IRadimed Corp (IRMD) 2025 Q1 法說會逐字稿

Welcome to the IRADIMED Corporation first-quarter of 2025 financial results conference call. (Operator Instructions) This call is being recorded today, Monday, May 5, 2025, and contains time-sensitive accurate information only today. Earlier, IRADIMED released its financial results for the first 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.

歡迎參加IRADIMED Corporation 2025 年第一季財務業績電話會議。（操作員指示）此通話於今天（2025 年 5 月 5 日，星期一）錄製，僅包含今天的時間敏感的準確信息。此前，IRADIMED發布了2025年第一季財務業績。該公司獲利新聞稿的副本可在公司網站 IRADIMED.com 的「新聞」欄位下查閱。新聞稿副本也已透過 8-K 表格提交給美國證券交易委員會 (SEC)，可在 sec.gov 網站上查閱。

This call is being broadcast live over the Internet on the company's website at IRADIMED.com, and a replay 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. [It] reminds you that future results may differ materially from these forward-looking statements due to several risk factors.

這次電話會議正在公司網站 IRADIMED.com 上進行網路現場直播，並且在接下來的 90 天內將在網站上提供重播。今天會議中的一些資訊將構成 1995 年《私人證券訴訟改革法案》所定義的前瞻性陳述。前瞻性陳述著重於未來的績效、結果、計畫和事件，可能包括公司預期的未來績效。 [此]提醒您，由於若干風險因素，未來業績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，該部分可從美國證券交易委員會網站 sec.gov 免費取得。

I would like to turn the call over to Roger Susi, President and Executive -- excuse me, Chief Executive Officer of IRADIMED Corporation. Mr. Susi?

我想將電話轉給 IRADIMED 公司總裁兼執行長 Roger Susi——不好意思，他是執行長。蘇西先生？

Thank you, operator, and good morning. Thanks, one and all for joining us on today's call. I am pleased to report another record quarter, making our 15th consecutive quarter of record revenues. For the first quarter of 2025, we achieved revenue of $19.5 million, which is an 11% increase over the same period last year. Gross profit came in at 76.1% with earnings very strong as well, with GAAP diluted earnings per share increasing 16% from Q1 of 2024.

謝謝接線員，早安。感謝大家參加今天的電話會議。我很高興地報告我們又一個創紀錄的季度，這是我們連續第 15 個季度創下收入記錄。2025年第一季度，我們營收1,950萬美元，比去年同期成長11%。毛利達到 76.1%，收益也非常強勁，GAAP 稀釋每股收益較 2024 年第一季成長 16%。

Performance in the quarter was led by pump shipments with bookings of our 3860 MRI IV pump continuing to excel in Q1. But I'm also very happy to report that shipments of our disposables grew well, and the bookings in Q1 indicate that our emphasis on the monitoring sales for 2025 can be expected to achieve our plans with this product line as well. Our CFO, Jack Glenn will walk you through the financial details in a bit, but I'd like to address two other issues. Questions of tariff impact and the FDA, particularly our 510(k) clearance and DOGE impacts.

本季的業績主要由泵浦的出貨量所驅動，我們的 3860 MRI IV 泵浦的預訂量在第一季繼續保持優異表現。但我也很高興地報告，我們的一次性產品的出貨量增長良好，第一季的預訂量表明，我們對 2025 年監控銷售的重視有望實現該產品線的計劃。我們的財務長傑克·格倫 (Jack Glenn) 將向您介紹財務細節，但我想討論另外兩個問題。關稅影響和 FDA 的問題，特別是我們的 510(k) 許可和 DOGE 影響。

Starting with the tariff impact, in a word, it's too soon to tell, but a review of the amount of foreign specifically Chinese materials we utilize it should provide a background. As you dive into our gross margin or conversely, our cost of goods, you would see that about 12% of revenue is form cost or the parts and stuff we buy to make our products. Examining this further, we find that about 3% of revenue, a quarter of this bond cost is connected to high tariff sources. If even in a horrible worst case, if Chinese tariffs should remain 145%, our 3% cost of such high tariff parts goes to 4.35%. So we do not see the risk of material cost impacts directly from even this current first shot over the bow high tar that we put in place against China.

