Silk Road Medical Inc (SILK) 2023 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Silk Road Medical's 2023 fourth-quarter earnings conference call. (Operator Instructions)

美好的一天，感謝您的支持。歡迎參加絲路醫療2023年第四季財報電話會議。（操作員說明）

Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Marissa Bych with Gilmartin Group, Investor Relations. Please go ahead.

請注意，今天的會議正在錄製中。現在我想將會議交給今天的第一位發言人，吉爾馬丁集團投資者關係部門的瑪麗莎·比奇 (Marissa Bych)。請繼續。

Great. Thank you all for joining today's call. Earlier today, Silk Road Medical released financial results for the three months and the year ended December 31, 2023. A copy of the press release is available on the company's website.

偉大的。感謝大家參加今天的電話會議。今天早些時候，絲路醫療發布了截至 2023 年 12 月 31 日的三個月和一年的財務表現。該新聞稿的副本可在該公司網站上取得。

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案》的安全港條款制定的1995 年。本次電話會議中包含的任何與對未來事件、結果或績效的預期或預測相關的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. 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.

所有前瞻性陳述，包括但不限於與我們的營運趨勢和未來財務表現、費用管理、我們組織和業務的招聘和成長預期、醫生培訓和採用、市場機會和滲透、商業和國際擴張相關的陳述、監管審批、報銷、競爭和產品開發均基於我們目前的估計和各種假設。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有重大差異。因此，您不應過度依賴這些陳述。

For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our latest annual report on Form 10-K filed with the Securities and Exchange Commission. Additionally, Silk Road Medical refers to adjusted EBITDA a non-GAAP financial measure. A reconciliation of adjusted EBITDA to net loss, which is the most directly comparable GAAP measure, is included in our press release, which is available on our website.

有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們向美國證券交易委員會提交的最新年度報告 10-K 中的風險因素部分。此外，Silk Road Medical 將調整後的 EBITDA 稱為非 GAAP 財務指標。調整後 EBITDA 與淨虧損的對賬，這是最直接可比較的 GAAP 指標，包含在我們的新聞稿中，該新聞稿可在我們的網站上取得。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 28, 2024. 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效性訊息，僅截至今天（2024 年 2 月 28 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聲明的意圖或義務，無論是由於新資訊、未來事件或其他原因。

And with that, I will now turn the call over to Chas McKhann, Chief Executive Officer.

現在，我將把電話轉給執行長 Chas McKhann。

Thank you, Marissa, and thank you all for joining today. I'm pleased to share that Silk Road Medical achieved full-year 2023 revenue of just over $177 million, supported by more than 25,250 procedures, reflecting 28% and 29% year-over-year growth in revenue and procedures, respectively. In 2023, more than ever, growth in the business was driven by deepening adoption of TCAR within our trained physician base.

謝謝瑪麗莎，也謝謝大家今天加入。我很高興與大家分享，絲路醫療 2023 年全年收入略高於 1.77 億美元，得益於超過 25,250 例手術，收入和手術分別同比增長 28% 和 29%。到 2023 年，我們訓練有素的醫生群體對 TCAR 的採用更加深入地推動了業務的成長。

As we begin the call today, I'd like to take a step back and offer a brief introduction of my background since there are some of you with whom I've not had a chance to connect since joining Silk Road Medical in November 2023. I've been focused on the advancement of minimally invasive medical technologies throughout my career.

在我們今天開始通話時，我想退後一步，簡要介紹一下我的背景，因為自 2023 年 11 月加入絲路醫療以來，我一直沒有機會與你們中的一些人聯繫。在我的整個職業生涯中，我一直專注於微創醫療技術的進步。

And over the last decade, I've been dedicated to the development and commercialization of several innovative products, most recently, as CEO of Apollo Endosurgery, where accelerated the company's growth through a transformational strategy rooted in product innovation, robust clinical evidence, and commercial discipline before successfully being acquired by Boston Scientific early last year. Following the sale of Apollo and after 25 years of developing and commercializing medical devices, I was afforded the luxury of taking a step back to look for the right next opportunity.

在過去的十年中，我一直致力於多種創新產品的開發和商業化，最近擔任Apollo Endosurgery 的首席執行官，透過植根於產品創新、可靠的臨床證據和商業化的轉型策略，加速了公司的發展。在阿波羅出售後，經過 25 年的醫療設備開發和商業化，我有幸退後一步，尋找下一個合適的機會。

In my diligence, I focused on three core tenets, which I see as the foundation for success, as measured by positive patient impact and durable growth. First, the technology must target a critical deficiency in the current practice of medicine. Second, the solution for that deficiency must consistently yield best-in-class outcomes in a generalizable fashion. And third, the solution for the market must be supported by an experienced team that can adapt to an ever-evolving commercial landscape to drive success.

在我的努力中，我專注於三個核心原則，我認為這是成功的基礎，以積極的患者影響和持久的成長來衡量。首先，該技術必須針對當前醫學實踐中的一個關鍵缺陷。其次，針對此缺陷的解決方案必須以可推廣的方式一致地產生一流的結果。第三，市場解決方案必須得到經驗豐富的團隊的支持，能夠適應不斷變化的商業環境以推動成功。

And so I took this opportunity here at Silk Road because I saw all three of those factors. And three months in, my experiences only serve to further validate the market for TCAR and our opportunity at Silk Road.

所以我在絲綢之路抓住了這個機會，因為我看到了這三個因素。三個月後，我的經驗只會進一步驗證 TCAR 的市場以及我們在 Silk Road 的機會。

So before turning to our 2024 strategy, I'd like to reiterate some of my remarks made at the recent JPMorgan Healthcare Conference, which underscore the winning tenets I just described. First, the deficiency in current carotid treatment is indisputable when we look at the devastating burden of stroke on patients and their families.

因此，在討論我們的 2024 年策略之前，我想重申我在最近的摩根大通醫療保健會議上發表的一些言論，其中強調了我剛才描述的獲勝原則。首先，當我們考慮中風對患者及其家人造成的毀滅性負擔時，目前頸動脈治療的缺陷是無可爭議的。

The consequences of stroke by the numbers are staggering. Stroke is a leading cause of morbidity and mortality in the US with millions living in a state of persistent disability and billions in stroke-related costs to the healthcare system. And in particular, prior treatment modalities for patients with carotid artery disease fall short of addressing the issue.

中風造成的後果是驚人的。中風是美國發病和死亡的主要原因，數百萬人生活在持續殘疾狀態，醫療系統因中風相關的費用達數十億美元。特別是，頸動脈疾病患者的先前治療方式無法解決這個問題。

Patients historically chose between carotid endarterectomy and invasive surgical procedure with significant patient morbidity and procedure-related complications, or transfemoral carotid stenting, a minimally invasive approach in which procedural difficulty and lack of effective neuroprotection can lead to excess procedure-related stroke risk. When patients are presented with an informed choice, evidence shows that they prefer TCAR, which leads me to my next point. TCAR works with incredible consistency, and the TCAR base of adoption is growing and healthy.

歷史上，患者選擇頸動脈內膜切除術和侵入性外科手術（患者發病率和手術相關併發症顯著），或者選擇經股動脈頸動脈支架置入術，這是一種微創方法，其中手術困難和缺乏有效的神經保護可能導致手術相關中風風險過高。當患者面臨明智的選擇時，有證據表明他們更喜歡 TCAR，這引出了我的下一個觀點。TCAR 的工作具有令人難以置信的一致性，而 TCAR 的採用基礎正在不斷增長且健康發展。

Silk Road is built on extensive evidence collection through the VQI Registry, a vast base of real-world evidence that includes nearly all of our commercial experience since launch and has contributed to more than 300 TCAR publications to date. Through the registry, we see market consistency and outcomes across different settings of care, operator experience levels, and patient profiles.

