職銷售代表。

We also believe we have other tailwinds influencing the adoption of this portfolio particularly within structural heart, as this sector continues to grow, Angio has a role to play, giving our team an accelerated opportunity to engage with interventional cardiologists and cardiothoracic surgeons. As the overall structural heart market continues to progress, we believe we will benefit from incremental synergies within our portfolio.

我們也相信，我們還有其他順風因素影響這個投資組合的採用，特別是在結構性心臟領域，隨著這一領域的持續增長，Angio 將發揮重要作用，為我們的團隊提供加速與介入性心臟病專家和心胸外科醫生接觸的機會。隨著整體結構性心臟市場持續發展，我們相信我們將受益於我們產品組合中的增量協同效應。

And lastly, NanoKnife. Although NanoKnife has been commercially available for a number of years, we achieved multiple key clinical reimbursement and regulatory milestones during the year that has positioned it for accelerated adoption moving forward. PRESERVE met its primary effectiveness end point. demonstrating the performance of a NanoKnife system for the ablation of prostate tissue in patients with intermediate risk prostate cancer. And just as importantly, the study demonstrated extremely compelling quality of life outcomes validating what we already knew about the technology and its ability to provide better care for prostate cancer patients.

最後是奈米刀。儘管奈米刀已投入商業化多年，但我們在今年實現了多個關鍵的臨床報銷和監管里程碑，這為其未來的加速應用奠定了基礎。PRESERVE 達到了其主要有效性終點。證明了奈米刀系統對中度風險前列腺癌患者前列腺組織消融的性能。同樣重要的是，該研究展示了極其令人信服的生活品質結果，證實了我們已經了解的該技術及其為前列腺癌患者提供更好護理的能力。

Next, in October of 2024, a CPT Category 1 as granted for the treatment of lesions in the prostate and in liver using IRE. The new code will be effective on January 1, 2026, and have put us in a fantastic position to ensure that reimbursement will be widely available across both the commercial and private payers as we move into calendar 2026. And lastly, in December, we've received an expanded indication for the NanoKnife system for prostate tissue ablation. With this clearance in hand, we have been able to more proactively market, educate and train for the procedure in ways that we've been previously unable to do. With these three milestones achieved, we have established the three pillars necessary for long-term growth: regulatory clearance, reimbursement pathway, and market awareness.

接下來，在 2024 年 10 月，CPT 第 1 類被授予使用 IRE 治療前列腺和肝臟病變的資格。新法規將於 2026 年 1 月 1 日生效，這將使我們處於有利地位，確保在進入 2026 年時商業和私人付款人都能廣泛獲得報銷。最後，12 月，我們獲得了用於前列腺組織消融的奈米刀系統的擴展適應症。獲得此項批准後，我們能夠以以前無法做到的方式更積極地推銷、教育和培訓該程序。隨著這三個里程碑的實現，我們建立了長期成長所需的三大支柱：監管許可、報銷途徑和市場意識。

Coming as a result of these efforts, we are very encouraged by the trends we have seen in NanoKnife business, in particular, with its adoption and utilization within prostate cancer care. We're seeing significant organic interest from the urology community and are seeing solid increases in the number of surgeons trained. The inbound interest in our technology has been strong. Importantly, we continue to receive exceptional feedback from physicians using NanoKnife in real-world settings.

透過這些努力，我們對奈米刀業務的趨勢感到非常鼓舞，特別是其在前列腺癌治療中的應用和利用。我們看到泌尿外科界的自然興趣顯著增加，接受訓練的外科醫師數量也在穩定增加。外界對我們的技術的興趣一直很濃厚。重要的是，我們不斷收到在現實環境中使用奈米刀的醫生的出色回饋。

While we are very excited about the demand for NanoKnife in prostate, we have continued to push to broaden its applicability within other disease states. In fact, a CPT level 1 code was granted for IRE in its use in pancreatic care. Admittedly, this is a smaller market than prostate, but it highlights the ability of this technology to change the way patients are cared for across a variety of oncology applications. The CPT1 code for IRE in pancreatic applications will become effective in January 2027. As you've just heard, we've made significant progress across our Med Tech portfolio during 2025.

雖然我們對奈米刀在前列腺治療中的需求感到非常興奮，但我們仍在繼續努力擴大其在其他疾病狀態下的適用性。事實上，IRE 在胰臟護理中的應用已獲得 CPT 1 級代碼。不可否認，這個市場比前列腺癌市場要小，但它凸顯了這項技術在各種腫瘤學應用中改變病患照護方式的能力。胰臟應用中 IRE 的 CPT1 代碼將於 2027 年 1 月生效。正如您剛才聽到的，我們在 2025 年期間在醫療技術產品組合方面取得了重大進展。

We have systematically executed on our strategy to drive growth in large, fast-growing markets. This execution has already paid off. For the full year, our Med Tech segment generated nearly $127 million in revenue, representing growth of approximately 20%. Over the last five years since we initiated our strategic transformation, our Med Tech segment as a percentage of total revenue has doubled from 22% to 43% and delivered a five-year revenue CAGR of approximately 25%.

我們有系統地執行了我們的策略，以推動大型、快速成長的市場的成長。這次執行已經取得了成效。全年，我們的醫療科技部門創造了近 1.27 億美元的收入，成長約 20%。自從我們啟動策略轉型以來的過去五年裡，我們的醫療科技部門佔總收入的比例翻了一番，從 22% 上升到 43%，五年收入複合年增長率約為 25%。

Beyond our commercial achievements, we've successfully executed on our operational efficiency initiatives, while maintaining our commitment to innovation and growth. During the quarter, we yet again generated positive adjusted EBITDA and over $15 million of free cash flow. And as Steve will go into in more detail, we expect to be cash flow positive during fiscal 2026. As we continue to work to deliver consistent profitable growth, we remain on track to deliver incremental cost optimization through our manufacturing transition process. We continue to expect to deliver approximately $15 million in annualized savings by fiscal 2027, fundamentally improving our cost structure.

