AtriCure Inc (ATRC) 2024 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon, and welcome to AtriCure's third-quarter 2024 earnings conference call.

    下午好,歡迎參加 AtriCure 2024 年第三季財報電話會議。

  • (Operator Instructions)

    (操作員說明)

  • I would now like to turn the call over to Marissa Bych from the Gilmartin Group for a few introductory comments.

    我現在想將電話轉給吉爾馬丁集團的瑪麗莎·比奇 (Marissa Bych),請其發表一些介紹性意見。

  • Marissa Bych - Investor Relations

    Marissa Bych - Investor Relations

  • Great, thank you.

    太好了,謝謝。

  • By now you should have received a copy of the earnings press release.

    現在您應該已經收到了收益新聞稿的副本。

  • If you have not received a copy, please call 513-644-4484 to have one emailed to you.

    如果您尚未收到副本,請致電 513-644-4484,讓我們透過電子郵件向您發送副本。

  • Before we begin today, let me remind you that the company's remarks include forward-looking statements.

    在今天開始之前,讓我提醒您,該公司的言論包含前瞻性陳述。

  • Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control, including risks and uncertainties described from time to time in AtriCure's SEC filings.

    前瞻性陳述受到眾多風險和不確定性的影響,其中許多風險和不確定性超出了 AtriCure 的控制範圍,包括 AtriCure 不時向 SEC 文件中描述的風險和不確定性。

  • These statements include, but are not limited to, financial expectations and guidance, expectations regarding the potential market opportunity for AtriCure's franchises and growth initiatives, future product approvals, clearances, competition, reimbursement, and clinical trial outcomes.

    這些聲明包括但不限於財務預期和指導、對 AtriCure 特許經營權和成長計劃的潛在市場機會的預期、未來產品批准、許可、競爭、報銷和臨床試驗結果。

  • AtriCure's results may differ materially from those projected.

    AtriCure 的結果可能與預測的結果有重大差異。

  • AtriCure undertakes no obligation to publicly update any forward-looking statement.

    AtriCure 不承擔公開更新任何前瞻性聲明的義務。

  • Additionally, we refer to non-GAAP financial measures specifically constant currency revenue, adjusted EBITDA, and adjusted loss per share.

    此外,我們也參考非公認會計準則財務指標,特別是恆定貨幣收入、調整後 EBITDA 和調整後每股虧損。

  • A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website.

    這些非公認會計原則財務指標與最直接可比較的公認會計原則指標的對帳已包含在我們的新聞稿中,該新聞稿可在我們的網站上取得。

  • And with that, I would like to turn the call over to Mike Carrel, President and CEO.

    接下來,我想將電話轉給總裁兼執行長 Mike Carrel。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Great.

    偉大的。

  • Good afternoon, and thank you for joining us, everyone.

    下午好,謝謝大家加入我們。

  • I'm happy to share that our third-quarter results, which reflect another strong quarter for AtriCure.

    我很高興與大家分享我們的第三季業績,這反映出 AtriCure 又一個強勁的季度。

  • We achieved total revenue of $116 million, or approximately 18% growth, showing broad-based demand across our portfolio of innovative products for patients with atrial fibrillation and postoperative pain.

    我們的總收入達到 1.16 億美元,成長約 18%,這表明我們針對心房顫動和術後疼痛患者的創新產品組合有著廣泛的需求。

  • In addition to our top-line performance, we continue to make progress to expand profitability, producing nearly $8 million of positive adjusted EBITDA for the quarter.

    除了我們的營收業績外,我們還繼續在擴大獲利能力方面取得進展,本季調整後的 EBITDA 為近 800 萬美元。

  • We also generated over $16 million in positive cash flow this quarter, marking our second consecutive quarter of positive cash flow.

    本季我們也產生了超過 1,600 萬美元的正現金流,這標誌著我們連續第二季實現正現金流。

  • As a result of the strength in our third-quarter results, we are raising our full year 2024 revenue guidance and now expect a range of $459 million to $462 million, reflecting growth of approximately 15% to 16% over full year 2023.

    由於第三季業績強勁,我們上調了 2024 年全年營收指引,目前預計營收範圍為 4.59 億美元至 4.62 億美元,較 2023 年全年成長約 15% 至 16%。

  • We are also reaffirming our plans to deliver a full year adjusted EBITDA of $26 million to $29 million.

    我們也重申,我們計劃實現全年調整後 EBITDA 達到 2,600 萬至 2,900 萬美元。

  • Turning to updates on our business and highlights in the quarter.

    轉向我們本季業務的最新動態和亮點。

  • Starting with our pain management franchise, which grew 36% worldwide, marking another quarter of acceleration in sales.

    首先是我們的疼痛管理特許經營權,該特許經營權在全球範圍內增長了 36%,標誌著銷售額又加速了一個季度。

  • Our performance was led by growth in our international markets and bolstered by the US launch of our cryoSPHERE+ probe.

    我們的業績受到國際市場成長的帶動,並受到美國推出的 CryoSPHERE+ 探針的推動。

  • We've seen outstanding adoption of this device, which contributed nearly half of our pain management sales in the quarter, and are hearing consistent, positive feedback from our physician partners on the 25% reduction in freeze time.

    我們看到該設備得到了出色的採用,該設備占我們本季度疼痛管理銷售額的近一半,並且從我們的醫生合作夥伴那裡聽到了關於凍結時間減少 25% 的一致、積極的反饋。

  • We are also excited about the recent launch of our cryoSPHERE Max Probe, which builds upon the success of cryoSPHERE+.

    我們也對最近推出的 CryoSPHERE Max Probe 感到興奮,它建立在 CryoSPHERE+ 成功的基礎上。

  • Our Max Probe features a larger 10 millimeter ball tip designed to optimize procedure efficiency by reducing freeze times even further than the cryoSPHERE+.

    我們的 Max Probe 具有更大的 10 毫米球尖,旨在透過比 CryoSPHERE+ 進一步縮短冷凍時間來優化程序效率。

  • Additionally, we are seeing a growing body of evidence supporting the economic value of cryo nerve block therapy.

    此外,我們看到越來越多的證據支持冷凍神經阻斷療法的經濟價值。

  • At the most recent AATS thoracic surgical Oncology Summit in New York City, Dr. Dan Miller, Chief of Thoracic Surgery at the Medical College of Georgia and Georgia Cancer Center, presented robust, multi-sensor data demonstrating a reduction in hospital stay duration by more than one day after cryoablation, representing more than $5,000 of reduced cost, 26% less opioid refill dosage at 90 days for all patients, and 28% less opioid refill dosage at 90 days after cryoablation in chronic opioid users and total healthcare cost reduction by $8,000 over six months for the cryo-nerve block patients.

    在最近於紐約市舉行的 AATS 胸腔外科腫瘤學峰會上,佐治亞醫學院和佐治亞癌症中心胸腔外科主任 Dan Miller 博士提出了可靠的多傳感器數據,表明住院時間減少了更多冷凍消融後一天以上,意味著成本降低超過5,000 美元,所有患者90 天阿片類藥物補充劑量減少26%,慢性阿片類藥物使用者冷凍消融後90 天阿片類藥物補充劑量減少28%,總醫療費用減少8,000 美元冷凍神經阻滯患者的治療時間超過六個月。

  • As we look back on the past five years, our progress in establishing this therapy has been remarkable.

    回顧過去五年,我們在建立這種療法方面取得了顯著的進展。

  • With new innovation leading to re-acceleration of growth, our success in thoracic procedures also gives us confidence and even broader opportunity for our pain management products as we continue to explore additional applications to expand our addressable markets.

    隨著新的創新重新加速成長,我們在胸部手術方面的成功也給了我們信心,並為我們的疼痛管理產品提供了更廣泛的機會,因為我們繼續探索其他應用以擴大我們的潛在市場。

  • Shifting now to our franchises centered on the treatment of atrial fibrillation.

    現在我們的特許經營權轉向以心房顫動治療為中心。

  • Our open ablation franchise grew 16% worldwide, driven by nearly 50% growth in the ENCOMPASS clamp in the United States.

    在美國 ENCOMPASS 夾鉗成長近 50% 的推動下,我們的開放式消融特許經營業務在全球成長了 16%。

  • We are adding accounts and new surgeons with the ENCOMPASS clamp and recently completed our first cases in Europe.

    我們正在增加使用 ENCOMPASS 夾鉗的客戶和新外科醫生,並最近在歐洲完成了第一例。

  • This device has accelerated treatment in our core market of cardiac surgery, and we look forward to driving sustainable growth with this product worldwide.

