LivaNova PLC (LIVN) 2024 Q3 法說會逐字稿

Good day, ladies and gentlemen and welcome to the LivaNova PLC third quarter 2024 earnings conference call. My name is Lydia and I'll be your operator today as a reminder, this conference call is being recorded.

女士們、先生們，大家好，歡迎參加 LivaNova PLC 2024 年第三季財報電話會議。我的名字是莉迪亞，今天我將擔任您的接線員，提醒一下，這次電話會議正在錄音。

I would now like to introduce your host for today's conference. Mr Matthew Dodds LivaNova Senior Vice President of Corporate Development and IT, please go ahead, sir.

現在我想介紹今天會議的主持人。Matthew Dodds 先生 LivaNova 企業發展和 IT 高級副總裁，請發言，先生。

Thank you Lydia and welcome to our conference call and webcast discussing LivaNova's financial results for the third quarter of 2024. Joining me on today's call are Vladimir Makatsaria our Chief Executive Officer and member of the Board of Directors, Alex Shvartsburg our Chief Financial Officer, Ahmet Tezel our Chief Innovation Officer, Stephanie Bolton President of Global Epilepsy, and Brianna Gotland, Director of Investor Relations.

謝謝 Lydia，歡迎參加我們的電話會議和網路廣播，討論 LivaNova 2024 年第三季的財務業績。參加今天電話會議的還有我們的執行長兼董事會成員 Vladimir Makatsaria、我們的財務長 Alex Shvartsburg、我們的首席創新長 Ahmet Tezel、全球癲癇總裁 Stephanie Bolton 和投資者關係總監 Brianna Gotland。

Before we begin, I would like to remind you that discussions during this call will include forward-looking statements, factors that could cause actual results to different materially are discussed in the company's most recent filings and documents furnished to the SEC including today's press release that is available on our website. We do not undertake to update any forward-looking statement.

在我們開始之前，我想提醒您，本次電話會議中的討論將包括前瞻性陳述，可能導致實際結果產生重大差異的因素在公司最近提交給證券交易委員會的文件和文件中進行了討論，包括今天的新聞稿，該文件可在我們的網站上查閱。我們不承諾更新任何前瞻性聲明。

Also, the discussions will include certain non-GAAP financial measures with respect to our performance, including but not limited to revenue results which will all be stated on a constant currency basis. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release which is available on our website.

此外，討論還將包括與我們績效相關的某些非公認會計準則財務指標，包括但不限於以固定匯率計算的收入結果。您可以在今天的新聞稿中找到與最直接可比較的 GAAP 財務指標的對帳表，該新聞稿可在我們的網站上找到。

We have also posted a presentation to our website that summarizes the points of today's call. This presentation is complementary to the other call materials and should be used as an enhanced communication tool. You can find the presentation and press release in the investors section of our website under news events and presentations at investor.livanova.com.

我們還在我們的網站上發布了一份演示文稿，總結了今天電話會議的要點。此簡報是其他通話資料的補充，應作為增強的溝通工具。您可以在我們網站的投資者部分（新聞事件和介紹）中找到該簡報和新聞稿，網址為 investor.livanova.com。

With that, I will turn the call over to Vald.

說完這些，我將把電話轉給瓦爾德。

Thank you, Matt and thank you everyone for joining us. Welcome to LivaNova's conference call for the third quarter of 2024. Our 11% revenue increase marks the seventh consecutive quarter of double digit growth.

謝謝你，馬特，也謝謝大家的參與。歡迎參加 LivaNova 2024 年第三季電話會議。我們的營收成長了 11%，這是我們連續第七個季度實現兩位數的成長。

Our performance is well balanced across geographies and business segments with 12% organic revenue growth year-to-date, geographically we achieved 15% in the US and 9% in the Europe and rest of the world regions. By business we achieved 15% in Cardiopulmonary and 9% in epilepsy.

我們在各個地區和業務部門的表現都很均衡，今年迄今的有機收入成長了 12%，其中美國地區成長了 15%，歐洲和世界其他地區成長了 9%。我們在心肺疾病領域的業務取得了 15% 的成績，在癲癇領域的業務取得了 9% 的成績。

This strength is supported by the following key growth drivers. First, our markets remain healthy with both Cardiopulmonary and Epilepsy procedure volumes estimated to be growing mid-single digits. Second, we gain market share by our commercial execution and ability to supply Cardiopulmonary consumables. We estimate our oxygenated market share percentage has grown from the low 30s in early 2023 to the mid 30s today, contributing more than 100 basis points of growth here to date.

這項優勢由以下關鍵成長動力支撐。首先，我們的市場保持健康，心肺和癲癇手術量預計都將以中位數個位數成長。其次，我們透過商業執行和供應心肺耗材的能力來獲得市場份額。我們估計，我們的含氧市場份額百分比已從 2023 年初的 30% 出頭增長到今天的 30% 中段，迄今為止已為該地區的增長貢獻了 100 多個基點。

Third, we've leveraged pricing strategies in Epilepsy in Cardiopulmonary consumables which contributed approximately 300 basis points of growth, year-to-date.

第三，我們利用了心肺耗材中癲癇治療的定價策略，今年迄今為止，該領域貢獻了約 300 個基點的成長。

And finally, we've benefited from a successful essence launch which contributed approximately 400 basis points of growth so far this year.

最後，我們受益於精華素的成功推出，今年迄今它貢獻了約 400 個基點的成長。

On the innovation front, we're pleased with the progress we have made in our Cardiopulmonary and Epilepsy pipeline development as well as in difficult to treat depression and obstructive sleep apnea programs, in difficult to treat depression or DTD we continue our efforts in pursuit of CMS coverage.

在創新方面，我們對心肺和癲癇管道開發以及難治性抑鬱症和阻塞性睡眠呼吸中止症項目所取得的進展感到滿意，在難治性抑鬱症或 DTD 方面，我們將繼續努力追求 CMS 覆蓋。

If any reimbursement is granted, it could represent a transformative opportunity for critically ill patients with DTD while further diversifying our portfolio. In obstructive sleep apnea or OSA in November, we expect all patients to complete seven months of follow up for primary endpoints for safety and effectiveness.

如果獲得報銷，這可能為患有 DTD 的重症患者帶來變革性的機會，同時進一步豐富我們的產品組合。對於阻塞性睡眠呼吸中止症 (OSA)，我們預計 11 月所有患者都能完成為期 7 個月的隨訪，以了解安全性和有效性的主要終點。

These growth drivers, our innovation agenda and focus on talent support the sustainability of above market growth.

這些成長動力、我們的創新議程以及對人才的關注支持了高於市場的成長的可持續性。

For the remainder of the call. I will discuss our third quarter results and after my comments, Ahmet will discuss our innovation pipeline and Alex will then provide details on our results and updates for 2024 guidance.

通話剩餘部分。我將討論我們第三季的業績，在我發表評論之後，Ahmet 將討論我們的創新管道，然後 Alex 將提供有關我們的業績的詳細資訊以及 2024 年指引的更新。

I will wrap up with closing remarks before moving to Q&A. In the quarter which is 11% revenue growth versus the prior year excluding the impact of the ACS segment [went down] revenue increased 12% versus 2023.

在進入問答環節之前，我將做結束語。本季營收較上年同期成長 11%，排除 ACS 部門（下降）的影響，營收較 2023 年同期成長 12%。

This growth was achieved while also significantly expanding operating margin, based on these results we are increasing our 2024 full year guidance. Now turning to segment results, for the Cardiopulmonary segment revenue was $172 million in the quarter. An increase of 15% versus the third quarter of 2023, (technical difficulty) revenue increased over 20% driven by a [cents]. We are pleased to see a sequential increase in essence, placements and continuing strong price mix in the quarter.

實現這一成長的同時也顯著擴大了營業利潤率，基於這些結果，我們上調了 2024 年全年業績預期。現在來看看分部業績，本季心肺分部營收為 1.72 億美元。與 2023 年第三季相比，營收成長了 15%，（技術難度）收入成長了 20% 以上，主要原因是[美分]。我們很高興看到本季本質、配置和價格組合連續增加。

As a point of reference, we expect essence will represent approximately 40% of our annual HLM unit placed in 2024 oxygenated revenue grew approximately 15% driven by customer demand and price. The oxygenated business continues to see strong demand, outpacing global supply and our efforts to increase manufacturing capacity remain on track. We now expect Cardiopulmonary revenue to grow 13% to 14% for full year 2024.

作為參考，我們預計精華將占我們 2024 年年度 HLM 單位的約 40%，受客戶需求和價格的推動，含氧收入增長約 15%。含氧業務持續保持強勁需求，超過全球供應量，我們提高生產能力的努力仍在進行中。我們現在預計 2024 年全年心肺收入將成長 13% 至 14%。

Our revised forecast incorporate strong demand for consumables and continue HLM growth despite difficult comparisons versus the fourth quarter of last year. Now turning to Epilepsy revenue increased 9% versus the third quarter of 2023. US Epilepsy revenue increased 10% year over year versus prior year we achieved approximately 10% growth in new patient implants and realized about 8% growth in replacement implants.

