Inari Medical Inc (NARI) 2022 Q4 法說會逐字稿

Good afternoon, and welcome to the Inari Medical Fourth Quarter 2022 Earnings Conference Call. (Operator Instructions) Please note, this event is being recorded. I would now like to turn the conference over to Caroline Corner, Investor Relations. Please go ahead.

下午好，歡迎來到 Inari Medical 2022 年第四季度收益電話會議。 （操作員說明）請注意，正在記錄此事件。我現在想將會議轉交給投資者關係部的 Caroline Corner。請繼續。

Thank you, operator. Welcome to Inari's Fourth Quarter 2022 Earnings Call. Joining me on today's call are Drew Hykes, President and Chief Executive Officer; and Mitch Hill, Chief Financial Officer. This call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the markets in which Inari operates, trends and expectations for Inari's products and technology, trends and demand for Inari's products, Inari's expected financial performance, expenses and position in the market; and the impact of COVID-19 on Inari's operations and Inari's customers' operations.

謝謝你，運營商。歡迎來到 Inari 2022 年第四季度財報電話會議。與我一起參加今天電話會議的還有總裁兼首席執行官 Drew Hykes；和首席財務官 Mitch Hill。本次電話會議將包括 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。本次電話會議上作出的與歷史事實無關的所有陳述均應視為前瞻性陳述，包括有關市場的陳述Inari 經營哪些公司、對 Inari 產品和技術的趨勢和預期、對 Inari 產品的趨勢和需求、Inari 的預期財務業績、費用和市場地位；以及 COVID-19 對 Inari 運營和 Inari 客戶運營的影響。

These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from any results, performance or achievements expressed or implied by the forward-looking statements.

這些陳述既不是承諾也不是保證，涉及已知和未知的風險和不確定性，這些風險和不確定性可能導致實際結果、業績或成就與前瞻性陳述明示或暗示的任何結果、業績或成就存在重大差異。

Please review Inari's most recent filings with the SEC, particularly the risk factors described in Inari's annual report on Form 10-K for the year ended December 31, 2022, 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. Inari's press release for fourth quarter 2022 results is available on Inari's website, www.inarimedical.com, under the Investors section and includes additional details about Inari's financial results.

請查看 Inari 向 SEC 提交的最新文件，特別是 Inari 截至 2022 年 12 月 31 日止年度 10-K 表格年度報告中描述的風險因素，以獲取更多信息。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，均基於管理層截至今日的預期。除非適用法律要求，否則 Inari 不承擔更新這些聲明的義務。 Inari 2022年第四季度業績的新聞稿可在 Inari 網站 www.inarimedical.com 的“投資者”部分獲取，其中包括有關 Inari 財務業績的更多詳細信息。

Inari's website also has the latest SEC filings, which you are encouraged to review. A recording of today's call will be available on Inari's website by 5:00 p.m. Pacific Time today. Now I would like to turn the call over to Drew for his comments and fourth quarter 2022 business highlights.

Inari 的網站上還有最新的 SEC 文件，我們鼓勵您查看這些文件。今天的通話錄音將於下午 5:00 之前在 Inari 的網站上提供。今天太平洋時間。現在我想把電話轉給德魯，聽取他的評論和 2022 年第四季度的業務亮點。

Thank you, Caroline, and thank you, everyone, for joining us today. Our fourth quarter was successful and highly productive. Revenue growth was strong, and we executed crisply across all our growth drivers. We presented important new data from the 2 largest prospective thrombectomy studies ever conducted in DVT and PE, and we initiated full market release of 2 new products, all while continuing our work to drive market expansion and uptake of our devices. I will share additional detail about all of this shortly, but we'd like to start now as we always do, with a patient story, which highlights the clinical impact and continued competitive advantage of our purpose-built technology.

謝謝 Caroline，也謝謝大家今天加入我們。我們的第四季度取得了成功並且富有成效。收入增長強勁，我們在所有增長動力方面都表現出色。我們提供了有史以來在 DVT 和 PE 中進行的兩項最大的前瞻性血栓切除術研究的重要新數據，我們啟動了兩種新產品的全面市場發布，同時繼續我們的工作以推動市場擴張和我們設備的採用。我將很快分享關於所有這些的更多細節，但我們想像往常一樣從現在開始，通過一個患者的故事來強調我們專門構建的技術的臨床影響和持續的競爭優勢。

Last month, a 50-year-old man in Texas with complex DVT involving both legs and a clotted IVC filter presented to the hospital. A consulting interventionalist decided to trial a new 16-French device to gain an understanding of how it performed. Despite the device's purported ability to minimize blood loss, over 1,000 milliliters of blood was removed, which is 20% of the patient's total blood volume. After over 2 hours of work, the physician abandoned the device trial due to inability to remove residual thrombus combined with safety concerns related to the significant blood loss. The physician then opted for treatment with the ClotTriever system, and in 30 minutes, the patient was completely thrombus free. That portion of the procedure only resulted in 10 milliliters of additional blood loss.

上個月，得克薩斯州一名 50 歲男子因雙腿複雜 DVT 和凝結的 IVC 濾器被送往醫院。一位諮詢介入醫師決定試用一種新的 16-French 設備，以了解其性能。儘管該設備聲稱能夠最大限度地減少失血，但還是抽取了超過 1,000 毫升的血液，佔患者總血容量的 20%。經過 2 個多小時的工作，由於無法清除殘餘血栓以及與大量失血相關的安全問題，醫生放棄了設備試驗。然後醫生選擇使用 ClotTriever 系統進行治療，在 30 分鐘內，患者完全沒有血栓。這部分手術僅導致額外失血 10 毫升。

We believe this case highlights the fundamental shortcomings of competitive platforms, which fail to remove all the clot while resulting in significant blood loss. Blood loss adds time and complexity for the physician operator, is economically disadvantageous for the hospital and most importantly, is dangerous for the patient. VTE patients who require just 1 unit of transfusion, roughly 200 milliliters, are associated with a threefold increase in mortality, double the hospital costs and 66% increase in 30-day readmission.

我們認為，該案例凸顯了競爭平台的根本缺點，即無法去除所有血塊，同時導致大量失血。失血增加了醫生操作者的時間和復雜性，對醫院來說在經濟上是不利的，最重要的是，對患者來說是危險的。僅需要 1 個單位輸血（大約 200 毫升）的 VTE 患者死亡率增加三倍，住院費用增加一倍，30 天再入院率增加 66%。

In contrast, our ClotTriever and FlowTriever systems have been purpose-built to safely and effectively remove all the clot in both DVT and PE and to do so with minimal blood loss. In fact, the blood loss from ClotTriever reported in our CLOUT registry was just 40 milliliters and the blood loss from FlowTriever reported in our FLASH registry after the introduction of FlowSaver was just 100 milliliters.

相比之下，我們的 ClotTriever 和 FlowTriever 系統專為安全有效地去除 DVT 和 PE 中的所有凝塊而設計，並以最小的失血量進行。事實上，我們的 CLOUT 註冊表中報告的 ClotTriever 失血量僅為 40 毫升，引入 FlowSaver 後我們的 FLASH 註冊表中報告的 FlowTriever 失血量僅為 100 毫升。

Now I'd like to provide a brief summary of our Q4 financial performance. Our revenue in Q4 was $107.8 million, at the high end of our preannounced revenue range of $107 million to $108 million, and up 30% year-over-year and 12% sequentially from Q3. The performance was driven by robust underlying procedure growth across both the ClotTriever and FlowTriever product lines. We are pleased with how our business performed in Q4 and enthusiastic about how we are positioned heading into 2023 and beyond.

現在我想簡要總結一下我們第四季度的財務業績。我們在第四季度的收入為 1.078 億美元，處於我們預先宣布的 1.07 億美元至 1.08 億美元收入範圍的高端，同比增長 30%，環比增長 12%。業績是由 ClotTriever 和 FlowTriever 產品線的強勁基礎程序增長推動的。我們對我們在第四季度的業務表現感到滿意，並對我們在 2023 年及以後的定位充滿熱情。

Our end markets are large and remain highly underpenetrated. And while we continue to view competition in VTE as potentially additive to our efforts to develop the market, make no mistake, as the clear market leader, we are highly confident in our ability to maintain our competitive position relative to devices with inferior safety or efficacy profiles. Our patients deserve the best possible outcomes, and we remain steadfast in our mission. With that, I'll now turn to our growth drivers.

我們的終端市場很大，而且滲透率仍然很低。儘管我們繼續將 VTE 中的競爭視為對我們開發市場的努力的潛在補充，但毫無疑問，作為明確的市場領導者，我們對保持相對於安全性或功效較差的設備的競爭地位的能力充滿信心配置文件。我們的患者應該得到最好的結果，我們始終堅定不移地履行我們的使命。有了這個，我現在將轉向我們的增長動力。

Our first growth driver is the expansion of our sales organization. We ended the year with just over 280 U.S. sales territories. Following the hiring of our largest sales class to date back in Q2, we intentionally moderated our hiring in Q3 and Q4. We're pleased with the resulting operating leverage and productivity gains we're beginning to recognize with our sales force. Consistent with that approach, in 2023, we expect to continue adding sales professionals each quarter, albeit at a more measured pace and anticipate ending the year with at least 310 territories.

我們的第一個增長動力是我們銷售組織的擴張。到年底，我們在美國的銷售區域超過 280 個。在第二季度招聘了迄今為止最大的銷售班級之後，我們有意減少了第三季度和第四季度的招聘。我們對由此產生的經營槓桿和生產率提高感到滿意，我們開始認識到我們的銷售人員。與這種方法一致，到 2023 年，我們預計將繼續每個季度增加銷售專業人員，儘管速度會更加謹慎，並預計到年底至少有 310 個地區。

Continued expansion of our sales organization results in smaller and smaller territories. This, in turn, positions us well to execute on our second growth driver, which is increasing penetration in existing accounts. Despite our commercial success, the vast majority of VTE patients continue to be treated with anticoagulation alone and never even see a physician who is a VTE expert. Our goal is to establish systems and processes, [so more stroke and MI] that ensure patients are consistently identified, screened and evaluated by a VTE expert. Our VTE Excellence program is a highly differentiated, comprehensive and repeatable approach to partner with hospitals to do just that. We are leveraging the capabilities we have created and are continuing to see solid progress moving our customers through to the most advanced phases of VTE Excellence, where TAM penetration is several times higher than in the earlier phases. Although VTE Excellence has proven to be very effective at developing the VTE market, we believe it also clearly differentiates us from competition.

我們的銷售組織的持續擴張導致在越來越小的地區。這反過來又使我們能夠很好地執行我們的第二個增長動力，即增加現有客戶的滲透率。儘管我們取得了商業上的成功，但絕大多數 VTE 患者繼續接受單獨的抗凝治療，甚至從未見過 VTE 專家醫生。我們的目標是建立系統和流程，[因此更多的中風和 MI] 確保 VTE 專家始終如一地識別、篩选和評估患者。我們的 VTE 卓越計劃是一種高度差異化、全面且可重複的方法，可以與醫院合作來做到這一點。我們正在利用我們創造的能力，並繼續看到穩步進展，將我們的客戶帶入 VTE 卓越的最高級階段，其中 TAM 滲透率比早期階段高出數倍。儘管 VTE Excellence 已被證明在開發 VTE 市場方面非常有效，但我們相信它也清楚地將我們與競爭對手區分開來。

Our third growth driver is to build upon our base of clinical evidence. The past several months have been among our most productive ever. We presented key updates from our CLOUT and FLASH registries in September and October. These studies once again highlighted that ClotTriever and FlowTriever are safe, remove more clot than any other devices ever studied and achieve best-in-class patient outcomes.

