Silk Road Medical Inc (SILK) 2023 Q1 法說會逐字稿

Good day. Thank you for standing by. Welcome to the Silk Road Medical's 2023 First Quarter Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded.

再會。謝謝你的支持。歡迎參加絲路醫療 2023 年第一季度財報電話會議。 （操作員指示）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker, Marissa Bych, Investor Relations. Please go ahead.

現在我想將會議交給您的發言人、投資者關係部的瑪麗莎·比奇 (Marissa Bych)。請繼續。

Great, and thank you for joining today's call. Joining me are Erica Rogers, Chief Executive Officer; and Lucas Buchanan, Chief Financial Officer and Chief Operating Officer. Earlier today, Silk Road Medical released financial results for the 3 months ended March 31, 2023. A copy of the press release is available on the company's website.

太好了，感謝您參加今天的電話會議。與我一起的還有首席執行官艾麗卡·羅傑斯 (Erica Rogers)；首席財務官兼首席運營官盧卡斯·布坎南 (Lucas Buchanan)。今天早些時候，Silk Road Medical 發布了截至 2023 年 3 月 31 日的三個月財務業績。該新聞稿的副本可在該公司網站上獲取。

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括根據 1995 年《私人證券訴訟改革法案》的安全港條款制定的聯邦證券法含義內的前瞻性聲明。

Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance, expense management, expectations for hiring and growth in our organization and our business, physician training and adoption, market opportunity and penetration, commercial and international expansion, regulatory approvals, reimbursement, competition and product development are based upon our current estimates and various assumptions.

本次電話會議中包含的任何與對未來事件、結果或業績的預期或預測相關的陳述均為前瞻性陳述。所有前瞻性陳述，包括但不限於與我們的運營趨勢和未來財務業績、費用管理、我們組織和業務的招聘和增長預期、醫生培訓和採用、市場機會和滲透、商業和國際相關的陳述擴張、監管批准、報銷、競爭和產品開發均基於我們當前的估計和各種假設。

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2023.

這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件存在重大差異。因此，您不應過分依賴這些陳述。有關與我們業務相關的風險和不確定性的列表和描述，請參閱我們於 2023 年 5 月 9 日向美國證券交易委員會提交的 10-Q 表格季度報告的風險因素部分。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 9, 2023. Silk Road Medical disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

本次電話會議包含時間敏感信息，僅截至今天（2023 年 5 月 9 日）直播時準確。除法律要求外，絲路醫療不承擔任何更新或修改任何財務預測或前瞻性的意圖或義務。陳述，無論是因為新信息、未來事件還是其他原因。

And with that, I will turn the call over to Erica Rogers, Chief Executive Officer.

接下來，我會將電話轉給首席執行官埃麗卡·羅傑斯 (Erica Rogers)。

Good afternoon, and thank you all for joining us. Our first quarter progress marks the start of an important year at Silk Road as we capitalize on the strong foundation we have built to drive TCAR adoption and alleviate the devastating burden of stroke on patients' lives. We delivered revenue of $40.1 million, reflecting 43% year-over-year growth, supported by over 5,800 procedures. We are pleased to see strong underlying demand for TCAR.

下午好，感謝大家加入我們。我們第一季度的進展標誌著 Silk Road 重要一年的開始，我們利用我們為推動 TCAR 採用並減輕中風給患者生活帶來的毀滅性負擔而建立的堅實基礎。在 5,800 多項手術的支持下，我們實現了 4010 萬美元的收入，同比增長 43%。我們很高興看到 TCAR 的強勁潛在需求。

And considering our progress thus far and our outlook ahead, we are reiterating our guidance for $176 million to $184 million in total 2023 revenue. As we make our way through the year, our most important objective remains to grow our business through U.S. physician adoption as we march towards the standard of care. The largest opportunity to do so comes from leveraging our broad commercial footprint to drive utilization across our trained physician base.

考慮到我們迄今為止的進展和未來的前景，我們重申 2023 年總收入為 1.76 億至 1.84 億美元的指導。在我們度過這一年的過程中，我們最重要的目標仍然是通過美國醫生的採用來發展我們的業務，同時我們向護理標準邁進。這樣做的最大機會來自於利用我們廣泛的商業足跡來提高我們訓練有素的醫生群體的利用率。

This includes onboarding and training new sales, sales management and other field professionals to expand and align our territories as we increase touch points with our customers. Early in the year, with this objective in mind, we carried forward an initiative to further optimize our expanding sales organization through hiring, promotions and territory design. We have been pleased with our recruiting ability and the quality of candidates that seek out Silk Road Medical. And we believe this effort creates the right structural balance for strong, continued growth looking forward.

這包括入職和培訓新的銷售人員、銷售管理人員和其他現場專業人員，以隨著我們增加與客戶的接觸點而擴大和調整我們的領域。今年年初，為了實現這一目標，我們實施了一項舉措，通過招聘、促銷和區域設計進一步優化不斷擴大的銷售組織。我們對我們的招聘能力和尋找絲路醫療的候選人的質量感到滿意。我們相信，這一努力為未來強勁、持續的增長創造了正確的結構平衡。

Simultaneously, we are strengthening our category leadership and commercial prospects following the expansion of our addressable market last year to include patients as standard surgical risk of surgical complications.

與此同時，繼去年擴大我們的目標市場以將患者納入手術並發症的標準手術風險之後，我們正在加強我們的類別領導地位和商業前景。

TCAR has demonstrated exceptional outcomes in this patient population, and we were pleased to see a paper published recently in JAMA Neurology, built on real-world propensity-matched data in over 20,000 patients from the vascular quality initiative or VQI, which investigated outcomes in standard surgical risk patients treated with TCAR versus CEA. Outcomes from the publication largely reflect Liang et al's presentation at the Vascular Annual Meeting in 2021.

