InspireMD Inc (NSPR) 2023 Q3 法說會逐字稿

Good morning and welcome to the InspireMD third quarter of 2023 earnings call. (Operator instructions) Please note that this conference is being recorded. I'd now like to turn the conference over to Mr. Chuck Padala, LifeSci Advisors

早安，歡迎參加 InspireMD 2023 年第三季財報電話會議。 （操作員說明）請注意，本次會議正在錄製中。我現在想將會議轉交給 LifeSci Advisors 的 Chuck Padala 先生

Thank you. You may begin.

謝謝。你可以開始了。

Thank you, operator, and good morning, everyone. Thank you for joining us to the InspireMD third quarter of 2023 financial results and corporate update conference call. Joining us today from InspireMD are Marvin Slosman, Chief Executive Officer; and Craig Shore, Chief Financial Officer.

謝謝接線員，大家早安。感謝您參加 InspireMD 2023 年第三季財務業績和公司更新電話會議。今天加入我們的還有 InspireMD 執行長 Marvin Slosman；克雷格‧肖爾（Craig Shore），財務長。

During the call, management will be making forward-looking statements not historical facts, which are based upon management's current expectations, beliefs and projections, many of which, by their nature are inherently uncertain. These forward-looking statements involve risks and uncertainty that may cause actual results to differ materially from those expressed in such forward-looking statements.

在電話會議期間，管理層將做出前瞻性陳述，而不是歷史事實，這些陳述基於管理層當前的期望、信念和預測，其中許多本質上是不確定的。這些前瞻性陳述涉及風險和不確定性，可能導致實際結果與此類前瞻性陳述中表達的結果有重大差異。

For more information about these risks, please refer to the risk factors described that InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q for any updates in our current reports on Form 8-K filed with the US Securities and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it.

有關這些風險的更多信息，請參閱 InspireMD 最近提交的 10-K 表格和 10-Q 表格定期報告中描述的風險因素，以了解我們向美國證券交易委員會提交的 8-K 表格當前報告中的任何更新委員會和InspireMD 隨此呼籲發布的新聞稿，特別是其中做出的警告性聲明。

This call contains time-sensitive information that is accurate only as of today, November sixth, 2023. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

本次電話會議所包含的時間敏感資訊僅截至今天（2023 年11 月6 日）準確。除非法律要求，否則InspireMD 不承擔任何公開更新或修改任何資訊以反映本次電話會議後發生的事件或情況的義務。

It is now my pleasure to turn the call over to Marvin Slosman, CEO. Please go ahead Marvin.

現在我很高興將電話轉給執行長 Marvin Slosman。請繼續，馬文。

Thank you, Chuck, and thanks to everyone for joining the call this morning. The third quarter proved to be a transformational time for our company with several milestones, further validating our strategy and mission to transform the carotid revascularization market with a superior next-generation stent implant, along with our focus on the broadest range of tools providing both patients and physicians optimal procedural solutions.

謝謝查克，也謝謝大家今天早上加入電話會議。第三季被證明是我們公司的轉型時期，取得了多個里程碑，進一步驗證了我們的策略和使命，即透過卓越的下一代支架植入物來改變頸動脈血運重建市場，同時我們專注於為患者提供最廣泛的工具和醫生最佳的程序解決方案。

Execution against internal objectives remains our focus but I would like to start today with a brief mention of the recent national coverage decision by CMS, enabling a monumental shift by expanding reimbursement for carotid artery stenting or CAS procedures to include both standard surgical risk and asymptomatic patients, neither of which were previously covered. We will get into those details shortly.

針對內部目標的執行仍然是我們的重點，但今天我想首先簡要提及CMS 最近的全國覆蓋決定，透過擴大頸動脈支架置入術或CAS 手術的報銷範圍以包括標準手術風險和無症狀患者，實現了重大轉變，這兩者之前都沒有涉及。我們將很快討論這些細節。

In terms of our financials for the third quarter of 2023, we generated total revenue of $1.556 million on 2,734 devices sold, representing nearly a 9% revenue growth over the comparable period in 2022. Measuring procedural volume continues to be a key metrics of our success, as our distributor model discounts our average sales price by way of transfer pricing.