    該設備加速了我們心臟手術核心市場的治療,我們期待透過該產品在全球範圍內推動永續成長。

  • Next, our appendage management franchise achieved worldwide revenue growth of 18% with outsized contribution from open chest devices.

    接下來,我們的肢體管理系列在開胸設備的巨大貢獻下實現了 18% 的全球收入成長。

  • In the United States, we saw a third consecutive quarter of acceleration in sales of open appendage management devices, achieving 20% growth in the third quarter.

    在美國,開放式肢體管理設備的銷售連續第三個季度加速成長,第三季實現了 20% 的成長。

  • We believe this acceleration is a testament to the pioneering design, quality, and performance of our AtriClip devices, which have reached over 600,000 units sold life to date.

    我們相信,這種加速證明了我們 AtriClip 設備的開創性設計、品質和性能,迄今為止,該設備的銷量已超過 60 萬台。

  • And on the innovation front, we completed the first cases with our new AtriClip FLEX-Mini device following the US launch in the third quarter.

    在創新方面,繼第三季在美國推出後,我們使用新的 AtriClip FLEX-Mini 設備完成了第一批案例。

  • The AtriClip FLEX-Mini is the smallest profile clip on the market, offering enhanced access and visibility of the appendage.

    AtriClip FLEX-Mini 是市場上最小的輪廓夾,提供增強的配件的存取和可視性。

  • Feedback from early adopters has been overwhelmingly positive, particularly on the enhanced visibility with the device.

    早期採用者的回饋非常積極,特別是在該設備增強的可見性方面。

  • While still early in the launch, we anticipate AtriClip FLEX-Mini will drive a strong tailwind for our appendage management franchise well into the future.

    雖然仍處於推出初期,但我們預計 AtriClip FLEX-Mini 將為我們的肢體管理系列在未來帶來強勁的推動力。

  • Internationally, we received an expanded CE-Mark indication for AtriClip devices to include patients at high risk for thromboembolism.

    在國際上,我們獲得了 AtriClip 設備的擴展 CE 標誌適應症,將血栓栓塞高風險患者納入其中。

  • The expanded indication resulted from a wealth of existing robust clinical data on our AtriClip devices through 85 peer-reviewed papers representing over 11,000 patients studied and analyzed.

    擴大的適應症源自於我們 AtriClip 設備上現有的大量可靠臨床數據,這些數據來自代表超過 11,000 名患者研究和分析的 85 篇同行評審論文。

  • We are also adding clinical evidence and awareness of the benefits of LAA management to our investment in the LEAPS Stroke Reduction Trial, the anticipated success of which will expand our global addressable market considerably.

    我們還在 LEAPS 減少中風試驗的投資中添加了臨床證據和對左心耳管理益處的認識,該試驗的預期成功將大大擴展我們的全球潛在市場。

  • The LEAPS trial is expected to show a clear benefit when using AtriClip devices to manage the appendage in patients who undergo cardiac surgery without preoperative Afib diagnosis, a market of well over 1 million patients globally.

    LEAPS 試驗預計將在使用 AtriClip 設備來管理未經術前心房顫動診斷而接受心臟手術的患者的附件時顯示出明顯的益處,全球市場上有超過 100 萬名患者。

  • To date, we have enrolled nearly 3,700 patients, and we are on track to complete enrollment of 6,500 patients in this study by mid-2025.

    到目前為止,我們已入組近 3,700 名患者,我們預計在 2025 年中期完成本研究的 6,500 名患者入組。

  • Finally, Our hybrid AF therapy remains resilient despite the market effects of broadening PFA adoption.

    最後,儘管擴大 PFA 採用範圍帶來了市場影響,但我們的混合 AF 療法仍然具有彈性。

  • In the third quarter, we saw continued positive trends with a number of accounts performing our convergent procedure as well as new account activations.

    在第三季度,我們看到了持續的積極趨勢,許多帳戶執行我們的融合程序以及新帳戶啟動。

  • However, given increased physician time focusing on PFA, we are experiencing pressure on the pace of MIS adoption or ablation and MIS AtriClip growth in the US.

    然而,鑑於醫生專注於 PFA 的時間增加,我們正面臨美國 MIS 採用或消融以及 MIS AtriClip 成長的壓力。

  • We know that hybrid therapy plays a vital role in practice and remains the only therapy with differentiated and durable results for longstanding persistent AF patients.

    我們知道,混合療法在實踐中發揮著至關重要的作用,並且仍然是對長期持續性心房顫動患者俱有差異化和持久效果的唯一療法。

  • As we have seen in Europe, over time, we expect the broad tailwinds PFA is driving around the awareness and diagnosis of Afib to expand the number of treatable patients for this therapy.

    正如我們在歐洲所看到的,隨著時間的推移,我們預計 PFA 將推動人們對心房顫動的認識和診斷,從而擴大該療法可治療的患者數量。

  • To build on that point, we believe that continuous innovation in Afib therapies has grown patient treatment across all markets.

    在此基礎上,我們相信心房顫動療法的不斷創新已經促進了所有市場的患者治療。

  • Therefore, we are excited to announce that we have entered into an exclusive license and development agreement with an expert in the PFA field to accelerate the introduction of PFA technology to our cardiac surgery devices.

    因此,我們很高興地宣布,我們已與 PFA 領域的專家簽訂了獨家授權和開發協議,以加速將 PFA 技術引入我們的心臟手術設備。

  • Ultimately, we anticipate PFA will be another foundational element of our portfolio of epicardial surgical ablation devices.

    最終,我們預期 PFA 將成為我們心外膜手術消融設備產品組合的另一個基本要素。

  • We expect to announce more details on our PFA development program and clinical progress early next year.

    我們預計將於明年初公佈有關 PFA 開發計劃和臨床進展的更多細節。

  • In closing, we are incredibly pleased with our third quarter's performance and trajectory of our business as we enter the fourth quarter.

    最後,隨著進入第四季度,我們對第三季的業績和業務軌跡感到非常滿意。

  • Our strong growth stems from investments across the pillars of our business of innovation, clinical science, and education, and is a testament to the strength of our diversified portfolio.

    我們的強勁成長源自於對創新、臨床科學和教育等業務支柱的投資,證明了我們多元化投資組合的實力。

  • Furthermore, recent product introductions and continued efforts to advance standards of care in each of our markets globally have made our entire team excited for the future of AtriCure.

    此外,最近推出的產品以及為提高全球每個市場的護理標準所做的持續努力,讓我們整個團隊對 AtriCure 的未來感到興奮。

  • And with that, I'll turn the call over to Angie Wirick, our Chief Financial Officer.

    接下來,我會將電話轉給我們的財務長 Angie Wirick。

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • Thank you, Mike.

    謝謝你,麥克。

  • Our third-quarter 2024 worldwide revenue of $115.9 million increased 17.9% on a reported basis and 17.8% on a constant currency basis when compared to the third quarter of 2023, demonstrating ongoing strong performance in key markets around the world and the impact of our diverse range of products.

    與2023 年第三季相比,我們2024 年第三季的全球營收為1.159 億美元,按報告計算成長17.9%,以固定匯率計算成長17.8%,這顯示我們在全球主要市場的持續強勁表現以及我們多元化的影響產品範圍。

  • On a sequential basis, the 0.3% decline in worldwide revenue from the second quarter to the third quarter of 2024 reflects normal seasonal variation in underlying procedures.

    從環比來看,2024 年第二季至第三季全球營收下降 0.3%,反映了基礎程序的正常季節性變化。

  • Third-quarter 2024, US revenue was $95.5 million, a 16.8% increase from the third quarter of 2023.

    2024年第三季度,美國營收為9,550萬美元,較2023年第三季成長16.8%。

  • Open ablation product sales in the US were $30.6 million, up 18.4% over 2023, from robust ENCOMPASS clamp sales across both existing and new accounts.

    美國的開放式消融產品銷售額為 3,060 萬美元,比 2023 年成長 18.4%,這得益於現有和新客戶的 ENCOMPASS 鉗夾銷售強勁。

  • US sales of appendage management products were $37.4 million, up 15.6% over the third quarter of 2023.

    美國肢體管理產品銷售額為 3,740 萬美元,較 2023 年第三季成長 15.6%。

  • Within US appendage management revenue, our open appendage management products, driven by our AtriClip FLEX-V device, realized a third sequential quarter of acceleration, reaching 20% growth over third quarter of 2023.