除了商業成就之外，我們還成功實施了營運效率計劃，同時保持了對創新和成長的承諾。在本季度，我們再次實現了正調整後 EBITDA 和超過 1500 萬美元的自由現金流。正如史蒂夫將更詳細地介紹的那樣，我們預計 2026 財年的現金流將為正值。在我們繼續努力實現持續獲利成長的同時，我們仍有望透過製造轉型過程實現增量成本優化。我們仍然預計到 2027 財年將實現約 1500 萬美元的年度節省，從根本上改善我們的成本結構。

This year's results demonstrate the successful transformation of AngioDynamics into a profitable, growth-oriented medical technology company. We've systematically built a portfolio of innovative products while achieving sustained profitability. The combination of regulatory achievements, clinical validation, commercial momentum and operational excellence provides strong momentum as we enter fiscal 2026. With our strong balance sheet, expanded market opportunities and proven ability to execute, we expect to continue to deliver for our shareholders.

今年的結果顯示 AngioDynamics 已成功轉型為一家獲利且以成長為導向的醫療科技公司。我們有系統地建構了創新產品組合，同時實現了持續獲利。監管成就、臨床驗證、商業勢頭和卓越營運的結合為我們進入 2026 財年提供了強勁動力。憑藉我們強大的資產負債表、擴大的市場機會和經過驗證的執行能力，我們期望繼續為股東帶來收益。

With that overview, I'll turn the call over to Steve to review our financial performance in more detail.

了解了這些概述後，我將把電話轉給史蒂夫，讓他更詳細地審查我們的財務表現。

Thanks, Jim. Good morning, everybody. As always, before I begin, I'd like to direct everyone to the presentation on our Investor Relations website, summarizing the key items from our quarterly results. As Jim mentioned, unless otherwise noted, all metrics and growth rates mentioned during today's call are on a pro forma basis which exclude the results of the dialysis and BioSentry businesses that we divested in June 2023, the PICC and midline products that we divested in February 2024, and the radio frequency and Syntax support catheter products that we discontinued in February 2024.

謝謝，吉姆。大家早安。像往常一樣，在開始之前，我想先引導大家查看我們投資者關係網站上的演示文稿，其中總結了我們季度業績的關鍵內容。正如 Jim 所提到的，除非另有說明，今天電話會議中提到的所有指標和增長率都是備考基礎，不包括我們在 2023 年 6 月剝離的透析和 BioSentry 業務的結果、我們在 2024 年 2 月剝離的 PICC 和中線產品，以及我們在 2024 年 2 月停產的支持和 Syntax 導管產品和 Syntax。

Additionally, unless otherwise noted, all comparisons will be the fourth fiscal quarter of 2025 versus the fourth fiscal quarter of 2024. Revenue increased 12.7% to $80.2 million, driven by growth across both our Med Tech and Med Device segments. Med Tech revenue was $35.8 million, a 22% increase while our Med Device revenue was $44.4 million, an increase of 6.2%.

此外，除非另有說明，所有比較均為 2025 財年第四季與 2024 財年第四季的比較。營收成長 12.7% 至 8,020 萬美元，這得益於醫療科技和醫療設備部門的成長。醫療技術收入為 3,580 萬美元，成長 22%，而醫療設備收入為 4,440 萬美元，成長 6.2%。

For the fourth fiscal quarter, our Med Tech platforms comprised 45% of our total revenue compared to 41% of total revenue a year ago, further illustrating the sustained execution of our strategy to increase the percentage of our overall revenue base coming from our Med Tech segment. Our Auryon platform contributed $15.6 million in revenue, growing 19.7% compared to last year. Auryon has now delivered double-digit year-over-year growth in each of the 16 quarters following the anniversary of its launch in September of 2021. Mechanical thrombectomy revenue, which includes AngioVac and AlphaVac sales, increased 44.7% year over year.

在第四財季，我們的醫療技術平台占我們總收入的 45%，而去年同期為 41%，這進一步說明了我們持續執行策略，以增加來自醫療技術部門的總收入比例。我們的 Auryon 平台貢獻了 1560 萬美元的收入，比去年增長了 19.7%。自 2021 年 9 月推出以來的 16 個季度中，Auryon 均實現了兩位數的同比增長。機械血栓切除術收入（包括 AngioVac 和 AlphaVac 的銷售）年增 44.7%。

As Jim mentioned earlier, we continue to be very pleased with our ability to take share in an increasingly competitive mechanical thrombectomy market coming as a result of the efforts of our skilled commercial team, the innovative differentiation of these products and the synergistic benefits we are seeing as a result of our joint commercialization efforts.

正如吉姆之前提到的，我們非常高興能夠在競爭日益激烈的機械血栓切除術市場中佔據一席之地，這得益於我們熟練的商業團隊的努力、這些產品的創新差異化以及我們在聯合商業化努力中看到的協同效益。

In the quarter, AngioVac revenue was $8.2 million, a 39.5% year-over-year increase and AlphaVac revenue was $3.1 million, a 60.8% year-over-year increase. Total NanoKnife revenue was $7.2 million, a decrease of 2.5%. Now this decrease is due to the year-over-year comparison of capital sales. Throughout our fiscal 2025, we consistently discussed that we expect capital sales during the year to be approximately half of what they were in 2024.

本季度，AngioVac 營收為 820 萬美元，年增 39.5%，AlphaVac 營收為 310 萬美元，年增 60.8%。NanoKnife 總收入為 720 萬美元，下降 2.5%。現在，這種下降是由於資本銷售額與去年同期相比所致。在整個 2025 財年，我們一直在討論，預計今年的資本銷售額將約為 2024 年的一半。

While capital sales were less than they were a year ago, we have continued to see strong demand for new systems with fourth quarter capital sales down just 24.9% and 26% for the full year, ahead of our initial expectations. Disposable sales, the more consistent barometer of our NanoKnife business remains strong, growing 5.5% in the quarter and we continue to be encouraged by the sustained utilization of NanoKnife within prostate cases which hit our projections for the full year.

