AtriCure Inc (ATRC) 2023 Q4 法說會逐字稿

Good afternoon, and welcome to AtriCure's Fourth Quarter and Full Year 2023 Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.

下午好，歡迎參加 AtriCure 2023 年第四季和全年財報電話會議。 （操作員說明）謹此提醒，此通話正在錄音以供重播之用。

I would now like to turn the call over to Marissa Bych from the Gilmartin Group for 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)，徵求介紹性意見。

Great. Thank you and good afternoon. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call (513) 644-4484 to have one e-mailed to you.

偉大的。謝謝你，下午好。到目前為止，您應該已經收到了收益新聞稿的副本。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. 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. 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, reimbursement and clinical trial outcomes. AtriCure's results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any 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。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。這些聲明包括但不限於財務預期和指導、對 AtriCure 特許經營和成長計劃的潛在市場機會的預期、未來產品批准、許可、報銷和臨床試驗結果。 AtriCure 的結果可能與預期的結果有重大差異。 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 revenue reported on a constant currency basis, adjusted EBITDA and adjusted loss per share. 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.

此外，我們也參考非公認會計準則財務指標，特別是以固定匯率計算的收入、調整後的 EBITDA 和調整後的每股虧損。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.

說到這裡，我想將電話轉給總裁兼執行長 Mike Carrel。

Good afternoon, and thank you for joining us today. 2023 was an exceptional year at AtriCure, and I am proud to report a strong finish with fourth quarter growth of 21%, showing robust momentum throughout our entire business. Our full year revenue of $399 million represents 21% over 2022, our third consecutive year of above 20% revenue growth.

下午好，感謝您今天加入我們。 2023 年對 AtriCure 來說是不平凡的一年，我很自豪地報告第四季度增長 21% 的強勁業績，顯示出我們整個業務的強勁勢頭。我們的全年營收為 3.99 億美元，比 2022 年成長 21%，這是我們連續第三年營收成長超過 20%。

And globally, we saw increasing adoption of our broad portfolio of products for the treatment of atrial fibrillation, the left atrial appendage and postoperative pain. Our patient impact extended further than before, resulting in the achievement of our 1 millionth patient treated with AtriCure technology.

在全球範圍內，我們看到越來越多的人採用我們廣泛的產品組合來治療心房顫動、左心耳和術後疼痛。我們對患者的影響比以前進一步擴大，第 100 萬例患者接受了 AtriCure 技術的治療。

In addition, our top line performance -- in addition, our top line performance and increasing leverage drove $19 million of positive adjusted EBITDA in 2023, making significant progress towards sustained profitability throughout our business.

此外，我們的營收業績——此外，我們的營收業績和不斷增加的槓桿率在 2023 年推動了 1900 萬美元的正調整 EBITDA，在整個業務的持續盈利方面取得了重大進展。

Before sharing operational highlights of the fourth quarter of 2023, I would like to frame the opportunity in front of AtriCure now. We identify markets where patients are underserved and create standards of care to improve these patients' lives. We know that creating new standards of care requires sustained investment in innovation, clinical science and comprehensive education and awareness. Investing across these areas has allowed us to unlock new opportunities over the last 2 decades, and we are now positioned to offer solutions for millions of patients worldwide. This translates to a more than $5 billion global market opportunity today with significant potential to expand our market opportunity in the future.

在分享 2023 年第四季的營運亮點之前，我想先介紹一下 AtriCure 面臨的機會。我們確定患者服務不足的市場，並制定護理標準以改善這些患者的生活。我們知道，創建新的護理標準需要對創新、臨床科學以及全面的教育和意識進行持續投資。在過去 20 年裡，對這些領域的投資使我們能夠釋放新的機遇，現在我們能夠為全球數百萬名患者提供解決方案。這相當於今天超過 50 億美元的全球市場機會，並且具有擴大我們未來市場機會的巨大潛力。

AtriCure is in a unique position as a leader in each of our markets with every market still significantly underpenetrated. Therefore, we remain focused on driving adoption as well as identifying and cultivating new opportunities to drive strong growth for many years to come. As such, we are reiterating our expectations for full year 2024 revenue of $459 million to $466 million, reflecting 15% to 17% growth over 2023. We are also reaffirming our expectations to achieve adjusted EBITDA of $26 million to $29 million for the full year, with improvements annually thereafter as we progress towards positive cash flow.

AtriCure 作為我們每個市場的領導者都處於獨特的地位，而每個市場的滲透率仍顯著不足。因此，我們仍然專注於推動採用以及識別和培育新機會，以推動未來許多年的強勁成長。因此，我們重申 2024 年全年營收為 4.59 億至 4.66 億美元的預期，較 2023 年增長 15% 至 17%。我們也重申全年調整後 EBITDA 為 2,600 萬至 2,900 萬美元的預期，隨著我們向正現金流邁進，此後每年都會有所改善。

Now shifting to highlights of the quarter and 2023. Starting with the open ablation franchise, where our ablation solutions for the treatment of Afib are used concomitant to open heart surgery. In the fourth quarter, we surpassed 10,000 patients treated with our EnCompass Clamp and achieved the best quarter yet for EnCompass Clamp sales, which accounted for nearly half of our U.S. open ablation revenue for the quarter. The uptake of this product has been extraordinary since the broad commercial launch in early 2022. At the recent Society of Thoracic Surgeons Conference, I heard from many surgeons about the impact this device is having on patients, expanding our reach throughout cardiac surgery procedures.

現在轉向本季和 2023 年的亮點。從開放式消融專營權開始，我們用於治療心房顫動的消融解決方案與心臟直視手術同時使用。第四季度，我們使用 EnCompass Clamp 治療的患者數量超過 10,000 名，實現了 EnCompass Clamp 銷售迄今為止最好的季度，占我們該​​季度美國開放式消融收入的近一半。自2022 年初廣泛商業推出以來，該產品的受歡迎程度非常高。在最近舉行的胸腔外科醫生協會會議上，我從許多外科醫生那裡聽到了該設備對患者的影響，擴大了我們在整個心臟手術過程中的影響範圍。

Globally, our open ablation franchise achieved 21% annual growth in 2023, showing a continued elevation over historical growth rates in this franchise. As we begin 2024, we are confident in the increasing adoption of the EnCompass Clamp in the United States and look forward to the European launch later in the year and other markets in the future.

在全球範圍內，我們的開放式消融特許經營業務在 2023 年實現了 21% 的年增長率，顯示該特許經營業務的歷史增長率持續上升。 2024 年伊始，我們對 EnCompass Clamp 在美國得到越來越多的採用充滿信心，並期待今年稍後在歐洲和其他市場推出。

Next, turning to appendage management. AtriClip products for left atrial appendage closure in both open heart and minimally invasive procedures remain a foundation of our business. In many markets around the world, AtriClip devices are leading our growth as left atrial appendage management becomes the standard of care in cardiac surgery. We are excited to have seen the STS, AHA and ACC all elevate surgical LAA exclusion to Class 1A within their guidelines recently. And we expect this evolution in guidelines to propel strong, continued growth for our business.

接下來，轉向附屬物管理。用於心臟直視和微創手術中左心耳封堵的 AtriClip 產品仍然是我們業務的基礎。在世界各地的許多市場，隨著左心耳管理成為心臟手術的護理標準，AtriClip 設備正在引領我們的成長。我們很高興看到 STS、AHA 和 ACC 最近都在其指南中將左心耳手術排除提升至 1A 級。我們預計指導方針的這一演變將推動我們業務的強勁、持續成長。

Overall, our appendage management business grew 21% in 2023, and we closed out the year with an acceleration in quarterly growth at 24% for the fourth quarter. Our growth was driven primarily by sales of AtriClip FLEX V, PRO2 and PRO V devices, reflecting strong attachment to both open and minimally invasive procedures and is indicative of the immense opportunity that is still ahead. To that end, we celebrated a milestone in 2023 with more than 0.5 million AtriClip devices sold to date. This milestone stands on AtriCure's long-standing commitment and decades of innovation and research, which we are continuing in 2024 and beyond.

總體而言，我們的肢體管理業務在 2023 年成長了 21%，並以第四季 24% 的季度成長加速結束了這一年。我們的成長主要是由 AtriClip FLEX V、PRO2 和 PRO V 設備的銷售所推動的，這反映出我們對開放式和微創手術的強烈依戀，也顯示了未來仍然存在巨大的機會。為此，我們在 2023 年慶祝了一個里程碑，迄今已售出超過 50 萬台 AtriClip 設備。這一里程碑體現了 AtriCure 的長期承諾以及數十年的創新和研究，我們將在 2024 年及以後繼續進行這些創新和研究。

In late 2023, we submitted a 510(k) clearance notification to the FDA for our next-generation AtriClip device, the FLEX Mini, which builds off our proven technology to increase ease of use and significantly decrease the size of our AtriClip device, which already has the smallest profile on the market. We anticipate clearance in late 2024 with the U.S. launch following quickly thereafter.

2023 年末，我們向 FDA 提交了下一代 AtriClip 設備 FLEX Mini 的 510(k) 許可通知，該設備基於我們經過驗證的技術，可提高易用性並顯著減小 AtriClip 設備的尺寸，已經擁有市場上最小的外形。我們預計將於 2024 年底獲得批准，隨後很快在美國推出。

Additionally, to extend our potential patient impact, we are actively investigating the application of AtriClip devices in patients with preoperative AFib diagnosis through our LeAAPS clinical trial. The LeAAPS trial seeks to demonstrate a clinically meaningful reduction in ischemic and systemic atrial -- or arterial embolism differentiating our AtriClip product from all other appendage management options in cardiac surgery and expanding our addressable markets globally.

