Artivion, Inc. (AORT) 2026 Q1 法說會逐字稿

Good afternoon. Welcome to Artivion's fourth-quarter and year-end 2025 earnings conference call. (Operator Instructions)

下午好。歡迎參加 Artivion 2025 年第四季暨全年財報電話會議。(接線員指示)

I would now like to turn the conference over to your host, Mr. Brian Johnston from The Gilmartin Group. Thank you. You may begin.

現在我想把會議交給本次主持人——來自 The Gilmartin Group 的 Brian Johnston 先生。謝謝。您可以開始了。

Thank you. Good afternoon, and thank you for joining the call today. Joining me from Artivion's management team are Pat Mackin, CEO; and Lance Berry, COO and CFO. Before we begin, I'd like to make the following statements to comply with the Safe Harbor requirements of the Private Securities Litigation Reform Act of 1995. Comments made on this call that look forward in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

謝謝。各位下午好，感謝今天加入本次電話會議。與我一同出席的 Artivion 管理團隊成員包括：執行長 Pat Mackin，以及營運長兼財務長 Lance Berry。在開始之前，為遵循 1995 年《私人證券訴訟改革法案》的「安全港」要求，我先做以下聲明。本次電話會議中涉及未來時間的評論包含風險與不確定性，並構成 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。

The forward-looking statements include statements made as to the company's or management's intentions, hopes, beliefs, expectations or predictions of the future. These forward-looking statements are subject to a number of risks, uncertainties, estimates and assumptions that may cause actual results to differ materially from these forward-looking statements.

前瞻性陳述包括公司或管理層對未來的意圖、希望、信念、預期或預測等陳述。這些前瞻性陳述受到多項風險、不確定性、估計與假設的影響，可能導致實際結果與這些前瞻性陳述存在重大差異。

Additional information concerning certain risks and uncertainties that may impact these forward-looking statements is contained from time to time in the company's SEC filings and in the press release that was issued earlier today. You can also find a brief presentation with details highlighted on today's call on the Investor Relations section of the Artivion website.

有關可能影響這些前瞻性陳述之特定風險與不確定性的更多資訊，會不時載於公司向 SEC 提交的文件，以及今天稍早發布的新聞稿中。您也可在 Artivion 官網的投資人關係專區找到一份簡報，其中重點說明了今天電話會議提及的細節。

Lastly, I would like to remind you to please refer to our press release published earlier today for information regarding our non-GAAP results, including a reconciliation of these results to our GAAP results. Unless otherwise stated, all comments today will be using our non-GAAP results. Additionally, all percentage changes discussed will be on a year-over-year basis. Revenue growth rates will be the adjusted constant currency rates and expenses as a percentage of sales will be based on adjusted revenues.

最後，提醒各位參閱我們今天稍早發布的新聞稿，以取得有關非 GAAP 結果的資訊，包括與 GAAP 結果的調節表。除非另有說明，今天所有評論將以非 GAAP 結果為準。此外，所有提及的百分比變動皆以年對年為基礎。營收成長率將採用調整後的固定匯率口徑，費用占銷售比率將以調整後營收為基礎。

With that, I'll turn the call to Artivion's CEO, Pat Mackin.

接下來，我把電話交給 Artivion 執行長 Pat Mackin。

Thanks, Brian, and good afternoon, everybody. Through the first quarter of 2026, we continue to execute our strategy designed to drive long-term profitable growth through an expanding and clinically differentiated product portfolio. In the quarter, we delivered constant currency revenue growth of 12% and adjusted EBITDA growth of 26% year-over-year.

謝謝你，Brian，各位下午好。截至 2026 年第一季，我們持續執行既定策略，透過不斷擴充且具臨床差異化的產品組合，推動長期且具獲利性的成長。本季我們在固定匯率口徑下實現營收年增 12%，調整後 EBITDA 年增 26%。

Revenue growth was driven primarily by On-X and stent grafts, including AMDS. We also benefited from growth within preservation services as tissue processing volumes normalized following the 2024 cybersecurity event. Before expanding further on product line performance, I'd like to take a moment to address today's exciting news regarding the exercise of our option to acquire Endospan.

營收成長主要由 On-X 與支架移植物（stent grafts）（包括 AMDS）帶動。我們也受惠於保存服務（preservation services）的成長，因為在 2024 年資安事件後，組織處理量已恢復正常。在進一步說明各產品線表現之前，我想先花點時間談談今天令人振奮的消息：我們已行使收購 Endospan 的選擇權。

This is following the PMA approval of its NEXUS Aortic Arch Stent Grafts system for chronic aortic dissections, which they achieved in early April. The NEXUS system is a branched endovascular stent graft system that is purpose-built for minimally invasive treatment of Aortic Arch disease where patients often have no choice other than open heart surgery.

此舉是在其 NEXUS 主動脈弓支架移植物系統（NEXUS Aortic Arch Stent Grafts system）於 4 月初取得針對慢性主動脈剝離的 PMA 核准之後。NEXUS 系統是一套分支式血管內支架移植物系統，專為以微創方式治療主動脈弓疾病而設計；對於這類患者而言，往往除了開心手術之外別無選擇。

The clinical data is compelling. Data from the chronic Aortic Arch dissection cohort of the TRIOMPHE trial demonstrated 93% of patients survived from lesion-related death, 90% freedom from disabling stroke and at one year post treatment. Also, 95% were free from intervention due to endoleaks, excluding type 2 endoleaks at one year, which is a very high-risk population.

臨床數據相當具說服力。TRIOMPHE 試驗中慢性主動脈弓剝離隊列的數據顯示：93% 的患者在治療後一年內未發生病灶相關死亡而存活，且 90% 在一年內未發生致殘性中風。此外，在治療後一年（排除第 2 型內漏）有 95% 的患者無需因內漏而再次介入治療；而該族群屬於高風險族群。

As a reminder, the total annual US addressable market opportunity associated with both cohorts is estimated to be around $150 million, with dissections representing about $100 million of that. We plan to pursue supplementing the label to include aortic aneurysms through formal regulatory processes expeditiously post acquisition. Importantly, our anticipated acquisition of Endospan and its NEXUS system will complete our market-leading three-pronged Aortic Arch portfolio.

提醒各位，與兩個隊列相關的美國年度可服務市場總機會估計約為 1.5 億美元，其中剝離約占 1 億美元。收購完成後，我們計畫透過正式法規程序，儘速推動擴充適應症標示（label），將主動脈瘤納入其中。重要的是，我們預期收購 Endospan 及其 NEXUS 系統，將完成我們市場領先的「三管齊下」主動脈弓產品組合。

This technology, if acquired alongside AMDS and our Arcevo LSA will position us at the forefront of this segment as the only company globally with a complete portfolio of Aortic Arch solutions. And importantly, NEXUS is the platform technology, not just a single product. It's supported by additional three PMA programs in development that we expect to further expand and solidify our leadership in the Aortic Arch market over time.

若能取得此技術並結合 AMDS 與我們的 Arcevo LSA，將使我們站上該細分市場的最前沿，成為全球唯一擁有完整主動脈弓解決方案產品組合的公司。同時，NEXUS 是平台型技術，而不僅是一項單一產品。其背後還有另外三個正在開發中的 PMA 專案支援，我們預期將隨時間進一步擴大並鞏固我們在主動脈弓市場的領導地位。

We are pleased to have had the financing already in place for this acquisition and subject to satisfactory and customary closing conditions, we expect to close in the second quarter of 2026. As Lance will discuss in greater detail, we expect a full US commercial launch of NEXUS in January 2027, following efforts to scale inventory production, complete value announced committee processes and augment our US sales team.

我們很高興此次收購所需融資已事先到位；在滿足令人滿意且慣常的交割條件下，我們預期將於 2026 年第二季完成交割。如 Lance 稍後將更詳細說明，我們預期在擴大庫存產能、完成價值分析委員會（VAC）流程並擴充美國銷售團隊後，於 2027 年 1 月在美國全面商業化上市 NEXUS。

With that, let me turn back to our Q1 '26 results. From a product category perspective, stent graft revenues grew 10% on a constant currency basis in the first quarter compared to the same period last year. Year-over-year constant currency growth fell below our expectations due to lower-than-expected AMDS set sales in the US as well as softer-than-expected performance internationally, particularly in the Middle East.

接著回到我們 2026 年第一季的業績。以產品類別來看，支架移植物營收在第一季以固定匯率口徑較去年同期成長 10%。年對年固定匯率成長低於我們預期，原因包括美國 AMDS 套組（set）銷售低於預期，以及國際市場表現較預期疲弱，尤其是中東地區。

Year-over-year growth also reflects a tougher comp in Europe following a strong Q1 2025 performance as we recovered from the 2024 cybersecurity event. While US AMDS sales associated with initial stocking fell short of our expectations in Q1, we've been very encouraged by implanting reorder patterns within the accounts already using AMDS. We view this as a much more critical item than the immediate impact of sales from starter sets as strong reordering patterns reflect positive user experience and ultimately, our long-term adoption of these in our growth thesis.

年對年成長也反映了歐洲較具挑戰的比較基期；因為在 2024 年資安事件後復原的帶動下，2025 年第一季表現強勁。雖然第一季美國 AMDS 因初始備貨所帶動的銷售未達我們預期，但我們對於已使用 AMDS 的客戶帳戶所呈現的植入後再訂購（reorder）模式感到非常鼓舞。我們認為這比起起始套組銷售的即時影響更為關鍵，因為強勁的再訂購模式反映良好的使用者體驗，並最終支持我們成長論述中對長期採用的預期。

Looking ahead, we expect US AMDS set sales to accelerate as more accounts are already through the VAC process, they finalize the procurement as we benefit from steps being taken, not to ease the initial upfront $100,000 cost burden associated with stocking.

展望未來，隨著更多客戶帳戶已完成 VAC 流程並完成採購，我們預期美國 AMDS 套組銷售將加速；同時我們也將受惠於正在採取的措施，以減輕備貨所需的 10 萬美元前期成本負擔。

We also anticipate PMA approval of AMDS in the coming months, which will obviate the need for entirely new accounts, which won't have to go through the IRB process, some of which have deferred the PMA approval because of this increasingly imminent date.

我們也預期 AMDS 將在未來幾個月內取得 PMA 核准，屆時新客戶帳戶將無需再走 IRB 流程；部分客戶也正因 PMA 核准日期日益臨近而延後導入。

Ultimately, we see our comprehensive stent graft portfolio as a foundational component to our growth strategy. We are encouraged by our enduring fundamental strength and increasingly strong competitive advantage within the segment.