TCAR 在該患者群體中展示了卓越的結果，我們很高興看到最近在《JAMA Neurology》上發表的一篇論文，該論文基於來自血管質量倡議或 VQI 的 20,000 多名患者的真實傾向匹配數據，該數據調查了標準的結果接受 TCAR 與 CEA 治療的手術風險患者。該出版物的結果在很大程度上反映了樑等人在 2021 年血管年會上的演講。

The study found statistically equivalent outcomes across primary endpoints with significantly lower incidence of cranial nerve injury and procedure time using TCAR. The paper represents another important piece of clinical evidence and provides a strong foundation for our early momentum in this expanded patient population. We will continue to reinforce TCAR's value proposition in this expanded population and all eligible patients, for that matter, through the continued collection and analysis of real-world outcomes in the VQI. In 2022 alone, there were 31 TCAR-related VQI papers published in major medical journals and another 11 in the first quarter of this year.

該研究發現，使用 TCAR 的主要終點具有統計學上相同的結果，且腦神經損傷的發生率和手術時間顯著降低。該論文代表了另一個重要的臨床證據，並為我們在這一擴大的患者群體中的早期勢頭提供了堅實的基礎。我們將通過持續收集和分析 VQI 中的真實結果，繼續強化 TCAR 在這一擴大的人群和所有符合條件的患者中的價值主張。僅2022年，主要醫學期刊上就發表了31篇TCAR相關VQI論文，今年第一季度又有11篇。

ROADSTER 3, our prospective post-approval study for patients at standard risk for surgical complications, recently eclipsed the 100 patients enrolled mark, and we are excited about the progress to date. The undeniable benefits of TCAR versus transfemoral carotid stenting and carotid endarterectomy continue to accrue. As we lead the field of stroke prevention forward, we are expanding and diversifying our portfolio by innovating around our transcarotid and neuroprotection core competencies.

ROADSTER 3 是我們針對手術並發症標準風險患者的前瞻性批准後研究，最近招募的患者人數超過了 100 名，我們對迄今為止的進展感到興奮。與經股動脈頸動脈支架置入術和頸動脈內膜切除術相比，TCAR 的不可否認的優勢不斷顯現。隨著我們引領中風預防領域的發展，我們正在通過圍繞經頸動脈和神經保護核心能力進行創新來擴大我們的產品組合併使其多樣化。

After a successful limited market release, we recently initiated the full-scale commercial launch of ENFLATE, the first balloon purpose-built for TCAR and the fifth product and our market-leading portfolio. Early traction and utilization patterns are encouraging as we work through hospital contracting and continue to conduct the first cases across many TCAR centers. I'm also excited to announce that we received 510(k) clearance for our next-generation ENROUTE neuroprotection system or NPS Plus. This product was designed to further support the ease of use and minimize the risk of complications. We anticipate a limited market release followed by a broader release later this year.

在成功進行有限市場發布後，我們最近啟動了 ENFLATE 的全面商業發布，這是第一個專門為 TCAR 製造的氣球，也是第五個產品和我們市場領先的產品組合。隨著我們與醫院簽訂合同並繼續在許多 TCAR 中心開展第一批病例，早期的牽引和利用模式令人鼓舞。我還很高興地宣布，我們的下一代 ENROUTE 神經保護系統或 NPS Plus 已獲得 510(k) 許可。該產品旨在進一步支持易用性並最大限度地降低並發症的風險。我們預計將在今年晚些時候進行有限的市場發布，然後進行更廣泛的發布。

Finally, we continue to lay the groundwork to broaden our geographic reach, starting with China and Japan. I am pleased to share that we received clearance in Q1 in China for our ENROUTE neuroprotection system.

最後，我們從中國和日本開始，繼續為擴大我們的地理覆蓋範圍奠定基礎。我很高興與大家分享，我們的 ENROUTE 神經保護系統已於第一季度在中國獲得許可。

We are now focused on approval for our ENROUTE stent as well as regulatory activities supporting future clearance of the ENROUTE NPS Plus. In Japan, we are actively investigating potential distribution partners while we work towards a reimbursement submission later this year, following the clearance of our ENROUTE neuroprotection system and ENROUTE stent last year. We are also working towards clearance of NPS Plus. While there are several steps ahead on our path to commercialization in these countries, we are well on our way to unlocking the $2.3 billion international market opportunity.

我們現在專注於 ENROUTE 支架的批准以及支持 ENROUTE NPS Plus 未來審批的監管活動。在日本，繼去年 ENROUTE 神經保護系統和 ENROUTE 支架獲得批准後，我們正在積極調查潛在的分銷合作夥伴，同時努力在今年晚些時候提交報銷申請。我們還在努力爭取 NPS Plus 的批准。儘管我們在這些國家的商業化道路上還有幾步之遙，但我們正在全力釋放 23 億美元的國際市場機遇。

In summary, we are pleased to deliver strong growth in our business while our investments to diversify through product and geographic expansion begin to deliver.

總之，我們很高興在我們的業務中實現強勁增長，同時我們通過產品和地域擴張實現多元化的投資開始發揮作用。

I'll now turn the call over to Lucas Buchanan, Chief Financial Officer and Chief Operating Officer.

我現在將把電話轉給首席財務官兼首席運營官盧卡斯·布坎南 (Lucas Buchanan)。

Thank you, Erica. Revenue for the 3 months ended March 31, 2023, was $40.1 million, a 43% increase from $28.0 million in the same period of the prior year. Growth was driven primarily by increased TCAR adoption as evidenced by greater than 5% sequential quarterly growth in procedures and our sixth straight quarter of sequential growth in procedures per trained physician.