雖然資本銷售額低於去年同期，但我們仍然看到對新系統的強勁需求，第四季資本銷售額僅下降 24.9%，全年下降 26%，高於我們最初的預期。一次性銷售額是我們奈米刀業務更一致的晴雨表，依然保持強勁，本季度增長了 5.5%，奈米刀在前列腺病例中的持續使用繼續鼓舞著我們，達到了我們對全年的預測。

NanoKnife prostate procedures in the quarter were 81% of all NanoKnife procedures, a record to date. In the fourth quarter, our Med Device segment increased 6.2% year over year. Now before turning to the rest of the income statement, I wanted to provide an update on the impact tariffs had on our business during the quarter. We announced our third-quarter results on the morning of April 2, which was just hours before the administration unveiled its tariff program. During our call, we had indicated that we believe we were positioned to not be derailed by tariffs.

本季奈米刀前列腺手術佔所有奈米刀手術的 81%，創下了迄今為止的最高紀錄。第四季度，我們的醫療器材部門年增6.2%。現在，在轉到損益表的其餘部分之前，我想提供有關關稅在本季度對我們業務的影響的最新資訊。我們於 4 月 2 日上午公佈了第三季業績，這距離政府公佈關稅計劃僅剩幾個小時。我們在通話中表示，我們相信我們不會因關稅而受阻。

Even though the tariff program that was ultimately announced clearly was more expensive than we were anticipating at the time, we've continued to execute on our strategy and illustrate that we will indeed not be derailed by tariffs. That being said, there obviously was an impact on our business, stemming from tariffs in the fourth quarter, and there will be an impact on our business during the new fiscal year.

儘管最終宣布的關稅計劃顯然比我們當時預期的要昂貴，但我們仍繼續執行我們的策略，並表明我們確實不會因關稅而脫軌。話雖如此，第四季度的關稅顯然對我們的業務產生了影響，新的財年也將對我們的業務產生影響。

As you are all well aware, the tariff environment remains unclear and unpredictable. However, we will provide an estimate of tariff impacts in connection with our fiscal year 2026 guidance that incorporates our best estimate of the impacts as of today. Now projected tariffs changed over the weekend, so the situation remains fluid. As the situation evolves, we will continue to be transparent regarding any changes in expected impacts. In the fourth quarter of FY25, we incurred $1.6 million of tariff expense with more than half of that cost associated with our Med Tech segment.

眾所周知，關稅環境仍然不明朗且難以預測。但是，我們將根據 2026 財年的指導意見提供關稅影響的估計，該估計包含了我們對截至今天的影響的最佳估計。現在預計的關稅在周末發生了變化，因此情況仍然不穩定。隨著情勢的發展，我們將繼續透明地告知預期影響的任何變化。在 25 財年第四季度，我們發生了 160 萬美元的關稅費用，其中超過一半的成本與我們的醫療技術部門有關。

This $1.6 million is included in our cost of goods sold and does impact gross margins and ultimately, our EBITDA and EPS results. Given this dynamic, we're particularly pleased with our results and our ability to drive accelerated profitability despite this headwind.

這 160 萬美元包含在我們的銷售成本中，確實會影響毛利率，並最終影響我們的 EBITDA 和 EPS 結果。鑑於這種動態，我們對我們的業績以及在逆風中推動加速盈利的能力感到特別滿意。

As I'll discuss further towards the end of my remarks, we currently expect the full year impact of tariffs in FY26 to be approximately $4 million to $6 million, and we continue to expect that tariffs will not materially alter our trajectory or our ability to execute on our strategic plan for fiscal '26. We do not expect it to alter our stated goals of continuing to generate positive adjusted EBITDA for the full year, and we continue to expect to be cash flow positive for the full year of FY26, inclusive of paying all associated tariffs. Now moving down the income statement. Our gross margin in the fourth quarter of FY25 was 52.7%. For the quarter, Med Tech gross margin was 59% and Med Device gross margin was 47.6%.

正如我在演講結束時將進一步討論的那樣，我們目前預計關稅對 26 財年的全年影響約為 400 萬至 600 萬美元，並且我們仍然預計關稅不會實質性地改變我們的軌跡或我們執行 26 財年戰略計劃的能力。我們預計這不會改變我們全年繼續產生正調整後 EBITDA 的既定目標，並且我們繼續預計 26 財年全年的現金流為正，包括支付所有相關關稅。現在向下移動損益表。我們25財年第四季的毛利率為52.7%。本季，醫療科技毛利率為 59%，醫療設備毛利率為 47.6%。

In this quarter, total gross margins saw an approximately 204 basis point negative impact from tariffs. Absent the $1.6 million paid in tariffs, full company gross margin would have been 54.7%. Med Tech gross margin would have been 62.1% and Med Device gross margin would have been 48.8%. Total operating expenses in the quarter were $48 million or 60% of sales compared to $52.9 million or of sales last year.

本季度，總毛利率因關稅而受到約 204 個基點的負面影響。如果不支付 160 萬美元的關稅，公司整體毛利率將達到 54.7%。醫療技術毛利率為 62.1%，醫療設備毛利率為 48.8%。本季總營運費用為 4,800 萬美元，佔銷售額的 60%，而去年同期為 5,290 萬美元，佔銷售額的 60%。

As a reminder, during the fourth quarter of fiscal 2024 last year, we incurred a number of onetime expenses, including amounts related to the settlement with CR Bard and our manufacturing transfer program. Now turning now to R&D. Our research and development expense was $6.6 million or 8.2% of sales compared to $6.7 million or 9.5% of sales a year ago. We remain committed to investing in R&D initiatives to support the long-term growth of our Med Tech segment and are targeting approximately 10% of sales going forward.

提醒一下，去年 2024 財年第四季度，我們發生了一些一次性費用，包括與 CR Bard 的和解以及我們的製造轉移計劃相關的金額。現在轉向研發。我們的研發費用為 660 萬美元，佔銷售額的 8.2%，而去年同期為 670 萬美元，佔銷售額的 9.5%。我們將繼續致力於投資研發計劃，以支持醫療技術部門的長期成長，並計劃在未來實現約 10% 的銷售額。

SG&A expense for the fourth quarter of FY25 was $36.7 million, representing 45.8% of sales compared to $35 million or 49.2% of sales a year ago. Our adjusted net loss for the fourth quarter of FY25 was $1.1 million or an adjusted loss per share of $0.03 compared to an adjusted net loss of $2.3 million or an adjusted loss per share of $0.06 in the fourth quarter of last year. This year-over-year improvement is largely attributable to our revenue growth and the success of our expense management initiatives.

