Inari Medical Inc (NARI) 2020 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to Inari Medical, Inc. Fourth Quarter 2020 Earnings Conference Call. (Operator Instructions) And now, I'd now like to introduce your host for today's program, Caroline Corner, Investor Relations. Please go ahead.

女士們、先生們，感謝大家的支持，歡迎參加 Inari Medical, Inc. 2020 年第四季財報電話會議。 （操作員說明） 現在，我想介紹一下今天節目的主持人，投資者關係部門的卡羅琳·科納 (Caroline Corner)。請繼續。

Thank you, operator. Welcome to Inari's Fourth Quarter and Full Year 2020 Earnings Call. Joining me on today's call are Bill Hoffman, President and Chief Executive Officer; and Mitch Hill, Chief Financial Officer.

謝謝你，接線生。歡迎參加 Inari 2020 年第四季和全年財報電話會議。與我一起參加今天電話會議的還有總裁兼執行長比爾霍夫曼 (Bill Hoffman)；財務長米奇希爾 (Mitch Hill)。

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 demands 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.

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。本次電話會議中所做的所有與歷史事實無關的陳述均應被視為前瞻性陳述，包括有關美國市場的陳述。伊納裡 (Inari) 經營的公司；對 Inari 產品和技術的趨勢和期望；伊納裡產品的趨勢與需求； Inari 的預期財務表現、費用和市場地位；以及 COVID-19 對 Inari 營運和 Inari 客戶營運的影響。

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. Please review Inari's most recent filings with the SEC, particularly the risk factors described in Inari's S-1 filing and in Inari's annual report on Form 10-K for the year ended December 31, 2020, 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.

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，可能導致實際結果、績效或成就與前瞻性陳述明示或暗示的任何結果、績效或成就有重大差異。請查看 Inari 最近向 SEC 提交的文件，特別是 Inari 的 S-1 文件和 Inari 截至 2020 年 12 月 31 日的年度 10-K 表格年度報告中描述的風險因素，以了解更多資訊。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，均基於管理層截至目前的預期。除適用法律要求外，Inari 不承擔更新這些聲明的義務。

Inari's press release for the fourth quarter and full year 2020 results is available on Inari's website, www.inarimedical.com, under the Investors section and includes additional details about Inari's financial results. Inari's website also has the latest SEC filings, which you're encouraged to review. A recording of today's call will be available on Inari's website by 5:00 p.m. Pacific Time today.

Inari 的 2020 年第四季和全年業績新聞稿可在 Inari 網站 www.inarimedical.com 的「投資者」部分查看，其中包括有關 Inari 財務業績的更多詳細資訊。 Inari 的網站還提供最新的 SEC 文件，鼓勵您查看。今天的通話錄音將於下午 5:00 之前在 Inari 網站上發布。今天太平洋時間。

Now I would like to turn the call over to Bill for his comments on fourth quarter 2020 business highlights.

現在我想將電話轉給 Bill，請他對 2020 年第四季業務亮點發表評論。

Thank you, Caroline, and thank you, everyone, for joining us today. As many of you know, based on our pre-announcement of revenue and procedure volume in January, we enjoy the success of a productive fourth quarter.

謝謝卡羅琳，也謝謝大家今天加入我們。正如你們許多人所知，根據我們一月份預先公佈的收入和程序量，我們享受了富有成效的第四季度的成功。

Most importantly, we treated a record number of patients. We are excited to share with you some of the detail about our nice progress, including an update on all of our growth drivers. But first, as is now officially a tradition, in our third earnings call as a publicly traded company, I'd like to share with you a patient's story that will remind you about the powerful impact our technology and our team have on the lives of our patients.

最重要的是，我們治療的患者數量創歷史新高。我們很高興與您分享我們取得的良好進展的一些細節，包括我們所有成長動力的最新資訊。但首先，按照現在正式的傳統，在我們作為一家上市公司的第三次財報電話會議上，我想與您分享一個患者的故事，它會提醒您我們的技術和我們的團隊對人們生活的強大影響。我們的病人。

Late in January, a 32-year-old mother of 2 young children presented at a hospital in Pennsylvania with a systemic blood infection, endocarditis and an infected blood clot or vegetation in her right atrium and on the tricuspid valve in her heart. She was very sick. Surgery in which the chest is cracked, the heart is incised and the infected clot is removed is sometimes considered for these patients. This young mom, however, like most patients with this condition, was far too sick for this sort of surgery. Still her only chance for survival depended on removal of this infected clot.

1 月底，一位 32 歲的 2 個孩子的母親因全身性血液感染、心內膜炎到賓州一家醫院就診，右心房和心臟三尖瓣上有受感染的血塊或贅生物。她病得很重。有時會考慮對這些患者進行胸腔破裂、心臟切開和感染血塊去除的手術。然而，這位年輕的媽媽和大多數患有這種疾病的患者一樣，病情太重，不適合進行這種手術。但她唯一的生存機會仍然取決於清除受感染的血塊。

The physician team opted to utilize the brand new Inari T20 Curve. The curve is a 20 French aspiration catheter with an angled or curved distal end that can be pointed directly at the clot, which is often stubbornly adhered to the valve. 2 aspiration passes or Whooshes, as we call them, through the curve and 20 minutes later, the entire infected clot was extracted. This eliminated not only the mechanical issues caused by this clot, but also the source of the infection, enabling successful antibiotic treatment of the systemic infection.

醫生團隊選擇使用全新的 Inari T20 曲線。 Curve 是 20 French 抽吸導管，其遠端有角度或彎曲，可以直接指向經常頑固地粘附在瓣膜上的凝塊。 2 次抽吸通過曲線或我們所說的呼嘯聲，穿過曲線，20 分鐘後，整個受感染的凝塊被提取出來。這不僅消除了由血栓引起的機械問題，也消除了感染源，從而能夠成功地用抗生素治療全身性感染。

The physician who treated this young mom told me that without the curve, the only other remaining option was palliative care, in which the patient would have been kept comfortable, but with no expectation for recovery. Instead, the patient recovered fully and was discharged to her home and to her children just a few days later.

治療這位年輕媽媽的醫生告訴我，如果沒有曲線，唯一剩下的選擇就是安寧療護，患者會保持舒適，但不會期望康復。相反，患者完全康復，幾天後就出院回家並與孩子們團聚。

This mom is not alone. We believe that just in the United States, there are approximately 20,000 patients who present with clot in transit or clots in the right side of the heart, either with or without endocarditis and vegetation.

這位媽媽並不孤單。我們相信，光是在美國，就有大約 20,000 名患者出現運輸中血栓或心臟右側血栓，無論是否患有心內膜炎和贅生物。

The T20 Curve represents a simple, safe and highly effective solution to this complex problem in a very sick patient population with otherwise limited and poor treatment options. In January, we received an FDA clearance for the T20 Curve along with an indication specifically for clot in transit, the first such clearance for any thrombectomy system that does not require cardiopulmonary bypass. The FDA clearance of the T20 Curve represents the first of several TAM-expanding products and a very robust pipeline of new products at Inari. We'll have more to say about this a bit later in the call.

T20 曲線代表了一種簡單、安全且高效的解決方案，可以解決治療選擇有限且較差的重症患者群體中的這一複雜問題。一月份，我們獲得了 FDA 對 T20 Curve 的許可，以及專門針對運輸中凝塊的適應症，這是對任何不需要體外循環的血栓切除系統的首個此類許可。 FDA 對 T20 Curve 的批准代表了幾種 TAM 擴展產品中的第一個，也是 Inari 非常強大的新產品管道。我們稍後會在電話會議中對此進行更多討論。

As a reminder, we are treating fewer than 5% of all the patients we believe can and probably should benefit from our devices in our core DVT and PE markets. We are still in the earliest phase of our mission, and we remain committed to this cause in ways that are far more important to us than business.

提醒一下，在我們的核心 DVT 和 PE 市場中，我們認為可以而且可能應該從我們的設備中受益的所有患者中，我們正在治療的患者不到 5%。我們仍處於使命的最初階段，我們仍然以比業務更重要的方式致力於這項事業。

I'd like now to turn our attention to our Q4 financial performance. Our revenue in Q4 was $48.6 million, up over 144% from the same quarter last year and up 26% from Q3. As you know, we pay close attention to procedure volume, as this metrics more closely than any other aligns with our mission to treat our patients. And over time, we believe it correlates strongly with revenue.

我現在想把注意力轉向我們第四季的財務表現。我們第四季的營收為 4,860 萬美元，比去年同期成長 144% 以上，比第三季成長 26%。如您所知，我們密切關注手術量，因為該指標比任何其他指標都更符合我們治療患者的使命。隨著時間的推移，我們相信它與收入密切相關。

During Q4, our physician customers performed approximately 4,600 procedures, up 156% from the same quarter last year and up 24% from Q3. While our sequential growth of approximately 25% in both revenue and procedures was strong, we experienced a number of important COVID-related headwinds, both anecdotal and measurable.

第四季度，我們的醫生客戶進行了約 4,600 例手術，比去年同期成長 156%，比第三季度成長 24%。雖然我們的收入和程序均強勁地連續增長了約 25%，但我們也經歷了許多與新冠病毒相關的重大逆風，無論是軼事還是可衡量的。

For example, the COVID surg pushed many hospitals beyond bed capacity, resulting in diversion of patients to other hospitals. When this occurred in our top centers, we saw a measurable decline in procedure volume. Many times, all of the hospitals in an entire city had more patients than capacity, resulting in medical management of patients who might otherwise have been treated with flow FlowTriever or ClotTriever. Similar to what we have observed earlier in the pandemic, during Q4 and at least some geographic regions, we also believe patients suffering from VTE were likely reluctant to even present for care.

例如，新冠疫情激增導致許多醫院床位超載，導致病患轉移到其他醫院。當這種情況發生在我們的頂級中心時，我們發現手術量明顯下降。很多時候，整個城市的所有醫院的病人數量都超過了容量，導致對本來可以接受 Flow Triever 或 ClotTriever 治療的病人進行醫療管理。與我們在疫情早期觀察到的情況類似，在第四季度和至少在某些地理區域，我們也認為患有 VTE 的患者可能甚至不願意就醫。

Finally, we saw important restrictions to access to hospitals. This limited our ability to in-service and educate noninterventional stakeholders, including emergency physicians, pulmonologists, hospitalists and intensivists, about our devices and the benefits to patients of the Inari procedures. Similarly, both physicians and administrators often had limited bandwidth to discuss the establishment of systematic processes for identification the triage of VTE patients that we believe will be important as we work to establish MI and stroke like programs. Still, throughout Q4, we found the hospital environment mostly constructive, despite the important increase and even acceleration in COVID diagnoses and hospitalizations.

