Artivion Inc (AORT) 2023 Q4 法說會逐字稿

Greetings and welcome to the Octavian Fourth Quarter and Year End 2023 financial conference.

歡迎參加 Octavian 2023 年第四季和年終財務會議。

Yes, at this time, all participants are in a listen only a brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone. As a reminder, this conference is being recorded, so we'll now turn the call over to Lynn Morgen from the Gilmartin Group. Thank you. You may begin.

是的，此時，所有參與者都在聆聽，在正式演示之後將進行簡短的問答環節。如果有人在會議期間需要接線員協助，請按電話上的星號零。提醒一下，本次會議正在錄音，因此我們現在將電話轉給吉爾馬丁集團的 Lynn Morgen。謝謝。你可以開始了。

Good afternoon and thank you for joining the call today. Joining me today from a TV and management team are Pat Mackin, CEO., and Lance Berry, CFO.

下午好，感謝您今天加入電話會議。今天與我一起參加電視和管理團隊的有執行長 Pat Mackin 和財務長蘭斯貝裡 (Lance Berry)。

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. 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 and 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 activity on our website. Now I'll turn it over to BNCEO. Pat Mackin.

在我們開始之前，為了遵守 1995 年《私人證券訴訟改革法案》的安全港要求，我想做出以下聲明。本次電話會議的前瞻性評論涉及風險和不確定性，屬於 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。前瞻性陳述包括有關公司或管理階層對未來的意圖、希望、信念、期望或預測的陳述。這些前瞻性陳述受到許多風險、不確定性、估計和假設的影響，這些風險、不確定性、估計和假設可能導致實際結果與這些前瞻性陳述有重大差異，並且包含有關可能影響這些前瞻性陳述的某些風險和不確定性的其他資訊不時出現在公司向 SEC 提交的文件和今天早些時候發布的新聞稿中。您還可以在我們網站上活動的投資者關係部分找到簡短的演示，其中重點介紹了今天電話會議的詳細資訊。現在我將把它交給 BNCEO。帕特·麥金。

Fairfax, Wayne, and good afternoon, everybody. I want to start off our call today by welcoming Lance Berry, our new Executive Vice President and Chief Financial Officer. Lance most recently served as Executive Vice President and Chief Financial Officer and Operations Officer at Wright Medical until the acquisition by Striker in November of 2020. We are thrilled to have Lance join our team during this exciting time, I am confident his broad expertise and proven leadership in medtech will add significant value to our TV on as we enter the next phase of profitable growth I'd also like to thank Ashley Lee for his many years of dedicated service start to be on his contributions. No doubt helped make our TV and the outstanding company. We are today now on to our fourth and Fourth Quarter and Full Year 2023 results. 2023 was an outstanding year for our TV on and I'm pleased to report that we achieved total company constant currency revenue growth just over 12% for the full year of 2023 compared to the full year of 2022. In addition, to exceeding our top-line growth revenue target. We achieved adjusted EBITDA growth of nearly 30% year over year, enabling us to deliver positive free cash flow while making strides in advancing our clinical programs and further expanding our global footprint.

費爾法克斯、韋恩，大家午安。在今天的電話會議中，我想先歡迎我們新任執行副總裁兼財務長蘭斯貝裡 (Lance Berry)。Lance 最近擔任 Wright Medical 的執行副總裁、財務長和營運官，直到 2020 年 11 月被 Striker 收購。我們很高興蘭斯在這個激動人心的時刻加入我們的團隊，我相信，隨著我們進入下一階段的盈利增長，他在醫療技術方面廣泛的專業知識和久經考驗的領導力將為我們的電視增加顯著的價值。我還要感謝阿什利李先生多年來的熱心服務始於他的貢獻。毫無疑問，我們的電視和公司成為了傑出的公司。今天我們將公佈 2023 年第四季和全年業績。 2023 年對我們的 TV 來說是出色的一年，我很高興地向大家報告，與 2022 年全年相比，我們 2023 年全年的公司固定貨幣總收入增長略高於 12%。此外，也要超越我們的營收成長目標。我們的調整後 EBITDA 年成長近 30%，使我們能夠提供正的自由現金流，同時在推進我們的臨床項目和進一步擴大我們的全球足跡方面取得長足進步。

Our achievements throughout 2023 culminated a particularly strong Q4, as we delivered constant currency revenue growth of 15% year over year, resulting in $93.7 million in revenue. Our performance was driven by improved revenue growth in our Onyx business, which increased 19%, followed by tissue processing at 18%, BioGlue at 11% and stent grafts at 8% growth each when compared to the fourth quarter of 2022, all on a constant currency basis. We've also benefited from the expansion of our commercial footprint through regulatory approvals across new geographies, especially in Latin America and Asia Pacific. Our strong top line performance led to $15.3 million in non-GAAP adjusted EBITDA in the fourth quarter, which is a 40% increase compared to the fourth quarter of last year. We expect our strong momentum in the fourth quarter to continue into 2024.

我們在 2023 年全年所取得的成就在第四季尤為強勁，貨幣收入年增 15%，營收達 9,370 萬美元。我們的業績得益於Onyx 業務收入成長的改善，與2022 年第四季相比，該業務成長了19%，其次是組織加工成長18%，BioGlue 成長11%，覆膜支架成長8%，所有這些均基於固定貨幣基礎。我們也透過新地區（尤其是拉丁美洲和亞太地區）的監管批准擴大了我們的商業足跡。我們強勁的營收業績使第四季的非 GAAP 調整後 EBITDA 達到 1,530 萬美元，比去年第四季成長了 40%。我們預計第四季的強勁勢頭將持續到 2024 年。

From a product perspective, as I mentioned earlier, On-X revenues increased 19% compared to the fourth quarter of last year on a constant currency basis. As we continue to take market share globally and have the only mechanical aortic heart valve that can be maintained at an INR of 1.5 to 2.0. We believe our valve is the best aortic valve on the market. Our market share gains each year and the recently presented results of the Onyx post-approval data, which showed an 85% reduction in major bleeding, clearly support our view.

從產品角度來看，正如我之前提到的，以固定匯率計算，On-X 營收比去年第四季成長了 19%。我們繼續佔據全球市場份額，並擁有唯一可以將 INR 維持在 1.5 至 2.0 的機械主動脈心臟瓣膜。我們相信我們的瓣膜是市場上最好的主動脈瓣膜。我們的市場份額逐年增長，最近公佈的 Onyx 批准後數據結果（顯示大出血減少了 85%）顯然支持了我們的觀點。

Tissue processing revenues increased 18% compared to the fourth quarter of last year on a constant currency basis due primarily to pricing issues and the increase in volume of the Ross procedure. We expect continued double-digit growth in our tissue business in 2024, driven primarily by our significantly improved supply of our proprietary SynerGraft pulmonary valve.

與去年第四季相比，以固定匯率計算，組織加工收入成長了 18%，這主要是由於定價問題和羅斯手術量的增加。我們預計 2024 年我們的衛生紙業務將繼續實現兩位數成長，這主要得益於我們專有的 SynerGraft 肺動脈瓣供應的顯著改善。

And lastly, stent graft revenues grew 8% on a constant currency basis in the fourth quarter compared to the fourth quarter of last year, driven by improved supply and strong performance in AMDS outside the US, we anticipate demand to remain strong through 2024 and beyond.

最後，在美國以外 AMDS 供應改善和強勁業績的推動下，以固定匯率計算，第四季度支架移植收入較去年第四季增長 8%，我們預計 2024 年及以後需求將保持強勁。

For our stent graft products which should sustain and continue our strong revenue performance. Our results will also be driven by the continued progress we are making expanding into new markets through new regulatory approvals and commercial footprint expansion in Asia Pacific and Latin America both delivered constant currency revenue growth of 19% compared to the fourth quarter of last year. We expect these regions to be important growth drivers over the coming years as we continue to leverage our industry-leading product portfolio further into these regions.