    在美國肢體管理收入中,我們的開放式肢體管理產品在 AtriClip FLEX-V 設備的推動下實現了連續第三個季度的加速增長,較 2023 年第三季度增長了 20%。

  • US minimally invasive ablation sales were $11.1 million, up 2.1% from 2023.

    美國微創消融銷售額為 1,110 萬美元,較 2023 年成長 2.1%。

  • As Mike mentioned in his remarks, although we are activating new accounts and seeing positive trends with respect to the accounts ordering, we continue to experience pressure on the pace of hybrid AF therapy uptake.

    正如麥克在演講中提到的,儘管我們正在啟動新帳戶並看到帳戶訂購方面的積極趨勢,但我們仍然面臨著混合房顫療法採用速度的壓力。

  • And finally, pain management product sales were $16.3 million, up 29.6% over the third quarter of 2023, reflecting accelerated growth driven by the recent launch of our cryoSPHERE+ probe.

    最後,疼痛管理產品銷售額為 1,630 萬美元,比 2023 年第三季成長 29.6%,反映出我們最近推出的 CryoSPHERE+ 探針推動了加速成長。

  • International markets once again delivered excellent results with revenue of $20.5 million, up 23.3% on a reported basis and 22.4% on a constant currency basis as compared to the third quarter of 2023.

    國際市場再次取得優異成績,營收達到 2,050 萬美元,與 2023 年第三季相比,按報告計算成長 23.3%,以固定匯率計算成長 22.4%。

  • European sales contributed $12.2 million in the quarter, representing 33% growth while sales in Asia Pacific and other international markets grew 12% to $8.2 million.

    本季歐洲銷售額貢獻 1,220 萬美元,成長 33%,而亞太地區和其他國際市場的銷售額則成長 12%,達到 820 萬美元。

  • Similar to the first half of 2024, our international business grew across key product lines and in nearly all major markets.

    與 2024 年上半年類似,我們的國際業務在主要產品線和幾乎所有主要市場都成長。

  • Looking forward, we expect continued strength in our international business as we focus on growing adoption of our therapies as well as new product introductions.

    展望未來,隨著我們專注於越來越多地採用我們的療法以及新產品的推出,我們預計我們的國際業務將繼續保持強勁。

  • Our gross margin this quarter was 74.9%, a decrease of 27 basis points from the third quarter 2023, driven primarily by less favorable geographic and product mix.

    我們本季的毛利率為 74.9%,較 2023 年第三季下降 27 個基點,主要是由於地理位置和產品組合較不利。

  • Operating expenses for the quarter totaled $94.2 million, an increase of $12.2 million, or 14.9% from the third quarter of 2023.

    該季度營運支出總計 9,420 萬美元,較 2023 年第三季增加 1,220 萬美元,增幅 14.9%。

  • Research and development expenses rose 3% from the third quarter of 2023 with patient enrollment in our LEAPS clinical trial driving the increase.

    研發費用較 2023 年第三季成長 3%,LEAPS 臨床試驗的病患入組推動了這一成長。

  • The expansion of R&D expense was offset by timing of product development costs as we've completed development and clearance efforts for three major product releases in the US thus far in 2024, the cryoSPHERE+ Probe, AtriClip FLEX-Mini, and most recently our cryoSPHERE Max Probe.

    研發費用的增加被產品開發成本的時間安排所抵消,因為我們已經完成了 2024 年在美國發布的三個主要產品的開發和批准工作,即 CryoSPHERE+ 探針、AtriClip FLEX-Mini 和最近的 CryoSPHERE Max探測。

  • SG&A expenses increased 18.9% primarily from personnel and travel costs due to the measured expansion of our teams globally, as well as one-time consulting costs associated with our planned facilities expansion.

    SG&A 費用增加了 18.9%,主要來自人員和差旅費用,這是由於我們在全球範圍內團隊的有計劃的擴張,以及與我們計劃的設施擴張相關的一次性諮詢費用。

  • Adjusted EBITDA for the quarter was $7.9 million compared to $4.7 million for the third quarter of 2023, an increase of 68%.

    本季調整後 EBITDA 為 790 萬美元,較 2023 年第三季的 470 萬美元成長 68%。

  • Our basic and diluted net loss per share, as well as the adjusted loss per share, was $0.17 in the third quarter 2024, as compared to $0.20 in the third quarter 2023.

    2024 年第三季我們的基本和稀釋每股淨虧損以及調整後每股虧損為 0.17 美元,而 2023 年第三季為 0.20 美元。

  • Our overall capital position remains strong as we enter the third quarter with $130.3 million in cash and investments, representing positive cash generation of $16.3 million for the quarter.

    進入第三季度,我們的整體資本狀況仍然強勁,現金和投資為 1.303 億美元,意味著本季產生的現金為 1,630 萬美元。

  • As Mike mentioned earlier, we have advanced our plans to bring PFA technology to market in our devices by entering into an exclusive licensing and co-development agreement with an expert in this field.

    正如 Mike 之前提到的,我們已經與該領域的專家簽訂了獨家許可和共同開發協議,從而推進了將 PFA 技術推向市場的計劃。

  • As part of this arrangement, we will incur a cash charge for the acquired IPR&D of $12 million in the fourth quarter, which is excluded from our adjusted EBITDA and adjusted EPS guidance.

    作為該安排的一部分,我們將在第四季度為收購的 IPR&D 支付 1200 萬美元的現金費用,該費用不包括在我們調整後的 EBITDA 和調整後的 EPS 指導中。

  • Absent this payment, we expect positive cash generation in the fourth quarter, and a modest burn overall for full year 2024.

    如果沒有這筆付款,我們預計第四季度將產生積極的現金,並在 2024 年全年總體上出現適度的燒錢。

  • Now closing with our outlook for the remainder of the year.

    現在結束我們對今年剩餘時間的展望。

  • Considering our third-quarter results and trajectory across our business, we now expect to achieve approximately $459 million to $462 million in full year 2024 revenue, reflecting approximately 15% to 16% growth compared to 2023.

    考慮到我們第三季的業績和整個業務的發展軌跡,我們現在預計 2024 年全年營收將實現約 4.59 億至 4.62 億美元,與 2023 年相比成長約 15% 至 16%。

  • We remain confident in our extensive portfolio delivering sustainable growth within the large, underpenetrated markets we serve globally.

    我們對我們廣泛的產品組合充滿信心,相信我們的產品組合能夠在我們服務的全球大型、滲透率較低的市場中實現永續成長。

  • From a margin perspective, we are reaffirming our full year 2024 gross margin to be roughly consistent with 2023 with the potential for varying impacts from geographic and product mix.

    從利潤率角度來看,我們重申 2024 年全年毛利率與 2023 年大致一致,但地理和產品組合可能會產生不同的影響。

  • Turning to the bottom line, we reiterate our commitment to increasing profitability while also continuing to invest in driving growth and innovation To that end, we are maintaining our positive adjusted EBITDA outlook of approximately $26 million to $29 million for the full year 2024, corresponding to adjusted loss per share of approximately $0.74 to $0.80.

    談到獲利,我們重申對提高獲利能力的承諾,同時繼續投資推動成長和創新。股虧損約為0.74 美元至0.80 美元。

  • We are very proud of our progress across many key strategic, operational, and financial metrics so far this year.

    我們對今年迄今在許多關鍵策略、營運和財務指標方面取得的進展感到非常自豪。

  • Our team's continued dedication to AtriCure's mission, supported by investments in innovation, clinical science, education and awareness has led to tens of thousands of patients treated.

    我們的團隊持續致力於 AtriCure 的使命,在創新、臨床科學、教育和意識方面的投資的支持下,已經使數以萬計的患者得到了治療。

  • The same dedication has created multiple avenues of growth for our company and will continue to propel us into the future.

    同樣的奉獻精神為我們公司創造了多種成長途徑,並將繼續推動我們走向未來。

  • Now, I'll turn the call back to Mike.

    現在,我將把電話轉回給麥克。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Thank you, Angie.

    謝謝你,安吉。

  • As we enter the second half of 2024, we saw strong growth on the top and bottom line.

    進入 2024 年下半年,我們看到營收和利潤均強勁成長。

  • Continued innovation with the AtriClip, FLEX-Mini, and cryoSPHERE Max launches. and expansion of the geographic reach of our products with our AtriClip now approved in China, our ENCOMPASS launch in the EU, and our AtriClip Stroke Label Expansion in Europe as well.

