Earnings Call Transcript - ICUI Q2 2025

Operator, Operator

Good afternoon, everyone, and welcome to today's ICU Medical Second Quarter 2025 Earnings Conference Call. Also, please note that today's event is being recorded. I would now like to turn the conference over to Mr. John Mills, Managing Partner at ICR. Please go ahead, sir.

John Mills, Managing Partner at ICR

Thank you, and thank you for joining us to discuss ICU Medical's financial results for the second quarter of 2025. 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 Events Calendar and is under the second quarter 2025 events. Before we start our prepared remarks, I want to touch upon any forward-looking statements made during the call, including beliefs 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 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.

Vivek Jain, CEO

Thanks, John, and good afternoon, everyone. I'll walk through our Q2 revenue and earnings performance and provide some commentary on the businesses, and then turn it over to Brian to recap the full Q2 results and the more positive gross margin implications of our IV Solutions joint venture now that it's operational and our current view on the impact of tariffs at the moment as there was an increase levied on our core production environment of Costa Rica. After that, I'll come back with some color on where we are in creating a comprehensive infusion therapy company and optimizing our portfolio and a bit of qualitative discussion on the evolving tariffs and just make a few comments about the medium-term activities of the company. Revenue for Q2 was in line with our expectations at $544 million for total company growth of 2% on an organic basis or minus 6% reported, which is driven by the impact of the joint venture being consummated. Consumables and IV Systems had good year-over-year growth. Adjusted EBITDA was $100 million and EPS was $2.10. Gross margins were ahead of our expectations due to the joint venture and cash generation was neutral as some cash was tied up in the joint venture creation itself, tax payment and tariffs. As a reminder, between excess cash generated in Q1 and the net proceeds from the creation of the joint venture, we have repaid $250 million in principal year-to-date and expect the only variance to our cash flow planning for the year to be tariff payments. The broader demand and utilization environment in Q2 continued to be attractive across almost every geography with the growth rate positive, but not at the levels we saw last year. The capital environment is status quo, and it does appear investments that customers need to get done are getting done. Currency at the moment is not quite as good as it was earlier in the quarter, but is obviously a benefit in the key selling geographies. Getting into our businesses more specifically, our consumables business grew 4% organic and 3% reported. It was a record quarter in absolute sales levels with good sequential growth driven by new global customer implementations, price improvements, rapid growth in some of our niche markets and solid census. We had mentioned on the previous call that last year, we had major sequential increases in Q2 over Q1 of 2024, so we didn't expect Q2 growth now to be at the same rates as Q1. For the near term of Q3, we again see sequential growth and are very comfortable with our comments of mid-single-digit growth for the year. On the last few calls, we've made some high-level comments around new product filings and innovation in our consumables business. One example of this in Q2 was we received an additional 510(k) clearance for our Clave neutral displacement connectors, which are the anchor product of the segment. Inside this updated 510(k) is a published study, which correlates the usage of Clave connectors with lower patient infection rates. Specifically, the study shows that hospitals that have standardized on Clave needle-free connector technology report significantly lower patient infection rates versus hospitals not using Clave technology. We're excited about this new clearance, both in that it provides more evidence around our largest, most differentiated business that we will market on for years to come, and it updates the regulatory approval to 2025 standards. We have a number of other new consumable line extensions and adjacencies that we're rapidly 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 and workflow efficiencies in the infusion drug delivery process. A number of these programs are combining the parts and pieces of legacy ICU and what we acquired from Smiths. Our IV Systems business grew 2% organic and reported. This was entirely driven by LVP growth, which was double digits even with some of the installs that came in a little ahead of schedule in Q1. LVP growth was from 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 multiyear refresh of our Plum 360 installed base with Plum Solo, now that it's cleared. As we described in the last call, we had an excellent 2024 in selling our CADD ambulatory pumps and would have a tougher set of comps on this line, particularly in Q2, which muted the overall segment growth. For the near term of Q3, we again see sequential growth here and frankly expect a record quarter in aggregate for the IV Systems segment and are comfortable with the previous comments on mid-single-digit growth for the year. On the last call, we provided a lot of detail on the actions related to the FDA warning letter, efforts to remediate products in the field and filings over this year to ensure all pump products had the most up-to-date 510(k)s and modern architecture. So I won't go into that detail again. What we are pleased to announce is that in early July, we did submit 510(k)s for both the Medfusion 5000 syringe pump, the CADD ambulatory pumps and all related LifeShield safety software. These submissions have crossed the first acceptance stage of the review process, and dialogue has started around the filings themselves. I would characterize the Medfusion 5000 as a groundbreaking new innovative product, but like what we did with Plum Duo and Plum Solo, we conserved the core of the product that made it a market leader based on accuracy and workflow. We would describe the CADD submission as more of a catch-up filing, bringing a variety of product iterations up to date in a current filing. But the most important aspect of this and what really is a milestone when these products get cleared is that all of our pumps will now connect on a single software solution across all pump modalities, bringing the ease of use and tighter control of all types of infusions to a hospital customer. This was a core tenet of the acquisition to have a single software solution across hospital LVPs, syringe and ambulatory pumps. We want customers to have the right tool for the right job, all connected with a common user interface and software solution that minimizes training, speeds onboarding, supports interoperability and enables standardization for our enterprise customers. The last development item that will take longer to finish is what we call CADD Connect and is really the final frontier, connecting the home care CADD environment back into the same common software framework. We believe we're seeing the benefits of this vision in the marketplace today. And in addition to continuing to focus on competitive opportunities, we are just in the very early stages of refreshing our own installed base with opportunities to create more value from the hardware and software offerings here. Just wrapping up the business segments, our Vital Care segment was down 4% and 34% reported as IV Solutions revenues were deconsolidated from our income statement. The non-IV Solutions product lines in the segment were basically down $4 million sequentially. For the year, we continue to believe these products to be flattish, either up or down marginally. I'll come back after Brian with some comments on the joint venture, how we're thinking about the overall portfolio within Vital Care and tariffs. And so with that, over to you, Brian.