此外，為了擴大我們對患者的潛在影響，我們正在透過 LeAAPS 臨床試驗積極研究 AtriClip 設備在術前診斷為 AFib 的患者中的應用。 LeAAPS 試驗旨在證明對缺血性和系統性心房或動脈栓塞的減少具有臨床意義，從而使我們的 AtriClip 產品與心臟手術中所有其他附件管理選項區分開來，並擴大我們的全球潛在市場。

Enrollment in LeAAPS began in late January 2023 and accelerated throughout the year. We ended 2023 far ahead of our internal expectations, and as of today, we have enrolled over 1,700 patients in the study. We are expanding clinical trial sites in 2024 and expect first enrollment from centers in Europe in the coming weeks. While the trial will take several years to complete, the pace of enrollment both validates our decision to embark on this trial and underscores the excitement from clinicians and patients.

LeAAPS 的註冊於 2023 年 1 月下旬開始，並全年加速。我們在 2023 年結束時遠遠超出了我們的內部預期，截至今天，我們已招募了 1,700 多名患者參加研究。我們將在 2024 年擴大臨床試驗地點，預計未來幾週內將在歐洲的中心進行首次招募。雖然試驗需要幾年時間才能完成，但入組速度既證實了我們進行這項試驗的決定，也凸顯了臨床醫師和病患的興奮。

Moving now to our pain management franchise, where our cryoSPHERE probe provides temporary relief for postoperative pain. Since the launch in 2019, the cryoSPHERE device has exhibited remarkable growth with full year 2023 revenue exceeding $50 million worldwide, reflecting growth of 26% year-over-year. The base of accounts we serve has expanded just as rapidly, and we saw more than 750 accounts purchasing globally in 2023.

現在轉向我們的疼痛管理專營權，我們的 CryoSPHERE 探針可暫時緩解術後疼痛。自 2019 年推出以來，cryoSPHERE 設備表現出顯著成長，2023 年全年全球收入超過 5,000 萬美元，較去年同期成長 26%。我們服務的客戶群也迅速擴大，到 2023 年，我們發現全球有超過 750 個客戶購買。

That said, to capitalize on the full market potential, we have several parallel efforts underway to add growth drivers for this business. First, our next-generation technology, the cryoSPHERE Plus probe, was cleared by the FDA in the fourth quarter. The cryoSPHERE Plus device will enable faster ablations, improving efficiency of procedures. Recently, we completed the first procedures with this device with a 25% reduction in ablation time. We expect to move to full launch in the second quarter. We are also conducting economic studies and partnering with multiple centers to expand clinical data to better illustrate the value proposition of Cryo Nerve Block therapy. We will continue to invest in commercial resources worldwide to promote awareness for this important alternative to traditional pain management practices.

也就是說，為了充分利用市場潛力，我們正在進行多項並行努力，以增加該業務的成長動力。首先，我們的下一代技術 CryoSPHERE Plus 探針已於第四季度獲得 FDA 批准。 CryoSPHERE Plus 設備將實現更快的消融速度，提高手術效率。最近，我們使用該設備完成了首個手術，消融時間縮短了 25%。我們預計將在第二季全面推出。我們也正在進行經濟研究，並與多個中心合作，擴大臨床數據，以便更好地說明冷凍神經阻斷療法的價值主張。我們將繼續投資全球商業資源，以提高人們對這種傳統疼痛管理實踐的重要替代方案的認識。

Lastly, while we focus on driving adoption in thoracic and sternotomy procedures, we are carefully evaluating potential new applications and market opportunities for Cryo Nerve Block therapy and look forward to updating you on progress.

最後，在我們專注於推動胸部和胸骨切開手術的採用的同時，我們正在仔細評估冷凍神經阻斷療法的潛在新應用和市場機會，並期待向您通報最新進展。

Finally, rounding out our portfolio is Hybrid AF therapy, focusing on standalone treatment of the millions of patients with long-standing persistent Afib. We ended 2023 on a high note with 27% year-over-year franchise growth in the fourth quarter. As I've said on several calls over the past year, 2023 was a building year for Hybrid AF therapy to ensure a strong foundation for lasting success throughout our accounts and leading to accelerating growth in the future. We were thoughtful about partnering with our customers to address workflow challenges and comprehensively understand their needs for program expansion. Our fourth quarter results confirmed that our work throughout 2023 is having an impact, and we will continue our efforts into 2024.

最後，我們的產品組合是混合性心房顫動療法，專注於對數百萬長期持續性心房顫動患者進行獨立治療。我們以高調結束 2023 年，第四季特許經營業務年增 27%。正如我在過去一年中多次電話會議中所說的那樣，2023 年是混合 AF 療法的建設年，以確保為我們整個客戶的持久成功奠定堅實的基礎，並導致未來加速增長。我們深思熟慮地與客戶合作解決工作流程挑戰並全面了解他們對專案擴展的需求。我們第四季的業績證實了我們 2023 年全年的工作正在產生影響，我們將繼續努力到 2024 年。

We expect 2024 to be an exciting year for standalone treatment of Afib as peers introduced PFA catheter technology in the U.S. market. The focus on more efficient endocardial ablation driven by PFA should provide a tailwind for everyone in the Afib market. Our hybrid approach remains complementary to PFA, just as it is complementary to other energy sources used in endocardial procedures. Further, AF therapy remains the only proven solution for long -- Hybrid AF therapy remains the only proven solution for long-standing persistent Afib patients.

我們預計 2024 年將是心房顫動獨立治療令人興奮的一年，因為同行將 PFA 導管技術引入美國市場。由 PFA 驅動的對更有效心內膜消融的關注應該為心房顫動市場中的每個人提供順風。我們的混合方法仍然是 PFA 的補充，就像它是心內膜手術中使用的其他能源的補充一樣。此外，心房顫動治療仍然是唯一經過驗證的長期解決方案—混合性心房顫動治療仍然是長期持續性心房顫動患者唯一經過驗證的解決方案。

In addition to our CONVERGE trial results, there is a rapidly growing body of clinical evidence from independent studies and registries showing catheter ablation alone is not an effective treatment for patients with advanced Afib. In 2023, data from our CEASE AF study and DEEP AF clinical trial provided even more support for a hybrid approach. Moreover, recent updates to clinical guidelines published by AHA and ACC demonstrate the importance of Hybrid AF therapy. As such, we will continue to build our program development efforts with the goal of cementing efficient, scalable workflows for a broader base of customers. We have a strong conviction in the accelerating adoption of our Hybrid AF therapy for the millions of patients suffering from long-standing persistent atrial fibrillation.

除了我們的 CONVERGE 試驗結果之外，來自獨立研究和登記的越來越多的臨床證據表明，單獨使用導管消融並不是治療晚期心房顫動患者的有效方法。 2023 年，我們的 CEASE AF 研究和 DEEP AF 臨床試驗的數據為混合方法提供了更多支持。此外，AHA 和 ACC 發布的臨床指南最近更新證明了混合 AF 治療的重要性。因此，我們將持續加強專案開發工作，目標是為更廣泛的客戶群鞏固高效、可擴展的工作流程。我們堅信，我們的混合性心房顫動療法將加速為數百萬患有長期持續性心房顫動的患者所採用。

In summary, 2023 was another truly exceptional year for AtriCure, defined by major milestones and patient impact and accelerating top and bottom line growth. We are excited to carry this momentum into 2024 as we advance adoption of our therapies and invest in future growth prospects that will propel AtriCure forward for many years to come. And with that, I will turn the call over to Angie Wirick, our Chief Financial Officer. Angie?

總之，2023 年對 AtriCure 來說是另一個真正非凡的一年，它實現了重大里程碑和患者影響，並加速了營收和利潤的成長。我們很高興能夠將這一勢頭延續到 2024 年，因為我們將推進我們的療法的採用，並投資於未來的成長前景，這將推動 AtriCure 在未來許多年向前發展。接下來，我會將電話轉給我們的財務長 Angie Wirick。安吉？

Thank you, Mike.

謝謝你，麥克。

Our fourth quarter 2023 worldwide revenue of $106.5 million increased 21% on a reported basis and 20.5% on a constant currency basis when compared to the fourth quarter of 2022. U.S. revenue was $88.8 million, a 20.1% increase from the fourth quarter of 2022, reflecting robust activity across each franchise, highlighted by an uptick in adoption of our Hybrid AF therapy, representing 30.6% growth for the quarter, along with continued strength from key appendage management, open ablation and pain management products.

與2022 年第四季相比，我們2023 年第四季的全球營收為1.065 億美元，按報告基礎成長21%，以固定匯率計算成長20.5%。美國營收為8,880 萬美元，比2022 年第四季度成長20.1%，反映了每個特許經營店的強勁活動，其中突出的是我們的混合AF 療法的採用率上升，本季度增長30.6%，以及關鍵附件管理、開放式消融和疼痛管理產品的持續增長。

International revenue totaled $17.8 million, up 25.8% on a reported basis and up 22.1% on a constant currency basis as compared to the fourth quarter of 2022. We continue to see strong demand for our differentiated solutions in major international markets with significant growth in appendage management and pain management. Sequentially, worldwide sales grew $8.3 million or 8.4% over Q3 2023.

國際營收總計1,780 萬美元，與2022 年第四季相比，按報告計算成長25.8%，以固定匯率計算成長22.1%。我們繼續看到主要國際市場對我們差異化解決方案的強勁需求，附屬產品顯著成長管理和疼痛管理。隨後，全球銷售額比 2023 年第三季成長了 830 萬美元，即 8.4%。

Gross margin for the fourth quarter 2023 was 74.9%, up 94 basis points from fourth quarter of 2022. The increase was driven primarily by favorable production efficiencies, partially offset by less favorable geographic and product mix.

2023 年第四季的毛利率為 74.9%，比 2022 年第四季成長 94 個基點。這一成長主要是由有利的生產效率推動的，但部分被不利的地理和產品組合所抵消。

Fourth quarter 2023 research and development expenses increased $7 million, or 51%, and SG&A expenses increased $12.2 million, or 22%, over the fourth quarter 2022.

