Good day, everyone, and welcome to today's ICU Medical Inc.’s Third Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note this call may be recorded and I will be standing by, if you need any assistance. It is now my pleasure to turn the conference over to Mr. John Mills. Please go ahead, sir.

Thank you. Good afternoon, everyone. Thank you for joining us to discuss ICU Medical's financial results for the third quarter of 2024. On the call today representing ICU Medical is Vivek Jain, Chief Executive Officer and Chairman and Brian Bonnell, Chief Financial Officer. We wanted to let everyone know that we have a presentation accompanying today's prepared remarks. To view the presentation, please go to our Investor page and click on the Events Calendar, and it will be under the third quarter 2024 events. Before we start our prepared remarks, I want to touch upon any forward-looking statements made during the call, including belief and expectations about the company's future results. Please be aware they are based on the best available information to management and assumptions that are reasonable. Such statements are not intended to be a representation of future results and are subject to risks and uncertainties. Future results may differ materially from management's current expectations. We refer all of you to the company's SEC filings for more detailed information on the risks and uncertainties that could have a direct bearing on operating results and financial position. Please note that during today's call, we will also discuss non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into ICU Medical's ongoing results of operations, particularly when comparing underlying results from period to period. We've also included a reconciliation of these non-GAAP measures in today's release and provided as much detail as possible on any addendums that are added back. And with that, it is my pleasure to turn the call over to Vivek.

Thanks, John, and good afternoon, everyone. I'll quickly walk through our summary Q3 revenue and earnings performance as we believe the results are straightforward and then provide a few highlights on the various earnings and quality improvement efforts. Brian will take it from there for more specifics on the quarter and the balance of the year. Then I'll come back with a discussion on the strategic joint venture we just announced today with Otsuka and the overall situation around IV Solutions and the implications for our customers and ICU Medical with this transaction. Revenue for Q3 was $580 million for total company growth of 7% on a constant currency basis or 6% on a reported basis. Adjusted EBITDA was $95 million and EPS was $1.59. Gross margins were a little higher than expected due to capture of supply chain efficiencies, FX, and sales mix. We again had a good quarter of free cash flow generation, which enabled us to reduce some of the AR factoring line as previously discussed and our cash balance increased to approximately $313 million. The broader demand and utilization environment in Q3 was healthy across all geographies and it's felt that way this year to date and since we're almost halfway through Q4, we've not really seen any major changes in the environment. The capital environment was status quo and the investments that customers need to make are getting made. Then finally, we had a quarter with a net impact of foreign exchange in our favor. Getting into our business units more specifically, consumables grew 9% on both the constant currency and reported basis. The largest lines in the segment in order infusion consumables, vascular access, and oncology all grew high single digits or better. We continue to advance the points made on previous calls around…

Thanks, Vivek, and good afternoon, everyone. Since Vivek covered the Q3 revenue for each of the businesses, I'll focus my remarks on recapping the Q3 performance for the remainder of the P&L, as well as the Q3 balance sheet and cash flow, and along the way provide commentary on any implications to our expectations for the full year. As you can see from the GAAP to non-GAAP reconciliation in the press release, adjusted gross margin for the second quarter was 37%, which was slightly better than our expectations. Similar to the first half of the year, we experienced favorable product mix with a higher proportion of disposables revenue relative to hardware during the quarter compared to our plan along with the benefits from supply chain synergies as we make progress towards capturing the balance of $50 million of synergies over the next few years. In the third quarter, we also experienced a more favorable foreign currency environment compared to the first half of the year, whereby the U.S. dollar weakened relative to the currencies in our key selling geographies and at the same time strengthened versus the Mexican peso, which is our primary manufacturing foreign currency. For Q4, we expect gross margins to be in the 36% to 37% range, reflecting the additional benefits from continued capture of synergies offset by the impacts of two items. The first of which is the expected higher revenue mix of IV Solutions, which has a lower gross margin profile, and the second being the recent reversal of the favorable foreign currency environment we experienced in Q3 as the U.S. Dollar has now strengthened relative to our selling foreign currencies. Adjusted SG&A expense was $120 million in Q3 and adjusted R&D was $20 million. Total adjusted operating expenses were $140 million and represented 24.2%…

