Merit Medical Systems Inc (MMSI) 2024 Q3 法說會逐字稿

Good day. And thank you for standing by. Welcome to the Merit Medical Q3 2024 earnings conference call.

再會。感謝您的支持。歡迎參加 Merit Medical 2024 年第三季財報電話會議。

(operator instructions)

（操作員說明）

I would now like to turn the conference over to your speaker for today, Fred Lampropoulos. Please go ahead.

現在我想將會議交給今天的發言人 Fred Lampropoulos。請繼續。

Thank you operator and welcome everyone. I am joined on the call today by Raul Parra, our Chief Financial Officer and treasurer, Joe Wright, our President and Brian Lloyd, our Chief Legal Officer and corporate secretary.

謝謝運營商並歡迎大家。我們的財務長兼財務主管勞爾·帕拉(Raul Parra)、我們的總裁喬·賴特(Joe Wright) 和我們的首席法務官兼公司秘書布萊恩·勞埃德(Brian Lloyd) 參加了今天的電話會議。

Brian. Would you mind taking us through the safe harbour statements, please?

布萊恩.您介意向我們介紹安全港聲明嗎？

Thank you, Fred.

謝謝你，弗雷德。

I would like to remind everyone that this presentation contains forward-looking statements that receive safe harbor protection under federal securities laws.

我想提醒大家，本簡報包含前瞻性陳述，這些陳述受到聯邦證券法的安全港保護。

Although we believe these forward-looking statements are based upon reasonable assumptions. They are subject to risks and uncertainties the realization of any of these risks or uncertainties as well as extraordinary events or transactions impacting our company could cause actual results to differ materially from the expectations and projections expressed or implied by our forward-looking statements.

儘管我們相信這些前瞻性陳述是基於合理的假設。它們面臨風險和不確定性，任何這些風險或不確定性的實現以及影響我們公司的特殊事件或交易都可能導致實際結果與我們的前瞻性陳述明示或暗示的預期和預測有重大差異。

In addition, any forward-looking statements represent our views only as of today, October 30, 2024 and should not be relied upon as representing our views as of any other date.

此外，任何前瞻性陳述僅代表我們截至今天（2024 年 10 月 30 日）的觀點，不應被視為代表我們在任何其他日期的觀點。

We specifically disclaim any obligation to update such statements, except as required by applicable law.

我們特別聲明不承擔更新此類聲明的義務，除非適用法律要求。

Please refer to the section entitled Cautionary statement regarding forward-looking statements in today's press release and presentation for important information regarding such statements.

請參閱今天的新聞稿和簡報中標題為「有關前瞻性陳述的警告聲明」的部分，以了解有關此類陳述的重要資訊。

For a discussion of factors which could cause actual results to differ from these forward-looking statements. Please also refer to our most recent filings with the SEC, which are available on our website.

討論可能導致實際結果與這些前瞻性陳述不同的因素。另請參閱我們最近向 SEC 提交的文件，這些文件可在我們的網站上找到。

Our financial statements are prepared in accordance with accounting principles which are generally accepted in the United States.

我們的財務報表是根據美國普遍接受的會計原則編製的。

However, we believe certain non-GAAP Financial measures provide investors with useful information regarding the underlying business trends and performance of our ongoing operations and can be useful for period over period comparisons of such operations.

然而，我們相信某些非公認會計原則財務指標為投資者提供了有關我們正在進行的業務的基本業務趨勢和業績的有用信息，並且對於此類業務的不同時期比較很有用。

This presentation also contains certain non-GAAP financial measures.

本簡報也包含某些非公認會計準則財務指標。

A reconciliation of non-GAAP financial measures to the most directly comparable us GAAP measures is included in today's press release and presentation furnished to the SEC under form 8-K.

今天根據表格 8-K 向 SEC 提供的新聞稿和簡報中包含了非 GAAP 財務指標與最直接可比較的美國 GAAP 指標的調整表。

Please refer to the sections of our press release and presentation entitled non-GAAP Financial Measures for important information regarding non-GAAP financial measures discussed on this call.

請參閱我們的新聞稿和簡報中題為「非 GAAP 財務指標」的部分，以了解有關本次電話會議討論的非 GAAP 財務指標的重要資訊。

Readers should consider non-GAAP financial measures, in addition to, not as a substitute, for financial reporting measures prepared in accordance with GAAP.

除了而非取代根據 GAAP 編制的財務報告措施之外，讀者還應考慮非 GAAP 財務措施。

Please note that these calculations may not be comparable with similarly titled measures of other companies.

請注意，這些計算可能無法與其他公司的類似名稱的衡量標準進行比較。

Both today's press release and our presentation are available on the Investors page of our website.

今天的新聞稿和我們的簡報都可以在我們網站的投資者頁面上找到。

I will now turn the call back to Fred.

我現在將把電話轉回給弗雷德。

Thank you, Brian. And let me start with a brief agenda of what we will cover during our proposed prepared remarks.

謝謝你，布萊恩。讓我先簡要介紹一下我們在擬議的準備好的發言中將討論的內容。

I will start with an overview of our third quarter financial results and a discussion of the strategic acquisition we announced on September '17. After my opening remarks, Joe Wright will provide an update on the notable progress we have achieved in recent months on our U.S. WRAPSODY program as well as a summary of our revenue results for the third quarter.

我將首先概述我們第三季的財務業績，並討論我們於 2017 年 9 月宣布的策略收購。在我的開場白之後，Joe Wright 將介紹我們近幾個月來在美國 WRAPSODY 計劃方面取得的顯著進展的最新情況，以及我們第三季度收入結果的摘要。

Then Raul will provide a more in depth review of our quarterly financial results and our financial guidance for 2024, which we updated today and in the press release.

然後，勞爾將對我們的季度財務業績和 2024 年財務指引進行更深入的審查，我們今天和新聞稿中更新了這些指引。

Then we will open the call for your questions.

然後我們將打開電話詢問您的問題。

Now beginning with a review of our third quarter results.

現在開始回顧我們第三季的業績。

We reported total revenue of $339.8 million, Up 7.8% year over year on a GAAP basis and up 7.9% year over year on a constant currency basis.

我們公佈的總收入為 3.398 億美元，以 GAAP 計算年增 7.8%，以固定匯率計算年增 7.9%。

The constant currency revenue growth we delivered in the third quarter, modestly exceeded the high end of the range of growth expectations that we outlined on our quarter two call. Specifically, we expected constant currency revenue growth for the third quarter in the range of 6.4% to 7.8% year over year.

我們在第三季實現的恆定貨幣收入成長略微超出了我們在第二季電話會議中概述的成長預期範圍的上限。具體來說，我們預計第三季貨幣收入將年比穩定成長在 6.4% 至 7.8% 之間。

Importantly, the 7.9% constant currency revenue growth in the third quarter was driven by strong organic growth and contributions from acquired products, both of which came in at the high end of our growth expectations. With respect to our profitability performance in the third quarter, we delivered financial results that exceeded our expectations.

重要的是，第三季 7.9% 的恆定貨幣收入成長是由強勁的有機成長和收購產品的貢獻所推動的，兩者都處於我們成長預期的高端。從第三季的獲利表現來看，我們的財務表現超出了我們的預期。

We leveraged the solid revenue results to deliver non-GAAP operating profit growth of 19% and a Non-GAAP operating margin of-- excuse me, 19.2% of sales, up approximately 175 basis points year over year.

我們利用穩健的收入業績，實現了 19% 的非 GAAP 營業利潤增長，以及佔銷售額的 19.2% 的非 GAAP 營業利潤率，同比增長約 175 個基點。

We also delivered 21% growth in our non-GAAP EPS, which exceeded the high end of our expectations as well. Perhaps most notably, we generated $38 million of free cash flow in the quarter and have generated more than $120 million of free cash flow over the first nine months of 2024, representing an increase of 116% year over year.

我們的非 GAAP 每股盈餘也實現了 21% 的成長，這也超出了我們預期的上限。也許最值得注意的是，我們在本季度產生了 3800 萬美元的自由現金流，並在 2024 年前 9 個月產生了超過 1.2 億美元的自由現金流，同比增長 116%。

We believe our third quarter results reflect continued strong momentum in the business, and we remain confident in our team's ability to deliver the updated financial guidance for 2024, that Raul will review later on the call.

我們相信，我們的第三季業績反映了業務持續強勁的勢頭，我們對我們的團隊提供更新的 2024 年財務指引的能力仍然充滿信心，勞爾將在稍後的電話會議上對此進行審查。

We are focused on delivering continued strong execution, solid constant currency growth, improving profitability and strong free cash flow in 2024 as well as continued progress in our continued growth initiatives program and related financial targets for the three year period ending December 31, 2026.

我們的重點是在2024 年實現持續強勁的執行力、穩定的貨幣穩定增長、提高盈利能力和強勁的自由現金流，以及在截至2026 年12 月31 日的三年期間持續推進持續增長計劃和相關財務目標。

Now before turning the time over to Joe, I would like to take a few minutes to discuss the important acquisition we announced on September '17. we announced the signing of a definitive asset agreement to purchase Cook Medical's lead management portfolio for a total cash consideration of approximately $210 million and the assumption of certain liabilities.

現在，在將時間交給 Joe 之前，我想花幾分鐘時間討論我們在 2017 年 9 月宣布的重要收購。我們宣布簽署最終資產協議，以約 2.1 億美元的總現金對價購買庫克醫療的領先管理投資組合併承擔某些負債。

We believe this acquisition represents multiple strategic and financial positives and importantly, this acquisition is consistent with and will not distract us from our continued growth initiatives.

我們相信這次收購代表了多重策略和財務正面因素，重要的是，這次收購符合並且不會分散我們對持續成長計畫的注意力。

This proposed transaction represents another example of Merit's selectivity investing to expand our product portfolio in key strategic markets that leverage our existing commercial footprint.

這項擬議交易是 Merit 選擇性投資的另一個例子，旨在利用我們現有的商業足跡，擴大我們在關鍵策略市場的產品組合。

Strategically, we believe the proposed acquisition will position Merit to offer clinicians an increasingly comprehensive set of solutions to support cardiac intervention patients from diagnosis to therapy and intervention to post procedure care.

從策略上講，我們相信擬議的收購將使 Merit 能夠為臨床醫生提供一套日益全面的解決方案，以支持心臟介入患者從診斷到治療、幹預到術後護理。

Cook medical's lead management business has many years of operating history and provides a comprehensive end-to-end product portfolio of medical devices and accessories used in the lead management procedures for patients who need a pacemaker or an implantable cardioverter defibrillator, an ICD, lead removed or replaced. The assets we propose to acquire from Cook include a full portfolio of tools for complete case support, including hand-triggered rotating extraction devices, sheets and snares for manual extraction and lead control tools for grasping and removing leads.

庫克醫療的導線管理業務擁有多年的營運歷史，為需要起搏器或植入式心律轉復除顫器、ICD、導線移除的患者提供導線管理程序中使用的全面的端到端醫療器械和配件產品組合。我們建議從庫克收購的資產包括用於完整病例支援的全套工具，包括手動觸發旋轉提取裝置、用於手動提取的床單和圈套以及用於抓取和移除引線的引線控制工具。

We believe these assets generated approximately $37 million of revenue over the 12 month period ended December 31, 2023 with sales to customers in the US EMEA, APAC and rest of the world representing approximately 41%, 42%, 11% and 6% respectively.

我們認為，在截至2023 年12 月31 日的12 個月期間，這些資產產生了約3,700 萬美元的收入，其中美國、歐洲、中東和非洲、亞太地區和世界其他地區客戶的銷售額分別約佔41%、42%、11% 和6%。

We believe this transaction will strengthen our fast-growing high-margin, electrophysiology and cardiac rhythm management or CRM business with the addition of differentiated products and an established commercial infrastructure. We believe the transaction will enhance our position in the cardiac intervention market, particularly in Europe, which is strategically attractive and has our commercial team very excited.