謝謝你，艾麗卡。截至 2023 年 3 月 31 日的三個月收入為 4010 萬美元，比上年同期的 2800 萬美元增長 43%。增長主要是由 TCAR 採用率的增加推動的，這一點可以從程序數量環比季度增長超過 5% 以及每位受過訓練的醫生的程序數量連續第六個季度實現環比增長來證明。

The number of TCAR procedures in the quarter was approximately 5,830, a 45% increase from the same period of the prior year. As our results suggest, despite continued strong performance on product level ASPs, revenue in the period divided by procedures in the period trended below historical average, which was a function of standard quarterly fluctuations as we have seen from time to time.

本季度TCAR手術數量約為5,830例，較上年同期增長45%。正如我們的結果所表明的，儘管產品級平均售價持續強勁，但該期間的收入除以該期間的程序，趨勢低於歷史平均水平，這是我們不時看到的標準季度波動的函數。

Our underlying procedure growth demonstrates ongoing strength in demand for TCAR. Gross margin for the first quarter of 2023 was 69%, similar to the first quarter of the prior year, but sequentially down due to unfavorable production variances associated with select components. We have resolved this specific issue, and beyond a modest expected impact to second quarter gross margins, we expect higher gross margins into the back half of the year.

我們的基礎手術增長表明對 TCAR 的需求持續強勁。 2023 年第一季度的毛利率為 69%，與去年第一季度相似，但由於與選定組件相關的不利生產差異而環比下降。我們已經解決了這個具體問題，除了對第二季度毛利率產生適度的預期影響之外，我們預計今年下半年的毛利率將會更高。

Total operating expenses for the first quarter of 2023 were $44.5 million, a 26% increase from $35.4 million in the first quarter of 2022. R&D expenses for the first quarter of 2023 were $10.4 million compared to $8.1 million in the first quarter of 2022. The increase in R&D spending was driven primarily by growth in personnel, along with continued investments in new and ongoing programs.

2023年第一季度的總運營費用為4450萬美元，比2022年第一季度的3540萬美元增長26%。2023年第一季度的研發費用為1040萬美元，而2022年第一季度的研發費用為810萬美元。研發支出的增加主要是由人員增長以及對新項目和正在進行的項目的持續投資推動的。

Sales, general and administrative expenses for the first quarter of 2023 were $34.1 million compared to $27.3 million in the first quarter of 2022. The increase was largely driven by growth in personnel and increased stock-based compensation expense. As we look forward, we are leveraging our years of investment in commercial, manufacturing, R&D, and back-office infrastructure to drive durable top line growth and operating leverage.

2023 年第一季度的銷售、一般和管理費用為 3410 萬美元，而 2022 年第一季度為 2730 萬美元。這一增長主要是由人員增長和股票薪酬費用增加推動的。展望未來，我們將利用多年來在商業、製造、研發和後台基礎設施方面的投資來推動持久的營收增長和運營槓桿。

Turning back to first quarter results. Net loss for the first quarter was $16.5 million or a loss of $0.43 per share as compared to a net loss of $16.7 million or a loss of $0.48 per share for the same period of the prior year. We ended the quarter with over $200 million in cash, cash equivalents and investments.

回到第一季度的業績。第一季度淨虧損為 1,650 萬美元，即每股虧損 0.43 美元，而上年同期淨虧損為 1,670 萬美元，即每股虧損 0.48 美元。本季度結束時，我們擁有超過 2 億美元的現金、現金等價物和投資。

As a reminder, we completed a debt financing at favorable terms in 2022 with current available capacity at roughly $175 million. Together, our balance sheet and committed capital provide us with substantial financial flexibility and great optionality to support our business and growth initiatives looking forward.

謹此提醒，我們於 2022 年以優惠條件完成了債務融資，目前可用產能約為 1.75 億美元。我們的資產負債表和承諾資本共同為我們提供了巨大的財務靈活性和巨大的選擇性，以支持我們未來的業務和增長計劃。

Turning to our 2023 outlook. We continue to expect full year revenue to be in the range of $176 million to $184 million, reflecting growth of 27% to 33% over 2022 based on roughly 25,000 TCAR procedures at the midpoint of the range.

轉向我們的 2023 年展望。我們仍然預計全年收入將在 1.76 億美元至 1.84 億美元之間，基於該範圍中點的大約 25,000 例 TCAR 手術，預計全年收入將比 2022 年增長 27% 至 33%。

Our guidance reflects several variables, including the pace and progress of our commercial organization expansion, expanded market access for TCAR and a modest tailwind from the rollout of the ENFLATE balloon. As a reminder, we ended 2022 with a commercial presence in over 1,100 hospitals with almost 2,500 trained physicians served by 70 active sales territories. We cited on our last call that we believe we have achieved a critical mass for ongoing TCAR adoption, and we continue to expect incremental physician training and sales territory additions throughout the year and beyond.

我們的指導反映了幾個變量，包括我們商業組織擴張的步伐和進展、TCAR 市場准入的擴大以及 ENFLATE 氣球推出帶來的適度推動力。提醒一下，截至 2022 年，我們在 1,100 多家醫院開展了商業業務，在 70 個活躍銷售區域擁有近 2,500 名訓練有素的醫生。我們在上次電話會議中表示，我們相信我們已經達到了持續採用 TCAR 的臨界質量，並且我們繼續期望全年及以後不斷增加醫生培訓和銷售區域。

In summary, we are proud of our leadership and resiliency. We look forward to continued progress on the path to establishing TCAR as the standard of care.

總之，我們為我們的領導力和韌性感到自豪。我們期待在將 TCAR 確立為護理標準的道路上不斷取得進展。

At this point, I will turn the call back to Erica for closing comments.

此時，我會將電話轉回給 Erica 以徵求結束意見。

Thank you, Lucas. I'd like to close by inviting everyone to join us in just a few weeks on May 25 for a panel discussion between our Executive Medical Director, Dr. Dr. Sumaira Macdonald leading practitioners in the treatment of carotid artery disease. This will be the first in a series of educational events that we plan to host over the coming year to connect analysts and investors directly to the experts and open the dialogue around the benefits of TCAR amidst the broader treatment landscape, especially as we acknowledge stroke awareness month.

