AngioDynamics Inc (ANGO) 2023 Q3 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good morning, and welcome to the AngioDynamics Fiscal Year 2023 Third Quarter Earnings Call. (Operator Instructions) As a reminder, this conference call is being recorded. The news release detailing our fiscal 2023 third quarter 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 website at www.angiodynamics.com, and the webcast replay of the call will be available at the same site approximately 1 hour after the end of today's call.

    早上好,歡迎來到 AngioDynamics 2023 財年第三季度財報電話會議。 (操作員說明)作為提醒,正在錄製此電話會議。詳細介紹我們 2023 財年第三季度業績的新聞稿於今天上午早些時候發布,可在公司網站上查閱。該電話會議還在公司網站 www.angiodynamics.com 的投資者部分通過互聯網進行現場直播,電話會議的網絡直播重播將在今天的電話會議結束後約 1 小時在同一站點提供。

  • Before we begin, I would 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 2023 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,包括關於 2023 財年預期收入、調整後收益和毛利率的陳述作為可能繼續的趨勢。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 和 10-K 表格,這些文件確定了可能導致實際結果或事件與前瞻性陳述。

  • The company will also discuss certain non-GAAP 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. Investors should consider these non-GAAP measures in addition to, not as a substitute for, or as superior to financial reporting measures prepared in accordance with GAAP.

    該公司還將在本次電話會議期間討論某些非 GAAP 財務指標。管理層使用這些指標來製定運營目標和審查運營績效,並認為這些指標可能有助於投資者分析公司業務隨時間推移的潛在趨勢。投資者應考慮將這些非 GAAP 措施作為根據 GAAP 編制的財務報告措施的補充,而不是替代或優於這些措施。

  • A slide package offering insight into the company's financial results is also available on the Investors section of the company's website under Events & Presentations. The presentation should be read in conjunction with the press release discussed in the company's operating results and financial performance during this morning's conference call.

    公司網站“活動與演示”下的“投資者”部分還提供了一個幻燈片包,可深入了解公司的財務業績。該演示文稿應與今天上午的電話會議上公司經營業績和財務業績中討論的新聞稿一起閱讀。

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

    我現在想把電話轉給 AngioDynamics 的總裁兼首席執行官 Jim Clemmer。克萊默先生?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Thank you, Darryl. Good morning, everyone, and thank you for joining us for AngioDynamics' Fiscal 2023 Third Quarter Earnings Call. Joining me on today's call is Steve Trowbridge, AngioDynamics' Executive Vice President and Chief Financial Officer, who will provide a detailed analysis of our third quarter financial performance.

    謝謝你,達里爾。大家早上好,感謝您加入我們的 AngioDynamics 2023 財年第三季度財報電話會議。 AngioDynamics 的執行副總裁兼首席財務官 Steve Trowbridge 和我一起參加今天的電話會議,他將對我們第三季度的財務業績進行詳細分析。

  • Turning to our results. We ended the quarter with revenue of $80.7 million, representing growth of 9% year-over-year, led by growth of about 17% from our Med Tech segment over the third quarter of last year. We continue to make progress towards our strategic goals during the quarter, including solid growth from our atherectomy and NanoKnife platforms as well as our recently launched AlphaVac system.

    轉向我們的結果。本季度結束時,我們的收入為 8070 萬美元,同比增長 9%,其中醫療技術部門在去年第三季度增長了約 17%。我們在本季度繼續朝著我們的戰略目標取得進展,包括我們的斑塊切除術和 NanoKnife 平台以及我們最近推出的 AlphaVac 系統的穩健增長。

  • Year-to-date, our net sales have grown 8%, with our Med Tech segment growing 25% and our Med Device segment growing 2.5%. We are now 21 months into our 36-month plan that we launched in July of '21, and we are progressing at or ahead of our revenue targets. Our Med Tech segment drove growth in the quarter, led by Auryon, AlphaVac and NanoKnife. AngioVac was a soft spot in the quarter, offsetting the strength we saw in the rest of the Med Tech portfolio. Auryon continued its impressive performance in the quarter, growing approximately 43% over the prior year and increasing sequentially over Q2.

    今年迄今為止,我們的淨銷售額增長了 8%,其中我們的醫療技術部門增長了 25%,我們的醫療設備部門增長了 2.5%。我們在 2021 年 7 月啟動的 36 個月計劃已經進行了 21 個月,我們正在或超過我們的收入目標。在 Auryon、AlphaVac 和 NanoKnife 的帶動下,我們的醫療技術部門推動了本季度的增長。 AngioVac 在本季度是一個軟肋,抵消了我們在其他醫療技術產品組合中看到的優勢。 Auryon 在本季度繼續保持著令人印象深刻的表現,比去年同期增長約 43%,並且比第二季度環比增長。

  • To date, we have treated more than 35,000 patients since launch, and we remain on track to achieve our full year target for Auryon. Our Mechanical Thrombectomy business comprising AngioVac and AlphaVac increased 4.5% during the quarter. AlphaVac revenue for the quarter was $2 million. Our launch is progressing according to plan, and we remain on track to meet our AlphaVac revenue expectations for the full year. With that being said, our Mechanical Thrombectomy business growth fell short of our expectations during the quarter due to AngioVac performance.

    迄今為止,自推出以來,我們已經治療了超過 35,000 名患者,我們仍有望實現 Auryon 的全年目標。我們的機械血栓切除術業務包括 AngioVac 和 AlphaVac,在本季度增長了 4.5%。 AlphaVac 本季度的收入為 200 萬美元。我們的發布正在按計劃進行,我們仍有望實現全年的 AlphaVac 收入預期。話雖如此,由於 AngioVac 的表現,我們的機械血栓切除術業務增長在本季度未達到我們的預期。

  • AngioVac sales declined 16% in the quarter and are down 8% year-to-date. As we stated last quarter, AngioVac is the most sensitive of our products to hospital staffing challenges due to the complex nature of the procedure, requiring numerous support specialties, including perfusionists and usually requiring an ICU bed. However, this is not the sole driver of AngioVac's softness. Our execution has played a role in softness as well.

    AngioVac 銷售額在本季度下降了 16%,今年迄今下降了 8%。正如我們上個季度所述,AngioVac 是我們產品中對醫院人員配備挑戰最敏感的產品,因為該程序的複雜性需要眾多專業支持人員,包括灌注師,並且通常需要 ICU 病床。然而,這並不是 AngioVac 柔軟的唯一驅動因素。我們的執行力也起到了柔軟的作用。

  • As we discussed last quarter, we are focused on optimizing our commercial strategy and implementing the most effective approach the selling AngioVac and AlphaVac from the same sales bag. Based on customer feedback as well as our own market observations, we are enhancing our selling process, which includes improved messaging and targeting as well as sales force and customer training with the goal of improving execution as we head into the fourth quarter of our fiscal year and our first quarter of fiscal 2024.

    正如我們上個季度所討論的那樣,我們專注於優化我們的商業戰略並實施最有效的方法,即從同一個銷售袋中銷售 AngioVac 和 AlphaVac。根據客戶反饋和我們自己的市場觀察,我們正在改進我們的銷售流程,包括改進消息傳遞和目標定位以及銷售人員和客戶培訓,目標是在我們進入本財年第四季度時提高執行力以及我們 2024 財年的第一季度。

  • These are growing pains that come with the launch and integration of any new platform, and I am confident that we have the tools in place to support our really talented commercial team to resolve them. While we are reducing our fiscal 2023 revenue expectations as a result of this AngioVac softness, which also flows down impact our margin and EPS outlook. We remain very bullish about the midterm and long-term prospects for our Mechanical Thrombectomy business.

    這些都是伴隨任何新平台的發布和集成而來的成長煩惱,我相信我們擁有適當的工具來支持我們真正有才華的商業團隊來解決這些問題。儘管我們由於 AngioVac 的疲軟而降低了 2023 財年的收入預期,但這種疲軟也會影響我們的利潤率和每股收益前景。我們仍然非常看好機械血栓切除術業務的中期和長期前景。

  • AngioVac is just one component of our Mechanical Thrombectomy platform, which is still in the early stages of development. We continue to work closely with our customers to generate additional data to support future indications while also working toward international expansion beyond our current U.S. market.