從關稅的影響開始，總之，現在下結論還為時過早，但回顧一下我們使用的外國材料（特別是中國材料）的數量應該可以提供一些背景資訊。當您深入了解我們的毛利率或相反的商品成本時，您會發現大約 12% 的收入來自成本或我們為製造產品而購買的零件和材料。進一步研究後我們發現，約有 3% 的收入，即四分之一的債券成本與高關稅來源有關。即使在最糟糕的情況下，如果中國的關稅仍維持在 145%，那麼我們這些高關稅零件的 3% 成本就會上升到 4.35%。因此，即使我們目前對中國發出的第一聲警告，我們也不認為會直接對材料成本造成影響。

Still, there are many other indirect effects of tariffs that are very difficult to predict at this time. For one, there is the threat that we already see with certain suppliers raising their pricing by using tariffs or as an excuse to gauge. We watch that carefully, though. We are actively dealing with such tactics and so far are managing those well. The good news thus far is that we do not see our customers reacting or feeling tariff pain.

不過，關稅還會產生許多其他間接影響，目前很難預測。首先，我們已經看到某些供應商利用關稅或以價格為藉口來提高價格的威脅。但我們會仔細觀察這一點。我們正在積極應對此類策略，目前為止處理得很好。到目前為止的好消息是，我們還沒有看到客戶做出反應或感受到關稅的痛苦。

Therefore, we can report that we remain optimistic with the plans and guidance we have given. As for DOGE impacts, particularly with the CDRH and FDA. It's interesting to note that we understand that some 20,000 jobs in this agency alone have reportedly been cut, yet we have felt nothing. We recently filed responses to the 50 or 60 additional information questions FDA asked us a few months ago regarding the 3870 510(k) filed back in October. And within a week, we had an FDA response.

因此，我們可以報告，我們對我們給予的計劃和指導仍然保持樂觀。至於 DOGE 的影響，特別是對 CDRH 和 FDA 的影響。有趣的是，據我們了解，光是該機構就有約 2 萬個工作被裁減，但我們卻沒有感受到任何影響。我們最近提交了對 FDA 幾個月前就 10 月提交的 3870 510(k) 提出的 50 或 60 個附加資訊問題的答覆。一週之內，我們就收到了 FDA 的回覆。

This sort of engagement appears very quick, certainly as quick as we have seen and would indicate that work at the FDA continues to get done. Along the lines of FDA and 510(k) clearance, we iterate what I explained in prior calls, this new device, the 3870 MRI IV pump will be a 2026 revenue story. We are on track and remain expecting of clearance in mid-2025, however, we expect only light revenue from this new device in Q4 of 2025. As the cell and shipment cycle is measured in months even for an exciting and anticipated new offering.

這種參與似乎非常迅速，肯定和我們所看到的一樣快，這表明 FDA 的工作正在繼續完成。按照 FDA 和 510(k) 許可的思路，我們重申了我在之前的電話會議中所解釋的內容，這款新設備 3870 MRI IV 泵將成為 2026 年的收入亮點。我們正按計劃進行，並預計在 2025 年中期完成清關，但是，我們預計這款新設備在 2025 年第四季的收入將非常有限。即使是一款令人興奮和期待的新產品，其電池和運送週期也是以月來計算的。

Tomorrow, as witnessed by the strong and continuing sales through customer replacement of the older 3860 IV pump, driven by discontinuing offering our extended maintenance on pumps seven years and older, the new 3870 pump sales are expected to dwarf sales of this older model as the quarters progress through 2026 and into 2027, certainly.

明天，正如客戶更換舊款 3860 IV 泵所見的強勁且持續的銷售，由於我們停止為七年及更舊的泵提供延長維護，預計隨著 2026 年和 2027 年各個季度的進展，新款 3870 泵的銷量將遠遠超過這款老款泵的銷量。

Finally, with regard to our new facility under construction, I'm pleased to report that we are at the finish stage with only minor material supply disturbances which the GC has managed to mitigate well. At this point, we are far enough that potential surprise material cost impacts are well behind us. We are confident in a June, July final certificate of occupancy with plans to begin moving as early as the fourth of July weekend with full operations in the new building by the end of July.

