Silk Road Medical Inc (SILK) 2022 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to the Fourth Quarter 2022 Silk Road Medical Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

美好的一天，謝謝你的支持。歡迎來到 2022 年第四季度絲綢之路醫療電話會議。 （操作員說明）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 today, Marissa Bych. Please go ahead.

我現在想把會議交給今天的發言人 Marissa Bych。請繼續。

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 and 12 months ended December 31, 2022. A copy of the press release is available on the company's website.

感謝您參加今天的電話會議。加入我的是首席執行官 Erica Rogers；首席財務官兼首席運營官 Lucas Buchanan。今天早些時候，Silk Road Medical 發布了截至 2022 年 12 月 31 日止的第 3 個月和第 12 個月的財務業績。新聞稿的副本可在公司網站上獲取。

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 the federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements.

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，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據《私人證券訴訟改革法》的安全港條款作出的1995 年。本次電話會議中包含的與對未來事件、結果或業績的預期或預測相關的任何陳述均為前瞻性陳述。

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.

所有前瞻性陳述，包括但不限於與我們的經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、商業和國際擴張、監管批准、報銷、競爭和產品開發是基於我們目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 November 9, 2022.

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 2022 年 11 月 9 日向美國證券交易委員會提交的 10-Q 表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, February 28, 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.

此電話會議包含時間敏感信息，並且僅在 2023 年 2 月 28 日今天的現場直播時準確無誤。Silk Road Medical 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性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.

然後我將把電話轉給首席執行官埃里卡羅傑斯。

Good afternoon, and thank you all for joining us. 2022 closes the books on a remarkable year at Silk Road. We achieved total revenue of $138.6 million, supported by over 19,500 procedures, representing 37% and 41% year-over-year growth respectively. Our performance was driven by growing physician adoption and acceptance of TCAR as the solution in minimally invasive stroke prevention.

下午好，感謝大家加入我們。 2022 年結束了絲綢之路非凡的一年。在超過 19,500 個程序的支持下，我們實現了 1.386 億美元的總收入，分別同比增長 37% 和 41%。我們的業績得益於越來越多的醫生採用和接受 TCAR 作為微創中風預防的解決方案。

We achieved our full year territory expansion expectations and exceeded our trained physician guidance in response to increased demand. We also made important progress toward our objective of strengthening Silk Road's category leadership in the treatment of carotid artery disease. With the expansion of TCAR labeled indication to include patients at standard risk for surgical complications.

我們實現了全年領土擴張預期，並超出了我們訓練有素的醫生指導，以應對不斷增長的需求。我們還朝著加強絲綢之路在治療頸動脈疾病領域的品類領導地位的目標取得了重要進展。隨著 TCAR 標記適應症的擴展，包括手術並發症標準風險的患者。

The FDA approval in May promptly followed by expanded Medicare coverage within the TCAR surveillance project opened our addressable market to the entire 170,000 annual carotid procedures in the United States. While expanding our access to the full 430,000 annual U.S. diagnoses, representing a $3.2 billion opportunity. Physicians are now able to simplify treatment decisions with the best interest and preference of patients at the core.

FDA 在 5 月迅速批准，隨後擴大了 TCAR 監測項目中的醫療保險覆蓋範圍，為美國每年 170,000 例頸動脈手術打開了我們的目標市場。同時擴大我們對美國每年全部 430,000 例診斷的訪問權限，代表著 32 億美元的機會。醫生現在能夠以患者的最大利益和偏好為核心來簡化治療決策。

Our success remains rooted in the large and expanding body of clinical evidence in support of TCAR. In 2002, we surpassed 25,000 patients worth of clinical data from trials and registries published in high impact factor peer-reviewed medical journals. In fact, we saw over 85 TCAR publications within the year, authored by over 75 distinguished physicians with broad reach across the United States.

我們的成功仍然植根於支持 TCAR 的大量且不斷擴大的臨床證據。 2002 年，我們從高影響因子同行評審醫學期刊上發表的試驗和註冊中獲得了超過 25,000 名患者的臨床數據。事實上，我們在這一年內看到了超過 85 篇 TCAR 出版物，由超過 75 位傑出的醫生撰寫，在美國具有廣泛的影響力。

And we are pleased that the Society for Vascular Surgery, Vascular Quality Initiative, the SVS, VQI dataset continues to grow rapidly. This allows TCAR performing physicians to assess real world data in a contemporary timeframe sourced independent of industry. Adding to our 2022 successes, we bolstered our balance sheet by nearly $135 million paving the way for ongoing investment in growth as we drive toward profitability.

我們很高興血管外科學會、血管質量倡議、SVS、VQI 數據集繼續快速增長。這使 TCAR 執行醫師能夠在獨立於行業的當代時間範圍內評估真實世界的數據。除了我們在 2022 年取得的成功之外，我們還增加了近 1.35 億美元的資產負債表，為我們在實現盈利的過程中持續投資增長鋪平了道路。

We also brought our Minnesota facility online adding manufacturing and distribution capacity as well as access to a talented workforce. We will continue to prioritize advancements in U.S. TCAR specifically in our commercial team, product R&D and ongoing clinical data such as ROADSTER 3. Our focus is on strategies to enhance our trajectory and meaningfully scale our business over time.

我們還使我們在明尼蘇達州的工廠上線，增加了製造和分銷能力以及獲得人才的機會。我們將繼續優先考慮美國 TCAR 的進步，特別是在我們的商業團隊、產品研發和正在進行的臨床數據（如 ROADSTER 3）方面。我們的重點是提高我們的軌跡並隨著時間的推移有意義地擴展我們的業務的戰略。

This brings me to our 2023 objectives. #1, grow. As we shift our focus to the year ahead, our first objective remains consistent. Driving increased TCAR utilization through strong commercial execution. We know that the largest opportunity in front of us is bringing physicians up the adoption curve in the form of higher TCAR usage. And we know, from years of commercial expansion that we achieve strong returns on increased physician engagement.

