Artivion Inc (AORT) 2021 Q4 法說會逐字稿

Greetings, and welcome to Artivion 4Q and Year-end 2021 Financial Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Artivion 第四季和 2021 年底財務電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

It's now my pleasure to introduce your host. I will now turn the call over to Brian Johnston from the Gilmartin Group. Thank you, and you may begin.

現在我很高興向大家介紹你們的主人。我現在將把電話轉給吉爾馬丁集團的布萊恩約翰斯頓。謝謝您，您可以開始了。

Thanks, operator. Good afternoon, and thank you for joining the call today. Joining me today from Artivion's management team are Pat Mackin, CEO; and Ashley Lee, CFO.

謝謝，接線生。下午好，感謝您今天加入通話。今天與我一起參加 Artivion 管理團隊的有執行長 Pat Mackin；和首席財務官阿什利·李。

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

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。年《私人證券訴訟改革法案》的涵義。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，可能導致實際結果與這些前瞻性陳述有重大差異。有關可能影響這些前瞻性陳述的某些風險和不確定性的更多信息，不時包含在該公司向 SEC 提交的文件和今天早些時候發布的新聞稿中。

Now I'll turn it over to Artivion's CEO, Pat Mackin.

現在我將把它交給 Artivion 的執行長 Pat Mackin。

Thanks, Brian, and good afternoon, and thanks for joining us on the call. This is our first call since rebranding as Artivion. This name was derived from the words aorta, innovation and vision and reflects our evolution to be a global leader, providing innovative treatments for aortic disease and our vision to continually innovate to maintain our position of leadership.

謝謝布萊恩，下午好，謝謝您加入我們的電話會議。這是我們更名為 Artivion 以來的第一次電話諮詢。這個名稱源自於「主動脈」、「創新」和「願景」等詞，反映了我們向全球領導者的發展，為主動脈疾病提供創新的治療方法，以及我們不斷創新以保持領導地位的願景。

It was time to change our name as we significantly evolved from the CryoLife I joined 7 years ago. During these past 7 years, as we continued to evolve, I would come across investors and customers who are not aware of the significant transformation that was taking place in our company. Investors and customers now have a fresh look at Artivion to see what we do and to learn more about our significant transformation.

是時候更改我們的名稱了，因為我們比我 7 年前加入的 CryoLife 有了顯著的發展。在過去的七年裡，隨著我們不斷發展，我會遇到一些投資者和客戶，他們並不知道我們公司正在發生的重大轉變。投資者和客戶現在可以重新審視 Artivion，了解我們所做的事情並了解更多有關我們重大轉型的資訊。

Artivion now encapsulates all that we've accomplished since we acquired On-X in 2016. Through a series of strategic acquisitions and divestitures and our new development initiatives, we've assembled a portfolio of products focused on aortic repair that we believe can compete with those of any company on the market today. We provide cardiac and vascular surgeons with innovative solutions to their most difficult challenges, and will continue to do so in the future as our product pipeline and new regulatory approvals will open access to our innovative therapies to many more patients around the globe.

Artivion 現在概括了我們自2016 年收購On-X 以來所取得的所有成就。這些產品可以與當今市場上任何公司的產品。我們為心臟和血管外科醫生提供創新的解決方案來應對他們最困難的挑戰，並將在未來繼續這樣做，因為我們的產品線和新的監管批准將為全球更多患者開放我們的創新療法。

My goal since becoming CEO of CryoLife was to transform into Artivion. And our employees, by collaborating with each other, and our physicians have basically done just that. We now expect to organically grow our revenue double digits at the midpoint of our 2022 guidance. We believe our product pipeline and regulatory strategy sets us up well for continued success for years to come.

自從成為 CryoLife 執行長以來，我的目標就是轉型為 Artivion。我們的員工和我們的醫生透過相互合作基本上做到了這一點。現在，我們預計在 2022 年指導的中點，我們的收入將實現兩位數的有機成長。我們相信，我們的產品線和監管策略將為我們在未來幾年的持續成功奠定良好的基礎。

Our rebrand followed on the heels of a record fourth quarter 2021 for Artivion as we posted strong quarterly revenue growth. Revenues for the fourth quarter were $79.4 million, that's up 16.9% compared to the fourth quarter of 2020 and up 18.8% on a pro forma constant currency basis. Revenues were up 13.5% on a pro forma constant currency basis compared to the fourth quarter of '19.

在 Artivion 2021 年第四季創紀錄的季度營收成長之後，我們進行了品牌重塑。第四季營收為 7,940 萬美元，較 2020 年第四季成長 16.9%，以預計固定匯率計算成長 18.8%。與 2019 年第四季相比，以預期固定匯率計算，營收成長了 13.5%。

Our growth in Q4 was driven by our stent grafts as well as our On-X product segments. More specifically, on a pro forma constant currency basis, comparing Q4 '21 to Q4 of '20, stents and stent grafts grew 33%, On-X grew 13.5%. Here, the growth rates for the products that are in the stent and stent graft segment: AMDS, up 20%; NEO, up 73%; E-nside, up 39%; NEXUS, up 233%. We also saw a return to growth in cardiac tissue as well as the relaunch of our TMR business.

我們第四季的成長是由覆膜支架和 On-X 產品領域所推動的。更具體地說，在預期的固定匯率基礎上，將 21 年第 4 季與 20 年第 4 季進行比較，支架和覆膜支架成長了 33%，On-X 成長了 13.5%。此處，支架和覆膜支架產品的成長率：AMDS，成長 20%； NEO，上漲73%； E-nside，上漲39%； NEXUS，上漲233%。我們也看到心臟組織恢復成長以及 TMR 業務的重新啟動。

In all, we are pleased with our fourth quarter results despite continued and lingering headwinds from the Delta variant and Omicron variants that were associated with staffing issues and patient overflow issues in the hospitals.

總而言之，我們對第四季度的業績感到滿意，儘管 Delta 變體和 Omicron 變體與醫院的人員配備問題和患者溢出問題相關的阻力持續存在且揮之不去。

As I explained on our last call, our near-term plan is to accelerate revenue growth through 3 main initiatives. First, we plan to drive On-X growth while commercializing AMDS, NEXUS, E-nside and NEO, our new aortic stent and stent graft products. Second, we plan to further expand into Asia Pacific and Latin America by gaining regulatory approvals and expanding our commercial channels. Finally, to secure regulatory approvals for PerClot and PROACT Mitral in the U.S. and BioGlue in China. I will walk you through an update on each of these 3 initiatives.

正如我在上次電話會議中所解釋的那樣，我們的近期計劃是透過 3 項主要舉措來加速收入成長。首先，我們計劃推動 On-X 的成長，同時將 AMDS、NEXUS、E-nside 和 NEO（我們的新主動脈支架和覆膜支架產品）商業化。其次，我們計劃透過獲得監管部門的批准並擴大我們的商業管道，進一步擴展到亞太和拉丁美洲。最後，確保 PerClot 和 PROACT Mitral 在美國以及 BioGlue 在中國獲得監管批准。我將向您介紹這 3 項舉措的最新情況。

Starting with AMDS. This is the world's first arch remodeling hybrid device for use in the treatment of acute type A aortic dissections, we remain very optimistic on the product line given our experience to date. As noted earlier, during the fourth quarter, revenues increased 20% on a pro forma constant currency basis over the fourth quarter of 2020. Increases were driven by continued strength in Europe and the regulatory approvals in countries outside of EMEA and the U.S.

從 AMDS 開始。這是世界上第一個用於治療急性 A 型主動脈剝離的弓形重塑混合設備，鑑於我們迄今為止的經驗，我們對該產品線仍然非常樂觀。如前所述，以預期固定匯率計算，第四季度營收比2020 年第四季成長了20%。 。

Second, NEXUS posted quarterly revenues of 233% increase on a constant currency basis compared to the fourth quarter of 2020. Given the anticipated decline in COVID-19 infection rates associated with hospital staffing shortages and travel restrictions as well as improved physician adoption, we anticipate an uptick in NEXUS procedures in 2022.