Silk Road 建立在透過VQI 註冊中心收集的廣泛證據的基礎上，這是一個龐大的現實世界證據基礎，幾乎包括我們自推出以來的所有商業經驗，迄今為止已為300 多份TCAR 出版物做出了貢獻。透過註冊，我們可以看到不同護理環境、操作員經驗水平和患者概況的市場一致性和結果。

TCAR is just as effective in a rural community hospital as it is in some of the most accomplished medical centers in the country. And the consistency of TCAR was recently highlighted at a presentation in November at the 2023 [VEEP] meeting in a retrospective study conducted by Schermerhorn, which studied real-world results in nearly 45,000 patients. The study, which showed very low rates of perioperative stroke and death across both symptomatic and asymptomatic patients, well below acceptable thresholds, represents one of the largest applications of real-world data in the analysis of carotid treatment.

TCAR 在農村社區醫院與在該國一些最先進的醫療中心一樣有效。最近，Schermerhorn 在 2023 年 [VEEP] 會議上的回顧性研究中強調了 TCAR 的一致性，該研究研究了近 45,000 名患者的真實結果。研究顯示，有症狀和無症狀患者的圍手術期中風和死亡率都非常低，遠低於可接受的閾值，是現實世界數據在頸動脈治療分析中最大的應用之一。

And in my more than 25 years in medtech, I have very rarely seen datasets of this size supporting a medical therapy. The consistency in outcomes and generalizability across patient cohorts speaks to an exquisite technology with a short learning curve. And these are critically important factors when the brain is at stake. Broad real-world clinical evidence and a short learning curve already have driven robust adoption, and we expect to see further tailwinds as TCAR becomes further entrenched in the marketplace.

在我超過 25 年的醫療技術經驗中，我很少看到如此規模的數據集支持醫學治療。患者群體中結果的一致性和普遍性說明了一項精湛的技術和較短的學習曲線。當大腦受到威脅時，這些都是至關重要的因素。廣泛的現實世界臨床證據和較短的學習曲線已經推動了強勁的採用，隨著 TCAR 在市場上的進一步鞏固，我們預計將看到進一步的推動力。

And third, Silk Road was founded by pure pioneers in carotid treatment. And today, Silk Road is the only scaled company focused on addressing one of the leading causes of ischemic stroke carotid artery disease.

第三，絲路是由頸動脈治療領域的純粹先驅創立的。如今，絲路是唯一一家專注於解決缺血性中風頸動脈疾病主要原因之一的規模化公司。

In my first 100 days, I've spent significant time with our leaders, most of whom have spent the majority of their careers focused on better treatments for carotid and other cardiovascular disease. That includes Lucas Buchanan, our CFO and COO, who's with me here today, along with the rest of our management team who have all worked extensively in large cardiovascular enterprises in medtech. That also includes Andy Davis, our experienced Chief Commercial Officer, who leads a strong commercial team, employing a high-touch model to wrap around our physicians and their staff to offer unmatched support to their carotid programs.

在我上任的前100 天裡，我與我們的領導者度過了很多時間，他們中的大多數人將職業生涯的大部分時間都花在了更好地治療頸動脈和其他心血管疾病上。其中包括今天和我在一起的我們的財務長兼營運長盧卡斯·布坎南(Lucas Buchanan)，以及我們管理團隊的其他成員，他們都在醫療技術領域的大型心血管企業中廣泛工作過。其中還包括我們經驗豐富的首席商務官安迪·戴維斯(Andy Davis)，他領導著一支強大的商業團隊，採用高接觸模式圍繞我們的醫生及其員工，為他們的頸動脈項目提供無與倫比的支持。

The outstanding clinical outcomes for TCAR are a testament to the excellent support that our team provides to our customers every single day. And with the guidance of Dr. Sumaira Macdonald, our Executive Medical Director, who's one of the leading experts in the world on the treatment of carotid artery disease; and the leadership of Bill Whealon, our EVP of R&D, our R&D team leads the way in credit innovation to ensure that we remain at the forefront of minimally invasive carotid treatment.

TCAR 出色的臨床結果證明了我們的團隊每天為客戶提供的出色支援。在我們的執行醫療總監 Sumaira Macdonald 博士的指導下，他是世界上治療頸動脈疾病的領先專家之一；在我們的研發執行副總裁 Bill Whealon 的領導下，我們的研發團隊在信貸創新方面處於領先地位，以確保我們始終處於微創頸動脈治療的最前沿。

And so with these strong fundamentals I've outlined, our focus in 2024 is optimizing the transition from broadening our reach to now deepening adoption among our trained physician base, while recognizing improving leverage that comes with scaled operations. I'll start by focusing on deepening physician adoption.

因此，有了我概述的這些強有力的基本面，我們2024 年的重點是優化從擴大覆蓋範圍到現在在訓練有素的醫生群體中加深採用的過渡，同時認識到規模化運營帶來的槓桿作用的提高。我將首先專注於加深醫生的採用。

Silk Road has built a formidable commercial presence. Today, our team is as strong as ever, following initiatives we took last year to optimize our commercial model and to achieve greater scale and continue to evolve from going broad to going deep.

絲綢之路已經建立了強大的商業影響力。今天，我們的團隊一如既往地強大，繼去年優化商業模式、實現更大規模的舉措之後，繼續由寬向深發展。

In the process, last year, we experience some growing pains, but we are confident that we are entering 2024 with the right talent and leadership in place to continue driving strong TCAR adoption. At the start of this year, approximately one-third of our sales reps have been with the company for less than a year, but we are already seeing that these additions to our team are strengthening their relationships and growing their case volumes across the physicians and staff they serve. And we look forward to seeing these reps continue to move up the adoption curve or the experience curve as our entire organization executes against the Silk Road mission of treating more patients at risk of stroke.

去年，在這個過程中，我們經歷了一些成長的陣痛，但我們有信心進入 2024 年，擁有合適的人才和領導力，繼續推動 TCAR 的強勁採用。今年年初，我們大約三分之一的銷售代表在公司工作的時間還不到一年，但我們已經看到，我們團隊的這些新增人員正在加強他們的關係，並增加了他們與醫生和醫生之間的關係。我們期待看到這些代表繼續提升採用曲線或經驗曲線，因為我們整個組織都在執行絲路使命，即治療更多有中風風險的患者。

And over the long term, we know that we will be able to increase our leverage with this organization to maximize adoption while moving towards sustained profitability. As we drive deeper adoption, we will continue to emphasize effective clinical data collection to complement our sales and marketing efforts. We are actively building on a track record of more than 85,000 patients treated to date, and most of whom are captured in the DQI database.

從長遠來看，我們知道我們將能夠增加與該組織的影響力，以最大限度地提高採用率，同時實現持續獲利。隨著我們推動更深入的採用，我們將繼續強調有效的臨床數據收集，以補充我們的銷售和行銷工作。到目前為止，我們正在積極建立超過 85,000 名患者的治療記錄，其中大部分患者都記錄在 DQI 資料庫中。

And we continue to analyze outcomes across all patient cohorts and profiles. This includes our prospective Roadster 3 post-market study, investigating outcomes in standard surgical risk patients, which is enrolling at a strong pace. We anticipate completing enrollment in Roadster 3 in the second half of this year.

我們繼續分析所有患者群體和概況的結果。這包括我們的前瞻性 Roadster 3 上市後研究，調查標準手術風險患者的結果，該研究正在快速招募。我們預計將在今年下半年完成 Roadster 3 的註冊。

Beyond the right commercial infrastructure, deepening adoption requires we continuously innovate on our key product lines to extend our leadership position in carotid treatment and enhance the offerings for TCAR. Last year, we rolled out our purpose-built TCAR balloon catheter, or Enflate, which is seeing steadily increasing adoption even with a premium price position relative to competitive balloons. And in 2024, we are introducing a tapered configuration of our ENROUTE transcarotid stent and our next-generation neuroprotection system, or NPS+.

除了正確的商業基礎設施之外，深化採用還要求我們持續創新我們的關鍵產品線，以擴大我們在頸動脈治療領域的領導地位並增強 TCAR 的產品。去年，我們推出了專門設計的 TCAR 球囊導管（或 Enflate），儘管與競爭性球囊相比，其價格定位較高，但其採用率仍在穩步增長。到 2024 年，我們將推出錐形配置的 ENROUTE 經頸動脈支架和下一代神經保護系統 (NPS+)。

Today, I'm excited to announce that we've initiated a limited market release of our tapered stent. Customer feedback has been outstanding, and we plan to ramp up to a full market release in Q2. We are also finalizing preparations for the launch of NPS+, which features important ease of use and technical advances, and we anticipate initiating the launch of NPS+ in the second quarter.