    AngioVac 只是我們機械血栓切除術平台的一個組成部分,該平台仍處於早期開發階段。我們繼續與客戶密切合作,以生成更多數據來支持未來的跡象,同時也致力於在我們目前的美國市場之外進行國際擴張。

  • Turning to our oncology segment. NanoKnife disposable sales grew approximately 22% during the quarter, with strength both domestically and internationally. We saw a continued uptick in prostate cases during the quarter, and physicians completed over 100 cases with NanoKnife, an increase of more than 70 cases over Q3 of last year. We believe that the continued strong performance of our NanoKnife platform is an illustration that platform -- illustration of the platform's ease of use, combined with positive patient outcomes.

    轉向我們的腫瘤學部分。 NanoKnife 一次性銷售額在本季度增長了約 22%,在國內和國際上都表現強勁。我們看到本季度前列腺病例持續上升,醫生使用 NanoKnife 完成了 100 多例病例,比去年第三季度增加了 70 多例。我們相信,我們的 NanoKnife 平台持續強勁的表現是該平台的一個例證——該平台的易用性與積極的患者結果相結合的例證。

  • Doctors appreciate that a NanoKnife procedure takes roughly 45 minutes versus over 2 hours for other focal treatments, while being safe for patients and preserving the quality of life. NanoKnife is currently trending ahead of the 3-year plan that we shared with you at our Investor Day in 2021, and I'm thrilled with the progress our team has made with this platform.

    醫生認為 NanoKnife 手術大約需要 45 分鐘,而其他局部治療需要 2 多個小時,同時對患者安全並保持生活質量。 NanoKnife 目前的趨勢領先於我們在 2021 年投資者日與您分享的 3 年計劃,我對我們的團隊在該平台上取得的進展感到興奮。

  • During the quarter, our Med Device segment grew 6% compared with the year ago period when the Med Device segment declined due to headwinds associated with a tight labor market and supply chain disruptions. Our teams have done a great job working their way diligently and deliberately through this environment. While we have seen improvements in a number of macro areas, specifically with the respect of availability of manufacturing labor and freight costs, our teams continue to navigate inflationary and supply chain pressures.

    在本季度,我們的醫療設備部門與去年同期相比增長了 6%,當時醫療設備部門由於勞動力市場緊張和供應鏈中斷相關的逆風而出現下滑。我們的團隊在這種環境中勤奮而刻意地工作,做得很好。雖然我們看到許多宏觀領域有所改善,特別是在製造勞動力和貨運成本的可用性方面,但我們的團隊繼續應對通貨膨脹和供應鏈壓力。

  • During our third quarter, we were backwarded on components that impacted approximately $3 million of revenue, which we had expected -- which we expect to clear during our fourth quarter. International markets had a strong quarter, growing 14% year-over-year, again driven by NanoKnife and solid contributions from our Med Device business. We expect our international business to be a positive growth contributor in FY '23.

    在我們的第三季度,我們在影響大約 300 萬美元收入的組件上落後,這是我們預期的 - 我們希望在第四季度清除。國際市場有一個強勁的季度,同比增長 14%,這再次受到 NanoKnife 和我們醫療設備業務的堅實貢獻的推動。我們預計我們的國際業務將在 23 財年成為積極的增長貢獻者。

  • And as our team continues to strengthen our sales network and expand our global scientific presence, our team continues to work hard to bring our products to international markets, and we expect to receive regulatory approvals to launch Auryon and AlphaVac internationally during our fiscal year 2024. Generating clinical data plays a key role in our ability to effectively develop our Med Tech platform technologies and expand into larger, faster-growing, higher-margin addressable markets.

    隨著我們的團隊繼續加強我們的銷售網絡並擴大我們的全球科學影響力,我們的團隊繼續努力將我們的產品推向國際市場,我們預計將在 2024 財年獲得監管批准,在國際上推出 Auryon 和 AlphaVac。生成臨床數據在我們有效開發 Med Tech 平台技術和擴展到更大、增長更快、利潤率更高的潛在市場的能力方面發揮著關鍵作用。

  • Our teams continue to execute on our clinical trials, including our 3 IDE studies. Our PRESERVE study for the treatment of prostate cancer with NanoKnife, our APEX study for the treatment of pulmonary embolism with our AlphaVac F18 and our DIRECT study for the treatment of pancreatic cancer with NanoKnife. We continue to be very pleased with the pace of enrollment in the PRESERVE study during the quarter.

    我們的團隊繼續執行我們的臨床試驗,包括我們的 3 項 IDE 研究。我們的 PRESERVE 研究使用 NanoKnife 治療前列腺癌,我們的 APEX 研究使用我們的 AlphaVac F18 治療肺栓塞,我們的 DIRECT 研究使用 NanoKnife 治療胰腺癌。我們繼續對本季度 PRESERVE 研究的註冊速度感到非常滿意。

  • In partnership with the Society of Urologic Oncology's Clinical Trial Consortium, this study aims to demonstrate that NanoKnife can be an effective focal treatment option for men with intermediate risk disease and provide favorable quality of life outcomes. We remain on track to finish enrollment in this study around the end of June. And as a reminder, the study has a 1-year follow-up. We estimate that the total potential market for focal treatment of prostate cancer that can be addressed by NanoKnife may exceed $700 million in the U.S. alone.

    本研究與泌尿腫瘤學會臨床試驗聯合會合作,旨在證明 NanoKnife 可以成為患有中度風險疾病的男性的有效局部治療選擇,並提供良好的生活質量結果。我們仍有望在 6 月底左右完成這項研究的招募。提醒一下,該研究有 1 年的隨訪期。我們估計,NanoKnife 可以解決的前列腺癌局灶性治療的總潛在市場可能僅在美國就超過 7 億美元。

  • With respect to our APEX study, we are pleased with the pace of enrollment, and we are particularly encouraged by the feedback we are receiving about our technology from the treating physicians. We currently have 17 activated sites in the APEX study. This study is in partnership with the PERT Consortium and has a 30-day follow-up. At the current pace of enrollment, we expect to close enrollment early calendar year 2024. We believe that our APEX study will prove that our unique AlphaVac products can effectively treat PE, providing ease of use while unlocking an opportunity in a large addressable market that we estimate to be more than $1.5 billion in the U.S. alone.

    關於我們的 APEX 研究,我們對入組速度感到滿意,並且我們從治療醫生那裡收到的關於我們技術的反饋讓我們感到特別鼓舞。我們目前在 APEX 研究中有 17 個激活的站點。這項研究是與 PERT 聯盟合作進行的,並進行了 30 天的隨訪。按照目前的註冊速度,我們預計將在 2024 日曆年年初結束註冊。我們相信我們的 APEX 研究將證明我們獨特的 AlphaVac 產品可以有效治療 PE,提供易用性,同時在我們的大型潛在市場中釋放機會估計僅在美國就超過 15 億美元。

  • These studies will bolster the scientific and clinical body of evidence that drives adoption worldwide regulatory clearances and patient access. We are targeting regulatory approval for both the prostate tissue indication for NanoKnife and the PE indication for AlphaVac in the United States by the end of calendar 2024. We look forward to providing you with additional details over the coming quarters. We'd like to highlight a few recent publications describing the use of NanoKnife in men with prostate cancer. Professor de la Rosette at AO recently published a multicenter, randomized, single-blind study in the Journal of Urology that evaluates the safety and quality of life profile after IRE for the ablation of localized low-to-intermediate risk prostate cancer.

    這些研究將加強科學和臨床證據,推動全球監管許可和患者准入。我們的目標是到 2024 年底在美國獲得 NanoKnife 的前列腺組織適應症和 AlphaVac 的 PE 適應症的監管批准。我們期待在未來幾個季度為您提供更多詳細信息。我們想重點介紹一些最近發表的描述 NanoKnife 在前列腺癌患者中的應用的文章。 AO 的 de la Rosette 教授最近在《泌尿外科雜誌》上發表了一項多中心、隨機、單盲研究,該研究評估了 IRE 消融局部中低風險前列腺癌後的安全性和生活質量。

  • In summary, the article published is work conducted by the Clinical Research Office of Endourological Society, or CROES. We believe it shows a very favorable safety and quality of life profile in 106 men. The same data set was also published in JAMA Surgery. This article focuses on the oncological control after IRE, finding more than 80% of patients were free from clinically significant cancer at 6 months. In addition, senior author, Professor Phillip Stricker at AO published in the British Journal of Urology International, a median 5-year outcomes of primary focal IRE for localized prostate cancer in 229 patients. In this long-term study, the authors also conclude that IRE is a good treatment option with the avoidance of radical treatment in 80% of the patients at 5 years. We are proud to support this work and continue anticipate great results from the clinical studies of our products.