就 2023 年第三季的財務數據而言，我們在售出 2,734 台設備上實現了 155.6 萬美元的總收入，比 2022 年同期收入增長了近 9%。衡量程序量仍然是我們成功的關鍵指標，因為我們的經銷商模型透過轉讓定價的方式對我們的平均銷售價格進行​​折扣。

Unit sales more accurately measure market share in our served territories, a key driver of our growth objectives. As we drive market awareness, utilization and global expansion implant performance will remain the cornerstone of our focus, having now established a baseline of real-world experience and world-class data with more than 45,000 CGuard stent sold to date and nearly 2,200 patients enrolled in clinical studies.

單位銷售額更準確地衡量我們所服務地區的市場份額，這是我們成長目標的關鍵驅動力。隨著我們提高市場意識，利用率和全球擴張植入物性能仍將是我們關注的基石，目前已建立了真實經驗和世界級數據的基線，迄今為止已售出超過45,000 個CGuard 支架，近2,200名患者入組臨床研究。

We were pleased a few days ago to present the 30-day data from our CGuardian's IV clinical trial at the VIVA conference. As a reminder, the CGuardian's trial is designed to support a PMA submission in the second half of next year, which would give us line of sight to possible approval of CGuard EPS in the US in the first half of 2025.

幾天前，我們很高興在 VIVA 會議上展示了 CGuardian IV 臨床試驗的 30 天數據。提醒一下，CGuardian 的試驗旨在支援明年下半年提交 PMA，這將使我們預計在 2025 年上半年在美國批准 CGuard EPS。

Reviewing the results from July 2021 through June 2023, 316 patients were prospectively enrolled in this single arm carotid artery stenting. Our cast study performed at 24 sites in the US and Europe, utilizing CGuard EPS as the carotid stent system. The primary endpoint is a composite of incidence of major adverse events, including death, all-cause mortality, any stroke or myocardial infarction through 30 days post index procedure or its lateral stroke from day 31 to day 365.

回顧 2021 年 7 月至 2023 年 6 月的結果，316 名患者前瞻性地參與了這種單臂頸動脈支架置放術。我們在美國和歐洲的 24 個地點進行了模型研究，並利用 CGuard EPS 作為頸動脈支架系統。主要終點是主要不良事件發生率的綜合，包括死亡、全因死亡率、索引手術後 30 天的任何中風或心肌梗塞或其從第 31 天到第 365 天的側向中風。

All events are adjudicated by clinical events committee. Dr Chris Metzger, the PI of the CGuardian's trial presented unprecedented data at 30 days, total major adverse events, DSMI of 0.95%, as measured by intent to treat analysis considered to be the most rigorous measure of results. These first in-kind results demonstrate the neuroprotective effect of the CGuard stent and add to the significant and growing body of evidence showing that CGuard delivers outstanding short and long-term patient outcomes as compared to alternative stent and the current standard of care in revascularization carotid endarterectomy.

所有賽事均由臨床賽事委員會裁決。 CGuardian 試驗的PI Chris Metzger 博士在30 天時提供了前所未有的數據，主要不良事件總數、DSMI 為0.95%，透過意向治療分析進行測量，被認為是最嚴格的結果衡量標準。這些首次實體結果證明了CGuard 支架的神經保護作用，並增加了越來越多的重要證據，表明與替代支架和當前頸動脈血管重建的護理標準相比，CGuard 可提供出色的短期和長期患者預後動脈內膜切除術。

We were pleased to share these compelling results at VIVA, which is among the most important gatherings of endovascular specialists and should go a long way toward raising awareness of CGuard among the endovascular community, key opinion leaders and other practitioners alike.

我們很高興在 VIVA 上分享這些引人注目的結果，VIVA 是血管內專家最重要的聚會之一，對於提高血管內社區、關鍵意見領袖和其他從業者對 CGuard 的認識大有幫助。

Staying on the topic of our IDE trial for a moment, we announced in June that we had completed enrolment of this trial, something that was achieved in just 23 months. And recall that this study also includes the first human cases performed with our new CGuard prime CAS stent delivery system. Study follow-up is progressing as planned, and we reiterated our expectation for primary endpoint results in the second half of next year with anticipated approval in the first half of 2025.

暫時停留在 IDE 試驗的主題上，我們在 6 月宣布我們已經完成了試驗的註冊，這是在短短 23 個月內實現的。請記住，這項研究還包括使用我們的新型 CGuard prime CAS 支架輸送系統進行的首例人體病例。研究後續工作正在按計劃進行，我們重申了對明年下半年主要終點結果的預期，預計在 2025 年上半年獲得批准。

Revisiting one of the key market drivers transforming revascularization towards stenting on October 11, CMS issued a national coverage determination or NCD, implementing coverage of cast for both symptomatic and asymptomatic patients, whether considered to be high or standard risk for surgery. This coverage determination is very consistent with the draft memo that was released in July.