我們的第三個增長動力是建立在我們的臨床證據基礎上。過去幾個月是我們有史以來最富有成效的幾個月。我們在 9 月和 10 月展示了 CLOUT 和 FLASH 登記處的重要更新。這些研究再次強調 ClotTriever 和 FlowTriever 是安全的，去除的凝塊比研究過的任何其他設備都多，並實現了一流的患者治療效果。

Importantly, the data also show our devices are highly effective with only a small amount of blood loss. This gives our physician customers the confidence to treat VTE patients completely and remove all the clot without compromising patient safety.

重要的是，數據還表明我們的設備非常有效，而且只損失了少量的血液。這使我們的醫生客戶有信心在不影響患者安全的情況下徹底治療 VTE 患者並清除所有血塊。

Looking ahead, the FLAME study has been accepted as a late-breaking clinical trial at the American College of Cardiology Conference in early March. FLAME is the largest ever prospective study in high-risk PE. These are the sickest 10% of PE patients who are in active hemodynamic collapse. We believe FLAME will change the standard of care in high-risk PE. Importantly, the results could also broaden adoption of FlowTriever therapy within intermediate-risk PE patients. Keep in mind, the intermediate risk PE patient population is 5x larger than the high-risk PE patient population.

展望未來，FLAME 研究已在 3 月初的美國心髒病學會會議上被接受為一項最新的臨床試驗。 FLAME 是有史以來規模最大的高危 PE 前瞻性研究。這些是處於活動性血液動力學崩潰中的最嚴重的 10% 的 PE 患者。我們相信 FLAME 將改變高風險 PE 的護理標準。重要的是，該結果還可以擴大中等風險 PE 患者對 FlowTriever 療法的採用。請記住，中度風險 PE 患者群體是高風險 PE 患者群體的 5 倍。

Turning to our RCTs. We're pleased to recently announce the first enrollment in our DEFIANCE RCT, comparing ClotTriever to anticoagulation alone. The study is designed to establish ClotTriever as the standard of care for DVT treatment. We're also seeing robust enrollment in our PEERLESS RCT, comparing FlowTriever to catheter-directed lytic therapy for the treatment of PE patients. If successful, PEERLESS will usher in the end of lytic-based interventions and intermediate risk PE. The significant investment we have made in our clinical competencies is paying off and we believe our commitment to generating high-quality data will help change the standard of care in VTE. Although this commitment is based upon a sense of responsibility to physicians and patients, it also serves to further differentiate and distance Inari from both current and future competition.

轉向我們的隨機對照試驗。我們很高興最近宣布首次參加我們的 DEFIANCE RCT，將 ClotTriever 與單獨的抗凝治療進行比較。該研究旨在將 ClotTriever 確立為 DVT 治療的護理標準。我們還看到我們的 PEERLESS RCT 中有大量註冊，將 FlowTriever 與導管導向溶解療法進行比較，用於治療 PE 患者。如果成功，PEERLESS 將迎來基於裂解的干預和中等風險 PE 的終結。我們在臨床能力方面所做的重大投資正在取得回報，我們相信我們對生成高質量數據的承諾將有助於改變 VTE 的護理標準。雖然這一承諾是基於對醫生和患者的責任感，但它也有助於進一步區分和拉開 Inari 與當前和未來競爭的距離。

Our fourth growth driver is to expand our product portfolio. We have several updates to share here as well. First, Protrieve has been in full mark release for the past several months. Protrieve is a device that provides protection to the heart and lung during complex DVT procedures involving extensive clot. We are pleased with how the launch is progressing and encouraged by the enthusiastic feedback from physicians. We estimate Protrieve can be used in approximately 15% of our existing DVT procedures. We believe a large percentage of competitive DVT interventions could also benefit from Protrieve. The device is generally sold outside of our per procedure pricing and an ASP of $4,000, representing a meaningful revenue opportunity.

我們的第四個增長動力是擴大我們的產品組合。我們也有幾個更新要在這里分享。首先，Protrieve 在過去幾個月一直處於滿分狀態。 Protrieve 是一種在涉及大量血塊的複雜 DVT 程序中為心臟和肺提供保護的裝置。我們對啟動的進展情況感到滿意，並受到醫生熱情反饋的鼓舞。我們估計 Protrieve 可用於我們現有 DVT 程序的大約 15%。我們認為，很大一部分競爭性 DVT 干預措施也可以從 Protrieve 中受益。該設備通常在我們按程序定價和 4,000 美元的 ASP 之外出售，這是一個有意義的收入機會。

InThrill is also progressing well in the early stages of full market release. InThrill is a thrombectomy system designed for small vessels including AV fistula and veins in the upper extremities and below the knee. We estimate the combined total addressable market is 250,000 to 300,000 procedures per year in the U.S. alone. At an ASP of $4,000, InThrill represents an additional $1 billion market.

InThrill 在全面上市的早期階段也進展順利。 InThrill 是一种血栓切除術系統，專為小血管設計，包括上肢和膝蓋以下的 AV 瘻管和靜脈。我們估計，僅在美國，可尋址市場的總和每年就有 250,000 到 300,000 次手術。 InThrill 的平均售價為 4,000 美元，代表著一個額外的 10 億美元市場。

We're also making progress on the development of our purpose-built chronic venous disease toolkit with an annual incidence of roughly 100,000 patients and a prevalence of over 1 million, chronic venous disease represents the largest incremental unmet need that we are addressing. We know that unlocking this opportunity will require us to leverage the same types of market development capabilities we have established while working in VTE.

我們還在開發我們的專用慢性靜脈疾病工具包方面取得了進展，每年約有 100,000 名患者發病，患病人數超過 100 萬，慢性靜脈疾病代表了我們正在解決的最大增量未滿足需求。我們知道，釋放這個機會需要我們利用我們在 VTE 工作時建立的相同類型的市場開發能力。

Next, I want to provide an update on Artix, our system that combines both aspiration and mechanical thrombectomy to treat peripheral arterial thrombosis. Although this is a mature market, there is still a high reliance on thrombolytics and open surgery. We recently completed the Artix limited market release or LMR. We observed some excellent case outcomes, and the system exhibited a pristine safety profile. Despite this, we have decided to implement some improvements to the system based upon physician feedback we gathered during the LMR. We expect the Artix toolkit to reenter LMR in 2024 once this work is completed. We remain committed to addressing important unmet needs in this patient population and will release Artix broadly when it meets the high standards that we and our customers expect.

接下來，我想提供有關 Artix 的最新信息，我們的系統結合了抽吸和機械血栓切除術來治療外周動脈血栓形成。儘管這是一個成熟的市場，但仍然高度依賴溶栓和開放手術。我們最近完成了 Artix 有限市場發布或 LMR。我們觀察到一些出色的案例結果，並且該系統表現出原始的安全性。儘管如此，我們還是決定根據我們在 LMR 期間收集到的醫生反饋對系統進行一些改進。一旦這項工作完成，我們預計 Artix 工具包將在 2024 年重新進入 LMR。我們仍然致力於解決這一患者群體中未滿足的重要需求，並將在滿足我們和我們的客戶期望的高標準時廣泛發布 Artix。

In summary, our pipeline is full, and we anticipate a steady cadence of additional product launches in 2023, a clear reflection of the investment we have made in innovation.

總而言之，我們的管道已滿，我們預計 2023 年將以穩定的節奏推出更多產品，這清楚地反映了我們在創新方面所做的投資。

Our last growth driver is expansion into international markets. Q4 marked another quarter of record case in revenue for our international business. Based upon continued growth and relevance, we are pleased to provide a revenue breakout for the first time. Growth in the quarter was 144% over Q4 of 2021 and up 27% sequentially. For the full year 2022, our international business generated revenue of $9.4 million compared to $2.6 million in 2021. Our performance was primarily driven by continued adoption in Europe.

我們最後的增長動力是進軍國際市場。第四季度標誌著我們國際業務收入的又一個創紀錄案例。基於持續的增長和相關性，我們很高興首次提供收入突破。本季度比 2021 年第四季度增長 144%，環比增長 27%。 2022 年全年，我們的國際業務收入為 940 萬美元，而 2021 年為 260 萬美元。我們的業績主要得益於歐洲的持續採用。

On the product front, we were pleased with the recent MDR approval of FlowSaver. Beyond Europe, we also saw a strong case growth during the quarter in our existing markets in Latin America, Canada and Asia Pacific. We recently completed our first cases in Australia, New Zealand and Argentina, and we anticipate additional launches later this year. In China and Japan, we are continuing to pursue regulatory approval while also exploring our go-to-market strategies.

在產品方面，我們對 FlowSaver 最近獲得 MDR 批准感到高興。在歐洲之外，本季度我們在拉丁美洲、加拿大和亞太地區的現有市場也看到了強勁的案例增長。我們最近在澳大利亞、新西蘭和阿根廷完成了第一批案例，我們預計今年晚些時候還會推出更多案例。在中國和日本，我們在繼續尋求監管批准的同時也在探索我們的上市戰略。

I'd like to close by commenting on my first 60 days as CEO. We completed 2022 with a record Q4, driven by strength across our core business. That momentum carried through into 2023, and we are off to a strong start with January and February among the best months we have ever had.

最後，我想談談我擔任 CEO 的前 60 天。在我們核心業務實力的推動下，我們以創紀錄的第四季度結束了 2022 年。這種勢頭一直延續到 2023 年，我們有了一個良好的開端，1 月和 2 月是我們有史以來最好的月份。

In short, I could not be more excited about the health of our business and the bright future of our company. Our markets are large, the unmet needs are significant, and we have never been more confident in our ability to compete. Most importantly, we are serious about our responsibility to do better for our patients. I have no doubt we can and will grow consistently for many quarters to come. With that, I'd like to turn things over to Mitch.

簡而言之，我對我們業務的健康發展和公司的光明未來感到無比興奮。我們的市場很大，未滿足的需求很大，而且我們對自己的競爭能力從未如此自信。最重要的是，我們認真對待為患者做得更好的責任。我毫不懷疑我們能夠並且將會在未來的許多季度持續增長。有了這個，我想把事情交給米奇。

Thank you, Drew, and good afternoon, everyone. Inari's revenues for the fourth quarter of 2022 were $107.8 million, up $24.6 million or 30% from $83.2 million for the same period of the prior year and up 12% or $11.6 million sequentially over the third quarter of 2022. Compared to Q4 of 2021, our revenue growth was due to our continued efforts to open new customer accounts, expand our sales force and deepen our relationship with existing customers.

