IRadimed Corp (IRMD) 2023 Q3 法說會逐字稿

Welcome to the IRadimed Corporation Third Quarter of 2023 Financial Results Conference Call. (Operator Instructions) As a reminder, this call is being recorded today, November 3, 2023, and contains time-sensitive information that is accurate only today. Earlier, IRadimed released its financial results for the third quarter of 2023. A copy of this press release announcing the company's earnings is available under the heading news on their website at iradimed.com. A press release copy was also furnished to the Securities and Exchange Commission on Form 8-K and can be found at sec.gov.

歡迎參加 IRadimed Corporation 2023 年第三季財務業績電話會議。 （操作員說明）謹此提醒，此通話於今天（2023 年 11 月 3 日）錄音，其中包含時效性信息，僅在今天準確。早些時候，IRadimed 發布了 2023 年第三季的財務業績。新聞稿的副本可在其網站 iradimed.com 的新聞標題下查看。也向美國證券交易委員會提供了 8-K 表中的新聞稿副本，可在 sec.gov 上找到。

This call is being broadcast live over the Internet on the company's website at iradimed.com, and a replay of the call will be available on the website for the next 90 days. Some of the information in today's session will constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements focus on future performance, results, plans and events and may include the company's expected future results. IRadimed reminds you that future results may differ materially from these forward-looking statements due to several risk factors.

該電話會議將在該公司網站 iradimed.com 上透過網路進行現場直播，並且在接下來的 90 天內將在該網站上提供該電話會議的重播。今天會議上的一些資訊將構成 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。前瞻性陳述側重於未來業績、業績、計劃和事件，並可能包括公司預期的未來業績。 IRadimed 提醒您，由於多種風險因素，未來結果可能與這些前瞻性陳述有重大差異。

For a description of the relevant risks and uncertainties that may affect the company's business, please see the Risk Factors section of the company's most recent reports filed with the Securities and Exchange Commission, which may be obtained free from the SEC's website at sec.gov.

有關可能影響公司業務的相關風險和不確定性的說明，請參閱本公司向美國證券交易委員會提交的最新報告的「風險因素」部分，該部分可從 SEC 網站 sec.gov 免費取得。

I would like to turn the call over to Roger Susi, President, and Chief Executive Officer of IRadimed Corporation. Mr. Susi, please go ahead.

我想將電話轉給 IRadimed Corporation 總裁兼執行長 Roger Susi。蘇西先生，請繼續。

Good morning. Thank you for joining us on today's call. I'm very pleased to report our ninth consecutive record quarter. With Q3 '23, again showing our ability to execute and grow our business. This morning's press release announced third quarter '23 revenue came in at $16.5 million, representing a 23% increase over the third quarter of 2022. GAAP diluted earnings per share for the third quarter were $0.40. Non-GAAP diluted earnings per share for the third quarter of '23 was $0.43 per share, a 48% increase over Q2 of '22.

早安.感謝您參加今天的電話會議。我很高興地報告我們連續第九個創紀錄的季度。 23 年第三季度，再次展現了我們執行和發展業務的能力。今天上午的新聞稿宣布，23 年第三季營收為 1,650 萬美元，比 2022 年第三季成長 23%。第三季公認會計原則攤薄後每股收益為 0.40 美元。 2023 年第三季非 GAAP 攤薄每股收益為 0.43 美元，比 22 年第二季成長 48%。

Our entire team remains strong, committed, and able to pull together to bring in orders, needed materials, production plans, delivery, and customer setup. The MRI patient vital science monitor continues to gain acceptance in new customers with some very large orders this past quarter. Sales of our MRIV pump remains strong. And with the new program for field replacements of older pumps, we anticipate growth of this older product line as well.