2025 財年第四季的銷售、一般及行政費用為 3,670 萬美元，佔銷售額的 45.8%，而去年同期為 3,500 萬美元，佔銷售額的 49.2%。我們 25 財年第四季的調整後淨虧損為 110 萬美元，即調整後每股虧損 0.03 美元，而去年第四季的調整後淨虧損為 230 萬美元，即調整後每股虧損 0.06 美元。這一同比增長主要歸功於我們的收入成長和費用管理措施的成功。

Adjusted EBITDA in the fourth quarter of FY25 was $3.4 million compared to an adjusted EBITDA of $1.5 million in the fourth quarter of 2024. As noted previously, during the fourth quarter, we entered into a revolving line of credit agreement with JPMorgan, which allows us to draw down up to $25 million at our discretion. Now while we are very comfortable with the amount of cash we have on the balance sheet, we view the addition of a revolver as a matter of prudent financial housekeeping and a good safety net to ensure that any short-term working capital fluctuations associated with the Spectrum transition manufacturing agreement doesn't impact our execution on our strategy.

2025 財年第四季調整後 EBITDA 為 340 萬美元，而 2024 年第四季調整後 EBITDA 為 150 萬美元。如前所述，在第四季度，我們與摩根大通簽訂了循環信貸額度協議，該協議允許我們自行提取最高 2,500 萬美元的信貸額度。現在，雖然我們對資產負債表上的現金數量非常滿意，但我們認為增加循環信貸是審慎的財務管理和良好的安全網，以確保與 Spectrum 過渡製造協議相關的任何短期營運資本波動不會影響我們執行策略。

At this point, we have not drawn down any of the available capital as part of the revolver agreement. At May 31, 2025, we had $55.9 million in cash and cash equivalents, compared to $44.8 million in cash and cash equivalents at February 28, 2025, which is inclusive of the payment of the final revenue performance-based milestone payment of $5 million made as part of the company's acquisition of Auryon in 2019 and the $1.6 million in tariff-driven COGS impacts and fees associated with our revolving credit facility.

目前，我們尚未根據循環信貸協議提取任何可用資金。截至 2025 年 5 月 31 日，我們擁有 5,590 萬美元的現金和現金等價物，而 2025 年 2 月 28 日的現金和現金等價物為 4,480 萬美元，其中包括公司在 2019 年收購 Auryon 時支付的 5,480 萬美元的最終交易影響和與我們的循環信貸安排相關的費用。

In the quarter, we generated $18.8 million in operating cash, had capital expenditures of $0.8 million in addition to Auryon's placement and evaluation units of 1.8 million. As expected, we generated $16.2 million in free cash flow. Now turning to a quick review of the fiscal full year results. Revenue increased 8.1% to $292.7 million, primarily driven by growth across our Med Tech segment. Med Tech revenue was $126.7 million, a 19.5% increase.

本季度，我們產生了 1880 萬美元的營運現金，除了 Auryon 的 180 萬個安置和評估單位外，還有 80 萬美元的資本支出。正如預期的那樣，我們產生了 1,620 萬美元的自由現金流。現在來快速回顧一下全年財政業績。營收成長 8.1% 至 2.927 億美元，主要得益於醫療技術部門的成長。醫療技術收入為 1.267 億美元，成長 19.5%。

Our Auryon platform contributed $56.9 million in revenue, growing 20.8% compared to last year. Mechanical thrombectomy revenue, which includes AngioVac and AlphaVac sales, increased 32.9% year over year. In the fiscal full year, AngioVac revenue was $28.9 million, a 25.1% year-over-year increase and AlphaVac revenue was $10.8 million, a 59.5% year-over-year increase. Total NanoKnife revenue was $24.5 million, flat compared to the prior fiscal year. NanoKnife probes grew 9.6% for the year and capital sales were down 26%.

我們的 Auryon 平台貢獻了 5,690 萬美元的收入，比去年增長了 20.8%。機械血栓切除術收入（包括 AngioVac 和 AlphaVac 的銷售）年增 32.9%。全年財報顯示，AngioVac營收為2,890萬美元，年增25.1%，AlphaVac營收為1,080萬美元，年增59.5%。NanoKnife 的總收入為 2,450 萬美元，與上一財年持平。奈米刀探針全年成長 9.6%，資本銷售額下降 26%。

In fiscal year 2025, our Med Device revenue was $166 million, an increase of 0.8%. In the fiscal full year 2025, the company incurred limited revenue impacts because of tariffs. Our gross margin for FY25 was 53.9%. For the year, Med Tech gross margin was 62% and Med Device gross margin was 47.7%. In the year, total gross margin saw an approximate 56 basis point negative impact from tariffs.

2025財年，我們的醫療器材收入為1.66億美元，成長0.8%。2025財年全年，關稅對公司收入的影響有限。我們 25 財年的毛利率為 53.9%。全年醫療科技毛利率為 62%，醫療設備毛利率為 47.7%。當年，總毛利率因關稅而受到約 56 個基點的負面影響。

Absent the $1.6 million paid in tariffs, full company gross margin would have been 54.5%. The Med Tech gross margin would have been 62.9% and Med Device gross margin would have been 48%. Turning to R&D. Our research and development expense during FY 2025 was $26.2 million or 9% of sales compared to $30.9 million or 11.4% of sales a year ago. SG&A expense for FY 2025 was $145.2 million, representing 49.6% of sales compared to $139.2 million or 51.4% of sales a year ago.

如果不支付 160 萬美元的關稅，公司整體毛利率將達到 54.5%。醫療技術毛利率為 62.9%，醫療設備毛利率為 48%。轉向研發。我們 2025 財年的研發費用為 2,620 萬美元，佔銷售額的 9%，而去年同期為 3,090 萬美元，佔銷售額的 11.4%。2025 財年的銷售、一般及行政費用為 1.452 億美元，佔銷售額的 49.6%，而去年同期為 1.392 億美元，佔銷售額的 51.4%。

Our adjusted net loss for FY25 was $10.2 million or an adjusted loss per share of $0.25 compared to an adjusted net loss of $18.2 million or an adjusted loss per share of $0.45 last year.