其次，與2020 年第四季相比，NEXUS 公佈的季度收入按固定匯率計算增長了233%。預計2022 年 NEXUS 程序有所增加。

Third, E-nside, this is our newest device in our portfolio to treat thoracoabdominal aneurysms with endovascular stent grafts. Our revenues in this product line, which include E-nside and E-xtra DESIGN, grew 39% on a constant currency basis when compared to Q4 2020.

第三，E-nside，這是我們產品組合中的最新設備，用於透過血管內支架移植治療胸腹動脈瘤。與 2020 年第四季相比，我們在該產品線（包括 E-nside 和 E-xtra DESIGN）的營收以固定匯率計算成長了 39%。

Fourth, E-vita OPEN NEO. This is our newest product in the frozen elephant trunk category. This is used to treat dissections and aneurysms in the aortic arch. Revenues from this product line, which include E-vita OPEN PLUS and NEO, grew 73% on a constant currency basis compared to Q4 2020.

第四，E-vita OPEN NEO。這是我們冷凍象鼻類別的最新產品。這用於治療主動脈弓剝離和動脈瘤。該產品線（包括 E-vita OPEN PLUS 和 NEO）的收入與 2020 年第四季相比，以固定匯率計算成長了 73%。

Regarding Enya, we've decided to make modifications to the delivery system based on customer input and anticipate rereleasing this product in early 2023.

關於 Enya，我們決定根據客戶的意見對交付系統進行修改，並預計在 2023 年初重新發布該產品。

We anticipate the demand for these products will continue to build as market adoption improves, COVID-19 infection decrease or become less virulent and hospital staffing shortages abate. Most of these products were fully launched during the COVID-19 pandemic or shortly before and, therefore, have not seen their full potential and environment not significantly hampered by the effects of the pandemic. In addition, while NEXUS and AMDS both launched shortly before the pandemic, they also benefited from our larger, more experienced sales force in Europe. Given the positive feedback we received in our newly offered products, I believe our growth in these product lines would have been even greater in the absence of the pandemic.

我們預計，隨著市場採用率的提高、COVID-19 感染的減少或毒性減弱以及醫院人員短缺的緩解，對這些產品的需求將繼續增加。這些產品大多數是在 COVID-19 大流行期間或之前不久全面推出的，因此尚未充分發揮其潛力，而且環境也沒有受到大流行影響的嚴重阻礙。此外，雖然 NEXUS 和 AMDS 都是在疫情爆發前不久推出的，但它們也受益於我們在歐洲規模更大、經驗更豐富的銷售團隊。鑑於我們在新推出的產品中收到的正面回饋，我相信如果沒有大流行，我們這些產品線的成長將會更大。

Moving on to our next initiative, international expansion in Asia Pacific and Latin America through new regulatory approvals and commercial footprint expansion. I'm pleased to report that we are executing very well on this strategy. Our quarterly revenues on a pro forma constant currency basis increased in Asia Pacific and Latin America by 29% and 34%, respectively. Those are over the fourth quarter of 2020. We continue to expect these regions to be important contributors to our growth over the coming years as we continue to execute on this strategy.

繼續我們的下一個計劃，透過新的監管批准和商業足跡擴張，在亞太和拉丁美洲進行國際擴張。我很高興地報告，我們在這項策略上執行得非常好。以預期固定匯率計算，我們在亞太地區和拉丁美洲的季度營收分別成長了 29% 和 34%。這些都是 2020 年第四季的情況。

Regarding our third initiative, we continue to make progress on achieving 3 regulatory approvals in major markets. Our first is to attain U.S. a lower INR label for the On-X mitral valve. We've submitted our PMA supplement to the FDA, and it is currently under review. If our new label is approved, we believe lower anticoagulation levels will be a significant clinical benefit for patients. We are in active dialogue with the FDA. We continue to expect to receive PMA approval for the lower INR label of the On-X mitral valve, like our lower INR label for aortic valve sometime during 2022. If approved, we believe we will take significant market share in the U.S. with the On-X mitral valve just as we've done and are continuing to do with the On-X aortic valve.

關於我們的第三項舉措，我們在主要市場獲得 3 項監管批准方面繼續取得進展。我們的首要任務是在美國為 On-X 二尖瓣獲得較低的 INR 標籤。我們已向 FDA 提交了 PMA 補充劑，目前正在接受審查。如果我們的新標籤獲得批准，我們相信較低的抗凝血程度將為患者帶來顯著的臨床益處。我們正在與 FDA 積極對話。我們繼續預期On-X 二尖瓣的較低INR 標籤將獲得PMA 批准，就像我們的主動脈瓣的較低INR 標籤一樣。市場份額-X 二尖瓣，就像我們已經並繼續對 On-X 主動脈瓣所做的那樣。

For PerClot, as you know, we filed a PMA with the FDA last quarter and we're working closely with the FDA. We still expect to receive approval from the FDA during the second half of 2022. If approved, for approximately 2 years thereafter, we will supply PerClot to Baxter and generate revenue.

對於 PerClot，如您所知，我們上季度向 FDA 提交了 PMA，並且我們正在與 FDA 密切合作。我們仍預計在 2022 年下半年獲得 FDA 的批准。

Lastly, as it relates to the regulatory approval for BioGlue in China, we remain actively engaged with NMPA and expect to have more clarity about a possible approval pathway within the next couple of months.

最後，由於涉及 BioGlue 在中國的監管審批，我們將繼續積極與 NMPA 合作，並期望在未來幾個月內更清楚地了解可能的審批途徑。

In addition to our progress in each of these initiatives, we also continue to make strides in our midterm pipeline, with key products currently in the U.S. clinical trials and others are expected to start later this quarter. These 3 products are PROACT Xa, NEXUS and AMDS. We continue to make significant progress in enrollment in our PROACT Xa trial. This is our prospective randomized clinical trial to determine if patients with the On-X aortic valve can be maintained safely and effectively on Eliquis versus warfarin. We currently have enrolled 573 patients in this trial, and feedback from surgeons and patients participating has been excellent. We anticipate completing enrollment in the trial around the end of the second quarter of 2022. And assuming the trial meets its endpoints, we believe we can achieve FDA approval for this new indication by late '24 or early '25. If approved by the FDA, we believe the On-X aortic valve using Eliquis rather than Coumadin should become the market share leader in the aortic valve market in patients under the age of 70.

除了在每項措施上取得進展外，我們還在中期管道方面繼續取得進展，關鍵產品目前正在進行美國臨床試驗，其他產品預計將於本季稍後啟動。這 3 款產品是 PROACT Xa、NEXUS 和 AMDS。我們在 PROACT Xa 試驗的註冊方面繼續取得重大進展。這是我們的前瞻性隨機臨床試驗，旨在確定 On-X 主動脈瓣患者是否可以安全有效地使用 Eliquis 與華法林進行維持治療。目前，我們已招募了 573 名患者參加這項試驗，參與的外科醫生和患者的回饋非常好。我們預計該試驗的註冊工作將於 2022 年第二季末左右完成。如果獲得 FDA 批准，我們相信使用 Eliquis 而不是 Coumadin 的 On-X 主動脈瓣應該成為 70 歲以下患者主動脈瓣市場的市場份額領導者。

As for AMDS, we recently received FDA approval to begin our pivotal clinical trial called PERSEVERE. The PERSEVERE trial is a nonrandomized clinical trial in up to 25 sites in the U.S. We expect to enroll approximately 100 participants who've experienced an acute type A dissection. The combined primary efficacy and safety endpoints of the trial are the reduction in: A, all-cause mortality; b, new disabilitating stroke; c, myocardial infarction; and d, new onset renal failure requiring dialysis; as well as the re-expansion of the true lumen of aorta. We anticipate enrolling the first patient this quarter and completing full enrollment by the end of this year. With a 1-year follow-up period, we anticipate we will receive FDA approval for AMDS in late '24.