最終，我們將完整的支架移植物產品組合視為成長策略的基礎性組成。我們對該細分市場長期穩健的基本面，以及日益強化的競爭優勢感到鼓舞。

Looking ahead, we intend to replicate our proven strategy by bringing additional stent graft products that are already generating revenue in Europe to the US and Japan, which we believe will unlock further meaningful expansion of our stent graft total addressable market.

展望未來，我們打算複製已驗證的策略，將目前已在歐洲創造營收的其他支架移植物產品引進美國與日本；我們相信這將進一步帶動支架移植物可服務市場（TAM）的顯著擴張。

Meanwhile, our Q1 On-X revenue was 17% year-over-year growth on a constant currency basis. This growth was driven by further global market share gains and continued early traction in our new $100 million US market opportunity unlocked by recently published data, which demonstrate improved outcomes with mechanical valves versus bioprosthetic valves for younger patients.

同時，我們第一季 On-X 營收以固定匯率口徑年增 17%。此成長來自全球市占率的進一步提升，以及我們新開啟的 1 億美元美國市場機會所帶來的持續早期動能；該機會源於近期發表的數據，顯示對較年輕患者而言，機械瓣膜相較於生物瓣膜可帶來更佳的治療結果。

We maintain our conviction that On-X is the best aortic valve in the market for patients under the age of 65, and we will continue to take market share worldwide in that product line. Tissue processing revenues increased 23% year-over-year on a constant currency basis in the first quarter as demand for our products remained strong and tissue volumes normalized year-over-year following the cybersecurity incident in late '24. Q1 results were slightly ahead of our expectations of roughly $24 million per quarter for that business.

我們仍堅信，對於 65 歲以下患者而言，On-X 是市場上最佳的主動脈瓣膜，我們將持續在全球範圍內於該產品線擴大市占。第一季組織處理（tissue processing）營收以固定匯率口徑年增 23%，因為產品需求維持強勁，且在 2024 年底資安事件後，組織量年對年已恢復正常。第一季結果略優於我們對該業務每季約 2,400 萬美元的預期。

Lastly, BioGlue was relatively flat on a constant currency basis compared to the same period last year. While this performance was slightly lower than our mid-single-digit growth expectation contemplated in our previously communicated full year revenue guidance, it falls within the range of normal quarter-to-quarter growth variability due to significant amount of stocking distributor business in that product line.

最後，BioGlue 以固定匯率計算，較去年同期相對持平。雖然此表現略低於我們先前在已溝通的全年營收指引中所預期的中個位數成長，但由於該產品線存在相當比例的經銷商備貨業務，導致季度間成長出現正常波動，因此仍落在正常的季度對季度成長變動範圍內。

Lastly, on our pipeline, we continue to make great progress on the ARTIZEN clinical trial for our Arcevo LSA product. We now have 26 patients enrolled in the trial, which is a nonrandomized clinical trial consisting of 132 patients in the US and Europe and up to 30 centers for treatment for aortic dissection and aneurysm in the arch.

最後，關於我們的產品研發管線，我們在 Arcevo LSA 產品的 ARTIZEN 臨床試驗上持續取得重大進展。目前已有 26 名病患納入試驗；該試驗為非隨機臨床試驗，總計將納入 132 名美國與歐洲病患，並在多達 30 個治療中心進行，用於主動脈弓部的主動脈剝離與動脈瘤治療。

We anticipate completing full enrollment in mid-'27. We are optimistic that the trial will be successful, supported by our clinical results from our current generation Frozen Elephant Trunk, E-vita OPEN NEO, which is available outside the US following our one-year follow-up period and assuming the trial meets its endpoints, we anticipate FDA approval for our Arcevo LSA in 2029, unlocking an incremental $80 million annual US market opportunity.

我們預期將於 2027 年年中完成全部收案。我們對試驗成功抱持樂觀態度，並有現行世代 Frozen Elephant Trunk（冷凍象鼻）產品 E-vita OPEN NEO 的臨床結果作為支持；該產品在完成一年期追蹤後已於美國以外地區上市。若試驗達成其終點，我們預期 Arcevo LSA 可於 2029 年取得 FDA 核准，進而開啟美國市場每年新增 8,000 萬美元的機會。

In conclusion, while Q1 results fell short of our constant currency expectation and reflected some moving pieces that Lance will walk you through in detail, it was a quarter of meaningful progress against our long-term strategy. The fundamentals that underpin our growth strategy remain intact, a comprehensive clinically differentiated portfolio, a focused commercial organization and a pipeline that stands to exceed the total addressable market, expand our total addressable market continuously over time.

總結而言，儘管第一季結果未達我們對固定匯率的預期，且反映出一些變動因素，Lance 將稍後為各位詳細說明，但這仍是一個在我們長期策略上取得實質進展的季度。支撐我們成長策略的基本面依然完好：具備全面且在臨床上具差異化的產品組合、聚焦的商業組織，以及有望超越整體可服務市場（TAM）、並隨時間持續擴大我們 TAM 的研發管線。

The reordering behavior we are seeing within AMDS accounts reinforces our conviction in the long-term adoption story, and we have a clear line of sight in the near-term drivers that will accelerate new account conversion. On-X continues to take share from both mechanical and bioprosthetic valves as the leading Aortic Valve in the market for patients under the age of 65. And with the addition of NEXUS, we now have what we believe is the most comprehensive Aortic Arch portfolio in the world, a position we have built deliberately and intend to extend.

我們在 AMDS 客戶中觀察到的重新下單行為，強化了我們對長期採用趨勢的信心；同時，我們也清楚掌握短期內將加速新客戶轉換的驅動因素。On-X 持續從機械瓣與生物瓣兩類產品中擴大市占，成為 65 歲以下病患市場中領先的主動脈瓣。隨著 NEXUS 的加入，我們現在擁有我們所認為全球最完整的主動脈弓產品組合；這是我們有意打造的地位，並打算持續擴展。

With that, I'll now turn the call over to Lance.

接下來，我把電話會議交給 Lance。

Thanks, Pat, and good afternoon, everyone. Before I begin, I would like to remind you that please refer to our press release published earlier today for information regarding our non-GAAP results, including a reconciliation of these results to our GAAP results.

謝謝你，Pat，各位下午好。在我開始之前，我想提醒各位，關於我們的非 GAAP 結果（包括與 GAAP 結果的調節表），請參閱我們今天稍早發布的新聞稿。

Additionally, all percentage changes discussed will be on a year-over-year basis, and revenue growth rates will be in constant currency unless otherwise noted. Total revenues were $116.3 million for the first quarter of 2026, up 12% compared to Q1 of 2025. Meanwhile, adjusted EBITDA increased approximately 26% from $17.5 million to $22.1 million in the first quarter of 2026.

另外，所有提及的百分比變動皆為年對年（YoY）基礎，除非另有說明，營收成長率皆以固定匯率計算。2026 年第一季總營收為 1.163 億美元，較 2025 年第一季成長 12%。同時，2026 年第一季調整後 EBITDA 由 1,750 萬美元增加約 26% 至 2,210 萬美元。

Adjusted EBITDA margin was 19% in the first quarter of 2026, an approximate 130 basis points improvement over the prior year, driven by leverage in SG&A and gross margin improvement. From a product line perspective, stent graft revenues increased 10%, On-X grew 17%, tissue processing revenues grew 23% and BioGlue revenues were relatively flat in the first quarter of 2026.

2026 年第一季調整後 EBITDA 利潤率為 19%，較去年同期約提升 130 個基點，主要受惠於 SG&A 的槓桿效益以及毛利率改善。以產品線來看，支架型人工血管（stent graft）營收成長 10%，On-X 成長 17%，組織處理（tissue processing）營收成長 23%，而 BioGlue 營收在 2026 年第一季相對持平。

On a regional basis, revenues in Asia Pacific increased 6%, North America 23%, EMEA increased 5% and Latin America decreased 23%, all compared to the first quarter of 2025. International growth was below what we typically see from that part of the business. EMEA underperformance was driven by the stent graft-related factors that Pat discussed earlier, while underperformance across APAC and LatAm was driven primarily due to quarterly fluctuations in distributor ordering patterns, which we expect to normalize over the course of the year.

以區域來看，與 2025 年第一季相比，亞太地區營收成長 6%，北美成長 23%，EMEA 成長 5%，拉丁美洲則下滑 23%。國際市場的成長低於我們通常在該業務部分所見的水準。EMEA 的表現不如預期，主要由 Pat 先前提到的支架型人工血管相關因素所致；而 APAC 與拉丁美洲的表現不如預期，主要是因經銷商下單模式的季度性波動所造成，我們預期將在今年內逐步回歸正常。

Q1 gross margins were 64.9% in Q1, an increase from 64.2% in the first quarter of 2025, primarily due to favorable product and geographic mix. General and administrative and marketing expenses in the first quarter were $60.8 million compared to $54.7 million in the first quarter of 2025.

第一季毛利率為 64.9%，較 2025 年第一季的 64.2% 提升，主要由於有利的產品與地理區域組合。第一季一般管理與行銷費用為 6,080 萬美元，較 2025 年第一季的 5,470 萬美元增加。

Non-GAAP general and administrative and marketing expenses were $59.3 million or 51% of sales in the first quarter compared to $53 million or 53.6% of sales in the first quarter of 2025, reflecting a 260 basis points improvement. Approximately 170 basis points were driven through leveraging existing infrastructure and annualizing our year one AMDS launch costs and approximately 90 basis points were from stock-based compensation.

第一季非 GAAP 一般管理與行銷費用為 5,930 萬美元，占銷售額 51%；相較之下，2025 年第一季為 5,300 萬美元，占銷售額 53.6%，反映出 260 個基點的改善。其中約 170 個基點來自既有基礎設施的槓桿效益，以及 AMDS 上市第一年成本的年度化；約 90 個基點則來自股票基礎薪酬。

Our as-reported expenses included a gain of approximately $1.5 million in Q1 associated with insurance reimbursement for cybersecurity costs we incurred in previous periods and approximately $1 million of diligence and integration planning costs associated with the planned acquisition of Endospan, both of which are excluded from adjusted EBITDA.

我們按報表列示的費用包含：第一季約 150 萬美元的收益，係與先前期間發生之資安成本所獲得的保險理賠相關；以及約 100 萬美元與計畫收購 Endospan 相關的盡職調查與整合規劃成本；上述兩項皆已自調整後 EBITDA 中排除。

R&D expenses for the first quarter were $8.8 million or 7.6% of sales compared to $6.7 million or 6.8% of sales in the first quarter of 2025. Interest expense net of interest income was $5.2 million as compared to $7.5 million in the prior year. Other income and expense this quarter included foreign currency translation losses of approximately $800,000.