我們相信，此次交易將透過增加差異化產品和成熟的商業基礎設施來加強我們快速成長的高利潤、電生理學和心律管理或 CRM 業務。我們相信，這筆交易將增強我們在心臟介入市場的地位，特別是在歐洲，這具有戰略吸引力，並且讓我們的商業團隊非常興奮。

We estimate this transaction represents an annual addressable opportunity of more than $900 million in the US EMEA A and APAC regions. Specifically, we anticipate that beginning in fiscal year 2025, the addition of Cook's lead management business will position Merit to represent more than $100 million in combined annualized electrophysiology and CRM revenue serving the global cardiac intervention market.

我們估計，這筆交易代表著美國、歐洲、中東和非洲 A 區和亞太地區每年可實現價值超過 9 億美元的機會。具體來說，我們預計從 2025 財年開始，庫克領先管理業務的增加將使 Merit 在服務全球心臟介入市場的電生理學和 CRM 年度綜合收入中代表超過 1 億美元。

In addition to the strong strategic rationale, we believe the financial profile of the proposed acquisition is extremely compelling. Raul will share some additional color on the favourable financial profile of the acquisition later on in the call. In the interim, I'll share that we expect sales contributions from the acquisition post-closing in the range of 4 to 6 million over the balance of 2024, and we expect this acquisition to add approximately $40 million of revenue on an annualized basis beginning in fiscal year 2025.

除了強有力的策略理由外，我們相信擬議收購的財務狀況也非常引人注目。勞爾稍後將在電話會議中分享有關此次收購的有利財務狀況的一些額外資訊。在此期間，我將分享我們預計 2024 年收購完成後的銷售貢獻將在 4000 至 600 萬美元之間，並且我們預計此次收購將在年化基礎上增加約 4000 萬美元的收入2025 財年。

Now with that said, let me turn the time over to Joe for an update on our U.S. WRAPSODY program and a review of our third quarter revenue performance.

現在，讓我把時間交給 Joe，了解我們美國 WRAPSODY 計畫的最新情況，並回顧我們第三季的營收表現。

Joe?

喬？

Thank you, Fred.

謝謝你，弗雷德。

I share Fred's sentiments as it relates to the notable progress we have made on our U.S. WRAPSODY program in recent months. First, with respect to our progress in the areas of clinical validation and raising awareness of the compelling safety and efficacy profile of WRAPSODY among clinicians.

我同意 Fred 的觀點，因為這與我們最近幾個月在美國 WRAPSODY 計劃上取得的顯著進展有關。首先，我們在臨床驗證和提高臨床醫生對 WRAPSODY 引人注目的安全性和有效性的認識方面取得的進展。

On September '16, we announced positive six month findings from the randomized arteriovenous or a AV fistula arm of a WRAPSODY WAVE pivotal trial.

2016 年 9 月，我們宣布了 WRAPSODY WAVE 關鍵試驗的隨機動靜脈或 AV 瘻管臂 6 個月的正面結果。

The data was shown at the Cardiovascular and Interventional Radiological Society of Europe, or CIRSI, annual Congress in Lisbon, Portugal. Dr Mahmood Razavi, the co-principal investigator of the wave trial, presented the extremely compelling results.

這些數據在葡萄牙里斯本舉行的歐洲心血管和介入放射學會 (CIRSI) 年度大會上發表。Wave 試驗的共同首席研究員 Mahmood Razavi 博士展示了極其引人注目的結果。

Specifically, the primary efficacy endpoint was target lesion primary patency, which represents the percentage of patients that did not need a clinical revascularization or have thrombosis. in patients treated with WRAPSODY was 89.8%.

具體來說，主要療效終點是目標病變的主要通暢率，它代表不需要臨床血管重建或有血栓形成的患者的百分比。接受 WRAPSODY 治療的患者的率為 89.8%。

This was 27% points higher than patients treated with the control percutaneous transluminal angioplasty or PTA, which is the current standard of care. With respect to the primary safety endpoint in the pivotal study, there were fewer adverse events for patients treated with WRAPSODY. However, the difference in the proportion of patients who experienced an adverse event was not statistically significant between the two cohorts.

這比接受對照經皮腔內血管成形術或 PTA（目前的護理標準）治療的患者高出 27%。關於關鍵研究中的主要安全終點，接受 WRAPSODY 治療的患者的不良事件較少。然而，兩個隊列之間經歷不良事件的患者比例差異並不具有統計意義。

Dr. Razavi was quoted saying the superiority of the six-month efficacy data is compelling and provides clinicians the chance to evaluate how WRAPSODY can help us prolong the vascular access of our patients. WRAPSODY should be the new standard of care for these patients.

Razavi 博士表示，六個月療效數據的優越性令人信服，並為臨床醫生提供了評估 WRAPSODY 如何幫助我們延長患者血管通路的機會。WRAPSODY 應該成為這些病人的新照護標準。

We were also pleased with the positive response and feedback from participants of the 2024 Controversies in dialysis access or CIDA meeting in Washington, D.C. on October '5 including positive commentary related to our WAVE trial for many participants at the meeting.

我們也對 2024 年透析訪問爭議或 2024 年 10 月 5 日在華盛頓特區舉行的 CIDA 會議參與者的積極回應和回饋感到高興，其中包括會議上許多參與者對我們的 WAVE 試驗相關的正面評論。

We expect further increases in awareness of WRAPSODY's safety and efficacy among clinicians including more clinical data results and look forward to WRAPSODY being featured in scientific sessions at the VEITH meeting on November '23 in New York City.

我們預計臨床醫生對 WRAPSODY 的安全性和有效性的認識將進一步提高，包括更多的臨床數據結果，並期待 WRAPSODY 在 23 日 11 月在紐約舉行的 VEITH 會議的科學會議上得到專題報導。

Second, we have made considerable progress in our U.S. regulatory and reimbursement strategies and in developing our post approval commercial strategy for WRAPSODY.

其次，我們在美國監管和報銷策略以及製定 WRAPSODY 批准後商業策略方面取得了相當大的進展。

As discussed on our last earnings call we completed the clinical study report and filed the final module with the FDA for pre-market approval or PMA, by the end of the second quarter of 2024 as expected.

正如我們在上次財報電話會議上所討論的那樣，我們完成了臨床研究報告，並向 FDA 提交了最終模組以獲得上市前批准或 PMA，按預期在 2024 年第二季末之前完成。

We are ready and willing to engage with FDA during their review as they review our PMA application for this innovative technology. The WRAPSODY cell impermeable endoprosthesis is built to combat the challenges dialysis patients can often experience due to stenosis and inclusions in the dialysis outflow circuit.

我們已準備好並願意在 FDA 審查我們針對這項創新技術的 PMA 申請時與他們合作。WRAPSODY 細胞不滲透內置假體旨在應對透析患者因透析流出迴路狹窄和夾雜物而經常遇到的挑戰。

We believe this technology can extend long-term vessel patency rates and reduce the complications associated with existing treatment options on the market today including the need for repeated interventions, frequent trips to the hospital and inadequate dialysis treatments.

我們相信這項技術可以延長血管的長期通暢率，並減少與當今市場上現有治療方案相關的併發症，包括需要重複幹預、頻繁去醫院和透析治療不足。

Our Renal therapies group has been working through intensive WRAPSODY training covering a range of important areas including technical story, anatomy and physiology and deployment technique. Clinical data training and live hands-on training are scheduled to increase in the coming months.

我們的腎臟治療小組一直在進行密集的 WRAPSODY 培訓，涵蓋一系列重要領域，包括技術故事、解剖學和生理學以及部署技術。臨床數據培訓和現場實踐培訓計劃在未來幾個月內增加。

We are focused on ensuring we are ready to enter the U.S. market. Following PMA approval. The team has completed a thorough evaluation of the U.S. market opportunity and is developing a comprehensive U.S. commercial strategy.

我們致力於確保我們做好進入美國市場的準備。繼 PMA 批准後。該團隊已完成對美國市場機會的全面評估，並正在製定全面的美國商業策略。

Importantly, our plans for U.S. commercialization, post PMA approval are part of a broader commercial strategy for our Renal Therapies group. We have an experienced dedicated sales and customer support team offering a strong portfolio of dialysis products that address the entire end stage Renal disease continuum of care including our HeRo Graft, our surfacer inside-out access catheter system and our portfolio of acute, chronic and peritoneal dialysis catheters.

重要的是，我們在 PMA 批准後的美國商業化計劃是我們腎臟治療集團更廣泛的商業策略的一部分。我們擁有經驗豐富的專業銷售和客戶支援團隊，提供強大的透析產品組合，可解決整個終末期腎病連續護理的問題，包括我們的HeRo 移植物、我們的Surfacer 由內而外接入導管系統以及我們的急性、慢性和腹膜產品組合透析導管。

We are excited to add WRAPSODY to this offering following PMA approval. The team is also focused on developing and executing our reimbursement strategy for WRAPSODY. Earlier this month, we submitted our application requesting a new technology APC assignment for Medicare's acute inpatient prospective payment system.

我們很高興在 PMA 批准後將 WRAPSODY 添加到此產品中。該團隊也專注於制定和執行 WRAPSODY 的報銷策略。本月早些時候，我們提交了申請，要求為 Medicare 的急性住院患者預期支付系統分配新技術 APC。

The new technology add-on payment or NTAP designation enables new medical service or technology meeting certain eligibility criteria to receive additional reimbursement payment for a period up to three years.

新技術附加付款或 NTAP 指定使符合某些資格標準的新醫療服務或技術能夠獲得最多三年的額外報銷付款。

We believe that WRAPSODY meets the eligibility criteria, particularly as it relates to the requirement that the technology represents an advance that substantially improves relative to technologies previously available the treatment of Medicare beneficiaries.

我們相信 WRAPSODY 符合資格標準，特別是因為它涉及到一項要求，即該技術代表了一項進步，相對於以前可用的技術，可大大改善醫療保險受益人的治療。

The application is currently under review, and we look forward to participating in the New Technology Town Hall meeting on December 11, 2024, which is the annual meeting held to provide a mechanism for public input on the eligibility criteria for NTAP applications before final decisions are made.

該申請目前正在審核中，我們期待參加 2024 年 12 月 11 日舉行的新技術市政廳會議，該會議是為在做出最終決定之前就 NTAP 申請的資格標準提供公眾意見而舉行的年度會議製成。

We are targeting submission of an application for transitional pass-through payment under the Medicare hospital outpatient prospective payment system or OPPS. The Transitional pass-through payment or TPT program is intended to facilitate access for Medicare beneficiaries to the advantages of new and innovative devices by allowing for adequate payment for these new devices while the requisite cost data is collected.

我們的目標是在 Medicare 醫院門診預期支付系統 (OPPS) 下提交過渡性轉手支付申請。過渡性轉手付款或 TPT 計劃旨在透過允許在收集必要的成本數據的同時為這些新設備提供足夠的付款，從而促進 Medicare 受益人獲得新的和創新設備的優勢。

We believe WRAPSODY meets the substantial clinical improvement threshold for new category eligibility for pass-through payment, if awarded pass-through status, WRAPSODY would be eligible for this additional payment as early as Q3 2025 and will continue for at least two years thereafter.

我們認為 WRAPSODY 滿足了新類別轉通付款資格的實質臨床改善門檻，如果獲得轉通付款資格，WRAPSODY 最早將於 2025 年第三季就有資格獲得這筆額外付款，並將持續至少兩年。

It is fair to say that we have made significant progress in our WRAPSODY program this year, and I applaud our team's efforts to ensure we are prepared and well positioned to introduce WRAPSODY to the U.S. market following PMA approval.