我們的整個團隊仍然強大、忠誠，能夠齊心協力，提供訂單、所需材料、生產計劃、交付和客戶設定。 MRI 患者生命科學監測儀繼續獲得新客戶的認可，上個季度有一些非常大的訂單。我們的 MRIV 幫浦的銷售依然強勁。透過現場更換舊幫浦的新計劃，我們預計該舊產品線也會成長。

As with last quarter, we again feel comfortable raising our guidance for the year, which we shall [learn] up in a moment. Q3 is typically our weakest quarter for new bookings due to the summer holidays, yet still our total backlog built year-to-date continues to be sizable. As I have said before, though a strong backlog provides excellent visibility and allows us to maneuver and reallocate resources as supply issues may arise, we are striving to reduce this backlog and deliver products with less customer lead time. However, we still have a bit more backlog and associated long lead times than we preferred. We recently quote domestic lead time to our customers of 90 days and international at 120. But we plan to shave off some lead time by close to 30 days in the coming quarter. This is being done through an acceleration of production and materials flow to provide customers quicker access to the products that they have purchased.

與上季一樣，我們再次放心地提高了今年的指導，我們稍後將了解這一點。由於暑假，第三季度通常是我們新預訂量最弱的季度，但今年迄今的積壓總量仍然很大。正如我之前所說，儘管大量積壓訂單提供了出色的可見性，並使我們能夠在可能出現供應問題時操縱和重新分配資源，但我們正在努力減少積壓訂單，並以更短的客戶交貨時間交付產品。然而，我們的積壓訂單和相關的交貨時間仍然比我們希望的要多一些。最近，我們向客戶報出的國內交貨時間為 90 天，國際交貨時間為 120 天。但我們計劃在下一季將交貨時間縮短近 30 天。這是透過加速生產和物料流動來實現的，以便客戶更快地獲得他們購買的產品。

Now I'd like to provide progress regarding our FDA efforts surrounding the new 3870 MRI IV pump. Last quarter, I spoke of the massive testing that's underway here, which continues with some tests finished, while still others remain in progress. I'd like to note that the results are positive so far. And so it's a matter of continued forward efforts and progress to complete the test.

現在我想介紹一下 FDA 圍繞新型 3870 MRI IV 幫浦所做的努力的進展。上個季度，我談到了這裡正在進行的大規模測試，其中一些測試已經完成，而其他測試仍在進行中。我想指出的是，到目前為止，結果是正面的。因此，需要繼續努力並取得進展才能完成測試。

As further support for our internal 510(k) team, we have engaged 2 external support consultants. One for technical help, and the other for statutory and relationship assistance, neither is inexpensive. Still, we feel it necessary to ensure 510(k) success with a minimal amount of FDA review time. We saw such a payoff for using external support with the recent 8-month approval of another manufacturer's new IV pump. Though we've been targeting late Q1 for refiling the new 3870s 510(k) should our new external help suggest additional or different elements that cost us additional time, but pay off with reduced FDA review time, we will consider such input carefully. Again, the hope is that such an external input should shorten the time FDA needs for clearance.

為了進一步支持我們的內部 510(k) 團隊，我們聘請了 2 位外部支援顧問。一個用於技術幫助，另一個用於法定和關係援助，兩者都不便宜。儘管如此，我們仍然認為有必要以最短的 FDA 審查時間確保 510(k) 的成功。最近另一家製造商的新型 IV 泵獲得了 8 個月的批准，我們看到了使用外部支援的回報。儘管我們的目標是在第一季末重新提交新的3870s 510(k)，但如果我們新的外部幫助提出額外或不同的要素，這會花費我們額外的時間，但會減少FDA 審查時間，我們會仔細考慮此類意見。同樣，我們希望這樣的外部輸入能夠縮短 FDA 批准所需的時間。

Now I'd like to recap our Q3 performance and indicate our confidence that this upward trajectory will continue. Therefore, we now announce an increase in our guidance with the expected revenue for the year 2023 of $65 million to $65.5 million. We also raised the forecasted annual GAAP diluted earnings per share to $1.34 to $1.37, and the non-GAAP diluted earnings of $1.48 to $1.41 -- I mean, $1.51, excuse me.