我們 25 財年的調整後淨虧損為 1,020 萬美元，即調整後每股虧損 0.25 美元，而去年的調整後淨虧損為 1,820 萬美元，即調整後每股虧損 0.45 美元。

This year-over-year improvement is largely attributable to our revenue growth and the success of our expense management initiatives, very similar to the story for the quarter. Adjusted EBITDA in the full fiscal year 2025 was $7.6 million compared to an adjusted EBITDA loss of $3.2 million in fiscal year 2024. Turning now to guidance. For the fiscal year 2026, we anticipate net sales to be in the range of $305 million to $310 million, representing growth of between 4% and 6% over fiscal '25 revenue of $292.7 million. Within each of our businesses, we expect Med Tech net sales to grow 12% to 15% year over year and we expect Med Device sales to be roughly flat.

這一同比增長主要歸功於我們的收入成長和費用管理措施的成功，這與本季的情況非常相似。2025 財年全年調整後 EBITDA 為 760 萬美元，而 2024 財年調整後 EBITDA 虧損為 320 萬美元。現在轉向指導。對於 2026 財年，我們預計淨銷售額將在 3.05 億美元至 3.1 億美元之間，比 2025 財年的 2.927 億美元營收成長 4% 至 6%。在我們的每個業務中，我們預計醫療科技淨銷售額將年增 12% 至 15%，而我們預計醫療設備銷售額將基本持平。

For fiscal '26, we expect gross margin to be in the range of 53.5% to 55.5%. Now this is inclusive of our estimated tariff impact of $4 million to $6 million. Absent this impact, gross margin guidance would have been 55% to 56%. We expect adjusted EBITDA to be in the range of $3 million to $8 million, again, inclusive of our estimated tariff impact.

對於 26 財年，我們預計毛利率將在 53.5% 至 55.5% 之間。這包括我們估計的 400 萬至 600 萬美元的關稅影響。若不考慮此影響，毛利率預期將達到 55% 至 56%。我們預計調整後的 EBITDA 將在 300 萬美元至 800 萬美元之間，同樣包含我們估計的關稅影響。

Absent this impact, adjusted EBITDA guidance would have been $7.5 million to $10.5 million. And finally, we expect adjusted loss per share in the range of negative $0.35 to negative $0.25. Absent the tariff impact, adjusted loss per share guidance would have been negative $0.30 to negative $0.25. Beyond our P&L guidance, we continue to expect to be cash flow positive for the full fiscal year 2026. As is the case with all companies, our first fiscal quarter will exhibit the highest use of cash.

若不計入此影響，調整後的 EBITDA 指引將達到 750 萬美元至 1,050 萬美元。最後，我們預期調整後每股虧損將在-0.35美元至-0.25美元之間。若不計入關稅影響，調整後每股虧損指引應為-0.30美元至-0.25美元。除損益指引外，我們預計2026財年全年現金流將為正值。與所有公司一樣，我們的第一財季的現金使用量將是最高的。

This is typical for AngioDynamics and the first quarter of fiscal 2016 will be no different. In the first quarter '26, we expect to utilize approximately $20 million of cash. We will return to cash generation in subsequent quarters and we will finish FY26 having generated positive cash for the full year. Our guidance on cash is inclusive of any tariffs that we expect to pay during the year.

這對 AngioDynamics 來說很常見，2016 財年第一季也不會例外。2026 年第一季度，我們預計將使用約 2,000 萬美元現金。我們將在接下來的幾季恢復現金創造，並在 2026 財年全年實現正現金創造。我們對現金的指導包括我們預計在年內支付的任何關稅。

With that, I'll turn it back to Jim.

說完這些，我就把話題轉回給吉姆。

As we look forward, toward fiscal 2026, we are exceptionally well positioned to build on the strong foundation established during fiscal 2025. We entered the new year with multiple regulatory clearances achieved, expanded market access, proven commercial momentum and sustained profitability. Our strategic transformation over the past several years has positioned us exceptionally well for the future. We've successfully built a portfolio of innovative Med Tech platforms addressing large, growing markets. We've optimized our Med Device business to provide steady cash generation, and we've strengthened our balance sheet and operational efficiency to support sustainable growth.

展望 2026 財年，我們已做好準備，在 2025 財年奠定的堅實基礎上繼續前進。進入新的一年，我們已獲得多項監管批准、擴大了市場准入、證明了商業勢頭並保持了盈利能力。我們過去幾年的策略轉型為我們的未來做好了充分的準備。我們已經成功地建構了一系列創新的醫療技術平台，以滿足龐大且不斷增長的市場需求。我們優化了醫療器材業務以提供穩定的現金產生，並加強了資產負債表和營運效率以支持永續成長。

Looking ahead, our priorities remain clear: continue to drive adoption and market share gains across our Med Tech platforms, maintain operational discipline while investing for growth, and deliver increasing value to our shareholders through sustainable profitable growth. We remain very excited about the future of AngioDynamics. We have built a fantastic portfolio focused on large, high-growth markets. We have strengthened our financial profile and operational capabilities.

展望未來，我們的優先事項仍然明確：繼續推動醫療技術平台的採用和市場份額的成長，在投資成長的同時保持營運紀律，並透過永續的獲利成長為股東創造越來越大的價值。我們對 AngioDynamics 的未來仍然感到非常興奮。我們已經建立了專注於大型高成長市場的出色投資組合。我們增強了財務狀況和營運能力。

And with our strong balance sheet and positive trajectory towards sustained profitability, we're well positioned to deliver long-term value creation. Before opening the line for questions, I would like to thank every member of the AngioDynamics team for their tireless work to bring innovative technologies to our customers and the patients they serve.

憑藉我們強勁的資產負債表和持續獲利的積極軌跡，我們完全有能力實現長期價值創造。在開始提問之前，我想感謝 AngioDynamics 團隊的每一位成員，感謝他們不懈地努力為我們的客戶和他們服務的患者帶來創新技術。

With that, let's open the line for questions.

現在，讓我們開始回答問題。

(Operator Instructions)

（操作員指示）

John Young, Canaccord Genuity.

John Young 的 Canaccord Genuity。

Hey, Jim and Steve. It's John. Congrats on the quarter. And it's really great to see the progress here. I wanted to start on the VTE business. I know you guys mentioned it's blood return product.

