Artivion Inc (AORT) 2022 Q4 法說會逐字稿

Greetings, and welcome to Artivion's Fourth Quarter and Full-Year End 2022 Financial Results Call (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎來到 Artivion 的 2022 年第四季度和全年財務業績電話會議（操作員說明）作為提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Brian Johnston, Vice President at Gilmartin Group. Thank you, you may begin.

現在我很高興向您介紹主持人，吉爾馬丁集團副總裁布賴恩約翰斯頓。謝謝，可以開始了。

Thanks Operator. Good afternoon, and thank you for joining the call today. Joining me from Artivion's management team are Pat Mackin, CEO; and Ashley Lee, CFO. Before we begin, I'd like to make the following statements to comply with a safe harbor requirements of the private securities litigation Reform Act of 1995. Comments made on this call that look forward in time involve risks or uncertainties that are forward-looking statements within the meaning of the private securities litigation Reform Act of 1995.

感謝運營商。下午好，感謝您今天加入電話會議。和我一起來自 Artivion 管理團隊的是 Pat Mackin，首席執行官；和首席財務官 Ashley Lee。在我們開始之前，我想發表以下聲明，以遵守 1995 年私人證券訴訟改革法案的安全港要求。對本次電話會議做出的及時展望的評論涉及前瞻性陳述的風險或不確定性在 1995 年私人證券訴訟改革法案的含義內。

The forward-looking statements include statements made to the companies 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. Additional information concerning certain risks and uncertainties that may impact these forward-looking statements is contained from time to time and the company's SEC filings and in the press release that was issued earlier today.

前瞻性陳述包括對公司或管理層對未來的意圖、希望、信念、預期或預測所做的陳述。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存在重大差異。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信息不時包含在公司提交給美國證券交易委員會的文件以及今天早些時候發布的新聞稿中。

With that, I'll turn the call over to Pat Mackin.

有了這個，我會把電話轉給 Pat Mackin。

Thanks, Brian, and good afternoon, everyone. Our strategy which I've discussed with you over the past few years, in which we further detailed in March of 2022 at our Investor Day, is to create significant shareholder value by driving sales of our innovative products, expanding within and into new geographies, and developing our pipeline of innovative products to substantially increase our addressable market.

謝謝，布萊恩，大家下午好。我在過去幾年與您討論過的我們的戰略是通過推動我們創新產品的銷售、在新地區內擴張和向新地區擴張來創造重要的股東價值，我們在 2022 年 3 月的投資者日進一步詳細說明了這一戰略，開發我們的創新產品線，以大幅增加我們的潛在市場。

As you'll hear today, we're doing just that. I'm pleased to report that our business continues to perform well as we closed out the full-year 2022 with just over 9% in constant currency revenue growth compared to the full-year of 2021. I'm also pleased to report that we made significant progress on the regulatory front. We received the BioGlue CE mark under the new MDR framework, and based on our recent conversations and interactions with the FDA, we are confident we receive approval for PerClot. You also hear that we continue to remain on track to deliver our revenue in EBITDA commitments, with 2023 expected to represent a major step forward.

正如您今天將聽到的那樣，我們正在這樣做。我很高興地報告，我們的業務繼續表現良好，因為我們在 2022 年全年結束時與 2021 年全年相比，貨幣收入的恆定增長率略高於 9%。我也很高興地報告，我們監管方面取得重大進展。我們在新的 MDR 框架下獲得了 BioGlue CE 標誌，並且根據我們最近與 FDA 的對話和互動，我們有信心獲得 PerClot 的批准。您還聽說我們繼續按計劃實現我們在 EBITDA 承諾中的收入，預計 2023 年將是向前邁出的重要一步。

Starting with our year-over-year revenue performance for the fourth quarter, we saw strong top line constant currency growth in stent graft which grew 16%, in On-X, which grew 11%. For the full-year, our constant currency basis, stent grafts were up 20%, On-X was up 13%, tissue processing was up 8% and BioGlue was down 5%, all compared to full-year 2021. As anticipated, fourth quarter 2022 constant currency revenue growth of 5% was strong was slightly below the quarter growth delivered through the first three quarters of the year.

從我們第四季度的同比收入表現開始，我們看到覆膜支架的收入強勁增長，增長了 16%，On-X 增長了 11%。與 2021 年全年相比，全年，我們的固定貨幣基礎上，支架移植物增長了 20%，On-X 增長了 13%，組織加工增長了 8%，BioGlue 下降了 5%。正如預期的那樣， 2022 年第四季度 5% 的固定貨幣收入增長強勁，略低於今年前三個季度的季度增長。

As we mentioned on our Q3 call, we expected some deceleration in the fourth quarter because our EU customers had accelerated approximately 1.5 million of BioGlue purchases into the third quarter that they otherwise would not have made in the fourth quarter. This was done to protect their supply of BioGlue for the fourth quarter in the event that company was unable to obtain BioGlue (inaudible) extensions beyond October 31. If customers had not made these increased BioGlue purchase in Q3, our total growth for the fourth quarter would have been around 7% on a constant currency basis compared to the prior year. We believe this BioGlue purchase was a one-time occurrence now that we have the CE mark for BioGlue and we anticipate our customers return to regular ordering patterns in the EU in those countries where commercialization is based on CE mark.

正如我們在第三季度電話會議上提到的那樣，我們預計第四季度會出現一些減速，因為我們的歐盟客戶在第三季度加快了大約 150 萬的 BioGlue 採購，否則他們將不會在第四季度進行採購。這樣做是為了在公司無法在 10 月 31 日之後獲得 BioGlue（聽不清）延期的情況下保護他們第四季度的 BioGlue 供應。如果客戶沒有在第三季度增加這些 BioGlue 採購，我們第四季度的總增長與上一年相比，按固定匯率計算約為 7%。我們相信這次 BioGlue 採購是一次性的，因為我們擁有 BioGlue 的 CE 標誌，我們預計我們的客戶會在歐盟的那些商業化基於 CE 標誌的國家恢復正常訂購模式。

You will recall at our Investor Day in March of 2022, we committed to delivering compounded double digit constant currency revenue growth through 2024 through 3 key initiatives. First, we will continue to drive our growth in aortic stent grafts and On-X. Second, we'll continue to benefit from our investments in commercial channels and new regulatory approvals in Asia Pacific and Latin America. And third, we will benefit in 2023 and beyond from PMA approvals in the U.S. for PerClot and PROACT Mitral.

您會記得在 2022 年 3 月的投資者日，我們承諾通過 3 項關鍵舉措在 2024 年之前實現兩位數的複合貨幣收入持續增長。首先，我們將繼續推動主動脈覆膜支架和 On-X 的增長。其次，我們將繼續受益於我們在亞太地區和拉丁美洲的商業渠道投資和新的監管批准。第三，我們將在 2023 年及以後受益於 PerClot 和 PROACT Mitral 在美國的 PMA 批准。

As mentioned previously, the stent graft revenues rebounded in the fourth quarter increased to 16% on a constant currency basis, compared to the fourth quarter last year. We finished the full-year with 20% year-over-year growth compared to '21 on a constant currency basis. Demand for our stent graft portfolio remains high. We've also made significant progress in hiring at our German manufacturing facility, which is now operating at nearly full staffing. As a result, we believe the improved productions -- this will improve production significantly over time, which will serve as a catalyst to continuing to drive growth in our stent graft portfolio.

如前所述，與去年第四季度相比，支架移植物收入在第四季度反彈，按固定匯率計算增長至 16%。與 21 年相比，按固定匯率計算，我們全年實現了 20% 的同比增長。對我們的覆膜支架產品組合的需求仍然很高。我們在德國製造工廠的招聘方面也取得了重大進展，該工廠目前幾乎滿員。因此，我們相信產量的提高——隨著時間的推移，這將顯著提高產量，這將成為繼續推動我們的覆膜支架產品組合增長的催化劑。

On-X revenue grew 11% on a constant currency basis in the fourth quarter of '22 compared to the fourth quarter last year and 13% full-year compared to '21. We remain confident we will continue to take market share globally. We're the only mechanical aortic heart valve that can be maintained in INR between 1.5 and 2.0. We are also executing very well on our next initiative to expand our presence in Asia Pacific and Latin America, through new regulatory approvals and commercial footprint expansion. APAC and Latin America had fourth quarter constant currency revenue growth of 21% and 12% respectively, in 30% and 38% for the full-year respectively.

與去年第四季度相比，22 年第四季度 On-X 收入按固定匯率計算增長 11%，與 21 年相比全年增長 13%。我們仍然相信我們將繼續在全球範圍內佔據市場份額。我們是唯一可以將 INR 維持在 1.5 到 2.0 之間的機械主動脈瓣。通過新的監管批准和商業足跡擴張，我們在下一個旨在擴大我們在亞太地區和拉丁美洲業務的計劃方面也執行得非常好。亞太地區和拉丁美洲第四季度的固定貨幣收入分別增長 21% 和 12%，全年分別增長 30% 和 38%。

We continue to expect these regions to be important growth drivers over the coming years. Regarding our third initiative based on recent discussions with the FDA, we are optimistic that we receive a PMA for our PerClot product. Upon approval, we receive approximately $19 million or $15 million net of amounts owed to a former partner and we will then commence shipping a product to Baxter. As for PROACT Mitral, we are maintaining interactive dialogues with the FDA and look forward to a potential approval in the second half of this year. We do not believe that securing this approval is imperative as it relates to our ability to achieve our near and longer term revenue growth forecasts. We've not included the potential approval in our outlook for 2023.