現在我想回顧一下我們第三季的表現，並表明我們對這種上升軌跡將持續下去的信心。因此，我們現在宣布將 2023 年預期收入 6,500 萬美元至 6,550 萬美元。我們還將預計年度 GAAP 攤薄收益上調至 1.34 美元至 1.37 美元，非 GAAP 攤薄收益上調至 1.48 美元至 1.41 美元——我的意思是，1.51 美元，對不起。

For the [first] (sic) [fourth] quarter of 2023, we expect to report revenue of -- did I say fourth -- yes, fourth quarter 2023, we expect to report revenue of $16.9 million to $17.4 million with GAAP diluted earnings per share of $0.35 to $0.38 and non-GAAP diluted earnings per share of $0.38 to $0.41.

對於2023 年的[第一]（原文如此）[第四]季度，我們預計報告的收入為- 我是否說過第四季度- 是的，2023 年第四季度，我們預計報告的收入為1690 萬美元至1,740 萬美元，以GAAP 稀釋後收益每股收益為 0.35 美元至 0.38 美元，非 GAAP 稀釋後每股收益為 0.38 美元至 0.41 美元。

Now I'd like to turn the call over to Jack Glenn, our CFO, to review the financial results for the quarter.

現在我想將電話轉給我們的財務長傑克·格倫 (Jack Glenn)，讓他審查本季的財務表現。

Thank you, Roger, and good morning, everyone. As in the past, our results are reported on a GAAP basis and non-GAAP basis. You can find a description of our non-GAAP operating measures in this morning's earnings release and a reconciliation of these non-GAAP measures to the GAAP measures on the last page of today's release. As we reported earlier this morning, revenue in the third quarter of 2023 was $16.5 million, an increase of 23% compared to the third quarter of 2022. Domestic sales increased 29% to $13.9 million and international sales remained flat at $2.6 million.

謝謝你，羅傑，大家早安。與過去一樣，我們的表現是根據公認會計原則和非公認會計原則報告的。您可以在今天早上的收益發布中找到我們的非 GAAP 營運指標的描述，並在今天發布的最後一頁找到這些非 GAAP 指標與 GAAP 指標的調整表。正如我們今天早上早些時候報道的那樣，2023 年第三季度的收入為1650 萬美元，比2022 年第三季度增長23%。國內銷售額增長29%，達到1390 萬美元，國際銷售額持平，為260 萬美元。

Overall, domestic revenue accounted for 85% of total revenue for Q3 of 2023 compared to 81% for Q3 of 2022. Device revenue increased 25% to $11.8 million. This was driven by a 40% increase in monitor revenue. Revenue from disposables and services increased 24% to $4.2 million for the third quarter of '23, while our maintenance contracts were consistent at $0.5 million for both periods. The gross margin was 77.8% for the 2023 quarter compared to 78.67% for the 2022 quarter.

整體而言，2023 年第三季國內營收佔總營收的 85%，而 2022 年第三季這一比例為 81%。設備營收成長 25%，達到 1,180 萬美元。這是由顯示器收入成長 40% 推動的。 2023 年第三季度，一次性用品和服務的收入成長了 24%，達到 420 萬美元，而我們的維護合約在這兩個時期都維持在 50 萬美元。 2023 年季度的毛利率為 77.8%，而 2022 年季度的毛利率為 78.67%。

The decrease in gross margin is primarily due to higher overhead costs and increased raw material costs. Operating expenses were $6.9 million or 42% of revenue compared to $6.4 million or 47.8% of revenue for the third quarter of 2022. On a dollar basis, this increase is primarily due to higher general and administrative expenses for additional headcount, higher regulatory and legal and professional expenses, and increased benefit expenses.

