ICU Medical (ICUI) Q3 2025 Earnings Transcript

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Date

Thursday, November 6, 2025 at 4:30 p.m. ET

Call participants

• Chairman and Chief Executive Officer — Vivek Jain
• Chief Financial Officer — Brian Michael Bonnell

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Takeaways

• Total revenue -- $533 million, representing 5% organic growth, influenced by the deconsolidation of the IV Solutions business following the Otsuka ICU Medical JV.
• Gross margin -- Improved by just under 0.5 percentage point due to a $4 million one-time settlement related to the Italian payback liability and continued benefits from integration synergies.
• Consumables segment revenue -- Grew 8% reported and 7% organic, reaching a record sales quarter driven by new global customer implementations and rapid growth in niche markets.
• IV systems segment revenue -- Increased 9% reported and 8% organic, led by double-digit growth in LVP pumps and dedicated sets, and benefited from advanced installations.
• Vital care segment revenue -- Decreased 52% reported.
• Adjusted EBITDA -- $106 million for the quarter, with growth attributable to higher gross margin and lower operating expenses.
• Adjusted diluted EPS -- $2.30, up 28% compared to $1.59 in the prior year's same quarter.
• Free cash flow -- Demonstrated improvement, supported by $273 million in year-to-date debt principal repayments and continued operating efficiency.
• Operating expenses -- $130 million, lower than the past two quarters due to reduced incentive compensation and deferred discretionary spend.
• Capital investments -- $29 million in capital expenditures allocated for both maintenance and expansion, including the placement of revenue-generating infusion pumps internationally.
• Balance sheet -- Ended with $1.3 billion of debt and $300 million in cash, after $25 million principal repayment on Term Loan B during the quarter.
• Credit facility refinance -- Post-quarter refinancing increased Term Loan A by $190 million, enabling repayment of higher-rate Term Loan B, and is expected to reduce annual interest expense by $2 million.
• Full-year guidance update -- Raised adjusted EBITDA guidance to $395 million-$405 million, with gross margin forecasted in the 40%-41% range, assuming stable tariff and FX conditions.
• New product submissions -- 510(k) filings for MedFusion 5000 syringe pump and CATA ambulatory pumps are under regulatory review, with management describing FDA engagement as “fair” and consistent.
• Pricing actions -- Brian Michael Bonnell stated, "we were expecting to get around 1% overall price increase. And I think we're very much on track to see that in the P&L this year."
• Pump platforms -- Orders for Plum Solo are now being accepted, while discussions continue on the multi-year refresh of the Plum 360 installed base.

Summary

ICU Medical (NASDAQ:ICUI) delivered record consumables sales and organic growth in both consumables and IV systems segments in Q3 2025, with adjusted diluted EPS increasing by 28% to $2.30 compared to $1.59 last year. The company finalized a refinancing of its credit facility after quarter-end, reallocating capital to lower interest costs. Management confirmed increased adjusted EBITDA and EPS guidance for the full year while maintaining targeted gross margin expectations. The quarter featured ongoing progress with regulatory filings for next-generation infusion pumps and continued patient innovation in the core product pipeline.

• Jain highlighted three near-term value drivers for infusion systems: competitive share gains via a refreshed product lineup, a large installed base ready for renewal, and expansion through new software and connectivity offerings.
• Bonnell described operating expense reductions as primarily stemming from deferred discretionary spending and lower incentive compensation.
• Jain said that, regarding tariffs, "We're working on all the things that one does in terms of supply chain manufacturing, etcetera, to do our best to offset as much as possible," but cautioned against annualizing current impacts.
• Management reiterated a commitment to closing the remaining two percentage point gross margin gap towards the 40%-45% target and achieving a leverage ratio near two times net debt to EBITDA.
• Jain indicated ongoing strategic portfolio evaluation in the Vital Care segment, with no definitive decisions on potential divestitures yet disclosed.
• No change was reported regarding the FDA warning letters, with management characterizing agency dialogue as business-as-usual and focused on product approvals.

