LivaNova PLC (LIVN) 2022 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the LivaNova PLC Fourth Quarter and Full Year 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

女士們先生們，美好的一天，歡迎參加 LivaNova PLC 2022 年第四季度和全年收益電話會議。 （操作員說明）作為提醒，正在錄製此電話會議。

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

現在我想介紹一下今天會議的主持人 Matthew Dodds 先生，他是 LivaNova 的企業發展高級副總裁。請繼續，先生。

Thank you, Emily, and welcome to our conference call and webcast discussing LivaNova's financial results for the fourth quarter and full year of 2022. Joining me on today's call are Damien McDonald, our Chief Executive Officer; Alex Shvartsburg, our Chief Financial Officer; and Briana Gotlin, Director of Investor Relations. Before we begin, I would like to remind you that the discussions during this call will include forward-looking statements. Factors that could cause actual results to differ 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.

謝謝 Emily，歡迎參加我們的電話會議和網絡廣播，討論 LivaNova 2022 年第四季度和全年的財務業績。與我一起參加今天電話會議的還有我們的首席執行官 Damien McDonald；我們的首席財務官 Alex Shvartsburg；和投資者關係總監 Briana Gotlin。在我們開始之前，我想提醒您，本次電話會議期間的討論將包括前瞻性陳述。公司最近向美國證券交易委員會提交的文件和文件中討論了可能導致實際結果出現重大差異的因素，包括今天在我們網站上發布的新聞稿。我們不承諾更新任何前瞻性陳述。

Also, the discussions will include certain non-GAAP financial measures with respect to our performance including, but not limited to, sales 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. 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 & Presentations at investor.livanova.com.

此外，討論將包括與我們的業績有關的某些非 GAAP 財務措施，包括但不限於銷售業績，這些都將以固定貨幣為基礎列示。可在今天的新聞稿中找到與最直接可比的 GAAP 財務指標的對賬，該新聞稿可在我們的網站上獲取。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。此演示文稿是對其他通話材料的補充，應用作增強的溝通工具。您可以在我們網站 investor.livanova.com 的新聞、活動和演示文稿下的投資者部分找到演示文稿和新聞稿。

With that, I will now turn the call over to Damien.

有了這個，我現在將把電話轉給 Damien。

Thank you, Matt, and thank you, everyone, for joining us. Welcome to our conference call for the fourth quarter and full year of 2022. I'll discuss our fourth quarter and full year results, provide 2023 revenue guidance and review our strategic portfolio initiatives. After my comments, Alex will provide additional details on our results and 2023 guidance. I'll wrap up with closing remarks before moving on to Q&A. In the quarter, we achieved 6% revenue growth. This was driven by the Cardiopulmonary and Neuromodulation businesses across all regions. Advanced Circulatory Support remained unfavorably impacted by a significant decline in severe COVID cases. I'm proud of our team for continuing to move the business forward against macro challenges, including inflation and supply chain complexities.

謝謝馬特，也謝謝大家加入我們。歡迎參加我們 2022 年第四季度和全年的電話會議。我將討論我們的第四季度和全年業績，提供 2023 年收入指導並審查我們的戰略組合計劃。在我發表意見後，亞歷克斯將提供有關我們結果和 2023 年指導的更多詳細信息。在繼續問答環節之前，我將以結束語結束。本季度，我們實現了 6% 的收入增長。這是由所有地區的心肺和神經調節業務推動的。高級循環支持仍受到嚴重 COVID 病例顯著下降的不利影響。我為我們的團隊繼續推動業務前進以應對宏觀挑戰（包括通貨膨脹和供應鏈複雜性）感到自豪。

Now turning to segment results. For the Cardiopulmonary segment, revenue was $137 million in the quarter, an increase of 9% versus the fourth quarter of 2021. Oxygenator revenue grew low double digit driven by continued procedure volume recovery across all regions. Heart-lung machine revenue increased mid-single digits led by growth in the Rest of World region. Cardiopulmonary revenue for the full year was $500 million and grew 11%. We expect the Cardiopulmonary revenue to grow 3% to 5% for the full year 2023. Our forecast includes the staged rollout of the next-generation HLM Essenz. In February, we initiated our limited commercial release in select centers throughout Europe following successful clinical cases in 2 major hospitals in Q4. Looking ahead, we anticipate a gradual ramp in Essenz sales throughout the year.