對於我們的覆膜支架產品來說，這將維持並持續我們強勁的營收表現。我們的業績也將受到我們透過新的監管批准以及亞太和拉丁美洲商業足跡擴張進軍新市場的持續進展的推動，與去年第四季相比，貨幣收入實現了 19% 的持續成長。我們預計這些地區將成為未來幾年重要的成長動力，因為我們將繼續利用我們行業領先的產品組合進一步進入這些地區。

In addition to our strong financial performance, we continued to advance our clinical programs and show leadership in aortic field with two late-breaking science presentations at the STS. Annual Meeting in San Antonio. First, the full dataset from the ANDS. persevered clinical trial, and second, the interim data from the Nexus three clinical trial. First, in November of last year, we completed the trial enrollment of persevere, our IDE clinical trial for PMA approval, which consists of 93 patients who have experienced an acute Type A. dissection. I'm pleased to report that the trial met its combined primary efficacy, efficacy and safety endpoints demonstrating a statistically significant reduction in all cause mortality in the primary endpoint of major adverse events as well as no occurrence of data, which are associated with increased risk for reintervention and mortality. As a reminder, the adverse events called MAE.s, which is the EMA endpoint for the IDE trial, is based on historical control of patients with mild perfusion in this reference core 58.2% of patients had greater than or equal to one major adverse events. The target goal of the trial from the FDA was a reduction in this endpoint to 40% of patients with greater than or equal to one MAE. The releases the recently presented 30 day data at STS. should only 28% of the patients had greater than or equal to one major adverse event, representing a 52% reduction compared to the standard of care MERs procedure as it relates to Dain tears for contact data occurs up to 70% of patients following Hemi arch repair without a MDS results from the full IDE. dataset has shown there have been no, no gains at all detected in any patients treated with AMBS., nor were there any gain tiers reported in DART study after three years of follow-up critically, the data up to 30 days also demonstrated a statistically significant 72% reduction of all-cause mortality. It truly REVENUES revolutionary results.

除了強勁的財務表現外，我們還繼續推進我們的臨床項目，並在 STS 上發表了兩場最新的科學演講，展現了在主動脈領域的領導地位。年會在聖安東尼奧舉行。首先，來自 ANDS 的完整資料集。第二，Nexus 三期臨床試驗的中期數據。首先，去年 11 月，我們完成了 Persever 的試驗入組，這是我們獲得 PMA 批准的 IDE 臨床試驗，其中包括 93 名經歷過急性 A 型夾層的患者。我很高興地報告，該試驗達到了其綜合主要功效、功效和安全性終點，表明主要不良事件主要終點的全因死亡率在統計上顯著降低，並且沒有出現與風險增加相關的數據重新幹預和死亡率。提醒一下，稱為 MAE.s 的不良事件是 IDE 試驗的 EMA 終點，基於該參考核心中輕度灌注患者的歷史控制。58.2% 的患者發生大於或等於一項主要不良事件。FDA 試驗的目標是將此終點降低至 40% 的 MAE 大於或等於 1 的患者。STS 發布了最近公佈的 30 天數據。應該只有 28% 的患者出現大於或等於一項主要不良事件，與標準護理 MER 程序相比減少了 52%，因為它與接觸數據的 Dain 撕裂有關，最多 70% 的半弓患者發生這種情況沒有MDS 的修復結果來自完整的IDE。數據集顯示，在接受 AMBS 治療的任何患者中都沒有檢測到任何增益。經過三年的嚴格隨訪，DART 研究中也沒有報告任何增益等級，長達 30 天的數據也顯示了統計上的全因死亡率顯著降低72%。它確實帶來了革命性的成果。

Second, the interim data from the Nexus three of US IDE trial included a 22 patient study. Participants demonstrated a 9% mortality, no detected strokes, peripheral iGA or renal failure in any patients treated with NEXUS aortic arch Stent Graft System. As of today, there have been 42 of 60 patients enrolled and the primary endpoint of the Nexus trial, and it remains on track for approval in 2026.

其次，美國 IDE 試驗的 Nexus 3 的中期數據包括一項 22 名患者的研究。在接受 NEXUS 主動脈弓覆膜支架系統治療的任何患者中，參與者的死亡率為 9%，未檢測到中風、週邊 iGA 或腎衰竭。截至目前，60 名患者中已有 42 名患者入組，並達到了 Nexus 試驗的主要終點，該試驗仍有望在 2026 年獲得批准。

In summary, we're very excited about these two native print. These two new data prints, which assuming we exit our exercise, our option to acquire Endospan should accelerate stent graft growth in markets where the products are currently approved. If these PMA processes proceed as we anticipate, we would expect PMA approval for AMBS. in 2025 and Nexus in 2026. At that time, again, assuming we exercise the option for Endospan, these two products will significantly increase our addressable market opportunity.

總而言之，我們對這兩種本土印刷品感到非常興奮。這兩個新的資料列印，假設我們退出我們的活動，我們收購 Endospan 的選擇應該會加速支架移植物在目前批准產品的市場的成長。如果這些 PMA 流程按我們的預期進行，我們預計 PMA 會批准 AMBS。 2025 年，Nexus 2026 年。屆時，再次假設我們行使 Endospan 的選擇權，這兩種產品將顯著增加我們的潛在市場機會。

Lastly, on our R&D pipeline, our third-generation frozen elephant trunk used to replace the entire aortic arch called RCBOLSA. is in the final testing stages, and we currently expect to start the US IDE trial later this year. I look forward to providing additional updates on our proprietary on our progress in future calls. With that, I'll now turn the call over to Lance.

最後，在我們的研發管線中，我們的第三代冷凍象鼻用於取代整個主動脈弓，稱為 RCBOLSA。正處於最後的測試階段，我們目前預計將於今年稍後開始美國 IDE 試用。我期待在未來的電話會議中提供有關我們專有進展的更多更新。這樣，我現在將把電話轉給蘭斯。

Thanks, Pat, and good afternoon, everyone. Before I begin, I'd 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. And 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 revenues were $93.7 million for the fourth quarter of 2023, up 15% compared to Q4 of 2022. Non-gaap adjusted EBITDA increased approximately 40% from $11 million to $15.3 million in the fourth quarter of 2023. And after generating $5.8 million of free cash flow in the third quarter of 2023, we generated $7.4 million of free cash flow in the fourth quarter. Importantly, we were free cash flow positive for the full year 2023, representing a critical milestone achievement for our TBR. As importantly, we expect that free cash flow will continue to be positive in 2024 from a product line perspective, On-X revenues grew 19%. Tissue processing revenues increased 18%, BioGlue revenues increased 11%, and stent graft revenues grew 8% in the fourth quarter of 2023 on a regional basis, revenues in both Asia Pacific and Latin America increased 19%, while North America increased 17% and EMEA increased 10%, all compared to the fourth quarter of 2022. Gross margin improved to 65% in Q4 compared to 64% in the fourth quarter of 2022. This increase was driven by price increases and product mix, partially offset by inflationary impact on materials and labor.