今天，我很高興地宣布，我們已開始在市場上限量發行錐形支架。客戶回饋非常出色，我們計劃在第二季全面向市場發布。我們也正在完成 NPS+ 推出的準備工作，它具有重要的易用性和技術進步，我們預計在第二季啟動 NPS+ 的推出。

In addition to our core commercial and product advancement strategy, we are looking beyond the horizon at the next phase of growth for Silk Road. Cultivating international markets offers an extension of TCAR growth in the long term. Our international focus has centered around China and Japan, two markets with compelling strategic and commercial dynamics for the treatment of carotid disease.

除了我們的核心商業和產品發展策略外，我們還著眼於絲綢之路下一階段的成長。從長遠來看，培育國際市場可以延長 TCAR 的成長。我們的國際重點集中在中國和日本，這兩個市場在頸動脈疾病治療方面具有引人注目的策略和商業活力。

In Japan, following clearance of our ENROUTE stent and ENROUTE neuroprotection system, I'm excited to announce that we've signed an agreement with a leading distribution partner, Medico’s Hirata, and we are actively working towards establishing reimbursement before initiating a post-market study. In China, I'm excited to announce that we've received clearance in January for our ENROUTE stent following approval of our ENROUTE NPS in 2023. And more recently, we signed an agreement with Genesis MedTech Group, a leading distributor in China.

在日本，繼我們的ENROUTE 支架和ENROUTE 神經保護系統獲得批准後，我很高興地宣布，我們已與領先的分銷合作夥伴Medico 的Hirata 簽署了一項協議，並且我們正在積極努力在啟動補償之前建立報銷機制。在中國，我很高興地宣布，繼 2023 年 ENROUTE NPS 獲得批准後，我們的 ENROUTE 支架已於 1 月獲得許可。最近，我們與中國領先的經銷商 Genesis MedTech Group 簽署了一項協議。

While market development activities in both countries will take some time, and we do not anticipate a meaningful revenue contribution in the near term, we are excited to move to this next phase of expanding TCAR internationally.

雖然這兩個國家的市場開發活動需要一些時間，我們預計短期內不會產生有意義的收入貢獻，但我們很高興進入 TCAR 國際擴張的下一階段。

Finally, we'd like to touch upon our efforts to expand into new disease states from our core competencies in carotid. Earlier this quarter, results of the NITE I study, or neuroprotection in transcarotid embolectomy, was presented at the International Stroke Conference. We are pleased with the outcomes of this early feasibility study, which showed that transcarotid acute stroke thrombectomy with flow reversal is feasible and safe. And importantly, there was a clear signal that flow reversal could potentially offer incremental clinical benefits to patients.

最後，我們想談談我們從頸動脈核心能力擴展到新疾病狀態的努力。本季度早些時候，NITE I 研究（即經頸動脈取栓術中的神經保護）的結果在國際中風會議上公佈。我們對這項早期可行性研究的結果感到高興，該研究表明經頸動脈急性中風血栓切除術與血流逆轉是可行且安全的。重要的是，有一個明確的信號表明血流逆轉可能為患者帶來更多的臨床益處。

While advancement into NITE II is not a strategic priority at the near term, results of the study directly inform other active R&D initiatives we are working on to extend our lead within carotid disease. And with our portfolio of over 250 issued and pending patents globally and our core competence in transcarotid access and neuroprotection, we are well positioned to serve our stroke prevention mission and drive durable long-term growth.

雖然 NITE II 的進展並不是近期的戰略重點，但該研究的結果直接為我們正在進行的其他積極研發計劃提供信息，以擴大我們在頸動脈疾病領域的領先地位。憑藉我們在全球範圍內擁有超過 250 項已發布和正在申請的專利組合，以及我們在經頸動脈通路和神經保護方面的核心能力，我們有能力履行我們的中風預防使命並推動持久的長期增長。

I'd like to close by discussing what all this means for our financial profile in 2024 and beyond. I hope it's abundantly clear that durable growth remains our number-one priority. In 2024, we anticipate full-year revenue of $194 million to $198 million, reflecting 10% to 12% year-over-year growth, as we capitalize on the strength of our commercial infrastructure to drive deeper adoption among our active physician base. At the same time, we are committed to driving sustainable progress towards profitability with a strong capital position and scaled infrastructure we have today.

最後，我想討論一下這一切對我們 2024 年及以後的財務狀況意味著什麼。我希望大家非常清楚，持久成長仍是我們的首要任務。到 2024 年，我們預計全年收入將達到 1.94 億至 1.98 億美元，年增 10% 至 12%，因為我們利用商業基礎設施的優勢來推動活躍醫生群體的更深入採用。同時，我們致力於利用當今強大的資本實力和規模化的基礎設施，推動獲利的永續發展。

To that end and to chart our path for investors -- path forward for investors, we are introducing adjusted EBITDA to our reporting framework, and we are targeting annual improvement in adjusted EBITDA in 2024 relative to 2023, building off our progress in recent years. Lucas will provide more detail shortly.

為此，為了為投資者制定未來的道路，我們將調整後的EBITDA 引入我們的報告框架，我們的目標是2024 年調整後的EBITDA 相對於2023 年實現年度改善，以鞏固我們近年來取得的進展。盧卡斯將很快提供更多細節。

And so in sum, I am very excited about the year ahead. Silk Road is a world-class company with a world-class opportunity, and we expect to capitalize on that opportunity for betterment of patients and shareholders.

總而言之，我對未來的一年感到非常興奮。絲綢之路是一家世界級公司，擁有世界級機會，我們希望利用這個機會改善患者和股東的生活。

And with that, I'd like to turn it over to Lucas, our Chief Financial and Chief Operating Officer, to review our results in more detail. Lucas?

接下來，我想將其交給我們的財務長兼營運長盧卡斯，以更詳細地審查我們的結果。盧卡斯？

Thank you, Chas for revenue for the three months ended December 31, 2023 was $47.3 million, an 18% increase from $40.1 million in the same period of the prior year. Growth was driven primarily by increased TCAR adoption and continued healthy demand, following expanded Medicare reimbursement, which went into effect October 11 of last year. The number of TCAR procedures in the quarter was approximately 6,625, a 20% increase from the same period of the prior year.

謝謝 Chas，截至 2023 年 12 月 31 日的三個月收入為 4,730 萬美元，比去年同期的 4,010 萬美元增長了 18%。成長的主要推動因素是 TCAR 採用率的提高以及去年 10 月 11 日生效的醫療保險報銷擴大後持續健康的需求。本季TCAR手術數量約6,625例，較上年同期成長20%。

Gross margin for the fourth quarter of 2023 was 74% compared to 73% in the fourth quarter of the prior year. The increase was a result of larger production volumes, which allowed us to spread fixed and overhead costs over a larger volume of units, as well as the benefit in stent unit COGS that will continue through Q1 before normalizing in Q2 and beyond. The benefit is related to a temporary favorable purchase price variance.

2023 年第四季的毛利率為 74%，而上年第四季為 73%。這一增長是由於產量增加，這使我們能夠將固定成本和間接成本分攤到更多的單位數量上，以及支架單位銷貨成本的收益將持續到第一季度，然後在第二季度及以後恢復正常。此收益與暫時有利的購買價格差異有關。

For 2024, we anticipate modest gross margin improvement over full-year 2023. Total operating expenses for the fourth quarter of 2023 were $49.2 million, an 18% increase from $41.7 million in the fourth quarter of 2022. R&D expenses for the fourth quarter of 2023 were $10.1 million compared to $9.2 million in the fourth 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.