最後，關於我們正在建造的新設施，我很高興地報告，我們已進入收尾階段，只出現了輕微的材料供應中斷，GC 已設法很好地緩解了這一問題。目前，我們已經走得夠遠，潛在的意外材料成本影響已經遠遠落後於我們。我們對 6 月和 7 月的最終入住許可證發放充滿信心，計劃最早在 7 月 4 日的周末開始搬遷，並在 7 月底前在新大樓全面投入運營。

Now I'd like to outline what we expect to see in Q2 2025. As the second quarter 2025 financial guidance we expect revenue of $19.7 million to $19.9 million, with GAAP diluted earnings per share of $0.37 to $0.40 and non-GAAP diluted earnings per share of $0.41 to $0.44. We reiterate our 2025 revenue guidance of $78 million to $82 million for the full year. GAAP diluted earnings per share was $1.55 to $1.65 and non-GAAP diluted earnings per share of $1.71 to $1.81.

現在我想概述一下我們對 2025 年第二季的預期。根據2025年第二季的財務指引，我們預計營收為1,970萬美元至1,990萬美元，GAAP稀釋每股收益為0.37美元至0.40美元，非GAAP稀釋每股收益為0.41美元至0.44美元。我們重申2025年全年營收指引：7,800萬美元至8,200萬美元。GAAP 稀釋每股收益為 1.55 美元至 1.65 美元，非 GAAP 稀釋每股收益為 1.71 美元至 1.81 美元。

Now I'll turn the call over to Jack Glenn, our CFO, to review the quarter's financial results.

現在我將把電話轉給我們的財務長傑克‧格倫 (Jack Glenn)，來回顧本季的財務結果。

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.

謝謝你，羅傑，大家早安。與過去一樣，我們的業績報告是基於 GAAP 和非 GAAP 基礎的。您可以在今天早上的收益報告中找到我們非公認會計準則 (GAAP) 營運指標的描述，並在今天報告的最後一頁找到這些非公認會計準則 (non-GAAP) 指標與公認會計準則 (GAAP) 指標的對帳。

For the first quarter of 2025, we reported revenue of $19.5 million, an 11% increase compared to $17.6 million in Q1 of 2024. This growth was driven by sustained demand for our IV and fusion pump systems, which grew 16% to $6 million and disposable revenue, which increased to 23% to $4.9 million. Patient vital signs monitoring systems revenue remained steady at $6.5 million. Domestic sales accounted for 82% of total revenue in Q1 2025, up from 76% in Q1 of 2024. Domestic revenue increased 19% to $16 million, while international sales declined 15% to $3.5 million.

2025 年第一季度，我們的營收為 1,950 萬美元，與 2024 年第一季的 1,760 萬美元相比成長了 11%。這一增長是由我們的靜脈注射和融合泵系統的持續需求推動的，該系統增長了 16%，達到 600 萬美元，可支配收入增長了 23%，達到 490 萬美元。患者生命徵象監測系統收入保持穩定，為 650 萬美元。2025 年第一季度，國內銷售額佔總營收的 82%，高於 2024 年第一季的 76%。國內收入成長 19% 至 1,600 萬美元，而國際銷售額下降 15% 至 350 萬美元。

Device revenue increased 9% to $13 million in the first quarter, driven by the increase in pump revenue and FMD systems. Revenue from disposables increased 23% in the quarter, reflecting higher pump utilization, and service revenue remained stable at $1 million. The gross margin was 76.1% for Q1 2025, consistent with Q1 of 2024 as we continue to manage our production cost effectively and maintain our ASPs for both products.

