LivaNova PLC (LIVN) 2025 Q1 法說會逐字稿

完整原文

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

  • Operator

    Operator

  • Good day, ladies and gentlemen, and welcome to the LivaNova PLC first quarter 2025 earnings conference call. My name is Emily and I'll be coordinating your call today.

    女士們、先生們,大家好,歡迎參加 LivaNova PLC 2025 年第一季財報電話會議。我叫艾米麗,今天我將負責協調您的通話。

  • As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Miss Briana Gotlin, LivaNova's Vice President of Investor Relations. Please go ahead.

    提醒一下,本次電話會議正在錄音。現在,我想介紹今天會議的主持人,LivaNova 投資者關係副總裁 Briana Gotlin 女士。請繼續。

  • Briana Gotlin - Vice President of Investor Relations

    Briana Gotlin - Vice President of Investor Relations

  • Thank you and welcome to our conference call and webcast discussing Ivanova's financial results for the first quarter of 2025.

    謝謝您,歡迎參加我們的電話會議和網路廣播,討論伊凡諾娃 2025 年第一季的財務表現。

  • Joining me on today's call are Vladimir Makatsaria, our Chief Executive Officer and member of the Board of Directors, Alex Schwartzberg, our Chief Financial Officer, Ahmet Tezel our Chief Innovation Officer, Stephanie Bolton, President of Global Epilepsy, and Zach Glazier, director of Investor Relations.

    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 Schwartzberg、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 Zach Glazier。

  • 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.

    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。本公司向美國證券交易委員會提交的最新文件和文件(包括我們網站上的今天的新聞稿)討論了可能導致實際結果出現重大差異的因素。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 be stated on a constant currency and organic basis.

    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,包括但不限於收入結果,這些指標將以固定貨幣和有機基礎表示。

  • Reconciliation to the most directly comparable GAAP financial measures can be found in today's press release, which is available on our website.

    您可以在今天的新聞稿中找到與最直接可比較的 GAAP 財務指標的對賬,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 complimentary to the other call material and should be used as an enhanced communication tool. You can find the presentation and press release in the investor section of our website under news, events and presentations at https://investor.livanova.com. With that, I'll turn the call over to Vlad.

    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「新聞、活動和簡報」版塊(https://investor.livanova.com)的投資者專區找到簡報和新聞稿。接下來,我將把電話交給 Vlad。

  • Vladimir Makatsaria - Chief Executive Officer

    Vladimir Makatsaria - Chief Executive Officer

  • Thank you, Brianna, and thank you everyone for joining us today. Welcome to LivaNova's conference call for the first quarter of 2025. Before turning to results in the quarter, allow me to comment on a few important updates. The 12-months data from our OSPREY trial, the SNIA ruling, and the impact of tariffs.

    謝謝你,布里安娜,也謝謝大家今天的到來。歡迎參加 LivaNova 2025 年第一季電話會議。在討論本季業績之前,請允許我對一些重要的更新發表評論。我們的 OSPREY 試驗、SNIA 裁決和關稅影響的 12 個月數據。

  • This morning, we announced 12 months topline data from OSPREY, a randomized controlled trial for moderate to severe obstructive sleep apnea, or OSA.

    今天上午,我們公佈了 OSPREY 的 12 個月頂線數據,OSPREY 是一項針對中度至重度阻塞性睡眠呼吸中止症 (OSA) 的隨機對照試驗。

  • The study featured a differentiated neurostimulation modality called proximal hypoglossal nerve stimulation or pHGNS.

    該研究採用了一種稱為近端舌下神經刺激或 pHGNS 的差異化神經刺激方式。

  • The OSPREY trial demonstrated rapid and sustained improvement for patients who received PHGNS, including those with severe OSA, elevated body mass index, or BMI, and high risk of complete concentric collapse.

    OSPREY 試驗表明,接受 PHGNS 治療的患者,包括患有嚴重 OSA、體重指數或 BMI 升高以及完全向心性塌陷風險高的患者,病情得到了快速且持續的改善。

  • At 12 months of therapy, the treatment on responder rate was 65%. The OSPREY 12 month results further validate the potential of this therapy as a treatment alternative for the large and growing OSA population.

    經過12個月的治療,治療反應率為65%。OSPREY 12 個月的結果進一步驗證了該療法作為龐大且不斷增長的 OSA 人群的治療替代方案的潛力。

  • With the strength of our clinical data, the expertise of our neuromodulation team, and the strategic growth opportunity ahead, we are eager to bring this innovation to patients.

    憑藉我們強大的臨床數據、神經調節團隊的專業知識以及未來的策略成長機會,我們渴望將這項創新帶給患者。

  • Ahmed will provide additional details on the trial results and our differentiated technology later in the call.

    艾哈邁德將在稍後的電話會議中提供有關試驗結果和我們的差異化技術的更多詳細資訊。

  • Turning to the new litigation, our first quarter results include a liability of $360 million related to the Italian Supreme Court decision which we disclosed a few weeks ago. Importantly, we believe the court's decision effectively retires a long-standing overhang on the company.

    談到新的訴訟,我們的第一季業績包括與幾週前披露的義大利最高法院裁決相關的 3.6 億美元負債。重要的是,我們相信法院的判決有效地消除了該公司長期以來面臨的困境。

  • Alex will provide more details on the financial implications of the ruling later in the call.

    亞歷克斯將在稍後的電話會議中提供有關該裁決的財務影響的更多細節。

  • Regarding tariffs, we're operating in an uncertain environment, and our top priority is to provide critical medical technologies to our customers and their patients.

    關於關稅,我們的營運環境不確定,我們的首要任務是為我們的客戶及其患者提供關鍵的醫療技術。

  • Based on an assessment of our geographic manufacturing footprint and supply chain. At present, we expect tariffs will be a small and manageable headwind for Ivanova, which is captured within the guidance provided today.

    基於對我們的地理製造足跡和供應鏈的評估。目前,我們預計關稅對伊凡諾娃來說將是一小段可控的阻力,這已在今天提供的指引中體現。

  • Alex will provide more details on our manufacturing footprint and financial consideration related to tariffs later in the call.

    亞歷克斯將在稍後的電話會議中提供有關我們的製造足跡和與關稅相關的財務考慮的更多細節。

  • For the remainder of the call, I will discuss our first quarter results and updates to our revenue guidance for the full year 2025. After my comments, Ahmet will discuss our significant clinical and regulatory achievements in OSA and progress in difficult to treat depression or DTD.

    在電話會議的剩餘時間裡,我將討論我們的第一季業績以及 2025 年全年收入預期的更新。在我發表評論之後,Ahmet 將討論我們在 OSA 方面取得的重大臨床和監管成就以及在難治性憂鬱症或 DTD 方面取得的進展。

  • Alex will then provide additional details on our results and updated 2025 guidance. I will wrap up with closing remarks before moving to Q&A.

    然後,亞歷克斯將提供有關我們的結果和更新的 2025 年指南的更多詳細資訊。在進入問答環節之前,我將做最後發言。

  • In the quarter, we achieved 10% organic revenue growth versus the prior year, driven by the continued success of the essence rollout, demand for cardiopulmonary consumables, and strong neuromodulation performance in the Europe and rest of world regions.

    本季度,我們實現了比上年同期 10% 的有機收入成長,這得益於精華產品的持續成功推出、心肺耗材的需求以及歐洲和世界其他地區強勁的神經調節表現。

  • Notably, this marks the 8th time in the past 9 quarters that LivaNova has delivered double-digit organic revenue growth. This top line result, coupled with operational efficiencies contributed to meaningful operating income growth and cash generation.

    值得注意的是,這是過去 9 個季度中 LivaNova 第 8 次實現兩位數的有機收入成長。這項營收績效加上營運效率促進了營業收入和現金流的顯著成長。

  • Now turning to segment results. For the cardiopulmonary segment, revenue was $176 million in the quarter.

    現在轉向細分結果。心肺部門本季營收為 1.76 億美元。

  • An increase of 15% versus the first quarter of 2024. Heart-lung machine revenue grew approximately 30% versus the prior year period.

    與 2024 年第一季相比成長了 15%。心肺機收入較去年同期成長約30%。

  • In the quarter, we achieved a strong increase in essence placements and sustained favorable price premiums. Oxygenator revenue grew in the high single digits driven by customer demand and price. The oxygenated business continues to see strong demand outpacing the market's ability to supply.

    本季度,我們的精華投放量實現了強勁成長,並維持了有利的價格溢價。在客戶需求和價格的推動下,氧合器收入實現了高個位數成長。含氧業務的需求仍然強勁,超出了市場的供應能力。

  • Our operations team is working diligently to increase manufacturing capacity to meet customer demand.

    我們的營運團隊正在努力提高製造能力以滿足客戶需求。

  • We now expect cardiopulmonary revenue to grow 9% to 10% for the full year of 2025, up from 7% to 8% previously. Our revised forecast incorporates continued HLM growth as we launch essence in the new markets and continue to increase penetration in existing markets.

    我們現在預計 2025 年全年心肺收入將成長 9% 至 10%,高於先前的 7% 至 8%。隨著我們在新市場推出精華產品並繼續增加在現有市場的滲透率,我們修訂後的預測包含了持續的 HLM 成長。

  • Notably, in April, we received regulatory approval for Essence in China, which is our second largest market for HLMs after the US. Our forecast also reflects increased demand for consumables.

    值得注意的是,今年 4 月,我們獲得了 Essence 在中國的監管批准,中國是繼美國之後我們第二大 HLM 市場。我們的預測也反映了對消耗品的需求增加。

  • Beyond 2025, we believe further oxygenated capacity expansion will continue to enable growth for the cardiopulmonary business. We're currently investing in an additional manufacturing line which we expect to have running by mid next year.

    我們相信,2025 年以後,進一步擴大氧合產能將持續推動心肺業務的成長。我們目前正在投資一條額外的生產線,預計明年年中投入營運。

  • We expect that this increase in output will support our strategy of taking additional share in consumables going forward.