最後，我們看到了進入醫院的重要限制。這限制了我們對非介入性利害關係人（包括急診科醫生、肺科醫生、住院醫師和重症監護醫生）進行服務和教育的能力，讓他們了解我們的設備以及 Inari 手術對患者的好處。同樣，醫生和管理人員通常都沒有足夠的資源來討論建立用於識別 VTE 患者分類的系統流程，我們認為這對於我們努力建立 MI 和中風類計劃非常重要。儘管如此，在整個第四季度，我們發現儘管新冠肺炎診斷和住院人數大幅增加甚至加速，但醫院環境大多是建設性的。

As highlighted several times in the past, to date, the characteristics of our products and procedures have proven perhaps more resistant to the impact of the pandemic than others in the med tech space. And we have continued to find ways to execute effectively in the COVID environment. We believe this is reflected in our growth.

正如過去多次強調的那樣，迄今為止，事實證明，我們的產品和程序的特性可能比醫療技術領域的其他產品和程序更能抵抗大流行的影響。我們不斷尋找在新冠疫情環境下有效執行的方法。我們相信這反映在我們的成長中。

For starters, our procedures are simple, require limited hospital resources and no ICU stay, all of which are important, given the significant resources and ICU requirements for COVID-positive patients. Our patients most often present emergently. So our procedures, particularly pulmonary embolism, are not usually designated as elective.

首先，我們的程序很簡單，需要有限的醫院資源，而且無需入住 ICU，考慮到新冠病毒陽性患者需要大量資源和 ICU 需求，所有這些都很重要。我們的患者最常出現緊急狀況。因此，我們的手術，尤其是肺栓塞手術，通常不被指定為選擇性手術。

Our sales professionals who typically cover approximately 90% of our procedures in-person are often deemed essential to the procedure by the hospital, which preserves valuable face-to-face time with our physician customers and cath lab staff. And we continue to use Clot Warrior Academy, our Zoom-based training platform accompanied by our online educational portal, to remotely communicate, train and educate physicians, nurses and tech in a highly effective manner.

我們的銷售專業人員通常會親自負責約 90% 的手術，他們通常被醫院視為對手術至關重要，這為我們的醫生客戶和導管實驗室工作人員保留了寶貴的面對面時間。我們繼續使用 Clot Warrior Academy（基於 Zoom 的培訓平台）以及線上教育門戶，以高效的方式遠端交流、培訓和教育醫生、護士和技術人員。

I'd like to turn now to our key growth drivers and to the progress we have made on each of them in the fourth quarter. First, we continue to expand our sales organization to target new hospitals and physicians. We estimate the size of our U.S. target addressable markets in the 460,000 patients recently expanded to include the 20,000 clot in transit patients, similar to the young mom story we shared earlier. This represents a $3.8 billion revenue potential. We remain very early in our efforts to penetrate our core markets, and the effort will require a lot more sales professionals.

我現在想談談我們的主要成長動力以及我們在第四季度在每個方面取得的進展。首先，我們繼續擴大我們的銷售組織，以瞄準新的醫院和醫生。我們估計美國目標市場的規模為 46 萬名患者，最近擴大到包括 2 萬名轉運患者的血栓，類似於我們之前分享的年輕媽媽的故事。這意味著 38 億美元的收入潛力。我們在滲透核心市場方面仍處於早期階段，而這項努力將需要更多的銷售專業人員。

We continue to believe that when fully built out, our sales organization will rival in size the largest interventionally focused sales organizations in the market today. We began Q4, as you know, with 120 territories, and we began Q1 with 130 territories. This is consistent with our historical cadence, excluding earlier pandemic anomalies, of adding about 10 territories per quarter.

我們仍然相信，完全建成後，我們的銷售組織在規模上將與當今市場上最大的專注於幹預的銷售組織相媲美。如您所知，我們從第四季度開始有 120 個地區，從第一季開始有 130 個地區。這與我們每季增加約 10 個地區的歷史節奏一致（排除早期的疫情異常情況）。

Increasingly, this expansion has and will provide opportunity to split territories to focus on our second growth driver, which is building awareness and driving deeper adoption at existing hospital customers. We believe as many as 85% to 90% of PE patients who can benefit from our FlowTriever system are nonetheless treated with conservative medical management or anti-coagulation alone. Similarly, over 60% of DVT patients who can benefit from our devices are managed conservatively.

這種擴張已經並將越來越多地提供機會來分割區域，以專注於我們的第二個成長動力，即提高意識並推動現有醫院客戶的更深入採用。我們相信，多達 85% 至 90% 的 PE 患者可以從我們的 FlowTriever 系統中受益，但仍接受保守的醫療管理或單獨抗凝血治療。同樣，超過 60% 可以從我們的設備中受益的 DVT 患者都得到了保守治療。

Our goal is to access this patient population by educating and communicating regularly about the benefits of large volume clot removal with the noninterventional physicians who manage these patients, again, such as the emergency physicians, pulmonologists, hospitals and intensivists. We're doing this in several ways.

我們的目標是透過定期與管理這些患者的非介入醫生（例如急診科醫生、肺科醫生、醫院和重症監護醫生）進行教育和交流，了解大量血栓清除的好處，從而接觸到這些患者群體。我們正在透過多種方式做到這一點。

We continue to leverage Clot Warrior Academy, and we have recently expanded it to include live cases, local hospital Clot Warrior Academy unplugged sessions and a leadership series for our key opinion leaders in both interventional and noninterventional specialties.

我們繼續利用 Clot Warrior Academy，並且最近將其擴展為包括現場案例、當地醫院 Clot Warrior Academy 不插電課程以及針對介入和非介入專業關鍵意見領袖的領導力系列。

Since its launch in March 2020, Clot Warrior Academy has engaged over 2,800 customers, 70% of whom are physicians, across 150 live-streamed events featuring over 50 physician faculty members. In addition, our CWA online portal has received over 1,000 unique customer visits to more than 100 online courses.

自 2020 年 3 月推出以來，Clot Warrior Academy 已吸引了 2,800 多名客戶，其中 70% 是醫生，透過 150 場直播活動吸引了 50 多名醫師教職員。此外，我們的 CWA 線上入口網站已收到超過 1,000 名獨立客戶訪問 100 多個線上課程。

We are continuing to build our medical affairs team and capabilities. We recently hired Dr. Venkat Tummala, a world-class high-volume interventional radiologist, as VP of Medical Affairs. This is a full-time position, and Dr. Tummala has exited his clinical practice. His broad clinical skills, deep technical expertise and strong social media presence in the interventional radiology community helped further our ability to communicate with a broad customer base. He was previously a frequent contributor to Clot Warrior Academy and is now serving as co-host of these events in addition to providing clinical support to customers worldwide.

我們正在繼續建立我們的醫療事務團隊和能力。我們最近聘請了世界一流的高通量介入放射科醫生 Venkat Tummala 博士擔任醫療事務副總裁。這是一個全職職位，Tummala 博士已退出臨床實踐。他廣泛的臨床技能、深厚的技術專業知識以及在介入放射學界強大的社交媒體影響力有助於進一步提高我們與廣泛客戶群溝通的能力。他以前是 Clot Warrior Academy 的專業撰稿人，現在除了為全球客戶提供臨床支援外，還擔任這些活動的共同主持人。

As we've discussed in the past, we continue to see interest from customers to establish more systematic processes for identifying VTE patients who might benefit from intervention and triaging these patients to the hospital-designated VTE experts. Such systems and processes are standard for heart attack and stroke patients but are virtually nonexistent for VTE patients. With the right resources and focus, we believe we can have a positive impact on these dynamics.

正如我們過去所討論的，我們繼續看到客戶有興趣建立更有系統的流程來識別可能受益於介入的 VTE 患者，並將這些患者分類給醫院指定的 VTE 專家。這樣的系統和流程對於心臟病發作和中風患者來說是標準的，但對於 VTE 患者來說幾乎不存在。憑藉正確的資源和重點，我們相信我們可以對這些動態產生積極影響。

Our third growth driver is to continue to build upon our base of clinical evidence. Last quarter, we shared with you the interim results on 230 patients enrolled into our real-world all-comer FLASH registry for PE. These acute data demonstrated excellent safety in dramatic on table improvement in a battery of hemodynamic variables. The day after our last earnings call, the 30-day follow-up from the same patient population were presented at the American Heart Association's scientific sessions. We believe the 30-day data demonstrate the potential for FlowTriever to both interrupt the natural progression of the disease and impact patient recovery in positive and significant ways.

我們的第三個成長動力是繼續建立在我們的臨床證據基礎上。上個季度，我們與您分享了 230 名患者的中期結果，這些患者參加了我們現實世界中所有參與者 FLASH 的 PE 登記。這些尖銳的數據證明了在一系列血流動力學變數的顯著改善中具有出色的安全性。我們上次財報電話會議的第二天，美國心臟協會的科學會議上公佈了同一患者群體 30 天的追蹤情況。我們相信 30 天的數據表明 FlowTriever 有潛力阻止疾病的自然進展，並以積極和重大的方式影響患者的康復。

The results show just one death at 30 days and a 6.7% readmission rate over that same time frame. By contrast, historical studies and registry on similar patient populations treated with anti-coagulation alone or with thrombolytic drugs have reported mortality of 5% to 15% and hospital readmissions of at least 25%.

結果顯示，30 天時僅有 1 例死亡，同一時間範圍內的再入院率為 6.7%。相較之下，僅接受抗凝血治療或接受溶栓藥物治療的類似患者群體的歷史研究和登記顯示，死亡率為 5% 至 15%，再入院率至少為 25%。

More recently, we also reported exciting results from CLOUT, our real-world all-comer DVT registry. A sub-analysis of challenging chronic clot patients showed that ClotTriever could achieve a 90% median clot removal. This was performed in a single 34-minute procedure on average with no thrombolytics. There were no device-related major adverse events, and the average blood loss was just 50cc.

最近，我們也報告了 CLOUT（我們現實世界的所有參與者 DVT 註冊表）的令人興奮的結果。對具有挑戰性的慢性血栓患者的子分析表明，ClotTriever 可以實現 90% 的中位血栓清除率。此手術平均耗時 34 分鐘，無需使用溶栓劑。沒有發生與設備相關的重大不良事件，平均失血量僅為 50cc。

The results were even more remarkable, given the chronic nature of the clot. Previous studies, like ATTRACT, for example, selected for patients with the most acute clot, focusing exclusively on patients whose symptoms were less than 2 weeks old. This CLOUT sub-analysis selected for patients whose clot was at least 6 weeks old. Older clot, as many of you know, is more firm and more adhered to the vessel wall, and therefore, more difficult to remove via other devices that rely on aspiration and/or thrombolytic drugs. The ClotTriever is purpose-built for this sort of clot. It is designed to get between the vessel wall and the clot and to core the clot from the vessel wall. This sub-analysis confirms that it does this really well in a safe and consistent way.