謝謝你，德魯，大家下午好。 Inari 2022 年第四季度的收入為 1.078 億美元，比上年同期的 8320 萬美元增長 2460 萬美元或 30%，比 2022 年第三季度增長 12% 或 1160 萬美元。與 2021 年第四季度相比，我們的收入增長歸功於我們不斷努力開立新客戶賬戶、擴大我們的銷售隊伍以及加深與現有客戶的關係。

In 2022, we significantly expanded both the FlowTriever and ClotTriever product lines and also begin commercializing the Protrieve and InThrill products. The revenue split between product lines was similar year-over-year with 32% of our revenue derived from the sale of ClotTriever and other systems during the fourth quarter of 2022 versus 30% in 2021 and 68% derived from the sale of FlowTriever systems compared to 70% in 2021.

2022 年，我們顯著擴展了 FlowTriever 和 ClotTriever 產品線，並開始將 Protrieve 和 InThrill 產品商業化。產品線之間的收入分配與去年同期相似，我們 32% 的收入來自 2022 年第四季度 ClotTriever 和其他系統的銷售，而 2021 年為 30%，68% 來自 FlowTriever 系統的銷售到 2021 年達到 70%。

Gross margin was 87.8% for the fourth quarter of 2022 compared with 90.1% in the fourth quarter of 2021. The decline was primarily due to the addition of new products to our FlowTriever system toolkit. This adds additional cost of goods sold due to our per-procedure pricing model.

2022 年第四季度的毛利率為 87.8%，而 2021 年第四季度為 90.1%。下降的主要原因是我們的 FlowTriever 系統工具包中增加了新產品。由於我們的按程序定價模型，這增加了銷售商品的額外成本。

Operating expenses were $100.5 million in the fourth quarter of 2022 compared with $73.2 million in the same period of the prior year. R&D expense was $20.4 million in the fourth quarter compared with $18.7 million for the same period of 2021. The $1.7 million net increase in R&D expense was primarily driven by an increase in headcount offset by a onetime licensing cost in Q4 of 2021 that didn't recur in Q4 of 2022.

2022 年第四季度的運營費用為 1.005 億美元，上年同期為 7320 萬美元。第四季度的研發費用為 2040 萬美元，而 2021 年同期為 1870 萬美元。研發費用淨增長 170 萬美元的主要原因是員工人數的增加被 2021 年第四季度的一次性許可成本所抵消2022 年第四季度再次出現。

SG&A expense was $80.1 million in the fourth quarter of 2022 compared with $54.5 million for the same period of the prior year. The $25.6 million increase was primarily due to personnel-related expenses as we increased our headcount and secondarily due to higher travel expenses. Net loss for the fourth quarter of 2022 was $5.8 million compared to net income of $1.1 million for the same period of the prior year. The basic and fully diluted net loss per share for the fourth quarter of 2022 was $0.11 based on the weighted average basic and fully diluted share count of 53.6 million. These compare with a basic and fully diluted net income per share of $0.02 based on a weighted average basic and fully diluted share count of 50 million and 55.6 million, respectively, for the same period of the prior year.

2022 年第四季度的 SG&A 費用為 8010 萬美元，上年同期為 5450 萬美元。 2560 萬美元的增長主要是由於我們增加了員工人數導致的人事相關費用，其次是由於差旅費用增加。 2022 年第四季度的淨虧損為 580 萬美元，而去年同期的淨收入為 110 萬美元。根據 5360 萬股加權平均基本和完全攤薄股份計算，2022 年第四季度每股基本和完全攤薄淨虧損為 0.11 美元。相比之下，基於上年同期的加權平均基本股數和完全稀釋股數分別為 5000 萬股和 5560 萬股，每股基本和完全稀釋淨收益為 0.02 美元。

Shifting to full year 2022 financial results. Inari's revenues for the full year were $383.5 million, up $106.5 million or 38% from $277 million for the full year 2021. 36% of this annual growth was driven by our U.S. business, while 2% of the growth was generated internationally, primarily in Europe.

轉向 2022 年全年財務業績。 Inari 的全年收入為 3.835 億美元，比 2021 年全年的 2.77 億美元增長 1.065 億美元或 38%。這一年增長的 36% 是由我們的美國業務推動的，而 2% 的增長來自國際市場，主要是在歐洲。

Compared to 2021, our revenue growth was due to our continued efforts to open new customer accounts, expand our sales force, introduce new products and deepen our relationship with existing customers. Revenue split between product lines was substantially the same year-over-year, with 32% of our revenue derived from the sale of ClotTriever and other systems and 68% derived from the sale of FlowTriever systems.

與 2021 年相比，我們的收入增長歸功於我們不斷努力開立新客戶賬戶、擴大銷售隊伍、推出新產品以及加深與現有客戶的關係。產品線之間的收入分配與去年同期基本相同，我們 32% 的收入來自 ClotTriever 和其他系統的銷售，68% 來自 FlowTriever 系統的銷售。

Gross margin was 88.4% for the full year 2022 compared with 91.1% for the full year 2021. The decline was primarily due to the addition of new products to our FlowTriever per-procedure model as well as a decrease in operating leverage due to the expanded footprint of our manufacturing operations.

2022 年全年毛利率為 88.4%，而 2021 年全年為 91.1%。下降的主要原因是我們的 FlowTriever 按程序模型增加了新產品，以及由於擴大我們製造業務的足跡。

Operating expenses were $367.1 million for the full year 2022 compared with $241.4 million for the full year 2021. R&D expense was $74.2 million for the full year 2022 compared with $51 million for the full year 2021. The $23.2 million increase in R&D expense was primarily driven by an increase in headcount as well as product development and clinical evidence development costs. These initiatives are consistent with our previously discussed growth drivers.

2022 年全年運營費用為 3.671 億美元，而 2021 年全年為 2.414 億美元。研發費用為 2022 年全年 7,420 萬美元，而 2021 年全年為 5,100 萬美元。研發費用增加 2,320 萬美元的主要原因是通過增加員工人數以及產品開發和臨床證據開發成本。這些舉措與我們之前討論的增長動力一致。

SG&A expense was $292.8 million for the full year 2022 compared with $190.4 million for the full year 2021. The $102.4 million increase was primarily due to personnel-related expenses as we increased headcount across the organization and secondarily due to higher travel expenses, marketing costs and professional service costs.

2022 年全年的 SG&A 費用為 2.928 億美元，而 2021 年全年為 1.904 億美元。增加的 1.024 億美元主要是由於我們增加了整個組織的員工人數而導致的人事相關費用，其次是差旅費用、營銷費用和專業服務成本。

Net loss for the full year 2022 was $29.3 million compared to net income of $9.8 million for the full year 2021. The basic and fully diluted net loss per share for 2022 year was $0.55 based on the weighted average basic and fully diluted share count of 52.8 million shares. These compare with a basic income per share of $0.20 and fully diluted net income share of $0.18 based on a weighted average basic share count of 49.8 million shares and fully diluted share count of 55.6 million shares for the year 2021.

2022 年全年淨虧損為 2930 萬美元，而 2021 年全年淨收入為 980 萬美元。根據 52.8 股基本和完全稀釋的加權平均股數計算，2022 年每股基本和完全稀釋的淨虧損為 0.55 美元萬股。相比之下，2021 年每股基本收益為 0.20 美元，完全攤薄淨收益份額為 0.18 美元，基於 4980 萬股的加權平均基本股數和 5560 萬股的完全稀釋股數。

Before I move on to the balance sheet updates, I'd like to comment briefly on the company's full year 2022 operating loss of $28.1 million. Consistent with our messaging during 2022, we invested aggressively in our growth drivers. We've leveraged these investments to deliver robust growth, build important capabilities and ultimately better serve our patients.

在繼續更新資產負債表之前，我想簡要評論一下公司 2022 年全年 2810 萬美元的營業虧損。與我們在 2022 年傳達的信息一致，我們積極投資於我們的增長動力。我們利用這些投資實現了強勁的增長，建立了重要的能力並最終更好地為我們的患者服務。

Earlier in the call, Drew shared the exciting progress we are making growing Inari's international business. Building this foundation has taken and will continue to take significant investment. In fact, the international business accounted for roughly half of our operating loss in 2022. As we look ahead to 2023, we are working to reduce the rate of operating expense growth while leveraging our previous investments. We expect to show sequential progress related to these efforts as we move through the year.

在電話會議的早些時候，德魯分享了我們在發展 Inari 的國際業務方面取得的令人振奮的進展。建立這個基礎已經並將繼續需要大量投資。事實上，國際業務約占我們 2022 年營業虧損的一半。展望 2023 年，我們正在努力降低營業費用增長率，同時利用我們之前的投資。我們希望在這一年中展示與這些努力相關的連續進展。

Looking even further ahead to 2024, I'd like to repeat our commitment to achieve sustained operating profitability by the first half of the year. Moving to the balance sheet. Our cash and investments at the end of Q4 totaled $326.4 million, consisting of $60.2 million of cash and $266.2 million of short-term investments.

展望更遠的 2024 年，我想重申我們的承諾，即到今年上半年實現持續的運營盈利能力。轉到資產負債表。截至第四季度末，我們的現金和投資總額為 3.264 億美元，包括 6020 萬美元現金和 2.662 億美元短期投資。

By way of reference, our cash and investments as of the end of Q3 of 2022 were $319.2 million. Our cash flows used in operating activities were $14 million for the full year 2022 compared to cash flows provided by operating activities of $25.5 million in the full year 2021.

作為參考，截至 2022 年第三季度末，我們的現金和投資為 3.192 億美元。 2022 年全年，我們用於經營活動的現金流為 1400 萬美元，而 2021 年全年經營活動產生的現金流為 2550 萬美元。

Lastly, I'd like to address Inari's financial guidance. For the full year 2023, I'd like to reaffirm our revenue guidance of $470 million to $480 million. With that, I'll turn the call back to the moderator for questions.

最後，我想談談 Inari 的財務指導。對於 2023 年全年，我想重申我們 4.7 億至 4.8 億美元的收入指引。有了這個，我會把電話轉回給主持人提問。

For the Q&A segment Drew and I will be joined by Dr. Tom Tu, Inari's Chief Medical Officer.

對於問答環節，Inari 的首席醫療官 Tom Tu 博士將與我和 Drew 一起參加。

(Operator Instructions) Our first question is from Travis Steed with Bank of America.

（操作員說明）我們的第一個問題來自美國銀行的 Travis Steed。

I guess to start with maybe some comments on Q1. I heard you say January, February were the best months you've ever had. But curious if you could kind of break out some of the competitive trialing impact that you saw if you're comfortable with consensus of $104 million.

我想首先可能對 Q1 發表一些評論。我聽說你說一月、二月是你度過的最好的幾個月。但好奇的是，如果你對 1.04 億美元的共識感到滿意，你是否可以打破你所看到的一些競爭性試驗影響。

And then on the 2023 guidance, just curious if you could help break out how you're thinking about the new product contribution versus share and market growth within the 2023 guidance?

然後關於 2023 年指南，只是好奇您是否可以幫助打破您如何考慮 2023 年指南中新產品貢獻與份額和市場增長的關係？

Sure. Thanks for the question, Travis. I can handle the -- some of the competitive dynamics and what we've seen here most recently. And then I think Mitch can probably take the guidance part of your question.