10 月11 日，CMS 重新審視了將血運重建轉向支架置入術的關鍵市場驅動因素之一，發布了一項全國覆蓋決定或NCD，對有症狀和無症狀患者實施石膏覆蓋，無論被認為是高手術風險還是標準手術風險。這項覆蓋範圍的確定與 7 月發布的備忘錄草案非常一致。

The updated NCD creates a very meaningful expansion of the addressable market forecast and will shift the standard of care toward a patient first approach with greater procedural options, including stenting. This adds to our enthusiasm for the US market opportunity for CGuard prime for both CAS and TCAR, both of which are an integral part of our long-term sales strategy.

更新後的非傳染性疾病對可尋址市場預測產生了非常有意義的擴展，並將把護理標準轉向患者優先的方法，並提供更多的手術選擇，包括支架置入術。這增加了我們對 CAS 和 TCAR 的 CGuard prime 在美國市場機會的熱情，這兩者都是我們長期銷售策略的組成部分。

We believe that broader access to endovascular options is good for patients. We'll call that CGuard EPS has demonstrated outstanding clinical results now in nearly 2,200 patients who were studied in rigorous clinical trials published in peer review journals and tens of thousands of real-world procedures performed to date, establishing a foundation of best in class results.

我們相信，更廣泛地獲得血管內選擇對患者有利。我們稱CGuard EPS 現已在近2,200 名患者中展示了出色的臨床結果，這些患者在同行評審期刊上發表的嚴格臨床試驗中進行了研究，並且迄今為止已執行了數以萬計的實際程序，為一流結果奠定了基礎。

This expansion of reimbursement and the broader trend toward an endovascular first shift away from surgery, support the approach we have advocated for some time. The consistent driver of outcomes remains the performance of the stent implant, which will remain our priority as clinical evidence remains the cornerstone of our story, leveraging our third-generation CGuard stent with its proprietary MicroNet mesh.

報銷範圍的擴大以及血管內優先從手術轉向的更廣泛趨勢支持了我們一段時間以來所倡導的方法。結果的一致驅動因素仍然是支架植入物的性能，這仍然是我們的首要任務，因為臨床證據仍然是我們故事的基石，利用我們的第三代 CGuard 支架及其專有的 MicroNet 網。

In anticipation of potential approval for CGuard in the first half of 2025, we've initiated pre-commercial activities in the US, and we continue to build out what I consider to be a world-class leadership team.

預計 CGuard 可能在 2025 年上半年獲得批准，我們已在美國啟動了預商業活動，並繼續打造​​我認為的世界一流的領導團隊。

Last month, we announced the hiring of Dr. Patrick Verta as our new Executive VP of Clinical and Medical Affairs. Patrick edge tremendous experience in the carotid field, having supported much of its clinical advancement over the last 20 years, and he brings an impeccable reputation amongst key opinion leaders, medical and regulatory bodies.

上個月，我們宣布聘請 Patrick Verta 博士擔任我們新的臨床和醫療事務執行副總裁。 Patrick 在頸動脈領域擁有豐富的經驗，在過去 20 年中支持了該領域的大部分臨床進展，並在關鍵意見領袖、醫療和監管機構中享有無可挑剔的聲譽。

We also announced the hiring of Cheryl Tal to lead our Quality Assurance and Regulatory Affairs function with tremendous expertise in building business scale and capability on a global level. And finally, after six months of having a significant impact as our General Manager of North America and VP of Global Marketing, Shane Gleason has been promoted to Chief Commercial Officer, expanding his responsibilities to support our global commercial growth.

我們也宣布聘請謝麗爾·塔爾（Cheryl Tal）來領導我們的品質保證和監管事務職能部門，他在全球範圍內建立業務規模和能力方面擁有豐富的專業知識。最後，在擔任我們的北美總經理和全球行銷副總裁六個月後，肖恩·格里森 (Shane Gleason) 被晉升為首席商務官，擴大了他支持我們全球商業成長的職責。

I would like to close with a word on behalf of our team based in Israel for their remarkable tenacity and bravery to deliver on commitments and objectives, allowing our company to operate without interruption during such a profoundly difficult time. It is truly a testament to our team, fulfilling our mission to deliver the best lifesaving and stroke preventing devices to patients worldwide.