    我們預計產量的增加將支持我們未來在消耗品領域佔據更多份額的策略。

  • We also anticipate sustaining double-digit growth in HLM as we continue to launch essence in new markets and further increase penetration in existing ones.

    隨著我們繼續在新市場推出精華產品並進一步提高現有市場的滲透率,我們也預期 HLM 將保持兩位數的成長。

  • Turning to epilepsy, revenue increased 4% versus the first quarter of 2024, led by the Europe and rest of world regions, which increased the combined 13% versus the prior year period. We were pleased by the notable improvements in commercial execution across Europe during the quarter. This performance was balanced by US epilepsy revenue growth, which increased 2% year over year.

    談到癲癇,營收與 2024 年第一季相比成長了 4%,其中歐洲和世界其他地區領先,與去年同期相比合計成長了 13%。我們很高興看到本季整個歐洲的商業執行情況顯著改善。這一表現與美國癲癇收入成長相平衡,美國癲癇收入較去年同期成長 2%。

  • During the quarter, our US epilepsy business experienced procedure deferrals related to a voluntary field safety notification, which we estimate had an unfavorable impact on revenue of less than $2 million.

    在本季度,我們的美國癲癇業務經歷了與自願現場安全通知相關的程序延期,我們估計這對收入產生了不到 200 萬美元的不利影響。

  • The field safety notice involved a component issue that affected 0.13% of current and past SenTiva generators and required a design change. While the current version of SenTiva continues to be implanted, the design change was recently approved by the FDA.

    現場安全通知涉及一個組件問題,該問題影響了 0.13% 的現有和過去的 SenTiva 發電機,需要進行設計變更。雖然目前版本的 SenTiva 仍在繼續植入,但其設計變更最近已獲得 FDA 的批准。

  • We expect the updated SenTiva generators to be available for distribution by mid-year in the US and most major geographies during the second half of 2025. We believe customer anticipation for the updated generators is delaying procedures in the first half of the year and will primarily impact timing rather than procedure loss.

    我們預計更新後的 SenTiva 發電機將於 2025 年下半年在美國和大多數主要地區上市。我們認為,客戶對更新後的發電機的期望會延遲上半年的流程,並且主要會影響時間而不是流程損失。

  • For the full year 2025, we continue to expect epilepsy revenue growth of 4% to 5%. Our forecast incorporates low single digit growth in the US versus mid-single digit growth previously. And assumes the Europe and rest of world regions will grow a combined low double digit for the year, up from high single digits previously.

    對於 2025 年全年,我們繼續預期癲癇收入將成長 4% 至 5%。我們的預測涵蓋了美國的低個位數成長,而先前的預測則是中等個位數成長。並假設歐洲和世界其他地區今年的綜合成長率將達到低兩位數,高於先前的高個位數。

  • We continue to see momentum in our global epilepsy business across volume, price, and mix, and we feel confident in our ability to achieve mid-single digit growth this year.

    我們的全球癲癇業務在數量、價格和組合方面繼續保持強勁勢頭,我們有信心今年能夠實現中等個位數的成長。

  • Before turning the call to Ahmet, I would like to mention a change in our reporting. Over the last year, as LivaNova 's CEO, I have reviewed our communication and disclosure practices. That reflection has led us to refine what we report on a quarterly basis.

    在將電話轉給艾哈邁德之前,我想提一下我們報道中的一個變化。在過去的一年裡,作為 LivaNova 的首席執行官,我審查了我們的溝通和揭露實踐。這種反思促使我們改進季度報告的內容。

  • While we have historically disclosed US new patient and replacement implant volume growth, going forward, we will not be disclosing these metrics each quarter. However, we will continue to periodically comment on and provide insights into trends when relevant and appropriate to do so.

    雖然我們過去曾揭露美國新患者和替換植入物數量的成長,但今後我們不會每季揭露這些指標。然而,我們將繼續定期對趨勢進行評論,並在相關且適當的時候提供見解。

  • We're making this change because we firmly believe that you in this business for a long term value creation framework is the best lens for investors. Our quarterly disclosure approach will focus on revenue growth, which best represents our business performance and is in line with our existing practice for the Europe and rest of world regions.

    我們之所以做出這項改變,是因為我們堅信,在這個產業中為長期價值創造而建立的框架是投資者的最佳視角。我們的季度揭露方法將側重於收入成長,這最能代表我們的業務績效,並且與我們在歐洲和世界其他地區的現有做法一致。

  • Our teams around the world remain focused on narrowing the drug-resistant epilepsy treatment GAAP and maximizing VNS therapy access.

    我們遍布全球的團隊始終致力於縮小藥物難治性癲癇治療的 GAAP 範圍並最大限度地擴大 VNS 治療的可及性。

  • In summary, due to the strong growth we saw in the first quarter, as well as the continued success of the essence rollout, market share gains, and cardiopulmonary consumables, and pricing strategies, we are raising our overall organic growth outlook by 100 basis points.

    綜上所述,由於我們在第一季看到的強勁成長,以及精華推出、市佔率成長、心肺耗材和定價策略的持續成功,我們將整體有機成長前景上調了 100 個基點。

  • To between 7% and 8%. Alex will provide additional details on our 2025 guidance later in the poll.

    達到 7% 至 8% 之間。亞歷克斯將在稍後的民意調查中提供有關我們 2025 年指導的更多詳細資訊。

  • With that I will turn the call over to Ahmed to provide an update on our recent clinical and regulatory achievements in OSA and progress in DTD.

    接下來,我將把電話轉給艾哈邁德,讓他介紹我們在 OSA 方面的最新臨床和監管成就以及 DTD 方面的進展。

  • Ahmet Tezel - Chief Innovation Officer

    Ahmet Tezel - Chief Innovation Officer

  • Thanks, Vlad. As lad mentioned and as was announced in a standalone press release this morning, Ivanova achieved two critical milestones in the OSA program.

    謝謝,弗拉德。正如拉德所提到的以及今天早上在獨立新聞稿中宣布的那樣,伊凡諾娃在 OSA 計劃中取得了兩個關鍵里程碑。

  • First, we're excited to share the strong 12 month topline data from our OSPREY clinical study for moderate to severe OSA. At 12 months of therapy, the treatment on responder rate was 65%, with responders defined as those who realized at least 50% improvement from the baseline apnoea/hypopnoea index, or AHI and an AHI value below 20.

    首先,我們很高興與大家分享 OSPREY 針對中度至重度 OSA 的臨床研究的 12 個月強勁頂線數據。經過 12 個月的治療,治療反應率為 65%,反應者定義為與基線呼吸暫停/低通氣指數 (AHI) 相比至少改善 50% 且 AHI 值低於 20 的患者。

  • Responder rates in the treatment group were strong throughout the first year, with 1 in 4 patients responding on day 1, 50% responding by month 3, and 65% responding by the 12-month mark, demonstrating rapid therapeutic onset and durable benefit over time.

    治療組的反應率在第一年一直很高,四分之一的患者在第 1 天有反應,50% 的患者在第 3 個月有反應,65% 的患者在第 12 個月有反應,表明治療效果迅速且具有持久的益處。

  • As a reminder, OSPREY is the first and only randomized controlled trial for hypoglossal nerve stimulation therapy to support US regulatory approval to date.

    提醒一下,OSPREY 是迄今為止第一個也是唯一一個獲得美國監管部門批准的舌下神經刺激療法隨機對照試驗。

  • The study features a differentiated neuro stimulation modality called proximal hypoglossal nerve stimulation or pHGNS, which utilizes 6 electrodes placed on the proximal trunk of the hypoglossal nerve. It offers broad access to the muscles controlling the airway and provides customized titration.

    該研究採用了一種稱為近端舌下神經刺激或 pHGNS 的差異化神經刺激方式,該方式利用放置在舌下神經近端主幹上的 6 個電極。它為控制氣道的肌肉提供了廣泛的途徑,並提供客製化的滴定。

  • The study enrolled a patient population representative of the general OSA population, including patients with greater OSA severity and higher BMI relative to other large-scale trials in support of US FDA approval.

    該研究招募了具有一般 OSA 人群代表性的患者群體,其中包括 OSA 嚴重程度較高且 BMI 較高的患者,相對於支持美國 FDA 批准的其他大規模試驗。

  • Notably, OSPREY was also designed to include patients with complete concentric collapse or CCC. Importantly, response rates and AHI reductions at month 12 for patients in OSPREY with predicted risk of CCC were consistent with the results of the full study population, demonstrating the robustness of the therapeutic response.

    值得注意的是,OSPREY 的設計也涵蓋了完全向心塌陷或 CCC 患者。重要的是,OSPREY 中預測患有 CCC 風險的患者在第 12 個月的反應率和 AHI 減少量與整個研究人群的結果一致,證明了治療反應的穩健性。

  • In addition, we're excited about the median implant procedure time of 72 minutes exhibiting speed and efficiency of implantation.

    此外,我們對 72 分鐘的中位植入手術時間感到非常興奮,這展現了植入的速度和效率。

  • We are pleased to announce that we recently completed our PMA submission to the FDA based on meeting the primary safety and efficacy endpoints. We have provided the agency with the interim 12-month results from the study and intend to share the complete 12-month data set in support of its inclusion on the product label.

    我們很高興地宣布,我們最近根據主要安全性和有效性終點完成了向 FDA 的 PMA 提交。我們已向該機構提供了該研究的 12 個月中期結果,並打算分享完整的 12 個月數據集,以支持將其納入產品標籤。

  • We look forward to continuing to work with the agency on their review. With respect to our product plans, we're pleased with the progress we have made in the development of our MRI compatible device as we work toward a full commercial launch.

