Vivek Jain
Analyst · Raymond James
Thanks, John. Good afternoon, everybody, and we hope you are well. Once again, it's been a quick 90 days or so since the last call, and our legacy ICU business unit revenues were again very predictable in Q3, and we did have operational performance improvements for the businesses that came with Smiths Medical. The external economic volatility in the supply chain around freight and fuel that we've been describing since mid-2021 surpassed even the Q2 2022 levels, which was hard to believe. As we said previously, Q2 was the highest peak for any time our team has been in the industry. However, the issues around raw material availability are narrowing. From a customer perspective, we felt U.S. hospital census was stable, and international underlying demand was good in all geographies in Q3. Like everyone in our industry, we wanted to start first by thanking all of our customers and their frontline workers for trusting us to serve you during these times. While Q3 revenues were generally in line with our previous comments for legacy ICU Medical, our revenues for Smiths Medical were ahead of our expectations that we laid out on the last call. And since everyone is now talking about items they would have never imagined describing in our earnings call, we'll join that group and wanted to use the time today on the call to comment on the year-over-year drivers of the 3 main legacy ICU businesses, explain the Smiths Medical revenues we achieved in Q3 and how that bridges with our comments on the last call, provide a status update on the Smiths Medical 2 buckets of challenges we've been highlighting all year, go a bit deeper on the specific items that have really hurt gross margins this year because the scale is so astounding, and it answers the question of where has the profit gone this year. For shadow and it's subject to change how we might report next year as we realign our reporting business units, highlight the continued challenges with the strong U.S. dollar and why we're taking our medicine today and its most up-to-date impact in the near term. And lastly, note a few important strategic items we've now finished as they will impact the base of 2022 going forward as these were the first must-do strategic items as they were negative situations. And we'll skip the standard long-term value creation comments as that is after we get the self-help items secured in the near term. Q3 2022 is our third quarter of joint reporting and finally, the story is getting a bit shorter. I'll quickly summarize the whole company results and then discuss each segment of the business. We finished the quarter with $582 million in adjusted revenue. Adjusted EBITDA came in at $93 million and adjusted EPS was $1.75. We had a softer quarter of investment into the business, and it was largely about inventory builds that Brian will describe. Again, it was a less clean quarter in the cost of goods as we spent at a very high rate to improve the service levels of Smiths Medical, and we had restructuring and integration costs that we remain focused on reducing next year as they impact cash flow. The strong dollar and current and FX impact are worse in Q2 -- worse than Q2 at the moment. So let me start with legacy ICU Medical, which is a relatively straightforward story. In Q2, legacy ICU had $320 million in revenue, which is flat on a constant currency basis and minus 2 reported. We had small growth on a year-over-year basis in our most differentiated businesses with negligible COVID impact, and as previously discussed, Q3 2021 had a strong COVID surge. Nothing was dramatically different on underlying demand in Q3, but there was some inter-quarter slowdown during the quarter and bounced back in September. The public hospital companies validated our view on their recent calls that surgeries were up and long-stay high acuity admissions were down. Our U.S. sales were flat to down year-over-year due to the strong COVID comp in Q3 of '21, and all the growth came from the international markets. So let's go through the businesses quickly and then come back to discuss the current environment. Starting as usual with Infusion Consumables, which is our largest business. Infusion Consumables had revenues of $141 million, which was a 1% increase on a year-over-year constant currency basis and minus 3% on a reported basis. We had growth in the OUS markets and the U.S. market was slightly down in core IV and helped by the specialty categories, which fits with the strong COVID comp in the summer of '21. In oncology, we've been a bit constrained due to some raw material challenges that should abate by the end of this year. We're happy the international markets are holding up, and the U.S. is a little harder to judge right now. Moving to Infusion Systems, which is primarily our LVP pumps and associated dedicated sets. This segment did $88 million in adjusted revenues, which was an increase of 1% on a constant currency basis or minus 3% on a reported basis. We did have a decent level of installs in Q3. And here, we had some dedicated set declines on a year-over-year basis in the U.S. due to COVID in '21, but the segment grew due to better international performance. On the last call, we said, we felt that customer attention was back with bandwidth have real discussions as some of the fatigue from COVID is passing and the acceptance of inflation and the cost of nursing, et cetera, being internally. Yes, the stresses of the current environment do make it a bit bumpier for decision-making, but we don't believe over the medium term relative to our size, there's any change to our competitive opportunity. And we are focused on commercial execution here and have no change to our previous commentary on this segment. Finishing the segment discussion with Infusion Systems. We had $81 million in adjusted revenue or about the same as last year on a year-over-year basis. No additional comments on the revenue side here. The bigger issue for us is, this is a segment that has disproportionately absorbed the majority of inflation at legacy ICU, which has impacted legacy ICU profits. The vast majority of unexpected inflation and earnings pressure relative