考慮到血栓的慢性性質，結果更加引人注目。先前的研究（例如 ATTRACT）選擇了血栓最嚴重的患者，專門關注症狀不到 2 週的患者。此 CLOUT 子分析選擇了血栓至少 6 週的患者。正如許多人所知，較舊的血栓更堅硬，更黏附在血管壁上，因此更難以透過其他依賴抽吸和/或溶栓藥物的設備去除。 ClotTriever 專為此類凝塊而設計。它的設計目的是進入血管壁和凝塊之間，並將凝塊從血管壁中取出。該子分析證實它以安全且一致的方式確實很好地做到了這一點。

Finally, we are excited to share that we recently saw publication of the first ever study in which a histopathological analysis was conducted on clot percutaneously extracted via ClotTriever and FlowTriever from DVT and PE patients. The study showed, not surprisingly, that PE and DVT clots are sub-acute to chronic in nature, containing limited fibrin. Because fibrin is the pharmacologic target of thrombolytic drugs like tPA, the limited fibrin content shown in this study suggests why these drugs have limited impact on PE and DVT clots.

最後，我們很高興與大家分享，我們最近看到了第一項研究的發表，其中對透過 ClotTriever 和 FlowTriever 從 DVT 和 PE 患者經皮提取的凝塊進行了組織病理學分析。研究表明，PE 和 DVT 血栓本質上是亞急性到慢性的，含有有限的纖維蛋白，這並不奇怪。由於纖維蛋白是 tPA 等溶栓藥物的藥理學靶點，因此本研究中顯示的有限纖維蛋白含量說明了為什麼這些藥物對 PE 和 DVT 血栓的影響有限。

We believe this is an important study and the first of many in which increasingly interesting questions will be asked and answered about these clots. We will have a lot more to say about chronic clot and the treatment of it in the coming quarters. Meantime, we continue to invest heavily in clinical studies and the production of data that is useful for expanding the market, driving adoption and informing the design of randomized and controlled trials that we remain committed to executing.

我們相信這是一項重要的研究，也是眾多研究中的第一項，其中將提出並回答有關這些凝塊的越來越有趣的問題。在接下來的幾個季度中，我們將有更多關於慢性血栓及其治療的內容。同時，我們繼續大力投資於臨床研究和數據生產，這些數據有助於擴大市場、推動採用並為我們仍然致力於執行的隨機和對照試驗的設計提供資訊。

Our fourth growth driver is to continue to expand our product portfolio. On this front, we have enjoyed an exciting and highly productive few months. Earlier, I shared with you that we recently received FDA clearance of our T20 Curve, along with the clearance for clot in transit for the entire FlowTriever system. The ability of physicians to direct the large bore tip of the curve toward the clot has been useful not only for clot in transit, but also for treating clot in very large diameter vessels such as the inferior vena cava and the most proximal pulmonary arteries.

我們的第四個成長動力是繼續擴大我們的產品組合。在這方面，我們度過了令人興奮且富有成效的幾個月。早些時候，我與您分享了我們的 T20 Curve 最近獲得 FDA 批准，以及整個 FlowTriever 系統運輸途中的凝塊批准。醫生將曲線的大口徑尖端引導至凝塊的能力不僅對於運輸中的凝塊有用，而且對於治療直徑非常大的血管（例如下腔靜脈和最近端肺動脈）中的凝塊也有用。

We have included the curve in our per-procedure pricing, so that it, like all devices in the FlowTriever system, can be used for a single price. This ensures that physicians can make appropriate decisions about which tools to use either procedurally, based exclusively on clinical need, without any concern for the impact on the hospital's procedural economic. We remain committed to the best possible patient outcomes above everything else.

我們已將該曲線包含在每個程式的定價中，因此它與 FlowTriever 系統中的所有設備一樣，可以以單一價格使用。這確保了醫生可以完全根據臨床需求就程序上使用哪些工具做出適當的決定，而無需擔心對醫院程序經濟的影響。我們始終致力於為患者提供盡可能最佳的治療效果。

Next, we recently completed the limited market release of our FLOWSTASIS venous closure system. FLOWSTASIS represents a simple and consistent method of tensioning the compression stitch often used to attain hemostasis after our procedures. We believe this device might have applications beyond Inari procedures, as there are many medium and large bore catheter-based procedures in electrophysiology and structural heart that might benefit from a simple closure system that leaves nothing behind and does not involve suturing into the vein.

接下來，我們最近完成了 FLOWSTASIS 靜脈閉合系統的有限市場發布。 FLOWSTASIS 代表了一種簡單且一致的張緊壓縮縫線的方法，通常用於在我們的手術後實現止血。我們相信該設備的應用可能超出Inari 手術，因為電生理學和結構性心臟領域有許多基於中型和大口徑導管的手術，這些手術可能受益於簡單的閉合系統，該系統不會留下任何痕跡，也不涉及縫合到靜脈。

Finally, we previously reported FDA clearance of our T24 FLEX, which is a much more flexible version of our 24 French aspiration catheter. You might recall that this flexibility makes the device more trackable, more deliverable and easier to use. This has accelerated migration to the larger 24 French system, and it is now used in more than half of our PE procedures. This is important, because the larger the diameter of the catheter, the stronger is the force on the clot and the more clot can be removed. As you know, we believe that maximization of clot retrieval is important to optimal patient outcomes. Looking further into 2021, we're excited about the robust lineup of new products and innovation in our pipeline.

最後，我們之前報告過 FDA 批准了我們的 T24 FLEX，這是我們 24 French 抽吸導管的更靈活的版本。您可能還記得，這種靈活性使設備更易於追蹤、更易於交付且更易於使用。這加速了向更大的 24 法國系統的遷移，現在我們一半以上的 PE 程式都使用它。這很重要，因為導管的直徑越大，作用在凝塊上的力就越強，可以去除的凝塊就越多。如您所知，我們相信最大限度地回收血栓對於獲得最佳患者治療結果非常重要。展望 2021 年，我們對產品線中強大的新產品陣容和創新感到興奮。

Our fifth and final growth driver is expansion into adjacent and international markets. We've made important progress toward expansion into international markets, especially in Western Europe. We reported during our Q3 earnings call that we received an updated CE Mark for ClotTriever. We are pleased to report that we have now completed several successful ClotTriever procedures in Germany. We are pleased also to report that we recently received an updated CE Mark for FlowTriever.

我們的第五個也是最後一個成長動力是擴展到鄰近的國際市場。我們在拓展國際市場，特別是西歐市場方面取得了重要進展。我們在第三季財報電話會議上報告稱，我們收到了 ClotTriever 的更新版 CE 標誌。我們很高興地報告，我們現在在德國成功完成了幾項 ClotTriever 手術。我們也很高興地報告，我們最近收到了 FlowTriever 的更新 CE 標誌。

We are seeing considerable enthusiasm for both devices, as many European physicians have seen the positive readouts from our FLASH and CLOUT registries and investigator-initiated trials. And they've heard positive anecdotal stories from their American counterparts over the past year or 2.

我們看到人們對這兩種設備相當熱情，因為許多歐洲醫生已經從我們的 FLASH 和 CLOUT 註冊以及研究者發起的試驗中看到了積極的結果。在過去的一兩年裡，他們從美國同行那裡聽到了積極的軼事。

Lockdown, limited access and other challenges caused by the pandemic have certainly created challenges for our initial European launch. But at the same time, we are encouraged by the interest we're seeing and the progress we're making. We look forward to a much more constructive environment in Europe soon.

疫情造成的封鎖、進入限制和其他挑戰無疑為我們最初在歐洲的推出帶來了挑戰。但同時，我們所看到的興趣和所取得的進展也讓我們感到鼓舞。我們期待歐洲很快就會出現更具建設性的環境。

Finally, in addition to our efforts in Europe, we have also begun work on the long path toward regulatory approval and reimbursement for our products in both Japan and China. Regarding opportunities in markets adjacent to our core DVT and PE markets, we have identified multiple unmet needs in the venous space and in the vascular space more broadly. And we continue to explore these ideas. We'll have more to say about these in upcoming calls.

最後，除了我們在歐洲的努力之外，我們也開始為我們的產品在日本和中國的監管審批和報銷邁出漫長的道路。關於與我們的核心 DVT 和 PE 市場相鄰的市場機會，我們已經確定了靜脈空間和更廣泛的血管空間中的多個未滿足的需求。我們將繼續探索這些想法。我們將在接下來的電話會議中詳細討論這些內容。

I'd like to conclude by reminding you that we are committed to our mission, to save and transform the lives of our patients. This cause is bigger than ourselves and much more important to us than business. We believe that nothing is more important than taking care of our patients. Any business success and consequent value creation that we might enjoy are never the goals, but instead are merely byproducts of doing the right thing for our patients while taking care of our customers and our teammates. We believe we are in the earliest phase of our mission and that we can and will grow sustainably and aggressively for many years to come.

最後，我想提醒大家，我們致力於履行我們的使命，拯救和改變病人的生活。這項事業比我們自己更重要，對我們來說比商業更重要。我們相信沒有什麼比照顧病人更重要。我們可能享受的任何業務成功和隨之而來的價值創造從來都不是目標，而只是為我們的患者做正確的事情，同時照顧我們的客戶和團隊成員的副產品。我們相信，我們正處於使命的最初階段，我們能夠而且將會在未來的許多年裡持續、積極地發展。

With that, I'd like to turn it over to Mitch.

有了這個，我想把它交給米奇。

Thank you, Bill, and good afternoon, everyone. Inari revenues for the fourth quarter of 2020 were $48.6 million compared to $38.7 million for the prior quarter and up $28.7 million or 144% from $19.9 million for the same period of the prior year. This year-on-year increase was driven by the continued expansion of our sales force, the opening of new accounts and deeper penetration of our products in existing accounts.

謝謝比爾，大家下午好。 Inari 2020 年第四季的營收為 4,860 萬美元，上一季的營收為 3,870 萬美元，較上年同期的 1,990 萬美元成長 2,870 萬美元，增幅 144%。這一同比增長是由於我們銷售隊伍的持續擴張、新客戶的開設以及我們的產品在現有客戶中的更深滲透所推動的。

Revenue was split between our 2 products as follows. 36% of our revenue was derived from the sale of ClotTriever products during the fourth quarter of 2020 compared with 38% in the fourth quarter of 2019. And 64% was derived from the sale of FlowTriever during the fourth quarter of 2020 compared to 62% in the same period of prior year.

我們的兩種產品的收入分配如下。我們的營收中有 36% 來自 2020 年第四季 ClotTriever 產品的銷售，而 2019 年第四季為 38%。64% 來自 2020 年第四季 FlowTriever 的銷售，而 2019 年第四季為 62%上年同期。

Gross margin was 92.4% for the fourth quarter of 2020 compared with 89.2% in the fourth quarter of 2019. Gross margin increased due to a modest 3% increase in average selling prices year-over-year as well as positive operating leverage in our manufacturing facility due to continuous improvement initiatives and the addition of a second production shift in Q4 of 2020.