第一季研發費用為 880 萬美元，占銷售額 7.6%；相較之下，2025 年第一季為 670 萬美元，占銷售額 6.8%。扣除利息收入後的利息費用為 520 萬美元，去年同期為 750 萬美元。本季其他收益與費用包含約 80 萬美元的外幣換算損失。

Free cash flow was negative $6.8 million in the first quarter of 2026 as compared to negative $20.6 million in the first quarter of 2025. As a reminder, the first quarter is typically our seasonally lowest free cash flow quarter. And although negative, this quarter's free cash flow results were actually slightly better than anticipated. As of March 31, 2026, we had approximately $55.8 million in cash and $215.4 million in debt, net of $4.6 million of unamortized loan origination costs. At the end of the first quarter, our net leverage ratio was 1.8, down from 4.0 in the prior year.

2026 年第一季自由現金流為負 680 萬美元，相較於 2025 年第一季的負 2,060 萬美元。提醒各位，第一季通常是我們季節性自由現金流最低的季度。此外，雖然仍為負值，但本季自由現金流結果實際上略優於預期。截至 2026 年 3 月 31 日，我們約有 5,580 萬美元現金，以及 2.154 億美元債務（已扣除 460 萬美元未攤銷的貸款發起成本）。第一季末，我們的淨槓桿比率為 1.8，低於去年同期的 4.0。

And now for our outlook for 2026. As Pat stated, our Q1 stent graft results did not meet our expectations due to factors that could continue to impact our revenue in the near term, primarily softness in our international markets, particularly in the Middle East and timing of AMDS set sales in the US. It is early in the year, and we are working to mitigate or offset these issues. However, given the uncertainty around the timing and impact of those actions, we believe it is prudent to adjust our guidance.

接著談我們對 2026 年的展望。如 Pat 所述，由於一些因素使我們第一季支架型人工血管的結果未達預期，而這些因素在短期內可能仍會持續影響營收，主要包括國際市場走弱（尤其是中東），以及美國 AMDS 套組銷售時點的影響。目前仍在年初，我們正努力緩解或抵消這些問題。然而，鑑於相關行動的時點與影響仍具不確定性，我們認為調整指引是審慎之舉。

We now expect adjusted constant currency growth between 7% to 11% for the full year 2026, representing a reported revenue range of $480 million to $496 million. This guidance contemplates FX to have an approximate 1 percentage-point tailwind on as-reported revenue for the full year.

我們目前預期 2026 全年調整後固定匯率成長介於 7% 至 11%，對應的報表營收區間為 4.80 億至 4.96 億美元。此指引假設外匯（FX）對全年報表營收約有 1 個百分點的順風助益。

From a product line perspective, the reduction relates primarily to stent grafts due to the factors we've discussed. This guidance assumes inconsequential revenue from the US NEXUS sales in 2026 as we seek value analysis committee approvals and build supply for an anticipated January 1, 2027, US launch.

以產品線來看，本次下修主要與支架型人工血管相關，原因即我們已討論的各項因素。此指引假設 2026 年美國 NEXUS 銷售營收影響不大，因我們仍在取得價值分析委員會核准，並為預期於 2027 年 1 月 1 日在美國上市進行備貨。

As a reminder, growth in the first quarter of 2026 was anticipated to be higher than the remaining quarters, driven by the easier comps for the preservation services business from the prior year cybersecurity event. These flipped to difficult comps for the preservation services business in Q2 and Q3 before normalizing in Q4.

提醒各位，原先預期 2026 年第一季的成長會高於其餘季度，主要因去年資安事件使保存服務（preservation services）業務的比較基期較容易。在第二季與第三季，保存服務業務的比較基期轉為較具挑戰，並在第四季恢復正常。

We currently anticipate our Q2 year-over-year growth rate will be the lowest in 2026, followed by more consistent sequential improvement as our US AMDS and US On-X sales accelerate during the year, and we return to normal comps for the Preservation services business in Q4. With these updated revenue expectations and excluding the impact of the planned Endospan acquisition, we now expect full year 2026 adjusted EBITDA to be in the range of $100 million to $107 million, representing a range of 12% to 20% growth over 2025 and approximately 100 basis points of adjusted EBITDA margin expansion at the midpoint of our ranges.

我們目前預期，2026 年第二季的年對年成長率將是全年最低，之後隨著我們在美國的 AMDS 與美國 On-X 銷售於年內加速，將呈現更一致的逐季改善，且我們在第四季將回到 Preservation 服務業務的正常比較基期。在這些更新後的營收預期下，並排除計畫中的 Endospan 收購影響，我們目前預期 2026 全年調整後 EBITDA 將落在 1 億至 1.07 億美元區間，代表相較 2025 年成長 12% 至 20%，且在區間中點約有 100 個基點的調整後 EBITDA 利潤率擴張。

Please note that this full year adjusted EBITDA guidance excludes any potential impact from the anticipated completion of the Endospan acquisition. Assuming the acquisition closes later in the quarter as anticipated, we would expect to incur approximately $8 million of incremental expense through 2026. This would include investments in launch costs and commercial infrastructure while also accounting for the absorption of Endospan operating costs, including ongoing R&D and clinical expenses.

請注意，此全年調整後 EBITDA 指引不包含預期完成 Endospan 收購的任何潛在影響。假設收購如預期於本季稍晚完成，我們預期至 2026 年將產生約 800 萬美元的增量費用。其中包括上市啟動成本與商業基礎設施的投資，同時也納入吸收 Endospan 的營運成本，包括持續的研發與臨床費用。

Given our expectation for immaterial revenue contribution from US NEXUS sales in 2026, this incremental $8 million would be expected to reduce our full year 2026 adjusted EBITDA to $92 million to $99 million.

鑑於我們預期 2026 年美國 NEXUS 銷售對營收的貢獻不具重大性，這筆額外的 800 萬美元預期將使我們 2026 全年調整後 EBITDA 降至 9,200 萬至 9,900 萬美元。

Looking forward, we would expect the first meaningful revenue contribution to begin in January 2027 and we anticipate our combined results to be EBITDA neutral for the full year 2027 as US NEXUS revenue ramps over the course of the year and as we get combined R&D and clinical spending into our targeted range of 7% to 8% of sales.

展望未來，我們預期第一筆具意義的營收貢獻將自 2027 年 1 月開始，且我們預期 2027 全年合併後的結果在 EBITDA 層面將大致持平（EBITDA neutral），因美國 NEXUS 營收將在年內逐步爬升，同時我們也會將合併後的研發與臨床支出控制在目標區間，即占銷售額的 7% 至 8%。

Relative to the pending acquisition, we also announced today that we drew $150 million under our existing term loan facility. The proceeds will be used to fund the $135 million upfront purchase price for the anticipated Endospan acquisition. Assuming the acquisition closes as anticipated, quarterly interest expense would increase to approximately $8 million starting in Q3 2026 with Q2 2026 interest expense expected to be slightly lower than that.

就這項待完成的收購而言，我們今天也宣布已在既有的定期貸款融資額度下動用 1.5 億美元。該筆資金將用於支付預期 Endospan 收購案 1.35 億美元的前期購買價金。假設收購如預期完成，自 2026 年第三季起，單季利息費用將增加至約 800 萬美元，而 2026 年第二季的利息費用預期會略低於此水準。

As a reminder, we also continue to anticipate paying a $25 million earn-out in the second half of 2026 following the anticipated mid-2026 AMDS PMA approval.

提醒一下，我們也仍預期在 2026 年下半年支付 2,500 萬美元的或有對價（earn-out），該款項將在預期於 2026 年年中取得 AMDS PMA 核准後支付。

With that, I'll turn the call back to Pat for his closing comments.

接下來，我把電話交回 Pat，請他做結語。

Thanks, Lance. Overall, we have near-term work to do, and we exited Q1 with greater conviction than even in our foundational growth strategy. We're excited to move forward with our pending acquisition of Endospan as the NEXUS platform stands to complete our market-leading Aortic Arch portfolio. We see PMA approval of AMDS as it's on track for midyear. Implant adoption for AMDS continues to build and our broader market expansion pipeline is accelerating to plan, particularly with ARTIZEN enrolling as expected, and our long-range growth thesis remains intact.

謝謝，Lance。整體而言，我們短期內仍有工作要做，而我們在第一季結束時，對於我們的基礎成長策略的信心甚至比以往更強。我們很期待推進對 Endospan 的待完成收購，因為 NEXUS 平台可望補齊我們市場領先的主動脈弓產品組合。我們看到 AMDS 的 PMA 核准正按計畫於年中進行。AMDS 的植入採用持續提升，我們更廣泛的市場擴張產品線也按計畫加速推進，特別是 ARTIZEN 如預期收案（enrolling），而我們的長期成長論點依然完好。

More specifically, we expect future growth to be driven by the following four key growth drivers:

更具體而言，我們預期未來成長將由以下四個關鍵成長動能所驅動：

Number one, the AMDS PMA. We're commercializing the AMDS in the US under the HDE, increasing penetration of the annual US market opportunity, with new clinical data, reimbursement dynamics and the PMA approval are likely to further be tailwinds for this growth.

第一，AMDS 的 PMA。我們目前在美國以 HDE 途徑商業化 AMDS，提升對美國年度市場機會的滲透；新的臨床數據、給付（reimbursement）動態以及 PMA 核准，預期都將進一步成為此成長的順風因素。

Number two, the On-X heart valve data. We're continuing to educate providers on the clinical data showing mortality and reoperation benefits in patients under 65 years of age compared to bioprosthetic valves and continue to expect this to translate into greater market share globally.

第二，On-X 心臟瓣膜數據。我們持續向醫療提供者宣導臨床數據：相較於生物瓣膜，On-X 在 65 歲以下患者具有降低死亡率與降低再次手術的效益，並仍預期這將轉化為全球更高的市占率。

Number three, we're pleased to announce that NEXUS is moving forward with our strategy and to acquire our partner, Endospan, following the FDA approval of NEXUS. This acquisition, if closed, will provide an additional near-term growth driver, position us at the forefront of this segment and significantly expand our pipeline with three additional PMA programs in development, extending our runway well beyond the initial approval.

第三，我們很高興宣布，NEXUS 正依我們的策略推進：在 NEXUS 取得 FDA 核准後，收購我們的合作夥伴 Endospan。若此收購完成，將提供額外的短期成長動能，使我們站上該細分市場的領先位置，並透過新增三項正在開發中的 PMA 計畫大幅擴充我們的產品線，讓我們的成長跑道遠超過初次核准之後。

And finally, number four, the ARTIZEN IDE trial. We continue to make progress in our third-generation Frozen Elephant Trunk trial called our Arcevo LSA. This clinical trial represents an incremental $80 million annual opportunity.