Industry glossary

• 510(k): U.S. FDA premarket submission for demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.
• Plum 360 / Plum Solo: ICU Medical infusion pump platforms for acute and ambulatory care settings.
• LVP pump: Large volume pump used to administer fluids in clinical settings.
• CADA Ambulatory: Refers to specific ambulatory infusion pump product lines under review and development at ICU Medical.
• Term Loan A/Term Loan B: Tranches of institutional debt financing distinguished by differing interest rates, maturity, and repayment structure.
• MedFusion 5000: ICU Medical’s in-development syringe infusion pump platform intended to deliver small doses of medication with high precision.
• LifeSealed safety software: Safety software platform for connectivity and compliance within ICU Medical ambulatory infusion solutions.

Full Conference Call Transcript

Vivek Jain: Thanks, Deirdre, and good afternoon, everyone. I'll walk through our Q3 revenue and earnings performance and provide some commentary on the businesses and then turn it over to Brian Michael Bonnell to recap the full Q3 results and balance sheet, and provide an update to our latest outlook. After that, I'll come back with a few comments on how we evaluate our performance year to date, where we are in our mission of creating a comprehensive infusion therapy company, our goals around the balance sheet and optimizing our portfolio, and lastly, a couple of thoughts on the medium-term priorities of the company.

The short story for Q3 is revenue was $533 million for total company growth of 5% on an organic basis. Gross margins increased, operating expenses declined, leading to more EBITDA and EPS. As a reminder, the reported results are impacted by the mid-year creation of the Otsuka ICU Medical JV and resulting deconsolidation of IV Solutions from our income statement. Consumables and IV Systems had good year-over-year growth. Both revenues and gross margins were slightly positively impacted from a settlement of a portion of the Italian payback liability, which was an expense we absorbed towards 2022, and Brian will provide more detail. Adjusted EBITDA was $106 million and EPS was $2.30.

Free cash flow generation improved, and as of today, we've repaid $273 million in principal year to date. The broader demand and utilization environment in Q3 continued to be attractive across almost every geography. The capital environment is status quo, but it does appear investments at customers need to get done are getting done, with the growth rates positive, but not at the levels we saw last year. Getting into our businesses more specifically, our consumables business in Q3 grew 8% reported and 7% organic. It was a record quarter in absolute sales levels with growth driven by new global customer implementations, rapid growth in some of our niche markets, and solid census.

We had the best sequential increase in absolute dollars since 2024. For the balance of the year, we're very comfortable with our common on mid-single-digit growth for the year. We don't expect Q4 to have the same growth rates as this quarter. On the last few calls, we've made some high-level comments around new product filings in innovation, our consumables business with a number of line extensions or adjacencies that are pushing in the development process and or have already submitted 510(k)s to further strengthen our market positions. These products at their core are around enhancing patient safety, workflow efficiencies in the infusion drug delivery process.

A number of these programs combine the parts and pieces of legacy ICU and what we acquired from Smith. We believe these developments alongside our existing commercial opportunity can keep this segment growing at historical rates into the medium term. Our IV Systems business grew 9% reported and 8% organic. Unlike Q2, this was driven by all three main product families, as we lapped the difficult comparison in the CADA Ambulatory product line. LVP pumps and dedicated sets were again the largest contributors with double-digit growth driven by new installations and strong census for dedicated set utilization.

We continue to be engaged in many new RFP processes and are beginning customer discussions around the multi-year refresh of our Plum 360 installed base with Plum Solo now that it's been cleared. As we've discussed, since the new Plum Duo Solo products have been approved, the installation schedule is not predictable enough to be perfectly smooth just yet. Hence, we knew Q3 would be a record quarter as some installs from Q2 pushed into Q3 and even a few Q4 installs came forward. For the balance of the year, we're very comfortable with the previous comments on mid-single-digit growth for the year.

We don't expect Q4 to have the same growth rates as this quarter, given the comments we just made on installs and the very large sequential step up in Q4 over Q3 in 2024. Since the last call, we've been in dialogue with FDA about the submitted 510(k)s for both the MedFusion 5000 syringe pump and the CATA ambulatory pumps and related LifeSealed safety software. These submissions are working their way through the process, we would call the process fair. And like prior experience, with no real change in responsiveness from the agency, even with all the challenges they're dealing with. As a reminder, we've characterized the MedFusion 5000 as a groundbreaking new innovative product.

But like what we did with PlumDuo and PlumSolo, we conserved the guts of the product that made MedFusion a market leader based on accuracy and workflow. We would describe the CAD submission as more like a catch-up 510(k) bringing a variety of product iterations up to date in a current filing. These products get cleared, all of our pump modalities will connect, speeding onboarding.