第一季設備收入成長 9%，達到 1,300 萬美元，這得益於泵浦收入和 FMD 系統收入的成長。本季一次性用品收入成長了 23%，反映出泵浦利用率更高，服務收入維持穩定在 100 萬美元。2025 年第一季的毛利率為 76.1%，與 2024 年第一季一致，因為我們繼續有效管理生產成本並維持兩種產品的平均銷售價格。

Operating expenses were $9.4 million or 48% of revenue compared to $8.6 million or 49% of revenue in Q1 of 2024. The dollar increase was primarily driven by higher general and administrative expenses, up 16% to $4.6 million due to a rise in legal and professional costs tied to the regulatory effort for the new pump and increased personnel and benefit costs.

營運費用為 940 萬美元，佔營收的 48%，而 2024 年第一季為 860 萬美元，佔營收的 49%。美元金額的成長主要是由於一般和行政費用的增加，由於與新泵浦的監管工作相關的法律和專業成本的增加以及人員和福利成本的增加，該費用上漲了 16%，達到 460 萬美元。

Sales and marketing expenses increased 9% to $4.2 million, reflecting all domestic sales territories being filled and higher commissions from strong domestic bookings in Q1. Research and development expenses decreased 24% to $0.6 million as we finalize key development pages for the 3870 pump. Operating income was $5.4 million or a 14% increase from $4.7 million in Q1 of 2024, maintaining a solid operating margin of 28%.

銷售和行銷費用成長 9% 至 420 萬美元，反映出所有國內銷售區域均已填滿，且第一季強勁的國內預訂帶來了更高的佣金。隨著我們最終完成 3870 泵的關鍵開發頁面，研發費用減少了 24% 至 60 萬美元。營業收入為 540 萬美元，較 2024 年第一季的 470 萬美元成長 14%，維持 28% 的穩健營業利潤率。

We recognized a tax expense of $1.3 million, resulting in an effective tax rate of 21.2% for Q1 2025 compared to 21.1% in Q1 of 2024. GAAP net income was $4.7 million or $0.37 per diluted share, a 16% increase from $4.1 million or $0.32 per diluted share in Q1 2024. On a non-GAAP basis, adjusted net income was $5.3 million or $0.42 per diluted share, up 17% from $4.6 million or $0.36 per diluted share in Q1 2024.

我們確認了 130 萬美元的稅費，導致 2025 年第一季的有效稅率為 21.2%，而 2024 年第一季的有效稅率為 21.1%。GAAP 淨收入為 470 萬美元或每股攤薄收益 0.37 美元，較 2024 年第一季的 410 萬美元或每股攤薄收益 0.32 美元增長 16%。以非公認會計準則計算，調整後淨收入為 530 萬美元或每股攤薄收益 0.42 美元，較 2024 年第一季的 460 萬美元或每股攤薄收益 0.36 美元增長 17%。

Cash flow from operations was $4.3 million in Q1 2025, up 10% from $3.9 million in Q1 2024. Free cash flow, a non-GAAP measure, was $0.4 million, down from $3.4 million in Q1 2024 due to $3.9 million in capital expenditures in the quarter, of which $3.5 million was for the new facility. We expect to spend approximately $3 million more on the facility through its completion in July of 2025.

2025 年第一季的經營現金流為 430 萬美元，比 2024 年第一季的 390 萬美元成長 10%。自由現金流（非 GAAP 指標）為 40 萬美元，低於 2024 年第一季的 340 萬美元，原因是本季資本支出為 390 萬美元，其中 350 萬美元用於新廠。我們預計到 2025 年 7 月該設施竣工時，我們將在該設施上再投入約 300 萬美元。

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

說完這些，我會把電話轉交給大家提問。操作員？

(Operator Instructions)

（操作員指示）

Frank Takkinen.

弗蘭克·塔基寧。

Great. Thanks for taking the questions. I was hoping to start with a question on disposables. Obviously, that was a really great number in the first quarter. I was curious if there was any anomalies in that number. Was there a catch-up in kind of burning down some of the backlog? Is this a new run rate in the disposable line item? Any color around that would be helpful. Thank you.