現在轉向細分結果。對於心肺部，本季度收入為 1.37 億美元，比 2021 年第四季度增長 9%。在所有地區持續的手術量恢復的推動下，氧合器收入增長低兩位數。在世界其他地區的增長帶動下，心肺機收入增長了中等個位數。全年心肺收入為 5 億美元，增長 11%。我們預計 2023 年全年心肺收入將增長 3% 至 5%。我們的預測包括分階段推出下一代 HLM Essenz。 2 月，繼第四季度在 2 家主要醫院取得成功的臨床病例後，我們在整個歐洲的選定中心啟動了我們的有限商業發布。展望未來，我們預計 Essenz 全年的銷售額將逐步增加。

Epilepsy revenue increased 7% versus the fourth quarter of 2021 with growth across all 3 regions. This performance was primarily driven by replacement implants in the U.S. and double-digit growth outside the U.S. for both new and replacement implants. U.S. epilepsy revenue increased 4% year-over-year. Similar to last quarter, total implant growth was driven by replacements. In the U.S. we are continuing to advance our go-to-market commercial strategy in comprehensive epilepsy centers, which included 15 dedicated teams. These teams accounted for approximately 21% of U.S. implants in the quarter as compared to 22% on a same account basis during the prior year. Epilepsy revenue in Europe grew 18% versus prior year led by the U.S. -- U.K. and Nordics. The Rest of World region achieved 18% growth led by Brazil. For the full year, epilepsy revenue increased 7%. For the full year 2023, we expect global epilepsy revenue to grow 3% to 5%.

與 2021 年第四季度相比，癲癇收入增長了 7%，所有 3 個地區均有增長。這一業績主要是由美國的替換植入物和美國以外的新植入物和替換植入物的兩位數增長推動的。美國癲癇收入同比增長 4%。與上一季度類似，植入物總量的增長是由替換驅動的。在美國，我們正在繼續推進我們在綜合性癲癇中心的上市商業戰略，其中包括 15 個專門團隊。這些團隊在本季度約占美國植入量的 21%，而去年同期為 22%。與美國、英國和北歐國家領先的上一年相比，歐洲的癲癇收入增長了 18%。世界其他地區在巴西的帶動下實現了 18% 的增長。全年，癲癇收入增長了 7%。對於 2023 年全年，我們預計全球癲癇收入將增長 3% 至 5%。

ACS revenue was $10 million in the quarter representing a decrease of 30% from the fourth quarter of 2021. Results continued to be impacted by the year-over-year reduction in severe COVID cases and in part by product mix, which was partially offset by growth in non-COVID cases. Our field data suggests ACS case volumes related to COVID declined more than 90% year-over-year as fewer hospitalized patients progressed to a severity that required ECMO therapy. However, ACS non-COVID cases increased more than 20% versus 4Q '21 driven by an easing of hospital capacity constraints. ACS revenue for the full year was $39 million representing a decline of 29%. For 2023, we expect ACS to grow 4% to 6%. Our forecast includes a return to growth once we anniversary the COVID impact after the first quarter.

本季度 ACS 收入為 1000 萬美元，比 2021 年第四季度下降 30%。結果繼續受到嚴重 COVID 病例同比減少的影響，部分受到產品組合的影響，這部分被以下因素所抵消非 COVID 病例的增長。我們的實地數據表明，與 COVID 相關的 ACS 病例數量同比下降了 90% 以上，因為進展到需要 ECMO 治療的嚴重程度的住院患者越來越少。然而，由於醫院容量限制的緩解，ACS 非 COVID 病例比 21 年第四季度增加了 20% 以上。 ACS 全年收入為 3900 萬美元，下降 29%。對於 2023 年，我們預計 ACS 將增長 4% 至 6%。我們的預測包括，一旦我們在第一季度後對 COVID 的影響進行週年紀念，就會恢復增長。

Turning now to the strategic portfolio initiatives. DTD revenue for the fourth quarter was $3 million and for the full year was $8 million. For 2023, we anticipate DTD revenue of approximately $8 million to $10 million primarily from the RECOVER study. The RECOVER study continues to advance. The randomized controlled study is designed with frequent interim analyses that will assess if predictive probability of success has been reached or if the study should continue enrolling. Our interim analysis for the 450th patient in the unipolar cohort was recently completed and confirmed the study's continuation. The next interim look is at 475 patients, at which point we can either transition to the prospective longitudinal study or complete enrollment to 500 patients for the unipolar cohort.

現在轉向戰略組合計劃。 DTD 第四季度的收入為 300 萬美元，全年為 800 萬美元。到 2023 年，我們預計主要來自 RECOVER 研究的 DTD 收入約為 800 萬至 1000 萬美元。 RECOVER 研究繼續推進。隨機對照研究設計有頻繁的中期分析，將評估是否達到成功的預測概率或研究是否應繼續招募。我們最近完成了對單極隊列中第 450 名患者的中期分析，並確認了該研究的繼續進行。下一次中期觀察是 475 名患者，此時我們可以過渡到前瞻性縱向研究或完成單極隊列 500 名患者的入組。

Earlier this week Dr. Conway, the principal investigator for the RECOVER study, delivered a poster presentation at the fifth International Brainstem Conference detailing the baseline unipolar demographic data for the RECOVER study participants collected so far. The majority of these patients are severely depressed and are highly treatment resistant having failed more aggressive treatments such as ECT, TMS and Ketamine. In heart failure, we enrolled the 500 patients in the ANTHEM-HFrEF U.S. pivotal trial last quarter, which triggered the second interim analysis. The analysis determined that the U.S. FDA early filing conditions were not met and the DSMC recommended that enrollment continue in accordance with the current study protocol. However, our further evaluation of the study data has not revealed a sufficiently positive impact on functional or mortality endpoints and it is unlikely that the study will demonstrate such an impact.

