Inari Medical Inc (NARI) 2023 Q4 法說會逐字稿

Good day, and welcome to Inari Medical's Fourth Quarter and Full Year 2023 conference call. At this time, all participants are in a listen only mode at the end of the Company's prepared remarks, we will conduct a question and answer session. As a reminder, this call is being recorded and will be available on the company's website for replay shortly. And now I will turn the call over to John Hsu, Vice President of Investor Relations. Please go ahead.

美好的一天，歡迎參加 Inari Medical 的 2023 年第四季和全年電話會議。此時，所有參與者都處於只聽模式，在公司準備好的發言結束後，我們將進行問答環節。提醒一下，這通通話正在錄音中，很快就會在公司網站上重播。現在我將把電話轉交給投資人關係副總裁 John Hsu。請繼續。

Thank you, operator, and welcome to Inari's conference call to discuss our fourth quarter and full year 2023 financial performance. Joining me on today's call are Drew Hykes, President and Chief Executive Officer, and Mitch Hill, Chief Financial Officer. This call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements made on this call that do not relate to matters of historical fact should be considered forward looking statements, including statements related to Inari's estimated full year 2020 for revenue, operating loss or profitability expectations and the expected operating performance and potential strategic benefits of Linde flow are based on Inari's current expectations, forecasts and assumptions, which are subject to inherent uncertainties, risks and assumptions that are difficult to predict.

謝謝運營商，歡迎參加 Inari 的電話會議，討論我們第四季度和 2023 年全年的財務業績。與我一起參加今天電話會議的還有總裁兼執行長德魯·海克斯 (Drew Hykes) 和財務長米奇·希爾 (Mitch Hill)。本次電話會議包括 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。本次電話會議中發表的與歷史事實無關的陳述應被視為前瞻性陳述，包括與 Inari 預計 2020 年全年收入、營運虧損或盈利預期以及 Linde flow 的預期營運績效和潛在戰略利益相關的陳述基於Inari 目前的預期、預測和假設，這些預期、預測和假設受到難以預測的固有不確定性、風險和假設的影響。

Actual outcomes and results could differ materially from any results, performance or achievements expressed or implied by the forward-looking statements due to several factors, please review Inari's most recent filings with the SEC, particularly the risk factors described in our latest Form 10 K for additional information. Any forward-looking statements provided during this call, including projections for future performance are based on management's expectations. As of today, Inari undertakes no obligation to update these statements except as required by applicable law.

由於多種因素，實際結果和結果可能與前瞻性陳述中明示或暗示的任何結果、業績或成就存在重大差異，請查看Inari 最近向SEC 提交的文件，特別是我們最新的10 K 表格中描述的風險因素：附加資訊。本次電話會議期間提供的任何前瞻性陳述，包括對未來業績的預測，均基於管理層的預期。截至今日，Inari 不承擔更新這些聲明的義務，除非適用法律要求。

On today's call, we will refer to both GAAP and non-GAAP financial measures in announcing our Q4 and full year 2023 results. Please refer to today's press release for a reconciliation of the non-GAAP measures discussed on this call and referred to in the press release press release in the slides accompanying this call are available on our website in Inari medical.com and a recording of today's call will be available on our website by 5 p.m. Pacific time today with that, I'll turn the call over to Drew.

在今天的電話會議上，我們將在宣布 2023 年第四季和全年業績時參考 GAAP 和非 GAAP 財務指標。請參閱今天的新聞稿，以了解本次電話會議中討論的非公認會計準則措施以及新聞稿中提到的本次電話會議隨附幻燈片中的新聞稿，可在我們的Inari Medical.com 網站上查看以及今天電話會議的錄音將於下午 5 點在我們的網站上提供今天是太平洋時間，我會將電話轉給德魯。

Thank you, John, and thank you for joining our call today. We are thrilled with our Q4 and full year 2023 performance in the fourth quarter, we achieved record revenue of more than $132 million, driven by strength in our core VT. business, strong growth from our emerging therapies portfolio and continued traction from international expansion. For the full year, we generated revenue of over $493 million, reflecting 29% growth for the year we also made meaningful progress on our path to profitability positioning in RA for sustained operating profitability in the first half of 2025, despite the incremental operating deficit support associated with our lead flow acquisition. I would like to thank our team for their hard work to make this year a success by every measure.

謝謝約翰，也謝謝您今天加入我們的電話會議。我們對第四季和 2023 年全年的業績感到非常興奮，在核心 VT 實力的推動下，我們實現了超過 1.32 億美元的創紀錄收入。業務、新興療法組合的強勁成長以及國際擴張的持續推動。全年收入超過 4.93 億美元，同比增長 29%，儘管營運赤字支持不斷增加，但我們在 RA 盈利定位方面也取得了有意義的進展，以在 2025 年上半年實現持續運營盈利與我們的潛在客戶流量獲取相關。我要感謝我們的團隊的辛勤工作，使今年在各個方面都取得了成功。

We are succeeding in our goal to drive strong adoption of our market-leading PE. and DBT. therapies, while also executing on our plans to expand internationally and diversify commercially into sizable new patient populations that are underserved by today's standard of care. This expansion to new patient populations included the acquisition of Linde flow, which we announced and closed in Q4. Lymphomas purpose-built system allows for the transcatheter virtualization of the deep veins and is indicated to treat patients with chronic limb threatening ischemia or CLTI.

我們正在成功實現推動市場領先的 PE 廣泛採用的目標。和 DBT。療法，同時也執行我們的國際擴張計劃和商業多元化計劃，以涵蓋當今護理標準服務不足的大量新患者群體。此次向新患者群體的擴張包括收購 Linde flow，我們在第四季度宣布並完成了收購。淋巴瘤專用系統可實現深部靜脈的經導管虛擬化，適用於治療患有慢性肢體威脅性缺血或 CLTI 的患者。

This technology addresses a spectacular unmet need for these patients, providing new hope and an important new treatment option. I'll have more to share about our progress and some flow later in the call. Going forward, we will begin providing a new revenue breakout that we believe better aligns with the three growth pillars of our business. Specifically, we'll report revenue from our global VT. portfolio and from our global emerging therapies portfolio. While also continuing to break out U.S. and international revenue mix. We'll have more to share about this new framework in his remarks.

這項技術解決了這些患者未滿足的巨大需求，提供了新的希望和重要的新治療選擇。我將在稍後的電話會議中分享更多有關我們的進展和一些流程的資訊。展望未來，我們將開始提供新的營收突破，我們相信它更符合我們業務的三大成長支柱。具體來說，我們將報告全球 VT 的收入。組合以及我們的全球新興療法組合。同時也持續突破美國和國際收入組合。我們將在他的演講中分享有關這個新框架的更多資訊。

Before turning to these growth pillars, I wanted to share as we always do a story about the incredible impact our technology has on patients recently a 30 year old woman, just two weeks post Farnam presented to an ER in Louisiana was severe trouble breathing and leg swelling as a complication from a recent pregnancy. This young mom was diagnosed with both a pulmonary embolism and a clot in her inferior vena cava or IDC a life-threatening situation. After consulting with our physicians, she decided to undergo thrombectomy first or physicians use the new Class three for XL catheter to effectively remove all the clocking or IBC as it was purpose-built to do. The Procuri sheet was also used adjunctively to protect against the risk of clot embolization.

在討論這些成長支柱之前，我想分享一個故事，因為我們總是做一個故事，講述我們的技術最近對患者產生的令人難以置信的影響，一位30 歲的女性，在Farnam 到路易斯安那州的急診室就診兩週後，出現了嚴重的呼吸和腿部困難腫脹是最近懷孕的併發症。這位年輕的媽媽被診斷出患有肺栓塞和下腔靜脈血栓或IDC，危及生命。在諮詢我們的醫生後，她決定先進行血栓切除術，或者醫生使用新的 XL 導管三級來有效去除所有時鐘或 IBC，因為它是專門設計的。Procuri 片也可輔助使用以防止血栓栓塞的風險。

Next for pulmonary embolism was successfully and efficiently treated using the T. 24 catheter. After a short hospital stay, the patient was able to return home to a newborn baby and family for a successful outcome was made possible by the scale of recruiting physicians and the breadth and depth of NRT's purpose-built toolkits across both DBT. and PE.

接下來使用 T.24 導管成功有效地治療了肺栓塞。經過短暫的住院治療後，患者能夠回到家中，與新生兒和家人團聚，並透過招募醫生的規模以及 NRT 跨 DBT 的專用工具包的廣度和深度來實現成功的結果。和體育。

During 2023, we surpassed 130,000 cumulative patients treated globally, including this young mom. This was a humbling milestone for our organization, but despite our success to date, much more work remains and we believe we're in the earliest phases of the impact we can have on patients globally across multiple disease states. I will now provide an update on each of our three growth pillars starting with VTE, which we believe represents a $6 billion TAM in the US alone.

2023 年，我們在全球累積治療的患者數量超過 13 萬名，其中包括這位年輕的媽媽。這對我們的組織來說是一個謙卑的里程碑，但儘管我們迄今為止取得了成功，但仍有許多工作要做，我們相信我們正處於對全球多種疾病狀態的患者產生影響的最早階段。我現在將介紹我們三個成長支柱的最新情況，從 VTE 開始，我們認為僅在美國就代表了 60 億美元的 TAM。

Our growth strategy in VTE. continues to focus on commercial expansion, market development high quality, clinical evidence and continuous innovation. Commercially, we remain committed to our high-touch approach. We continue to split territories, adding reps selectively at a measured pace in areas with the greatest need. Given our high level of national account penetration. As the pace of new territory adds continues to moderate, we've started to see some nice corresponding productivity gains.

我們在 VTE 領域的成長策略。繼續專注於商業擴張、高品質的市場開發、臨床證據和持續創新。在商業上，我們仍然致力於我們的高接觸方式。我們繼續劃分區域，並有選擇地在最需要的區域增加代表。鑑於我們的國民帳滲透率很高。隨著新領域增加的步伐繼續放緩，我們開始看到一些相應的生產力的良好提高。

Looking ahead, we remain confident ability of our world-class commercial team, the largest VTE. focused sales force in the industry to drive significant growth. Turning to market development, we're increasing penetration within existing accounts VIVTE. excellence, our comprehensive market development program, VT. excellence is a series of playbooks and activities that we systematically execute to help support hospitals and the development of VTE. programs.