毛利率下降主要是由於管理費用增加和原物料成本增加所致。營運費用為690 萬美元，佔收入的42%，而2022 年第三季營運費用為640 萬美元，佔收入的47.8%。以美元計算，這一增長主要是由於人員增加、監管和法律費用增加導致一般和管理費用增加和專業費用，以及增加的福利費用。

As a result, income from operations grew 43% to $5.9 million for the 2023 third quarter. We recognized the tax expense during the third quarter of 2023 of approximately $1,341 million, resulting in an effective tax rate of 20.9% compared to a tax expense of approximately $810,000 in the 2022 quarter. This increase is due to higher taxable income in 2023.

因此，2023 年第三季的營運收入成長了 43%，達到 590 萬美元。我們確認 2023 年第三季的稅費約為 13.41 億美元，有效稅率為 20.9%，而 2022 年第三季的稅費約為 81 萬美元。這一增長是由於 2023 年應稅收入增加。

On a GAAP basis, net income was $0.40 per diluted share compared to $0.27 for the 2022 quarter. On a non-GAAP basis, adjusted income was $0.43 per diluted share for the '23 third quarter compared to $0.27 for the third quarter of 2022. Cash from operations was $1.4 million for the 3 months ended September 30, 2023, down from $3.9 million for the same period in 2022. And for the 3 months ended September 30, 2023 and 2022, our free cash flow, a non-GAAP measure was $1 million and $3.4 million, respectively.

以 GAAP 計算，稀釋後每股淨利潤為 0.40 美元，而 2022 年季度為 0.27 美元。根據非公認會計原則，2023 年第三季調整後每股攤薄收益為0.43 美元，而2022 年第三季為0.27 美元。截至2023 年9 月30 日的三個月營運現金為140 萬美元，低於390 萬美元2022 年同期。截至2023 年9 月30 日和2022 年9 月30 日止的三個月，我們的自由現金流（非公認會計原則衡量標準）分別為100 萬美元和340 萬美元。

And with that, I will now turn the call over for questions. Operator?

現在，我將轉交電話詢問問題。操作員？

(Operator Instructions) Our first question will come from Scott Henry of ROTH Capital Partners.

（操作員說明）我們的第一個問題將來自 ROTH Capital Partners 的 Scott Henry。

Congratulations another strong quarter. Just a couple of questions. First, any thoughts on what you're seeing on the pricing environment? And perhaps with the monitors how the shift is between U.S. and OUS?

祝賀又一個強勁的季度。只是幾個問題。首先，您對定價環境有何想法？也許透過監視器，美國和海外國家之間的轉變如何？

Scott, this is Roger. So maybe I'll take that one. So our pricing has with the monitor specifically, we increased that by negotiating a lot of the contracts over the previous 18 months. The largest, I think, to those increases actually began in July. So actually, our prices are going up a bit. And that's on the monitor, it was a decent increase there. The pump increase was very, very small, actually. So relatively insignificant.

斯科特，這是羅傑。所以也許我會選擇那個。因此，我們的定價是針對顯示器的具體定價，我們透過在過去 18 個月內談判大量合約來提高定價。我認為，最大的成長實際上是在 7 月開始的。所以實際上，我們的價格上漲了一點。這是在顯示器上，這是一個相當大的增長。實際上，泵浦的增加非常非常小。所以相對來說微不足道。

So we're seeing -- we're not seeing a pushback from that sort of thing if that was your question. As far as international goes with the monitor, monitor sales internationally are very strong. The rate of adoption and growth in the sales internationally for the monitor has been pretty stout both from just penetrating the countries that we had been in historically, but as well as cultivating some new areas. So we've had some pleasant surprises in Mexico and Colombia, for example, with some nice opportunities for the monitor there. So all in all, just positive, I guess, positive things to report.

所以我們看到——如果這是你的問題，我們不會看到此類事情的阻力。就顯示器的國際化而言，顯示器的國際銷售非常強勁。這款顯示器在國際上的採用率和銷售成長相當強勁，不僅是滲透到我們歷史上去過的國家，而且還開拓了一些新領域。例如，我們在墨西哥和哥倫比亞獲得了一些驚喜，為那裡的顯示器提供了一些很好的機會。總而言之，我想，只是正面的事情值得報告。

Okay. Great. And then on the monitor side, we know 1 of your competitors appears to be less focused on that segment. Has anything changed on that landscape? Or do you feel still you're in a position to take share right now?