我們繼續預計這些地區將成為未來幾年重要的增長動力。關於我們最近與 FDA 討論的第三項舉措，我們對我們的 PerClot 產品收到 PMA 感到樂觀。獲得批准後，我們將收到約 1900 萬美元或 1500 萬美元的款項（扣除欠前合作夥伴的款項），然後我們將開始向百特運送產品。至於 PROACT Mitral，我們正在與 FDA 保持互動對話，並期待在今年下半年獲得批准。我們不認為獲得這一批准是必要的，因為它關係到我們實現近期和長期收入增長預測的能力。我們沒有將潛在的批准納入我們對 2023 年的展望。

In addition, our progress in each of these 3 initiatives, we continue to make progress in our pipeline, which includes the AMDS clinical trial and the NEXUS PERSEVERE trial of our partner. We've enrolled 25 patients in our PERSEVERE trial, which is a nonrandomized clinical trial of up to 30 centers in the U.S. with 100 patients, who have experienced acute type A aortic dissections. The combined primary efficacy and safety endpoints of this trial are reduction of all-cause mortality, new disability stroke, myocardial infarction, new onset renal failure requiring dialysis and re-expansion of the true lumen of the aorta.

此外，我們在這三項舉措中的每一項都取得了進展，我們繼續在我們的管道中取得進展，其中包括 AMDS 臨床試驗和我們合作夥伴的 NEXUS PERSEVERE 試驗。我們已經在我們的 PERSEVERE 試驗中招募了 25 名患者，這是一項非隨機臨床試驗，涉及美國多達 30 個中心，有 100 名患者，他們都經歷過急性 A 型主動脈夾層。該試驗的主要療效和安全性綜合終點是降低全因死亡率、新發殘疾性卒中、心肌梗塞、新發腎衰竭需要透析和主動脈真腔再擴張。

We now anticipate completing full enrollment in the second half of this year following a 1-year follow-up period and assume the trial meets its endpoints. We anticipate we would receive FDA approval for AMDS in 2025. In addition, as I previously stated, our partner, Endospan is making progress on the U.S. ID called TRIOMPHE for its NEXUS aortic arch stent graft system. In that trial, there are approximately 32 patients enrolled and treated in total 47 patients enrolled and approved for treatment. Endospan estimates enrollment completion in mid-2023 with a PMA approval in 2025, again, assuming the trial hit its endpoints.

我們現在預計在經過 1 年的隨訪期後，將在今年下半年完成全部入組，並假設試驗達到終點。我們預計我們將在 2025 年獲得 FDA 對 AMDS 的批准。此外，正如我之前所說，我們的合作夥伴 Endospan 正在為其 NEXUS 主動脈弓支架移植系統的名為 TRIOMPHE 的美國 ID 取得進展。在該試驗中，大約有 32 名患者入組並接受了治療，總共有 47 名患者入組並獲准進行治療。 Endospan 估計在 2023 年年中完成註冊，並在 2025 年獲得 PMA 批准，再次假設試驗達到終點。

To reiterate, if these PMA trials succeed as anticipated or proceed as anticipated, we expect FDA approval for AMDS and NEXUS in 2025. At that time, assuming we exercise our option for Endospan, these products would increase our addressable market opportunity by an estimated $700 million.

重申一下，如果這些 PMA 試驗按預期成功或按預期進行，我們預計 FDA 將在 2025 年批准 AMDS 和 NEXUS。屆時，假設我們行使對 Endospan 的選擇權，這些產品將使我們的潛在市場機會增加約 700 美元百萬。

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

有了這個，我現在將電話轉給阿什利。

Thanks, Pat, and good afternoon, everyone. Total revenues were $79.4 million for the fourth quarter, flat on a GAAP basis and up 5% on a constant currency basis, both compared to Q4 of 2021. For the full-year, revenues increased 5% on a GAAP basis and 9% on a constant currency basis. On a year-over-year basis, in the fourth quarter of 2022, On-X revenues increased 8%. Tissue processing revenues increased 2%. Aortic stent grafts grew 2% and BioGlue decreased to 12%. On a constant currency basis compared to the fourth quarter of '21, stent grafts grew 16%. On-X grew 11%. Tissue processing increased 2% and BioGlue revenues decreased 8%. On a regional basis, fourth quarter 2020 revenues -- 2022 revenues in Asia Pacific increased 20%. Latin America increased 13%. North America increased 4% and EMEA decreased 11%, all compared to the fourth quarter of 2021.

謝謝帕特，大家下午好。與 2021 年第四季度相比，第四季度總收入為 7940 萬美元，按 GAAP 計算持平，按固定匯率計算增長 5%。全年按 GAAP 計算收入增長 5%，按 GAAP 計算增長 9%一個固定的貨幣基礎。與去年同期相比，2022 年第四季度，On-X 收入增長了 8%。組織加工收入增長了 2%。主動脈覆膜支架增長 2%，BioGlue 下降至 12%。與 21 年第四季度相比，以固定匯率計算，覆膜支架增長了 16%。 On-X 增長了 11%。組織加工收入增長 2%，而 BioGlue 收入下降 8%。按區域劃分，2020 年第四季度亞太地區收入——2022 年收入增長 20%。拉丁美洲增長了 13%。與 2021 年第四季度相比，北美增長 4%，歐洲、中東和非洲地區下降 11%。

On a constant currency basis, revenues in Asia Pacific increased to 21%, Latin America increased 12%. North America increased 4%, and Europe increased 2%, all compared to the fourth quarter of 2021. Gross margins improved sequentially from the third quarter to 64.1% in Q4, which compares to 64.7% for the fourth quarter of '21. The decrease compared to the prior year was driven primarily by inflation impacts on materials and labor as well as product mix within our aortic stent graft line. While inflation rates globally remain persistently high and continue to weigh on our gross margins, we believe that gross margins -- we expect them to improve and stabilize in 2023 and then improve after that.

按固定匯率計算，亞太地區的收入增長了 21%，拉丁美洲增長了 12%。與 2021 年第四季度相比，北美增長了 4%，歐洲增長了 2%。毛利率從第三季度開始環比提高至 64.1%，而 2021 年第四季度為 64.7%。與上一年相比下降的主要原因是通貨膨脹對材料和勞動力的影響以及我們主動脈覆膜支架產品線的產品組合。儘管全球通脹率持續居高不下並繼續對我們的毛利率構成壓力，但我們相信毛利率——我們預計它們將在 2023 年改善並穩定下來，然後再改善。

G&A expenses in the fourth quarter were $38.5 million compared to $51.3 million in the fourth quarter of 2021. Excluding nonrecurring acquisition-related business development benefits and other nonrecurring charges, G&A expenses were $41.9 million for the fourth quarter of '22 compared to $40.3 million for the fourth quarter of 2021. R&D expenses for the fourth quarter were $8.3 million compared to $9.5 million in the fourth quarter of 2021. R&D expenses in the fourth quarter of 2022 include $1.9 million for prelaunch PerClot inventory. If PerClot is approved, which we expect, then the majority of the PerClot sales to Baxter expected in 2023 will have no cost of goods associated with these sales. We have treated these costs as nonrecurring and have excluded them for purposes of calculating adjusted EBITDA and non-GAAP earnings per share.

第四季度的 G&A 費用為 3850 萬美元，而 2021 年第四季度為 5130 萬美元。不包括與收購相關的非經常性業務發展收益和其他非經常性費用，2022 年第四季度的 G&A 費用為 4190 萬美元，而 2021 年第四季度為 4030 萬美元2021 年第四季度。第四季度的研發費用為 830 萬美元，而 2021 年第四季度為 950 萬美元。2022 年第四季度的研發費用包括 190 萬美元的上市前 PerClot 庫存。如果 PerClot 獲得批准（我們預計），那麼預計在 2023 年向百特出售的大部分 PerClot 將沒有與這些銷售相關的商品成本。我們將這些成本視為非經常性成本，並在計算調整後的 EBITDA 和非 GAAP 每股收益時將其排除在外。

Other income and expenses include $5.3 million in net interest expense and foreign currency translation gains of approximately $4.5 million. On the bottom line, we reported GAAP net income of approximately $2.2 million or $0.05 per fully diluted share in the fourth quarter of 2022. Non-GAAP net income was $4.2 million or $0.10 per share in the fourth quarter. Non-GAAP income includes foreign currency gains and excludes business development and other nonrecurring charges.