偉大的。感謝您回答這些問題。我希望從有關一次性用品的問題開始。顯然，第一季這是一個非常好的數字。我很好奇這個數字是否有異常。是否有一種追趕的方法可以解決一些積壓問題？這是一次性專案中的新運行率嗎？周圍的任何顏色都會有幫助。謝謝。

Sure, Frank. I can address that one. I think from the disposable standpoint, what we've said in the past, typically, we would expect the disposables to grow commensurate with the capital growth and certainly tied to the pump utilization, most of that. The quarter, there was some working down in the backlog as we strive to decrease our backlog, our lead time on the disposables due to making sure we're meeting customer demand. So we have -- we did some of that in Q1, so that played a part in that.

當然，弗蘭克。我可以解決這個問題。我認為從一次性用品的角度來看，正如我們過去所說的，通常我們預計一次性用品的增長將與資本增長相稱，並且肯定與泵的利用率掛鉤，大部分都是如此。本季度，我們努力減少積壓訂單，並縮短一次性用品的交貨時間，以確保滿足客戶需求，因此積壓訂單減少。所以我們在第一季做了一些這樣的事，這在其中發揮了一定作用。

But going forward, certainly, I think it's always a little bit hard to -- because of the lead times are shorter for the visibility for us. But we expect it to be sort of in line with kind of the growth overall on the capital side.

但展望未來，當然，我認為這總是有點困難——因為交貨時間對我們來說更短，難以看清。但我們預計它將與資本方面的整體成長保持一致。

Okay. That's helpful. And then, Roger, you made a comment around the composition of bookings. We're indicating monitoring sales being in line with your expectations for this year, which I think was implied for that reaccelerate a little bit as you adjusted some of the incentive compensation around that product. Can you maybe go a little bit deeper into the composition of the backlog and why you feel pretty confident that monitors is going to recover through the year?

好的。這很有幫助。然後，羅傑，您對預訂的組成發表了評論。我們表示，監控銷售情況符合您對今年的預期，我認為這意味著隨著您調整該產品的一些激勵薪酬，銷售將略有加速。您能否更深入地介紹一下積壓訂單的構成情況，以及為什麼您非常有信心顯示器將在全年恢復？

Yeah. Thanks, Frank. Good to hear from you. Yes, as we spoke before, previous quarter, right, that we were going to push hard on bringing up the monitor sales in 2025, basically expecting that there will be a drop in the pump revenues later in the year. Certainly, once this new pump is cleared, this huge run rate that we've experienced in the last five, six quarters for the old 3860 pump, that will come to an end.

是的。謝謝，弗蘭克。很高興收到你的來信。是的，正如我們之前所說的，上個季度，我們將努力推動 2025 年顯示器銷量的成長，基本上預計今年稍後泵浦的收入會下降。當然，一旦這個新泵清理完畢，我們在過去五六個季度中經歷的舊 3860 泵的巨大運行率將會結束。

And so as we mentioned at least a quarter ago, for 2025, we really did reemphasize the monitor with the sales force vis-a-vis commission structure and just highlighting it at our meeting in January, et cetera. And that is showing fruit. We did well. Bookings were strong in Q1. Usually, Q1 is kind of weak generally after a big Q4 finish.

因此，正如我們至少一個季度前提到的那樣，對於 2025 年，我們確實再次強調了對銷售人員佣金結構的監控，並在 1 月的會議上強調了這一點，等等。這就是成果。我們做得很好。第一季的預訂量強勁。通常情況下，在 Q4 取得巨大成功後，Q1 通常會比較弱。

But monitor bookings in Q1 held up the rate that they had ended Q4 at. And thus far, that we're only five weeks into this Q2, I can tell you that the bookings for the monitor have been very strong already for the start of Q2. So that's why I mentioned, it looks like our plans are firming up as we expected along the lines of increasing the monitor bookings.

但第一季的顯示器預訂量與第四季末的預訂量持平。到目前為止，我們進入第二季才五週，我可以告訴你，第二季開始時顯示器的預訂量已經非常強勁。所以這就是我提到的，看起來我們的計劃正在按照我們預期的那樣逐步鞏固，以增加顯示器預訂量。

Great. That's great color. And then just one last one. I wanted to follow up on some of the FDA interactions. I heard your comment that you submitted the file and then you had heard back or submitted the file to answering the questions and then you had heard back from the FDA. What's left now where we stand today until we should see the clearance occur?