好的。偉大的。然後在顯示器方面，我們知道您的競爭對手之一似乎不太關注該細分市場。那個景觀有什麼變化嗎？或者你覺得你現在仍然有能力分享市場佔有率嗎？

Well, good question. So they are less focused. They still have huge problems that are in the news at least weekly, so you can tell where their focus is. But we had another little [mana] during COVID from them because not only were they not so focused, which remains to be the case, generally, but their deliveries got extremely long because they had a real supply chain issues much greater than we did. So we see them catching up there. So that's, let's say, 1 point for them. But it removes one of their -- one of their hurdles. But overall, the focus is still light the size of the sales force is still lighter than it had been and they have their hands full dealing with, let's say, bigger fish to fry just the same.

嗯，好問題。所以他們注意力不集中。他們仍然面臨至少每週都會出現在新聞中的巨大問題，因此您可以看出他們的重點在哪裡。但在新冠疫情期間，我們從他們那裡得到了另一點[法力]，因為他們不僅沒有那麼專注（總體情況仍然如此），而且他們的交貨時間非常長，因為他們的供應鏈問題比我們嚴重得多。所以我們看到他們正在迎頭趕上。這麼說吧，他們得 1 分。但這消除了他們的障礙之一。但總體而言，重點仍然很輕，銷售團隊的規模仍然比以前輕，而且他們仍然忙於處理，比如說，更大的魚要炸。

Okay. Great, Roger. And final question, gross margin strong in the third quarter. As we start to think about 2024, 2025 in higher volume of monitors and pumps. How do you think about is 78%, 79%, does that start to move in on the ceiling for gross margins? Or do you think with higher volumes could you get to that 80% level?

好的。太棒了，羅傑。最後一個問題是，第三季的毛利率強勁。當我們開始考慮 2024 年、2025 年監測器和幫浦的數量增加時。您如何看待78%、79%，這是否開始接近毛利率的上限？或者您認為如果銷量更高，您能否達到 80% 的水平？

Another good question, okay? Another good question. So during COVID, you can't really see it that much, but we did lose some pricing advantage with suppliers. We were paying -- we were paying through the nose, let's say, for a lot of components just to get our hands on them. And so worst, as a matter of fact, just the last -- it's been a big subject for a few days this week that I've had with our materials people. It is a visible impact to our raw materials costs. They're up a couple of percent. So there is something there to be corrected.

另一個好問題，好嗎？另一個好問題。因此，在新冠疫情期間，你實際上看不到那麼多，但我們確實失去了與供應商的一些定價優勢。我們付出了高昂的代價，比如說，我們花了很多錢來購買很多組件，只是為了得到它們。事實上，最糟糕的是最後一個——這週幾天來，這一直是我和材料人員討論的一個大話題。這對我們的原材料成本產生了明顯的影響。他們上漲了幾個百分點。所以有一些地方需要糾正。

How long it will take? Of course, it's not going to be like a 1-quarter fix. But that's -- that's a mandate now for this coming year in 2024. We think -- and you can see it, right? The semiconductor suppliers are now -- their shortages have reversed where they have surpluses and they're even thinking of cutting and scaling back some output. But -- so there's opportunity there to sort of recover ground that was lost to expedite in an effort to get parts that were very short supplier during COVID and upped our cost to turn that back around. But it won't be quick, but you should -- you can -- I'm counting on the effect over this coming year. So short answer to your question is, yes, I hope that we will be able to even boost our gross margin.

這要花多久時間？當然，這不會像第一季那樣修復。但這是 2024 年的一項任務。我們認為，您可以看到它，對嗎？半導體供應商現在——他們的短缺已經扭轉了過剩的局面，他們甚至正在考慮削減和縮減一些產量。但是，因此，我們有機會收復因加快獲得新冠疫情期間供應商非常短缺的零件而失去的土地，並提高我們的成本來扭轉局面。但這不會很快，但你應該——你可以——我指望來年的效果。對你的問題的簡短回答是，是的，我希望我們能夠提高毛利率。

(Operator Instructions) Our next question will come from Frank Takkinen of Lake Street Capital Markets LLC.