2020 年第四季的毛利率為 92.4%，而 2019 年第四季的毛利率為 89.2%。毛利率的成長得益於平均銷售價格同比小幅上漲 3%，以及我們製造業的積極營運槓桿由於持續改善措施以及2020 年第四季增加了第二個生產班次，該工廠的規模不斷擴大。

Operating expenses were $37.9 million in the fourth quarter of 2020 compared with $16.6 million for the same period of the prior year. R&D expense was $6.5 million in the fourth quarter compared with $2.7 million for the same period in 2019. The $3.8 million increase in R&D expense was primarily driven by an increase in headcount as well as product development and clinical evidence development costs.

2020 年第四季營運費用為 3,790 萬美元，去年同期為 1,660 萬美元。第四季研發費用為 650 萬美元，而 2019 年同期為 270 萬美元。研發費用增加 380 萬美元主要是由於人員數量以及產品開發和臨床證據開發成本的增加。

SG&A expense was $31.4 million in the fourth quarter of 2020 compared with $13.9 million for the same period of the prior year. The $17.5 million increase was primarily due to personnel-related expenses as a result of increased headcount across our organization and public company compliance costs.

2020 年第四季的 SG&A 費用為 3,140 萬美元，去年同期為 1,390 萬美元。 1750 萬美元的成長主要是由於我們整個組織的員工人數增加以及上市公司合規成本導致的人員相關費用。

Net income for the fourth quarter of 2020 was $7 million compared with net income of $0.4 million for the same period of the prior year. As I did with our Q3 results, I'd like to make a quick comment on the company's positive net income during Q4. As Bill mentioned a few minutes ago, we believe Inari is well positioned for quarters and even years of sustainable revenue growth. We're not optimizing the company operations to produce net income. We plan to continue to invest aggressively in our growth drivers, and we do not necessarily expect to produce positive net income each quarter.

2020年第四季淨利為700萬美元，而上年同期淨利為40萬美元。正如我對第三季業績所做的那樣，我想對公司第四季的淨利潤進行快速評論。正如比爾幾分鐘前提到的那樣，我們相信 Inari 處於有利地位，可以實現幾個季度甚至幾年的可持續收入成長。我們沒有優化公司營運以產生淨利潤。我們計劃繼續積極投資於我們的成長動力，我們不一定期望每季都能產生正的淨利潤。

The basic and fully diluted net income per share for the fourth quarter were $0.14 and $0.13, respectively, and the weighted average basic and diluted share counts were 48.7 million and 55.2 million, respectively, compared with a basic and fully diluted net income per share of $0.06 and $0.01, respectively, and a weighted average basic and diluted share count of 6.2 million and 44.7 million, respectively, for the same period of the prior year. The number of shares last year is significantly lower because of the conversion of the preferred stock and additional common shares issued as a result of the IPO.

第四季基本和完全稀釋每股淨利潤分別為 0.14 美元和 0.13 美元，加權平均基本和稀釋股票數量分別為 4870 萬股和 5520 萬股，而基本和完全稀釋每股淨利潤為上年同期分別為0.06 美元和0.01 美元，加權平均基本股和稀釋股數分別為620 萬股和4,470 萬股。由於優先股和因首次公開發行而發行的額外普通股的轉換，去年的股票數量大幅減少。

In terms of our full year 2020 financial results, revenue was $139.7 million for the full year 2020, representing an increase of 173% over revenue of $51.1 million in 2019. Our product mix remained constant. 37% of our revenue was derived from the sale of ClotTriever products during 2020 compared with 38% in 2019. And 63% was derived from the sale of FlowTriever during 2020 compared to 62% for 2019.

就我們2020年全年財務表現而言，2020年全年營收為1.397億美元，比2019年營收5,110萬美元成長173%。我們的產品結構維持不變。我們的收入中有 37% 來自 2020 年 ClotTriever 產品的銷售，而 2019 年為 38%。63% 來自 2020 年 FlowTriever 的銷售，而 2019 年為 62%。

Gross margin increased slightly to 90.6% for the full year of 2020 compared to 88.4% in 2019. Operating expenses were $108.1 million for the full year of 2020 compared with $44.4 million in 2019. R&D expense increased by 155% to $18.4 million in 2020 compared to $7.2 million in 2019. SG&A expense was $89.7 million for 2020 compared to $37.2 million for 2019.

2020 年全年毛利率小幅成長至90.6%，而2019 年為88.4%。2020 年全年營運費用為1.081 億美元，而2019 年為4,440 萬美元。研發費用成長155%，2020 年為1,840 萬美元. 2019 年為 720 萬美元。2020 年的 SG&A 費用為 8,970 萬美元，而 2019 年為 3,720 萬美元。

Net income was $13.8 million for the full year 2020, and net income per share was $0.43 on a weighted average basic share count of 32 million and $0.27 on a diluted share count of 51.6 million compared to a net loss of $1.2 million and a loss per share of $0.20 on a weighted average basic and diluted share count of 5.9 million for the prior year.

2020 年全年淨利為1,380 萬美元，加權平均基本股數為3,200 萬股時，每股淨利為0.43 美元，稀釋後股數為5,160 萬股，每股淨利為0.27 美元，而淨虧損為120 萬美元，每股淨虧損為120 萬美元。上一年加權平均基本股和稀釋股數為 590 萬股，每股股數為 0.20 美元。

I'd now like to move on to a few balance sheet updates. Our cash of $114.2 million and short-term investment balance of $50 million at the end of the fourth quarter totaled $164.2 million compared to $168 million at the end of the third quarter. We have not yet utilized our $30 million revolving credit facility, although we ended Q4 with borrowing capacity into the credit line of approximately $20 million. Our cash flows from operating activities were $1.9 million in 2020 compared to cash used in operating activities of $4.9 million in 2019.

我現在想談談一些資產負債表的更新。截至第四季末，我們的現金為 1.142 億美元，短期投資餘額為 5,000 萬美元，總計 1.642 億美元，而第三季末為 1.68 億美元。儘管第四季末我們的信貸額度借款能力約為 2,000 萬美元，但我們尚未動用 3,000 萬美元的循環信貸額度。 2020 年，我們的經營活動現金流量為 190 萬美元，而 2019 年經營活動所用現金為 490 萬美元。

As I've mentioned in previous quarters, Inari continues to operate and grow with a relatively neutral cash flow profile.

正如我在前幾個季度提到的，Inari 繼續以相對中性的現金流狀況運作和成長。

I'd now like to turn to guidance. While we continue to experience COVID-related challenges and uncertainties, we are comfortable providing forward-looking guidance as follows. For the first quarter of 2021, we are guiding to $54 million to $56 million in revenue. For the full year 2021, we are guiding to $225 million to $235 million in revenue.

我現在想轉向指導。雖然我們繼續面臨與新冠病毒相關的挑戰和不確定性，但我們很樂意提供以下前瞻性指導。我們預計 2021 年第一季的營收為 5,400 萬至 5,600 萬美元。 2021 年全年，我們預計收入為 2.25 億至 2.35 億美元。

With that, I would like to thank you for your attention. And I'll now turn the call back over to the operator for your questions.

在此，我要感謝您的關注。現在我將把電話轉回給接線員詢問您的問題。

(Operator Instructions)

（操作員說明）

And Jonathan, this is Mitch from Inari. I thought I'd mention that Bill and I actually were just joined by Drew Hykes, who is our Chief Operating Officer; and then by Dr. Tom Tu, who is our Chief Medical Officer. We thought they could be helpful for some of the questions that may be asked.

喬納森，這是來自伊納裡的米奇。我想我應該提到比爾和我實際上剛剛加入了我們的營運長德魯·海克斯 (Drew Hykes)；然後是我們的首席醫療官 Tom Tu 博士。我們認為它們可能對解決一些可能提出的問題有幫助。

Certainly. And our first question comes from the line of Bob Hopkins from Bank of America.

當然。我們的第一個問題來自美國銀行的鮑伯霍普金斯。

Great, and congrats on all the progress. I've 2 quick questions I wanted to ask. But the first thing I wanted to ask, because I was just wondering, Bill, if you could just sort of take a step back, and maybe Drew could chime in here too. Just clearly, despite COVID, it looks like things are just inflecting in your business and in this category generally.

太棒了，祝賀所有的進步。我想問兩個簡單的問題。但我想問的第一件事是，因為我只是想知道，比爾，你是否可以退後一步，也許德魯也可以在這裡插話。很明顯，儘管有新冠疫情，但您的業務和這一類別的情況似乎正在改變。

So I was just wondering if you could maybe take a little bit of a step back for us and just highlight like what do you think is driving the inflection now. Is it maybe just the cumulative effect of all the work that you've done over the past 18 months in the U.S.? Or wondering if there's anything more specific than that, because it really is quite a remarkable last 12 months in terms of your performance in the United States. So just would love to start there with any kind of top-down comments.

所以我只是想知道你是否可以為我們退後一步，強調你認為現在是什麼在推動這種變化。這可能只是您過去 18 個月在美國所做的所有工作的累積效應？或者想知道是否有比這更具體的事情，因為就您在美國的表現而言，過去 12 個月確實非常出色。因此，我很樂意從任何自上而下的評論開始。

Yes. I'll jump in first, and then we'll have Drew fill in some details if you like. So first of all, thanks for the good words, Bob. It's been a grind through COVID. We found ways to execute crisply. I would say -- let me just say 2 things. First of all, I don't think there are any -- there's not one driver. And we've said this about our potential for growth going forward as well. There is not an inflection point. There's not a one binary sort of catalyst that's going to drive things, for better or for worse. This is a pure execution play, and I think all the variables from data to new products to crisp commercial execution and so forth play an equal role here.

是的。我會先介入，然後如果您願意的話，我們會讓德魯填寫一些細節。首先，感謝鮑伯的好話。經歷了新冠疫情，這真是一場磨難。我們找到了清晰執行的方法。我想說——讓我只說兩件事。首先，我認為沒有——沒有一個驅動程式。我們也談到了我們未來的成長潛力。不存在拐點。沒有一種二元催化劑可以驅動事物，無論是好是壞。這是一個純粹的執行遊戲，我認為從數據到新產品再到清晰的商業執行等所有變數在這裡都發揮著同等的作用。

I will say this also, we had a VIP visit. We do these pretty routinely. And there was a physician here just a few days ago, and he was telling me about a patient that he treated. And the patient was dying, right? The patient had that look. He said, this patient has that look. And the patient was dying. And everyone in the room knows that the patient recognizes if their potential to die is right now. And a few seconds later, he took out a big chunk of clot. In another few seconds after that, he took another big chunk of clot.