最後，第四，ARTIZEN IDE 試驗。我們在第三代 Frozen Elephant Trunk 試驗（我們稱為 Arcevo LSA）方面持續取得進展。此臨床試驗代表每年額外 8,000 萬美元的機會。

Finally, I want to thank our employees around the globe for the continued dedication to our mission of being a leading partner to surgeons focused on aortic disease. With that, operator, please open the line for questions.

最後，我要感謝全球員工持續投入，致力於我們的使命：成為專注於主動脈疾病之外科醫師的領先合作夥伴。接下來，接線員，請開放提問。

(Operator Instructions) John McAulay, Stifel.

（接線員指示）John McAulay，Stifel。

Hi, Pat and Lance. Thanks for taking the question. Just want to understand, I think, better on this guidance reset, what's exactly contemplated in it now? Because I think there's a few key assumptions in here. And the key one is exactly when AMDS receives PMA and then sort of more broadly, what kind of opportunity the PMA unlocks? And I guess the question of, is this truly conservative, adequate?

嗨，Pat 和 Lance。謝謝讓我提問。我想更清楚了解這次指引重設（guidance reset）現在到底納入了哪些內容？因為我認為這裡面有幾個關鍵假設。其中最關鍵的是 AMDS 何時取得 PMA，以及更廣泛來說，PMA 會解鎖（unlock）什麼樣的機會？我想問的是：這份指引是否真的保守、是否足夠？

Or how would you frame it in terms of, one, the expectations for when you get this AMDS approval? And then two, how should we think about the opportunity that, that approval unlocks in the context of the revenue ramp throughout the year?

或者你會如何框架（frame）來看：第一，你們對於何時取得 AMDS 核准的預期？第二，在全年營收爬升（revenue ramp）的脈絡下，我們應該如何看待該核准所帶來的機會？

Thanks, John. Yes. So, I would say a couple of things. One, there were two things that didn't go as planned in the first quarter, right? Number one was international stents were off, and that was mostly due to unplanned things. One was the Middle East and two was some supply chain challenges. Those are temporary, and we're working to fix those. And the second, as we pointed out, was the AMDS set sales. Those are the starter sets where the hospital has to buy four.

謝謝，John。是的。我會說幾點。第一季有兩件事沒有按計畫進行，對吧？第一是國際支架（stents）表現不如預期，主要是因為一些非計畫性的因素。一是中東，二是一些供應鏈挑戰。這些都是暫時性的，我們正在努力解決。第二，如我們指出的，是 AMDS 套組（set）銷售。那是入門套組（starter sets），醫院必須一次購買四套。

We do think that the PMA will help. We've been saying all along that we didn't think the PMA was going to be that much of a difference. But the closer we get to getting the PMA approval, there's some bureaucracy and work that the hospitals have to do to get these IRBs in place. And with the PMA so close, I think that they're just going to wait. So we do think that will be helpful.

我們確實認為 PMA 會有所幫助。我們一直以來都說，我們原本不認為 PMA 會帶來那麼大的差異。但越接近取得 PMA 核准，醫院端就有一些行政流程與工作要做，才能把這些 IRB 建置到位。而在 PMA 這麼接近的情況下，我認為他們可能就會選擇等待。所以我們確實認為這會有幫助。

So again, we're also working to knock down some of the barriers that we're seeing on getting these starter sets. The encouraging thing is that we saw, we were ahead of plan on the actual implants. So I think that's what we're working on right now is to make sure we can get access to these starter sets and working through that process.

另外，我們也正在努力排除我們在取得這些入門套組時看到的一些障礙。令人鼓舞的是，我們看到實際植入量（implants）是超出計畫的。因此我認為我們目前正在做的，就是確保能取得這些入門套組的進入權，並把流程逐步推進。

Lance, would you add anything there?

Lance，你要補充嗎？

Yeah. And then I would say we've been saying we expect PMA approval midyear. We still expect that. And then as far as what the guidance contemplates, I mean, it basically contemplates the trends we're seeing right now. I mean we're working to improve those, but that is probably going to take a little bit of time. And I think this is a prudent guidance given the trends we have right now.

是的。我會說，我們一直都在說預期 PMA 於年中核准。我們仍然這麼預期。至於指引納入了什麼，我的意思是，它基本上反映了我們目前看到的趨勢。我們正在努力改善，但這可能需要一點時間。我認為以目前的趨勢來看，這是一份審慎的指引。

Got it. That's helpful. And then I also wanted to hit on NEXUS here. So, you talked about working towards closing the acquisition. Just wanted to understand from this point forward, what you're doing as you work up to Jan 1, 2027 in terms of building out the commercial infrastructure from here, whether it be hiring and whatever else is required. So if you could just talk through sort of key next steps as you build to NEXUS, that would be great.

了解。這很有幫助。接著我也想談一下 NEXUS。所以，你提到正朝著完成這項收購邁進。我想了解從現在開始，到 2027 年 1 月 1 日之前，在建立商業化基礎設施方面你們會做些什麼——不論是招募人員或其他必要事項。所以如果你能談談在推進到 NEXUS 的過程中，接下來的關鍵步驟，那就太好了。

Yes. So, we're very excited about this NEXUS platform. As I mentioned in my comments, it's the third piece of the puzzle, right? It's AMDS, Arcevo, and NEXUS, and that really gives us a kind of a comprehensive portfolio for the Arch, we're basically going to have to do a few things to get ready.

是的。所以，我們對這個 NEXUS 平台感到非常興奮。如我在評論中提到的，它是拼圖的第三塊，對吧？也就是 AMDS、Arcevo 和 NEXUS，而這確實讓我們為 Arch 建立起一個相當完整的產品組合；基本上，我們需要做幾件事來做好準備。

Number one, we've got to go with through value analysis committees. So, as you've experienced with us with AMDS, it can take four to six months. So, we're going to use that time while we're doing that to do two things. One is building inventory and two is to hire dedicated clinical specialists for that. The good news about this is it's a very different market than AMDS in that there's only probably 100 accounts that are on our list to begin with. These are very high-end, high-volume accounts.

第一，我們必須通過價值分析委員會（value analysis committees）。所以，正如你在 AMDS 上與我們的經驗，這可能需要四到六個月。因此，在進行這件事的同時，我們會利用這段時間做兩件事。一是建立庫存，二是聘用專職的臨床專員。好消息是，這是一個與 AMDS 非常不同的市場，因為一開始我們名單上大概只有 100 個客戶。這些都是非常高端、用量很大的客戶。

We know who they are, and we can cover that call point with not a lot of reps. So, we're going to start hiring reps. We've already got a couple, and we're going to start hiring more as we go through the value analysis committee. So that's really going to be the two main focuses once we close this transaction, getting ready for a January one launch.

我們知道他們是誰，而且用不多的業務代表就能覆蓋這個拜訪點。所以，我們會開始招募業務代表。我們已經有幾位了，並且在通過價值分析委員會的過程中會持續招募更多。因此，一旦我們完成這筆交易，主要就會聚焦在兩件事上，為 1 月 1 日的上市做好準備。

Thanks. That's helpful. Thanks for taking the questions.

謝謝。這很有幫助。謝謝你回答問題。

Frank Takkinen, Lake Street Capital.

Frank Takkinen，Lake Street Capital。

All right. Thank you for taking the questions. I was just hoping to get maybe a little bit more color on some of the reordering and versus maybe a plateauing of new accounts. Just trying to kind of really understand the concept there of is it a factor of really new accounts are starting to slow down or the reordering isn't yet occurring? Because it feels like we've had a really steep trajectory with some of the initial ordering patterns and then we're just waiting for the reordering? Or is it the new ordering starting to plateau?

好的。謝謝你回答問題。我希望能多了解一些關於再訂購（reordering）以及新客戶是否進入平台期（plateauing）的情況。我想更清楚理解：是新客戶的增加真的開始放緩，還是再訂購尚未發生？因為感覺我們在初期下單模式上有非常陡峭的成長軌跡，然後現在只是等待再訂購？還是新下單開始進入平台期？

Yeah. Let me clarify. So we've started using this term starter sets, right, which is basically account that doesn't have AMDS. To get AMDS, they need to purchase four devices for $100,000, right? That is not kind of a normal practice. A lot of business will consign units or sell them lot of trunk stock. We are having hospitals they have to acquire four units.

是的。我來澄清一下。所以我們開始使用「starter sets（入門套組）」這個詞，基本上是指尚未擁有 AMDS 的客戶。要取得 AMDS，他們需要購買四台設備，金額是 10 萬美元，對吧？這並不是一種常見的做法。很多企業會採用寄售（consign）或以大量備貨（trunk stock）的方式銷售。而我們的情況是，醫院必須先取得四台設備。

The other piece of the equation is the actual implants of the existing accounts. So those actually went quite well, and we're ahead of our plan. So, we're very encouraged and pleased by the adoption of the technology of the accounts have purchased. What we're working on now is we've got a lot of accounts out there that have AMD kind of in the queue, and we're working through trying to get the units on the shelf.

方程式的另一部分是既有客戶的實際植入物（implants）使用量。那部分其實表現得相當好，而且我們超前於計畫。所以，我們對已購買的客戶對這項技術的採用情況感到非常鼓舞、也很滿意。我們現在在做的是：外面有很多客戶把 AMD 排在流程隊列中，我們正努力推進，讓設備能上架到庫存架上。

There could be a number of different barriers, whether it's the IRB or just the 100,000 upfront purchase getting someone. So, we're working on programs to kind of minimize and need that anything.

可能會有許多不同的障礙，不論是 IRB（機構審查委員會）或是 10 萬美元的前期採購，讓某些人卡在那裡。所以，我們正在推動一些方案，來盡量降低並減少對這些因素的需求。

No, I think that's, yes. So, I mean, in summary, there's the upfront $100,000 investment. And then every time that device gets used, they need to reorder a device. So, we call that the initial 1000 is a set sale and everything after that is implant sales. So, implant sales went great. They were actually ahead of our expectations and all the feedback we're getting on those is fantastic.

不，我想是的。所以，總結來說，有 10 萬美元的前期投資。然後每次那台設備被使用時，他們就需要再訂購一台設備。因此，我們把最初的 10 萬美元稱為套組銷售（set sale），之後的所有則是植入物銷售（implant sales）。所以，植入物銷售表現非常好。實際上超出我們的預期，而且我們收到的所有回饋都非常棒。

What we're running into is some barriers into getting this upfront $100,000 investment for a number of different reasons. We talked about the PMA and the IRB. There's also financial considerations. So, we're putting things in place now to try and help overcome those barriers, and we think we'll see a reacceleration of that set sales.