至於 AMDS，我們最近獲得 FDA 批准開始我們名為 PERSEVERE 的關鍵臨床試驗。 PERSEVERE 試驗是一項在美國多達 25 個地點進行的非隨機臨床試驗。本試驗的綜合主要療效和安全性終點是：A、全因死亡率的降低； b、新的致殘性中風； c、心肌梗塞； d、新發腎衰竭需要透析；以及主動脈真腔的重新擴張。我們預計本季將招募第一位患者，並在今年年底前完成全部招募。經過 1 年的追蹤期，我們預計我們將在 24 年底獲得 FDA 對 AMDS 的批准。

In addition to the progress we've made on the PROACT Xa trial as well as the AMDS trial, we also wanted to update investors about our partner, Endospan, and how they're making progress on their U.S. IDE trial for NEXUS called TRIOMPHE. As you recall, we've secured an option to potentially acquire Endospan. Due primarily to delays resulting from the pandemic, enrollment in the TRIOMPHE trial has been slower than anticipated. As a result, we do not believe an enrollment in the trial will be completed until sometime in 2023. We, therefore, do not anticipate approval for the NEXUS system until sometime in 2025, at the earliest, given the time required for follow-up, PMA submission and FDA review and approval.

除了我們在 PROACT Xa 試驗和 AMDS 試驗上取得的進展之外，我們還想向投資者介紹我們的合作夥伴 Endospan 的最新情況，以及他們在美國 NEXUS IDE 試驗 TRIOMPHE 上取得的進展。您還記得嗎，我們已經獲得了可能收購 Endospan 的選擇權。主要由於疫情造成的延誤，TRIOMPHE 試驗的入組速度比預期慢。因此，我們認為該試驗的註冊要到 2023 年某個時候才能完成。批准。

Given this delay as well as associated challenges related to market adoption during the pandemic, we've also fully impaired the value of the option to purchase Endospan and recorded as associated charge. Accordingly, we'd push the potential capital need out at least 1 year if we decided to proceed. With that said, we still remain bullish on the NEXUS technology, and Ashley will provide more color in his comments.

考慮到這種延遲以及疫情期間與市場採用相關的相關挑戰，我們也完全損害了購買 Endospan 的選擇權的價值，並記錄為相關費用。因此，如果我們決定繼續進行，我們會將潛在的資本需求推遲至少一年。話雖如此，我們仍然看好 NEXUS 技術，Ashley 將在他的評論中提供更多內容。

If each of these 3 trials proceed as anticipated, we anticipate FDA approval for PROACT Xa, AMDS and NEXUS by late '24 or into '25, which would increase our addressable market opportunity by an estimated $1.5 billion.

如果這 3 項試驗均按預期進行，我們預計 FDA 將在 24 年末或 25 年批准 PROACT Xa、AMDS 和 NEXUS，這將使我們的潛在市場機會增加約 15 億美元。

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

現在，我將把電話轉給阿什利。

Thanks, Pat, and good afternoon, everyone. Total revenues were $79.4 million for the fourth quarter, up 16.9% on a GAAP basis and up 18.8% on a pro forma constant currency basis, both compared to the fourth quarter of 2020. Revenues benefited from strength in aortic stent and stent grafts, On-X, cardiac tissues and the relaunch of TMR. On a year-over-year basis, in the fourth quarter of 2021, aortic stent and stent graft revenues increased to 31%, reflecting increased procedure volumes and revenues from our new product launches.

謝謝帕特，大家下午好。與 2020 年第四季相比，第四季總營收為 7,940 萬美元，以 GAAP 計算成長 16.9%，按預期固定匯率計算成長 18.8%。 X，心臟組織和TMR 的重新啟動。與去年同期相比，2021 年第四季度，主動脈支架和覆膜支架收入成長至 31%，反映出我們新產品推出帶來的手術量和收入的增加。

On-X revenues increased 14% and BioGlue revenues increased 8%, reflecting improved procedure volumes relative to the fourth quarter of 2020. And tissue processing revenues increased 17%, benefiting from the release of tissue impacted by the TRIS hold in 2020.

On-X 營收成長 14%，BioGlue 營收成長 8%，反映出相對 2020 年第四季的手術量有所改善。

On a pro forma constant currency basis, compared to the fourth quarter of 2020, aortic stent and stent graft revenues increased 33%; On-X revenues increased 13%; BioGlue revenues increased 8%; and tissue processing revenues increased 17%. On a pro forma constant currency basis compared to the fourth quarter of 2019, On-X revenues increased 16%; aortic stent and stent graft revenues increased 37%; BioGlue increased 3%; and tissue processing revenues increased 4%.

以預期固定匯率計算，與 2020 年第四季相比，主動脈支架和覆膜支架收入成長了 33%； On-X 營收成長 13%； BioGlue 營收成長 8%；組織加工收入成長了 17%。與 2019 年第四季相比，以預期固定匯率計算，On-X 營收成長了 16%；主動脈支架和覆膜支架收入成長37%； BioGlue增加3%；組織加工收入成長 4%。

On a regional basis, fourth quarter 2020 revenues in EMEA increased 22%, Asia Pacific increased 28%. Latin America increased 31% and North America increased 12%, all compared to the fourth quarter of 2020. On a pro forma constant currency basis, revenues in Europe increased 27%, Asia Pacific increased 29%, Latin America increased 34% and North America increased 11%, all compared to the fourth quarter of 2020.

從地區來看，2020 年第四季歐洲、中東和非洲地區營收成長 22%，亞太地區成長 28%。與 2020 年第四季相比，拉丁美洲成長 31%，北美成長 12%。第四季相比成長了11%。

Gross margins were 64.7% in the fourth quarter compared to 65.7% for the fourth quarter of 2020. The decrease was driven by higher-than-anticipated inventory obsolescence and inflationary impacts.

第四季的毛利率為 64.7%，而 2020 年第四季的毛利率為 65.7%。

G&A expenses in the fourth quarter were $51.3 million compared to $36.1 million in the fourth quarter of 2020. Excluding nonrecurring acquisition-related and business development charges of $10 million in 2021, which primarily consists of a noncash $4.5 million charge related to fair value adjustments for Ascyrus contingent consideration and a noncash $4.9 million charge related to the impairment of the Endospan purchase option and excluding $4.8 million in charges in 2020 primarily related to noncash fair value adjustments for Ascyrus, G&A expenses were $41.2 million and $31.3 million, respectively, in the fourth quarters of 2021 and 2020.

第四季的一般管理費用為5,130 萬美元，而2020 年第四季為3,610 萬美元。的450 萬美元非現金費用Ascyrus 或有對價和與Endospan 購買選擇權減值相關的490 萬美元非現金費用，不包括2020 年主要與Ascyrus 非現金公允價值調整相關的480 萬美元費用，第四季度的一般管理費用分別為4,120 萬美元和3,130 萬美元2021 年和 2020 年季度。

With the impact of the pandemic and physician adoption on sales of NEXUS, both historically and in the future, we evaluated the purchase option relative to the purchase price and forecasted operating results and determined that it was appropriate to take an impairment charge. The remaining increase in SG&A primarily relates to personnel-related expenses, including salaries, commissions, stock compensation and travel as our spending returned closer to pre-COVID levels and additional expenses to support our expected future growth.

鑑於疫情和醫生採用對 NEXUS 銷售的影響，無論是歷史上還是未來，我們評估了相對於購買價格和預測經營績效的購買選擇，並確定採取減損費用是適當的。 SG&A 的剩餘成長主要與人事相關費用有關，包括薪資、佣金、股票補償和差旅費，因為我們的支出已接近新冠疫情前的水平，以及支持我們預期未來成長的額外費用。

R&D expenses were $9.5 million in the fourth quarter compared to $6.6 million for the fourth quarter of 2020, reflecting increased spending related to the PROACT Xa trial and investments to bring our aortic stent pipeline in the U.S.

