ICU Medical, Inc. (ICUI) Earnings Call Transcript & Summary
September 15, 2026
Earnings Call Speaker Segments
Peter Harrison
analystGreat. Good morning. This is Peter Harrison from Morgan Stanley's Investment Banking division. Today with me, I'd like to introduce Vivek Jain from ICU Medical, Chairman and CEO. Welcome, Vivek, and thanks for joining us.
Vivek Jain
executiveThanks, Peter, for having us at this great event. I appreciate people showing up at 7:00 a.m. New York time.
Peter Harrison
analystPerfect. Let's get started. Maybe let's start with the macro environment. On your Q2 call, you reiterated continued stable demand and utilization environment and status quo capital equipment market. It's different from some people we heard about ACA subsidy expirations affecting surgical volumes. That does not seem to have an effect on you guys. Do you agree that consensus continues to be healthy?
Vivek Jain
executiveSure. I mean, there was obviously some news last week with some of the large companies having their own specific commentary around procedure volumes. For us, our business is tied to hospital admissions. And from what we've seen, our customers are busy, census appears pretty good. We haven't seen any slowdown. It's, to use the words we said in our call script, it's in line with the assumptions underlying our guidance, which was okay growth underlying, not spectacular in terms of markets, but still positive.
Peter Harrison
analystAnd the rest of this year feels better, worse, the same?
Vivek Jain
executiveRest of the year feels very consistent with those comments. We haven't seen any big swings in either direction.
Peter Harrison
analystOkay. You've obviously spent a lot of work reshaping the portfolio in recent years. You did the IV Solutions JV with Otsuka, SKU rationalization in Vital Care. Obviously, you did the Smiths acquisition. What is your ultimate goal in portfolio management transition? Is it to improve the WAMGR, drive faster sales growth and/or better profitability? And if you had to say what inning you are in, in this transformation, what inning do you feel you're in?
Vivek Jain
executiveI don't know that it was so much transformation. I mean, we -- for all the challenges, we look back on the last 7 or 8 years and said we took a $200 million direct sales parts supplier and turned it into a comprehensive integrated infusion company. That's the largest set producer in the world. Our goal wasn't necessarily about improving the underlying growth rates. We -- the first transaction had -- the first big transaction had to happen out of defense. It's been really about trying to build a coherent portfolio, things that make sense together and trying to have the best pumps, the best consumables, the best IV solutions we can have, products that make sense together to the customer in the way the customer buys them.
Peter Harrison
analystGreat. Maybe dive a little bit into the businesses. Let's start with IV Systems. That business grew a robust 12% organic in Q2, nearly plus 10% in the first half. Some of that was due to installations being pulled forward from later in the year and some was from competitive wins. What are the sustainable growth drivers into the second half of this year?
Vivek Jain
executiveI think on our calls, we've been trying to be very transparent about the value, the drivers in the IV Systems business. And there's really 3, 3.5 of them. The biggest 2 opportunities are on our LVP pumps where we create value by either winning competitively or rolling over, upgrading our existing installed base. Most of the growth to date over the last 4 quarters, 5 quarters, and the business has grown nicely for 2.5 years in a row, has been from competitive wins. Next year, it will be a mix of both competitive and rollovers. The third way we grow value in the pump business is by refreshing our own syringe pumps. Those are the pumps that came in the last acquisition. We have a strong market share position there. And maybe the half or half-plus is how do we go deeper with the installed base, reprofitize it by adding value around software, services, et cetera.
Peter Harrison
analystAll right. I mean, obviously, the competitive environment for LVPs has been changing of late with Alaris remediation essentially completed, Novum IQ still off the market. How is the Plum family positioned competitively? And who do you think you're taking share from?
Vivek Jain
executiveI think we've been very -- everybody in these calls is the math doesn't make sense. Obviously, everybody says they're winning and taking share. We have stayed away from those comments, and we have simply said it will show up on our P&L, which we believe it's starting to. And if you read our scripts prior to the latest acquisition, our pump is not that big. Our LVP business reported independently, and so you could make a judgment of the size of it. So small wins make a huge difference on our income statement. I think the competitive environment is active as ever. There's plenty of opportunities out there, and there's a reasonable amount -- our installed base included -- old equipment in America that needs refresh and old equipment globally, that's a good opportunity.
Peter Harrison
analystAll right. And thinking about your pump business a little bit more granularly, when do you expect the upgrade cycle to really start? And what is that opportunity for investors, units, timeline?
Vivek Jain
executiveNormally, these devices have a 7- to 10-year life. And if we think about our own U.S. installed base, which is 20-ish percent of the market, we are in the very early days of refreshing that. That process is just starting. It will start in earnest next year. You have to be sensitive. It's a little bit like going to a customer, just like a software vendor and saying, even though this product is still functional and we built these things like tanks, they can pump a long time. We no longer support the software. We no longer offer spare parts, et cetera, and sort of encourage a refresh to a modern architecture.
Peter Harrison
analystAnd how do you think about with that upgrade cycle, the timing of the pull-through of consumables?
Vivek Jain
executiveOur consumables business, for the most part, where we have the pumps today already, so when you talk about the upgrade cycle to the installed base, more often than not, we already have those consumables. So I wouldn't want you to think that it's incremental consumables to a large degree from rollovers. We probably have those already. The opportunity to drive more consumables related to LVPs is more about the competitive wins where we have a reasonable chance of getting the consumable. I mean, our consumable market share was higher than our pump share anyway, right, historically. And consumables growth for lots of other reasons outside of the LVPs, but specific to LVPs, it's more on the competitive side.
Peter Harrison
analystOkay. One aspect of this business is hospital profitability headwinds from both payer mix and 340B. How could that influence the infusion pump spend? Or would those pressures have to be greater to drive hospitals to alter their replacement schedules?