其他收入和支出包括 530 萬美元的淨利息支出和約 450 萬美元的外幣換算收益。最重要的是，我們報告了 2022 年第四季度的 GAAP 淨收入約為 220 萬美元或每股完全攤薄收益 0.05 美元。第四季度的非 GAAP 淨收入為 420 萬美元或每股 0.10 美元。非 GAAP 收入包括外匯收益，不包括業務發展和其他非經常性費用。

As of December 31, 2022, we had approximately $39.4 million in cash, $306 million in debt and the full $30 million available to us under our revolving credit facility. Adjusted EBITDA for the fourth quarter of 2022 was $11 million compared to $10.8 million for the fourth quarter of 2021. 2022 full-year adjusted EBITDA was $41.6 million compared to $44.3 million for 2021. Please refer to our press release for additional information about our non-GAAP results, including a reconciliation of these results to our GAAP results.

截至 2022 年 12 月 31 日，我們擁有大約 3940 萬美元的現金、3.06 億美元的債務以及我們在循環信貸額度下可用的全部 3000 萬美元。 2022 年第四季度的調整後 EBITDA 為 1100 萬美元，而 2021 年第四季度為 1080 萬美元。2022 年全年調整後的 EBITDA 為 4160 萬美元，而 2021 年為 4430 萬美元。請參閱我們的新聞稿，了解有關我們非-GAAP 結果，包括將這些結果與我們的 GAAP 結果進行核對。

And now for our initial 2023 outlook. We expect constant currency revenue growth of between 8% and 12% for the full-year of 2023. We expect revenues to be in a range of $331 million to $343 million. We see timing of the PerClot PMA and timing of supply upside following increased production staffing in Germany as key factors that could move us toward the lower or higher end of this range. As noted earlier, approval and initial revenue contribution from PROACT Mitral is not included in our 2023 outlook and could represent further upside. Our guidance also reflects a recent communication we received from our sole source supplier for TMR handpieces, indicating that they are exiting this business and will no longer supply us with handpieces effectively immediately. We, therefore, expect to have minimal contribution from TMR revenues in 2023. We currently are evaluating our options for TMR, but none would contribute any revenues prior to 2024. For context, we generated approximately $3 million in revenue from the TMR product line last year and therefore, do not see this as a meaningful impediment to long-term growth.

現在是我們對 2023 年的初步展望。我們預計 2023 年全年貨幣收入將持續增長 8% 至 12%。我們預計收入將在 3.31 億美元至 3.43 億美元之間。我們認為 PerClot PMA 的時機和德國生產人員增加後供應上行的時機是可能使我們走向該範圍較低或較高端的關鍵因素。如前所述，PROACT Mitral 的批准和初始收入貢獻不包括在我們的 2023 年展望中，可能代表進一步上漲。我們的指南還反映了我們最近從我們的 TMR 手機唯一來源供應商那裡收到的一封信，表明他們正在退出該業務，並且將不再立即有效地向我們提供手機。因此，我們預計 2023 年 TMR 收入的貢獻微乎其微。我們目前正在評估我們對 TMR 的選擇，但沒有人會在 2024 年之前貢獻任何收入。就背景而言，我們去年從 TMR 產品線產生了大約 300 萬美元的收入因此，不要將此視為長期增長的重大障礙。

For the first quarter, we expect to see an approximate $2 million revenue currency headwind compared to the first quarter of 2022. Additionally, giving the meaningful contribution of stent grafts to our growth, we expect revenue growth for the first half of the year to be closer to the lower end of our range of revenue guidance as recent hires in Germany will take time to become fully productive. We then expect growth in the second half of the year to be closer to the higher end of our range of revenue guidance.

對於第一季度，與 2022 年第一季度相比，我們預計將出現約 200 萬美元的收入貨幣逆風。此外，考慮到支架移植物對我們的增長做出了有意義的貢獻，我們預計今年上半年的收入增長將為接近我們收入指導範圍的下限，因為最近在德國招聘的員工需要時間才能充分發揮作用。然後，我們預計今年下半年的增長將更接近我們收入指導範圍的高端。

With the continued growth in our top line revenues, general expense management and a decrease in R&D spending, we anticipate delivering 20-plus percent growth in 2023 and adjusted EBITDA to a minimum of $50-plus million. This will put us on track to meet our 2024 adjusted EBITDA commitments we made in March of last year at our Investor Day. Further, we do not see the need to raise additional capital to fund our debt obligations, our investments in our channels or our pipeline. Even if so for increases to approximately 5%, we should be able to comfortably service our debt and continue to invest in growth.

隨著我們收入的持續增長、一般費用管理和研發支出的減少，我們預計 2023 年將實現 20% 以上的增長，並將 EBITDA 調整為至少 50 多萬美元。這將使我們走上正軌，實現我們在去年 3 月投資者日做出的 2024 年調整後 EBITDA 承諾。此外，我們認為不需要籌集額外資金來為我們的債務義務、我們對渠道或管道的投資提供資金。即使增加到大約 5%，我們也應該能夠輕鬆地償還我們的債務並繼續投資於增長。

And finally, our term loan B contains no financial covenants that would place us in default unless we were to have more than $7.5 million drawn on our revolving credit facility at the end of any calendar quarter, which we do not. As of now, we have the full $30 million available under our credit facility and do not foresee the need to draw on it. Additionally, our convertible notes do not contain any financial covenants.

最後，我們的定期貸款 B 不包含使我們違約的財務契約，除非我們在任何日曆季度末從我們的循環信貸額度中提取超過 750 萬美元，而我們沒有這樣做。截至目前，我們的信貸額度已足足提供了 3000 萬美元，預計無需動用。此外，我們的可轉換票據不包含任何財務契約。

I will turn the call back over to Pat for his closing comments.

我會將電話轉回給帕特，聽取他的結束評論。

Thanks, Ashley. We're pleased with our performance in 2022 and our position entering 2023. And particularly considering the multitude of macro headwinds, including among other things, COVID significant staffing and inflationary pressures. Our growth strategy is working and delivering on the results we've envisioned. To summarize, our stent graft business returned to strong growth in the fourth quarter. We expect recent staffing improvements in Germany to significantly benefit supply and drive future growth.

謝謝，艾希禮。我們對我們在 2022 年的表現和我們進入 2023 年的立場感到滿意。特別是考慮到眾多宏觀逆風，包括 COVID 大量人員配置和通脹壓力等。我們的增長戰略正在發揮作用並實現我們預期的結果。總而言之，我們的覆膜支架業務在第四季度恢復了強勁增長。我們預計德國最近的人員配置改善將大大有利於供應並推動未來增長。

On-X continues to perform well, and we're hopeful that PROACT Mitral will be approved later this year. Asia Pacific and Latin America continue to outperform, and we expect more of the same moving forward. Our recent BioGlue CE mark should drive growth, and we're very optimistic that we'll soon have approval for PerClot. And then our 2 U.S. clinical trials, AMDS PERSEVERE and Endospan NEXUS TRIOMPHE are currently enrolling. Combined, we expect to expand our total addressable market for these 2 products by over $700 million in 2025, assuming we execute on the end of (inaudible)

On-X 繼續表現良好，我們希望 PROACT Mitral 能在今年晚些時候獲得批准。亞太地區和拉丁美洲繼續表現出色，我們預計未來會有更多相同的表現。我們最近的 BioGlue CE 標誌應該會推動增長，我們非常樂觀地認為我們將很快獲得 PerClot 的批准。然後我們的 2 個美國臨床試驗 AMDS PERSEVERE 和 Endospan NEXUS TRIOMPHE 目前正在註冊。假設我們在（聽不清）結束時執行，我們預計到 2025 年這兩種產品的總潛在市場將擴大 7 億美元以上

Through 2024, we expect revenue growth to grow double digits on a compounded annual basis to generate $75 million to $80 million in adjusted EBITDA and to reduce our net leverage to less than 3x despite the headwinds we face from inflation and its impact on gross margins. At this point, we have the essential pieces in place for sustained growth and can continue our focus on execution to create shareholder value. We are further solidifying our position as a leading company (inaudible) thanks to our innovative products, accomplished sales organization and experienced leadership team. We are confident our positive momentum will continue, and I want to thank all of Artivion employees around the world for continuing to deliver for the people we endeavor to help.

到 2024 年，儘管我們面臨通貨膨脹及其對毛利率的影響，但我們預計收入將以復合年增長率增長兩位數，從而產生 7500 萬至 8000 萬美元的調整後 EBITDA，並將我們的淨槓桿率降至 3 倍以下。在這一點上，我們已經具備了持續增長的必要條件，可以繼續專注於執行以創造股東價值。由於我們的創新產品、完善的銷售組織和經驗豐富的領導團隊，我們正在進一步鞏固我們作為領先公司（聽不清）的地位。我們相信我們的積極勢頭將繼續下去，我要感謝全球所有 Artivion 員工繼續為我們努力幫助的人們提供服務。

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

那麼，接線員，請打開問題熱線。

(Operator Instructions) Our first question comes from the line of [Charlie Montane] with Lake Street.