謝謝帕特，大家下午好。在開始之前，我想提醒您，請參閱我們今天早些時候發布的新聞稿，以了解有關我們的非公認會計原則結果的信息，包括這些結果與我們的公認會計原則結果的調節。此外，除非另有說明，討論的所有百分比變化都將按年計算，收入增長率將以固定匯率計算，除非另有說明，2023 年第四季度的收入為9370 萬美元，比2022 年第四季度增長15%。2023 年第四季度，非 GAAP 調整後 EBITDA 成長約 40%，從 1,100 萬美元增至 1,530 萬美元。在 2023 年第三季產生 580 萬美元的自由現金流後，我們在第四季產生了 740 萬美元的自由現金流。重要的是，我們 2023 年全年的自由現金流為正，這代表了我們 TBR 的一個重要里程碑成就。同樣重要的是，我們預期從產品線的角度來看，2024 年自由現金流將持續為正，On-X 營收成長 19%。2023 年第四季度，按地區劃分，組織加工收入增長 18%，BioGlue 收入增長 11%，覆膜支架收入增長 8%，亞太和拉丁美洲收入增長 19%，北美增長 17%，與2022 年第四季度相比，歐洲、中東和非洲地區成長了10%。第四季的毛利率提高至 65%，而 2022 年第四季的毛利率為 64%。這一增長是由價格上漲和產品組合推動的，但部分被通膨對材料和勞動力的影響所抵消。

General.

一般的。

Administrative and marketing expenses in the fourth quarter were $50.3 million compared to $38.5 million in the fourth quarter of 2022. Non-gaap general, administrative and marketing expenses were $47.7 million compared to $41.9 million in the fourth quarter of 2022.

第四季的管理和行銷費用為 5,030 萬美元，而 2022 年第四季為 3,850 萬美元。非 GAAP 一般、管理和行銷費用為 4,770 萬美元，而 2022 年第四季為 4,190 萬美元。

R and D expenses for the fourth quarter were $7.6 million compared to $8.3 million in the fourth quarter of 2022. Other income and expenses include $5.8 million in net interest expense and foreign currency translation gains of approximately $2.2 million. On the bottom line, we reported GAAP net loss of approximately $4 million or $0.1 per fully diluted share in the fourth quarter of 2023, non-GAAP net income was $4.6 million or $0.11 per share in the fourth quarter. As of December 31st, 2023, we had approximately $58.9 million in cash and $312 million in debt is important to note that this does not contemplate the impact of our recently closed comprehensive credit agreement, which I will speak to shortly. And now for our initial outlook for 2024, we expect to continue building on our momentum, enabling us to achieve as reported revenues in the range of $382 million to $396 million at current FX rates, the year-over-year impact on revenue is expected to be negligible. Therefore, this range represents revenue growth of 8% to 12%, both as reported and on a constant currency basis. With our continued top-line revenue growth and general expense management, we expect adjusted EBITDA to be in the range of $68 million to $72 million for the full year 2024, representing 26% to 34% growth over 2023 and 280 basis points of adjusted EBITDA margin expansion at the midpoint of our ranges, we expect gross margins to remain at levels similar to 2023. We expect to continue to drive significant leverage from our global sales force and G&A infrastructure. Additionally, R&D expense is expected to remain relatively flat as a percentage of sales. I would like to proactively note that our guidance range is below the $75 million that we originally targeted for 2024. At our March 2022 Investor Day, there has been no change to our commitment to drive significant adjusted EBITDA growth in 2024, as evidenced by our expectation for 30% year-over-year growth at the midpoint of our range, which is three times our midpoint top line growth rate. We are driving this level of improvement while maintaining our investment levels in R&D as a percentage of sales driving strong adjusted EBITDA growth is a top priority, but not at the expense of the investments we need to make for the future. We feel that the strength of our underlying business, our longer-term growth outlook and our balance sheet today validate this approach in regard to our capital structure. We are very pleased to have recently closed the comprehensive nondilutive financing for $350 million of senior secured interest only credit facilities with six year maturities. The facilities include an initial $190 million term loan, a $60 million revolving credit facility and an additional $100 million in unfunded delayed draw term loan that may be drawn to refinance our convertible bonds at any time prior to their maturity in July 2025. As a reminder, our convertible notes do not contain any financial covenants. The initial $190 million term loan and $30 million from the revolving credit facility were drawn at close, along with the use of some cash on our balance sheet to retire the existing senior secured credit facilities and pay related transaction expenses. Overall, this credit agreement, coupled with our strong financial performance, gives us flexibility with no near term debt maturity overhang as we continue to evaluate the best options to address our convertible debt. We also intend to file a shelf registration statement on Form S-3 with the SEC following the filing of our 10-K. We view this strictly as a matter of good corporate housekeeping and prudent considering the reestablishment of our weekly status as it relates to free cash flow we are not giving formal guidance. However, we are confident in our ability to be free cash flow positive in 2024 the $16 million of incremental adjusted EBITDA at the midpoint more than covers the $5.7 million of additional interest from the new credit facility, which provides us room for working capital expansion to support the growth of the business while still being free cash flow positive.

第四季的研發費用為 760 萬美元，而 2022 年第四季的研發費用為 830 萬美元。其他收入和支出包括 580 萬美元的淨利息支出和約 220 萬美元的外幣換算收益。總而言之，我們報告 2023 年第四季 GAAP 淨虧損約為 400 萬美元，即每股完全稀釋每股 0.1 美元，非 GAAP 淨利潤為 460 萬美元，即每股 0.11 美元。截至 2023 年 12 月 31 日，我們擁有約 5,890 萬美元的現金和 3.12 億美元的債務，值得注意的是，這沒有考慮我們最近結束的全面信貸協議的影響，我很快就會談到該協議。現在，對於我們對 2024 年的初步展望，我們預計將繼續鞏固我們的勢頭，使我們能夠以當前匯率實現所報告的收入在 3.82 億美元至 3.96 億美元之間，預計對收入的同比影響可以忽略不計。因此，無論是按報告或固定匯率計算，這一範圍代表著 8% 至 12% 的收入成長。隨著我們持續的營收成長和一般費用管理，我們預計2024 年全年調整後EBITDA 將在6,800 萬美元至7,200 萬美元之間，較2023 年成長26% 至34%，調整後EBITDA 成長280 個基點由於利潤率擴張處於我們範圍的中點，我們預計毛利率將保持在與 2023 年類似的水平。我們預計將繼續充分利用我們的全球銷售團隊和 G&A 基礎設施。此外，研發費用佔銷售額的比例預計將保持相對穩定。我想主動指出，我們的指導範圍低於我們最初設定的 2024 年 7500 萬美元目標。在2022 年3 月的投資者日，我們致力於在2024 年推動調整後EBITDA 大幅增長的承諾沒有改變，我們的預期為我們範圍中點的同比增長30%，這是我們的三倍，就證明了這一點。中點收入成長率。我們正在推動這一水平的改進，同時保持我們的研發投資水平，因為推動調整後的EBITDA 強勁增長佔銷售額的百分比是重中之重，但不以犧牲我們未來所需的投資為代價。我們認為，我們的基礎業務實力、我們的長期成長前景和我們今天的資產負債表證實了我們資本結構的這種方法。我們非常高興最近完成了 3.5 億美元的六年期優先擔保利息信貸安排的全面非稀釋性融資。這些融資包括初始1.9 億美元的定期貸款、6,000 萬美元的循環信貸融資以及另外1 億美元的無資金籌措延遲提取定期貸款，這些貸款可以在2025 年7 月到期之前的任何時間提取，為我們的可轉換債券再融資。提醒一下，我們的可轉換票據不包含任何財務契約。最初的 1.9 億美元定期貸款和 3000 萬美元的循環信貸安排已於交易結束時提取，同時使用我們資產負債表上的一些現金來償還現有的高級擔保信貸安排並支付相關交易費用。總體而言，這項信貸協議加上我們強勁的財務業績，為我們提供了靈活性，在我們繼續評估解決可轉換債務的最佳選擇時，不會出現短期債務到期問題。我們還打算在提交 10-K 後向 SEC 提交表格 S-3 上的擱置註冊聲明。我們嚴格認為這是一個良好的企業管理問題，並謹慎考慮重新建立我們的每週狀態，因為它與自由現金流有關，我們沒有提供正式的指導。然而，我們對2024 年自由現金流為正值的能力充滿信心，中點1600 萬美元的增量調整後EBITDA 超過了新信貸安排帶來的570 萬美元的額外利息，這為我們提供了營運資本擴張的空間支持業務成長，同時仍保持正的自由現金流。

Finally, I want to make a few comments on quarterly cadence to assist you with your modeling as it relates to revenue seasonality, the third quarter is typically our lowest growth quarter, particularly due to the impact of the European vacation season. Q1 is our most cash-intensive quarter due to the payment of annual bonuses and due to normal activities such as sales meetings and industry conferences, which are heavier in the first quarter, despite our expectations for free cash flow to be negative in Q1 because of these items, we still expect cash flow to be free to be free cash flow positive for the full year of 2024.