    持續創新,推出 AtriClip、FLEX-Mini 和 CryoSPHERE Max。擴大我們產品的地理覆蓋範圍,我們的 AtriClip 現已在中國獲得批准,我們的 ENCOMPASS 在歐盟推出,我們的 AtriClip 中風標籤也在歐洲擴展。

  • Our strong revenue growth in the third quarter is a testament to the resilience and diversification of the portfolio of therapies we have built.

    我們第三季營收的強勁成長證明了我們所建立的治療組合的彈性和多樣化。

  • With the strength of our team worldwide, the quality of our products, and the clinical data behind our therapies, there is little doubt in my mind that AtriCure is well positioned to drive compelling growth and expand profitability for years to come.

    憑藉我們全球團隊的實力、產品的品質以及治療背後的臨床數據,我認為 AtriCure 毫無疑問地處於有利位置,可以在未來幾年推動引人注目的成長並擴大盈利能力。

  • And with that, we'll turn it over to the operators.

    這樣,我們就會將其移交給營運商。

  • Operator

    Operator

  • (Operator Instructions) Robbie Marcus, JPMorgan.

    (操作員指示)Robbie Marcus,摩根大通。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Hi, this is Lillian for Robbie.

    大家好,我是羅比的莉蓮。

  • Thanks for taking the question.

    感謝您提出問題。

  • Just wanted to get your thoughts on the trends that you're seeing from PFA.

    只是想了解一下您對 PFA 趨勢的看法。

  • Is this the new normal to expect with pressure to both MIS Ablation and the MIS Clip business?

    這是否會成為 MIS Ablation 和 MIS Clip 業務面臨壓力的新常態?

  • Or do you think momentum in those areas can improve as CFA becomes more commonplace in the market.

    或者您認為隨著 CFA 在市場上變得更加普遍,這些領域的勢頭會有所改善嗎?

  • And what sort of assumptions regarding those dynamics are you taking into guidance?

    您將哪些關於這些動態的假設作為指引?

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, as we looked at the rest of this year, I'd say that's kind of more the new normal for the rest of this year.

    是的,當我們回顧今年剩餘時間時,我想說這更像是今年剩餘時間的新常態。

  • But as you look out over into the future, because there's going to be a lot, there's a lot of new products coming into market, et cetera, right now, causing the distraction of the site as they get up and running, using those new products, et cetera.

    但當你展望未來時,因為將會有許多新產品進入市場,等等,現在,在網站啟動和運行時,使用這些新產品會導致網站分散注意力。

  • But what we're also seeing is an incredible amount of new patients coming into the funnel so that the top of the funnel of patients is very large.

    但我們也看到大量新患者進入漏斗,因此患者漏斗的頂部非常大。

  • And with our experience in Europe, what we can see is that they eventually have non-responders, a great deal of non-responders.

    根據我們在歐洲的經驗,我們可以看到,他們最終會出現無反應者,大量無反應者。

  • And so what we do anticipate is that that funnel is going to lead to a lot more patients needing to be treated once they don't respond to PFA or that second or third ablation.

    因此,我們確實預計,一旦 PFA 或第二次或第三次消融沒有反應,這個漏斗將導致更多的患者需要接受治療。

  • They're going to kind of fall down that funnel.

    他們會掉進那個漏斗。

  • Now, we do believe that in 2025, we'll start to see some of those.

    現在,我們確實相信,到 2025 年,我們將開始看到其中的一些。

  • We've seen some of it already a little bit from patients that were involved in some of the original PFA trials here in the US.

    我們已經從參與美國一些最初的 PFA 試驗的患者身上看到了其中的一些情況。

  • We do anticipate that that will probably begin to start up in 2025.

    我們確實預計這可能會在 2025 年開始啟動。

  • Not ready to kind of give any kind of month or quarter that you're going to start to see any kind of spike necessarily, but we do anticipate that with that huge volume in the top of the funnel, you're going to see a lot more patients come out that need another ablation [epicardially] to really help them out for those long-term and difficult-to-treat patients.

    還沒有準備好給出任何類型的月份或季度,你將開始看到任何類型的峰值,但我們確實預計,隨著漏斗頂部的巨大交易量,你將看到更多的患者需要再次進行心外膜消融,以真正幫助那些長期且難以治療的患者。

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • And Lily, relative to the guidance, I would say, as you know, Q4 last year was a very strong quarter for our US hybrid and also our MIS AtriClip business.

    莉莉,相對於指導,我想說,正如你所知,去年第四季度對於我們的美國混合動力以及我們的 MIS AtriClip 業務來說是一個非常強勁的季度。

  • So that was one of the considerations as we thought through kind of the rest of the year guide.

    所以這是我們在思考今年剩餘時間指南時考慮的因素之一。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Got it.

    知道了。

  • That's helpful.

    這很有幫助。

  • And then as a follow up, I was hoping you could give a bit more color on the PFA partnership.

    作為後續行動,我希望您能為 PFA 合作夥伴關係提供更多的資訊。

  • Is there anything you can share on who this partner is that you're working with and what sort of timeline should we expect for a launch here?

    您可以分享您正在合作的合作夥伴是誰以及我們應該在此處發布的時間表嗎?

  • Thanks so much.

    非常感謝。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, I appreciate that question.

    是的,我很欣賞這個問題。

  • And of course, I anticipated, you know, we're really excited about what we've done there.

    當然,我預計,你知道,我們對我們在那裡所做的事情感到非常興奮。

  • The reason we were able to announce now is obviously we signed the agreement and we'll be obviously writing the check that Angie talked about.

    我們現在能夠宣布的原因顯然是我們簽署了協議,我們顯然會寫安吉談到的支票。

  • But in addition to that, we've made a tremendous amount of progress over the course of the last nine months on development.

    但除此之外,我們在過去九個月的開發過程中取得了巨大的進展。

  • And we feel like we're in a really good development place for that as well.

    我們覺得我們在這方面也處於一個非常好的發展階段。

  • So there's a lot of confidence on our side that this is going to be a real technology for us that's going to be embedded into our cardiac surgery devices, not ready to give timelines on first in human or when we might go into a clinical trial with it, or who the partner is yet, but in due time that will definitely come out.

    因此,我們非常有信心,這對我們來說將是一項真正的技術,將被嵌入到我們的心臟手術設備中,但還沒有準備好在人體上首次使用或何時進行臨床試驗。或合作夥伴是誰,但在適當的時候肯定會出來。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Great.

    偉大的。

  • Thanks so much.

    非常感謝。

  • Operator

    Operator

  • William Plovanic, Canaccord Genuity.

    威廉‧普洛瓦尼克 (William Plovanic),Canaccord Genuity。

  • William Plovanic - Analyst

    William Plovanic - Analyst

  • Just first on ENCOMPASS CLAMP, I just wanted to clarify, did you say that the US business, the CLAMP, grew 50% year-over-year, is that correct?

    首先關於ENCOMPASS CLAMP,我只是想澄清一下,您是否說美國業務CLAMP同比增長了50%,這是正確的嗎?

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • Yeah, it was about 50% growth of the ENCOMPASS CLAMP in the third quarter.

    是的,第三季 ENCOMPASS CLAMP 的成長約為 50%。

  • William Plovanic - Analyst

    William Plovanic - Analyst

  • Okay, and then as we think about ENCOMPASS OUS, you just got that CE-Mark.

    好的,當我們想到 ENCOMPASS OUS 時,您剛剛獲得了 CE 標誌。

  • Given the growth OUS in the third quarter, I would assume that you really didn't see a benefit from that.

    考慮到第三季 OUS 的成長,我認為您確實沒有看到從中受益。

  • If anything, you might have seen some destocking or what have you.

    如果有的話,你可能已經看到了一些去庫存或其他什麼。

  • How should we think about that impact as you go into the fourth quarter and forward now that you have that CE-Mark, given what we've seen in the US from that product?

    鑑於我們在美國從該產品中看到的情況,既然您已經獲得了 CE 標誌,那麼當您進入第四季度並展望未來時,我們應該如何考慮這種影響?

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, first I'll start.

    是的,首先我要開始。

  • And I mean, the European team is really excited about the ENCOMPASS clamp.

    我的意思是,歐洲團隊對 ENCOMPASS 夾具感到非常興奮。

  • I was over at the major cardiac surgery society meeting over there called EACS just in the early part of October.

    十月初,我參加了在那裡舉行的名為 EACS 的大型心臟外科學會會議。

  • Our booth was packed.

    我們的攤位擠滿了人。

  • We had a simulation lab and we had over 250 people and physicians visit our booth, go through simulation lab, leveraging that.

    我們有一個模擬實驗室,有超過 250 名人員和醫生參觀我們的展位,參觀模擬實驗室,並利用它。

  • We actually launched the product officially while we were there.