當然。謝謝你的問題，特拉維斯。我可以處理 - 一些競爭動態以及我們最近在這裡看到的情況。然後我認為米奇可能會接受你問題的指導部分。

Maybe I'll start just by reminding everybody that this is a $6 billion market that we are operating in, and we believe it's 6%, maybe 7% penetrated with our technologies. Our focus, as you know, historically, has largely been on market growth, on market expansion, on making the investments we need to make to really begin changing the standard of care for these patients.

也許我會首先提醒大家，這是一個我們正在經營的價值 60 億美元的市場，我們相信我們的技術滲透了 6%，也許 7%。如您所知，從歷史上看，我們的重點主要放在市場增長、市場擴張、進行我們需要進行的投資以真正開始改變這些患者的護理標準。

1 point of market growth is worth 10x the point of market share at this rate of penetration. So our focus historically and as we move forward is largely on market expansion. To the extent we're having new high-quality rivals enter the market, they can help with that market development effort. And I think that has the potential to be quite valuable and impactful for patients.

在此滲透率下，1 個市場增長點相當於 10 倍的市場份額點。因此，我們過去和未來的重點主要放在市場擴張上。就我們有新的高質量競爭對手進入市場而言，他們可以幫助市場開發工作。我認為這可能對患者非常有價值和有影響。

Having said all that, where we compete head-to-head, we continue to feel very confident in our ability to protect and even extend our existing leadership position.

話雖如此，在我們正面交鋒的地方，我們仍然對我們保護甚至擴大我們現有領導地位的能力充滿信心。

We've got a significant head start. We've got hands down, the best field team in the market. We've got a highly differentiated approach to market development. We've got a mountain of clinical data that is growing larger by the day. We've got innovative, purpose-built technology and a robust innovation pipeline. I think all of that gives us a lot of confidence we're going to be able to continue to protect and extend our leadership position.

我們已經取得了重要的領先優勢。我們擁有市場上最好的現場團隊。我們有一個高度差異化的市場開發方法。我們擁有堆積如山的臨床數據，而且每天都在增加。我們擁有創新的、專門構建的技術和強大的創新管道。我認為所有這些都給了我們很大的信心，我們將能夠繼續保護和擴大我們的領導地位。

Specific to Lightning FLASH, we're 6 weeks into that product launch. We have seen competitive trialing. We are quite familiar with what a 16-French platform offers clinically. We've had that product in our own portfolio for a couple of years now. And the feedback we're hearing from our team and from physicians is very consistent. 16-French platform, we believe, is underpowered in PE and is going to leave clot behind, and that's exactly what we're hearing consistently.

具體到 Lightning FLASH，該產品發布已有 6 週時間。我們已經看到了競爭性試驗。我們非常熟悉 16-French 平台在臨床上提供的功能。幾年來，我們已經在自己的產品組合中擁有該產品。我們從我們的團隊和醫生那裡聽到的反饋非常一致。我們認為，16-French 平台在 PE 方面動力不足，並且會留下血塊，而這正是我們一直聽到的。

On the DVT side, we believe an aspiration only approach is going to leave clot behind for the vast majority of these patients that have chronic well-adhered clot. And again, that's exactly what we anticipated and exactly the feedback we're hearing consistently. At the same time, as they've moved from a 12 French to a 16 French platform, they're going to increase exponentially, the amount of aspirational flow and the amount of blood loss that goes along with that. And despite attempted mitigations, we are hearing consistently of significant blood loss. Tom can talk more about the clinical implications that blood loss along the way here. But that's what we're hearing. And as a result, we have not had a single Inari account that has trialed CAT 16 and converted to Penumbra. So we believe bottom line that the CAT 16 product, the impact will be limited to cannibalizing CAT 12 in existing Penumbra accounts.

在 DVT 方面，我們認為對於絕大多數具有慢性良好粘附血塊的患者來說，僅抽吸方法將留下血塊。再一次，這正是我們的預期，也是我們一直聽到的反饋。同時，隨著他們從 12 法語平台轉移到 16 法語平台，他們將成倍增加，吸入流量和隨之而來的失血量。儘管嘗試了緩解措施，我們還是不斷聽到大量失血的消息。湯姆可以在這裡詳細談談失血的臨床意義。但這就是我們聽到的。因此，我們還沒有一個 Inari 帳戶試用過 CAT 16 並轉換為 Penumbra。因此，我們相信 CAT 16 產品的底線，其影響將僅限於蠶食現有 Penumbra 賬戶中的 CAT 12。

So maybe I'll pause there and hand things over to Mitch to address the guidance part of your questions.

所以也許我會停在那裡，把事情交給米奇來解決你問題的指導部分。

Yes, Travis, on the Drew -- sorry, on the guidance question, when we put together our 2023 guidance, we really tried to contemplate all of these factors that are going into the business this year, such as the ability to grow our 2 sort of core VTE markets, the new TAMs that we're sort of focused on for the year, specifically that's made available with Protrieve and InThrill. We also thought about the U.S. and OUS business and the competitive landscape, as you just heard about from Drew.

是的，特拉維斯，關於德魯 - 抱歉，關於指導問題，當我們整理 2023 年指導時，我們真的試圖考慮今年業務中的所有這些因素，例如發展我們 2 的能力某種核心 VTE 市場，我們今年關注的新 TAM，特別是 Protrieve 和 InThrill 提供的。正如您剛剛從 Drew 那裡聽到的那樣，我們還考慮了美國和 OUS 業務以及競爭格局。

Finally, we considered all the pricing dynamics that are going on in the marketplace. And we tried to reflect all of those in the numbers that we've discussed, the $470 million to $480 million number for the year. And we believe that's reflective of the sort of continued confidence in the growth of our business, the U.S. market and internationally as well.

最後，我們考慮了市場上發生的所有定價動態。我們試圖將所有這些反映在我們討論過的數字中，即今年 4.7 億至 4.8 億美元的數字。我們認為，這反映了對我們業務、美國市場和國際市場增長的持續信心。

The new TAMs, specifically to your question, I think the contribution there is going to be relatively modest. It's kind of early in both of those stories. They're still launching. They're doing well. But we're working through the VAC approval process with our hospital customers across the U.S., and it's going to be sort of a slow build for those. As we're able to share some more specific sort of anecdotal feedback on those, we'll certainly do so.

新的 TAM，特別是針對你的問題，我認為那裡的貢獻將相對適度。這兩個故事都有些早。他們還在發射。他們做得很好。但我們正在與美國各地的醫院客戶一起完成 VAC 批准流程，對於那些客戶來說，這將是一個緩慢的過程。由於我們能夠分享一些更具體的軼事反饋，我們當然會這樣做。

All right. That's helpful. And then a quick follow-up is it sounds like, I guess, 6 weeks into the FLOW launch. There's always this worry that maybe you just haven't seen the full impact of the launch yet. Curious if you're seeing it in all of your accounts, have you seen trialing kind of widespread or there's still more to come?

好的。這很有幫助。然後快速跟進，我猜，FLOW 發布已經 6 週了。人們總是擔心也許您還沒有看到發布的全部影響。很好奇您是否在所有帳戶中都看到了它，您是否看到了廣泛的試用或還有更多的試用？

And then curious what kind of feedback you got on Artix, and the limited market release and I'll drop.

然後好奇你對 Artix 有什麼樣的反饋，以及有限的市場發布，我會放棄。

Great. Thanks, Travis. Yes. So we are 6 weeks in. We've seen a pretty steady cadence of competitive trialing. This is not a new phenomenon. This is exactly the pattern that we observed with the CAT 12 launch, for instance. Some of the VAC approvals undoubtedly are going to take longer and some go faster. We see that in our own new product launches. So I would imagine they're likely in the middle innings, if you will, of the rollout. I think they've shared publicly, they've entered full market release in early January and didn't have any supply constraints, and they certainly have talked about navigating their way through VAC approvals exactly as you expect.

偉大的。謝謝，特拉維斯。是的。所以我們已經 6 週了。我們已經看到了相當穩定的競爭性試驗節奏。這不是一個新現象。例如，這正是我們在 CAT 12 發佈時觀察到的模式。毫無疑問，一些 VAC 批准需要更長的時間，而有些則更快。我們在自己的新產品發布中看到了這一點。所以我想他們很可能在推出的中間局，如果你願意的話。我認為他們已經公開分享，他們已經在 1 月初進入全面市場發布並且沒有任何供應限制，而且他們當然已經討論過完全按照您的預期通過 VAC 批准。

So I think we're in the middle innings and I think we've got a pretty good sense of how the product is performing, as you heard me describe. Tom, maybe you'd want to talk about Artix?

所以我認為我們處於中間局，我認為我們對產品的表現有很好的了解，正如你聽到我描述的那樣。湯姆，也許你想談談 Artix？

Sure, Travis. So -- just as a reminder, arterial thrombosis is the smallest of our new TAMs, but still a space that has significant unmet needs. It's different than our other markets in that it's mature. It's got established therapies and a high bar for entry. We completed the Artix LMR recently, and we're very satisfied with some of the case results and the safety record was pristine. But it didn't quite meet our very high standards for commercialization. What we want to do is work to improve the ease of use and effectiveness of the device and expect to complete that work in early 2024.

當然，特拉維斯。所以 - 提醒一下，動脈血栓形成是我們新 TAM 中最小的，但仍然是一個有重大未滿足需求的空間。它不同於我們的其他市場，因為它很成熟。它有既定的治療方法和很高的准入門檻。我們最近完成了 Artix LMR，我們對一些案例結果非常滿意，安全記錄也很完好。但它不太符合我們對商業化的高標準。我們想要做的是努力提高設備的易用性和有效性，並預計在 2024 年初完成這項工作。

This is part of the process. It's similar to the journey that we undertook with early technologies like FlowTriever and ClotTriever. We're committed to doing this right, just like we did with our core products. And this is still a compelling unmet need. We're going to confidently bring a solution that our patients deserve.

這是流程的一部分。這類似於我們使用 FlowTriever 和 ClotTriever 等早期技術進行的旅程。我們致力於正確地做這件事，就像我們對我們的核心產品所做的那樣。這仍然是一個迫切的未滿足需求。我們將自信地帶來患者應得的解決方案。

The next question is from Cecilia Furlong with Morgan Stanley.

下一個問題來自摩根士丹利的 Cecilia Furlong。

I wanted to start with Protrieve. If you could comment really where you are at this point in the full market release, but then also what you're seeing to date in terms of use with competitive products.

我想從 Protrieve 開始。如果您真的可以評論您目前在完整市場發布中所處的位置，那麼也可以評論您迄今為止在競爭產品的使用方面所看到的情況。

And then just second product-related question, if you could comment too, just, across your chronic venous disease toolkit, new products currently planned to launch this year.

然後是第二個與產品相關的問題，如果你也可以在你的慢性靜脈疾病工具包中發表評論，目前計劃今年推出的新產品。

Sure. Thanks for those, Cecilia. So relative to Protrieve, we are, I don't know, 4 months into the full market release. So we're clearly still working to gain a VAC approval for that product. We've got that product stocked at this point in less than 50% of our account base. But we're getting very good feedback, enthusiastic feedback from physicians. It does a very effective job at addressing a pretty significant unmet need for complex DVT procedures where they're at risk of embolizing a clot and causing a PE.