Okay. Thanks, Brian. I'll send the balance of the time and what's happening with our IV Solutions business and our excitement about the joint venture we're announcing. Why Otsuka is the best partner in the world for us? How this will be a great outcome for our customers and the broader North American market? Our strategic thinking on why this structure and some economic implications for ICU Medical. Obviously, the U.S. IV Solutions market has been impacted by the events in North Carolina and we empathize with the people and customers impacted by the crisis. We had and still have unabsorbed capacity in our Austin location and have been ramping up to first ensure our long-term committed customers are well served and to be able to help new systems that are willing to make longer-term commitments as we learned a few lessons in our experience through Hurricane Maria. Frankly, we've seen the best of customers and human nature in these moments. And we've also seen some of the characteristics that led to the market concentration that the country has faced. On these earnings calls for years, we've talked about the intrinsic value of IV Solutions being out of line with its economic price. Maybe a simple analogy, it's the $0.10 screw that keeps the wheels on the bus. We spent years pitching geographic diversification. We went as far as asking the GPOs if they wanted to buy into our business over the years. And we've read the same articles in these times of crisis arguing that the government should mandate diversification when it practically has very few tools to do so and the market has chosen not to. Yes, there are certain customers who get it and are willing to do the work to diversify. But our conclusion, which predates…

[Operator Instructions] We'll go first to Brett Fishbin with KeyBanc.

Hey, guys. Thank you so much for taking the questions. Vivek, you definitely gave a lot of detail around why this was the best partner, in terms of entering this type of JV arrangement. I was just curious if you could give a little bit more around the strategic thought process of going in this direction with the JV, whether you guys consider to sell, and then why you think sticking around in the solutions business for the foreseeable future is the best decision for the company.

Sure. Hi, Brett. I don't think we ever had any considerations about a sale. It's a core product for our customers that's deeply linked with the other things that we do. I think where we struggled is what I tried to outline in the script is trying to be the best innovator we can be on pumps and software, trying to be the best innovator around consumables and category creation. It was hard for us to do all of it. And our portfolio was a little narrower here than some of the other players. We were looking for a way to stay in the market, still absolutely deliver these items to our customer, but make sure we could bring the innovation that could be more relevant to them and diversify the market a little bit. And for us like the choices in the other countries, it came down to who had market leadership around the world and the other geographies and who had the most innovation.

All right. I appreciate that color. And then just one question on the ERP. You touched on it briefly. I believe that you've now completed the U.S. and North America portion of it and sounds like it was relatively successful. Just curious if there was any disruption intra-quarter from that at all. And what kind of incremental benefits you might be seeing as we progress into the fourth quarter?

I mean, there was certainly disruption to the team members' lives during the quarter. We had to deal with it ourselves included. I -- it's a lot of work. A lot of people sacrificed. I mean during I would say the month of August, yeah, there was a little bit of bumpiness. We had the month of September to clean up some of those items, but it only gets cleaned up because people gave a lot.

Brett to your point, I would say that although there was some volatility during the quarter, the quarter itself really wasn't impacted at all when you look at it kind of in total. So from my standpoint as CFO, that's the definition of success.

All right. Thanks again. I'll jump back in queue. Appreciate it, guys.

We'll go next to Eric Fleming with Raymond James.

Hey, guys. It's on for Jason tonight. A couple of quick questions. On LVP on Duo, has have you been able to hold the pricing levels that you were talking about earlier this year?

I don't know that we've publicly articulated the pricing levels, but I would say we recognize that you don't have many chances to have new technology reset in the market. We believe in the technology. We want customers who believe in that. We're focused on holding that level. We have not made any changes to where we thought we would start marketing that product.

And how's the market share looking with everyone now back in the market?