（操作員說明）我們的第一個問題來自 [Charlie Montane] 與 Lake Street 的台詞。

Congrats on a great quarter. Just a couple of quick questions for me. My first one is can you kind of remind us on how we should be thinking about FX impact in 2023? I mean, when those headwinds might start to moderate when comparing year-over-year USD numbers?

祝賀一個偉大的季度。只是幾個簡單的問題問我。我的第一個問題是您能否提醒我們我們應該如何考慮 2023 年的外匯影響？我的意思是，當比較同比美元數據時，這些逆風何時開始緩和？

Ash, I'll let you take that one.

阿什，我會讓你拿那個。

Yes. A lot of it obviously depends on where primarily the Euro-USD relationship moves and -- because that is the one that has the most outsized impact on our business. Based on where rates are currently, we expect that beginning in the second half of the year, FX could actually become a tailwind for us. So again, it ultimately depends on where rates move. But based on what we're currently looking at, we expect, again, FX to become a tailwind for us in the second half of the year.

是的。顯然，這在很大程度上取決於歐元與美元關係的主要發展方向——因為這是對我們業務影響最大的因素。根據目前的利率水平，我們預計從今年下半年開始，外匯實際上可能成為我們的順風車。同樣，這最終取決於利率的走勢。但根據我們目前的觀察，我們預計 FX 將在今年下半年成為我們的順風車。

And then my next one is at your last Analyst Day, you stated stent should grow high teens, On-X, 10% to low teens, preservation, mid-single digits and surgical sealants, low to mid-single digits. Does this remain the case? And is there anything you are seeing today that could alter that trajectory?

然後我的下一個是在你的最後一個分析師日，你說支架應該增長高青少年，On-X，10% 到低青少年，保存，中個位數和手術密封劑，低到中個位數。情況是否仍然如此？您今天看到的有什麼可以改變這一軌蹟的嗎？

Yes, I'll take that one. I mean, if you look back at kind of what we presented in March of last year, it was roughly 15 -- we projected roughly 15% to 20% growth for stent graft. We came in at 20% for the year. So at the high end of that range. On-X, we said kind of 10% to 15%. We came in at 13% midpoint of that. So well in line. Tissue, mid-single, we came in at 8% kind of at the high end of that range. The only one that disappointed was obviously BioGlue and the fact that it took us an entire year to get the CE Mark through the MDR process was a big contributor to that. We had several countries that we couldn't get (inaudible) for -- and then we -- in the countries we did get -- it took us longer than we thought. So the great news is we got the BioGlue CE Mark right at the end of the year. That's all behind us. We now have an MDR CE mark for BioGlue and we don't have to hear about that anymore.

是的，我會拿那個。我的意思是，如果你回顧一下我們去年 3 月展示的內容，大約有 15 個——我們預計支架移植物的增長率約為 15% 到 20%。我們今年的收入為 20%。所以在那個範圍的高端。在 X 上，我們說是 10% 到 15%。我們以 13% 的中點進入。非常符合。紙巾，中單，我們以 8% 的價格進入該範圍的高端。唯一令人失望的顯然是 BioGlue，我們花了整整一年的時間才通過 MDR 流程獲得 CE 標誌，這是一個很大的貢獻者。我們有幾個我們無法（聽不清）的國家 - 然後我們 - 在我們確實獲得的國家 - 我們花了比我們想像的更長的時間。所以好消息是我們在年底獲得了 BioGlue CE 標誌。這一切都在我們身後。我們現在有了 BioGlue 的 MDR CE 標誌，我們不必再聽說了。

So I think BioGlue should return back to kind of that low single digits, and that was really the only outlier and one of the reasons we were at the lower end of the range for the full-year. Okay.

所以我認為 BioGlue 應該回到那種低的個位數，這確實是唯一的異常值，也是我們處於全年範圍低端的原因之一。好的。

And then just one last quick one here. The supply chain issues within the stent business resolved? And if not, kind of what else needs to be done?

然後這裡只是最後一個快速的。支架企業內部的供應鏈問題解決了嗎？如果沒有，還需要做什麼？

Yes. I mentioned this in my comments. It's obviously -- it's a good problem to have. We have huge demand on our stent graft portfolio, partly because we have such innovative products. This is a bit of a growth challenge in that. We're growing at the high end of our range of 20%. We had some issues hiring in one of our major factory in Germany, and we actually changed our labor rates. And where we couldn't find people at the lower rates, we all of a sudden magically find a bunch of people. This is, again, inflation in action. We hired a number of people in the fourth quarter. They're being trained as we speak. It takes about 90 days to get up and trained. So we -- as Ashley commented, we should expect to see kind of continued strength in our supply chain to support that growth and even hopefully going beyond where we are as we get the new manufacturing employees trained and getting the supply chain primed. So we should see growth kind of increase throughout the year on our stent graft business.

是的。我在評論中提到了這一點。很明顯——這是一個很好的問題。我們對覆膜支架產品組合有巨大需求，部分原因是我們擁有此類創新產品。這是一個增長挑戰。我們的增長處於 20% 範圍的高端。我們在德國的一家主要工廠招聘時遇到了一些問題，我們實際上改變了我們的人工費率。在我們找不到低價人員的地方，我們突然神奇地找到了一群人。這又是通貨膨脹在起作用。我們在第四季度僱傭了一些人。我們說話的時候，他們正在接受培訓。起床和訓練大約需要90天。因此，正如 Ashley 所評論的那樣，我們應該期望看到我們的供應鏈中有某種持續的力量來支持這種增長，甚至希望在我們對新的製造員工進行培訓並為供應鏈做好準備時超越我們目前的水平。因此，我們應該看到我們的支架移植業務全年都在增長。

Our next question comes from the line of Jeffrey Cohen from Ladenburg Thalmann.

我們的下一個問題來自 Ladenburg Thalmann 的 Jeffrey Cohen。

So as a few quick ones. As far as guidance goes for '23, are you including or not including PerClot in the range?

所以作為一些快速的。就 23 年的指導而言，您是否在該範圍內包括或不包括 PerClot？

Yes, that's in the range.

是的，在這個範圍內。

And then could you talk about margins a bit, supply chain? It seems like '23 will remain challenging?

然後你能談談利潤率嗎，供應鏈？看起來'23 仍將具有挑戰性？

I mean, margins, I mean, kind of our -- one of our -- other than the BioGlue CE mark taken forever last year, the inflationary impact, so the labor increase, the rates of labor and the cost of materials was really one of our kind of challenges as a headwind that many companies face. I mean, we finished 2021 at around 66% gross margin, and we finished '22 at about 64.5%, so about 150 basis point decline and all directly related to inflationary pressure. So those are somewhat baked in. Our gross margins, we're planning on kind of holding them flat this year with a lot of those inflationary pressures baked in.

我的意思是，利潤率，我的意思是，我們的一種——我們的一種——除了去年永久取消的 BioGlue CE 標誌，通貨膨脹的影響，所以勞動力增加，勞動力率和材料成本真的是一個我們的挑戰是許多公司面臨的不利因素。我的意思是，我們 2021 年的毛利率約為 66%，22 年的毛利率約為 64.5%，因此下降了約 150 個基點，所有這些都與通脹壓力直接相關。所以這些在某種程度上已經被消化了。我們的毛利率，我們計劃在今年將它們持平，因為有很多通脹壓力。

The supply chain thing, I mean, this -- we talked about TMR, and you've been around covering the company for a long time. I mean, in these kind of older product lines that are nonstrategic like TMR, and that was not exactly our future. But it was a decent product with good margin. I mean, we had multiple suppliers just go down, and we don't have the supply chain kind of infrastructure really supporting that because it is such a small product and it's not strategic. And I think that's a good example of it, just -- it's more probably effort than it's worth. We're going to evaluate whether or not we want to revive that. But at a minimum, we're not going to see revenue from TMR for the next 2 years. So -- but I think that's a good example of where we don't have a strategic focus that kind of stuff can happen.

供應鏈的事情，我的意思是，這個——我們談到了 TMR，你已經在公司報導了很長時間。我的意思是，在像 TMR 這樣非戰略性的舊產品線中，那不完全是我們的未來。但這是一個不錯的產品，利潤率很高。我的意思是，我們有多個供應商倒閉了，我們沒有真正支持它的供應鏈基礎設施，因為它是一個很小的產品，而且不具有戰略意義。我認為這是一個很好的例子，只是 - 它更可能是努力而不是值得的。我們將評估是否要恢復它。但至少，我們不會在未來 2 年內看到來自 TMR 的收入。所以 - 但我認為這是一個很好的例子，說明我們沒有戰略重點，這種事情可能會發生。

We deal with it kind of every day, but we're able to on our faster-growing, larger product lines. We have a good infrastructure around supporting those. So I think that's part of our job and manage those supply chain issues.

我們每天都在處理它，但我們能夠在我們增長更快、更大的產品線上處理。我們在支持這些方面擁有良好的基礎設施。所以我認為這是我們工作的一部分，管理這些供應鏈問題。

And then lastly for us, any commentary, Pat, as far as the stent graft platform out there in Europe and some more color on NEXUS versus (inaudible) what kind of reception and presence and growth you're seeing?