    我們期待繼續與該機構合作進行審查。關於我們的產品計劃,我們對我們在 MRI 相容設備開發方面取得的進展感到滿意,我們正在努力實現全面商業化。

  • As we look ahead, we are working to ensure a competitive and differentiated product portfolio through our proximal hypoglossal nerve stimulation platform. For example, one area of exploration is fully utilizing all 6 electrodes of our pHGNS technology to further improve the already strong treatment effects.

    展望未來,我們正致力於透過近端舌下神經刺激平台確保具有競爭力和差異化的產品組合。例如,其中一個探索領域是充分利用我們的 pHGNS 技術的所有 6 個電極來進一步提高已經很強的治療效果。

  • Since each electrode can be operated independently, proximal HNS offers the potential to further customize therapy for challenging patients.

    由於每個電極都可以獨立操作,近端 HNS 可以為有挑戰性的患者進一步客製化治療方案。

  • We will provide additional details on our product roadmap and launch plans during the investor day later this year. Turning to difficult to treat depression, we are pleased to share that 2 additional critical publications have been released, bringing the total to 4th. The 5th and final critical publication is expected to be published in the second quarter.

    我們將在今年稍後的投資者日上提供有關我們的產品路線圖和發布計劃的更多詳細資訊。談到難以治療的憂鬱症,我們很高興地告訴大家,又有 2 份重要出版品發布,總數達到第 4 份。第五份也是最後一份重要出版品預計將於第二季出版。

  • Collectively, the articles highlight the significant unmet need of this markedly ill population with treatment resistant depression or TRD. The recovered data demonstrates that VNS therapy improves symptoms, function, and quality of life in TRD patients over time. These are outcome measures identified as clinically relevant by CMS.

    總的來說,這些文章強調了患有難治性憂鬱症或 TRD 的嚴重疾病族群的巨大未滿足需求。恢復的數據表明,VNS 療法可以隨著時間的推移改善 TRD 患者的症狀、功能和生活品質。這些是 CMS 認定為具有臨床相關性的結果測量。

  • Depressive symptoms, daily function and quality of life taken together as a novel composite metric present a more complete picture of the treatment effectiveness than symptoms alone. The fifth and final critical publication currently under review utilizes this composite metric and demonstrates favorable response to venous therapy in TRD patients who had previously failed multiple treatments, including interventional therapies.

    憂鬱症狀、日常功能和生活品質結合在一起作為一種新的綜合指標,比單獨的症狀更能全面地反映治療效果。目前正在審查的第五篇也是最後一篇重要出版物利用了這一綜合指標,並證明了先前多次治療(包括介入治療)失敗的 TRD 患者對靜脈治療有良好的反應。

  • Researchers found that patients with previous electrical muscle therapy or transcranial magnetic stimulation treatment had statistically significant and clinically meaningful benefit with VNS therapy. Notably, VNS therapy is the only treatment that has demonstrated therapeutic effects in patients that previously failed electroconvulsive therapy.

    研究人員發現,接受過電肌肉治療或經顱磁刺激治療的患者透過 VNS 治療可獲得具有統計學意義和臨床意義的益處。值得注意的是,VNS 療法是唯一對先前電痙攣療法失敗的患者有治療效果的治療方法。

  • As a reminder, all pre-specified recovery endpoints favored active VNS therapy, and the totality of evidence supports our pursuit of Medicare coverage for VNS therapy for TRD patients with high unmet treatment needs.

    提醒一下,所有預先指定的恢復終點都有利於主動 VNS 治療,並且全部證據支持我們追求醫療保險覆蓋治療需求未滿足的 TRD 患者的 VNS 治療。

  • As we have done throughout the recovery program, we continue to partner with CMS through the coverage with Evidence Development program, working toward a request for national coverage. We will initiate the reconsideration submission process following publication of the 5th and final critical manuscript.

    正如我們在整個恢復計劃中所做的那樣,我們繼續透過證據發展計劃的覆蓋範圍與 CMS 合作,努力實現全國覆蓋範圍的要求。我們將在第五份也是最後一份重要稿件發表後啟動重新審議提交流程。

  • In summary, we're encouraged by the significant regulatory and clinical milestones achieved in OSA and our progress in the difficult to treat depression program. We look forward to sharing future updates. With that, I will turn the call over to Alex.

    總而言之,我們對 OSA 領域的重大監管和臨床里程碑以及難治性憂鬱症治療計畫的進展感到鼓舞。我們期待分享未來的更新。說完這些,我會把電話轉給亞歷克斯。

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Thanks, Ahmet.

    謝謝,艾哈邁德。

  • During my portion of the call, I'll share a brief recap of the first quarter results and provide commentary on our updated full year 2025 guidance, which reflects improving business performance and incorporates the impact of SNIA and tariffs.

    在電話會議中,我將簡要回顧第一季的業績,並對我們更新後的 2025 年全年指引發表評論,該指引反映了業務績效的改善,並考慮了 SNIA 和關稅的影響。

  • Turning to results, revenue in the quarter was $317 million an increase of 9% on a constant currency basis and 10% on an organic basis versus the prior year.

    談到業績,本季營收為 3.17 億美元,以固定匯率計算比上年增長 9%,以有機計算成長 10%。

  • Foreign exchange in the quarter had an unfavorable year over year impact of approximately $4 million or 1%. Adjusted gross margin as a percent of net revenue was 70% compared to 71% in the first quarter of 2024.

    本季外匯對去年同期產生了約 400 萬美元或 1% 的不利影響。調整後的毛利率佔淨收入的百分比為 70%,而 2024 年第一季為 71%。

  • This year over year decrease was driven by unfavorable product mix and inflationary headwinds partially offset by favorable pricing across segments and geographies. Adjusted R&D expense in the first quarter was $38 million compared to $43 million in the first quarter of 2024.

    年比下降的原因是不利的產品組合和通膨逆風,但各部門和各地區的優惠定價部分抵消了這一影響。第一季調整後的研發費用為 3,800 萬美元,而 2024 年第一季為 4,300 萬美元。

  • R&D is a percent of net revenue with 12%, down from 15% in the first quarter of 2024.

    研發佔淨收入的百分比為 12%,低於 2024 年第一季的 15%。

  • The year over year decrease was primarily driven by investment optimization in the DTD program as we continue to pursue CMS coverage and the wind down of the ACS segment.

    同比下降主要是由於我們繼續追求 CMS 覆蓋範圍並逐步減少 ACS 部門,因此對 DTD 計劃的投資進行了優化。

  • Adjusted SGNA expense for the first quarter was $120 million compared to $113 million in the first quarter of 2024. SGNA as a percent of net revenue was 38% and in line with the first quarter of 2024.

    第一季調整後的 SGNA 費用為 1.2 億美元,而 2024 年第一季為 1.13 億美元。SGNA 佔淨收入的百分比為 38%,與 2024 年第一季持平。

  • The year over year increase on a dollar basis was driven by commercial investments to support growth as well as systems infrastructure to drive efficiencies and scalability.

    美元金額較去年同期成長的動力來自於支持成長的商業投資以及推動效率和可擴展性的系統基礎設施。

  • Adjusted operating income was $65 million compared to $53 million in the first quarter of 2024. Adjusted operating income margin was 20% compared to 18% in the first quarter of 2024. This increase was primarily driven by higher revenue, optimization of DTD program spend, and the wind down of the ACS segment.

    調整後的營業收入為 6,500 萬美元,而 2024 年第一季為 5,300 萬美元。調整後的營業收入利潤率為 20%,而 2024 年第一季為 18%。這一增長主要得益於收入增加、DTD 計劃支出的優化以及 ACS 部門的縮減。

  • Adjusted effective tax rate in the quarter was 24% compared to 21% in the first quarter of 2024. The increase was related to changes in geographic mix and a roll off of tax attributes that have contributed to our historically low effective tax rate.

    本季調整後有效稅率為 24%,而 2024 年第一季為 21%。這一增長與地理分佈的變化以及稅收屬性的下降有關,這些變化導致了我們的有效稅率處於歷史低點。

  • Adjusted diluted earnings per share was $0.88 compared to $0.73 in the first quarter of 2024. The increase was primarily driven by adjusted operating income growth. And partially offset by higher effective tax rates, which negatively impacted EPS by $0.03.

    調整後每股攤薄收益為 0.88 美元,而 2024 年第一季為 0.73 美元。這一成長主要得益於調整後的營業收入成長。但較高的有效稅率對每股盈餘產生了 0.03 美元的負面影響,部分抵銷了這一影響。

  • Our cash balance at March 31 was $738 million up from $429 million at year end 2024. The increase primarily reflects the reclassification of $295 million of restricted cash due to the termination of the collateral cash deposit associated with the SNIA litigation guarantee.

    截至 3 月 31 日,我們的現金餘額為 7.38 億美元,高於 2024 年底的 4.29 億美元。這一增長主要反映了因終止與 SNIA 訴訟擔保相關的抵押現金存款而導致的 2.95 億美元受限現金的重新分類。

  • Total debt of March 31st was $629 million compared to $628 million at year end 2024.

    截至 3 月 31 日的總債務為 6.29 億美元,而 2024 年底的總債務為 6.28 億美元。

  • Adjusted free cash flow for the quarter was $20 million up from $11 million in the prior year period. The year over year increase was primarily driven by stronger operating results and continued working capital improvements.

    本季調整後的自由現金流為 2,000 萬美元,高於去年同期的 1,100 萬美元。年成長主要得益於更強勁的經營業績和持續的營運資本改善。

  • I'd like to point out this year we accelerated Ivanova's short-term incentive bonus payoffs in the 1st quarter which have historically been paid in the second quarter. This will also create a tailwind for our free cash flow in the second quarter on a year over year basis.

    我想指出的是,今年我們在第一季加速了伊凡諾娃的短期激勵獎金支付,而以往獎金是在第二季支付的。這也將為我們第二季的自由現金流帶來年比順風。

  • Capital spend was $11 million in the first quarter compared to $6 million in the prior year period. The year over year increase was driven by IT investments and cardiopulmonary capacity expansion initiatives.