本週早些時候，RECOVER 研究的首席研究員 Conway 博士在第五屆國際腦干會議上發表了海報展示，詳細介紹了迄今為止收集的 RECOVER 研究參與者的基線單極人口統計數據。這些患者中的大多數都患有嚴重的抑鬱症，並且對更積極的治療（如 ECT、TMS 和氯胺酮）失敗後具有高度的治療抵抗力。在心力衰竭方面，我們在上個季度的 ANTHEM-HFrEF 美國關鍵試驗中招募了 500 名患者，這引發了第二次中期分析。分析確定不符合美國 FDA 的早期備案條件，DSMC 建議根據當前的研究方案繼續招募。然而，我們對研究數據的進一步評估並未顯示對功能或死亡率終點有足夠積極的影響，而且該研究不太可能證明這種影響。

As a result; we are stopping enrollment, beginning the process to close the clinical study and winding down the heart failure program. It's important to note that the decision to stop enrolling was not associated with any safety concerns. We'd like to thank the patients who participated in the trial and also thank the investigators, study committees and employees for their commitment to this program. Moving to OSA. The OSPREY trial continues to progress. In January we received approval from the FDA to include an additional 5 sites, 1 of which has already been activated. We still assume FDA approval in 2024.

因此;我們將停止註冊，開始關閉臨床研究並逐步結束心力衰竭計劃。重要的是要注意停止註冊的決定與任何安全問題無關。我們要感謝參與試驗的患者，還要感謝研究人員、研究委員會和員工對這項計劃的承諾。搬到 OSA。 OSPREY 試驗繼續取得進展。 1 月份，我們獲得了 FDA 的批准，包括另外 5 個站點，其中 1 個已經被激活。我們仍然假設 2024 年獲得 FDA 批准。

And with that, I'll turn the call over to Alex.

有了這個，我會把電話轉給亞歷克斯。

Thanks, Damien. During my portion of the call, I'll share a brief recap of the fourth quarter results and provide commentary on 2023 guidance. Turning to results. Revenue in the quarter was $275 million, an increase of 6% versus 2021. Foreign exchange had an unfavorable year-over-year impact of approximately $12 million or 4% of revenue. Adjusted gross margin as a percent of net revenue was 69% compared to 70% in the fourth quarter of 2021. Adjusted gross margin was unfavorably impacted by inflationary pressures, supply chain challenges and product mix partially offset by pricing improvements. Adjusted R&D expense in the fourth quarter was $43 million compared to $41 million in the fourth quarter of 2021. R&D as a percent of net revenue was 16% versus 15% in the fourth quarter of 2021. While sequentially flat, the year-over-year increase was driven by continued investment in our strategic portfolio initiatives.

謝謝，達米恩。在我的電話會議中，我將簡要回顧第四季度的業績，並對 2023 年的指導意見進行評論。轉向結果。本季度收入為 2.75 億美元，比 2021 年增長 6%。外匯產生的同比不利影響約為 1200 萬美元，佔收入的 4%。調整後的毛利率占淨收入的百分比為 69%，而 2021 年第四季度為 70%。調整後的毛利率受到通脹壓力、供應鏈挑戰和產品組合的不利影響，但部分被定價改善所抵消。第四季度調整後的研發費用為 4300 萬美元，而 2021 年第四季度為 4100 萬美元。研發占淨收入的百分比為 16%，而 2021 年第四季度為 15%。雖然環比持平，但同比年度增長是由我們對戰略投資組合計劃的持續投資推動的。

Adjusted SG&A expense for the fourth quarter was $100 million compared to $107 million in the fourth quarter of 2021. SG&A as a percent of net revenue was 36%, down from 40% for the fourth quarter of 2021. Adjusted operating income was $47 million compared to $40 million in the fourth quarter of last year. Adjusted operating income margin was 17% compared to 15% in the fourth quarter of 2021. Adjusted effective tax rate in the quarter was negative 3% compared to 14% in the fourth quarter of 2021. The lower tax rate is primarily attributable to full year changes in geographic income mix. Adjusted diluted earnings per share was $0.81 compared to $0.57 in the fourth quarter of 2021. Adjusted diluted earnings per share for the full year was $2.39. Our cash balance at December 31, 2022, was $214 million, up from $208 million at year-end 2021. Total debt at year-end 2022 was $542 million versus $240 million at year-end 2021. The increase primarily relates to the $300 million term loan facility that we executed in July.