最後，我想對季度節奏發表一些評論，以幫助您進行與收入季節性相關的建模，第三季度通常是我們成長最低的季度，特別是由於歐洲假期的影響。第一季是我們現金最密集的季度，原因是年度獎金的支付以及銷售會議和行業會議等正常活動，第一季的活動量較大，儘管我們預計第一季的自由現金流為負數，因為這些項目，我們仍然預計2024 年全年現金流為正。

In summary, we are thrilled with our 2023 performance and are excited about the prospects of the business in 2024 and beyond.

總之，我們對 2023 年的業績感到興奮，並對 2024 年及以後的業務前景感到興奮。

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

至此，我將把電話轉回給帕特，聽取他的結束語。

A Thanks, Lance. As you heard from Lance, we're extremely pleased with our 2023 performance and continue to deliver on our mission to build a world-class aortic company. We finished strong with 15% revenue growth and 40% adjusted EBITDA growth in the fourth quarter, we continued to expand our markets and meaningfully advance our clinical pipeline, positioning us well for long-term growth. We also executed a nondilutive capital structure, giving us a six year runway with no financing overhang. Our strategy to deliver sustained profitable growth is working, and we look forward to continuing the momentum we built in 2023 through 2024 and beyond. More specifically, our growth this year will be driven by the following number one, our continued growth in our stent graft business, driven by the recent 30 day persevered data presented at STS. showing a 72% reduction in mortality and a 52% reduction in major adverse events compared to the standard of care literature trial. Number two, continued market share gains for Onyx, driven by data recently presented in Europe of 510 patients in our aortic valve showing an 85% reduction in major bleeding. Number three, continued growth of our proprietary SynerGraft pulmonary valve, driven by price increases, growth of the Ross procedure as well as our ability to capture that growth from our efforts to improve supply.

謝謝，蘭斯。正如您從 Lance 那裡聽到的，我們對 2023 年的業績非常滿意，並將繼續履行我們的使命，打造世界一流的主動脈公司。我們第四季的營收成長了 15%，調整後的 EBITDA 成長了 40%，表現強勁，我們繼續擴大市場並有意義地推進我們的臨床管道，為我們的長期成長做好了準備。我們也執行了非稀釋資本結構，為我們提供了六年的跑道，沒有融資過剩。我們實現持續獲利成長的策略正在發揮作用，我們期待繼續保持 2023 年至 2024 年及以後建立的勢頭。更具體地說，我們今年的成長將受到以下第一大因素的推動，即我們支架移植業務的持續成長，這受到 STS 上最近 30 天持續數據的推動。與護理標準文獻試驗相比，死亡率降低了 72%，主要不良事件降低了 52%。第二，Onyx 的市佔率持續成長，這得益於最近在歐洲公佈的 510 名主動脈瓣患者的數據，顯示大出血減少了 85%。第三，我們專有的 SynerGraft 肺動脈瓣持續成長，這是由價格上漲、羅斯手術的成長以及我們從改善供應的努力中獲得成長的能力所推動的。

And fourth, our continued growth in Asia-Pacific and Latin America from our channel investments and new regulatory approvals. So in conclusion, we are more than confident we are more confident than ever in our near and long-term prospects of our business.

第四，我們在亞太和拉丁美洲的持續成長得益於我們的通路投資和新的監管批准。因此總而言之，我們對我們業務的近期和長期前景比以往任何時候都更有信心。

Finally, I want to thank all of our employees around the globe for delivering an exceptional year.

最後，我要感謝全球所有員工，感謝他們度過了非凡的一年。

So with that, operator, please open the line for questions.

那麼，接線員，請打開線路提問。

Thank you. We will now be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue and you may press star two. If you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing One moment please while we poll for questions.

謝謝。我們現在將進行問答環節。如果您想提問，請按電話鍵盤上的星號一。確認音將表示您的線路已在問題佇列中，您可以按星號二。如果您想從佇列中刪除您的問題。對於使用揚聲器裝置的參與者，當我們投票提問時，可能需要先拿起聽筒，然後按「請稍候」。

Our first question comes from the line of Rick Wise with Stifel. Please proceed with your question.

我們的第一個問題來自 Rick Wise 和 Stifel 的對話。請繼續你的問題。

Hey, Lance, this is John on for Rick. Today.

嘿，蘭斯，我是為瑞克代言的約翰。今天。

Just wanted to start off with MDS.

只是想從 MDS 開始。

You had some really positive strong data readout at STS. recently. And I just wanted you to maybe remind us about just how clinically meaningful this is in the eyes of doctors, how that technology is performing in Europe today and how we should be thinking about the U.S. opportunity as we look ahead to '25?

您在 STS 上獲得了一些非常積極、強勁的數據讀數。最近。我只是想讓你提醒我們，這在醫生眼中具有多大的臨床意義，這項技術今天在歐洲的表現如何，以及當我們展望「25」時，我們應該如何考慮美國的機會？

Yes, I'll take that one. So clearly, this is a very exciting technology. I've been in the field, a cardiac devices for 30 years and associated with a lot of breakthrough technologies. I've never seen one that actually has the patient benefit that we've seen in this in this device. And I'll give you just a kind of a background right so an acute Type A. dissection is a very extreme disease state where patients are metabolic and typically the middle of the night and we did this trial was done in patients with mild profusion, which means they have kind of blood not flowing to the to the brain to the kidneys to the lakes. This this device in an FDA trial of 93 patients, which is the largest series ever done in acute Type A. dissection patients showed a statistically significant reduction of 72% in mortality. That's death, right? So 72% more patients were alive on. It also showed reduction in the major adverse events of strokes. People have require kidney dialysis and myocardial infarctions. So we saw 52% reduction in those four major adverse events. So I think this is a really a light until it's truly a life-saving technology and we're very excited. Our investigators are very excited about this it's about $150 million market opportunity in the US. We'll have obviously we'll have to go through all the steps you have to go through in the adoption of a new technology, but we're all alone in the market. There's no other competitor. The competitor is a Hemi Arch, which is a surgical graft that's been done for 50 years there have been no innovation. This is a highly patented protected product. So we feel like this is a market of that RT. alone for a very long time. And we're super excited about getting it out to the patients.

是的，我會接受那個。顯然，這是一項非常令人興奮的技術。我在心臟設備領域工作了 30 年，並與許多突破性技術相關。我從未見過任何一種設備能夠像我們在該設備中看到的那樣真正為患者帶來好處。我會給你一個背景知識，所以急性 A 型夾層是一種非常極端的疾病狀態，患者處於代謝狀態，通常是在半夜，我們所做的這項試驗是在輕度豐富的患者中進行的，這意味著他們的血液不流向大腦、腎臟、湖泊。FDA 對 93 名患者進行了一項試驗，這是迄今為止在急性 A 型夾層患者中進行的最大規模的系列試驗，結果顯示，該裝置在統計上顯著降低了 72% 的死亡率。這就是死亡，對嗎？因此，存活率增加了 72%。它還表明中風的主要不良事件有所減少。人們有需要腎臟透析和心肌梗塞的情況。因此，我們看到這四種主要不良事件減少了 52%。所以我認為這真的是一盞燈，直到它成為真正的拯救生命的技術，我們非常興奮。我們的調查人員對此感到非常興奮，因為這是美國價值約 1.5 億美元的市場機會。顯然，我們必須經歷採用新技術時必須經歷的所有步驟，但我們在市場上是獨一無二的。沒有其他競爭對手。競爭對手是半弓，這是一種手術移植物，已經進行了 50 年，沒有任何創新。這是受高度專利保護的產品。所以我們覺得這就是 RT 的市場。獨自一人很長一段時間。我們非常高興能夠提供給患者。

Thanks. That's helpful.