    總之,發表的文章是由腔內泌尿學會臨床研究辦公室 (CROES) 開展的工作。我們相信它在 106 名男性中顯示出非常有利的安全性和生活質量。同樣的數據集也發表在 JAMA Surgery 上。本文重點關注 IRE 後的腫瘤控制,發現超過 80% 的患者在 6 個月時沒有出現有臨床意義的癌症。此外,AO 的資深作者 Phillip Stricker 教授在英國國際泌尿外科雜誌上發表了 229 名局限性前列腺癌患者原發性局灶性 IRE 的中位 5 年結果。在這項長期研究中,作者還得出結論,IRE 是一種很好的治療選擇,5 年時 80% 的患者避免了根治性治療。我們很自豪能夠支持這項工作,並繼續期待我們產品的臨床研究取得巨大成果。

  • Before turning the call over to Steve, I'd like to recognize our team here at AngioDynamics for the continued hard work as we pursue our goals of becoming a high-growth, profitable Med Tech company. As I mentioned in my remarks, the team has made incredible progress on our initiatives as we continue to build life-saving technology that improves upon the existing standard of care.

    在將電話轉給史蒂夫之前,我想感謝我們在 AngioDynamics 的團隊在我們追求成為高增長、盈利的醫療技術公司的目標過程中的持續努力。正如我在發言中提到的那樣,隨著我們繼續構建可改進現有護理標準的救生技術,該團隊在我們的舉措方面取得了令人難以置信的進展。

  • With that, let me turn the call over to Steve Trowbridge, our Executive Vice President, and Chief Financial Officer, to review the quarter in more detail.

    有了這個,讓我把電話轉給我們的執行副總裁兼首席財務官史蒂夫特羅布里奇,以更詳細地審查本季度。

  • Stephen A. Trowbridge - Executive VP & CFO

    Stephen A. Trowbridge - Executive VP & CFO

  • Thanks, Jim. Good morning, everyone. 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. And while we had a softer quarter than we would have liked, there were a number of strong points during the quarter. Revenue in the quarter increased 9.1% year-over-year to $80.7 million, driven by growth in Auryon and NanoKnife as well as a strong performance from our Med Device business.

    謝謝,吉姆。大家,早安。在開始之前,我想引導大家閱讀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項目。雖然我們的季度比我們希望的要疲軟,但本季度有許多優點。在 Auryon 和 NanoKnife 的增長以及我們的 Med Device 業務的強勁表現的推動下,本季度收入同比增長 9.1% 至 8070 萬美元。

  • Med Tech revenue was $22.9 million, a 16.6% year-over-year increase, while Med Device revenue was $57.8 million, an increase of 6.4% year-over-year. For the quarter, our Med Tech segment comprised 28% of our total revenue compared to 27% of total revenue a year ago. Year-to-date, FY '23 revenue increased 8.1% year-over-year, driven by Med Tech segment revenue growth of 25.1% and Med Device segment growth of 2.5%.

    Med Tech 收入為 2290 萬美元,同比增長 16.6%,而 Med Device 收入為 5780 萬美元,同比增長 6.4%。本季度,我們的醫療技術部門佔總收入的 28%,而一年前佔總收入的 27%。年初至今,受醫療技術部門收入增長 25.1% 和醫療器械部門收入增長 2.5% 的推動,23 財年收入同比增長 8.1%。

  • Our Auryon platform contributed $10.4 million in revenue during the third quarter, a 42.8% increase compared to last year. We continue to be pleased with the growth of the platform and remain confident in our ability to achieve full year Auryon revenue in the range of $40 million to $45 million. As we head into fiscal 2024 and beyond, there are a number of positive indicators supporting the continued performance of this business. First, we're seeing an accelerated shift towards hospitals from OBLs. Second, we're seeing consistent strength in below-the-knee procedures, which are now outpacing above-the-knee procedures for Auryon. Third, we have completed supply chain enhancements for our disposables, which will drive improved margins over time. And finally, we expect regulatory clearance to enter international markets during our fiscal 2024.

    我們的 Auryon 平台在第三季度貢獻了 1040 萬美元的收入,與去年相比增長了 42.8%。我們繼續對該平台的增長感到滿意,並對我們實現 Auryon 全年收入在 4000 萬至 4500 萬美元範圍內的能力充滿信心。隨著我們進入 2024 財年及以後,有許多積極的指標支持該業務的持續表現。首先,我們看到 OBL 向醫院的加速轉變。其次,我們看到膝蓋以下手術的持續優勢,現在已經超過 Auryon 的膝蓋以上手術。第三,我們已經完成了一次性用品供應鏈的改進,這將隨著時間的推移推動利潤率的提高。最後,我們預計監管許可將在 2024 財年進入國際市場。

  • Mechanical Thrombectomy revenue, which includes AngioVac and AlphaVac sales, increased 4.5% over the third quarter of FY '22. AlphaVac revenue for the third quarter was $2 million. We remain very pleased with the performance of our AlphaVac products, including the F22 and F18 versions. Physician feedback continues to be very positive with respect to usability, features and outcomes. Year-to-date revenue for AlphaVac is $5.4 million, and we remain on track to generate AlphaVac revenue for the full fiscal year of $7 million to $9 million.

    包括 AngioVac 和 AlphaVac 銷售額在內的機械血栓切除術收入比 22 財年第三季度增長了 4.5%。 AlphaVac 第三季度的收入為 200 萬美元。我們對我們的 AlphaVac 產品(包括 F22 和 F18 版本)的性能非常滿意。醫生在可用性、功能和結果方面的反饋仍然非常積極。 AlphaVac 年初至今的收入為 540 萬美元,我們仍有望在整個財政年度產生 700 萬至 900 萬美元的 AlphaVac 收入。

  • AngioVac revenue was $5.5 million in the quarter, representing a decline of 15.7% over the prior year. As Jim discussed, AngioVac faced challenges during the quarter, we've taken action to address it. Year-to-date, AngioVac revenue is $18.4 million, a decline of 8.2%. We now anticipate our Mechanical Thrombectomy platform led by growth in AlphaVac to grow 10% to 20% in fiscal 2023, below our prior expectation of 25% to 30%.

    AngioVac 本季度的收入為 550 萬美元,較上年同期下降 15.7%。正如 Jim 所討論的那樣,AngioVac 在本季度面臨挑戰,我們已經採取行動來解決這個問題。年初至今,AngioVac 的收入為 1840 萬美元,下降了 8.2%。我們現在預計,在 AlphaVac 的增長帶動下,我們的機械血栓切除術平台將在 2023 財年增長 10% 至 20%,低於我們此前預期的 25% 至 30%。

  • Despite of this change, we remain confident that Mechanical Thrombectomy will be a significant contributor to our growth strategy over the medium and long term, and will continue to prioritize investments in this platform. NanoKnife disposable revenue increased 22.2% year-over-year. Year-to-date, sales of NanoKnife disposables grew 26.7%. As Jim mentioned, we're very pleased with the pace of sales growth as well as clinical enrollment of our NanoKnife platform.

    儘管發生了這種變化,我們仍然相信,機械血栓切除術將在中長期內為我們的增長戰略做出重要貢獻,並將繼續優先投資該平台。 NanoKnife 的可支配收入同比增長 22.2%。今年迄今為止,NanoKnife 一次性用品的銷售額增長了 26.7%。正如 Jim 所提到的,我們對 NanoKnife 平台的銷售增長速度和臨床註冊感到非常滿意。

  • Our Med Device segment grew 6.4% year-over-year, with strength in our angiographic products, ports, dialysis and microwave, offsetting a decline in our EVLT business during the quarter. The growth in the third quarter was positively impacted by a less challenging comp due to the headwinds we faced stemming from the tight labor market and supply chain disruptions during last year's third quarter. Nonetheless, we are pleased with our team's continued progress in driving operational capacity and supply chain strategies. As of the end of our third quarter, our backlog stood at $5.4 million. Year-to-date, our Med Device segment has grown 2.5%.