We were seeing the benefits of this vision in the marketplace today with three distinct value drivers, which can be summarized as first, the opportunity to win competitive market share with a full suite of the newest and best-in-class products, second, the opportunity to refresh our installed base of not only the LVP pumps but also the installed base of the syringe and ambulatory pumps as that is a very significant installed base, and lastly, to create new revenue streams via software and home care connectivity which are still in the very early days. We believe these drivers, again, which are frankly the main reasons for the acquisition, position us for sustained growth in the medium term.

Just wrapping up the business segments, our Vital Care segment was down 52% reported and down four were slightly up year over year.

Brian Michael Bonnell: On the implications for our latest outlook, the first was the excess accruals, which resulted in a one-time increase to both revenue and gross profit of approximately $4 million, improving the gross margin rate by just under a half percentage point. The second item was that consistent with our previous guidance, we saw the full benefit from deconsolidation of the IV Solutions business, which improved our gross margin. Here, we incur expense in Q2. Also contributing to the year-over-year improvement and favorable foreign exchange were continued benefits from integration synergies. With the third quarter results, we progress towards our goal of 40% gross margins to 45% to reflect the ex.

This target of 40 to 45% is two percentage points of our goal. And we continue to believe sufficient operational improvement opportunities exist to allow us to close this remaining two percentage point gap over time. Adjusted SG&A expense was January. Operating expenses were $130 million. The total dollar amount of spend was less than the past two quarters as a result of lower incentive compensation expense and the timing benefit from the deferral of discretionary spending as we've implemented due to the uncertain and changing environment. Restructuring, integration, and strategic transaction cost controls across the company, IT systems, and consolidate our manufacturing network.

Adjusted diluted earnings per share for the quarter increased by 28% to $2.30 compared to $1.59 last year. The current quarter results reflect net outstanding of 24,800,000.0. During the quarter, we invested $12 million of cash spend for quality system and product-related remediation activities, $13 million on restructuring and integration, and $29 million on CapEx for general maintenance and capacity expansion at our facilities as well as placement of revenue-generating infusion pumps with customers outside the US. And just to wrap up, the balance sheet, we finished the quarter with $1.3 billion of debt and $300 million of cash.

During the quarter, we paid down $25 million of principal on our Term Loan B, bringing total debt principal payments during 2025 to $273 million. Subsequent to quarter end, on October 31, we completed the refinancing of the pro rata portion of our credit facility that reset the five-year term of the revolver and term loan A, which were scheduled to become current in January 2026. As part of the refinancing, we increased the size of the term loan A by $190 million and used these additional proceeds to pay down our higher rate term loan B by $190 million.

We expect the refinancing to save approximately $2 million annually in interest expense, as a result of this reallocation of principal along with other more favorable pricing terms. Moving forward to the outlook for the remainder of the year, given the strong performance in Q3, we are increasing our previously provided guidance of $6.85 to $7.15 per share, full-year EBITDA guidance range of $380 million to $390 million to a range of $395 million to $405 million. And for the full-year adjusted EPS, we are updating our previous guidance range with the third quarter in the absence of the discrete $4 million. That increased from 10% to item is sequentially higher deferral of discretionary spend.

Result for the fourth quarter assuming after considering these items, Q4 gross margin through the end of this year should be in the range of 40% to 41% consistent with our previous guidance and assumes the current tariff environment and foreign exchange rates remain in place of 25%, and fourth quarter diluted shares outstanding. Net interest expense should be approximately $19 million in Q4. And for modeling purposes, you can assume a fourth quarter adjusted tax rate of 25,000,000. To wrap up, we're happy with the solid performance of the business during 2025. Our goals around the balance sheet, assessing our financial performance on the income impact is approximately $25 million as compared to the previous year.

We understand and insist on the importance of maintaining a strong balance sheet and optimizing our portfolio. In infusion consumables, we have the scale underpinned by leading brands and great clinical data that will be supported with more innovation in the core and adjacent segments to support growth. We believe these investments, alongside good commercial execution, will continue the revenue trends seen on the chart I just referenced. The balance sheet and overall portfolio also play a role in maximizing revenue growth and EPS. We assume over time we'll have less leverage and be in a lower rate environment, so we would expect EPS would increase faster than EBITDA.