偉大的。顏色真棒。最後再說一句。我想跟進一些 FDA 的互動。我聽到了您的評論，您提交了文件，然後收到了回复，或者提交了文件來回答問題，然後收到了 FDA 的回复。在我們看到清理發生之前，我們現在還剩下什麼？

Well -- that's -- if I can have to read tea leaves, but it's more or less a guess. So just to refresh, right? We refiled the 3875 10-K back in October. And we got an AI letter relatively quickly after that. I think it's four or five weeks or so after we submitted, we got a letter with, like I said, 50-plus questions in it. And we work basically for five months coming up with responses to all those questions.

嗯 — — 那是 — — 如果我可以讀茶葉的話，但這或多或少只是一種猜測。所以只是為了刷新一下，對吧？我們在十月重新提交了 3875 10-K 表格。此後我們很快就收到了一封 AI 信。我想我們提交申請後大約四、五週，我們收到了一封信，就像我說的，裡面有 50 多個問題。我們花了基本上五個月的時間來回答所有這些問題。

That was returned, I believe, about two weeks ago. And last week, we started hearing from the FDA interactively. Quickie e-mails, hey, could you find this, this in the filing? Hey, did you answer this, use a different phrase that we like to see for this or helping them finalize and clarify some questions that are open to IRADIMED.

我相信那是大約兩週前歸還的。上週，我們開始以互動方式聽取 FDA 的意見。快速電子郵件，嘿，你能在文件中找到這個嗎？嘿，你回答了這個問題嗎？用一個我們喜歡看到的不同短語來回答這個問題，或幫助他們最終確定並澄清一些對 IRADIMED 開放的問題。

So we'll see how that continues. We had had two such e-mail questions last week, and we returned those late Friday. We'll take it week by week, but there's two ways that can go. These interactive questions can be a good sign. They get things done quickly without formalities of a formal AI letter.

我們將拭目以待，看看情況如何發展。上週我們收到了兩封這樣的電子郵件詢問，並在週五晚些時候回覆了這些問題。我們會每週進行一次，但有兩種方法可以實現。這些互動問題可能是個好兆頭。他們很快就完成了工作，無需正式的 AI 信函手續。

And that's generally a good sign. But it could be that they get off the rails again as we go but too many of these sorts of questions. Too soon to tell, Frank. If all goes well, though, this shouldn't go on for more than three or four weeks. At that point, we'll know where we stand much better.

這通常是一個好兆頭。但隨著我們繼續前進，他們可能會再次偏離軌道，但這類問題太多了。現在說還太早，弗蘭克。但如果一切順利的話，這種情況不會持續超過三到四週。到那時，我們會更了解自己的處境。

Got it. Okay. That's helpful. Appreciate the color. Thanks, and congrats on the solid start to the year.

知道了。好的。這很有幫助。欣賞色彩。謝謝，並祝賀您今年取得了良好的開端。

Thank you. And that does conclude today's Q&A session. I would like to turn the call back over to Roger for closing remarks.

謝謝。今天的問答環節到此結束。我想將電話轉回給羅傑，請他做最後發言。

Well, thank you, operator. Once again, it's been my pleasure to report IRADIMED's performance for this opening quarter of 2025. The company's business foundation is strong. We look forward to attaining our plan for the year as guided. At this point, the execution of those plans is the order of business, and I look forward to reporting our continued positive momentum with the next call. Until then, thank you all.

好的，謝謝您，接線生。我很高興再次報告 IRADIMED 在 2025 年第一季的業績。公司業務基礎雄厚。我們期待按照指導實現今年的計劃。目前，執行這些計劃是當務之急，我期待在下次電話會議上報告我們繼續保持積極的勢頭。到那時為止，謝謝大家。

Thank you. And this concludes today's call, and you may now disconnect.

謝謝。今天的通話到此結束，您可以掛斷電話了。