我們遇到的問題是，基於多種不同原因，在取得這筆 10 萬美元的前期投資上存在一些障礙。我們談過 PMA 和 IRB。也有財務方面的考量。所以，我們現在正在建立一些措施來協助克服這些障礙，我們認為套組銷售將會再次加速。

I think the other point on that, the $100,000 upfront lands on a financial person's desk and can get stuck there for a while. I think the thing that's very interesting about this is with the DRG-209 for complex arch work, there's very strong reimbursement for AMDS. But as you know, it takes a while to get that information disseminated out to the account. So, we're also working on making sure they have good visibility to the publicly available information on DRG-209 and what that means to their procedural billing.

我想另一點是，這 10 萬美元的前期支出會落到財務人員的桌上，可能會在那裡卡一段時間。我認為這件事很有意思的是，針對複雜主動脈弓（arch）手術的 DRG-209，AMDS 有非常強的給付（reimbursement）。但如你所知，要把這些資訊傳遞到各個客戶端需要一些時間。所以，我們也在確保他們能清楚看到公開可得的 DRG-209 資訊，以及這對他們手術申報（procedural billing）的意義。

Got it. That's very helpful. Thank you very much. And then maybe as a second one also on NEXUS. How should we think about kind of growth trajectory of this product? I know we've spoke about in the past that there's potentially a little bit more training upfront, but obviously, very novel, expect a strong growth trajectory coming out of that.

了解。這非常有幫助。非常感謝。另外第二個問題也關於 NEXUS。我們應該如何看待這個產品的成長軌跡？我知道我們過去談過，前期可能需要更多訓練，但顯然它非常新穎，預期會有很強的成長軌跡。

So maybe how should we kind of think about that as we're looking at 2027? And then is there a point in time that you can see that $8 million incremental cost be kind of offset by revenue that you're thinking about as you're thinking about the ramp?

所以，當我們看 2027 年時，應該如何思考？另外，你們提到的 800 萬美元增量成本，是否有一個時間點，你們預期在爬坡（ramp）過程中會被營收抵消？

Yeah. So, I think one of the things that's clear about this technology is that the vascular surgeons, they've got a lot of patients that aren't being treated right now because there's no option, right? These are patients that are too sick for cardiac surgery, and we now have a solution in the arch to treat those patients. They also adopt technology very rapidly because they really have had no, they've got a significant need.

是的。所以，我認為這項技術有一點很明確：血管外科醫師手上有很多病患目前沒有被治療，因為沒有選項，對吧？這些病患病情太重，不適合做心臟外科手術，而我們現在在主動脈弓領域有一個解決方案可以治療這些病患。他們也會非常快速地採用新技術，因為他們確實一直缺乏選項，而且需求非常大。

So, I think really, it's just the building blocks, right? It's like we've got to get through value analysis committees, which you're experienced with. We've got to train the surgeons. We've got to hire the team, and we've got to get the inventory in place. So, our goal is to really be ready to go by January one. And I think this technology has some real opportunity to drive growth for the company and also help a lot of patients along the way.

所以，我認為重點其實就是那些基礎建設的積木，對吧？就像我們必須通過價值分析委員會，你也有相關經驗。我們必須訓練外科醫師。我們必須招募團隊，並且必須把庫存準備到位。所以，我們的目標是在 1 月 1 日前真正做到隨時可以啟動。我認為這項技術確實有機會推動公司的成長，同時也能在過程中幫助很多病患。

So obviously, I want to get some cases under our belt. We know that the technology is very well appreciated. But we think it's going to do quite well. We'll obviously give you more information as we go into 2027.

所以很明顯，我希望我們能先累積一些案例。我們知道這項技術受到高度肯定。但我們認為它會表現得相當好。隨著我們進入 2027 年，我們也會提供你更多資訊。

Yeah, maybe a little information on the $8 million.

是的，也許可以再補充一些關於那 800 萬美元的資訊。

Just one other thing on NEXUS is different than AMDS, there won't be any set sales. So our revenue will come from implants only. And then on the $8 million, just a little more color on that. It kind of is broken up into, I would say, three pieces. One is some additional costs related to getting ready to launch the product that won't carry forward into next year. There is R&D and clinical-related expenses that are just going to be incremental this year.

另外關於 NEXUS 有一點跟 AMDS 不同的是，不會有任何套組銷售。所以我們的營收只會來自植入物。至於那 800 萬美元，再多補充一點背景。我會說它大致可分成三個部分。其中一部分是為了產品上市準備所產生的額外成本，明年不會延續。另外有研發與臨床相關費用，這些今年會是增量。

But as we roll into '27, we will make that fit into our normal 7% to 8% of sales. So it's not really incremental if you think about it from a '27 standpoint. And then there are some expenses, just run rate expenses of the sales force and some G&A that will carry forward. And we think that will be covered by the actual NEXUS revenue that we have in the US in 2027 and make it EBITDA neutral overall. So hopefully that makes sense.

但到了 2027 年，我們會把它納入我們正常的營收 7% 到 8% 的比例。所以如果從 2027 年的角度來看，它其實不算真正的增量。然後還有一些費用，就是銷售團隊的常態性費用以及部分 G&A（一般及行政）費用，這些會延續到之後。我們認為這些會由我們在 2027 年於美國的實際 NEXUS 營收所覆蓋，整體上使 EBITDA 影響為中性。希望這樣說得清楚。

Yeah. I think one other point, Lance, on the supply chain for this product, it's very different than AMDS. We're not making people buy it upfront. These are, AMDS cases are acute Type A, which is an emergency. So you have to have the stock on the shelf. Chronic dissections are elective.

是的。Lance，我想再補充一點，這個產品的供應鏈跟 AMDS 非常不同。我們不會讓客戶先行一次性購買。AMDS 的案例是急性 A 型，屬於緊急狀況。所以你必須把庫存放在架上備用。而慢性剝離則是選擇性手術。

So we have plenty of time beforehand to know exactly which size devices, and we'll ship them into the cases that will get paid at the case. So there's really going to be no stocking of the shelves and have that be a limiter. We're going to basically be able to support cases one by one as they need them.

所以我們在手術前有充足時間能確定需要哪些尺寸的器械，並把產品出貨到該手術案例，並在該案例中收款。因此基本上不會有把庫存放在架上、進而成為限制因素的情況。我們基本上可以依照需求逐案支援。

Got it. Very helpful. Thank you, guys.

了解。非常有幫助。謝謝各位。

Bill Plovanic, Canaccord Genuity.

Bill Plovanic，Canaccord Genuity。

Hey, great. Thanks. Good evening. Thanks for taking my questions. I just wanted to unpack the AMDS a little more in some of the commentary. So one of the challenges that's been brought up multiple times is starter set, and you mentioned strategies to get around this. Are you going to ship the product to consignment? Or is the strategy, you believe the PMA is really going to open up that? And is there a backlog?

嗨，很好。謝謝。晚安。謝謝回答我的問題。我想把你們一些評論中提到的 AMDS 再拆解得更清楚一點。所以多次被提到的一個挑戰是入門套組（starter set），你也提到一些因應策略。你們會把產品以寄售（consignment）的方式出貨嗎？還是你們的策略是認為 PMA 真的會把這件事打開？另外是否有積壓（backlog）？

And I guess what I'm kind of really trying to think back to, are we through the early adopter phase and now we're getting into a broader customer base, and it's just going to be a slower ramp for new accounts? And then lastly, on that list is what was the growth of the core stent business if you back out the AMDS, like it used to be about mid-teens. Kind of obviously, the growth came off a lot this quarter. Kind of what was that kind of core growth? Thanks.

我真正想回頭思考的是：我們是否已經度過早期採用者階段，現在正進入更廣泛的客戶基礎，而新帳戶的爬坡會比較慢？最後一點，如果把 AMDS 扣除，你們核心支架業務的成長是多少？以前大概是十幾%的中段。很明顯這一季成長放緩很多。那核心成長大概是多少？謝謝。

A lot there. Yes. Yes. So I would say we have plenty of hospitals. If you step back when we set the plan internal, our expectations for the year, we had plenty of accounts on our target list to hit the numbers that we set out. And like I said, we were pleased with the implants, the ongoing implants were ahead of what we expected.

問題很多。是。是。所以我會說，我們有足夠多的醫院。如果你退一步看我們內部制定計畫、對今年的預期，我們的目標名單上有足夠多的帳戶可以達成我們設定的數字。而且如我所說，我們對植入量感到滿意，持續性的植入量高於我們的預期。

So again, I think the challenges of getting into these hospitals this kind of upfront 100,000 purchase, we're not going to consignment. We could always have that be our last stop on the train, but that's not where we're going. We've come up with some programs to kind of address ways to address the barriers of this 100,000 upfront. We've got some programs for that.

所以再說一次，我認為進入這些醫院的挑戰在於這種前期 10 萬美元的採購；我們不會走寄售。我們當然可以把那當作最後一站的選項，但目前不是我們要走的方向。我們已經設計了一些方案，來處理這個 10 萬美元前期門檻的障礙。我們有一些對應的計畫。

We also mentioned the PMA that once the PMA is out, there's no longer an IRB, and we think that's going to be very helpful. So I think it's just really getting these accounts to kind of through these processes is what we're working on. And that's harder to control that timing than it is the actual implant timing. Do you want to.

我們也提到 PMA，一旦 PMA 下來，就不再需要 IRB，我們認為這會非常有幫助。所以我想我們正在做的，就是讓這些帳戶走完這些流程。而這些流程的時程比起實際植入的時程更難控制。你要不要。

Yeah. And then on the, we don't break out the details on US AMDS revenue as compared to all the international stent grafts. But I think you can tell just by looking at the geographic growth rates, the international growth was much lower than we typically expect this quarter for the reasons we've discussed.

是的。另外，關於美國 AMDS 營收相較於所有國際支架移植物（stent grafts）的細節，我們不會拆分揭露。但我想你可以從各地區的成長率看出來，國際市場這一季的成長明顯低於我們通常的預期，原因我們也已經討論過。

And you can also look at the North America growth rate, which you have to normalize a little bit for the comps in easy comps in Q4 and Q1. But if you do that, the North America growth rate is pretty similar in Q4 to Q1. So I think that would all point you to the slowdown was driven significantly by international, but AMDS US starter set sales were definitely below our expectations for the quarter.

你也可以看北美的成長率，不過需要稍微做一下常態化，因為 Q4 和 Q1 的比較基期較容易。但如果你這樣處理，北美的成長率在 Q4 到 Q1 其實相當接近。所以我認為這些都指向：這次放緩主要是由國際市場顯著驅動；但 AMDS 在美國的入門套組銷售確實低於我們對本季的預期。

Yeah. And then kind of on that same topic is I think when we started out in the launch in the first quarter last year, talked about 140 targeted accounts. And I think it was like 600 full potential, and that was opening up over time. Can you give us anything on kind of what you feel the targeted number of accounts will be in total or where you are targeting today, kind of how far you've penetrated that? Just so we get an understanding of if there's 600 hospitals, are you in 150 or are you in 600 and then it's all resale from reuse from here versus starter kits?