謝謝。這很有幫助。

And then just to follow up on the guidance, I understand the logic on adjusted EBITDA reinvesting in the business just curious, one exactly what particular areas of focus are you reinvesting in innovating in?

然後，為了跟進指導，我理解調整後的 EBITDA 再投資於業務的邏輯，只是好奇，您到底在哪些特定的重點領域進行再投資創新？

And then on the revenue side, I noticed that in the fourth quarter sense graphs on an organic basis were more like high single digits, then preservation tissue business was high 10s.

然後在收入方面，我注意到第四季度有機基礎上的感覺圖表更像是高個位數，然後保存紙巾業務是高十位。

So just as we think about that into '24, should we expect similar growth rates from those two or maybe find somewhere in the middle?

因此，正如我們在 24 年思考這個問題時，我們是否應該期望這兩者的成長率相似，或者也許找到中間的某個地方？

Yes.

是的。

Let me just let me take the first one. I'll answer the second one. So as far as the investments from as we've said all along, we're building an aortic company, right? So you've seen a significant investment in AMBS. in the US FDA trial for severe, which you just heard about we're literally starting as that one is getting ready to get to market where we're literally starting our next-generation device to replace the entire aortic arch called our CFO. And we've been developing it for several years. It's a breakthrough technology as identified by the FDA. We will start that clinical trial this year from here in the US and Europe. And then we've got some some technology behind it. But as Lance said in his comments, we can do this in our P & L and not really holding to increase our percentage of R&D as a percentage of revenue because we're growing the top line as well. So we're being very pragmatic about being financially disciplined, grown the top line midpoint of our range, 10%, bottom line, 30% and still being able to invest in innovation. So I think this is something that shareholders should like because we can deliver top line bottom line cash flow and a pipeline. So Lance, maybe you can take that second question.

讓我先拿第一個。我來回答第二個。就我們一直以來所說的投資而言，我們正在建立一家主動脈公司，對嗎？您已經看到了對 AMBS 的重大投資。在美國 FDA 的重症試驗中，您剛剛聽說我們實際上正在開始，因為該試驗正準備進入市場，我們實際上正在開始我們的下一代設備來替換整個主動脈弓，稱為我們的 CFO。我們已經開發它好幾年了。這是 FDA 認定的突破性技術。我們今年將從美國和歐洲開始臨床試驗。然後我們有一些技術支援。但正如蘭斯在評論中所說，我們可以在損益表中做到這一點，而不是真正堅持增加研發佔收入的百分比，因為我們的營收也在成長。因此，我們非常務實地遵守財務紀律，將我們的收入範圍中點增長了 10%，淨利潤增長了 30%，並且仍然能夠投資於創新。所以我認為這是股東應該喜歡的事情，因為我們可以提供頂線現金流和管道。蘭斯，也許你可以回答第二個問題。

Sure. So the question was about on stent graft growth and tissue processing growth and how those flow into 2024.

當然。所以問題是關於支架移植物生長和組織加工生長以及它們如何流入 2024 年。

So first on stent grafts on, I think the Q4, I would call that just kind of normal a level of quarterly fluctuation on growth rates for the full year stent grafts grew in the mid 10s, and that's really how we think about that business going into for full year 2024. Again, you may see some variation quarter to quarter on the tissue processing, we are benefiting from the price increase we took in second quarter of 2023 on our own SynerGraft technology. So we're benefiting from that and we began to see a little bit of improved supply as well in the fourth quarter that helped help that. So we may see the tissue processing revenues be a little higher in the beginning of 2024 for the full year, we think about that more kind of a double digit growers as we've kind of talked about in the recent past.

首先，在支架移植物方面，我認為第四季度，我認為全年支架移植物增長率在 10 年代中期增長，這只是一種正常的季度波動水平，這就是我們對業務發展的真正看法進入2024年全年。同樣，您可能會看到組織加工每個季度都有一些變化，我們受益於 2023 年第二季度我們自己的 SynerGraft 技術的價格上漲。因此，我們正在從中受益，我們開始看到第四季度的供應有所改善，這有助於這一點。因此，我們可能會看到 2024 年初全年的組織加工收入會略高，我們認為種植者的數量將達到兩位數，正如我們最近談到的那樣。

Thanks for taking the questions.

感謝您提出問題。

Our next question comes from the line of Mike Matson with Needham. Please proceed there.

我們的下一個問題來自麥克·馬特森和李約瑟的對話。請繼續那裡。

Yes.

是的。

Thanks on. So I guess I'll just start with the financing on the new credit facility. So can you just call it kind of where you'll be with regard to your leverage ratio following that data transaction and where you kind of ended up the year last year in terms of EBITDA.

謝謝。所以我想我將從新信貸安排的融資開始。那麼，您可以將其稱為數據交易後槓桿率的情況以及去年以 EBITDA 計算的情況。

You've read last.

你已經讀到最後了。

Yes. So on the route of my head, but we did $52.8 million of EBITDA are shown at the end of this in 2023. And you know, post transaction, you're really thinking about net debt of about $260 million. So I mean, I guess do the math on that real quick. (multiple speakers) five point pumping roughly a [$4.8 million], and you know, is where it is right now and we think we'll get it, you know, the midpoint of the range and some cash flow will kind of get that approaching [$3.5 million to $3 million] by the end of 2024 So some really good progress there. I would point out that there are covenants in the new debt, but they're well above that, that level and we actually have a favorable definition of EBITDA in the credit agreement. So per the actual credit agreement, that net leverage ratio is even less than than what it is on a on an as-adjusted basis.

是的。所以在我的腦海中，我們確實在 2023 年底顯示了 5,280 萬美元的 EBITDA。你知道，交易後，你真正考慮的淨債務約為 2.6 億美元。所以我的意思是，我想盡快計算一下。 （多個發言者）五點泵大約是[480萬美元]，你知道，這就是現在的情況，我們認為我們會得到它，你知道，範圍的中點和一些現金流會得到這個到2024 年底將接近[350 萬至300 萬美元] 所以這方面取得了一些非常好的進展。我想指出的是，新債務中有契約，但它們遠高於這個水平，而且我們實際上在信貸協議中對 EBITDA 有一個有利的定義。因此，根據實際的信貸協議，淨槓桿率甚至低於調整後的水平。

Okay, thanks.

好的謝謝。

That's helpful. And then just on the MDS, I mean, obviously, the data looked really good on. Do you expect to would the FDA require a panel for that? Or do you think they'll just do approval without a panel.

這很有幫助。然後就 MDS 而言，我的意思是，顯然，數據看起來非常好。您預計 FDA 會為此設立一個小組嗎？或者你認為他們會在沒有小組的情況下進行批准。

We haven't gotten like we haven't gotten to that level of detail yet. I mean, I am not going to opine on what the FDA is going to do, but obviously, but I think the data speaks for itself, right? I mean, it's this is a super sick population with phenomenal results. So we're obviously going to work with them to get the technology out as soon as we possibly can. So at what point or not, I don't I can't really comment.

我們還沒有達到那種程度的細節。我的意思是，我不會對 FDA 將要做什麼發表意見，但顯然，但我認為數據不言自明，對嗎？我的意思是，這是一個超級病態的人群，卻帶來了驚人的結果。因此，我們顯然將與他們合作，盡快推出這項技術。所以在什麼時候，我不知道，我無法評論。

Okay. And then on as far as our CFO goes on just the timing, I mean, would that be it's not really more 2027 at this point? Or could it be early to add?