對於 2024 年，我們預計毛利率將比 2023 年全年略有改善。2023 年第四季的總營運費用為 4,920 萬美元，比 2022 年第四季的 4,170 萬美元成長 18%。2023 年第四季的研發費用為 1,010 萬美元，而 2022 年第四季的研發費用為 920 萬美元。研發支出的增加主要是由人員成長以及對新項目和正在進行的項目的持續投資所推動的。

Sales, general, and administrative expenses for the fourth quarter of 2023 were $39.1 million compared to $32.5 million in the fourth quarter of 2022. The increase was primarily driven by the commercial expansion efforts we conducted throughout 2023. Now more than ever, we are leveraging the years of work and investment we have put behind commercial R&D and back office infrastructure. Accordingly, we expect our forward revenue growth rate to outpace growth in operating expenses.

2023 年第四季的銷售、一般和管理費用為 3,910 萬美元，而 2022 年第四季為 3,250 萬美元。這一成長主要是由我們在 2023 年全年進行的商業擴張努力所推動的。現在，我們比以往任何時候都更充分地利用我們多年來在商業研發和後台基礎設施方面投入的工作和投資。因此，我們預計我們的預期收入成長率將超過營運費用的成長。

Net loss for the fourth quarter was $13 million, or a loss of $0.33 per share, as compared to a net loss of $12.6 million, or a loss of $0.34 per share, for the same period of the prior year. As Chas noted, we are introducing adjusted EBITDA into our reporting framework to further illuminate our operating profile and path to sustained operating profitability. Adjusted EBITDA for the fourth quarter 2023 was a loss of $4.1 million compared to an adjusted EBITDA loss of $4.4 million in the prior-year period.

第四季淨虧損為 1,300 萬美元，即每股虧損 0.33 美元，而去年同期淨虧損為 1,260 萬美元，即每股虧損 0.34 美元。正如查斯所指出的，我們正在將調整後的 EBITDA 引入我們的報告框架，以進一步闡明我們的營運概況和持續營運獲利能力的道路。2023 年第四季調整後 EBITDA 虧損 410 萬美元，而上年同期調整後 EBITDA 虧損 440 萬美元。

On a full-year basis, 2023 adjusted EBITDA was a loss of $17.7 million, reflecting an improvement of $7.4 million over full year 2022 adjusted EBITDA loss of $25.1 million. Our expectation is for adjusted EBITDA improvement in the full-year 2024 relative to 2023. However, note that we expect our first-quarter 2024 adjusted EBITDA loss to be larger than the loss we saw in the fourth quarter of 2023, given standard first-quarter expenses against an expectation for a mid-single digit sequential revenue decline related to seasonal patterns.

從全年來看，2023 年調整後 EBITDA 虧損 1,770 萬美元，比 2022 年全年調整後 EBITDA 虧損 2,510 萬美元減少了 740 萬美元。我們預計 2024 年全年調整後 EBITDA 較 2023 年有所改善。然而，請注意，考慮到第一季的標準支出以及與季節性相關的中個位數環比下降的預期，我們預計 2024 年第一季調整後 EBITDA 損失將大於 2023 年第四季的損失模式。

Finally, we ended 2023 with $190.9 million in cash, cash equivalents, and investments. In combination with our modest burn profile, we remain confident in our ability to achieve profitability with existing capital.

最後，截至 2023 年，我們擁有 1.909 億美元的現金、現金等價物和投資。結合我們適度的資金消耗情況，我們對利用現有資本來實現盈利的能力仍然充滿信心。

Turning to our 2024 outlook and commercial strategy. As Chas mentioned, we expect full-year 2024 revenue to be in the range of $194 million to $198 million, reflecting revenue growth of 10% to 12% over 2023, driven primarily by growth in procedures and relatively stable revenue per procedure with normal quarter-to-quarter variation. As a reminder, we recognize revenue when we sell units to hospitals, and those hospital-owned inventory units are later used by physicians and procedures, leading to some quarter-to-quarter variation in revenue growth relative to procedure growth.

談談我們的 2024 年展望和商業策略。正如Chas 所提到的，我們預計2024 年全年收入將在1.94 億至1.98 億美元之間，反映出收入比2023 年增長10% 至12%，這主要是由於手術數量的增長以及正常季度每個手術相對穩定的收入推動的季度變化。提醒一下，我們在向醫院出售設備時確認收入，而這些醫院擁有的庫存設備後來被醫生和程序使用，導致收入增長相對於程序增長存在一些季度差異。

We are actively focused on driving adoption within our 2,800 strong trained physician base, supported by 85 active sales territories. And we are excited to expand our patient impact as we execute on our 2024 commercial strategy with this established network.

在 85 個活躍銷售區域的支持下，我們積極致力於推動 2,800 名訓練有素的醫生群體的採用。我們很高興透過這個已建立的網路執行 2024 年商業策略，擴大我們對患者的影響。

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

此時，我想將電話轉回 Chas 以徵求結束意見。

Thanks, Lucas. At this point in my career, it's all about delivering excellent patient outcomes, supporting an unmatched provider experience, and contributing to a better healthcare system. And I want to emphasize that we have a special opportunity to do just that at Silk Road. And so in closing, I'd simply like to say thank you to our customers and our team at Silk Road who impacted the lives of more than 25,000 patients undergoing the TCAR procedure last year.

謝謝，盧卡斯。在我職業生涯的這個階段，一切都是為了提供卓越的患者治療效果、支持無與倫比的醫療服務提供者體驗以及為更好的醫療保健系統做出貢獻。我想強調的是，我們有一個特殊的機會在絲綢之路上做到這一點。最後，我只想對 Silk Road 的客戶和團隊表示感謝，他們去年影響了超過 25,000 名接受 TCAR 手術的患者的生活。

And with that, we'll turn to our operator for questions. Gerald, please open it up for questions.

然後，我們將向我們的運營商詢問問題。傑拉德，請打開它提問。

(Operator Instructions) Rick Wise, Stifel.

（操作員說明）Rick Wise，Stifel。

Good afternoon. Thanks to you both. Maybe we could start off just first, if you could talk about the guidance and just help us think about two aspects of the guidance. Just one, talk about what's incorporated in your guidance, some of the key elements, particularly, if you would, some of the headwinds and tailwinds related to the CMS CAS decision. What are you baking in? And are there any other sort of larger concerns that you want us to be sensitive to?

午安.謝謝你們倆。如果您能談談該指南並幫助我們思考指南的兩個方面，也許我們可以先開始。首先，請談談您的指導方針中包含的內容，一些關鍵要素，特別是（如果您願意的話）與 CMS CAS 決定相關的一些不利因素和有利因素。你用什麼來烘焙？您是否希望我們關注其他更大的問題？

And just the second aspect of that, if I heard you correctly in terms of the first quarter, Lucas, it sounds like something like a $44 million number, if I'm doing my quick math correctly, would be somewhere in the kind of territory you'd hope we would center around as first-quarter guidance gets put into place.

第二個方面，盧卡斯，如果我沒聽錯你所說的第一季度的情況，這聽起來像是4400 萬美元的數字，如果我的快速數學計算正確的話，這將在這種領域的某個地方您希望我們能夠在第一季指導到位後集中精力。

Sure. Why don't I take the first part, Rick, and then I'll hand over to Lucas on some of the details. But as we think about overall on the guidance and kind of key puts and takes that went into it, first and foremost, I hope you heard me loud and clear, I feel very good about the overall fundamentals of the market and where we can take things.

當然。為什麼我不先完成第一部分，里克，然後我將把一些細節交給盧卡斯。但是，當我們總體考慮其中的指導和關鍵看跌期權時，我希望您能清楚地聽到我的聲音，我對市場的整體基本面以及我們可以採取的方向感到非常好事物。

I think areas that factor into our guidance, first is just as I mentioned, our sales force experience and time and territory. We do have about a third of our team who are working their way up the experience curve. And so we do see that progressing over the first couple of quarters this year and really teeing us up on the back half of the year.

我認為，正如我所提到的，我們的指導因素首先是我們的銷售人員經驗、時間和地理。我們團隊中確實有大約三分之一的人正在努力提升經驗曲線。因此，我們確實看到今年前幾季取得了進展，並為我們下半年做好了準備。

I will say we just recently had our national sales meeting and it was great. The energy levels there were fantastic. People are excited, but a lot of new faces. And so we're working through that.