嘿，吉姆和史蒂夫。是約翰。恭喜本季取得佳績。看到這裡的進展真是令人高興。我想開始從事 VTE 業務。我知道你們提到它是回血產品。

I was wondering to get some more incremental detail on the pathway forward for it. I know you're in regulatory discussions with it. Will this be a 510(k) product that just benchtop testing for hemolysis? Will this need a clinical trial? And is this an ancillary product to the existing AlphaVac business? And then as a follow-up to that question, too, looking at the AlphaVac revenue from this quarter, are you guys hitting a ceiling without having the blood return product because it's interesting you've seen the growth in AngioVac versus AlphaVac in this quarter?

我想要獲得有關其未來發展道路的更多細節。我知道您正在就監管問題進行討論。這會是僅進行溶血台式測試的 510(k) 產品嗎？這需要臨床試驗嗎？這是現有 AlphaVac 業務的輔助產品嗎？然後作為該問題的後續，看看本季度 AlphaVac 的收入，你們在沒有血液回輸產品的情況下是否達到了上限，因為有趣的是，您看到本季度 AngioVac 與 AlphaVac 相比有所增長？

Hi, John, it's Jim. Thanks for the question. So let me take a step backwards. AlphaVac was designed and developed with the blood loss aspect in mind. We knew during our initial design and development work with a lot of conversations with our advisory board of physicians who use other products that one of the issues with the leading product in the market was that it drew a lot of blood out, lost a lot of blood.

嗨，約翰，我是吉姆。謝謝你的提問。因此，讓我退一步來說。AlphaVac 的設計和開發充分考慮了失血因素。在最初的設計和開發工作中，我們與使用其他產品的醫生顧問委員會進行了多次交談，了解到市場上領先產品的問題之一是它會流出大量血液，從而導致大量失血。

They had to have a system to deal with that. So I'll leave that alone. We purposely built in, as you know, a blood loss feature into our product. It really limits the loss of blood during the pull. As the APEX study showed, we pulled more clot out than the market leader and we lose less blood.

他們必須有一個系統來解決這個問題。所以我不會再管它了。如您所知，我們特意在我們的產品中加入了失血功能。它確實限制了拉血過程中的失血量。正如 APEX 研究所表明的那樣，我們比市場領導者提取出了更多的血塊，而且失血量更少。

APEX study showed our blood loss was less than 250 cc in over 60% of the procedures done. So we're very confident in how the product works, how safe and effective it is. That being said now, the market has been conditioned a bit by the market leader to have a blood return feature available because they lose a lot more of that. So we knew that coming into it.

APEX 研究表明，在超過 60% 的手術中，失血量少於 250 cc。因此，我們對該產品的功效、安全性和有效性非常有信心。話雖如此，但現在市場已經被市場領導者稍微調教了一下，擁有血液回流功能，因為他們損失了更多。所以我們知道這一點。

We devised a product now to be kind of an ancillary add-on and it needs to go through a 510(k) process. There's been a process there, as you know how predicates work. So we tried to follow what was established. And in conversations with the FDA, they're watching the space. We haven't come to agree yet as to how to get the product approved and on the market.

我們現在設計的產品是一種輔助附加產品，它需要經過 510(k) 流程。這裡有一個過程，正如您所知，謂詞是如何運作的。因此我們嘗試遵循既定原則。在與 FDA 的對話中，他們正在關注這一領域。我們尚未就如何讓產品獲得批准並投放市場達成一致。

But we're confident we'll get there. As far as a ceiling note, we've had more and more getting to doctors' hands, more kind of hospitals approve us in the VAC committee process. And we've added new sales reps, as you know, in the past quarter because we're bullish about where AlphaVac can go. So this product has a high ceiling. And combined with AngioVac, which as you said, we had a terrific year at AngioVac, the fact we can sell both together and now we're getting multidisciplines involved in these conversations, meaning interventional cardiologists that maybe didn't know about AngioVac 18 months ago are now seeing it --seeing the applications it can be used for. So John, we have a great suite of products. These two will be leading products in thrombectomy for years to come. And we have a great business. We'll keep you up to date, but we expect sequential growth of products from here on it.

但我們有信心我們能夠實現目標。就上限而言，我們已經越來越多地接觸到醫生，越來越多的醫院在 VAC 委員會流程中批准我們。如您所知，我們在過去的一個季度增加了新的銷售代表，因為我們對 AlphaVac 的發展前景充滿信心。所以這個產品的上限很高。結合 AngioVac，正如您所說，我們在 AngioVac 度過了非常棒的一年，事實上我們可以同時銷售這兩種產品，現在我們讓多學科參與到這些對話中，這意味著 18 個月前可能不知道 AngioVac 的介入心臟病專家現在看到了它——看到了它可以用於哪些應用。約翰，我們有一套很棒的產品。這兩種產品將成為未來幾年血栓切除術領域的主導產品。我們的業務很棒。我們會隨時向您通報最新情況，但我們預計從現在開始產品將會持續成長。

Okay. That's great to hear. And then just as a quick follow-up, too. NanoKnife, especially with the approval, we'll see -- or I to say the reimbursement we'll see beginning in 2026, calendar 2026. As we think of the Med Tech guidance, are you guys thinking of an inflection essentially around that January approval timeline?

好的。聽到這個消息真是太好了。然後也只是進行快速的跟進。奈米刀，特別是獲得批准後，我們將看到——或者說我們將在 2026 年（2026 年日曆）開始看到報銷。當我們考慮醫療技術指導時，你們是否考慮在 1 月批准時間表前後發生根本性的變化？

Yes, John, this is Steve. Thanks for the question. So with NanoKnife, we've always said that there's three things that lead to the growth that we expect to see in NanoKnife. It's going to be the indication, which is table stakes. We were able to get that. Reimbursement was probably the most important.

是的，約翰，這是史蒂夫。謝謝你的提問。因此，對於 NanoKnife，我們一直說有三個因素將推動我們預期 NanoKnife 的成長。這將是指示，也是賭注。我們能夠做到這一點。報銷可能是最重要的。

That is coming into effect in January of 2026. And the third is continued increase in the adoption and awareness of the urology community. We're absolutely seeing that increase in awareness. We're very pleased with the trajectory that we're seeing with new urologists coming on board and choosing NanoKnife as one of their options for treatments. We do expect that the reimbursement is going to be something that's going to drive growth. I don't know that you're going to see an immediate hockey stick.