最後，我想代表我們駐以色列的團隊致辭，感謝他們在兌現承諾和目標方面表現出的非凡堅韌和勇氣，使我們公司能夠在如此困難的時期不間斷地運作。這確實是對我們團隊的證明，履行了我們為全世界患者提供最好的救生和中風預防設備的使命。

I'm now pleased to re-welcome Craig Shore back to the call as our CFO. Craig?

我現在很高興再次歡迎克雷格·肖爾 (Craig Shore) 再次參加電話會議，擔任我們的財務長。克雷格？

Thanks, Marvin. For the three months ended September 30, 2023, revenue was $1,556,000 compared to $1,431,000 during the three months ended September 30, 2022. This revenue increase of $125,000 was predominantly driven by an increase in commercial sales of $166,000 of CGuard EPS to existing geographies. Offset by a $41,000 decrease in the United States, as we completed in June 2023, the enrolment of patients of the CGuardian's IDE clinical trial. And accordingly, there was no further enrolments in the three months ended September 30, 2023.

謝謝，馬文。截至2023 年9 月30 日的三個月，收入為1,556,000 美元，而截至2022 年9 月30 日的三個月為1,431,000 美元。收入增加125,000 美元，主要是由於CGuard EPS 向現有地區的商業銷售增加了166,000 美元。我們於 2023 年 6 月完成了 CGuardian IDE 臨床試驗的患者入組，抵消了美國境內 41,000 美元的減少。因此，截至 2023 年 9 月 30 日的三個月內沒有進一步招生。

For the three months ended September 30, 2023, gross profit increased by 19.7% to $438,000 from $366,000 during the same period in 2022. This increase in gross profit resulted from a $85,000 increase in revenues, less the associated related material labour, offset by miscellaneous expenses. Gross margin increased to 28.1% during the three months ended September 30, 2023, from 25.6% during the three months ended September 30, 2022, driven by the factors just mentioned.

截至2023 年9 月30 日的三個月，毛利從2022 年同期的366,000 美元增加到438,000 美元，增長了19.7%。毛利的增加是由於收入增加了85,000 美元，減去相關的相關材料勞動力，並被雜項所抵銷花費。受上述因素推動，毛利率從截至2022年9月30日止三個月的25.6%增加至截至2023年9月30日止三個月的28.1%。

Total operating expenses for the third quarter of 2023 were $6,077,000, an increase of $1.1 million or 22% compared to $4,976,000 for the third quarter of 2022. This increase was predominantly due to an increase in compensation expenses.

2023 年第三季的總營運費用為 6,077,000 美元，與 2022 年第三季的 4,976,000 美元相比增加了 110 萬美元，即 22%。這一增長主要是由於薪酬費用的增加。

Total financial income for the third quarter of 2023 was $461,000, an increase of $380,000 or 469% compared to $81,000 for the third quarter of 2022. This increase was primarily due to the $412,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

2023年第三季的總財務收入為461,000美元，與2022年第三季的81,000美元相比增加了380,000美元，即469%。這一增長主要是由於投資於有價證券、貨幣市場基金的利息收入增加了412,000美元和短期銀行存款。

Net loss for the third quarter of 2023 totaled $5,178,000 or $0.15 per basic and diluted shar compared to a net loss of $4,529,000 or $0.58 per basic and diluted share for the same period in 2022.

2023 年第三季的淨虧損總計 5,178,000 美元，或每股基本和稀釋每股 0.15 美元，而 2022 年同期淨虧損為 4,529,000 美元，或每股基本和稀釋每股 0.58 美元。

After September 30, 2023, cash, cash equivalents and short-term investments and bank deposits were $43 million compared to $78.8 million as of December 31, 2022.

2023 年 9 月 30 日之後，現金、現金等價物、短期投資和銀行存款為 4,300 萬美元，而截至 2022 年 12 月 31 日為 7,880 萬美元。

That concludes our prepared remarks. We will now open the call for questions. Operator?

我們準備好的演講到此結束。我們現在開始提問。操作員？

Thank you, sir. Ladies and gentlemen, we will now be conducting the question and answer session. (Operator instructions)

謝謝你，先生。女士們、先生們，我們現在將進行問答環節。 （操作員說明）

Adam Maeder, Piper Sandler.

亞當梅德，派珀桑德勒。

Thank you for taking the questions. Congrats on the excellent interim data presentation last week, the print and the operating progress. Maybe just to start wanted to give you the opportunity to kind of flash out the Q3 performance just a little bit more. Can you talk about kind of the key trends, messages in the quarter. And then I had a handful of follow-ups. Thanks.