    第一季的資本支出為 1,100 萬美元,而去年同期為 600 萬美元。年成長主要得益於 IT 投資和心肺容量擴展計劃。

  • Now turning to our updated 2025 guidance.

    現在轉向我們更新的 2025 年指南。

  • We now forecast 2025 revenue growth between 6% and 7% on a constant currency basis. And between 7% and 8% on an organic basis.

    我們現在預測 2025 年收入成長率將以固定匯率計算在 6% 至 7% 之間。有機成長率在 7% 至 8% 之間。

  • The impact of foreign currency is now expected to be a headwind between 0 and 1%. We continue to forecast a full year adjusted effective tax rate of approximately 24%, representing an increase of 300 basis points versus 2024.

    目前預計外匯的影響將達到 0 至 1% 之間的逆風。我們繼續預測全年調整後有效稅率約為 24%,比 2024 年增加 300 個基點。

  • And now I'll provide an update on the environmental litigation matter. In connection with the Italian Supreme Court decision on March 14th that Ivanova can be held liable for the established liabilities of SNNA.

    現在我將提供有關環境訴訟事宜的最新進展。義大利最高法院於 3 月 14 日作出裁決,判定伊凡諾娃應對 SNNA 的既定債務負責。

  • The company recorded a liability of $360 million in the first quarter. The court also ruled that Ivanova should not be held responsible for certain payments as previously decided by the Court of Appeal of Milan in the amount of approximately $170 million.

    該公司第一季負債3.6億美元。法院還裁定,伊凡諾娃不應承擔米蘭上訴法院先前裁定的約 1.7 億美元的某些款項的責任。

  • Considering the Supreme Court's ruling and our strong cash position on May second, we repaid $200 million of term facilities, which had a principal balance of $313 million as of March 31st.

    考慮到最高法院的裁決和我們 5 月 2 日的強勁現金狀況,我們償還了 2 億美元的定期貸款,截至 3 月 31 日,其本金餘額為 3.13 億美元。

  • The remaining term facilities balance is now considered a permanent part of the company's capital structure.

    剩餘的定期貸款餘額現在被視為公司資本結構的永久組成部分。

  • As a result, beginning in the second quarter, the related net interest expense will no longer be excluded from operational financial results.

    因此,從第二季開始,相關的淨利息支出將不再被排除在營運財務結果之外。

  • The adjusted diluted earnings per share impact for the balance of 2025 is approximately $0.20. Importantly, we believe the court's decision effectively retires a long-standing overhang on the company.

    2025年剩餘時間的調整後稀釋每股盈餘影響約為0.20美元。重要的是,我們認為法院的判決有效地消除了公司長期以來面臨的困境。

  • To incorporate the SNIA impact and reflect the stronger operational performance in our business, we're updating our 2025 adjusted diluted earnings per share range to $3.60 to $3.70.

    為了納入 SNIA 的影響並反映我們業務更強勁的營運業績,我們將 2025 年調整後每股攤薄收益範圍更新為 3.60 美元至 3.70 美元。

  • With adjusted diluted weighted average shares outstanding to be approximately $55 million for the full year. If we were to exclude this near headwind as we did in the fourth quarter, our previous guidance range would have increased by approximately $0.15 to $3.85 at midpoint.

    全年調整後的稀釋加權平均流通股數約為 5,500 萬美元。如果我們像第四季一樣排除這個逆風因素,我們先前的指導範圍中點將增加約 0.15 美元至 3.85 美元。

  • Adjusted pre-cash flow is still expected to be in the range of $135 to $155 million due to working capital improvements.

    由於營運資本的改善,調整後的預現金流預計仍將在 1.35 億美元至 1.55 億美元之間。

  • This range includes approximately $90 million of capital spend. Driven by critical investments in IT infrastructure, innovation and growth, including the cardiopulmonary capacity expansion initiatives.

    該範圍包括約 9000 萬美元的資本支出。受到 IT 基礎設施、創新和成長的關鍵投資(包括心肺容量擴展計劃)的推動。

  • I'd also like to call out that the guidance ranges shared today incorporate our best estimate of the potential impact of currently applicable tariffs.

    我還想指出,今天分享的指導範圍包含了我們對目前適用關稅的潛在影響的最佳估計。

  • We have initiated a tariff mitigation plan that includes both a holistic assessment of our supply chain, as well as potential pricing actions.

    我們已經啟動了一項關稅減免計劃,其中包括對我們的供應鏈進行全面評估以及潛在的定價行動。

  • Based on the assessment, LivaNova is well positioned to manage the impact of tariffs. Tariff impacts on our supply chain. And component costs are currently estimated to be negligible. With respect to our manufacturing footprint, our neuromodulation products are manufactured in the US. And approximately 80% of the corresponding revenue is generated in the US.

    根據評估,LivaNova 有能力應對關稅的影響。關稅對我們的供應鏈產生影響。並且目前估計零件成本可以忽略不計。就我們的製造足跡而言,我們的神經調節產品是在美國製造的。其中約80%的收入來自美國。

  • Our HLMs and the bulk of our cardiopulmonary disposables are manufactured in Germany and Italy respectively. And approximately 2/3 of our cardiopulmonary revenue is generated outside of the US.

    我們的 HLM 和大部分心肺一次性用品分別在德國和義大利製造。我們的心肺收入約有 2/3 來自美國以外。

  • In total, we estimate a tariff impact of less than $5 million on adjusted operating income for the balance of the year.

    總體而言,我們估計關稅對今年剩餘調整後的營業收入的影響不到 500 萬美元。

  • The 2025 guidance ranges shared today fully incorporate the impact from currently applicable tariffs, though we acknowledge the environment remains uncertain.

    今天分享的 2025 年指導範圍充分考慮了目前適用關稅的影響,儘管我們承認環境仍然不確定。

  • In summary, we had another quarter of strong execution marked by double digit organic revenue growth. This drove over 200 basis points of operating income expansion.

    總而言之,我們又度過了一個表現強勁的季度,有機收入實現了兩位數成長。這推動營業收入成長超過200個基點。

  • A 21% increase in adjusted diluted earnings per share. And meaningful improvement in cash generation.

    調整後每股攤薄收益成長21%。現金產生能力也顯著提升。

  • Our updated 2025 guidance reflects both the strength of our underlying performance and continued investment in our core businesses and innovation pipeline. We look forward to providing a more comprehensive update on our capital allocation plans at our investor day. With that, I'll turn the call back over to Vlad.

    我們更新的 2025 年指引反映了我們基本業績的強勁以及對核心業務和創新管道的持續投資。我們期待在投資者日提供有關資本配置計劃的更全面更新。說完這些,我將把電話轉回給弗拉德。

  • Vladimir Makatsaria - Chief Executive Officer

    Vladimir Makatsaria - Chief Executive Officer

  • Thank you, Alex.

    謝謝你,亞歷克斯。

  • Let me close by reinforcing what makes LivaNova unique.

    最後,請容許我強調一下 LivaNova 的獨特之處。

  • We hold leadership positions in both cardiopulmonary and epilepsy where we are continuing to drive growth and marginal expansion while investing in innovation.

    我們在心肺和癲癇領域都佔據領導地位,我們在投資創新的同時繼續推動成長和邊際擴張。

  • Cardiopulmonary grew double digits in the first quarter, with increasing adoption of essence, strong demand for consumables, and clear line of sight to additional growth as we continue the essence rollout and expand manufacturing capacity.

    第一季度,心肺功能實現了兩位數成長,隨著精華的採用不斷增加,對消耗品的需求強勁,並且隨著我們繼續推出精華並擴大製造能力,進一步增長的前景清晰。

  • In epilepsy, our full year trajectory remains unchanged as we focus on maximizing VNS therapy access. In the under penetrated drug-resistant epilepsy patient population.

    在癲癇方面,我們的全年軌跡保持不變,因為我們專注於最大限度地擴大 VNS 治療的可及性。在藥物難治性癲癇患者群體中。

  • Beyond the core, we're successfully executing against clinical and regulatory milestones in OSA.

    除了核心之外,我們還成功實現了 OSA 的臨床和監管里程碑。

  • In particular, the strong 12-month data from the OSPREY trial validates the potential of our differentiated proximal pHGNS therapy and positions OSA as a significant long term growth opportunity for Ivanova.

    特別是,OSPREY 試驗的強勁 12 個月數據證實了我們差異化近端 pHGNS 療法的潛力,並將 OSA 定位為 Ivanova 的重要長期成長機會。

  • We are also making important progress towards CMS reimbursement or consideration in difficult to treat depression. This program represents a meaningful opportunity to expand our portfolio and serve a large patient population with high unmet needs.

    我們也在 CMS 報銷或考慮難以治療的憂鬱症方面取得了重要進展。該計劃為我們擴大產品組合、服務大量未滿足需求的患者群體提供了一個有意義的機會。

  • Finally, we believe the Italian Supreme Court's decision regarding the SN matter effectively requires a long-standing overhang for Ivanova and enables us to allocate capital with greater flexibility in line with our focus on long term value creation.

    最後,我們認為,義大利最高法院關於 SN 問題的裁決實際上要求對 Ivanova 進行長期懸而未決的處理,並使我們能夠根據對長期價值創造的關注,更靈活地分配資本。

  • We look forward to providing more detail on our pipeline growth opportunities and capital allocation strategy at our invest today.

    我們期待在今天的投資中提供有關我們的管道成長機會和資本配置策略的更多細節。

  • With that, we are ready to open the call for questions.

    現在,我們準備開始回答問題了。

  • Operator

    Operator

  • Thank you. (Operator Instructions)

    謝謝。(操作員指示)

  • As we enter the Q&A session, please limit yourself to one question and one follow up question and then return to the queue if you have additional follow-ups.

    當我們進入問答環節時,請將自己限制在一個問題和一個後續問題上,然後如果您還有其他後續問題,請返回隊列。

  • Rick Wise, Stifel Nicolaus

    瑞克懷斯、史提費爾尼古拉斯

  • Rick Wise - Analyst

    Rick Wise - Analyst

  • Good morning, everybody. Hi, Vlad. A lot to unpack here in a clearly directionally positive, very constructive performance.