    我們的醫療設備部門同比增長 6.4%,我們的血管造影產品、港口、透析和微波業務表現強勁,抵消了本季度 EVLT 業務的下滑。由於去年第三季度勞動力市場緊張和供應鏈中斷導致我們面臨不利因素,第三季度的增長受到了挑戰較小的競爭的積極影響。儘管如此,我們對我們的團隊在推動運營能力和供應鏈戰略方面的持續進步感到高興。截至第三季度末,我們的積壓訂單為 540 萬美元。年初至今,我們的醫療設備部門增長了 2.5%。

  • Moving down the income statement. Our gross margin for the third quarter of FY '23 was 50.2%, a decrease of 200 basis points compared to the year ago period. As a reminder, gross margin in the third quarter of fiscal 2022 included a roughly 115 basis point benefit from the CARES Act. Gross margins for the third quarter of fiscal '23 were positively impacted by increased production and sales mix of roughly 225 basis points. However, this benefit was offset by roughly 210 basis points of inflationary pressures, including 110 basis points of raw material inflation, 90 basis points of labor inflation and 10 basis points of increased freight costs and depreciation from hardware placements. In addition, the benefit from mix was offset by lower AngioVac sales.

    向下移動損益表。我們 23 財年第三季度的毛利率為 50.2%,與去年同期相比下降了 200 個基點。提醒一下,2022 財年第三季度的毛利率包括 CARES 法案帶來的大約 115 個基點的收益。 23 財年第三季度的毛利率受到產銷組合增加約 225 個基點的積極影響。然而,這一收益被大約 210 個基點的通脹壓力所抵消,其中包括 110 個基點的原材料通脹、90 個基點的勞動力通脹以及 10 個基點的貨運成本增加和硬件安置折舊。此外,混合帶來的好處被較低的 AngioVac 銷售額所抵消。

  • Gross margin for our Med Tech segment was 64.6%, a decrease of 150 basis points compared to the year ago period. The year-over-year decrease was driven by lower sales of AngioVac and depreciation costs from the growing Auryon installed base. Gross margin for our Med Device segment was 54.5%, a 260 basis point decrease compared to the year ago period. And the drivers for Med Device were those that I had mentioned previously.

    我們的醫療技術部門的毛利率為 64.6%,與去年同期相比下降了 150 個基點。同比下降的原因是 AngioVac 銷售額下降以及 Auryon 安裝基礎不斷增長的折舊成本。我們的醫療設備部門的毛利率為 54.5%,與去年同期相比下降了 260 個基點。 Med Device 的驅動程序是我之前提到的那些。

  • Our research and development expense during the third quarter of FY '23 was $6.9 million or 8.5% of sales compared to $7.3 million or 9.8% of sales a year ago. We'll continue our disciplined investment in R&D, focused on driving our key technology platforms, including the clinical and product development spend for our Med Tech portfolio. For FY '23, we anticipate R&D spend to target 8% to 10% of sales. SG&A expense for the third quarter of FY '23 was $34.2 million, representing 42.4% of sales compared to $29.1 million or 39.4% of sales a year ago. The year-over-year increase in SG&A spending was primarily driven by the annualization of investments in our sales team, particularly Auryon. For FY '23, we continue to anticipate SG&A spend to target 40% to 45% of revenue.

    我們在 23 財年第三季度的研發費用為 690 萬美元,佔銷售額的 8.5%,而去年同期為 730 萬美元,佔銷售額的 9.8%。我們將繼續對研發進行嚴格的投資,專注於推動我們的關鍵技術平台,包括我們醫療技術產品組合的臨床和產品開發支出。對於 23 財年,我們預計研發支出的目標是佔銷售額的 8% 至 10%。 23 財年第三季度的 SG&A 費用為 3420 萬美元,佔銷售額的 42.4%,而去年同期為 2910 萬美元,佔銷售額的 39.4%。 SG&A 支出的同比增長主要是由我們銷售團隊(尤其是 Auryon)的投資年化所推動的。對於 23 財年,我們繼續預計 SG&A 支出將佔收入的 40% 至 45%。

  • Our adjusted net loss for the third quarter of FY '23 was $1 million or adjusted loss per share of $0.03 compared to an adjusted net income of $1.3 million or adjusted earnings per share of $0.03 in the third quarter of last year. Our adjusted earnings this quarter were directly impacted by the AngioVac revenue shortfall as well as roughly $900,000 of inflation in excess of our expectations.

    我們調整後的 23 財年第三季度淨虧損為 100 萬美元或調整後每股虧損 0.03 美元,而去年第三季度調整後淨收入為 130 萬美元或調整後每股收益為 0.03 美元。我們本季度調整後的收益直接受到 AngioVac 收入不足以及超出我們預期的約 900,000 美元通貨膨脹的影響。

  • In addition, as a reminder, our adjusted earnings per share in the third quarter of last year included a $4.2 million or $0.08 per share benefit related to the reimbursement of certain expenses under the employee retention credit as part of the CARES Act. Adjusted EBITDA in the third quarter of FY '23 was $4.3 million compared to $6.7 million in the third quarter of FY '22, which included the $4.2 million from the CARES Act. During the third quarter, we generated $1.4 million of cash from operations, increasing net cash by $250,000.

    此外,作為提醒,我們去年第三季度調整後的每股收益包括 420 萬美元或每股 0.08 美元的收益,與作為 CARES 法案的一部分的員工保留信用項下的某些費用的報銷有關。 23 財年第三季度調整後的 EBITDA 為 430 萬美元,而 22 財年第三季度為 670 萬美元,其中包括來自 CARES 法案的 420 萬美元。第三季度,我們從運營中產生了 140 萬美元的現金,淨現金增加了 250,000 美元。

  • Turning to our FY '23 outlook. We are revising our full year revenue guidance to a range of $338 million to $342 million from our prior guidance of $342 million to $348 million. We're revising our FY '23 adjusted earnings guidance to a range of a loss of $0.06 to a loss of $0.01 per share from our prior guidance of earnings of $0.01 to $0.06 per share. This reduction in our guidance is fueled primarily by the weaker-than-anticipated AngioVac performance and secondarily by higher inflationary pressure than previously anticipated. Year-to-date, we've absorbed over $7 million of inflation, roughly half of which was contemplated in our original guidance for the year. As a result of this, we expect fiscal year 2023 gross margin to be in the range of 51% to 52%, down from 52.5% to 54.5%.

    轉向我們的 FY '23 展望。我們正在將我們的全年收入指引從之前的 3.42 億美元至 3.48 億美元修改為 3.38 億美元至 3.42 億美元。我們正在將我們的 23 財年調整後收益指引從我們之前每股收益 0.01 美元至 0.06 美元的指引調整為每股虧損 0.06 美元至 0.01 美元。我們指引的下調主要是由於 AngioVac 的性能弱於預期,其次是通貨膨脹壓力高於先前預期。年初至今,我們已經吸收了超過 700 萬美元的通貨膨脹,其中大約一半是我們當年最初的指導方針中考慮到的。因此,我們預計 2023 財年的毛利率將在 51% 至 52% 之間,低於 52.5% 至 54.5%。

  • On July of 2021, we said we're building a very different company, and we're doing just that. Year-to-date, our revenue has grown 8.1% or $18.5 million over last year. We did expect that this would drop additional EBITDA and profitability. However, inflation has taken a significant amount of costs right off the top. Through 3 quarters, total inflation has exceeded $7 million, leading to excess inflationary costs of approximately $0.07 of adjusted EPS. In spite of this, our EBITDA and adjusted EPS are up year-over-year when accounting for last year's CARES Act impact.

    2021 年 7 月,我們說我們正在建立一家非常不同的公司,而我們正在這樣做。年初至今,我們的收入比去年增長了 8.1% 或 1850 萬美元。我們確實預計這會降低額外的 EBITDA 和盈利能力。然而,通貨膨脹已經將大量成本從頭頂上拿掉了。三個季度以來,通貨膨脹總額已超過 700 萬美元,導致調整後每股收益的超額通貨膨脹成本約為 0.07 美元。儘管如此,考慮到去年 CARES 法案的影響,我們的 EBITDA 和調整後的每股收益仍同比增長。

  • We'll continue to manage costs in the external environment while prioritizing investments to drive the growth depicted in our 3-year plan. I'll wrap up my comments by highlighting the entire AngioDynamics team for their ongoing persistence and dedication to achieving our goals as we pursue our transformation towards becoming a platform-focused medical technology company.