這讓我想到了我們的 2023 年目標。 #1，成長。當我們將重點轉移到未來一年時，我們的首要目標保持不變。通過強大的商業執行力推動 TCAR 利用率的提高。我們知道，擺在我們面前的最大機會是以更高的 TCAR 使用率的形式提升醫生的採用曲線。我們知道，從多年的商業擴張中，我們通過增加醫生參與度獲得了豐厚的回報。

That's why throughout this year, we remain focused on driving more touch points with physicians through territory expansion and comprehensive marketing campaigns. Now more than ever, we are focused on highlighting the patient benefits of TCAR over other alternatives. We will continue to generate evidence to support patient decision making and extend our commercial reach to more patient-centered stakeholders.

這就是為什麼在今年全年，我們仍然專注於通過領土擴張和全面的營銷活動來推動與醫生的更多接觸點。現在，我們比以往任何時候都更加專注於強調 TCAR 相對於其他替代方案對患者的益處。我們將繼續收集證據來支持患者的決策，並將我們的商業影響力擴展到更多以患者為中心的利益相關者。

As we drive TCAR market penetration from roughly 12% in 2022 to mid-teens over the coming year and strong double-digits beyond. We are immensely excited about the trajectory ahead and remain focused on progressing TCAR toward the standard of care.

隨著我們將 TCAR 市場滲透率從 2022 年的大約 12% 提高到來年的十幾歲左右，以及更高的兩位數。我們對未來的發展軌跡感到非常興奮，並將繼續專注於使 TCAR 朝著護理標準發展。

Our second priority is to strengthen the business. We spent the last 5 plus years laying a foundation for growth in the U.S. carotid disease market, through our broad portfolio of TCAR products, solid commercial footprint and robust operations. We are building upon the strength of this foundation to support our growth outlook and further extend our category leadership while we drive operating leverage on the path to creating and sustaining a profitable business.

我們的第二個優先事項是加強業務。在過去的 5 年多時間裡，我們通過廣泛的 TCAR 產品組合、堅實的商業足跡和穩健的運營，為美國頸動脈疾病市場的增長奠定了基礎。我們正在鞏固這一基礎的力量，以支持我們的增長前景並進一步擴大我們的品類領導地位，同時我們在創造和維持盈利業務的道路上推動運營槓桿。

And finally, diversify where our intentions are twofold. For 1, this includes extending our geographic reach. Our goal has always been to make TCAR the standard of care for the treatment of carotid artery disease globally. We made meaningful progress in 2022 on this front receiving shown and approvals in Japan for both our ENROUTE Neuroprotection System and the ENROUTE Stent.

最後，在我們有雙重意圖的地方實現多樣化。對於 1，這包括擴大我們的地理範圍。我們的目標一直是使 TCAR 成為全球治療頸動脈疾病的護理標準。 2022 年，我們的 ENROUTE 神經保護系統和 ENROUTE 支架在日本的接收顯示和批准方面取得了有意義的進展。

In addition to preparing for global launches, we will continue to expand on our core competencies through product innovation. This effort begins within carotid artery disease and positions us to expand the application of our category-leading technology beyond. As part of our ongoing pursuit of innovation in transcarotid technologies, we recently announced the clearance of our Enflate Transcarotid Rapid Exchange Balloon Dilation Catheter or Enflate for short, the first balloon purpose-built for TCAR and the fifth product in our TCAR portfolio.

除了為全球發布做準備外，我們還將通過產品創新繼續擴大我們的核心競爭力。這項工作始於頸動脈疾病，使我們能夠將我們領先的技術的應用擴展到其他領域。作為我們不斷追求經頸動脈技術創新的一部分，我們最近宣布我們的 Enflate 經頸動脈快速交換球囊擴張導管或簡稱 Enflate 獲得批准，這是第一個專為 TCAR 製造的球囊，也是我們 TCAR 產品組合中的第五個產品。

We initiated a limited launch of Enflate in the fourth quarter of 2022 and we plan to commence our full scale commercial launch in the second quarter of this year. We have also made enrollment progress in our NITE 1 feasibility study in acute ischemic stroke. And we continue enrolling and learning in 2023.

我們在 2022 年第四季度啟動了 Enflate 的有限發布，我們計劃在今年第二季度開始全面的商業發布。我們在急性缺血性中風的 NITE 1 可行性研究中也取得了招募進展。我們將在 2023 年繼續招生和學習。

All said, we are enormously optimistic about the future of Silk Road Medical. We are pleased to initiate guidance of $176 million to $184 million in full year 2023 revenue, reflecting roughly 25,000 TCAR procedures at the midpoint of the range. We are confident in the year ahead and in our prospects for continued long-term growth.

總之，我們對絲路醫療的未來非常樂觀。我們很高興啟動 2023 年全年收入 1.76 億美元至 1.84 億美元的指導，反映了該範圍中點的大約 25,000 個 TCAR 程序。我們對來年以及我們持續長期增長的前景充滿信心。

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

我現在將把電話轉給我們的首席財務官兼首席運營官 Lucas Buchanan。

Thank you, Erica. Revenue for the 3 months ended December 31, 2022 was $40.1 million, a 42% increase from $28.3 million in the same period of the prior year. Growth was driven primarily by increased TCAR adoption, as evidenced by our fifth straight quarter of growth in procedures per trained physicians. The number of TCAR procedures in the quarter was over 5,500 a 43% increase from the same period of the prior year.