第四季度調整後的 SG&A 費用為 1 億美元，而 2021 年第四季度為 1.07 億美元。SG&A 占淨收入的百分比為 36%，低於 2021 年第四季度的 40%。調整後的營業收入為 4700 萬美元，相比之下去年第四季度達到 4000 萬美元。調整後的營業利潤率為 17%，而 2021 年第四季度為 15%。本季度調整後的有效稅率為負 3%，而 2021 年第四季度為 14%。較低的稅率主要歸因於全年地域收入結構的變化。調整後的攤薄每股收益為 0.81 美元，而 2021 年第四季度為 0.57 美元。全年調整後的攤薄每股收益為 2.39 美元。截至 2022 年 12 月 31 日，我們的現金餘額為 2.14 億美元，高於 2021 年底的 2.08 億美元。2022 年底的總債務為 5.42 億美元，而 2021 年底為 2.4 億美元。增長主要與 3 億美元有關我們在 7 月份執行的定期貸款安排。

Net debt, including restricted cash at year-end, was $85 million. Adjusted free cash flow for the quarter was $31 million and was $75 million for the full year. Free cash flow generation was unfavorably impacted by inventory build and inflationary pressures partially offset by improvements in working capital. The free cash flow conversion ratio was 58%. Capital investments were $27 million during 2022 compared to $26 million in the prior year. Now turning to 2023 guidance. We forecast 2023 revenue growth on a constant currency basis between 3% and 5% and assume approximately a 1% tailwind from exchange rates. We are projecting adjusted diluted earnings per share in the range of $2.45 and $2.65 with adjusted weighted average shares outstanding to be $54 million for the full year. Adjusted free cash flow is expected to be in the range of $80 million to $100 million. We forecast capital spending in the range of approximately $35 million to $40 million.

包括年末受限制現金在內的淨債務為 8500 萬美元。本季度調整後的自由現金流為 3100 萬美元，全年為 7500 萬美元。自由現金流的產生受到庫存增加和通脹壓力的不利影響，部分被營運資本的改善所抵消。自由現金流轉換率為58%。 2022 年的資本投資為 2700 萬美元，而上一年為 2600 萬美元。現在轉向 2023 年指導。我們預測 2023 年收入在固定貨幣基礎上增長 3% 至 5%，並假設匯率帶來大約 1% 的順風。我們預計全年調整後的稀釋每股收益在 2.45 美元至 2.65 美元之間，調整後的加權平均流通股為 5400 萬美元。調整後的自由現金流量預計在 8000 萬至 1 億美元之間。我們預測資本支出約為 3500 萬至 4000 萬美元。

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

有了這個，我會把電話轉回 Damien。

Thank you, Alex. Our 2022 performance was balanced by our diverse portfolio. While some macro challenges may linger, our pipeline remains robust and (technical difficulty) we remain committed to delivering differentiated products and therapies to patients and physicians. In the year ahead, we will continue to use the strategic triangle of our guide for goal setting and execution. With quality at the center, we remain focused on 3 key areas: growth, pipeline and profitability. We believe this focus underpinned by the LivaNova business system positions us to create value for all stakeholders.

謝謝你，亞歷克斯。我們的多元化投資組合平衡了我們 2022 年的業績。雖然一些宏觀挑戰可能會持續存在，但我們的產品線仍然強勁，並且（技術困難）我們仍然致力於為患者和醫生提供差異化的產品和療法。在未來的一年裡，我們將繼續使用我們指南中的戰略三角來製定和執行目標。以質量為中心，我們仍然專注於 3 個關鍵領域：增長、管道和盈利能力。我們相信，這種以 LivaNova 業務系統為基礎的重點使我們能夠為所有利益相關者創造價值。

And with that, Emily, we're open to questions.

有了這個，艾米麗，我們可以接受提問。

(Operator Instructions) Our first question comes from the line of Rick Wise with Stifel.

（操作員說明）我們的第一個問題來自 Rick Wise 與 Stifel 的合作。

Maybe they are sort of related questions in a way. But let's start off with the guidance and maybe help us better understand your thinking in providing the guide both from how conservative is it actually or optimistic relative to what you're seeing? But maybe more specifically, the top line guide is well below the long-term aspirational goals you laid out back in December of '21 at the Analyst Day. How are you thinking about, how would you have us think about it; the guide, the outlook, your long-term aspirations? And then I'll have a follow-up related to that.

也許它們在某種程度上是相關的問題。但是讓我們從指南開始，也許可以幫助我們更好地理解您在提供指南時的想法，無論是相對於您所看到的情況而言，它實際上是多麼保守還是樂觀？但也許更具體地說，頂線指南遠低於您在 21 年 12 月分析師日制定的長期理想目標。你怎麼想的，你會讓我們怎麼想的；指南、前景、您的長期願望？然後我將進行相關的跟進。

I think at the Investor Day we laid out 5% to 8% and we thought we'd ramp over time. I will say I think 2022 was a stronger year than we anticipated in our ramp and there are lots of reasons for that and we could cover that. I think '22 was right in the middle of that range. For '23, we're just looking at things like the transition year for the end of service to NPI drive up the Essenz transition and let's be honest, the ACS plan is behind after the COVID disruption. But we're confident that that's going to get back to a growth trajectory. So the CP market we think is stabilized and back to '20 pre-COVID levels. And I think that normally that market grows 3% to 5% and we're expecting to be in that range with this portfolio as we transition to the Essenz. So I like the way we're approaching this year. Do we think there's upside? Yes, we do if oxygenators and the Rest of World HLMs continue to run like they have been, if the neuromod NPIs ramp, if the non-COVID case ramp in ACS takes off as we ultimately hope it will. So we think this is prudent guidance and gives us a chance to deliver on our promises.