與 2022 年第四季相比，2023 年第四季的研發費用增加了 700 萬美元，即 51%，SG&A 費用增加了 1,220 萬美元，即 22%。

Turning to the bottom line, we drove positive adjusted EBITDA of $4.8 million for the fourth quarter 2023 compared to positive adjusted EBITDA of $6 million for the fourth quarter of 2022. While we are continuing to drive improvement to gross margin and realizing operating leverage in our commercial and administrative infrastructure, we experienced a significant increase in research and development costs in the fourth quarter of 2023 due to the rapid enrollment and expansion of our LeAAPS clinical trial and multiple product development initiatives underway. Our loss per share and adjusted loss per share was $0.21 for the fourth quarter 2023 compared to a loss per share and adjusted loss per share of $0.09 for the fourth quarter of 2022.

談到利潤，我們在 2023 年第四季實現了 480 萬美元的正調整 EBITDA，而 2022 年第四季的正調整 EBITDA 為 600 萬美元。在我們繼續推動毛利率改善並實現營運槓桿的同時，在商業和行政基礎設施方面，由於LeAAPS 臨床試驗的快速註冊和擴大以及正在進行的多項產品開發計劃，我們的研發成本在2023 年第四季大幅增加。 2023 年第四季的每股虧損和調整後每股虧損為 0.21 美元，而 2022 年第四季的每股虧損和調整後每股虧損為 0.09 美元。

Now to review full year 2023 results. Worldwide revenue was $399.2 million, an increase of 20.8% on a reported basis and 20.6% on a constant currency basis. U.S. sales increased 20.3% to $333.5 million. And international sales increased 23.5%, or 22.1% on a constant currency basis, to $65.7 million. The continued expansion of the EnCompass Clamp drove U.S. open ablation sales to $105.3 million or 22.3% growth over 2022.

現在回顧 2023 年全年業績。全球營收為 3.992 億美元，按報告計算成長 20.8%，以固定匯率計算成長 20.6%。美國銷售額成長 20.3%，達到 3.335 億美元。國際銷售額成長 23.5%，以固定匯率計算成長 22.1%，達到 6,570 萬美元。 EnCompass Clamp 的持續擴張推動美國開放式消融銷售額達到 1.053 億美元，比 2022 年成長 22.3%。

In 2023, our U.S. pain management franchise grew 23.1% to $49.2 million from increasing activity in existing accounts, along with the new account adoption. U.S. MIS revenue was $44.6 million, reflecting single digit growth in our legacy device sales, bolstered by approximately 18% growth in EPi-Sense sales, where we are successfully laying the groundwork for long-term growth.

2023 年，由於現有帳戶活動的增加以及新帳戶的採用，我們的美國疼痛管理特許經營權增長了 23.1%，達到 4,920 萬美元。美國 MIS 收入為 4,460 萬美元，反映了我們傳統設備銷售的個位數成長，這得益於 EPi-Sense 銷售約 18% 的成長，我們正在成功為長期成長奠定基礎。

2023 U.S. appendage management sales reached $134.5 million, a 19.5% increase over 2022, driven largely by our AtriClip FLEX V device. And much like U.S. trends in activity in 2023, our international revenue growth was propelled by appendage management, open ablation and pain management products.

2023 年美國肢體管理銷售額達到 1.345 億美元，比 2022 年成長 19.5%，這主要是由我們的 AtriClip FLEX V 設備推動的。與美國 2023 年的活動趨勢非常相似，我們的國際收入成長是由肢體管理、開放式消融和疼痛管理產品所推動的。

Gross margin for the year ended at 75.2%, an increase of 79 basis points from 2022. Similar to our fourth quarter results, the increase in gross margin reflects production efficiencies realized throughout the year, partially offset by less favorable geographic and product mix.

截至本年度的毛利率為75.2%，較2022 年成長79 個基點。與第四季的業績類似，毛利率的成長反映了全年實現的生產效率，部分被不太有利的地域和產品組合所抵消。

Moving to operating expenses. Full year 2023 operating expenses increased 13.3% to $327.1 million from $288.6 million in 2022. Research and development costs expanded by $16.6 million, or 28.9%, on both clinical trial and product development project spend as we extend our pipeline with clinical evidence and innovation. SG&A expenses increased $21.9 million, or 9.5%, with leverage in our training and education programs, commercial team and infrastructure driving down operating expenses as a portion of revenue, in addition to a one-time benefit in 2023 from legal settlements. We remain focused on continued efficiencies in SG&A while maintaining investments in R&D for future expansion.

轉向營運費用。 2023 年全年營運費用從2022 年的2.886 億美元增加13.3% 至3.271 億美元。隨著我們透過臨床證據和創新擴展我們的產品線，臨床試驗和產品開發項目支出的研發成本增加了1,660 萬美元，即28.9%。 SG&A 費用增加了 2,190 萬美元，即 9.5%，除了 2023 年法律和解帶來的一次性收益外，我們的培訓和教育計劃、商業團隊和基礎設施的影響力降低了營運費用佔收入的一部分。我們仍專注於持續提高SG&A效率，同時維持對研發的投資以因應未來的擴張。

Full year 2023 adjusted EBITDA was positive $19.4 million compared to a negative $2.2 million in 2022, an improvement of $21.6 million. Our loss per share was $0.66 in 2023 compared to a loss per share of $1.02 in 2022. Adjusted loss per share was $0.75 and $1.02, respectively. We ended 2023 with $137.3 million of cash and investments, a robust working capital position and the flexibility to fund future opportunities and investments.

2023 年全年調整後 EBITDA 為正 1,940 萬美元，而 2022 年為負 220 萬美元，增加了 2,160 萬美元。 2023 年每股虧損為 0.66 美元，而 2022 年每股虧損為 1.02 美元。調整後每股虧損分別為 0.75 美元和 1.02 美元。截至 2023 年，我們擁有 1.373 億美元的現金和投資、強勁的營運資金狀況以及為未來機會和投資提供資金的靈活性。

Finally, turning to our outlook for 2024. Consistent with our guidance in early January, we expect to achieve between $459 million and $466 million in revenue for the year, reflecting growth of 15% to 17% over full year 2023 results. Embedded in our guidance is the assumption that product innovation and supporting clinical data will propel us to 15% growth and beyond. Also included in our guidance are market dynamics that include increasing competition. As we look at our progress with market development and the opportunities of each franchise, we expect our franchise growth rates in the United States to align closely with our expectations of 15% to 17% annual growth.

最後，轉向我們對 2024 年的展望。與我們 1 月初的指導一致，我們預計全年收入將在 4.59 億美元至 4.66 億美元之間，較 2023 年全年業績增長 15% 至 17%。我們的指導中包含這樣的假設：產品創新和支持性臨床數據將推動我們實現 15% 甚至更高的成長。我們的指導也包括市場動態，包括日益激烈的競爭。當我們審視市場開發的進展和每個特許經營的機會時，我們預計我們在美國的特許經營增長率將與我們 15% 至 17% 的年增長率的預期緊密一致。

We continue to see growth in our pain management business through deepening use in thoracic procedures and the addition of clinical data to lead to even wider acceptance of this therapy. We believe the exceptional adoption of our EnCompass Clamp will continue to drive performance in open ablation while broader progress with Hybrid AF therapy using our EPi-Sense system to lift MIS ablation growth in 2024. Complementing these drivers is our AtriClip products, which we see continuing delivery of steady growth over the large base of revenue.

透過深化在胸部手術中的使用以及增加臨床數據，我們的疼痛管理業務不斷增長，從而使這種療法得到更廣泛的接受。我們相信，EnCompass Clamp 的出色採用將繼續推動開放式消融的性能，同時使用我們的EPi-Sense 系統的混合AF 治療將取得更廣泛的進展，以提升2024 年MIS 消融的增長。我們的AtriClip 產品將補充這些驅動力，我們認為該產品將繼續發展在龐大的收入基礎上實現穩定成長。

Additionally, we anticipate our international growth to remain on pace with the United States in 2024 and beyond. In terms of revenue cadence for the year, we expect typical seasonality to inform 2024 with first quarter revenue likely to be flat to our fourth quarter of 2023. From a margin perspective, we expect 2024 gross margin to be in line with our 2023 results with potential for modest improvement from cost savings initiatives later this year. We anticipate headwinds from product and geographic mix as well as increasing material costs to be offset by continued production efficiencies and leveraging scale within our operations as we grow.

此外，我們預計 2024 年及以後我們的國際成長將與美國保持同步。就今年的收入節奏而言，我們預計典型的季節性因素將影響2024 年的情況，第一季的收入可能與2023 年第四季持平。從利潤率的角度來看，我們預計2024 年的毛利率將與我們2023 年的業績一致今年稍後的成本節約舉措有可能略有改善。我們預計，隨著我們的發展，產品和地理組合帶來的不利因素以及不斷增加的材料成本將透過持續的生產效率和利用我們營運中的規模來抵消。

And as we have said before, our primary focus with capital allocation is to incubate the next set of growth drivers for AtriCure. Therefore, we expect to maintain R&D as a percentage of revenue at roughly 19% to 20% in 2024. Our spending across SG&A will continue to moderate in proportion to revenue, providing leverage and sustained improvement to profitability. With these priorities in mind, we expect full year 2024 adjusted EBITDA to range from $26 million to $29 million, translating to an adjusted loss per share of approximately $0.74 to $0.82. We also anticipate a moderate cash burn in 2024 against our strong cash balance and capital position. And as a reminder, our first quarter expense profile is typically highest. Variable compensation payouts, share vesting and other operational needs will drive the higher overall cash burn and modest bottom line results.