是的。同樣在這個主題上，我記得我們在去年第一季啟動上市時，提到 140 個目標帳戶。我想當時也提到大概有 600 個具完整潛力的帳戶，會隨時間逐步開放。你們能否分享一下，你們認為目標帳戶的總數會是多少，或是你們今天的目標範圍、目前滲透到什麼程度？這樣我們才能理解：如果有 600 家醫院，你們是進到 150 家，還是已經進到 600 家，接下來就主要是重複使用帶來的再銷售，而不是入門套組？

Yeah. that's a good question, Bill. I mean we haven't broken that out. I mean, I think I would just say at this point, we still have plenty of opportunity to sell starter sets. I think as we move along, we'll consider giving a little more detail on that because at some point, that the starter set is a onetime revenue thing that won't repeat, and it's the implants that matter the most long term. So we'll consider giving you a little more information on that later down the line, but not breaking that out at the moment.

是的，這是個好問題，Bill。我們目前沒有把這個拆開來揭露。我想我只能說，就目前而言，我們仍然有很多銷售入門套組的機會。我認為隨著時間推進，我們會考慮提供更多細節，因為到某個時間點，入門套組是一次性營收，不會重複；長期最重要的是植入量。所以之後我們會考慮再提供你更多資訊，但目前暫時不拆分。

Okay. And just on NEXUS, you're pushing it to a '27 launch. Is manufacturing scaled and ready to go? Or is that something you need to really invest a lot in as companies transition from PMA approvals to commercial, sometimes that can be a challenge, but I believe this is being sold in Europe. So I assume that commercial is scaled, the manufacturing, but I want to ask the question.

好的。另外關於 NEXUS，你們把上市推到 2027 年。製造端是否已經擴產並準備就緒？還是說你們需要投入很多資本與資源？因為公司從 PMA 核准轉到商業化時，有時候會遇到挑戰；但我相信這產品在歐洲已經有在銷售。所以我推測商業化與製造應該已經具規模，但我還是想確認一下。

Yeah. So I mean, yes, they're manufacturing today. So it's not like they're going from no manufacturing to having to start because they've been manufacturing, we've been selling the product in Europe for over five years. But we do need to expand that and then we actually need to build the inventory.

是的。所以我的意思是，是的，他們目前就在製造。所以不是從零製造到必須開始生產，因為他們一直在製造，而且我們在歐洲銷售這個產品已經超過五年。但我們確實需要擴充產能，然後也需要建立庫存。

I mean, as you can imagine, this company, they had an agreement with us essentially for us to acquire them upon PMA approval. They really had no intention of ever commercializing the product. They did not spend any money to build product for a US launch like we would have if we had owned the business. So now there's a little bit of scale up, but mainly it's just, we just got to, these guys build the product.

我的意思是，如你所能想像的，這家公司基本上與我們有一項協議，也就是在PMA核准後由我們收購他們。他們其實從來沒有打算把這個產品商業化。他們沒有花任何錢去打造可用於美國上市的產品；如果當時是我們擁有這門業務，我們就會那樣做。所以現在需要做一點規模放大，但主要就是——我們得讓這些人把產品做出來。

Thanks for taking my questions.

謝謝讓我提問。

Thanks, Bill.

謝謝，Bill。

Suraj Kalia, Oppenheimer.

Suraj Kalia，Oppenheimer。

Hi, Lance. This is Shaymus on for Suraj. Thank you for taking our questions. Just to start, I know we've kind of been hammering on AMDS, and apologies is going to keep in on that a little bit. But I guess, can you quantify kind of how many accounts are kind of deferring AMDS for this PMA approval? I mean, is this the first time you kind of called it out?

嗨，Lance。我是代替Suraj的Shaymus。謝謝讓我們提問。先從這裡開始，我知道我們一直在反覆追問AMDS，先說聲抱歉，我還是想再就這點多問一些。不過我想問的是，你能否量化一下，大概有多少客戶帳戶因為等待這次PMA核准而延後AMDS？我的意思是，這是你們第一次特別點出來嗎？

Has this been kind of an ongoing trend you've seen and now it's kind of just coming more to ahead? Or anything on that? And just with that, should we expect kind of a bolus once you kind of get this PMA approval in this? Is it kind of been once they kind of get that $100,000 bill of the starter set that they say, 'hold on, we want to wait until maybe PMA?' Or just any color there you can give? Thank you.

這是否一直是你們看到的趨勢，只是現在變得更明顯？或是有任何相關補充？另外，基於這點，我們是否應該預期在你們拿到這個PMA核准後會出現一波「衝量」？是不是他們一看到入門套組要付10萬美元的帳單，就會說「等一下，我們想等到也許拿到PMA再說」？或是你能提供任何相關背景？謝謝。

Yeah. No. So let me take that. Like I said, we've been saying for, I think, pretty much every quarter that we didn't really see the PMA as a big catalyst for good growth. I think what's happened is what we've seen is, I'll give you a great example. We have to go to an IRB in a hospital and the surgeon has to take four hours of training. And surges like when are you going to get the PMA, it's like sometime in the second quarter.

是的。不。我來回答這個。如我所說，我們在我想幾乎每一季都在講，我們並不認為PMA會是推動強勁成長的一個重大催化劑。我認為實際發生的是——我給你一個很好的例子。我們必須到醫院走IRB流程，而且外科醫師必須接受四小時的訓練。而外科醫師會問你們什麼時候拿到PMA？我們會說大概在第二季的某個時間。

So they guys like, well, I'll just wait. I'm not going to do four hours of training for this IRB, right? It's just a practical thing. We do have a number of accounts. We're not going to get specifics on how many accounts are this, how many accounts are that. But we do see the PMA two quarters ago, it really didn't matter. But now as it gets closer, I think people are not wanting to do the work for the IRB, and we see that as an opportunity when it comes out, and that's contemplated in our guidance.

所以他們就會說，那我就等一下。我不會為了這個IRB去做四小時訓練，對吧？這只是很實際的考量。我們確實有一些客戶帳戶是這樣。我們不會具體說明有多少帳戶是這種情況、多少帳戶是那種情況。但我們確實看到，兩季前PMA其實不太重要。但現在隨著時間越來越近，我認為大家不太想為了IRB去做那些工作；我們把這視為一個機會，等它核准出來時就會反映出來，而這也已經納入我們的財測指引。

Got it. I appreciate that. And then kind of just on the cross-selling opportunities you guys have had with On-X via, it's been about a year. Obviously, you've kind of seen that. Any difference you've been seeing kind of in physician utilization for those? Are they kind of ramping up on a similar curve that you've seen for those that you've taken on? Or is it kind of just been something that kind of added to our portfolio, but it's been, I'd say, minimal at best? Thank you.

了解。謝謝你的說明。接著想問一下你們透過On-X所帶來的交叉銷售機會，已經差不多一年了。顯然你們也看到了相關情況。在醫師使用行為上，你們有看到任何差異嗎？他們的採用爬坡曲線是否與你們過去接手的產品類似？還是說它只是被加入到我們的產品組合中，但到目前為止充其量影響很小？謝謝。

Yeah, it's a great question. I think it really speaks to our strategy. We are a valve company that treats patients under 65 with Ross and with On-X, and we're an Aortic Arch company. And if you think about our interactions, I just came from ATS. I met with 20 top aortic surgeons. They were involved in the PERSEVERE trial. They're involved in ARTIZEN. They were involved in the TRIOMPHE trial.

是的，這是個很好的問題。我認為這其實很能說明我們的策略。我們是一家瓣膜公司，透過Ross與On-X治療65歲以下的病患，同時我們也是一家主動脈弓（Aortic Arch）公司。如果你想想我們的互動，我剛從ATS回來。我與20位頂尖的主動脈外科醫師會面。他們參與了PERSEVERE試驗。他們也參與ARTIZEN。他們也參與TRIOMPHE試驗。

So if you think about it, we're going to be, if you fast forward kind of go through even the next three quarters, we're training AMDS centers and we have these kind of AMDS trainings. We're going to have NEXUS trainings, and we bring the heart surgeon and the vascular surgeon. All of those events, we have ARTIZEN investigator meetings.

所以如果你這樣看，往後推進、甚至看接下來三個季度，我們會培訓AMDS中心，並進行這類AMDS訓練。我們也會有NEXUS訓練，而且我們會把心臟外科醫師與血管外科醫師一起帶來。在所有這些活動中，我們也會舉辦ARTIZEN研究者會議。

All of those events are ways for us to continue to build our relationship with the aortic surgeons, both on the cardiac and vascular side and deliver our messages across all of our products, whether it's On-X for bioprosthetic, whether it's AMDS in acute Type A or whether it's NEXUS in the arch, it's very kind of complementary, right?

所有這些活動，都是我們持續深化與主動脈外科醫師（心臟端與血管端）的關係、並把我們在所有產品上的訊息傳遞出去的方式——不論是用於生物瓣膜的On-X、用於急性A型的AMDS，或是用於主動脈弓的NEXUS——它們彼此非常互補，對吧？

It's all about the aorta. And I think the more we do, just the more powerful that we become. So, we're already seeing the cross-selling, but it's just going to get better because we're going to do, our first NEXUS training will have 25 centers with 25 vascular surgeons and 25 cardiac surgeons. I always go to present and we'll talk about AMDS, we'll talk about On-X. So again, I think it's just, we're surrounding the cardiac and vascular surgeon for the arch.

核心都圍繞著主動脈。我認為我們做得越多，我們就會變得越有力量。所以，我們已經看到交叉銷售，但它只會變得更好，因為我們的第一場NEXUS訓練將涵蓋25個中心、25位血管外科醫師與25位心臟外科醫師。我總是會上台報告，我們會談AMDS，也會談On-X。所以再說一次，我認為這就是——我們在主動脈弓領域把心臟與血管外科醫師都包圍起來。

Thank you.

謝謝。

Jeffrey Cohen, Ladenburg Thalmann.

Jeffrey Cohen，Ladenburg Thalmann。

Hi, Pat and Lance. Thanks for taking the questions. Two from us. I guess you did touch upon it with NEXUS, but I wanted to know any updates as far as the commercial organization, both US, EU and perhaps Japan, W2s and 1099s as far as trends, puts and takes for, say, the balance of this year that we should anticipate.