我想說的是，我們最近剛召開了全國銷售會議，非常棒。那裡的能量水平非常棒。人們很興奮，但也有很多新面孔。所以我們正在解決這個問題。

The second piece to it is we are moving from going broad to going deep as an overall approach. Doesn't mean we don't have some new customers, we will, but a big part of it is going deep, and that's a bit of an evolution for us. And so we're focusing on that.

第二點是我們正在從整體方法的廣泛轉向深入。這並不意味著我們沒有一些新客戶，我們會的，但其中很大一部分正在深入，這對我們來說是一種演變。所以我們正在關注這一點。

And then you ask specifically about the NTD and TF-CAS and I'll just hit at a high level. The NTD was put in place in early October. So we've got about four months here. And while we are aware of anecdotes of some people picking up CAS, it's not a big, broad wave of new users for transfemoral stenting. Our customers feel very good about the ongoing demand for TCAR. We're going to keep watching it incredibly carefully. But as the only company that really is dedicated to this space, we feel good about our ability to keep driving demand for TCAR in a world that over time will move to be more endovascular, but we think that we're well-positioned for that.

然後你具體詢問 NTD 和 TF-CAS 的情況，我就會回答得很高。NTD於10月初實施。所以我們在這裡有大約四個月的時間。雖然我們知道有些人開始使用 CAS 的軼事，但這並不是經股動脈支架置入術的新用戶大潮。我們的客戶對 TCAR 的持續需求感到非常滿意。我們將繼續非常仔細地觀察它。但作為唯一一家真正致力於這一領域的公司，我們對自己有能力繼續推動TCAR 的需求感到滿意，因為隨著時間的推移，世界將變得更加血管內，但我們認為我們已經做好了充分的準備。

So those are some of the high-level comments. But Lucas, other specifics on the guidance you wanted to do?

這些是一些高層評論。但是盧卡斯，您想做的指導的其他細節是什麼？

Sure, I'll tackle the second half of your question, Rick. I think the historical pattern we've seen, Q4 into Q1 has been has been flattish. And as I mentioned, sometimes there's kind of flat to slightly up on procedures and flat to slightly down on revenue just given some of those timing effects. So I think carrying forward the Q4 result into Q1 is probably not the right approach because we do see and expect that normal dip in revenue per procedures even if procedures are strong. So I think you're in the right ballpark, maybe a slight tick higher.

當然，我會解決你問題的後半部分，里克。我認為我們看到的歷史模式，從第四季到第一季一直表現平平。正如我所提到的，有時，考慮到一些時間效應，程式上會出現持平或略有上升的情況，收入也會持平或略有下降。因此，我認為將第四季度的結果結轉到第一季可能不是正確的方法，因為我們確實看到並預計每個程序的收入會正常下降，即使程序很強大。所以我認為你的猜測是正確的，也許會稍微高一點。

Okay. Just if I could follow up on one comment you made, Chas, you clearly are emphasizing your focus and you're making innovation a priority. Maybe just broadly talk about the innovation pipeline. What are you excited about? What do you want us to be excited about and expect from you and that pipeline? Thank you.

好的。Chas，如果我可以跟進您的評論，您顯然在強調您的重點，並將創新作為優先事項。也許只是廣泛地談論創新管道。你在興奮什麼？您希望我們對您和該頻道感到興奮和期待什麼？謝謝。

Sure. Yeah, and I appreciate the question. For the pipeline, well, we've got the immediate opportunities which now really are coming to fruition. And so just happy to see, as I mentioned, very good uptake with the balloon and nice progression there having the tapered stent, and as I mentioned -- and a pretty limited number of accounts initially, but very good feedback from customers.

當然。是的，我很欣賞這個問題。對於管道，我們已經獲得了立即的機會，現在這些機會確實正在實現。因此，正如我所提到的，很高興看到球囊的使用非常好，並且錐形支架的進展也很好，正如我所提到的，最初的帳戶數量相當有限，但客戶的反饋非常好。

And then NPS+, which I know was discussed last year, but we're putting the final touches to be ready to launch that as well. And so just showing the marketplace that we are innovating and staying on top of the existing TCAR procedure.

然後是 NPS+，我知道去年就討論過這個問題，但我們正在做最後的準備工作，準備推出它。因此，我們只是向市場展示我們正在創新並保持在現有 TCAR 程序的領先地位。

And then beyond that, since I've come in, I have spent a lot of time with our R&D team. And we've got some really interesting things we're working on to extend our leadership in the carotid space. I want to get a little further along, frankly, in terms of those development efforts before we talk about it, a lot publicly just so we know where we have and what some of the timelines are, et cetera. But the team's been doing some very good work and I look forward to sharing more on future calls.

除此之外，自從我加入以來，我花了很多時間與我們的研發團隊在一起。我們正在做一些非常有趣的事情，以擴大我們在頸動脈領域的領導地位。坦白說，在我們公開談論這些開發工作之前，我想進一步了解這些開發工作，以便我們知道我們的進展以及一些時間表等等。但該團隊一直在做一些非常好的工作，我期待在未來的電話會議上分享更多資訊。

Thanks again.

再次感謝。

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Hey, Chas. Hey, Lucas. Thanks for taking the questions. Congrats on a strong first 90 days, Chas. Look forward to many quarters going forward. I wanted to start with a follow-up on your previous answer. You talked about the go-deep strategy increasing that utilization rather than broadly heard the comments still adding incremental here and there, but clearly focused on going deeper.

嘿，查斯。嘿，盧卡斯。感謝您提出問題。恭喜 Chas 在前 90 天表現出色。期待未來許多季度的發展。我想從您之前的回答開始跟進。您談到了提高利用率的深入策略，而不是廣泛聽到仍然到處增加增量的評論，但顯然專注於更深入。

Maybe walk through that strategy. What does that look like in the field? Any changes you think you need to make related to the selling organization to achieve that strategy?

也許可以演練一下這個策略。現場看起來是什麼樣子？您認為需要對銷售組織做出哪些改變才能實現策略？

Sure. Thanks for the question, Frank. Yeah, so going deep, it's something that happens naturally in the evolution of a lot of medical technologies. Your initial -- and it's not binary, right? The company's been evolving towards this for a while. But as we look at it, partly, it's having the scale of the organization sort of fully up and operating in all cylinders, which -- so 85 territories we think is a good number.

當然。謝謝你的提問，弗蘭克。是的，深入來說，這是許多醫療技術發展過程中自然發生的事情。你的首字母 - 它不是二進制的，對嗎？該公司已經朝著這個方向發展了一段時間。但從我們的角度來看，它的組織規模在一定程度上已經完全啟動並在所有氣缸中運行，因此我們認為 85 個地區是一個不錯的數字。

We don't have plans to have large growth over that, but if we see opportunities incrementally, we will. We'll also probably add some additional of our therapy development specialists just for case coverage will be a piece of that. But a big part of it then is just refining our playbook as we go forward there. So things like customer segmentation and being really smart about what do we -- and what our approach is with someone who's a TCAR first adopter, how do we help him or her be most successful in growing and developing their practice versus someone who may be a more mid-level adopter and earlier in that adoption curve. What are all the tools in the toolbox that we can use to help them expedite that? That could be things like our therapy awareness team that really helps work with and educate referring physicians. That could be patient marketing, which we do see playing an important active role here.

我們沒有計劃實現大幅增長，但如果我們逐步看到機會，我們就會實現。我們也可能會增加一些額外的治療開發專家，只是為了病例覆蓋將是其中的一部分。但其中很大一部分就是在我們前進的過程中完善我們的劇本。因此，諸如客戶細分之類的事情，以及真正明智地了解我們對TCAR 第一個採用者的做法以及我們對TCAR 第一個採用者的方法是什麼，我們如何幫助他或她在發展和發展他們的實踐方面與可能是TCAR 的人相比最成功。我們可以使用工具箱中的哪些工具來幫助他們加快這一速度？這可能是像我們的治療意識團隊這樣的事情，真正有助於與轉診醫生合作並對其進行教育。這可能是耐心的營銷，我們確實看到它在這裡發揮著重要的積極作用。

And I mentioned also fellows and early-career physicians. And we have made a change -- I haven't made a lot of big changes to the team, but I have made a change organizationally and promoted Jorge O'Hara is now our VP of marketing. Jorge has a lot of experience in his background, starting at P&G in marketing and then at Medtronic and EV3, as well as a lot of really good other healthcare experience.