I mean, again, I think everybody it's obviously it's a very hot topic given all the competitors' comments on it. I think we feel good about the cards we're holding. We feel good about it from a competitive standpoint with Duo in the market and the amount of conversations. And again, we were very transparent on the power of incumbency etcetera on the previous calls. It's all relative to the size of our business, which frankly isn't that big in the U. S. And we feel very good if Solo comes and the ability to access our own install base where our equipment is finally aging out and needing a little bit of refresh. So I think we feel good on both of those fronts. And then the CAD product is almost a separate conversation but continues to be the best asset that came with the acquisition.

Sorry. And one other follow-up, I mean, not follow-up another question. On the Mexican peso, with the recent election results, what's the outlook in terms of any potential tariffs and the impact on the benefit you're getting in the peso right now?

I mean, I think obviously it's unclear. Last time around, it was not particularly meaningful. I would say we are a big player of the amount of stuff coming from Mexico not only in the health care industry, but automotive consumer or whatever and we'll all be treated the same way. Right now we're not sitting around and spending a lot of time planning on that scenario.

Okay. And then just sorry one last one. You mentioned the FDA has inspected that Smiths facility with the warning letter and you're just awaiting the final report. Is that correct?

We said at the site, it at the site that where the warning letter was issued, we did have a very thorough follow-up inspection. We had no observations. That's one of the components to getting a full clean bill of health. It's the hardest and most strenuous one. And so that box got checked. At the end of that, you're issued an end-of-inspection report. You could receive that any number of months after the inspection and we don't have that in hand yet.

Okay. Appreciate it. Thanks guys.

[Operator Instructions] We'll go next to Larry Solow with CJS Securities.

Hi, good afternoon. I guess just in fact going back to the strategy of the deal, I guess you kind of get the best of both worlds in that you can still control the solutions piece and enable it to sell it with the systems and the consumables, while you also have another partner helping I guess, take 50% of that investment. And also, you're adding, I assume some complementary products that they're bringing as well as the manufacturing redundancy, right? So to me it seems like almost a win-win if I'm looking at that correctly. A –Vivek Jain: I mean, we thought about it a lot. I appreciate the comments are. We thought about it a lot. It's obviously joking aside, it's a very fluid time in the market. We tried to come up with a structure that protected us in the near term sort of in the medium term and maybe hedged a little bit of the risk we have today, but kept certainly kept us in the business for the long term. If we can do what we think we can do together. So we are we really think we found a win-win on the structure and it's we had searched for this for a long time. It's not easy to do. It took a long time to --

And the valuation right and the valuation like looks like it's 16 times EBITDA. I guess that there must be Otsuka must have and you as well, think that this number is certainly a depressed number for the last couple of years. So I'm sure there's some low-hanging fruit just on pricing and things, but then the ability to add their products into your distribution network, I guess, brings that up a lot more potentially. But I guess the question I have is there's a decent amount of assets right on your balance sheet tied to solutions that I guess will come off in the deconsolidation. Is there any way to frame that?

Yeah, Larry. Hey, it's Brian. Your question around multiples, which we don't really pay attention to, I think it's probably closer to 13 times or something like that rather than the 16 you mentioned. But we think it's representative of the value of the business of course and the value that can be created as of with our partners. Yeah. And then of course, I guess just from an accounting standpoint, we will deconsolidate the financial results as well as kind of the assets and liabilities on the balance sheet.

So I think the decision making structure was one part of it, Larry. The other decision making was fundamentally about, is this better for customers? Is it better for the marketplace to check the boxes that help undo the concentration by bringing innovation and more choice? And we looked in the mirror and said every one of those, we felt like this will be better for the marketplace, better for customer. We couldn't get there on our own.

Got you. Great. And if I could just squeeze one more question just on the gross margin. Independent of the lift you expect from the deconsolidation. But just on the core or the entire business ex the solutions piece. You've captured, it sounds like some supply chain efficiencies or expedited those in the last couple of quarters. Are those kind of just a little bit faster than you assume you get them, but nothing really to perhaps the outlook for next year doesn't really change that much. You've just gotten a little bit better this year faster. I guess question one. And then you still expect consolidation to drive like a 200 basis point improvement in gross margin plus or minus, I'd say ‘26 when you get the full-year benefit? Thanks.