好的。然後，就我們的財務長所說的時間安排而言，我的意思是，現在不是真的已經超過 2027 年了嗎？還是說現在添加還太早？

Yes, I think that's I think that's about right, probably late '27. So we we expect to get the IDE approved this year and hopefully, we'll get some patients enrolled but again, there's a lot of bureaucracy at the startup of a trial. So I think that's right. We feel like just the centers we have in this and the kind of the a lot of these top centers were involved in the development of this technology, and they're super excited about it. So I expect our enrollment to go pretty well, but there is a one-year follow-up, and then you've got to go through an FDA PMA cycle. So there's some time, but kind of late '27 is probably a good timing for that.

是的，我認為這是正確的，可能是 27 年末。因此，我們預計 IDE 今年會獲得批准，並希望我們能夠招募一些患者，但同樣，在試驗啟動時存在許多官僚作風。所以我認為這是對的。我們覺得我們在這方面的中心以及許多頂級中心都參與了這項技術的開發，他們對此感到非常興奮。所以我預計我們的註冊會進展順利，但有一年的後續行動，然後你必須經歷 FDA PMA 週期。所以還有一些時間，但 27 年晚些時候可能是一個很好的時機。

Okay. Got it.

好的。知道了。

Thank you.

謝謝。

Thank you.

謝謝。

Our next question comes from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.

我們的下一個問題來自蘇拉吉·卡利亞（Suraj Kalia）和奧本海默（Oppenheimer）的對話。請繼續你的問題。

Our lines, can you hear me all right.

我們的台詞，你聽得到嗎？

Yes, we hear you fine.

是的，我們聽得很好。

Pat, let me start out, David, congratulations. I mean, you guys have consistently even through COVID, probably one of the few that consistently beat numbers every quarter. So congrats once again. And I know Pat, on MDS, a number of questions there. Just for the audience again, can you size the US market? What how do you define the low-hanging fruit.

派特，讓我開始吧，大衛，恭喜你。我的意思是，即使在新冠疫情期間，你們也始終如一，可能是少數幾個每季都能持續擊敗數字的人之一。所以再次祝賀。我認識 Pat，關於 MDS，有很多問題。再次向觀眾請教一下，您能估量一下美國市場嗎？您如何定義唾手可得的成果？

Yes.

是的。

So basically, if you if you look at there's a number of different ways to kind of slice of the market. So we come up with a number of $150 million. The ASP. on that device is going to be about $25,000. So there's about 6,000 acute Type A. dissection has done in the US. So that's really kind of the back of a napkin is the math on 6,000 cases, 25,000 device multiplied together and you get $150 million. We've done market research with a number of physicians and I can talk, you know, some of the physicians that are in the trial. This is a very substantial technology on again, as I said from an earlier question, I've not seen you see these heart failure trials that what you're trying to get somebody to walk 12 more feet. You're talking about a 72% reduction in mortality. The mortality in this standard of care control group was 35%. At 30 days. We were at 9.7. So that is a significant technology. And you know, these are these are extremely sick patients that are met of act in an emergency and is life-saving technology. So we're very excited and we've got a sales force on BioGlue is used in aortic dissections. Our sales team sells the On-X valves, aortic repair, Tom, our CFO devices, used in replacing the arcs of we are an aortic company. And this is kind of the first significant innovation in the acute Type A. dissections in 50 years. So I mean, I'm super excited about it and think this is really going to change a lot of lots.

基本上，如果你觀察一下，有很多不同的方法可以分割市場。所以我們提出了1.5億美元的數字。ASP。該設備的費用約為 25,000 美元。美國大約進行了 6,000 例急性 A 型解剖。因此，這實際上是餐巾紙背面的數學計算，將 6,000 個箱子、25,000 個設備相乘，得出 1.5 億美元。我們已經與許多醫生進行了市場調查，我可以與參與試驗的一些醫生進行交談。這又是一項非常重要的技術，正如我在之前的問題中所說，我還沒有看到你看到這些心臟衰竭試驗，你試圖讓某人多走 12 英尺。你說的是死亡率降低了 72%。此護理標準對照組的死亡率為 35%。30天時。我們當時是9.7。所以這是一項重要的技術。你知道，這些都是病重的病人，他們在緊急情況下會採取行動，並且是挽救生命的技術。所以我們非常興奮，我們有一支銷售人員負責主動脈剝離治療中使用的 BioGlue。我們的銷售團隊銷售 On-X 瓣膜、主動脈修復術，Tom，我們的 CFO 設備，用於替換我們是一家主動脈公司的弧。這是 50 年來急性 A 型解剖領域的首次重大創新。所以我的意思是，我對此感到非常興奮，並認為這確實會改變很多事情。

Fair enough patents. I'll just throw a bunch of questions your way and hop back in queue. Lance, for you, net ASP impact in the quarter and for Q1, how should we think about the sequential for you in terms of On-X mitral label, any or just in terms of On-X mitral, I know the FDA process is behind us, but just kind of give us next steps and the status also of more generally, TJ, at this point in time, do you think the portfolio is optimal, not what else needs to be.

足夠公平的專利。我會按照你的方式拋出一堆問題，然後跳回隊列。Lance，對於您來說，本季和第一季度的淨ASP 影響，我們應該如何考慮On-X 二尖瓣標籤方面的順序，任何或僅就On-X 二尖瓣而言，我知道FDA 流程是在我們身後，但只是告訴我們下一步的步驟和更一般的狀態，TJ，在這個時間點，你認為投資組合是最優的，而不是其他需要的。

Gentlemen, thank you for taking my questions and congrats again.

先生們，感謝您提出我的問題，並再次恭喜您。

Sure. I'll take the first. I'll take the last two. I'll let Lance work on the number piece, one pocket of. So as far as the ProAct mitral, as we talked about last year, I guess we've been making into Q3, we ended up withdrawing the PMA because we missed our statistical end point, which is really I don't want to get into the details around the statistics of the trial. The fact that it is the largest body of evidence ever with a mechanical mitral valve. We just had a recent presentation at SCS. in January. There's nothing close from a significant level of data and the fact of the matter is the micro business grew 20% in 2023, right? So people are recognizing the value that we're not off. We were promoting it, but people I recognize that you can actually lower than INR if that's the physician's choice arm. So maybe over to Lance, you can grab a couple of the other ones.

當然。我就拿第一個吧我要拿最後兩個。我會讓蘭斯處理號碼片，一袋。因此，就 ProAct 二尖瓣而言，正如我們去年談到的那樣，我想我們已經進入了第三季度，我們最終撤回了 PMA，因為我們錯過了統計終點，這確實是我不想討論的有關試驗統計數據的詳細資訊。事實上，這是有史以​​來關於機械二尖瓣的最大證據。我們最近剛在 SCS 上做了一次演講。在一月。沒有什麼可以與大量數據相媲美，事實是微型企業在 2023 年成長了 20%，對嗎？因此，人們正在認識到我們並未偏離的價值。我們正在推廣它，但我認識到，如果這是醫生的選擇，你實際上可以低於 INR。所以也許到蘭斯那裡，你可以拿一些其他的。

Yes.

是的。

So on ASP., I think without giving you an exact number on the total company, which can be kind of tough with different products, different mix and different countries, I think the things to highlight is obviously our our tissue business benefited meaningfully from price, which we've talked about. We took a significant price increase in Q2 of this year. And so in Q1 we will still benefit from that and we'll annualize that in Q2. And then we have had some favorable pricing on at Onyx in particular, I would call out on that we will have for a portion of the year as well. Other than that, we're taking price increases, but not anything outside of the kind of normal running the business type price increases.