    我們將繼續管理外部環境的成本,同時優先投資以推動我們 3 年計劃中描述的增長。我將通過強調整個 AngioDynamics 團隊的持續堅持和奉獻來結束我的評論,因為他們在我們追求轉型成為一家以平台為中心的醫療技術公司的過程中實現我們的目標。

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

    有了這個,我會把它轉回給吉姆。

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Thanks, Steve. In closing, I'd like to say, while I'm pleased with many of the things that we're doing in AngioDynamics and our progress that we're making to becoming a long-term, high-growth profitable company, we have also identified and put plans in place for areas that we can do better. So our focus will turn to those areas. We want to bring value to our customers, our employees and our investors. We know that we have a great plan. We'll work hard to do that for each of those 3 constituencies over time. Thank you for listening today. Darryl, I'll turn the call back to you.

    謝謝,史蒂夫。最後,我想說,雖然我對我們在 AngioDynamics 所做的許多事情以及我們在成為一家長期、高增長的盈利公司方面取得的進展感到高興,但我們有還確定並製定了我們可以做得更好的領域的計劃。因此,我們的重點將轉向這些領域。我們希望為我們的客戶、員工和投資者帶來價值。我們知道我們有一個偉大的計劃。隨著時間的推移,我們將努力為這 3 個選區中的每一個選區做到這一點。感謝您今天的收聽。達里爾,我會把電話轉給你。

  • Operator

    Operator

  • (Operator Instructions) Our first questions come from the line of Matthew Mishan with KeyBanc Capital Markets.

    (操作員說明)我們的第一個問題來自 KeyBanc Capital Markets 的 Matthew Mishan。

  • Brett Adam Fishbin - Senior Equity Research Associate

    Brett Adam Fishbin - Senior Equity Research Associate

  • This is Brett Fishbin on today for Matt. Just wanted to start off a little bit on some of the broader macro trends. Just given a lot of the moving pieces discussed today like staffing constraints and then inflation, supply chain and free costs, have kind of been themes for several quarters, just wondering a little bit like what changed incrementally versus January around some of those dynamics and how you're looking at them moving forward?

    我是今天為馬特做的 Brett Fishbin。只是想從一些更廣泛的宏觀趨勢開始。鑑於今天討論的許多變動因素,例如人員配置限制,然後是通貨膨脹、供應鍊和免費成本,已經成為幾個季度的主題,只是想知道與 1 月份相比,圍繞其中一些動態發生了哪些變化,以及如何變化你在看著他們前進嗎?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Brett, it's Jim. So a couple of things. We actually think that the macro environment from our customer angle, from the hospital side is getting better. We think that their staffing challenges are getting better. It's regional in approach when we speak to our customers. We think it's in a better spot than it was 3 or 6 months ago. So we've seen some of the dynamics from that. The AngioVac challenge we mentioned, again, part of that is due to that, but we don't want to put all the attention there. We also know we can do better, and we will and how we execute there.

    布雷特,是吉姆。所以有幾件事。我們實際上認為,從我們的客戶角度,從醫院方面來看,宏觀環境正在變得更好。我們認為他們的人員配備挑戰正在好轉。當我們與客戶交談時,它是區域性的。我們認為它比 3 或 6 個月前處於更好的位置。所以我們從中看到了一些動態。我們再次提到的 AngioVac 挑戰,部分原因在於此,但我們不想把所有註意力都放在那裡。我們也知道我們可以做得更好,我們會以及我們如何在那裡執行。

  • Also, Brett, we talked about it, we have more stabilization in our internal supply chain from the employee side. And we've seen freight costs abate a bit, which is terrific. But we're still seeing some disruptions from our supply chain partners. Sometimes we're not getting all the parts we order, the raw materials we order. And we're also seeing still inflation hit there. So things are better, but they're still not back to what we'd call normal.

    另外,布雷特,我們談到了這一點,從員工方面來看,我們的內部供應鏈更加穩定。而且我們看到運費有所下降,這太棒了。但我們仍然看到來自我們供應鏈合作夥伴的一些中斷。有時我們沒有得到我們訂購的所有零件,我們訂購的原材料。而且我們還看到通貨膨脹仍然在那裡受到打擊。所以情況有所好轉,但仍未恢復到我們所說的正常狀態。

  • Brett Adam Fishbin - Senior Equity Research Associate

    Brett Adam Fishbin - Senior Equity Research Associate

  • All right. And then just shifting over a bit to Mechanical Thrombectomy. Just wondering if you could also expand a bit on some of the new selling processes. You mentioned for AngioVac. And would it be challenging to do some of this in the current environment, given like all the staffing that's involved in the procedure, which is limiting current procedural dynamics? And then also just how are you thinking about AngioVac from here? Could we see some sequential growth into 4Q and early thoughts on maybe FY '24 as well?

    好的。然後稍微轉向機械血栓切除術。只是想知道您是否也可以擴展一些新的銷售流程。你提到了 AngioVac。在當前環境下做一些這樣的事情是否具有挑戰性,就像程序中涉及的所有人員配置一樣,這限制了當前的程序動態?然後你從這裡如何看待 AngioVac?我們能否看到第四季度的一些連續增長以及對 FY '24 的早期想法?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Sure. Good questions. So a couple of things. So we've taken a look at how we've integrated the sales bag going back to last June 1, our fiscal year, putting the new AlphaVac products in the bag with AngioVac. Remember, we're also running our APEX study aligned with this because we'd love to get that PE indication for AlphaVac F18. But we're being very cautious as we enter this market. We're learning from our customers, learning how great our devices are, but also how to sell them combined in a bag.

    當然。好問題。所以有幾件事。因此,我們已經了解了我們如何將銷售袋整合到去年 6 月 1 日,即我們的財政年度,將新的 AlphaVac 產品與 AngioVac 一起放入袋中。請記住,我們也在運行與此一致的 APEX 研究,因為我們很樂意獲得 AlphaVac F18 的 PE 指示。但我們在進入這個市場時非常謹慎。我們正在向客戶學習,了解我們的設備有多棒,以及如何將它們組合在一起銷售。

  • And again, we only have limited indications at this point. We don't have the full bag we'd like to have as we've identified, Brett. Over time, we're looking to launch our Auryon for thrombectomy for small vessel over time. So we're in the kind of the middle innings of our whole Mechanical Thrombectomy program. What we can do better is our internal messaging to our customers, making sure we're clearly identifying what we do and what we don't do and how we can do that better.

    同樣,我們目前只有有限的跡象。布雷特,我們沒有像我們確定的那樣擁有我們想要的完整袋子。隨著時間的推移,我們希望推出我們的 Auryon 用於小血管的血栓切除術。所以我們正處於整個機械血栓切除術計劃的中間階段。我們可以做得更好的是向客戶發送內部消息,確保我們清楚地確定我們做什麼和不做什麼以及我們如何才能做得更好。

  • We also believe we can train our own people and our customers better. We have a great team of clinical resources in the field to work with our customers. We'll make sure that we can get our sales force and our customers trained properly, and we'll watch AlphaVac and AngioVac together grow sequentially. We're actually off to a good start this quarter. So it's a good sign that our -- we think program we put in place is working as we're seeing already a positive sign and the uptick back to where we expect performance to be as we look at the current quarter we sit in today.

    我們也相信我們可以更好地培訓我們自己的員工和我們的客戶。我們在該領域擁有一支強大的臨床資源團隊,可以與我們的客戶合作。我們將確保我們的銷售人員和客戶得到適當的培訓,我們將看到 AlphaVac 和 AngioVac 一起連續成長。我們本季度實際上開局不錯。因此,這是一個好兆頭,我們認為我們實施的計劃正在發揮作用,因為我們已經看到了一個積極的跡象,並且在我們今天看到的當前季度中,業績回升到我們預期的水平。

  • Brett Adam Fishbin - Senior Equity Research Associate

    Brett Adam Fishbin - Senior Equity Research Associate

  • All right. Awesome. And then last question from me. Just you mentioned some possible international approvals in the coming quarters for Auryon and AlphaVac. Are there any particular markets that you think investors should be focusing on as bigger opportunities or ones that could come earlier in the time line?

    好的。驚人的。然後是我的最後一個問題。剛才你提到了 Auryon 和 AlphaVac 在未來幾個季度可能獲得的一些國際批准。您認為投資者應該關注哪些特定市場,將其視為更大的機會或可能在時間線中更早出現的市場?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Thanks, Brett. Good questions. We actually think we have a great team now in Western Europe. And today, we're actually holding right as we speak in Rome, our Third Scientific Clinical Symposium that AngioDynamics is hosting with over 200 world-renowned key opinion leaders and clinicians and professors who are attending our symposium today to be trained in our products and speak to some of the outcomes that they've foreseen when they use our products. So we're going to focus on our Western European growth first, where we have a lot of opportunity for these products that are unique and there's a lot of need that we're going to align to.