謝謝你，盧卡斯。最後，我想邀請大家在短短幾週內於 5 月 25 日參加我們的小組討論，我們的執行醫療主任、Sumaira Macdonald 博士是頸動脈疾病治療領域的領先從業者。這將是我們計劃在明年舉辦的一系列教育活動中的第一個，旨在將分析師和投資者直接與專家聯繫起來，並在更廣泛的治療領域中圍繞 TCAR 的益處展開對話，特別是在我們認識到中風的情況下月。

We hope our May 25 event sheds light into the current treatment landscape and how TCAR is uniquely positioned to deliver long-term value to patients and providers as we evolve the standard of care. We're excited for the discussion, and we hope you'll join us.

我們希望 5 月 25 日的活動能夠揭示當前的治療格局，以及 TCAR 如何在我們不斷發展護理標準的過程中發揮獨特的優勢，為患者和醫療服務提供者提供長期價值。我們很高興能進行討論，希望您能加入我們。

With that, I'll open it up to Q&A. Operator?

接下來，我將進行問答。操作員？

(Operator Instructions) Our first question comes from the line of Robbie Marcus of JPMorgan.

（操作員說明）我們的第一個問題來自摩根大通的羅比·馬庫斯。

Great. Wanted to start with first quarter trends. Lucas, you talked about normal quarterly fluctuations. The quarter came in below The Street. This is one of the first quarters guidance hadn't been raised. So I was hoping you could dig into exactly what's going on. Is there a stall in the standard risk indication? Is it less utilization? Is it some other seasonal trend that we aren't aware of because I think most investors were expecting a number a bit higher than this. So I'd love to dive into the underlying trends here.

偉大的。想從第一季度的趨勢開始。盧卡斯，您談到了正常的季度波動。該季度排名低於華爾街。這是第一季度尚未提出的指導意見之一。所以我希望你能深入了解到底發生了什麼。標準風險指示是否存在停滯？是不是利用率比較低？這是否是我們不知道的其他季節性趨勢，因為我認為大多數投資者的預期數字會比這個高一些。所以我很想深入探討這裡的潛在趨勢。

Sure, Robbie. Maybe I'll give a quick answer, and then I'll turn it back to Erica for kind of the bigger picture. The procedures in the quarter grew nicely, as we said, and the adoption trends were great. Where we were a little bit light was in revenue per procedure. That's within the variation we've seen historically. But slightly less than we modeled, and we can talk about that further later, but I'll turn it back to Erica for the broader dynamics quarter.

當然，羅比。也許我會快速給出答案，然後我會將其轉回給埃麗卡以了解更大的情況。正如我們所說，本季度的程序發展良好，採用趨勢也很好。我們的薄弱之處在於每個程序的收入。這在我們歷史上見過的變化範圍內。但比我們建模的要少一些，我們稍後可以進一步討論這個問題，但我將把它轉回到埃里卡，以了解更廣泛的動態季度。

Robbie, thanks so much for being on. So look, we took the first quarter to catch up on some necessary sales organization architecture. And that's really to prepare us for continued high growth. It's normal course of business in a fast-growing med tech, but we accelerated our planned pace of creating new leadership positions, balancing some territory geographies, creating new territories, all in service of increasing physician touch points.

羅比，非常感謝您的參與。所以看，我們花了第一季度的時間來趕上一些必要的銷售組織架構。這確實是為了讓我們為持續的高速增長做好準備。對於快速發展的醫療技術來說，這是正常的業務過程，但我們加快了創建新領導職位、平衡一些地區地理、創建新領域的計劃步伐，所有這些都是為了增加醫生接觸點。

We know from our own data, when we do this, we see accelerated adoption. As a result of all of that, we saw some temporal distortions in revenue. And we've seen this before, as you alluded to, in our business with fluctuations in the timing of orders, and that was slightly exacerbated by our territory-balancing efforts. But I will say we're really pleased with the quality of the people we're attracting, the people we already have and the pace of adding these sales professionals and leaders and therefore, we're confident in the guidance range.

我們從自己的數據中知道，當我們這樣做時，我們會看到加速的採用。所有這些的結果是，我們看到了收入的一些時間扭曲。正如您所提到的，我們之前已經在我們的業務中看到過這種情況，訂單時間的波動，而我們的領土平衡努力稍微加劇了這種情況。但我要說的是，我們對我們所吸引的人員的質量、我們現有的人員以及增加這些銷售專業人員和領導者的速度感到非常滿意，因此，我們對指導範圍充滿信心。

Got it. And maybe to touch on the full year guidance range. Are you still thinking about the same revenues, which I think was about 20 -- just under 25,000 procedures for the year and something about $7,200 in ASP per procedure for the year. Are there any changes to that? And does it have anything to do with the slowdown in first quarter of stocking from trained physicians?

知道了。也許還可以觸及全年指導範圍。您是否還在考慮相同的收入，我認為該收入約為 20 — 當年的手術量略低於 25,000 例，當年每個手術的 ASP 約為 7,200 美元。有什麼變化嗎？這與第一季度訓練有素的醫生備貨放緩有什麼關係嗎？

Sure, Robbie. I'm happy to address that. So the nuance is we're slightly more confident in total procedures for the year. So the roughly 25,000 on the last call was the under. Now it's the over. So again, the procedure trends are good. To your point, of $7,200, the average last year was $7,100. So in our own expectations and modeling, we brought that down slightly. And just to do a little bit of math, if we take $180 million at the midpoint of our 2023 guidance and divide it by roughly where we came in, in 2022 on revenue per procedure at $7,100 rounded, that's 25,400 procedures. If we came in at $7,200, that would get us towards the higher side of our range. And if we came in less than $7,100, the math is the math. So we've reduced our -- we've increased our procedures. We're at plan relative to our ASP discipline, and we're slightly lowering our expectations on revenue per procedure to end up at the same point.