Vivek Jain
executiveI mean, hospitals have obviously been under economic pressure since certainly as long as I've been doing this, and they've been trained to behave in a certain way. I think I would say whether it's 340B or whatever, we -- we don't -- we focus on you need these products to deliver medications. You can't deliver care without them. Nobody buys a pump voluntarily. My joke is it's like teaching your mom to use a new cell phone, right? You only upgrade when you have to. And at a certain point, these devices hit their age, they time out, the support isn't there, the parts aren't there and refresh needs to occur like your desktop PC or whatever it may be. And if you look at just what's happened in the U.S. market where the market share leaders had to remediate, et cetera, people obviously had capital available for those remediations. You need the pump.
Peter Harrison
analystFor the syringe pump, obviously, you've been in discussions with the FDA. You're making progress on the additional verification testing. You expected to refile the 510(k) in the second half. What is your confidence level that this new filing will fully address their concerns?
Vivek Jain
executiveI think the questions were real time of things happening in the industry real time. This was the first one we didn't have, which is the danger of talking about them out loud because historically, we only talked about when you had them in hand. And so it's the same team that's gotten 6 in the last 2 years and a bunch historically through the regulator. And we think we have the right data in hand and the right submission strategy, et cetera. And we feel confident that we'll -- the submission at least for the syringe pump will go in this year.
Peter Harrison
analystSo if it goes in this year, what's the timeline for FDA clearance in your mind?
Vivek Jain
executiveTypically, it's a 6- to 9-month review cycle. It really comes down to are the items reviewed only what was the test information required or other changes that may have happened in the industry. It's -- I think we'd be scared to handicap it one way or the other.
Peter Harrison
analystDo you see the FDA being slower, quicker than historical standards?
Vivek Jain
executiveIt's -- I'm not sure folks necessarily believe this, but everything from a review has been exactly on timeline, as responsive as they've ever.
Peter Harrison
analystThat's great. It's good to hear. We talked a little bit about the LVP competitive environment. And what is the benefits of having a syringe pump with your LVP? And how do you think about the share over time?
Vivek Jain
executiveIf you just kind of unwind history a little bit, right, the advantage that the market share-leading pump platform, where Dan Woolson here, Dan, our President in the front row, and I worked for a long time was when it came on market, there was real innovation around multiplexing and convenience of having all the pumping modalities in sort of a single software solution. The remainder of the market that was using our system or the other competitor system, so players 2 and 3, typically we were using their LVP and either a Smiths syringe and CADD pump, which required the customer to have 2 separate software packages, run 2 separate drug libraries, have different training, et cetera. The advantage of having syringe, which is 1 of the 2 or 3 core reasons why we took on the headache of the Smiths acquisition was to have what we believe was the best motor, the best pump, the most accurate syringe and make it simpler for customers by integrating with the same user interface, same feel and same software package as the LVP. And the multiplexed Plum combined with an integrated software syringe eliminated some of the historical challenges that we had on our LVP platform, deficiencies, you might say that we have in our LVP platform.
Peter Harrison
analystYou did mention in passing the CADD program. When do you think you'll restart development of that?
Vivek Jain
executiveCADD hasn't stopped. It just is lower priority. There's a finite amount of testing resources we had to address some of these questions. Medfusion in the NICU in the hospital is a more acute issue, is an older product. We had to get that done first. CADD is happening as we speak, but it's only getting a fraction of the lab capacity, not all of it. So it will be a couple of months behind Medfusion.
Peter Harrison
analystAnd do you have a sense of the work that's needed to get it from here to clearance and the timeline?
Vivek Jain
executiveIn a strange way, the request on CADD was almost less than the request on Medfusion. There just aren't as many sets you use on CADD as there are with syringes, and therefore, the testing volume isn't quite as dramatic on CADD as it is on Medfusion. So I think we have a good sense of what needs to get done.
Peter Harrison
analystAnd is that timeline for Medfusion a good proxy precedent for where you think CADD will land?
Vivek Jain
executiveI think we'd probably pause on answering that right now until we see the response to Medfusion.
Peter Harrison
analystLet's wrap up on this part of the business with the software platform, LifeShield. How does this stack up versus the competition? How do you drive utilization?
Vivek Jain
executiveYes. I mean, the software offering is intended to be an enterprise-wide offering. We were limited in scale a little bit with our historical offerings at the size of IDN and the simplicity that it could run with an IDN, you could do it, but it required extra work. Having a full kind of enterprise cloud-based system, the ability for customers to immediately update their drug libraries across a huge multistate IDN across all different pumping modalities in a matter of minutes is a real advantage versus running 2 separate pump platforms, 2 separate software systems. There's lots of other features and analytics and things people will pay for, but the safety aspect of Medfusion and interoperability, which has really become table stakes, is what we focus on making sure both pumps have and look and feel the exact same way.
Peter Harrison
analystAnd are you charging for that today?
Vivek Jain
executiveWe've always charged for software. I think the $64,000 question is, is there enough value in the LifeShield offering that we can illustrate and demonstrate that to our existing installed base and try to reprofitize that a bit? Because at some level, while the period-to-period revenues are great for the next few years on the rollover of existing installed base, we're already getting those dedicated sets. So that's not necessarily so NPV creating, right? The 10 years you get to get that. So we'd love to reprofitize the software if we can prove there's enough value to customers there.
Peter Harrison
analystOkay. Before we move on to consumables, I think the Otsuka JV you did was a very interesting transaction. It has led to some investor questions about what it means for future and how does it look? Maybe talk a little bit and describe that JV and the benefits that ICU gets from it.
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