Brian Michael Bonnell, CFO

Thanks, Vivek, and good afternoon, everyone. Since Vivek covered the Q2 revenue for each of the businesses, I'll focus my remarks on recapping the Q2 performance for the remainder of the P&L, along with the Q2 balance sheet and cash flow and then provide commentary on the rest of the year given the closing of the joint venture transaction and ongoing developments in the tariff environment. As you can see from the GAAP to non-GAAP reconciliation in the press release, adjusted gross margin for the second quarter was 40%, which was in line with our expectations. Here, we saw meaningful improvement with a 3 percentage point expansion on both a year-over-year as well as a sequential basis. The biggest driver of this improvement was the deconsolidation of the IV Solutions business, which contributed approximately 2.5 percentage points of gross margin expansion for the quarter. Continued integration synergies and favorable foreign exchange also contributed to the improvement. For the second quarter, the P&L impact from tariffs was not significant, reducing gross margins by only 50 basis points. That is because while we incurred and paid a little over $10 million in new tariffs, the majority of this was capitalized in inventory as of the end of the quarter, and therefore, only $3 million of expense was recognized in the P&L. Adjusted SG&A expense was $116 million in Q2, and adjusted R&D was $21 million. Total adjusted operating expenses were $138 million and represented 25.3% of revenue. The total dollar amount of spend was the same as the past 2 quarters and a bit below our original full year guidance as we have been measured in making some of the strategic R&D and commercial investments that we mentioned earlier this year, as well as exercising general cost controls across the company given the uncertain and changing environment. Restructuring, integration and strategic transaction expenses were $16 million in the second quarter and related primarily to continued efforts to integrate our IT systems and consolidate our manufacturing network, along with transaction expenses associated with the IV Solutions joint venture. Adjusted diluted earnings per share for the quarter was $2.10 compared to $1.56 last year. The current quarter results reflect net interest expense of $21 million. The second quarter adjusted effective tax rate was 16% and includes a discrete benefit from the release of tax contingencies as a result of the expiration of various tax statutes of limitation periods, which contributed approximately $0.20 per share. For comparison purposes, the prior year tax rate reflected discrete benefits, which contributed approximately $0.15 per share. Diluted shares outstanding for the quarter were 24.7 million. And finally, adjusted EBITDA for Q2 increased by 10% to $100 million compared to $91 million last year. And it's worth noting that the second quarter EBITDA results positively benefited from $3 million of income related to our remaining 40% equity investment in the IV Solutions joint venture, which is now reported as a separate line item in our P&L. The earnings contribution from the joint venture was higher than planned and is not expected to continue at the same level. Now moving on to cash flow and the balance sheet. For the quarter, free cash flow was a net outflow of $8 million, which largely reflects the offsetting impact associated with the positive timing benefits from working capital that we experienced during the first quarter and mentioned on our last earnings call, in particular, for accounts receivable and accounts payable. It also reflects the timing impact of higher tax payments in Q2, which will not recur this year, along with higher tariff payments, which will continue. During the quarter, we invested $13 million of cash spent for quality system and product-related remediation activities, $16 million on restructuring and integration, and $20 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 U.S. And just to wrap up on the balance sheet, we finished the quarter with $1.35 billion of debt and $300 million of cash. During the second quarter, upon closing the joint venture transaction on May 1, we used all of the $200 million of net proceeds to pay down the Term Loan A, bringing total principal payments year-to-date to approximately $250 million. Moving forward to the 2025 outlook. Recall that during our last earnings call, we quantified the expected full year financial impacts of the joint venture transaction, which are included as referenced on Slide #4 of the presentation. And we are confirming that the previously provided impacts for revenue, adjusted EBITDA and adjusted EPS have not changed. We also provided updates on the expected impacts of the evolving situation around tariffs and foreign exchange. Specifically, we said that we anticipated the direct expense from tariffs in FY '25 to be in the range of $25 million to $30 million, the vast majority of which would be recognized in the back