當然。謝謝你，塞西莉亞。因此，相對於 Protrieve，我不知道，我們已經進入全面市場發布 4 個月了。因此，我們顯然仍在努力為該產品獲得 VAC 批准。目前，我們在不到 50% 的客戶群中存有該產品。但是我們得到了非常好的反饋，來自醫生的熱情反饋。它非常有效地解決了對複雜 DVT 程序的相當大的未滿足需求，在這些程序中，它們有栓塞血塊和導致 PE 的風險。

So we like what we're seeing so far. The fact that we've priced it outside of the per-procedure price model gives us some nice incremental revenue opportunity on top of the clinical impact that it's having. But again, we're still in the relative early phases of navigating our way through VAC approvals and getting the product fully stocked across our entire account base. Relative to CBD, you know that we're already helping some of those patients with ClotTriever Bold, although Bold wasn't necessarily designed specifically for that group of patients that has indeed provided some utility and some relief for those patients.

所以我們喜歡我們目前所看到的。我們在按程序定價模型之外對其進行定價這一事實為我們提供了一些很好的增量收入機會，除了它所具有的臨床影響之外。但同樣，我們仍處於通過 VAC 批准的相對早期階段，並在我們的整個客戶群中充分儲備產品。相對於 CBD，你知道我們已經在幫助一些使用 ClotTriever Bold 的患者，儘管 Bold 不一定是專門為那些確實為這些患者提供了一些效用和一些緩解的患者群體設計的。

And then we've got a series of additional tools that we'll be adding to the CBD toolkit as we move through the rest of this year and looking out further beyond that. We've talked in a fair amount of detail about [REVCOR], which is going to be the first of those new incremental tools. That was one of the products that we shared at the Investor Day, for instance, back in September. That product will be coming out here in the first half of this year and will be kind of the second addition to that CBD toolkit alongside Bold. And then as you look out further into the end of this year and into next year, we'll have additional tools that we will be adding to that toolkit just like you've seen us execute with FlowTriever and ClotTriever.

然後我們有一系列額外的工具，我們將在今年剩餘時間裡將它們添加到 CBD 工具包中，並進一步展望未來。我們已經詳細討論了 [REVCOR]，它將成為這些新的增量工具中的第一個。例如，那是我們在 9 月份的投資者日分享的產品之一。該產品將於今年上半年推出，並將成為 CBD 工具包中與 Bold 並列的第二個產品。然後，當您進一步展望今年年底和明年時，我們將有更多工具添加到該工具包中，就像您看到我們使用 FlowTriever 和 ClotTriever 執行一樣。

Great. And if I could follow up also just on gross margins, how we should think about '23 versus the long-term outlook for mid-80s factoring and how you're thinking about OUS expansion, new product launches and also just the per-procedure pricing impact on margins?

偉大的。如果我也可以跟進毛利率，我們應該如何考慮 23 年與 80 年代中期保理的長期前景，以及您如何考慮 OUS 擴張、新產品發布以及每個程序定價對利潤的影響？

Yes. Thank you, Cecilia. I'll try to get started with that one. So the number you saw for Q4 of last year is something that we believe -- is something we plan for essentially as a result of the additions to the FlowTriever toolkit and as well some of the operating leverage issues we've dealt with in our manufacturing facility. The longer-term view towards gross margins is still kind of in that low to mid-80s sort of ZIP code, I would call it. And I think it will be a very gradual sort of migration towards that point. The factors that will contribute to that are the ones that you've mentioned there.

是的。謝謝你，塞西莉亞。我會嘗試從那個開始。所以你看到的去年第四季度的數字是我們相信的——是我們計劃的，主要是由於 FlowTriever 工具包的增加以及我們在製造中處理的一些運營槓桿問題設施。對毛利率的長期看法仍然是那種 80 年代中期的郵政編碼，我稱之為。我認為這將是一種非常漸進的遷移方式。促成這一點的因素就是你在那裡提到的那些。

Some of the products that we'll introduce in the future have a lower gross margin profile than the 2 products that primarily drive that today, the ClotTriever and the FlowTriever. The international side of the business is something that has a -- sort of it detracts from the current gross margin profile of the business, but we're committed to serve patients throughout the world. So that's something we really want to do.

我們將在未來推出的一些產品的毛利率低於今天主要推動這兩種產品的毛利率，即 ClotTriever 和 FlowTriever。該業務的國際化方面有某種程度的降低了該業務當前的毛利率，但我們致力於為世界各地的患者提供服務。所以這是我們真正想做的事情。

We do continue to evaluate opportunities to sort of work against that. We're consistently looking for opportunities to basically sell based on the kind of the value bundle, if you will, of our products. And so we look for opportunities to take price. And we also look for opportunities to change our gross margin through some of our manufacturing, purchasing and other things that we can do to sort of reduce the cost of goods sold of the product as we go along.

我們確實會繼續評估針對這種情況開展工作的機會。我們一直在尋找機會，基本上根據我們產品的價值組合類型進行銷售。因此，我們尋找機會接受價格。我們還尋找機會通過我們的一些製造、採購和其他我們可以做的事情來改變我們的毛利率，以便在我們進行的過程中降低產品的銷售成本。

The next question is from Larry Biegelsen with Wells Fargo.

下一個問題來自富國銀行的 Larry Biegelsen。

I wanted to -- I have 2 questions, 1 on REVCOR, 1 on competition, but I was hoping you could answer Travis' question. On Q1 last year, you were up 4% sequentially, consensus has you down 3% sequentially. If I missed it, I apologize, but I didn't hear you kind of respond to that part of his question.

我想——我有 2 個問題，1 個關於 REVCOR，1 個關於競爭，但我希望你能回答 Travis 的問題。去年第一季度，你連續上漲了 4%，普遍認為你連續下跌了 3%。如果我錯過了，我深表歉意，但我沒有聽到你對他問題的那一部分做出回應。

Yes. So Larry, it's a little tricky here. As you obviously know, being 6 weeks into the quarter, we've not had a habit historically of commenting in a lot of specifics on intra-quarter trends. Given some of the competitive noise, we did want at least acknowledge that we had January and February as 2 of -- among our strongest months ever. So we did want to make sure people heard that. Beyond that, I'm not sure what additional color we're comfortable providing at this point in the quarter.

是的。所以拉里，這裡有點棘手。正如您顯然知道的那樣，進入本季度 6 週後，我們歷史上沒有對季度內趨勢的許多細節發表評論的習慣。考慮到一些競爭噪音，我們確實希望至少承認我們將 1 月和 2 月列為我們有史以來最強勁的月份之一。所以我們確實想確保人們聽到了。除此之外，我不確定在本季度的這個時候我們願意提供什麼額外的顏色。

The consensus number has not been updated, as you know, since we put out guidance at the beginning of the year at the conference in January. Mitch, would you want to add anything beyond that on guidance? And then I can follow-up on the [REVCOR], and the competition.

如您所知，自從我們在年初 1 月份的會議上發布指南以來，共識編號尚未更新。米奇，除此之外，您還想在指南中添加任何內容嗎？然後我可以跟進 [REVCOR] 和比賽。

Sure. I mean, Larry, the Q1, certainly, we like what we're seeing. We're bullish about the quarter, as Drew mentioned. And that's all, I think, very positive. But we get to start the month of March. It's a big month. It has a lot of operating days in it, and so we don't want to get ahead of ourselves there. And I think we're also sensitive as you can expect to this concept of kind of giving the inter-quarter guidance for the business. I think we're just trying to help people understand that we're continuing to feel very confident in our plans for 2023, and 2023 is off to a great start.

當然。我的意思是，拉里，Q1，當然，我們喜歡我們所看到的。正如德魯所提到的，我們對本季度持樂觀態度。我認為，這就是非常積極的。但是我們要從三月份開始。這是一個重要的月份。它有很多運營日，所以我們不想在那裡超前。而且我認為我們也很敏感，因為您可以期待這種為業務提供季度間指導的概念。我認為我們只是想幫助人們了解我們繼續對 2023 年的計劃充滿信心，而 2023 年是一個良好的開端。

Okay. That's helpful. Drew, on so [REVCOR] and competition. So REVCOR , I'm sorry, yes, can you talk about the market opportunity, the mechanism of action? And do you think it's going to work for acute and chronic venous clots and plots? And I did have one follow-up.

好的。這很有幫助。德魯，就這樣 [REVCOR] 和比賽。所以 REVCOR ，對不起，是的，你能談談市場機會，行動機制嗎？你認為它對急性和慢性靜脈血栓和陰謀有用嗎？我確實有一個後續行動。

Yes, I can get started. Tom may want to chime in clinically as well. So [REVCOR], you may recall, it's a product that we designed specifically for in-stent thrombosis. So lots of venous stents being implanted and many of those stents go down over time and have thrombosis and clot that forms inside the stent. Today, no good solutions and certainly no purpose-built solutions to address that clinical problem, and that's exactly what we have targeted at REVCOR to address, a way to safely and effectively remove clot from an implanted venous stent. Tom, would you want to add anything clinically beyond that?

是的，我可以開始了。湯姆可能也想在臨床上插話。所以 [REVCOR]，你可能還記得，這是我們專門為支架內血栓形成設計的產品。因此，植入了大量靜脈支架，其中許多支架會隨著時間的推移而下降，並在支架內形成血栓和凝塊。今天，沒有好的解決方案，當然也沒有專門設計的解決方案來解決這個臨床問題，而這正是我們在 REVCOR 上的目標，即一種安全有效地從植入的靜脈支架中去除血塊的方法。湯姆，除此之外你還想添加任何臨床上的東西嗎？

Sure. So Larry, as you know, our customers are highly creative interventionalists that will use tools that have FDA approval in any manner that they think might help their patients. So although [REVCOR] is purpose-built to address the in-stent thrombosis problem that currently has no good solutions, we think that potentially physicians will find additional uses for it in their VTE armamentarium.

當然。因此，拉里，如你所知，我們的客戶是極富創造力的介入醫生，他們將以他們認為可能對患者有幫助的任何方式使用獲得 FDA 批准的工具。因此，儘管 [REVCOR] 是專門為解決目前沒有好的解決方案的支架內血栓形成問題而設計的，但我們認為醫生可能會在他們的 VTE 設備中找到它的其他用途。

Okay. I got it. All right. So on the competition, so obviously, Penumbra is comparing Lightning FLASH to your products in their promotional material. It sounds like, Drew, on this call, you're saying you believe you can remove more clot with less blood loss. And I heard that both for, I believe, DVT and PE. So I guess my question is, one, is there any way to quantify this -- how do you quantify this, I guess?

好的。我得到了它。好的。因此，在競爭中，很明顯，Penumbra 在其宣傳材料中將 Lightning FLASH 與您的產品進行了比較。聽起來，德魯，在這次電話會議上，你是說你相信你可以用更少的失血去除更多的凝塊。而且我聽說，我相信，DVT 和 PE。所以我想我的問題是，第一，有沒有辦法量化這個——我想你如何量化這個？

And two, the case you mentioned upfront with the new 16 French device, I have to believe that was Lightning FLASH. So my question is, how common do you think 1,000 milliliters of blood loss is? Is that -- that sounds like an outlier, I'm just curious. So a little more quantification of why you believe the reasons that your products are better.