正如我們之前所說，我們資本配置的主要重點是為 AtriCure 孵化下一組成長動力。因此，我們預計到 2024 年，研發費用佔收入的比例將保持在 19% 至 20% 左右。我們的 SG&A 支出將繼續按收入比例減少，從而提供槓桿並持續改善盈利能力。考慮到這些優先事項，我們預計 2024 年全年調整後 EBITDA 範圍為 2,600 萬美元至 2,900 萬美元，相當於調整後每股虧損約為 0.74 至 0.82 美元。我們也預計，鑑於我們強勁的現金餘額和資本狀況，2024 年將出現適度的現金消耗。提醒一下，我們第一季的支出狀況通常是最高的。可變的薪酬支出、股票歸屬和其他營運需求將推動整體現金消耗的增加和利潤的適度成長。

As I turn the call back to Mike for closing comments, I would like to reiterate 2023 was a stellar year at AtriCure. From expanding patient impact and revenue growth to realizing positive adjusted EBITDA, our results stem from the powerful collaboration of my AtriCure teammates. We enter 2024 with an unrelenting dedication to the patients we serve and drive to continue our financial progress. Mike?

當我將電話轉回給 Mike 進行總結評論時，我想重申 2023 年對 AtriCure 來說是輝煌的一年。從擴大病患影響力和收入成長到實現正調整 EBITDA，我們的成果源自於我的 AtriCure 團隊成員的強而有力的合作。進入 2024 年，我們將不懈地致力於為我們服務的患者提供服務，並推動我們的財務持續進步。麥克風？

Thank you, Angie. I would like to close by congratulating our entire team on an incredible 2023. Patient outcomes are our guiding principle, and we are most proud of that at AtriCure. Your teamwork led to over 100,000 patients treated this year and over 1 million in our company's history. We are making a difference for patients with advanced forms of Afib, higher risk of stroke and pain after surgery. As we grow and evolve in the future, patient outcomes will continue to drive our efforts as we capitalize on our leadership in these markets. And with that, I will turn it over to the operator for questions.

謝謝你，安吉。最後，我想祝賀我們整個團隊度過了令人難以置信的 2023 年。患者的治療結果是我們的指導原則，我們對此感到最自豪。你們的團隊合作使今年治療了超過 10 萬名患者，在我們公司的歷史上治療了超過 100 萬名患者。我們正在為患有晚期心房顫動、中風和術後疼痛風險較高的患者帶來改變。隨著我們未來的成長和發展，隨著我們利用我們在這些市場的領導地位，患者的治療結果將繼續推動我們的努力。然後，我會將其轉交給接線員詢問。

(Operator Instructions) Our first question comes from the line of Robbie Marcus with JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的羅比·馬庫斯（Robbie Marcus）。

Congrats on a good quarter. I wanted to start on the clip business and minimally invasive. Had good fourth quarters, beat expectations. Just, you kind of talked about it broadly, but maybe a little more specifically, how you're thinking about those 2 relative to open and pain as we progress into 2024.

恭喜季度表現良好。我想開始夾子業務和微創業務。第四季表現良好，超出預期。只是，您廣泛地談論了這個問題，但也許更具體一點，當我們進入 2024 年時，您如何看待這兩個相對於開放和痛苦的問題。

Yes. Robbie, thanks for the comments. I think as you heard in the scripted comments, when we look at the guidance for the year, our expectation is that in the U.S., the growth rates of each franchise are pretty tightly coupled around the corporate average. I think unlike what we were saying in 2023 based on kind of our expectations of the year of having some franchises as outperforming and some franchises kind of falling below the corporate growth rate, given the progress within each franchise and kind of development opportunities, would expect them to be more closely aligned around the corporate growth rate.

是的。羅比，謝謝你的評論。我認為，正如您在腳本評論中聽到的那樣，當我們查看今年的指導時，我們的預期是，在美國，每個特許經營權的增長率與企業平均水平緊密相關。我認為，與我們在2023 年所說的不同，我們對這一年的預期是，考慮到每個特許經營權的進展和發展機會，一些特許經營權表現出色，而一些特許經營權則低於公司成長率。它們與企業成長率更加緊密地結合在一起。

Great. And I guess I have to ask, just given all the investor angst around your competitor Medtronic launching, an AtriClip competitor, what you're seeing so far in the field in 2024 so far. How the sales force is reacting to it and any feedback you have from physicians.

偉大的。考慮到投資者對您的競爭對手美敦力（Medtronic）（AtriClip 競爭對手）的推出感到擔憂，我想我必須問一下，您在 2024 年迄今為止在該領域看到了什麼。銷售人員對此有何反應以及您從醫生那裡得到的任何回饋。

I appreciate the second question there, Robbie. I'll handle it from a couple of different angles. I'd say first is just a reminder, we welcome competition. We think it's actually a really good thing and validates the market. And what I mean by that is that there -- as we talked about, we're still less than 5% penetrated in the overall worldwide market. There are over 2 million patients that undergo cardiac surgery worldwide. Less than 5% or so actually have an AtriClip or their appendage managed today. We have really big opportunities in front of us as we continue to invest in innovation. We're talking about the FLEX Mini product coming out later on this year, which is our 8th generation of the AtriClip product. In addition to that, we're investing in clinical evidence with the LeAAPS trial to show a stroke reduction for patients that are undergoing cardiac surgery. So we're making the necessary investments on those particular fronts.

我很欣賞第二個問題，羅比。我將從幾個不同的角度來處理它。我首先想說的是，我們歡迎競爭。我們認為這實際上是一件非常好的事情並且驗證了市場。我的意思是，正如我們所討論的，我們在全球整個市場的滲透率仍然不到 5%。全球有超過 200 萬名患者接受心臟手術。如今，只有不到 5% 左右的人實際上擁有 AtriClip 或其附屬物。當我們繼續投資創新時，我們面臨著巨大的機會。我們談論的是今年稍後推出的 FLEX Mini 產品，這是我們的第 8 代 AtriClip 產品。除此之外，我們正在投資 LeAAPS 試驗的臨床證據，以顯示接受心臟手術的患者中風的減少。因此，我們正在這些特定領域進行必要的投資。

We are seeing Medtronic and their clip out in the market, and we think it's great that they've actually made that kind of investment. We do see people trialing it out and using the product. But we also feel very confident that we have a superior product today in the market with our FLEX V product. And we feel like with the innovation we're coming out with the FLEX Mini and others, we're really well positioned to manage competition that comes into the market. We don't think they're going to be the first competitor in any of our franchises.

我們看到美敦力（Medtronic）和他們的剪輯在市場上被淘汰，我們認為他們實際上進行了這種投資是很棒的。我們確實看到人們試用並使用該產品。但我們也非常有信心，我們的 FLEX V 產品在當今市場上擁有卓越的產品。我們認為，透過 FLEX Mini 和其他產品的創新，我們確實能夠很好地管理進入市場的競爭。我們認為他們不會成為我們任何特許經營權中的第一個競爭對手。

One of the things for AtriCure is that we are dedicated, as I mentioned upfront, to really establishing new standards of care in areas and putting investments in R&D on both the innovation side, so new products and continuing that. In fact, we've got 7 new products coming out over the next 2 years. Combining that with exceptional clinical evidence to demonstrate why our products work incredibly well. And then also putting efforts around our sales team and teams out in the field to specifically be the best in the world at understanding our products and understanding how to help patient care on that front. And we think that we're really well positioned across all of our product lines on that and welcome the competition and also welcome the validation of the markets that we're in.

AtriCure 的一件事是，正如我之前提到的，我們致力於真正在各領域建立新的護理標準，並在創新方面進行研發投資，因此新產品並繼續這樣做。事實上，我們將在未來 2 年內推出 7 款新產品。將其與卓越的臨床證據相結合，證明我們的產品為何效果如此出色。然後，我們也圍繞著我們的銷售團隊和現場團隊做出努力，特別是在了解我們的產品並了解如何在這方面幫助患者護理方面成為世界上最好的團隊。我們認為，我們在所有產品線上都處於有利位置，歡迎競爭，也歡迎我們所在市場的驗證。

Our next question comes from the line of Danielle Antalffy with UBS.

我們的下一個問題來自瑞銀集團的 Danielle Antalffy。

Everyone, can you hear me? This is Simon on for Danielle.

各位，你們聽得到我說話嗎？這是丹尼爾的西蒙。

We can hear you, Simon.

我們聽得到你的聲音，西蒙。

We can hear you, Simon.

我們聽得到你的聲音，西蒙。

This is Simon Negin. Your cryo segments really demonstrated great growth over the past several years, but it's naturally moderated just given the scale. Do you think mid-teens growth in this segment is sustainable? And what are the puts and takes to really think about moving forward here?

這是西蒙·內金。你們的低溫領域在過去幾年中確實表現出了巨大的成長，但考慮到規模，它自然會受到抑制。您認為該細分市場的青少年成長是否可持續？真正考慮在這裡前進的關鍵是什麼？

Yes, appreciate the question. You stated it very well. It's obviously gotten to the size and scale, a $50 million business that grew 26% this year. We do think that those mid-teen plus growth rates are absolutely sustainable, not only in thoracic. So if you look at just the thoracic market, we're less than 20% penetrated today. So we have a long way to go. And as I mentioned in my comments, we're investing in clinical evidence to demonstrate both the economic and clinical value around that to hopefully push those numbers up even more over the coming years. You top that off with us investing in, much like I talked about all of our product lines, we've got the cryoSPHERE Plus that just came out this year.

是的，感謝這個問題。你說得很好。顯然，它已經達到了規模和規模，一家價值 5,000 萬美元的企業今年成長了 26%。我們確實認為，這些十幾歲以上的成長率絕對是可持續的，而不僅僅是在胸部。因此，如果您只關注胸部市場，我們今天的滲透率不到 20%。所以我們還有很長的路要走。正如我在評論中提到的，我們正在投資臨床證據，以證明其經濟和臨床價值，希望在未來幾年內進一步推動這些數字。最重要的是，我們投資了今年剛推出的 CryoSPHERE Plus，就像我談到我們所有的產品線一樣。

We've got a new product coming out later on this year that is an advancement on top of that, that are hopefully going to reduce the time that they need to actually do their ablation, which hopefully will also open up the sternotomy market a little more aggressively than it has because that's been the pushback in that market. So for economies alone, less than 20% penetrated. We're coming out with new products that reduce time that will hopefully enable and actually get us into the sternotomy market a little bit more aggressively as you look in future years. And so we feel like we're in a really good position relative to the growth there.