謝謝你，艾麗卡。截至 2022 年 12 月 31 日止三個月的收入為 4010 萬美元，較上年同期的 2830 萬美元增長 42%。增長主要是由 TCAR 的採用率增加推動的，正如我們連續第五個季度在每個受過培訓的醫生的手術中增長所證明的那樣。本季度 TCAR 手術數量超過 5,500 例，同比增長 43%。

Gross margin for the fourth quarter of 2022, was 73% compared to 74% in the fourth quarter of the prior year. The decline was driven by higher manufacturing costs, associated with labor and materials and maintaining 2 manufacturing facilities. With our recent investment in manufacturing capacity, we expect our gross margin to be slightly lower than prior periods in the short-term, but we anticipate improved margins over time with increased volumes and continued price discipline.

2022 年第四季度的毛利率為 73%，而去年第四季度為 74%。下降的原因是與勞動力和材料相關的製造成本增加以及維護 2 個製造設施。憑藉我們最近對製造能力的投資，我們預計短期內我們的毛利率將略低於前期，但我們預計隨著銷量的增加和持續的價格約束，利潤率會隨著時間的推移而提高。

Total operating expenses for the fourth quarter of 2022 were $41.7 million, a 19% increase from $35.1 million in the fourth quarter of 2021. R&D expenses for the fourth quarter of 2022 were $9.2 million compared to $7.5 million in the fourth quarter of 2021. The increase in R&D spending was driven primarily by growth in personnel along with continued investments in new and ongoing programs.

2022 年第四季度總運營費用為 4170 萬美元，比 2021 年第四季度的 3510 萬美元增長 19%。2022 年第四季度的研發費用為 920 萬美元，而 2021 年第四季度為 750 萬美元。研發支出的增長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 fourth quarter of 2022 were $32.5 million compared to $27.6 million in the fourth quarter of 2021. Now more than ever, we are focused on operational excellence as we achieve greater scale. Last year, we dramatically increased our manufacturing capacity and human resources and with these expanded efforts in place, we are increasingly focused on supply chain, quality and design for manufacturing initiatives to mitigate risk and manage input costs.

2022 年第四季度的銷售、一般和行政費用為 3250 萬美元，而 2021 年第四季度為 2760 萬美元。現在，隨著我們實現更大的規模，我們比以往任何時候都更加專注於卓越運營。去年，我們大幅提高了製造能力和人力資源，隨著這些擴大的努力到位，我們越來越關注製造計劃的供應鏈、質量和設計，以降低風險和管理投入成本。

We look forward to leveraging the years of work and investment. We have put behind commercial, manufacturing, R&D and back-office infrastructure and we expect operating expenses as a percentage of revenue to decrease going forward.

我們期待利用多年的工作和投資。我們已經擱置了商業、製造、研發和後台基礎設施，我們預計未來運營費用佔收入的百分比將會下降。

Net loss for the fourth quarter was $12.6 million or a loss of $0.34 per share, as compared to a net loss of $14.7 million or a loss of $0.42 per share for the same period of the prior year. We ended 2022 with $213.7 million in cash, cash equivalents and short-term investments having bolstered our balance sheet through a debt refinancing in the second quarter, which added approximately $25 million to our cash balance, while also providing further access to liquidity and an equity financing in the fourth quarter, which contributed approximately $109 million in net proceeds. Together these raises, provides substantial additional flexibility in support of our business and growth initiatives.

第四季度淨虧損為 1260 萬美元或每股虧損 0.34 美元，而去年同期為淨虧損 1470 萬美元或每股虧損 0.42 美元。到 2022 年底，我們擁有 2.137 億美元的現金、現金等價物和短期投資，通過第二季度的債務再融資增強了我們的資產負債表，這使我們的現金餘額增加了約 2500 萬美元，同時還提供了進一步獲得流動性和股權的途徑第四季度融資，貢獻了約 1.09 億美元的淨收益。這些加薪共同為支持我們的業務和增長計劃提供了實質性的額外靈活性。

Turning to our 2023 outlook and commercial strategy, 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 anticipate incremental physician training and territory growth in 2023 and beyond as we respond to strong TCAR demand with the intent to maximize our return on investment as part of our long-term profitability goals.

談到我們的 2023 年展望和商業戰略，到 2022 年底，我們在 1,100 多家醫院開展了商業業務，擁有近 2,500 名訓練有素的醫生，由 70 個活躍的銷售區域提供服務。我們預計 2023 年及以後將增加醫生培訓和領土增長，因為我們響應強勁的 TCAR 需求，目的是將我們的投資回報最大化，作為我們長期盈利目標的一部分。

With a critical mass of territories, trained physicians and hospital accounts entering 2023, we are well positioned to drive growth in procedures per trained physician while also driving operating leverage. As Erica mentioned, we expect full-year revenue to be in the range of $176 million to $184 million reflecting revenue growth of 27% to 33% over 2022, based on roughly 25,000 TCAR procedures at the midpoint of the range.

隨著進入 2023 年的大量地區、訓練有素的醫生和醫院賬戶，我們有能力推動每個訓練有素的醫生的程序增長，同時也推動運營槓桿。正如 Erica 提到的那樣，我們預計全年收入將在 1.76 億美元至 1.84 億美元之間，反映出收入比 2022 年增長 27% 至 33%，基於該範圍中點的大約 25,000 個 TCAR 程序。

As always, our guidance accounts for several variables including ongoing macro uncertainty and also assumes continued normalization in the hospital operating environment. The gradual layering effect of our recent -- standard surgical risk label expansion is reflected in our guidance range and we also expect our revenue per procedure opportunity to benefit modestly from the rollout of the Enflate balloon.