第二，你前面提到的新 16 法國設備的案例，我不得不相信那是 Lightning FLASH。所以我的問題是，您認為 1,000 毫升的失血有多常見？那是——這聽起來像是異常值，我只是好奇。因此，對為什麼您相信您的產品更好的原因進行更多量化。

Sure. So the first part of your question related to clot removal and blood loss. Thankfully, we can point to the 2 largest prospective registries ever conducted in venous thrombectomy to use data to answer the question how effective does ClotTriever remove clot. You can look at the CLOUT data and see very effectively, the vast majority of patients, we removed the vast majority of clot regardless of chronicity. Blood loss in the CLOUT registry was 40 milliliters. So you can see very objectively in the data, the kind of performance that we have from a clot removal and blood loss perspective.

當然。所以你的問題的第一部分與去除血塊和失血有關。值得慶幸的是，我們可以指出有史以來在靜脈血栓切除術中進行的 2 個最大的前瞻性登記，以使用數據來回答 ClotTriever 清除血栓的效果如何的問題。您可以查看 CLOUT 數據並非常有效地看到，對於絕大多數患者，我們去除了絕大多數血塊，而不管其長期性如何。 CLOUT 登記中的失血量為 40 毫升。所以你可以在數據中非常客觀地看到我們從血塊清除和失血的角度來看的那種表現。

See the same thing when you look at FlowTriever relative to the FLASH industry, blood loss there, for instance, you heard in the prepared remarks, 100 milliliters. We've had line of sight to a couple of dozen CAT 16 cases at this point. And the average blood loss that we're seeing, catalog in those cases is north of 500 milliliters.

當您查看與 FLASH 行業相關的 FlowTriever 時，您會看到同樣的事情，例如，您在準備好的評論中聽到的失血量為 100 毫升。在這一點上，我們已經看到了幾十個 CAT 16 案例。我們看到的平均失血量，這些病例的目錄在 500 毫升以上。

Certainly, 1,000 milliliters is north of that even. Keep in mind, that's a pretty significant part of the overall blood volume, 20% of the blood volume. So obviously, a very significant clinical finding to have that amount of blood loss. And it's not insignificant. Tom can talk more specifically about some of the clinical implications, but blood loss is a known risk factor for all interventional procedures and venous thrombectomy is no different.

當然，1,000 毫升甚至更高。請記住，這是總血量的相當大的一部分，佔血量的 20%。很明顯，大量失血是一個非常重要的臨床發現。這不是微不足道的。湯姆可以更具體地談論一些臨床意義，但失血是所有介入手術的已知風險因素，靜脈血栓切除術也不例外。

The next question is from Adam Maeder with Piper Sandler.

下一個問題來自 Adam Maeder 和 Piper Sandler。

I wanted to start on guidance construction and test my luck there. I guess as we look at the 23% to 25% year-over-year growth, is it reasonable to think that 20% plus of that growth is from the core business? And can you just elaborate a little bit how you're thinking about ClotTriever and FlowTriever growth this year? I guess that's the first one. And then I have a follow-up or 2.

我想開始指導建設並在那裡測試我的運氣。我想當我們看到 23% 到 25% 的同比增長時，認為 20% 以上的增長來自核心業務是否合理？您能否詳細說明一下您對今年 ClotTriever 和 FlowTriever 增長的看法？我想這是第一個。然後我有一個跟進或 2。

Yes. I can start on that, Adam, and Mitch may want to chime in as well. I think the way we constructed guidance, as you heard Mitch mentioned earlier, we were very deliberate about contemplating all the different dynamics across the business, the core business, the new TAMs, U.S., OUS, competitive dynamics, pricing, all of those factors were contemplated in the guidance. It was, at the same time, I think, largely driven by or reflective of our confidence and the continued growth of the core VTE franchise here in the U.S. That's obviously the largest part of the business still. The part of the business we have best line of sight and can forecast most confidently.

是的。我可以開始了，亞當，米奇可能也想插話。我認為我們構建指南的方式，正如你之前聽到米奇提到的那樣，我們非常慎重地考慮了整個業務、核心業務、新 TAM、美國、OUS、競爭動態、定價以及所有這些因素的所有不同動態指南中考慮到了。同時，我認為，這在很大程度上是由我們的信心和美國核心 VTE 特許經營權的持續增長所驅動或反映的。這顯然仍然是該業務的最大部分。我們擁有最佳視線並且可以最自信地預測的業務部分。

So that 24% growth at the midpoint, I think, is clearly driven by and reflective of our confidence in the core franchise. And then as you add on, the new products and the new TAMs, I think it's additive to that core and then clearly, continued traction internationally is also additive to the core. Relative to the composition between ClotTriever and FlowTriever, I think just like we saw in Q4, we would anticipate continued balanced growth across the franchise. That mix and the contribution of the 2 on a relative basis has been fairly consistent. Over time, we see some quarter-to-quarter fluctuations. But as we thought about guidance this year, I think, by and large, we contemplated a relatively consistent, balanced contribution from both FlowTriever and ClotTriever.

因此，我認為，中點 24% 的增長顯然是由我們對核心特許經營權的信心推動的，並反映了我們對核心特許經營權的信心。然後當你添加新產品和新 TAM 時，我認為它是對核心的補充，然後很明顯，國際上的持續牽引力也是對核心的補充。相對於 ClotTriever 和 FlowTriever 之間的組合，我認為就像我們在第四季度看到的那樣，我們預計整個特許經營權將持續平衡增長。這種組合和 2 在相對基礎上的貢獻是相當一致的。隨著時間的推移，我們會看到一些季度間的波動。但當我們考慮今年的指導時，我認為，總的來說，我們考慮了 FlowTriever 和 ClotTriever 的相對一致、平衡的貢獻。

That's really helpful, Drew. I appreciate that. And I guess just one clarification as it relates to Artix. So when you issued the guidance in January for the first time for 2023 revenue, was anything baked into that guidance range for Artix? I just wanted to clarify that. And then for the follow-up, I was hoping you could just talk a little bit more about the FLAME study that you have at ACC in the coming days. I think you've talked about potential to eventually change guidelines, and I think you're hopeful that FlowTriever will see an outsized benefit there.

這真的很有幫助，德魯。我很感激。我想只有一項與 Artix 相關的說明。因此，當您在 1 月份首次發布 2023 年收入指南時，Artix 的指南範圍內是否包含了任何內容？我只是想澄清一下。然後對於後續行動，我希望你能在未來幾天多談談你在 ACC 進行的 FLAME 研究。我想你已經談到了最終改變指南的可能性，我認為你希望 FlowTriever 能在那裡看到巨大的好處。

So maybe just kind of walk through time lines there and how you think about potential impact to your business?

因此，也許只是瀏覽一下時間線，以及您如何看待對您的業務的潛在影響？

Sure. Yes. Thanks for those, Adam. I can talk about Artix and guidance, and then I'll invite Tom to talk about FLAME from there. But to answer your question on Artix, yes, there was a modest amount of Artix revenue that was included in guidance back in early January.

當然。是的。謝謝你，亞當。我可以談論 Artix 和指導，然後我會邀請 Tom 從那裡談論 FLAME。但是要回答你關於 Artix 的問題，是的，1 月初的指導中包含了少量的 Artix 收入。

At that point in time, the LMR was still underway. But keep in mind, that was the smallest of the new TAMs and as a result, had an even more modest contribution or contemplation within the guidance. And despite us making the decision that we need to do more work before that product is ready for prime time, we feel as though we've got plenty of other levers and offsets to the modest contribution that was factored into the guidance.

當時，LMR 仍在進行中。但請記住，這是最小的新 TAM，因此在指南中的貢獻或考慮更為有限。儘管我們決定在該產品準備好進入黃金時段之前我們需要做更多的工作，但我們覺得我們還有很多其他的槓桿和抵消指南中考慮的適度貢獻。

So we still feel really confident in the $475 million, as you heard Mitch talk about, and that's despite the incremental news on Artix. So with that, maybe I'll turn things over to Tom, and he can tackle the FLAME questions.

所以我們仍然對 4.75 億美元充滿信心，正如你聽到 Mitch 所說的那樣，儘管關於 Artix 的新聞越來越多。因此，也許我會把事情交給湯姆，他可以解決 FLAME 問題。

Thanks, Drew. Yes. So Adam, thank you for the question about FLAME. As you can tell, we're very excited about this data release because it is the largest ever interventional study for high-risk PE. This is a group of patients with a predicted mortality anywhere from 25% to 50%. And frankly, the existing solutions, even guideline-directed solutions are unsatisfactory for this patient population. So if these trial results are positive and are well-accepted, I think there is a very good chance that FlowTriever will make its debut in guidelines for the treatment of this patient subset.

謝謝，德魯。是的。 Adam，謝謝你提出關於 FLAME 的問題。如您所知，我們對該數據發布感到非常興奮，因為它是有史以來規模最大的高風險 PE 干預研究。這是一組預測死亡率在 25% 到 50% 之間的患者。坦率地說，現有的解決方案，甚至指南指導的解決方案都不能滿足這一患者群體的要求。因此，如果這些試驗結果是積極的並且被廣泛接受，我認為 FlowTriever 很有可能在該患者亞群的治療指南中首次亮相。

And I do think FlowTriever will get the outsized benefit for 2 reasons. First of all, we're the ones who've invested the hard work in studying these patients and establishing our technologies through rigorous scientific methods and I think the physicians making choices about patient care acknowledge that.

我確實認為 FlowTriever 會因為兩個原因而獲得巨大的好處。首先，我們是那些投入辛勤工作研究這些患者並通過嚴格的科學方法建立我們的技術的人，我認為在患者護理方面做出選擇的醫生承認這一點。

Secondly, we have quite a bit of real-world data that suggests that our treatment effect is not a class effect. We have a unique mechanism of action. Our safety profile is pristine. And I think because of that, you're going to see further publications that distinguish our treatments, FlowTriever and ClotTriever from other similar mechanical thrombectomy approaches, which is why I believe Inari is going to get the nod in terms of specific mention in guidelines.

其次，我們有相當多的真實世界數據表明我們的治療效果不是類別效應。我們有獨特的作用機制。我們的安全概況是原始的。我認為正因為如此，您將看到更多的出版物將我們的治療方法 FlowTriever 和 ClotTriever 與其他類似的機械血栓切除術方法區分開來，這就是為什麼我相信 Inari 將在指南中具體提及方面得到認可。

The next question is from Marie Thibault with BTIG.

下一個問題來自 BTIG 的 Marie Thibault。

I wanted to start here with international. Would love to hear a little bit more about that market in terms of how you're pricing the devices and where that could go over the next year. So you mentioned obviously some very nice percentage growth metrics here in the fourth quarter, but just wondering, should we expect to see a doubling in revenue? Can you give us kind of a sense of how you're thinking about the international growth expansion this year?