At the end of 2025, we would expect to be 2.5x levered net debt to EBITDA, our previous comments still apply. The ideal place is to be around two times levered given the innovation we believe we have in-house, to return any additional capital to shareholders in the most efficient fashion. The most obvious structuring integrates any available portfolio trades. We're on better footing to work with our partners at FDA to gain approvals. We produce essential items that require some regulatory oversight.

Operator: At this time, if you would like to ask a question, please press star then one. Again, it is star then one to ask a question, and we will go first to Jayson Bedford with Raymond James.

Jayson Bedford: Good afternoon, and congratulations on the progress. I have a tough time believing that it's all a bit more detail on the source. I necessarily in the order of priority, but where we have one more often than not, we'd win the consumables. So I think that's been in the background. Market share gains, I think some of the late in the year last year and early this year around customer wins that had really IV solutions and consumables have come to fruition and are getting installed. That's probably the second reason. And the third is the niche markets. Embedded in there is still oncology, dialysis, some of the specialty markets. We've done a nice job of developing.

I think those are going well. Talk more is a little bit of the international. I don't know, Brian, you'd add anything else. Think those are the top three reasons. And then maybe fourth just to markets, particularly Western Europe, some pretty good. Nothing else to add.

Vivek Jain: Okay. And just on the growth, I appreciate the comment that it won't seem the same. Consumables won't see the same sequential lift as it did. Can we assume the expectation is 2Q to 3Q, but it grows consumables grow sequentially?

Jayson Bedford: I mean, I think, Jason, I don't know that we'd want to be so precise in everything. We hit a really good plateau here. You can look at the track record, and slide lays out exactly what's happening. Consumables, we're by our mid-single digits comments for the year. We feel very good about it for the balance of the year. We feel very good about it next year. I don't want to be in a place where we say something we're not 100% able to commit to. So I don't want to be so precise.

Vivek Jain: Okay. That's fair. Maybe just one more for me, and I'll let some others jump in. On infusion systems, can you comment on Duo and the traction you're seeing in the market, if there's any metrics you can provide in terms of percent of installs, orders, anything like that, that would be great. And then just are you taking orders for Solo now?

Jayson Bedford: We are taking orders for Solo now, and so we are signing contracts, which is great. I think the installs are still in the relative early days. I'm not sure we'd say a lot more than that other than there's a lot of dialogue going on in the pump market in the US.

Vivek Jain: Okay. Thanks.

Operator: And we can move next to Brett Fishbin with KeyBanc Capital Markets.

Brett Fishbin: Hey, guys. Thank you very much for taking the questions. I'm just gonna stick to one, and then I'll jump back in the queue. One, it's just ask about 2026. I think you gave some maybe directional commentary on, like, tariffs. Just curious how you're thinking about maybe the full-year picture for 2026 in regards to tariff exposure, you know, given you've had some additional updates last few months and maybe a little more time to work on potential mitigation. I know in the past, you've said not to necessarily annualize the two h impact, but just sounds like, you know, kind of a high four q exit rate. Thank you very much.

Vivek Jain: Sure. Obviously, an important topic, Brett, and we don't want to make it all about that. Thank you for the question. I think we would stand by exactly the same things we've said when we've been out on the road in the fall, which was it is the actual number that we set here this year. Please don't annualize it. We're working on all the things that one does in terms of supply chain manufacturing, etcetera, to do our best to offset as much as possible. A lot of that work is in flight. I would prefer to leave it at that right now, not make this whole conversation about tariffs.

Operator: And we will move next to Mike Matson with Needham.

Mike Matson: Yeah. Thanks. So you talked about the 45% gross margin target. And I understand the tariffs have affected that. But, you know, let's just say you get to that 45% on a tariff-adjusted basis. What happens then? I mean, is there still room to go higher? Will you be able to get leveraged earnings growth, or are you gonna be sort of more reliant on financial leverage where, you know, as you said, with the leverage ratio coming down, you'll return, you know, maybe do buybacks and things like that to drive more earnings growth?