    謝謝,布雷特。好問題。我們實際上認為我們現在在西歐擁有一支很棒的團隊。今天,我們在羅馬發言時實際上是正確的,我們的第三次科學臨床研討會由 AngioDynamics 主辦,有 200 多位世界知名的關鍵意見領袖、臨床醫生和教授今天參加我們的研討會,接受我們的產品培訓和談談他們在使用我們的產品時預見到的一些結果。因此,我們將首先關注我們的西歐增長,在那裡我們有很多機會獲得這些獨特的產品,並且有很多我們將要調整的需求。

  • So we'll see, Brett, indications next calendar year, starting with Auryon, then AlphaVac as the first 2 products will get launched, which are important because we think they can be global growth drivers for a company for years to come. We'll also then make sure we have the right indications in Canada, in Latin America, in Asia Pacific and the Middle East as well.

    因此,布雷特,我們將在下個日曆年看到跡象,首先是 Auryon,然後是 AlphaVac,因為前兩種產品將推出,這很重要,因為我們認為它們可以成為公司未來幾年的全球增長動力。然後,我們還將確保我們在加拿大、拉丁美洲、亞太地區和中東都有正確的適應症。

  • Operator

    Operator

  • Our next questions come from the line of Steven Lichtman with Oppenheimer.

    我們的下一個問題來自 Steven Lichtman 和 Oppenheimer 的對話。

  • Steven Michael Lichtman - MD & Senior Analyst

    Steven Michael Lichtman - MD & Senior Analyst

  • I wanted to ask a little bit about NanoKnife. We've had strong disposable sales profile and to handle such effect from the ongoing studies. How much of a runway do you guys see for that continuing after trial enrollment complete and before you get indication expansion approved?

    我想問一些關於 NanoKnife 的問題。我們擁有強大的一次性銷售概況,並且可以處理正在進行的研究帶來的這種影響。在試驗註冊完成後和適應症擴展獲得批准之前,你們看到了多少跑道?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • So good question. So if you look back at last fiscal year, we guided about 20% disposable growth and we overachieved that. This year, again, we guided about 20% disposable growth and we're overachieving that as well. So we think it's due to -- some of it is the halo effect from the DIRECT study on the pancreatic cancer patients and now are PRESERVE. People are just getting more awareness about how NanoKnife works, why it's so special and can treat very delicate organs in a unique manner.

    好問題。因此,如果你回顧上一財年,我們指導的可支配增長約為 20%,而且我們超額實現了這一目標。今年,我們再次指導了約 20% 的可支配增長,而且我們也超額完成了這一目標。所以我們認為這是由於 - 其中一些是來自對胰腺癌患者的直接研究的光環效應,現在是 PRESERVE。人們越來越了解 NanoKnife 的工作原理,為什麼它如此特別並且可以以獨特的方式治療非常脆弱的器官。

  • So I think that when there's more awareness generated, I think there's more interest generated, we're seeing more inbound interest from physicians, and we're able to train them properly, let them choose how they want to treat and where they treat while we're committed to getting the data published to prove these sources can be areas. We also know, as we identified, when we complete enrollment and complete the final study 12 months later on PRESERVE, we believe that we'll open up about a $700 million market in the U.S. for those intermediate risk patients, give them a chance for a good focal treatment.

    所以我認為當產生更多的意識時,我認為會產生更多的興趣,我們看到醫生有更多的入境興趣,我們能夠正確地培訓他們,讓他們選擇他們想要治療的方式和治療地點我們致力於發布數據以證明這些來源可以是區域。我們還知道,正如我們確定的那樣,當我們在 PRESERVE 上完成註冊並在 12 個月後完成最終研究時,我們相信我們將在美國為那些中度風險患者開闢大約 7 億美元的市場,讓他們有機會一個很好的焦點治療。

  • So it's going to be a combination of a few factors. We think we'll continue to grow the business at about this rate up until we get that indication end of next year, and we'll give you more guidance there is what we can do. We're trying to align the indication of regulatory approvals with reimbursement and then patient and customer awareness. And when we do those together, we really think we have a special product that can grow in this market.

    所以這將是幾個因素的結合。我們認為我們將繼續以大約這個速度增長業務,直到我們在明年年底得到指示,我們會給你更多的指導,我們可以做些什麼。我們正在努力使監管批准的指示與報銷以及患者和客戶的意識保持一致。當我們一起做這些時,我們真的認為我們有一種可以在這個市場上發展的特殊產品。

  • Steven Michael Lichtman - MD & Senior Analyst

    Steven Michael Lichtman - MD & Senior Analyst

  • That's very helpful. And then my other question was about Auryon and small vessel. You guys have said that you got feedback from docs that they want it and you're that opportunity. But this is pretty new in the field. Can you let us know a little bit about how that development process is unfolding? Have you reached to a point where you can say this receivable and definitely going to be followed through?

    這很有幫助。然後我的另一個問題是關於 Auryon 和小型船隻。你們說你們從文檔那裡得到了他們想要它的反饋,而你們就是那個機會。但這在該領域是相當新的。您能否讓我們了解一下開發過程的進展情況?您是否達到了可以說出此應收款並且肯定會跟進的地步?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Yes. So let me take a swing at it. If I get your question wrong, please stop me or chime in again. So we're hearing a lot of great feedback. Again, we launched Auryon in September of 2020 when the pandemic hit, and we are rolling out this product. And there's good competitors in the field, they're good effective systems out there. But we knew ours was professional, we knew it was different. And the physician feedback we received from that date has been really tremendous.

    是的。所以讓我嘗試一下。如果我答錯了你的問題,請打斷我或再次插話。所以我們聽到了很多很好的反饋。同樣,我們在 2020 年 9 月大流行來襲時推出了 Auryon,我們正在推出這款產品。這個領域有很好的競爭對手,他們是很好的有效系統。但我們知道我們是專業的,我們知道它是不同的。從那天起,我們收到的醫生反饋非常好。

  • So we also told our physicians, this is a platform technology. We're going to grow what we do first in PAD and atherectomy. And we've done that already with the hydrophilic coating catheters we launched this year. Later this calendar year, we're looking to launch radial products, give our physicians a new access point, a new way to use our atherectomy tools, a new way to use Auryon in the anatomy.

    所以我們也告訴我們的醫生,這是一個平台技術。我們將發展我們首先在 PAD 和粥樣斑塊切除術中所做的工作。我們已經通過今年推出的親水塗層導管做到了這一點。今年晚些時候,我們希望推出徑向產品,為我們的醫生提供一個新的接入點,一種使用我們的粥樣斑塊切除術工具的新方法,一種在解剖學中使用 Auryon 的新方法。

  • So we'll continue to develop not just the products but we're also working with the science behind it. You've seen and we'll see during the course of this year more publications driven by some of our physicians who believe in the science and have seen unique elements of how it treats the anatomy. We're also committed, as you know, we believe that Auryon will complement our Mechanical Thrombectomy platform with an Auryon version, a Mechanical Thrombectomy, coming to the end of calendar year 2024 for small vessel DVT, utilizing the power and energy that Auryon delivers and the safety efficacy within the vessel wall in a manner that we believe will give physicians a new way to treat thrombectomy.

    因此,我們不僅會繼續開發產品,還會繼續研究產品背後的科學。你已經看到,我們將在今年看到更多的出版物,這些出版物是由我們的一些相信科學並且已經看到它如何治療解剖學的獨特元素的醫生推動的。我們還承諾,如您所知,我們相信 Auryon 將利用 Auryon 提供的能量和能量,在 2024 年年底為小型血管 DVT 補充我們的機械血栓切除術平台 Auryon 版本,機械血栓切除術以及血管壁內的安全有效性,我們相信這將為醫生提供一種治療血栓切除術的新方法。

  • Operator

    Operator

  • Our next questions come from the line of Jayson Bedford with Raymond James.

    我們的下一個問題來自 Jayson Bedford 和 Raymond James 的台詞。

  • Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

  • I guess just a few questions. Maybe to start on gross margin. I understand some of the headwinds, but I'm a bit surprised at the acute nature of some of the inflationary dynamics, meaning Med Device gross margin kind of down quarter-on-quarter, down year-over-year. Is there anything what was new that popped up more on the Med Device gross margin side in the quarter?