展望未來，我們對我們世界一流的商業團隊、最大的VTE的能力仍然充滿信心。集中銷售力量推動產業顯著成長。談到市場開發，我們正在提高現有 VIVTE 帳戶的滲透率。卓越，我們全面的市場開發計劃，VT。卓越是我們系統地執行的一系列行動手冊和活動，旨在幫助支持醫院和 VTE 的發展。程式。

The goal is analogous to the programs have been created in stroke, semi and Teva as we execute BT. BT excellence, our penetration into the TAM at the account level increases, and we are encouraged by the progress we are making today. In many of our most advanced accounts, we're now seeing TAM penetration rates above 50% most importantly, we believe VT. excellence is scalable and repeatable. On the clinical evidence front, we remain steadfast in our commitment to produce the highest quality clinical data to drive awareness and ultimately change the standard of care and VTE.

目標類似於我們執行 BT 時在中風、半和 Teva 中創建的程序。BT 卓越，我們在帳戶層級對 TAM 的滲透不斷增加，我們對今天所取得的進展感到鼓舞。在我們許多最先進的帳戶中，我們現在看到 TAM 滲透率超過 50%，最重要的是，我們相信 VT。卓越是可擴展和可重複的。在臨床證據方面，我們仍然堅定地致力於提供最高品質的臨床數據，以提高意識並最終改變護理和靜脈血栓栓塞的標準。

This commitment is reflected in the significant progress we continue to make across all three of our randomized controlled trials in fact, we just completed patient enrollment for Peerless, our trial randomizing FlowTriever to catheter directed thrombolysis. We were able to fully enroll this study in just over two years, a considerably faster pace than other currently enrolling RCTs. We look forward to the data readout in the second half of 2020 for enrollment for Defiance and privileged to are also tracking in line with our expectations currently across the industry, there are no fewer than seven actively enrolling RCTs each studying different aspects of VTE.

這項承諾體現在我們在所有三個隨機對照試驗中繼續取得的重大進展。事實上，我們剛剛完成了 Peerless 的患者入組，我們的試驗將 FlowTriever 隨機分配到導管定向溶栓治療。我們在短短兩年多的時間裡就完全完成了這項研究的招募，比目前其他招募的隨機對照試驗的速度要快得多。我們期待在 2020 年下半年公佈 Defiance 的註冊數據，並且很榮幸能夠按照我們目前整個行業的預期進行跟踪，有不少於 7 個積極註冊的隨機對照試驗，每個試驗都研究 VTE 的不同方面。

This represents an exciting new era of investment and shared commitment to change the standard of care for this huge underserved group of patients, but make no mistake, Inari continues to be the clear leader in this effort. Taken together we will study over 2000 patients in our three RCT.s more than those conducted by all other sponsors combined. We believe this high-quality clinical evidence will ultimately enable us to treat a significant portion of the 700,000 U.S. patients suffering from BTY. each year. Finally, we continue to innovate across our best-in-class toolkits to protect and extend our leadership position.

這代表著一個令人興奮的新時代的投資和共同承諾，以改變這一龐大的服務不足的患者群體的護理標準，但毫無疑問，伊納裡仍然是這項努力的明顯領導者。總的來說，我們將在三個 RCT 中研究超過 2000 名患者，這比所有其他申辦者進行的研究總和還要多。我們相信，這些高品質的臨床證據最終將使我們能夠治療美國 70 萬名 BTY 患者中的很大一部分。每年。最後，我們繼續在一流的工具包中進行創新，以保護和擴大我們的領導地位。

Over the past 12 months, we commercialized multiple new products to augment our VTE. franchise, including T 16 curve, FlowTriever XL and clot Super Bowl Gen two FlowTriever and client server systems, our fourth and third generation platforms, respectively, benefiting from six years of continuous iteration and improvement. However, we remain committed to further innovation within VTE. Next, I'll provide some updates across our portfolio of emerging therapies.

在過去 12 個月中，我們將多種新產品商業化，以增強我們的 VTE。特許經營權，包括 T 16 curve、FlowTriever XL 和 clot Super Bowl Gen 2 FlowTriever 和客戶端伺服器系統，分別是我們的第四代和第三代平台，受益於六年的不斷迭代和改進。然而，我們仍致力於 VTE 內的進一步創新。接下來，我將提供我們新興療法組合的一些更新。

Our second growth pillar. The segment consists of four distinct patient populations outside of VTE., where we have identified an unmet need we believe we can address by leveraging our core competencies taken together. We believe these markets represent a $4 billion TAM in the U.S. alone, and we're just getting started in each beginning with chronic venous disease. We continue to be encouraged by the initial commercial traction of Revascor, the first mechanical thrombectomy device to treat venous stent thrombosis between incidence and prevalence pools. We believe the addressable market for our core totals nearly 50,000 patients, representing a $500 million U.S. TAM.

我們的第二個成長支柱。該細分市場由 VTE 以外的四個不同患者群體組成，我們已經確定了未滿足的需求，我們相信我們可以透過綜合利用我們的核心能力來解決這一需求。我們相信這些市場僅在美國就代表了 40 億美元的 TAM，而我們在慢性靜脈疾病方面才剛開始。我們繼續對 Revascor 的最初商業吸引力感到鼓舞，Revascor 是第一個用於治療發病率和盛行率之間的靜脈支架血栓的機械血栓切除設備。我們相信我們核心的潛在市場總數接近 50,000 名患者，相當於 5 億美元。塔姆。

Looking ahead in 2024, we plan to launch the second purpose built tool within the CBD toolkit, further augmenting our portfolio and unlocking another portion of this significant TAM. Turning to dialysis access management, enteral continues to build commercial traction over the past several quarters and thrills of thrombectomy system designed for small vessels, including AV fistulas and veins in the upper extremities and below the knee. The combined total addressable market is 250,000 procedures per year in the U.S., representing an incremental $1 billion market opportunity.

展望 2024 年，我們計劃在 CBD 工具包中推出第二個專用工具，進一步擴大我們的產品組合併解鎖這一重要 TAM 的另一部分。轉向透析通路管理，腸內治療在過去幾個季度中繼續建立商業吸引力，並為小血管（包括上肢和膝蓋以下的動靜脈瘻管和靜脈）設計的血栓切除系統帶來興奮。美國每年的潛在市場總計為 25 萬例手術，這代表著 10 億美元的增量市場機會。

Turning to CLTI. Since closing, the Limpopo acquisition in mid-November, we've made important progress and beginning to integrate the business into Inari. While also executing early US launch. We have successfully established the initial employee organization through a combination of Linde flow and in our personnel and a small number of external hires, we've undertaken important work to stabilize and build capacity across the supply chain, while also beginning to integrate Corporate Support Services commercially, the US launch is proceeding in line with our expectations.

轉向 CLTI。自 11 月中旬完成林波波收購以來，我們取得了重要進展，並開始將業務整合到 Inari 中。同時也執行早期美國發布。我們透過林德流程的結合，成功建立了最初的員工組織，在我們的人員和少量外部員工中，我們開展了穩定和建立整個供應鏈能力的重要工作，同時也開始整合企業支援服務在商業上，美國的發布進展符合我們的預期。

We are successfully navigating back approvals and the completed initial series of commercial cases. We held our first training summit in late January and had great engagement and feedback from the event. We anticipate building momentum throughout the year, highlighted by incremental reimbursement via an endcap, which would go into effect in October. Taken together, we continue to view 2024 as a foundational year focused on physician training that approvals, thoughtful patient selection and deliberate wound care.Follow-up landfill offers New Hope and new options to the 55,000 no option CLTI. patients. We are encouraged by the progress we've made to date and accessing this $1.5 billion U.S. TAM.

我們正在成功地返回審批並完成初始系列商業案例。我們在一月下旬舉辦了第一次培訓高峰會，這次活動獲得了很高的參與和回饋。我們預計全年都會形成勢頭，特別是透過將於 10 月生效的結束上限進行增量報銷。總而言之，我們繼續將 2024 年視為基礎年，重點關注醫生培訓、批准、深思熟慮的患者選擇和深思熟慮的傷口護理。後續垃圾掩埋場為 55,000 名無選擇的 CLTI 提供了新希望和新選擇。患者。我們對迄今為止所取得的進展以及獲得這 15 億美元的資金感到鼓舞。塔姆。

Our last emerging therapies category is acute liver ischemia, a $600 billion U.S. TAM characterized by tremendous unmet needs and a lack of purpose-built tools. In fact, roughly 50% of ALI. patients today must undergo an open surgical procedure to successfully remove their clot. We remain committed to better outcomes for these patients and continue working to bring our second generation Rx system to market later in 2024. Finally, I would like to discuss our third pillar International. In Q4, we continued to see strong growth led first and foremost by our European franchise. Alongside Europe, we continued to gain incremental product approvals and are now commercial in over 30 countries globally.

我們最後一個新興療法類別是急性肝缺血，這是一個價值 6000 億美元的美國 TAM，其特徵是巨大的未滿足需求和缺乏專用工具。事實上，大約 50% 是 ALI。如今，患者必須接受開放式手術才能成功去除血栓。我們仍然致力於為這些患者提供更好的治療結果，並繼續努力在 2024 年稍後將我們的第二代 Rx 系統推向市場。最後，我想談談我們的第三個支柱——國際。在第四季度，我們繼續看到強勁的成長，這首先是我們的歐洲特許經營所帶動的。與歐洲一起，我們繼續獲得增量產品批准，目前已在全球 30 多個國家/地區投入商用。

Overall, international revenue was nearly 8 million in Q4, up more than 100, 30% versus the prior year. Looking forward, we recently received favorable incremental reimbursement in France. Also, we remain on track to treat patients in both China and Japan this year on a commercial basis, while international sales are just 5% of our total revenue today, given the spectacular unmet need and the investment we've made in establishing our international commercial footprint, we expect international sales to account for at least 20% of revenue over time. In closing, we're pleased with how the business performed in Q4 and 2023. For the year, we generated record revenue and strong growth of nearly 30%, driven by crisp execution across our growth pillars.