我認為在投資者日我們設定了 5% 到 8% 並且我們認為我們會隨著時間的推移而增加。我會說，我認為 2022 年是比我們預期的更強勁的一年，這有很多原因，我們可以涵蓋這一點。我認為 22 年恰好處於該範圍的中間。對於 23 年，我們只是在研究諸如 NPI 服務結束的過渡年之類的事情，以推動 Essenz 過渡，老實說，ACS 計劃在 COVID 中斷後落後了。但我們相信這將回到增長軌道。因此，我們認為 CP 市場已經穩定並回到 20 世紀 COVID 前的水平。而且我認為通常該市場會增長 3% 到 5%，並且隨著我們過渡到 Essenz，我們預計該投資組合將處於該範圍內。所以我喜歡我們接近今年的方式。我們認為有好處嗎？是的，如果氧合器和世界其他地方的 HLM 繼續像以前一樣運行，如果神經調節劑 NPI 增加，如果 ACS 中的非 COVID 病例增加如我們最終希望的那樣增加，我們就會這樣做。因此，我們認為這是謹慎的指導，讓我們有機會兌現我們的承諾。

Good. And separate but also related, can you talk about the heart failure trial shutdown, the ANTHEM-HFrEF shutdown? What could the R&D savings be from winding it down and the cash implications? What's that savings contributing to the EPS outlook, Damien?

好的。分開但也相關，你能談談心力衰竭試驗關閉，ANTHEM-HFrEF 關閉嗎？關閉它可以節省多少研發費用以及現金影響？ Damien，對 EPS 前景的貢獻是什麼？

Yes, this is a great question. And as you might expect, we're disappointed that we're ending this program after a long commitment. But as we saw, the 500-patient interim analysis didn't give us the signal for the early FDA filing and while the DSMC, their protocol following the analysis is to recommend 1 or 3 options and they recommended continuing to enroll. But we just took a look under the hood and the further analysis was not revealing a sufficiently strong positive impact on the functional or the primary composite endpoint and it was pretty unlikely that the full study would demonstrate that impact. We're really early in the cycle of this close-down and so we're going to assume that it takes us some time to work through the process. We're going to work with the FDA and the investigators to ensure that we have the right process for patients. And in terms of math, on average we spent about $30 million a year on this program and as we work through the process, we'll establish how much of that is in which bucket.

是的，這是一個很好的問題。正如您所預料的那樣，我們對在長期承諾後結束該計劃感到失望。但正如我們所見，500 名患者的中期分析並沒有給我們早期 FDA 備案的信號，而 DSMC，他們在分析後的協議是推薦 1 或 3 個選項，他們建議繼續註冊。但我們只是深入了解，進一步的分析並未揭示對功能或主要復合終點的足夠強大的積極影響，而且完整的研究不太可能證明這種影響。我們確實處於關閉週期的早期階段，因此我們假設我們需要一些時間來完成這個過程。我們將與 FDA 和調查人員合作，以確保我們擁有適合患者的正確流程。在數學方面，我們平均每年在這個項目上花費大約 3000 萬美元，在我們完成這個過程的過程中，我們將確定其中有多少是在哪個桶中。

Okay. No early color maybe even looking out a year about what annual savings could be?

好的。沒有早期的顏色甚至可能會展望一年每年節省多少？

Rick, this is Alex. As Damien said, our burn rate was approximately $30 million a year. We could see by 2024 we should start to recoup and perhaps even earlier sometime this year as we figure out how to winddown the program.

瑞克，這是亞歷克斯。正如 Damien 所說，我們每年的燒錢率約為 3000 萬美元。我們可以看到，到 2024 年我們應該開始收回成本，甚至可能在今年的某個時候更早，因為我們想出瞭如何結束該計劃。

Got you. I'll try to be respectful of your 2 question rule even though I have a lot more questions. Thanks so much.

明白了我會盡量尊重你的 2 個問題規則，即使我還有很多問題。非常感謝。

The next question comes from Michael Polark with Wolfe Research.

下一個問題來自 Wolfe Research 的 Michael Polark。

First one, gross margin in '23. Some sequential and year-on-year weakness in the fourth quarter not something we've clearly seen from others as that takes with inflation and supply chain snaps and currency and whatnot. I guess what's the baseline for that adjusted gross margin metric in your 2023 outlook?

第一個，23 年的毛利率。第四季度的一些連續和同比疲軟不是我們從其他人那裡清楚地看到的，因為通貨膨脹和供應鏈斷裂以及貨幣等等。我猜你 2023 年展望中調整後的毛利率指標的基線是什麼？

Mike, yes, I think you're right. It's relatively flat. The improvements that we're seeing is in terms of productivity and price still being impacted by the inflationary pressures that we've seen over the last 18 months again so we're anticipating that to continue.