Yeah, Larry. So on the two questions, one, as it relates to the favorability we saw in Q3, yes, we're getting those synergies a little bit sooner than expected. We've talked about $50 million is kind of what we expect as part of Phase 2 in total. Most of that's going to show up in the gross margin line. And we but we still think that the timeline for capturing everything is by the end of next year. So, we're still we just happen to be a little bit ahead of schedule. So I don't think it really changes the opportunity.

I just want to rephrase. I'm sorry, I felt like the projects will be all done by the end of next year, right? It might take a little bit longer for the projects to be done. I think, Larry, I would focus on the gross margin percentage. We've been very clear, Brian, in every script, we had a target of 40 that we wanted to get to and that 50 was part of filling the gap. So it's all relative to where we're against that target.

Yeah. Vivek did reference as it relates to the joint venture and the margin impact there. The remaining 1 to 2 percentage point change would probably be coming later on than 2026 when the joint venture would potentially be stand a little more on its own as it relates to certain commercial type of activities.

Right, got you. And you're going to get to 40 well, just do the math just with the consolidation alone from where we are today are pretty close, right?

Yes.

Got you. Okay. Great. I appreciate all the color. Thanks.

We'll move next to Kristen Stewart with CL King.

Hi. Thanks for taking the question. I was wondering if you could just share a little bit more details on what you're seeing today with IV Solutions and your ability to ramp up manufacturing, how much you're able to ramp up to really take advantage of the get this location from your competitor.

I mean, we feel Kristen, it's Vivek. Thanks for the question. We feel like, we're not interested in really playing a short term game. We got burned on that in Maria and our prize at the end of that was going to have to restructure our business back then and we don't want to do that again. And so for us, the business we're interested in is if truly people want to diversify and take a long term view on their either dual or sole whatever it may be supply. I don't think we're running around trying to be opportunistic and part of this decision on this partnership was saying we thought by bringing these set of skills and redundancy and innovation together, we could wind up with higher market share than we have today over time. It wasn't about exploiting what's going on right now. And it's a very awkward time for customers because we certainly believe that just like what happened in Maria, the situation will get rectified. People will come back and there will be adequate supply in the market. I think no one has -- we certainly don't want to speak for anybody, but no one has the illusion that that share that that capacity is not going to come back online. Absolutely. So for us, this is much more about the long term.

Okay. Thanks very much.

We'll move next to Mike Matson with Needham and Company.

Yeah. Thanks for taking my questions. I joined the call a little late, so I apologize if he's gone through this. But just so on this deal, it's going to be a JV. So all the -- is there any revenue benefit to ICU once the deal is completely set up or is all that revenue going to be flowing through the JV?

So, Mike, just I guess kind of how does how do the activities of the joint venture show up in our P&L? We will deconsolidate the results. So on the P&L, all we will show is the -- our portion in the net earnings of the joint venture. So we will benefit economically from any incremental revenues if they generate incremental profits, but it doesn't it won't show up on our revenue line.

Okay. Got it. And then, does your sales team would be, selling the IV solutions or I mean, would those people move over to be part of the JV then or I guess, how would it -- A –Vivek Jain: Mike, it's Vivek. Commercially, everything to the customer remains exactly the same. You order it via ICU, ship via ICU, we run the warehouse, et cetera, we bill. Now those may be services that are provided on behalf of the JV, but the whole experience is seamless to the customer and the integrated value that's delivered, meaning the co-mingling of the value prop of some of these products across other infusion items continues because it's all held together commercially. The revenue benefit is really one of there's two different parts of that question. One part of the revenue benefits, if we believe on our own, we had a better chance of the first two pillars of our company that we described in the call, the infusion consumables, the infusion pumps growing at a superior growth rate to solutions over time, it could be revenue growth accretive. That may not be the case in the short term given what's going on. But the idea is the experience for the customer will feel exactly the same as it does today.