第四季的研發費用為 950 萬美元，而 2020 年第四季的研發費用為 660 萬美元，反映出與 PROACT Xa 試驗相關的支出增加以及將我們的主動脈支架管道引入美國的投資。

Fourth quarter interest expense of $3.9 million included approximately $2.5 million of expense related to our Term Loan B; $1.1 million related to our convertible debt; and approximately $300,000 in amortization of debt origination costs. Other expense in Q4 includes $2.9 million in realized and unrealized foreign currency translation losses. Income tax expense of $4 million in the fourth quarter reflects valuation allowances against deferred tax assets.

第四季利息支出為 390 萬美元，其中包括與定期貸款 B 相關的約 250 萬美元支出； 110 萬美元與我們的可轉換債務有關；以及約 30 萬美元的債務發起成本攤銷。第四季的其他費用包括 290 萬美元的已實現和未實現外幣換算損失。第四季所得稅費用 400 萬美元反映了遞延稅資產的估價備抵。

On the bottom line, we reported GAAP net loss of approximately $20.1 million or $0.51 per diluted share in the fourth quarter. Non-GAAP net loss was $141,000 or $0.00 per share in the fourth quarter. GAAP and non-GAAP earnings includes the pretax loss of approximately $2.4 million or approximately $0.05 per share related to foreign currency translation losses.

就利潤而言，我們報告第四季度 GAAP 淨虧損約為 2,010 萬美元，即稀釋後每股虧損 0.51 美元。第四季非 GAAP 淨虧損為 141,000 美元，即每股 0.00 美元。 GAAP 和非 GAAP 收益包括與外幣折算損失相關的稅前損失約 240 萬美元或每股約 0.05 美元。

Adjusted operating income was $5.7 million for the fourth quarter of '21 compared to $11.1 million for the fourth quarter of 2020. Adjusted operating income reflects add-backs of amortization expense, business development and other nonrecurring charges to operating income.

2021 年第四季調整後營業收入為 570 萬美元，而 2020 年第四季為 1,110 萬美元。

As of December 31, 2021, we had approximately $55 million in cash, $317 million in debt and the full $30 million available under our revolving credit facility. Adjusted EBITDA for the fourth quarter of 2021 was $10.8 million compared to $12.1 million for the fourth quarter of 2020. Net leverage, as defined by our credit facility, stood at 5.1x.

截至 2021 年 12 月 31 日，我們擁有約 5,500 萬美元現金、3.17 億美元債務以及循環信貸額度下的全部 3,000 萬美元可用資金。 2021 年第四季調整後 EBITDA 為 1,080 萬美元，而 2020 年第四季為 1,210 萬美元。

On other balance sheet-related items, Pat mentioned our Endospan relationship. As he mentioned, given pandemic-related delays and commercial traction in Europe to date, we recorded an impairment in the value of the option related to this opportunity. While we remain positive on this product, the clinical timing delays push out any potential deal to acquire Endospan and any associated capital need by at least 1 year to 2025 or later. Please refer to our press release for additional information about our non-GAAP results, including a reconciliation of these results to our GAAP results.

在其他與資產負債表相關的項目上，帕特提到了我們與 Endospan 的關係。正如他所提到的，鑑於迄今為止與大流行相關的延誤和歐洲的商業吸引力，我們記錄了與此機會相關的選擇權價值的減損。雖然我們對該產品保持樂觀態度，但臨床時間的延遲將任何收購 Endospan 的潛在交易和任何相關資本需求推遲至少 1 年至 2025 年或更晚。請參閱我們的新聞稿，以了解有關我們的非 GAAP 業績的更多信息，包括這些業績與我們的 GAAP 業績的對照表。

And now for our initial 2022 outlook. We expect constant currency growth of between 9% and 11% for the full year of 2022 compared to 2021. Using a euro-USD exchange rate of 1.13, revenues are expected to be $319 million to $325 million. The average euro-USD exchange rate in 2021 was 1.18, resulting in a $6 million revenue headwind for 2022. Our guidance assumes an impact from COVID during the first quarter of this year and a return to a more normal operating environment for the balance of the year, meaning limited deferred surgeries and staff shortages and more in-person selling. Although we do not anticipate a significant improvement in operating margin and adjusted EBITDA in 2022, we believe that we can comfortably continue to invest in our commercial channels in Asia and Latin America, our R&D pipeline and service our debt without having to raise additional capital.

現在我們對 2022 年進行初步展望。我們預計，與 2021 年相比，2022 年全年的貨幣成長率將維持在 9% 至 11% 之間。 2021 年歐元兌美元平均匯率為 1.18，導致 2022 年收入出現 600 萬美元的逆風。意味著有限的延期手術和人員短缺以及更多的面對面銷售。儘管我們預計2022 年營業利潤率和調整後EBITDA 不會顯著改善，但我們相信，我們可以輕鬆地繼續投資於我們在亞洲和拉丁美洲的商業管道、研發管道和償還債務，而無需籌集額外資本。

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

我將把電話轉回給帕特，聽取他的結束語。

Thanks, Ashley. So before we move to take your questions, I'll leave you with a few final thoughts. Our business momentum is strong, and we believe we have the strategy, the products and the team in place to continue that trend. We just posted strong year-over-year revenue growth despite COVID-related headwinds. We expect this momentum to continue into 2022, particularly into the second quarter and beyond.

謝謝，阿什利。因此，在我們開始回答您的問題之前，我將留給您一些最後的想法。我們的業務勢頭強勁，我們相信我們有適當的策略、產品和團隊來延續這一趨勢。儘管存在與新冠疫情相關的不利因素，但我們剛剛公佈了強勁的同比收入成長。我們預計這種勢頭將持續到 2022 年，特別是第二季及以後。

As I explained earlier, we have 3 short-term initiatives that will drive growth from now through the end of '24. First, we should see continued growth in On-X and our new aortic stents and stent grafts, AMDS, NEXUS, E-nside and NEO. Second, we anticipate further upside from our investments in our channels and new regulatory approvals in Asia and Latin America. Third, in 2022, we expect to receive PMA approval for PerClot and On-X PROACT Mitral in the U.S. And finally, we have a robust midterm pipeline with 3 U.S. PMAs that are currently enrolling, i.e., PROACT Xa or NEXUS TRIOMPHE or about to start enrolling AMDS PERSEVERE.

正如我之前所解釋的，我們有 3 項短期舉措，將推動從現在到 24 世紀末的成長。首先，我們應該看到 On-X 以及我們的新型主動脈支架和覆膜支架 AMDS、NEXUS、E-nside 和 NEO 的持續成長。其次，我們預期亞洲和拉丁美洲的通路投資以及新的監管批准將帶來進一步的好處。第三，到 2022 年，我們預計 PerClot 和 On-X PROACT Mitral 在美國獲得 PMA 批准。註冊AMDS PERSEVERE。

Based on our enrollment projections for these 3 trials, we anticipate 3 PMA approvals in late '24 or into '25 and will expand our total addressable market by $1.5 billion. I would encourage all of you to join us in New York City for our Investor Analyst Day on March 23. It will be an excellent opportunity for you to learn more about our strategy, our products, our R&D pipeline and our leadership team. If any questions you'd like to attend in-person, please reach out to our Investor Relations team at investors@artivion.com.

根據我們對這 3 項試驗的入組預測，我們預計 24 年末或 25 年將有 3 項 PMA 獲得批准，並將使我們的總目標市場擴大 15 億美元。我鼓勵大家參加 3 月 23 日在紐約舉行的投資者分析師日活動。如果您想親自諮詢任何問題，請透過 Investors@artivion.com 聯絡我們的投資者關係團隊。

Operator, would you please open the line for questions?

接線生，請您撥打電話提問好嗎？

(Operator Instructions) Our first question is from Cecilia Furlong with Morgan Stanley.

（操作員說明）我們的第一個問題來自摩根士丹利的塞西莉亞·弗隆。

This is Calvin on for Cecilia. Just 2 kind of buckets of questions. First off, I want to ask about the AMDS trial progress. So wondering if you could speak a little bit more to your confidence in enrolling this within sort of a 9-month period as you spoke to in your prepared remarks? How -- and how you think about potential COVID-related pressure on your enrollment that you've seen kind of in your other trials? And also just initial thoughts on driving awareness around AMDS? And then I had a follow-up.