    大家早安。你好,弗拉德。這裡有很多東西要解開,這是一個方向明確、積極、非常有建設性的表現。

  • Good to see it and I could start in 10 places. I'll start with the OSPREY data, maybe just at a high level, can you help us understand, can you help us frame? Where you feel the data puts you on a market dynamic market competitive basis against the existing competitors? And maybe just give us some color on timelines and how you're thinking about developing the commercial potential as you move forward.

    很高興看到它,我可以從 10 個地方開始。我將從 OSPREY 數據開始,也許只是從高層次來看,您能幫助我們理解嗎,您能幫助我們建立嗎?您認為這些數據如何幫助您在市場上與現有競爭對手進行動態競爭?也許您可以向我們介紹一下時間表,以及您打算如何在未來開發商業潛力。

  • Ahmet Tezel - Chief Innovation Officer

    Ahmet Tezel - Chief Innovation Officer

  • This is Ahmet, good to hear you. So, we're very happy with the strength of the clinical data and just to recap.

    我是艾哈邁德 (Ahmet),很高興聽到您的消息。因此,我們對臨床數據的強度感到非常滿意,並且只是回顧一下。

  • In our pivotal, which was the first RCT in this field for FDA approval, we enrolled more severe patients compared to the other pivotal trials. So, we started with higher AHI, higher BMI.

    在我們的關鍵研究中,這是該領域第一個獲得 FDA 批准的 RCT,與其他關鍵試驗相比,我們招募了更多重症患者。因此,我們從更高的 AHI 和更高的 BMI 開始。

  • The other really important differentiation is that we did not exclude CCC patients. Actually, in our trial, about a third of the patients were high risk for CCC, and in the general population it's about 25%. So, we enrolled in slightly higher patients than the general population in terms of CCC risk.

    另一個真正重要的區別是我們沒有排除 CCC 患者。實際上,在我們的試驗中,大約三分之一的患者患 CCC 的風險較高,而在一般人群中,這一比例約為 25%。因此,我們招募的患者在 CCC 風險方面比一般人略高。

  • Now despite this, more severe patients may sign and not excluding triple C patients. We were able to achieve a rapid onset of therapy, 1 in 4 patients responded in day one. About 50% of the patients responded by day 90 and as we released 65% at 12 months. So, despite its severity and no exclusion of CCC, the therapeutic response was very strong. So, we're very excited about it.

    儘管如此,現在更嚴重的患者可能會簽名,並且不排除三重 C 患者。我們能夠快速開始治療,四分之一的患者在第一天就有反應。大約 50% 的患者在第 90 天有反應,而 12 個月時這一比例為 65%。因此,儘管病情嚴重且不排除CCC,但治療反應非常強烈。因此,我們對此感到非常興奮。

  • Now moving forward, while these results are already very strong, we believe there's further optimization we can do of this technology because of that differentiated 6 electrode architecture where you put the electrodes on the proximal end of the nerve at the trunk of the nerve, and that allows you to control broader muscle groups that control the airway.

    現在繼續前進,雖然這些結果已經非常強勁,但我們相信我們可以對這項技術進行進一步優化,因為這種差異化的 6 電極結構可以將電極放在神經乾的近端,這樣就可以控制控制氣道的更廣泛的肌肉群。

  • And what that means is that in the future we can further improve these results by doing personalized titration by using different electrodes with different frequencies, turning them on and off at different time points, and we're going to achieve that by using some automated algorithms.

    這意味著,未來我們可以透過使用不同頻率的不同電極,在不同的時間點打開和關閉它們來進行個人化滴定,從而進一步改善這些結果,我們將透過使用一些自動化演算法來實現這一點。

  • So, the existing techno technology is very strong, but where this could go is even stronger. So, we're very excited about it. And I think you asked about a little bit of timelines. I don't want to comment on FDA timelines, but this is a modular PMA, so we already submitted multiple modules working closely with the agency and our last.

    因此,現有的技術已經非常強大,但這項技術可以走得更遠,甚至更強大。因此,我們對此感到非常興奮。我認為您詢問了一些時間表。我不想對 FDA 的時間表發表評論,但這是一個模組化 PMA,因此我們已經提交了多個模組,與該機構密切合作,以及我們的最後一個模組。

  • The module was the clinical module and as we mentioned we submitted that as well, so we're hoping for a relatively quick review and the fact that it's a modular PMA also helps that as well. And in terms of the commercial piece, I'll turn it over to the Vlad.

    該模組是臨床模組,正如我們所提到的,我們也提交了該模組,因此我們希望進行相對快速的審核,並且它是一個模組化 PMA 這一事實也有助於實現這一點。至於商業部分,我將把它交給 Vlad。

  • Vladimir Makatsaria - Chief Executive Officer

    Vladimir Makatsaria - Chief Executive Officer

  • And Rick, good morning. Thank you for the question. So, from a strategy point of view, this aligns very well with our direction to expand our portfolio into the areas of high and met clinical need, high growth, and the areas where we have the right to win with our capabilities in neuromodulation.

    里克,早安。謝謝你的提問。因此,從策略角度來看,這與我們將產品組合擴展到高臨床需求和滿足臨床需求、高成長領域以及我們有權憑藉神經調節能力取勝的領域的方向非常一致。

  • And we believe that this differentiation, first in the approach with the proximal hypoglossal nerve stimulation, secondly, with the technology with 6 electrodes, and then finally with the addressable market with more severe patients with high BMI with CCC that we also anticipate a differentiated commercial strategy. And while we're confident in our ability to commercialize this portfolio ourselves, we are also in discussions with a number of potential partners to do that.

    我們相信,這種差異化首先體現在近端舌下神經刺激的方法上,其次是採用 6 個電極的技術,最後是針對患有 CCC 的高 BMI 重症患者的目標市場,我們也預計會採取差異化的商業策略。雖然我們對自己將這項產品組合商業化的能力充滿信心,但我們也在與一些潛在合作夥伴進行討論。

  • And now that we have 12 months' data, we're able to continue those discussions moving forward. And by the investor day we will frame our full strategy, including commercial execution moving forward.

    現在我們有了 12 個月的數據,我們可以繼續進行這些討論。到投資者日時,我們將制定完整的策略,包括未來的商業執行。

  • Rick Wise - Analyst

    Rick Wise - Analyst

  • Great, and just my follow up question, I was hoping you could unpack the outlook for the HLM business in a little more detail, for essence you've got some new geographic approvals, etc.

    太好了,這只是我的後續問題,我希望您能更詳細地闡述 HLM 業務的前景,本質上您獲得了一些新的地理批准等。

  • And just help us understand where we in the essence placement roll roll out life cycle and on the oxygenator side, you're expanding capacity. But is there anything new, any new perspectives on competitor returns to the market, or what's your line of sight there? Thank you so much.

    並幫助我們了解我們在本質上的位置、滾動推出的生命週期以及在氧合器方面,您正在擴大容量。但是,有沒有什麼新的東西,對競爭對手重返市場有什麼新的看法,或者你對此的看法是什麼?太感謝了。

  • Vladimir Makatsaria - Chief Executive Officer

    Vladimir Makatsaria - Chief Executive Officer

  • Thank you again. So, let me start with oxygenator. Over the last two years we've gained a share. We estimate that we've progressed our share from low to mid-30s, and getting the exit from surgical perfusion business gives us additional op opportunity for share gain moving forward in the areas of HLM, heater cooler, and then bypass disposables.

    再次感謝您。那麼,讓我從氧合器開始吧。在過去的兩年裡,我們的份額有所增加。我們估計,我們的市場份額已從 30% 出頭上升至 30% 中段,退出外科灌注業務為我們在 HLM、加熱器冷卻器和旁路一次性用品領域獲得更多的市場份額機會。

  • On the oxygenator, we continue to see strong demand and the demand continues to outpace the market's ability to supply. We continue to see our share gain momentum. Just to remind you that in 2024 we increased our capacity and output by 10%.

    對於氧合器,我們繼續看到強勁的需求,並且需求持續超過市場的供應能力。我們繼續看到我們的份額成長勢頭。需要提醒您的是,2024 年我們的產能和產量將增加 10%。

  • In 2025 we are on track to have another 10% increase. And we have invested an additional manufacturing line which we expect to go live in the middle of next year, and that will give us a step change in terms of capacity in Greece.

    2025年,我們可望再實現10%的成長。我們還投資了一條額外的生產線,預計明年年中投入使用,這將使我們在希臘的產能發生重大變化。

  • So, on the disposable business, we, we're pleased with the performance in terms of share gain, and we see a path for longer term growth and market share gain given our expansion and our capacity. So, that's on oxygenator front. On the HLM front, just to remind you that Athens was represented 40% of all the HLM placements in 2024, and this year we are on the path to get to 60%. Then if we look forward we will go from 60% to 80% and then to 100%.

    因此,就一次性業務而言,我們對份額成長方面的表現感到滿意,並考慮到我們的擴張和產能,我們看到了長期成長和市場份額成長的道路。這就是氧合器前端的情況。在 HLM 方面,需要提醒您的是,雅典在 2024 年所有 HLM 安置中所佔比例為 40%,而今年我們的目標是達到 60%。那麼,如果我們展望未來,我們將從 60% 上升到 80%,然後上升到 100%。

  • A major milestone for us is China, where we got regulatory approval for essence ahead of expected timeline. So, in April we will receive the approval in China. China is our second largest market worldwide after the US in terms of HLM.

    對我們來說,一個重要的里程碑是中國,我們提前預期獲得了監管部門的批准。因此,四月我們將在中國獲得批准。就 HLM 而言,中國是我們繼美國之後的全球第二大市場。

  • The other thing that we're pleased with is we were able so far to maintain the price premium versus the previous generation and that obviously is a significant growth driver for us. So, I think on HLM, we're very pleased with the performance in the first quarter. We're on the path to get to 60% placement penetration and to maintain price premium.