    我們在那裡時實際上正式推出了該產品。

  • And then we also had a standing room only audience to kind of talk about what that product meant for the market as well.

    然後我們還有一群只能站著的觀眾來談論該產品對市場的意義。

  • So the team there is really excited.

    所以那裡的團隊真的很興奮。

  • They've been well trained and positioned on it in the market.

    他們接受過良好的培訓並在市場上擁有良好的定位。

  • We won't see much of an impact in the fourth quarter, per se, but we do see that we'll obviously have an impact on next year, for sure, as we enter the market.

    我們本身不會在第四季度看到太大的影響,但我們確實看到,當我們進入市場時,我們顯然會對明年產生影響。

  • It won't go as fast as the US, just because individual countries have different reimbursement plays, et cetera, but they're ready to kind of get through that, and we do anticipate some impact in 2025.

    它不會像美國那麼快,只是因為各國有不同的報銷方式等等,但他們已經準備好渡過難關,我們確實預計 2025 年會產生一些影響。

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • Yeah, Bill, just would add, relative to the international numbers and open ablation, more impacted by kind of our markets outside of Europe.

    是的,比爾,我想補充一點,相對於國際數據和公開消融,更受歐洲以外市場的影響。

  • Our European growth in open ablation was very strong.

    我們歐洲的開放消融成長非常強勁。

  • This is more kind of the distributor ordering in the third quarter that impacted open growth.

    這更像是第三季經銷商的訂單,影響了開放式成長。

  • William Plovanic - Analyst

    William Plovanic - Analyst

  • Okay.

    好的。

  • And then just on this PFA partnership, I know you'll give us more details in the future, but I'm kind of curious, I think you've had plans of kind of getting to that cash flow consistently positive.

    關於 PFA 合作夥伴關係,我知道您將來會向我們提供更多詳細信息,但我有點好奇,我認為您已經制定了讓現金流持續保持正值的計劃。

  • Now you're talking about an investment in this PFA for the cardiac devices.

    現在您正在談論對心臟設備 PFA 的投資。

  • Does that change the kind of near-term, intermediate-term outlook?

    這是否會改變近期、中期前景?

  • Is maybe you're increasing the R&D spend, or is this just shifting priorities within an R&D?

    也許您正在增加研發支出,或者這只是在研發中改變優先事項?

  • And thanks for taking my questions.

    感謝您回答我的問題。

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • I think this was part of our overall R&D plan and has been for a while.

    我認為這是我們整體研發計劃的一部分,並且已經存在了一段時間。

  • No change in terms of outlook relative to kind of overall spend or cash burn.

    相對於整體支出或現金消耗的前景沒有改變。

  • Obviously, we'll take a charge here in the fourth quarter for the upfront cost, but even with that charge expected to be an overall modest burn for full year 2024.

    顯然,我們將在第四季度收取前期成本,但即使收取這筆費用,預計 2024 年全年的整體消耗也將適度。

  • So no change relative to the trajectory there, and it's something that we've been working towards, like Mike said, for a while now, and part of our longer-term plans.

    因此,相對於那裡的軌跡沒有任何變化,正如麥克所說,這是我們一段時間以來一直在努力的方向,也是我們長期計劃的一部分。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • And I think that consistent with what Angie has, and we've stated before, that when we look at, we're not giving guidance for 2025, but we've always talked about the fact that we're going to continue to improve our bottom line from year to year.

    我認為這與 Angie 的觀點一致,我們之前也說過,當我們審視時,我們不會給出 2025 年的指導,但我們一直在談論我們將繼續改進的事實我們年復一年的底線。

  • And so, with that, it's not changed at all, and our thoughts on that haven't changed in any way.

    因此,它根本沒有改變,我們對此的想法也沒有任何改變。

  • William Plovanic - Analyst

    William Plovanic - Analyst

  • Great, thanks for taking my questions.

    太好了,感謝您回答我的問題。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • Our next question comes from Matthew O’Brien with Piper Sandler.

    我們的下一個問題來自馬修·奧布萊恩和派珀·桑德勒。

  • Your line is open.

    您的線路已開通。

  • Unidentified Participant 2

    Unidentified Participant 2

  • Hey, this is Phil on for Matt.

    嘿,這是為馬特代言的菲爾。

  • Thanks for taking our questions.

    感謝您回答我們的問題。

  • I guess just, another, a third great quarter of the US open business.

    我想這只是美國開放業務的另一個第三季。

  • Is it safe to say that a bigger competitor coming into this market is perhaps aiding in general market growth?

    是否可以肯定地說,更大的競爭對手進入這個市場可能有助於整體市場的成長?

  • Any thoughts on what that underlying market grew in relation to your 20% domestic growth here in the quarter?

    您對基礎市場的成長與本季 20% 的國內成長之間的關係有什麼想法嗎?

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, I mean, as we talked about earlier, and it's a great question, Phil, when we looked at the market and competition coming in, we always said competition is a good thing, because it does create awareness exactly as you've described.

    是的,我的意思是,正如我們之前談到的,這是一個很好的問題,菲爾,當我們審視市場和競爭時,我們總是說競爭是一件好事,因為它確實會產生正如你所描述的那樣的意識。

  • And I think we're definitely seeing that greater awareness get created in the market by having somebody else that's out there talking about the benefits of treating the appendage.

    我認為我們肯定會看到,透過讓其他人談論治療附肢的好處,市場上會產生更大的意識。

  • And so I'd say the answer, the simple answer is absolutely.

    所以我想說的答案是,簡單的答案是絕對的。

  • I can't give a specific underlying growth, but I know that the competition is getting some share.

    我無法給出具體的潛在成長,但我知道競爭對手正在獲得一些份額。

  • Obviously, they're getting some sales that are out there, but we still feel like our product is -- our original product, the FLEX-V, is an exceptional product was the best product on the market before the FLEX-Mini, and the FLEX-Mini that we talked about on this call has been receiving great reviews.

    顯然,他們獲得了一些銷售,但我們仍然覺得我們的產品是 - 我們的原始產品 FLEX-V 是一款出色的產品,是 FLEX-Mini 之前市場上最好的產品,並且我們在本次電話會議中談到的FLEX-Mini 受到了好評。

  • It is a much smaller profile product on the market.

    它是市場上外形尺寸小得多的產品。

  • I've been out on the road talking to a lot of customers, getting feedback, and just looking at them as they kind of use it for the first time, and it's been just incredible feedback.

    我一直在路上與很多客戶交談,獲得反饋,並在他們第一次使用它時觀察他們,這是令人難以置信的反饋。

  • So that product is going to make a big difference, not just for the end of this year, but also for many years to come.

    因此,該產品將產生巨大的影響,不僅在今年年底,而且在未來的許多年裡。

  • Unidentified Participant 2

    Unidentified Participant 2

  • Thanks, that's helpful.

    謝謝,這很有幫助。

  • My second question is, we've been hearing some recent chatter on the HEAL-IST study.

    我的第二個問題是,我們最近聽到了一些關於 HEAL-IST 研究的討論。

  • You haven't talked about it in a little bit of time.

    你們已經有一段時間沒有談論這件事了。

  • Any renewed interest there?

    那裡有新的興趣嗎?

  • Any updates would be helpful.

    任何更新都會有幫助。

  • Thank you.

    謝謝。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • HEAL-IST is an important study relative to a patient population.

    HEAL-IST 是一項針對患者群體的重要研究。

  • For those that don't recall, it's for patients that have inappropriate sinus tachycardia.

    對於那些不記得的人來說,它適用於患有不適當竇性心搏過速的患者。

  • It's important, not necessarily for our long-term growth, but for the hybrid aspect of our business.

    這不一定對我們的長期成長很重要,但對我們業務的混合方面很重要。

  • We do believe it's really where a surgeon is working with an electrophysiologist to solve this very difficult patient that, quite frankly, has zero solution out there in the market right now.

    我們確實相信,這確實是外科醫生與電生理學家合作來解決這個非常困難的患者的地方,坦白說,目前市場上的解決方案為零。

  • We've had solid enrollment to date, but we've got to train all these sites as we get them up and running.

    到目前為止,我們的註冊人數已經足夠多,但我們必須在所有這些網站啟動和運行時對其進行培訓。

  • So there hasn't been a lot to update, per se, until we get to some sort of enrollment that we can actually look at the data, which we anticipate sometime in 2025, and we can kind of get more reporting out at that point in time.