因此，在平均售價方面，我認為，如果沒有給您整個公司的確切數字，這對於不同的產品、不同的組合和不同的國家來說可能有點困難，我認為要強調的事情顯然是我們的紙巾業務從價格中受益匪淺，我們已經討論過。今年第二季我們大幅漲價。因此，在第一季度，我們仍將從中受益，我們將在第二季度對其進行年度化。然後我們在 Onyx 上獲得了一些優惠的定價，我想強調的是，我們在今年的一部分時間也會有這些優惠。除此之外，我們正在接受價格上漲，但除了正常運作的業務類型價格上漲之外，沒有其他價格上漲。

And then the other question you had, Suraj was on the portfolio.

然後你提出的另一個問題是，蘇拉吉（Suraj）在投資組合中。

I mean we would have because we said is we did three acquisitions in one kind of a distribution agreement with an option to acquire with Endospan with the Nexus device, you're fairly fairly quickly over four or five year period. We feel like our portfolio is in excellent shape and as I mentioned from an earlier question, you can see us going from the AMDS. US FDA trial to the RCM FDA trial, and then we got more stacked up behind them. So we really we do not need to acquire anything. We're very well set up from a portfolio standpoint.

我的意思是我們會這樣做，因為我們說過，我們在一種分銷協議中進行了三項收購，並可以選擇透過 Endospan 收購 Nexus 設備，在四到五年的時間內相當快。我們覺得我們的產品組合狀況良好，正如我在之前的問題中提到的，您可以看到我們從 AMDS 出發。從美國 FDA 試驗到 RCM FDA 試驗，然後我們在它們後面堆積了更多的東西。所以我們真的不需要獲得任何東西。從投資組合的角度來看，我們的設置非常好。

The only other point I would make on the pricing and I've said this to a number of times. I mean, we did get some significant price increases on SynerGraft pulmonary valves in 2023. And is that kind of asymptote on itself at the end of the first quarter, '23 was a year the price for SynerGraft at 20 for the year, the volume because we've had some significant yield improvements in our processing where we're going to potentially double our availability of those valves, and we sell every single one of them because of the significant growth of the Ross procedure. So again, we feel very confident in that tissue business is continuing to grow pretty significantly.

我要說的唯一一點是關於定價，我已經說過很多次了。我的意思是，2023 年 SynerGraft 肺動脈瓣的價格確實出現了一些大幅上漲。在第一季末，這種漸近線本身就是這樣的嗎？23 年 SynerGraft 的價格為 20 年，銷量是因為我們在加工過程中取得了一些顯著的產量提高使我們的這些閥門的可用性可能增加一倍，由於羅斯手術的顯著增長，我們銷售了每一個閥門。因此，我們再次對衛生紙業務持續大幅成長充滿信心。

Thank you.

謝謝。

Our next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann. Please proceed with your question.

我們的下一個問題來自傑弗裡·科恩和拉登堡·塔爾曼的對話。請繼續你的問題。

The hotel manager are you.

酒店經理就是你。

Good. How are you.

好的。你好嗎。

Good. Thanks. May segue right into my first question, which is on 59% in tissue forms that's all-time high for the Company. Is that sustainable? Or how should we think about that folding them in the tissue business for '24?

好的。謝謝。可以直接進入我的第一個問題，即組織形式的 59%，這是公司的歷史最高水準。這是可持續的嗎？或者我們應該如何考慮將它們折疊到 24 世紀的紙巾產業？

As I just mentioned, Jeff, and I think it's also Lance commented on the pricing. We obviously had some significant increases on SynerGraft in '23, which we'll still get some benefit in the first quarter during that year. By working with some of our top top surgeons. We've also seen significant yield improvements in our processing area. So we think that that growth will continue because we, like I said, we've almost doubled the availability of our pulmonary valves. And because of this rapid growth of the Ross procedure, we're literally selling every one that kind of comes out the off the line. So the answer your question is yes, it's going to continue.

正如我剛才提到的，傑夫，我認為蘭斯也對定價發表了評論。顯然，我們在 23 年的 SynerGraft 上有了一些顯著的成長，我們仍然會在那一年的第一季獲得一些好處。透過與我們的一些頂級外科醫生合作。我們也看到加工區域的產量顯著提高。因此，我們認為這種增長將繼續下去，因為正如我所說，我們的肺動脈瓣可用性幾乎增加了一倍。由於羅斯程序的快速發展，我們實際上正在銷售每一種離線的程序。所以你的問題的答案是肯定的，它將繼續下去。

Wonderful. And I guess secondly, first, could you comment a little bit on some of the geographies out there? I know you called out Asia and LatAm at the 19% rate by any specific geographies, and how does that tie in specific product lines by geography or in geographies.

精彩的。我想其次，首先，你能對一些地區發表一下評論嗎？我知道您在任何特定地區都以 19% 的比例提到了亞洲和拉丁美洲，以及這如何與按地區或地區劃分的特定產品線聯繫起來。

Yet February every region grew double digits. Obviously, Asia Pacific and Latin America are smaller in size. They're growing 20% or so. Again, we're seeing double digits across all four of our regions.

然而，2 月每個地區的成長率均達到兩位數。顯然，亞太地區和拉丁美洲的面積較小。它們的成長率為 20% 左右。同樣，我們在所有四個地區都看到了兩位數的成長。

Okay, got it. And then lastly for us, could you talk about gain a little bit as far as be the prevention of a tear in the structure and are on clinicians and hospitals looking at that as a cost associated or it's just debt period?

好，知道了。最後對我們來說，您能否談談防止結構撕裂方面的收益，以及臨床醫生和醫院是否將其視為相關成本或只是債務期？

Patrick, I'm not sure if I caught that, Jeff.

派崔克，我不確定我是否聽懂了，傑夫。

As foreseen and its measurement and how it's being viewed by Celanese chains? (technical difficulty)

正如所預見的那樣，它的測量以及塞拉尼斯連鎖店如何看待它？（技術難度）

Yes.

是的。

Yes. Yes. Actually, it's a again, it's probably not a topic, many people understand. I mean, I certainly didn't know what Dan was until we got into this specific area. So think about it this way in the current standard, Hemi Arch, where they actually I tried to make a plumbing analogy, right? You have a tear in the pipe you got to fix that little piece of pipe. So you take the bad desal, you put a new piece in it connected to the old kind of connect the oil piece of the pipes and you've got a fully functioning pipe. That's what they do with any large up to 70% of times the connection you make end up having a leak which requires a reoperation and can lead to higher mortality. It's a real problem and it can happen like ITO, again, depends on where you're doing it, but 35% to 70% of time. They get a leak in the connection, which is again now we don't see it at all with Andreas three years in the 50 patient starts trial and 93 patients in the person of your trial to zero. So we're running the house economics on that, but relapse and mortality for these patients. I mean, this is obviously a significant thing and the FDA has been extremely interested in India and actually how does I add it as a primary efficacy endpoint.

是的。是的。其實又是一個，可能不是一個話題，很多人都懂。我的意思是，在我們進入這個特定領域之前，我當然不知道丹是什麼。因此，在目前的標準 Hemi Arch 中這樣想，我實際上試圖做一個管道類比，對嗎？管道上有裂口，你必須修復那一小段管道。所以你把壞的海水淡化器放在裡面，把一個新的部件連接到舊的連接管的油部件上，你就得到了一個功能齊全的管道。他們就是這樣做的，最多 70% 的連接最終會出現洩漏，需要重新手術，並可能導致更高的死亡率。這是一個真正的問題，它可能會像 ITO 一樣發生，同樣取決於你在哪裡做，但發生率是 35% 到 70%。他們在連接中出現洩漏，現在我們根本看不到這一點，安德烈亞斯三年來在 50 名患者開始試驗，而 93 名患者在您的試驗中為零。因此，我們正在以此為基礎來管理房屋經濟學，但這些患者的復發和死亡率。我的意思是，這顯然是一件重要的事情，FDA 對印度非常感興趣，實際上我如何將其添加為主要療效終點。

Okay. That's super helpful. Again, thanks for the questions and fantastic readout on the year.