當然，羅比。我很高興解決這個問題。所以細微差別是我們對今年的總體程序更有信心。因此，最後一次電話會議中大約 25,000 美元的金額低於預期。現在結束了。再說一遍，程序趨勢良好。就您而言，去年的平均收入為 7,200 美元，為 7,100 美元。因此，根據我們自己的期望和模型，我們稍微降低了這一點。做一點數學計算，如果我們將 2023 年指導中值的 1.8 億美元除以我們的大致收入，即 2022 年每台手術的收入為 7,100 美元，即為 25,400 台手術。如果我們的價格為 7,200 美元，這將使我們走向區間的較高一側。如果我們的收入低於 7,100 美元，那就是數學了。因此，我們減少了——我們增加了程序。我們正在按照與 ASP 規則相關的計劃進行，並且我們稍微降低了對每個程序收入的預期，以達到相同的目標。

Our next question comes from Rick Wise of Stifel. Your line is now open.

我們的下一個問題來自 Stifel 的 Rick Wise。您的線路現已開通。

Let me start off, and I just want to really make sure I'm understanding it. Your procedure numbers were basically exactly what we look for. Help me better understand the -- if you could just give us a little more color on the why the dollars per procedure were less. I mean that doesn't really have anything to do with the sales force expansion or the disruption. I understand that, that's going to be helpful later in the year. But I just want to make sure I'm really understanding this point.

讓我開始吧，我只是想真正確保我理解它。您的程序編號基本上正是我們所尋找的。請幫助我更好地理解——如果你能給我們更多的信息來解釋為什麼每次手術的費用更少。我的意思是，這與銷售隊伍的擴張或中斷實際上沒有任何關係。我明白，這對今年晚些時候會有幫助。但我只是想確保我真的理解這一點。

Yes. No, Rick, I'm so glad you asked that. Let me clarify that, which is when we add sales leadership, we generally are promoting from within. And so now we have a sales leader who's leading and also managing that territory they left behind. When we talk about balancing territories, what we're doing is splitting and moving people around. And so what that does in effect is leave some vacancies, leave some holes in territories.

是的。不，瑞克，我很高興你問這個問題。讓我澄清一下，當我們增加銷售領導力時，我們通常是從內部進行晉升。現在我們有了一位銷售主管，他負責領導並管理他們留下的領域。當我們談論平衡領土時，我們所做的就是分裂和轉移人員。因此，這實際上會留下一些空缺，在領土上留下一些漏洞。

And while our therapy development specialists are just terrific at covering cases and case planning in that aspect, they're not the quota-carrying professionals. And so there's a lag in sweeping back around to pick up the revenue or the order, if you will, from that case. And so that's why we talk about temporal distortions as it relates to these expansions. And so overall, we're feeling good and confident in the revenue guidance for the year.

雖然我們的治療開發專家在這方面的病例報導和病例規劃方面非常出色，但他們並不是持有配額的專業人員。因此，如果你願意的話，從這種情況下回過頭來獲取收入或訂單會存在滯後。這就是為什麼我們談論與這些擴張相關的時間扭曲。總的來說，我們對今年的收入指引感覺良好且充滿信心。

No, I got that. That's -- I appreciate that. And maybe just to make sure I'm understanding. So does that suggest that maybe some of the revenue that might have been in the first quarter falls into the second quarter as a result? Or am I not thinking about it correctly? And maybe just as part of that, Lucas, I get to be the one who says, "Can you help us think through the cadence of the first to second, second to third, third to fourth." You did say first quarter flattish, and I'm understanding it is sort of flattish. I was a shade more exuberant. But again, the procedures are right. So can you help us think through how to think sequentially in the distribution to get to the midpoint of your guidance range.

不，我明白了。那是——我很欣賞這一點。也許只是為了確保我理解。那麼，這是否表明第一季度的部分收入可能會因此落入第二季度？還是我沒有正確思考？也許正是作為其中的一部分，盧卡斯，我會說：“你能幫助我們思考一下第一到第二、第二到第三、第三到第四的節奏嗎？”你確實說過第一季度平淡，我知道它有點平淡。我的心情更激動一些。但話又說回來，程序是正確的。那麼，您能否幫助我們思考如何在分佈中按順序思考，以達到指導範圍的中點。

Sure, Rick. I think that's a 2-part question. So the first was it -- could it be somewhat of a timing issue? And the answer -- the quick answer is yes. Again, we've seen this before. In Q4, we were at just over $7,200 revenue per procedure. In Q1, we were just shy of $6,900. That matches trends from the prior year. Obviously, it's hard to make comparisons with different dynamics and the scale of our organization and the pandemic and things like that. And keep in mind, revenue per procedure is a derivative of units sold per procedure, that's when we recognize revenue.

當然，瑞克。我認為這是一個由兩部分組成的問題。那麼第一個問題是——這可能是一個時間問題嗎？答案是肯定的。再說一遍，我們以前已經見過這種情況。第四季度，我們每次手術的收入略高於 7,200 美元。第一季度，我們的價格略低於 6,900 美元。這與去年的趨勢相符。顯然，很難對我們組織的不同動態和規模以及流行病等進行比較。請記住，每個程序的收入是每個程序銷售的單位的衍生品，這是我們確認收入的時間。

And the units sold in the quarter is a function of how many new hospitals we have, how many total hospitals we have, how many docs trained per hospital we have, how many territories we have, where we are at splitting territories? Is there a body? Is there a quota-carrying rep actually in the territory at the time? The par levels that the hospitals carry across our different product lines and SKUs, whether the hospitals are being affected by their own financial pressures or pandemic pressures, all of that makes that particular metric somewhat uncertain and which is why it has ranged between that kind of $6,900 and $7,300, $7,400 historically.