可以公平地說，今年我們的 WRAPSODY 計劃取得了重大進展，我對我們團隊所做的努力表示讚賞，以確保我們做好準備並做好準備，在 PMA 批准後將 WRAPSODY 引入美國市場。

For avoidance of doubt, we intend to continue providing updates as we achieve material milestones in our WRAPSODY program going forward.

為避免疑義，當我們在 WRAPSODY 計劃中實現重大里程碑時，我們打算繼續提供最新資訊。

We also intend to host a WRAPSODY specific virtual investor event in advance of our U.S. Commercial introductions.

我們也打算在美國商業推廣之前舉辦一場針對 WRAPSODY 的虛擬投資者活動。

Details for this event will be shared once we secure PMA approval.

一旦我們獲得 PMA 批准，我們將分享此活動的詳細資訊。

I will now provide a detailed review of our revenue results in the third quarter, beginning with the sales performance in each of our primary reportable product categories.

我現在將詳細回顧第三季的營收結果，首先是我們每個主要可報告產品類別的銷售業績。

Note, unless otherwise stated, all growth rates are approximated and presents on both a year over year and constant currency basis. Third quarter total revenue growth was driven by 6% growth in our Cardiovascular segment and 86% growth in our Endoscopy segment, both of which modestly exceeded the high end of the expectations we outlined on our second quarter call.

請注意，除非另有說明，所有成長率均為近似值，並以同比和固定貨幣計算。第三季總收入成長是由我們的心血管部門成長 6% 和內視鏡部門成長 86% 推動的，這兩個部門都略微超出了我們在第二季電話會議中概述的預期上限。

Our total revenue results included approximately $6.8 million of revenue from our acquisition of Endo Gastric solutions Inc. Excluding sales of acquired products, our total revenue growth in the third quarter was 5.7% and our Endoscopy segment revenue growth was 11.5% on an organic constant currency basis.

我們的總收入結果包括收購Endo Gastric Solutions Inc. 帶來的約680 萬美元的收入。的內視鏡部門營收成長為11.5%基礎。

Sales of our peripheral intervention or PI, products increased 7.7% representing nearly 60% of total Cardiovascular segment growth in the period. Growth in the PI product category was driven by sales of our radar localization products, which increased 17% and sales of our drainage products, which increased 10%. Together, they represented more than half of total PI sales growth in Q3.

我們的周邊介入產品或 PI 產品的銷售額成長了 7.7%，占同期心血管部門總成長的近 60%。PI 產品類別的成長是由雷達定位產品的銷售成長 17% 和排水產品的銷售成長 10% 所推動的。它們合計佔第三季 PI 總銷售額成長的一半以上。

Sales of our custom procedural solutions or CPS, products increased 4% which was slightly better than a low single digit increase we expected in Q3.

我們的定製程式解決方案或 CPS 產品的銷售額成長了 4%，略好於我們在第三季預期的低個位數成長。

Growth was driven by strong sales of critical care products, offset partially by more modest sales of kits and trays as expected due to the ongoing SKU rationalization efforts discussed on prior calls. Cardiac intervention product sales increased 2%, slightly above the high end of our growth expectations, driven primarily by strong sales of EP/CRM products and to a lesser extent, growth in sales of fluid management products.

成長是由重症監護產品的強勁銷售推動的，但由於先前電話會議中討論的持續 SKU 合理化工作，套件和托盤的銷售量如預期的減少，部分抵消了成長。心臟介入產品銷售額成長 2%，略高於我們成長預期的上限，這主要是由於 EP/CRM 產品的強勁銷售以及液體管理產品的銷售成長所推動。

Sales of our OEM products increased 8.5% in Q3, and we are the only area of our cardiovascular segment that came in softer than our growth expectations heading into the quarter. Notably, demand trends from customers in the U.S. improved from Q2 as expected.

我們的 OEM 產品銷售額在第三季成長了 8.5%，我們是心血管領域中唯一在本季成長低於我們預期的領域。值得注意的是，美國客戶的需求趨勢較第二季有所改善，符合預期。

Product sales to OEM customers outside the U.S., however, were significantly lower than expected in Q3. We had a discrete logistics related issue that impacted our Q3 OEM results, but the softer than expected product sales to OEM customers outside the U.S. is primarily related to navigating a more challenging raw material and supply chain environment.

然而，第三季向美國以外 OEM 客戶的產品銷售明顯低於預期。我們遇到了一個與物流相關的問題，影響了第三季 OEM 業績，但對美國以外 OEM 客戶的產品銷售低於預期，主要與應對更具挑戰性的原材料和供應鏈環境有關。

Our updated revenue guidance for 2024 reflects the softer than expected OEM sales in Q3 and modestly lower OEM sales expectations in Q4 as compared to what our prior guidance range assumed. Demand remains strong, but as a result of supply chain. Challenges, we now expect OEM sales growth of approximately 7% in 2024 compared to 10% previously expected.

我們更新的 2024 年營收指引反映了第三季 OEM 銷售低於預期，與我們先前指引範圍的假設相比，第四季 OEM 銷售預期略有下降。需求依然強勁，但這是供應鏈的結果。挑戰，我們現在預計 2024 年 OEM 銷售額將成長約 7%，而先前預期為 10%。

Turning to a brief summary of our sales performance on a geographic basis. Our third quarter sales in the U.S. increased 10% on a constant currency basis and 7% on an organic constant currency basis.

接下來簡要總結我們按地區劃分的銷售業績。我們第三季在美國的銷售額以固定匯率計算成長了 10%，以有機固定匯率計算成長了 7%。

We were pleased to see improving trends in our U.S. business as we outlined on our second quarter call.

正如我們在第二季電話會議中所概述的那樣，我們很高興看到美國業務的改善趨勢。

We continue to expect to deliver approximately 6% organic growth in the U.S. at the midpoint of our 2024 guidance range. Note, this growth assumption contemplates our updated expectations for OEM growth in the second half of 2024, offset by stronger organic growth in the non-OEM portions of our business which by way of reminder, are expected to represent approximately 87% of our total organic constant currency revenue in 2024.

我們繼續預計美國將在 2024 年指導範圍的中點實現約 6% 的有機成長。請注意，這一成長假設考慮了我們對 2024 年下半年 OEM 成長的最新預期，但被我們業務的非 OEM 部分強勁的有機成長所抵消，提醒一下，預計將占我們總有機成長的約 87% 2024 年貨幣收入不變。

International sales increased 4.5% year over year and increased 4.4% on an organic constant currency basis, exceeding the low end of our growth expectations.

國際銷售額年增 4.5%，以有機固定匯率計算成長 4.4%，超出了我們成長預期的下限。

Sales results in Rest of World and APAC exceeded the high end of our expectations, while sales in the EMEA region were softer than expected, largely related to the aforementioned OEM challenges in the quarter.

世界其他地區和亞太地區的銷售業績超出了我們的預期上限，而歐洲、中東和非洲地區的銷售低於預期，很大程度上與上述本季 OEM 挑戰有關。

With respect to China specifically, sales decreased 5.1%, modestly better than what our guidance had assumed.

具體到中國，銷售額下降了 5.1%，略好於我們的指引假設。

We continue to see quarter to quarter variability in growth trends related to volume based purchasing tenders as expected.

正如預期的那樣，我們繼續看到與基於數量的採購招標相關的成長趨勢出現季度變化。

By way of reminder, while we are not providing country specific growth assumptions in our guidance, messaging, the midpoint of our 2024 constant currency growth guidance range now assumes our total international sales will increase 4.8% year over year, driven by 2% growth in APAC, 6% growth in EMEA and 15% growth in the Rest of World region compared to 0%, 7% and 11% respectively assumed in our prior guidance range.

提醒一下，雖然我們沒有在我們的指導、信息中提供特定國家/地區的增長假設，但我們2024 年固定貨幣增長指導範圍的中點現在假設我們的國際總銷售額將同比增長4.8%，由2 % 的成長推動。

The improving growth trends in APAC assumed in our updated guidance is driven by better than expected results in China over the first nine months of 2024, driven primarily by better than expected sales of units, which are now expected to modestly offset continued pricing headwinds related to value based purchasing.

我們更新的指引中假設亞太地區成長趨勢的改善是由 2024 年前 9 個月中國好於預期的業績推動的，這主要是由於單位銷售好於預期，目前預計這將適度抵消與基於價值的採購。

With that, let me turn the call over to Raul, who will take you through a detailed review of our third quarter financial results balance sheet and financial condition at September '30.

接下來，讓我將電話轉給勞爾，他將帶您詳細審查我們截至 9 月 30 日的第三季財務業績、資產負債表和財務狀況。

Thank you, Joe.

謝謝你，喬。

Beginning with a review of our P&L performance, for the avoidance of doubt, unless otherwise noted, my commentary will focus on the company's non-GAAP results during the third quarter of fiscal year 2024, and all growth rates are approximated and presented on a year over year basis.

首先回顧我們的損益表表現，為避免疑義，除非另有說明，我的評論將重點關注公司 2024 財年第三季度的非 GAAP 業績，所有增長率均為近似值並按一年呈現超過一年的基礎上。

We have included reconciliations from our GAAP reported results to the related NON-GAAP item in our press release and presentation available on our website. Gross profit increased approximately 10% in the third quarter.

我們已在我們網站上提供的新聞稿和簡報中納入了 GAAP 報告結果與相關非 GAAP 項目的調整表。第三季毛利成長約10%。

Our gross margin was 50.9% up 108 basis points. The increase in gross margin year over year was driven by pricing uplift, favorable product and geographic revenue mix, and improvement in freight and distribution costs, offset partially by manufacturing variances compared to the prior period.

我們的毛利率為 50.9%，上升 108 個基點。毛利率年增率是由於定價上漲、有利的產品和地理收入組合以及貨運和分銷成本的改善，但與上一時期相比的製造差異部分抵消了毛利率的增長。

Operating expenses increased 6% from the third quarter of 2023. The increase in operating expenses was driven by a 5% increase in SG&A expense and an 8% increase in R&D expense compared to the prior year period. Total operating income in the third quarter increased $10.2 million or 19% from the third quarter of 2023 to $65.1 million.

營運費用較 2023 年第三季成長 6%。與去年同期相比，營業費用增加的原因是銷售、管理及行政費用 (SG&A) 費用增加 5%，研發費用增加 8%。第三季總營業收入較 2023 年第三季增加 1,020 萬美元，或 19%，達到 6,510 萬美元。

Our operating margin was 19.2% compared to 17.4% in the prior year period.

我們的營業利益率為 19.2%，而去年同期為 17.4%。

The 175 basis point increase in operating margin was driven by a 108 basis point increase in our non-GAAP gross margin and by a 67 basis point decreased in our non-GAAP OPEX margin compared to the prior year period.

與去年同期相比，我們的非 GAAP 毛利率成長了 108 個基點，而我們的非 GAAP 營運支出利潤率下降了 67 個基點，推動了營業利潤率成長 175 個基點。

Third quarter other expense net was a benefit of $0.9 million compared to expense of $4.5 million last year. The change in other expense net was driven by an increase in interest income associated with our higher cash balances, partially offset by an increase in net interest expense associated with increased borrowings.

第三季其他費用淨額為 90 萬美元，而去年的費用為 450 萬美元。其他費用淨額的變動是由於現金餘額增加導致的利息收入增加所致，但部分被借款增加相關的淨利息費用增加所抵銷。

Third quarter net income was $51.2 million or $0.86 per share compared to $41.4 million or $0.71 per share in the prior year period.

第三季淨利為 5,120 萬美元，即每股 0.86 美元，而去年同期淨利為 4,140 萬美元，即每股 0.71 美元。

We are pleased with our profitability performance in the third quarter where we leverage stronger than expected revenue results to drive significant expansion in operating margins and strong growth in non-GAAP diluted earnings per share, both of which exceeded the high end of our expectations.