我還要說的是，我們進行了 VIP 訪問。我們經常這樣做。幾天前這裡有一位醫生，他正在向我講述他治療過的一位病人的情況。病人快要死了，對嗎？病人就是這樣的表情。他說，這個病人就是這個樣子。病人快要死了。房間裡的每個人都知道，病人知道他們現在是否有死亡的可能性。幾秒鐘後，他取出了一大塊血塊。又過了幾秒鐘，他又拿出了一大塊血塊。

The anesthesiologist commented that the -- what did you do, right? The heart rate is down. The blood pressure is back up. The patient is joking about dinner and how bad the chicken sandwiches are going to be here at the hospital. And the whole mood changes, right? That is visceral, right? That has nothing to do with data, has nothing to do with the product per se or price, right? And there's a visceral component to this that I think cannot be overlooked. And I believe there's a cumulative effect to those sorts of experiences that are going on in cath labs all over the country.

麻醉師評論說——你做了什麼，對吧？心率下降。血壓又回升了。病人開玩笑說晚餐以及醫院裡的雞肉三明治有多糟糕。整個心情都變了，對吧？這是發自內心的，對吧？這與數據無關，與產品本身或價格無關，對嗎？我認為其中有一個不可忽視的內在因素。我相信全國各地導管實驗室中發生的這些經驗會產生累積效應。

Drew, I'm sure you're probably going to add something, a little more of data like.

德魯，我確信你可能會添加一些東西，例如更多的數據。

No, I think those are all the key points here. I think it's the aggregate impact of all the growth drivers coming together. So it's the expansion of the field team and the methodical addition of new reps and territory expansion. I think we are making progress in driving deeper and deeper penetration in our existing accounts. And some of the investments and programs we've developed along those lines, I think, are really starting to bear fruit.

不，我認為這些都是這裡的關鍵點。我認為這是所有成長動力共同作用的綜合影響。因此，這是現場團隊的擴張以及新代表的有條不紊的增加和領土擴張。我認為我們在推動現有帳戶的滲透越來越深入方面正在取得進展。我認為，我們沿著這些思路開發的一些投資和專案確實開始取得成果。

Some of the new products and some of the new R&D investments that we've made continue to improve the speed and the efficacy and the safety of the procedures. And then the clinical evidence portfolio building along with that, supporting all of the immediate impact that docs are seeing firsthand with hard clinical evidence that supports the impact we're having. So I think it's all those things taken together that's really driving the growth, Bob.

我們所做的一些新產品和一些新的研發投資不斷提高程序的速度、有效性和安全性。然後臨床證據組合隨之建立，支持醫生親眼所見的所有直接影響，並用確切的臨床證據支持我們所產生的影響。所以我認為正是所有這些因素綜合在一起才真正推動了增長，鮑勃。

Okay. I realize it's kind of a softball question, but just wanted to get your overview taken. The second question I wanted to ask really quickly is just on -- you're starting to talk about some new opportunities, both in terms of outside the United States and then in the U.S. and specifically with closure. And I was wondering if you could put any more kind of meat on the bone, if you will, in terms of quantifying the opportunity that comes from these new markets and new technologies, specifically, again, with the venous closure system?

好的。我知道這是一個壘球問題，但只是想讓您了解一下。我想很快問的第二個問題是——你開始談論一些新的機會，無論是在美國境外還是在美國，特別是在結束時。我想知道您是否可以在量化來自這些新市場和新技術的機會方面，特別是靜脈閉合系統帶來的機會方面，添加更多種類的肉？

Yes. Thanks, Bob. I think we're maybe a little too early to be talking about quantifying these opportunities. I will say that we developed the FLOWSTASIS for our own procedures. The full intent was just include this in our per-procedure price as part of our FlowTriever pricing and system. It certainly looks like there are opportunities beyond our procedures. There are lots of structural heart, electrophysiology and other venous closure type procedures for which we think this might be useful.

是的。謝謝，鮑伯。我認為我們現在談論量化這些機會可能有點為時過早。我想說的是，我們為自己的程式開發了 FLOWSTASIS。完整的意圖只是將其包含在我們的每個程序價格中，作為我們 FlowTriever 定價和系統的一部分。看起來確實有超出我們程序的機會。我們認為這可能對許多結構性心臟、電生理學和其他靜脈閉合類型手術有用。

It's a really simple method of tensioning the compression stitch that can very often be used to close venous wounds. The venous pressure is much, much lower, of course. And so this is a really simple system. It doesn't leave anything behind. And it doesn't kind of get into the vein. There's no stitch into the vein. So we like the simplicity. It's a pretty interesting story here. It seems to work through our limited market release, but we are certainly in the very, very early stages here. We just completed our limited market release. We'll be getting into more full market commercialization. We'll have more to say on that in upcoming calls.

這是一種非常簡單的拉緊壓縮縫線的方法，通常可用於閉合靜脈傷口。當然，靜脈壓也低得多。所以這是一個非常簡單的系統。它不會留下任何東西。而且它並沒有進入血管。靜脈裡沒有縫針。所以我們喜歡簡單。這是一個非常有趣的故事。它似乎在我們有限的市場發布中發揮作用，但我們肯定處於非常非常早期的階段。我們剛剛完成了有限的市場發布。我們將進入更全面的市場商業化。我們將在接下來的電話會議中對此進行更多討論。

And have you included that in the guide that you gave to any meaningful degree?

您是否已將其納入您提供的指南中，達到任何有意義的程度？

No, we haven't really quantified any meaningful revenue for FLOWSTASIS. Certainly, nothing in the guidance would suggest there's a meaningful number for FLOWSTASIS.

不，我們還沒有真正量化 FLOWSTASIS 任何有意義的收入。當然，指南中沒有任何內容顯示流動停滯有一個有意義的數字。

Your next question comes from the line of David Lewis from Morgan Stanley.

你的下一個問題來自摩根士丹利的大衛劉易斯。

Congrats on the quarter and a very constructive guide. I want to start with the guide, and then I'll kind of maybe follow back up with Bill. But just thinking about the guide here, and I appreciate it's still COVID, but you've been doing anywhere from 15% to 25% sequential growth and obviously 13% sequential into the first quarter, even with, obviously, a tough January. If you kind of take out the first quarter, the guidance implies Q2 to Q4 low single-digit type sequential growth.

恭喜這個季度和一個非常有建設性的指南。我想從指南開始，然後我可能會跟進比爾。但只要想想這裡的指南，我很高興它仍然是新冠疫情，但你的環比增長在 15% 到 25% 之間，第一季的環比增長顯然是 13%，即使一月份顯然很艱難。如果您考慮第一季度，則該指引意味著第二季度至第四季度的低個位數連續成長。

So is there sort of anything momentum-wise comps trends in the business that would drive that? Or is it just simply early in the year and we're still dealing with some COVID dynamics? So let me just sort of flush out how you see the business sort of first half, second half or across the quarters, given that drop off here into the second quarter?

那麼，該行業是否有任何動力的比較趨勢可以推動這一趨勢呢？或者只是今年年初，我們仍在應對一些新冠疫情動態？那麼，讓我簡單介紹一下您如何看待上半年、下半年或整個季度的業務，考慮到第二季度的下滑？

Sure, David. Thanks for that question. As you mentioned, the Q1 guidance would be about sort of a low double-digit sequential improvement compared to Q4. So that's something that we really feel comfortable and confident in. This March 9, actually, today is the 1-year anniversary of what we affectionately at Inari call the meltdown day. It's the day we were supposed to start our road show for the IPO last year. We didn't really know what would happen.

當然，大衛。謝謝你提出這個問題。正如您所提到的，與第四季度相比，第一季的指導將是低兩位數的連續改善。所以這是我們真正感到舒適和自信的事情。實際上，3 月 9 日是我們在 Inari 親切地稱之為「崩潰日」的一周年紀念日。去年我們本應在這一天開始 IPO 路演。我們真的不知道會發生什麼事。

After the meltdown day, we kind of shut things down a bit for those next couple of months. And we felt fortunate that we were able to do the IPO in late May. But we've really operated under this COVID cloud for the past 3 quarters now. This is our third public report. I think we just want to kind of start out with something and not get ahead of ourselves. And we really look forward to updating our annual guidance as we move along through the year.

在崩潰的那天之後，我們在接下來的幾個月裡稍微關閉了一些東西。我們感到很幸運，我們能夠在五月底進行首次公開發行。但在過去的三個季度裡，我們確實是在新冠疫情的陰雲下運作的。這是我們第三次的公開報告。我認為我們只是想從某些事情開始，而不是超越自己。我們非常期待在這一年更新我們的年度指導。

Okay. That's super-helpful. And then just my second kind of follow-up question is really sort of 2-part. If we think about sort of the trends in PE versus DVT that we saw through the back half of 2020, is there any reason to believe that in a percent of mix where that PE-DVT mix materially changes in '21 and sort of what's implied in guidance?

好的。這非常有幫助。然後我的第二種後續問題實際上是由兩個部分組成的。如果我們考慮一下 2020 年下半年 PE 與 DVT 的趨勢，是否有任何理由相信，PE-DVT 混合比例在 21 年發生了重大變化，以及隱含的含義在指導中？

And then just, Bill, I wanted to push a little more on this international question. I mean it was -- our current estimates basically call for 0 international revenue, I guess, given the approvals and some commercial agreements you signed here in the first quarter that's looking a little conservative. So is there any international specifically modeled in your guide for 2021? Those 2 questions, and I'll jump back in queue.

然後，比爾，我想在這個國際議題上進一步推動一點。我的意思是——我們目前的估計基本上要求國際收入為 0，我想，考慮到您在第一季在這裡簽署的批准和一些商業協議，這看起來有點保守。那麼，您的 2021 年指南中是否有專門建模的國際賽事？這兩個問題，我會跳回隊列。

Yes. Thanks, David. So with regard to the mix, one of the characteristics -- I don't know that we would have necessarily predicted this, but the mix has been remarkably consistent from quarter-to-quarter. With no -- there's no emphasis on one product versus the other, either nominally or through compensation or anything of that nature. I think both of these markets are growing equally based on the way that we've chosen to communicate our story, based on the data that are emerging and product development, products being introduced into the mix and so forth.

是的。謝謝，大衛。因此，就組合而言，其中一個特徵 - 我不知道我們是否一定會預測到這一點，但每個季度的組合都非常一致。沒有 - 沒有強調一種產品與另一種產品的對比，無論是名義上還是通過補償或任何類似性質的東西。我認為這兩個市場都在平等地成長，這取決於我們選擇的傳達故事的方式，基於正在出現的數據和產品開發、引入的產品等等。

So we are not modeling any change in the percent of revenue or percent of cases represented by one product versus the other. It's been pretty consistent. They bounce around a percentage or 2, but that's no change.

因此，我們不會對一種產品相對於另一種產品所代表的收入百分比或案例百分比的任何變化進行建模。一直很一致。它們的反彈幅度大約是百分之一或百分之二，但這並沒有改變。

With regard to international, I think, we've characterized this multiple times as being measurable but not really meaningful. So I don't think I would characterize any of the guidance as representing a significant chunk of international sales, and I think that's a pretty healthy way to think about it. The COVID environment in Europe is considerably more challenging than it is here in Europe. I suspect you're hearing that from most of our peers and other med tech companies. And it's been -- that's been a challenge. And there's a lot of interest, a lot of enthusiasm. These physicians have seen and heard about Inari devices through data releases and through anecdotal communication back and forth with their American counterparts for a year or 2.