本季度銷售的單位取決於我們有多少家新醫院、我們總共有多少家醫院、我們每家醫院培訓了多少醫生、我們有多少個地區、我們的地區劃分情況如何？有屍體嗎？當時該地區是否有實際持有配額的代表？醫院在我們不同產品線和 SKU 中的標準水平，無論醫院是否受到自身財務壓力或流行病壓力的影響，所有這些都使得該特定指標有些不確定，這就是為什麼它介於這種之間的原因歷史價格為 6,900 美元、7,300 美元、7,400 美元。

Again, what gives us confidence is strong pricing discipline, strong procedure growth and strong adoption curve metrics. And so as we look at the cadence of the rest of the year, as Erica mentioned, we were -- last year, we wanted to get to 70 to 75 territories. We hit the low end of that range. So we had some catch-up to do. And we really not only focused on catching up, but really accelerating based on the talent we were seeing in the marketplace. And again, that creates some kind of first half disruption as you're going through that change, but sets us up really well for the back half of the year beyond.

同樣，給我們信心的是強有力的定價紀律、強勁的流程增長和強勁的採用曲線指標。因此，當我們審視今年剩餘時間的節奏時，正如 Erica 提到的，去年我們希望覆蓋 70 到 75 個地區。我們達到了該範圍的低端。所以我們有一些事情要做。我們不僅專注於追趕，而且根據我們在市場上看到的人才真正加速發展。再說一遍，當你經歷這種變化時，這會造成某種上半年的干擾，但為我們下半年的發展奠定了良好的基礎。

And so obviously, in the second half of the year, we will have more touch points per physician based on all of the training and hiring we're doing right now. I would say the busiest people in the organization are the hiring managers and the sales organizations and their partners in HR while we continue to conduct the business of TCAR. And we'll also get the benefit in the back half of -- on the margin of the balloon revenue, right? Right now, we're transitioning to that full market release, but there's hospital contracting and getting first cases done. And so we're really set up well for the second half of the year based on all of the activity in Q1 and Q2.

顯然，在今年下半年，根據我們目前正在進行的所有培訓和招聘，我們將為每位醫生提供更多的接觸點。我想說，在我們繼續開展 TCAR 業務的同時，組織中最忙碌的人是招聘經理和銷售組織及其人力資源合作夥伴。我們還將在後半段獲得收益——在氣球收入的邊際上，對嗎？目前，我們正在過渡到全面的市場發布，但醫院已經簽約並完成了第一批病例。因此，根據第一季度和第二季度的所有活動，我們確實為今年下半年做好了準備。

Yes, I'll let somebody else ask if the second quarter will be sequentially flat or up.

是的，我會讓其他人問第二季度是連續持平還是上漲。

Our next question comes from Adam Maeder of Piper Sandler.

我們的下一個問題來自 Piper Sandler 的 Adam Maeder。

Great. I guess I'll take that question on Q2 and just ask, I showed Q2 revenue around $43.5 million for consensus. I think that implies 8% to 9% growth sequentially quarter-over-quarter versus your Q1 results. Any reaction to that figure? And then I have a follow-up or 2.

偉大的。我想我會在第二季度回答這個問題，只是問一下，我顯示第二季度的收入約為 4350 萬美元，以達成共識。我認為這意味著與第一季度業績相比，環比增長 8% 至 9%。對這個數字有什麼反應嗎？然後我有一個或兩個後續行動。

Yes. I think, again, the first quarter versus fourth quarter trend, obviously, is flattish. That matches prior year trends. What we're seeing with the adoption curve, what we're investing in with the commercial organization expansion and reiterating our guidance, all of that implies kind of a quarterly step-up in growth Q2 over Q1, Q3 over Q2, Q4 over Q3, with all of the other inputs we model and seasonality and things like that. I think that's a reasonable expectation.

是的。我再次認為，第一季度與第四季度的趨勢顯然是持平的。這與去年的趨勢相符。我們所看到的採用曲線、我們在商業組織擴張方面的投資以及重申我們的指導，所有這些都意味著第二季度比第一季度、第三季度比第二季度、第四季度比第三季度的季度增長，以及我們建模的所有其他輸入和季節性以及類似的東西。我認為這是一個合理的期望。

Okay. And then maybe we can turn to China. So congrats on the clearance there for the ENROUTE system. It sounds like you're focusing on getting the stent across the regulatory goal line. Maybe just talk about pathway forward for that for the stent. Do you need to run a study? Can you use already available clinical data? And really the genesis of the question is, could we potentially see revenue from China or Japan later this year in 2023? Or is that more of a '24 event? And then I have one follow-up.

好的。然後也許我們可以轉向中國。恭喜 ENROUTE 系統獲得許可。聽起來你的重點是讓支架跨越監管目標線。也許只是談談支架的前進道路。您需要進行一項研究嗎？您可以使用現有的臨床數據嗎？事實上，問題的根源在於，我們是否有可能在 2023 年晚些時候看到來自中國或日本的收入？或者這更像是 '24 事件？然後我有一個後續行動。

Yes. Sure. Adam, I'll take that one. Thanks for joining us. Yes, we're really excited to see NPS clearance in China. And you're right, we're working on the stent. We haven't given the specifics in part because we're working with the Chinese regulatory authorities. So we haven't given those specifics. What I can say is that the approval process is going well and as expected on ENROUTE stent. But as we've said in prior calls, I think it's fair to say there will not be a revenue contribution from either China or Japan in 2023.

是的。當然。亞當，我要那個。感謝您加入我們。是的，我們非常高興看到 NPS 在中國獲得許可。你是對的，我們正在研究支架。我們沒有透露具體細節，部分原因是我們正在與中國監管機構合作。所以我們沒有給出這些細節。我能說的是，ENROUTE 支架的審批流程進展順利，符合預期。但正如我們在之前的電話會議中所說，我認為可以公平地說，2023 年中國或日本都不會貢獻收入。

Okay. I appreciate the clarification there, Erica. And then just one last one. It's around the CAS NCD reconsideration from CMS. Just wondering if there's any update there and how you are thinking about potential likelihoods of outcomes and timing. And I saw that you submitted a common document to CMS. Just was hoping you could kind of walk us through the Cliffs Notes version of what that document says and your view on the NCD reopening.