（操作員說明）我們的下一個問題將來自 Lake Street Capital Markets LLC 的 Frank Takkinen。

This is Nelson Cox on for Frank. Congrats on another strong quarter. Jack, you mentioned Q3 being a seasonally slower quarter for orders. I was hoping to hear your expectations for Q4?

這是弗蘭克的納爾遜·考克斯。祝賀又一個強勁的季度。傑克，您提到第三季是訂單季節性放緩的季度。我希望聽到您對第四季的期望？

Well, the flip is Q4 is usually a big quarter for us, yes. Q3 is conventionally light and Q4 is conventionally strong. And last year, I think we also had a pretty strong Q1 because a lot of stuff, even though we had a good Q4 last year, there were still stuff that carried over didn't get written as far as the orders until Q1. So yes, I mean we don't expect the seasonality factor to change.

嗯，翻轉的是第四季度對我們來說通常是一個重要的季度，是的。 Q3 通常較輕，Q4 通常較堅固。去年，我認為我們的第一季也非常強勁，因為很多東西，儘管我們去年第四季表現不錯，但仍然有一些東西直到第一季才被寫入訂單。所以是的，我的意思是我們預計季節性因素不會改變。

Got it. And then in relation to the customer announcement to discontinue service on IV pumps over 7 years old. Can you help us understand your installed base better to try and place context around how many of your pumps could be over 7 years old? And how large could that increase per year going forward?

知道了。然後是關於客戶宣布停止對使用超過 7 年的 IV 泵提供服務的消息。您能否幫助我們更了解您的安裝基礎，以便嘗試了解您有多少台幫浦的使用時間超過 7 年？未來每年成長幅度有多大？

Well, I believe -- let me think. I somehow lost that number.

好吧，我相信——讓我想想。我不知何故遺失了那個號碼。

I think we think that it's somewhere in that 1,500 to 2,000 units out there that are in that category over 7 years.

我認為我們認為 7 年來，該類別中有 1,500 到 2,000 個單位。

Yes. So a large number of pumps. And we've had -- we've quoted -- we've quoted, I think, close to 400 already. So that kicks in at the end of December, right? So we see that as being a factor that might bring in some orders certainly in the Q4, but much more so Q1 and 2. Those will be -- we start -- we're going to start seeing those turn into orders here very soon. But I think the strength of it being great in Q1.

是的。所以需要大量的幫浦。我想，我們已經——我們已經引用了——我們已經引用了接近 400 個。那麼從十二月底開始，對嗎？因此，我們認為這是一個可能在第四季度帶來一些訂單的因素，但在第一季度和第二季度更是如此。我們開始，我們將很快開始看到這些訂單轉化為訂單。 。但我認為第一季的實力非常強大。

(Operator Instructions) Our next question will come from Frank DiLorenzo of Singular Research.

（操作員說明）我們的下一個問題將來自 Singular Research 的 Frank DiLorenzo。

Can you expound upon the strength you saw in the ferromagnetic detection systems this past quarter? And can you talk about to what extent you may be able to maintain growth going forward for the fourth quarter and into next year?

您能否闡述一下上個季度您在鐵磁檢測系統中看到的優勢？您能否談談第四季度和明年您能夠在多大程度上保持成長？

Okay. Yes. Well, the sales have been growing slowly, frankly with the FMD product. The -- it's a matter of -- it's a matter of our sales force really learning what the critical call point is. International demand has actually grown quicker than our domestic, but the market is quite huge compared to where we're at now. So we've got a decent number on the backlog but it is not up to our expectations. So I think with the U.S., with the domestic market, it's a matter of that sale is a little different to our sales folks than it is to sell a pump or a monitor. And they're learning how to come to grips with that. And as they do, we see different territories starting to sell FMDs as those different reps in those territories really learn who they should be talking to. And the international it seems to be a little bit more quick for them. They're picking up the ball on that 1 a little quicker.