我們對第三季的獲利表現感到滿意，我們利用強於預期的收入結果來推動營業利潤率的大幅擴張和非公認會計原則攤薄每股收益的強勁增長，這兩者都超出了我們預期的上限。

Note, our third quarter, non-GAAP EPS results included incremental dilution related to our convertible debt that represented approximately $0.01 to Q3 EPS versus what our guidance had assumed. Turning to a review of our balance sheet and financial condition.

請注意，我們第三季的非 GAAP 每股盈餘結果包括與我們的可轉換債務相關的增量稀釋，與我們的指導假設相比，第三季每股收益約為 0.01 美元。轉向對我們的資產負債表和財務狀況的審查。

As of September 30, 2024, we had cash and cash equivalents of $523.1 million, total debt obligations of $770.5 million and available borrowing capacity of approximately $697 million compared to cash and cash equivalents of $587 million, total debt obligations of $846.6 million and available borrowing capacity of approximately $626 million as of December 31, 2023. Our net leverage ratio as of September '30 was 2.08 times on an adjusted basis.

截至2024年9月30日，我們的現金及現金等價物為5.231億美元，債務總額為7.705億美元，可用借款能力約為6.97億美元，而現金及現金等價物為5.87億美元，債務總額為8.466億美元，可用借款能力約6.97億美元截至2023年12月31日，產能約6.26億美元。截至 30 年 9 月，我們的淨槓桿率為調整後的 2.08 倍。

We generated $38 million of free cash flow in the third quarter and have generated more than $120 million of free cash flow over the first nine months of 2024, up 116%.

我們在第三季產生了 3,800 萬美元的自由現金流，並在 2024 年前 9 個月產生了超過 1.2 億美元的自由現金流，成長了 116%。

The improvement in free cash flow generation is a result of growth in net income and significant improvement in cash used in working capital compared to the first nine months of 2023. We now expect to generate approximately $150 million of free cash flow in 2024 compared to our prior guidance of $130 million. And importantly, we continue to believe our CGI program will generate more than $400 million of free cash flow in a three year period ending December 31, 2026.

與 2023 年頭 9 個月相比，淨利成長以及營運資金使用的現金顯著改善，是自由現金流產生的改善的結果。我們現在預計 2024 年將產生約 1.5 億美元的自由現金流，而我們先前的指引為 1.3 億美元。重要的是，我們仍然相信我們的 CGI 計劃將在截至 2026 年 12 月 31 日的三年內產生超過 4 億美元的自由現金流。

For reference, we have included a table in our earnings press release, which details each of our updated formal financial guidance items and how those ranges compared to the prior ranges as of September 17, 2024 when we updated our guidance to reflect the projected impact of our proposed acquisition of lead management assets from Cook Medical.

作為參考，我們在收益新聞稿中包含了一個表格，其中詳細介紹了我們更新的每項正式財務指導項目，以及這些範圍與截至2024 年9 月17 日的先前範圍相比如何，當時我們更新了指導，以反映預計的影響我們擬收購庫克醫療公司的主導管理資產。

By way of a reminder, our updated financial guidance assumes that Cook medical transaction closes on November 1, 2024.

提醒一下，我們更新的財務指引假設庫克醫療交易將於 2024 年 11 月 1 日結束。

Our updated guidance ranges now assume the following - GAAP net revenue growth of 6.9% to 7.6% net revenue growth of approximately 5% to 6% in our Cardiovascular segment, and net revenue growth of approximately 49% to 52% in our Endoscopy segment, and a headwind from changes in foreign currency exchange rates of approximately $7 million or approximately 60 basis points in growth year over year excluding the impact of changes in foreign currency exchange rates, we expect total net revenue growth on a constant currency basis in the range of 7.4% to 8.1% in 2024.

我們更新的指導範圍現在假設如下- 我們的心血管部門的GAAP 淨收入增長為6.9% 至7.6%，淨收入增長約5% 至6%，我們的內視鏡部門的淨收入增長約49% 至52%，由於外幣匯率變化帶來的阻力約為 700 萬美元，即同比增長約 60 個基點（不包括外幣匯率變化的影響），我們預計按固定匯率計算的總淨收入增長範圍為2024 年將由7.4% 增至8.1%。

Note, the increase in constant currency growth expectations at the low end of the guidance range reflects the flow through of the better than expected revenue results in Q3, $2 million lower FX headwind to GAAP revenue, and the contributions from our acquisition of assets from Cook Medical from the expected closing date of November '1 to December '31, offset partially by our revised expectations for our OEM business in the fourth quarter. All other assumptions supporting our Q4 growth expectations remain unchanged versus what our prior guidance had assumed.

請注意，在指導範圍低端的恆定貨幣增長預期的增加反映了第三季度好於預期的收入結果、GAAP 收入的 200 萬美元外匯阻力減少以及我們從庫克收購資產的貢獻醫療從預計截止日期11 月1 日至12 月31 日，部分被我們對第四季OEM 業務的修訂預期所抵銷。支持我們第四季度成長預期的所有其他假設與我們先前的指導假設相比保持不變。

Finally, our total net revenue guidance for the fiscal year 2024 now assumes inorganic revenue contributions from the acquisitions announced on June 8, 2023, July 1, 2024, and September 17, 2024, in the range of $29.5million to $32.5 million in the aggregate.

最後，我們對2024 財年的總淨收入指引現在假設2023 年6 月8 日、2024 年7 月1 日和2024 年9 月17 日宣布的收購帶來的無機收入貢獻總計在2,950 萬美元至3,250萬美元之間。

For avoidance of doubt, this aggregate range consists of approximately $11.6 million of inorganic revenue related to our acquisition of assets from Angio Dynamics, Inc. In Q1 and Q2 plus, the contributions from our acquisition of assets from Endo Gastric solutions in Q3 and Q4 in the range of approximately $40 million to $50 million, plus the contributions from our acquisition of assets from Cook Medical post-closing in the range of approximately $4 million to $6 million, excluding inorganic revenue, our updated guidance reflects total net revenue growth on a constant currency organic basis in the range of approximately 5.1% to 5.5%.

為避免疑義，此一總範圍包括與我們從Angio Dynamics, Inc. 收購資產相關的約1,160 萬美元的無機收入。 Endo Gastric 解決方案收購資產的貢獻約4,000 萬至5,000 萬美元的範圍，加上我們在交割後收購庫克醫療資產約400 萬至600 萬美元的貢獻（不包括無機收入），我們更新的指導反映了總淨收入的持續成長貨幣有機基礎範圍約為5.1%至5.5%。

With respect to our updated profitability guidance for 2024, we now expect non-GAAP diluted earnings per share in the range of $3.33 to $3.38 representing an increase of 17% to 19%.

關於我們更新的 2024 年獲利指引，我們目前預計非 GAAP 攤薄每股收益在 3.33 美元至 3.38 美元之間，增幅為 17% 至 19%。

Note, this updated range reflects the better than expected EPS results in Q3 and includes the expected dilution related to our acquisition of assets from Cook Medical, which, as disclosed on September '17 is expected to be in the range of $0.01 to $0.02.

請注意，此更新範圍反映了第三季度優於預期的每股收益結果，並包括與我們從庫克醫療收購資產相關的預期攤薄，正如2017 年9 月披露的那樣，預計攤薄範圍為0.01 至0.02 美元。

As Fred discussed earlier, we believe the Cook Medical acquisition offers a very attractive financial profile.

正如 Fred 之前討論的那樣，我們認為收購庫克醫療公司可以提供非常有吸引力的財務狀況。

While we believe the proposed acquisition will be modestly dilutive to our full year 2024 non-GAAP profitability given the partial year contribution and the impact of approximately $1.8 million of lower interest income on cash balances used for the total purchase consideration, we expect the acquisition to be accretive to our non-GAAP gross and operating margins in the first full year post closing.

雖然我們認為，考慮到部分年度貢獻以及用於總購買對價的現金餘額約180 萬美元利息收入減少的影響，擬議的收購將適度稀釋我們2024 年全年非GAAP 盈利能力，但我們預計此次收購將在交易完成後的第一個全年中，我們的非公認會計原則毛利率和營業利潤率將增加。

We expect the acquisition to be accretive to our non-GAAP net income and non-GAAP EPS in the second full year post closing. For modelling purposes, our updated fiscal year 2024 financial guidance now assumes non-GAAP operating margins in the range of approximately 18.5% to 18.8% of 130 to 160 basis points, non-GAAP interest and other expense net of approximately $0.9 million of income Non-GAAP tax rate of approximately 21.3%, diluted shares outstanding of approximately $59.1 million compared to $58.8 million previously. And we now expect CapEx of approximately $50 million and free cash flow of at least $150 million.

我們預計此次收購將在交易結束後的第二個完整年度增加我們的非公認會計準則淨利潤和非公認會計準則每股收益。出於建模目的，我們更新後的2024 財年財務指引現在假設非GAAP 營業利潤率約為130 至160 個基點的18.5% 至18.8%，非GAAP 利息和其他費用扣除約90 萬美元的收入後非- GAAP 稅率約為 21.3%，攤薄後流通股約為 5,910 萬美元，而之前為 5,880 萬美元。我們現在預計資本支出約為 5000 萬美元，自由現金流至少 1.5 億美元。

We would also like to provide additional transparency related to our growth and profitability expectations for the fourth quarter of 2024.

我們還希望提供與 2024 年第四季的成長和獲利預期相關的額外透明度。

Specifically, we expect our total revenue to increase in the range of approximately 5.5% to 8.2% on a GAAP basis and up approximately 6.1% to 8.8% on a constant currency basis. The midpoint of our fourth quarter, constant currency sales growth expectation assumes approximately 12% growth in the U.S. and 2% growth in international markets.

具體來說，我們預計我們的總收入將按公認會計準則計算將成長約 5.5% 至 8.2%，以固定匯率計算將成長約 6.1% 至 8.8%。我們第四季的中點，以固定匯率計算的銷售成長預期假設美國成長約 12%，國際市場成長 2%。

Note, our fourth quarter constant currency sales growth expectations include inorganic revenue in the range of $11 million to $14 million. Excluding inorganic contributions, our fourth quarter total revenue is expected to increase in the range of approximately 3% to 4% on an organic constant currency basis.

請注意，我們對第四季度以固定匯率計算的銷售成長預期包括 1,100 萬美元至 1,400 萬美元的無機收入。排除無機貢獻，我們第四季的總營收預計在固定貨幣有機基礎上成長約 3% 至 4%。

With respect to our profitability expectations for the fourth quarter of 2024, we expect non-GAAP operating margins in the range of approximately 17.8% to 18.8%. And we expect non-GAAP EPS in the range of $0.8 to $0.86. That wraps up our prepared remarks.

關於我們對 2024 年第四季的獲利預期，我們預計非 GAAP 營業利潤率約為 17.8% 至 18.8%。我們預計非 GAAP 每股收益在 0.8 美元至 0.86 美元之間。我們準備好的發言就到此結束。

Operator, we would not like to open up the line for questions.

接線員，我們不想開放提問線路。

(Operator instructions)

（操作員說明）

And the first question that we have for the day is coming from John Young of Canaccord your line is open.

今天我們收到的第一個問題來自 Canaccord 的 John Young，您的線路已開通。

Hi, everyone. Thanks for taking our questions tonight and congrats on the quarter. You know, first with the Cook acquisition, I just wanted to ask you a bit of a 2025 question. I am not sure if you can totally answer it, but just are you expecting a halo effect essentially with, you know, the other products in the CI segment?

大家好。感謝您今晚回答我們的問題，並祝賀本季。你知道，首先關於庫克收購，我只是想問你一些關於 2025 年的問題。我不確定您是否能完全回答這個問題，但您是否期望 CI 領域的其他產品本質上產生光環效應？

Yes. This is Joe. I think that's exactly the rationale behind the acquisition. We have a number of very good EP/CRM focused products but not really an anchor portfolio. So I think with this acquisition, it gives us the revenue the gross margin profile and allows us to actually build out a EP focused sales force that can drive not just the Cook acquired product revenue, but also some of the products we have already, whether it be transseptal crossing products or some that we have in our product roadmap.