邁克，是的，我認為你是對的。它相對平坦。我們在生產力和價格方面看到的改善仍然受到我們在過去 18 個月中再次看到的通脹壓力的影響，因此我們預計這種情況將繼續下去。

69% seem like a good input for now.

69% 目前看來是一個不錯的輸入。

Yes.

是的。

Okay. The follow-up. Intrigued by the mention of the Dr. Conway poster presentation. I guess I have not seen that data. Is there anything in there that's new to you that kind of tells you about how the RECOVER unipolar cohort may be shaping up here late in the enrollment process?

好的。後續行動。對康威博士海報展示的提及很感興趣。我想我還沒有看到那個數據。那裡有什麼對您來說是新的，可以告訴您 RECOVER 單極隊列在註冊過程的後期可能會如何形成？

Mike, it's Matt. So yes, the poster it came out again earlier this week and we can make it available. It was the first look at the unipolar kind of call it the demographic of underlying patient numbers so you can see things like the modular score, average age, other therapies they were on. And what we think is interesting about it is the average age is older, there's a lot more what we call -- Damien called aggressive therapies like ECT, TMS, even ketamine patients have failed in this trial. That's not normal in a pharmaceutical trial to even have any patients with those types of therapies in there. And so you can see just a lot more baseline demographics of how unique this trial is to any other I think depression trial that has been undertaken to date.

邁克，是馬特。所以是的，本週早些時候再次發布了海報，我們可以提供它。這是對單極類型的第一次觀察，將其稱為潛在患者人數的人口統計，因此您可以看到模塊化評分、平均年齡、他們接受的其他療法等信息。我們認為有趣的是，平均年齡更大，我們稱之為 - Damien 稱之為積極療法，如 ECT、TMS，甚至氯胺酮患者在該試驗中都失敗了。在藥物試驗中，即使有任何患者接受這些類型的治療，這也是不正常的。因此，您可以看到更多基線人口統計數據，說明該試驗與我認為迄今為止進行的任何其他抑鬱症試驗相比有多麼獨特。

Our next question comes from Matt Taylor with Jefferies.

我們的下一個問題來自 Jefferies 的 Matt Taylor。

I had a follow-up on depression. I guess Matt, maybe I'll just start with could you take that thought 1 step further and help us understand based on the unique composition of some of the patients in this trial? Do you think that will have any implications for the likelihood of success or the strength of the treatment impact or what do you think that means for the ultimate result?

我對抑鬱症進行了跟進。我想馬特，也許我會開始，你能不能把這個想法更進一步，幫助我們根據這個試驗中一些患者的獨特組成來理解？您認為這對成功的可能性或治療影響的強度有任何影響，或者您認為這對最終結果意味著什麼？

So I would say overall the impression we've got is that this is not unexpected in terms of what the age was, the modular score was. The people on these aggressive therapies, the number of pharmaceuticals that they've been on over a lifetime. What I think it helps with is if you look at time and response, which is a relatively unique endpoint when we talk about overall response rates, the initial design shows lower percentages than I think a lot of people have come to expect in some of these prior depression studies. And this is an example of why they're overall potentially lower, but still can be incredibly powerful just because this patient population has never had a therapy that kind of fits there where they are in their depressive state.

所以我想說，總的來說，我們得到的印像是，就年齡、模塊化分數而言，這並不意外。接受這些積極療法的人，他們一生中服用的藥物數量。我認為它有幫助的是，如果你看一下時間和響應，當我們談論整體響應率時，這是一個相對獨特的端點，初始設計顯示的百分比低於我認為很多人在其中一些中的預期先前的抑鬱症研究。這是一個例子，說明為什麼他們總體上可能較低，但仍然可以非常強大，因為這個患者群體從未接受過適合他們處於抑鬱狀態的療法。

Got you. Okay. And then 1 follow-up on depression. So obviously last interim look did not transition into registry or show early stoppage success. I guess the question I think a lot of investors have is now that we have more data points, more water under the bridge and versus your initial expectation at 350 that you could show your early stoppage; does this have any implications for the overall strength of the treatment effect in the active arm meaning could we see a weaker treatment effect because of the lack of early stoppage or is that reading too much into what's going on here?

明白了好的。然後對抑鬱症進行 1 次跟進。所以很明顯，最後的臨時外觀沒有過渡到註冊表或顯示提前停止成功。我想很多投資者的問題是，現在我們有更多的數據點，橋下有更多的水，而且與你最初預期的 350 點相比，你可能會提前停止；這對主動臂治療效果的整體強度有任何影響嗎？這意味著我們是否會因為缺乏早期停止而看到較弱的治療效果，或者是對這裡發生的事情讀得太多了？

It's probably reading too much in what's going on because again it's all blinded. It could mean that. It could mean that the control arm is doing better, but the therapy arm is also doing better. What we are confident in is there is a futility curve on the bottom of this and that continues to go up every look. So we know we are seeing some benefit. We just haven't gotten to that level that would allow us to stop early. But the other thing I'd say, Matt, is data can actually improve over time especially when you go out to month 7, 8, 9, 10, 11, 12 where we believe that the therapy arm will have a more pronounced effect than the control arm. So you could not hit an early stoppage, but actually see data improve over time before you get to the final number. So that's why we're still really confident overall.