該法案將於 2026 年 1 月生效。第三是泌尿科界的採用率和認知度不斷提高。我們確實看到了意識的提高。我們很高興看到越來越多的泌尿科醫生加入並選擇奈米刀作為治療方案之一。我們確實預計報銷將會推動成長。我不知道您是否會立即看到曲棍球棒。

We've always said that the reimbursement landscape is a growth that's pretty complex. There's a lot of things that go into that. Just last night, CMS put out their proposed rules for the RBUs in this space. That ended up pretty much where we expected. There's a lot that we're still unpacking and our team is still going through that.

我們一直說，報銷情勢的成長相當複雜。這其中涉及很多因素。就在昨晚，CMS 發布了針對該領域的 RBU 的擬議規則。最終結果與我們預期的差不多。我們還有很多事情需要處理，我們的團隊仍在處理這些事情。

But it was right where we wanted it to be in terms of that piece. Then on top of that, there's the private payers making sure that they're putting in their coverage decisions. We're doing all that work as we've always said. We do expect we're going to see accelerated growth for NanoKnife and we're going to continue to drive to try to shorten that hockey stick. It may not be immediate. It's not like a light switch. But it is absolutely something that's going to continue to drive NanoKnife growth and adoption in the second half of our fiscal year here.

但就那件作品而言，它正是我們想要的樣子。除此之外，還有私人付款人確保他們做出承保決定。正如我們一直所說的那樣，我們正在做所有這些工作。我們確實預期奈米刀將會加速成長，我們將繼續努力縮短曲棍球棒的長度。這可能不是立即的。它不像電燈開關。但它絕對會繼續推動納米刀在我們下半年的財政年度的成長和應用。

Great. Congrats again, guys.

偉大的。再次恭喜你們，夥計們。

Steve Lichtman, Oppenheimer.

奧本海默的史蒂夫·利希特曼。

Thank you. Good morning, Jim and Steve, and congratulations on the quarter. On FY26 sales, can you give us any color on the major product growth between MT, Auryon and NanoKnife within Med Tech? And separately, what level of contribution do you think you can achieve from Auryon outside of the US? It sounds like you're off to a nice start there.

謝謝。早安，吉姆和史蒂夫，恭喜本季取得佳績。關於 26 財年的銷售情況，您能否向我們介紹一下 Med Tech 中 MT、Auryon 和 NanoKnife 的主要產品成長？另外，您認為 Auryon 在美國以外能做出什麼程度的貢獻？聽起來你已經有了一個好的開始。

Yes, Steve, I think that's absolutely true. We're very pleased with the uptick in some of the international markets that we're seeing with Auryon. As we've always said, the US is going to be the biggest market. International will be a contributor, but it's not going to be at the same level that we've seen here in the US.

是的，史蒂夫，我認為這絕對是真的。我們對 Auryon 在一些國際市場上的銷售成長感到非常高興。正如我們一直所說，美國將成為最大的市場。國際上將會做出貢獻，但其貢獻程度不會達到我們在美國所看到的水平。

So when you think about FY26, if you look at what we did last year, Auryon grew just about 20% for the full year. We said that we expected Auryon kind of in this time frame of its life cycle now to be about a mid-teens grower. That's a good way to think about it for FY26. And then for NanoKnife, we expected to see continued disposable adoption, probably a little bit of a step back in capital. We didn't see the level of step back that we said we expected to see at the beginning of the year last year. We'll still bring on some new capital, but it may be a little bit of a step back.

因此，當您考慮 26 財年時，如果您看看我們去年的表現，您會發現 Auryon 全年的成長率僅為 20% 左右。我們說過，我們預計 Auryon 在生命週期的時間範圍內將達到十幾歲的生長速度。這是思考 26 財年的一個好方法。對於奈米刀，我們預計將繼續被一次性採用，但資本方面可能會略有回落。去年，我們並沒有看到我們年初所預期的那種回落程度。我們仍將引入一些新資本，但可能會稍微退後一步。

So very similar progress with the coming into the back half as we talked about reimbursement coming online in NanoKnife. And then thrombectomy, mechanical thrombectomy, particular AngioVac and AlphaVac, expect that to continue to be a very strong role for us, probably the strongest growth that you see in the business there. So when you put that all together, that's how you get to that Med Tech guide that we gave you.

因此，當我們談到 NanoKnife 上線報銷時，後半部的進展非常相似。然後是血栓切除術、機械血栓切除術，特別是 AngioVac 和 AlphaVac，預計這將繼續在我們中發揮非常重要的作用，可能是您在該業務中看到的最強勁的增長。因此，當您將所有這些放在一起時，您就得到了我們給您的醫療技術指南。

Got it. Appreciate that. And then just secondly, on gross margin, Steve. I appreciate the tariff details. Does the potential impact you laid out in FY26 include offsets -- and then separately, the ex tariffs gross margin is ahead of our thinking. I was wondering how much of the outsourcing initiative you'll think you'll accrue benefits from in FY26.

知道了。非常感謝。其次，關於毛利率，史蒂夫。我很感謝關稅詳情。您在 FY26 中列出的潛在影響是否包括抵消 - 然後單獨計算，不含關稅的毛利率超出了我們的預期。我想知道您認為在 2026 財年您將從外包計畫中獲得多少收益。

Yeah, it's a great question. So there is a lot of moving parts when it goes into tariffs. So there's a lot that we put into our guide there. There's the current thinking that we know today as we've all said, that changes daily, right? Even just a couple of days ago, there were some changes with -- some potential changes there in the EU community.

是的，這是一個很好的問題。因此，在涉及關稅時，有很多因素會改變。因此我們在指南中加入了非常多的內容。正如我們所說，我們今天所知道的當前思維每天都在變化，對嗎？甚至就在幾天前，歐盟內部就發生了一些變化——一些潛在的變化。

So there's puts and takes when it cut our expectations around tariffs. We're also doing a lot of the things that you'd expect us to do to try to mitigate any potential tariff impacts. So we'll continue to be transparent as possible with tariffs as we move forward into this fiscal year. I think the point about our manufacturing transfer plan, we've absolutely started to see the benefits coming from that manufacturing transfer plan even in FY25.