    因此,本身並沒有太多需要更新的內容,直到我們進行某種登記,我們可以實際查看數據,我們預計在 2025 年的某個時候,那時我們可以得到更多報告及時。

  • Unidentified Participant 2

    Unidentified Participant 2

  • Helpful.

    有幫助。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Marie Thibault, BTIG.

    瑪麗蒂博,BTIG。

  • Marie Marie - Analyst

    Marie Marie - Analyst

  • Hi, thanks for taking the questions this evening and congrats on a nice quarter.

    您好,感謝您今晚提出問題,並祝賀您度過了一個愉快的季度。

  • I wanted to see if I could kind of understand a rundown of product catalysts, other market catalysts that we might see throughout 2025.

    我想看看我是否能理解 2025 年我們可能會看到的產品催化劑和其他市場催化劑的概要。

  • Definitely not looking for guidance, but just trying to understand tailwinds, headwinds, things that might be anniversary as you think about the products launching here now and products that you've enjoyed throughout 2024.

    絕對不是在尋求指導,而只是試圖了解順風、逆風,以及當您考慮現在在這裡推出的產品以及您在 2024 年喜歡的產品時可能會發生的事情。

  • Just how to think about those catalysts in 2025.

    2025 年如何思考這些催化劑。

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • Great question, Marie.

    好問題,瑪麗。

  • I'd say if we start at the top with our open franchise The expansion of the ENCOMPASS clamp in Europe, you'll see, obviously, a full year's worth of activity over there.

    我想說,如果我們從我們的開放特許經營權開始,在歐洲擴展 ENCOMPASS 夾具,您顯然會看到那裡全年的活動價值。

  • That being said, we still think that this is a catalyst for the US business as we continue to reach additional accounts.

    話雖如此,我們仍然認為這是美國業務的催化劑,因為我們不斷獲得更多客戶。

  • We've made great progress on that front, a little under 700 accounts at this point in time, so still room for us to continue to grow in the US.

    我們在這方面取得了很大進展,目前帳戶數量略低於 700 個,因此我們在美國仍有持續成長的空間。

  • When we think about our pain management franchise, you'll have a full year of the cryoSPHERE Max as well as the cryoSPHERE+ Probe, both offering reduced freeze times, which we think are accelerating our growth.

    當我們考慮我們的疼痛管理特許經營權時,您將擁有一整年的 CryoSPHERE Max 和 CryoSPHERE+ Probe,兩者都可以縮短冷凍時間,我們認為這正在加速我們的成長。

  • We've obviously seen that this past quarter in the US and we'll continue our efforts to expand pay management throughout our international markets.

    上個季度我們在美國顯然已經看到了這一點,我們將繼續努力擴大整個國際市場的薪酬管理。

  • We've seen some nice activity in Europe in particular on that front.

    我們在歐洲看到了一些不錯的活動,特別是在這方面。

  • Within our hybrid franchise, I'd say this is one where we're likely to see pressure, no catalyst per se at this point in time.

    在我們的混合特許經營權中,我想說這是我們可能會看到壓力的一個,目前本身沒有催化劑。

  • And I'd say within appendage management, the big thing will be our FLEX-Mini clip full year of activity within the US as well as the expansion of AtriClip into China and the enhanced labeling within Europe.

    我想說,在附屬物管理方面,最重要的是我們的 FLEX-Mini 夾子在美國全年的活動,以及 AtriClip 向中國的擴張以及在歐洲的增強標籤。

  • So I think that probably the biggest headwind for growth for us, I think, would just remind law of large numbers, we continue to make great progress here and the growth that we're expecting off of a pretty nice runway over the past couple years.

    因此,我認為,對我們來說,成長的最大阻力可能只是提醒大數定律,我們繼續在這裡取得巨大進展,以及我們期望在過去幾年中取得相當不錯的成長。

  • Marie Marie - Analyst

    Marie Marie - Analyst

  • Really helpful rundown, Angie, appreciate that.

    非常有幫助的綱要,安吉,很感激。

  • My follow-up on the PSA partnership, at the risk of sounding a little naive, is this for the MIS product?

    我對 PSA 合作關係的後續行動,冒著聽起來有點幼稚的風險,是針對 MIS 產品的嗎?

  • Is it also for the open product?

    開放產品也是如此嗎?

  • Is the vision eventually that PFA replaces the RF ablation within your franchises?

    您的願景最終是 PFA 取代射頻消融術嗎?

  • And what sort of change?

    什麼樣的改變?

  • I know you've known and followed the PFA space very, very closely for a few years.

    我知道您多年來一直非常非常密切地了解並關注 PFA 領域。

  • What sort of precipitated this decision?

    是什麼樣的因素促成了這個決定?

  • Thanks so much.

    非常感謝。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, we've been looking at PFA for over five years in terms of getting it into our cardiac surgery products.

    是的,五年多來,我們一直在考慮將 PFA 納入我們的心臟手術產品中。

  • There really isn't a change.

    確實沒有什麼改變。

  • It's just we finally got realization that now we've actually got product.

    只是我們終於意識到現在我們實際上已經有了產品。

  • We've actually done testing on it.

    我們實際上已經對其進行了測試。

  • We're at the point that we could actually feel comfortable coming out and giving you some guidance that we're very close to being able to give some very specific milestones and deadlines here to the market.

    我們現在實際上可以放心地出來並向您提供一些指導,我們非常接近能夠向市場提供一些非常具體的里程碑和最後期限。

  • And so we want to kind of preliminary kind of say that.

    所以我們想初步說明這一點。

  • But we've been working on it for a long time, and there really isn't any changes.

    但我們已經為此努力了很長時間,而且確實沒有任何改變。

  • Angie talked about earlier.

    安吉之前說過。

  • In terms of our focus and our strategy, it's really all of our epicardial ablation products.

    就我們的重點和策略而言,這實際上是我們所有的心外膜消融產品。

  • We do anticipate bring it to market through those.

    我們確實預計透過這些將其推向市場。

  • We'll give more details at a later date, but the plan is to bring that in.

    我們將在稍後提供更多細節,但計劃是把它納入其中。

  • It's not planning on replacing our RF and cryo.

    它不打算取代我們的射頻和低溫。

  • RF and cryo are incredibly durable, they're incredibly safe, and they work incredibly well in the market today.

    射頻和低溫技術非常耐用,非常安全,而且在當今市場上運作得非常好。

  • They're great products.

    它們是很棒的產品。

  • However, we're an Afib ablation company, and we feel that we need to have all ablation technologies to be able to offer to people, and then give physicians that choice as to which they may or may not like better based on whatever their preferences are and what types of tools they might want to use.

    然而,我們是一家心房顫動消融公司,我們認為我們需要擁有能夠向人們提供的所有消融技術,然後讓醫生根據他們的喜好選擇他們可能更喜歡或不喜歡的技術他們是什麼類型的工具以及他們可能想要使用什麼類型的工具。

  • And so, yes, it will be embedded into some of our existing technology in terms of the disposables that we have today.

    因此,是的,它將嵌入到我們現有的一些一次性用品的技術中。

  • But our overall vision is to be able to provide a full solution so that we can give our customers, our physicians, a choice as to how they want to treat their patients best.

    但我們的整體願景是能夠提供完整的解決方案,以便我們的客戶和醫生可以選擇如何最好地治療患者。

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • Yeah, maybe to put a finer point on that, Marie, we would expect, as Mike said in his prepared comments, first up would be an open cardiac clamp, then followed by some more work in the minimally invasive space.

    是的,也許為了更詳細地說明這一點,瑪麗,我們預計,正如邁克在他準備好的評論中所說,首先是開放式心臟鉗夾,然後是在微創空間進行更多的工作。

  • Marie Marie - Analyst

    Marie Marie - Analyst

  • Got you.

    明白你了。

  • Thank you so much.

    太感謝了。

  • Operator

    Operator

  • (Operator Instructions) Mike Matson, Needham.

    (操作員說明)Mike Matson,Needham。

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Congrats on the strong quarter.

    恭喜季度表現強勁。

  • Maybe a question for pain management.

    也許是疼痛管理的問題。

  • I think you both had talked about cryoSPHERE Max really being more of a product to break into the sternotomy market as opposed to PLOS or the original cryoSPHERE.

    我想你們都談過,cryoSPHERE Max 確實更像是一款打入胸骨切開術市場的產品,而不是 PLOS 或最初的 CryoSPHERE。

  • So what, I guess, what are your expectations for the sternotomy market in 2025 now that the Max has been launched?

    那麼,我猜,既然 Max 已經推出,您對 2025 年胸骨切開術市場有何期望?