最後對我們來說，任何評論，帕特，就歐洲的支架移植平台和 NEXUS 上的更多顏色與（聽不清）你看到什麼樣的接受、存在和增長？

Yes. I mean, we're seeing a really excellent growth. Like I said, I mean, we somewhat decelerated as the year went on in 2022, primarily because of supply. I mean, our sales team over there is running around moving product around because as I mentioned earlier, we had a hard time hiring in our facility in Germany. And once we change those labor rates to get in line with kind of the German market rates, we were able to hire very quickly in the fourth quarter and filled the factory up and those people are being trained now. So -- but as far as the product lines, I mean, we're seeing really good growth across all of our products. And that's really one of the -- it's an opportunity. We've got such unique technology in the NEO frozen elephant trunk up in the arch, the 2 offerings in the thoracic abdominal area for end side and what we call extra design that we just got to make sure we got the product where it needs to be on time, and we can continue to drive this growth for a long period of time.

是的。我的意思是，我們看到了非常出色的增長。就像我說的，我的意思是，隨著時間的推移，我們在 2022 年有所放緩，主要是因為供應。我的意思是，我們那邊的銷售團隊正在四處移動產品，因為正如我之前提到的，我們在德國的工廠很難招到人。一旦我們改變這些勞動力率以與德國市場利率保持一致，我們就能夠在第四季度非常迅速地招聘並填補工廠，這些人現在正在接受培訓。所以 - 但就產品線而言，我的意思是，我們看到我們所有產品的增長非常好。這確實是其中之一——這是一個機會。我們在拱形的 NEO 冷凍象鼻中採用瞭如此獨特的技術，在端側的胸腹部區域提供了 2 個產品，我們稱之為額外設計，我們只需要確保我們在需要的地方獲得產品準時，我們可以在很長一段時間內繼續推動這種增長。

Our next question comes from the line of Rick Wise with Stifel.

我們的下一個問題來自 Rick Wise 與 Stifel 的對話。

A couple of questions. Sorry to make you go over the macro again. I just want to be absolutely clear that I'm hearing the messaging. A lot of the companies that have reported so far, Pat have probably over simplistically characterize it, I'd say they've been talking about a stable to improving environment. I just was wondering, is that how we should think about things in a general sense for you? I mean, I hear -- and when I think about it again, Germany getting better as the year unfolds. It sounds like supply chain is less an issue. currency, lesser effect (inaudible) staffing, I just want to make sure we're clear on the key macro drivers being less?

幾個問題。很抱歉讓你再過一遍宏。我只是想絕對清楚我正在聽到消息。到目前為止，許多已經報告的公司，帕特可能過於簡單地描述了它，我想說他們一直在談論一個穩定到改善的環境。我只是想知道，我們應該如何為您考慮一般意義上的事情？我的意思是，我聽說——當我再次考慮時，德國會隨著時間的推移變得更好。聽起來供應鏈不是什麼大問題。貨幣、影響較小（聽不清）的人員配備，我只是想確保我們清楚關鍵的宏觀驅動因素正在減少？

Yes. So if you think about -- I made a comment about just the number of -- in 30 years of doing this, I've never had as many macro headwinds, right. You had COVID, you had staffing, hospital striking. You had inflationary pressures. You had supply chain pressures, currency pressures, right. So there was a lot. I think we actually put up a pretty good year given all the stuff that was thrown at us. If you kind of unpack those, I mean, inflation, you can read the papers, everybody is kind of trying to figure out what's going to happen. But we feel like our gross margins are going to be flat and answers to your inflation question. We took 150 basis point WACC last year, and we think we can be stable this year. So we kind of got it baked in.

是的。因此，如果你想想——我只是評論了——在 30 年的工作中，我從來沒有遇到過這麼多的宏觀逆風，對吧。你有 COVID，你有人員配備，醫院罷工。你有通貨膨脹壓力。你有供應鏈壓力，貨幣壓力，對吧。所以有很多。考慮到扔給我們的所有東西，我認為我們實際上度過了一個相當不錯的一年。如果你解開那些，我的意思是，通貨膨脹，你可以閱讀報紙，每個人都在試圖弄清楚會發生什麼。但我們覺得我們的毛利率將持平並回答你的通貨膨脹問題。去年我們拿了150個基點的WACC，我們覺得今年可以穩定。所以我們有點把它烤進去了。

COVID, I mean, I don't really even see COVID being an issue. Now again, who knows what happens in the future, but I really just don't see it. We're seeing staffing here and there, and I talked to a lot of surgeons, and there are strikes. Mount Sinai had a nurse strike and Minneapolis had a nurse strike and Stanford had a nurse strike. I mean, at the end of the day, our procedures get done. So whether they strike for a week or 2, it's not going to change our macro procedure volume in a year. So that I don't see -- I mean, we have heard a lot of noise out of the U.K., the NHS health systems in kind of disarray. But again, our emergent -- these aren't facelifts, right. These are aortic heart repairs and heart valves. So I think we tend to -- and we've proven this through the pandemic, we tend to actually -- our procedures get done. So I think that one is in better shape. I think actually comment on currency in the second half. So I do think, to your point, I think a lot of these are much -- in a much better way than they were last year.

COVID，我的意思是，我什至不認為 COVID 是一個問題。再一次，誰知道未來會發生什麼，但我真的只是看不到。我們到處都看到人員配備，我和很多外科醫生談過，而且有罷工。西奈山發生了護士罷工，明尼阿波利斯發生了護士罷工，斯坦福發生了護士罷工。我的意思是，在一天結束時，我們的程序完成了。因此，無論他們罷工一周還是兩週，都不會在一年內改變我們的宏觀手術量。所以我看不到——我的意思是，我們從英國聽到了很多聲音，NHS 衛生系統有點混亂。但同樣，我們的緊急情況 - 這些不是整容，對吧。這些是主動脈心臟修復和心臟瓣膜。所以我認為我們傾向於——我們已經通過大流行證明了這一點，我們實際上傾向於——我們的程序已經完成。所以我認為那個狀態更好。我認為實際上是在下半年對貨幣發表評論。所以我確實認為，就你的觀點而言，我認為其中很多 - 比去年要好得多。

Yes, the supply chain stuff kind of can jump up and bite you, but we've got teams in place to manage that. There's lots of kind of noise under the hood, but we continue to drive the business. And I think simplifying the product line. I mean, having a nonstrategic product like a TMR, it's just hard to manage an old supply chain and it doesn't have a lot of revenue. And I think it's a good example of stuff you probably don't want to be involved in going forward.

是的，供應鏈的事情有點像跳起來咬你，但我們有團隊來管理它。引擎蓋下有很多噪音，但我們繼續推動業務發展。我認為簡化產品線。我的意思是，擁有像 TMR 這樣的非戰略性產品，很難管理舊的供應鏈，而且收入也不多。而且我認為這是一個很好的例子，說明你可能不想參與未來的事情。

Can you take us through some of the key drivers in 2023 for the aortic stent graft portfolio? Obviously, you're doing great. How do we think about just the blocking and tackling this year? Is it -- to what extent is it important to add sales guys? Is it -- what are your top couple of priorities for that portfolio around that one?

您能否為我們介紹 2023 年主動脈覆膜支架產品組合的一些關鍵驅動因素？顯然，你做得很好。我們如何看待今年的攔截和攔截？增加銷售人員在多大程度上重要？是——圍繞那個投資組合，你最優先考慮的是什麼？

Yes. So our fastest-growing products, and there's 4 of them inside that stent craft portfolio. And it's really our differentiated portfolio. So if you kind of go from the top of the aorta down on the surgical side, our Neo device is doing extremely well. We're both opening up new markets in Asia Pacific and Latin America, and we're also adding feet on the street there. We saw tremendous growth in Asia and Latin America as combined businesses, but that was one of the underlying drivers. We continue to add some people here and there as we see a very fast-growing market, but that Neo device is growing quite well.

是的。所以我們增長最快的產品，其中有 4 個在支架工藝產品組合中。這確實是我們差異化的產品組合。因此，如果您從主動脈頂部向下移動到手術側，我們的 Neo 設備表現非常出色。我們都在亞太和拉丁美洲開闢新市場，我們也在那裡增加業務。我們看到亞洲和拉丁美洲作為合併業務的巨大增長，但這是潛在的驅動力之一。我們繼續在這里和那裡增加一些人，因為我們看到一個非常快速增長的市場，但 Neo 設備增長得很好。

We just launched our second-generation stent graft for the Arch, the (inaudible) which is a 2-branch device. And you're familiar with this from some of the work you've done with our physicians. The current NEXUS that's in U.S. clinical trials is a single branch into the nominate, that's got some limitations. We've got a 2-branch device that was just launched in Europe that is getting very, very positive reviews. We expect that to be a growth driver. The AMDS for acute type A dissections, which is approved in Europe, Canada and a handful of international markets is growing very rapidly. And we continue to get more and more data out on that device. PERSEVERE's continuing to enroll, which obviously some of the anecdotal things we're hearing from U.S. surgeons are kind of spanning across the oceans and people are hearing about them.