整體而言，第四季國際營收接近 800 萬美元，年增 100 多倍，成長 30%。展望未來，我們最近在法國收到了有利的增量報銷。此外，我們今年仍有望在商業基礎上治療中國和日本的患者，而考慮到巨大的未滿足需求以及我們在建立國際化業務方面所進行的投資，國際銷售額僅占我們今天總收入的5% 。隨著時間的推移，我們預計國際銷售額將至少佔收入的 20%。最後，我們對該業務在第四季和 2023 年的表現感到滿意。今年，在我們成長支柱的清晰執行的推動下，我們創造了創紀錄的收入和近 30% 的強勁成長。

Our field team continued to drive patients toward frontline treatment with our therapies while working to support the development of VT. programs, we announced our third RCT and build meaningful momentum across new product launches, and we saw another record quarter and strong growth from our international business. In addition, we laid the foundation for strong sustained revenue growth. The expansion of our purpose still toolkits into new disease states with significant unmet need.

我們的現場團隊繼續利用我們的療法推動患者接受第一線治療，同時努力支持 VT 的發展。計劃中，我們宣布了第三個 RCT，並在新產品發布中建立了有意義的勢頭，我們看到了另一個創紀錄的季度和國際業務的強勁增長。此外，我們也為營收的強勁持續成長奠定了基礎。我們的目標仍然是將工具包擴展到具有重大未滿足需求的新疾病狀態。

We also announced closed and began to integrate Linde flow our first acquisition. Finally, we delivered meaningful operating leverage while continuing to invest in burgeoning parts of the business going forward. I've never been more confident in the health of our business and our ability to generate meaningful revenue growth across our three growth pillars in 2024 and for many years to come. With that, I'll now turn the call over to Mitch.

我們也宣布結束並開始整合林德流我們的第一次收購。最後，我們提供了有意義的營運槓桿，同時繼續投資於未來業務的新興部分。我對我們業務的健康狀況以及我們在 2024 年和未來許多年在三大成長支柱上實現有意義的收入成長的能力充滿信心。這樣，我現在會把電話轉給米奇。

Thanks, Drew. Before I begin, I want to share additional color on the revenue breakout. Drew described, we're pleased to be introducing additional visibility to our growth pillars by sharing the revenue contributions of our VTE. and our emerging therapies products. VT. includes sales of the entire class Trevor and FlowTriever product families globally. Emerging therapies includes our portfolio of products addressing on a global basis chronic venous disease, dialysis access management, chronic winter and into Scania and acute limb ischemia.

謝謝，德魯。在開始之前，我想分享更多有關收入突破的資訊。Drew 表示，我們很高興透過分享 VTE 的收入貢獻來提高我們的成長支柱的可見度。以及我們的新興療法產品。VT。包括整個 Trevor 和 FlowTriever 產品系列在全球的銷售情況。新興療法包括我們在全球範圍內解決慢性靜脈疾病、透析通道管理、慢性冬季和斯堪尼亞以及急性肢體缺血的產品組合。

In our press release, we have provided quarterly historical revenue for these growth pillars going back to the start of 2022 to provide a sense of the strong growth and adoption we are seeing in all areas of the business. Please note that we will also continue to provide US and international revenue splits as we have done historically Turning to the fourth quarter and full year 2023 results. I know revenue in the fourth quarter of 2023 was $132.1 million, up 23% over the same period of the prior year. On a year-over-year basis, VT. drove more than 85% of the growth and emerging therapies accounted for roughly 15% of the growth. Gross margin was 87.1% for the fourth quarter of 2023 compared with 87.8% in the prior year period.

在我們的新聞稿中，我們提供了自 2022 年初以來這些成長支柱的季度歷史收入，以讓我們了解我們在所有業務領域看到的強勁成長和採用情況。請注意，我們也將繼續提供美國和國際收入分成，就像我們歷史上所做的那樣。轉向 2023 年第四季和全年業績。據我所知，2023年第四季的營收為1.321億美元，比上年同期成長23%。與去年同期相比，VT。推動了超過 85% 的成長，新興療法約佔成長的 15%。2023 年第四季毛利率為 87.1%，去年同期毛利率為 87.8%。

Operating expenses were $124.4 million in the fourth quarter 2023 compared with $100.5 million for the same period of the prior year. R&d expense was $22.9 million in the fourth quarter of 2023, up 12% compared with $20.4 million for the same period of 2022. The increase in R&D expense was primarily due to increases in professional fees and clinical and regulatory expenses. Sg&a expense was $101.5 million in fourth quarter 2023, up 27% compared with 80.1 million for the same period prior year. The increase in SG&A expense was primarily due to increases in personnel-related expenses from increased headcount, increased commissions due to higher revenue and professional fees, which are primarily attributable to the acquisition of lymphoma.

2023 年第四季營運費用為 1.244 億美元，去年同期營運費用為 1.005 億美元。2023年第四季研發費用為2,290萬美元，較2022年同期的2,040萬美元成長12%。研發費用的增加主要是由於專業費用以及臨床和監管費用的增加。2023 年第四季的銷售、管理及行政費用為 1.015 億美元，較上年同期的 8,010 萬美元成長 27%。SG&A 費用的增加主要是由於員工人數增加導致的人員相關費用增加、收入增加導致的佣金增加和專業費用的增加，這主要歸因於淋巴瘤的收購。

Also in December 2023, we received a civil investigative demand from the Department of Justice requesting information primarily related to meals and consulting service payments provided to healthcare professionals. We are cooperating with this investigation going forward. Legal and associated expert expenses related to this matter will be recorded in our SG&A expense. And I recorded a GAAP operating loss of $9.3 million in the fourth quarter of 2023 compared with a GAAP operating loss of $5.9 million for the same period in the prior year. On a non-GAAP basis, which excludes acquisition related expenses and acquired intangible asset amortization.

同樣是在 2023 年 12 月，我們收到了司法部的民事調查要求，要求提供主要與向醫療保健專業人員提供的膳食和諮詢服務付款相關的資訊。我們正在配合這項調查的進展。與此事相關的法律和相關專家費用將記錄在我們的銷售、管理和行政費用中。我記錄的 2023 年第四季 GAAP 營運虧損為 930 萬美元，而去年同期的 GAAP 營運虧損為 590 萬美元。以非公認會計原則計算，不包括收購相關費用和收購的無形資產攤銷。

Fourth quarter operating loss was just 300,000. There were no non-GAAP adjustments related to our 2022 operating loss. Net loss for the fourth quarter of 2023 was $4.7 million compared to a net loss of $5.8 million for the same period of the prior year. The basic and fully diluted diluted net loss per share for the fourth quarter of 2023 was $0.08 based on the weighted average basic and fully diluted share count of $57.6 million. This compares with a basic and fully diluted net loss per share of $0.11 based on a weighted average basic and fully diluted share count of $53.6 million for the same period of the prior year.

第四季營業虧損僅30萬。沒有與我們 2022 年經營虧損相關的非 GAAP 調整。2023 年第四季淨虧損為 470 萬美元，而去年同期淨虧損為 580 萬美元。根據加權平均基本和完全稀釋股數 5,760 萬美元計算，2023 年第四季基本和完全稀釋每股攤薄淨虧損為 0.08 美元。相比之下，根據上年同期加權平均基本和完全稀釋股數 5,360 萬美元計算，基本和完全稀釋每股淨虧損為 0.11 美元。

Shifting to full year 2023 results, we reported revenue of $493.6 million, up 29% over the prior year. P/t accounted for over 85% of the growth, while emerging therapies contributed nearly 15% on a year-over-year basis, gross margin was 88% for the full year 2023 compared to 88.4% for the full year 2022. Operating expenses were $448.6 million for the full year 2023, up 22% compared with $367.1 million for the full year 2022, including one-time expenses related to the Winslow acquisition.

轉向 2023 年全年業績，我們報告營收為 4.936 億美元，比上一年增長 29%。P/t 貢獻了超過 85% 的成長，而新興療法較去年同期貢獻了近 15%，2023 年全年毛利率為 88%，而 2022 年全年毛利率為 88.4%。2023 年全年營運費用為 4.486 億美元，較 2022 年全年 3.671 億美元成長 22%，其中包括與 Winslow 收購相關的一次性費用。

R&d expense was $87.5 million for the full year 2023, up 18% compared with $74.2 million for the full year 2022. The increase in R&D expense was primarily due to increases in personnel related expenses, materials and supplies, clinical and regulatory expenses and software costs and depreciation in support of our growth pillars. Sg&a expense was $361.1 million for the full year 2023, up 23% compared with $292.8 million for the full year 2022. The increase in SG&A expense was primarily due to increases in personnel-related expenses and professional fees, largely associated with the acquisition of lymphoma.

2023 年全年研發費用為 8,750 萬美元，較 2022 年全年的 7,420 萬美元成長 18%。研發費用的增加主要是由於人員相關費用、材料和用品、臨床和監管費用以及軟體成本和折舊的增加，以支持我們的成長支柱。2023 年全年的銷售、管理及行政費用為 3.611 億美元，比 2022 年全年的 2.928 億美元成長 23%。SG&A 費用的增加主要是由於人員相關費用和專業費用的增加，主要與淋巴瘤的獲得有關。

Gaap operating loss was $14 million for the full year 2023 compared with $28.1 million for the full year 2022. On a non-GAAP basis, which excludes acquisition-related expenses and amortization of acquired intangible assets. Operating loss was $2.4 million for the full year 2023. There were no non-GAAP adjustments related to our 2022 operating loss. Net loss for the full year 2023 was $1.6 million compared to a net loss of $29.3 million for the full year 2022 basic and fully diluted net loss per share for the full year 2023 was $0.03 based on a weighted average basic and fully diluted share count of 56.8 million. These compared with a basic and fully diluted net loss per share of $0.55 based on a weighted average basic and fully diluted share count of $52.8 million for the full year 2022.