    另一件讓我們感到高興的事情是,到目前為止,我們能夠保持相對於上一代產品的價格溢價,這顯然是我們的一個重要的成長動力。因此,我認為,我們對 HLM 第一季的表現非常滿意。我們正努力實現 60% 的投放滲透率並保持溢價。

  • Rick Wise - Analyst

    Rick Wise - Analyst

  • Thank you so much.

    太感謝了。

  • Operator

    Operator

  • David Roman, Goldman Sachs.

    高盛的大衛‧羅曼(David Roman)。

  • David Roman - Analyst

    David Roman - Analyst

  • Thank you. Good morning, everybody. I wanted to start on the OUS neuromodulation business which very much trended as you had communicated earlier this year, but could you just go through a little bit more detail as you think about the progression of what transpired between Q4 and Q1 and help us think about the sustainability of some of the changes you've made and the updated guidance you provided for that segment.

    謝謝。大家早安。我想從 OUS 神經調節業務開始談起,正如您今年早些時候所說的那樣,該業務的趨勢非常明顯,但您能否在思考第四季度和第一季度之間發生的事情的進展的同時,更詳細地介紹一下,並幫助我們思考您為該部門所做的某些改變的可持續性以及您提供的最新指導。

  • Stephanie Bolton - President of Global Epilepsy

    Stephanie Bolton - President of Global Epilepsy

  • Hi David, it's Stephanie. Thanks for the question.

    你好,大衛,我是史蒂芬妮。謝謝你的提問。

  • So, our first quarter results for Europe certainly demonstrate the improved commercial execution outside the US that we described on quarter 4 call.

    因此,我們第一季的歐洲業績確實證明了我們在第四季度電話會議上描述的美國以外商業執行情況的改善。

  • We're really pleased with the progress that the team has made, focusing on the fundamental strengthening our talent, improving our customer segmentation. And focusing on our organic patient demand, we have started the year in a very healthy position, and our performance is indicative of organic patient demand.

    我們對團隊所取得的進步感到非常高興,我們專注於從根本上加強我們的人才,改善我們的客戶細分。我們專注於有機患者需求,今年我們處於非常健康的狀態,我們的表現顯示了有機患者需求。

  • We've made some talent changes and the impact of those are starting to read through. We've got experienced leaders supporting the field in the team in the field, and we believe that the performance OUS will continue, and we've incorporated that in the improved expectations for Europe for the guide.

    我們對一些人才做出了改變,其影響已開始顯現。我們擁有經驗豐富的領導者在現場團隊中提供支持,我們相信 OUS 的表現將會持續下去,並且我們已將這一點納入對歐洲指南的改進期望中。

  • So, the other thing I would say is that we still know there's significant opportunity in the EU region. The DRE population is even less penetrated, outside the US and with our footprint and market leadership position, we're able to drive penetration.

    所以,我想說的另一件事是,我們仍然知道歐盟地區存在著巨大的機會。在美國以外,DRE 人口的滲透率甚至更低,憑藉我們的足跡和市場領導地位,我們能夠推動滲透。

  • Thanks for the question.

    謝謝你的提問。

  • David Roman - Analyst

    David Roman - Analyst

  • And then maybe as a follow up on I know Alex you've given the earnings walk here on slide 18, but if you kind of put the pieces together here, the $0.21 of revenue and margin improvements is that we think about the takeaway as you're utilizing is that revenue and gross profit. Improvements that are helping cover the incremental investments in in OSA and or are there other kind of OpEx adjustments included in there as well.

    然後也許作為後續,我知道亞歷克斯,您在第 18 張幻燈片上給出了盈利情況,但是如果您將這些部分放在一起,那麼 0.21 美元的收入和利潤率改善就是我們認為的要點,因為您利用的是收入和毛利潤。這些改進有助於涵蓋 OSA 中的增量投資,或者其中是否還包含其他類型的 OpEx 調整。

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Hi David, yes, it's largely revenue and gross margin outside, we continue to optimize our spend across the P&L, but it's largely the top line and the associated gross margin.

    嗨,大衛,是的,主要是外部收入和毛利率,我們繼續優化整個損益表中的支出,但主要是營業收入和相關的毛利率。

  • David Roman - Analyst

    David Roman - Analyst

  • Got it thank you.

    明白了,謝謝。

  • Operator

    Operator

  • Adam Maeder, Piper Sandler.

    亞當梅德、派珀桑德勒。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Hi, good morning and thank you for taking the questions. Congrats on a nice start to the year. From my vantage point, wanted to start on tariffs. Alex, if I heard the commentary correctly, it sounds pretty manageable. I think you said $5 million dollar impact to adjusted operating income this year.

    大家好,早安,感謝您回答問題。恭喜您新的一年有一個好的開始。從我的角度來看,我想先從關稅開始。亞歷克斯,如果我沒有聽錯的話,這聽起來相當容易處理。我認為您說的是今年調整後的營業收入將受到 500 萬美元的影響。

  • Hopefully I heard that right. Can you just double click on some of the assumptions and the tariff math that's built into, the guidance. I think that came in better than expected. And then in terms of the tariff mitigation strategy and kind of what's baked into the guidance, does that assume you're taking price or passing on price, or is that not contemplated as an offset at this time and then a follow up thanks.

    希望我沒聽錯。您能否雙擊指南中包含的一些假設和關稅計算?我認為這比預期的要好。然後,就關稅減免策略和指導意見中的內容而言,是否假設您正在收取價格或轉嫁價格,或者這在目前不被視為一種抵消,然後再進行後續感謝。

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Hi Adam. Yeah, so let me just start off. I think it's important to note that we are very well positioned in terms of the tariff situation.

    你好,亞當。是的,那麼讓我開始吧。我認為值得注意的是,就關稅狀況而言,我們處於非常有利的地位。

  • Our plans, so at first we assessed our overall supply chain and, looking at the components coming in to our manufacturing sites, we largely assess that as as negligible. So, from that perspective we're in good shape.

    我們的計劃,所以首先我們評估了我們的整體供應鏈,並查看了進入我們製造基地的零件,我們基本上認為這是可以忽略不計的。所以,從這個角度來看,我們的狀況良好。

  • I want to just again reemphasize our manufacturing footprints. So, our neuromodulation products, right, are manufactured in the US. 80% of our revenue comes from the US. Our HLM business, and the bulk of our CP consumables are manufactured in Germany and Italy. Right, and then 2/3 of that revenue base comes from outside the US.

    我想再次強調我們的製造足跡。所以,我們的神經調節產品是在美國製造的。我們 80% 的收入來自美國。我們的 HLM 業務和大部分 CP 耗材在德國和義大利製造。是的,其中 2/3 的收入來自美國以外。

  • So, you take that sort of as a whole, and, I think we have a largely manageable situation, based on what we know today. And again, the tariffs are indeed captured in our guidance that we provided today.

    因此,從整體上看,根據我們目前所了解的情況,我認為我們基本上可以控制局勢。再次強調,關稅確實體現在我們今天提供的指導中。

  • And that's less than $5 million impact on our adjusted operating income for the balance of the year.

    這對我們今年剩餘時間的調整後營業收入的影響不到 500 萬美元。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Understood, thanks Alex for the color there. Maybe I'll just ask one on the guidance front as well, you raised the guidance 7% to 8% organic.

    明白了,感謝 Alex 提供的顏色。也許我也會在指導方面問一個問題,您將指導比例從 7% 提高到了 8%。

  • On the top line, just maybe walk us through, quarterly sequencing, and I showed the street stating that Q2 revenue, I think 331 million. Or so $0.97 for just VPS just any reaction to those figures and any comments as you kind of think about the rest of your playing out.

    在頂線上,也許只是帶我們了解季度排序,我向街道展示了第二季度的收入,我認為是 3.31 億美元。或者僅 VPS 的價格為 0.97 美元,只是對這些數字的任何反應以及您在考慮其餘遊戲時的任何評論。

  • Thank you.

    謝謝。

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • I think from a top line perspective, the street is probably in the right zip code. I think our investments begin to kind of ramp, usually our Q1 is kind of on the lower end of the spectrum as it relates to OpEx, so we start to ramp our operating expenses kind of in the neighborhood of $160 to $165 million per quarter.

    我認為從頂線角度來看,這條街道的郵遞區號可能是正確的。我認為我們的投資開始增加,通常我們的第一季在營運支出方面處於較低水平,因此我們開始將營運支出增加到每季 1.6 億至 1.65 億美元左右。

  • So, I think that that's largely in line. Then of course in Q2 we start to see the impact of the interest, the net interest expense related to the. The balance of the term loan facilities, so that's now incorporated into the into the operational performance metrics. So, that's kind of the key adjustment there.

    所以,我認為這基本上是一致的。當然,在第二季度,我們開始看到利息的影響,以及與之相關的淨利息支出。定期貸款餘額現已納入營運績效指標。所以,這就是關鍵的調整。

  • Adam Maeder - Analyst

    Adam Maeder - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Matthew Taylor, Jefferies.

    馬修泰勒,傑富瑞。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Good morning. This is Mike Sarcone from Matt Taylor. Thanks for taking the question. Just a quick clarification on Adam's first question, that that $5 million tariff impact, does that include, the offsets from the mitigation strategies, or is that just, gross tariff impact and then any mitigation strategy would reduce that impact?

    早安.我是 Matt Taylor 的 Mike Sarcone。感謝您回答這個問題。我只是想快速澄清一下亞當的第一個問題,即 500 萬美元的關稅影響是否包括緩解策略的抵消,還是僅僅是總關稅影響,然後任何緩解策略都會減少這種影響?

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Yeah, so, and I apologize to Adam for missing that part of this question. Yeah, so we had assumed that there might be some call it marginal price pricing actions to offset the costs related to the tariffs.