一如既往，我們的指南考慮了幾個變量，包括持續的宏觀不確定性，並假設醫院運營環境持續正常化。我們最近的標準手術風險標籤擴展的逐漸分層效應反映在我們的指導範圍內，我們還預計我們的每次手術機會收入將從 Enflate 氣球的推出中適度受益。

As a reminder, we will maintain our reporting framework going forward. And as such will not be breaking out contributions of TCAR procedures by patient surgical risk profile nor product level revenues.

提醒一下，我們將繼續保持我們的報告框架。因此，不會按患者手術風險狀況或產品水平收入來劃分 TCAR 程序的貢獻。

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

在這一點上，我想把電話轉回給 Erica 以徵求意見。

Thank you, Lucas. I'd like to reiterate, that 2023 will be a year of growth and leverage for Silk Road carried by our team who has focused on building and scaling our platform for the last several years to put TCAR in the hands of more physicians and benefit as many patients as possible. Collaboration, excellence and a commitment to doing the best we can for our providers and their patients are the values at the core of Silk Road culture.

謝謝你，盧卡斯。我想重申，2023 年將是我們團隊承載的 Silk Road 增長和影響力的一年，他們在過去幾年一直專注於構建和擴展我們的平台，以將 TCAR 交到更多醫生手中並從中受益盡可能多的病人。協作、卓越以及竭盡所能為我們的提供者及其患者服務的承諾是絲綢之路文化的核心價值觀。

And we know that the next phase of our company's growth will be driven by a culmination of these factors. With our broad base -- of clinical evidence, established commercial footprint and full market access, we are in many ways, arriving at the next era in the Silk Road Medical story. We are excited to continue our work in earnest.

我們知道，我們公司下一階段的增長將由這些因素共同推動。憑藉我們廣泛的臨床證據基礎、成熟的商業足跡和全面的市場准入，我們在很多方面都在進入絲綢之路醫療故事的下一個時代。我們很高興能夠認真地繼續我們的工作。

We will now open the line to questions. Operator?

我們現在將打開問題熱線。操作員？

(Operator Instructions) Our next caller is Travis Steed of Bank of America Securities.

（接線員說明）我們的下一位來電者是美國銀行證券公司的特拉維斯·斯蒂德。

I guess I'll start with the guidance. And maybe to start, how to think about the quarterly progression Q1 versus Q4, you just did. And then on the 2023 guide, curious if you can define the modest benefit on price is that, low-single digits, or mid-single digits, how to think about the pricing and when you think about market penetration and the 2023 guidance?

我想我將從指導開始。也許首先，如何考慮 Q1 與 Q4 的季度進展，你剛剛做到了。然後在 2023 年指南中，想知道您是否可以定義適度的價格收益，即低個位數或中個位數，如何考慮定價以及何時考慮市場滲透和 2023 年指南？

It looks like you did around 2.5 points, or 3 points of market penetration last year and guiding for about the similar level of market penetration in 2023 despite standard risk. So just kind of thinking about it that fulfilling for market penetration or how we should think about the upside to that?

看起來你去年做了大約 2.5 個點，或 3 個點的市場滲透，並且儘管有標準風險，但在 2023 年指導了大約類似水平的市場滲透。因此，只是考慮一下滿足市場滲透的需求，或者我們應該如何考慮它的好處？

Yes, hi, Travis. Thanks very much for your question and good to have you on the call here. So let me just talk about the kind of top-line puts and takes first of all. As we said in our prepared remarks, the guide really reflects what we consider to be ongoing normalization of the operating environment and hospitals stability.

是的，嗨，特拉維斯。非常感謝您提出問題，很高興您能來接電話。因此，讓我先談談頂線看跌期權的類型。正如我們在準備好的評論中所說，該指南確實反映了我們認為正在持續正常化的運營環境和醫院穩定性。

Of course with pockets -- here and there, I would say, of some labor shortages, but it also represents the increased momentum in our business and to your point, the full market access in standard surgical risk approval. As we've talked about before, we're not going to break out those trends by risk factor, but instead, sort of talk about it collectively.

當然有口袋 - 我會說這里和那裡有一些勞動力短缺，但這也代表了我們業務的增長勢頭以及你的觀點，即標準手術風險批准的全面市場准入。正如我們之前所討論的，我們不會按風險因素分解這些趨勢，而是集體討論。

But I do think it's important to point out that even in Q4, it was still early days in the rollout of standard surgical risk approval and safe to say that that momentum is building. I'll let Lucas take some of the detailed answers to your questions.

但我確實認為重要的是要指出，即使在第四季度，標準手術風險審批的推出仍處於早期階段，可以肯定地說這種勢頭正在增強。我會讓盧卡斯對你的問題做一些詳細的回答。

Yes, Travis, thanks for the question. In terms of the quarterly cadence, it's going to be another year, where it's kind of back half loaded which is partly a function of a cadence of our continued territory expansion. And our goal for territories was 70 to 75 last year and we reported that we met that at the low end of the range. So we're still building from 70 to 75 and beyond throughout the year.

是的，特拉維斯，謝謝你提出這個問題。就季度節奏而言，這將是又一年，它有點後半載，這部分是我們持續擴張的節奏的一個功能。去年我們的地區目標是 70 到 75，我們報告說我們在範圍的低端達到了目標。所以我們全年仍在建設 70 到 75 甚至更多。

And so, we'll see kind of that step up, Q1 historically has been flattish to Q4. There some COVID noise in that. So maybe it's flattish to modest increase and then we built from there. In terms of the pricing implied pricing and kind of revenue per procedure from Enflate, obviously we need some more time to gather data as to what the pricing will be in the full market what the utilization, what the units per procedure.

