IRadimed Corp (IRMD) 2025 Q3 法說會逐字稿

Welcome to the IRADIMED CORPORATION third quarter 2025 financial results conference call. (Operator Instructions) This call is being recorded today, November 3, 2025, and contains time-sensitive, accurate information that is valid only for today.

歡迎參加 IRADIMED CORPORATION 2025 年第三季財務業績電話會議。（操作員指示）本次通話於 2025 年 11 月 3 日錄製，包含有時效性的準確信息，該信息僅在今天有效。

IRADIMED released its financial results for the third quarter of 2025. A copy of this press release announcing the company's earnings is available under the heading News on their website at iradimed.com. A copy of the press release was also furnished to the Securities and Exchange Commission on Form 8-K and can be found at sec.gov. This call is being broadcast live on the company's website at iradimed.com and a replay will be available 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.

IRADIMED 發布了 2025 年第三季的財務業績。本公司發布獲利報告的新聞稿可在本公司網站 iradimed.com 的「新聞」欄位下查閱。新聞稿的副本也已以 8-K 表格的形式提交給美國證券交易委員會 (SEC)，可在 sec.gov 網站上查閱。本次電話會議正在公司網站 iradimed.com 上進行直播，並將在未來 90 天內提供回放。本次會議中的一些資訊將構成 1995 年《私人證券訴訟改革法案》意義上的前瞻性陳述。

Forward-looking statements focus on future performance, results, plans, and events that may include the company's expected future results. IRADIMED remind you that future results may differ materially from those forward-looking statements due to several risk factors. For a description of the relevant risks and uncertainties that may affect the company's business, please see the risk factors section in 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. I would now like to turn the call over to Roger Susi, President and Chief Executive Officer of IRADIMED CORPORATION Mr. Susi?

前瞻性陳述著重於未來的績效、結果、計畫和事件，其中可能包括公司預期的未來績效。IRADIMED提醒您，由於多種風險因素，未來的結果可能與這些前瞻性聲明有重大差異。有關可能影響公司業務的相關風險和不確定性的描述，請參閱本公司向美國證券交易委員會提交的最新報告中的風險因素部分。這些資訊可以從美國證券交易委員會（SEC）的網站sec.gov免費取得。現在我想把電話交給IRADIMED CORPORATION的總裁兼執行長羅傑‧蘇西先生。蘇西先生？

Thank you, operator, good morning and thank you all for joining us on today's call. I am indeed very proud to report that IRADIMED achieved its 17th consecutive quarter of record revenue, with the recent third quarter surpassing the 2024 third quarter by 16%. In the third quarter of 2025, we achieved revenue of $21.2 million. Our gross profit came in at 78%, and earnings remained strong, with GAAP diluted earnings per share increasing 8% from Q3 to '24. Pump shipments again led performance in the quarter as our 3860 MRI I`V pump grew another 20% year over year in Q3.

謝謝接線員，早安，謝謝各位參加今天的電話會議。我非常自豪地宣布，IRADIMED 連續第 17 季創下營收紀錄，最近的第三季比 2024 年第三季成長了 16%。2025年第三季度，我們實現了2,120萬美元的營收。我們的毛利率為 78%，獲利能力依然強勁，GAAP 稀釋後每股收益從 2024 年第三季成長了 8%。本季泵浦出貨量再次引領業績成長，我們的 3860 MRI I`V 泵浦在第三季年增 20%。

Our MR monitor sales have also continued to impress. I am also pleased to report that shipments of our MRI patient monitor grew by 16%, clearly showing that our emphasis on monitoring sales for 2025 is proving successful. Next, I want to touch on the planned rollout and commercial launch of the new 3870 MRI IV pump system which was cleared in Q2.

我們的磁振造影儀銷售量也持續表現亮眼。我很高興地報告，我們的 MRI 病人監視器出貨量增加了 16%，這清楚地表明，我們對 2025 年銷售狀況的監測重點取得了成功。接下來，我想談談計劃推出的新型 3870 MRI IV 幫浦系統，該系統已於第二季獲得批准。

Let's recap what I have been saying about the number one growth driver for the new 3870 pump, but first, yes, we anticipate a price increase of 10% to 14%, and yes, the 3870 design is such that we fully expect to penetrate the greenfield opportunity more effectively and also drive increased utilization, among some of the existing customers who only use their older pumps rather sporadically.