好的。我很感謝埃麗卡的澄清。然後只有最後一張。這是圍繞 CMS 的 CAS NCD 重新考慮。只是想知道是否有任何更新以及您如何考慮結果和時間安排的潛在可能性。我看到您向 CMS 提交了一份通用文檔。只是希望您能向我們介紹一下 Cliffs Notes 版本的文件內容以及您對 NCD 重新開放的看法。

Absolutely. So the NCD reconsideration is underway. We just passed the kind of open comment period. And so CMS, Medicare is off doing the work that they do and evaluating the body of clinical evidence that exists around TCAR, transfemoral CAS, carotid endarterectomy, optimal medical therapy, all of the above. And so as we said before, Adam, we couldn't be more pleased with the body of evidence that exists around TCAR. And as you well know, CMS just leaned into kind of positively covering TCAR for standard surgical risk within the VQI TCAR Surveillance Project. And so we feel like we're sitting in a really good place. The question that's being asked is whether or not coverage should be expanded and some of the restrictions removed overall on transfemoral CAS and TCAR.

絕對地。因此，NCD 重新審議正在進行中。我們剛剛度過了公開評論期。因此，CMS、Medicare 正在開展他們所做的工作，並評估圍繞 TCAR、經股動脈 CAS、頸動脈內膜切除術、最佳藥物治療等所有方面存在的臨床證據。正如我們之前所說，Adam，我們對圍繞 TCAR 存在的大量證據感到非常滿意。正如您所知，CMS 只是傾向於在 VQI TCAR 監視項目中積極承保 TCAR 以應對標準手術風險。所以我們感覺我們坐在一個非常好的地方。人們提出的問題是是否應該擴大經股動脈 CAS 和 TCAR 的覆蓋範圍並全面取消一些限制。

And so I think it's safe to say CMS is going to do the work they do and review the evidence. As we alluded to in the prepared remarks, we continue to excel in outcomes over transfemoral CAS, both historically and in side-by-side comparisons from the VQI, large database comparisons.

因此，我認為可以肯定地說 CMS 將做他們所做的工作並審查證據。正如我們在準備好的發言中提到的，無論是歷史數據還是 VQI（大型數據庫比較）的並列比較，我們在經股動脈 CAS 的結果方面繼續表現出色。

So next step in the process, there will be a kind of June 12 -- or sorry, July 12 draft decision memo and we'll come back to you with what we think that means for us. But right now, we're feeling confident. And as we've said, we see a range of positive outcomes for TCAR.

因此，在該過程的下一步中，將會有一種 6 月 12 日——或者抱歉，7 月 12 日的決定草案備忘錄，我們將向您反饋我們認為這對我們意味著什麼。但現在，我們充滿信心。正如我們所說，我們看到 TCAR 取得了一系列積極成果。

Our next question comes from Joanne Wuensch of Citi.

我們的下一個問題來自花旗銀行的 Joanne Wuensch。

This is Anthony on for Joanne. The first, just going back to the commercial reorganization. Is the impact from this supposed to be contained to the first quarter? Or is this still ongoing? And then I just had one follow-up.

這是安東尼替喬安妮上場。第一，回到商業重組。由此帶來的影響是否應該被控制在第一季度？或者這仍在繼續？然後我就進行了一次後續行動。

Yes. Anthony, thanks for joining us. I think reorganization might not be the choice of words I would use. We really refer to this as kind of balancing out territory geographies. And we've done this historically, and it's a very commonplace in med tech. As the business grows, so does the sales organization to kind of meet and get ahead of that demand and getting ahead of driving adoption. So what we did here, Anthony, was accelerate the pace of our own plan and create a little more disruption and distortion in Q1 kind of taking more of the medicine upfront rather than spread out slowly over the year.

是的。安東尼，感謝您加入我們。我認為重組可能不是我會使用的詞。我們實際上將其稱為平衡領土地理。我們歷史上就這樣做過，這在醫療技術中非常常見。隨著業務的增長，銷售組織也在某種程度上滿足並領先於這種需求，並領先於推動採用。因此，安東尼，我們在這裡所做的就是加快我們自己計劃的步伐，並在第一季度製造更多的干擾和扭曲，提前服用更多藥物，而不是在一年中緩慢展開。

And in part, we were responding to the amazing talent that is coming our way and taking advantage of that talent being available or wanting to be available now and seeking out Silk Road. So there's more to do here, but I'd say that in Q1, we made some real significant progress, and I couldn't be more excited about the folks who are in training and their TCAR training right now.

在某種程度上，我們是在回應即將到來的優秀人才，並利用現有或希望現在可用的人才來尋找絲綢之路。因此，這裡還有更多工作要做，但我想說，在第一季度，我們取得了一些真正重大的進展，我對現在正在接受培訓的人員和他們的 TCAR 培訓感到非常興奮。

Got it. That's helpful. And then my second one, Lucas, is there any way you could quantify -- I know you said modest impact to gross margin in the second quarter, just if you can maybe put any numbers around that. Just trying to understand what the ramp looks like in the back half of the year.

知道了。這很有幫助。然後我的第二個問題，盧卡斯，有沒有什麼方法可以量化——我知道你說過對第二季度毛利率的影響不大，只要你能給出任何數字。只是想了解下半年的坡道是什麼樣子。

Sure. Well, gross margin came in at 69%, as I referenced. Q4 of last year was just shy of 73%. So that gives you -- kind of that range gives you a sense of the impact because we had strong price discipline. And each quarter, we have higher unit volume against a relatively fixed overhead at this point with 2 main manufacturing facilities. And so we took some period expense related to some issues that we needed to solve. That's mostly a Q1 impact. It will partially impact Q2 as well, and then we'll get back to normal barring any other specific issues.