因此，我們會看到某種程度的提升，從歷史上看，第一季度與第四季度持平。那裡有一些 COVID 的噪音。因此，適度增長可能是持平的，然後我們從那裡開始建設。就 Enflate 的定價隱含定價和每個程序的收入類型而言，顯然我們需要更多時間來收集數據，以了解整個市場的定價是多少，利用率是多少，每個程序的單位是多少。

So we'll give some color on that as we go forward. If you do the math on our implied guidance, we're talking about a revenue, per procedure metric and roughly the $7,200 to $7,300 range. And obviously that will kind of be at the lower end at the beginning of the year and potentially at the higher end. That's our best estimate as we sit here today. And then on the penetration question, you're right.

所以我們會在前進的過程中給出一些顏色。如果你根據我們的隱含指導進行數學計算，我們談論的是收入，每個程序指標和大約 7,200 美元到 7,300 美元的範圍。顯然，這將在今年年初處於低端，並可能處於高端。這是我們今天坐在這裡的最佳估計。然後關於滲透問題，你是對的。

You've done the math roughly right at the midpoint and procedures per doc, is the goal of the organization and moving this procedure up the adoption curve with the full label and the clinical evidence and the critical mass we have is the job, it's a very sensitive metric. And so, if we're slightly better or slightly worse, the output will be, as such, but that's where we're focused is on driving the adoption curve in 2023, it's really a year of commercial execution.

您已經大致正確地完成了每個文檔的中點和程序的數學計算，這是組織的目標，並且將這個程序提升到採用曲線的完整標籤和臨床證據以及我們擁有的臨界質量是工作，這是一個非常敏感的指標。因此，如果我們稍微好一點或稍微差一點，輸出就會如此，但這就是我們關注的重點是在 2023 年推動採用曲線，這實際上是商業執行的一年。

Great, very helpful. And I guess a follow-up for Lucas, would it be on the better leverage you can get this year. Just curious how you can put some numbers around the leverage you could get or market penetration for breakeven. And then a follow-up for Erica, would just be on the CMS, NCD review, anything that come out of that, curious what would happen if, the sense that the reimbursement there?

太好了，很有幫助。而且我想 Lucas 的後續行動是否會在今年獲得更好的槓桿作用。只是好奇你如何能用一些數字來衡量你可以獲得的槓桿作用或盈虧平衡的市場滲透率。然後是 Erica 的後續行動，只是關於 CMS、NCD 審查，以及由此產生的任何結果，好奇如果那裡有報銷會發生什麼？

Yes, so we certainly expect revenue to grow faster than operating expenses this year. We are, in 2023 will have the full year effect of quite a bit of hiring we did in 2022. We will also incrementally invest in sales force expansion, as I mentioned, but we do expect operating expenses as a percentage of revenue to continue to tick down. We did not provide specific revenue scale or timing of profitability again.

是的，所以我們當然預計今年的收入增長將快於運營支出。我們在 2023 年將對 2022 年進行的大量招聘產生全年影響。正如我提到的，我們還將逐步投資於銷售隊伍擴張，但我們確實預計運營支出佔收入的百分比將繼續打勾。我們沒有再次提供具體的收入規模或盈利時間。

We really want 2023, the year of commercial execution to show us what we're capable of with the full label, the additional product, the product portfolio and the overall critical mass. And so as we progress throughout the year on revenue growth, and see that operating leverage we can start to think about that path to profitability.

我們真的希望 2023 年，即商業執行年，向我們展示我們在完整標籤、附加產品、產品組合和整體臨界質量方面的能力。因此，隨著我們全年在收入增長方面取得進展，並看到運營槓桿，我們可以開始考慮通往盈利的道路。

Yes and Travis on your NCD, reconsideration question, we continue to believe there are a range of favorable outcomes for Silk Road and for TCAR and generally we welcome this opportunity for a wholesome review of the evidence. As you heard in the prepared remarks, we're sitting here with greater than 25,000 patients worth of data in peer-reviewed high impact factor journals and more data are generated on a daily basis in the real world evidence of the TCAR surveillance project.

是的，Travis 關於您的 NCD，重新考慮的問題，我們仍然相信絲綢之路和 TCAR 有一系列有利的結果，總的來說，我們歡迎這個對證據進行全面審查的機會。正如您在準備好的發言中所聽到的那樣，我們坐在這裡，在同行評審的高影響因子期刊中擁有超過 25,000 名患者的數據，並且每天在 TCAR 監測項目的真實世界證據中生成更多數據。

So we're -- pleased with the outcomes that have been posted so far. We know that the training metrics less restrictive patient criteria, all of those things are in our favor. In terms of where we are from a process point of view, the first comment period behind us, the public comments are public, so you can see them and we did of course post public comment June -- July, is the first draft decision memo that will come from CMS, and we'll wait to see what happens and -- keep our heads down and do the good work we're doing in the meantime.

所以我們 - 對迄今為止發布的結果感到滿意。我們知道培訓指標對患者標準的限制較少，所有這些都對我們有利。從流程的角度來看，我們在第一個意見徵詢期之後，公眾意見是公開的，所以你可以看到它們，我們當然在 6 月至 7 月發布了公眾意見，這是第一份決定備忘錄草案這將來自 CMS，我們將拭目以待，看看會發生什麼——保持低調，同時做好我們正在做的工作。

(Operator Instructions) And our next question comes from Robbie Marcus of JPMorgan.

（操作員說明）我們的下一個問題來自摩根大通的羅比馬庫斯。

Great, congrats on a nice quarter.

太好了，祝賀你度過了一個美好的季度。

Thank you.