    我想只是幾個問題。也許從毛利率開始。我理解一些逆風,但我對一些通貨膨脹動態的嚴重性感到有點驚訝,這意味著 Med Device 毛利率環比下降,同比下降。在本季度的 Med Device 毛利率方面,有沒有什麼新東西出現得更多?

  • Stephen A. Trowbridge - Executive VP & CFO

    Stephen A. Trowbridge - Executive VP & CFO

  • Jayson, this is Steve. Jim had mentioned in his prepared remarks, some of the disruption that we're seeing from some of our supply chain partners and our component suppliers. That has been part of it. As we mentioned, there's about $1.5 million of components that we were expecting to get in that would have allowed us to get about $3 million of revenue out in the quarter. They were scheduled to be earlier in the quarter. We were told that they were going to be pushed out. We do expect those to come into Q4. So some of that was tied up in terms of the WIP and coming from the supply chain disruption.

    傑森,這是史蒂夫。吉姆在他準備好的發言中提到了我們從我們的一些供應鏈合作夥伴和我們的組件供應商那裡看到的一些中斷。那是其中的一部分。正如我們所提到的,我們預計將獲得約 150 萬美元的組件,這將使我們在本季度獲得約 300 萬美元的收入。他們原定在本季度早些時候。我們被告知他們將被推出。我們確實希望這些會進入第四季度。因此,其中一些與 WIP 相關,並且來自供應鏈中斷。

  • And the other piece really is the raw material inflation. As we've talked about, specifically in the Device business, we've got a large number of SKUs in that business all throughout the different products that are there. And we're just not the largest purchaser for most of our suppliers. And so as the macro environment continues, we're finding that we're a little bit in the middle of the line there, not enough to really drive extensive volume benefits. We're not at the end of the line, but at the same time, dealing with some of those price increases, which we found to be stickier this year than we were expecting in the summer and will probably extend a little bit into the next year as well.

    另一塊確實是原材料通脹。正如我們所討論的,特別是在設備業務中,我們在該業務中擁有大量的 SKU,涵蓋所有不同的產品。而且我們只是不是我們大多數供應商的最大採購商。因此,隨著宏觀環境的繼續,我們發現我們有點處於中間位置,不足以真正推動廣泛的銷量收益。我們還沒有走到盡頭,但與此同時,我們要應對其中的一些價格上漲,我們發現今年的價格上漲比我們在夏季預期的更加棘手,並且可能會延長到明年年也是如此。

  • And we're going to -- we expect that's going to happen as we build into the thinking about the next year. So those raw material components have driven a big part of that as well as just some of the timing and mix of turning product into finished goods and getting them out the door.

    我們將 - 我們希望隨著我們對明年的思考而發生這種情況。因此,這些原材料成分推動了其中的很大一部分,以及將產品轉化為成品並將它們運出門的一些時間和組合。

  • Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

  • Okay. And the $3 million that was lost here or pushed out here -- loss is probably not the right word, but the $3 million that you mentioned, that will all benefit the fourth quarter. Is that the expectation?

    好的。在這裡損失或推到這裡的 300 萬美元——損失可能不是正確的詞,但你提到的 300 萬美元,這將使第四季度受益。那是期望嗎?

  • Stephen A. Trowbridge - Executive VP & CFO

    Stephen A. Trowbridge - Executive VP & CFO

  • We definitely expected to clear the fourth quarter. Now there may be -- we don't expect it to be at that same level. But as we said, it's not like the component supplier issues are going to completely vanish. We're going to be dealing with component supplier issues for a while. And our team is managing that on a day-to-day basis. But yes, we do expect those to clear into the fourth quarter.

    我們絕對希望清除第四季度。現在可能 - 我們不希望它處於同一水平。但正如我們所說,組件供應商問題不會完全消失。我們將在一段時間內處理組件供應商問題。我們的團隊每天都在管理它。但是,是的,我們確實預計這些會在第四季度結束。

  • Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

  • And just on the backlog, I think you talked about a little over $5 million in total. Is the math here into it with a reduction of $3 million from the last quarter, but you added another $3 million. Is that kind of the math on it?

    就積壓而言,我想你談到的總額略高於 500 萬美元。這裡的數學是不是比上一季度減少了 300 萬美元,但你又增加了 300 萬美元。是那種數學嗎?

  • Stephen A. Trowbridge - Executive VP & CFO

    Stephen A. Trowbridge - Executive VP & CFO

  • The timing that you're talking about is the right way to think of it. So if you think about where the back order stood at the end of the quarter, although the numbers were relatively consistent from the end of Q2 to Q3, the mix of that was very different. And so the way you described it is exactly right. We were eating into it clearing it kind of at the same pace that we had been over the past few quarters. And then some of the timing on the component supply means that you end up with a different mix at the end of the quarter.

    你所說的時機是正確的思考方式。因此,如果您考慮一下本季度末的延期交貨情況,儘管從第二季度末到第三季度的數字相對一致,但兩者的組合卻大不相同。所以你描述的方式是完全正確的。我們正在以與過去幾個季度相同的速度清理它。然後組件供應的一些時間意味著你在本季度末會得到不同的組合。

  • Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

  • Okay. Maybe just switching gears to the other dynamic here in the quarter. AngioVac, I guess, the question for me is, do you have fewer users in the technology? Or do you have the same number of users just using it for fewer cases? If that question makes sense.

    好的。也許只是在本季度在這里切換到另一個動態。 AngioVac,我想,我的問題是,你們在這項技術中的用戶較少嗎?或者您是否有相同數量的用戶只是在更少的情況下使用它?如果這個問題有意義。

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • It does make sense. Jayson, it's Jim. A little bit of -- it's a mix of everything. So we're always gaining new users. And sometimes you lose users, too. So it's just kind of a mix that happens all the time. The product is so unique and special that we're always getting new interest in new users. And sometimes we've been under challenged to continue that usage to make sure that the physicians trained and can use it. With other things happening, there's also a gray area between where AngioVac works, our AlphaVac can work or other competitive products can work.

    它確實有道理。傑森,是吉姆。一點點——它是一切的混合體。所以我們總是在獲得新用戶。有時你也會失去用戶。所以這只是一種一直在發生的混合。該產品是如此獨特和特別,以至於我們總是對新用戶產生新的興趣。有時我們面臨著繼續使用這種方法的挑戰,以確保醫生接受過培訓並可以使用它。隨著其他事情的發生,在 AngioVac 工作、我們的 AlphaVac 可以工作或其他競爭產品可以工作之間也存在灰色區域。

  • So as we're learning that and getting our customers better aligned to the change in market is better trained, we'll see a little of choppiness there. We've learned a lot, we had a master class 2 weeks ago, where I sat in again over a weekend with some of new users. And right afterwards, a couple of users use it the first week right after the master training class. So we know that people see the value of it, how easy it is to use, although it's complex from the user standpoint. The benefits it drives and patient outcomes are dynamic. So Jayson, it's choppy. Yes, there's always some accounts leaving, some accounts are coming in. I'm trying to give you a straight answer, but it's a moving target.

    因此,當我們了解到這一點並讓我們的客戶更好地適應市場變化並接受更好的培訓時,我們會在那裡看到一些波動。我們學到了很多東西,兩週前我們舉辦了一次大師班,週末我又和一些新用戶一起坐在那裡。緊接著,幾個用戶在大師培訓課程結束後的第一周就使用了它。所以我們知道人們看到了它的價值,它是多麼容易使用,儘管從用戶的角度來看它很複雜。它帶來的好處和患者的結果是動態的。所以傑森,這是波濤洶湧的。是的,總是有一些賬戶離開,一些賬戶進來。我試圖給你一個直接的答案,但它是一個移動的目標。

  • Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

    Jayson Tyler Bedford - MD & Senior Medical Supplies and Devices Analyst

  • Okay. And I don't think I heard you mention left heart and where you are with AngioVac or time line regulatory process?

    好的。而且我不認為我聽到你提到左心和你在哪裡使用 AngioVac 或時間線監管程序?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Yes. We're really excited by what we believe AngioVac can do in the left heart, the size of the market, we believe how we can treat. What we've gotten from the FDA is different guidance than they gave us initially. They've kind of rethought the approach that they want us to take and have given us different guidance. So it's changing our approach towards it. So we have to look at the time line again and how that will affect the new level of really they've raised the bar and what they want what they initially communicated with us.