2023 年全年公認的會計原則營運虧損為 1,400 萬美元，而 2022 年全年的營運虧損為 2,810 萬美元。以非公認會計原則計算，不包括收購相關費用及所收購無形資產的攤銷。2023 年全年營運虧損為 240 萬美元。沒有與我們 2022 年經營虧損相關的非 GAAP 調整。2023 年全年淨虧損為 160 萬美元，而 2022 年全年淨虧損為 2,930 萬美元 根據加權平均基本和完全稀釋股數計算，2023 年全年基本和完全稀釋每股淨虧損為 0.03 美元5680萬。相比之下，基於 2022 年全年加權平均基本和完全稀釋股數 5,280 萬美元，基本和完全稀釋每股淨虧損為 0.55 美元。

Moving on to the balance sheet, our cash and investments at the end of the fourth quarter totaled $116.1 million. Our cash flows provided by operating activities were $35.9 million in 2023 compared to cash flows used in operating activities of $14 million in 2022 Turning to our 2024 outlook, we are reiterating our full year 2024 revenue guidance of 580 to $595 million for effect, reflecting growth of approximately 17.5% to 20.5% over 2023. Our guidance reflects contributions across all three of our growth pillars VTE. for emerging therapies and international for lymphoma. We continue to view 2024 as a foundational year and expect a modest revenue contribution. We currently anticipate sequential revenue growth of approximately 4% for Q1 2024 relative to Q4 of 2023 for 2024.

轉向資產負債表，第四季末我們的現金和投資總額為 1.161 億美元。2023 年我們經營活動提供的現金流為3,590 萬美元，而2022 年經營活動使用的現金流為1,400 萬美元。談到2024 年展望，我們重申2024 年全年收入指引為580 至5.95 億美元，反映了成長2023 年將成長約 17.5% 至 20.5%。我們的指導反映了我們所有三個成長支柱 VTE 的貢獻。新興療法和國際淋巴瘤。我們仍將 2024 年視為基礎年，並預期營收貢獻不大。我們目前預計 2024 年第一季的營收將較 2023 年第四季成長約 4%。

From a phasing perspective, we expect strong revenue growth momentum in the back half of the year. Turning to profitability, we are continuing to invest in our growth pillars while positioning the business to achieve sustained operating profitability. In 2024, we expect to see greater operating losses in the first half of the year than in the second half of the year. And as we shared earlier in the year, we continue to forecast reaching sustained operating profitability on a consolidated basis in the first half of 2025.

從階段性角度來看，我們預期下半年營收成長動能強勁。談到獲利能力，我們將繼續投資於我們的成長支柱，同時定位業務以實現持續的營運獲利能力。2024年，我們預計上半年的營運虧損將大於下半年。正如我們今年稍早分享的那樣，我們繼續預測 2025 年上半年將實現持續的綜合營運獲利。

With that, I'll turn the call back to the moderator for questions for the Q&A segment. Drew, John and I will be joined by Dr. Thomas Tu, Inari's Chief Medical Officer. We will now begin the question and answer session to ask a question.

這樣，我會將電話轉回給主持人，詢問問答環節的問題。德魯、約翰和我以及 Inari 首席醫療官 Thomas Tu 博士也將加入。我們現在開始問答環節來提問。

(Operator Instructions) Travis Steed, Bank of America.

（操作員指示）Travis Steed，美國銀行。

Hey, thanks for taking the question. I wanted to ask about the DOJ investigation. You did you mention which I guess was the question I'd have on that is I know how broad is the investigation. When does it start? What are the next steps? How long you expect it to last? And do you expect it to have any impact on customers or revenue and 24?

嘿，謝謝你提出問題。我想詢問司法部的調查情況。你有沒有提到我想我要問的問題是我知道調查的範圍有多大。什麼時候開始？什麼是下一個步驟？你預計它能持續多久？您預計這會對客戶或收入產生任何影響嗎？24？

Yes. Thanks for the question, Travis. This is Drew. I can get started on that. So as you likely understand from some of the precedent examples of other companies navigating the same waters. We're not going to have a lot of additional background. We can be able to share beyond what's in the disclosure we got the CIDI. back in December. And so it's still relatively early on. We are cooperating with the DOJ. We take compliance seriously today. We always have that every step of our commercial activity here in the US going back to 2018.

是的。謝謝你的提問，崔維斯。這是德魯。我可以開始做這件事。正如您可能從其他公司在同一水域航行的先例中了解到的那樣。我們不會有太多額外的背景。我們可以分享 CIDI 揭露內容以外的內容。回到十二月。所以現在還相對較早。我們正在與司法部合作。今天，我們認真對待合規性。自 2018 年以來，我們在美國商業活動的每一步都始終如此。

And we do not expect that this will have any impact on our ability to execute commercially on the focus of the CID. As described in the 10 K. It's a couple of very specific areas related to health care, professional relationships, some going forward. We'll update you as we can. But again, based on the precedent, I think the time line is most likely going to be measured in years as opposed to two months and quarters.

我們預計這不會對我們以 CID 為重點的商業執行能力產生任何影響。正如 10 K 中所描述的。這是與醫療保健、職業關係以及一些未來相關的幾個非常具體的領域。我們會盡力向您通報最新情況。但同樣，根據先例，我認為時間線很可能以年為單位，而不是兩個月和幾季。

Okay. Thanks for that. And then a question on the 24 guidance. I'm curious how you're seeing the core and that 17.5% to 20.5% guide when you look at the core for 2023, it was around 25%. So just curious why you're assuming, but just for the slowdown in the core business and 24 if it's just conservatism or anything else you'd call out on that?

好的。感謝那。然後是關於24指導的問題。我很好奇你如何看待核心，當你查看 2023 年的核心時，17.5% 到 20.5% 的指導值約為 25%。所以只是好奇你為什麼這麼假設，但只是為了核心業務的放緩和24，如果這只是保守主義或其他你會呼籲的東西？

Yes. I think in general, I'd probably start with reiterating what our philosophy is around guidance. And, you know, historically when we put out a number, we want to be highly confident in being able to deliver on that number. That's been our historical practice since that was certainly consistent with how we approach guidance here last month for 2024, we feel really good, very comfortable and confident in that guidance range of five 80 to 5 95. And that factors growth in across all three of our growth pillars. Certainly VTE. will be the majority of the growth and the revenue still in 2024.

是的。我認為總的來說，我可能會先重申我們圍繞指導的理念。而且，你知道，從歷史上看，當我們公佈一個數字時，我們希望對能夠實現該數字充滿信心。這是我們的歷史慣例，因為這肯定與我們上個月制定的 2024 年指導方針一致，我們對 5 80 到 5 95 的指導範圍感覺非常好、非常舒服和充滿信心。這也是我們所有三個成長支柱的成長因素。當然是靜脈血栓栓塞。到 2024 年，這仍將是成長的主要部分和收入。

We anticipate continued strong growth there from commercial expansion from taking share from a lytic based interventions from TAM expansion via market development efforts, new data innovation, all of that factored into the anticipated growth in the VTE., our pillar, emerging therapies, we're factoring in growth across all four of those new patient populations that we're beginning to do work in on certainly continued traction in CBD on enteral on new products coming out with Artix. And as you've heard us describe a modest contribution from wind flow.

我們預計，該領域的持續強勁成長將來自於商業擴張、從基於裂解的干預措施中獲取份額、來自TAM 擴張、市場開發工作、新數據創新，所有這些都影響了VTE 的預期成長。我們的支柱、新興療法，我們」重新考慮我們開始研究的所有四個新患者群體的增長，這肯定會持續吸引 CBD 對 Artix 推出的新產品的腸內治療。正如您所聽到的，我們描述了風流的微小貢獻。

And then finally, we're factoring in continued growth and strength internationally led first and foremost by Europe, but also factoring in contributions from from some of the other geographies as well. So we'll have an opportunity to discuss guidance again here in 60 days or so on the formal Q1 call. But in the meantime, we're going to continue to focus on execution and that we've always taken great pride in.

最後，我們考慮了首先由歐洲主導的國際持續成長和實力，但也考慮了其他一些地區的貢獻。因此，我們將有機會在 60 天左右的正式第一季電話會議上再次討論指導意見。但同時，我們將繼續專注於執行力，我們一直對此感到非常自豪。

Adam Maeder, Piper Sandler.

亞當梅德，派珀桑德勒。

Hi, good afternoon and thank you for taking the questions. I wanted to start with a Q4 question and apologies for the granularity with great granularity here, but I was hoping you could give us some color on Q4 in terms of kind of how that played out in terms of monthly progression and commercial momentum. Your competitor is talking about a pickup in their business in Q4, I think in the late November timeframe. I'm wondering if you have any reaction to that comment. And then just any early commentary that you can give us on your business thus far year to date and in Q1? Thank you.

您好，下午好，感謝您提出問題。我想從第四季度的問題開始，並對這裡的詳細程度表示歉意，但我希望您能為我們提供有關第四季度的一些信息，說明其在每月進展和商業勢頭方面的表現。你的競爭對手正在談論他們的業務在第四季度的回升，我認為是在 11 月下旬的時間範圍內。我想知道你對此評論有何反應。那麼您可以就今年迄今為止和第一季的業務向我們提供任何早期評論嗎？謝謝。

Yes. Thanks for that. And so we saw a nice momentum building in Q4, particularly in the tail end of the quarter. And we saw that momentum carry over here into the beginning of this year. As you know, we don't normally provide detailed intra quarter commentary. But what I can tell you is that that momentum did carry over nicely into the beginning of this year. A January was a step up actually a nice step up from what we saw in December, and that momentum has continued here.

是的。感謝那。因此，我們在第四季度看到了良好的勢頭，特別是在季度末。我們看到這種勢頭一直持續到今年年初。如您所知，我們通常不提供詳細的季度內評論。但我可以告訴你的是，這種勢頭確實很好地延續到了今年年初。一月份實際上是我們在 12 月看到的一個很好的進步，而且這種勢頭在這裡一直持續著。

So taken together, we're feeling really good about how we're positioned here at the beginning of the year. We like the plan. The team is executing really crisply really consistently are seeing nice growth across all three of those growth pillars. And looking ahead from here, we see some really nice catalysts shaping up for the remainder of the year across those pillars, new territories and new data driving continued traction in VTE. on new products and new markets that we'll be getting started in with emerging therapies, contributions from Linde flow along the way there as well on.