Vivek Jain: So we might appreciate the question. We're chuckling here. You're talking to people who were at 36% not that long ago. So it was very we're happy with what we've done. We still need to close the gap to get there. I appreciate you asking. Beyond that, no. It's two things. It's about the value of the technology and the hardware, and how what's our ability to sustain and improve that over time? What's our ability to change the mix, add more software products to market to grow consumables, the overall mix of the company?

Consumables, obviously, we were before we did all the things over the last few years, you can look up the 10-K and see the margins of consumables are very attractive. But they have to have the right mix to make a difference on the whole, and we continue to work that. To get there. And we do have some businesses that are obviously below the corporate margin average. Right? In the right circumstance, we would probably out if we can do something with those. And so I think there's a couple shots on goal. There's the value of the technology. There's the mix of the old portfolio. There's pieces of the portfolio. Then the financial rubrics you talked about too.

Those are all arrows in the quiver about how we have to earnings. I mean, I've listened to the industry calls over the last week. Everybody's talking about returning capital and doing all those supposed to do with what the industry's gone through. And so we're no different.

Mike Matson: Thanks. Not to take anything away from the tremendous gross margin improvement we've seen. So which is great. And then I guess my other question would just be around, you know, pricing. You know, what are you seeing? I know you'd talked in the past about some of these contract renewals and things like that and, you know, are you getting improved pricing anywhere?

Vivek Jain: You're asking the question that's been at the heart of this industry's challenge, right, that the industry sold under fixed price contracts for a number of these categories for a long period of time, and absorbing inflation was hard. So all of us, I think, have been very focused on making sure we're getting fair value for our products. We try at every opportunity. It doesn't mean it's an easy conversation. The system is under pressure in a few spots. But where the market structure is right and where the clinical value is right and where our competitiveness is right, yeah, we think we have eked out and Brian can go through kind of the macro numbers each year.

It's a bit of a high-level number we give to say, what's the annual impact of price? Right? Do you want to make a few comments on that?

Brian Michael Bonnell: Yeah. I mean, I think earlier in the year, we said we were expecting to get around 1% overall price increase. And I think we're very much on track to see that in the P&L this year.

Mike Matson: Okay. That's great. Thank you.

Vivek Jain: Thanks, Mike.

Operator: Once again, as a reminder, it is star then one to register for a question. We will go next to Larry Solow with CJS Securities.

Larry Solow: Great. Thanks very much. Just hey, Zach. Just a couple follow-ups on the systems in particular. Could you maybe just characterize, you know, your on the replacement side. The opportunity there. I think you've just discussed, you know, mentioned that I think your discussions on the a large part of your base is actually eligible or, you know, that will has come up on the timeline where it's up for a refresh. So could you just maybe discuss sort of that opportunity over the next few years? And anything a little bit more, I know you mentioned a refresh cycle for ambulatory and syringe.

I imagine assuming those are all, you know, you get those newer 510(k) approvals, could that be something that also begins next year?

Vivek Jain: Yeah. Sure. Yeah, Larry. I think we tried to articulate in the pump business there are three ways to create value. Right? Ultimately, for us, for the last couple of years, because post Hospira, the PLUM 360 was a relatively new entrant into the US pump market, new device into the pump market. We didn't have a lot of opportunity for refresh or replacement of our own install base, and we really had to focus on competitive share gains. We are still absolutely the number one way to create value is to focus on competitive share gains.

If we can offer more tech in the current device of the Duo and Solitaire existing installed base, that existing installed base buys multiple of these products. Us across each of our pillars. That's an opportunity to create value and kind of most of those devices entered the US market and add more value to that existing customer base. That process is in the very early days. When Hospira brought the 360 back on the market in 2016, 2017. So that will start in earnest, I think, you know, the middle of next year, end of next year from a contract perspective. If we see any benefit from it, it won't be really till the end of next year.

It's just starting.

Larry Solow: Gotcha. And just a question on free cash flow. Sorry. I'm sorry. Let me answer the cat and met fusion points are the same on Smith. They those are very large and small bases too. We've been so focused on the LVP discussion opportunities there too that we're focused on. And that's why 5,000 is really important. And then on the free cash flow in the quarter, pretty solid, and especially if you back out the AR impact and then the remediation or restructuring, you would actually have done $60 million.

I know the remediation and restructuring are probably not stopping anytime soon, but maybe you can't just say you're gonna do $150 million next year and multiply it by four. But, does this demonstrate the sort of, you know, ability for your business to generate significant free cash flow and as remediation and restructuring expenses start to hopefully wane over the next coming quarters, should we see a nice jump in free cash flow?