我們今年稍後推出了一款新產品，這是一個進步，希望能減少他們實際進行消融所需的時間，這也希望能稍微打開胸骨切開術市場比以前更加積極，因為這是該市場的阻力。因此，僅就經濟體而言，滲透率不到 20%。我們正在推出可以縮短時間的新產品，正如您在未來幾年看到的那樣，這些新產品有望使我們更積極地進入胸骨切開術市場。因此，我們覺得相對於那裡的成長而言，我們處於非常有利的位置。

And the final thing I'll add is when we talked about, or you heard it in my comments as well, there are other areas, extremities in particular, that could also benefit from the cryoablation that we use. And we're in the process of actually looking at that, evaluating it and studying it. We're not ready to announce anything yet. But over the next couple of years, I do believe that we'll be announcing getting into other areas outside of just thoracic and sternotomy, which have a lot of room for growth already. So that's a good -- that's a long way of answering, yes, we feel comfortable with the kind of mid-teens growth, being in that range for a long time.

我要補充的最後一件事是，當我們談論時，或者您也在我的評論中聽到時，還有其他區域，特別是四肢，也可以從我們使用的冷凍消融中受益。我們正在實際觀察、評估和研究它。我們還沒有準備好宣布任何事情。但在接下來的幾年裡，我確實相信我們將宣布進入胸部和胸骨切開術之外的其他領域，這些領域已經有很大的成長空間。所以這是一個很好的問題——這是一個很長的答案，是的，我們對青少年中期的成長感到滿意，長期處於這個範圍。

That's really helpful. One quick one for you. You mentioned potentially watching a product in the IST segment this year. Is that still on target? And any ideas on that would be incredibly helpful.

這真的很有幫助。快給你一份。您提到今年可能會關注 IST 細分市場的一款產品。這仍然是目標嗎？任何關於這方面的想法都會非常有幫助。

Yes, so a reminder for people because we didn't really go into detail on today's call. We're running a trial called HEAL-IST for patients with inappropriate sinus tachycardia. What that represents are people that have elevated heart rates while they're resting, typically above 90. Consistently, most of these patients are in the mid-100s. And it tends to affect women kind of in their 20s to 40s or so. It's a very large patient population, well over 1 million patients that actually represent this market.

是的，這是對人們的提醒，因為我們在今天的電話會議上並沒有真正詳細說明。我們正在針對患有不適當竇性心搏過速的患者進行一項名為 HEAL-IST 的試驗。這代表的是人們在休息時心率升高，通常超過 90。一直以來，這些患者中的大多數都在 100 多歲左右。它往往會影響 20 多歲到 40 多歲左右的女性。這是一個非常龐大的患者群體，實際上代表了這個市場的患者數量遠遠超過 100 萬。

There were some -- an EP and a surgeon out of Belgium kind of invented a procedure in which you could leverage using our technology in combination with the mapping and the work done by the electrophysiologist to basically reduce that. And they showed almost 100% improvement at both a 6-month and 1-year time frame after the procedure. The existing products that we have work incredibly well. It's under investigation for this particular disease in the United States right now, and we're making great progress on enrollment there. And yes, we are developing a new product, because right now our product today works incredibly well, but it takes a little while to actually get access to what you need to do there. And so the new product is custom built very specifically for IST and for this specific surgery. And we do anticipate late this year, early next year to kind of have that product on the market.

有一些 - 一位來自比利時的 EP 和一位外科醫生發明了一種程序，您可以利用我們的技術結合繪圖和電生理學家所做的工作來從根本上減少這種情況。術後 6 個月和 1 年的時間範圍內，他們的改善幾乎達到 100%。我們現有的產品運作得非常好。美國目前正在對這種特殊疾病進行調查，我們在該國的入組方面取得了巨大進展。是的，我們正在開發一種新產品，因為現在我們的產品運作得非常好，但需要一段時間才能真正獲得您需要在那裡做的事情。因此，新產品是專門為 IST 和這種特定手術量身定制的。我們確實預計在今年年底、明年初將該產品推向市場。

Our next question comes from the line of Bill Plovanic with Canaccord.

我們的下一個問題來自 Bill Plovanic 與 Canaccord 的對話。

It's John on for Bill tonight. Congrats on a strong Q4, too. Maybe just starting on EnCompass. You said about 50% of U.S. revenue is from the clamp now. Can you just talk about what hurdles still exist to get the remaining users to shift to the new device? Is this just contract timing or price sensitivity? And do you plan on eventually stop selling the older versions of the clamp?

今晚由約翰代替比爾。也恭喜第四季的強勁表現。也許 EnCompass 才剛開始。你說現在美國大約50%的收入來自箝位。您能否談談讓剩餘用戶轉向新設備仍存在哪些障礙？這只是合約時間還是價格敏感度？您是否計劃最終停止銷售舊版本的夾子？

Yes, I'll start with the last. We don't anticipate stopping selling any of our old clamps. They're actually exceptional. We continue to get really good feedback on that. They work incredibly well. They're really geared towards specific surgeons who are doing the full Cox-Maze 4. They're the ones that we studied in our PMA. For EnCompass, quite frankly, it's just going to take time to educate people how to use the product, get people comfortable with that. We're expanding into new sites. We're in about 55% to 60% of the sites in the U.S. So we've got a lot of room for growth relative to that. We're also planning to do a clinical trial as well, very specifically, much like we did for the ABLATE trial, which was what got us the PMA approval for our original clamps. We will anticipate doing that. We think that with that additional clinical evidence, that could also have an impact on adoption over time.

是的，我將從最後一個開始。我們預計不會停止銷售任何舊夾具。他們實際上很出色。我們繼續得到對此非常好的回饋。他們工作得非常好。它們確實適合進行完整 Cox-Maze 4 的特定外科醫生。我們在 PMA 中研究了它們。坦白說，對於 EnCompass 來說，需要時間來教育人們如何使用該產品，讓人們對此感到滿意。我們正在擴展到新站點。我們的業務涵蓋美國約 55% 到 60% 的站點，因此相對於此，我們還有很大的成長空間。我們還計劃進行一項臨床試驗，非常具體，就像我們在 ABLATE 試驗中所做的那樣，這就是我們原始夾具獲得 PMA 批准的原因。我們預計會這樣做。我們認為，有了更多的臨床證據，隨著時間的推移，這也可能會對採用產生影響。

This isn't one of those ones that it's just going to grow overnight, but it's accelerated our growth rate. If you would have asked, I think, anybody if our open business could grow kind of above the low-double digits, kind of the 9%, 10%, 11% that we were growing for many, many years, this combined with reimbursement changes that have happened over the last couple of years have really accelerated adoption and more ablations that have happened. So I think I feel really good about the progress. It's much better than we ever expected. And we'll continue to kind of talk about it out in the field from that standpoint.

這不是一夕之間就能成長的，但它加速了我們的成長速度。我想，如果你問任何人，我們的開放業務能否成長到兩位數以上，例如我們多年來成長的 9%、10%、11%，這與報銷結合過去幾年發生的變化確實加速了採用，並且發生了更多的消融。所以我認為我對進展感到非常滿意。這比我們預期的要好得多。我們將繼續從這個角度在現場討論它。

Great. And then just on pain management, too, to kind of circle back to some of the other comments. How should we think about the timing of the economic outcome data that you had mentioned? Should -- is that going to move the needle in 2024 or beyond? And are you still considering gathering data to support an opioid reduction label?

偉大的。然後再談一下疼痛管理，回到其他一些評論。我們應該如何看待您提到的經濟結果數據的發佈時間？應該——這會在 2024 年或更晚的時間內取得進展嗎？您是否仍在考慮收集數據來支持阿片類藥物減少標籤？

Yes, I don't know that I would say that it's going to be a 2024 event relative to that data. It's going to be a cumulative aspect of the data for Cryo Nerve Block and not one definitive trial. We're actually supporting many trials that are multicenter across the country and over in Europe. The purpose of that is that the totality of all that evidence we think is what's going to actually change practice. That's going to take several years to kind of do it, but I think more and more papers are coming out every year. We had 14 trials that we were supporting or so last year. That number is going to continue into this year. Many of those are looking at opioid reduction as part of what they're looking at overall as the outcome. And so I do believe that, that is something that's very important for people to track and to know. And I think more and more papers are going to be written about the fact that people that do use this product tend to have a lower use of opioids once they leave the hospital.

是的，我不知道我是否會說這將是與該數據相關的 2024 年事件。這將是冷凍神經阻斷數據的累積方面，而不是一項明確的試驗。實際上，我們正​​在支持全國和歐洲各地的許多多中心試驗。這樣做的目的是，我們認為所有證據的總和將真正改變實踐。這需要幾年的時間才能完成，但我認為每年都會有越來越多的論文發表。去年我們支持了大約 14 項試驗。這一數字將持續到今年。其中許多人將減少阿片類藥物作為他們整體結果的一部分。所以我確實相信，這對於人們追蹤和了解非常重要。我認為越來越多的論文將會寫到這樣一個事實：使用該產品的人出院後往往會減少阿片類藥物的使用。

Our next question comes from the line of 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·桑德勒的對話。

So I don't know if this is for Mike or Angie, but I think Angie mentioned that you're factoring in some competitive pressure here in 2024 into your guide. You've grown 20% the last 2 years on the top line. You're guiding 16% at the midpoint, so about 400 basis points. That's around $16 million, I think, of potential competition you're factoring in. Or I don't know if it's law of large numbers, whatever it may be. Is that the right way to characterize the amount of pressure that you're anticipating? Is it only in the clip business? And then if I do the math on it, it would seem like you're kind of incorporating in around 10%, maybe a little bit north of that share loss. Is that the right way to characterize it?