總而言之，我們對今年年初的定位感覺非常好。我們喜歡這個計劃。團隊執行得非常清晰，始終如一，在所有三個成長支柱上都看到了良好的成長。展望未來，我們看到在今年剩餘時間裡，這些支柱、新領域和新數據將形成一些非常好的催化劑，推動 VTE 的持續發展。在我們將開始使用新興療法的新產品和新市場上，林德的貢獻也不斷出現。

And obviously some nice traction continuing internationally with Europe leading the way more geographies are contributing more meaningful ways and still on track in both China and Japan for treating patients in those two markets. So so far so good. We're feeling very confident in our position here and not only in Q1, but as we look out from here through the remainder of the year.

顯然，國際上繼續存在一些良好的吸引力，歐洲處於領先地位，更多地區正在貢獻更有意義的方式，並且在中國和日本這兩個市場的患者治療方面仍處於正軌。到目前為止一切順利。我們對自己的地位非常有信心，不僅在第一季度，而且從這裡展望今年剩餘時間。

Thanks for the color there, Drew. And I guess for the follow up or I'll ask the question on competition as it relates to 2024, it the last Travis was asking about your outlook for 24, but was curious kind of what you're baking in from a competition standpoint, competitive standpoint for your guidance in 24, both from your primary competitor and then any new market entrants on the DBTDBT. side of things. Thanks for taking the questions.

謝謝你的顏色，德魯。我想在後續行動中，或者我會問與 2024 年相關的競爭問題，特拉維斯最後一次詢問你對 24 的展望，但很好奇你從競爭的角度來看會做什麼， 24 中您的指導的競爭立場，包括來自您的主要競爭對手以及DBTDBT 上的任何新市場進入者。事情的一面。感謝您提出問題。

Yes. So competition and competitive dynamics are clearly incorporated into our guidance. This is an attractive market. We are going to see competitive entrants become active in this market. Keep in mind, it's a $6 billion market, 6% penetrated. Our focus primarily historically and today remains on market growth and making the investments we believe are necessary to change the standard of care for this patient population. That's where we have focused on training, education and innovation, high quality evidence all those areas you've heard us describe before, all of them designed to drive market growth.

是的。因此，競爭和競爭動態已明確納入我們的指導中。這是一個有吸引力的市場。我們將看到有競爭力的進入者在這個市場上變得活躍。請記住，這是一個 60 億美元的市場，滲透率為 6%。我們過去和現在的重點仍然是市場成長，並進行我們認為改變該患者群體護理標準所需的投資。這就是我們專注於培訓、教育和創新的領域，以及您之前聽我們描述過的所有這些領域的高品質證據，所有這些都是為了推動市場成長。

That's where the real opportunity is, how we're going to see competitive entrants. We factor that into our guidance, and we started 2023 as the clear market leader. We exited 2023 as the clear market leader, and we would absolutely expect to continue to be the market leader in 2024. That confidence and leadership comes from the performance of our products as the undisputed. So solid clinical data that we have, the new innovation the way our team is executing. All that gives us confidence.

這就是真正的機會所在，我們將如何看到有競爭力的進入者。我們將這一點納入我們的指導方針，並從 2023 年開始成為明確的市場領導者。2023 年，我們以明顯的市場領導者身份退出，我們絕對期望在 2024 年繼續成為市場領導者。這種信心和領導力來自於我們產品無可爭議的表現。我們擁有如此可靠的臨床數據，我們團隊執行新創新的方式。這一切都給了我們信心。

We're going to continue to be the leader in this market, and that is despite what will undoubtedly be new entrants maybe the last point I'd make is to the extent we do have new entrants that can help participate in the market development work. That's obviously going to be constructive for everyone and ultimately constructive for patients.

我們將繼續成為這個市場的領導者，儘管毫無疑問將是新進者，也許我要說的最後一點是，我們確實有新進業者可以幫助參與市場開發工作。這顯然對每個人都有建設性，最終對病人也有建設性。

Kallum, Titchmarsh, Morgan Stanley.

卡勒姆、蒂奇馬什、摩根士丹利。

Please go ahead because I'm taking the question, I think one for Mitch here. But just on the gross margin side, I think 87.1% in the fourth quarter was a bit below where the Street was. I'm just keen to understand how we should be thinking about the setup for this in 2024? And maybe just some color on how you expect gross margins to trend longer term with these emerging products coming for I guess, are you still comfortable remaining in that mid to high 80% range longer term and for long term?

請繼續，因為我正在回答這個問題，我想這是給米奇的。但就毛利率而言，我認為第四季的 87.1% 略低於華爾街的水平。我只是想知道我們應該如何考慮 2024 年的設定？也許只是關於您預計隨著這些新興產品的出現，毛利率將如何長期發展的一些顏色，我猜，您是否仍然願意長期保持在 80% 的中高水平範圍內？

Thanks for the question, Salim. And in terms of the Q4 gross margin, we saw some impact from the acquisition. There's a portion of the gross margin decline that related to the Linde flow acquisition, even though that was just in the picture for about 45 days. We continue to see some margin impact due to the internationalization of the business as well as the new some of the emerging therapy products have a lower gross margin profile and then the kind of the key products that we've historically been selling.

謝謝你的提問，薩利姆。就第四季的毛利率而言，我們看到了收購帶來的一些影響。毛利率下降的一部分與林德流收購有關，儘管這種情況只出現了大約 45 天。由於業務的國際化以及一些新的新興治療產品的毛利率較低，以及我們歷史上一直在銷售的關鍵產品的類型，我們繼續看到一些利潤率影響。

So that's kind of a couple of different factors that affected the change in gross margin from Q3 to Q4. As we think about the gross margin in 2024, I would say we're going to likely have another quarter or so of margin kind of in the low 87% range. And then we probably actually look for some margin pickup in the second half of the year. And then longer term, we've messaged we still feel confident in our messaging about the gross margin kind of in the mid 80s. And there's a lot of different factors that kind of go into the stool when we put that together. But the overall we think this business has a premium gross margin profile.

因此，有幾個不同的因素影響了第三季到第四季毛利率的變化。當我們考慮 2024 年的毛利率時，我想說我們可能還會有四分之一左右的時間毛利率處於 87% 的低水平。然後我們實際上可能會在下半年尋求利潤率的回升。從長遠來看，我們仍然對 80 年代中期的毛利率充滿信心。當我們把它們放在一起時，糞便中會包含許多不同的因素。但整體而言，我們認為該業務的毛利率較高。

We expect it'll continue to have that. We've kind of accounted for all the different factors in there as we kind of forecast that mid 80s percent gross margin over time.

我們預計它將繼續如此。我們已經考慮了其中的所有不同因素，因為我們預測隨著時間的推移，毛利率將達到 80% 左右。

Great. Thanks a lot.

偉大的。多謝。

Lawrence, Biegelsen, Wells Fargo.

勞倫斯、比格森、富國銀行。

Yes, good afternoon. Thanks for taking the question. Drew, historically, you've said the core USVTE. market was a 20% growth, 20% plus I think growth market. What are you seeing now? And what are your expectations for 2024?

是的，下午好。感謝您提出問題。德魯，從歷史上看，您說過核心的 USVTE。市場成長了 20%，我認為市場成長了 20%。你現在看到了什麼？您對 2024 年有何期望？

Yes. We still see this as a massive market in the earliest stages of penetration, and we're making the investments to drive that market growth. And we're continuing to see a very robust backdrop of market growth. We have every expectation that that's going to continue as we look out from here certainly in 2024. So no change in our view of the underlying strength of the market growth, you know, month to month quarter to quarter, there may be fluctuations here and there just given how early we are in penetrating this market. But the trend line is unmistakable. This is a $6 billion market in the earliest phases of transitioning from conservative medical management to front-line therapy with FlowTriever and FlowTriever.

是的。我們仍然認為這是一個處於滲透早期階段的巨大市場，我們正在進行投資來推動該市場的成長。我們繼續看到非常強勁的市場成長背景。展望 2024 年，我們完全期望這種情況會持續下去。因此，我們對市場成長的潛在力量的看法沒有改變，你知道，每個月、每個季度，考慮到我們進入這個市場的時間有多早，可能會出現一些波動。但趨勢線是明確無誤的。這是一個價值 60 億美元的市場，正處於從保守醫療管理過渡到 FlowTriever 和 FlowTriever 一線治療的初始階段。

Thank you. And to help us understand the emerging technology and international lines better, can you talk about what's assumed for Artix and what's assumed for Japan and China. Any color on those those market opportunities and your confidence in Artix the second time around here that you're going to be successful? Thank you.

謝謝。為了幫助我們更好地理解新興技術和國際路線，您能否談談 Artix 的假設以及日本和中國的假設。這些市場機會以及您對 Artix 的第二次成功充滿信心嗎？謝謝。

Yes. So relative to RDX, we've been working almost a back a year and a half now to reset that platform and do the development work. You've heard us describe coming out of the first gen LMR. We've been hard at work. We are cautiously optimistic that we've improved the product in terms of the effectiveness and ease of use that you've heard us describe before. But until we actually execute the LMR, we'll need to be a little cautious about and what kind of contribution we're going to be describing.

是的。因此，相對於 RDX，我們已經花了近一年半的時間來重置該平台並進行開發工作。您已經聽過我們描述第一代 LMR 的誕生。我們一直在努力工作。我們謹慎樂觀地認為，我們已經在您之前聽到我們描述過的有效性和易用性方面改進了產品。但在我們真正執行 LMR 之前，我們需要對我們將要描述的貢獻類型保持謹慎。

We've taken that into account in the guidance. It's a relatively modest component of our guidance as a result. Similarly, with China and Japan, we're confident we're going to be able to treat patients in those two markets this year, but there's some uncertainty around when the exact approvals will take place as well as how quickly the initial ramp will take place. And as a result of those uncertainties. We've also factored in a pretty modest contribution from both China and Japan into the 2024 guidance.