感謝您提出問題。恭喜上週出色的中期數據演示、列印和營運進度。也許只是想給你一個機會來展示第三季的表現。您能談談本季的主要趨勢和資訊嗎？然後我進行了一些後續行動。謝謝。

Morning, Adam, thanks. Thanks for the question. Our progress in commercial growth outside of the US continues to be strong. And I think the message continues to be consistent, which is to drive clinical outcomes and performance by way of data. Our distributors, I think, are becoming more and more comfortable with CGuard.

早安，亞當，謝謝。謝謝你的提問。我們在美國以外地區的商業成長持續強勁。我認為資訊仍然是一致的，即透過數據來推動臨床結果和表現。我認為，我們的經銷商對 CGuard 越來越滿意。

In fact, we had a full distributor call the other day with all of them. And I think the momentum that we're building just in recognizing what's happening in the US is also engaging them more and is paying residual benefits to our markets outside the US. So in terms of real numbers and growth, we're seeing consistency there, and we'll continue to drive that in those markets as our foundation of revenue at this point.

事實上，前幾天我們接到了一個完整的經銷商電話，他們都來了。我認為，我們在認識到美國正在發生的事情時所建立的勢頭也讓他們更多地參與進來，並為我們在美國以外的市場帶來了剩餘利益。因此，就實際數字和成長而言，我們看到了一致性，我們將繼續在這些市場中推動這一點，作為我們目前收入的基礎。

That's helpful color. Thank you for that. My next question is of a multipart question on the Israel-Hamas war. I hope all of your team members are staying safe. Can you just talk about, you know, kind of any thoughts around, you know, your ability to supply the market? Do you anticipate any future impact to commercial sales or any kind of hindrances to push for the US initiatives in an efficient manner? And then I guess I'm just wondering as well, just are you taking any precautions or proactive steps with inventory management or alternative manufacturing?

這是有用的顏色。謝謝你。我的下一個問題是關於以色列與哈馬斯戰爭的多部分問題。我希望您所有的團隊成員都保持安全。能否談談您供應市場的能力？您預期未來會對商業銷售產生任何影響，或會遇到任何阻礙美國有效推動措施的障礙嗎？然後我想我也想知道，您是否在庫存管理或替代製造方面採取了任何預防措施或主動措施？

Yes, thanks. Thanks for the question, Adam. Thus far, we've not had any direct impact on our ability to deliver and perform by way of the war and -- but we're not sitting still obviously, we're keeping a very close eye on things and have put into place some examples of mitigating risks there by, way of advancing our supply chain, building inventory, looking at alternative locations for securing finished goods and just other things that are good practices under the circumstances, you know, our shift toward a US focus continues as well.

對了謝謝。謝謝你的提問，亞當。到目前為止，我們還沒有透過戰爭對我們的交付和執行能力產生任何直接影響——但顯然我們並沒有坐以待斃，我們正在密切關注事情並已落實到位通過一些減輕風險的例子，推進我們的供應鏈的方式，建立庫存，尋找替代地點來確保成品的安全以及其他在這種情況下是良好做法的事情，你知道，我們向美國重點的轉變也在繼續。

But in the short term, all of our team is operating pretty much according to plan there. We have a couple of folks that have gone to active duty from reserve, but everybody is picking up the extra work to be done in terms of our progress toward US approval nothing changes there we're all on plan. Many of our consultants and activities are actually based outside of Israel as it relates to our regulatory effort and work and testing and those kinds of things.

但從短期來看，我們所有的團隊基本上都按照計畫運作。我們有幾個人已經從預備役轉入現役，但每個人都在為獲得美國批准而進行額外的工作，沒有任何變化，我們都按計劃進行。我們的許多顧問和活動實際上都在以色列境外，因為這與我們的監管工作、工作和測試等有關。

So I think most critical right now is to make sure that our supply chain and production remain sound and we're continuing to see good results there but are also looking at making sure that if this progresses into a different direction that we're on good ground as well there.

因此，我認為現在最重要的是確保我們的供應鏈和生產保持健全，我們將繼續看到良好的結果，但也在考慮確保如果這進展到一個不同的方向，我們會取得良好的進展地面也在那裡。

And that's great to hear, Marvin. Thank you for the fulsome response there. Maybe switching over to kind of the forward outlook, certainly recognizing you don't have guidance, but I was wondering if you can give any broad strokes or color, about how you're thinking about the business in Q4 as well as 2024 from a top line standpoint?