我想從國際開始。很想听聽更多有關該市場的信息，例如您如何為設備定價以及明年可能走向何方。所以你在第四季度顯然提到了一些非常好的百分比增長指標，但只是想知道，我們應該期望看到收入翻番嗎？你能告訴我們你是如何看待今年的國際增長擴張的嗎？

Yes. Thanks, Marie. I can get started on that and Mitch may want to pile on as well. But yes, we are excited to break out international for the first time you heard the 9 million in revenue for 2022. I think it continues to reflect the traction and the investment that we have made and the unmet need that exists internationally. Much of that growth being driven at this point is still out of Europe. We've got a nice commercial footprint that has now been established. We're doing cases now across all of those markets. We've got incremental reimbursement established, as you've heard us talk about in Germany, we recently got some incremental reimbursement established in France. Each month, each quarter that goes by, we continue to see nice traction coming out of Western Europe, but still lots of work to do.

是的。謝謝，瑪麗。我可以開始著手，米奇可能也想繼續努力。但是，是的，我們很高興第一次聽到 2022 年的 900 萬收入。我認為這繼續反映了我們所做的牽引力和投資以及國際上存在的未滿足需求。目前推動的大部分增長仍來自歐洲。我們已經建立了良好的商業足跡。我們現在正在所有這些市場上做案例。我們已經建立了增量報銷，正如您在德國聽到我們談論的那樣，我們最近在法國建立了一些增量報銷。每個月，每個季度過去，我們繼續看到來自西歐的良好牽引力，但仍有許多工作要做。

I mean we're still very, very early in the rollout and the penetration rates in that market even more modest at this stage than what we see here in the U.S.

我的意思是我們還處於非常、非常早的推出階段，現階段該市場的滲透率甚至比我們在美國看到的還要低。

It is clearly included in the guidance, as you heard us talk about. I don't think we'll break out specifically necessarily the dollar amount, but we would continue to anticipate robust growth internationally driven by primarily at this point, still Western Europe. Pricing has been, candidly, better than we had anticipated when we got started internationally a couple of years ago. In Europe, we have a mix of primarily direct markets, and then we're indirect in some of the southern European markets, for instance.

正如您聽到我們談論的那樣，它明確包含在指南中。我認為我們不一定會具體打破美元金額，但我們將繼續預計在這一點上主要由西歐推動的國際強勁增長。坦率地說，定價比我們幾年前在國際上起步時的預期要好。在歐洲，我們有一個主要是直接市場的組合，然後我們在一些南歐市場是間接的，例如。

But by and large, the margin profile has come together much more strongly than even we had anticipated. Doesn't quite compare to the U.S. margin. So it does factor into the longer-term degradation in the margin that you've heard us talk about. But I think we've been pleased with the pricing landscape in Europe. And then on top of Europe, as you look more broadly internationally, we continue to do work from a regulatory standpoint to get on market in Japan and China. We're increasingly focused on exploring what the go-to-market strategy will be in those 2 respective markets.

但總的來說，利潤率比我們預期的要強得多。與美國利潤率相比並不完全。因此，它確實會影響您聽到我們談論的利潤率的長期下降。但我認為我們對歐洲的定價格局感到滿意。然後在歐洲之上，當你放眼更廣泛的國際時，我們繼續從監管的角度開展工作，以便在日本和中國上市。我們越來越專注於探索這兩個市場的上市策略。

And then we're opportunistically continuing to do cases and add new markets globally. I think we're north of 20-some markets now in total internationally. So we're doing cases now in Australia and New Zealand, Singapore, Chile, Colombia, a fairly large list now, all still relatively early. But again, this is a key growth driver for us. And I think over time, we'll be an increasingly important contributor not only to our growth, but also the kind of clinical impact we're having on patients.

然後我們機會主義地繼續做案例並在全球範圍內增加新市場。我認為我們現在在國際上總共超過 20 個市場。所以我們現在在澳大利亞和新西蘭、新加坡、智利、哥倫比亞做案例，現在有一個相當大的名單，所有這些都還相對較早。但同樣，這對我們來說是一個關鍵的增長動力。而且我認為隨著時間的推移，我們將成為越來越重要的貢獻者，不僅對我們的成長，而且對我們對患者產生的臨床影響。

Sorry, Marie, just to add, I made a brief comment there about the portion of our operating loss that's kind of related to the international business. We believe that this is a very worthwhile and significant and important investment for the company. And that's why we're willing to kind of deal with that. And as time goes on, we believe this will actually be a significant part of the company's overall revenue picture. And so I think that could be a few years, hence, obviously. But we're very excited about the international prospects for the business, and we see some really positive developments for the business coming up in 2023.

對不起，瑪麗，我只是補充一下，我在那裡對我們與國際業務有關的經營虧損部分做了一個簡短的評論。我們認為，這對公司來說是一項非常值得、意義重大和重要的投資。這就是為什麼我們願意處理這個問題。隨著時間的推移，我們相信這實際上將成為公司整體收入的重要組成部分。因此，我認為這可能需要幾年時間，因此，很明顯。但我們對該業務的國際前景感到非常興奮，我們看到該業務在 2023 年將出現一些非常積極的發展。

Okay. Very helpful. Maybe my follow-up here. If you could give us any details. It's hard for us to track given we don't have a lot of real numbers from some of your competitors. What is your latest market research on sort of market penetration of VTE and then your own market share within that penetrated portion at this point? Any detail there is helpful.

好的。很有幫助。也許我在這裡跟進。如果你能給我們任何細節。鑑於我們沒有很多來自您的競爭對手的真實數據，我們很難追踪。您關於 VTE 市場滲透率的最新市場研究是什麼？此時您在該滲透部分的市場份額是多少？任何細節都有幫助。

Yes, Marie. I'll do our best. As you point out, it's sometimes a difficult market to triangulate on the -- most of the competitors have their results kind of buried within much larger portfolio. So we believe if you start at the highest level of the overall incidence of VTE, we believe that market is growing in the low single digits alongside population growth.

是的，瑪麗。我會盡力的。正如你所指出的，有時很難對市場進行三角測量——大多數競爭對手的結果都隱藏在更大的投資組合中。所以我們相信，如果你從 VTE 總體發病率的最高水平開始，我們相信市場正在隨著人口增長而以較低的個位數增長。

If you look at the penetration within that broad group of patients of any interventional therapy today, both legacy lytic-based interventions as well as mechanical thrombectomy interventions like Inari, we believe in both DVT and PE, the interventional penetration is still somewhere between 10% and 15%, very, very modest, vast majority of patients still getting treated with conservative medical management and coagulation alone.

如果你看看今天任何介入治療在廣大患者群體中的滲透率，無論是傳統的基於裂解的干預措施還是像 Inari 這樣的機械血栓切除術干預措施，我們都相信 DVT 和 PE，介入滲透率仍介於 10% 之間15%，非常非常溫和，絕大多數患者仍在接受保守的醫療管理和單獨的凝血治療。

If you look at just then the sliver of interventional treatment, we believe lytics still today are being used in nearly half of those interventions, still today despite all the traction of mechanical thrombectomy. And if you looked at mechanical thrombectomy as a subset of that interventional market, we believe that segment is growing easily at 20%.

如果您只看一下介入治療的一小部分，我們相信今天仍然在近一半的干預中使用溶解劑，儘管機械血栓切除術的所有牽引力仍在今天。如果您將機械血栓切除術視為該介入市場的一個子集，我們相信該細分市場很容易以 20% 的速度增長。

So those numbers are all estimates and come with a fair amount of art and science to arrive at those estimates, but hopefully, that gives you some sense of how we view the market and some of the estimates that we're making across the board.

所以這些數字都是估計值，並伴隨著大量的藝術和科學來得出這些估計值，但希望這能讓你對我們如何看待市場以及我們正在全面做出的一些估計有所了解。

The next question is from Bill Plovanic with Canaccord.

下一個問題來自 Canaccord 的 Bill Plovanic。

I'd like to get a little clarity on the FLAME data that's coming out in the commentary that this could really change guidelines. And just, Tom, help us understand if we see this data at ACC and it's super powerful, what is the process in terms of guidelines getting changed, like how long would that take in your opinion? And then how long do you think that takes to flow down to kind of everybody else? And that's -- I'll have a follow-up. That's -- I'll start with that, please.

我想稍微澄清一下評論中出現的 FLAME 數據，這可能真的會改變指導方針。湯姆，請幫助我們了解，如果我們在 ACC 看到這些數據並且它非常強大，那麼指南更改的過程是什麼，比如您認為這需要多長時間？然後你認為這需要多長時間才能流向其他人？那就是——我會進行跟進。那是——請讓我從那開始。

Well, thanks for the question, Bill. So of course, the FLAME study design has been published already. So that is public information. And certainly, anything that affects a baseline mortality of 25% to 50%, I think, could be paradigm shifting in this space. Now we all talk about guidelines and standard of care. And I just want to be a little more particular because those 2 are not interchangeable. Standard of care is what doctors do. Guidelines are simply what's codified in some kind of expert consensus document. And I wouldn't necessarily portray it as behavior flows down from guidelines.

好吧，謝謝你的問題，比爾。當然，FLAME 研究設計已經發布。所以這是公開信息。當然，我認為任何影響 25% 到 50% 基線死亡率的事情都可能是這個領域的範式轉變。現在我們都在談論指南和護理標準。而且我只是想更具體一點，因為這兩個是不可互換的。護理標準是醫生所做的。指南只是某種專家共識文件中編纂的內容。而且我不一定會將其描述為行為遵循準則。

I think it's a 2-way street. It is quite likely that the compelling data that is presented at ACC next week is going to immediately shift behavior patterns of physicians that are already kind of on the cusp of change of practice patterns. I think guidelines are written by various physician organizations. They all have different schedules on when they meet, how often they meet, how often they update their guidelines. Although it is not unheard of for out-of-sequence meetings to be held and guidelines to be updated when compelling data is presented. So certainly, that could be the case. But we may certainly see behavioral changes well before you see any codification in printed guidelines.

我認為這是一條兩條路。下週在 ACC 上展示的令人信服的數據很可能會立即改變醫生的行為模式，而這些行為模式已經處於改變實踐模式的風口浪尖。我認為指南是由各種醫師組織編寫的。他們在開會的時間、開會的頻率、更新指南的頻率上都有不同的時間表。儘管在提出令人信服的數據時，亂序召開會議和更新指導方針並非聞所未聞。當然，情況可能是這樣。但是，在您看到印刷指南中的任何編纂之前，我們肯定會看到行為上的變化。

Great. And then just the clarification. I know there's been obviously a lot of questions around just the guidance, but I just wanted to confirm that -- and I heard this right, that January and February were the 2 best months for the company in its history. Is that accurate?

偉大的。然後只是澄清。我知道圍繞指南顯然存在很多問題，但我只是想確認這一點——我沒聽錯，1 月和 2 月是公司歷史上最好的兩個月份。那是準確的嗎？

Yes. What we said in the prepared remarks, Bill, were that January and February were among the strongest months we've ever had. And obviously, February is not quite over yet, but that's the way we framed it.

是的。比爾，我們在準備好的發言中所說的是，一月和二月是我們經歷過的最強勁的月份。顯然，二月還沒有結束，但我們就是這樣設計的。

Okay. And then just, again, which I think Mitch's comment that -- and then March is a longer than typical month.

好的。然後再一次，我認為 Mitch 的評論是——然後 3 月比通常的月份要長。

Yes, certainly relative to February. And I think the way the calendar shapes up this year, I think there's even more working days, if you will, in the month of March.