我認為，就國際而言，我們多次將其描述為可衡量但沒有真正意義。因此，我認為我不會將任何指導意見描述為代表國際銷售的很大一部分，而且我認為這是一種非常健康的思考方式。歐洲的新冠疫情環境比歐洲更具挑戰性。我懷疑您是從我們的大多數同行和其他醫療科技公司聽到的。這一直是個挑戰。人們有很多興趣、很多熱情。這些醫生透過數據發布以及與美國同行的來回交流一兩年來看到和聽說過 Inari 設備。

That's been highly favorable. And so it's a little frustrating that with 20,000-something procedures total that we can't be on the ground training and getting people through their learning curve very quickly. So it's all Zoom-based. And those challenges persist. So I would just ask you don't get too far ahead of us here on international as well, because there are some things too to work through, including reimbursement as well. So I'll leave it there.

這是非常有利的。因此，令人有點沮喪的是，由於總共有 20,000 多個程序，我們無法進行實地培訓並讓人們很快完成學習曲線。所以這一切都是基於 Zoom 的。這些挑戰仍然存在。所以我想請你們在國際航班上也不要走太遠，因為還有一些事情需要解決，包括報銷。所以我會把它留在那裡。

Our next question comes from the line of Larry Biegelsen from Wells Fargo.

我們的下一個問題來自富國銀行的 Larry Biegelsen。

Congrats to really strong 2020. 2 from for me. Let me start with just sales force adds and center adds that you expect in 2021. For sales force adds, should we think about 10 per quarter? And on center adds, I'm not sure I heard you give the Q4 number. But it looks like you added about, by my math, call it, 400 centers in 2020. Is that accurate? And what should we expect for 2021? And I had one follow-up.

恭喜我的 2020.2 真的很強大。讓我從您預計 2021 年增加的銷售人員和中心人員開始。對於增加的銷售人員，我們是否應該考慮每季增加 10 名銷售人員？關於中心補充，我不確定是否聽到你給了 Q4 號碼。但看起來您添加了大約 2020 年 400 個中心。這準確嗎？ 2021 年我們該期待什麼？我有一個後續行動。

Would Drew take that one?

德魯會接受那個嗎？

Yes. So Larry, on the sales force side, as you heard, we added 10 heading into Q1. So exactly in line with what our historical kind of average cadence have been. I think we're going to reserve the right to flex that up or down depending on what we're seeing on the ground as we get into any specific quarter and what we're seeing in our target territories. But I do think that, that 10 per quarter is a pretty good starting point to how to think about the rest of the year. Keep in mind, if we bring on 10 incremental territories, we're actually hiring more bodies than that, given our promote-from-within kind of approach to sales leadership.

是的。 Larry，在銷售團隊方面，正如您所聽到的，我們在第一季增加了 10 名員工。完全符合我們歷史上的平均節奏。我認為我們將保留向上或向下調整的權利，具體取決於我們進入任何特定季度時所看到的情況以及我們在目標地區所看到的情況。但我確實認為，每季 10 點對於如何思考今年剩餘時間來說是一個很好的起點。請記住，如果我們增加 10 個區域，考慮到我們採用從內部提拔的銷售領導方式，我們實際上會僱用更多的人員。

On the center adds, I think, the number you quoted is about right. We believe we exited Q4 someplace north of 800 active accounts using the technology. And that's a combination of accounts that are using just FlowTriever, just ClotTriever or both technologies. We think about half of our accounts are using both technologies. So we have quite a bit of runway still even within that group of 800 accounts to pull in the respective secondary technology where that's an opportunity for us.

中心補充說，我認為您引用的數字大約是正確的。我們相信我們在第四季度退出時使用該技術的活躍帳戶已超過 800 個。這是僅使用 FlowTriever、僅使用 ClotTriever 或同時使用這兩種技術的帳戶組合。我們認為我們有一半的帳戶正在使用這兩種技術。因此，即使在 800 個帳戶中，我們仍然有相當多的跑道來引入各自的二級技術，這對我們來說是一個機會。

Keep in mind, we think there's, call it, 1,500 potential targets. There's 1,500 cath labs in the U.S. There's 1,300-some hospitals with 200 or more beds, which would also be a way to gauge the ultimate opportunity here. So we still think we're in kind of early to mid-innings in terms of the account penetration at this stage.

請記住，我們認為有 1,500 個潛在目標。美國有 1,500 個導管實驗室。有 1,300 多家醫院擁有 200 張或更多床位，這也是衡量這裡最終機會的一種方式。因此，我們仍然認為，就現階段的帳戶滲透率而言，我們仍處於早期到中期階段。

That's helpful, Drew. And second from me, could you talk about other new product launches in 2021 and data that we might see this year, just specifically on new products? Could you give us an update on FlowSaver?

這很有幫助，德魯。其次，您能否談談 2021 年推出的其他新產品以及我們今年可能看到的數據，特別是新產品的數據？可以為我們介紹一下 FlowSaver 的最新狀況嗎？

Well, Larry, if there's one thing we've learned -- let me say it's -- our history as a public company is don't overpromise on new products. We certainly stepped in that. The first opportunity we had in our first earnings call, we talked about FlowSaver and we were dealt a curveball by FDA. So we expect to see that a little later on this year, but probably we shouldn't make the same mistake and tell you a month or week and date. So we'll leave it there. But there are a number of other products beyond FlowSaver that we like. The pipeline is full.

好吧，拉里，如果我們學到了一件事的話——讓我說吧——我們作為一家上市公司的歷史就是不要對新產品過度承諾。我們當然介入了。我們在第一次財報電話會議中獲得的第一個機會，我們討論了 FlowSaver，FDA 給了我們一個曲線球。因此，我們預計會在今年晚些時候看到這一點，但也許我們不應該犯同樣的錯誤並告訴您一個月或一周和日期。所以我們就把它留在那裡。但除了 FlowSaver 之外，我們還喜歡許多其他產品。管道已滿。

Some of these products are inclusive in our per-procedure pricing. So there'll be no new revenue, like FlowSaver perhaps, for example. And some others would be TAM expanding, but we'll have much more to say about those as we get a little closer. There's FDA risk, of course. There's LMR risk, what will we see, will the devices be ready for prime time. So there's a few things to work through. But we're very pleased with our pipeline.

其中一些產品已包含在我們的每次手術定價中。因此，不會有新的收入，例如 FlowSaver。還有一些是 TAM 的擴張，但當我們越來越接近時，我們會對這些有更多的內容要說。當然，存在 FDA 風險。有 LMR 風險，我們會看到什麼，設備是否準備好迎接黃金時段。所以有一些事情需要解決。但我們對我們的管道非常滿意。

And data, Bill?

還有數據，比爾？

Yes, clinical. We have -- we continue to run -- sorry, we continue to run our FLASH and our CLOUT registries, 500 patients plus. We are going to expand our FLASH registry. We'll have more detail on that as it emerges here. But I think we'll see some additional readouts over the coming quarters. There are any number of investigator-initiated trials that will get to the starting line, so to speak, here with regards to submission and publication. So we'll have other readouts on data coming down the pike here as well.

是的，臨床。我們已經——我們繼續運行——抱歉，我們繼續運行我們的 FLASH 和 CLOUT 註冊中心，有超過 500 名患者。我們將擴展我們的 FLASH 註冊表。我們將在此處提供更多詳細資訊。但我認為我們將在未來幾季看到一些額外的數據。有許多研究者發起的試驗將到達起跑線，可以說，這裡涉及提交和發表。因此，我們還將在此處提供其他數據讀數。

And again, just as a reminder, we're -- none of them are inflection. None of them will represent some sort of an important binary inflection point. They're all contributory to the same sort of story and execution play that we've been sharing with you all along.

再次提醒一下，我們——它們都不是變形。它們都不會代表某種重要的二元拐點。他們都對我們一直與您分享的相同類型的故事和執行戲劇做出了貢獻。

Our next question comes from the line of Bill Plovanic from Canaccord.

我們的下一個問題來自 Canaccord 的 Bill Plovanic。

A couple here. Just first -- and I might have missed this. Was there any commentary regarding the FLAME study? And have you begun enrollment on that?

這裡有一對夫婦。首先——我可能錯過了這一點。對於 FLAME 研究有任何評論嗎？你們已經開始報名了嗎？

You did not miss anything. Let's let Tom take that.

你沒有錯過任何東西。讓我們讓湯姆來接受吧。

Sure. Thanks, Bill. So you -- just to remind everybody, the FLAME study is our trial in massive pulmonary embolism, this is the most mortal of all PE conditions, and is planned to be the largest contemporary trial in this disease state. The trial design has been completed, and we are anxiously awaiting enrollment of our first patient.

當然。謝謝，比爾。所以你——只是想提醒大家，FLAME 研究是我們對大規模肺栓塞的試驗，這是所有 PE 疾病中最致命的，並且計劃成為該疾病狀態下最大的當代試驗。試驗設計已經完成，我們正在焦急地等待第一位患者的入組。

Okay. So you have ID approval and you're good to go. You're just waiting to get the first patients enrolled?

好的。這樣您就獲得了身分證件批准，就可以開始了。您只是在等待第一批患者入組嗎？

Yes.

是的。

Great. And then how -- what is the size of this study? Are there any details you're willing to provide on time? How long do you think it will take to enroll and when we could see some of the first data off of this?

偉大的。那麼這項研究的規模有多大？您願意按時提供任何詳細資訊嗎？您認為註冊需要多長時間？我們什麼時候可以看到一些第一批資料？

So massive pulmonary embolism represents about 5% of all pulmonary embolism. So it is not very common, and these are quite critically ill patients. So you can imagine enrollment in this study may be somewhat hard to predict. We anticipate it will probably be 18 months to complete the study. And we will -- we have no plans to present any preliminary data. So we hope to complete that study before reasonably.

因此，大量肺栓塞約佔所有肺栓塞的 5%。所以這種情況並不常見，而且這些都是相當危急的病人。所以你可以想像這項研究的註冊人數可能有點難以預測。我們預計完成這項研究可能需要 18 個月的時間。我們將—我們沒有計劃提供任何初步數據。所以我們希望能合理地提前完成這項研究。

Okay. And then on just -- I was wondering, if you penetrate in your -- in over 800 facilities, I think that was roughly the number last quarter. But I'm trying to get a handle on, as you look at those facilities that you're in, have you been able to fully penetrate any? If so, what does that look like? And how long does it take to get there?

好的。然後，我想知道，如果你滲透到 800 多個設施中，我認為這大約是上個季度的數字。但我試著弄清楚，當你看看你所在的那些設施時，你是否能夠完全滲透任何設施？如果是這樣，那是什麼樣子的？到達那裡需要多長時間？

You want to dive in, Drew?