它可能對正在發生的事情讀得太多了，因為它又一次被蒙蔽了。這可能意味著。這可能意味著控制臂做得更好，但治療臂也做得更好。我們有信心的是，在這個底部有一條徒勞的曲線，而且每一次看起來都會繼續上升。所以我們知道我們看到了一些好處。我們只是還沒有達到允許我們提前停止的水平。但我要說的另一件事是，馬特，數據實際上可以隨著時間的推移而改善，尤其是當你去到第 7、8、9、10、11、12 個月時，我們相信治療組的效果會比控制臂。所以你不能提前停止，但實際上在你得到最終數字之前看到數據隨著時間的推移而改善。所以這就是為什麼我們總體上仍然非常有信心。

Which is what in the Arenson paper. This whole study is predicated on 6 prior studies, 1,400 patients. But particularly the Arenson paper showed that at month 6, you started to see the separation and it continued to separate and improve over time. So I think the point Matt's making is quite valid that the longer this runs -- I mean the trial was set up to run to 500 patients. So we continue to be believers in this showing a significant response to treat these patients.

這就是阿倫森論文中的內容。整個研究基於 6 項先前的研究，共 1,400 名患者。但特別是阿倫森的論文表明，在第 6 個月，你開始看到分離，並且隨著時間的推移它繼續分離和改善。因此，我認為 Matt 提出的觀點是非常有效的，即運行時間越長——我的意思是該試驗被設置為運行 500 名患者。因此，我們繼續相信這一點，顯示出對治療這些患者的顯著反應。

The next question comes from Adam Maeder with Piper Sandler.

下一個問題來自 Adam Maeder 和 Piper Sandler。

I wanted to start with a 2-part question on Neuromodulation and I guess really epilepsy. So first, I was hoping you could give a little bit more color on the epilepsy performance in Q4 and break out performance by NPIs and replacements. I'm wondering if NPI had growth either year-over-year or sequentially. And then as we look at the general mod guidance for 2023 the 3% to 5% range, maybe just kind of walk through the different assumptions there on the NPI and replacement side as well as by geography? And then I had a follow-up.

我想從一個關於神經調節的兩部分問題開始，我猜真的是癲癇。所以首先，我希望你能在第四季度的癲癇表現上多加一點色彩，並通過 NPI 和替代品來突破表現。我想知道 NPI 是同比增長還是環比增長。然後，當我們查看 2023 年 3% 到 5% 範圍內的一般模組指南時，也許只是在 NPI 和替代方面以及按地理位置逐步了解那裡的不同假設？然後我進行了跟進。

Sure. So let's take it from the top. U.S. implants grew in low single digits and they were above the 2019 levels, I think which was important for us to see that signal. Unit sales were flat and we were up mid-single digits with a combination of price and mix. The end of service outpaced the NPIs and they grew mid-single digits. NPIs in the quarter declined year-over-year and sequentially they were flat. For us, we looked at this from multiple different angles. We looked at the macro, we looked at that storm in December, we looked at the share and the bottom line is we just didn't execute. The team I think has some work to do. December really just didn't drive NPIs like we anticipated and the team has to really dig into their performance management and commercial execution. And we've increased oversight of their funnel processes, removed the bottom 10% of the performance. We've looked at the growth profile of the various businesses that we have that we're covering in the CEC. So we're expecting a change in that performance. So for 2023, this 3% to 5% is really looking at a decline in end of service as we previously discussed as we anniversary into the backlog of the COVID delayed cases and then we're expecting sequential improvement in the NPIs throughout the year.

當然。所以讓我們從頭開始。美國植入物以較低的個位數增長，並且高於 2019 年的水平，我認為這對我們看到該信號很重要。單位銷售額持平，我們在價格和組合方面取得了中等個位數的增長。服務結束超過了 NPI，並且它們增長了中等個位數。本季度的 NPI 同比下降，環比持平。對於我們來說，我們從多個不同的角度看待這個問題。我們看了宏觀，我們看了 12 月的那場風暴，我們看了股票，底線是我們沒有執行。我認為團隊還有一些工作要做。 12 月確實沒有像我們預期的那樣推動 NPI，團隊必須真正深入研究他們的績效管理和商業執行。我們加強了對他們漏斗流程的監督，移除了表現最差的 10%。我們已經研究了我們在 CEC 中涵蓋的各種業務的增長情況。所以我們期待這種表現的改變。因此，對於 2023 年，這 3% 到 5% 實際上是在考慮服務終止的下降，正如我們之前討論的那樣，因為我們在 COVID 延遲案件積壓的周年紀念日，然後我們預計全年 NPI 的連續改善。

And just for international again it's a small piece, but double-digit growth in international. So that should give you enough variables to get there.