我還提到了研究員和早期職業醫生。我們已經做出了改變——我沒有對團隊做出很多重大改變，但我在組織上進行了改變，並晉升豪爾赫·奧哈拉（Jorge O'Hara）現在是我們的行銷副總裁。Jorge 擁有豐富的背景經驗，首先在寶潔公司從事行銷工作，然後在美敦力和 EV3，以及許多非常好的其他醫療保健經驗。

And so, Jorge already was at Silk Road. He led our marketing and business -- sorry, our strategy and business development efforts. He's now going to lead our marketing efforts and take on this work working with -- and again, an already strong team. I mentioned Andy Davis and the team that he has. So it's an evolution, but I think areas of emphasis and focus, a lot of which we just talked about at the sales meeting I mentioned.

所以，豪爾赫已經在絲路了。他領導了我們的行銷和業務——抱歉，是我們的策略和業務發展工作。他現在將領導我們的行銷工作，並與一支已經很強大的團隊合作承擔這項工作。我提到了安迪戴維斯和他的團隊。所以這是一個演變，但我認為重點和重點領域，其中許多我們剛剛在我提到的銷售會議上討論過。

Got it. That's helpful. And then maybe just one follow-up related to the reimbursement changes around transfemoral stenting. I know you've only been there for a limited amount of time and the feedback is only anecdotal. We haven't seen this play out. But if we were to speak theoretically, how do you think the share shift end up playing out?

知道了。這很有幫助。然後也許只是一項與經股動脈支架置放術報銷變化相關的後續行動。我知道您只在那裡待了有限的時間，並且反饋只是軼事。我們還沒有看到這種情況發生。但如果我們從理論上講，您認為份額轉移最終會如何發揮作用？

Obviously, open is still the lion's share of procedures, TCAR second, and then transfemoral stenting third. But if transfemoral stenting is more successful, do you think that's more likely coming out of open? Or is there a possibility that comes from TCAR if you were to think theoretically?

顯然，開放性手術仍佔手術的最大份額，其次是 TCAR，然後是經股動脈支架置入術。但如果經股動脈支架置放術更成功，您是否認為更有可能採用開放式療法？或者說如果你從理論上思考的話，TCAR有沒有一種可能性？

Yeah, no. I think we do see a world that over time becomes more endovascular based, right? And we certainly expect that TCAR is very well positioned to capture the majority of that growth. And that, as I said, Silk Road Medical is well positioned to capture and continue to be the leader in treatment of CAD, right? We know the space really well, and we've got a level of commitment to it that others just don't have.

是的，不。我認為我們確實看到了一個隨著時間的推移而變得更加基於血管內的世界，對吧？我們當然預計 TCAR 能夠很好地抓住這一增長的大部分。正如我所說，絲路醫療處於有利地位，能夠佔領並繼續成為 CAD 治療領域的領導者，對吧？我們非常了解這個領域，我們對此有一定程度的承諾，這是其他人所沒有的。

The other thing I would emphasize, though, is just the time element to it. I think as I was going through my interviews and process last year, you had a little bit of sort of this feeling that somehow there's this wave that was going to happen, Frank, we're not seeing that. We just aren't.

不過，我要強調的另一件事是時間因素。我想當我去年經歷採訪和過程時，你有一點這種感覺，不知何故會有一股浪潮即將發生，弗蘭克，我們沒有看到這一點。我們只是不是。

There may be pockets of where we see some changes and views, but a lot of it's already existing carotid stent users. And so the steps to then get new people doing the procedures can take time. And so it doesn't mean it can't happen over time and we're going to watch it all really carefully, but our primary area of focus, our primary driver continues to be evolving behavior among what is still the bulk of the market that being CEA.

我們可能會在某些地方看到一些變化和觀點，但其中許多已經是頸動脈支架使用者。因此，讓新人執行這些程序的步驟可能需要時間。因此，這並不意味著它不會隨著時間的推移而發生，我們將非常仔細地觀察這一切，但我們的主要關注領域，我們的主要驅動力仍然是市場主體中不斷變化的行為那就是CEA。

Okay. That's good color. I'll stop there. Thanks for answering the questions.

好的。這顏色真好啊我就到此為止。感謝您回答問題。

Robbie Marcus, JPMorgan.

羅比馬庫斯，摩根大通。

Hi. This is actually Rohan on for Robbie. I just had a question on the outlook down the P&L. Still growth's proven the ability to obtain a pretty healthy 70%-plus gross margin for some time, but just trying to gauge what's required on the OpEx side to maintain revenue growth while also achieving profitability, ultimately. I know you talked about how you expect an OpEx growth to be lower than sales growth. So I was wondering if you could just give some more specifics on that for 2024 and maybe a timeline for potential adjusted EBITDA profitability as well.

你好。這其實是羅漢為羅比做的。我只是對損益表的前景有疑問。事實證明，成長仍然能夠在一段時間內獲得 70% 以上的相當健康的毛利率，但只是試圖衡量營運支出方面需要什麼才能保持收入成長，同時最終實現盈利。我知道您談到了您預計營運支出成長將低於銷售成長。因此，我想知道您是否可以提供 2024 年的更多具體信息，以及潛在的調整後 EBITDA 盈利能力的時間表。

Sure, Rohan. Thank you for the question. I'll tackle that one. So the short answer, and as we've mentioned in these prepared remarks and talked about prior is we are really at critical mass across our key functions. And we do have a hiring plan in 2024, of course, but it's much more modest than years prior. And so the infrastructure we have, whether you're thinking about the manufacturing capacity or the commercial organization or the commercial support, R&D, G&A back office, that can support a much higher unit volume, much higher revenue line.

當然，羅漢。感謝你的提問。我會解決這個問題。因此，簡短的回答是，正如我們在這些準備好的評論中提到的以及之前討論過的那樣，我們的關鍵職能確實處於臨界狀態。當然，我們確實有 2024 年的招聘計劃，但比幾年前要溫和得多。因此，我們擁有的基礎設施，無論您考慮的是製造能力、商業組織或商業支援、研發、G&A 後台，都可以支援更高的單位產量、更高的收入線。

So we like where we sit today on our base of OpEx, and if you take, a Q4 run rate $49 million, and change and tick it up ever so slightly, that's where we think (technical difficulty) in 2024 . And so we were at 100 -- OpEx as a percentage of revenue was 105% in 2023, 104% in Q4. We want to continue our march towards 100%. This year, obviously, we want to really put our main focus on top-line growth because that can now start to flow through more and more into that relatively fixed OpEx base.

因此，我們喜歡今天我們在營運支出基礎上的位置，如果你考慮第四季度的運行費用 4900 萬美元，並稍微改變和調整它，這就是我們認為 2024 年的（技術難度）。所以我們的排名是 100——2023 年營運支出佔收入的百分比為 105%，第四季為 104%。我們希望繼續朝 100% 邁進。顯然，今年我們希望真正將主要重點放在營收成長上，因為這現在可以開始越來越多地流入相對固定的營運支出基礎。

So as you mentioned, we are highlighting adjusted EBITDA as a new reporting metric?

正如您所提到的，我們強調調整後的 EBITDA 作為新的報告指標？

We were $17.7 million loss in '23 versus $25 million and change loss in '22. And so we do expect to have another year of improvement on that important metric as well, sitting here with $191 million of cash on the balance sheet.

23 年我們虧損 1,770 萬美元，而 22 年虧損為 2,500 萬美元。因此，我們確實預期這項重要指標還會再有一年的改善，資產負債表上的現金為 1.91 億美元。

Got it. Thank you. And I just had a quick follow up more on the top-line guidance. Is this assuming any kind of increases in revenue per procedure from the new product launches like the NPS+ or the new tapered stent?

知道了。謝謝。我剛剛對頂線指導進行了快速跟進。這是假設每次手術的收入因 NPS+ 或新錐形支架等新產品的推出而增加嗎？

Yeah. I'll give a quick kind of math answer, and Chas, feel free to weigh in. There's a lot of puts and takes in there. As I mentioned, we expect revenue per procedure to be slightly less variation, but still quarter-to-quarter variation. So I think we ended just over 7,000 on average for the year, and I think around 7,000, maybe slightly less is a good ballpark to be in for 2024.