儘管與去年第四季相比存在困難，但我們修改後的預測仍考慮到對消耗品的強勁需求，並將繼續實現 HLM 成長。現在轉向癲癇治療的收入與 2023 年第三季相比成長了 9%。與前一年相比，美國癲癇收入年增了 10%，新患者植入物增加了約 10%，替換植入物增加了約 8%。

Epilepsy revenue in Europe and rest of world grew a combined 3% versus prior year with double digit growth in rest of world offset by a decline in Europe, for the full year 2024 we now expect global Epilepsy revenue to grow 7% to 8%.

歐洲和世界其他地區的癲癇治療收入較上年同期總計增長了 3%，其中世界其他地區的兩位數增長被歐洲的下滑所抵消，我們預計 2024 年全年全球癲癇治療收入將增長 7% 至 8%。

Our 2024 forecast continues to incorporate mid-single digit growth for US new patients and low to mid-single digit growth for US replacements which assumes US replacements volume to be flat beginning of the fourth quarter, we now expect the combined Europe and rest of world regions to grow in the low single digits.

我們對 2024 年的預測繼續考慮美國新患者的中等個位數增長和美國替代患者的低至中等個位數增長，這假設美國替代患者數量在第四季度初持平，我們現在預計歐洲和世界其他地區的總和將以低個位數增長。

With that, I will turn the call over to Ahmet to discuss our innovation pipeline.

說完這些，我將把電話轉給艾哈邁德 (Ahmet)，討論我們的創新管道。

Thank you, Vlad and good morning. As Vlad mentioned, innovation is a key growth driver for LivaNova.

謝謝你，弗拉德，早安。正如 Vlad 所說，創新是 LivaNova 的主要成長動力。

Since I joined in May, our Innovation committee has focused on four key areas which are processes and governance, operational model, talent and our innovation culture. We targeted these areas to drive our core portfolio road map while we simultaneously advance our depression and OSA programs,

自從我五月加入以來，我們的創新委員會一直專注於四個關鍵領域，即流程和治理、營運模式、人才和創新文化。我們瞄準這些領域來推動我們的核心投資組合路線圖，同時推進我們的憂鬱症和 OSA 項目，

Let me provide a few examples starting with our [CT business], furthering our leading market position in Heart-lung machines. [Essence] will serve as a foundational platform for our future innovation, particularly around future upgrades including data capture and analytics.

讓我舉幾個例子，從我們的[CT業務]開始，進一步鞏固我們在心肺機領域的領先市場地位。 [Essence] 將成為我們未來創新的基礎平台，特別是圍繞數據捕獲和分析等未來升級。

For example, we are investing in our in line blood monitoring capabilities, utilizing sensor technologies. This is designed to deliver additional real time data to guide the [profusion] during the procedure to further optimize patient tailored outcomes.

例如，我們正在利用感測器技術投資於線上血液監測功能。這是為了提供額外的即時數據來指導手術過程中的[豐富]，以進一步優化患者量身定制的結果。

In our consumables business we are developing a next generation oxygenator with a unique design targeting a best-in-class feature set and performance standards. In Epilepsy we are focusing our work on the next generation VNS therapy system that includes enhanced features such as connectivity that enables remote programming, offering value to both patients and physicians in a connected environment.

在我們的消耗品業務中，我們正在開發具有獨特設計的下一代氧合器，旨在實現一流的功能集和性能標準。在癲癇治療方面，我們致力於下一代 VNS 治療系統，該系統包括增強功能，如支援遠端程式設計的連接性，在互聯環境中為患者和醫生提供價值。

Similar to CP we are also investing in data capture and analytics which has the potential to combine treatment detection and prediction of seizures to improve patient outcomes. In difficult to treat depression We continue our efforts in pursuit of national coverage by CMS. We expect five critical publications over the coming months.

與 CP 類似，我們也在投資數據擷取和分析，這有可能結合治療檢測和癲癇發作預測，以改善患者的治療效果。對於難以治療的憂鬱症，我們將繼續努力，爭取 CMS 覆蓋全國。我們期待未來幾個月內出版五本重要出版品。

The first two pivotal manuscripts on the unipolar cohort data from the recover study should be published in a peer review journal this quarter.

關於恢復研究中單極隊列數據的前兩篇關鍵手稿將於本季在同行評審期刊上發表。

These publications will provide details on the primary and secondary endpoints of the study. Based on the subsequent in-depth analysis we anticipate the next three supporting manuscripts will be submitted in the fourth quarter and are expected to be published in the first quarter of 2025. We look forward to discussing the findings with CMS to define a path forward for coverage for critically ill patients with difficult to treat depression.

這些出版物將提供有關該研究的主要和次要終點的詳細資訊。根據後續的深入分析，我們預計接下來的三份支持手稿將在第四季度提交，並預計在 2025 年第一季出版。我們期待與 CMS 討論調查結果，以確定如何為患有難以治療的憂鬱症的重症患者提供保險。

Once all manuscripts are published, we will make a formal request to CMS for coverage. In OSA we are encouraged by the early stoppage and enrolment of the OSPREY study in March, which was based on a determination that there is a 97.5% or greater chance that there will be a statistically significant result in the primary endpoint for effectiveness.

一旦所有稿件發表，我們將向 CMS 提出正式的報道請求。在 OSA 中，我們對 3 月 OSPREY 研究的提前停止和招募感到鼓舞，這是基於確定在有效性的主要終點上出現具有統計意義的結果的可能性為 97.5% 或更大。

We continue to expect all patients to reach seven months of follow up in November and this is again the primary end point. This data is part of our [PMA] submission, which is expected in the first half of 2025. In summary, we are pleased with our progress in core innovation as well as difficult to treat depression at OSA programs.

我們繼續預計所有患者將在 11 月達到七個月的隨訪，這再次是主要終點。這些數據是我們[PMA]提交的一部分，預計在2025年上半年完成。總而言之，我們對 OSA 計畫在核心創新以及難以治療的憂鬱症方面取得的進展感到滿意。

With that, I will turn the call over to Alex.

說完這些，我會把電話轉給亞歷克斯。

Thanks Ahmet. During my portion of the call, I'll share a brief recap of the third quarter results and provide commentary on 2024 guidance.

謝謝艾哈邁德。在電話會議中，我將簡要回顧第三季的業績並對 2024 年的指引發表評論。

Turning to results revenue in the quarter was $318 million, an increase of 11% versus '23 excluding the impact of the ACS segment wind down revenue increased 12% versus 2023.

談到本季的業績，營收為 3.18 億美元，較 23 年成長 11%，不包括 ACS 部門清盤的影響，營收較 2023 年成長 12%。

Foreign exchange in the quarter had a negligible year over year impact adjusted gross margin as a percent of net revenue with 71% in line with the third quarter of 2023, adjusted R&D expense in the third quarter was $47 million compared to $42 million in the third quarter of '23, R&D as a percent of net revenue was 15% in line with the third quarter of 2023.

本季的外匯對調整後毛利率佔淨收入的百分比的影響與去年同期相比可以忽略不計，為 71%，與 2023 年第三季度持平，第三季度調整後的研發費用為 4700 萬美元，而 23 年第三季度為 4200 萬美元，研發費用為 200 萬美元，而 23 年第三季度為 4,200 萬美元，研發淨收入的百分比為 153 年。

The year over year increase on a dollar basis included a one-time charge associated with the DTD program, as well as higher investments in the Epilepsy business.

以美元計算的同比增長包括與 DTD 計劃相關的一次性費用，以及對癲癇業務的更多投資。

This increase was partially offset by the close out of the heart failure trial and the wind down of the ACS segment adjusted SG&A expense for the third quarter was $116 million compared to $115 million in the third quarter of 2023, SG&A as a percent of net revenue was 37% as compared to 40% in the third quarter of 2023.

這一增長被心臟衰竭試驗的結束和 ACS 部門的逐步減少部分抵消。

The year over year decrease as a percent of revenue was driven by improved operating leverage and was favorably impacted by the wind down of the ACS segment. Adjusted operating income was $64 million compared to $45 million in the third quarter of 2023, adjusted operating income margin was 20% compared to 16% in the third quarter of 2023.

收入百分比年減是由於營運槓桿提高，以及 ACS 部門關閉帶來的正面影響。調整後營業收入為 6,400 萬美元，而 2023 年第三季為 4,500 萬美元，調整後營業收入利潤率為 20%，而 2023 年第三季為 16%。

This increase was primarily driven by higher revenue, improved operating leverage and the wind down of the heart failure program and the ACS segment adjusted effective tax rate in the quarter was 23% compared to 10% in the third quarter of 2023. The increase is related to developments in the global tax landscape.

這一成長主要得益於收入增加、營運槓桿提高以及心臟衰竭項目逐步結束，本季 ACS 部門調整後有效稅率為 23%，而 2023 年第三季為 10%。這一增長與全球稅收格局的發展有關。

Looking ahead, we are anticipating A 24% to 25% effective tax rate in 2025 driven by geographic mix and the phase out of tax attributes that have contributed to our historically low effective tax rate, adjusted diluted earnings per share was $0.90 compared to $0.73 in the third quarter of 2023.