我們已在指南中考慮到這一點。因此，這是我們指導中相對較小的組成部分。同樣，對於中國和日本，我們有信心今年能夠治療這兩個市場的患者，但確切的批准何時以及最初的增長需要多快都存在一些不確定性地方。由於這些不確定性。我們也在 2024 年指導中考慮了中國和日本的相當適度的貢獻。

Marie Thibault, BTIG.

瑪麗蒂博，BTIG。

Am I fair in assuming most of that out of the US all of that out of the US? Or are there some emerging therapy treatments doing being done internationally?

我假設大部分都來自美國，所有這些都來自美國，這樣公平嗎？或者國際上是否正在進行一些新興的治療方法？

Yes, Marie, there's that is primarily US revenue. When we're looking at the emerging therapies so for example, if you look at the table at the back of the press release, those are those are almost exclusively in the US and for the reasons you'd imagine we're in the process of pursuing regulatory approval for many of those products for international markets. I'll be initially focused on Europe and then we'll kind of roll those out into other parts of the world, but we're still kind of going through the process.

是的，瑪麗，這主要是美國的收入。當我們研究新興療法時，例如，如果您查看新聞稿後面的表格，這些療法幾乎完全在美國，並且出於您想像中的原因，我們正在進行這一過程尋求監管部門批准其中許多產品進入國際市場。我最初將專注於歐洲，然後我們將其推廣到世界其他地區，但我們仍在經歷這個過程。

Okay. That's helpful. And then let me ask, I guess a two-part question, largely on cadence and sort of the path to think about this year of cadence for the sales as sales guidance throughout this year, if I'm recalling correctly, you know, Q2 was just a slight sequential step-up from Q1 so I'd like to trying to understand that for modeling purposes. And then similarly, the path to profitability and first half of 25 on operating profitability, what do you need to do kind of operating leverage wise? And what will it get to on to that to that goal?nEmory?

好的。這很有幫助。然後讓我問，我猜是一個由兩部分組成的問題，主要是關於節奏和將今年的銷售節奏視為今年全年銷售指導的路徑，如果我沒記錯的話，你知道，第二季度只是從第一季開始的一個輕微的連續升級，所以我想嘗試理解這一點以用於建模目的。同樣，獲利之路和 25 上半年的營運獲利能力，您需要明智地採取什麼樣的營運槓桿？它將對實現這一目標產生什麼影響？nEmory？

Thanks for the question. In the prepared remarks, I commented on kind of a Q4 target sorry, at a 4% target in terms of sequential growth from Q4 to Q1. As we move into 2025 past couple of years, we've seen some seasonality softness in Q2. We're still not sure about that if that's if that's a real thing in our business or not different reasons and theories around that. But then I did mention in the script that we would expect accelerating revenue sort of in the second half of the year.

謝謝你的提問。在準備好的發言中，我對第四季度的目標進行了評論，抱歉，從第四季度到第一季的環比增長為 4%。過去幾年，隨著我們進入 2025 年，我們在第二季度看到了一些季節性疲軟。我們仍然不確定這是否是我們業務中的真實情況，或者是否有不同的原因和理論。但後來我確實在劇本中提到，我們預計下半年營收會加速成長。

So that would give you a sense for kind of the overall revenue profile from an operating leverage and kind of passive profitability point of view? Glad you asked about that year. And I was just thinking in Q4 in terms of our Q4 numbers, it was 23% revenue growth. Opex grew by 24%.But if we exclude the windfall onetime costs, OpEx grew by 15%.

那麼，這會讓您從營運槓桿和被動獲利的角度了解整體收入狀況嗎？很高興你問起那一年的事。我只是在想，就我們第四季的數據而言，第四季的營收成長了 23%。營運支出成長了 24%。但是如果我們排除意外的一次性成本，營運支出增加了 15%。

So really nice progress there in Q4. And then looking at the full year numbers, revenue growth of 29%, OpEx growth of 22%. And then if we exclude the wind flow one-time stuff about 19%.

第四季的進展非常好。再來看全年數據，營收成長 29%，營運支出成長 22%。然後，如果我們排除風流量一次性的東西，大約是 19%。

So we've taken this challenge of operating leverage seriously as a company. At some point, there's a lot of buy-in across the Company to looking at all the areas of the OpEx spend and making sure that we are seeing some nice productivity of our investments there. That's contributing to our confidence as we think about the progress of the business from a profitability point of view in the first half of 2024 versus the second half of 2024. So less basically operating losses as we move through the course of the year and then moving towards sustained operating profitability in the first half of 2025.

因此，作為一家公司，我們認真看待經營槓桿的挑戰。在某些時候，整個公司都會對營運支出支出的所有領域進行大量的支持，並確保我們在那裡的投資取得了良好的生產力。當我們從獲利能力的角度思考 2024 年上半年與 2024 年下半年的業務進展時，這增強了我們的信心。因此，隨著這一年的進展，我們的營運虧損基本上會減少，然後在 2025 年上半年實現持續的營運獲利。

Will Plovanic, Canaccord.

威爾·普洛瓦尼奇，卡納科德。

Hi, Bill. Are you there.

嗨，比爾。你在嗎。

Yes, Amir, thanks for taking my questions. I'll start off with. Can you help us understand just any commentary regarding competitive trialing share gain was? Where are you seeing the biggest impact DVTPE. I think as we look at these number on the VTE. business, you grew just under 20%. You've had some solid growth internationally, which puts the US more into the mid to high 10s. And I guess what I'm trying to get at is how much of this is behind you and what are you expecting in 24 in terms of this?

是的，阿米爾，感謝您回答我的問題。我將從.您能否幫助我們理解有關競爭性試用份額增益的任何評論？您在哪裡看到 DVTPE 影響最大。我認為當我們查看 VTE 上的這些數字時。業務方面，您的成長率略低於 20%。國際上已經有了一些穩健的成長，這使得美國的排名更接近 10 名左右。我想我想知道的是，這其中有多少是你已經過去的，以及你對 24 小時對此有何期望？

Yes. So happy to answer some of that, Bill and Mitch may want to pile on as well. We've been pretty clear about the competitive dynamics as we move through 2023. I think much of the competitive trialing was front end loaded on the year, but we did see it kind of splash over into Q3 and Q4. You've heard us describe those are cases that we would have had that's revenue that we would have generated.

是的。很高興回答其中的一些問題，比爾和米奇可能也想繼續回答。進入 2023 年，我們已經非常清楚競爭動態。我認為今年的大部分競爭性試驗都是前端加載的，但我們確實看到它有點蔓延到第三季和第四季。您已經聽過我們描述過我們本來會產生的收入。

And due to the competitive trialing, we don't have access to it. So it has definitely had an impact at the same time. Again, we began the year as the market leader. We're exiting the year as the market leader we are very confident in continuing to be the market leader. This is an attractive market. There are going to be new entrants that come where we compete head to head. We like our chances.

由於競爭性試用，我們無法存取它。所以它肯定同時產生了影響。新年伊始，我們再次成為市場領導者。我們將以市場領導者的身分結束這一年，我們非常有信心繼續成為市場領導者。這是一個有吸引力的市場。將會有新的進入者來到我們正面競爭的地方。我們喜歡我們的機會。

We like the way our technology is performing third, fourth generation platforms.At this point, we have a very capable and well established commercial presence and field team that are doing good work day in day out, and we've got a mountain of high-quality clinical evidence getting bigger every day. And I will continue to innovate on the technology as well.

我們喜歡我們的技術執行第三代、第四代平台的方式。在這一點上，我們擁有非常有能力且完善的商業存在和現場團隊，他們日復一日地做好工作，並且我們已經擁有了一座高山-高品質的臨床證據每天都在變得越來越大。我也將繼續在技術上進行創新。

On top of that, a very differentiated approach to market development. If you take all that together, we're very confident in our ability to continue to lead in this market and to the extent new entrants can help develop the market after all, that's where our focus is. That's where the real value is on a patient front as well as the value creation front. Anything you want to add to that, Mitch?

最重要的是，採取非常差異化的市場開發方法。如果你把所有這些放在一起，我們對我們繼續在這個市場保持領先地位的能力非常有信心，並且在新進入者可以幫助開發市場的程度上，這就是我們的重點所在。這就是患者和價值創造方面的真正價值。米奇，你還有什麼要補充的嗎？

Yes, just the bill, from the point of view of the VT. growth, so I'm kind of looking at some of the revenue aggregation that's in that table. We disclosed in the back half of the press release. I'm just looking at the sequential revenue growth, let's say, of Q4 over Q3. So just over 4% there. Then when I look at the year-over-year number for VT. by 19.5%, revenue growth comparing 2023 to 2022. So I think those numbers are pretty attractive from a growth perspective, and we feel pleased with the progress and the performance of the business during during 2023 for all the reasons you heard from Drew very optimistic about 2024 as well.

是的，從 VT 的角度來看，只是帳單。增長，所以我正在研究該表中的一些收入匯總。我們在新聞稿的後半部分進行了披露。我只是專注於第四季相對於第三季的連續營收成長。所以只有 4% 多一點。然後當我查看 VT 的同比數據時。與 2022 年相比，2023 年營收成長 19.5%。因此，我認為從成長的角度來看，這些數字非常有吸引力，我們對 2023 年業務的進展和業績感到滿意，因為您從 Drew 那裡聽到的所有原因也對 2024 年非常樂觀。

And then just you mentioned, Mitch, on the profitability of the business, you subtracted out the WinDoor acquisition costs.

米奇，剛才你提到，在業務獲利能力方面，你減去了 WinDoor 的收購成本。

I'm sure there's some when you did that.

我確信當你這樣做的時候肯定有一些。

Is it just the acquisition or is that also the ongoing loan flow costs when we kind of looked at that from the court was that like a core business? Look, in terms of your answer to a prior question and the answer to the prior question, I was just looking at the 2023 Q4 numbers and also the full year numbers. And then just backing out the one-time costs which were identified in the press release, essentially that was $9 million in Q4. And then $11.7 million for the full year. I'm happy to share some commentary, if you'd like in terms of how that looks in 2024 as well.