所以我不知道這是針對 Mike 還是 Angie，但我認為 Angie 提到您在指南中考慮了 2024 年的一些競爭壓力。過去 2 年您的收入成長了 20%。您的指導值為中點 16%，即約 400 個基點。我認為，您所考慮的潛在競爭價值約為 1600 萬美元。或者我不知道這是否是大數定律，無論它是什麼。這是描述您預期壓力大小的正確方法嗎？僅限剪輯產業嗎？然後如果我計算一下，你似乎會吸收大約 10% 的份額，也許比份額損失稍高。這是描述它的正確方式嗎？

Yes, Matt. I think you know based on years here that we start the year, and we want to make sure that we're putting out a guide that we feel really good about executing against that gives us -- positions us well to kind of beat and raise as we go throughout the year. The range does consider both the growth drivers in our business as well as the potential competition in our market. But I think to that point, we are working in markets that are very, very underpenetrated and that we believe that there's still significant growth potential even with competitive pressure. So a long-winded way of saying it's not 10 points of -- or that kind of loss relative to Medtronic share. More importantly, I think what informed our guide through 2024 is just the strength of our portfolio and the momentum that we're seeing as we exit 2023 and start a new year in 2024. But want to make sure that we guide to numbers that we can execute strongly against. That's been our philosophy for years and continues to be as we start the new year.

是的，馬特。我想你知道，根據我們在這裡的歲月，我們開始了新的一年，我們希望確保我們推出了一份我們感覺非常適合執行的指南，這給了我們——使我們能夠很好地擊敗和提高隨著我們全年的發展。該範圍確實考慮了我們業務的成長動力以及市場的潛在競爭。但我認為，到目前為止，我們所從事的市場滲透率非常非常低，我們相信，即使面臨競爭壓力，仍然存在著巨大的成長潛力。因此，這是一種囉嗦的說法，這不是 10 個百分點，也不是相對於美敦力 (Medtronic) 股票的那種損失。更重要的是，我認為為我們的2024 年指南提供資訊的只是我們投資組合的實力以及我們在退出2023 年並在2024 年開始新的一年時所看到的勢頭。但要確保我們指導的數字是我們所預期的可以強烈反對。這一直是我們多年來的理念，並且在新的一年開始時仍然如此。

Okay. And Angie, specifically, I know there's a lot of trialing going on. Have you seen people flipping over to Penditure and using it in a lot more cases? Or are you still seeing a dynamic where they maybe trial it and they just say, you know what, I don't like this for the most part. I'm sure there's some people that will flip. But what are you seeing specifically there? And I do have one more follow-up.

好的。具體來說，安吉，我知道正在進行很多試驗。您是否看到人們轉向 Pendture 並在更多情況下使用它？或者你是否仍然看到一種動態，他們可能會嘗試它，然後他們只是說，你知道嗎，我在很大程度上不喜歡這個。我確信有些人會翻轉。但你在那裡具體看到了什麼？我還有一個後續行動。

I mean we're definitely seeing people trial it across the country, but we feel really good about the strength of our franchise out there, Matt, and feel like people really love the AtriClip. It set a very high bar in terms of how well it works. People understand that we have a tremendous amount of clinical evidence and data behind it. On the closure in particular, showing exceptional closure and exceptional safety profile with that device. And so we feel like we're in a great position even though people are trying it at various different places throughout the country.

我的意思是，我們確實看到全國各地的人們都在試用它，但我們對我們的特許經營權的實力感到非常滿意，馬特，並且感覺人們真的很喜歡 AtriClip。它在工作效果方面設定了非常高的標準。人們知道我們背後有大量的臨床證據和數據。特別是在閉合方面，該設備顯示出出色的閉合性能和出色的安全性能。因此，儘管人們在全國各地不同的地方進行嘗試，但我們感覺自己處於有利地位。

Got it. Okay. And then on the open business, it looks like it accelerated in Q4 on a 2-year stack basis, but it was a little bit softer than I might have thought on a quarter-over-quarter basis. So just curious what you're seeing there in terms of adoption, expectations for growth there? Is it still another mid-teens? I don't know if the guidelines can help a little bit as well. And then just any thoughts on competition? I know there's somebody that's filed to compete with you. Is that something that you're building in a little bit this year or something that essentially could impact that business as we head into 2025?

知道了。好的。然後在開放業務方面，看起來第四季度在兩年堆疊的基礎上有所加速，但在季度環比的基礎上，它比我想像的要軟一些。所以只是好奇您在採用方面看到了什麼，對成長的期望是什麼？又是一個十幾歲的孩子嗎？我不知道指南是否也能有所幫助。那麼關於競爭有什麼想法嗎？我知道有人申請跟你競爭。這是你們今年正在做的一些事情，還是在我們進入 2025 年時可能會本質上影響該業務的事情？

As Angie mentioned on the guidance, pretty much all of our businesses we think being around that 15% to 17%. I mean, pun intended, they're all converging around that particular area. And so we feel like obviously there's upside potential in every one of our businesses, to your point, Matt. We're seeing great growth there. I think that to be able to continue to grow on the kind of base numbers that we've got at that kind of rate in cardiac surgery the way we are, we feel really good about it. But we anticipate that being kind of in that 15% to 17%. Pretty much all of our franchises across that from that standpoint. And we're always looking at competition. I mean there's nothing specific to comment on at this point. And if competition does come in, I think that we will obviously address it. But we feel really comfortable with the guidance that we've given. And that as Angie mentioned, we try to take a really conservative look at it at the beginning of the year to ensure that we can make sure that we can meet and beat it throughout the year.

正如 Angie 在指導下提到的那樣，我們認為幾乎所有業務都在 15% 到 17% 左右。我的意思是，雙關語，它們都聚集在那個特定區域。因此，我們覺得我們的每一項業務顯然都存在上升潛力，正如您所說，馬特。我們在那裡看到了巨大的成長。我認為，能夠繼續以我們在心臟手術中所獲得的基數繼續增長，我們對此感覺非常好。但我們預計這一比例約為 15% 至 17%。從這個角度來看，我們幾乎所有的特許經營權都是如此。我們一直在關注競爭。我的意思是，目前沒有什麼具體可評論的。如果競爭確實出現，我認為我們顯然會解決這個問題。但我們對所提供的指導感到非常滿意。正如安吉所提到的，我們試圖在年初採取非常保守的態度來看待它，以確保我們能夠確保我們能夠在全年滿足並擊敗它。

Our next question comes from the line of Marie Thibault with BITG.

我們的下一個問題來自 Marie Thibault 與 BITG 的關係。

You've got Sam Eiber on for Marie. Congrats on the nice finish to the year. Maybe I can start on CONVERGE and just looking at the U.S. business growing, for the MIS business growing 16% sequentially, 30% year-over-year. It does sound like things are really starting to click there. And I know you addressed a little bit in your prepared remarks, but any more color you can give on any specifics? And maybe does that give you the confidence now to push a little bit harder on new site activation this year?

瑪麗由薩姆·艾伯擔任。祝賀今年圓滿成功。也許我可以從 CONVERGE 開始，只專注於美國業務的成長，因為 MIS 業務環比成長 16%，年成長 30%。聽起來事情確實開始順利了。我知道你在準備好的發言中提到了一些內容，但你還能對具體細節給予更多的說明嗎？也許這會讓您有信心今年更努力地推動新網站的啟動？

Yes, Sam. I think we feel really good about the activity in the fourth quarter. I think this is reflective of a year-plus of our team in the field, supported by many others in the business, really trying to hone in on where programs had a really good interest in starting a CONVERGE program, why they have not been able to accelerate and see the kind of growth that we would expect. So we feel really good that the activities are paying off and that we're making a difference in the accounts that we're focusing in on. I'd say longer term, when you think through 2024, we're looking for that to be more broadly replicated throughout the base of accounts so that we can continue these kinds of growth rates. But I'd say the efforts in the field are really what we're seeing is starting to pay off and looking for that to have a broader impact in 2024.

是的，山姆。我認為我們對第四季度的活動感覺非常好。我認為這反映了我們團隊在該領域一年多的時間，在業內許多其他人的支持下，真正努力磨練哪些項目對啟動 CONVERGE 項目非常感興趣，以及為什麼他們未能成功加速並看到我們期望的增長。因此，我們感到非常高興，因為這些活動正在取得成效，我們正在為我們關注的客戶帶來改變。我想說的是，從長遠來看，當你考慮到 2024 年時，我們希望在整個帳戶基礎上更廣泛地複製這一點，以便我們可以繼續保持這種成長率。但我想說的是，我們看到該領域的努力確實開始得到回報，並希望在 2024 年產生更廣泛的影響。

Relative -- I think the second part of your question was new account activations. We did see a couple of new account activations in 2023. I'd say the focus of our team at this point in time is on existing accounts I think as they operate throughout 2024. There's still a lot of interest from customers. There's still -- we're very underpenetrated in terms of the universe of accounts that could have CONVERGE procedures or CONVERGE programs and are still training new accounts. And I think the work that we're doing today to help existing accounts be more efficient and think about building their programs I think long term will help us initiate new accounts and have them scale quickly.

相對 - 我認為你問題的第二部分是新帳戶激活。我們確實在 2023 年啟動了幾個新帳戶。我想說，我們團隊目前的重點是現有帳戶，我認為它們將在 2024 年運作。客戶仍然有很大興趣。就可能具有 CONVERGE 程序或 CONVERGE 計劃的帳戶領域而言，我們的滲透率仍然很低，並且仍在培訓新帳戶。我認為我們今天所做的工作是為了幫助現有帳戶提高效率，並考慮建立他們的計劃，我認為長期來看將幫助我們啟動新帳戶並使其快速擴展。

Really helpful, Angie. Maybe just flipping to AtriClip and maybe looking beyond maybe some of the competitive dynamics, but you also mentioned some guideline changes. And I'm just wondering if that can be maybe an additional tailwind to the underlying market and adoption for the clip business.