讓我們回顧一下我之前所說的關於新型 3870 水泵的首要增長驅動因素，但首先，是的，我們預計價格將上漲 10% 到 14%，是的，3870 的設計使我們完全有信心更有效地滲透到新建水泵。

But most significant increases come from the large replacement opportunity, which is the number one driver. We see step changing the pump revenue and will continue to be our key growth driver in pump area for several years to come. It is very telling that even the old 3860 model delivered 20% growth in the third quarter. Now this driven mainly by limiting again our extended maintenance offering to pumps under seven years old to two pumps rather under seven years old, which has brought in replacement orders for about a third of the pumps in that seven and up age group.

但最顯著的成長來自大規模的更新換代機會，這是最大的驅動因素。我們看到泵浦的收入發生了翻天覆地的變化，並且在未來幾年內，泵浦領域仍將是我們的主成長動力。非常說明問題的是，即使是老款的 3860 型號在第三季也實現了 20% 的成長。現在，這主要是因為我們再次將延長的維護服務範圍限制在7年以下的泵，而不是7年以下的泵，這導致7年及以上年齡組的泵的更換訂單約佔三分之一。

With the new state of the art 3870 pump having 20 years of technological advancement over the aging 3860, we anticipate a significant demand to replace the very large pool of older 3860 model pumps starting now at a five year and older level. Consider that in the US market alone there are approximately 6,300 five plus year old or older, 3860 61 pump channels up for replacement.

由於新型的 3870 型泵浦比老舊的 3860 型泵浦擁有 20 年的技術進步，我們預計從現在開始，將會有大量老舊的 3860 型泵浦需要更換，更換對象將是使用年限超過五年的舊款 3860 型泵浦。光是在美國市場，就有大約 6300 個使用年限超過五年或更久的 3860 個 61 泵通道需要更換。

And we currently sell approximately 1,000 such channels annually in the domestic market. We will target adding another 1,000 channels per year in sales through replacement sales out of that existing 6,300 units that are over five years old. This will be our target starting in Q2 and throughout the rest of 2026, and as you can see, replacing 1,000 channels per year leaves many thousands more to replace in the years to come.

目前，我們在國內市場每年約銷售 1000 個此類頻道。我們將以每年新增 1,000 個銷售管道為目標，透過替換現有 6,300 台使用超過五年的設備來實現這一目標。從第二季開始，我們將以此為目標，並持續到 2026 年底。正如你所看到的，每年更換 1000 個頻道，這意味著未來幾年還需要更換數千個頻道。

Put numbers to this opportunity for our domestic business only selling north of [203,870] pump channels annually at the slightly higher anticipated ASP, we would be approaching nearly a $50 million revenue run rate for pumps. Adding disposables and maintenance, international sales, and the MR monitoring business, one can understand our confidence in breaking into the $100 plus million revenue range.

如果僅就我們國內業務而言，每年銷售超過 [203,870] 個泵浦通道，並以略高的預期平均售價計算，那麼我們將獲得接近 5,000 萬美元的泵浦收入。加上耗材和維修、國際銷售以及磁振造影監測業務，就不難理解我們有信心突破 1 億美元的營收大關了。

I'd like to provide our thoughts as to timing on the rollout of the 3870 in December we will deliver an initial order 23 3870 systems for which we will provide an extraordinarily level, extraordinarily high level of clinical support and monitoring of the use of the pumps through January and February to review and adjust planning based on user input. The full sales team rollout in the US will begin after the national sales meeting in the third week of January. Given the time required for our hospital customers to be sold, approve funding, and issue orders, we expect bookings to build beginning in Q2 ramp significantly in the second half of the year. We expect to maintain quarterly revenue in the first half of 2026 through the increasing MRI monitoring business and our 3860-pump backlog. Now let's discuss our updated financial guidance. For the fourth quarter 2025.