    是的,因此,我為亞當遺漏了這個問題的這一部分而向他道歉。是的,所以我們假設可能會有一些所謂的邊際價格定價行動來抵銷與關稅相關的成本。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Okay, thank you. That's very helpful. And then I had one on US epilepsy. You know what type of visibility do you have into the channel and I'm really trying to get at your level of confidence that the US epilepsy business won't be impacted in the near term more severely than you're baking into guidance?

    好的,謝謝。這非常有幫助。然後我又讀了一篇關於美國癲癇的文章。您知道您對該頻道有什麼樣的了解嗎?我真的想了解您的信心水平,即美國癲癇業務在短期內不會受到比您指導的更嚴重的影響?

  • Stephanie Bolton - President of Global Epilepsy

    Stephanie Bolton - President of Global Epilepsy

  • Mike, it's Stephanie. So, we continue to be confident in the long-term trajectory of the business which we believe is the mid-single digit range.

    麥克,我是史蒂芬妮。因此,我們仍然對業務的長期發展軌跡充滿信心,我們相信該業務的成長速度將達到中等個位數。

  • The epilepsy market is large, it's growing, and we are the market leader in neuromodulation. From a shorter-term perspective, we're pleased, as I've already alluded to, with the performance and the execution that we've seen in Europe and the rest of the world. Which is reflected in this guide, we remain committed to our strategy, which is to maximize VNS therapy access and to address this large unmet need in DRE.

    癲癇市場規模很大,而且還在持續成長,我們是神經調節領域的市場領導者。從短期角度來看,正如我已經提到的,我們對歐洲和世界其他地區的表現和執行感到滿意。本指南反映出,我們將繼續致力於我們的策略,即最大限度地擴大 VNS 治療的可及性並解決 DRE 中這一巨大的未滿足需求。

  • When you think about it, there are 40,000 patients in the US that are diagnosed each year and less than 25% of them are treated with a surgical intervention. So, that's very much our mission to ensure that patients get access to therapy.

    想想看,美國每年有 4 萬名患者被診斷出患有這種疾病,但其中只有不到 25% 的患者透過手術治療。因此,我們的使命就是確保患者能夠接受治療。

  • Michael Sarcone - Analyst

    Michael Sarcone - Analyst

  • Got it, thank you very much.

    明白了,非常感謝。

  • Operator

    Operator

  • Mike Matson, Needham & Co.

    麥克‧馬森(Mike Matson),Needham & Co.

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Thanks for taking my questions. Just with all the moving parts on the balance sheet with the potential payment of the cash out for SNIA and then, the debt repayment that you did, can you just give us an estimate of where your leverage ratio is going to be, once all that's kind of done?

    感謝您回答我的問題。考慮到資產負債表上的所有活動部分,以及 SNIA 的潛在現金支付,然後是您所償還的債務,您能否在完成所有這些之後,給我們一個估算,您的槓桿率將會達到什麼水平?

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • And our leverage ratio today is extremely healthy, so I'll provide sort of the exact numbers on some of our follow-up calls, Mike. I don't have that off the top of my head, but I assure you that our leverage ratio is very healthy at this point.

    我們今天的槓桿率非常健康,所以我會在一些後續電話會議中提供確切的數字,麥克。我還沒有完全想清楚這一點,但我向你保證,我們目前的槓桿率非常健康。

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Yeah, no, I'm not worried about it. I just was curious, how much, flexibility you have to do things like share repurchases or M&A now that you've kind of resolved that that overhang of uncertainty around how much you would have to pay Italy for the person.

    是的,不,我並不擔心。我只是好奇,既然您已經解決了需要向義大利支付多少錢來聘請該人員的不確定性問題,那麼您在股票回購或併購等方面有多少靈活性?

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Yeah, so look, we've accounted for the liability. We obviously recorded our best estimate of approximately $360 million in liability in the quarter. We had a very healthy and strong cash balance to deal with that.

    是的,看,我們已經考慮到責任了。我們顯然記錄了本季約 3.6 億美元負債的最佳估計。我們擁有非常健康和充足的現金餘額來應對這個問題。

  • We took the opportunity to repay $200 million of the term facility. In terms of our capital allocation strategy, I say, our priority is to continue to build on the strong foundation and continue to invest in the core to build on our market leadership there with innovation and in epilepsy and CP, as when we talk about the CP manufacturing investments are. Our second priority is around OSA and because that presents a significant growth opportunity.

    我們藉此機會償還了 2 億美元的定期貸款。就我們的資本配置策略而言,我想說,我們的首要任務是繼續鞏固基礎,繼續投資核心業務,透過創新以及在癲癇和腦性癱瘓領域的市場領導地位,就像我們談論腦性癱瘓製造投資時所說的那樣。我們的第二個優先事項是 OSA,因為它代表著重大的成長機會。

  • Obviously, we've made great progress on that so far from a clinical and regulatory perspective and you know then then we're open to inorganic options for growth, right, and really focused on attractive markets.

    顯然,從臨床和監管角度來看,我們迄今為止在這方面取得了巨大進展,而且你知道,我們對無機成長選擇持開放態度,對吧,並且真正專注於有吸引力的市場。

  • High unmet needs and our right to win and that will be done in a very disciplined approach. So, overall, I'm very comfortable with our capital structure as it stands today. We do have additional borrowing capacity if necessary.

    未滿足的需求很高,我們有權贏得勝利,而這將透過非常自律的方式實現。所以,總的來說,我對我們目前的資本結構非常滿意。如果有必要,我們確實有額外的借貸能力。

  • Mike Matson - Analyst

    Mike Matson - Analyst

  • Okay, got it. And then just one quick one on the tariff. So, you're saying that the $5 million is based on current tariffs. So, I'm assuming that if the tariff rates were to increase when we hit that 90-day mark post April 2, that that number would likely increase. I mean, obviously, who knows what what's going to actually happen, but we're operating in an uncertain and kind of evolving environment, when the 90-day time frame expires, we'll reassess, right?

    好的,明白了。然後我們再簡單談談關稅問題。所以,您說這 500 萬美元是基於當前關稅計算的。因此,我假設,如果在 4 月 2 日之後達到 90 天期限時關稅稅率增加,那麼這個數字可能會增加。我的意思是,顯然,誰知道實際上會發生什麼,但我們在一個不確定且不斷變化的環境中運作,當 90 天的時間框架到期時,我們會重新評估,對嗎?

  • Our teams are focused on the fundamentals and making sure that we have continuity supply. To our customers and serving our patients, so as the 90 day clock expires, we'll take a look at our mitigation strategies should the tariff situation change again.

    我們的團隊專注於基本面並確保我們擁有連續的供應。對於我們的客戶和服務我們的患者,隨著 90 天期限的到期,如果關稅情況再次發生變化,我們將研究我們的緩解策略。

  • Okay, got it, thank you.

    好的,知道了,謝謝。

  • Operator

    Operator

  • David Wescott, Baird.

    大衛‧韋斯科特,貝爾德。

  • David Wescott - Analyst

    David Wescott - Analyst

  • Oh great, thanks for taking the questions. I wanted to ask on this, the bridge to the updated EPS, outlook that you provided in the investor deck, when I think what you called out is, had this environmental liability payout and associated debt reduction, not been there you would have raised by $0.15, can see the math again in the slide.

    哦,太好了,感謝您回答這些問題。我想問一下,關於您在投資者簡報中提供的更新每股收益和展望,我認為您所說的是,如果沒有這筆環境責任支出和相關的債務減免,您就會籌集 0.15 美元,您可以在幻燈片中再次看到計算結果。

  • Our initial look at some of the back of the envelope math was you had the $0.12 feat in the quarter, maybe 7 or $0.08 of a headwind from tariffs and our math at the at the time was about a 20 you know cent FX kind of net change benefit so would imply that maybe the raise could have been higher than the $0.15.

    我們最初根據信封背面的數學計算得出的結果是,本季的利潤為 0.12 美元,可能是關稅帶來的 7% 或 0.08 美元的不利因素,而我們當時的計算結果是外匯淨變化收益約為 20 美分,因此這意味著加薪幅度可能高於 0.15 美元。

  • So, just want to get an understanding what the effective kind of communication is here on the rays and then maybe any quantification that you have on what that tariff, or sorry, the FX change would have impacted or is baked into the guide at this point.

    因此,只是想了解這裡關於射線的有效溝通方式,然後也許您對關稅有任何量化,或者抱歉,外匯變化會產生什麼影響,或者此時是否已納入指南。

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Hi David. Our FX impact is largely reflected in the top line. Our given our sort of geographic footprint where in our geography of our OpEx, our P&L is kind of naturally hedged, right?

    你好,大衛。我們的外匯影響很大程度上反映在營業收入上。考慮到我們的地理分佈,我們的營運支出所在的地理位置,我們的損益表是自然避險的,對嗎?

  • So, when the dollar gets stronger, top line is impacted negatively, but we get the benefit of the OpEx games there. So, we don't really have a massive impact on our on our bottom line from a from an FX perspective. It's kind of a naturally hedged, if you will.

    因此,當美元走強時,營收會受到負面影響,但我們可以從營運支出遊戲中獲益。因此,從外匯角度來看,我們的底線並沒有受到太大影響。如果你願意的話,這是一種自然的對沖。

  • David Wescott - Analyst

    David Wescott - Analyst

  • Okay, perfect, that makes sense, on, the updated guide for the cardio palm segment this year, you talked about, China, recent approvals there wondering if maybe it could size up, the opportunity there, the 30%, I think it was 30% HLM growth in in the quarter, I think was pretty impressive, relative to where you were exiting last year and even given the comps that you had last year, I don't think those comps even really get that much tougher in the second half or in Q2 or the rest of 2025.