是的。這是喬。我認為這正是收購背後的理由。我們擁有許多非常好的 EP/CRM 重點產品，但不是真正的主力產品組合。因此，我認為透過這次收購，它為我們提供了收入和毛利率概況，並使我們能夠真正建立一支以EP 為重點的銷售隊伍，不僅可以推動庫克收購的產品收入，還可以推動我們已經擁有的一些產品，無論是它是房間隔交叉產品或我們產品路線圖中的一些產品。

So, Yes

所以，是的

And Joe, can I add that? Just like RTG, we've seen success in aligning and having the focus to get deeper into those specific products, John.

喬，可以補充一下嗎？就像 RTG 一樣，我們在協調和專注於更深入地了解這些特定產品方面取得了成功，John。

And it'll, it'll add about $40 million in annualized revenue starting in fiscal year 2025,John.

從 2025 財年開始，年化收入將增加約 4,000 萬美元，約翰。

That's all very helpful. And then just a point of clarification on WRAPSODY for the add on payment. Do you also expect NTAP to go live Q3 '25 if you got that? or is that just TPT? And also, when it comes to pricing the product, will you price the product with NTAP in mind? Thanks again, take care of questions.

這一切都非常有幫助。然後對 WRAPSODY 的附加付款進行澄清。如果您知道的話，您是否也希望 NTAP 能夠在 25 年第 3 季上線？還是這只是TPT？另外，在為產品定價時，您會考慮使用 NTAP 來為產品定價嗎？再次感謝，請解答問題。

We have submitted for NTAP. And yes, we will price as if we are going to get that NTAP. But of course, we won't know for several months. As far as the add on payment that will be submitted or that application will be submitted after we receive FDA approval.

我們已提交 NTAP。是的，我們的定價就像我們要獲得 NTAP 一樣。但當然，幾個月後我們才會知道。至於將提交的附加付款或在我們收到 FDA 批准後提交的申請。

Great, thanks again.

太好了，再次感謝。

And our next question will be coming from Jayson Bedford of Raymond James. Your line is open.

我們的下一個問題將來自雷蒙德詹姆斯的傑森貝德福德。您的線路已開通。

Hi, good afternoon. Thanks for, for taking the questions and congrats on the progress. Maybe just two to keep it moving here. With the WAVE results on WRAPSODY is the data impacted faction in Europe at all?

嗨，下午好。感謝您提出問題並祝賀取得的進展。也許只有兩個才能讓它在這裡移動。WRAPSODY 上的 WAVE 結果是否受到歐洲資料影響？

Yeah, I think it's a little bit too early to say Jayson.

是的，我認為現在說傑森有點太早了。

Of course, we released the six-month data at the Lisbon Conference or the Lisbon.

當然，我們在里斯本會議或里斯本會議上發布了六個月的數據。

Thank you, Fred. And that was very well received.

謝謝你，弗雷德。這很受歡迎。

Of course, there are a lot of European physicians there, but I think it will take some time for that to really take hold.

當然，那裡有很多歐洲醫生，但我認為這需要一些時間才能真正紮根。

We have made great progress though in, in pushing awareness of the product and particularly that excellent data. We released.

儘管如此，我們在提高產品意識，特別是優秀數據方面取得了巨大進展。我們釋放了。

Okay. And then maybe for rule or others. The 3% to 4% organic growth guide for 4Q, I realize it's a tougher comp, but what's the expected weight on growth to get to that level?

好的。然後也許是為了規則或其他。第四季 3% 至 4% 的有機成長指導，我意識到這是一個更艱難的競爭，但達到這一水平的預期成長權重是多少？

Yeah, I mean, I think, you know, generally I'll start Jayson by, by just highlighting kind of the overall performance that we're going, that we've guided to.

是的，我的意思是，我想，你知道，一般來說，我會透過強調我們將要實現的、我們已經指導的整體表現來開始傑森。

I think, you know, for the year is going to be, you know, a solid execution on the revenue front, you know, operating margin expansion and, and really strong earnings growth.

我認為，今年將是收入方面的堅實執行，營業利潤率的擴張以及非常強勁的獲利成長。

we call it 17% to 19% growth on the EPS side.

我們稱為 EPS 方面 17% 至 19% 的成長。

But look, I think when we look at our guidance for the fourth quarter, it's really not materially different than what we've been guiding to, you know, since Q3 or even before that.

但是，我認為，當我們查看第四季度的指導時，它實際上與我們自第三季度甚至之前的指導沒有太大不同。

It's right in line with kind of our expectations, really the delta that we're kind of adjusting for is just the OEM expectations. we had a little bit of a supply chain challenge that could impact the fourth quarter, which we have accounted for.

這完全符合我們的預期，實際上我們要調整的增量只是 OEM 的預期。我們遇到了一些供應鏈挑戰，可能會影響第四季度，我們已經考慮到了這一點。

Obviously, everybody knows about the Baxter IV impacting procedures, and I think we have tried to account for any disruption that may happen there.

顯然，每個人都知道巴克斯特 IV 影響程序，我認為我們已經嘗試解釋那裡可能發生的任何中斷。

But generally speaking, we feel really strong about the year that we are putting together. And then obviously the fourth quarter is going to be strong too, just from a growth perspective overall and just an earnings perspective.

但總的來說，我們對我們正在籌劃的這一年感覺非常強烈。顯然，從整體成長角度和獲利角度來看，第四季也將表現強勁。

All right. Thank you.

好的。謝謝。

And our next question will be coming from Larry Biegelsen of Wells Fargo. Your line is open.

我們的下一個問題將來自富國銀行的拉里·比格爾森。您的線路已開通。

Hey, guys, this is Simran on for Larry. Thanks for taking the questions here. Maybe just to start off on WRAPSODY congrats on the results there. The data looks really strong and I appreciate all the colour on the reimbursement pathway.

嘿，夥計們，這是拉里的西姆蘭。感謝您在這裡提出問題。也許只是從 WRAPSODY 開始祝賀那裡的結果。數據看起來非常強大，我很欣賞報銷途徑上的所有顏色。

I guess. Just to ask the question in a more pointed way, is it reasonable to assume WRAPSODY will be priced at a significant premium to the competitive sense in order to meet that cross cost criteria for the add on payment?

我猜。只是以更尖銳的方式提出問題，為了滿足附加付款的交叉成本標準，假設 WRAPSODY 的定價將明顯高於競爭意識，是否合理？

Yeah, typically that's how it would work, So we will see as we get closer to launch and we'll give more detail at an Investor day post approval. But yeah, that's a fair assumption.

是的，通常這就是它的工作方式，所以當我們接近發佈時我們會看到，我們將在批准後的投資者日提供更多細節。但是，是的，這是一個合理的假設。

Okay, great. And then just any additional colour on the commercial strategy? How are you positioning the sales force to add WRAPSODY to the bag? And are you going to be able to launch the product right away after FDA approval?

好的，太好了。那麼商業策略還有什麼額外的色彩嗎？您如何定位銷售人員以將 WRAPSODY 添加到袋子中？FDA 核准後您能立即推出產品嗎？

So this is Fred, Look, we are preparing on the clinical side, regulatory reimbursement and the commercial side and we will follow all this up shortly after our approval.

這是弗雷德，你看，我們正在臨床方面、監管報銷和商業方面做準備，我們將在獲得批准後不久跟進這一切。

We will have a virtual meeting and go through all these details at that time when all these things play out and come together and we will share that publicly in a virtual meeting.

我們將舉行一次虛擬會議，並在所有這些事情發生並彙集在一起時討論所有這些細節，我們將在虛擬會議中公開分享這些細節。

Got it. Thank you.

知道了。謝謝。

And our next question will be coming from Jason Bednar of Piper Sandler. Your line is open.

我們的下一個問題將來自 Piper Sandler 的 Jason Bednar。您的線路已開通。

Hey, good afternoon. Thanks for taking the questions. I'll preface this by saying, please don't shoot me for asking this, but I'll because I'm going to ask it anyways. You know, you’ve got the NTAP, the TPT you're pursuing on WRAPSODY. You sound confident securing each. Both maybe could take it back next year. TBD, I guess on NTAP.

嘿，下午好。感謝您提出問題。我會在序言中說，請不要因為我問這個而開槍打我，但我會開槍，因為無論如何我都會問這個問題。您知道，您已經獲得了 NTAP，即您在 WRAPSODY 上追求的 TPT。聽起來你對確保每一項都充滿信心。兩人也許都可以在明年收回它。TBD，我猜是在 NTAP 上。

But you're launching next year, presumably after approval, I'll take a stab here. You know, how should you, how do you want the analyst community thinking about the volume and or revenue opportunity for a city in '25? You, I can take an improved approach with setting guidance and expectations, but I think all of us are trying to feel out, you know, how much this could actually add in '25 or the first full year of launch. You've got a lot of different variables to consider. So how do you want us thinking about that?

但你明年就會推出，大概是在獲得批准後，我會在這裡試試看。您知道，您應該如何、您希望分析師社群如何考慮 25 年城市的數量和/或收入機會？你，我可以採取一種改進的方法來設定指導和期望，但我認為我們所有人都在努力摸索，你知道，這在 25 年或發布的第一個全年中實際上可以增加多少。您需要考慮很多不同的變數。那你希望我們如何思考這個問題？

Well, first of all, these are all good comments that we're receiving today. We're very excited about the product as we have been, we'll provide more at the appropriate time we're going to hold steady to the course as we've said and we'll be as conservative as always. But again, you're going to have to wait Jason.

嗯，首先，這些都是我們今天收到的好評。我們對這個產品一如既往地感到非常興奮，我們將在適當的時候提供更多產品，我們將像我們所說的那樣保持穩定，我們將一如既往地保守。但同樣，你必須等待傑森。

I wish we could do it faster, but that's not what we're going to do. We've given you it's we've given you everything we have what we want you to have. Now we'll look forward to talking to that to you in the virtual meeting.

我希望我們能做得更快，但這不是我們要做的。我們已經給了你我們想要你擁有的一切。現在我們期待在虛擬會議中與您討論這一點。

Okay? Alright. Fair enough. It's all, it's all been very helpful today. So we, we do appreciate it.

好的？好吧。很公平。就這樣，今天這一切都非常有幫助。所以我們非常感激。

We hope so. We're working hard and we're progressing. We're doing things that have to be done and.

我們希望如此。我們正在努力，我們正在進步。我們正在做必須做的事情。

And, and Jason, as we've talked, you know, our, our intent is to provide material updates every quarter as, as they happen. So, but, you know, we provided a pretty good amount of colour, you know, today. And you know, more to come.

而且，傑森，正如我們所說，您知道，我們的目的是每季度提供材料更新。所以，但是，你知道，我們今天提供了相當多的顏色。你知道，還會有更多。

No, you, you did, you did and more, more than I think a lot of us were expecting. So that's, it's all been helpful. The maybe I'll shift over to, you know, the margin side. This has been, you know, extremely successful and impressive here the last few years. Can you talk about, whether you have additional skew rationalization plans for the business is, you know, over the next few quarters or next year, or maybe just bigger picture, you know, as we start thinking about, you know, our models for next year. Is any other considerations that we should think about this, you know, and sustaining this margin improvement, not looking for specific guidance, of course, big picture items that we should have in mind?