好的。是的。坦白說，FMD 產品的銷售量成長緩慢。這是一個我們的銷售人員真正了解關鍵呼叫點是什麼的問題。國際需求實際上比國內成長得更快，但與我們現在相比，市場相當巨大。因此，我們的積壓數量相當可觀，但沒有達到我們的預期。因此，我認為在美國，在國內市場，對我們的銷售人員來說，銷售與銷售幫浦或顯示器有點不同。他們正在學習如何應對這個問題。正如他們所做的那樣，我們看到不同的地區開始銷售 FMD，因為這些地區的不同代表真正了解他們應該與誰交談。而國際賽對他們來說似乎要快一點。他們在 1 號球上的接球速度要快一些。

So long runway yet for the FMD, lots of opportunity, and we hope to over the year 2024 in the U.S. gained the keys to how we position that product and to whom we position that product to increase the sales.

FMD 的發展道路還很長，機會也很多，我們希望 2024 年在美國能夠掌握如何定位該產品以及向誰定位該產品以增加銷量的關鍵。

Okay. One other question regarding your next-generation pump. Can you talk a little bit about your strategy outside the U.S. for that as far as getting approvals and launch kind of the timing on that going forward?

好的。關於您的下一代幫浦的另一個問題。您能否談談您在美國以外的策略，包括獲得批准和啟動該專案的時間表？

Oh, yes, we won't turn our guns to obtain the CE mark for that one, probably until mid-late summer that's one will have the capacity with our team is working on the 510(k) to deal with making the tech file and getting our notified body on board to do that. And with the changes in Europe, though they've delayed all this MDR stuff for products like ours yet, the notified bodies are still kind of applying the logic of the future mandatory MDR stuff currently. So they're taking a long time to review tech files and clear them. So an estimate of that would be mid-2025 before we'd have a CE-marked pump.

哦，是的，我們不會轉而為該產品獲得 CE 標誌，可能要到夏中末，我們的團隊才會有能力處理 510(k) 的技術文件。並讓我們的公告機構參與其中。隨著歐洲的變化，儘管他們已經推遲了像我們這樣的產品的所有 MDR 內容，但指定機構目前仍在應用未來強制性 MDR 內容的邏輯。因此，他們需要很長時間來審查技術文件並清除它們。因此，預計到 2025 年中期我們才會擁有帶有 CE 標誌的泵浦。

Now having said that, that's probably accounts for 1/3 of our international business. The other 2/3s of it doesn't need a CE mark. And so we'll enter those markets very soon -- much sooner. Those will enter as soon as we're launched in the U.S.

話雖如此，這可能占我們國際業務的 1/3。另外 2/3 不需要 CE 標誌。因此，我們將很快進入這些市場——更快。一旦我們在美國推出，這些就會進入。

(Operator Instructions) This will end the Q&A session. I would now like to turn the conference back to Roger Susi for closing remarks.

（操作員說明）這將結束問答環節。現在我想請羅傑蘇西 (Roger Susi) 致閉幕詞。

Thank you, operator. Again, it was great pleasure to report our Q3 2023 results, demonstrating yet another quarter of strong growth. It is also a great pride that we can guide that we expect strong performance as the year concludes. With that, I look forward to reporting our year-end success. And thank you all for participating in today's call.

謝謝你，接線生。我們很高興再次報告 2023 年第三季的業績，展示了另一個季度的強勁成長。我們也非常自豪能夠在今年結束時預計會有強勁的業績表現。至此，我期待著報導我們年終的成功。感謝大家參加今天的電話會議。

Thank you. This does conclude the call. You may now disconnect. Have a pleasant day, and enjoy your weekend.

謝謝。這確實結束了通話。您現在可以斷開連線。祝你有愉快的一天，享受你的週末。