你想潛入水中嗎，德魯？

Yes. I think if you looked across those 800 accounts, Bill, you'd see evidence of accounts at different stages of their evolution and how they're thinking about VTE. You'd certainly see a group of accounts that are just starting. They're focused on initial outcomes. They're getting used to the technology. They're adopting it into their existing treatment paradigm.

是的。 Bill，我認為如果您查看這 800 個帳戶，您會看到處於不同發展階段的帳戶的證據以及他們如何看待 VTE。您肯定會看到一組剛開始的帳戶。他們專注於最初的結果。他們正在習慣這項技術。他們正在將其納入現有的治療範例中。

You'd see a group of accounts that have progressed past that or in the middle. They are trying to understand the economic value proposition at that stage. They're probably more proactively trying to identify these patients. They may be refining their clinical care pathways at the account level and really trying to proactively investigate and invest in these patients in a way that was not like they had thought historically.

您會看到一組已超過該進度或處於中間狀態的帳戶。他們正在嘗試了解該階段的經濟價值主張。他們可能會更主動地嘗試識別這些患者。他們可能正在帳戶層面完善他們的臨床護理途徑，並真正嘗試以不同於他們歷史上想像的方式主動調查和投資這些患者。

And then the last group of accounts are at the final end of their evolution. And they are accounts that have really made a proactive commitment to VTE program development, like you've seen with MI and stroke, for instance. They have a very sophisticated approach to this patient population. They are making significant investment and time and other resources to manage these patients.

然後最後一組帳戶處於其演變的最後階段。他們是真正積極致力於 VTE 專案開發的客戶，就像您在 MI 和中風方面看到的那樣。他們對這群患者採取了非常複雜的方法。他們正在投入大量投資、時間和其他資源來管理這些患者。

And if you looked at our product adoption across those phases, you'd see obviously growing adoption across those phases. And at least in that last group of accounts, you'd see our technologies being used frontline as standard of care, as the go-to option for both DVT and PE patients. That evolution takes a different amount of time based on the account dynamics and specifics. But we have seen accounts kind of move methodically through that evolution. It gives us some confidence. We are developing a systematic approach to helping support that evolution with different programs and different investments and learning how to help support accounts move through that process.

如果您查看我們在這些階段的產品採用情況，您會發現這些階段的採用情況明顯在成長。至少在最後一組帳戶中，您會看到我們的技術被用作第一線護理標準，作為 DVT 和 PE 患者的首選。根據帳戶動態和具體情況，這種演變需要不同的時間。但我們已經看到帳戶在這種演變中有條不紊地發展。這給了我們一些信心。我們正在開發一種系統方法，透過不同的計劃和不同的投資來幫助支持這一演變，並學習如何幫助支援帳戶完成此過程。

Great. And today, Drew, what percent of your accounts do you think has kind of hit that endpoint to the final phase and you have the penetration you're looking for? The bucket at the beginning, middle end?

偉大的。今天，德魯，您認為您的帳戶中有多少百分比已經到達最後階段的終點並且您已經達到了您所尋求的滲透率？桶子在開頭，中間結尾？

So that last group has got to be our top, probably 10% of accounts are in that final group. So we're -- we've got a small number that have made that evolution. It gives us some confidence that we're doing the right things. But there's not many that have navigated their way all the way through that evolution yet.

所以最後一組必須是我們的頂部，可能 10% 的帳戶屬於最後一組。所以我們——我們有一小部分人已經實現了這一演變。它給了我們一些信心，讓我們相信我們正在做正確的事情。但目前為止，能夠完成這演變的人並不多。

If I could add just a bit of color there. There was a paper just presented out of -- published out of University Hospitals in Cleveland, which is a very old established PERT, Pulmonary Embolism Response Team, program. And they showed, not surprisingly, that patients who were admitted to the hospital or who see -- come into the hospital with the pulmonary emblem and see the PERT team as a hospital-designated pulmonary embolism experts, they not surprisingly do well on almost -- by almost every measure, on almost clinical measure you can imagine.

如果我能在那裡添加一點顏色就好了。克利夫蘭大學醫院剛剛發表了一篇論文，這是一個非常古老的 PERT（肺栓塞反應小組）計畫。毫不奇怪，他們表明，入院的患者或帶著肺標誌進入醫院並看到 PERT 團隊作為醫院指定的肺栓塞專家的患者，他們在幾乎 - - 幾乎每一個衡量標準，幾乎是你可以想像的臨床衡量標準。

The problem is that 70% of the patients who should have been seen by the PERT, by their own admission, by their own criteria, were not seen by PERT. And that's the challenge that we face. Even in the best -- our best centers, the consistency with which these patients are identified and triaged to the VTE experts remains limited. Those aren't problems that you face that we see in MI and stroke. Most of those problems, certainly, in MI have been fixed a long time ago. So there's a lot of heavy lifting to do with regard to surfacing, identifying and triaging these patients consistently through systems and processes. And we're spending quite a bit of time and energy with that -- kind of that last bucket, that bucket of customers that have progressed to that point.

問題是，根據他們自己的入院標準，本應接受 PERT 檢查的患者中有 70% 沒有接受 PERT 檢查。這就是我們面臨的挑戰。即使在最好的——我們最好的中心，VTE 專家對這些患者進行識別和分類的一致性仍然有限。這些不是我們在心肌梗塞和中風中看到的您面臨的問題。當然，MI 中的大多數問題很久以前就已經解決。因此，在透過系統和流程一致地顯示、識別和分類這些患者方面，還有很多繁重的工作要做。我們花了大量的時間和精力來處理這最後一桶，也就是已經進展到這一點的客戶。

Our next question comes from the line of Danielle Antalffy from SVB Leerink.

我們的下一個問題來自 SVB Leerink 的 Danielle Antalffy。

Congrats on a really strong year despite COVID. And I just have 2 questions. So my first question is probably for you, and it's around -- you touched on it a little bit, but like how to think about the guidance and the COVID situation we're in now and the COVID recovery? And I appreciate that a lot of your patients are urgent/emergent. But there is some component of the business that's likely driven by patients getting diagnosed, getting into the system. And I guess that's more what I'm focused on. And is there any sort of recovery baked into the guidance? Or is it kind of just sustaining momentum from where we are today and there's no sort of backlog that we should be thinking about here and if there is that sort of upside? That's my first question.

儘管有新冠疫情，但還是祝賀今年的表現非常強勁。我只有兩個問題。所以我的第一個問題可能是針對你的，而且它是圍繞著 - 你稍微觸及了它，但就像如何思考我們現在所處的指導方針和新冠病毒情況以及新冠病毒的恢復？我很感激你們的許多病人都是緊急的。但該業務的某些組成部分可能是由患者被診斷、進入系統所驅動的。我想這才是我比較關注的。指導意見是否包含任何形式的復甦？或者這只是維持我們今天所處的勢頭，我們不應該考慮這裡的積壓情況，以及是否有這種好處？這是我的第一個問題。

Yes. Yes. I know the question you're asking. Thanks, Danielle. I think the short answer is there's no backlog. Approximately 70% of both PE and DVT patients in the studies that we've conducted, in the way that we keep track of these things for FLASH and CLOUT, for example, present through the ER. So they are emergent by that definition. So I think this has protected us in ways that many of our peers and other med tech companies didn't benefit from devices that treat that sort of patient population. So we have benefited from that. Through the pandemic, our procedures were probably a little bit more insulated from the pandemic challenges and the challenges that the elective procedures faced, for example.

是的。是的。我知道你問的問題。謝謝，丹妮爾。我認為簡短的答案是沒有積壓。在我們進行的研究中，大約 70% 的 PE 和 DVT 患者，例如，我們透過 ER 記錄 FLASH 和 CLOUT 的情況。因此，根據這個定義，它們是新興的。因此，我認為這以某種方式保護了我們，而我們的許多同行和其他醫療科技公司卻沒有從治療此類患者群體的設備中受益。所以我們從中受益匪淺。例如，透過大流行，我們的程序可能更能免受大流行挑戰和選擇性程序面臨的挑戰的影響。

PE cannot be -- you either treat it at the moment that the PE presents or there's very limited capacity to treat it later. DVT on some cases can be delayed for a week or 2. But the problem is, even when patients may have been entering a hospital that was on diversion, for example, come in with a painful, really painful and swollen leg and were sent home, simply because there was no capacity. I don't think most hospitals have any mechanisms for keeping track of those patients. And so again, the short answer is I don't think we're going to see a bolus of patients coming down the pike here for 2021 or beyond. I think those patients were either treated or not.

PE 不可能——你要么在 PE 出現的那一刻治療它，要么以後治療它的能力非常有限。某些病例的 DVT 可能會延遲一周或兩週。但問題是，即使患者可能已進入轉院醫院，例如，腿部疼痛、非常疼痛且腫脹，並被送回家，只是因為沒有能力。我認為大多數醫院沒有任何機制來追蹤這些患者。再說一遍，簡短的回答是，我認為 2021 年或以後我們不會看到大量患者湧入這裡。我認為這些患者要么接受治療，要么沒有接受治療。

Okay. Okay. Totally fair. And then my next question is a 2-part question. So I'm really asking 3 questions, not 2. So Drew, this is probably for you, and both of these are probably sort of in your camp. So just trying to get a sense of same-store sales versus the new center adds. And how to think about how that progressed in 2020 and how that will progress in 2021? Sort of what's reflected in guidance, anything you can say there?

好的。好的。完全公平。然後我的下一個問題是一個由兩個部分組成的問題。所以我實際上是在問 3 個問題，而不是 2 個問題。德魯，這可能適合你，這兩個問題可能都屬於你的陣營。因此，我只是想了解同店銷售額與新中心增加的情況。如何思考 2020 年的進展以及 2021 年的進展？指導意見中反映了哪些內容，您有什麼可以說的嗎？

Yes. I think the short answer is we like what we're seeing. We think the growth we're seeing is sustainable and not overly weighted towards the addition of new accounts. I'll give you a couple of metrics that I think support that belief. In Q4, we believe about 90% of our cases in that quarter came from existing customers, only 10% came from new account adds in that quarter.

是的。我認為簡短的答案是我們喜歡我們所看到的。我們認為我們所看到的成長是可持續的，並且不會過度重視新帳戶的增加。我將為您提供一些我認為支持這一信念的指標。在第四季度，我們相信該季度約 90% 的案例來自現有客戶，只有 10% 來自該季度新增的客戶。

And if you look at it through the lens of growth in cases, sequential growth in cases that we saw incrementally in Q4, it was balanced about 50-50 between existing accounts and brand new accounts acquired in that quarter. So we like what we're seeing there. We think there's a nice balance where we are seeing evidence of success in supporting accounts for broader and deeper adoption of the technology. And I think you see that reflected in those metrics.