不，你，你做到了，你做到了，而且比我認為我們很多人所期望的還要多。所以，這一切都很有幫助。也許我會轉向，你知道，邊際。你知道，過去幾年這裡非常成功且令人印象深刻。你能談談，你是否有額外的業務合理化計劃，你知道，在接下來的幾個季度或明年，或者也許只是更大的藍圖，你知道，當我們開始考慮我們的模型時明年。您知道，我們是否還應該考慮其他任何考慮因素，以及維持利潤率的提高，而不是尋找具體的指導，當然，我們應該牢記的大局項目？

Yeah, look, I mean, I'll take, you know, the question is pretty broad, Jason. So, I'm going to take, you know, just a minute to highlight, you know, the 108 basis point improvement year over year, you know, we have 50.9%. Obviously, you know, the sales team is working really hard on pricing, uplift. They've been working really hard on the favourable, you know, kind of product and geography revenue mix.

是的，聽著，我的意思是，我會接受，你知道，這個問題非常廣泛，傑森。所以，我要花一分鐘強調一下，你知道，年比提高了 108 個基點，你知道，我們有 50.9%。顯然，你知道，銷售團隊在定價和提升方面非常努力。他們一直在努力打造有利的產品和地理收入組合。

And our operations group has been doing a great job on the freight and distribution side. So, you know, that that's all driving the, the gross margin improvement. And as, as we talked about, you know, in CGI, when we laid out those goals for 2026, a significant portion of the improvement, you know, comes from gross margin right on the low end. And as we get to the higher end, obviously, there's an incremental gross margin improvement there too, with additional leverage to the operating expense line.

我們的營運團隊在貨運和配送方面一直做得很好。所以，你知道，這都是推動毛利率改善的因素。正如我們所討論的，您知道，在 CGI 領域，當我們制定 2026 年的目標時，您知道，很大一部分改進來自低端的毛利率。顯然，當我們達到高端時，毛利率也會逐步提高，營運費用線也會有額外的槓桿作用。

So generally speaking, I think this gives us a big vote of confidence for us, you know, that we're heading in the right direction, we're making the right improvements, but it's, you know, it's, it's going, it's progressing, I guess as we planned and you know, it's, it's part of the CGI program to increase the gross margin and let it flow through to the operating margin.

所以總的來說，我認為這給了我們很大的信心，你知道，我們正在朝著正確的方向前進，我們正在做出正確的改進，但是，你知道，它正在前進，它正在進展，我想正如我們計劃的那樣，你知道，這是CGI 計劃的一部分，旨在增加毛利率並讓它流入營業利潤率。

All right. Thank you.

好的。謝謝。

And maybe just one more thing, Jason, I didn't hit on the SKU rationalization piece. So let me answer that here real quick. But generally speaking, our commitment there hasn't changed. You know, there's two aspects to the SKU rationalization.

也許還有一件事，傑森，我沒有想到 SKU 合理化部分。讓我在這裡快速回答這個問題。但總的來說，我們的承諾並沒有改變。您知道，SKU 合理化有兩個面向。

Once is just replacing our legacy products with newer products that are, you know, the, the same, but just, improvements and also obviously lower cost to manufacture. And then the second piece, the more material, one that I think people generally ask about is whether we're going to exit businesses or exit products. And you know, generally we'll give colour and we'll give people a heads up when those material kind of, you know, items come up. We don't anticipate anything for 2025. It'll be more of the internal stuff that you guys won't really notice or we hope you don't notice other than through the incremental margin improvement.

一次只是用新產品替換我們的舊產品，你知道，新產品是相同的，但只是改進，而且製造成本也明顯更低。第二部分是更重要的部分，我認為人們通常會問的是我們是否要退出業務或退出產品。你知道，通常我們會提供顏色，當這些材料出現時，我們會提醒人們。我們對 2025 年沒有任何預期。這將更多是你們不會真正注意到的內部內容，或者我們希望你們除了透過增量利潤改善之外不會注意到。

Perfect. Appreciate it.

完美的。欣賞它。

And our next question will be coming from David Rescott of R.W. Baird. Your line is open.

我們的下一個問題將來自 R.W. Baird 的 David Rescott。您的線路已開通。

Oh, great. Thanks for, for taking the questions. Congrats on, on the quarter and I appreciate all the colour on WRAPSODY. Just a couple on WRAPSODY from us and maybe attack some of the market opportunity questions a little bit of a different way. You know, you look at the, what we'll call it the covered graft market out there where, you know, some of the physician feedback is obviously very positive around the potential to, to transition toward a WRAPSODY product. The trial itself obviously looked at, you know, use of the therapy versus PTA. And so, I'm curious when you think about the opportunities to enter these markets is he stunt covered graph kind of the lowest hanging fruit out there. And, and going after kind of what you looked at in the control arm is more upside or do you think that both of those markets are, are kind of up for grabs with with rhas once you get out there?

哦，太好了。謝謝您提出問題。恭喜這個季度，我很欣賞 WRAPSODY 上的所有顏色。我們在 WRAPSODY 上發表了一些評論，也許會以不同的方式回答一些市場機會問題。你知道，你看看我們稱之為覆蓋移植市場的地方，你知道，一些醫生的回饋顯然對向 WRAPSODY 產品過渡的潛力非常積極。顯然，試驗本身著眼於該療法與 PTA 的使用。因此，我很好奇，當你想到進入這些市場的機會時，他的特技覆蓋圖是否是最容易實現的目標。而且，追求你在控制臂中看到的那種東西更具優勢，或者你認為一旦你走出去，這兩個市場都可以與 RHA 爭奪嗎？

Yeah. David, first of all, a very thoughtful question and we appreciate why you're asking. And we look forward, you know, we're going to share all of the thoughts on all of these issues in the future.

是的。大衛，首先，這是一個非常深思熟慮的問題，我們感謝您提出這個問題。我們期待著，你知道，我們將在未來分享關於所有這些問題的所有想法。

As everything plays out, we're focused on preparing for the commercial launch as we speak. And then we will talk about all of this stuff at our virtual meeting. I I'm sorry to have to repeat that and I appreciate you guys trying and, but listen, we are focused on CGI, we're focused on launching this product. We're focused on, on operating margins, free cash for all the things we've talked about. So the WRAPSODY is important to us, but we have a big business we have to run and we'll talk to you as soon as we get to that closing time and get ready and we, in the meantime, we're getting ready to go to the market.

隨著一切的進展，我們正在專注於為商業發布做準備。然後我們將在虛擬會議上討論所有這些內容。我很抱歉必須重複一遍，我感謝你們的嘗試，但聽著，我們專注於 CGI，我們專注於推出這個產品。我們關注的是營業利潤率和我們所討論的所有事情的自由現金。因此，WRAPSODY 對我們來說很重要，但我們有一項必須經營的大生意，一旦到達關閉時間，我們就會與您聯繫並做好準備，同時，我們正在準備去市場。

Alright, thanks. And then just maybe as a follow up on that and some of the prior comments, you know, you, you talked about again, the out year margin expansion story, I just, I'm not sure you're going to provide much on it, but just curious on the assumptions around not necessarily the impact WRAPSODY would have, but, but assuming that the WRAPSODY contribution on a margin perspective should be aligned with the expansion story over the CGI. Thank you.

好的，謝謝。然後，也許作為這一點和之前的一些評論的後續行動，你知道，你再次談到了今年利潤擴張的故事，我只是，我不確定你會提供太多關於它，但只是好奇周圍的假設不一定會產生WRAPSODY 的影響，但是，假設WRAPSODY 在利潤角度的貢獻應該與CGI 的擴張故事保持一致。謝謝。

Yeah, again, you know, thanks, thanks for the question. But, you know, we're obviously focused on, on, on the PMA approval getting through that process and, and you know, we're excited about the product just as just as everybody is. But, you know, clearly, we're focused on delivering at least 20% operating margins per CGI I, that's the goal, that's what everybody's focused on. We're also focused on making sure that we get, you know, the WRAPSODY product line across the finish line from PMA approval, there's a lot of work that's being done internally.

是的，再次，你知道，謝謝，謝謝你的問題。但是，您知道，我們顯然專注於 PMA 批准通過該流程，並且您知道，我們和每個人一樣對該產品感到興奮。但是，你知道，很明顯，我們的重點是為每個 CGI I 提供至少 20% 的營業利潤，這是我們的目標，也是每個人都關注的目標。我們也致力於確保 WRAPSODY 產品線獲得 PMA 批准，內部正在進行大量工作。

We're just as excited as everybody, but, you know, we're just going to hold off on KInd of the financial, you know, modelling questions until we actually, you know, that post approval meeting that we have. So, again, I appreciate the question.

我們和大家一樣興奮，但是，你知道，我們只是要推遲一些財務、建模問題，直到我們真正召開批准後會議。所以，我再次感謝這個問題。

And our next question is coming from Mike Matson of Needham. Your line is open.

我們的下一個問題來自尼達姆的麥克·馬特森。您的線路已開通。

Yeah, thanks. So just kind of a higher-level question. You know, merit's been sort of making this move from you know, more kind of basic accessory type products into these more position preference item therapeutic products like WRAPSODY, the Cook Lead Management devices and then the Endo Gastric solution product.

是的，謝謝。這只是一個更高層次的問題。您知道，優點是從更多類型的基本配件類型產品轉變為這些更具位置偏好的治療產品，如 WRAPSODY、Cook Lead Management 設備和 Endo Gastric 解決方案產品。

So do you believe that your, your sales force has sort of the right skill set to sell you know, these types of products that are more kind of dictated by physician preference and physician relationships as opposed to maybe, you know, kind of more of the, the purchasing or c suite side of the hospital.

那麼，您是否相信您的銷售人員擁有適當的技能來銷售您知道的這些類型的產品，這些產品更多地取決於醫生的偏好和醫生的關係，而不是，您知道，更多的是由醫生的偏好和醫生的關係決定的。

Yeah, I think that those are fair questions. I'm very confident in our sales team. We have been selling a lot of more accessory type devices, that's for sure, but that's really built the company to where it is today and has enabled us to make these select bets on therapeutic products.

是的，我認為這些問題都是公平的。我對我們的銷售團隊非常有信心。我們一直在銷售更多的配件類型設備，這是肯定的，但這確實使公司達到了今天的水平，並使我們能夠在治療產品上進行這些精選的賭注。

There's clearly a change in selling. I will be clear about that. But we are confident that we can get our attract and retain top sales talent that know how to sell therapeutics. We are already this year, we have been training up our renal therapies group in preparation for WRAPSODY. They're already selling physician preference products in that portfolio and we're confident they can take on WRAPSODY. And listen, we'll do the same with the Cardiac therapies group really anchored by Cook's Lead management Business.

銷售方面顯然發生了變化。我會明確這一點。但我們有信心能吸引並留住懂得如何銷售治療藥物的頂尖銷售人才。今年我們已經在培訓我們的腎臟治療小組，為 WRAPSODY 做準備。他們已經在該產品組合中銷售醫生偏好的產品，我們相信他們可以與 WRAPSODY 競爭。聽著，我們將對真正以庫克領導管理業務為基礎的心臟治療小組做同樣的事情。

In our EGS in our endoscopy group too.

在我們的 EGS 內視鏡組中也是如此。

Okay. Got it. And then just one more, I got to try one more on WRAPSODY. I Know you may not answer this but one more stab at the market opportunity here.

好的。知道了。然後還有一件事，我必須在 WRAPSODY 上再嘗試一件事。我知道您可能不會回答這個問題，但您會再次嘗試這裡的市場機會。

I mean, can you just tell us like what the kind of TAM is for the indications you're expecting to get here?

我的意思是，您能告訴我們您期望在這裡得到的指示是什麼樣的 TAM 嗎？

So in other words, covered stent used specifically for AVGs or AVFs mean, I've ballparked it kind of in the $300 million to $600 million range, but it's, it's not very scientific.

換句話說，專門用於 AVG 或 AVF 的覆膜支架意味著，我將其估計在 3 億至 6 億美元範圍內，但事實是，這不是很科學。

So, I don't. Is that reasonable? And, and so that's the U.S. number specifically.

所以，我不。這樣合理嗎？這就是美國的具體數字。

Yeah, Mike, we are not going to confirm or deny anything. What we are going to say is yes, we can provide it at the virtual meeting right after we get approved.