嗨，Pat和Lance。謝謝讓我提問。我們有兩個問題。我想你們確實提到了NEXUS，但我想了解一下商業組織方面的最新情況——包括美國、歐盟，或許還有日本——就W2與1099（人員編制/聘用型態）而言，今年剩餘時間我們應該預期哪些趨勢、哪些增加與減少？

And this is for NEXUS Jeff?

Jeff，這是針對NEXUS嗎？

Well, you addressed NEXUS. I was thinking of everything else.

嗯，你已經談到NEXUS了。我想問的是其他所有部分。

Yeah. I mean I think, Jeff, same thing said that Pat talked about we're going to have to hire some specialists for NEXUS. But other than that, I mean, sales force adds would be, I mean, fairly limited across the globe and still highly leverageable with our focused sales force.

是的。我的意思是，Jeff，我想同樣的重點如Pat所說，我們確實需要為NEXUS聘用一些專家型人員。但除此之外，我的意思是，全球範圍內的銷售人力增加應該會相當有限，而且在我們聚焦的銷售團隊架構下仍然具有很高的槓桿效益。

Yeah. And just a couple of points on NEXUS, right? I think I mentioned earlier, our initial target is like 100 accounts. We can cover that with a pretty small team, a dedicated team because they are elective cases, and we can cover those out of kind of central locations. We do have, as part of this acquisition, we do have a relationship with a distributor in Japan, who's got a dedicated team on the ground and is very good.

是的。再補充幾點關於NEXUS，對吧？我想我先前提過，我們初期的目標大概是100個客戶帳戶。我們可以用一個相當小的團隊、專責團隊來覆蓋，因為這些是選擇性手術案例，而且我們可以從一些中心據點來支援這些帳戶。另外，作為這次收購的一部分，我們在日本與一家經銷商有合作關係；他們在當地有一支專責團隊，而且做得非常好。

So, we've already got the commercial infrastructure in Japan. We just have to work through that approval process. And again, like I said, we haven't owned the company. So, we really are just starting those conversations now, but that's pretty well developed.

所以，我們在日本已經具備商業基礎設施。我們只需要把核准流程走完。再者，如我所說，我們之前並未擁有這家公司。因此，我們其實現在才剛開始進行這些對話，但整體而言這部分已經相當成熟。

Got it. Okay. And as a follow-up, can we touch upon the tissue business. It was a strong quarter. I know it was extensively comp last year. But could you talk about that a little bit as far as any puts and takes or trends on the balance of the year? And maybe any commentary on cardiac versus vascular, loss procedures, et cetera?

了解。好。接著追問一下，我們能談談組織（tissue）業務嗎？這一季表現很強。我知道去年基期比較高、比較難比。但能否稍微談談今年剩餘期間有哪些拉抬與抵銷因素或趨勢？以及是否能評論一下心臟（cardiac）相較於血管（vascular）、灌流不足（malperfusion）相關手術等等？

Yeah. Maybe I'll take that one on the preservation. I think we told people to kind of think about that as a $24 million a quarter business. We obviously did a little bit better than that this quarter. I think that's great. I would put that within the realm of normal quarterly fluctuations.

可以。也許我來回答保存（preservation）這一塊。我想我們之前跟大家說過，可以把它大致視為每季約2,400萬美元的業務。這一季我們顯然比那個水準好一些。我覺得這很好。我會把它視為正常的季度波動範圍之內。

So if it's a little bit less in the future quarter, I wouldn't read anything into that. As long as it's kind of in the ZIP code of that $24 million and averaging out to that to the year, that would be in line with what we expect. So this quarter was good. It would be great if we can keep that going, but don't be surprised if it dips down a little bit in future quarters.

所以如果未來某一季稍微低一點，我不會對此做過度解讀。只要大致落在每季2,400萬美元這個區間，全年平均也接近這個水準，就符合我們的預期。所以這一季表現不錯。如果能延續當然很好，但未來幾季若稍微回落也不用意外。

Okay. Got it. That is helpful. Thanks for taking the questions.

好。了解。這很有幫助。謝謝回答問題。

Mike Matson, Needham & Company.

Needham & Company 的 Mike Matson。

Thanks for taking my question. I guess just starting with AMDS, I mean, I understand the commentary around consignment and these $100,000 sets. But I guess, why not put it on consignment? I didn't really hear you address that. Is it just tying up too much of your company's capital and the inventory that will be sitting on hospital shelves? Or is there some other reason that you're requiring the hospitals to have this big expense to get started?

謝謝讓我提問。我想先從 AMDS 開始。我理解你們對寄售（consignment）以及這些10萬美元套組的說法。但我想問的是，為什麼不採用寄售？我沒有真正聽到你們回應這點。是因為會占用公司太多資金，且庫存會放在醫院的貨架上嗎？還是有其他原因，讓你們要求醫院一開始就要負擔這麼大的費用？

Yes. I mean I think, look, you can always flip the consignment, you can never flip back, right? It's an emergency case. They need it on the shelf. It needs to be there. It's a differentiated product, has incredible reimbursement. And we think it's something that they should stock. And that's how we launched the product. We have a lot of accounts that have made the purchase. I think we just kind of hit a point where we're starting to see as we get further down the list, some resistance to that, that we had not seen in the past. And now it's just our job to overcome that barrier, right?

是。我的意思是，我想你看，寄售你隨時可以改成寄售，但一旦改成寄售就很難再改回來，對吧？這是急診案例。他們需要把它放在架上。它必須在那裡。這是差異化產品，報銷（reimbursement）非常好。我們認為這是他們應該備貨的東西。而這就是我們推出產品時採用的方式。我們有很多客戶已經完成採購。我想我們只是到了某個點：當我們往名單後段推進時，開始看到一些阻力，而這是過去沒有看到的。現在就是我們的工作去克服這個障礙，對吧？

I mean it's been great if we've seen it earlier. But now we see it. We have multiple levers that we're pulling to try and get over those barriers. And I'm sure we'll run into additional ones as we move along, and we'll come up with solutions for those as well. But we're not going to throw in at the first time of resistance. We need to work to overcome the barrier.

如果能更早看到當然更好。但現在我們看到了。我們正在動用多個槓桿來嘗試跨越這些障礙。我相信隨著我們繼續推進，還會遇到其他障礙，我們也會提出相應的解決方案。但我們不會在第一次遇到阻力時就放棄。我們必須努力去克服這個障礙。

Okay. Understand.

好。理解。

Yeah, I think --

是，我想--

Yeah, go ahead, sorry.

是，你先說，不好意思。

No, I was just going to say, I mean, to Lance's point, it's extremely compelling data. We have a device that can turn a non-malperfusion patient or malperfusion patient into a non-malperfusion patient, both in terms of mortality and restore blood flow. We have a device that eliminates in which carries a 20% difference in reoperation or 30% difference in reoperation at 10 years and a 20% difference in mortality at 50 years. I mean it's like super compelling data.

不，我只是想說，呼應 Lance 的觀點，這些數據非常有說服力。我們有一個裝置，能把原本沒有灌流不足（non-malperfusion）的病人，或有灌流不足（malperfusion）的病人，轉變成沒有灌流不足的狀態，無論是在死亡率或恢復血流方面。我們有一個裝置可以消除某種情況，而那種情況在10年時的再手術率（reoperation）差異達20%或30%，在50年時的死亡率差異達20%。我的意思是，這些數據真的非常有說服力。

It's an emergency. There hasn't been an innovation in the space in 50 years, and it's got the best DRG in the market. Like you should buy those, and we're working on it. So again, it's a fair point, but I think the most important one is like once you do it, like we ever started doing that in whatever field, like they never stop.

這是急診。這個領域50年來沒有創新，而且它在市場上有最好的 DRG（診斷相關群）給付。所以你就應該買，我們也正在努力推進。所以再說一次，這個問題問得很公平，但我認為最重要的是：一旦你開始在任何領域這麼做，他們就不會再停下來。

Yeah, I understand. Okay. And then on the international issues in stent grafts, you called out the Middle East as well as distributor destocking in some of the other regions. So, can you, I know you're probably not going to quantify them in terms of dollars, but which of the two is bigger? Is it Middle East the bigger problem? Are they similar in terms of the impact?

是，我理解。好。另外關於支架型人工血管（stent graft）在國際市場的問題，你們提到中東，以及其他一些地區的經銷商去庫存（destocking）。所以你能否說明一下——我知道你們可能不會用金額量化——這兩者哪一個影響比較大？是中東比較大的問題嗎？還是兩者影響程度差不多？

Yeah. It was about half and half. I mean, clearly, we didn't, we have a pretty significant business in the Middle East, and we obviously didn't contemplate what's going on there to have an impact and it did. We also had some supply chain things in the quarter that we weren't anticipating. So I think the combination of those two things was not something we had planned on.

是。大概各占一半一半。很明顯，我們在中東有相當可觀的業務，而我們當然沒有預期那邊正在發生的事情會造成影響，但確實造成了影響。另外這一季我們也遇到一些供應鏈狀況，是我們原本沒有預料到的。所以我認為這兩件事的組合，是我們事前沒有規劃到的。

Yeah. Okay. And then the revenue guidance, the 7% to 11% organic, or sorry, constant currency, does that, what are your assumptions there about the AMDS sets and then the international stent graft sales? Is it, are you assuming any improvement? Or is it maybe like no improvement at the low end and some improvement at the high end of the range or something like that?

是。好。再來關於營收指引：7%到11%的有機成長——抱歉，是以固定匯率（constant currency）計——你們在那裡對 AMDS 套組以及國際支架型人工血管銷售的假設是什麼？你們是否假設會有改善？還是說區間低端假設沒有改善、高端假設有一些改善之類的？

There's definitely some improvement expected for AMDS set sales. It's just at a rate that was lower than it was originally anticipated. And so I think rough numbers, if you want to think about the guidance reduction, think about half of that is kind of AMDS set sales and half of that is international stent grafts. And the international stent grafts is kind of split roughly evenly between the Middle East situation and the supply chain situation that we're working through.

AMDS 套組銷售確實預期會有一些改善。只是改善的速度比原先預期的要慢。所以如果你想用粗略數字來看指引下修的原因，可以把它想成大約一半來自 AMDS 套組銷售，一半來自國際支架型人工血管。而國際支架型人工血管的部分，又大致平均分攤在中東情勢與我們正在處理的供應鏈狀況上。

Okay. Got it. Thank you.

好。了解。謝謝。

Danny Stauder, Citizens.

Citizens 的 Danny Stauder。

Yeah, great. Thanks for taking the questions. Just for my first one on AMDS, just on the reordering behavior. Good to see that, that was strong. But could you expand on any trends here? Why has usage been more than you expected? Are multiple surgeons utilizing at some of your larger accounts? Or just anything more here about what's going on or some dynamics would be great.