展望未來，我們預計 2025 年的有效稅率為 24% 至 25%，這得益於地域組合和導致我們歷史性低有效稅率的稅收屬性的逐步取消，調整後每股攤薄收益為 0.90 美元，而 2023 年第三季度為 0.73 美元。

Our cash balance at September 30, was $346 million up from $267 million at year end 2023, total debt at September 30, was $626 million up from $587 million at year end 2023.

我們的現金餘額截至 9 月 30 日為 3.46 億美元，高於 2023 年底的 2.67 億美元，截至 9 月 30 日的總債務為 6.26 億美元，高於 2023 年底的 5.87 億美元。

This increase in total debt was driven by the closing of a $345 million private offering of convertible senior notes maturing in 2029 and repurchase of the $230 million of convertible senior notes, net debt including restricted cash at September 30, was $61 million, adjusted free cash flow for the quarter was $47 million up from $26 million in the prior year period. The year over year increase was primarily driven by stronger operating results and working capital improvements.

總債務的增加是由於 2029 年到期的 3.45 億美元可轉換優先票據的私募完成以及 2.3 億美元可轉換優先票據的回購，截至 9 月 30 日包括受限現金在內的淨債務為 6,100 萬美元，本季度調整後的自由現金流為 4,700 萬美元，而去年同期的高於 260 萬美元。年成長主要得益於更強勁的經營業績和營運資本的改善。

Capital spend was $37 million in the first nine months of 2024 compared to $22 million in the prior year period. The year over year increase was driven by Cardiopulmonary capacity expansion initiatives and IT investments.

2024 年前 9 個月的資本支出為 3,700 萬美元，而去年同期為 2,200 萬美元。年成長主要得益於心肺容量擴張計劃和 IT 投資。

Now turning to our revised 2024 guidance, as Vlad mentioned based on our performance in the third quarter, we are increasing our full year 2024 guidance. We now expect 2024 revenue growth on a constant currency basis between 8.5% and 9.5% and between 10% and 11% when excluding the portion of the [ATS] business that we are exiting.

現在談談我們修訂後的 2024 年指引，正如 Vlad 所提到的，根據我們第三季的表現，我們正在上調 2024 年全年指引。我們現在預計，2024 年的收入成長率以固定匯率計算將在 8.5% 至 9.5% 之間，如果不包括我們正在退出的 [ATS] 業務部分，則將在 10% 至 11% 之間。

Foreign currency impact is expected to be negligible based on the current exchange rates. We forecast a full year adjusted effective tax rate between 21% and 22%.

根據當前匯率，預計外幣影響可以忽略不計。我們預測全年調整後有效稅率在 21% 至 22% 之間。

We project adjusted diluted earnings per share in the range of [$3.30 to $3.40] with adjusted diluted weighted average shares outstanding to be approximately $55 million for the full year.

我們預計全年調整後稀釋每股收益在 3.30 美元至 3.40 美元之間，調整後稀釋加權平均流通股數約為 5,500 萬美元。

Our forecast contemplates higher operating expenses in the fourth quarter compared to quarterly run rates Year-to-date. This [includes] higher R&D investments based on our plans to accelerate innovation. Additionally, we expect SG&A to peak in the fourth quarter of 2024 driven by commercial activities to support growth and enabling infrastructure for scalability.

我們預測第四季的營運費用將比年初至今的季度運行率更高。這[包括]根據我們加速創新的計劃增加研發投資。此外，我們預計，在支持成長和實現基礎設施可擴展性的商業活動的推動下，銷售、一般和行政費用將在 2024 年第四季達到高峰。

Adjusted free cash flow is now expected to be in the range of $110 million to $130 million, an increase of approximately 25% at midpoint versus the prior year. This range includes a meaningful step up in capital spending versus the prior year which we forecast to be approximately $60 million.

調整後的自由現金流目前預計在 1.1 億美元至 1.3 億美元之間，比上年中位數成長約 25%。這一範圍包括資本支出與前一年相比的顯著增加，我們預測上一年資本支出約為 6,000 萬美元。

As a reminder, our cash flow projections include costs associated with the ACS wind down in the range of approximately $15 to $20 million the majority of which occurs in 2024. In summary, I'm pleased with our team's continued execution which has led to consistent growth and margin expansion.

提醒一下，我們的現金流量預測包括與 ACS 清算相關的成本，大約在 1,500 萬至 2,000 萬美元之間，其中大部分發生在 2024 年。總而言之，我對我們團隊的持續執行感到滿意，這帶來了持續的成長和利潤的擴大。

We remain well positioned to deliver our financial commitments in 2024 including more than [400 basis points] of operating leverage over 40% growth in adjusted operating income and approximately 20% growth in adjusted diluted earnings per share. Despite the significant step up in our effective tax rate.

我們仍有可能在 2024 年實現我們的財務承諾，包括超過 [400 個基點] 的營業槓桿、調整後營業收入增長 40% 以及調整後每股攤薄收益增長約 20%。儘管我們的有效稅率大幅提高。

With that, I'll turn the call back over to Vlad.

說完這些，我將把電話轉回給弗拉德。

Thank you, Alex.

謝謝你，亞歷克斯。

To conclude. We ae pleased with the progress we have made over the first three quarters of this year including double digit revenue growth and significant operating margin extension. Importantly, this performance was achieved while positioning LivaNova for future success.

總結一下。我們對今年前三個季度的進展感到滿意，包括兩位數的收入成長和大幅的營業利潤率提高。重要的是，取得這樣的成績的同時，也為 LivaNova 未來的成功奠定了基礎。

Our growth is supported by strong business drivers as well as well-balanced across geographies and the portfolio. This foundation gives us confidence in the sustainability of our Cardiopulmonary and Epilepsy businesses. Additionally, we continue to make progress on our innovation efforts in the core as well as the DTD and OSA programs.

我們的成長得益於強勁的業務驅動力以及跨地域和投資組合的均衡發展。這個基礎使我們對心肺和癲癇業務的可持續性充滿信心。此外，我們在核心以及 DTD 和 OSA 計劃的創新工作方面繼續取得進展。

We look forward to building on this momentum in the fourth quarter and in 2025 driven by our continued focus on performance, innovation and talent. Finally, our success would not be possible without the strength of our team's ongoing execution and steadfast commitment to serving customers in their patience and for that, I say a big Thank you.

我們期待在第四季度和 2025 年繼續保持這一勢頭，並繼續關注業績、創新和人才。最後，如果沒有我們團隊的持續執行力和耐心服務客戶的堅定承諾，我們的成功就不可能實現，對此，我要向你們表示衷心的感謝。

With that Lydia. I will turn it over to you for questions.

和那個莉迪亞一起。我將把這個交給你們來回答問題。

(Operator Instructions)

（操作員指令）

Our first question today comes from David Roman with Goldman Sachs.

我們今天的第一個問題來自高盛的大衛‧羅曼 (David Roman)。

Thank you and Good morning, everybody. I wanted just to start maybe on a higher-level strategy question and then I had a follow up related to the, [outlook for the] balance of the year.

謝謝大家，早安。我可能只是想先討論更高層次的策略問題，然後再跟進今年的平衡前景。

You have been in the, the CEO role kind of a year when you kind of get into 2025 and can you maybe just help us reflect a little bit on how you are approaching portfolio management and maybe more specifically as it relates to R&D deployment and the balance between investment and some of the higher risk programs like DTD and OSA versus incremental innovation to support continued share gains and momentum in the core business.

進入 2025 年，您已經擔任了首席執行官一職，能否幫助我們反思一下您如何處理投資組合管理，更具體地說，是如何與研發部署以及投資與一些高風險項目（如 DTD 和 OSA）之間的平衡，以及漸進式創新如何支持核心業務的持續份額增長和發展勢頭。

David. Good morning. First of all. And thank you for the question.

大衛。早安.首先。感謝您的提問。

Yeah, it's been just over seven months, I think. And look, I think first of all, [kudos] to the team that was, that made some really strong portfolio decisions before I arrived, which was really to focus and refocus our portfolio in the areas where, you know, we have better execution and have the right to win.

是的，我想已經過去七個多月了。首先，我認為，我要向團隊表示敬意，在我到來之前，他們做出了一些非常強有力的投資組合決策，這些決策實際上是將我們的投資組合集中並重新集中在我們執行力更強、更有機會取勝的領域。

So I think wind down on ACS is an example of that you know, one of those decisions, but the way I kind of look forward and we are in the middle of working on the longer-term strategy to shape how LivaNova is going to look in for the next decade and we look forward to communicating that strategy in 2025.

所以我認為 ACS 的終止就是一個例子，你知道，這些決定之一，但我有點期待，我們正在製定長期戰略，以塑造 LivaNova 在未來十年的發展方向，我們期待在 2025 年傳達這一戰略。

But I think the key chapters within that is number one is maximize our core businesses, Epilepsy and Cardiopulmonary and we are like Alex said, we are reinvesting into the core R&D and making sure that those businesses have sustainable innovation pipeline. You see that not just in dollar investments but also in investment in the human capital.