這是卡爾文為西西莉亞配音的節目。只有兩類問題。首先，我想問AMDS試驗的進展。所以想知道您是否可以像您在準備好的發言中所說的那樣，對在 9 個月內註冊此項目的信心有更多的發言權？您如何看待在其他試驗中看到的與新冠病毒相關的潛在入學壓力？以及關於提高 AMDS 意識的初步想法？然後我進行了跟進。

Yes. So I think maybe one good surrogate is the PROACT Xa trial. I mean we started enrollment in that trial in May of 2022, about 6 weeks after COVID hit the U.S. And we've enrolled almost 570 patients during the pandemic. So we're on track to enroll 1,000-patient trial in 2 years under a pandemic.

是的。所以我認為 PROACT Xa 試驗也許是一個很好的替代方案。我的意思是，我們在 2022 年 5 月開始參加該試驗，大約是在新冠病毒襲擊美國 6 週後。因此，我們預計在 2 年內在大流行期間招募 1,000 名患者進行試驗。

I think the second thing about AMDS, we've got the IDE approved. We should enroll our first patient this quarter. We have 25 centers. The trial is about 100 patients. Those 25 centers represent the largest aortic centers in the country. I've personally visited all of them. I know how many cases they do a year. And this is a life-saving procedure. These patients are typically Medevac in at night. So COVID's the least of people's worries when it comes to acute type A dissections.

我認為關於 AMDS 的第二件事是我們已經獲得了 IDE 的批准。我們應該在本季招募第一位患者。我們有 25 個中心。該試驗約有100名患者。這 25 個中心代表了全國最大的主動脈中心。我親自拜訪過他們所有人。我知道他們一年做多少案子。這是一個挽救生命的程序。這些患者通常在夜間接受醫療後送。因此，當涉及急性 A 型解剖時，新冠病毒是人們最不擔心的。

So there's always kind of the contracting and getting through IRBs and these kind of things. It takes time, but we feel that given the importance of this technology, the lifesaving nature of this procedure, that with the centers we're in and the volume that they do, that we should enroll this trial pretty quickly.

因此，總是會有一些合約和通過 IRB 之類的事情。這需要時間，但我們認為，考慮到這項技術的重要性、該程序的救生性質，以及我們所在的中心和他們所做的工作量，我們應該很快就會註冊這項試驗。

Got it. That's very helpful. The second one is just on margins. I have 2 checks. One is on gross margin. I wanted to dig a little bit into the sequential compression. So just curious what's reflected in 4Q associated with kind of your tissue coming back versus inflationary pressures that you spoke to? And how you think about that jumping off into '22? And then also on the R&D cadence in '22 between PROACT Xa, ramping AMDS and just other drivers, what would drive that R&D cadence in '22?

知道了。這非常有幫助。第二個只是邊緣。我有兩張支票。一是毛利率。我想深入研究一下順序壓縮。所以只是好奇第四季度反映了與您所說的組織類型恢復與通膨壓力相關的什麼？您如何看待進入 22 世紀？然後，關於 PROACT Xa、AMDS 和其他驅動因素之間 22 年的研發節奏，什麼會推動 22 年的研發節奏？

Yes. So gross margins, as you know, are a combination of many moving parts, right? So clearly, the inflationary pressures from whether it's increased labor costs or increased materials are baked in there.

是的。如您所知，毛利率是許多活動部分的組合，對嗎？很明顯，無論是勞動成本增加或是材料增加所帶來的通膨壓力都在其中。

The second thing we've seen in '21 is increased obsolescence, primarily around we were staffed up and had product in the field to support the normal growth rates. And we just had more exposure to obsolescence given the kind of the volume reductions.

我們在 21 年看到的第二件事是過時的增加，主要是因為我們配備了人員並擁有現場產品來支援正常的成長率。考慮到體積的減少，我們面臨更多的過時風險。

And then third, as you mentioned, there's mix, whether it's international or our product line. And we did see a higher return to growth of our cardiac tissue, which is a lower gross margin than our -- kind of our high-end devices. So it was kind of a mix of all those things. And clearly, the inflationary pressures was one that was unforecasted at the beginning of the year.

第三，正如您所提到的，存在混合，無論是國際的還是我們的產品線。我們確實看到了心臟組織生長的更高回報，但毛利率低於我們的高端設備。所以它是所有這些東西的混合體。顯然，通膨壓力是年初未曾預料到的。

And then maybe you can comment on the R&D actually.

然後也許你可以對研發進行實際評論。

Yes. So we ended up fourth quarter at about $9.5 million in R&D. And clearly, PROACT Xa continues to ramp up. We're going to be starting AMDS, but we're also going to have some R&D efforts that are going to be rolling off this year. We invested a lot of money in getting to the point where we could submit PerClot to the FDA. So we are going to have some progress. And PROACT Mitral just recently wrapped up as well. So with all that being said, we think that R&D in 2022 is going to be in the high $30 millions to the low $40 millions, and a lot of it will just depend on the progress that we make with the programs.

是的。因此，我們第四季的研發費用約為 950 萬美元。顯然，PROACT Xa 的發展仍在繼續。我們將啟動 AMDS，但我們也將在今年進行一些研發工作。我們投入了大量資金來向 FDA 提交 PerClot。所以我們將會取得一些進展。 PROACT Mitral 最近也剛結束。綜上所述，我們認為 2022 年的研發費用將在 3,000 萬美元到 4,000 萬美元之間，其中很大一部分將取決於我們專案的進度。

The next question is from Jeffrey Cohen with Ladenburg Thalmann.

下一個問題是傑弗裡·科恩和拉登堡·塔爾曼提出的。

So firstly, could you talk a little bit about the aortic stent pipeline? I know you had some manufacturers and throughput issues out of JOTEC, and you were putting up a second source under development. What's the status there? And are you caught up? Have you caught up? What are the plans going forward?

首先，您能談談主動脈支架管路嗎？我知道你們在 JOTEC 方面遇到了一些製造商和吞吐量問題，並且你們正在開發第二個來源。那裡的狀況如何？你追上了嗎？你跟上了嗎？未來有何計畫？

We grew 33% in the fourth quarter.

第四季我們成長了 33%。

So no issues on backlog whatsoever?

那麼積壓方面就沒有問題嗎？

Yes. We brought in new selling suppliers, as we mentioned. We've built a new facility, which is not up and running, but we've had no issues on the supply side. And I said, we put up -- depending on which number you want to look at, versus '20, we grew the stents and stent grafts almost 30%. And versus '19, we grew them 22%, so...

是的。正如我們所提到的，我們引入了新的銷售供應商。我們建造了一個新設施，尚未啟動並運行，但我們在供應方面沒有遇到任何問題。我說，我們提出——取決於你想看哪個數字，與 20 年相比，我們的支架和覆膜支架增加了近 30%。與 19 年相比，我們成長了 22%，所以...

Got it. Fantastic. Okay. And then could you comment a little bit on your channels and the size of the commercial force for Asia and Latin America? And how you're tackling that as far as direct versus distribution arrangements?

知道了。極好的。好的。那麼您能否評論一下您的管道以及亞洲和拉丁美洲商業力量的規模？就直接與分銷安排而言，您如何解決這個問題？

Yes. So we've talked kind of consistently over the last probably 18 months about we see this as one of our growth drivers. And we saw a nice performance in both of those markets this quarter. I commented on the growth rates in Asia Pacific and Latin America. We're seeing 34% growth in Latin America and 29% growth in Asia. Those channels, we're expecting to build Asia up more. It's obviously a bigger geography. So I think there's probably another 15 to 20 people we'll be adding there over the next 3 years. Probably half of that in Latin America. And then we basically are fully staffed up and don't need to add any more.