是，很好。謝謝讓我提問。我第一個問題是關於 AMDS 的再訂購（reordering）行為。很高興看到那部分很強勁。但你能否延伸談談這裡的趨勢？為什麼使用量會超出你們的預期？是在一些較大的客戶中有多位外科醫師在使用嗎？或是能否多分享一些目前發生的狀況或動態？

No, it's actually, it's a good question because I mean, one of the things that's really interesting, we knew it, but it's something that we're working on as well, which is typically, what happens is you have a surgeon come from an account who goes to the training program and he goes back and starts to implant. But then he starts to train his partners or his partner goes to a training program.

不，這其實是個好問題。因為我的意思是，有一件很有趣的事：我們其實知道，但也正在針對它做一些工作。通常會發生的是，有一位外科醫師從某家醫院去參加訓練課程，回去之後開始植入。接著他會開始訓練他的合夥人，或是他的合夥人也去參加訓練課程。

So in a lot of these bigger centers, there's two or three or four guys that do these acute type A dissections in the middle of the night. And we trained in hospital, but there's four people that take calls. So we're also having to train more and more surgeons. So again, it takes time, but that's what I think we're seeing is that it's spreading in the accounts. So when we open account, if you have one guy using and all use, you get more usage. So we were pleased with the reorder pattern in the quarter was ahead of our expectations.

因此在許多這些較大的中心，半夜會有兩三位或四位醫師處理這類急性 A 型主動脈剝離。我們在院內進行培訓，但有四個人輪值接聽值班。所以我們也必須培訓越來越多的外科醫師。所以同樣地，這需要時間，但我認為我們看到的是，它正在在各個客戶中擴散。因此當我們開立一個帳戶時，如果原本只有一位醫師在使用、後來大家都使用，就會帶來更多用量。所以我們對本季的再訂購模式感到滿意，表現超出我們的預期。

Great. And just following up on that, could you remind us if there's any different margin contribution from reordering sales compared to initial orders because gross margins were still pretty strong during the quarter despite some of the AMD starter softness. So just trying to get a hold of the dynamics here. And any more color would be awesome. Thank you.

很好。再追問一下，您能否提醒我們：再訂購的銷售相較於首次下單，在毛利貢獻上是否有任何差異？因為儘管本季 AMD 起始套件（starter）有些疲弱，毛利率仍然相當強勁。所以只是想掌握這裡面的動態。如果能再多提供一些說明就太好了。謝謝。

Yeah, there's no meaningful difference in gross margin in both are also.

是的，兩者在毛利率上沒有任何實質差異。

Great. Simple enough. Thank you.

很好。夠簡單明瞭。謝謝。

Thanks, Daniel.

謝謝你，Daniel。

Keith Hinton, Freedom Capital Markets.

Freedom Capital Markets 的 Keith Hinton。

Great. Thank you. Great. I just have one on On-X and then one on NEXUS. So for On-X, can you talk a little bit about the current usage, how that splits between younger patients and older kind of before this data came out and then where it is today? Yes. And then I'll follow up.

很好。謝謝。很好。我只有一個關於 On-X 的問題，然後一個關於 NEXUS 的問題。先談 On-X：你能否談談目前的使用情況，在這些數據出來之前，年輕病患與年長病患的使用占比大概如何分布，以及今天的情況又是如何？是的。然後我再追問。

Yeah. So we, unfortunately, we don't get like real-time data on like where the surgeon puts a valve and sends us a postcard and tells us how old the patient was, right? We just, we've got historical data of roughly kind of where our patient populations are. So real time, that's not something we have access to.

是的。所以很可惜，我們拿不到像即時數據那樣的資訊，例如外科醫師把瓣膜植入後寄張明信片告訴我們病患幾歲，對吧？我們只有歷史數據，大致了解我們的病患族群分布。所以即時而言，這不是我們能取得的資料。

I can tell you, just based on, like I said, I just came from ATS, there's lots of conversation about these papers that have been published showing a mortality benefit to mechanical valves in patients under 60 and almost a 20% reoperation benefit at 10 years in mechanical valves versus tissue valves under 65.

我可以告訴你，僅就我剛才說的、我剛從 ATS 回來的觀察，大家對已發表的這些論文有很多討論：顯示在 60 歲以下病患中，機械瓣膜具有死亡率獲益；而在 65 歲以下族群中，機械瓣膜相較於組織瓣膜，在 10 年時點幾乎有 20% 的再手術獲益。

So we're in the process of getting that data out, and we are definitely growing our share in the bioprosthetic space, which previously we had not. So I think that the fact that a lot of our growth is coming from kind of, when you say older, it's like 50- to 65-year olds because our focus is under 65, and that's really the segment we're going after.

所以我們正在把這些數據推廣出去，而且我們在生物瓣膜（bioprosthetic）領域的市占確實在成長，而過去我們並沒有。所以我認為，我們很多成長來自於你所說的「年長」族群，其實大概是 50 到 65 歲，因為我們的重點是 65 歲以下，而這正是我們鎖定的區隔。

Great, thanks. And then just on the go-forward plan for NEXUS, can you talk a little bit about whether there are plans to bring the Duo and Tre into the US? And if so, what are kind of the regulatory steps required there? And then logistically, do you see it as an issue to have a custom-made product coming from Israel into the US just in terms of lead times?

很好，謝謝。接著談 NEXUS 的後續計畫：你能否談談是否有計畫把 Duo 和 Tre 引進美國？如果有，大概需要哪些法規／監管步驟？另外在物流上，你是否認為從以色列把客製化產品運到美國，在交期（lead time）方面會是個問題？

Yeah. So a couple of things. It's obviously still early. We don't own the company yet. We're in the, we triggered our option. So we just have to do the kind of customary paperwork to close the transaction. But we've already been working with their team. We've got great collaboration across the two companies.

是的。有幾點。顯然現在還很早期。我們還沒有擁有這家公司。我們已觸發我們的選擇權。所以我們只需要完成一些慣例性的文件作業來完成交易交割。但我們已經在和他們的團隊合作。兩家公司之間的協作非常好。

So we are planning on bringing the Duo tray to the US It will require, we have not met with the FDA on it yet. So this is just kind of my kind of spitballing, but it will require a clinical trial. It's a, we will have an off-the-shelf version. I think what's new is that we will have an off-the-shelf version, not a custom-made version. So that's, I think, some of the innovation there.

所以我們計畫把 Duo 托盤（tray）引進美國。這將需要——我們尚未就此與 FDA 會面。所以這只是我先做一些推估，但它將需要一項臨床試驗。它是——我們會有一個現成品（off-the-shelf）版本。我認為新的地方在於：我們會提供現成品版本，而不是客製化版本。所以我想這就是其中的一些創新。

So we're in the process of working on the timing of that, what that looks like, and we'll give an update on our pipeline once we've acquired them and digested it and are able to kind of come back to you guys with an updated pipeline.

所以我們正在規劃其時程、以及具體會是什麼樣子；一旦我們完成收購、消化整合後，我們會更新我們的產品管線（pipeline），並能回來向各位提供一個更新後的管線說明。

Okay, great. Thank you.

好的，很好。謝謝。

Bill Plovanic, Canaccord Genuity.

Canaccord Genuity 的 Bill Plovanic。

Hey, great. Thanks. Thanks for taking my follow-up. Just there's been some discussion on supply chain challenges, and it sounds like that is going to continue to impact going forward for the comments. So I was just wondering if you could unpack that and help us understand more of what exactly it is? What's the, have you ring-fenced the issue? What's the solution? And what's the timing? Thanks.

嗨，很好。謝謝。謝謝接受我的追問。剛才有一些關於供應鏈挑戰的討論，聽起來這在未來一段時間仍會持續影響你們的表現與評論。所以我想請你們拆解說明一下，幫我們更了解到底是什麼問題？你們是否已經把問題範圍圈定（ring-fenced）？解決方案是什麼？時程如何？謝謝。

Yeah. So we're not get into a ton of detail, but I'd say we have ring-fenced the issue. It has somewhat to do with our supplier network, but we've got our arms around that. We feel confident about solving it, but it will take a little bit of time. And the time to solve it is what is contemplated in our guidance. But it's not, I'd say it's, we've moved on into execution of the solution stage, if that makes sense.

是的。所以我們不會談太多細節，但我會說我們已經把問題範圍圈定了。它在某種程度上與我們的供應商網絡有關，但我們已經掌握住了。我們對解決它有信心，但仍需要一點時間。而解決所需的時間已反映在我們的財測指引中。但我會說，如果這樣講得通的話，我們已經進入解決方案的執行階段。

And how much of your portfolio does it impact?

那它影響你們產品組合的比例有多少？

It's not broadly across the graft portfolio. It's specific to a small number of products.

它並不是廣泛影響整個移植物（graft）產品組合。它只針對少數幾個產品。

Okay, great. Thanks.

好的，很好。謝謝。

Mr. Mackin, we have reached the end of the question-and-answer session. I'd now like to turn the call back over to management for closing comments.

Mackin 先生，我們已到達問答環節的結束。現在我想把電話交回管理層作結語。

Yes. Well, thank you for joining the call, and we're super excited about the Endospan transaction, and we'll be working to close that. And I think this is an exciting day for the company because it's kind of the final piece to the puzzle of our Aortic Arch solutions. We have AMDS approved with an HDE in the US right now. We're hoping to get PMA in midyear.

是的。感謝各位參與本次電話會議，我們對 Endospan 這筆交易感到非常興奮，並將努力完成交割。我認為這對公司而言是令人振奮的一天，因為它某種程度上是我們主動脈弓解決方案拼圖的最後一塊。我們目前在美國已取得 AMDS 的 HDE 核准。我們希望在年中取得 PMA。

We've got NEXUS just got FDA approval, and you heard about our plans to launch that. And we've got ARTIZEN that's enrolling ahead of schedule, which is our next. We've got three PMAs in the arch, one approved, one about to be approved and then one on its way. So very excited in what that means for the company and appreciate your support as we continue to build this aorta company.

我們的 NEXUS 剛獲得 FDA 核准，你也聽到我們對其上市的計畫。另外，我們的 ARTIZEN 招募進度超前於計畫，這是我們下一個項目。我們在主動脈弓領域有三個 PMA：一個已核准、一個即將核准，另一個正在推進中。所以我們對這對公司所代表的意義感到非常興奮，也感謝各位在我們持續打造這家「主動脈公司」過程中的支持。

Thank you. This concludes today's call. You may disconnect your lines at this time. And we thank you for your participation, and have a wonderful evening.

謝謝。今天的電話會議到此結束。您現在可以掛斷電話線。感謝您的參與，祝您今晚愉快。