就國際而言，這只是一小部分，但在國際上實現了兩位數的增長。所以這應該給你足夠的變量來到達那裡。

Appreciate that, Damien and Matt. And then as for the follow-up, similar guidance question, but switching over to the Cardiopulmonary. CP grew double digits in 2022, the guidance for '23 is 3% to 5%. The last time that you launched a new heart-lung machine, you got a nice lift to growth. And I think you referenced the CP market kind of growing in that 3% to 5% range. So I guess when I take that all together, why is 3% to 5% guidance for the CP business in '23, why is that the right range at this juncture?

達米恩和馬特，對此表示讚賞。然後至於後續，類似的指導問題，但切換到心肺。 CP 在 2022 年增長了兩位數，'23 的指導是 3% 到 5%。上次您推出新的心肺機時，您的成長得到了很好的提升。我認為你提到了 CP 市場在 3% 到 5% 的範圍內增長。所以我想當我把所有這些放在一起時，為什麼 23 年 CP 業務的指導是 3% 到 5%，為什麼在這個時候這個範圍是正確的？

Adam, it's Alex. So for CP, typically the way we think about the market is in the developed markets it's probably a low to mid-single-digit growth business. 2/3 of our business is in consumables. Obviously 2022 the growth was fantastic. It was based on a lot of the recovery from the surgical procedures coming out of COVID. So we still believe that we're going to grow at a sort of a market rate from a consumables perspective. And from a capital perspective, this is kind of a transition year. We expect our limited commercial release to be effective and as we start to ramp Essenz sales in the back half of the year, we should expect a step-up in growth, but we're being prudent about the way we're forecasting this business.

亞當，是亞歷克斯。因此，對於 CP，通常我們對市場的看法是在發達市場，它可能是一個中低個位數增長的業務。我們 2/3 的業務是消耗品。顯然，2022 年的增長非常好。它基於 COVID 的外科手術的大量恢復。因此，我們仍然相信，從消耗品的角度來看，我們將以某種市場速度增長。從資本的角度來看，今年是一個過渡年。我們預計我們有限的商業發布會有效，並且隨著我們在今年下半年開始增加 Essenz 的銷售額，我們應該期望增長會加快，但我們對預測這項業務的方式持謹慎態度.

Our next question comes from Mike Matson with Needham & Company.

我們的下一個問題來自 Needham & Company 的 Mike Matson。

So I have 1 on your covenants. I think the covenant requires the interest coverage ratio of 3:1. I was curious if that includes or excludes the interest on this neo loan and then are you comfortable you can stay within that compliance with that during 2023?

所以我有 1 你的契約。我認為契約要求利息保障比率為 3:1。我很好奇這是否包括或不包括這筆 Neo 貸款的利息，那麼您是否願意在 2023 年期間遵守該規定？

Yes. We're fine on our compliance with our covenants. So we pressure tested them and we're in a good shape, Mike.

是的。我們很好地遵守了我們的契約。所以我們對它們進行了壓力測試，我們的狀態很好，邁克。

Okay. All right. And then just as far as the OSPREY trial goes, I hear you on the potential approval in 2024. But when do you think we could see data from the trial? Is it possible we could see late this year or is going to be really more 2024?

好的。好的。就 OSPREY 試驗而言，我聽說你可能會在 2024 年獲得批准。但你認為我們什麼時候能看到試驗數據？我們有可能在今年晚些時候看到還是真的要到 2024 年才能看到？

I'll take that one. It's 2024. It's a pivotal FDA ID so we need to complete the study, file the data and then seek to publish or podium that. So it won't be until 2024.

我會拿那個。現在是 2024 年。這是一個關鍵的 FDA ID，因此我們需要完成研究、歸檔數據，然後尋求發布或登上領獎台。所以要到 2024 年才能實現。

Our next question comes from Matt Miksic with Barclays. Matt, unfortunately we're not receiving any media from the line. Could you please just check that you're not muted?

我們的下一個問題來自巴克萊銀行的 Matt Miksic。馬特，不幸的是我們沒有收到來自線路的任何媒體。你能檢查一下你沒有靜音嗎？

We might have lost him, Emily.

我們可能已經失去他了，艾米麗。

Perfect. So at the moment, we have no further questions registered. So I will turn the call back to Damien McDonald for closing remarks.

完美的。所以目前，我們沒有登記更多的問題。所以我會把電話轉回 Damien McDonald 作結束語。

Thanks, Emily, and thank you, everyone, for joining us on the call today. And on behalf of the entire team, we appreciate your support and continued interest in LivaNova and we'll talk to you on the first quarter call. Thanks very much.

謝謝艾米麗，也謝謝大家今天加入我們的電話會議。我們代表整個團隊感謝您對 LivaNova 的支持和持續關注，我們將在第一季度電話會議上與您交談。非常感謝。

Thank you, everyone, for joining us today. This concludes our call and you may now disconnect your lines.

謝謝大家今天加入我們。我們的通話到此結束，您現在可以斷開您的線路。