to our view on 2022 legacy ICU profits is primarily about fuel and shipping costs and currency and to a lesser degree, electronic component surge pricing. Through Q3, labor has been much more consistent this year, and we budgeted those items properly. Yes, there's been some raw material surge pricing, but as we highlighted in the last few calls, these items are not so much more inherently valuable over the long term. We have talked about believing in the markets and when capacity increases, pricing should rationalize. So for us, it's about trying to run a stable and predictable operation in a normal environment to get price improvement where we can and to try to illustrate to customers the need to have some of these costs indexed with the belief that supply and demand will balance over time. But there is a longer-term tactical element to this in some of the businesses. We listened to the comments on price actions from the larger players in the industry, and we obviously support that. But we're also focused on the next round of contracting, how to separate the costing on some of these items. For example, our transportation and logistics costs should be separate items, no different than airline seat and baggage fees for next-day delivery. Given the historical margin structure of the health care industry and historical negligible inflation, suppliers never had to think this way. Okay. So let me move to the Smiths businesses. First, talking about aggregate revenues relative to our last comments and then to update the 2 buckets of issues we've been talking about all year. The Smiths Medical revenues came in at $262 million with Infusion Systems at $97 million, Vascular Access at $95 million and Vital Care at $70 million. This was more than we expected, and the short story on why this happened is a combination of a few more billing days that part we knew, but with more stable operational processes in terms of IT systems and labor, all of which led to improved performance on clearing some of our back orders, albeit again spending freely to do so. The underlying performance for the domestic business has substantially improved with international performance still under repair. On the last call, we talked about more confidence and predictability in the Smiths Infusion Systems. We did better than we thought in Q3 as we supported existing Med Fusion customers and more importantly, all U.S. backorders on CAD disposables were cleared, which makes the competitive focus on new wins more actionable. We had not anticipated a recovery until Q4, but regardless, the entire unit is running better now with reliable production and fulfillment on the Smiths dedicated pump sets and some of the other items. On the last call, we also said Vascular Access would have some improvement, but still a work in progress even. With a strong Q3, we did benefit $5 million from the last COVID syringe order. And here, too, we're very healthy from a production and U.S. distribution standpoint on all the major subproduct lines, but our commercial execution remains a work in progress, as Smiths like Hospira did go backwards here. Lastly, Vital Care remains an area where some of the supply challenges remaining back orders continue to be worked as it was neglected the most. We spent a lot of time -- airtime on the last 2 calls explaining the 2 buckets of issues. Let me take them in a reverse order today from the previous scripts. On the quality-related interruptions, we continue to make execution progress that supports the previous communication to both customers and regulators in our view of the path forward and have made some significant decisions. Those decisions such as stopping sales for certain older generation -- old generation products and committing to a deliberate and timely remediation plan have allowed us to begin supporting existing Med Fusion syringe pump customers in early Q3. We've also made progress in addressing the root causes of the warning letter that we received in late 2021. This part feels very similar to Hospira and our previous experience, and we have the right people who have been through the exact same experience, and our team is fully embedded into the operation. We say, the main difference since the last call is, in Q3, we began to execute the various field actions in line with our commitments that we had made in the earlier communication period. As we said on our last calls, the existence of a warning letter, while undesirable, is the regulatory agency trying to move the ball forward, and we talked about how these regulations give us the right to participate. We're making progress in solidifying the foundation and hope to be in a position where we can demonstrate further progress as soon as possible. Again, regardless of where it appears on the P&L, we're spending heavily, so making progress here is extremely important. On the operational issues with regards to production, it can generally be said that the entire Smiths production network is producing at acceptable levels with a few minor interruptions. The silicone availability we described on the last call has resolved and now we're fully producing those items. We continue to work on securing the base of supply and in-sourcing the key high-margin disposable components with proper factory staffing levels. From an expense perspective, we've been spending launch to improve customer service levels with an ICU mindset and with the factories only getting to scale recently. There continues to be a drag to gross margins. In the vein, we can't believe we're talking about this. We did want to give a little more detail on the largest gross margin variances from expectations because at this moment, those are the largest buckets of addressable opportunities and the scale is so astounding, and it goes a long way to answering where has the product goes this year. Brian will go through those in more detail. We've already seen our ability to manage our costs across operating expenses, and our focus obviously needs to be on growing revenues, but it's equally important to improve our gross margin performance. One area I'd highlight is our freight and logistics costs, which will approach $250 