    好的,太好了,這很有道理,關於今年有氧手掌細分市場的最新指南,您談到了中國最近獲得的批准,想知道它是否可以擴大規模,那裡的機會,30%,我認為本季度 HLM 增長率是 30%,我認為相對於您去年退出時的水平,這是相當令人印象深刻的,即使考慮到您去年的時間可能比數據艱難,我認為這些時間在下半年或第 25 年

  • So, can you help us think about how you arrived at this, new cardio pulm growth outlook, especially with again what seems to be pretty strong trends, not as strong kind of comps even on the HLM side next year or in the back half of this year, and then China coming on as well. Thank you.

    那麼,您能否幫助我們思考一下您是如何得出這一結論的,新的心血管增長前景,尤其是再次出現看似非常強勁的趨勢,明年或今年下半年即使在 HLM 方面也沒有那麼強勁的可比性,然後中國也將崛起。謝謝。

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • So, as we said in our initial guides, we expect HLM to grow at double digit rates. We obviously assumed, our regulatory approval in China came a bit earlier than we expected, but really not a major impact in terms of our guide. We still expect strong growth with HLM. Q1.

    因此,正如我們在最初的指南中所說,我們預計 HLM 將以兩位數的速度成長。我們顯然認為,我們在中國獲得的監管批准比我們預期的要早一些,但對我們的指導而言並沒有太大的影響。我們仍然期待 HLM 實現強勁成長。問1.

  • I just want to remind everybody, the capital equipment sales are not linear, right? So, Q1, we had a very strong quarter with 30% growth. We don't expect that to continue throughout the year, but we still have assumed a strong ramp, in the last three quarters of the year.

    我只是想提醒大家,資本設備銷售不是線性的,對嗎?因此,第一季我們表現非常強勁,成長了 30%。我們預計這種趨勢不會持續全年,但我們仍然預計今年最後三個季度將出現強勁增長。

  • So, you know that's space into our adjusted guide for CP which is now you know expected to be 9% to 10%, relative to 7% to 8% that we projected at the end of 2024.

    因此,您知道這是我們調整後的 CP 指南中的空間,現在預計為 9% 到 10%,而我們在 2024 年底預測的是 7% 到 8%。

  • Vladimir Makatsaria - Chief Executive Officer

    Vladimir Makatsaria - Chief Executive Officer

  • And David, this is, and we're very pleased with our execution in both on HLM and Oxygenator front and obviously very pleased with our first quarter performance. It's early in the year, so we are working very hard to maintain this momentum and you know when the time is right, we will keep informing you on our progress on growth.

    大衛,我們對 HLM 和氧合器的執行情況非常滿意,顯然對第一季的表現非常滿意。現在才年初,所以我們正在努力保持這種勢頭,當時機成熟時,我們會繼續向大家通報我們的成長進展。

  • Operator

    Operator

  • Alright, great, thanks.

    好的,太好了,謝謝。

  • Michael Polark with Wolf Research.

    沃爾夫研究公司的麥可‧波拉克 (Michael Polark)。

  • Michael Polark - Analyst

    Michael Polark - Analyst

  • Hey, good morning. I have a question on depression. In the slide deck, I see that depression revenue and the guidance is $12 million at the midpoint. I didn't see that in the fourth quarter deck. So, is all that incremental, or was there a placeholder in before?

    嘿,早安。我有一個關於憂鬱症的問題。在幻燈片中,我看到蕭條收入和指導中間值為 1200 萬美元。我在第四節的甲板上沒有看到這一點。那麼,所有這些都是增量的,還是之前就有一個佔位符?

  • And then the driver, it says driven by program optimization efforts, and I'm curious what that means because $12 million is the best number I've seen out of depression. It's even better than peak recover enrollment year, so I'm curious what's driving the uptick.

    然後是驅動因素,它說是由程式優化工作驅動的,我很好奇這意味著什麼,因為 1200 萬美元是我見過的擺脫蕭條的最佳數字。這甚至比恢復入學高峰年的入學人數還要好,所以我很好奇是什麼推動了這一增長。

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Hey Mike, it's Alex. So, yeah, we upped our revenue assumption in DTD.

    嘿,麥克,我是亞歷克斯。是的,我們提高了 DTD 的收入假設。

  • I think you've heard us talk about this in the past; we have a small commercial infrastructure in place. The team was during the recover enrollment period; they were largely focused on driving the patient funnel for recover. What we've done now is we're waiting, our re-engagement with CMS. We basically, we started our process that we've had over time to look at.

    我想您以前聽過我們談論這個問題;我們已經建立了一個小型商業基礎設施。該團隊正處於康復招募期;他們主要致力於推動康復的患者管道。我們現在所做的就是等待與 CMS 重新合作。基本上,我們已經開始了經過一段時間的審視的過程。

  • Basically, driving the new patient funnel for patients who are interested in in the device, right? And so that goes through a very long appeals process with payers, which is not very efficient and that is the reason we're so keen on getting reimbursement with CMS. So, that is the that is the rationale for increasing our revenue in DTD.

    基本上,為對該設備感興趣的患者提供新的患者管道,對嗎?因此,這需要經過與付款人非常漫長的上訴過程,效率不高,這也是我們如此熱衷於從 CMS 獲得報銷的原因。所以,這就是增加 DTD 收入的理由。

  • Michael Polark - Analyst

    Michael Polark - Analyst

  • Was there something in the guidance before? It wasn't in the old deck, so I'm curious what the old input was?

    之前的指導中有沒有什麼內容?它不在舊卡組中,所以我很好奇舊的輸入是什麼?

  • Alex Schwartzberg - Chief Financial Officer

    Alex Schwartzberg - Chief Financial Officer

  • Yeah, it was largely the same. I mean it was a marginal increase relative to the previous guide, yeah.

    是的,基本上是一樣的。我的意思是,與之前的指南相比,這是一個小幅的增長,是的。

  • Michael Polark - Analyst

    Michael Polark - Analyst

  • Okay. For my follow up, I want to ask on sleep apnea. I have small two parts: a 72-minute average case time in OSPREY. What's your perspective on what that could be in the real world as you train surgeons and get them comfortable with your device and how do you think that compares to what the competitors delivered in their pivotal trials.

    好的。為了進行後續跟進,我想詢問有關睡眠呼吸中止症的問題。我有兩個小部分:OSPREY 中的平均案例時間為 72 分鐘。當您培訓外科醫生並讓他們熟悉您的設備時,您對現實世界中的情況有何看法?您認為與競爭對手在關鍵試驗中提供的結果相比如何?

  • And then the second part is on pricing. Any preliminary view of how you might approach price as you develop a commercial strategy at the market level of hypoglossal nerve stem or perhaps a discount to differentiate. Thank you so much.

    第二部分是定價。當您在舌下神經乾市場層級制定商業策略時,您對如何處理價格有什麼初步看法,或者可能透過折扣來區分。太感謝了。

  • Ahmet Tezel - Chief Innovation Officer

    Ahmet Tezel - Chief Innovation Officer

  • Yeah, I'll start with more of the clinical questions and I'll ask Alex the comments on the pricing piece. So, one of the key points of our design is that you put the electrode cuff at the proximal end. So, that really limits or minimizes dissection in the tissue when you're placing the cuff. Therefore, you win a lot of time. That is one reason we're 72 minutes in other trials.

    是的,我將從更多的臨床問題開始,然後我會向亞歷克斯詢問有關定價部分的評論。因此,我們設計的關鍵點之一是將電極袖帶放在近端。因此,當您放置袖口時,這確實會限製或減少組織中的解剖。因此,你贏得了很多時間。這就是我們在其他試驗中用時 72 分鐘的原因之一。

  • For example, inspire, they had a longer time period, but one reason for that was that they had a secondary sensor that they had to implant, so there were 3 incisions instead of 2. So, it's a little bit of apples to orange comparison, but 72 minutes is low. We're very excited about it because it's an easy implant to the proximal end. And the last comment I'll make is that What we hear from our surgeons is that if you have done inspire, it's very easy to move and implant an OSPREY device.

    例如,inspire,他們的時間週期更長,但其中一個原因是他們必須植入第二個感測器,所以切口有 3 個而不是 2 個。因此,這有點像蘋果和橘子的比較,但 72 分鐘確實很短。我們對此感到非常興奮,因為它很容易植入近端。我最後要說的是,我們從外科醫生那裡聽到的是,如果你已經進行了啟發,那麼移動和植入 OSPREY 設備就非常容易。

  • You do not need to learn new skills. It's actually because of the proximal end piece; it's actually something very straightforward to transfer into.

    您不需要學習新技能。這實際上是因為近端部件;它實際上是一種非常容易轉移的東西。

  • So, with that I'll ask the commercial. Yeah. I think it's part of our go to market commercial strategy, and we'll talk a little bit more about that later in the year during an investor day. Our team, I don't want to, do a big roll out of our pricing strategy, but our teams, continuing to work on an appropriate coating for this therapy.

    因此,我會問一下商業廣告。是的。我認為這是我們進入市場的商業策略的一部分,我們將在今年稍後的投資者日上進一步討論這個問題。我不想讓我們的團隊大力推行我們的定價策略,但我們的團隊會繼續致力於為這種療法尋找合適的塗層。

  • Operator

    Operator

  • Thank you. Those are all the questions we have time for today, and so I'll turn the call back to Vladimir Makassara for closing remarks.

    謝謝。這些就是我們今天有時間回答的所有問題,因此我將把電話轉回給 Vladimir Makassara 進行結束語。

  • Vladimir Makatsaria - Chief Executive Officer

    Vladimir Makatsaria - Chief Executive Officer

  • Thank you, Emily, for facilitating the call and thank you everyone for joining the call today. And on behalf of our entire team, we really appreciate your support and interest in LivaNova and have a great day.

    謝謝艾蜜莉主持這次電話會議,也謝謝大家今天參加這次電話會議。我代表我們整個團隊,非常感謝您對 LivaNova 的支持和關注,祝您有個愉快的一天。

  • Operator

    Operator

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

    感謝大家今天的參與。我們的通話到此結束,您可以掛斷電話了。