    是的。我們對我們相信 AngioVac 可以在左心、市場規模、我們相信我們如何治療的事情感到非常興奮。我們從 FDA 那裡得到的指導與他們最初給我們的指導不同。他們重新考慮了他們希望我們採用的方法,並給了我們不同的指導。所以它正在改變我們對它的態度。因此,我們必須重新審視時間線,以及這將如何影響他們真正提高標準的新水平,以及他們想要什麼,他們最初與我們溝通的內容。

  • So we've got to come back to Jayson and communicate to you what that means from a time line perspective because it will push our time line out. What they've asked us for is a little more comprehensive than the initial request was.

    所以我們必須回到 Jayson 並從時間線的角度向您傳達這意味著什麼,因為它會推遲我們的時間線。他們向我們提出的要求比最初的要求更全面一些。

  • Operator

    Operator

  • (Operator Instructions) Our next questions come from the line of Bill Plovanic with Canaccord.

    (操作員說明)我們的下一個問題來自 Bill Plovanic 與 Canaccord 的合作。

  • William John Plovanic - Analyst

    William John Plovanic - Analyst

  • My first question is, as we look at guidance for the year, that will be a pretty big jump in the fourth quarter. I was just -- help us just to get to the low end. So help us understand what you're contemplating in terms of getting to the low end, meeting the low end or even getting to the high end of that updated guidance.

    我的第一個問題是,當我們審視今年的指引時,第四季度將是一個相當大的飛躍。我只是 - 幫助我們達到低端。因此,請幫助我們了解您在達到更新指南的低端、達到低端甚至是高端方面的考慮。

  • Stephen A. Trowbridge - Executive VP & CFO

    Stephen A. Trowbridge - Executive VP & CFO

  • Yes, Bill, it's a good question. I mean, part of the things I understand is structurally the fourth quarter has about 4 more selling days in it than the third quarter. So -- and it doesn't have the same holiday cadence that the Q3 had. So we typically see a big jump going into the Q4 from Q3 every year, given our typical seasonality. So I think that's the first part of it.

    是的,比爾,這是個好問題。我的意思是,我的部分理解是,從結構上講,第四季度的銷售天數比第三季度多了大約 4 天。所以 - 它沒有與第三季度相同的假期節奏。因此,考慮到我們典型的季節性,我們通常會看到每年從第三季度到第四季度的大幅躍升。所以我認為這是它的第一部分。

  • Second part is if you look at some of the products like Auryon and NanoKnife that are on their growth trajectory, we're very excited and they're going to continue their sequential growth, which is going to add to that increased selling days. We do expect we're going to see a pickup in AngioVac, as Jim mentioned. And we have seen that here in the first month of March so far. We've been very pleased with the pace that we've seen at AngioVac coming from some of those changes that Jim had mentioned.

    第二部分是,如果你看看 Auryon 和 NanoKnife 等一些處於增長軌道上的產品,我們非常興奮,它們將繼續連續增長,這將增加銷售天數。正如 Jim 提到的,我們確實希望看到 AngioVac 的回升。到目前為止,我們已經在 3 月的第一個月看到了這一點。我們對我們在 AngioVac 看到的來自吉姆提到的一些變化的步伐感到非常滿意。

  • And then when you build into that some of the dynamics that we were talking about with Jayson on the previous call around the back order, getting some of those components in and clearing that, all those dynamics together give us confidence, certainly to what you were asking to is the bottom end of the range. But we're -- as you can imagine, we put the range out there, and we're looking at that range and targeting midpoint.

    然後,當你將我們在之前的電話會議上與 Jayson 討論過的一些動力納入其中時,將其中一些組件納入並清除它,所有這些動力一起給了我們信心,當然是對你的信心要求是范圍的底端。但是我們 - 正如你可以想像的那樣,我們把範圍放在那裡,我們正在研究這個範圍並瞄準中點。

  • William John Plovanic - Analyst

    William John Plovanic - Analyst

  • Okay. And then from a cash flow standpoint, I think -- and correct me if I'm wrong, originally, you were targeting that you would end the year being cash flow neutral for the year. Given where you sit today, kind of how do you feel about that? Do you still think that's the case?

    好的。然後從現金流的角度來看,我認為——如果我錯了,請糾正我,最初,你的目標是你將在今年結束時保持現金流中性。鑑於您今天的坐姿,您對此有何感想?你仍然認為是這樣嗎?

  • Stephen A. Trowbridge - Executive VP & CFO

    Stephen A. Trowbridge - Executive VP & CFO

  • Look, we're still striving for that. I think given the revenue change that we talked about here, if you look at the kind of midpoint to midpoint from our original guidance to where we're going, we do think that we may be, maybe $5 million or so off of that, but we're still going to continue to strive for it. We do expect we're going to see significant cash generation and we'll continue to push towards that.

    看,我們仍在為此努力。我認為考慮到我們在這裡討論的收入變化,如果你看看從我們最初的指導到我們要去的地方的那種中點到中點,我們確實認為我們可能是,也許 500 萬美元左右,但我們仍將繼續為之奮鬥。我們確實預計我們會看到大量的現金產生,我們將繼續朝著這個方向努力。

  • William John Plovanic - Analyst

    William John Plovanic - Analyst

  • Okay. And then just with the AlphaVac and AngioVac, I mean as you look at the AlphaVac growth and the kind of decrease in the AngioVac, do you think this is just cannibalization of the same doctors and customers? Or is AlphaVac really drawing in a new customer and you're just kind of with the AngioVac just going down and kind of losing some of that share?

    好的。然後就 AlphaVac 和 AngioVac,我的意思是,當你看到 AlphaVac 的增長和 AngioVac 的減少時,你認為這只是同一醫生和客戶的蠶食嗎?還是 AlphaVac 真的吸引了新客戶,而您只是覺得 AngioVac 正在走下坡路,失去了一些份額?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • So Bill, a little bit of both. Back when we launched the AlphaVac last summer, we tracked every procedure we've done, tracked who did the procedure which specialty, which physician had performed the procedure and what they would have used as an alternative. And early on, we saw some of that cannibalization. Now that was also when last summer and last fall, there was a little more pressure in the hospitals as far as employee staffing and some challenges there.

    所以比爾,兩者都有一點。去年夏天我們推出 AlphaVac 時,我們跟踪了我們完成的每一個程序,跟踪誰做了哪個專業的程序,哪個醫生執行了該程序以及他們會使用什麼作為替代方案。在早期,我們看到了一些蠶食。那也是去年夏天和去年秋天的時候,就員工人員配置和那裡的一些挑戰而言,醫院的壓力要大一些。

  • Lately, we've seen that shift change, and we're finding less and less. We knew there'd be some cannibalization. It's gotten a lot less so we're finding -- we're replacing a potential other products or other technology or other treatment protocol than we were 6 or 9 months ago. So we like the way that shift is occurring. It has been a challenge for us during this year, and it will always remain there. But we think the shift is working well as we educate our teams and our customers as to when to use which product and how.

    最近,我們看到了這種轉變,而且我們發現的越來越少。我們知道會有一些蠶食。與 6 個月或 9 個月前相比,它已經少了很多,所以我們發現——我們正在更換潛在的其他產品或其他技術或其他治療方案。所以我們喜歡這種轉變發生的方式。今年這對我們來說是一個挑戰,而且它將永遠存在。但我們認為這種轉變效果很好,因為我們教育我們的團隊和客戶何時使用哪種產品以及如何使用。

  • Operator

    Operator

  • I'd now like to turn the call back over to Mr. Clemmer for any closing remarks. Mr. Clemmer?

    我現在想將電話轉回給克萊默先生,聽取任何結束語。克萊默先生?

  • James C. Clemmer - CEO, President & Director

    James C. Clemmer - CEO, President & Director

  • Thanks, Darryl, and thanks to the listeners today. We appreciate the feedback we've received. We'll work hard to continue to grow our company and show our investors we can become a growth and profitable company as we treat patients in need around the globe. Thank you for listening today.

    謝謝,Darryl,也感謝今天的聽眾。我們感謝收到的反饋。我們將努力工作,繼續發展我們的公司,並向我們的投資者展示我們可以成為一家成長型和盈利的公司,因為我們在全球範圍內治療有需要的患者。感謝您今天的收聽。

  • Operator

    Operator

  • Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

    謝謝。今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路。享受你剩下的一天。