但我認為其中的關鍵章節之一是最大化我們的核心業務，癲癇和心肺，就像亞歷克斯所說的那樣，我們正在重新投資於核心研發並確保這些業務擁有可持續的創新管道。您會發現，這不僅體現在美元投資上，也體現在人力資本投資上。

Number two is setting directions for DTD and OSA and like Ahmet said, on we are pleased with the progress we are waiting for kind of the reimbursement piece on the DTD and then on the clinical data for OSA to make further decisions. But on the DTD front, for example, we are freeing up some of the investment plan for next year and dropping some to the bottom line and reinvesting some back into the core.

第二是為 DTD 和 OSA 設定方向，正如 Ahmet 所說，我們對進展感到滿意，我們正在等待 DTD 的報銷部分，然後等待 OSA 的臨床數據以做出進一步的決定。但在DTD方面，我們正在釋放明年的一些投資計劃，將一些資金投入底線業務，並將一些資金重新投資到核心業務中。

And then the third chapter would be what's the next growth portfolio for LivaNova getting in a faster growth markets in the markets where there's significant unmet clinical need, but also in the markets where we have the right to win leveraging either our commercial or R&D capabilities and like I said, I look forward communicating that and getting the feedback from the investment community in 2025.

第三章是 LivaNova 的下一個成長組合是什麼，如何在存在大量未滿足臨床需求的市場中進入更快成長的市場，同時也在我們有權利用我們的商業或研發能力贏得的市場中，就像我說過的，我期待著在 2025 年傳達這一點並獲得投資界的反饋。

Greate, appreciate all the detail there and maybe Alex just a follow up here trying to put some of the pieces together with the commentary around the momentum in the business, what you've seen year-to-date and the kind of guidance for the rest of the year.

太好了，感謝您提供的所有細節，也許亞歷克斯只是在這裡進行跟進，試圖將一些部分與對業務發展勢頭的評論、今年迄今為止所看到的情況以及對今年剩餘時間的指導結合起來。

Can you just maybe help us think through kind of the assumptions here on the fourth quarter? And is there anything specific related to maybe timing of capital sales or any other drivers that would produce kind of the implied slowdown in revenue growth in Q4 as well as kind of the sequential step down in earnings. And then any initial comments that you're willing to offer on, on how we should think about that as setting the base for 2025.

您能否幫助我們思考一下有關第四季的假設？是否有任何具體因素與資本銷售時機或其他驅動因素有關，可能導致第四季營收成長放緩以及收益連續下降。然後，您願意就我們應該如何考慮將此作為 2025 年的基礎提出任何初步意見嗎？

Thanks for your question, David. So, we have seen tremendous performance in the first three quarters of the year the slowdown in revenue, that we are contemplating is really a function of our strong performance in the fourth quarter of 2023.

謝謝你的提問，大衛。因此，我們看到了今年前三個季度的出色表現，而收入放緩，我們認為這實際上是我們 2023 年第四季度強勁表現的結果。

If you recall, we had accelerated our placements of essence in, in the fourth quarter. This was related to the launch of the additional software that we were working on throughout the year. So it's really a comparison issue that appears to be showing a slowdown and in growth, the fundamentals are there we are well positioned to deliver on continued performance for the balance of the year.

如果您還記得的話，我們在第四季度加快了精華的投放。這與我們全年致力於開發的附加軟體的推出有關。因此，這實際上是一個比較問題，似乎顯示出經濟放緩和成長，但基本面仍然存在，我們有能力繼續保持今年餘下時間的良好表現。

As far as the margin component goes sort of goes hand in hand with the revenue commentary, but we are investing on a sort of incremental basis in the fourth quarter relative to our run rate over the first three quarters of the year and that's really just sort of positioning ourselves to continue to drive growth at above market rates, right.

就利潤率部分而言，它與收入評論密切相關，但相對於今年前三個季度的運行率，我們在第四季度的投資是增量式的，這實際上只是為了讓我們繼續以高於市場的速度推動增長，對吧。

So, we are investing in innovation programs we are trying to accelerate our sort of core portfolio in CD and Epilepsy, and we are still continuing to invest in DTD and OSA. So, that's the response on the margin.

因此，我們正在投資創新項目，試圖加速我們在 CD 和癲癇領域的核心產品組合，並且我們仍在繼續投資 DTD 和 OSA。這就是邊際反應。

Okay and sorry, are you willing to make any comments as related to kind of 2025? I think you had made it in some public forms. Setting sort of some view around high single digit growth or the comment about above market growth if markets are kind of mid single digits, is that a reasonable starting point for next year? That that high single digit growth number or how should we think about 2025? And then then I'll jump back in queue.

好的，抱歉，您願意就 2025 年發表任何評論嗎？我認為你已經在一些公開形式上做到了這一點。如果市場處於中等個位數成長水平，那麼圍繞高個位數成長設定某種觀點或關於高於市場成長的評論，這是明年的合理起點嗎？那麼那個高個位數的成長數字或我們應該如何看待 2025 年？然後我會重新回到隊列。

Yeah. So, David, at we will not give any indication for 2025 and as for the comments about high single digit growth, the comments I made and I kind of went through the growth drivers that we have in a similar manner that I tried to do in in my opening comments. And those levers of growth, if you like the market growth and, kind of in 2024 we see a very healthy, maybe a bit above what we expected in terms of market growth.

是的。因此，大衛，我們不會給出 2025 年的任何跡象，至於關於高個位數增長的評論，我所做的評論和我以類似方式介紹了我們擁有的增長動力，就像我在開場白中嘗試做的那樣。如果你喜歡這些成長槓桿，那麼在 2024 年，我們將看到一個非常健康的市場成長，甚至可能略高於我們對市場成長的預期。

Pricing is the second lever that continues to be driving our growth. The third level is continuous upgrade of our equipment fleet to essence. And so that's another major growth driver that will continue into next year.

定價是繼續推動我們成長的第二個槓桿。第三層次是，不斷升級我們的裝備隊伍，使其精進到底。這是另一個主要的成長動力，並將持續到明年。

And then finally, market share and here kind of on the plus we anticipate to see continued market share gains in our CP disposables on the minus what we also anticipate is the slowdown in the replacements procedures for Epilepsy.

最後，市場份額，從好的方面看，我們預計 CP 一次性產品的市場份額將繼續增長，從壞的方面看，我們也預計癲癇的替代程序將會放緩。

So, my comment in that forum was saying, if all those levers fire in a positive way, we will be looking at obviously at a high single digit growth. But I'm sure there will be some ups and downs as well in terms of the levers.

因此，我在該論壇的評論是，如果所有這些槓桿都以積極的方式發揮作用，我們顯然將看到高個位數的增長。但我確信在槓桿方面也會有一些起伏。

Understood. Thanks for indulging extra. Follow up.

明白了。感謝您的額外包容。跟進。

Our next question comes from Rick Wise, Stifel.

下一個問題來自 Stifel 的 Rick Wise。

Hi, good morning, everybody. And nice to see a really solid quarter. Very impressive. Thank you.

大家早安。很高興看到本季業績表現穩健。非常令人印象深刻。謝謝。

I want to dig into two things. First glad for you. Maybe you can unpack a little more detail. The oxygenator outlook, talk to us about any update on the competitor return to market or not or you are thinking about it. Maybe give us a little more colour about your capacity, which you talked about being you are sort of on track to for your capacity expansion. Where are we in that process? And again, just the sustainability of this excellent performance in this story into next year.

我想深入探討兩件事。首先為你感到高興。也許您可以揭示更多細節。氧合器的展望，請與我們談談競爭對手重返市場的任何最新消息，或者您是否正在考慮此事。也許您可以向我們詳細介紹一下你們的產能，您之前說過您的產能擴張正在按計劃進行。我們目前處於這個過程的哪個階段？再次強調，這個故事的出色表現將持續到明年。

Thank you. Thank you for the question. So maybe just to step back on why are we facing the situation of market constraint or supply constraint in in the oxygenators? It really is driven by two factors, one is the procedure growth, we estimate is above historic average and above what we anticipated for this year as an industry.

謝謝。感謝您的提問。因此，也許我們只是退一步來看看，為什麼我們在氧合器方面面臨市場限製或供應限​​制的情況？這實際上是由兩個因素推動的，一是流程成長，我們估計其高於歷史平均水平，也高於我們對今年整個行業的預期。

What is driving this is first of all growth of procedure in emerging markets which by nature the starting point is low penetration of cardiovascular procedures. And so, that's not, that's probably the biggest driver that we see in terms of procedures. And from that point of view, I don't have any indication to kind of assume that the market will slow down. We see a healthy growth of the market and reaching more patients.

推動這一趨勢的首先是新興市場的手術成長，而新興市場的起點本質上就是心血管手術的普及率低。所以，這不是，這可能是我們在程式方面看到的最大驅動因素。從這個角度來看，我沒有任何跡象表明市場將會放緩。我們看到市場健康成長並惠及更多的患者。

The second factor that contributed to this deficit of products is that the entire industry is kind of because of the way we plan for market go into and it's faster than kind of a plan, the entire industry is facing a capacity constraint. And to the benefit of our business we were able to grow the capacity in 2024 in our estimate better than some of our competitors.