謝謝。

Maybe to follow-up, after Travis asked all the questions. If I take Lucas that, 25,000 procedures, it gives us revenue per procedure about $7,200 for the year. How do we think about the cadence of that through the year as you add in the balloon?

也許在特拉維斯問完所有問題後進行跟進。如果我把 Lucas 算作 25,000 個程序，那麼每年每個程序的收入約為 7,200 美元。當您添加氣球時，我們如何看待這一年的節奏？

Is it more second half weighted revenue per procedure, similar to how you're building out the territories and I appreciate the first quarter color, but is there anything abnormal about the 2Q through 4Q ramp we should be thinking about?

每個程序的下半年加權收入是否更多，類似於您建立區域的方式，我很欣賞第一季度的顏色，但是我們應該考慮的第二季度到第四季度的斜坡是否有任何異常？

Yes, first of all I would interpret that roughly 25,000 as on the under, not the over. And again, I think the average is probably going to be in that $7,250 range there has always been quarter-to-quarter variability, but yes, it would, it would likely scale from the $7,200 range up towards the $7,300 range.

是的，首先我會將大約 25,000 解釋為低於，而不是高於。再一次，我認為平均值可能會在 7,250 美元的範圍內，一直存在季度到季度的變化，但是，是的，它可能會從 7,200 美元的範圍擴大到 7,300 美元的範圍。

Again there some uncertainty on exactly how much utilization and units per procedure, as we get into the full market release in Q2 and beyond and a full market release still requires the administrative churn of that committees and pricing contracts and those things. So we'll progress throughout the year in terms of both, the territory expansion, the procedures per physician and the Enflate contribution on the margin.

同樣，隨著我們在第二季度及以後進入完整的市場發布，並且完整的市場發布仍然需要委員會和定價合同以及那些東西的行政變動，每個程序的利用率和單位數量仍然存在一些不確定性。因此，我們全年都將在領土擴張、每位醫生的程序和 Enflate 的邊際貢獻方面取得進展。

Got it. And as you contemplate expanding outside the U.S. versus the cash you have on the balance sheet. How are you considering M&A at this point? Is there something else you can add into the bag of the sales reps that you think might be worthwhile and accretive to the business or is the use of cash solely on -- the U.S. and outside the U.S.?

知道了。當您考慮將資產負債表上的現金與美國以外的地區進行擴張時。您目前如何考慮併購？您是否可以在銷售代表的包中添加您認為可能對業務有價值和增值的其他東西，或者僅在美國和美國以外使用現金？

Yes, I appreciate the question, Robbie. Look, the way to think about this business with 12% penetration closing out 2022 in the United States is there is so much room to run here. And as I said in my prepared remarks, our best investment for growth is right here in the United States in U.S. TCAR expansion.

是的，我很欣賞這個問題，羅比。看，考慮到 2022 年在美國結束時滲透率為 12% 的業務的方式是這裡有很大的運行空間。正如我在準備好的發言中所說，我們最好的增長投資就在美國的美國 TCAR 擴張中。

If you look at the total market opportunity adjust the treated patients alone, we're just getting started. So I think it's safe to say the focus is on increasing the adoption of TCAR and driving the leverage we have right here at home in the United States.

如果您只看整個市場機會調整接受治療的患者，我們才剛剛開始。所以我認為可以肯定地說，重點是增加 TCAR 的採用並推動我們在美國本土擁有的影響力。

(Operator Instructions) And our next question comes from Adam Maeder of Piper Sandler.

（操作員說明）我們的下一個問題來自 Piper Sandler 的 Adam Maeder。

And congrats on the progress in 2022. Did want to start with 1 on Q4 and just dig in a little bit more there, I'm curious if you're able to kind of talk about the trends month-by-month, October through December, certainly solid performance and good to see the business up 7% sequentially, but the quarter-over-quarter growth was a little bit lighter than past quarters?

祝賀 2022 年取得的進展。我想從第 4 季度的 1 開始，然後再深入一點，我很好奇你是否能夠逐月談論趨勢，從 10 月到 10 月12 月，當然表現穩健，很高興看到該業務連續增長 7%，但環比增長比過去幾個季度要輕一些？

So just wanted to understand any considerations there and it frankly could just be a difference in selling days or seasonality from holiday, but anything you'd call out and then I have a follow-up or 2?

所以只是想了解那裡的任何考慮因素，坦率地說，這可能只是銷售天數或假期季節性的不同，但你會說什麼，然後我有一個或 2 個跟進？

Yes hi, good to hear from you. Let me just give you some high level views. Coming out of Q3, we talked about the relatively more normal healthcare operating environment. We did caution around the cold, flu, COVID season, potentially having an impact on labor shortages in Q4, but I think it's safe to say that we continue to see relative normalization in the operating environment and I'll let Lucas talk about kind of specifically your points on selling days, et cetera.

是的，嗨，很高興收到你的來信。讓我給你一些高層次的觀點。從第三季度開始，我們談到了相對更正常的醫療保健運營環境。我們確實對感冒、流感、COVID 季節持謹慎態度，這可能會對第四季度的勞動力短缺產生影響，但我認為可以肯定地說，我們繼續看到運營環境相對正常化，我會讓盧卡斯談一談特別是您在銷售日等方面的積分。

Yes Adam, I guess the short answer is nothing specific to call out. We're not really providing month-to-month commentary it was a strong quarter with 70 territories going out to work. We had the normal seasonality that we always plan for. And we're excited about the momentum into 2023.