很高興聽到這個消息，馬文。感謝您的充分答复。也許會轉向某種前瞻性的展望，當然認識到你沒有指導，但我想知道你是否可以給出任何大致的輪廓或顏色，關於你如何從一個角度思考第四季度以及 2024 年的業務。頂線立場？

Yeah, I think the way to frame our growth direction at this point is to say that we continue to operate effectively in the 30 countries that we serve. We want to see consistent growth in those countries, until we're able to offer new toolsets, which we're working on aggressively in the area of TCAR and obviously, our new CGuard Prime, a transfemoral cast delivery system.

是的，我認為目前製定我們成長方向的方法是，我們繼續在我們服務的 30 個國家/地區有效運作。我們希望看到這些國家的持續成長，直到我們能夠提供新的工具集，我們正在 TCAR 領域積極致力於這些工具集，顯然還有我們新的 CGuard Prime，一種經股動脈石膏輸送系統。

I think things will remain consistent according to what we've presented up to this point. But obviously, those new tools at a very different dimension to how we believe we can penetrate the market. Our objective outside of the US is the same as it will be in the US, which is to convert surgeries to endovascular first, by using our stent performance to do that. And that is no different outside of the US So there's still a lot of endarterectomy being practiced. There's a lot of have surgeries being done.

我認為根據我們到目前為止所呈現的內容，事情將保持一致。但顯然，這些新工具與我們認為如何滲透市場的維度非常不同。我們在美國以外的目標與在美國的目標相同，即首先利用我們的支架性能將手術轉變為血管內手術。這在美國以外也沒有什麼不同，所以仍然有很多動脈內膜切除術正在實施。有很多手術正在進行中。

And our goal is not just to have the premier stent in the market, but most importantly to continue to convert surgeries. So that will remain consistent. And I think our growth plan is to just show consistency there as well.

我們的目標不僅是擁有市場上一流的支架，最重要的是繼續改變手術方式。所以這將保持一致。我認為我們的成長計劃也是為了展現一致性。

It's helpful. If I was to maybe push a little bit there, Marvin, the CGuard Prime and the TCAR European, CEA mark approval. Are you able to kind of give an update at this point? Obviously, I know MDR is a little bit unpredictable, but just any latest thoughts on when you could have those commercially available internationally?

這很有幫助。如果我想在這方面稍微推動一下，Marvin、CGuard Prime 和 TCAR 歐洲、CEA 都會表示認可。現在您能提供更新嗎？顯然，我知道 MDR 有點不可預測，但是關於何時可以在國際上實現這些商業化，您有什麼最新的想法嗎？

Yeah, I think as you said, the whole MDR process and just the regulatory environment in Europe in general has been somewhat frustrating, we're certainly prepared but are waiting for the longest pole in the tent here, which remains, the ability to get this through the regulatory cycles, but I'm anticipating that midyear 2024, we'll be in a good position to hopefully be able to launch new tools into the 30 countries that we're serving now.

是的，我認為正如你所說，整個 MDR 流程以及整個歐洲的監管環境都有些令人沮喪，我們當然已經做好了準備，但正在等待帳篷中最長的桿子，這仍然是獲得獲得的能力這是整個監管週期的一部分，但我預計到2024 年年中，我們將處於有利位置，預計將能夠向我們目前服務的30 個國家推出新工具。

That's helpful. Thank you. Wanted to ask a similar kind of forward outlook question. This one for Craig and Craig, welcome back. Nice to hear from you. I wanted to ask about Q4 and 24 in terms of the P&L components, gross margin, do you think you can continue to drive year-over-year growth improvement there? And then how do we think about the pace of OpEx spend in '24 as we -- as you guys start to prepare for US launch.

這很有幫助。謝謝。想問類似的前瞻性問題。這是給克雷格和克雷格的，歡迎回來。很高興聽到你的消息。我想問一下第四季和第二十四季的損益組成部分、毛利率，您認為您可以繼續推動年成長改善嗎？然後，當你們開始準備在美國推出時，我們如何考慮 24 年營運支出的支出速度。

Okay. So thanks, Adam for welcoming back. 2024 in the fourth quarter, anticipating a higher spend, as we start doing more of the studies that we talked about, any particular team core. And also as we start focusing a little bit more on the sales and marketing activities in Europe. I wouldn't be expecting a huge amount of money to be spent in the United States until we get closer to the launch. I mean a few physicians here and there and nothing major.