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, and the [ceramic] market is something that we anticipate could be a potential market for us, but we're not going to commit to any kind of revenue or guidance on it quite yet.

    是的,我們預期[陶瓷]市場可能是我們的潛在市場,但我們目前還不會承諾任何形式的收入或指引。

  • We do think that being able to reduce the time in half, that it's going to definitely be something that is going to be much more approachable for a surgeon to kind of add it to their procedure at that time.

    我們確實認為,能夠將時間減少一半,對於外科醫生來說,將其添加到當時的手術中肯定會更容易。

  • That was one of the primary reasons we did it, but it also affects pretty much every other usage of the technology today.

    這是我們這樣做的主要原因之一,但它也影響了當今該技術的幾乎所有其他用途。

  • We're already seeing it in mini thoracotomies and regular thoracotomies, and people are adopting it very, very quickly.

    我們已經在小型胸廓切開術和常規胸廓切開術中看到了它,人們正在非常非常快速地採用它。

  • We're not focused in saying we're definitely going after Sternotomy quite yet.

    我們還沒有重點說我們肯定會進行胸骨切開術。

  • We kind of want to let it kind of grow organically.

    我們想讓它有機地成長。

  • Once we get that and we get some more feedback, and our people want to spend any time doing that for the benefit they get, we'll have more to kind of talk about relative to Sternotomy.

    一旦我們得到了這一點並得到了更多回饋,並且我們的員工希望花任何時間這樣做以獲得他們所獲得的利益,我們將有更多關於胸骨切開術的討論。

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Okay, great, great.

    好的,太好了,太好了。

  • And then maybe one on cash flow.

    然後也許是現金流。

  • Had a couple of quarters, positive cash flow.

    有幾個季度,現金流為正。

  • Angie, I think you said, excluding the cash charge next quarter would have positive cash flow.

    安吉,我想你說過,排除下個季度的現金費用將會有正現金流。

  • So I'm just kind of wondering how you guys are thinking about that moving forward into 2025, do you think AtriCure is consistently cash flow positive moving forward?

    所以我只是想知道你們如何看待進入 2025 年的情況,你們認為 AtriCure 的現金流是否持續呈正值?

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • I think on a full year basis, 2025, likely to be cash flow positive.

    我認為從全年來看,2025 年現金流可能會為正。

  • The first quarter tends to be very heavy burned, just structurally with some of the payments that are made in the first quarter around variable compensation, et cetera, tends to be a heavy cash burn.

    第一季的燒錢往往非常嚴重,只是從結構上看,第一季圍繞著可變薪酬等支付的一些款項往往是嚴重的現金燒錢。

  • You've seen that for a number of years now, but on the balance.

    這種情況你已經看到很多年了,但總的來說。

  • And I would just end by saying really happy with the progress that we're making in this area and expect to continue to be able to enhance our cash flow going forward.

    最後我想說,我們對我們在這一領域的進展感到非常滿意,並期望能夠繼續增強我們未來的現金流。

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Okay, very helpful.

    好的,非常有幫助。

  • Congrats on the quarter.

    恭喜本季。

  • Operator

    Operator

  • Danielle Antalffy, UBS.

    丹妮爾·安塔菲,瑞銀集團。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Just two quick product questions.

    只是兩個簡單的產品問題。

  • One on the AtriClip business.

    其中之一是關於 AtriClip 業務。

  • You talked a little bit about the competitive dynamics here.

    您在這裡談到了一些競爭動態。

  • I'm just curious, Mike, if we look at the trend throughout the year, it feels like Q1 was maybe the nadir for AtriClip US growth.

    我只是好奇,麥克,如果我們看看全年的趨勢,感覺第一季可能是 AtriClip 美國成長的最低點。

  • And I'm wondering if you would agree with that.

    我想知道你是否同意這一點。

  • Are we past the sort of trialing dynamic here?

    我們已經過了這裡的那種嘗試動力了嗎?

  • And maybe you could comment on how you're seeing centers adopt both the clip and the competitive product, or have you lost any centers?

    也許您可以評論一下您如何看待中心同時採用剪輯和競爭產品,或者您是否失去了任何中心?

  • Any sort of commentary you can give there would be helpful.

    您可以在那裡發表的任何評論都會有所幫助。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, I mean, the competition is out there, and as I think I had referred to in one of the questions earlier, Danielle, what we do see is that, obviously, market growth is growing as a result of having competition in the space.

    是的,我的意思是,競爭就在那裡,正如我在之前的一個問題中提到的,丹妮爾,我們確實看到的是,顯然,由於該領域的競爭,市場成長正在成長。

  • That's definitely what we're seeing, and why you saw an acceleration overall in ours.

    這絕對是我們所看到的,也是我們整體加速成長的原因。

  • Plus, we're also bringing out new innovative products.

    此外,我們也推出了新的創新產品。

  • So you come out with the FLEX-Mini, and I anticipate that's going to also help drive the growth relative to that.

    因此,您推出了 FLEX-Mini,我預計這也將有助於推動相關的成長。

  • We do see them in some accounts.

    我們確實在一些帳戶中看到了它們。

  • In those accounts, we haven't lost those accounts completely.

    在這些帳戶中,我們並沒有完全失去這些帳戶。

  • They definitely use both of the technologies.

    他們肯定使用這兩種技術。

  • I've had the opportunity to kind of meet with many of those accounts, had very nice conversations with them, and they just kind of make that choice on their own relative to some of, whether it's anatomy or something, that they're basically making some personal physician choice on it.

    我有機會與其中許多客戶會面,與他們進行了非常愉快的交談,他們只是自己做出了相對於某些人的選擇,無論是解剖學還是其他什麼,他們基本上是對此做出一些個人醫生的選擇。

  • But I feel really confident in the quality of our product, the quality of what we bring to the market relative to this, both in terms of the innovations with the FLEX-Mini and with the FLEX-V original product.

    但我對我們的產品品質以及我們推向市場的產品品質充滿信心,無論是 FLEX-Mini 的創新還是 FLEX-V 原始產品的創新。

  • They are just outstanding products.

    它們只是傑出的產品。

  • And the fact that we've invested in clinical evidence, which you can see what happened in Europe with the 85 peer-reviewed papers and over 11,000 patients.

    事實上,我們已經投資了臨床證據,您可以透過 85 篇同行評審論文和超過 11,000 名患者來了解歐洲發生的情況。

  • That is a lot of evidence demonstrating how good the closure rates are and actually even the impact on stroke rates are.

    有大量證據顯示閉合率有多好,甚至對中風率的影響也很大。

  • And so that got us that label over in Europe.

    這讓我們在歐洲獲得了這個標籤。

  • And that's a long way for anybody else to kind of catch up to that. and we're running this trial here.

    對於其他人來說,要趕上這一點還有很長的路要走。我們在這裡進行這個試驗。

  • I think that we're really making the right types of investments for the long term for this franchise.

    我認為我們確實為這個特許經營權進行了正確的長期投資。

  • And the investments aren't just for existing Afib patients.

    這些投資不僅針對現有的心房顫動患者。

  • LEAPS is all about tripling the size of that market and getting to over 1 million more patients that undergo cardiac surgery globally.

    LEAPS 的目標是將該市場規模擴大兩倍,並讓全球接受心臟手術的患者增加超過 100 萬人。

  • So we're pretty excited about kind of where we are.

    所以我們對我們現在的處境感到非常興奮。

  • Again, we do see the competition, but I think it's really good for us and for the market overall.

    同樣,我們確實看到了競爭,但我認為這對我們和整個市場來說確實有好處。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Okay, that's helpful.

    好的,這很有幫助。

  • And then just a quick question on another great quarter for ENCOMPASS.

    然後是關於 ENCOMPASS 另一個出色季度的簡短問題。

  • I mean, this clamp just has really seemed to open up the [cabbage] market, especially for you guys.

    我的意思是,這個夾子似乎真的打開了[捲心菜]市場,特別是對你們來說。

  • Just curious about what you can say as far as where we are from a penetration perspective at this point with [cabbage], now that you've got what's it been like two years, I guess, rolling out ENCOMPASS here in the US?

    只是好奇你能說一下我們目前在[捲心菜]方面的滲透角度,現在你已經了解了在美國推出 ENCOMPASS 的兩年情況如何?

  • Thanks so much.

    非常感謝。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Yeah, I mean, it's a great question.

    是的,我的意思是,這是一個很好的問題。

  • And I do think that we're making impact on adoption, for sure, of people treating, but we still have a long way to go.