我們剛剛推出了用於 Arch 的第二代覆膜支架，這是一種雙分支裝置（聽不清）。從您與我們的醫生一起完成的一些工作中，您已經熟悉了這一點。目前在美國臨床試驗中的 NEXUS 是提名的一個分支，有一些局限性。我們有一款剛剛在歐洲推出的 2 分支設備，獲得了非常非常積極的評價。我們預計這將成為增長動力。用於急性 A 型夾層的 AMDS 在歐洲、加拿大和少數國際市場獲得批准，發展非常迅速。我們繼續在該設備上獲取越來越多的數據。 PERSEVERE 繼續招募，顯然我們從美國外科醫生那裡聽到的一些軼事有點跨越大洋，人們正在聽說它們。

And then our thoracal abdominal is really a -- we're kind of a key player in that segment with 2 offerings, right, the only off-the-shelf (inaudible). And then the custom-made extra design. And combined, we basically can treat really any thorical abdominal injury. So it's really those 4 unique technologies where we have very little competition, we may have 1 or 2, but it's a very kind of surgeons love the portfolio. It's allowing them to treat patients they can't treat with some of the other companies.

然後我們的胸腹部真的是——我們是該領域的關鍵參與者，有 2 種產品，對，唯一現成的（聽不清）。然後是定制的額外設計。結合起來，我們基本上可以真正治療任何胸部腹部損傷。所以這真的是我們幾乎沒有競爭的那 4 種獨特技術，我們可能有 1 或 2 種，但這是一種非常外科醫生喜歡的產品組合。這使他們能夠治療其他一些公司無法治療的患者。

And like I said, we had some challenges and own up the factory in the second half of last year, and we've now resolved that. So it's really just a training, getting those employees up and trained and we -- as long as we can feed those reps, we'll continue to grow that stent graft business pretty significantly.

就像我說的，我們在去年下半年遇到了一些挑戰並擁有了這家工廠，現在我們已經解決了這個問題。所以這真的只是一次培訓，讓這些員工起來接受培訓，我們——只要我們能養活這些代表，我們就會繼續顯著發展支架移植業務。

Just a couple more for me, if you don't mind, and I appreciate all the color very helpful. If I remember correctly, your long-term guidance at the Analyst Day or you've talked about your aspiration for $400 million in 2024. How are you feeling about that number now?

如果你不介意的話，再給我幾張，我很欣賞所有對我很有幫助的顏色。如果我沒記錯的話，你在分析師日的長期指導或者你已經談到了你在 2024 年達到 4 億美元的願望。你現在對這個數字有什麼看法？

Yes, I think. I mean -- obviously, currently --

是的，我認為。我的意思是 - 顯然，目前 -

What's that great about and not so great, maybe

有什麼好和不好的，也許

One thing is as we learned last year, I mean, obviously, when we launched that in March, I didn't know the euro was going to decline 16%. And we have a big chunk of our business in euros. So I think you'd have to -- what I'd say -- what I would draw you more to is the revenue shale chart that basically showed we thought we could grow 10% on average over the next 3 years. We grew 9% this year. It's never, as you know, businesses are never linear. There were a lot of challenges in 2022. And so I think that 10%, if you look at our guidance, we're between 8% and 12%, we're shooting for over the 3 years that we have a 10% CAGR. So again, I think the end number has a lot of factors including a big currency factor for us. But I think what we are holding to is our 10% growth rate. And I think that's well within reach for the company.

一件事是我們去年了解到的，我的意思是，很明顯，當我們在 3 月份推出該計劃時，我並不知道歐元會下跌 16%。我們有很大一部分業務以歐元計價。所以我認為你必須——我要說的——我更想吸引你的是收入頁岩圖表，它基本上表明我們認為我們可以在未來 3 年內平均增長 10%。我們今年增長了 9%。如您所知，企業從來都不是線性的。 2022 年有很多挑戰。所以我認為 10%，如果你看一下我們的指導，我們在 8% 到 12% 之間，我們正在爭取在 3 年內達到 10% 的複合年增長率.所以，我認為最終數字有很多因素，包括對我們來說很大的貨幣因素。但我認為我們堅持的是我們 10% 的增長率。我認為這對公司來說是觸手可及的。

And just last, I just want to make sure, again, maybe I'm just being dense about it. You had guided PROACT Mitral, I think, to the end of '22 before now it's second half. I just want to make sure I'm understanding why delay in timing and what are the factors there and why are you confident about QH '23?

最後，我只是想再次確定，也許我只是對此很敏感。我認為，您已經將 PROACT Mitral 引導到 22 年底，現在是下半年。我只是想確保我理解為什麼延遲時間以及那裡的因素是什麼以及為什麼您對 QH '23 充滿信心？

Yes. So it's a good question, Rick. So we had 2 PMAs in front of the FDA, and we had hoped to hear from about both of them by the end of the year. On the good news, we heard from the FDA on PerClot, I'm happy to report that they basically said, this thing is going to get approved. We're basically working on labeling right now. I've been through a lot of these. We're in the final steps of the process. Now again, I can't tell you exactly when the things can get approved, but I mean the fact that they told us it's going to get approved, and we're working on labeling is a pretty good indicator.

是的。所以這是一個很好的問題，瑞克。所以我們在 FDA 面前有 2 個 PMA，我們希望在今年年底之前聽到他們兩個的消息。好消息是，我們從 FDA 那裡聽到了關於 PerClot 的消息，我很高興地報告說他們基本上說，這件事將獲得批准。我們現在基本上是在做標籤工作。這些我都經歷過很多。我們正處於該過程的最後步驟。再一次，我不能確切地告訴你這些東西什麼時候能獲得批准，但我的意思是他們告訴我們它會獲得批准，而且我們正在研究標籤，這是一個很好的指標。

I think conversely, if you look at PROACT Mitral, it wasn't as clean. The trial wasn't as clean and you'll understand this because you've done a lot of work here. If you look at the PROACT Mitral, which started a decade ago, right. This is -- it started a long time ago. It missed its primary endpoint of noninferiority of -- it was a composite endpoint of bleeding in thromboembolic events, okay. And that was exactly the same way PROACT Aortic was done. And the FDA didn't like it that the 2 variables were kind of co-mingled, right, bleeding and thromboembolic event because one can drive a noninferior event, right, a better performance on bleeding can mask a thromboembolic miss. In PROACT Xa, they made us take those variables apart. They made us primary thromboembolic secondary bleeding.

相反，我認為，如果你看一下 PROACT Mitral，它就沒有那麼乾淨了。審判沒有那麼乾淨，你會理解這一點，因為你在這裡做了很多工作。如果你看看十年前開始的 PROACT Mitral，對吧。這是——很久以前就開始了。它錯過了非劣效性的主要終點——它是血栓栓塞事件中出血的複合終點，好吧。這與 PROACT Aortic 的完成方式完全相同。 FDA 不喜歡這兩個變量混合在一起，對，出血和血栓栓塞事件，因為一個可以驅動非劣效事件，對，更好的出血表現可以掩蓋血栓栓塞事件。在 PROACT Xa 中，他們讓我們將這些變量分開。他們使我們成為原發性血栓栓塞性繼發性出血。

So if you look at that trial, then you look at the fact that the average patient in the treatment group was at 2.5% and the average -- or it's like a 2.47 an average patient in the control group was around 3, one would suspect that the bleeding would be less. It just -- I don't know how you have a lower INR of 0.5 and there's no difference in bleeding, but it wasn't because it obviously wasn't powered enough. But the fact that you had an INR of 2.5 to 3, you should get a lower bleeding. It did have a noninferior -- it did hit noninferiority for thromboembolic events.

因此，如果您看一下該試驗，那麼您會看到這樣一個事實，即治療組中的平均患者為 2.5%，而對照組中的平均患者為 2.47 左右，人們會懷疑出血會更少。它只是 - 我不知道你如何將 INR 降低到 0.5，並且出血沒有差異，但這不是因為它顯然沒有足夠的動力。但事實上，您的 INR 為 2.5 至 3，您的出血應該會減少。它確實具有非劣效性——它確實達到了血栓栓塞事件的非劣效性。

So again, I think what I'm trying to get to all that, it's just going to take us longer talking with the FDA about it. Because I think in totality, when you look at all the data, while we might have missed the primary endpoint for the trial, if you really look at how they look at the data, which is take apart the endpoints and you look at the totality of the data, you can run an On-X Mitral Valve at 2.5 compared to a non On-X Valve that it's 3 year over and have no difference in thromboembolic events.