Yeah. Okay. Yeah. That makes a lot of sense then. So you're kind of potentially removing a slower growth business and, you know, but maintaining the benefits of bringing all the bringing that along with everything else to the table for the customers.

I think just to be super blunt about it, over the if we learned, yes, there's some shortage today, but if we learned what happened last time and we learned what happened through the people who supplied things during COVID, the market has a habit of vaccines, ventilators, testing, whatever you want. The market has a chance of reverting to the mean rather even if there's some uplift and recognition of the value of this market. The only way to make it a faster growth business for us was with more innovation and we needed a partner to help us do that.

Okay. Got it. And then just want to ask one on the pump market and competitive dynamics there. So, I guess, I don't cover (indiscernible), but just looking through their comments, it sounds like they kind of they're saying at least that they're delivering on what they thought they could do in terms of reentering that market. So, what are you seeing and, how to what degree have you been able to pick off share from them or, you other players?

Yes. It's an active market because a lot of people are forced to make a decision right now. I think, again, we've grown up in this business in our comments in the last couple of calls, which is a huge advantage to incumbency to all players. But again, relative to our LVP size, which wasn't that big, there's enough choices out there to have us certainly get a meaningful return on our R&D investments into the Plum Duo and Plum Solo programs and there's more conversations going on than there ever have been. We certainly think a huge majority of people generally stay with the incumbent, But the amount of market that needs to change is plenty for us to grow and feed on at once.

Okay. Yeah, that makes sense. Thank you.

We will go next to Michael Toomey with Jefferies.

Hey, guys. Thanks for taking my question. Most have been answered already, but just on the Otsuka JV, what would the free cash flow accretion look like for the deal? How much funding will that need on a CapEx perspective? I know you said it's neutral on adjusted EPS, but just on the CapEx and free cash flow.

I would say, Mike, in terms of free cash flow, marginally positive -- neutral to marginally positive for us. A –Vivek Jain: I mean, we haven't had hey, Mike, welcome to the call by the way. It's not like we had tons of excess cash lying around in the last year or two. There are some spots we want to invest in. I wouldn't on some of the production assets in the other areas, I wouldn't assume like it changes the overall cash flow picture that much. It may just get reinvested in some other areas that are we can make more of a difference.

Okay, got it. Thank you.

We'll return now to Brett Fishbin with KeyBanc.

Hey, thanks for taking the follow-up. Just wanted to clarify one point. So, yes, totally appreciate the comments around like short-term versus long-term and in full agreement. Just wanted to see you did mention that there was some incremental capacity, if there was some additional revenue or EBITDA that you're expecting to realize from that increased demand in the fourth quarter, and what's included in guidance?

We just haven't thought about it that much, Brett. We're going as fast as we can go and we're doing that on the belief that there will be enough volume that's sustainable there. We're really not sitting around looking at it on a short-term basis.

All right. Fair enough. And last question for me. Just can you explain any more you can about the put call option that's embedded in the JV agreement and what the mechanics look like at a high level? Thank you.

It will all be public in our filings over the next couple of days or weeks whenever they go in. Essentially, it's an option that goes out a decade that can't exercise that option until the fifth year and that option is based on a multiple of revenues. So if the market grows and expands in value, we participate in that and we receive that multiple of revenues times our ownership percentage. And so it's an incentive to keep growing the business to make it as large and relevant to customers as possible and vice versa, if companies only wound up supplying call it wet items if customers only want to buy fluids or solutions individually, a call option exists if there's no need to have some of these items together. But no one really knows today how the market is going to develop and I think that's the best of all worlds as we can figure it out as it comes and to the customer, it just needs to be seamless.

With no other questions holding, I'll now turn the conference back to our presenters for any additional or closing comments.

Thanks, everyone for your interest in ICU Medical. Sorry, the call was so late. We're obviously busy trying to get stuff done. I think this is certainly the latest relative to the quarter and we've done it and we will make sure it happens faster in the future. Have a good fall and talk to you soon. Thanks very much.

This does conclude today's call. We thank you for your participation. You may disconnect at any time.