是的。我會給一個快速的數學答案，查斯，請隨意參與。那裡有很多投入和投入。正如我所提到的，我們預計每個程序的收入變化會略小，但仍存在季度與季度的變化。因此，我認為我們今年的平均產量略高於 7,000 輛，而且我認為 7,000 輛左右，也許稍微少一點是 2024 年的一個不錯的數字。

But as you point out, there are various puts and takes that lead to that average. So all of our price assumptions, our units sold and ordering patterns, product launches, things of those sort are all baked into that number.

但正如您所指出的，有多種看跌期權和看跌期權會導致該平均值。因此，我們所有的價格假設、銷售量和訂購模式、產品發布等都被納入這個數字。

The only thing I would is that price -- our pricing really is stable in a good way. And so the variability we're talking about does have to do with things like order patterns. But we feel good about the overall health there, and the primary driver will be procedure growth.

我唯一想要的是價格——我們的定價確實非常穩定。因此，我們所討論的可變性確實與訂單模式等因素有關。但我們對那裡的整體健康狀況感覺良好，主要驅動力將是手術的成長。

Suraj Khalia, Oppenheimer & Co.

蘇拉吉‧卡利亞 (Suraj Khalia)，奧本海默公司

Good afternoon, Chas, Lucas. Can you hear me alright?

下午好，查斯，盧卡斯。你聽得到我說話嗎？

Yes, we can. Hi, Suraj.

我們可以。嗨，蘇拉吉。

Perfect. Hey. So Chas, congrats on a nice quarter. I hope to see many more. Chas, I want to focus on two things. First, field force. Can characterize -- in your prepared remarks, you said a third of them were, I think you said new or non-tenured -- some word you use. I split that out a little more, Chas, in terms of what has been the sales force churn, especially given the NCD, how many feet on the ground currently whether you're expecting to end calendar '24?

完美的。嘿。Chas，恭喜您度過了一個美好的季度。我希望能看到更多。查斯，我想關注兩件事。第一，現場力量。可以描述——在你準備好的發言中，你說其中三分之一是，我認為你說的是新的或非終身製的——你使用的一些詞。Chas，我根據銷售人員的流失情況進行了進一步分析，特別是考慮到非傳染性疾病，目前您是否預計在 24 日曆年結束？

Sure. Yeah. And as what I said just to recap was that as of the beginning of this year, about a third of our sales force, especially at the rep level, is new within the last year, so within the last 12 months. And it really is a variety of factors that impacted that, primarily was the expansion, right? We went from about 70 territories to 85 territories. We promoted some people into either manager level roles or into things like sales training.

當然。是的。正如我剛才所說的，回顧一下，截至今年年初，我們約有三分之一的銷售人員（尤其是銷售代表級別）是去年（即過去 12 個月內）的新員工。這確實是由多種因素影響的，主要是擴張，對吧？我們從大約 70 個地區增加到 85 個地區。我們將一些人提拔為經理級別的職位或銷售培訓等職位。

We had some attrition, or this will go back to early 2023, but nothing out of the norm of what I've seen in my career, and certainly not in the back half of the year as you would think would be related to the NCD. So it's just a variety of factors that led to a lot of change last year.

我們有一些人員流失，或者這會追溯到 2023 年初，但沒有什麼不符合我職業生涯中所見的情況，當然也不會像你認為的與非傳染性疾病有關的下半年發生。所以去年有很多因素導致了很多變化。

But I will tell you we feel good about people we hired. We hire from the best places in medtech. I met pretty much all of this group at the sales meeting I mentioned. The mood is good; the attitude is good; the excitement for the year is good. We just got to help them get up the learning curve as fast as we can.

但我會告訴你，我們對我們僱用的人感覺良好。我們從醫療技術領域最好的地方招募人才。在我提到的銷售會議上，我幾乎見到了這群人的所有人。心情好；態度好；今年的興奮是好的。我們只需幫助他們盡快提高學習曲線。

And the good news is we've got a lot of really good experienced reps who can help them do that and as well as our marketing team and our reimbursement team and all the other folks that help do that, our sales training, obviously. So hopefully that gives you a little more color.

好消息是，我們有很多非常優秀、經驗豐富的代表可以幫助他們做到這一點，我們的行銷團隊、報銷團隊以及所有其他幫助做到這一點的人，顯然還有我們的銷售培訓。希望這能給你更多的色彩。

And then to answer the final part, right now, we don't have big expansion plans at the rep level over the course of this year. Doesn't mean we may not add some in certain spots, but it's much more about kind of consolidating with the group we have. We will probably add some additional therapy development specialists who, as you know, support the reps for things like case coverage over the course of the year to make sure we've got everything we need to support the growth in volumes we expect.

然後回答最後一部分，目前，我們在今年的代表級別上沒有大型擴張計劃。這並不意味著我們可能不會在某些地方添加一些內容，但這更多的是與我們現有的團隊進行整合。我們可能會增加一些額外的治療開發專家，如您所知，他們在一年中為代表提供病例覆蓋等方面的支持，以確保我們擁有支持我們預期的數量增長所需的一切。

Got it. And Chas, in terms of your accounts, one of the things you mentioned in your remarks was you're not focusing going deep. So if I use that context, right now in 1,200 or so accounts, do the rough math, average utilization is about 5.5 units per quarter per hospital.

知道了。查斯，就你的帳戶而言，你在演講中提到的一件事是你沒有專注於深入。因此，如果我使用這種背景，現在在 1,200 個左右的帳戶中，進行粗略計算，平均利用率約為每家醫院每季 5.5 個單位。

Chas, walk us through. If I were to divide your accounts into high volume, medium volume, and low volume buckets, arbitrary, I defined them in these three buckets. What is the stress test show you right now with NCD, just given what's going on with the entity? Are the high volume accounts pulling back a little bit versus medium? Just compare and contrast for us. Thank you for taking my questions.

查斯，帶我們過去。如果我將你的帳戶任意劃分為高容量、中容量和低容量桶，我將它們定義在這三個桶中。考慮到該實體正在發生的情況，壓力測試現在向您展示的非傳染性疾病是什麼？高交易量帳戶相對於中交易量帳戶是否有所回落？只是為我們進行比較和對比。感謝您回答我的問題。

Yeah, I'll provide some overall thoughts, and then Lucas, feel free to chime in as well. I mean, I think like a lot of medical device situations, we certainly have a version of -- our top customers are the ones who are the primary drivers of a lot of our volume. Those are the ones who truly have adopted what I said, a TCAR-first mentality. And we certainly aim to grow that group.

是的，我會提供一些整體想法，然後盧卡斯也請隨意插話。我的意思是，我認為就像許多醫療設備情況一樣，我們當然有一個版本——我們的頂級客戶是我們大量銷售的主要驅動力。那些人真正採取了我所說的「TCAR優先」心態。我們的目標當然是發展這個群體。

I mentioned in my remarks at JP Morgan, we've got a lot of data to show that those, in fact, happen over time. The learning curve with TCAR is slow. The adoption -- I mean, it is fast, the learning curve is quick. The adoption curve takes a while as people continue to move from, I'm going to do some TCAR on just the right patients, to then eventually, why wouldn't I do a TCAR, meaning TCAR first. And it does happen over time.

我在摩根大通的演講中提到，我們有大量數據表明，這些實際上是隨著時間的推移而發生的。TCAR 的學習曲線很慢。採用－我的意思是，速度很快，學習曲線也很快。採用曲線需要一段時間，因為人們繼續從“我要對合適的患者做一些 TCAR”，到最終，為什麼我不做 TCAR，意思是先做 TCAR。隨著時間的推移，它確實會發生。

So we still have a lot of -- you asked about accounts, but let's talk about physicians. Physicians who are in that sort of middle bucket that we can continue to work on and develop and grow their adoption to keep moving forward. And all the comments I've made are really independent of the NCD, because again, our surgeon customers are not reverting to transfemoral CAS. And we do monitor very carefully and we're not seeing a widespread change, and for example, in referring patterns.