造成產品短缺的第二個因素是，整個產業都面臨產能限制，因為我們計劃進入市場的方式比計畫的要快。為了我們的業務利益，我們預計到 2024 年我們的產能成長將比一些競爭對手更好。

And so, from our point of view, our first step was to do better in terms of productivity, with the footprint that we have today. And we are on track to achieve a 10% at least 10% volume growth in terms of manufacturing output from the end of 2023 to the end of '24. And it's been a gradual increase throughout the year.

因此，從我們的角度來看，我們的第一步是在現有的基礎上進一步提高生產力。我們預計在 2023 年底至 2024 年底期間實現製造業產量至少 10% 的成長。並且全年都呈現逐步成長趨勢。

And so, we have learned a lot, and we still have some room to keep improving that beyond kind of the end of this year so and keep driving our productivity.

因此，我們學到了很多東西，並且在今年年底之後我們仍然有一定的改進空間，可以繼續提高我們的生產力。

The second factor that is influencing this year is that they are kind of on the competitive side, we don't see any movement, meaning in terms of improvement. So we see the capacity constraint and kind of flat supply if you like of oxygenators on the market overall outside of LivaNova.

影響今年的第二個因素是他們在競爭方面沒有任何進展，也就是說沒有任何進展。因此，我們看到，除了 LivaNova 之外，整個市場上的氧合器都存在產能限制和供應持平的情況。

Again, if this continues, gives us additional opportunity in 2025 for continued gain of share. But for us to achieve that beyond just improving the productivity with what we have today, we are also looking in terms of how do we expand our capacity for the long term. And that has two factors in that one launch of new products that Ahmet talked about and the continued supply of our legacy oxygenators. So the team is developing and designing a plan to build that long term capacity.

同樣，如果這種情況持續下去，我們將在 2025 年獲得更多機會繼續增加市場份額。但為了實現這一目標，我們除了在現有基礎上提高生產力之外，還在考慮如何擴大我們的長期產能。這有兩個因素：一是艾哈邁德談到的新產品的推出，二是我們傳統的氧合器的持續供應。因此，該團隊正在製定和設計一項計劃來建立長期能力。

Vlad I would just add to your second question about the competitor dynamics are our understanding is that our major competitors resume full operations in the US and have increased supply in several countries around the world.

弗拉德，我只想補充一下你關於競爭對手動態的第二個問題，我們的理解是，我們的主要競爭對手在美國恢復了全面運營，並在全球多個國家增加了供應。

But you know, despite that, we see that the customer demand is continuing to outpace global supply. In fact, we still remain in the back order. So, we feel pretty good about how the market is shaping up for the quarter and then to 2025.

但你知道，儘管如此，我們仍然看到客戶需求持續超過全球供應。事實上，我們仍然處於訂單積壓狀態。因此，我們對本季以及 2025 年的市場發展前景感到非常樂觀。

That's great.

那太棒了。

Maybe for Ahmet as my follow up question is, Ahmet you highlighted your, I think very thoughtful, well-articulated plan and outlook and the innovation progress you are making in each of the area you detailed, maybe help us understand from an innovation perspective, what the timelines associated with some of these initiatives.

也許對於 Ahmet 來說，我的後續問題是，Ahmet，您強調了您的計劃和展望，我認為您計劃得非常周到、闡述清晰，而且您在每個詳述的領域都取得了創新進展，這也許有助於我們從創新的角度了解這些舉措的一些時間表。

I know it's not perfect. But I mean, are we going to see these interesting products with data capture and some of the attributes you talked about starting in '25 or no, this is going to take two or three years. And maybe specifically on DTD. You're saying once all of the publications are out there, you will request CMS coverage, any updated, thinking about potential timing there as well. Thank you.

我知道它並不完美。但我的意思是，我們是否會在 25 年開始看到這些具有資料擷取功能和您談到的一些屬性的有趣產品，這將需要兩三年的時間。可能具體涉及 DTD。您說的是，一旦所有出版物都發佈出來，您就會要求 CMS 報告任何更新，同時也考慮潛在的時間表。謝謝。

Good morning, Rick. So maybe I'll start with the, the depression [piece].

早上好，里克。所以我先從憂鬱症開始[片]。

So it is hard for us to predict the time lines with CMS. You know, the general rule of thumb is from the point that you do your formal application, it is about a year. But there's definitely some variance there.

因此我們很難預測 CMS 的時間軸。你知道，一般的經驗法則是從你正式申請開始，大約需要一年的時間。但那裡肯定存在一些差異。

What makes us hopeful is that this patient cohort has a very high unmet need. There are not a lot of alternative therapies. So, we believe that will help us collaborate with CMS quickly. We, believe because there are no alternative therapies that CMS primary purpose is to serve this patient population and they will look at the data with us together quickly, but generally, the rule of thumb is about a year. We will, as I outlined, we will initiate that process right after the final publications which we anticipate in early part of 2025.

讓我們充滿希望的是，這群患者有很高的未滿足需求。目前沒有太多的替代療法。因此，我們相信這將有助於我們快速與 CMS 合作。我們相信，由於沒有替代療法，CMS 的主要目的是服務這個患者群體，他們會與我們一起快速查看數據，但一般來說，經驗法則是大約一年的時間。正如我所概述的，我們將在預計 2025 年初的最終出版物發布後立即啟動此流程。

In terms of overall timelines for competitive reasons, we don't share our timelines. However many of the programs that I mentioned, they are not what I can share, they are not early stage, early feasibility programs, they are mid to late development programs. But beyond that, I don't want to share timelines with the exception of stating that these are not discovery research, they are not very high-risk programs. They are engineering execution programs.

就整體時間表而言，出於競爭原因，我們不會分享我們的時間表。然而，我提到的許多項目並不是我可以分享的，它們不是早期階段，不是早期可行性項目，而是中後期開發項目。但除此之外，我不想分享時間表，但需要說明的是，這些不是發現性研究，也不是高風險的專案。它們是工程執行程序。

On the OSA, so we will have our primary endpoint is the seven months for both effectiveness and for safety. We will have our last patients exit the study from that primary standpoint and primary end point standpoint in early November. And then that data will be utilized for the [PMA submission]. And we plan to have a press release in November with the preliminary top line data of the seven-month safety and effectiveness endpoints for OSA and move forward with our [PMA] application in the first half of 2025.

對於 OSA，我們的主要終點是七個月的有效性和安全性。我們的最後一位患者將於 11 月初從主要角度和主要終點角度退出研究。然後這些數據將用於[PMA 提交]。我們計劃在 11 月發布新聞稿，公佈 OSA 七個月安全性和有效性終點的初步頂線數據，並在 2025 年上半年推進我們的 [PMA] 申請。

Thank you very much.

非常感謝。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Great. Thanks for taking the questions and congrats on the quarter here.

偉大的。感謝您回答問題，並祝賀本季取得的成績。

I wanted to follow up a little bit more on some of the, the 2025 comments more so on the EPS kind of margin expansion line. I think you called out 20% plus EPS growth this year. You have a benefit from some drop through from prior trials.

我想進一步跟進一些關於 2025 年的評論，尤其是關於 EPS 利潤率擴張線的評論。我認為你曾說過今年的每股收益將成長 20% 以上。您可以從先前的試驗中獲益。

A little bit of a tax headwind this year as well. Sounds like there might be [an metal even] smaller tax headwind next year relative this year. The DTD program kind of dropping through as well. So, can you help us maybe think about how some of those pieces play out next year, as well as just the ability to expand margins, grow margins above whatever that top line growth number shakes out now.

今年的稅收也面臨一些阻力。聽起來明年的金屬稅收阻力可能比今年更小。DTD 程序也失敗了。那麼，您能否幫助我們思考這些因素明年將如何發揮作用，以及如何擴大利潤率，如何使利潤率超過目前營收成長數字所確定的範圍。

Yes. So, thanks for your question, David. Again, it's premature to talk about 2025 guidance. Our stated goal has and will continue to be to grow our margins faster than our revenue base. That is our objective as we move into 2025.

是的。所以，謝謝你的提問，大衛。再次強調，現在談論 2025 年的指導還為時過早。我們的目標是，並將繼續是，讓我們的利潤成長速度快於我們的收入基礎成長速度。這是我們邁向 2025 年的目標。

We started our modelling on the tax rate. That's why I highlighted that in my prepared comments. We started looking at our geographic mix around, the statutory tax rates and hence, I wanted to provide that insight early on so you can update your models, but just broadly speaking, at the highest level we intend to to grow our margins at a faster pace than revenues in 2025.

我們開始對稅率進行建模。這就是我在準備好的評論中強調這一點的原因。我們開始研究我們的地理分佈、法定稅率，因此，我想儘早提供這些見解，以便您可以更新您的模型，但從廣義上講，在最高層面上，我們打算在 2025 年讓我們的利潤率以比收入更快的速度增長。

Okay. I guess to clarify, would the margin growth above revenue be inclusive or exclusive of the DTD kind of drop through.

好的。我想澄清一下，收入以上的利潤率成長是否包括或不包括 DTD 類型的下降。

Be inclusive of DTD drop through as well as the benefits of the roll off of the ACS of business which we are exiting this year?