half of the year given the cap and roll accounting process. At that time, we also expected the weaker U.S. dollar to offset almost half of the direct tariff expense and said that we would offset a portion of the remaining net exposure through various measures, including lower incentive compensation expense and general cost controls, but expected $5 million to $10 million of unmitigated residual impact from tariffs that would cause us to be at the low end of our annual guidance range for adjusted EBITDA, adjusted EPS and adjusted gross margin. Now that we've reached the midpoint of the fiscal year when we typically update our outlook, in consideration of these items, we are updating our full year guidance for adjusted EBITDA and adjusted EPS. For full year adjusted EBITDA, we are narrowing our previous guidance range of $380 million to $405 million to a range of $380 million to $390 million for the full year. And for adjusted EPS, we are narrowing our previous guidance range of $6.55 to $7.25 per share to $6.85 to $7.15 per share. Our updated guidance for adjusted EBITDA includes the expected impact from last week's executive order, which established new reciprocal tariffs that became effective today, and we estimate will cause our 2025 tariff expense to increase by an additional $5 million. The majority of this $5 million is driven by the tariff rate for Costa Rica, increasing from 10% to 15% as Costa Rica represented our largest tariff exposure country even prior to this latest increase. As a result, we now expect to be at the high end of the $25 million to $30 million range for FY '25 tariff expense. The updated EPS guidance includes the same impacts as adjusted EBITDA plus lower net interest expense and the previously mentioned $0.20 tax benefit recognized in the second quarter. On the revenue line, as Vivek alluded to, there are no changes from our original expectations for the full year. For gross margin, despite the $30 million impact from tariffs, we continue to expect full year adjusted gross margin in the range of 39% to 40%, consistent with our original pre-tariff guidance at the beginning of the year. The impact from tariffs is being largely offset by realization of the full gross margin expansion from the IV Solutions deconsolidation sooner than previously modeled. This implies a back half average gross margin rate of just above 40%, inclusive of the tariff headwind of between 2 to 3 percentage points. As we said before, the gross margin expansion resulting from the JV deconsolidation doesn't actually generate higher EBITDA, but it does highlight and make more obvious the actual gross margin contribution of the rest of the ICU portfolio, and Vivek will provide some further thoughts on that topic. Adjusted operating expenses should be approximately 26% of revenue for the back half of the year. Net interest expense should be approximately $83 million for the full year. And for modeling purposes, you can assume a back half adjusted tax rate of 25% and back half diluted shares outstanding of 24.9 million. Note that our updated guidance reflects tariff policies that are in place today and assumes foreign exchange rates as of August 3. It does not consider potential future impacts such as additional retaliatory tariffs or the broader effects from higher inflation. We are also assuming the income from our equity interest of the joint venture is minimal in the back half of the year, given the additional costs related to the scheduled annual maintenance shutdown of the joint venture's Austin plant. To wrap up, we're happy with the performance of the business for the first half of this year. And although it is difficult to see given all the moving pieces, we expect both Q3 and Q4 to continue to show underlying sequential improvement for revenue and adjusted EBITDA when you exclude the quarterly phasing from the joint venture transaction, tariffs and foreign exchange. These improvements are driven by growth within the consumables business and LVP pump line, along with continued synergy capture and cost management. And just to help quantify the underlying performance improvements in the business that we expect this year, if you were to exclude the $30 million impact of tariffs, the midpoint of our updated EBITDA guidance range would be $10 million above the top end of our original post-JV guidance. But we understand tariffs aren't something that can be ignored as they reduce our profitability and it's real cash out the door. So while others can speculate on the permanence of the current tariffs or future trading deals for individual countries, our goal is to minimize and offset the impact anywhere we can, including implementation of price increases where possible, realization of cost savings and carefully managing cash spend for integration and remediation activities. And that's what we're focused on as we begin to approach 2026. Now I'll hand the call back over to Vivek to expand upon some of the initiatives we're currently focused on.