是的，亞當，我想簡短的回答沒什麼特別的。我們並沒有真正提供月度評論，這是一個強勁的季度，有 70 個地區正在開展工作。我們有我們一直計劃的正常季節性。我們對進入 2023 年的勢頭感到興奮。

Okay. And then for the follow-up, wanted to ask about gross margin, Lucas, a little bit of choppiness in '22, I think because of the -- second manufacturing site and getting that up and running. How do we think about 2023? I think I heard in the prepared remarks may be some near-term challenges, but how do we think about progression of gross margin this year?

好的。然後對於後續行動，想問一下毛利率，盧卡斯，22 年有點不穩定，我想是因為——第二個製造基地，並讓它開始運行。我們如何看待 2023 年？我想我在準備好的發言中聽到的可能是一些近期挑戰，但我們如何看待今年毛利率的進展？

Yes, I think you should think about it similarly, the kind of the top-line commentary, which is, which is, improvements more back half loaded. And I think overall will be roughly similar in gross margin percentage as 2022 for different reasons, we're carrying kind of higher labor and materials costs that have been capitalized into inventory and we're obviously carrying the overhead of 2 manufacturing facilities versus 1.

是的，我認為您應該以類似的方式考慮，頂線評論的類型，即改進後半載。而且我認為由於不同的原因，總體毛利率將與 2022 年大致相似，我們承擔著更高的勞動力和材料成本，這些成本已資本化為庫存，而且我們顯然承擔了 2 個製造設施的間接費用，而不是 1 個。

And so, as we -- maintain price discipline and drive increased unit volume over time, we'll see some improvement, potentially in the back half of the year and beyond and a little bit lighter in the front half of the year.

因此，隨著我們 - 維持價格紀律並隨著時間的推移推動單位數量的增加，我們將看到一些改善，可能會在今年下半年及以後，並且在今年上半年會有所改善。

(Operator Instructions) The next question comes from Joanne Wuensch, of Citi.

（操作員說明）下一個問題來自花旗銀行的 Joanne Wuensch。

I appreciate the sequential commentary I just want to make sure that the first quarter gets set-up right. I mean, how are, you thinking about the sequential quarter in terms of revenue delivery. And I'll ask a follow-up question, if I did my math correctly you ended 2022 with roughly 300 physicians trained. Are you in a position to establish a goal for 2023?

我很欣賞順序評論，我只是想確保第一季度的設置正確。我的意思是，你如何考慮收入交付方面的連續季度。我會問一個後續問題，如果我的計算正確的話，到 2022 年結束時，大約有 300 名醫生接受了培訓。您是否可以為 2023 年制定目標？

Why do we take those in reverse order Joanne, thanks so much for joining us and for your questions. So in the year of 2022, we achieved roughly greater than 400 physicians trained, which was in excess of how we've guided in the first part of the year, ending the year with roughly 2,500 physicians trained, which is a great setup for 2023.

為什麼我們以相反的順序接受這些問題 Joanne，非常感謝您加入我們並提出您的問題。因此，在 2022 年，我們培訓了大約 400 多名醫生，這超過了我們在今年上半年的指導，到年底，培訓了大約 2,500 名醫生，這是 2023 年的一個很好的設置.

As we've talked about before, training physicians is kind of an investment in our future and you probably noticed, Joanne, that we did not guide to a specific number of trained physicians for this year in 2023 and we probably won't going forward. And that's because it's -- kind of de-minimis compared to the number of physicians that are already trained and the real growth driver being -- moving these trained physicians up the adoption curve.

正如我們之前談到的，培訓醫生是對我們未來的一種投資，喬安妮，你可能已經註意到，我們沒有在 2023 年為今年指導特定數量的受過培訓的醫生，我們可能不會繼續前進.那是因為——與已經接受過培訓的醫生數量相比，這是微不足道的，真正的增長動力是——將這些訓練有素的醫生推向採用曲線。

So, the best way to think about it is kind of mid to highish single-digit percentage growth in trained physicians every year from here on forward and that would include of course fellows and younger physicians coming in replacing the old retirees.

因此，最好的思考方式是從現在開始，受過培訓的醫生每年都以中高個位數百分比增長，其中當然包括取代老退休人員的研究員和年輕醫生。

And Joanne, your question on sequential growth was Q1 of this year versus Q4 of last year. Is that correct?

喬安妮，你關於連續增長的問題是今年第一季度與去年第四季度的對比。那是對的嗎？

Yes please.

是的，請。

So I'll reiterate some of the prepared comments and if there is a follow-up, let me know, but again the historical trend has been has been roughly flat, but the historical trend include some -- COVID spikes in various time periods. We ended the year with 70 territories and started the year with 70 and again have a goal to expand.

因此，我將重申一些準備好的評論，如果有後續行動，請告訴我，但歷史趨勢再次大致持平，但歷史趨勢包括一些 - COVID 在不同時期的峰值。我們以 70 個地區結束了這一年，並以 70 個開始了這一年，並再次製定了擴張的目標。

And so I think, I think, modest sequential growth is the right way to think about Q1. And then as we -- get the year progressing and continued commercial expansion and continue all of our initiatives and continue the on slight rollout we'll -- have some sequential step-ups from there with the normal seasonality adjustments that we make.

所以我認為，適度的連續增長是思考第一季度的正確方式。然後，隨著我們 - 取得進展並繼續進行商業擴張並繼續我們所有的舉措並繼續我們將進行的輕微推出 - 從那裡進行一些連續的升級，並進行正常的季節性調整。

But at the end of the day, it's really procedures per doc and what is the, what are the inputs around driving -- physician utilization and obviously having the folks out in the field go do their thing, more and more with more touch points is the goal.

但歸根結底，這實際上是每個文檔的程序，它是什麼，駕駛方面的投入是什麼——醫生的利用，顯然讓外地的人去做他們的事情，越來越多的接觸點是目標。

(Operator Instructions) And our next question comes from John McAulay of Stifel.