million this fiscal year. That is orders of magnitude more than any historical level. Part of that is diesel cost, part is ocean freight rates, part is expedited shipping costs, not only to our customers, but also to ensure we have the right raw material supply to our network. This is not something we intend to talk about regularly, but it's hard to understand the profit shortfall without some huge drivers as it's not like ASP is going down anywhere in the business. This area, along with other large items like improving the quality system and reducing remediation costs, are all large areas for self-help and cash flow generation. In terms of next year, we did want to foreshadow and it's subject to change how we might report as we realign our reporting business units. It's likely that we'll aggregate revenues into 3 segments. The largest would be a consumable segment that would contain the legacy ICU IV consumables, most of the legacy Smiths Medical, Vascular Access and a few other consumable slides. We think production and operations for most of that pillar should be improved in 2023 with work needed on the Vascular Access commercial execution, as previously mentioned. The second segment would be a System segment, which was all the legacy ICU IV pumps combined with most of the legacy Smiths Medical IV systems segment and the associated dedicated disposables. Again, we think service levels and quality for most of that pillar should be improved in 2023. This segment would have almost all the capital sales of the company. And as a reminder, we published in previous investor presentation, capital sales are less than 15% of the total company and that includes a large amount of software service, spare parts, accessories, et cetera. The remaining segment would be a Vital Care segment, combining legacy ICU IV solutions, critical care and most of what is in the legacy Smiths Medical Vital Care segment. We'll provide some schedules already. And just to note, there are a few strategic efforts that would adjust the base year of 2022. Some examples are items we just finished recently such as an agreement to exit India as a direct selling organization via distributor and exiting other negative margin situations, if pricing or costs cannot be rational. So these may be a small hit to base year revenues but are being done to improve a negative profit situation to a neutral or positive. In terms of the balance of this year, from an earnings perspective, the only real difference from our last -- from our previous call is currency. Even though the euro has been in the more stable range the last few months, our largest direct countries are Canada, Japan, Australia, which have all had additional currency weakness. For what it's worth, we only carried the legacy currency hedges inherited from Smiths this year. ICU always ran unhedged, so to speak. As a result, we've really taken our medicine today, and it's had a large impact on the year. From a revenue standpoint, we felt Q3 showed what we can do when fulfillment operations are more stable even if more expensive. We did catch up on some of the back orders faster than we thought, so that may impact Q4 depending on where this underlying market settles. Regarding longer-term performance, I'm not going to repeat the comments from the previous calls as we feel we've been transparent here on the size and scale of the self-help opportunities. What we want to get back to after the challenges of this year is to the aggregate positioning of the combined portfolio and its relevance for customers and their reactions. Yes, the situation is harder than we expected, but the customer logic continues to make sense. Like with the Hospira transaction, we need to change the conversation from the historical perception to demonstrating our value through innovation and service. These portfolios make sense together, and we're working on how to integrate them either literally or economically when sensible. And we do believe more doors are being opened as a result of having a broader set of items that are mandatory for care. We get this needs to show up on the P&L to prove that value. For legacy ICU, our most differentiated businesses will end 2022 larger than ever with appropriate profitability levels. The core premise of the Smiths transaction is to enhance the product offering for these exact categories that drive our returns as well as have logical adjacencies predicated on the same characteristics, sticky categories, low capital intensity, single-use disposables opportunities to innovate and participate in a logical industry structure. Even though we've been consumed with basic operations, we still believe this is all the strategic case and the big opportunity over the long term is using this combined portfolio to improve our position in existing markets and also move to the right areas as the value shifts into new spaces. The construction of the Smiths portfolio was logical, and frankly, why it survived over the years. The other part of value is maximizing the opportunity with each piece of the portfolio. We believe as we clean up, stabilize and improve the operations, we could be presented with more opportunities here. While the pandemic introduced substantial volatility, strategically, we do think the weakness that it has exposed in the health care supply chain add to the argument for all participants to be healthy and stable, which has been our commentary since we became a full line supplier. Smiths Medical also produces essential items that require significant clinical training, hold manufacturing barriers and in general, are items that customers do not want to switch unless they have to. The market needs Smiths Medical to be a reliable supplier and the combination positions us better. Our company has emerged stronger from all the events over the last few years. We've gotten knocked down a bit, but we see the hill to run up again together with our new colleagues drive value out of the combination. Thank you to all the customers, suppliers and frontline health care workers as we improve each day. Our company appreciates the role each of us has had to play. And with that, I'll turn it over to Brian.