好的。謝謝亞當的歡迎回來。 2024 年第四季度，隨著我們開始進行更多我們談到的任何特定團隊核心的研究，預計支出會更高。而且我們開始更專注於歐洲的銷售和行銷活動。在我們接近發布之前，我預計不會在美國花費大量資金。我的意思是這裡那裡有一些醫生，沒什麼大不了的。

Okay. Thank you for the color there. And I think that's a good segue into my last question, which is on some of the clinical work you're doing outside of the pivotal. The USTCAR study, I think you pointed to early '24 for a start date. What's the latest there? Any more specifics on timing or trial design? And then also the tandem lesion early feasibility study. Are you still targeting first half '24 for that -- that clinical work? Thank you.

好的。謝謝你那裡的顏色。我認為這是我最後一個問題的一個很好的延續，這個問題是關於你在關鍵之外所做的一些臨床工作。 USTCAR 研究，我認為您指出了 24 年初的開始日期。那裡最新的情況是什麼？關於時間或試​​驗設計的更多細節嗎？然後還有串聯病變早期可行性研究。您是否仍將 24 年上半年的臨床工作作為目標？謝謝。

Yeah, let's start with -- Yeah. Thanks, Adam. Let's start with the last first. We are still anticipating for the tandem EFS first half of 2024 for enrolment in that and continue to progress in that area. Just to note, we've had two conversations, separate conversations with the FDA on a presale basis for both our TCAR study as well as the tandem EFS, which have gone very well. So we're just in the midst right now of buttoning up all of the procedural details, the protocols, aligning the investigators to begin this process of enrolment.

是的，讓我們從－－是的開始。謝謝，亞當。我們先從最後一個開始。我們仍然期待 2024 年上半年的串聯 EFS 註冊，並繼續在該領域取得進展。需要注意的是，我們已經與 FDA 進行了兩次對話，分別針對我們的 TCAR 研究和串聯 EFS 進行了售前對話，進展非常順利。因此，我們現在正在敲定所有程序細節和協議，協調研究人員以開始這項註冊程序。

And so I think it's safe to assume that both of them will initiate those studies in the first half of 2024 as we get to all those details, as you know, there's a lot of administrative effort that goes into the setup and the role in and to get started there. But what I will mention is that we've had a remarkable response on both fronts, both from the surgical community on our TCAR system as well as the EFS within the neuro community. We think that the neuro community is has been underserved by carotid focus, and we're looking forward to having both those added to our toolset for our foundational cash system.

因此，我認為可以放心地假設，當我們了解所有這些細節時，他們都將在 2024 年上半年啟動這些研究，如您所知，在設置和角色方面投入了大量的行政工作，從那裡開始。但我要提到的是，我們在兩個方面都得到了顯著的回應，無論是來自我們 TCAR 系統的外科界還是神經界內的 EFS。我們認為頸動脈焦點對神經社群的服務不足，我們期待將這兩者添加到我們的基礎現金系統的工具集中。

Thanks for the color, Marvin, and that's all for me. I'll hop back in queue. Thanks.

謝謝你的顏色，馬文，這就是我的全部了。我會跳回隊列。謝謝。

Thanks.

謝謝。

Ben Haynor of Alliance Global Partners.

聯盟全球合作夥伴的 Ben Haynor。

Good morning, gentlemen. Thanks for taking the questions. First of for me -- congrats on the national coverage determination. But regarding that, I guess what's your view on the expansion in terms of numbers, if the addressable patient population was X and now it's X plus Y, what are those X's and Y's?

早安，先生們。感謝您提出問題。首先對我來說——祝賀全國覆蓋的決定。但關於這一點，我想您對數量擴張有何看法，如果可尋址患者群體是 X，現在是 X 加 Y，那麼那些 X 和 Y 是什麼？

Yeah, great question, Ben. Thanks. I think some of that is certainly to be determined, right. What we know is that there's a tremendous amount of energy behind this decision by CMS. What we think about over the next several years is a shift from surgery first, let's call it a 70% or 80% surgery first to a 70 or 80% endovascular stenting first. How that plays out in terms of what percent of that market is CAS procedures versus TCAR is still to be determined. We know that both are very viable options, which is why we invested in both of those toolsets in order to give us the broadest range within carotid revascularization.