（操作員說明）我們的下一個問題來自 Stifel 的 John McAulay。

I guess to start off taking a look at operating leverage for '23 maybe putting a finer point on it. In '22 you grew top-line around 37% and OpEx is around 24%, it's like 13% delta. What do you see in '23? Do you see that gap potentially -- widening as you kind of reach more scale with the sales force or -- you see OpEx kind of continuing to grow in that 20 mid '20s percentage range?

我想開始看一下 23 年的經營槓桿，也許會在上面放一個更好的點。在 22 年，您的收入增長了 37% 左右，運營支出增長了 24% 左右，大約是 13% 的增量。你在 23 年看到了什麼？您是否看到這種差距可能會隨著銷售人員規模的擴大而擴大，或者您是否看到 OpEx 在 20 世紀 20 年代中期的百分比範圍內繼續增長？

Yes -- short answer, mid '20s growth, and we don't have specific OpEx guidance, but the things to think about again, the biggest line item in the company is people costs and compensation costs across all functions and we did -- a fair amount of hiring in 2022. So, we'll get the full year effect of salaries and bonuses and stock comp and things like that. The second is the continued expansion of the number of sales territories, and the human resources to drive those territories.

是的——簡短的回答，20 年代中期的增長，我們沒有具體的運營支出指導，但再次考慮的事情是，公司最大的項目是所有職能部門的人員成本和薪酬成本，我們做到了—— 2022 年會有相當數量的招聘。因此，我們將獲得薪水和獎金以及股票補償等類似的全年影響。第二是銷售區域數量的持續擴張，以及驅動這些區域的人力資源。

I think from a G&A perspective an R&D perspective, as I've said prior, those are really at steady-state, there always quarter-to-quarter variability, but I think that all pencils out to roughly mid '20s growth including non-cash stock compensation expenses, where there are always things going on that line item specifically.

我認為從 G&A 的角度和研發的角度來看，正如我之前所說，它們確實處於穩定狀態，總是存在季度到季度的變化，但我認為所有的增長都在 20 年代中期左右，包括非-現金股票補償費用，其中總是有專門針對該行項目的事情。

Great, that's helpful. And then just 1 more for me kind of from a bigger picture perspective, you're talking about kind of reaching a critical mass of docs trained of clinical data, I mean what other factors? What else do you need in place? Do you think Lucas or Erica to -- accelerate CAGR growth to the 20%, 30%, 40%, 80% penetration, just kind of looking for your big picture thoughts there?

太好了，這很有幫助。然後從更大的角度來看，對我來說還有 1 個，你說的是達到臨床數據訓練的臨界數量的文檔，我的意思是還有什麼其他因素？你還需要什麼？你認為盧卡斯或埃里卡——將復合年增長率加速到 20%、30%、40%、80% 的滲透率，只是在尋找你的大局觀？

Yes, absolutely and you're right, John recognized that the set-up for success is really there, with trained physicians, open territories, open hospital accounts and access to the full market. So I think that the short answer to your question is we are growing and we're growing meaningfully in procedures per physician and overall. And the business of the treating the brain is one we're time and experience matter.

是的，絕對是，你是對的，約翰認識到成功的設置確實存在，有訓練有素的醫生、開放的領域、開放的醫院賬戶和進入整個市場的機會。所以我認為對你的問題的簡短回答是我們正在成長，而且我們在每個醫生和整體的程序方面都在有意義地增長。治療大腦的業務是我們時間和經驗很重要的業務。

And we've said this before that it takes an individual physician a year, to year and a half just to get comfortable with switching more and more patients to TCAR versus carotid endarterectomy. And we know from our own experience that increasing the touch points, the number of times the quota-carrying professionals are in front of their physicians that that helps to drive adoption, which is 1 of our key areas of focus for this year and beyond.

我們之前已經說過，個體醫生需要一年到一年半的時間才能適應將越來越多的患者轉換為 TCAR 與頸動脈內膜切除術。我們從自己的經驗中知道，增加接觸點，增加配額專業人士在他們的醫生面前的次數，有助於推動採用，這是我們今年及以後的重點關注領域之一。

And I also said in my prepared remarks that more and more, we're turning our attention to patients. And we know that patients are doing more work than ever on informing themselves around treatment decisions. And this is true of any disease state not just here in carotid artery disease. And so, we have really up leveled our engagement in this area, both in terms of providing patients with the educational material that they need.

我還在準備好的發言中說，我們越來越多地將注意力轉向患者。我們知道，患者在了解治療決策方面比以往任何時候都做更多的工作。這不僅適用於頸動脈疾病，而且適用於任何疾病狀態。因此，我們確實提高了我們在這一領域的參與度，無論是在為患者提供他們需要的教育材料方面。

But also really assessing how patients think about TCAR and particularly patients who had both TCAR and carotid endarterectomy. And taking some results of some early work that we've done there and capitalizing on patients prefer TCAR. And that's just 1 example of many on our focus to have patients asking for TCAR more and more.

但也真正評估患者如何看待 TCAR，特別是同時接受 TCAR 和頸動脈內膜切除術的患者。並利用我們在那裡所做的一些早期工作的一些結果，並利用患者更喜歡 TCAR。這只是我們專注於讓越來越多的患者要求 TCAR 的眾多例子中的一個。

Okay.

好的。

At this time, I would now like to turn the call back to Erica Rogers for closing remarks.

此時，我想將電話轉回給 Erica Rogers 以作結束語。

Thank you all for joining us.

謝謝大家加入我們。

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，本次會議到此結束。您現在可以斷開連接。