是的。因此，在過去大約 18 個月裡，我們一直在談論我們將此視為我們的成長動力之一。本季我們在這兩個市場都看到了良好的表現。我評論了亞太地區和拉丁美洲的成長率。我們看到拉丁美洲成長了 34%，亞洲成長了 29%。我們期望透過這些管道進一步增強亞洲的實力。這顯然是一個更大的地理。因此，我認為未來 3 年內我們可能會再增加 15 到 20 名人員。可能有一半在拉丁美洲。然後我們的人員基本上已經滿了，不需要再增加了。

So it's an investment that's actually returning, right now, really nice growth rates. And we're also feeding the regions as they grow. So when COVID hit, we kind of slowed it down. And then when things started loosening it up, we started adding people back on. But we expect to have that investment probably flattening out itself in the next 24 months.

因此，這是一項實際上正在回報的投資，目前，成長率非常好。隨著這些地區的生長，我們也會為其提供食物。因此，當新冠疫情來襲時，我們放慢了速度。然後當情況開始放鬆時，我們開始重新增加人員。但我們預計該投資可能在未來 24 個月內趨於穩定。

Okay. Perfect. And then lastly for us, Ashley, any comment on the $10 million integration severance and business development from Q4? Is that onetime in nature? Or should we expect any further impacts into the first half this year?

好的。完美的。最後，我們 Ashley 對第四季 1000 萬美元的整合遣散費和業務發展有何評論？自然界中是一次性的嗎？或者我們應該預期今年上半年會受到進一步的影響？

Yes. The fair value accounting for the Ascyrus contingent consideration is something that we will see every quarter going forward until the milestones are fully earned and paid and that's way out in the future. So going forward, our best estimate right now for Ascyrus is maybe $1.5 million per quarter. But again, that could change based on a variety of factors, progress that's made, discount rates, there are a lot of things. But that's our best guess.

是的。 Ascyrus 或有對價的公允價值會計是我們每季都會看到的東西，直到里程碑完全獲得和支付，這是未來的出路。因此，展望未來，我們目前對 Ascyrus 的最佳估計可能是每季 150 萬美元。但同樣，這可能會根據各種因素、取得的進展、折扣率等因素而改變。但這是我們最好的猜測。

For Endospan, the option is fully written off. So you won't see any charges related to that. we do have an obligation to pay them another $5 million once they reach 50% enrollment in their clinical trial. We anticipate them hitting 50% at some point this year. And whenever they reach that milestone and we make that payment, there will be a $5 million charge approximately in other expense.

對於 Endospan，該選項已完全取消。因此您不會看到任何與此相關的費用。一旦他們的臨床試驗入組率達到 50%，我們就有義務再支付他們 500 萬美元。我們預計今年某個時候這一比例將達到 50%。每當他們達到這一里程碑並且我們付款時，就會產生大約 500 萬美元的其他費用。

The next question is from Mike Matson with Needham & Company.

下一個問題來自 Needham & Company 的 Mike Matson。

I guess I just want to ask about the revenue guidance. So you just grew 19% on a pro forma constant currency basis. You're guiding to around 10%. I mean I understand there's some COVID impact expected, particularly in the early part of the year. But why the slowdown, I guess? And I guess, as a follow-up to that, just was there any kind of one-offs in the fourth quarter that helped your growth that aren't really sustainable, I guess, but maybe that's probably why you're guiding forward?

我想我只是想問一下收入指導。因此，以預計固定匯率計算，您的成長率僅為 19%。你指導的是10%左右。我的意思是，我知道新冠疫情預計會產生一些影響，尤其是在今年年初。但我猜為什麼會放緩？我想，作為後續行動，第四季度是否有任何一次性的事情幫助了您的成長，但這些成長並不是真正可持續的，我想，但這可能是您指導前進的原因？

Yes. I think the biggest issue, Mike, and again, this is one that's probably not common for a lot of companies of our size that have single products and are mostly in the U.S. I mean almost 40% of our business is in Europe, and the euro has dropped 7 points in the last year. That's a $6 million headwind. So if people are kind of taking our Q4 number and trying to straight line it out to next year, it's the wrong math equation. I mean the euro a year ago was 1.22 this quarter, and now it's 1.13. So we got a serious headwind when it comes to the euro in Europe, and we have a big chunk of business there. So it's got nothing to do with our -- we're backing off on what we think is going to happen. It's more -- we got a lot more to do with the headwind on currency.

是的。我認為最大的問題，麥克，再說一遍，這對我們這種規模的許多公司來說可能並不常見，這些公司擁有單一產品並且主要在美國。而且歐元去年下跌了7點。這是 600 萬美元的逆風。因此，如果人們試圖將第四季的數據直接推算到明年，那麼這是錯誤的數學方程式。我的意思是一年前這個季度歐元是1.22，現在是1.13。因此，當談到歐洲的歐元時，我們遇到了嚴重的阻力，而我們在那裡有很大一部分業務。所以這與我們無關——我們正在放棄我們認為將會發生的事情。更重要的是──我們與貨幣逆風有更多關係。

Yes. And the other thing, Mike, too, is that 18% growth, that was against the fourth quarter of '20. We were up 13.5% against the fourth quarter of 2019. So we're guiding to between 9% and 11% versus, again, if the comparison is 2019, it was 13.5%.

是的。麥克的另一件事是，與 20 世紀第四季相比，成長了 18%。與 2019 年第四季相比，我們成長了 13.5%。

Yes, I don't think -- yes, I think the big thing people aren't catching is the currency, right? Because if you revalue 2021 revenues at the new currency, our $298.8 million turns into like $293 million. It's the 7% drop and it's all currency. So we're saying we're going to grow 9% to 11%. You just got to -- I'm not going to get set up with -- I can't control currency.

是的，我不認為——是的，我認為人們沒有註意到的最重要的事情是貨幣，對嗎？因為如果你以新貨幣重新評估 2021 年的收入，我們的 2.988 億美元就會變成 2.93 億美元。就是7%的跌幅，而且都是貨幣。所以我們說我們將成長 9% 到 11%。你必須——我不會接受——我無法控制貨幣。

Yes. No, I understand that. I mean it's consequent to guidance. So that's fine. Okay. All right. And then let's see. So just want to ask about the first quarter specifically. It sounds like you're expecting some COVID impact there. I didn't really hear any specific revenue ranges or anything. It looks like consensus is just under $79 million, which would sort of imply 11% growth versus the first quarter of '21, if my math is right. So that probably too high based on what you're saying because of your full year guidance. I mean that's at the high end of the range for the full year.

是的。不，我明白。我的意思是這是指導的結果。所以沒關係。好的。好的。然後讓我們看看。所以只想具體詢問第一季的情況。聽起來您預計新冠疫情會對該地區產生一些影響。我真的沒有聽到任何特定的收入範圍或任何內容。看起來共識價格略低於 7900 萬美元，如果我的計算正確的話，這意味著與 21 年第一季相比增長了 11%。因此，根據您所說的全年指導，這個數字可能太高了。我的意思是，這是全年範圍的高端。

Yes. So that $79 million has no impact of the 6% drop in currency. So I think people need to readjust their numbers based on the 2022 currency. And we're giving -- we've given full year guidance, 9% to 11%. And clearly, COVID is an issue in the first quarter. I mean January was slow. In our checks with hospitals, the -- a lot of these hospitals had as many patients in January as they did at any point in the pandemic. They were reducing elective procedures. The bigger issue is, frankly, hospital staffing. I think the good news is we're seeing cases drop, hospitals emptying out and staffing coming back. So we don't think it's going to persist, but we definitely think Q1 is going to be lighter than the rest of the year.