好的。這非常有幫助。再次感謝您提出的問題和對這一年的精彩解讀。

Thanks, Jeff.

謝謝，傑夫。

Thank you. Our next question comes from the line of Frank Chapman with Lake Street Capital. Please proceed with your.

謝謝。我們的下一個問題來自弗蘭克·查普曼 (Frank Chapman) 與湖街資本 (Lake Street Capital) 的對話。請繼續您的。

Hey, this is Nelson Cox on for Frank. I'll just start maybe internationally as well. Can you refresh us on the current size of the sales force there and maybe thinking about the team size there throughout the year. Obviously, you've seen some nice nice gross growth there, but maybe just walk through your thinking there.

嘿，我是弗蘭克的納爾遜·考克斯。我也可能會開始國際化。您能否向我們介紹一下那裡目前銷售隊伍的規模，也許考慮一下那裡全年的團隊規模。顯然，您已經看到了一些不錯的總增長，但也許只是回顧一下您的想法。

We've been able to we've talked about Asia and Latin America as when I started the company. We had one person in Asia, nobody in Latin America. We're now probably about 30 people in Asia and probably 15 in Latin America. We feel like Latin America is kind of where it needs to be. We may have a kind of onesie twosies here and there from Asia, obviously is a significant opportunity and we'll continue to add to those regions, but we treated somewhat like a like a venture capitalist, right? I mean, as we get product approved products approved, for example, we've had some big approvals in Australia done a lot of feet on the street. We've got approvals in Hong Kong. We're direct there. We've had approvals in Thailand or direct there that approvals in Taiwan. We're adding people there. So as as we get the product approved, which is really just the incremental cost of the regulatory approval, if we see the size of that market makes sense. And we do run an NBV and then we'll add people. So it's really a gated sort of fulfilling a self-funding process that we go through. But Asia is the area that we can pull that back. We can titrate that depending on our EBITDA requirements and commitments and what we see coming from an approval standpoint. Hopefully that helps you.

當我創辦公司時，我們就已經能夠談論亞洲和拉丁美洲了。我們在亞洲只有一個人，在拉丁美洲沒有人。我們現在在亞洲大約有 30 名員工，在拉丁美洲大約有 15 名員工。我們覺得拉丁美洲已經達到它需要的位置了。我們可能會有來自亞洲的連身衣，這顯然是一個重要的機會，我們將繼續增加這些地區的業務，但我們的待遇有點像風險投資家，對吧？我的意思是，例如，當我們獲得產品批准的產品時，我們在澳洲獲得了一些重大批准，並在街上進行了許多活動。我們已在香港獲得批准。我們直接到那裡。我們已經在泰國獲得了批准，或者直接在台灣獲得了批准。我們正在那裡增加人員。因此，當我們的產品獲得批准時，如果我們看到該市場的規模有意義的話，這實際上只是監管批准的增量成本。我們確實運營了 NBV，然後我們會增加人員。因此，這其實是我們經歷的一種封閉式的自籌資金流程。但亞洲是我們可以扭轉局面的地區。我們可以根據我們的 EBITDA 要求和承諾以及我們從批准的角度看到的情況來調整這一點。希望這對您有幫助。

Yes, no, that does.

是的，不，確實如此。

And then obviously I'll switch over to Onyx, obviously a strong quarter there.

然後顯然我會轉向 Onyx，顯然那裡的季度表現強勁。

Can you maybe just talk a bit more about the competitive landscape?

能多談談競爭格局嗎？

Maybe just what you're seeing from the other competitive competitors there, you can clearly continue to take share, but just curious what you're hearing out there from maybe their investments or lack thereof.

也許正如您從其他競爭者那裡看到的那樣，您顯然可以繼續佔據份額，但只是好奇您從他們的投資或缺乏投資中聽到了什麼。

Yes. So I mean, I'll talk about what customers are saying. We just as I mentioned in November or I guess October last year, we presented a 510 patient study, the kind of the FDA post-approval trial on the low INR, which is a typical requirement. They want to see that your valve performs in the community as it performed in the kind of rigorous FDA trial. So 60 centers, 510 valves, we saw an 85% reduction in major bleeding. So we went and did some market research talked to 100 cardiac surgeons by the way. It's very unique research that a lot of this over my career, we did research in competitive accounts what we call competitive accounts, which have Onex share like less than 25%. And it shows that we continue to take share over the next three years and basically double our share. So this is a very meaningful new dataset. We're excited about and our customers are excited about it, and we're going to be going after.

是的。所以我的意思是，我將談論客戶的意見。正如我在去年 11 月或我猜是 10 月提到的，我們提出了一項 510 名患者的研究，這種針對低 INR 的 FDA 批准後試驗，這是一種典型的要求。他們希望看到您的閥門在社區中的表現與 FDA 嚴格試驗中的表現一樣。因此，60 個中心、510 個瓣膜，我們發現大出血減少了 85%。所以我們順便做了一些市場調查，訪問了 100 位心臟外科醫師。這是非常獨特的研究，在我的職業生涯中，我們對競爭性帳戶進行了許多研究，我們稱之為競爭性帳戶，其中 Onex 的份額不到 25%。這表明我們在未來三年內將繼續佔據份額，並且份額基本上翻倍。所以這是一個非常有意義的新資料集。我們對此感到興奮，我們的客戶也對此感到興奮，我們將繼續努力。

It, Al, thanks, guys.

是的，阿爾，謝謝你們。

Thank you. There are no further questions at this time, and I'd like to turn the floor back over to management for closing comments.

謝謝。目前沒有其他問題，我想將發言權交還給管理層以徵求結束意見。

Yes. We're obviously, we appreciate everybody's time here. I mean, I'm I'll be quick in my wrap up. We're super excited about about '24. We have this great persevered rate, a readout on on MDS with 72% reduction in mortality, 52% reduction in major adverse events. So we're going to be working with the FDA to get this technology here in the US, but we're also approved around it in multiple countries in Europe, Canada and Asia, where we're going to use that data to continue to take care of patients and drive growth.

是的。顯然，我們感謝大家在這裡度過的時光。我的意思是，我會很快總結一下。我們對「24」感到非常興奮。我們擁有如此高的持續率，MDS 的死亡率降低了 72%，主要不良事件降低了 52%。因此，我們將與 FDA 合作，在美國獲得這項技術，但我們也在歐洲、加拿大和亞洲的多個國家/地區獲得了批准，我們將在這些國家使用這些數據繼續照顧患者並推動成長。

I just got done talking about the Onyx post-approval trial of 510 patients showing an 85% reduction in major bleeding, and we're going after share there. I talked about a couple of times about our price increases on SynerGraft as well as our our efforts to improve supply, and we'll continue to see growth there. And we talked about Asia Pacific, Latin America. We're also advancing our pipeline. We're going to be starting the third-generation Frozen Elephant total arch repair system called RCBOLSA. later this year. So we continue to build an aortic company and are excited about delivering for you again in 2024.

我剛剛談論完 Onyx 批准後試驗，該試驗對 510 名患者進行，顯示大出血減少了 85%，我們正在尋求那裡的分享。我談到了許多 SynerGraft 的價格上漲以及我們改善供應的努力，我們將繼續看到那裡的成長。我們談到了亞太地區和拉丁美洲。我們也在推進我們的管道。我們將啟動第三代「冰凍大象」全牙弓修復系統，稱為 RCBOLSA。今年晚些時候。因此，我們將繼續打造一家主動脈公司，並很高興能在 2024 年再次為您服務。

Thank you.

謝謝。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。