Vivek Jain: Thanks. Yeah, Larry. Good question. I mean, it's hard to take any individual quarter for free cash flow and annualize it just because you do tend to have a lot of things that show up in one quarter and not to the side another. But, you know, but I do we do absolutely believe that free cash flow is really an opportunity for us to drive value, especially as improvements in gross margin, you know, some of the, you know, begin to get to our goals on that. So, yeah, I think that's, I think you've identified kind of the next value driver for us. And, you're right.

It does it's not gonna be seen in the very short term in terms of some of the spend coming down, but that's the opportunity that we have in front of us. It's about time. The remediation, get the consolidation done and yeah. We've been pumping we've been pumping capital in. Right? Logistics done, etcetera. I think that I mean, go ahead. Those remediation, restructuring expenses have averaged close to $100 million a year. Right? I think since you acquired Smith. Is that number directionally going to start dropping materially as we look out over the next few years?

Larry Solow: Yeah. I mean, I hate to be I hate to be a little bit of a downer on this one, Larry. Yes. That number is going to go down, but the tariffs do consume some cash on the front end too. So we're trying to balance. Yes. Yeah. Yeah. We'll note it on your income. You already taken that on your operating. You know, on the yeah. Above that. But yeah. That's fair. Okay. Great. I appreciate all the color. Thanks, guys.

Vivek Jain: Bye.

Operator: And we will move next to Jason Bednar with Piper Sandler.

Jason Bednar: Hey, good afternoon. Thanks for taking the questions. Congrats on a really good quarter here, guys. I'm sorry to bounce around a couple of calls, so apologies if these have been asked. But I would assume if there was an update to be shared on the FDA and the warning letters, we'd have heard it today. You'd proactively addressed that. But just checking in on that topic, is there anything new to share on those warning letters? Any updated dialogue or scheduled interactions with the agency?

Vivek Jain: We tried to thanks for the question, Jason. It's good we didn't talk about it in the Q&A. I think there is some attempts by us to bring them to resolution. I think they really center around getting the new product approvals done. We're very focused on that. I tried to give an update in the script on the dialogue's been normal even though with all the stuff the government's got on, they're being responsive. And it feels like the other things we went through on the Duo solo. So there's been good dialogue. We're focused on getting the products approved. First and foremost. No change in our view book.

Or no change in the feel of that with what's going on there. Okay. Perfect. Yeah. Kinda status quo.

Jason Bednar: Maybe just for a follow-up question, I got a similar thing here, but I'll ask it. You know, it's something that's come up in past calls, Vivek, you've been a little more open to the idea of some more portfolio management within that Vital Care segment. Obviously, nothing to announce here today, but you know, maybe give us a you know, kinda your feelings or kind of a status update on where discussions are as far as, like, evaluating strategically what fits, what fit. Are there interested parties out there? Are there discussions happening? Just that anything there that can help with kinda where you know, thinking about what that segment looks like. Going forward.

Vivek Jain: Yeah. I mean, it's dangerous to, you know, to commit when people say we're adamantly going down this path and then that doesn't happen. I think we've been trying to be transparent. If you look at the company, you know, we were a $300 million parts supplier seven years ago, and so we've had the ability to get things done with large multinationals across the globe. That is kind of one of the team's competencies over the years. And so we continue to explore all available avenues. Was something to get done, it would've got done already. Right?

And so I think we were trying to be a little bit introspective about saying we don't want to do things that are value destructive. The balance sheet's in a Brian did an amazing job, got the financing data, etcetera. We got a little time to be patient, and we continue to explore what's available. I'm not sure I'd want to give more color than that or certainty because it's not 100% in our control. The slide speaks for itself. It shows a very Right? And I think we're pretty transparent in the script, and a varying difference in growth rates across the businesses. And we're very transparent.

Like, in the case of IV Solutions, we didn't feel we had all the tech that you need to be competitive in hand. We went out and found a partner. The same logic could apply to some of the smaller businesses too.

Jason Bednar: Alright. Perfect. Thanks so much, guys. Thank you for the questions.

Operator: This does conclude the Q&A session. I'd like to turn the program back to Vivek Jain for any closing remarks.

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