真的很有幫助，安吉。也許只是轉向 AtriClip，也許會超越一些競爭動態，但您也提到了一些指導方針的變化。我只是想知道這是否可能成為基礎市場和剪輯業務採用的額外推動力。

Yes, absolutely. We think that the guidelines are pretty monumental for the entire space. And it's basically saying -- a Class 1A recommendation is basically saying you should treat this appendage every single time somebody has atrial fibrillation today. And that is not just the cardiac surgeons doing it, but it's ACC and AHA to the referring cardiology community is basically saying everybody needs to treat the appendage when they're undergoing cardiac surgery. And so absolutely, we think that's a really good sign for this market overall, and obviously, AtriClip is being used to manage the appendage by many people around the globe. So it's a great validation, just like competition is a great validation of the space and what we're doing there.

是的，一點沒錯。我們認為這些指導方針對整個空間來說非常具有紀念意義。它基本上是說——1A 級建議基本上是說，今天每當有人患有心房顫動時，您都應該治療這個附件。這不僅僅是心臟外科醫生在做，ACC 和 AHA 向心臟病學界提出的建議基本上是說，每個人在接受心臟手術時都需要治療闌尾。所以絕對，我們認為這對整個市場來說是一個非常好的跡象，顯然，AtriClip 正在被全球許多人用來管理附肢。所以這是一個很好的驗證，就像競爭是對這個領域和我們正在做的事情的一個很好的驗證。

And then obviously, we're expanding that market with LeAAPS, so that eventually the data we get with that changes the guidelines for every patient, not just those that have Afib. That's our goal with that. That's why we're investigating it. And you can see the excitement with 1,700 patients already enrolled out of a 6,500 person trial. It's pretty remarkable to see that kind of growth. That's the excitement people have and the belief in managing the appendage.

顯然，我們正在透過 LeAAPS 擴大這個市場，因此最終我們獲得的數據會改變每位患者的指導方針，而不僅僅是那些患有心房顫動的患者。這就是我們的目標。這就是我們正在調查它的原因。您可以看到 6,500 人試驗中已招募 1,700 名患者的興奮之情。看到這種增長是非常了不起的。這就是人們的興奮和管理附肢的信念。

Our next question comes from the line of Joseph Conway with Needham.

我們的下一個問題來自約瑟夫·康威和李約瑟的對話。

It's Joseph on for Mike. I guess maybe just touching on gross margin improvement in the quarter. I think Angie called out some production efficiencies. And looking into 2024, I think in the comments, you guys talked about just being in line for 2024, potential modest improvement. I was just wondering if you could maybe give some more color around what happened in this quarter and some of those cost saving initiatives that you expect to roll out this year, how you expect that to be phased.

約瑟夫代替麥克。我想也許只是觸及本季毛利率的改善。我認為安吉提到了一些生產效率。展望 2024 年，我認為在評論中，你們談到了 2024 年的情況，潛在的適度改進。我只是想知道您是否可以對本季度發生的情況以及您預計今年推出的一些成本節約舉措提供更多說明，以及您預計如何分階段實施。

Yes. So what you saw in the fourth quarter, really strong, I'd say, production efficiencies offsetting -- we had quite a few headwinds coming from the mix of our international business. That led to an improvement off of 2022, the fourth quarter comp. And as we enter into 2024, I'd say kind of more of the same. You're going to see nice improvement. If the only thing that we saw was improvements to kind of production efficiencies with the same kind of mix of revenue, you'd see some nice improvements in 2024, but we are expecting some headwinds, given the mix anticipation in 2024.

是的。所以你在第四季度看到的，我想說，生產效率非常強勁，抵消了——我們的國際業務組合帶來了相當多的阻力。這導致 2022 年第四季業績有所改善。當我們進入 2024 年時，我想說的是更多的相同。你會看到很好的改進。如果我們看到的唯一事情是在相同收入組合的情況下提高生產效率，那麼您會在 2024 年看到一些不錯的改進，但考慮到 2024 年的組合預期，我們預計會遇到一些阻力。

We've talked about in the past a couple of areas where we expect to see some improvements to margin. The first would be with the launch of the cryoSPHERE Plus probe. To the extent that the adoption of that probe takes off in comparison or replaces our existing cryoSPHERE probe, there is a nice benefit to our gross margin. Again, our launch is anticipated in the second quarter, so you would see more of that benefit in the second half of the year. And then the other thing we've talked about on other calls is the EnCompass Clamp.

我們過去討論過一些我們預期利潤率會有所改善的領域。第一個是隨著cryoSPHERE Plus 探針的推出。與我們現有的 CryoSPHERE 探頭相比，該探頭的採用取得了成功，或取代了我們現有的 CryoSPHERE 探頭，這對我們的毛利率有很大的好處。同樣，我們預計在第二季推出，因此您將在下半年看到更多的好處。我們在其他電話中討論的另一件事是 EnCompass 夾。

Our team -- our operations team and engineering team did really nice work throughout 2023 to say, given the demand that we're seeing in this particular product line, what are some ways that we can produce this product better and more efficiently, but also have come with some cost savings that we would anticipate later in 2024. So I think the big driver in 2024 when you think about gross margin is primarily mix, but knowing that there's some fundamental production efficiencies and some nice things happening within our operations that help be a tailwind to the overall number.

我們的團隊—我們的營運團隊和工程團隊在2023 年做了非常出色的工作，考慮到我們在這個特定產品線中看到的需求，我們可以透過哪些方法更好、更有效率地生產該產品，而且我們預計在2024 年晚些時候會節省一些成本。因此，我認為2024 年，當你考慮毛利率時，主要驅動因素主要是混合，但要知道，我們的運營中存在一些基本的生產效率和一些好的事情，這些都有助於成為總數的推動力。

Okay. That's very helpful. And then I guess just a quick one on the new AtriClip product. You gave some commentary around timing for the launch. But just maybe if you could talk about pricing, what you guys are thinking about that. Especially with Medtronic coming into the market, if there's anything that you're trying to hold back any price increases for that?

好的。這非常有幫助。然後我想簡單介紹一下新的 AtriClip 產品。您對發佈時間發表了一些評論。但也許你可以談談定價，你們對此有何看法。特別是隨著美敦力進入市場，您是否有什麼努力阻止其價格上漲？

Yes. So first of all, I'll comment on the product. It's called the FLEX Mini. We did file for a 510(k). And we feel like this product is going to be incredibly well received. It's about 1/3 of the profile and size of our product, our FLEX V product on the market today. It's incredibly easy to deploy. All the testing that we've seen so far is that it is going to be by far and away the most superior product on the market going forward. We have not determined our pricing strategy at this point, and so we'll probably hold back in terms of discussing that in any kind of detail. But we're evaluating what the best pricing strategy is right now.

是的。首先，我將對產品進行評論。它被稱為 FLEX Mini。我們確實申請了 510(k)。我們覺得這款產品將會非常受歡迎。它大約是我們目前市場上的 FLEX V 產品的外觀和尺寸的 1/3。部署起來非常容易。到目前為止，我們所看到的所有測試都表明，它將成為未來市場上最優質的產品。目前我們還沒有確定我們的定價策略，因此我們可能不會詳細討論這一點。但我們正在評估目前最好的定價策略是什麼。

Okay. Great. Congrats on a great quarter.

好的。偉大的。恭喜您度過了一個出色的季度。

Our next question as from the line of Danny Stauder with Citizens JMP.

我們的下一個問題來自 Citizens JMP 的 Danny Stauder。

Can you hear me?

你聽得到我嗎？

We can hear you.

我們能聽到你的聲音。

Great. So first off, just wanted to ask broadly about procedure volumes. So just -- we've heard from some of your peers comment on elevated volume levels and just wanted to get your color on that. And particularly as it relates to the open surgical market, have you seen any notable change in valve or CABG procedures that have led to some of the growth in open ablation in your open AtriClip procedures?

偉大的。首先，我只是想廣泛詢問一下手術量。所以，我們聽到一些同行對音量水平升高的評論，只是想了解一下您對此的看法。尤其是與開放手術市場相關的情況下，您是否發現瓣膜或 CABG 手術有任何顯著變化，這些變化導致開放式 AtriClip 手術中開放式消融術的成長？

Yes, I don't know that we've seen any kind of dramatic improvement. There's been steady improvement since COVID. But I think we're in a good, normalized period now where typically you'll see cardiac surgery growing in that kind of 1% to 2% per year. And I don't think we've seen anything different than that over the course of the last year or so. I've heard different reports that, that might change and you might start to see some improved growth across the procedure in 2024 from some places. I know HCA talked about it on one of their calls in terms of their cardiac surgery volumes. I don't know that I've heard that across every single system. So I guess I'd say right now, I'm cautiously optimistic on that one.

是的，我不知道我們是否看到了任何顯著的改進。自新冠疫情以來，情況一直在穩步改善。但我認為我們現在正處於一個良好的、正常化的時期，通常你會看到心臟手術每年以 1% 到 2% 的速度成長。我認為我們在過去一年左右的時間裡沒有看到任何不同的情況。我聽過不同的報道稱，這種情況可能會發生變化，你可能會開始看到 2024 年某些地方的整個過程有所改善。我知道 HCA 在一次電話會議上談到了他們的心臟手術量。我不知道我是否在每個系統中都聽過這樣的說法。所以我想我現在會說，我對此持謹慎樂觀的態度。

Great. And then just one follow-up. Turning to appendage management. The growth in MIS ablation was great to see. But with that, are you seeing an uptick in some of your AtriClip minimally invasive procedures? And then could you remind us where that AtriClip mix of open to MIS sits today? And how has that changed over the past, say, year or so and where you think that could go in 2024.