    我確實認為,我們確實正在對人們接受治療產生影響,但我們還有很長的路要走。

  • I mean, we're still, I'd say that we used to quote, call it that 25% to 30%.

    我的意思是,我們仍然,我會說我們過去常常引用,稱之為 25% 到 30%。

  • We're probably closer to 30% to 35% of the patients today that are actually getting treated overall for cardiac surgery that have Afib, which tells you there's still 65% of the patients that should be treated.

    如今,實際上接受心臟手術治療的患有心房顫動的患者中,可能有接近 30% 到 35% 的患者患有心房顫動,這表明仍有 65% 的患者需要接受治療。

  • All of the guidelines globally, I mean, let me repeat that, every guideline globally from every society, HRS, ACC, EACS, which is the surgical one over in Europe, ERAS over in Europe as well, which covers all cardiology, and also STS, which covers cardiac surgery in the US.

    我的意思是,讓我重複一遍,全球所有的指南,來自每個社會的全球指南,HRS、ACC、EACS,這是歐洲的外科指南,ERAS 也是歐洲的指南,涵蓋所有心臟病學,以及STS ,涵蓋美國的心臟手術。

  • Every one of them have a class 1A level guidelines for it, and that you should be treating this patient population, both with an ablation and with managing the appendage.

    他們每個人都有 1A 級指南,您應該透過消融和管理附肢來治療這群患者。

  • And so, from our standpoint, we think that there's still a long way to go just within that patient population, and a lot of growth ahead of us with that.

    因此,從我們的角度來看,我們認為在患者群體中還有很長的路要走,而且我們還有很大的成長空間。

  • And I think the ENCOMPASS clamp hopefully is going to unlock it to make it a lot easier for patients to get treated.

    我認為 ENCOMPASS 夾鉗有望將其解鎖,使患者更容易接受治療。

  • Danielle Antalffy - Analyst

    Danielle Antalffy - Analyst

  • Thanks all.

    謝謝大家。

  • Operator

    Operator

  • (Operator Instructions) Suraj Kalia with Oppenheimer & Co. Your line is open.

    (操作員指示)Suraj Kalia 與 Oppenheimer & Co. 您的線路已開通。

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • Hey, congrats on a nice quarter.

    嘿,恭喜你度過了一個愉快的季度。

  • So Mike, one question for you, one for Angie, and I'll pose the first one to you, Mike.

    麥克,一個問題問你,一個問題問安吉,我將向你提出第一個問題,麥克。

  • On the surgical PFA products, so Mike, there was a point in time specifically picking off on hybrid or convergent.

    在外科 PFA 產品上,Mike 有一個時間點專門選擇混合型或聚合型產品。

  • The whole argument was like, look, hybrid prevents esophageal fistulas.

    整個爭論就像,看,混合可以預防食道瘺。

  • You can do back wall ablation.

    您可以進行後壁消融。

  • So this is additive to existing cash flow relation, right?

    所以這是對現有現金流關係的補充,對嗎?

  • That was the whole argument.

    這就是整個爭論。

  • When surgical products have PFA, I guess, help us understand what is the clinical need from a surgical product for a new energy modality?

    我想,當外科產品具有 PFA 時,可以幫助我們了解外科產品對新能源方式的臨床需求是什麼?

  • It isn't very obvious to me in terms of how you are thinking through this.

    對我來說,你是如何思考這個問題的,這並不是很明顯。

  • Also, what is going to be the regulatory pathway?

    另外,監管途徑將是什麼?

  • Would you all have to do new clinical trials for this new energy modality?

    你們都需要對這種新能源方式進行新的臨床試驗嗎?

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • It's a really great question, Suraj, and I think there's a lot of questions to be answered about what the additional clinical benefit is going to be for PFA.

    Suraj,這是一個非常好的問題,我認為關於 PFA 的額外臨床益處還有很多問題需要回答。

  • As I mentioned, we have great cryo and great RF.

    正如我所提到的,我們擁有出色的冷凍技術和出色的射頻技術。

  • We do believe that with obviously all of the excitement around this energy source, that it was imperative and important for us to basically bring it into our products as well so we could offer it as a solution.

    我們確實相信,顯然,圍繞這種能源的所有令人興奮的事情,對我們來說將其納入我們的產品中是必要且重要的,這樣我們就可以將其作為解決方案提供。

  • I think whether or not it is more efficacious than the cryo or the RF is to be determined at this point in time.

    我認為它是否比冷凍或射頻更有效需要在此時確定。

  • When it comes to the clamp technologies, it really, quite frankly, is something that we have to learn through the trials that we have to run relative to going into that area.

    當談到夾具技術時,坦白說,我們必須透過與進入該領域相關的試驗來學習這些技術。

  • Relative to the MIS space and putting it onto like an EPi-Sense-like type device, that's where speed is going to probably matter a little bit because you'll be able to kind of take out some of the time relative to that.

    相對於 MIS 空間並將其放置在類似 EPi-Sense 類型的裝置上,速度可能會更重要,因為您將能夠節省一些相對於此的時間。

  • On the open cardiac side, you can take out some speed, but it's not, that's not where the time is based on the time on the open cardiac with the clamps is mostly in getting access to it, not necessarily in the time for using RF per se.

    在心臟直視方面,您可以採取一些速度,但事實並非如此,這不是時間基於使用夾鉗進行心臟直視的時間,主要是為了接近它,不一定是在使用射頻的時間本身。

  • That's different on the MIS side.

    MIS 方面的情況有所不同。

  • And so there will be a different use case for it from that standpoint.

    因此,從這個角度來看,它會有不同的用例。

  • So that's some of the thought process behind it.

    這就是背後的一些思考過程。

  • I think we have to have it.

    我認為我們必須擁有它。

  • I think it's an important energy to study and to learn about.

    我認為這是研究和學習的重要能量。

  • I believe that the FDA has made it very clear that the PFA technology, epicardially, will likely have to go down a PMA-type pathway.

    我相信 FDA 已經明確表示,從心外膜角度來看,PFA 技術可能必須走 PMA 型途徑。

  • And so we're anticipating, that's why I say we'll give timelines and guidelines in the future about what that might look like once we're kind of at that point.

    所以我們正在預期,這就是為什麼我說我們將來會給出時間表和指導方針,說明一旦我們到了那個點,情況可能會是什麼樣子。

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • Fair enough.

    很公平。

  • Mike, appreciate the transparency.

    麥克,欣賞透明度。

  • Angie, one question for you.

    安吉,問你一個問題。

  • What was ASP contribution for the new line of cryoSPHERE probes?

    ASP 對新的 CryoSPHERE 探針系列有何貢獻?

  • I guess just for pain management, what was the net ASP impact in the quarter?

    我想僅就疼痛管理而言,本季的淨 ASP 影響是多少?

  • Thank you for taking my questions.

    感謝您回答我的問題。

  • Angela Wirick - Chief Financial Officer

    Angela Wirick - Chief Financial Officer

  • Suraj, good question.

    蘇拉吉,好問題。

  • Almost nothing.

    幾乎什麼都沒有。

  • The majority of the revenue was the cryoSPHERE+. cryoSPHERE Max, not a big contributor in the third quarter. cryoSPHERE+ is at the same ASP as our legacy cryoSPHERE devices.

    大部分收入來自 CryoSPHERE+。 CryoSPHERE Max,在第三季的貢獻並不是很大。 CryoSPHERE+ 的 ASP 與我們傳統的 CryoSPHERE 裝置相同。

  • So when you see 29.6% growth in the quarter, that is all volume growth.

    因此,當您看到本季 29.6% 的成長時,這就是銷量成長。

  • Suraj Kalia - Analyst

    Suraj Kalia - Analyst

  • Fantastic.

    極好的。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • I'm showing no further questions at this time.

    我目前沒有提出任何進一步的問題。

  • I would now like to turn it back to Mike Carrel for closing remarks.

    現在我想請麥克·卡雷爾(Mike Carrel)發表結束語。

  • Michael Carrel - President, Chief Executive Officer, Director

    Michael Carrel - President, Chief Executive Officer, Director

  • Great.

    偉大的。

  • Again, everyone, thank you for joining us today, and we look forward to talking to you after the fourth-quarter call.

    再次感謝大家今天加入我們,我們期待在第四季度電話會議後與您交談。

  • Have a great evening.

    祝您有個美好的夜晚。

  • Bye now.

    再見了。

  • Operator

    Operator

  • This concludes today's conference call.

    今天的電話會議到此結束。

  • Thank you for participating.

    感謝您的參與。

  • You may now disconnect.

    您現在可以斷開連線。