是的，麥克，我們不會確認或否認任何事情。我們要說的是，是的，我們可以在獲得批准後立即在虛擬會議上提供它。

Okay. Fair, enough. We look forward to.

好的。很公平。我們期待。

Discussing. Yeah, it'll be good to get on to. Yeah. Anyway, thank you very much, Mike.

討論中。是啊，能繼續下去就好了。是的。不管怎樣，非常感謝你，麥克。

Thank you one moment for the next question and our next question will be coming from Craig Bijou of Bank of America Securities. Your line is open.

感謝您提出下一個問題，我們的下一個問題將來自美國銀行證券公司的 Craig Bijou。您的線路已開通。

Good afternoon guys. Thanks for taking the questions. Wanted to start with the OEM business and you know, maybe just I guess the question is, you know, any of these logistical challenges, you know, that, you know, bleed into '25 and I guess that's the first part and then just how to think about that business going forward in terms of the growth rate.

各位下午好。感謝您提出問題。想從 OEM 業務開始，你知道，也許只是我猜問題是，你知道，任何這些後勤挑戰，你知道，你知道，滲透到 25 年，我想這是第一部分，然後只是如何從增長率角度考慮該業務的未來發展。

Obviously over the last couple of years, it's been a pretty strong grower for you. Maybe it's slowed down a little bit this year but would, would love any thoughts you had on, on that business and the any potential disruption kind of bleeding into early '25.

顯然，在過去的幾年裡，它對您來說是一個非常強大的種植者。也許今年它的速度有所放緩，但我會喜歡你對這項業務的任何想法，以及 25 年初可能出現的任何潛在破壞。

Yeah, no, great question. You know, first of all, I think just to, just to highlight right? I mean, I think, you know, Q3 revenue came in, you know, a above our you know, the high end of our guidance. So generally speaking, even though we did have a little bit, you know, we weren't as high on, on the revenue growth in OEM as we expected, we were still able to beat the high end of our guidance.

是的，不，很好的問題。你知道，首先，我想只是為了強調，對吧？我的意思是，我認為，你知道，第三季的收入高於我們指導的高端。所以總的來說，儘管我們確實有一點，你知道，我們的 OEM 收入成長沒有我們預期的那麼高，但我們仍然能夠超過我們指導的上限。

And also I just, I want, I want to make sure that it's clear like, you know, we're not concerned here, you know, internally about OEM. I mean, you know if you look at Q1, they were down 5% they were up 5% in Q2 and they were up 8.5% in Q3. So, the demand is there, the logistics issue was, was a kind of is really isolated to Q3. Is a customer that couldn't arrange pickup for Q3. Then you ran into kind of the Chinese New Year that led to some delays. So it was really kind of a discrete item.

而且我只是，我想，我想確保這一點很清楚，你知道，我們內部不關心 OEM。我的意思是，如果你看看第一季度，他們下降了 5%，第二季度增長了 5%，第三季度增長了 8.5%。因此，需求是存在的，物流問題是一種真正孤立於第三季的問題。是一位無法安排第三季取貨的客戶。然後你遇到了中國新年，導致了一些延誤。所以它確實是一個離散的項目。

It’s Golden week just for clarity. Yes.

為清楚起見，現在是黃金週。是的。

Golden week. Yeah, thank you.

黃金周。是的，謝謝。

And so you know, we can put that one kind of behind us. I think what we've tried to accommodate for is really the supply chain. You know, that's something that kind of that we, you know, we don't really have control over there as we've talked before in multiple quarters, there's still some areas of that haven't recovered from a supply chain standpoint.

所以你知道，我們可以把這種情況拋在腦後。我認為我們試圖適應的其實是供應鏈。你知道，就像我們之前在多個季度討論過的那樣，我們實際上無法控制這一點，從供應鏈的角度來看，仍然有一些領域尚未恢復。

And this just happens to be, you know, one of the areas that you know that that's, that's limiting us to be able to deliver on the demand that we're seeing from customers. So the demand is there, we have visibility to that. We continue to be excited about OEM.

你知道，這恰好是你知道的領域之一，這限制了我們滿足客戶需求的能力。所以需求就在那裡，我們對此有可見性。我們仍然對 OEM 感到興奮。

And again, we're still talking about 7% growth in 2024 for OEM, which is at the high end of our, you know CGI I guidance. So again, we have good visibility into the business. We're confident in the expectations. We're not going to provide anything for 2025.

再說一遍，我們仍在談論 2024 年 OEM 成長 7%，這是我們 CGI I 指導的高端。再說一遍，我們對業務有很好的了解。我們對期望充滿信心。我們不會在 2025 年提供任何東西。

But I want to make sure that everybody understands that, you know, that the kind of the, the impacts that we were seeing in Q1 are you know and coming out of into Q2 are really different from what we're seeing, you know, heading into Q4, they're discrete. So, again, super confident in the overall business.

但我想確保每個人都明白，我們在第一季度看到的影響以及進入第二季度的影響與我們所看到的確實不同，你知道，進入第四季度，它們是離散的。因此，再次對整體業務充滿信心。

I think if you look at the U.S. growth on a constant currency basis, organic, we are approaching almost 7% really solid number for the U.S. You know, the rest of our U.S. business is almost 86%, 87%. So we're really talking about a small portion of our business but continue to be excited about the demand we're seeing in OEM.

我認為，如果你以固定匯率為基礎來看美國的有機成長，我們正在接近 7%，這是美國的一個可靠數字。因此，我們實際上談論的是我們業務的一小部分，但我們仍然對 OEM 領域的需求感到興奮。

Got it. Thanks, roll. And maybe for, for Fred or Joe, obviously, you know, we're all excited about WRAPSODY. I am going to spare you a question on WRAPSODY specifically and I don't mean to look past it, but, you know, you guys have talked about the Cook Deal, the product roadmap.

知道了。謝謝，滾。也許對於弗雷德或喬來說，顯然，我們都對 WRAPSODY 感到興奮。我將專門向你們提出一個關於 WRAPSODY 的問題，我並不是有意忽略它，但是，你們知道，你們已經討論了庫克交易、產品路線圖。

Fred, I think in past quarters you've even teased that there's, you know, you have other pipeline products, you know, beyond WRAPSODY. So, you know, maybe just help us understand when we may, you know, hear about some of these, you know, new products or what the pipeline looks like or when you would disclose that to us or just how we should think about, you know, the pipeline other than WRAPSODY over the next couple of years.

Fred，我想在過去的幾個季度裡，您甚至開玩笑說，除了 WRAPSODY 之外，您還有其他管道產品。所以，你知道，也許只是幫助我們了解什麼時候我們可能會聽到其中的一些新產品或管道是什麼樣子，或者什麼時候你會向我們披露這些信息，或者我們應該如何思考，你知道，未來幾年除了WRAPSODY 之外還有其他管道。

Yeah. Well, listen, it's again, these have all been really good questions which we appreciate. Look, we're not revealing the details. I will say that we're focused on the CGI as we've been talking about on the call. I think in terms of new product development, it continues to be a priority at Merit.

是的。好吧，聽著，再說一遍，這些都是非常好的問題，我們對此表示讚賞。聽著，我們不會透露細節。我想說的是，正如我們在電話會議中所討論的那樣，我們的重點是 CGI。我認為就新產品開發而言，它仍然是 Merit 的首要任務。

We have certain technologies here that we developed over the last several years and when appropriate, we will bring it forth. So I, we just want to keep focused on the things that are in front of us. But in the meantime, there's ongoing product development.

我們擁有過去幾年開發的某些技術，在適當的時候，我們將推出它。所以我，我們只想繼續專注在眼前的事。但與此同時，產品開發仍在進行中。

Great. Thanks guys.

偉大的。謝謝你們。

Our next question will be coming from James Sidoti of Sidoti and company. Your line is open.

我們的下一個問題將來自 Sidoti 及其公司的 James Sidoti。您的線路已開通。

Hi, good afternoon. Thanks for taking the questions. Can you talk a little bit more about the integration of the cook medical products? Are you bringing on any of their sales folks? And will you move the manufacturer into your facilities?

嗨，下午好。感謝您提出問題。能多談談庫克醫療產品的整合嗎？您是否聘請了他們的銷售人員？您會將製造商遷入您的工廠嗎？

Yes, we are planning on taking on some sales professionals in the transaction. And yes, we will be transferring the manufacturing of that product to a Merit facility.

是的，我們計劃在交易中聘請一些銷售專業人員。是的，我們將將該產品的製造轉移到 Merit 工廠。

In the meantime, however, we will have a TSA to bridge the time between close and transfer to a Merit site.

但同時，我們將透過 TSA 來縮短關閉和轉移到優秀站點之間的時間。

So once that transfer is complete, what will the impact be on gross margins?

那麼一旦轉讓完成，會對毛利率產生什麼影響呢？

Well, we'll talk about that, Jim when it's.

好吧，吉姆，到時候我們會討論這個的。

Complete. Yeah, I mean, again, I think if you look at our original guidance that we gave out when the acquisition came out, We, we said it was going to be accretive to non-GAAP gross margins, accretive to non-GAAP operating margins in the first full year post close.

完全的。是的，我的意思是，我想如果你看看我們在收購時給出的最初指導，我們說這將增加非公認會計原則毛利率，增加非公認會計原則營業利潤在關閉後的第一個全年。

Okay. And you know, if you look at the business now compared to where you were 78 years ago, I mean, the cash flow has just improved dramatically.

好的。你知道，如果你看看現在的業務與 78 年前相比，我的意思是，現金流有了顯著改善。

You know, what's the plan long term with cash? Do, do you anticipate continuing to use cash or acquisitions or would you ever consider? You know, are there, there are other options out there for.

你知道，現金的長期計畫是什麼？您預計會繼續使用現金或收購嗎？你知道，還有其他選擇。

Well, Jim, as you can see, you know, we've made acquisitions because we have not only a line that line comes from our ability to generate cash. I think we've done a great job. You can see the numbers that we're talking about for this year. And as someone told me that lives in New York City, Cash is king and you might know that guy quite well. So

好吧，吉姆，正如你所看到的，你知道，我們進行收購是因為我們不僅擁有一條來自我們產生現金的能力的資金。我認為我們做得很好。您可以看到我們今年討論的數字。正如有人告訴我，住在紐約市，現金為王，你可能很了解那個人。所以

Yeah, just, you know, I thank you for the question. First of all, we're working really hard to, you know, to, make those improvements. I think it’s, you know, it's obviously shown in the performance that we've generated. You know, obviously we're off to a really good start under our CGI program. You know, Jim, you know, we're, we're at, you know, 100 and $20 million of free cash flow for the year. You know, we're going to do a minimum of $400 million under the, under the CGI program.

是的，只是，你知道，我感謝你提出這個問題。首先，我們正在非常努力地進行這些改進。我認為，你知道，這在我們的表現中得到了明顯體現。您知道，顯然我們的 CGI 計劃有了一個非常好的開始。你知道，吉姆，你知道，我們今年的自由現金流為 100 到 2000 萬美元。你知道，我們將在 CGI 計劃下投入至少 4 億美元。

So, you know, we're off, we're off to a good start. We've got plenty of capacity. Our balance sheet is strong, and we continue to work on our working capital. So all solid points that are generating that free cash flow.

所以，你知道，我們出發了，我們有了一個好的開始。我們有足夠的能力。我們的資產負債表強勁，我們將繼續努力提高營運資本。因此，所有產生自由現金流的堅實點。

All right. And then with WRAPSODY, I know you don't want to answer a lot of questions, but when it does get approved, is this something that you think you can get in the market with relatively quickly or you think there'll be significant amount of training involved to launch the product?