所以，我想我想要達到的目的是，這只會讓我們花更長的時間與 FDA 討論這個問題。因為我認為總的來說，當你查看所有數據時，雖然我們可能錯過了試驗的主要終點，但如果你真的看看他們如何看待數據，那就是拆開終點，你會看到整體根據數據，您可以在 2.5 時運行 On-X 二尖瓣，而與非 On-X 瓣膜相比，它已超過 3 年，並且在血栓栓塞事件方面沒有差異。

To me, that's meaningful for patients and surgeons are telling me this. The PI of the trial is telling us this. So it's just going to take us longer. It's not as clean. So I think it's -- that's the reason for the delay. Hopefully, that was helpful to kind of give you some (inaudible)

對我來說，這對患者和外科醫生都告訴我這一點很有意義。試用的 PI 正在告訴我們這一點。所以這只會花費我們更長的時間。它不是那麼乾淨。所以我認為這是 - 這就是延遲的原因。希望這有助於給你一些（聽不清）

Our next question comes from the line of Michael Matson with Needham & Company.

我們的下一個問題來自 Michael Matson 與 Needham & Company 的合作。

So just one on the stent graft business. This is the second time that you've kind of had the staffing challenge there in Germany. And I mean, I understand that it's been a really difficult labor market and everything. But I guess you kind of have a forecast for how fast that business is going to grow, and it's kind of been growing in line with that forecast. So I guess, can you try to -- I mean what can you do differently to try to get ahead of this so this doesn't happen again next time you kind of -- either you (crosstalk)

所以只有一個關於覆膜支架業務。這是您第二次在德國遇到人員配備挑戰。我的意思是，我知道這是一個非常困難的勞動力市場和一切。但我猜你對這項業務的增長速度有一定的預測，而且它的增長與該預測一致。所以我想，你能不能嘗試——我的意思是你能做些什麼不同的事情來嘗試領先於此，這樣下次你就不會再發生這種情況了——你（串音）

Yes, it's a fair question, Mike. And again, I think part of this is -- I've been involved with this business, the stent graft business going back, I ran Medtronics business 20 years ago. It's a very complex supply chain. There are -- if you have an individual case, you may ship in 5 or 6 pieces because there's different sizes, and you have to put different pieces together and then 2 or 3 may come back. So there's a lot of logistical excellence that's involved in it, and we weren't necessarily up to snuff with that. There's also a lot of consignment involved where you actually put units on the shelf. So if you spread your units out in consignment and you're in the wrong places, you can see how you can get ahead of yourself.

是的，這是一個公平的問題，邁克。再一次，我認為部分原因是——我參與了這項業務，支架移植業務可以追溯到 20 年前，我經營美敦力公司的業務。這是一個非常複雜的供應鏈。有——如果你有一個單獨的箱子，你可能會分 5 或 6 件運送，因為尺寸不同，你必須將不同的件放在一起，然後可能會返回 2 或 3 件。因此，其中涉及很多卓越的後勤保障，而我們不一定能做到這一點。在實際將商品放在貨架上時，還涉及很多寄售。因此，如果您將您的設備散佈在寄售中，而您在錯誤的地方，您可以看到如何超越自己。

So we actually brought in an outside firm to help us with this, and we're kind of going through that right now. So I agree with you. This is something we're going to kind of put to bed for once. We're doing a lot around the supply chain excellence about getting product back as well as making sure our consignment accounts are having the right number of turns. So again, there's a whole project going on in that area because it's not just a factory. The factory is part of it, but there's also a kind of a supply chain excellence. And to your point, we're not going back to this. Again, we expect this business to grow very fast, and we're going to put the kind of supply chain infrastructure in place so that we don't have to go back to this.

所以我們實際上引進了一家外部公司來幫助我們解決這個問題，我們現在正在經歷這個過程。所以我同意你的看法。這是我們要暫時解決的問題。我們圍繞卓越的供應鏈做了很多工作，包括取回產品以及確保我們的寄售賬戶有正確的周轉次數。再一次，那個地區正在進行一個完整的項目，因為它不僅僅是一個工廠。工廠是其中的一部分，但也有一種卓越的供應鏈。就你的觀點而言，我們不會回到這個問題上。同樣，我們希望這項業務增長非常快，我們將把這種供應鏈基礎設施放在適當的位置，這樣我們就不必回到這個位置了。

And then just on the EBITDA. So I mean, the guidance is for in excess of $50 million, but you're reiterating the guidance for $75 million for 2024. So I guess, I mean, if you come in closer to that $50 million number, I mean, that seems to be a pretty big step up almost 50% growth to get to that $75 million in 2024. So how confident are you that you can kind of get maybe more to like $60 million, $65 million this year and before that step-up doesn't look quite as difficult in 2024?

然後就在 EBITDA 上。所以我的意思是，指導是超過 5000 萬美元，但你重申了 2024 年 7500 萬美元的指導。所以我想，我的意思是，如果你接近這個 5000 萬美元的數字，我的意思是，這似乎在 2024 年達到 7500 萬美元的增長將近 50% 是一個相當大的進步。所以你有多大信心你可以得到更多的 6000 萬美元，今年 6500 萬美元，在此之前沒有到 2024 年看起來不會那麼困難嗎？

Yes. No, and that's a fair question, Mike. I mean, if you just do the math, I mean, one of the things we said at the kind of Analyst Day was that we were going to return 50% of the incremental gross margin as EBITDA, which is pretty much what we're doing this year, which gets you to the $50 million. I mean, we're driving for upside, right. So it's exactly to your point, we gave a range of $8 million to $12 million with a $50 million EBITDA number. So we obviously want to become in as high as we can on that range. And every $1 million you get, every point of growth, every $3 million of growth, which is a point of growth, it gets you almost $2 million in profit. So we're going to be pushing to get to a higher number than the $50 million because to your point, it will put more pressure on next year, but that's what we're should to do.

是的。不，邁克，這是一個公平的問題。我的意思是，如果你只是算一下，我的意思是，我們在那種分析師日上說過的一件事是，我們將把增量毛利率的 50% 作為 EBITDA 返還，這幾乎就是我們現在所做的今年做，這會讓你達到 5000 萬美元。我的意思是，我們正在推動上漲，對吧。所以這正是你的觀點，我們給出了 800 萬到 1200 萬美元的範圍和 5000 萬美元的 EBITDA 數字。因此，我們顯然希望在該範圍內盡可能高。你獲得的每 100 萬美元，每一個增長點，每 300 萬美元的增長，也就是一個增長點，都會讓你獲得近 200 萬美元的利潤。因此，我們將努力達到比 5000 萬美元更高的數字，因為就你的觀點而言，這將給明年帶來更大的壓力，但這是我們應該做的。

And then just on the TMR handpiece thing. So it's a little confusing to me. I know you went through the numbers, but I just wanted to revisit that because -- so the -- just can you tell me what the actual revenues were in 2022? Because I don't know -- I can't remember if you were selling it every quarter. You had some -- you've had pricing on this.

然後就在 TMR 手機上。所以這讓我有點困惑。我知道你看過這些數字，但我只是想重新審視一下，因為 - 所以 - 你能告訴我 2022 年的實際收入是多少嗎？因為我不知道——我不記得你是否每個季度都在賣它。你有一些 - 你已經定價了。

So just to give you some rough numbers. Last year '21, we did about $3 million. We're going to do about 500,000, I think, in the first quarter until we run out of handpieces and then we're out and they aren't going to be any more for 2 years. So I think that pretty much tells you the -- I think all the numbers you need to know.

所以只是給你一些粗略的數字。去年 21 年，我們做了大約 300 萬美元。我想，我們將在第一季度做大約 500,000 次，直到我們用完手機，然後我們就用完了，而且它們在 2 年內不會再有。所以我認為這幾乎可以告訴你 - 我認為你需要知道的所有數字。

But I mean, is the intention that this is dead and it never comes back or I mean?

但我的意思是，它的意圖是死了，它永遠不會回來，還是我的意思？

Yes. I mean, part of the challenge of this, Mike, is we just were notified a few days ago. So I need some time to kind of evaluate. I mean, we had looked at potentially going to another supplier, but it was going to take us a couple of years and a couple of million dollars of investment. I just don't know if it's worth it, but I also got -- I need some time to actually invest. Like I said, this is -- we just got a letter from our contract manufacturers said, we're done making this thing. And I really haven't had time to react other than the fact that I know that I'm not going to have TMR handpieces for 2 years. I do know that. But I do need some time just to see if it's worthwhile and how long it will take, how much it will cost. So you got me kind of in the middle of the (inaudible) making.

是的。我的意思是，邁克，這其中的部分挑戰是我們幾天前才收到通知。所以我需要一些時間來評估。我的意思是，我們曾考慮過尋找另一家供應商的可能性，但這需要我們幾年的時間和幾百萬美元的投資。我只是不知道這是否值得，但我也得到了——我需要一些時間來實際投資。就像我說的，這是——我們剛收到合同製造商的一封信說，我們已經完成了這件事。我真的沒有時間做出反應，除了我知道我 2 年內不會使用 TMR 手機這一事實。我確實知道。但我確實需要一些時間，看看它是否值得，需要多長時間，要花多少錢。所以你讓我有點處於（聽不清）製作的中間。

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

我們的下一個問題來自 Suraj Kalia 與 Oppenheimer 的對話。

Pat, so a couple of questions for you and one for Ashley. all on On-X. First question, Pat. Maybe I'm over reading this, but for the first time I sensed some level of hedging in terms of PROACT Mitral approval, did I -- am I over reading into that, Pat?