我想就 3870 的推出時間提出一些想法。 12 月，我們將交付首批 23 套 3870 系統，我們將為這些系統提供極其高水平的臨床支持，並在 1 月和 2 月期間監測泵的使用情況，以便根據用戶的反饋審查和調整計劃。美國銷售團隊的全面部署將在1月第三週的全國銷售會議後開始。考慮到醫院客戶需要時間來完成銷售、批准資金和下訂單，我們預計預訂量將從第二季開始成長，並在下半年大幅成長。我們預計，隨著 MRI 監測業務的成長和 3860 台幫浦的積壓訂單，2026 年上半年將維持季度收入。現在我們來討論一下我們更新後的財務指導意見。2025年第四季。

We expect revenue now $21.4 million to $22.4 million and anticipated GAAP per diluted earnings per share of $0.43 to $0.47 and non-GAAP diluted EPS of $0.47 to $0.50 for the full year 2025, we are raising our guidance to $82.5 million to $83.5 million, up from our prior range of $80 million to $82.5 million. GAAP diluted earnings per share is now expected to be $1.68 to $1.72 up from $1.60 to $1.70 and non-GAAP diluted earning per share is expected is $1.84 to $1.88 up from $1.76 to $1.86.

我們現在預計 2025 年全年營收為 2,140 萬美元至 2,240 萬美元，GAAP 攤薄後每股收益預計為 0.43 美元至 0.47 美元，非 GAAP 攤薄後每股收益預計為 0.47 美元至 0.50 美元。因此，我們將營收預期從先前的 8,000 萬美元至 8,250 萬美元上調至 8,250 萬美元。GAAP稀釋後每股盈餘預估為1.68美元至1.72美元，高於先前的1.60美元至1.70美元；非GAAP稀釋後每股盈餘預估為1.84美元至1.88美元，高於先前的1.76美元至1.86美元。

We also remain committed to delivering value through our $0.17 per share quarterly divi dividend. Declared for Q4 and payable on November 5, I'll turn over the call to Jack Glenn, our CFO, now, to review the quarter's financial results, Jack

我們將繼續致力於透過每股 0.17 美元的季度股息為股東創造價值。已宣布計入第四季度，將於11月5日支付。現在我將把電話交給我們的財務長傑克·格倫，讓他回顧一下本季的財務表現。傑克

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 GAAP measure on the last page of today's release. For the three months ended September 30, 2025, we reported revenue of $21.2 million, a 16% increase from $18.3 million in the third quarter of 2024.

謝謝羅傑，大家早安。與以往一樣，我們的業績報告將以GAAP準則和非GAAP準則進行。您可以在今天早上發布的收益報告中找到我們非GAAP營運指標的說明，並在今天發布的收益報告最後一頁找到這些非GAAP指標與GAAP指標的調節表。截至 2025 年 9 月 30 日的三個月，我們報告的營收為 2,120 萬美元，比 2024 年第三季的 1,830 萬美元成長了 16%。

This growth was driven by strong performance across our product lines with MRI-compatible IV infusion pump systems contributing $8.3 million, up 20% year over year, and patient vital signs monitoring systems contributing $6.9 million, up 16%. Disposable revenue grew 12% to $4.1 million, reflecting increased utilization of our devices, while ferromagnetic detection systems also saw solid gains. Domestic sales increased 19% to $18.1 million, and international sales remained consistent at $3.1 million. Overall domestic revenue accounted for 85% of total revenue for Q3 2025 compared to 83% for Q3 2024.

這一增長得益於我們各產品線的強勁表現，其中 MRI 兼容型靜脈輸液泵系統貢獻了 830 萬美元，同比增長 20%；患者生命體徵監測系統貢獻了 690 萬美元，同比增長 16%。一次性用品收入成長 12% 至 410 萬美元，反映出我們設備的使用量增加，同時鐵磁檢測系統也取得了穩健成長。國內銷售額成長19%至1810萬美元，國際銷售額維持穩定在310萬美元。2025 年第三季國內總營收佔總營收的 85%，而 2024 年第三季則為 83%。

Gross profit was $16.4 million, up 16% from $14.1 million in Q3 2024, with a gross margin of 78% compared to 77% in Q3 of 2024. The strong margin performance was especially noteworthy as we moved manufacturing operations into the new facility at the beginning of the quarter and stayed on track with our shipment and cost of goods sold targets.