好的。然後對於 WRAPSODY，我知道您不想回答很多問題，但是當它獲得批准時，您認為您可以相對較快地進入市場，或者您認為會有大量的產品推出產品所需的培訓？

Yeah, great question. The training has started this year. So we've had the ongoing training sessions with our sales group and we'll be ready to go from that perspective as far as adoption out of the gate, keep in mind this is this like most new medical devices will require a VAC committee in most cases. So that takes time.

是的，很好的問題。今年的培訓已經開始。因此，我們已經與我們的銷售團隊進行了持續的培訓課程，我們將準備好從這個角度出發，直到採用為止，請記住，這就像大多數新的醫療設備將需要一個 VAC 委員會一樣大多數情況下。所以需要時間。

But I don't think it's any greater than any other product, and of course, with the data we have, we expect that process to be certainly not easy but easier than it would be without such great data.

但我不認為它比任何其他產品更好，當然，根據我們擁有的數據，我們預計這個過程肯定不容易，但比沒有如此大量數據的情況要容易。

Alright, thank, thank you for taking the questions.

好的，謝謝，謝謝你問問題。

The next question will be coming from Michael Petuksy of Barrington Research. Your line is open.

下一個問題將由巴靈頓研究公司的邁克爾·佩圖克西提出。您的線路已開通。

Good evening. I've challenged myself to try to ask a WRAPSODY question you guys can answer. So, let's see if it's how it works. I'm just curious in terms of your communication with the FDA, have there been, have there, I guess the clock started at the end, maybe the end of June or the '1 of July. Have there been any stoppages during your, you know, any, any communication with the FDA since then?

晚安.我挑戰自己，試著問一個你們可以回答的 WRAPSODY 問題。那麼，讓我們看看它是如何工作的。我只是好奇你與 FDA 的溝通情況，有沒有，有沒有，我猜時鐘是從年底開始的，也許是 6 月底或 7 月 1 日。從那時起，您與 FDA 的任何溝通是否有任何中斷？

Yeah, So as you know, Mike, we promised or we indicated that we would file by the end of the second quarter which we did, there's 180 FDA days and we have had no stoppages. So we'll leave it at that.

是的，麥克，正如你所知，我們承諾或表示我們將在第二季末之前提交文件，我們確實做到了，FDA 有 180 天，而且我們沒有任何中斷。所以我們就這樣吧。

All right, I'm going to try my luck with the second one.

好吧，我要去第二個碰碰運氣。

No, in terms of just website traffic or inquiries, have you guys noticed any pick up just in, in people clicking around and, and trying to learn about WRAPSODY since since the day in Portugal.

不，就網站流量或查詢而言，你們有沒有註意到，從葡萄牙的那一天起，人們點擊並嘗試了解 WRAPSODY 的情況有所改善。

You know, I haven't, I mean, I haven't candidly looked at it but the guys you want to speak to that Joe. Yeah.

你知道，我沒有，我的意思是，我還沒有坦誠地看過它，但你想和那個喬說話的人。是的。

I mean, look, I think it continues to track well, in multiple markets, you know, where it's available commercially, obviously, there's a lot of positive feedback from clinicians.

我的意思是，看，我認為它在多個市場中繼續保持良好的勢頭，你知道，在商業上可以買到的地方，顯然，臨床醫生有很多積極的反饋。

And there continues to be a lot of data released, you know, that in the coming months, Mike. So, I mean, I think that's all generating a buzz. Generally speaking, as, I mean, as you saw just today alone, you know, just with the questions we're getting. So, that's probably the best way to answer it.

麥克，在接下來的幾個月裡，將會繼續發布大量數據。所以，我的意思是，我認為這一切都引起了轟動。一般來說，我的意思是，正如您今天所看到的，您知道，就我們收到的問題而言。所以，這可能是回答這個問題的最佳方式。

Absolutely. All right, let's, that's one real quickly.

絕對地。好吧，讓我們，這真的很快。

you know, in terms of M&A you know, you guys, for few years, there were pretty quiet. You've picked up a little bit, not doing anything huge but doing some deals that you know, seem meaningful, both strategically and even financially.

你們知道，就併購而言，你們知道，幾年來，情況相當安靜。你已經有所進步，沒有做任何大事，但做了一些你知道的、在策略上甚至在財務上似乎都很有意義的交易。

Just curious in terms of, you know, comfort with leverage, I mean, is there, is there a number and forgive me if you put this out either tonight or recently? But I, I'm just not sure. I heard it. Is there, is there not, is there a sort of a leverage ratio you guys are comfortable with going up to?

只是好奇，你知道，槓桿的舒適度，我的意思是，有沒有，有沒有一個數字，如果你今晚或最近把這個公佈出來，請原諒我？但我，我只是不確定。我聽到了。有沒有一種你們可以接受的槓桿比率？

Yeah, Mike. You know, I think, you know, had you asked me this year, you know, this question, you know, three years ago when the interest rates were low, you know, we'd probably say a higher number, right? We, we'd probably go up to four times.

是的，麥克。你知道，我想，你知道，如果你今年問我，你知道，這個問題，你知道，三年前，當利率很低時，你知道，我們可能會說一個更高的數字，對吧？我們，我們可能會去四次。

I think generally speaking in this interest rate environment, you know, we're probably somewhere around three unless we can deliver really quick. Right? But look, I think we're, we're our discipline on the transactions that, that we're you know, that we're showing right now.

我認為一般來說，在這種利率環境下，我們可能會在三個左右，除非我們能夠非常快速地交付。正確的？但是看，我認為我們是我們對交易的紀律，我們是你知道的，我們現在正在展示。

I think, you know, they're real right. I mean, I think you're looking at the transactions, you can pick up on the theme pretty easily. You know, we're looking at areas that we can go deeper into the bag that we can make investments in salesforces to make sure that they can get deeper into the bags that we already have, including the new products that we're bringing on with these acquisitions.

我認為，你知道，他們是對的。我的意思是，我認為你正在查看交易，你可以輕鬆掌握這個主題。你知道，我們正在尋找可以深入研究的領域，我們可以對銷售人員進行投資，以確保他們能夠深入研究我們已有的產品，包括我們正在推出的新產品透過這些收購。

And, you know, we're sitting right now at 2.08 times levered. We've got plenty of cash on the balance sheet. We have a strong balance sheet, and we've got plenty of firepower, but we're going to continue to remain disciplined.

而且，你知道，我們現在的槓桿率為 2.08 倍。我們的資產負債表上有大量現金。我們擁有強大的資產負債表，並且擁有充足的火力，但我們將繼續保持紀律。

We've got our crosshairs on the CGI program. And you know that that's our, that's our goal is to execute to the CG I program that we've, that we've promised and everything that, you know, falls under that scope, I guess we are making sure that any transaction that we do generally meets or exceeds those targets

我們已經將十字線瞄準了 CGI 程式。你知道，這就是我們的目標，我們的目標是執行我們已經承諾的 CG I 程序，以及所有屬於該範圍的內容，我想我們正在確保任何交易我們通常確實達到或超過了這些目標

Outstanding. Thanks guys. Appreciate it.

傑出的。謝謝你們。欣賞它。

Thanks. Mike

謝謝。麥克風

Thank you one moment for the next question.

謝謝您提出下一個問題。

And our next question will be coming from Steve Lichtman of Oppenheimer. Your line is open.

我們的下一個問題將來自奧本海默的史蒂夫·利希特曼。您的線路已開通。

Thank you evening guys and congrats on the progress. I guess first on Cook, where do you see the biggest sales synergy opportunities with your legacy CRM franchise, whether is it cross sell in the U.S. store opening in other countries? Any thoughts on that would be helpful?

謝謝晚上的大家，恭喜你們的進展。我想首先就庫克而言，您認為與您的傳統 CRM 特許經營權最大的銷售協同機會在哪裡，是否是在美國開設的其他國家/地區商店中的交叉銷售？對此有什麼想法會有幫助嗎？

Yeah. One of the nice things about these assets are they truly are global. Unlike a lot of the acquisition candidates we evaluate, they have about as much revenue in the U.S. as they do in Europe. I guess I should have said that the other way around but also some exciting opportunities in APAC, we think

是的。這些資產的好處之一是它們確實是全球性的。與我們評估的許多收購候選者不同，他們在美國的收入與在歐洲的收入大致相同。我想我應該說相反，但我們認為亞太地區也有一些令人興奮的機會

So, globally it really helps our global franchises. As far as product products, we have, we have the Worley, we have the SNAP Splittable Sheath. We have the Ventrax which will be coming out soon. We have transseptal crossing catheters, both steerable and fixed curve. We have the PTA balloon.

因此，在全球範圍內，它確實對我們的全球特許經營權有幫助。就產品而言，我們有 Worley，我們有 SNAP 可分離護套。我們有 Ventrax，即將推出。我們有房間隔交叉導管，包括可操縱的和固定曲線的。我們有 PTA 氣球。

So, we have a number of products that really haven't had the attention they deserve. And we're confident in the products we already have that. If we put the folks behind them, we will get more adoption and with more dedicated feet on the street, we're confident that will happen.

因此，我們有許多產品確實沒有得到應有的關注。我們對已經擁有的產品充滿信心。如果我們讓人們支持他們，我們將得到更多的採用，並且有更多的人投入街頭，我們相信這將會發生。

Great. Thanks and then just a follow up on China. Good to see growth continuing to hold up for you guys there. Can you talk about the environment overall there? How much VBP are you absorbing your confidence on procedure Volume growth? Thought that would be great as well.

偉大的。謝謝，然後是關於中國的後續行動。很高興看到你們繼續保持成長。能談談那裡的整體環境嗎？您對手術量增長的信心是多少 VBP？我想那也很棒。

Yeah, look, I think, you know, Steve, look, I think it's, you know, for us, you know, first of all, volume based purchasing has kind of come in as expected. I think the nice thing that we've seen is we've seen a strong demand and an increase in units, which is why you're seeing the better-than-expected results, you know, in China.

是的，看，我想，你知道，史蒂夫，看，我認為，你知道，對我們來說，你知道，首先，基於數量的採購已經按預期進行了。我認為我們看到的一件好事是我們看到了強勁的需求和數量的增加，這就是為什麼你在中國看到了好於預期的結果。

So, I think for us, you know, the business continues to be strong or stronger than we anticipated. And, you know, we're dealing with volume-based purchasing, which is, as, you know, continues to be, you know, from quarter to quarter, pretty volatile I would say.

因此，我認為對我們來說，業務持續強勁，甚至比我們預期的還要強勁。而且，你知道，我們正在處理基於數量的採購，我想說，你知道，從一個季度到另一個季度，這種採購仍然相當不穩定。

But generally speaking, we are outpacing it with the unit growth. And so, I think we continue to be excited about, you know, the performance of our Chinese team. And generally speaking, just the APAC region.

但總的來說，我們的單位成長速度超過了它。因此，我認為我們仍然對中國隊的表現感到興奮。一般來說，僅限亞太地區。

Great. Thank you guys.

偉大的。謝謝你們。

Thank you. And this does conclude the Q&A session for today.

謝謝。今天的問答環節到此結束。

I would now like to turn the call back over to Fred for closing remarks. Please go ahead.

我現在想將電話轉回給弗雷德，讓他發表結束語。請繼續。

Well, listen, it's been a long call. We appreciate all the questions Raul and I and Joe will be around for the next couple of hours. Best wishes.

好吧，聽著，這是一通漫長的電話。我們感謝勞爾、我和喬在接下來的幾個小時內提出的所有問題。最好的祝愿。

It's cold out in Salt Lake City, warmers up with your questions. Thanks again for taking the time.

鹽湖城的天氣很冷，你的問題會讓你感到溫暖。再次感謝您抽出時間。

We appreciate it. And good evening from Salt Lake City. Good night.

我們很感激。鹽湖城晚上好。晚安。

Thank you for participating in today's conference call. You may all disconnect.

感謝您參加今天的電話會議。你們都可以斷開連線。