是的。因此，這 7,900 萬美元並沒有受到貨幣貶值 6% 的影響。所以我認為人們需要根據2022年的貨幣重新調整他們的數字。我們給了全年指導，9% 到 11%。顯然，新冠疫情是第一季的一個問題。我的意思是一月過得很慢。在我們對醫院的檢查中，許多醫院一月份的病人數量與大流行期間任何時候的病人數量一樣多。他們正在減少選擇性手術。坦白說，更大的問題是醫院人員配備。我認為好消息是我們看到病例數下降、醫院空出、人員配備恢復。因此，我們認為這種情況不會持續下去，但我們肯定認為第一季的情況會比今年剩餘時間要輕。

Yes, Mike, this is Ashley. So I mean, to Pat's point, talking about currency, last year, we posted $71 million in revenue. And if you take into account the change in FX rates, that $71 million translates to $69 million. So that's really the base that you should be looking at. And if you just take the midpoint of our guidance that we guided to, which is 9% to 11%, 10% on top of that is 76%. And as Pat indicated, the COVID's really had an impact at least to date this quarter.

是的，麥克，這是阿什利。所以我的意思是，就帕特的觀點而言，談到貨幣，去年我們公佈了 7100 萬美元的收入。如果考慮到外匯匯率的變化，這 7,100 萬美元就相當於 6,900 萬美元。所以這確實是您應該關注的基礎。如果你只取我們指導的中點，即 9% 到 11%，再加上 10% 就是 76%。正如帕特所指出的那樣，至少在本季度迄今為止，新冠疫情確實產生了影響。

Yes. Okay. I understand. All right. And then just as far as On-X Mitral goes, so when you hopefully get that approval for the lower INR, how quickly do you think the uptake will be on that? I mean you've talked about it being, I think, a $40 million, if I remember right, opportunity.

是的。好的。我明白。好的。然後就 On-X Mitral 而言，當您希望獲得較低 INR 的批准時，您認為採用該方案的速度有多快？我的意思是，如果我沒記錯的話，你說過這是一個價值 4000 萬美元的機會。

Yes.

是的。

So how quickly can you get to $40 million, I guess, there?

那麼，我想，你能多快達到 4,000 萬美元呢？

Yes. I think you've seen -- I mean, we have a great case study, right, because we've already done this. We did it on the aortic side, where we got the exact same -- it's the sister product, right? We had a lower INR for the aortic. It has to -- the paper has to get out. It has to get socialized and educate -- you have to educate your physicians.

是的。我想你已經看到了——我的意思是，我們有一個很好的案例研究，對吧，因為我們已經做到了這一點。我們在主動脈側進行了實驗，得到了完全相同的結果——這是姊妹產品，對嗎？我們的主動脈 INR 較低。它必須——報紙必須出去。它必須社會化和教育——你必須教育你的醫生。

The great news about PROACT Mitral is we -- again, we've already done it with aortic, number one. Number two, the valves are already on the shelves. We have mitral valves in probably 500 accounts in this country. So all that's going to happen. The label is going to change, and our reps are going to market the paper. So as far as like making new product and getting it out and all that, what happens with a lot of our other products, that doesn't exist. We already have product on the shelf. So I think we're going to see a steady increase in the mitral like we did with On-X aortic over the next 3 or 4 years.

關於 PROACT 二尖瓣的好消息是，我們已經在主動脈上做到了這一點，這是第一個。第二，閥門已經上架。我們國家大約有 500 個帳戶有二尖瓣。所以這一切都會發生。標籤將會改變，我們的代表將推銷該紙張。因此，就製造新產品並推出它之類的事情而言，我們的許多其他產品所發生的情況是不存在的。我們已經有產品上架了。因此，我認為我們將看到二尖瓣的穩定增長，就像我們在未來 3 到 4 年內對 On-X 主動脈所做的那樣。

Our next question is from Suraj Kalia with Oppenheimer & Company.

我們的下一個問題來自 Oppenheimer & Company 的 Suraj Kalia。

Pat, Ashley. hope everyone is safe and healthy. So Pat, On-X Mitral, I'd love to get you guys' perspective what has the reception been on the data? And if I could piggyback on the previous questioner, On-X aortic, right? If my math is right, like within 5 years, you guys became pretty much the market leader in your day. Just kind of map us the trajectory of On-X Mitral, if you could, knowing that this is, let's say, a $40 million, $50 million opportunity in the U.S.

帕特，阿什利。希望每個人都安全健康。 Pat、On-X Mitral，我很想聽聽你們對數據的看法如何？如果我可以藉用之前的提問者 On-X 主動脈，對嗎？如果我的數學正確的話，大概在 5 年內，你們幾乎成為了那個時代的市場領導者。如果可以的話，請為我們繪製 On-X Mitral 的軌跡，並知道這在美國是一個價值 4000 萬美元、5000 萬美元的機會。

Yes. No, I think it's a good point and dovetailing off Mike Matson's question. I mean I'm looking at the On-X numbers. So compared to 2021 versus '20, we grew On-X 18%. '21 versus '19, if you think that's too easy, we grew 14%. So here we are 5 years after we acquired them and after they got the indication. And given the pandemic, we had a little bit of a slowdown in the pandemic. But we've basically grown On-X double digits every year for the last 5 years.

是的。不，我認為這是一個很好的觀點，並且與麥克馬森的問題相吻合。我的意思是我正在查看 On-X 資料。因此，與 2021 年和 20 年相比，我們的 On-X 成長了 18%。 21 年與 19 年相比，如果你認為這太簡單了，我們成長了 14%。現在是我們收購它們以及他們獲得適應症之後的五年。考慮到這場流行病，我們的流行病速度有所放緩。但在過去 5 年裡，我們的 On-X 基本上每年都以兩位數的速度成長。

So one of the things you see, and you know this well from -- as a new paper gets out, you've got to educate your physicians, you've got to look to get the guidelines changed. And I do think we have a kind of a tailwind because we just did it for the last 5 years with On-X aortic. So I think that the brand represents a different valve within a coagulation.

所以你看到的一件事，你很清楚——當一篇新論文發表時，你必須教育你的醫生，你必須尋求改變指導方針。我確實認為我們有一種順風，因為我們在過去 5 年裡剛剛透過 On-X 主動脈做到了這一點。所以我認為該品牌代表了凝固中的不同閥門。

So I think the steps here are getting the publication out, educating physicians and obviously, we've got to get the FDA approval, right? I mean we can't really do any of this stuff until we get the FDA approval. Once we get that, I mean, the products on the shelves, our reps know the surgeons and we'll present the data. The feedback we've had has been excellent. We've got a lot of market research.

所以我認為這裡的步驟是發佈出版物，教育醫生，顯然，我們必須獲得 FDA 的批准，對嗎？我的意思是，在獲得 FDA 批准之前，我們不能真正做任何這些事情。一旦我們得到了貨架上的產品，我們的代表就了解外科醫生，我們將提供數據。我們收到的回饋非常好。我們進行了大量的市場調查。

I mean, again, it's a little bit like the aortic valve in that, why wouldn't you want a lower INR if you're a patient who's going to get a mitral valve? We've shown that we can protect the valve with less Coumadin in the aortic position and that was very well adopted. And now we're -- we've done it with the mitral valve.

我的意思是，這有點像主動脈瓣，如果您是一名要接受二尖瓣的患者，為什麼不希望 INR 較低呢？我們已經證明，我們可以在主動脈位置使用較少的香豆素來保護瓣膜，並且這一點得到了很好的採用。現在我們已經用二尖瓣做到了。

So I think it's -- you don't get it all. You don't get all $40 million in 1 year. Nobody does that, right? It's a technology adoption and uptake. But I do think it's going to probably go faster than the aortic did.

所以我認為——你並沒有完全明白。你不可能在一年內拿到全部 4000 萬美元。沒有人這樣做，對嗎？這是一種技術的採用和吸收。但我確實認為它可能會比主動脈更快。

Pat, PROACT Xa, 570 patients enrolled so far, if I heard you guys correctly.

Pat，PROACT Xa，如果我沒聽錯的話，到目前為止已有 570 名患者入組。

That's right. That's correct.

這是正確的。這是正確的。

Do we need to -- or do you anticipate a pickup in enrollment to maintain the Q2 timing for finishing up enrollment?