Vivek Jain, CEO

Thanks, Brian. I want to revisit our strategy and how we aim to achieve profitability amid the current challenges, which matters to our shareholders. Our primary objective has been to evolve from being a needle-free component supplier to becoming a comprehensive infusion-focused company. We believe our successful track record in infusion consumables is evident, supported by strong brands, clinical data, and competitive manufacturing scale that can withstand global tariffs. We plan to introduce more innovations in our core and adjacent segments to drive growth. In our IV Systems business, we are nearing the completion of a comprehensive platform solution that includes cutting-edge clinically relevant devices and enterprise cloud-based software for our customers. This solution will serve as a foundation for the segment for the next decade or more, presenting significant opportunities to attract new customers while enhancing value for our current client base. Although our IV Systems business is currently under significant tariff pressure due to our investments in Costa Rica, we believe we will navigate these challenges as we work through our existing backlog and as contracts renew, thanks to the technological value we provide. We have made significant R&D investments that have not been compromised despite the hurdles following our acquisition, and many of these investments are now coming to fruition. Furthermore, we view IV Solutions as integral to our overall customer offering. While other companies may innovate more effectively in this product category, we have established a unique relationship with Otsuka. Although still in its early stages, Otsuka has shown strong commitment and a promising roadmap in key areas, including PVC-free delivery technology and various nutrition formats, which require substantial capital investment and time. We intend to combine these developments with our consumables and systems offerings over time. While everything sounds promising, it must translate into profits. We acknowledged last year that we were underperforming, and we have made strides in improving gross margins due to synergies and accounting impacts from our joint venture. For the past 18 months, after stabilizing our business, our main goal has been to enhance gross margins, recovering from historical inflation and inconsistent volume. The tariffs expected in 2025 will affect some of the gains we've made, impacting our cash flow and gross margins despite visible improvements. While mitigation was discussed in our last call, we continue to work proactively to offset the tariff burden, assuming these changes will be long-term. This will be our focus for the remainder of the year, and we will provide further updates later. We are in a strong position as our top businesses continue to grow, reaching record revenue levels, and projects are nearing completion, allowing us to evaluate our infrastructure needs effectively. We remain on track with consolidating our production network, order-to-cash conversions globally, logistics, and real estate, all crucial for boosting profitability in 2025 and beyond. Even if tariffs impact our benefits, our efforts remain unchanged, and we have covered these points in previous calls. It’s important that these initiatives coincide with revenue growth. Regarding our balance sheet, income statement, portfolio optimization, and capital deployment, I want to emphasize a few points. Our top priority has been establishing the IV Solutions joint venture, which has positively impacted our income statement and balance sheet and will continue to do so as we expect to receive an earn-out payment. When comparing the Vital Care portfolio to the innovations in the Consumables and Systems segment, it's clear that Vital Care is hindering overall company growth and likely affecting our corporate gross margin negatively. However, these businesses still generate positive cash flow with minimal capital investment, and we want to avoid making decisions that could harm our value in pursuit of margins or growth rates. We can now consider how to optimize each part of the portfolio if opportunities arise. Our previous comments still hold. We aim to maintain around 2x leverage and, given our in-house innovations, return any surplus capital to shareholders efficiently. Alongside addressing tariff offsets, we must also reduce capital expenses related to restructuring, integration, and quality. Our goals for the next couple of years are to ensure our consumables and systems segments are consistent growth drivers with competitive profit margins, an optimized manufacturing network, and a multi-year innovation pipeline, ultimately shifting value from debt to equity. There is a clear focus within the company towards these goals, and we are not engaging in unnecessary activities. We produce essential products that necessitate significant clinical training, have barriers to manufacturing, and customers typically prefer not to switch unless necessary. The market requires ICU Medical to be an innovative and trustworthy supplier, and our company has emerged stronger from recent challenges. Thank you to all our team members and customers as we strive for continual improvement. Now, we will open the floor for Q&A.

Operator, Operator

And we'll go first this afternoon to Jayson Bedford of Raymond James.