毛利為 1,640 萬美元，比 2024 年第三季的 1,410 萬美元成長了 16%，毛利率為 78%，而 2024 年第三季為 77%。在本季初我們將生產營運轉移到新工廠後，強勁的利潤率表現尤其值得關注，並且我們保持了出貨量和銷售成本目標的穩定。

Operating expenses for the quarter were $9.7 million up 15% from $8.4 million in Q3 of 2024, driven by higher sales and marketing expenses to support our growth and modest increases in general administrative costs and research and development expenses. The increase in sales and marketing and expenses was primarily due to higher sales commissions for our direct sales force in the US as they exceeded their bookings plan in the quarter. Income from operations grew 17% to $6.8 million from $5.8 million in Q3 of 2024. Tax expense for the quarter was $1.7 million, resulting in an effective tax rate of 23.6%. The increase in the effective tax rate was primarily due to a catch up in the quarter, with our projected effective tax rate for the year now estimated at 22%.

本季營運費用為 970 萬美元，比 2024 年第三季的 840 萬美元增加了 15%，主要原因是銷售和行銷費用增加以支持我們的成長，以及一般管理費用和研發費用略有增加。銷售、行銷和費用的增加主要是由於美國直銷團隊的銷售佣金提高，因為他們在本季度超額完成了預訂計劃。2024 年第三季營業收入成長 17%，達到 680 萬美元，而 2024 年第三季為 580 萬美元。本季稅金支出為 170 萬美元，實際稅率為 23.6%。實際稅率的上升主要是由於本季的補繳稅款，我們預計今年的實際稅率將達到 22%。

Net income was $5.6 million or $0.43 per diluted share, a 12% increase from $5 million or $0.40 per diluted share in Q3 of 2024. On a non-GAAP basis, net income was $6.1 million or $0.47 per diluted year, up 9% from $0.43, excluding a half a million dollars of stock-based compensation expense net of tax. Now turning to our balance sheet, we ended the quarter with cash and cash equivalents of $56.5 million, up from $52.2 million at year end 2024. Cash flow from operations was a strong $7 million for the quarter and $19 million year-to-date. Free cash flow, a non-GAAP measure, was $5.7 million for the quarter and $11 million year-to-date, reflecting capital expenditures of $8 million year-to-date, primarily related to the new facility.

淨收入為 560 萬美元，即每股攤薄收益 0.43 美元，比 2024 年第三季的 500 萬美元或每股攤薄收益 0.40 美元增長了 12%。以非GAAP準則計算，淨收入為610萬美元，即每股攤薄收益0.47美元，較上年同期的0.43美元增長9%，不包括扣除稅項後的50萬美元股票選擇權費用。現在來看我們的資產負債表，本季末我們的現金及現金等價物為 5,650 萬美元，高於 2024 年底的 5,220 萬美元。本季經營活動產生的現金流強勁，達到 700 萬美元，年初至今已達 1,900 萬美元。本季自由現金流（非GAAP指標）為570萬美元，年初至今為1100萬美元，反映了年初至今800萬美元的資本支出，主要與新設施有關。

Final payments totaling approximately $1.3 million for the facility were made in the third quarter, bringing the total construction cost to approximately $13.3 million. And with that I will now turn the call over to you for questions operator.

第三季支付了該設施的尾款，總額約 130 萬美元，使總建設成本達到約 1,330 萬美元。那麼，現在我將把電話交給接線員，供您提問。

(Operator Instructions)

（操作說明）

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Great, thanks for taking the questions. Congrats on the solid quarter and all the progress. I was hoping I could start with some more color around the kind of bridge to $50 million run rate in pumps. Appreciate the timing that you laid out related to sales meeting launching after that in January. And then ramping the backlog in Q2 through mid 2026. When should we expect that to flow through to kind of revenue to that $50 million run rate? Can we see that in late '26, or is that more of a 2027 event?