是的，當然是相對於 2 月而言。而且我認為今年日曆的形成方式，如果你願意的話，我認為 3 月份的工作日會更多。

The next question is from Mike Sarcone with Jefferies.

下一個問題來自 Jefferies 的 Mike Sarcone。

The first one, I think, for Mitch. Mitch, you had mentioned when you were talking about '23 guidance that you also incorporated pricing trends and dynamics. Do you think you can just walk us through how ASP has trended through 4Q and then what you're expecting in 2023?

第一個，我想，是給米奇的。米奇，你在談論 23 年指南時曾提到你還納入了定價趨勢和動態。您是否認為您可以向我們介紹 ASP 在第四季度的趨勢以及您對 2023 年的預期？

Yes. We were -- we've been very pleased with the pricing performance of the business really throughout the year 2022. And so it's been a stable market for us. And as we've added value to the FlowTriever toolkit, and we're sort of heading in the direction of toolkits for ClotTriever and eventually for chronic venous as well. We're looking for ways to make sure we can sell based on value rather than sort of price-based competition. And I think we've been successful as our hospital contracts roll over to emphasize the value and the kind of the clinical outcomes that the treating physicians are able to gain with these products.

是的。我們曾經——我們對整個 2022 年業務的定價表現非常滿意。因此，這對我們來說是一個穩定的市場。隨著我們為 FlowTriever 工具包增加價值，我們正朝著 ClotTriever 工具包的方向前進，最終也將用於慢性靜脈。我們正在尋找方法來確保我們可以根據價值而不是基於價格的競爭進行銷售。而且我認為我們已經取得了成功，因為我們的醫院合同延期以強調治療醫生能夠通過這些產品獲得的價值和臨床結果的種類。

And as well, we have a -- we're in a nice position because as a lytic free treatment, we're able to keep patients out of the ICU. So from a hospital point of view, the concept of mechanical thrombectomy without lytics is something that tends to be a positive margin contribution procedure for the hospitals.

而且，我們還有一個 - 我們處於一個很好的位置，因為作為一種無溶解的治療，我們能夠讓患者遠離 ICU。因此，從醫院的角度來看，沒有溶血劑的機械血栓切除術的概念對醫院來說往往是一種積極的保證金貢獻程序。

Whenever hospitals resort to the use of lytics for the treatment of VTE, it becomes a loser for them based on the reimbursement profile, either for DVT or PE. So that helps us as well in these price discussions and negotiations with our hospital customers as these contracts roll over.

每當醫院使用 lytics 治療 VTE 時，根據報銷情況，無論是 DVT 還是 PE，它都會成為他們的失敗者。因此，隨著這些合同的到期，這也有助於我們與醫院客戶進行這些價格討論和談判。

So we're continuing to be optimistic about the opportunities to selectively take price as these hospital contracts roll over, and we were able to basically bundle more value into our product offering.

因此，隨著這些醫院合同的到期，我們繼續對有選擇地採取價格的機會持樂觀態度，並且我們基本上能夠將更多價值捆綁到我們的產品中。

Okay. Thanks, Mitch. And just one follow-up for Tom. Just on the FLAME data. Tom, you've mentioned a few times that if the data looks good, not only could this help change guidelines for high risk, but maybe it could also drive adoption in intermediate risk. Could you just talk about what the strategy and the messaging there looks like for the intermediate risk population? And how long it might take before you could see some incremental impact from positive FLAME data?

好的。謝謝，米奇。湯姆的後續行動。就在 FLAME 數據上。湯姆，您曾多次提到，如果數據看起來不錯，這不僅可以幫助改變高風險指南，而且還可以推動中等風險的採用。您能否談談針對中等風險人群的策略和消息傳遞是什麼樣的？您可能需要多長時間才能看到積極的 FLAME 數據帶來的一些增量影響？

Sure. Happy to answer that one pretty quickly. So the high-risk PE patient population, although very compelling and very high risk constitutes really only 5% to 10% of the overall PE patient population. So I think you might see some immediate messaging around that population. But I think it stands to reason if you can get excellent outcomes and safe procedures in the sickest of the sick patients, why wouldn't you want to offer that kind of therapy for the patients who are a little more stable, but much more numerous?

當然。很高興很快回答這個問題。因此，高風險 PE 患者群體雖然非常引人注目且風險非常高，但實際上僅佔整個 PE 患者群體的 5% 至 10%。因此，我認為您可能會看到圍繞該人群的一些即時消息。但我認為，如果你能在病情最嚴重的患者身上獲得出色的結果和安全的手術，這是有道理的，為什麼你不想為稍微穩定一點但數量更多的患者提供這種治療呢？ ？

And I think that kind of justification could be very compelling for the bulk of our customers out there. Understand that we are simultaneously gathering randomized data in those patient populations. So more data will be forthcoming. But in the meantime, I think the FLAME data results could move even the middle of the pack there as far as intermediate risk patients.

而且我認為，對於我們的大部分客戶來說，這種理由可能非常有說服力。了解我們正在同時收集這些患者群體的隨機數據。所以會有更多的數據出現。但與此同時，我認為 FLAME 數據結果甚至可以將中間風險患者移動到中間位置。

The next question is from Richard Newitter with Truist.

下一個問題來自 Truist 的 Richard Newitter。

Maybe just to start, on the international contribution, could you give us a sense, do you think international as a percentage of sales is going to increase in '23?

也許只是開始，關於國際貢獻，你能給我們一個感覺，你認為國際作為銷售額的百分比會在 23 年增加嗎？

Yes. So I think we're relatively early still, obviously, in the international rollout. It's a very modest percent of sales you saw some place in the low single-digit percent of sales. I think as we continue to ramp internationally and gain traction in Europe and then in particular, as we start adding some of the larger markets in Asia Pacific, both Japan and China, I think over time, clearly, it will become a larger and larger percentage of the overall revenue mix. I think on a relative basis in '23, I got to think, of course, it's going to be north of where it was in '22.

是的。所以我認為我們在國際推廣方面顯然還相對較早。您在銷售額的低個位數百分比中看到的銷售額佔銷售額的百分比非常適中。我認為隨著我們繼續在國際上發展並在歐洲獲得牽引力，特別是隨著我們開始在亞太地區增加一些更大的市場，包括日本和中國，我認為隨著時間的推移，顯然，它會變得越來越大佔總收入組合的百分比。我認為在 23 年的相對基礎上，我必須考慮，當然，它會比 22 年的位置更靠北。

Beyond that, I'm not sure we're going to put a specific number to it, but it is clearly growing faster than the broader business now of, albeit a pretty modest base still.

除此之外，我不確定我們是否會給它一個具體的數字，但它顯然比現在更廣泛的業務增長得更快，儘管基數仍然很小。

Okay. That's helpful. And then maybe just on the new products and the pricing strategy there. It's still early. This is a little bit different than the way you've priced your portfolio historically. So I'm just curious on how you arrived at the price point, particularly, Protrieve $4,000, how the pricing strategy is going so far for some of these newer products? What are you learning? Do you think there will need to be any fine-tuning?

好的。這很有幫助。然後可能只是關於新產品和那裡的定價策略。現在還早。這與您以往為投資組合定價的方式略有不同。所以我很好奇你是如何達到這個價格點的，特別是 Protrieve 4,000 美元，這些新產品的定價策略到目前為止是如何進行的？你在學什麼？您認為需要進行任何微調嗎？

And then I'm just curious from a modeling standpoint, how we should be thinking about or modeling, specifically pricing here? Is this just ASP lift for DVT on Protrieve? Or I'm just trying to think from a modeling standpoint, what you may or may not disclose going forward so we can parse out the contribution from core U.S. VTE.

然後我只是從建模的角度很好奇，我們應該如何思考或建模，特別是在這裡定價？這只是 Protrieve 上 DVT 的 ASP 提升嗎？或者我只是想從建模的角度思考，你可能會或可能不會透露未來的內容，以便我們可以分析出美國核心 VTE 的貢獻。

Yes. So I think pricing is going to have multiple elements, right? I think most importantly, we're going to continue to try and take price relative to the established FlowTriever and ClotTriever franchises. You heard Mitch describe some of those dynamics. And I think leveraging the broader economic value proposition, leveraging some of the new introductions we brought under the PPP models, I think, gives us some confidence we're going to be able to maintain, if not take price with the core part of the business.

是的。所以我認為定價將包含多個元素，對嗎？我認為最重要的是，我們將繼續嘗試相對於已建立的 FlowTriever 和 ClotTriever 特許經營權定價。你聽說米奇描述了其中的一些動態。而且我認為，利用更廣泛的經濟價值主張，利用我們在 PPP 模式下引入的一些新產品，我認為，如果不對核心部分進行定價，我們將能夠保持一些信心商業。

As we bring out some of these new products, we have priced some of them outside of those PPPs. Protrieve and InThrill are the first 2 examples of those. Those pricing -- those price points were established based upon understanding the hospital economics, understanding the clinical unmet need, understanding the physician economics, all of the traditional inputs are reflected in those two $4,000 price points. And I think as you look across the introductions that are coming in the pipeline, I think you'll see, again, a mix of us adding new products under the PPP as well as pricing products outside the PPP, as you saw us do with Protrieve and InThrill.

當我們推出其中一些新產品時，我們已將其中一些產品定價在這些 PPP 之外。 Protrieve 和 InThrill 是其中的前兩個例子。這些定價——這些價格點是基於對醫院經濟學的理解、對臨床未滿足的需求的理解、對醫生經濟學的理解而建立的，所有傳統投入都反映在這兩個 4,000 美元的價格點中。而且我認為，當您查看即將推出的產品時，我想您會再次看到我們在 PPP 下添加新產品以及在 PPP 之外定價產品的組合，正如您看到的那樣Protrieve 和 InThrill。

And I think those strategies will be specific to the products as they enter the market.

而且我認為這些策略將針對進入市場的產品。

Okay. And sorry, just if I can field one last one. On the taking price, did you -- are you starting to do that in the first half of this year? Or is that more of a second half '23 opportunity for you?

好的。抱歉，如果我能派出最後一個就好了。在接受價格方面，你是否 - 你在今年上半年開始這樣做了嗎？或者這對你來說更像是 23 年下半年的機會？

Yes. I don't think we've ever stopped trying to take price. Most of our contracts are multiyear. So most of that work takes place as contracts expire. But we've got 9 products now in the FlowTriever toolkit. And I think as we built out that toolkit, for instance, and those contracts have come up for renewal, that's something that we're always focused on. That will be true here in the first half of the year and looking out to the back half of the year as well.

是的。我認為我們從未停止嘗試定價。我們的大部分合同都是多年期的。因此，大部分工作都是在合同到期時進行的。但我們現在在 FlowTriever 工具包中有 9 種產品。我認為，例如，當我們構建了該工具包，並且這些合同已經提出續籤時，這是我們一直關注的事情。今年上半年如此，展望下半年也是如此。

This concludes our question-and-answer session, and the conference is also now concluded. Thank you for attending today's presentation. You may now disconnect.

我們的問答環節到此結束，會議也到此結束。感謝您參加今天的演講。您現在可以斷開連接。