是的，很好的問題，本。謝謝。我認為其中一些肯定是有待確定的，對吧。我們知道，CMS 的這個決定背後蘊含著巨大的能量。未來幾年我們考慮的是從手術優先（我們稱之為 70% 或 80% 手術優先）轉向 70% 或 80% 血管內支架置入優先。 CAS 程序與 TCAR 程序在市場中所佔的比例如何影響仍有待確定。我們知道這兩者都是非常可行的選擇，這就是為什麼我們投資這兩個工具集，以便為我們提供最廣泛的頸動脈血管重建範圍。

It's interesting that at the conferences, some of the discussion now is becoming, is that a stentable lesion which you've never heard before as opposed to just assuming the default on endarterectomy or surgery being sort of the baseline.

有趣的是，在會議上，現在的一些討論正在成為一種你以前從未聽說過的可支架病變，而不是僅僅假設默認的動脈內膜切除術或手術是某種基線。

So the CMS coverage really opens up the market opportunity for us and I think fits perfectly to our strategy, which is to make sure that we've got full coverage of tool set, regardless of which access is used for the best implant. So I think we're in good shape there and feel good about the transition. The question of timing and percentage is still to be determined.

因此，CMS 覆蓋確實為我們打開了市場機會，我認為完全符合我們的策略，確保我們擁有工具集的全面覆蓋，無論哪種訪問用於最佳植入。所以我認為我們的狀態很好，並且對過渡感覺良好。時間和百分比問題仍有待確定。

Okay. That's helpful. And then, just regarding the, you mentioned the discussion that's going on at these conferences in obviously at VIVA, any additional color there and any surprises on the discussions where, is that a sensible lesion, things that maybe you hadn't thought of or just anything surprising there?

好的。這很有幫助。然後，就這一點而言，您提到了這些會議上正在進行的討論，顯然是在 VIVA，任何其他顏色以及討論中的任何驚喜，這是一個明智的病變，您可能沒有想到的事情或有什麼令人驚訝的嗎？

Well, I think what's been most surprising is just the remarkable results that we presented. I mean, let's think about the unprecedented nature of being able to deliver even in 30 days, a sub 1% complication rate is really unprecedented. So I think it goes beyond just, stents become standard of care. It's really a question of this is a unique platform that, frankly, has never been seen before in terms of these outcomes.

嗯，我認為最令人驚訝的是我們呈現的顯著結果。我的意思是，讓我們想想，即使在 30 天內就能分娩，併發症發生率低於 1%，這確實是前所未有的。所以我認為這不僅僅是支架成為護理標準。這實際上是一個獨特的平台，坦白說，就這些結果而言，以前從未見過。

Now I will mention also that this validates our previous experience, in the 1,850 patients, we've studied it about a 1.2% rate. So I think it's listen, it's a combination of a lot more discussion, momentum and transition, but we'd like being in a position of being able to lead that way by talking about clinical outcomes and procedural opportunities that really result in best implant and best outcomes because that's going to be the trend, right. There will be more momentum in CAS and in TCAR. But I think ultimately the decision points will be what's best for the patient. And how do those outcomes translate from the implant itself and not just the procedure.

現在我還要提到，這驗證了我們先前的經驗，在 1,850 名患者中，我們研究了大約 1.2% 的比率。所以我認為這就是傾聽，這是更多討論、動力和過渡的結合，但我們希望能夠透過討論臨床結果和手術機會來引領這種方式，從而真正實現最佳種植和治療。最好的結果，因為這將成為趨勢，對吧。 CAS 和 TCAR 將會有更多的動力。但我認為最終的決策點將是對病人最好的。這些結果是如何從植入物本身而不只是手術過程轉化而來的。

Okay. That makes sense. I think that's all I have, gentlemen, thanks for taking the questions.

好的。這就說得通了。先生們，我想這就是我的全部了，感謝您提出問題。

Thanks, Ben. Good to hear from you.

謝謝，本。很高興聽到你的消息。

Thank you. Ladies and gentlemen, we have reached the end of our question and answer session. I will now hand over to Mr. Marvin Slosman for closing remarks.

謝謝。女士們先生們，我們的問答環節已經結束。現在請馬文·斯洛斯曼先生致閉幕詞。

I would like to thank everyone for joining the call today, we look forward to a strong finish in 2023 and advancing our plans of growth toward great execution for 2023 and beyond. Thank you.

我要感謝大家參加今天的電話會議，我們期待 2023 年取得圓滿成功，並推進我們的成長計劃，以實現 2023 年及以後的出色執行。謝謝。

Thank you, sir. Ladies and gentlemen, that concludes today's event. Thank you for attending, and you may now disconnect your lines.

謝謝你，先生。女士們、先生們，今天的活動到此結束。感謝您的出席，您現在可以斷開線路了。