太好了，謝謝你回答這些問題。恭喜本季業績穩健，取得所有進展。我原本希望能夠更詳細地介紹一下泵浦的年化產量如何達到 5,000 萬美元。感謝您安排的銷售會議時間，會議將於一月舉行。然後在第二季到 2026 年中逐步增加積壓訂單。我們應該何時才能預期這部分收入能夠轉化為5000萬美元的年化收入？我們能在 2026 年底看到這種情況嗎？還是說這更可能要等到 2027 年才會發生？

We should, yeah, Frank it's Roger. Maybe I'll pick it up first and let Jack help jump in if he has some more color for you. As I said, most of that, given that we start. Pounding the pavement, shall we say, to sell the 3870 here in mid January, the early part, but you know by the time they get out there you're basically, half of Q1 and as I mentioned, orders don't just immediately get turned around even from people that are. We think we are pretty well pent up with a desire to get, a new pump now after all these 20 years with 3860. So yeah, the story is in the back half of 2026 for revenue, we anticipate bookings and so forth. What you'll we'll be able to report on in the in the first half certainly but the real revenue will start to ramp up in the third and fourth quarter and so yeah that by that fourth quarter we think it'll be pretty clear that we're doubling the number of pump channels that we're booking certainly and the revenues should start to reflect that as well.

我們應該，是的，弗蘭克，我是羅傑。也許我會先拿起來，如果傑克還有什麼顏色可以給你補充，就讓他來幫忙。正如我所說，大部分都是如此，前提是我們要開始。可以說，我們在一月中旬，也就是一月初，四處奔走推銷 3870，但你知道，等到它們上市的時候，基本上已經是第一季度的一半了，而且正如我提到的，即使是那些正在訂購的人，他們的訂單也不會立即得到處理。在用了 3860 型水泵 20 年後，我們想換一台新水泵的願望已經非常強烈了。是的，就收入而言，我們預計在 2026 年下半年會有不錯的表現，包括預訂量等等。我們當然可以在上半年匯報一些情況，但真正的收入將在第三季度和第四季度開始增長，所以到第四季度，我們認為很明顯，我們預訂的泵渠道數量肯定會翻一番，收入也應該開始反映這一點。

Got it. That's helpful. And then I wanted to follow-up on one comment in the press release. I think it was along the lines of despite some inefficiencies with the transition. We maintained a 78% gross margin. Quite honestly, I figured that would be followed with, our gross margin was negatively impacted and below expectations, but that was still above expectations. Is this maybe kind of hinting at the fact that you can get even better gross margins out of this product, potentially into the 80%, or how should we kind of read through on that inefficiencies and how that impacted the quarter?

知道了。那很有幫助。然後，我想就新聞稿中的一則評論進行後續說明。我認為大致意思是，儘管過渡期間存在一些效率低下的問題。我們維持了78%的毛利率。說實話，我原本以為接下來會說，我們的毛利率受到了負面影響，低於預期，但結果仍然高於預期。這是否暗示該產品的毛利率可以更高，甚至可能達到 80%？或者我們應該如何解讀這些效率低下之處以及它們對本季業績的影響？

Well, I think it shows that we did a great job. Transition moving the entire operation across Orlando essentially and getting it plugged in and running again that we didn't have any glitch negatively impacting you know revenues and subsequently you know cost of goods and but I think the real impact there is that the revenue that stuff that we didn't ship out by and large in Q3 was heavily domestic and so that is probably what accounts for that 1% boost. In the gross margin.

我認為這表明我們做得非常出色。基本上，整個營運流程都轉移到了奧蘭多，並且重新投入運行，我們沒有遇到任何故障，沒有對收入和商品成本產生負面影響。但我認為真正的影響在於，我們在第三季沒有出貨的商品，大部分都是國內訂單，這可能是那1%成長的原因。在毛利率中。

So, can it be sustained? Well, as we get quarters where domestic business is, a little bit on the less, lesser side from international business that will fluctuate probably by that point.

那麼，這種模式能夠持續下去嗎？嗯，隨著季度的推進，國內業務會略微減少，國際業務也會相應減少，到那時可能會出現波動。

Okay, that's helpful. I'll stop there. Thanks for the questions.

好的，這很有幫助。我就說到這裡吧。謝謝大家的提問。

Kyle Bauser, Roth Capital Partners.

Kyle Bauser，Roth Capital Partners。

Great, thanks so much and congrats on the great results. Maybe we can talk a little bit about inventory levels for 3860 and 3870, maybe first on 3860 obviously demand is. Still very strong here. Doesn't sound like any air pockets, which is impressive. Is pricing stable on that? Or are you planning on maybe sort of providing any sort of discounted levels there as you kind of roll off that inventory and move into 3870?