所以我們還有很多——你問的是帳戶，但我們來談談醫生。對於處於中間位置的醫生，我們可以繼續努力、發展和提高他們的採用率，以繼續前進。我所做的所有評論實際上都與 NCD 無關，因為我們的外科醫生客戶不會恢復使用經股動脈 CAS。我們確實非常仔細地進行監控，但我們沒有看到廣泛的變化，例如在建議模式方面。

We're going to keep watching it. It's early. But the dynamics are much more, again, on us and our customers and how we move that adoption more than the NCD, I think. Lucas, what else would you add there?

我們將繼續關注。現在還早。但我認為，動態更多地取決於我們和我們的客戶以及我們如何推動這種採用，而不是非傳染性疾病。盧卡斯，您還要加什麼？

Yeah, Suraj, I think I'll just add, at a hospital level in the treatment of carotid disease, you've got value analysis committees, you've got credentialing committees, you've got data collection of CEA and TCAR. If they do CAS, CAS itself as well. You've got multidisciplinary folks weighing in first and foremost on what's best for the patient, right? And then you get into what's best for the hospital bottom line.

是的，Suraj，我想我要補充一點，在醫院級別的頸動脈疾病治療中，有價值分析委員會，有資格認證委員會，有 CEA 和 TCAR 的數據收集。如果他們做 CAS，那麼 CAS 本身也是如此。您已經讓多學科人員首先權衡什麼對患者最好，對吧？然後你就會了解什麼對醫院的利潤最有利。

And TCAR stacks up really favorable when you consider all those variables at the hospital level. First of all, we're already there; we're already entrenched. We continue to collect data showing that this works. We continue to show hospital administrators and CFOs the money they're making, the money they're saving, the throughput they're getting. They're now serving their patients and realizing this, indeed, from the patient perspective, is a great procedure.

當您考慮醫院層級的所有這些變數時，TCAR 確實非常有利。首先，我們已經到了；我們已經根深蒂固了。我們繼續收集數據，表明這是有效的。我們繼續向醫院管理人員和財務長展示他們賺到的錢、節省的錢和獲得的吞吐量。他們現在正在為患者提供服務，並意識到，從患者的角度來看，這確實是一個很好的過程。

So the NCD, the physicians, our sales team, right now, it's really viewed as an opportunity and folks are excited that a few additional administrative barriers have been removed from a TCAR perspective, and we can go out and compete against CEA primarily, but CAS too, where there is interest or ongoing activity. But ultimately, this is all in service to the patient. Having options is a good thing and we'll lead with the best option in most cases.

因此，NCD、醫生、我們的銷售團隊，現在確實被視為一個機會，人們很興奮，因為從 TCAR 的角度消除了一些額外的行政障礙，我們可以主要與 CEA 競爭，但是CAS 也是如此，只要有興趣或正在進行活動。但歸根結底，這一切都是為了患者。有選擇是件好事，在大多數情況下我們會選擇最好的選擇。

Thank you.

謝謝。

Kristen Stewart, C.L. King.

克莉絲汀史都華，C.L.國王。

Hi. Thanks for taking my question (technical difficulty) I just wanted to ask, Chas, if you think that the 12% guidance (technical difficulty) company long term about? Or do you think there's some things that you're factoring in '24 that are leading to a slightly lower (technical difficulty) than you otherwise expect in the outer years?

你好。感謝您提出我的問題（技術難度），我只是想問 Chas，您是否認為 12% 的指導（技術難度）公司是長期的？或者您認為您在 24 年考慮的某些因素會導致比您在外部幾年中預期的技術難度略低？

Yeah. No, thanks, Kristen. You cut in and out of just a little bit on your question, but I think you were asking about the 2024 guidance in relation to views over time. Is that correct? Okay. I think it was. Sorry, you cut out just a little bit.

是的。不，謝謝，克里斯汀。您在問題上插話了一點，但我認為您是在詢問 2024 年關於隨時間推移觀點的指導意見。那是對的嗎？好的。我想是的。抱歉，你刪掉了一點點。

Yeah, no, as I think about the guidance at this point, I did mention a few factors that I think impacts us here this year as we sort of head into the year. A big one, as I mentioned, is just the sales force piece of it and just getting fully up to speed with a pretty significant portion of our group. I feel really good about our ability to do that. I already touched on that and mentioned the like just overall positive elements of this meeting.

是的，不，當我考慮此時的指導時，我確實提到了一些我認為在我們即將進入今年時影響我們的因素。正如我所提到的，一個重要的因素就是銷售人員的一部分，以及我們團隊中相當大一部分人完全跟上進度。我對我們做到這一點的能力感到非常滿意。我已經談到了這一點，並提到了本次會議的整體積極因素。

I think evolving our strategy on the going broad to going deep element is important, and we already have a lot of the ingredients, but I think there's more we can do there and we're working on it. And then honestly, I've been in my role for about 100 days. And so partly, I also feel very good about the fundamentals, but I'm still working with the team to really dive deeply into the specific plans that are going to maximize success.

我認為從廣泛到深入發展我們的策略很重要，我們已經有了很多要素，但我認為我們可以做更多的事情，我們正在努力。老實說，我已經擔任這個職位大約 100 天了。因此，我對基本面也感覺非常好，但我仍在與團隊合作，真正深入研究將取得最大成功的具體計劃。

And so for the year, we want a heavy, heavy emphasis on predictability and accountability going forward. And then over time, we'll layer in additional growth in the US to be able to move adoption further. International growth will eventually start kicking in and will be a factor there. Other R&D programs that I know as a little cryptic, but I alluded to, will help. And so, our view is to be a sustainable grower over the long term, and we're going to keep working on a range of plans to do that.

因此，今年我們希望非常重視未來的可預測性和問責制。然後隨著時間的推移，我們將在美國增加額外的成長，以便能夠進一步推動採用。國際成長最終將開始發揮作用，並將成為其中的一個因素。我知道有些神秘但我提到的其他研發項目也會有所幫助。因此，我們的願景是成為長期可持續的種植者，我們將繼續制定一系列計劃來實現這一目標。

Okay, perfect. And then I just want to clarify whether or not the NPS, the new one and the tapered stent, would have a premium (technical difficulty) You said that there's a lot of moving parts just thinking about things, but are those coming out at a premium price?

好的，完美。然後我只是想澄清一下NPS，新的和錐形支架是否會有溢價（技術難度） 你說有很多移動部件只是在考慮事情，但是那些出來的東西是在一個溢價？

Hi, Kristen, it's Lucas. I'll take that one. Fundamentally, it is factored into that overall kind of 7,000 or slightly under revenue per procedure guidance. Ultimately all of our new product efforts are in service to the adoption curve, right? We want to make this procedure better, faster, safer, easier. And so, across what is now five products that make up the TCAR procedure and iterations thereof at the product level, you might have price opportunity in certain times and certain products and price pressure elsewhere, and all of that is factored into our guidance.

嗨，克莉絲汀，我是盧卡斯。我會接受那個。從根本上說，它被計入 7,000 美元的總收入中，或略低於每個程式指導的收入。最終，我們所有的新產品努力都是為了適應採用曲線，對吧？我們希望讓這個過程更好、更快、更安全、更容易。因此，現在構成TCAR 程序的五種產品及其在產品級別的迭代中，您可能在某些時間和某些產品上有價格機會，在其他地方可能有價格壓力，所有這些都已納入我們的指導中。

Okay. Thanks very much for taking the questions.

好的。非常感謝您提出問題。

Thank you.

謝謝。

Thanks, Kristen.

謝謝，克里斯汀。

Thank you. This concludes the question-and-answer session. I would now like to turn it back to Chas McKhann for closing remarks.

謝謝。問答環節到此結束。現在我想請查斯·麥克卡恩 (Chas McKhann) 發表閉幕詞。

Listen, thank you all very much for joining us again today and look forward to keeping the dialogue going over the course of the year. Appreciate it.

聽著，非常感謝大家今天再次加入我們，並期待在這一年中保持對話。欣賞它。

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

感謝您參加今天的會議。現在程式就結束了。您可以斷開連線。