Pat，有幾個問題要問你，一個要問 Ashley。全部在 On-X 上。第一個問題，帕特。也許我讀完了這篇文章，但我第一次感覺到在 PROACT Mitral 批准方面存在某種程度的對沖，我是不是 - 我是否讀完了，帕特？

No, I think that's fair. I mean, I think it's part of the --

不，我認為這很公平。我的意思是，我認為這是——

-- risk of not getting -- specifically not getting approval or for a restricted label, high risk, whatever, any additional color?

-- 沒有得到的風險 -- 特別是沒有得到批准或限制標籤，高風險，任何其他顏色？

I think that's fair. I mean, part of it is we obviously learned where FDA was. And I just -- in Rick's question, I tried to help and again, you know probably more about this stuff than anybody on the trial designs. What I found interesting is that in -- they didn't like PROACT. I personally met with the FDA about PROACT Xa, and they did not like the composite endpoint of PROACT Aortic because bleeding, reduction in bleeding drove the endpoint. So they made us take them apart, right. And I get it, they made us take them apart. Thromboembolic is really the goal, bleeding secondary, which is what we did in PROACT Xa.

我認為這很公平。我的意思是，部分原因是我們顯然了解了 FDA 的位置。我只是 - 在 Rick 的問題中，我再次嘗試提供幫助，你可能比試驗設計中的任何人都更了解這些東西。我發現有趣的是——他們不喜歡 PROACT。我親自就 PROACT Xa 與 FDA 會面，他們不喜歡 PROACT Aortic 的複合終點，因為出血、出血減少推動了終點。所以他們讓我們把它們拆開，對吧。我明白了，他們讓我們把它們拆開。血栓栓塞才是真正的目標，出血是次要的，這就是我們在 PROACT Xa 中所做的。

What's interesting is that in PROACT Mitral, we missed the primary endpoint. It was a composite of the 2. But when you do the way that they like it, which is when you take them apart, we actually are not inferiority for (inaudible) which is the big safety issue, and there was no difference in bleeding, which also makes no sense, but that's what the data shows. Even though the treatment group was at a 2.5 and the control group is at a 3, anyone would tell you there has to be more bleeding in that arm.

有趣的是，在 PROACT Mitral 中，我們錯過了主要終點。它是兩者的複合體。但是當你按照他們喜歡的方式去做時，也就是當你把它們拆開時，我們實際上並不遜色於（聽不清）這是一個很大的安全問題，而且出血沒有區別，這也沒有任何意義，但這就是數據所顯示的。即使治療組為 2.5 而對照組為 3，但任何人都會告訴您那隻手臂必須有更多的出血。

So again, I think part of it is, yes, I mean, you learn more as you have the conversations with the FDA. I mean, we're going to present -- we think you should look at the totality of that data. And what the surgeons are telling me is that trial, it was a 10-year trial in 400 patients that showed that you could run On-X Valves at a 2.5 and have no difference in thromboembolic events compared to the standard of care at between 2.5 and 3.5, right, so which is at 3.0. So again, I can't speak for the FDA. I think I understand why it wasn't a layup. I mean PerClot was much cleaner. We hit all the numbers and everything was much cleaner. So it's just taken us longer. But I can't predict what the FDA is going to do. We're going to put our best case forward and we'll see what happens. I think in the end, I mean, the data is out there, the paper was published in December. We're not going to promote off-label. But I think surgeons, when I talk to surgeons, they see the benefit of the valve. And hopefully, the FDA sees it the same way.

所以，我認為部分原因是，是的，我的意思是，當你與 FDA 進行對話時，你會學到更多。我的意思是，我們將展示——我們認為您應該查看所有數據。外科醫生告訴我的是，這項試驗是對 400 名患者進行的為期 10 年的試驗，表明您可以在 2.5 時運行 On-X 閥門，並且與 2.5 之間的護理標準相比，血栓栓塞事件沒有差異和 3.5，對，所以是 3.0。再說一遍，我不能代表 FDA。我想我明白為什麼那不是上籃了。我的意思是 PerClot 更乾淨。我們達到了所有的數字，一切都變得更乾淨了。所以它只是花了我們更長的時間。但我無法預測 FDA 將要做什麼。我們將提出我們最好的案例，然後看看會發生什麼。我認為最終，我的意思是，數據已經公開，論文於 12 月發表。我們不會推廣標籤外的產品。但我認為外科醫生，當我與外科醫生交談時，他們看到了瓣膜的好處。希望 FDA 以同樣的方式看待它。

Pat, PROACT Xa, remind us again when the publication is and also Post Xa, the top line or the trial stoppage to the extent that you can at characterize the sales force productivity pre and post, if any additional handholding was needed specifically as it relates to On-X in the field?

Pat, PROACT Xa，在發布和發布 Xa 時再次提醒我們，頂線或試驗停止，您可以在一定程度上描述銷售人員生產力前後的特徵，如果需要任何額外的手持設備，因為它特別相關到現場的 On-X？

Yes. So first, on your first question on PROACT Xa, that will be presented, its recent news and I was going to cover this -- I was hopefully I was get that question. It's going to be presented in a plenary session at ATS in Los Angeles like May that, whatever is the first week of May, 5, 6, 7 around there. So that's going to be, I think, a very important presentation both for the field as well as I'm very interested to see the control group how it performed. So I'll just leave you with that foreshadowing.

是的。因此，首先，關於您關於 PROACT Xa 的第一個問題，將提出它的最新消息，我將對此進行介紹——我希望我能得到那個問題。它將像 5 月那樣在洛杉磯 ATS 的全體會議上展示，無論是 5 月 5 日、6 日、7 日左右的第一周。因此，我認為這將是一個非常重要的演示文稿，無論是對於該領域還是我都非常有興趣了解控制組的表現。所以我只會給你留下舖墊。

I think from a field standpoint, it's very interesting. We've got a great sales force. And they went out after PROACT Xa, they talked to all the surgeons. We heard great comments from our surgeons like you guys you were cutting edge. This would have been huge for patients. You've still got the best mechanical Aortic Valve and Mitral Valve and you're still the only ones with a lot INR on the aortic side. So kind of keep doing what you're doing, right. So again, I don't think -- I didn't see much of a setback. I mean, I'm sure our competitors will try to jump on it. But I think the other piece to think about, Suraj, is the amount of things we're doing in the aortic field, everything from frozen elephant trunk with Neo to AMDS to NEXUS to thoracoabdominal.

我認為從現場的角度來看，這非常有趣。我們有一支優秀的銷售隊伍。他們在 PROACT Xa 之後出去了，他們與所有外科醫生交談。我們從我們的外科醫生那裡聽到了很好的評論，就像你們是最前沿的人一樣。這對患者來說意義重大。你仍然擁有最好的機械主動脈瓣和二尖瓣，你仍然是唯一在主動脈側有很多 INR 的人。所以繼續做你正在做的事情，對吧。所以，我不認為 - 我沒有看到太多挫折。我的意思是，我相信我們的競爭對手會嘗試加入它。但我認為另一件要考慮的事情，Suraj，是我們在主動脈領域所做的事情的數量，從帶有 Neo 的冷凍象鼻到 AMDS 到 NEXUS 到胸腹。

I mean, we're an aorta company, and we're investing heavily in the aortic space, and On-X is one of our platforms that's best-in-class. So again, I think to me, our sales force didn't really require any handholding.

我的意思是，我們是一家主動脈公司，我們在主動脈領域進行了大量投資，而 On-X 是我們同類最佳的平台之一。因此，我認為，我們的銷售人員並不真正需要任何幫助。

And lastly, last one, I'll throw your way (inaudible) I do appreciate you guys taking all my questions. Ashley, maybe I missed it, what was the On-X split U.S., OUS?

最後，最後一個，我會拋出你的方式（聽不清）我非常感謝你們回答我所有的問題。 Ashley，也許我錯過了，On-X split U.S., OUS 是什麼？

It is roughly 60-40 roughly, Suraj. And I can get back with you on the exact split, but I think that it's approximately around there.

Suraj，大概是 60-40。我可以在確切的拆分上與您聯繫，但我認為它大約在那裡。

There are no further questions in the queue. I'd like to hand the call back to management for closing remarks.

隊列中沒有其他問題。我想將電話轉回管理層以作結束語。

Well, thanks for attending the call. And we're looking forward to continuing to drive forward on our strategy and driving growth in our stent grafts and our On-X franchise, significant growth in Asia Pacific, Latin America and bringing the pipeline forward. So we'll be back at you next quarter, and thanks for joining. Bye-bye.

好吧，感謝您參加電話會議。我們期待繼續推進我們的戰略，推動我們的覆膜支架和 On-X 特許經營權的增長，在亞太地區、拉丁美洲的顯著增長，並推動管道向前發展。所以我們將在下個季度回來，感謝您的加入。再見。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.

女士們，先生們，今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路，度過美好的一天。