因此，當它降低我們對關稅的預期時，就會出現利弊。我們也正在採取許多您期望我們採取的措施，以盡量減輕任何潛在的關稅影響。因此，隨著本財政年度的推進，我們將繼續盡可能保持關稅的透明度。我認為關於我們的製造業轉移計劃的重點是，即使在 25 財年，我們已經開始看到製造業轉移計劃帶來的好處。

So as we said, we expected to complete the program by the end of this calendar year, and that's when you're going to start to see the full benefit of that manufacturing transfer plan with FY27, which starts June 1 of '26, when you're going to see the full year impact. We do expect that we're going to see some of that benefit in the back half of this fiscal '26 that we just started as we started to see some of that benefit in FY25. So some of the expense management initiatives that we talked about as well as gross margin and the results that we've seen in gross margin, particularly that the results of gross margin ex tariff. We're starting to see some of the benefits of our operations team bringing in some of those cost benefits a little earlier and we expect that to continue.

正如我們所說，我們預計將在今年年底前完成該計劃，屆時您將開始看到製造業轉移計劃在 2027 財年（從 2026 年 6 月 1 日開始）帶來的全部好處，屆時您將看到全年影響。我們確實預計，我們將在剛開始的 26 財年下半年看到一些好處，就像我們在 25 財年看到一些好處一樣。因此，我們討論的一些費用管理舉措以及毛利率和我們在毛利率中看到的成果，特別是不含關稅的毛利率成果。我們開始看到我們的營運團隊提前帶來一些成本效益，我們預計這種情況將會持續下去。

Okay, great. Thanks, guys.

好的，太好了。謝謝大家。

Yi Chen, H.C. Wainwright.

陳毅，H.C.溫賴特。

Thank you for taking my question. Do you have any plan to acquire new Med Tech products with high growth potential in fiscal year '26? And do you plan to divest any additional products within that device segment in the next fiscal?

感謝您回答我的問題。您是否有計劃在 26 財年收購具有高成長潛力的新型醫療技術產品？您是否計劃在下一財年剝離該設備領域的其他產品？

Thanks for the question this morning. This is Jim. We really like the portfolio we have. We've talked to you and to others about the development of this portfolio getting to where it's at today. We think we have a healthy balance between our medical device products which are kind of four different little classes within Med Device, but they're really good.

感謝您今天早上提出的問題。這是吉姆。我們非常喜歡我們現有的投資組合。我們已經與您和其他人討論了該投資組合的發展情況，並了解到了它今天的狀況。我們認為我們的醫療器材產品之間保持著健康的平衡，這些產品在醫療器材領域分為四個不同的小類別，但它們確實很好。

They're market-leading products. We have a great selling and marketing and clinical team supporting them. And now with Med Tech, you've seen as I said in my remarks earlier, we've had a five-year CAGR of 25% growth in our Med Tech products. That's really important to us. Now that we've actually entered some of these markets we're trying to get through with market development assets like our APEX and PRESERVE study, our CE marks, other things opening up access, we're really, really busy here the next couple of years on just kind of doing the execution mode here and supporting some of their clinical studies.

它們是市場領先的產品。我們擁有一支優秀的銷售、行銷和臨床團隊為他們提供支援。現在有了醫療技術，正如我之前所說，我們的醫療技術產品的五年複合年增長率為 25%。這對我們來說真的很重要。現在我們實際上已經進入了其中一些市場，我們正試圖透過市場開發資產（例如我們的 APEX 和 PRESERVE 研究、我們的 CE 標誌以及其他開放管道）來實現這一目標，未來幾年我們真的非常忙碌，只是在這裡進行執行模式並支持他們的一些臨床研究。

We think they'll expand opportunities of these markets. So we're really pleased with the development of the products themselves. Now we're pleased with the market access, reimbursement, awareness, clinical regulatory hurdles we've cleared, I think we're pretty busy here. So we don't see the need to add definitely another platform to what we have and even adding pieces to it, maybe we'll come across an item or something that looks interesting. But as a company strategy, we want to focus on these assets that we own and make sure we can drive the opportunity because the TAMs are large and we want to drive the opportunity we can to give our shareholders the best fastest return on growth here.

我們認為他們會擴大這些市場的機會。因此，我們對產品本身的開發感到非常滿意。現在我們對已經清除的市場准入、報銷、意識和臨床監管障礙感到滿意，我想我們在這裡相當忙碌。因此，我們認為沒有必要在現有平台上添加另一個平台，甚至添加一些部分，也許我們會遇到一個看起來很有趣的項目或東西。但作為一項公司策略，我們希望專注於我們擁有的這些資產，並確保我們能夠抓住機遇，因為 TAM 很大，我們希望抓住機遇，為我們的股東帶來最佳、最快的成長回報。

I think that's what you'll see from us going forward.

我想這就是你們將會看到的我們前進的步伐。

Thank you.

謝謝。

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

至此，問答環節已經結束。我將把發言權交還給克萊默先生，請他作最後發言。

Thank you for joining us today. AngioDynamics is really proud of our transformation. We've really changed our company, become now a leading Med Tech provider or really, really counted on products to treat patients with severe disease. I want this journey. It's been hard to do, but we know what our outcome could be, and now we're getting close. We'll be a company that will be well managed and really great results to our shareholders for years to come. We're a really good company.

感謝您今天加入我們。AngioDynamics 對我們的轉型感到非常自豪。我們確實改變了我們的公司，現在成為領先的醫療技術提供者，或真正依靠產品來治療重症患者。我想要這趟旅程。這很難做到，但我們知道結果會是什麼，現在我們已經很接近了。我們將成為一家管理良好、在未來的幾年為股東帶來豐厚回報的公司。我們是一家非常好的公司。

Thank you for your interest today and we'll talk to you soon.

感謝您今天的關注，我們很快就會與您聯繫。

This will conclude today's conference. You may disconnect your lines at this time. We thank you for your participation. Have a wonderful day.

今天的會議到此結束。現在您可以斷開線路。我們感謝您的參與。祝您有美好的一天。