這只是收購，還是當我們從法庭上看這是否是一項核心業務時，這也是持續的貸款流動成本？看，就您對先前問題的回答和對先前問題的回答而言，我只是查看 2023 年第四季度的數據以及全年數據。然後只是取消新聞稿中確定的一次性成本，基本上是第四季的 900 萬美元。然後全年 1170 萬美元。如果您也想了解 2024 年的情況，我很樂意分享一些評論。

No, I think we would expect the Yum, one-time costs if you're kind of interested in that from a Q4 perspective, I think one-time costs in Q1 will be about the same as Q4 and then potentially dropping to about half of that for the remainder of the year. And that's made up of both the transaction costs, which dissipate as we move through the year and then this purchase price amortization thing that we've talked about, the amortization of the acquired intangible assets.

不，我認為如果您對第四季度的角度感興趣的話，我們會期望百勝一次性成本，我認為第一季度的一次性成本將與第四季度大致相同，然後可能下降到一半左右今年剩下的時間裡。這由交易成本組成，交易成本隨著我們一年的推移而消失，然後是我們討論過的購買價格攤銷，即所收購無形資產的攤銷。

And so happy to talk further about that. But hopefully that's helpful. Send at least some directional feeling on that. Yes, you're seeing another $9 million in Q. one and then we'll see about 2.5 to $3 million a quarter from the amortization in Q two through four. Is that a how to think about it?

很高興進一步討論這一點。但希望有幫助。至少傳達一些方向感。是的，您會在第一季看到另外 900 萬美元，然後我們會在第二季到第四季看到每季約 2.5 至 300 萬美元的攤銷。這是一個如何思考的問題嗎？

Yes, that amortization number stays pretty consistent through the course of the year and $2.5 million the total one-time stuff in Q2 through Q4 is more in the 4 to 5 million range because there's still some transaction costs involved.

是的，這個攤銷數字在一年中保持相當穩定，第二季度到第四季度的一次性費用總額為250 萬美元，更多地在4 到500 萬美元範圍內，因為仍然涉及一些交易成本。

Great. Thank you. Thanks for taking my questions.

偉大的。謝謝。感謝您回答我的問題。

But Bill, just to make sure I'm clear, when I was talking earlier about the Company's profitability, we're speaking about GAAP profitability. So I'm not I'm not talking about this. The non-GAAP number that we have in the press release. I just want to make sure everybody is clear on that.

但是比爾，為了確保我說清楚，當我早些時候談論公司的盈利能力時，我們談論的是 GAAP 盈利能力。所以我不是我不會談論這個。我們在新聞稿中提供的非公認會計原則數字。我只是想確保每個人都清楚這一點。

Thank you.

謝謝。

Chris Pasquale, Nephron Research.

克里斯·帕斯誇萊，腎臟單位研究。

Thanks, Tom. Just one quick one on the quarter. Any color on the VT. mix between FlowTriever and clots, RayVa and 14?

謝謝，湯姆。本季只有一個快速的。VT 上的任何顏色。 FlowTriever 和凝塊、RayVa 和 14 之間的混合？

You know, the overall mix, Chris, still has been pretty consistent. I think you've kind of seen historically, you can look back for several years actually for us. And you can see that the breakdown in terms of product wise revenue wise between the FlowTriever family and the Quattro family. So I would say that's pretty consistent. That's one thing that as a part of this new revenue aggregation, as we move forward?

你知道，克里斯，整體組合仍然相當一致。我想你已經看到了歷史，你實際上可以為我們回顧幾年。您可以看到 FlowTriever 系列和 Quattro 系列之間在產品收入方面的細分。所以我想說這是非常一致的。隨著我們前進，作為新收入聚合的一部分，這是一件事嗎？

You know, we're not going to talk specifically about that, but I think you've got a pretty good flavor for it based on how the business has operated historically.

你知道，我們不會具體討論這一點，但我認為根據該業務的歷史運作方式，你對此有很好的了解。

Okay. That's fair enough. And then just a couple of questions on Peerless completed enrollment, it's short follow-up. You talked about data being presented in the back half of this year. It seems like you might know what it looks like before then just given the timing here. So are you targeting a particular venue for that? And how would you frame the impact positively that could have what percentage of patients are getting CDT. today and could shift to mechanical thrombectomy if that data is really compelling.

好的。這很公平。然後只有幾個關於 Peerless 完成註冊的問題，這是一個簡短的後續行動。您談到了今年下半年公佈的數據。看起來你可能知道它是什麼樣子，然後再給這裡的時間。那麼您是否為此瞄準了特定的場地？您如何積極地描述可能對接受 CDT 的患者百分比的影響。如果這些數據確實令人信服，那麼今天可能會轉向機械血栓切除術。

Great questions, Chris, thanks for bringing them.Up. So firstly, as regards to the timing of the Peerless data release, we're really excited about the completion of enrollment in the study. I think it's a testament to the level of interest of clinical investigation in this space as well as the execution of that clinical team. We are targeting a major cardiovascular meeting for the release of the data and you can imagine towards the back half of the year, what possible meetings that might be?

很好的問題，克里斯，謝謝你提出這些問題。首先，關於 Peerless 數據發布的時間，我們對這項研究的註冊完成感到非常興奮。我認為這證明了對該領域臨床研究的興趣程度以及該臨床團隊的執行力。我們的目標是召開一次重要的心血管會議來發布數據，您可以想像到今年下半年，可能會舉行哪些會議？

I think this being a groundbreaking study deserves the kind of platform that that might provide. So that's as much as a timing. As far as on the potential impact, we know that CDT. has been progressively diminishing as a treatment for pulmonary embolism, although there are still people who consider that as a therapy. And I think this dataset is going to go a long way towards targeting conversion of CDT. on therapy to definitive mechanical.

我認為這是一項開創性的研究，值得提供這樣的平台。所以這就是一個時機。至於潛在的影響，我們知道CDT。儘管仍有人認為這是一種治療方法，但作為肺栓塞的治療方法已逐漸減少。我認為這個資料集將對 CDT 的目標轉換大有幫助。對最終機械療法進行治療。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Great. Thanks for taking the question. The afternoon. I wanted to start on the emerging therapies bucket and some of the prior year over year prior data that you provided. When we look at, I think maybe Q2 through Q4 of 2023, it looks like there a pretty significant step-up at least closer that four to $5 million per quarter number versus the 2 million or so in Q and Q one.

偉大的。感謝您提出問題。這個下午。我想從新興療法以及您提供的一些去年同期的數據開始。當我們看時，我認為也許是2023 年第二季度到第四季度，看起來有一個相當顯著的提升，至少接近每季度4 到500 萬美元的數字，而第一季度和第二季度的數字約200 萬美元。

So I'm wondering one if that is kind of the right way to start off thinking about emerging therapy contribution as early as, I guess, the first quarter of 2024. And I'm curious what the maybe the biggest kind of contribution segment or product in that 4 to 5 million per quarter that we've seen and whether or not that spend steady throughout those two to three quarters in the back half of 2023? Or if there's any movement around some of those new products having a bigger contribution on a quarterly basis?

因此，我想知道這是否是最早在 2024 年第一季開始考慮新興治療貢獻的正確方法。我很好奇我們所看到的每季 400 到 500 萬美元中最大的貢獻部分或產品是什麼，以及在 2023 年下半年的兩到三個季度中支出是否穩定？或者，其中一些新產品是否有任何變化，對季度的貢獻更大？

Yes, David, I'm happy to get started on that Mitch may want to add some additional thoughts as well. So as you look back over the course of 2023 across the emerging therapies portfolio, keep in mind these are still relatively small numbers, but you're seeing the impact of some of the new product introductions that we made earlier in 2023, specifically rather core and then through so you're seeing the impact of those product launches and some of those step-ups looking ahead from here, we absolutely would expect the emerging therapies portfolio to grow on a relative basis quite a bit faster than VT.,

是的，大衛，我很高興開始，米奇可能也想添加一些額外的想法。因此，當您回顧 2023 年的新興療法產品組合時，請記住，這些數字仍然相對較小，但您會看到我們在 2023 年早些時候推出的一些新產品的影響，特別是核心產品然後透過這些產品發布的影響以及展望未來，我們絕對預期新興療法組合的成長速度將比VT 快得多。

but obviously off a much smaller base and we will be bringing new product into the CBD toolkit alongside Revascor. We talked about that in the prepared remarks, there will be some incremental growth, hopefully from that new product introduction will have continued traction within thrill lead flow is included obviously in the CLTI. component of emerging therapies. We've only factored in a modest contribution from loan flow, but that will be ramping as we move through 2024 and the U.S. launch progresses. And then finally, we will get started on Artix if all goes to plan later in the year.

但顯然基礎要小得多，我們將與 Revascor 一起將新產品引入 CBD 工具包。我們在準備好的發言中談到，將會有一些增量成長，希望新產品的推出將在令人興奮的領先流量中產生持續的吸引力，顯然包括在 CLTI 中。新興療法的組成部分。我們只考慮了貸款流量的適度貢獻，但隨著 2024 年的到來以及美國推出的進展，這項貢獻將會不斷增加。最後，如果今年稍後一切按計劃進行，我們將開始開發 Artix。

And that will be incremental growth in the fourth and final segment of emerging therapies that David, the thing I would add quickly is I think the growth in emerging therapies is likely to be a bit little bit lumpy. I guess I would call it, and that's both due to the fact that we have in some quarters a new product that's been introduced. And you can kind of see that looking at the numbers for 2023 actually back to 2022 as well. And then also due to kind of the way these products are moved through the back approval process and time line with the hospitals that takes, you know, X number of months typically for that to get through. And so where those actually begin to impact the revenue line, it tends to be a little bit lumpy as opposed to really smooth.