是否包括 DTD 的放棄以及我們今年退出的 ACS 業務的推廣帶來的好處？

Okay. And then maybe on DTD, it sounds like heard the comments there sounds like maybe at least at the margin, slightly more positive sounding, at least in our view on the potential for that program to play out, So can you just maybe help us think about some of the scenarios there around what the data, you know, should bring about the submissions to the FDA or the CMS. And how you're thinking about that program again on a relative basis to maybe what some of the comments were earlier this year.

好的。然後也許關於 DTD，聽起來好像聽到那裡的評論至少在邊緣上聽起來稍微更積極一些，至少在我們看來該計劃有潛力發揮作用，所以你能不能幫助我們思考一下那裡的一些情景，圍繞著數據，你知道，應該帶來向 FDA 或 CMS 的提交。以及相對於今年早些時候的一些評論，您如何再次看待該計劃。

Thank you.

謝謝。

Sure, this is Ahmet. So I mean, there's a few key points that makes us fairly optimistic. One is something that I mentioned earlier, this patient population has a very high unmet medical need that doesn't have other therapies available to them today that works. For example, in our patient's population and study the mean duration of depression was more than a decade.

當然，這是艾哈邁德。所以我的意思是，有幾個關鍵點讓我們相當樂觀。一是我之前提到的，這類患者族群有很高的未滿足的醫療需求，目前還沒有其他有效的治療方法。例如，在我們的患者群體和研究中，憂鬱症的平均持續時間超過十年。

The mean number of failed therapies was more than [10]. So, the fact that there is a very high on that medical need is something that CMS would like to resolve for. So that is that is one reason that we are feeling optimistic.

平均治療失敗次數超過[10]。因此，醫療需求非常高這一事實是 CMS 想要解決的問題。這就是我們感到樂觀的一個原因。

The second is when, we disclose the primary and secondary end points, if you recall while the primary endpoints were not met, certain secondary endpoints were met and we know that CMS looks at the totality of the therapy and the trial, they do not single out.

第二，當我們揭露主要和次要終點時，如果您還記得的話，雖然主要終點未達到，但某些次要終點已達到，並且我們知道 CMS 會考慮治療和試驗的整體性，它們不會單獨挑出某一項。

For example, just looking at the primary end points and moving on to the secondary end points if those are successful, like an HDA trial does.

例如，只需查看主要終點，如果成功則轉到次要終點，就像 HDA 試驗一樣。

And then the third piece is that we have done a secondary analysis and try to answer key questions. Like, why did the control arm perform better than anticipated? Why was the placebo effect better than anticipated? And are there certain subgroups and cohorts that respond differently?

第三部分是我們進行了二次分析並嘗試回答關鍵問題。比如，為什麼控制臂的表現比預期的還要好？安慰劑效應為何比預期更好？是否存在某些特定亞群體和群體有不同的反應？

So, when we looked at everything and worked with experts in the world that have worked with CMS in the past, that's why we decided to pursue our path. And once the publications are out, that is the strategy that we will take and initiate our formal application with CMS. So just to summarize the fact that there's a very high unmet medical need, the fact that in our trial, we were able to demonstrate that the (technical difficulty) therapy has a very positive impact on this very ill patient group.

因此，當我們審視一切，並與過去曾使用過 CMS 的世界專家合作時，我們決定走自己的路。一旦出版物發布，我們就會採取這個策略並啟動向 CMS 的正式申請。總而言之，存在著非常高的未滿足的醫療需求，事實上，在我們的試驗中，我們能夠證明（技術難度）治療對這群病情嚴重的患者有非常積極的影響。

We are feeling optimistic to progress with our application to CMS.

我們對 CMS 申請的進展感到樂觀。

I'm great. Thank you.

我很好。謝謝。

Michael Pollack, Wolf research.

邁克爾·波拉克，沃爾夫研究。

Hey, good morning. I have a question on US Epilepsy. How do you handicap here? In the next week, the prospects of getting the coding moved up to a level six payment. And if that were to be achieved, how would you frame the impacts for us next year and beyond is there a price opportunity if that were to happen? Is it more you would expect volume to react positively? Because procedure economics improved. Any puts and takes provisionally would be helpful.

嘿，早安。我對美國癲癇症有疑問。您在這裡如何設置障礙？在接下來的一周內，獲得編碼的前景將上升至六級付款。如果實現這一點，您如何看待這對我們明年及以後的影響？您是否更期望成交量能做出正面的反應？因為程序經濟性得到了改善。任何暫時的投入和產出都會有幫助。

Sure, thanks Michael. It's definitely so sort of on a wider scale, LivoNova had a reimbursement strategy in place for a number of years and being able to support our drug-resistant patient access to our therapy has obviously been central to that mission and level six is very much part of that and a couple of points on the process.

當然，謝謝邁克爾。從更大範圍來看，LivoNova 多年來一直實行報銷策略，能夠支持抗藥性患者獲得我們的治療顯然是該使命的核心，而六級是其中非常重要的一部分，也是該流程中的幾個要點。

So, while CMS is not obligated to follow the hot panel recommendation, and we are very encouraged to see the unanimous report of our request to come to sort of how we quantify the potential impact.

因此，雖然 CMS 沒有義務遵循熱門小組的建議，但我們非常高興看到我們的請求得到了一致的報告，以確定我們如何量化潛在影響。

There are a number of different factors involved here. But we do believe that it will make a meaningful difference to implanting centers due to largely retiring economic headwinds based by centres prescribing the [NS] to Medicare patients.

這裡涉及許多不同的因素。但我們確實相信，這將對植入中心產生重大影響，因為基於為醫療保險患者開立 [NS] 處方的中心所面臨的經濟阻力基本上已經消失。

And over time, what we hope to see is that the increase in reimbursement will drive greater VNS therapy utilization to this very underserved drug-resistant Epilepsy population.

隨著時間的推移，我們希望看到報銷金額的增加將推動更多 VNS 治療應用於這一醫療資源極其匱乏的抗藥性癲癇患者群體。

From pricing standpoint, we intend to continue with our annual inflationary price increase strategy but obviously, level six will give us the potential for greater flexibility with future innovative products which are in our pipeline.

從定價的角度來看，我們打算繼續我們的年度通膨價格上漲策略，但顯然，第六級將為我們正在研發的未來創新產品帶來更大的靈活性。

And then just maybe what you said, Mike it's a great question just to add this as well.

然後也許正如你所說，麥克，這是一個很好的問題，只是為了補充這一點。

If you step back just from the clinical unmet need, there are over a million patients with drug resistant Epilepsy there that are untreated today. And while the procedure penetration, if you look at that patient population is very low, it's below 5%.

如果僅從臨床未滿足的需求來看，目前有超過一百萬患有抗藥性癲癇的患者未接受治療。雖然該手術的滲透率很高，但是如果你看一下患者人數，你會發現其比例非常低，低於 5%。

So there's still significant opportunity to grow the procedure penetration and one of the barriers to that growth is reimbursement. And so, if the improvement and reimbursement were achieved, that will obviously unlock, it won't solve the complete puzzle, but it will unlock a very important area for us.

因此，仍有很大的空間來提高該程序的滲透率，而成長的障礙之一就是報銷。因此，如果實現了改進和報銷，這顯然會解開謎團，雖然它不會解決整個難題，但它將為我們解開一個非常重要的領域。

Thank you. Quick follow up another fishing expedition for 2025. I want to keep it simple. You're raising 2024 EPS by $0.20 at the midpoint. If I just knew that, next year's number might be biased higher by $0.20, but tax rate's going to step up again. If I do the math on Alex 24% to 25% it's another, it's a $0.15 headwind. So, the rate this year plus $0.20 the tax rate coming up minus $0.15, its kind of, it kind of leaves the street unchanged. Maybe up a nickel [365, 370]. That's 10% EPS growth year on year off this new '24 EPS base. How does this sound? Thank you.

謝謝。快速跟進 2025 年的另一次釣魚探險。我想讓它保持簡單。您將 2024 年每股收益中位數提高 0.20 美元。如果我知道這一點，明年的數字可能會高出 0.20 美元，但稅率將再次上升。如果我計算一下 Alex 的 24% 到 25% 的比例，那就是另一個 0.15 美元的逆風。因此，今年的稅率加上 0.20 美元，減去 0.15 美元，基本上與街道保持不變。可能漲五美分[365，370]。這意味著在新的 24 年每股盈餘基礎上，每股盈餘較去年同期成長 10%。這聽起來怎麼樣？謝謝。

I appreciate the fishing expedition, Mike. I mean, you are always good with your modeling. So, I'll just Leave it at that.

我很欣賞這次釣魚之旅，麥克。我的意思是，你的模特兒工作一直都很棒。所以，我就不說了。

Okay. Thank you.

好的。謝謝。

Adam Maeder, Piper Sandler & Co.

梅德（Adam Maeder），Piper Sandler & Co.

Hi, good morning. Thank you for taking the questions and congrats on the nice quarter.

嗨，早安。感謝您回答這些問題，並祝賀本季取得良好業績。

One quick clarification for me on DTD. I just wanted to confirm that there is no change to your plans for the cost savings next year. I think you talked about $20 million plus or pre-tax cost savings that will go back into models in '25 on last quarter's call. So, is that correct? And then I had a follow up. Thanks.