我們是否需要—或者您是否預計註冊人數會增加，以維持第二季完成註冊的時間？

Yes. I mean, I think we continue to add centers. So we're -- we've got 60 centers signed up. We have 55 on board at this point. So we've got 5 more centers coming in. And we typically see a bolus of patients when a new center comes in. And we've seen nice enrollment.

是的。我的意思是，我認為我們會繼續增加中心。所以我們——我們已經有 60 個中心簽約了。目前船上有 55 人。所以我們還有另外 5 個中心加入。

I do think -- I think it's not misstating it, when you see a massive surge in a hospital, like in January, I think it's fair to say that clinical trials probably get impacted. People are busy in doing other things. So I think it's helpful for us as things kind of calm down on the COVID front with the hospital that it should help. But we're -- I mean, we're very aggressive. We're having regular investigator meetings, but we've got the centers all up and running. It's now a matter just of putting the foot down and getting these patients in.

我確實認為——我認為這並沒有說錯，當你看到醫院的人數大幅增加時，就像一月份一樣，我認為可以公平地說，臨床試驗可能會受到影響。人們忙著做其他事情。所以我認為這對我們很有幫助，因為醫院在新冠疫情方面的局勢有所平靜，應該會有所幫助。但我們——我的意思是，我們非常積極進取。我們定期召開調查員會議，但我們已經讓這些中心全部啟動並運行。現在的問題只是放下腳步，讓這些病人進來。

Fair enough. And Pat, last question from my side, and I'll hop back in queue. So Pat, you've been there 7 years, right? Take a step back, and obviously, you have transformed the company. And I'm curious, as you look at it at the cutting junction, how would you characterize, let's say, average rep productivity, average revs per account? What do you see as optimal levels? What does the gap analysis tell you? And how do we fill that gap?

很公平。派特，我這邊的最後一個問題，我會跳回隊列。帕特，你已經在那裡待了 7 年了，對吧？退後一步，顯然，你已經改變了公司。我很好奇，當你在關鍵時刻觀察時，你會如何描述平均代表生產力、每個帳戶的平均轉速？您認為最佳水平是多少？差距分析告訴您什麼？我們如何填補這一空白？

Yes, thanks. Yes, so I think it depends on the region, right? So if you look at Europe, we've thrown a lot of new products with them, right? We acquired JOTEC and then we brought on Endospan with NEXUS and then we brought on AMDS. We've launched E-nside. We've launched NEO. So it's like we've got kind of a treasurer of products in Europe where they've got the whole pipeline. So I would say that, that group is extremely busy.

對了謝謝。是的，所以我認為這取決於地區，對嗎？所以如果你看看歐洲，我們已經向他們推出了很多新產品，對吧？我們收購了 JOTEC，然後我們引入了 Endospan 和 NEXUS，然後我們引入了 AMDS。我們推出了 E-nside。我們已經推出了 NEO。所以這就像我們在歐洲有一個產品財務主管，他們擁有整個管道。所以我想說，那個小組非常忙碌。

The U.S. team, as a kind of comparison, they haven't really got any of the new stuff. But they've got PROACT Mitral coming and they're very well positioned for that. So we've got kind of 60 feet on the street in the U.S. They're well positioned for PROACT Mitral. They're well positioned for PROACT Xa when it comes. They're well positioned for AMDS. And I think that's one that people don't necessarily grasp. And a lot of these businesses that I've been, you've really got to add a lot more reps when you bring in new products. We don't need to add any more reps. I can add $400 million worth of new revenue into the U.S. and not add a single rep.

作為一種比較，美國隊並沒有真正獲得任何新東西。但他們已經有了 PROACT Mitral，並且他們為此做好了充分的準備。所以我們在美國的街道上有大約 60 英尺的距離，它們對於 PROACT Mitral 來說位置很好。當 PROACT Xa 到來時，他們已經做好了充分的準備。他們為 AMDS 做好了充分準備。我認為人們不一定能理解這一點。我去過的很多這樣的企業，當你引進新產品時，你真的必須增加更多的代表。我們不需要增加更多代表。我可以在美國增加價值 4 億美元的新收入，而無需增加任何代表。

So I think that's one of the real kind of secret sauces of Artivion, is once we finish our investment in Asia Pacific, and maybe some spotty things here and there in Europe as you maybe go direct in countries and we're mostly direct there now, we're going to kind of flatten out our investment in direct distribution. And all these new products that come through, we're going to see significant drop-through to the bottom line, accelerating growth and accelerating gross margin as well as just sheer drop-through because we don't have to add any more reps. So I think it's a unique thing about cardiac surgery in particular, where you can cover a lot of accounts without a lot of reps.

所以我認為這是Artivion 真正的秘密武器之一，一旦我們完成了在亞太地區的投資，也許歐洲各地也會出現一些參差不齊的事情，因為你可能會直接進入一些國家，而我們現在大部分都是直接在那裡，我們將在某種程度上壓平我們對直接分銷的投資。所有這些新產品的推出，我們將看到利潤顯著下降，加速成長並加速毛利率，以及純粹的下降，因為我們不需要增加任何更多的代表。所以我認為這是心臟手術的一個獨特之處，特別是在心臟手術中，您可以在沒有大量代表的情況下處理大量帳戶。

Okay, operator, any more questions?

好的，接線生，還有問題嗎？

Mr. Mackin, there are no further questions at this time. I would like to turn the floor back over to management for closing comments.

麥金先生，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。

Okay. Yes. Well, first of all, thanks for joining today, and we appreciate you spending some time with us. And we've tried to simplify the story to a pretty digestible plan, which is Phase I or the current growth initiative. Number one is our new products, right? We were showing significant growth. Our On-X platform grew this year 18% versus '20 or 14% versus '19. Our stents and stent grafts grew 28% versus 2020 or 22% versus '19. So any comparator, we're talking about nice growth that is driving the growth of Artivion. So that's our first pillar in our growth.

好的。是的。首先，感謝您今天加入，我們感謝您花一些時間與我們在一起。我們試圖將故事簡化為一個相當容易理解的計劃，即第一階段或當前的成長計劃。第一個是我們的新產品，對嗎？我們呈現出顯著的成長。我們的 On-X 平台今年比 20 年成長了 18%，與 19 年相比成長了 14%。我們的支架和覆膜支架與 2020 年相比成長了 28%，與 19 年相比成長了 22%。因此，對於任何比較者來說，我們談論的是推動 Artivion 成長的良好成長。所以這是我們成長的第一個支柱。

The second is Asia Pacific, Latin America. We talked about the growth rates in those 2 regions. We continue to invest in those areas.

第二個是亞太地區、拉丁美洲。我們討論了這兩個地區的成長率。我們將繼續在這些領域進行投資。

The third is we've got 2 PMAs that should come through this year. PerClot, which will give us a $25 million payment from Baxter, and then revenue that we sell to them. And then PROACT Mitral, which we talked a lot about on the call.

第三個是我們今年應該會通過兩項 PMA。 PerClot，Baxter 將向我們支付 2500 萬美元，然後我們將收入出售給他們。然後是 PROACT Mitral，我們在電話中討論了很多。

And then the fourth piece of the puzzle is 3 PMAs. We're enrolling PROACT Xa. We're 57% of the way done with that trial. We expect to enroll in the first half of this year. We expect to enroll our first patient in the second trial PERSEVERE, which is AMDS. And we're still pursuing FDA approval with the NEXUS device.

第四塊拼圖是 3 個 PMA。我們正在註冊 PROACT Xa。該試驗已完成 57%。我們預計今年上半年入學。我們預計在第二項試驗 PERSEVERE（AMDS）中招募第一位患者。我們仍在尋求 FDA 對 NEXUS 設備的批准。

So I think we've got a great story, and we're looking to deliver the numbers we talked about and look forward to updating you on the next call. So thanks for attending.

因此，我認為我們已經有了一個很棒的故事，我們希望提供我們討論過的數字，並期待在下次通話中向您通報最新情況。感謝您的參加。

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

謝謝。今天的會議到此結束。此時您可以斷開線路。感謝您的參與。