偉大的。然後只有一個後續行動。轉向附件管理。 MIS 消融的成長令人欣喜。但是，您是否看到一些 AtriClip 微創手術有所增加？那麼您能否提醒我們開放 MIS 的 AtriClip 組合如今處於什麼位置？過去一年左右情況發生了怎樣的變化，以及您認為 2024 年會發生什麼變化。

Yes, that was a nice byproduct of the strength of our MIS business in the fourth quarter. We saw an uptick in our MIS appendage management, the AtriClip Pro products realizing pretty equal growth to the open AtriClip products leading to about 22% growth for the fourth quarter in the U.S. And our attachment rates, we continue to see a steady increase in attachment. A year or so ago, we were talking about around a 75% attachment to our CONVERGE procedure.

是的，這是我們第四季 MIS 業務實力的一個很好的副產品。我們看到我們的 MIS 肢體管理有所上升，AtriClip Pro 產品實現了與開放式 AtriClip 產品相當的增長，導緻美國第四季度增長約 22%。而我們的附著率，我們繼續看到附著率穩步增長。大約一年前，我們談論了大約 75% 的人對我們的 CONVERGE 計畫的依戀。

And now we're at, say, kind of mid-80s at this point in time and continue to receive really good, strong feedback from accounts that are starting CONVERGE programs or have adopted CONVERGE programs, the interest in treating the appendage surgically during the CONVERGE procedure. As we exited the year, when you look at our U.S. appendage management business, about 25% of the revenue was from our MIS AtriClip business, and about 75% of the revenue was in our open clip business. And I think given the strength of both of those franchises, our open and MIS ablation businesses would expect for that mix to remain relatively similar with the potential for upside, I think, for the MIS product.

現在我們正處於 80 年代中期，並且繼續從正在啟動 CONVERGE 計劃或已經採用 CONVERGE 計劃的帳戶中收到非常好的、強烈的反饋，以及在收斂過程中。今年結束時，如果你看看我們的美國肢體管理業務，你會發現大約 25% 的收入來自我們的 MIS AtriClip 業務，大約 75% 的收入來自我們的開放夾業務。我認為，鑑於這兩個特許經營權的實力，我們的開放式和 MIS 消融業務預計這種組合將保持相對相似，並且我認為 MIS 產品具有上升潛力。

Our next question comes from the line of Suraj Kalia with Oppenheimer & Company.

我們的下一個問題來自奧本海默公司的蘇拉吉·卡利亞 (Suraj Kalia)。

Angie, Mike, can you hear me all right?

安吉，麥克，你們聽得到我說話嗎？

We can hear you.

我們能聽到你的聲音。

Perfect. Mike, so a couple of esoteric questions was wondering if you could help us out. AtriClip in general, is it on consignment, or should we think about inventory also? And more specifically, as you'll enter FY '24, just given all the dynamics in your prepared remarks, how should we think about the pricing flow through that you'll think about for FY '24?

完美的。麥克，有幾個深奧的問題想知道你是否可以幫助我們。一般來說，AtriClip 是寄售還是我們也應該考慮庫存？更具體地說，當您進入 24 財年時，考慮到您準備好的發言中的所有動態，我們應該如何考慮您為 24 財年考慮的定價流程？

Yes. On the consignment, we don't really have any consignment product. That's not -- typically it's -- we're very much on kind of a use and then replace. So we keep very, very little inventory whatsoever at sites, just enough for them to kind of plan out the procedures in the upcoming week or 2. But we do not have a lot of inventory on shelf. That's actually purposeful. We want to understand the demand. And we've got great inventory here to be able to supply that on a real-time basis. We've got 99.8% kind of delivery to make sure that no patient is not being treated from that standpoint.

是的。在寄售方面，我們確實沒有任何寄售產品。這不是——通常是——我們非常喜歡使用然後更換。因此，我們在現場保留的庫存非常非常少，足以讓他們在未來一周或兩週內規劃出程序。但我們的貨架上沒有很多庫存。這其實是有目的的。我們想了解需求。我們這裡有大量庫存，能夠即時供應。從這個角度來看，我們的交付率達到 99.8%，以確保沒有患者無法接受治療。

Related to price, we feel like we've got a really good pricing strategy today. We've obviously got a product in the market. Our initial one, our original AtriClip of the kind of first 3 generations of the products are out there today. Those are priced at a lower level. The FLEX V, which was our premium product, today is also in the market. Our highest priced products are the minimally invasive products above that. So I think we're in a really good position relative to pricing today, and we don't have any specific things to change anything on that front in the near future.

與價格相關，我們覺得我們今天有一個非常好的定價策略。顯然我們已經在市場上有了產品。我們的第一款產品，即前 3 代產品中的原始 AtriClip 現已上市。這些產品的價格較低。 FLEX V 是我們的優質產品，今天也已上市。我們價格最高的產品是上面的微創產品。因此，我認為相對於今天的定價，我們處於非常有利的位置，並且在不久的將來我們沒有任何具體的事情可以改變這方面的任何事情。

Got it. Mike, in terms of AtriClip Mini, is this just a desire for product stratification? And what I'm looking at is in terms of complete isolation of the LAA, you're presumably going a smaller form factor. So just kind of walk us through the rationale for introducing Mini. And Michael, to remind us, in terms of persistent AF, what percent of the cases being done by AtriCure today are persistent AF versus long-standing persistent AF?

知道了。 Mike，就AtriClip Mini而言，這只是產品分層的願望嗎？我所關注的是 LAA 的完全隔離，您可能會採用更小的外形尺寸。請向我們介紹一下引進 Mini 的理由。 Michael，提醒我們，就持續性心房顫動而言，AtriCure 目前處理的病例中持續性心房顫動與長期持續性心房顫動的百分比是多少？

Sure. On the FLEX Mini, we spent a lot of time. As we mentioned in our comments, we've had 500,000 implants to date. And we do a lot of work with our customers to figure out what improvements do they want to have to the product. And so the biggest thing was really, quite frankly, they wanted a smaller product, meaning that just a smaller profile overall. That's what the FLEX Mini does. It actually is about 1/3 of the profile of the other products. And that's the biggest benefit that people are going to get relative to using that.

當然。在FLEX Mini上，我們花了很多時間。正如我們在評論中提到的，迄今為止我們已經植入了 50 萬個植入物。我們與客戶進行了大量工作，以確定他們希望對產品進行哪些改進。因此，坦白說，最重要的是，他們想要一款更小的產品，這意味著整體外形更小。這就是 FLEX Mini 的作用。它實際上只有其他產品的1/3左右。這是人們使用它所能獲得的最大好處。

Also, as many of you may know, we've got a V-shaped product, and we also have a hoop-like product, which is the original product that we had on the market. The hoop-like product is the one that does not have as good of a deployment as the V product. And so many people wanted a hoop-like product that was smaller and had a very nice and easy and usable deployment tool with it as well. And so that was the primary feedback that we got from people, and that's effectively what the Mini brings to market.

另外，正如你們很多人可能知道的，我們有一個V形的產品，我們還有一個箍狀的產品，這是我們在市場上的原始產品。環狀產品的部署效果不如 V 產品。很多人想要一個類似箍的產品，它更小，並且有一個非常漂亮、簡單且可用的部署工具。這就是我們從人們那裡得到的主要回饋，這也是 Mini 為市場帶來的有效回饋。

In addition to that and probably as important is that the Mini is also going to be used in our -- we have the PRO V product for minimally invasive, and we will have a PRO Mini product as well that will come out in late 2025, likely. And that product is going to be able to go through at least a 7-millimeter, possibly a 5-millimeter trocar to make it even less invasive as somebody actually has to do the procedure from a minimally invasive perspective. So the product, by being so -- the profile being so small, it can go through those smaller trocars, and there's a big benefit on that.

除此之外，可能同樣重要的是，Mini 也將用於我們的——我們有用於微創的 PRO V 產品，我們還將有一個 PRO Mini 產品，將於 2025 年末推出，可能。該產品將能夠穿過至少 7 毫米、可能是 5 毫米的套管針，使其侵入性更小，因為實際上必須從微創的角度進行手術。因此，該產品的外形非常小，它可以穿過那些較小的套管針，這有很大的好處。

In terms of your second question, I guess, I believe you're probably talking about the CONVERGE area in terms of kind of the distinction between persistent and long-standing persistent. Our label is for long-standing persistent. That's what we talk to. I'd say most of the patients fit within the long-standing persistent marketplace. Very few are persistent patients in terms of what we're seeing. Most of the patients that we see are patients that have had failed catheter ablations. 1, 2 or 3 failed catheter ablations before they then go to a convergent or a hybrid type procedure. And so I believe that might be what you're referring to, and hopefully, I answered that question.

關於你的第二個問題，我想，我相信你可能是在談論 CONVERGE 領域的持久性和長期持久性之間的差異。我們的標籤是長久的執著。這就是我們所說的。我想說大多數患者都適合長期存在的市場。就我們所看到的情況而言，很少有人是頑固的患者。我們看到的大多數患者都是導管消融失敗的患者。 1、2 或 3 次導管消融失敗後，才進行聚合或混合型手術。所以我相信這可能就是你所指的，希望我回答了這個問題。

Thank you. This concludes the question-and-answer session. I'd now like to hand the call back over to Mike Carrel, CEO, for closing remarks.

謝謝。問答環節到此結束。現在我想將電話交回給執行長 Mike Carrel，讓其致閉幕詞。

Great. Again, everybody, thank you for joining us today, and we look forward to having a great 2024 together. Have a good one. Bye now.

偉大的。再次感謝大家今天加入我們，我們期待共同度過一個美好的 2024 年。祝你有個好的一天。再見了。

This concludes today's conference call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。