關於 DTD，我簡單解釋一下。我只是想確認您明年的成本節約計劃沒有改變。我認為您在上個季度的電話會議上談到了 2000 萬美元以上的稅前成本節省，這些節省將在 25 年重新投入到模型中。那麼，這是正確的嗎？然後我進行了跟進。謝謝。

Adam, that is, that is absolutely correct $20 million pre-tax drop through on 2025 earnings.

亞當，這是完全正確的，2025 年稅前收益將下降 2000 萬美元。

Okay, perfect. Thanks for that Alex. And then I wanted to pivot over to obstructive sleep apnea. So, it sounds like we will get the seven-month data in November. The I guess the question is, what, what do you think is a good result for your hypoglossal nerve stimulation technology? obviously, we have this 97.5% predictive probability of success. That's hanging out there.

好的，完美。謝謝你，亞歷克斯。然後我想轉到阻塞性睡眠呼吸中止症。所以，聽起來我們將在十一月獲得七個月的數據。我想問題是，您認為舌下神經刺激技術的良好效果是什麼？顯然，我們有 97.5% 的成功預測機率。就掛在那裡。

But what's a good result in your opinion? What do you need to see that kind of ultimately push the program forward commercially? And how do we think about the importance of the seven month data that will get in November versus maybe the 12 month data that we get in the first half of '25? Thanks for taking the questions.

但您認為什麼樣的結果才是好的結果呢？您需要看到什麼最終推動該專案的商業化？我們如何看待 11 月獲得的 7 個月數據與 25 年上半年獲得的 12 個月數據的重要性？感謝您回答這些問題。

Yeah. Adam, thank you for the question. So, I'll start and then Ahmet can, can maybe help us build on that.

是的。亞當，謝謝你的提問。因此，我先開始，然後艾哈邁德也許可以幫助我們在此基礎上再接再厲。

But if I step back and say what success looks like, I think it all starts with the clinical data first, right? and what success from that perspective would look like is a competitive data to the current standard of care in the neural modulation treatment of OSA.

但如果我退一步來說成功是什麼樣子的，我認為一切都先從臨床數據開始，對嗎？從這個角度來看，成功將是與 OSA 神經調節治療的現行標準護理相媲美的競爭數據。

What we also know from the previous research is that the clinical outcome improves from 6 to 12 or from 7 to 13 months treatment. So we will be looking at the, you know, at the seven month result, we will be looking at how that compares with the current standard of care or current devices performance at the same time.

我們也從先前的研究中了解到，臨床結果從 6 到 12 個月或從 7 到 13 個月的治療有所改善。因此，我們將觀察七個月的結果，同時觀察其與目前護理標準或當前設備性能的比較。

And then we will, extrapolate it into the future. But ultimately, the most important is what is our clinical result going to show at 13 months and for our success will be to be at least comparable with the data of competitors, so that's number one.

然後我們將其推斷至未來。但最終，最重要的是我們的臨床結果在 13 個月時會如何，而我們的成功至少要與競爭對手的數據相媲美，所以這是最重要的。

Then beyond that, obviously, we are also working to make sure that our device from a technology point of view is competitive in terms of ease of use and just technology that kind of is in the device. So, the second one is more engineering compatibility with current competitors.

除此之外，顯然，我們還在努力確保我們的設備從技術角度來看在易用性和設備所採用的技術方面具有競爭力。因此，第二個是與當前競爭對手更具工程相容性。

And then the third one is the decision on how we are going to commercialize it and again, there are different options for us moving forward. So those are the three big factors that we are going to take into consideration, but overwhelmingly most important one is the clinical outcome and, and how it compares to other devices on the market.

第三個是決定如何將其商業化，同樣，我們在未來也會有不同的選擇。所以這些是我們要考慮的三個主要因素，但最重要的是臨床結果以及與市場上其他設備的比較。

Yeah, maybe I'll add a couple of quick points. One is with our device and our trial design if you recall, there is no dice requirement and complete concentric collapse CCC will not be a contraindication. So, we feel very excited about that.

是的，也許我會補充幾點。一個是如果您還記得的話，我們的設備和試驗設計沒有骰子要求，並且完全同心塌陷CCC不會成為禁忌症。因此，我們對此感到非常興奮。

And the second point I'll make is that you asked about the performance of the trial, obviously, we have not seen the final seven-month data. However, we truncated the study back in March based on the results that we saw that you know, will indicate that the device performs better than our original expectations that allowed us to truncate the study and move forward with a much smaller study than or plan.

我要說的第二點是，您詢問試驗的表現，顯然我們還沒有看到最終的七個月數據。然而，根據我們看到的結果，我們在 3 月縮短了這項研究，結果顯示該設備的性能比我們最初的預期要好，這使我們能夠縮短研究時間，並繼續進行比計劃小得多的研究。

So maybe those will be the two points I will make. We are very excited about the not requiring dice because dice adds a significant treatment pathway obstacle for patients. It prolongs the process. It's not a very well reimbursed process. So we think that has a significant advantage with our technology.

所以也許這就是我要說的兩點。我們對不需要骰子感到非常興奮，因為骰子為患者的治療途徑增加了重大障礙。它延長了這個過程。這不是一個很好的報銷過程。因此我們認為我們的技術具有顯著的優勢。

Thank you.

謝謝。

Anthony Patron with Mizuho.

瑞穗的 Anthony Patron。

Thanks, and congrats on the quarter here, maybe back to DTD. The study is comprehensive with 12 additional end points.

謝謝，並祝賀本季取得圓滿成功，也許可以回到 DTD。研究十分全面，共有 12 個附加終點。

And when we had the press release earlier in the year, there was indication that certain of those endpoints saw some benefit the overall composite endpoint was not met but certainly it wanted warranted further analysis on the data.

當我們在今年稍早發布新聞稿時，有跡象表明其中某些終點看到了一些益處，但總體綜合終點尚未達到，但肯定需要對數據進行進一步分析。

So, maybe just a little bit on the secondary endpoints that we should be looking at to gauge success. Is it, is it the suicide attempt end point? Is it time to first remission time to rate of response, etc? So maybe just a little bit as we go through the details in these publications, as they come out on which secondary endpoints really will drive the decision on whether or not to go ahead with depression and I'll have one follow up.

因此，也許我們應該稍微關註一下次要終點，以衡量成功。是的，這是自殺未遂的終點嗎？現在是首次緩解時間、反應率時間等等嗎？因此，當我們仔細研究這些出版物中的細節時，也許只需一點，當它們出來時，哪些次要終點真正會決定是否繼續治療憂鬱症，我會進行跟進。

Thanks.

謝謝。

Thank you, Anthony for questions.

謝謝安東尼的提問。

So, what I would say is both the primary and secondary endpoints, they would be published very soon. So, I do not want to comment prior to the publications because that won't be appropriate for the publications. But at that time, you would be able to very clearly see.

所以，我想說的是，主要終點和次要終點都將很快公佈。所以，我不想在出版物之前發表評論，因為這對出版物來說不合適。但那時候，你就能夠看得非常清楚。

And as I mentioned during my speech, we anticipate those publications for primary and secondary points first to publications to be available in fourth quarter of this year.

正如我在演講中提到的那樣，我們預計主要和次要觀點的出版物將在今年第四季發布。

Right. And when we look at those end points, are there any of that jump out as being more heavily weighted as it relates to the company's decision on whether or not they would move forward to mark to commercialize depression. In other words, when the data comes out, how should we be thinking about which of these 12 secondary endpoints will really be the drivers in the decision-making process to commercialize depression.

正確的。當我們查看這些終點時，是否有任何一點顯得更為重要，因為它與公司是否繼續推進憂鬱症商業化的決定有關。換句話說，當數據出來時，我們應該如何思考這 12 個次要終點中的哪一個將真正成為將憂鬱症商業化的決策過程中的驅動因素。

So, Anthony, thank you for this again. If we take it from the point of view of decision to commercialize, it will be driven by the outcome of the reimbursement. And so, from our point of view, our current assumption is if the reimbursement is outcome is positive, we will commercialize this technology for two reasons.

所以，安東尼，再次感謝你。如果我們從商業化決策的角度來看，它將受到報銷結果的驅動。因此，從我們的角度來看，我們目前的假設是，如果報銷結果是正面的，我們將出於兩個原因將這項技術商業化。

Really, one is there are many critically ill patients that don't have another option in terms of treatment but also the consequences of that is that the kind of the market of business opportunity is significant for us, and it will really expand our portfolio. So the decision to commercialize is not driven by which primary secondary points we are looking at. It will be purely driven by the reimbursement decision of the CMS.

確實，一方面有很多重症患者在治療方面沒有其他選擇，但其後果是，這種市場商業機會對我們來說意義重大，它將真正擴大我們的投資組合。因此，商業化的決定並不取決於我們關注的主要次要點。它將完全由 CMS 的報銷決定驅動。

Very helpful and then just their process just to round that out. I'm sure CMS will dig into the data after publication. But is there any update just on how long the CMS process itself will take?