這將是新興療法第四個也是最後一個領域的增量增長，大衛，我要快速補充的是，我認為新興療法的增長可能會有點不穩定。我想我會這樣稱呼它，這都是因為我們在某些​​方面推出了新產品。您可以看到，查看 2023 年的數字實際上也可以追溯到 2022 年。此外，由於這些產品通過醫院審批流程和時間表的方式，通常需要 X 個月才能完成。因此，當這些因素真正開始影響收入線時，它往往會有點不穩定，而不是真正穩定。

Okay. So would it be fair to say that maybe all of these segments on a go forward basis and thus far are contributing to the growth and there doesn't really appear to be a clear winner among the core products that are in your view, is there maybe clear winner products so far?

好的。因此，可以公平地說，也許所有這些細分市場在未來的基礎上，到目前為止都對增長做出了貢獻，並且在您看來，核心產品中似乎並沒有真正的贏家，是嗎？到目前為止也許明確的獲勝產品？

So I do think all four will contribute on a go-forward basis on on a relative basis. Artix is, of course, going to start from zero as we relaunch. So that will be a pure incremental across the other three, I think they will grow as we move through the year and to Mitch's point. And you might see some lumpiness driven by some of the new product introductions and the back approvals coming through across those respective new products. Yes.

因此，我確實認為所有四個人都將在相對的基礎上做出未來的貢獻。當然，當我們重新啟動時，Artix 將從零開始。因此，這將是其他三個的純粹增量，我認為隨著我們今年的發展以及米奇的觀點，它們將會成長。您可能會看到一些新產品的推出和這些新產品的後續批准導致了一些混亂。是的。

Richard Newitter, Truist Securities.

理查德紐特 (Richard Newitter)，Truist 證券公司。

Hi. Thanks for taking the questions. And thanks for providing the revenue disclosure. Maybe just on on kind of the pieces of the disclosure that you provided as they roll up to 24. I'm just trying to get a sense directionally, I'm could you tell me if I'm directionally close, I'm getting to the midpoint of your guidance. You're thinking about the core USVTE. in kind of the mid to high 10s, I'm assuming international about 5% to 6% of revenue. And um, and that implies the leftover being the emerging therapies, I guess, are those the directional component, understanding you strive to outperform the initial outlook or those interests are reasonable directional components of how to get to the midpoint of your guidance for now is specifically comment on that international as a percent of total in that 5% to 6% range.

你好。感謝您提出問題。感謝您提供收入揭露。也許只是您提供的披露內容，因為它們已累計到 24 條。我只是想獲得一種方向感，你能告訴我我的方向是否接近，我正在達到你指導的中點。您正在考慮核心 USVTE。在 10 左右左右，我假設國際業務佔收入的 5% 到 6% 左右。嗯，這意味著剩下的新興療法，我想，是那些方向性的組成部分，理解你努力超越最初的前景，或者這些興趣是目前如何達到你的指導中點的合理的方向性組成部分特別評論該國際佔總數的百分比，範圍在5% 到6% 之間。

And Richard, thanks for the question. I think we closed out the year with international at six, and that's something it's good. It's going to continue to make progress. I think there's potentially some step up as we move through the year and as we continue to get more traction, you know, in the more developed markets as well. We may have some additional products for sale at some point in these markets. I mentioned earlier during the call that we're still pursuing regulatory approval for many of the new product things that we've launched.

理查德，謝謝你的提問。我認為我們以六場國際比賽結束了這一年，這很好。它將繼續取得進步。我認為，隨著這一年的推移，隨著我們在更發達的市場中繼續獲得更大的吸引力，我們可能會取得一些進展。我們可能會在某個時候在這些市場上出售一些額外的產品。我之前在電話會議中提到，我們仍在尋求監管部門對我們推出的許多新產品的批准。

As Drew mentioned, we think that the international contribution from China and Japan is likely to be very modest and probably more back-end kind of loaded in terms of thinking about 2024. And from the point of view of the other pieces of the puzzle in terms of your revenue build. I think you're I think you're kind of headed in the right direction there in terms of how that's how that how certainly how we close out the year 2023, and then how we'll kind of think about 2024.

正如德魯所提到的，我們認為中國和日本的國際貢獻可能非常有限，而且考慮到 2024 年，可能更多的是後端負載。從收入建構方面的其他難題來看。我認為，就我們如何結束 2023 年，以及我們如何看待 2024 年而言，我認為您正在朝著正確的方向前進。

Okay. And just to be clear, so maybe international, even though you have incremental emerging therapies contribution international as a percentage of sales. So we'll gravitate higher than the 6% than 20, I guess?

好的。需要明確的是，即使您的新興療法在國際上的貢獻佔銷售額的百分比增加，但也許是國際化的。所以我猜我們會傾向比 6% 更高的人？

Yes, that's what we expect. Okay. Thank you very much. And I think Bruce talked about that longer term growing into a 20% type factor, but certainly it's going to be a multiyear build to that level.

是的，這就是我們所期望的。好的。非常感謝。我認為 Bruce 談到了從長遠來看增長到 20% 的類型因素，但肯定需要多年的時間才能達到這個水平。

Thank you.

謝謝。

Sure.

當然。

Mike Matson, Needham & Company.

麥克馬森，李約瑟公司。

Yes, thanks, Al. So just wanted to ask one on one flow. So you mentioned that and tap com opportunity. So on deal. I assume you've it's been applied for, but you don't know whether or not you're getting it yet. Is that right? How critical is that to driving adoption of the product to Nuvion.

是的，謝謝，艾爾。所以只是想問一對一的流程。所以你提到了這一點並挖掘了機會。所以就成交了。我假設你已經申請了，但你不知道是否已經收到。是對的嗎？這對於推動 Nuvion 產品的採用至關重要。

Yes. Great question, Mike. I'm happy to get started on that. So so far, so good. With LIN flow. We closed in November. We made some really nice progress on the integration front, and we've also made some nice progress on the initial U.S. launch. We obviously don't have access to the untapped today, but if you look at the existing reimbursement inpatient reimbursement today at our target first group of limb salvage centers, it is in the neighborhood of $30,000. So it is a positive contribution margin procedure even today with the existing reimbursement we have applied for and TAP and are confident we will receive it.

是的。好問題，麥克。我很高興開始做這件事。到目前為止，一切都很好。具有LIN流。我們十一月份關門了。我們在整合方面取得了一些非常好的進展，並且在美國的首次發布方面也取得了一些不錯的進展。顯然，今天我們無法獲得未開發的資金，但如果你看看今天我們目標第一組肢體搶救中心現有的住院報銷費用，就會發現約為 30,000 美元。因此，即使在今天，憑藉我們已申請的現有報銷和 TAP，這也是一個積極的邊際貢獻程序，並且我們有信心收到它。

It will go into effect in October, and that will add incrementally about another $16,000 and incremental reimbursement on top of the existing DRG. So it obviously provides a lot of incremental economic value to the hospital at that point. But even today in advance of the intent and we are gaining back approvals and beginning to do initial cases in the US. And I think the economic value proposition is broader and ties back into lymphoma being a really important part of any limb salvage center armamentarium and some of the broader economic considerations I think are helping fuel the growth here and the traction even in advance of the untapped, which again, we anticipate coming online in October.

該法案將於 10 月生效，在現有 DRG 的基礎上，將再增加約 16,000 美元和增量報銷。因此，它顯然為醫院提供了大量增量經濟價值。但即使在今天，我們仍在獲得批准並開始在美國進行初步案例。我認為經濟價值主張更廣泛，並且與淋巴瘤有關，淋巴瘤是任何肢體搶救中心軍備庫中非常重要的一部分，我認為一些更廣泛的經濟考慮因素正在幫助推動這裡的增長，甚至在未開發的領域之前也能產生牽引力，我們預計在 10 月上線。

Okay. Thanks. And then I know there's a lot of focus on competition from a number, but I just wanted to ask if you've seen any sort of impact from a cost-sensitive XARELTO study, I think that was presented at TCT kind of in the fall. Did that drive any kind of it pickup in their Ecos sales or I mean that you could see your share gains from you guys?

好的。謝謝。然後我知道人們非常關注來自一些數字的競爭，但我只是想問一下您是否看到了成本敏感的 XARELTO 研究的任何影響，我認為該研究是在秋季的 TCT 上提出的。這是否推動了他們的 Ecos 銷售的任何形式的回升，或者我的意思是你可以從你們那裡看到你的份額收益？

Yes, I think Tom might have some perspective to share on that dataset and the impact? Yes. Thanks for the question, Mike. So on first of all, to call, the real PE. dataset, a trial, I think, is maybe overstating its value. It really was a kind of an exercise in electronic medical record assessment. And what it showed is that when you retrospectively look at who got FlowTriever, you oftentimes saw patients who were too sick to get any other therapies.

是的，我認為 Tom 可能會分享一些關於該資料集及其影響的觀點？是的。謝謝你的提問，麥克。首先，要稱呼的是真正的PE。我認為，數據集這項試驗可能誇大了它的價值。這確實是一種電子病歷評估的練習。結果表明，當您回顧性地觀察誰接受了 FlowTriever 時，您經常會看到病情嚴重而無法接受任何其他治療的患者。

You got patients who are actively bleeding who got the only therapy that really was appropriate for somebody who cannot get lytics, and that would be mechanical thrombectomy and so I think it was a nice exercise in selection bias. I think the vast majority of physicians see it for what it is. We're excited about Peerless because Peerless is actually high quality quality, randomized data. And I think that the community can't wait to see the results of that. We really have not seen any commercial impact from that data release Okay. Got it.

對於那些正在積極出血的患者，他們接受了唯一真正適合無法進行溶解的治療的治療方法，那就是機械血栓切除術，所以我認為這是一個很好的選擇偏差練習。我認為絕大多數醫生都看到了它的本質。我們對 Peerless 感到興奮，因為 Peerless 實際上是高品質的隨機數據。我認為社區迫不及待地想看到結果。我們確實沒有看到該數據發布帶來的任何商業影響。知道了。

Thank you.

謝謝。

Thank you, Mike.

謝謝你，麥克。

This concludes our conference call and thank you for attending today's presentation. You may now disconnect and move in. We know that no, no not in the end and.

我們的電話會議到此結束，感謝您參加今天的演示。現在您可以斷開連線並入住。我們知道，不，不到底和。