太好了，非常感謝，也恭喜你們取得了這麼棒的成績。或許我們可以稍微談談 3860 和 3870 的庫存水平，或許可以先談談 3860，顯然需求量很大。這裡依然非常強勁。聽起來不像是有氣泡，這令人印象深刻。價格穩定嗎？或者，您是否計劃在逐步淘汰現有庫存並過渡到 3870 型號時，提供某種折扣優惠？

Oh Kyle, hey, nice to have you on Board here with us, by the way, and hope to meet face to face soon. But, to answer your question, the question is simple. No, we haven't, it, it's surprising maybe, but yeah, that boost that gift that keeps on giving from these old 3860 pump orders is straight. The straight at the ASPs we've always enjoyed, no discounting, no, haven't done that.

哦，凱爾，嘿，很高興你能加入我們，順便說一句，希望很快能見到你。但是，要回答你的問題，這個問題很簡單。不，我們沒有，這可能令人驚訝，但確實，這些舊的 3860 泵訂單帶來的持續增長的推動作用是顯而易見的。我們一直堅持以平均售價出售，不打折，不，我們沒有這樣做。

Great to hear. And maybe on how you are thinking about inventory levels for 3870, ahead of the launch and start, what are current levels, or do you expect, how do you expect to manage that etc.

聽到這個消息真是太好了。或許您還想談談您對 3870 的庫存水準的看法，在產品上市和開始之前，目前的庫存水準是多少？或者您預計庫存水準是多少？您打算如何管理庫存等等。

Well, there's lots of money going there. I'll let Jack pick that one up.

嗯，那裡投入了大量資金。我讓傑克去取吧。

Sure, so, good to hear from you, Kyle. So yeah, as far as the inventories of the levels of 3860, certainly we have the inventory and we'll plan the inventories for the backlog that we have currently with the 3860, which will be, shipping throughout Q1 of next year and end of Q2 it looks like. As far as the 3870, we are beginning those buys now and so you'll see in Q4 they're certainly we're building up inventory for those 3870s and now, would be appropriate build for Q1 and beyond and so certainly we have the working capital from that perspective, no issues there.

當然，很高興收到你的消息，凱爾。是的，關於 3860 的庫存水平，我們當然有庫存，我們會根據目前 3860 的積壓訂單來規劃庫存，這些訂單預計將在明年第一季和第二季末發貨。至於 3870，我們現在已經開始採購了，所以你會看到在第四季度，我們肯定會為這些 3870 建立庫存，現在，為第一季度及以後的生產做好準備，所以從這個角度來看，我們的營運資金肯定足夠，沒有問題。

Okay. Appreciate that and I don't want to get ahead of myself here since you're just kind of beginning to roll out in the US, but can you remind me plans eventually to secure entry into international markets for 3870 and how your kind of thinking about that?

好的。非常感謝。鑑於你們在美國的業務才剛起步，我不想操之過急，但你們能否提醒我一下，你們最終是否有計劃確保 3870 進入國際市場，以及你們是如何考慮這個問題的？

Yeah, it's primarily a regulatory issue, there's the new MDR requirements to maintain your CE mark for European Community business, that's a heavy lift, but, our regulatory folks, they came off of a long battle with FDAs, to clear the, 3870, but that was back in May. They took a breather, but they're hot and heavy on obtaining that MDR, let's call it a clearance, but it's a registration with CE mark.

是的，這主要是一個監管問題，歐盟企業需要滿足新的 MDR 要求才能維持 CE 標誌，這很困難，但是，我們的監管人員在五月份與 FDA 進行了一場漫長的鬥爭，才最終通過了 3870 號法規。他們稍作喘息，但他們正全力以赴地爭取獲得 MDR，我們姑且稱之為許可，但它實際上是帶有 CE 標誌的註冊。

And that will that's we're targeting to be done in Q4 so international business will switch over to the 3870 next year in 2027 I should say, not in 2026. We'll just be getting the MDR towards the latter part of 2026. Likewise, our other large market, for pumps is Japan and. I'll be speaking with them. I'm in Japan calling on this call right now. I'm speaking to them here, in the next day or two and working with the Japanese to clear the product here in Japan.