當然。正如我提到的，毛利率為 69%。去年第四季度略低於 73%。因此，這個範圍可以讓您感受到影響，因為我們有嚴格的價格紀律。每個季度，我們都有更高的單位產量，而此時的管理費用相對固定，有 2 個主要製造工廠。因此，我們花費了一些與我們需要解決的問題相關的期間費用。這主要是第一季度的影響。這也會對第二季度產生部分影響，然後除非出現任何其他具體問題，否則我們將恢復正常。

Our next question comes from Neil Chatterji of B. Riley.

我們的下一個問題來自 B. Riley 的 Neil Chatterji。

Just curious -- I know you said that the procedure growth was healthy in first quarter. Just curious if you could maybe just give us an update on kind of the operating environment in the first quarter and as we kind of move to the early second quarter, any impact from staffing or COVID or any other factors on volumes?

只是好奇 - 我知道你說過第一季度的程序增長是健康的。只是好奇您能否向我們介紹第一季度運營環境的最新情況，以及隨著我們進入第二季度初，人員配置、新冠疫情或任何其他因素對銷量有何影響？

Yes. Neil, I'm glad that you asked that question. Embedded in the kind of reiterating our guidance range is the fact that we're seeing hospital inpatient -- U.S. inpatient hospital business kind of normalize. There are, as you've heard from others, some pockets still here and there of labor shortages. But by and large, I think patients are back to the business of getting screened and seeing their physicians and physicians are back to doing procedures in hospitals. So it feels like a more normalized operating environment, which is one of the assumptions in our guidance.

是的。尼爾，我很高興你問這個問題。重申我們的指導範圍的一個事實是，我們看到住院病人——美國住院病人的醫院業務正在趨於正常化。正如您從其他人那裡聽說的那樣，一些地方仍然存在勞動力短缺的情況。但總的來說，我認為患者又回到了接受篩查的狀態，看到他們的醫生和醫生又回到了醫院做手術。因此，這感覺像是一個更加規範化的操作環境，這是我們指南中的假設之一。

Great. Maybe just on ENFLATE. You touched on starting to get some feedback there from the full launch. Just curious, any more color with those kind of initial sites? And then just remind us if you're still expecting a positive impact on the revenue per procedure.

偉大的。也許只是在 ENFLATE 上。您談到從全面發布開始獲得一些反饋。只是好奇，這些初始網站還有更多顏色嗎？然後提醒我們您是否仍然期望對每個程序的收入產生積極影響。

Sure. I'll take part of that, Neil. Yes, the feedback has been very positive, just as we expected. The balloon was really to solve kind of some ergonomic challenges and some ease-of-use procedural benefits, improving the safety margin of that particular step in the procedure. That was the purpose of developing the ENFLATE balloon, and all of that is turning out to be true. So the feedback is quite positive. We're in the early days of the full market release, which really happened in Q2. And so we're still working through hospital pricing, hospital contracting, that sort of thing. I'll let Lucas take the back half of your question.

當然。我會參與其中，尼爾。是的，正如我們預期的那樣，反饋非常積極。氣球實際上是為了解決一些人體工程學挑戰和一些易於使用的程序優勢，提高程序中特定步驟的安全裕度。這就是開發 ENFLATE 氣球的目的，而所有這一切都被證明是正確的。所以反饋是相當積極的。我們正處於全面市場發布的早期階段，這確實發生在第二季度。因此，我們仍在研究醫院定價、醫院承包等問題。我會讓盧卡斯回答你問題的後半部分。

Yes. Yes. In terms of the revenue per procedure, given that it's a new product, it's our fifth product, as we spoke about on the last call, we do expect that to be a tailwind over time to revenue per procedure against the headwind of some of the slightly lower units per procedure of all the other products for all the reasons I listed in a prior question. So there's a net effect there.

是的。是的。就每個程序的收入而言，鑑於它是一個新產品，這是我們的第五個產品，正如我們在上次電話會議中談到的那樣，我們確實預計隨著時間的推移，這將成為每個程序收入的順風車，以對抗某些由於我在上一個問題中列出的所有原因，所有其他產品的每個程序的單位都略低。所以那裡有一個淨效應。

We've taken a step back. We've always said that kind of the revenue per procedure would ultimately come closer to kind of our actual product level ASP, assuming kind of 1 unit each in a TCAR procedure as we get to this critical mass and there's fewer and fewer kind of new accounts and new stocking orders, and it's really utilization-driven revenue. And we show that in our investor deck we're very focused on managing the business that way. We want all of our revenue to come from reorders and growing utilization.

我們退了一步。我們總是說，每個程序的收入最終會更接近我們實際產品水平的 ASP，假設 TCAR 程序中每個程序 1 個單位，當我們達到這個臨界質量時，新產品的種類越來越少帳戶和新的庫存訂單，這確實是利用率驅動的收入。我們表明，在我們的投資者平台中，我們非常注重以這種方式管理業務。我們希望所有收入都來自重新訂購和不斷提高的利用率。

And again, we've seen peaks and valleys in the revenue per procedure for timing and other factors. But we're getting closer to a normalized metric on that front going forward. But small changes up or down have big impacts for a very focused business.

再次，我們看到每個程序的收入因時間和其他因素而出現高峰和低谷。但我們在這方面正越來越接近標準化指標。但微小的向上或向下的變化對於一個非常專注的企業來說卻會產生巨大的影響。

I would now like to turn it back to Erica Rogers, Chief Executive Officer, for closing remarks.

現在我想請首席執行官艾麗卡·羅傑斯 (Erica Rogers) 致閉幕詞。

Thank you very much for joining us.

非常感謝您加入我們。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。這確實結束了該程序。您現在可以斷開連接。