非常有幫助，然後他們的流程就完成了。我確信 CMS 會在發布後深入挖掘數據。但是，有沒有關於 CMS 流程本身需要多長時間的最新消息？

Thanks again, congrats on the quarter.

再次感謝，恭喜本季取得佳績。

Thank you again. So, the first two publications will come out in Q4 and our secondary analysis which we looked at the data very carefully. We are, they are going to generate three publications, and we believe the totality of the data that CMS should review together with us is those five papers not just the primary and secondary endpoint analysis.

再次感謝您。因此，前兩份出版物將於第四季度發布，而我們的二次分析是基於非常仔細查看的數據。他們將會發表三份出版物，我們認為 CMS 應該與我們一起審查的全部數據是這五篇論文，而不僅僅是主要和次要終點分析。

So once they come out which we anticipate in Q1 of '25 we will apply for the formal consideration. And the timelines are, I think wide if you look at historically, but generally it's about a year or less. But again, we can't control or commit to any timelines. It's a wide range if you look historically.

因此，一旦它們發布（我們預計將於 25 年第一季發布），我們將申請正式考慮。如果從歷史角度來看，時間線很長，但一般約為一年或更短。但同樣，我們無法控製或承諾任何時間表。如果從歷史角度來看，其範圍非常廣泛。

Thank you.

謝謝。

Mike Matson, Needham.

麥克馬森，尼德姆。

Yeah, thanks. So just starting with essence. So, I think you said it was around 40% of HLM sales this year. I would assume that's a global number, is that right? And then where do you think that sort of peaks? I mean, can it get to 100% eventually or are you going to continue to sell the older system in some of the developing markets?

是的，謝謝。所以就從本質開始。所以，我認為您說的是今年 HLM 銷售額的 40% 左右。我認為這是一個全球數字，對嗎？那麼您認為這種高峰在哪裡呢？我的意思是，它最終能達到 100% 嗎，或者你會繼續在一些發展中市場銷售舊系統嗎？

Yeah. Mike, thank you for the question.

是的。麥克，謝謝你的提問。

You're right. The global number this year will be around 40% penetration of essence in our total portfolio of placements. We assume at this point that we can keep improving by about 20% points every year, you know, which will then kind of take about a three-year cycle for us to get to 100%.

你說得對。今年全球範圍內，精華滲透率將達到我們總投資組合的 40% 左右。我們假設目前我們每年可以維持大約 20% 的進步，這樣大約需要三年的週期才能達到 100%。

The goal is to get one platform to 100% of, of our placements. And then the way I think about essence, it really gives a wide range of opportunities for upgrades.

我們的目標是讓一個平台覆蓋我們 100% 的展示位置。然後，我認為本質確實提供了廣泛的升級機會。

It's a bit like you get a car and you have different options within that. And so you can really get a hardware with various number of options and to your comment between emerging and developed markets or kind of more economically wealthy customers versus less the differentiator will be in those options that they can get with the machine and rather than having two different platforms on the market, so that's our strategy.

這有點像你買了一輛車並且有不同的選擇。因此，您確實可以獲得具有多種選項的硬件，並且對於新興市場和發達市場或經濟上較富裕的客戶之間的評論，差異在於他們可以透過機器獲得的選項，而不是在市場上推出兩個不同的平台，所以這就是我們的策略。

Okay. Got it. And then I just want to ask one on Epilepsy following up on Mike's question on this potential reimbursement change.

好的。知道了。然後，我想問一個關於癲癇的問題，跟進麥克關於這個潛在的報銷變化的問題。

So, can you just tell us the portion of Epilepsy patients that are on Medicare currently? I imagine it's lower just I think it's a younger patient population. And then would this change if this change does happen to Medicare? Could that have a spillover effect on the private insurers? Could it result in private insurer reimbursement increasing or is that totally separate?

那麼，您能告訴我們目前享有醫療保險的癲癇患者比例嗎？我認為這個數字較低，因為我認為患者群體比較年輕。那麼，如果醫療保險確實發生這種變化，情況會改變嗎？這會對私人保險公司產生外溢效應嗎？這會導致私人保險公司的報銷金額增加，還是完全無關？

Yeah, thanks Mike. So, we equate our Medicare population to be about 40% of our [MPI] numbers and the team is still working at the potential spillover effects. So we'll have more information as time goes by, but that is a possibility.

是的，謝謝邁克。因此，我們將醫療保險人口視為我們 [MPI] 數字的約 40%，團隊仍在努力研究潛在的外溢效應。所以隨著時間的推移我們會獲得更多信息，但這是一種可能性。

Great. Thanks.

偉大的。謝謝。

Matt Miksic, Barclays.

巴克萊銀行的馬特‧米克西克 (Matt Miksic)。

Hey, thanks for fitting me in. So, I wanted to, I know we have covered a bunch of questions around 2025 and around the portfolio. But maybe if you could just talk a little bit about the puts and takes to the P&L depending on, you know, which direction you decide to go, understanding that's a hypothetical based on the results in November and the safety results in the first quarter.

嘿，謝謝你幫我安排。所以，我想，我知道我們已經討論了一系列有關 2025 年和投資組合的問題。但是，如果您可以稍微談一下損益表的投入和產出，這取決於您決定採取哪個方向，請理解這是基於 11 月的結果和第一季的安全結果做出的假設。

Maybe where is the puts and takes in terms of moving forward with investment, maybe slowing or sidelining investments and reassessing on OSA and on the DDD.

或許在推進投資方面，需要付出和收穫的地方在哪裡，或許會放緩或擱置投資，並重新評估 OSA 和 DDD。

Thanks.

謝謝。

Thanks for your question, Matt.

謝謝你的提問，馬特。

Right. So, the, the big investments that you're probably thinking about are related to DTD and OSA. The way as Vlad said, we are going to continue to run the program sort of at its, at its bare minimum in, in terms of investments. Up until the point, we, we get the positive signal from CMS. So, we are that's the gate in terms of and expanding our investments in commercializing the asset.

正確的。所以，您可能正在考慮的大型投資與 DTD 和 OSA 有關。正如弗拉德所說，就投資而言，我們將繼續以最低限度的方式運行該計劃。到目前為止，我們從 CMS 獲得了積極的信號。因此，這是我們擴大資產商業化投資的大門。

On the OSA front, we have to, obviously the gating item here is the, the [PMA] submission and approval from the FDA. If positive that gives us an opportunity to think about commercializing the asset. Again, we have some, have lots of options and how we go to market with this asset. So, we can choose to commercialize it ourselves, we can choose to partner it or other options. So we are, trying to create as much optionality as we can to to create value.

在 OSA 方面，我們必須，顯然這裡的門控項目是 FDA 的 [PMA] 提交和批准。如果結果為肯定的，這將使我們有機會考慮將資產商業化。再說一遍，我們有很多選擇，以及如何利用這種資產進入市場。因此，我們可以選擇自己將其商業化，也可以選擇與他人合作或採用其他選擇。因此，我們嘗試創造盡可能多的可選性來創造價值。

Sure. And the, and just to put numbers around those, the baseline minimum investment level for DTD is kind of where now and just remind us maybe where the spend is, up until decision point on, on OSA roughly.

當然。而且，只是為了將這些數字匯總在一起，DTD 的基線最低投資水平現在大概是在哪裡，這只是提醒我們，直到 OSA 的決策點為止，支出大概在哪裡。

Yeah, we are at this point we said in last orders call, we were thinking about $10 million in 2025 for DTD. And for OSA is we, we are sort of coming up on the completion of the trial. So, we are now starting to focus more on the medical affairs side. So, it's more preparatory to make sure we are in a good place to potentially commercialize the asset.

是的，我們在上次訂單中說過，我們考慮在 2025 年為 DTD 投資 1000 萬美元。對於 OSA 來說，我們即將完成試驗。所以，我們現在開始更加關注醫療事務方面。因此，我們需要做更多的準備，以確保我們能夠處於有利位置，以實現資產的商業化。

And then just to add on the OSA front, like I said we are targeting submission in the first half of 2025. So, to your point, if we make a decision to commercialize or extend the investment, this is most likely not the 2025 story. This is the '26 and beyond.

然後，再補充一下 OSA 方面，就像我說的，我們的目標是在 2025 年上半年提交。所以，正如您所說，如果我們決定商業化或擴大投資，這很可能不是 2025 年的故事。這就是'26及以後的事情。

Got it. Thanks so much. Glad and thanks everybody.

知道了。非常感謝。很高興並感謝大家。

Thank you. We have no further questions in the queue. So I'll turn the call back to Vladimir Maaria for any closing remarks.

謝謝。我們沒有其他問題了。因此，我將把電話轉回給 Vladimir Maaria，請他做最後發言。

Yeah, Lydia, thank you for helping us facilitate the call and thank you everyone for joining the call today and more importantly for your support and interest in LivaNova. Have a great day ahead. Thank you.

是的，莉迪亞，感謝您幫助我們主持這次電話會議，也感謝大家今天參加這次電話會議，更重要的是，感謝您對 LivaNova 的支持和關注。祝您有個愉快的一天。謝謝。

This concludes our call. Thank you very much for joining you. May now disconnect your line.

我們的通話到此結束。非常感謝您的加入。現在可以斷開您的線路了。