而我們的目標是在第四季度完成這項工作，因此國際業務將在明年（2027 年）而不是 2026 年切換到 3870。我們大概要到 2026 年下半年才能拿到 MDR。同樣，我們的另一個大型泵浦市場是日本。我會和他們談談。我現在在日本，正在接聽這通電話。我將在未來一兩天內與他們溝通，並與日本方面合作，爭取讓該產品在日本獲得批准。

We're going to do that simultaneously, but it probably still will be somewhere in the fourth quarter by the time we get that cleared. And then we'll switch Japan over so both those large, largest international markets, will be a 2027 kicked in.

我們將同時進行這項工作，但要等到第四季才能完成。然後我們將把日本也納入進來，這樣這兩個最大的國際市場都將在 2027 年啟動。

Okay, great, appreciate that maybe just one more quick one, I'm glad to hear you're fully moved into the new facility. I think it's 2.5 times the size of the previous facility. Correct me if I'm wrong, but any sense as to kind of what level of sales this could support or capacity, however you want to frame it.

好的，太好了，非常感謝。也許再問一個問題，我很高興聽到你已經完全搬進了新址。我認為它的面積是之前設施的2.5倍。如果我理解有誤請指正，但無論你怎麼稱呼它，你能否大致估算一下這能支持多大的銷售水平或產能？

Well, we, it is 2.5 times the size that's right, and, we were doing $20 million a quarter out of the, out of that 2.5 times smaller space so you know the math of it's pretty equal. We don't see any reason why we can't get to $50 million a quarter in the, in the new facility, and, so yeah, 2.5 times, but, unlike the old facility, we're not landlocked where we are, as you might recall, Jack mentioned the cost of construction of the building. That we did pay cash and built it with our cash flow, but we also purchased the 26 acres. The building sits on about five of it, five or six of that, so there's lots of space around us that's ours to and the way we constructed the building was so it could easily be expanded into that adjacent space that we own. So, we have plenty of space without spending another nickel. On any construction or buy more land and to expand the production side of the building into the land that we already own is not that heavy of a lift, so we have I guess paid forward quite a ways, there's plenty of capacity physically.

嗯，我們的規模是原來的 2.5 倍，沒錯，而且，我們之前在那個只有原來 2.5 倍大小的空間裡，每個季度也創造了 2000 萬美元的業績，所以你知道，從數學角度來看，兩者基本相當。我們看不出有什麼理由說新工廠每季度不能達到 5000 萬美元，所以，是的，是 2.5 倍，但是，與舊工廠不同的是，我們現在的位置並不受限，你可能還記得，傑克提到了這座建築的建設成本。我們確實是用現金支付並利用現金流建造的，但我們也購買了 26 英畝土地。這座建築佔地大約五、六英畝，所以我們周圍有很多屬於我們的空間，而且我們建造這座建築的方式就是為了讓它能夠輕鬆地擴展到我們擁有的相鄰空間。所以，我們不用再花一分錢就能擁有充足的空間。無論是建造新大樓還是購買更多土地，將生產設施擴展到我們已有的土地上，都不是什麼難事，所以我想我們已經提前投入了相當多的資金，物理產能也足夠。

Okay, I appreciate that. Thank you, Roger and Jack for taking my questions.

好的，謝謝。謝謝羅傑和傑克回答我的問題。

Great, good to talk to you.

太好了，很高興和你聊天。

Thank you, and this will conclude today's question-and-answer session, and I would now like to turn the conference back over to Roger Susi for closing remarks.

謝謝大家，今天的問答環節到此結束，現在我將把會議交還給羅傑·蘇西，請他作閉幕致辭。

Thank you, operator, and I thank you all once again for joining today's call and look forward to displaying IRADIMED ability to execute once again as we introduce our new MRI IV pump and capitalize on the huge replacement opportunity throughout 2026 and beyond. Thank you.

謝謝接線員，我再次感謝各位參加今天的電話會議，期待著再次展現 IRADIMED 的執行能力，推出我們的新型 MRI IV 泵，並抓住 2026 年及以後巨大的更換機會。謝謝。

Thank you. This concludes the call. You may now disconnect. Everyone, have a great day.

謝謝。通話到此結束。您現在可以斷開連線了。祝大家今天過得愉快。