如果你從案件成長的角度來看，我們在第四季度看到案件的連續成長，現有客戶和該季度獲得的全新客戶之間的比例約為 50-50。所以我們喜歡在那裡看到的東西。我們認為，在支持更廣泛、更深入採用該技術的帳戶方面，我們看到了成功的證據，這是一個很好的平衡。我認為您會在這些指標中看到這一點。

Got it. Yes. That was very helpful. And then last question for you. So you gave some good color on half the accounts are using both devices. I'm just curious, what percentage of the accounts you're in today are not using FlowTriever? And what's the barrier to getting them to adopt that? Is it just a matter of time getting them to adopt FlowTriever? And I'm obviously asking, because it feels like that's where the longest growth runway is and where you guys obviously have the biggest, I think, competitive advantage and price advantage there?

知道了。是的。這非常有幫助。然後是最後一個問題。因此，您對使用這兩種設備的一半帳戶進行了一些很好的描述。我只是好奇，您今天所在的帳戶中有多少百分比沒有使用 FlowTriever？讓他們採用這一點的障礙是什麼？讓他們採用 FlowTriever 只是時間問題嗎？我顯然是在問，因為感覺那是最長的成長跑道，而且我認為你們顯然擁有最大的競爭優勢和價格優勢？

Yes. No, I understand where you're coming from. I'm not sure I'd completely agree with some of the things that were kind of folded in there. Maybe first, of the 50% of accounts that are using both technology, it's really a mix of accounts that have adopted just ClotTriever or just FlowTriever. So we don't see it necessarily bias towards accounts just starting with ClotTriever and pulling in FlowTriever. It's really a balance between the 2.

是的。不，我明白你來自哪裡。我不確定我是否完全同意其中的一些內容。也許首先，在使用這兩種技術的 50% 帳戶中，實際上是只採用 ClotTriever 或 FlowTriever 的帳戶的混合體。因此，我們認為它不一定偏向剛開始使用 ClotTriever 並引入 FlowTriever 的帳戶。這確實是兩者之間的平衡。

And I think going forward, we would anticipate continued kind of balance between the 2. We don't necessarily need to manage the growth of one of the platforms versus the other. At least historically, we haven't. They've really developed and grown organically right alongside each other at roughly the same growth rates. And I think that would be what we'd anticipate going forward as well.

我認為，展望未來，我們預計這兩個平台之間將繼續保持平衡。我們不一定需要管理其中一個平台相對於另一個平台的成長。至少從歷史上看，我們沒有。他們確實以大致相同的成長率彼此有機地發展和成長。我認為這也是我們預期的未來。

Our next question comes from the line of Marie Thibault from BTIG.

我們的下一個問題來自 BTIG 的 Marie Thibault。

Bill, Mitch, Drew and Dr. Tu, congrats on a very strong year. I wanted to ask one more follow-on here on guidance. I wonder if you could parse out for us a little bit more of the COVID impact you've seen so far in Q1. And then because we haven't seen you as a public company without COVID impact, I'm wondering if you can sort of set out for us any seasonality or sort of how we should think about cadence throughout the year going forward?

Bill、Mitch、Drew 和 Tu 博士祝賀您度過了非常美好的一年。我想在這裡詢問一位後續的指導。我想知道您是否能為我們解析一下您在第一季迄今所看到的新冠疫情影響。然後，因為我們還沒有看到你們作為一家沒有受到新冠疫情影響的上市公司，所以我想知道你們是否可以為我們列出任何季節性因素，或者我們應該如何考慮未來一年的節奏？

Yes. I'll dive into that. We get the seasonality question. Maybe not surprising, we get asked quite a bit. We don't -- we have not seen it thus far. But I just was peeking at some numbers this morning in our -- Q4 of 2019 was the last quarter in which there was no COVID impact for all of us, of course. In 2019, we did less revenue than we are projecting for Q1. The entire year of 2019 was less revenue than we're projecting for Q1 of this year. And so the point here is that we really don't have anything to compare to, right? We don't really know what a non-COVID or post-COVID environment looks like. So will we see seasonality? We have not seen it thus far. And is that because we're insulated from it in some way? Or is it because we were just very, very early in our growth phase and it will start to emerge at some other moment?

是的。我將深入探討這一點。我們得到了季節性問題。也許不奇怪，我們常被問到。我們沒有——到目前為止我們還沒有看到它。但今天早上我只是看了一些數據——2019 年第四季當然是最後一個沒有受到新冠疫情影響的季度。 2019 年，我們的營收低於第一季的預期。 2019 年全年的營收低於我們對今年第一季的預測。所以這裡的重點是我們真的沒有什麼可以比較的，對吧？我們真的不知道非新冠疫情或後新冠疫情環境是什麼樣子。那我們會看到季節性嗎？到目前為止我們還沒有看到它。這是因為我們在某種程度上與它隔絕了嗎？還是因為我們正處於成長階段的非常非常早期，它會在其他時刻開始出現？

I think we just don't know. And so with regard to guidance, we want to make sure that we're not getting out ahead of ourselves, because there's any number of things that -- there's any number of potential risks. And we've learned one thing through the pandemic -- well, we learned many things, I guess, but humility is one of them. So we just want to be a little thoughtful about the way we're thinking about guidance.

我想我們只是不知道。因此，在指導方面，我們希望確保我們不會超前，因為有很多事情有潛在風險。我們透過這場大流行學到了一件事——嗯，我想我們學到了很多東西，但謙遜就是其中之一。因此，我們只是想對我們思考指導的方式進行一些深思熟慮。

And Marie, if I can add to that just a bit. In terms of some of the signals that we see for COVID impact, actually, as Drew was talking about our accounts, we see the case mix fluctuate in the accounts, sometimes week-to-week, sometimes definitely month-to-month, depending on the relative sort of impact of COVID on that hospital. And that's something that we've noticed. You see the case mix for the year as a whole, it was kind of the 54, 46 thing that we sometimes see the case mix fluctuate and there could be a sort of a disproportionate number of PE cases in some months in some hospitals.

瑪麗，如果我可以補充一點的話。就我們看到的新冠影響的一些信號而言，實際上，當德魯談論我們的帳戶時，我們看到帳戶中的病例組合有所波動，有時是每週，有時肯定是每月，具體取決於關於新冠病毒對該醫院的相對影響。這是我們注意到的。你可以看到全年的病例組合，我們有時會看到病例組合出現波動，有 54、46 例，在某些醫院的某些月份裡，PE 病例的數量可能不成比例。

And that tends to correlate with a higher amount of COVID impact in that hospital. But then sometimes when the ICU beds kind of go down, then the case mix kind of returns to the historical relationships. I don't know that -- I don't think we went into that really level of detail in terms of thinking about how that would play out through the remainder of 2021. As I mentioned, we're hoping to continue to update as we go along here.

這往往與該醫院的新冠疫情影響更大有關。但有時候，當 ICU 床位減少時，病例組合就會回歸到歷史關係。我不知道這一點 - 我認為我們並沒有真正深入地思考 2021 年剩餘時間裡這將如何發揮作用。正如我所提到的，我們希望繼續更新我們一起去這裡。

All right. That's really helpful. And I understand that there's no easy comparable. So I appreciate you helping me make sure there's nothing I'm overlooking here. I guess my follow-up would be around gross margins. Your Q4 gross margins, again, very stellar. And I know in the past, there's been some talk about pricing trends and that gross margins aren't necessarily going to stay at this very healthy level. So I wondered if you could help us think about that, given some of the new products you have rolling out and then your earlier comments on the international opportunity, if there's any change there on the gross margin outlook.

好的。這真的很有幫助。我知道這沒有簡單的可比性。所以我很感謝你幫我確保這裡沒有我忽略的任何東西。我想我的後續行動將圍繞毛利率進行。你們第四季的毛利率再次非常出色。我知道過去有一些關於定價趨勢的討論，而且毛利率不一定會保持在這個非常健康的水平。因此，我想知道您是否可以幫助我們考慮一下，考慮到您推出的一些新產品，以及您之前對國際機會的評論，毛利率前景是否有任何變化。

Sure. I can start that, Marie. So we're pleased, obviously, with the 92%-plus gross margin for the quarter up just a bit. As we think about 2021, we had a very productive Q4. The efficiency of our manufacturing operation, the second shift we added, we're continuing to build up inventory. I think we've announced that we're moving into a larger office here in Orange County kind of midyear in 2021. So we're taking steps to prepare for that move.

當然。我可以開始了，瑪麗。顯然，我們對本季超過 92% 的毛利率略有上升感到滿意。展望 2021 年，我們的第四季非常有成效。我們的製造業務的效率，我們增加的第二班，我們正在繼續建立庫存。我想我們已經宣布，我們將於 2021 年年中搬進奧蘭治縣的一個更大的辦公室。因此，我們正在採取措施為這一搬遷做好準備。

Some of the things that we think -- and we're in a great position in terms of our average selling prices. They were up just a bit in Q4 as well. And so we feel like we're in a very strong position. Should we ever need to respond from a competitive point of view to price -- sort of pricing, we could. We're not currently seeing that. And I think we've been successful selling our services to the hospitals based on the value of the procedure essentially compared to the alternative interventional techniques, which all involve a ICU stay. So they're not really positive contributors from a hospital point of view.

我們認為的一些事情 - 就平均售價而言，我們處於有利地位。他們在第四季也略有上升。所以我們覺得我們處於非常有利的地位。如果我們需要從競爭的角度對價格做出反應——某種定價，我們可以。我們目前還沒有看到這一點。我認為，我們已經成功地將我們的服務出售給醫院，因為手術的價值本質上是與替代介入技術相比，這些技術都需要入住 ICU。因此，從醫院的角度來看，他們並不是真正的積極貢獻者。

From a future thinking point of view, as we put more products into the FlowTriever price-per-procedure bag, that's something that could have a drag on the margin. I think as we're continuing to build our international business, that could likewise have a drag on the margin as we go forward. And we've talked in a longer-term sense about a kind of a low to mid-80% gross margin target for the business. I think it may take us some time to get there. I don't know if it's going to be 1 or 2 years or if it's going to be more of like a 3- to 5-year thing. But that's kind of how we are thinking about the business over a longer term for modeling purposes.

從未來的角度來看，隨著我們將更多產品放入 FlowTriever 以程式定價的產品中，這可能會拖累利潤。我認為，隨著我們繼續發展國際業務，這同樣可能會拖累我們前進的利潤率。我們從長遠角度討論了該業務的低至中 80% 的毛利率目標。我認為我們可能需要一些時間才能到達那裡。我不知道是1年還是2年，還是3到5年。但這就是我們出於建模目的對業務進行長期思考的方式。

Thank you. This does conclude the question-and-answer session as well as today's program. Thank you, ladies and gentlemen, for your participation. You may now disconnect. Good day.

謝謝。問答環節和今天的節目到此結束。謝謝女士們先生們的參與。您現在可以斷開連線。再會。